Activities of Luisa REGIMENTI
Plenary speeches (22)
Fight against cancer (topical debate)
Macro-financial assistance to Jordan (debate)
Macro-financial assistance to Jordan (debate)
Coronavirus outbreak (debate)
Gender Equality Strategy (debate)
Preparation of an EU Strategy on COVID-19 vaccination, including its external dimension (debate)
EU global strategy on COVID-19 vaccinations (debate)
Challenges ahead for women’s rights: more than 25 years after the Beijing Declaration and Platform for Action (debate)
Programme for the Union’s action in the field of health for the period 2021-2027 (‘EU4Health programme’) (debate)
Justice programme 2021-2027 (continuation of debate)
Meeting the Global COVID-19 challenge: effects of waiver of the WTO TRIPS agreement on COVID-19 vaccines, treatment, equipment and increasing production and manufacturing capacity in developing countries (debate)
The impact of intimate partner violence and custody rights on women and children (debate)
The impact of intimate partner violence and custody rights on women and children (debate)
EU Health Emergency Preparedness and Response Authority: ensuring a coordinated EU approach for future health crises and the role of the European Parliament in this (debate)
A pharmaceutical strategy for Europe (debate)
The International Day of Elimination of Violence Against Women and the State of play on the ratification of the Istanbul Convention (continuation of debate)
Recent heat wave and drought in the EU (debate)
Better regulation: joining forces to make better laws (debate)
Prevention, management and better care of diabetes in the EU on the occasion of World Diabetes Day (debate)
Eliminating violence against Women (debate)
Establishing the Digital Decade Policy Programme 2030 (debate)
The EU priorities for the 67th session of the UN Commission on the Status of Women (debate)
Reports (2)
REPORT on the proposal for a decision of the European Parliament and of the Council providing further macro-financial assistance to the Hashemite Kingdom of Jordan
REPORT on the impact of intimate partner violence and custody rights on women and children
Shadow reports (4)
REPORT on the shortage of medicines – how to address an emerging problem
REPORT on intellectual property rights for the development of artificial intelligence technologies
REPORT on the proposal for a regulation of the European Parliament and of the Council on the establishment of a Programme for the Union's action in the field of health –for the period 2021-2027 and repealing Regulation (EU) No 282/2014 (“EU4Health Programme”)
REPORT on Better regulation: Joining forces to make better laws
Opinions (3)
OPINION on a pharmaceutical strategy for Europe
OPINION on Sustainable and Smart Mobility Strategy
OPINION on the new EU forest strategy for 2030 – sustainable forest management in Europe
Shadow opinions (6)
OPINION on A new EU-Africa Strategy - a partnership for sustainable and inclusive development
OPINION with recommendations to the Commission on corporate due diligence and corporate accountability
OPINION on the EU Gender Action Plan III
OPINION on the proposal for a regulation of the European Parliament and of the Council on Contestable and fair markets in the digital sector (Digital Markets Act)
OPINION on the proposal for a regulation of the European Parliament and of the Council on harmonised rules on fair access to and use of data (Data Act)
OPINION on the proposal for a directive of the European Parliament and of the Council Combating violence against women and domestic violence
Institutional motions (4)
MOTION FOR A RESOLUTION on the EU Pollinators Initiative
MOTION FOR A RESOLUTION on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society
MOTION FOR A RESOLUTION on the draft Commission regulation amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards lead in gunshot in or around wetlands
MOTION FOR A RESOLUTION Situation in Eastern Democratic Republic of Congo and the assassination of the Italian Ambassador Luca Attanasio and his entourage
Oral questions (4)
Digital transformation of health and care
EU pollinators initiative
Vaccination of children against COVID‑19 in the light of Article 2 of the Treaty on European Union
Putting forward an EU Strategy for Demography
Written explanations (1)
Farm to Fork Strategy (A9-0271/2021 - Anja Hazekamp, Herbert Dorfmann)
. – La relazione sulla strategia UE "Dal produttore al consumatore" ha lo scopo di indicare alla Commissione europea le posizioni rilevanti del Parlamento. La strategia nasce con l'obiettivo di migliorare la qualità della catena alimentare in Europa nel suo complesso e di rendere l'alimentazione più equilibrata e più sana, che condivido, ma il testo finale presenta alcuni elementi problematici per le nostre filiere agro-alimentari e che spero saranno attentamente valutati dalla Commissione. Esempi ne sono il sistema di etichettatura Nutrizionale uniforme obbligatorio, che rischia di stigmatizzare alimenti sani, come le eccellenze del "Made in Italy" o i prodotti a indicazione geografica protetta o con denominazione d'origine protetta, e danneggiare la dieta mediterranea, che è patrimonio culturale dell'umanità, oltre ad essere fuorviante per il consumatore. Ancora, la prescrizione di sanzioni per il mancato rispetto dell'obiettivo di ridurre le vendite di antimicrobici per gli animali d'allevamento del 50% entro il 2030, considerando che l'impatto di questo obiettivo non è stato ufficialmente valutato cumulativamente con gli altri obiettivi F2F e di biodiversità.Buona la relazione nel suo complesso, ma al momento dell'attuazione concreta e legislativa della strategia sarà necessario essere vigili per evitare gli effetti negativi menzionati nello studio del Joint Research Center, come l'aumento dei prezzi, i cali di produzione in Europa o la delocalizzazione di parte dell'agricoltura.
Written questions (83)
Israeli flags banned at the stadium
Uncontrolled proliferation of the brown marmorated stink bug (Halyomorpha halys) affecting crops in northern Italy
Requested deployment of emergency team and possible inspections in response to damage caused by brown marmorated stink bug (Halyomorpha Halys) in southern Italy
Use of European Solidarity Fund and bad weather in Piedmont
Swift mobilisation of the EUSF – damage caused by bad weather in Italy
Disastrous flooding in Venice: urgent EU action required through deployment of the European Solidarity Fund and special funds
Crisis in Lebanon and corruption
Damage caused by bad weather in Emilia-Romagna
Nutri-Score and food labelling schemes: Mediterranean diet and high-quality agri-food products at risk
Imposition of US trade tariffs in connection with the Airbus dispute
Possible spread within Europe of 2019-nCoV virus from China
Consultation of Parliament on future decisions concerning the multiannual plan for small pelagic fisheries in the Adriatic Sea
Foibe massacres – importance of European remembrance and the need to preserve it
EU commitment to remembering the Vajont disaster
Turkey’s decision not to stop Syrian refugees entering the EU
Suspension of flights to and from Italy following coronavirus cases
Amendments to the ESM system: Suspension of the ratification procedure
Shortages of medicines
European Union and transparency of Chinese information
Reshaping the EU-China relations framework
Revision of European food strategies in view of the COVID-19 emergency
Migrants landing in Sicily
Exponential increase in number of cases of ‘Kawasaki syndrome’
Need for a health protocol on the systematic prescription of swab tests and serological tests
‘Scientific lockdown’: COVID-19 autopsies
Fibromyalgia: need for research to improve access to diagnosis and treatment
Endometriosis: research under the new 2021-2027 health programme
Identification of asbestos-based inert waste storage sites
Exploitation of child labour in Pakistan
Abuses in collection of users’ personal data for coronavirus tracing in France
Imports of fake honey from China
Casimirri – the Italian terrorist hiding in Nicaragua
Migration flows in the Mediterranean and risks to public health
Need for specific measures to protect women who are victims of violence
European funding for the Wuhan Institute of Virology
Child exploitation in cobalt mines in the Democratic Republic of Congo
Italy’s pandemic plan – its updating and secrecy
Impact of the COVID-19 pandemic on the increase in suicides
The detention of Nasibe Semsai and Turkey’s migration policies towards totalitarian regimes
Closure of ski resorts
Call for action to deal with problems relating to the transport of live pigs within Europe
EU dependence on third country economies and the (medical) goods shortages arising from over-reliance on non-European production
Measures to prevent and combat the spread of the new variant of Sars-CoV-2
Combating the online sale within the EU of banned items that cause animal suffering
EU support for research into Restless Legs Syndrome
Measures to protect children on the internet
No obligation to be vaccinated and a ban on discrimination against people who do not wish to be vaccinated
Preventing cervical cancer
Need for a health protocol for visits by family members to very frail or dying patients in healthcare facilities in the EU
Access for the Republic of San Marino to the procurement mechanism for medicines and vaccines
Further restrictions on the free movement of commercial vehicles in transit through Austria and Germany
Protection of Italian balsamic vinegar label
COVID treatments and care in the home
EU COVID-19 risk management compensation fund
Unequal treatment of ITA compared to Lufthansa and Air France-KLM
Novavax vaccine negotiations and transparency
New post for Carles Esteva Mosso, in light of the sliding doors phenomenon
Fresh revelations concerning the updating of the Italian pandemic plan and the WHO report
Implementation of hepatitis C screening programmes in the EU
‘Anni 20’ programme on RAI 2
Sodium nitrite
EU’s position on Cuban repression
Need for medical aid in Afghanistan and EU humanitarian action
Commission inclusive communication guidelines
COVID-19: rising energy prices
Persecution of Christians in India and Myanmar
Agricultural prices and aggressive Chinese policies
Daphne Caruana Galizia and EU funds for Electrogas
Rules on activities incompatible with the profession of real estate brokers under Article 5(3) of Italian Law No 39/1989, as reformulated by Article 4(2) of Italian Law No 238 of 23 December 2021
War – economic measures in support of defence, families and businesses
Agricultural prices, ban on cereal exports by Hungary and the risk to European food security
War: high petrol prices and protecting the road transport sector
Extension of reporting with the N+3 mechanism
Erasmus4Ukraine
Increase under the de minimis rule for the agricultural sector
Waste emergency in Rome (Malagrotta)
Protection of passenger rights from the practice of overbooking
Protection of consumers purchasing package travel
EU emissions trading system: emergency mechanism and suspension
WHO resolution and damage to the wine industry in Europe
Current political and electoral situation in Bangladesh
Ireland’s plan to introduce warning labels on alcoholic drinks
Fresh threat of drought and risk of a water emergency in Europe
Individual motions (5)
MOTION FOR A RESOLUTION on the illegal foster care of children
MOTION FOR A RESOLUTION on Nutri-score and food labelling schemes
MOTION FOR A RESOLUTION on support for the Israel-Palestine Peace Plan
PROPOSTA DI RISOLUZIONE sullꞌemergenza relativa allꞌepidemia di 2019-nCoV
MOTION FOR A RESOLUTION on establishing a Europe-wide ‘Remembrance Day’ to commemorate the victims of the foibe massacres
Amendments (942)
Amendment 343 #
2022/0140(COD)
Proposal for a regulation
Recital 39 a (new)
Recital 39 a (new)
Amendment 346 #
2022/0140(COD)
Proposal for a regulation
Recital 40
Recital 40
(40) The data holders can be public, non for profit or private health or care providers, public, non for profit and private organisations, associations or other entities, public and private entities that carry out research with regards to the health sector that process the categories of health and health related data mentioned above. In order to avoid a disproportionate burden on small entities, micro-enterprises are excluded from the obligation to make their data available for secondary use in the framework of EHDS. The public or private entities often receive public funding, from national or Union funds to collect and process electronic health data for research, statistics (official or not) or other similar purposes, including in area where the collection of such data is fragmented of difficult, such as rare diseases, cancer etc. Such data, collected and processed by data holders with the support of Union or national public funding, should be made available by data holders to health data access bodies, in order to maximise the impact of the public investment and support research, innovation, patient safety or policy making benefitting the society. In some Member States, private entities, including private healthcare providers and professional associations, play a pivotal role in the health sector. The health data held by such providers should also be made available for secondary use. At the same time, data benefiting from specific legal protection such as intellectual property from medical device companies or pharmaceutical companies often enjoy copyright protection or similar types of protectionshall be granted the level of protection of confidential information mandated by Article 39(2) of the TRIPS Agreement and the Trade Secrets Directive (2016/943) with the protection of the main IP rights i.e. patents, SPCs, utility models, copyright, trademarks, database rights (as per Directive 96/9/EC), design rights, etc.. However, public authorities and regulators should have access to such data, for instance in the event of pandemics, to verify defective devices and protect human health. In times of severe public health concerns (for example, PIP breast implants fraud) it appeared very difficult for public authorities to get access to such data to understand the causes and knowledge of manufacturer concerning the defects of some devices. The COVID-19 pandemic also revealed the difficulty for policy makers to have access to health data and other data related to health. Such data should be made available for public and regulatory activities, supporting public bodies to carry out their legal mandate, while complying with, where relevant and possible, the protection enjoyed by commercial data. Specific rules in relation to the secondary use of health data should be provided. Data altruism activities may be carried out by different entities, in the context of Regulation […] [Data Governance Act COM/2020/767 final] and taking into account the specificities of the health sector.
Amendment 392 #
2022/0140(COD)
(49) Given the sensitivity of electronic health data, it is necessary to reduce risks on the privacy of natural persons by applying the data minimisation principle as set out in Article 5 (1), point (c) of Regulation (EU) 2016/679. Therefore, the use of anonymised electronic health data which is devoid of any personal data should be made availablethat ensures, to the maximum extent possible, by making use of state-of-the-art technologies, that a person cannot be reidentified, should be made available by the health data access bodies when possible and if the data user asks it. If the data user needs to use personal electronic health data, it should clearly indicate in its request the justification for the use of this type of data for the planned data processing activity. The personal electronic health data should only be made available in pseudonymised format and the encryption key can only be held by the health data access body. Data users should not attempt to re-identify natural persons from the dataset provided under this Regulation, subject to administrative or possible criminal penalties, where the national laws foresee this. However, this should not prevent, in cases where the results of a project carried out based on a data permit has a health benefit or impact to a concerned natural person (for instance, discovering treatments or risk factors to develop a certain disease), the data users would inform the health data access body, which in turn would inform the concerned natural person(s). Moreover, the applicant can request the health data access bodies to provide the answer to a data request, including in statistical form. In this case, the data users would not process health data and the health data access body would remain sole controller for the data necessary to provide the answer to the data request.
Amendment 784 #
2022/0140(COD)
Proposal for a regulation
Article 6 – paragraph 1 – introductory part
Article 6 – paragraph 1 – introductory part
1. The Commission shall, by means of implementing acts, lay down the technical specifications for the priority categories of personal electronic health data referred to in Article 5, setting out the European electronic health record exchange format, ensuring consistency with the technical specifications prevailing in the Member States. The format shall include the following elements:
Amendment 885 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 5
Article 10 – paragraph 5
5. In the performance of its tasks, the digital health authority shall actively cooperate with stakeholders’ representatives, including patients’ representatives. Members of the digital health authority shall avoid any conflicts of interest. Essential health stakeholders’ representatives on national level, including patient organisations, healthcare professionals and industry associations shall be present in the governance and decision-making structures of the digital health authority.
Amendment 948 #
2022/0140(COD)
Proposal for a regulation
Article 14 – paragraph 2
Article 14 – paragraph 2
2. This Chapter shall not apply to general software used in a healthcare environment. Manufacturers of EHR systems that also qualify as medical devices as defined under Article 2(1) of Regulation (EU) 2017/745 and claim interoperability of those medical devices with EHR systems under this Regulation shall prove compliance with the essential requirements for interoperability laid down in Section 2 of Annex II to this Regulation. Article 23 of this Regulation shall be applicable to those medical devices.
Amendment 1028 #
2022/0140(COD)
Proposal for a regulation
Article 23 – paragraph 1 – subparagraph 1
Article 23 – paragraph 1 – subparagraph 1
The Commission shall, by means of implementing acts, adopt common specifications in respect of the essential requirements set out in Annex II, including a common template document and a time limit for implementing those common specifications. Those common specifications shall be based on existing harmonised standards or international standards and shall be adopted only after consulting the European standardisation organisations as well as the relevant stakeholders. Where relevant, the common specifications shall take into account the specificities and verify compatibility with sectorial legislation and harmonized standards of medical devices and high risk AI systems referred to in paragraphs 3 and 4 of Article 14, including the state-of-the art standards for health informatics and the European electronic health record exchange format.
Amendment 1180 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 – point g
Article 33 – paragraph 1 – point g
(g) identification data related to health professionals involved in the treatment of a natural personresearch should be limited to data which is absolutely necessary;
Amendment 1187 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 – point j
Article 33 – paragraph 1 – point j
(j) electronic health data from clinical trialsfully completed clinical trials in accordance with definitions in Article 2(2) and Article 2(26) of Regulation (EU) No 536/2014;
Amendment 1211 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 a (new)
Article 33 – paragraph 1 a (new)
1 a. Data holders have the right to refuse access to the data referred to in par.1 for one of the following reasons: a) if there are legal or contractual impediments that prevent the data holder from sharing; b) if it could compromise the scientific integrity of a scientific research study, including a clinical trial; c) if it could compromise the protection of data entailing IP rights (including trade secrets) or commercial property, with the scope of each category of data to be further clarified;
Amendment 1231 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 4
Article 33 – paragraph 4
4. Electronic health data entailingWithout prejudice to the law relating to the protectedion of intellectual property and trade secrets from private enterprises shall be made available for secondary useindustrial property (including of trade secrets) (“IP rights”) and commercial property, electronic health data entailing protected IP rights from private enterprises shall be made available for secondary use. Data sharing should be based on a data sharing agreement persuant to Articles 46.6(g) and 46A between data holders and data users that respects the conditions of use listed in article 33(4a). Where such data is made available for secondary use, all measures necessary to preserve the confidentiality of IP rights and, including trade secrets, shall be taken in advance. The data holder shall identify the data which are protected as trade secrets. When no agreement is reached regarding the necessary measures to preserve the confidentiality of trade secrets or the recepient fails to implement those measures, the data holder is entitled to refuse the user’s access to data which are protected as trade secrets.
Amendment 1258 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 5
Article 33 – paragraph 5
5. Where the consent of the natural person is required by national law, health data access bodies shall rely on the obligations laid down in this Chapter to provide access to electronic health data.To the extent the electronic health data referred to in paragraph 1(a) includes personal data, the individual concerned shall be offered an additional safeguard in the form of a right to opt-out from the use of his personal data under Chapter IV of this regulation. The exercise of this right to opt-out shall not affect the lawfulness of the processing that took place under this Chapter IV before the individual opted-out
Amendment 1284 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 8 a (new)
Article 33 – paragraph 8 a (new)
8 a. Regarding the electronic health data referred to in paragraph 1(j) of this Article, a summary of results of the clinical trial shall be published, and individual patient data may be shared, in accordance with Article 37(4) of Regulation (EU) No 536/2014.
Amendment 1382 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point c
Article 35 – paragraph 1 – point c
(c) advertising or marketing activities towards health professionals, organisations in health or natural persons with the exception of communication in line with approved regulatory information or to provide up-to date, verifiable and complete scientific information to health care professionals for educational purpose in line with Directive 2001/83/EC;
Amendment 1398 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point e a (new)
Article 35 – paragraph 1 – point e a (new)
(e a) unfair commercial use or other unfair competition, in accordance with Article 39 of TRIPS; using data from private enterprises in regulatory or reimbursement submissions for any generic or biosimilar product without an agreement from the private sector data holder while the data holder’s referenced product is under patent or regulatory data protection (including such use of data outside of the EU), or equivalent protected data of nonmedicinal products such as medical devices and software medical devices
Amendment 1446 #
2022/0140(COD)
Proposal for a regulation
Article 36 – paragraph 3
Article 36 – paragraph 3
3. In the performance of their tasks, health data access bodies shall actively cooperate with stakeholders’ representatives, especially with representatives of patients, data holders and data users. Staff of health data access bodies shall avoid any conflicts of interest. Health data access bodies shall not be bound by any instructions, when making their decisions. Member States shall ensure that essential health stakeholders’ representatives, including patient organisations, healthcare professional and industry associations shall be present in the governance and decision-making structures of the health data access bodies.
Amendment 1481 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 1 – point g
Article 37 – paragraph 1 – point g
(g) gather and compile or provide access to the necessary electronic health data from the various data holders whose electronic health data fall within the scope of this Regulation, ensuring a secure sharing environment, and put those data at the disposal of data users in a secure processing environment in accordance with the requirements laid down in Article 50;
Amendment 1590 #
2022/0140(COD)
Proposal for a regulation
Article 39 – paragraph 1 – introductory part
Article 39 – paragraph 1 – introductory part
1. Each health data access body shall publish an annual activity report that shall include summary data only which shall contain at least the following:
Amendment 1598 #
2022/0140(COD)
Proposal for a regulation
Article 39 – paragraph 1 a (new)
Article 39 – paragraph 1 a (new)
1 a. Data holders should be consulted prior to any results or output of the secondary use being made publicly available to allow for vetting for any unauthorised disclosure related to the IP rights, trade secrets and confidential information of data holders.
Amendment 1789 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 1
Article 46 – paragraph 1
1. Health data access bodies shall assess if the application fulfils one of the purposes listed in Article 34(1) of this Regulation, if the requested data is necessary for the purpose listed in the application and if the requirements in this Chapter are fulfilled by the applicant. If that is the case, the health data access body shall issue a data permitand only after any data sharing agreement(s) on mutually agreed terms required by this Regulation, such as set out in Article 46a, are signed, the health data access body shall issue a data permit. However, any assessments by health data access bodies of an application concerning any data under Article 33(4) shall require the health data access bodies to consult the data holder(s).
Amendment 1809 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 2
Article 46 – paragraph 2
2. Health data access bodies shall refuse all applications including one or more purposes listed in Article 35 or where requirements in this Chapter are not met, including in the event a data holder permissibly refuses to give access to its data under Article 33(1).
Amendment 1815 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 3
Article 46 – paragraph 3
3. A health data access body shall issue or refuse a data permit within 2 months of receiving the data access application. By way of derogation from that Regulation […] [Data Governance Act COM/2020/767 final], the health data access body may extend the period for responding to a data access application by 2 additional months where necessary, taking into account the complexity of the request. In such cases, the health data access body shall notify the applicant as soon as possible that more time is needed for examining the application, together with the reasons for the delay. Where a health data access body fails to provide a decision within the time limit, the data permit shall be issued.
Amendment 1833 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 6 – point f a (new)
Article 46 – paragraph 6 – point f a (new)
(f a) when required, signed data sharing agreements, as set out in Article 46a;
Amendment 1836 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 7
Article 46 – paragraph 7
7. Data users shall have the right to access and process the electronic health data in accordance with the data permit delivered to them on the basis of this Regulation. Pursuant to Article 9)(1), point (j), of Regulation (EU)2016/679, where the permit allows data users to process personal electronic health data, data users shall have a right to process such data, subject to the safeguards and limitations set out in this Regulation and the permit.
Amendment 1847 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 11
Article 46 – paragraph 11
11. Data users shall make public the results or output (in accordance with the definition of results /outputs under Article 2) of the secondary use of electronic health data on a voluntary basis, including information relevant for the provision of healthcare and in compliance with minimum requirements of what needs to be published, but such that this will not prejudice the IP rights in the secondary use results/outputs, particularly if the secondary use is for development or innovation as referred to in Article 34(f), no later than 18 months after the completion of the electronic health data processing or after having received the answer to the data request referred to in Article 47with a possible extension to 24 months. Those results or output shall only contain anonymised data. The data user shall inform the health data access bodies from which a data permit was obtained and support them to make the information public on health data access bodies’ websites. Whenever the data users have used electronic health data in accordance with this Chapter, they shall acknowledge the electronic health data sources and the fact that electronic health data has been obtained in the context of the EHDS.
Amendment 1860 #
2022/0140(COD)
Proposal for a regulation
Article 46 a (new)
Article 46 a (new)
Amendment 1880 #
2022/0140(COD)
Proposal for a regulation
Article 48 – paragraph 1
Article 48 – paragraph 1
By derogation from Article 46 of this Regulation, a data permit shall not be required to access the electronic health data under this Article. Where electronic health data involving protected intellectual property and trade secrets are made available, it shall be ensured that all necessary measures are taken to protect the confidentiality of intellectual property rights and trade secrets. When carrying out those tasks under Article 37 (1), points (b) and (c), the health data access body shall inform public sector bodies and the Union institutions, offices, agencies and bodies, about the availability of data within 2 months of the data access application, in accordance with Article 9 of Regulation […...] [Data Governance Act COM/2020/767 final]. By way of derogation from that Regulation […...] [Data Governance Act COM/2020/767 final ], the health data access body may extend the period by 2 additional months where necessary, taking into account the complexity of the request. The health data access body shall make available the electronic health data to the data user within 2 months after receiving them from the data holders, unless it specifies that it will provide the data within a longer specified timeframe.
Amendment 1899 #
2022/0140(COD)
Proposal for a regulation
Article 50 – paragraph 1 – introductory part
Article 50 – paragraph 1 – introductory part
1. The health data access bodies shall provide access to electronic health data only through a secure processing environment, with technical and organisational measures and security and interoperability requirements and protection of intellectual property and trade secrets. In particular, they shall take the following security measures:
Amendment 1999 #
2022/0140(COD)
Proposal for a regulation
Article 61 – paragraph 1
Article 61 – paragraph 1
1. Non-personal electronic data made available by health data access bodies, that are based on a natural person’s electronic data falling within one of the categories of Article 33 [(a), (e), (f), (i), (j), (k), (m)] shall be deemed highly sensitive within the meaning of Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final], provided that their transfer to third countries presents a risk of re-identification through means going beyond those likely reasonably to be used, in view of the limited number of natural persons involved in that data, the fact that they are geographically scattered or the technological developments expected in the near future.
Amendment 2015 #
2022/0140(COD)
Proposal for a regulation
Article 63 – paragraph 1
Article 63 – paragraph 1
Amendment 301 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point b
Article 1 – paragraph 1 – point 3 – point b
Directive 2010/75/EU
Article 3 – paragraph 1 – point 12
Article 3 – paragraph 1 – point 12
(12) ‘BAT conclusions’ means a document containing the parts of a BAT reference document laying down the conclusions on: (a) best available techniques, their description, information to assess their applicability, the emission levels associated with the best available techniques, the environmental performance levels associated with the best available techniques, (b) the minimum content of an environmental management system including benchmarks associated with the best available techniques, (c) emission levels associated with emerging techniques, environmental performance levels associated with emerging techniques, (d) associated monitoring, associated consumption levels and, where appropriate, relevant site remediation measures;;
Amendment 312 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2010/75/EU
Article 3 – paragraph 1 – point 13 a
Article 3 – paragraph 1 – point 13 a
(13a) ‘environmental performance levels associated with the best available techniques’ means the range of environmental performance levels, except emission levels, obtained under normal operating conditions using a BAT or a combination of BATs, as described in BAT conclusions, expressed as an average over a given period of time, under specified reference conditions;.
Amendment 356 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point f
Article 1 – paragraph 1 – point 3 – point f
Directive 2010/75/EU
Article 3 – paragraph 1 – point 48
Article 3 – paragraph 1 – point 48
(48) ‘industrial minerals’ means minerals used in industry for the production of semi-finished or finished products, with the exception of metalliferous ores, energy minerals, and minerals used for the production of construction minaterials and precious stones;
Amendment 362 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point f
Article 1 – paragraph 1 – point 3 – point f
Directive 2010/75/EU
Article 3 – paragraph 1 – point 50
Article 3 – paragraph 1 – point 50
(50) ‘emission levels associated with emerging techniques’ means the expected range of emission levels obtained under normal operating conditions using an emerging technique or a combination of emerging techniques, as described in BAT conclusions, expressed as an average over a given period of time, under specified reference conditions;
Amendment 369 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point f
Article 1 – paragraph 1 – point 3 – point f
Directive 2010/75/EU
Article 3 – paragraph 1 – point 51
Article 3 – paragraph 1 – point 51
(51) ‘environmental performance levels associated with emerging techniques’ means the expected range of environmental performance levels, except emission levels, obtained under normal operating conditions using an emerging technique or a combination of emerging techniques, as described in BAT conclusions, expressed as an average over a given period of time, under specified reference conditions;
Amendment 385 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point f
Article 1 – paragraph 1 – point 3 – point f
Directive 2010/75/EU
Article 3 – paragraph 1 – point 53 – introductory part
Article 3 – paragraph 1 – point 53 – introductory part
(53) ‘‘benchmarks’ means the indicative range of environmental performance levels, which are under the control of the operator, associated with best available techniques, other than emission levels, and may include:
Amendment 400 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point f
Article 1 – paragraph 1 – point 3 – point f
Directive 2010/75/EU
Article 3 – paragraph 1 – point f
Article 3 – paragraph 1 – point f
(f) other levels as described in BAT conclusions, expressed as an average over a given period of time, obtained under specified reference conditions, obtained under specified reference conditions.
Amendment 407 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point f
Article 1 – paragraph 1 – point 3 – point f
Directive 2010/75/EU
Article 3 – paragraph 1 – point 53 a (new)
Article 3 – paragraph 1 – point 53 a (new)
In Article 3, paragraph 1, point 53a (new) is inserted (53a) ‘Li-ion cell’ means the basic functional unit in a battery with Li-ions as charge carrier, constituted by electrodes, electrolyte, container, terminals and, if applicable, separators and containing the active materials the reaction of which generates electrical energy;
Amendment 500 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive 2010/75/EU
Article 9 – paragraph 2
Article 9 – paragraph 2
Amendment 504 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive 2010/75/EU
Article 9 – paragraph 2 a (new)
Article 9 – paragraph 2 a (new)
(7) In Article 9, paragraph 2a (new) is added: 2a. For activities listed in Annex I to Directive 2003/87/EC, Member States may choose not to impose requirements relating to energy efficiency in respect of combustion units or other units emitting carbon dioxide on the site in case installations are covered by the obligation to conduct an energy audit or implement an energy management system pursuant to Article 8 of Directive 2012/27/EU or the operator implements equivalent measures.
Amendment 529 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 8
Article 1 – paragraph 1 – point 8
Directive 2010/75/EU
Article 11 – paragraph 1 – point f b
Article 11 – paragraph 1 – point f b
Amendment 536 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 8
Article 1 – paragraph 1 – point 8
Directive 2010/75/EU
Article 11 – paragraph 1 – point f c
Article 11 – paragraph 1 – point f c
Amendment 569 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9 – point a
Article 1 – paragraph 1 – point 9 – point a
Dir. 2010/75/EU
Article 13 – paragraph 1
Article 13 – paragraph 1
1. In order to draw up, review and, where necessary, update BAT reference documents, the Commission shall organise an exchange of information between Member States, the industries concerned, non-governmental organisations promoting environmental protection, the European Chemicals Agency and the Commission. The European Chemicals Agency will act as an observer of the process only providing scientific technical input for updating documents and will not have a role in the decision making process’.
Amendment 644 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 10 – point a – point i
Article 1 – paragraph 1 – point 10 – point a – point i
Directive 2010/75/EU
Article 14 – paragraph 1 – subparagraph 1
Article 14 – paragraph 1 – subparagraph 1
Member States shall ensure that the permit includes all measures necessary to comply with the requirements of Articles 11 and 18. To that effect, Member States shall ensure that permits are granted further to consultation of all relevant authorities who ensure compliance with Union environmental legislation, including with environmental quality standards.;.
Amendment 699 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Directive 2010/75/EU
Article 14a
Article 14a
Amendment 796 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12
Article 1 – paragraph 1 – point 12
Dir. 2010/75/EU
Article 15 – paragraph 3 – subparagraph 1 – introductory part
Article 15 – paragraph 3 – subparagraph 1 – introductory part
Amendment 826 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12
Article 1 – paragraph 1 – point 12
Dir. 2010/75/EU
Article 15 – paragraph 3 a
Article 15 – paragraph 3 a
Amendment 861 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12
Article 1 – paragraph 1 – point 12
Directive 2010/75/EU
Article 15 – paragraph 4 – subparagraph 1 – point b a (new)
Article 15 – paragraph 4 – subparagraph 1 – point b a (new)
(ba) investment cycle related to the sustainability transition of the operator’s group.
Amendment 879 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12
Article 1 – paragraph 1 – point 12
Directive 2010/75/EU
Article 15 – paragraph 4 – subparagraph 4
Article 15 – paragraph 4 – subparagraph 4
Derogations referred to in this paragraph shall respect the principles set out in Annex II. The competent authority shall in any case ensure that no significant pollution is caused and that a high level of protection of the environment as a whole is achieved. Derogations shall not be granted where they mayin case it is proven that the specific contribution of the installation puts at risk compliance with environmental quality standards referred to in Article 18.
Amendment 893 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12
Article 1 – paragraph 1 – point 12
Dir. 2010/75/EU
Article 15 – paragraph 4 – subparagraph 6
Article 15 – paragraph 4 – subparagraph 6
The Commission shall adopt an implementing act, to establish a standardised methodology for assessing the disproportionality between the costs of implementation of the BAT conclusions and the potential environmental benefits referred to in the first subparagraph and considering the investment cycle related to the sustainability transition of the operator's group . That implementing act shall be adopted in accordance with the examination procedure referred to in Article 75(2).
Amendment 901 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12
Article 1 – paragraph 1 – point 12
Dir. 2010/75/EU
Article 15 – paragraph 4 a (new)
Article 15 – paragraph 4 a (new)
4a. By way of derogation from paragraph 3, the competent authority may, in cases where an installation faces a sudden interruption in the supply of raw materials or fuels or a disruption of abatement technique’s elements, establish less strict emission limit values, for a maximum of 3 months, which may be extended when the extraordinary circumstances persist, subject to a simplified assessment justifying the reasons and period for this temporary adjustment. Member States shall inform the Commission of any derogation granted under these circumstances. As soon as the supply conditions are restored then the derogation will no longer be valid. However, if the same circumstances keep prevailing, the adjustment of the emission limit values may be prolonged for another period of 6months.
Amendment 939 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 15
Article 1 – paragraph 1 – point 15
Directive 2010/75/EU
Article 18 – paragraph 1
Article 18 – paragraph 1
Where an environmental quality standard requires stricter conditions than those achievable by the use of the best available techniques, additional measures shall be included in the permit with a view to reducing the specific contribution of the installation to the pollution occurring in the relevant area. without prejudice to other measures which may be taken to comply with environmental quality standards
Amendment 966 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 16
Article 1 – paragraph 1 – point 16
Directive 2010/75/EU
Article 21 – paragraph 5 – point c
Article 21 – paragraph 5 – point c
(c) where it is necessary to comply with an environmental quality standard referred to in Article 18 and the specific contribution of the installation is proven, including in the case of a new or revised quality standard or where the status of the receiving environment requires a revision of the permit in order to achieve compliance with plans and programmes set under Union legislation.
Amendment 1035 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 21
Article 1 – paragraph 1 – point 21
Directive 2010/75/EU
Article 27 – paragraph 1
Article 27 – paragraph 1
Member States shall, where appropriate, encourage the development and application of emerging techniques, in particular where such techniques have been identified inby the BAT conclusions, the BAT reference documents or the findings of the innovation centre for industrial transformation and emissions referred to in Article 27ainnovation centre for industrial transformation and emissions (‘INCITE’) referred to in Article 27a and included in the BAT reference documents. Member States may, where appropriate, encourage the application of emerging techniques where such techniques have been identified in the BAT conclusions.
Amendment 1051 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22
Article 1 – paragraph 1 – point 22
Without prejudice to Article 18, the competent authority may grant temporary derogations from the requirements set out in Article 15(2) and (3) and from the principles set out in Article 11, points (a) and (b), for the testing of emerging techniquesinnovative techniques, including emerging techniques identified by the innovation centre for industrial transformation and emissions (‘INCITE’) referred to in Article 27a for a total period of time not exceeding 2436 months, subjected to extension depending on the Technology Readiness Levels of the specific technique.
Amendment 1068 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22
Article 1 – paragraph 1 – point 22
Directive 2010/75/EU
Article 27 c – paragraph 1
Article 27 c – paragraph 1
By way of derogation from Article 21(3), the competent authority may set indicative emission limit values that ensure that, within 6 years of publication of a decision on BAT conclusions in accordance with Article 13(5) relating to the main activity of an installation, emissions shall not, under normal operating conditions, exceed emissioncomply with the indicative levels associated with emerging techniques as laid down in the decisions on BAT conclusions.
Amendment 1072 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22
Article 1 – paragraph 1 – point 22
Directive 2010/75/EU
Article 27 d – number
Article 27 d – number
Amendment 1080 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22
Article 1 – paragraph 1 – point 22
Amendment 1084 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22
Article 1 – paragraph 1 – point 22
Directive 2010/75/EU
Article 27 d – paragraph 1
Article 27 d – paragraph 1
Amendment 1127 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22
Article 1 – paragraph 1 – point 22
Directive 2010/75/EU
Article 27 d – paragraph 2
Article 27 d – paragraph 2
Amendment 1152 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22
Article 1 – paragraph 1 – point 22
Directive 2010/75/EU
Article 27 d – paragraph 3
Article 27 d – paragraph 3
Amendment 1171 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22
Article 1 – paragraph 1 – point 22
Directive 2010/75/EU
Article 27 d – paragraph 4
Article 27 d – paragraph 4
Amendment 1454 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 27
Article 1 – paragraph 1 – point 27
Directive 2010/75/EU
Article 74 – paragraph 2
Article 74 – paragraph 2
Amendment 1492 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 31
Article 1 – paragraph 1 – point 31
Directive 2010/75/EU
Article 79 – paragraph 1
Article 79 – paragraph 1
1. Without prejudice to the obligations of Member States under Directive 2008/99/EC of the European Parliament and of the Council of 19 November 2008 on the protection of the environment through criminal law, Member States shall lay down rules on penalties applicable to violations of national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are applied. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall without delay notify the Commission of those rules and of those provisions, and shall notify without delay any subsequent amendment affecting them. Member States shall ensure that any criminal and administrative sanctions respect the provisions of the Charter of Fundamental Rights of the European Union, including but not limited to the ne bis in idem principle and the proportionality principle. Member States shall ensure that any criminal sanctions are imposed only if culpability of the person responsible for the violation has been established.
Amendment 1499 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 31
Article 1 – paragraph 1 – point 31
Directive 2010/75/EU
Article 79 – paragraph 2
Article 79 – paragraph 2
2. The penalties referred to in paragraph 1 shall include fines proportionate to the naturnover of the legal person or to the income of the natural person having committed the infringemente and severity of the violation concerned, and not exceed the level necessary for fines to be effective and dissuasive. The level of the fines shall be calculated in such a way as to make sure that they effectively deprive the person responsible for the violation of the economic benefits derived from that violation. The level of the fines shall be gradually increased for repeated infringements. In the case of a violation committed by a legal person, the maximum amount of such fines shall be at least 8 % of the operator’s annual turnover in the Member State concerned of the same nature.
Amendment 1584 #
2022/0104(COD)
Proposal for a directive
Article 3 a (new)
Article 3 a (new)
Article 3 a Transitional provisions 1. In relation to installations carrying out activities referred to in Annex I, points 1.1, to 1.3, point 1.4 (except pyrolysis), point 2.1, point 2.2, point 2.3(a), point 2.3(b), point 2.3(c), points 2.4 to 2.6, points 3.1 to 3.5, points 4.1 to 4.6, point 5.1 to 5.6, point 5.3 (except anaerobic digestion), points 5.4 to 5.6, point 6.1, point 6.2 (except finishing of textile fibres), point 6.3, point 6.4, point 6.5 (except animal by products), point 6.7 which are in operation and hold a permit before [OP please insert the date = the first day of the month following 18 months after the date of entry into force of this Directive] or the operators of which have submitted a complete application for a permit before that date, provided that those installations are put into operation no later than [one year after the first day of the month following 18 months after the date of entry into force of this Directive], Member States shall apply the laws, regulations and administrative laws, regulations and administrative provisions adopted in accordance with Article 3(1) of the recast of Directive 2010/75/EU from [one year after the first day of the month following 18 months after the date of entry into force of this Directive]. 2. In relation to installations carrying out activities referred to in Annex I, point 1.4 for activities concerning pyrolysis, points 2.3(aa), point 2.3(ab), point 2.3 (bb), point 2.7, point 3.6, point 5.3 for activities concerning anaerobic digestion, point 6.2 for activities concerning finishing of textile fibres and point 6.5 for activities concerning animal by-products which are in operation before [OP please insert the date = the first day of the month following 18 months after the date of entry into force of this Directive], Member States shall apply the laws, regulations and administrative provisions adopted in accordance with this Directive from [two years after the first day of the month following 18 months after the date of entry into force of this Directive].
Amendment 1595 #
2022/0104(COD)
Proposal for a directive
Annex I – paragraph 1 – point b
Annex I – paragraph 1 – point b
Directive 2010/75/EU
Annex I – paragraph 3 – subparagraph 2 – point 2.3 – point a a
Annex I – paragraph 3 – subparagraph 2 – point 2.3 – point a a
Amendment 1600 #
2022/0104(COD)
Proposal for a directive
Annex I – paragraph 1 – point b
Annex I – paragraph 1 – point b
Directive 2010/75/EU
Annex I – paragraph 1 – subparagraph 2 – point 2.3 – point a b
Annex I – paragraph 1 – subparagraph 2 – point 2.3 – point a b
Amendment 1605 #
2022/0104(COD)
Proposal for a directive
Annex I – paragraph 1 – point b
Annex I – paragraph 1 – point b
Directive 2010/75/EU
Annex I – paragraph 1 – subparagraph 2 – point 2.3 – point b
Annex I – paragraph 1 – subparagraph 2 – point 2.3 – point b
(b) operation of smitheries with hammers the energy of which exceeds 250 kilojoule per hammer;
Amendment 1609 #
2022/0104(COD)
Proposal for a directive
Annex I – paragraph 1 – point b
Annex I – paragraph 1 – point b
Directive 2010/75/EU
Annex I – paragraph 1 – subparagraph 2 – point 2.3 – point b a
Annex I – paragraph 1 – subparagraph 2 – point 2.3 – point b a
Amendment 1613 #
2022/0104(COD)
Proposal for a directive
Annex I – paragraph 1 – point c
Annex I – paragraph 1 – point c
Directive 2010/75/EU
Annex I – paragraph 3 – subparagraph 2 – point 2.7
Annex I – paragraph 3 – subparagraph 2 – point 2.7
2.7. Manufacture of lithium-ion batteriecells (inexcluding assembling of battery cellmodules and battery packs), with a production capacity of 3,5exceeding 10 GWh or more per year;
Amendment 159 #
2022/0095(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) Chemical safety is a recognised element of product sustainability. It is based on chemicals’ intrinsic hazards to health or the environment in combination with specific or generic exposure, and is addressed by chemicals legislation, such as Regulation (EC) No 1935/2004 of the European Parliament and of the Council58 , Regulation (EC) No 1907/2006 of the European Parliament and of the Council59 , Regulation (EC) No 1223/2009 of the European Parliament and of the Council60 , Regulation (EU) 2017/745 of the European Parliament and of the Council61 and Directive 2009/48/EC of the European Parliament and of the Council62 . This Regulation shouldall not enable the restriction of substances based on chemical safety, as done under other Union legislation. Similarly, this Regulation should not enable the restriction of substances for reasons related to food safety. Union law on chemicals and food, however, does not allow addressing, through restrictions on certain substances, impacts on sustainability that are unrelated to chemical safety or food safety. To overcome this limitation, this Regulation should allow, under certain conditions, for the restriction, primarily for reasons other than chemical or food safety, of substances present in products or used in their manufacturing processes which negatively affect products’ sustainability. This Regulation also should not result in the duplication or replacement of restrictions of substances covered by other legislations, including Directive 2011/65/EU of the European Parliament and of the Council63 , which has as its objective the protection of human health and the environment, including the environmentally sound recovery and disposal of waste from electrical and electronic equipment __________________ 58 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4). 59 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1). 60 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59). 61 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176). 62 Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1). 63 Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88).
Amendment 180 #
2022/0095(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) Information on the presence of substances of concern in products is a key element to identify and promote products that are sustainable. The chemical composition of products determines largely their functionalities and impacts, as well as the possibilities for their re-use or for recovery once they become waste. The Chemicals Strategy for Sustainability64 calls for minimising the presence of substances of concern in products, and ensuring the availability of information on chemical content and safe use, by introducing information requirements and tracking the presence of substances of concern throughout the life cycle of materials and products. Regulation (EC) No 1272/2008 of the European Parliament and of the Council65 and other existing chemicals legislation such as Regulation (EC) No 1223/2009 already ensure communication on hazards to health or the environment posed by certain substances of concern on their own or in a mixture. Users of substances and mixtures should also be informed about pertinent sustainability- related information not primarily related to hazards to health or the environment. Furthermore, users of products other than substances or mixtures, and managers of waste from such products, should also receive sustainability-related information, including information primarily related to chemicals’ hazards to health or the environment. Therefore, this Regulation should allow for the setting of requirements related to the tracking and communication of sustainability information, including the presence of relevant substances of concern in products throughout their life cycle, including with a view to their decontamination and recovery when they become waste. Such a framework should aim to progressively cover all substances of concern in all products listed in working plans setting out the product groups the Commission intends to tacklInformation requirements should only require actors to deliver data once. __________________ 64 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions Chemicals Strategy for Sustainability Towards a Toxic-Free Environment COM(2020)667 final. 65 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
Amendment 259 #
2022/0095(COD)
Proposal for a regulation
Recital 105 a (new)
Recital 105 a (new)
(105a) Business Models, such as Product- as-a-Service, have a high potential of circularity. Instead, the ownership remains with the business and the need to buy new products is a business cost. Policy and economic incentives are necessary to scale up these business models. Therefore, when establishing ecodesign requirements related to the product aspects listed in Article 5, the European Commission shall consider the potential of a product to be placed on the EU market under Product-as-a-Service business models.
Amendment 272 #
2022/0095(COD)
Proposal for a regulation
Article 1 – paragraph 1 – subparagraph 1 – point f
Article 1 – paragraph 1 – subparagraph 1 – point f
(f) recycled content in products and recyclability of products;
Amendment 274 #
2022/0095(COD)
Proposal for a regulation
Article 1 – paragraph 1 – subparagraph 1 – point g
Article 1 – paragraph 1 – subparagraph 1 – point g
(g) product remanufacturing and recycling;
Amendment 294 #
2022/0095(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point g a (new)
Article 1 – paragraph 2 – point g a (new)
(ga) energy carriers according to Directive (UE) 2018/2001 and Directive 2009/30/EC.
Amendment 334 #
2022/0095(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 23
Article 2 – paragraph 1 – point 23
(23) ‘environmental footprint’ means a quantification of a product’s environmental impacts, whether in relation to a single environmental impact category or an aggregated set of impact categories based on the Product Environmental Footprint method and relevant Product Environmental Footprint Category Rules (PEFCRs), or other scientifically validated standards ensuring accuracy and reliability according to the future Green Claims framework legislation;
Amendment 350 #
2022/0095(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 28 – introductory part
Article 2 – paragraph 1 – point 28 – introductory part
(28) ‘substance of concern’ means a substance that is both present in the product as placed on the market and in practice impedes the re-use and recycling of materials in that product. A substance can be of concern only if it:
Amendment 361 #
2022/0095(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 28 – point b – indent 6
Article 2 – paragraph 1 – point 28 – point b – indent 6
— chronic hazard to the aquatic environment categories 1 to 42,
Amendment 362 #
2022/0095(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 28 – point b – indent 8
Article 2 – paragraph 1 – point 28 – point b – indent 8
— specific target organ toxicity – repeated exposure categories 1 and 2, and
Amendment 364 #
2022/0095(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 28 – point b – indent 9
Article 2 – paragraph 1 – point 28 – point b – indent 9
Amendment 381 #
2022/0095(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 28 – point c
Article 2 – paragraph 1 – point 28 – point c
(c) negatively affectsthe evaluation on an ongoing basis of the state-of-the-art recycling techniques and waste collection systems, has confirmed that the substance continues to impede the re-use and recycling of materials in the product in which it is present;
Amendment 511 #
2022/0095(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point g
Article 5 – paragraph 1 – point g
(g) presence of substances of concern which negatively affect product’s sustainability;
Amendment 521 #
2022/0095(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point j
Article 5 – paragraph 1 – point j
(j) recycled content and recyclability;
Amendment 523 #
2022/0095(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point j a (new)
Article 5 – paragraph 1 – point j a (new)
(ja) renewability of raw material content;
Amendment 569 #
2022/0095(COD)
Proposal for a regulation
Article 5 – paragraph 4 – point a – point ii
Article 5 – paragraph 4 – point a – point ii
(ii) relevant Union legislation, including the extent to which it addresses the relevant product aspects listed in paragraph 1, to ensure harmonisation and assure the avoidance of double regulation or over-regulation;
Amendment 580 #
2022/0095(COD)
Proposal for a regulation
Article 5 – paragraph 4 – point a – point v a (new)
Article 5 – paragraph 4 – point a – point v a (new)
(va) appropriate consultations, including at expert level.
Amendment 589 #
2022/0095(COD)
Proposal for a regulation
Article 5 – paragraph 4 – point c
Article 5 – paragraph 4 – point c
(c) take into consideration relevant technical information used as a basis for or derived from Union legislation or instruments, including Regulation (EC) No 66/2010, Directive 2010/75/EU, technical screening criteria adopted pursuant to Regulation (EU) 2020/852 and green public procurement criteria;
Amendment 637 #
2022/0095(COD)
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. Performance requirements based on the product parameter set out in Annex I, point (f), shall not restrict the presence of substances in products for reasons relating primarily to chemical safety. When the reason relates to chemical safety, the Commission shall initiate, where appropriate, the procedures referred to in Regulation (EC) No 1907/2006.
Amendment 661 #
2022/0095(COD)
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
3. Information requirements based on the product parameter set out in Annex I, point (f), shall not provide obligations on the labelling of substances or mixtures for reasons relating primarily to their hazards to health or the environment. When the reason relates to chemical safety, the Commission shall initiate, where appropriate, the procedures referred to in Regulation (EC) No 1907/2006.
Amendment 664 #
2022/0095(COD)
Proposal for a regulation
Article 7 – paragraph 5 – subparagraph 1 – introductory part
Article 7 – paragraph 5 – subparagraph 1 – introductory part
The information requirements referred to in paragraph 1 shall enable throughout the life cycle of products the tracking of allrelevant substances of concern throughout the life cycle of products, unless such tracking is already enabled by anotherremaining in the product as placed in the market and negatively impacting its sustainability, according to a threshold-based approach equal to or higher than those already set out in the relevant reference legislation on chemicals and products and covered by delegated acts adopted pursuant to Article 4 covering the products concerned, and shall include at least the following:
Amendment 686 #
2022/0095(COD)
Proposal for a regulation
Article 7 – paragraph 5 – subparagraph 1 – point b
Article 7 – paragraph 5 – subparagraph 1 – point b
(b) where relevant, the location of the substances of concern within the product;
Amendment 691 #
2022/0095(COD)
Proposal for a regulation
Article 7 – paragraph 5 – subparagraph 1 – point d
Article 7 – paragraph 5 – subparagraph 1 – point d
Amendment 698 #
2022/0095(COD)
Proposal for a regulation
Article 7 – paragraph 5 – subparagraph 2 – point a
Article 7 – paragraph 5 – subparagraph 2 – point a
(a) establish which substances fall under the definition in Article 2(28), point (c),and are relevant for the purposes of the product groups covered; this relevance evaluation should be based on horizontal criteria developed in dialogue with stakeholders;
Amendment 703 #
2022/0095(COD)
Proposal for a regulation
Article 7 – paragraph 5 – subparagraph 2 – point b
Article 7 – paragraph 5 – subparagraph 2 – point b
(b) lay down deadlines for the entry into application of the information requirements, in a step-by-step process, referred to in the first subparagraph, with possible differentiation between substances; and. Substances of concern should be selected and reported based on science- based evidence, technical feasibility, direct relevance to circularity for the specific product group, and the need to protect confidential business information and in other duly justified cases. Substances of concern falling under the definition in Article 2(28), point (a), shall not be exempted from the information requirement referred to in the first subparagraph if they are present in the relevant products, or spare parts in a concentration above 0,1% weight by weight.
Amendment 707 #
2022/0095(COD)
Proposal for a regulation
Article 7 – paragraph 5 – subparagraph 2 – point c
Article 7 – paragraph 5 – subparagraph 2 – point c
Amendment 780 #
2022/0095(COD)
Proposal for a regulation
Article 8 – paragraph 3 – point a
Article 8 – paragraph 3 – point a
(a) ensure that actors along the value chain, in particular consumers, economic operators and competent national authorities, can access product information relevabe justified to significantly improve the environmental sustainability of products and to ensure free movement toin them internal market;
Amendment 789 #
2022/0095(COD)
Proposal for a regulation
Article 8 – paragraph 3 – point b
Article 8 – paragraph 3 – point b
(b) facilitate the verification of product compliance by competent national authorities; andensure that actors along the value chain, in particular consumers, economic operators and competent national authorities, can access product information relevant to them according to a need-to-know basis approach and to the product groups covered;
Amendment 790 #
2022/0095(COD)
Proposal for a regulation
Article 8 – paragraph 3 – point c
Article 8 – paragraph 3 – point c
(c) improve traceability of products along the value chain.facilitate the verification of product compliance by competent national authorities; and
Amendment 793 #
2022/0095(COD)
Proposal for a regulation
Article 8 – paragraph 3 – point c a (new)
Article 8 – paragraph 3 – point c a (new)
(ca) improve traceability of products along the value chain without compromising data security of economical actors. To protect confidential business information and comply with requirement (b) of paragraph 3, actors in the value chains should make a specific request to the manufacturer when the information cannot be shared publicly, and the information needs to be shared in a secure way.
Amendment 828 #
2022/0095(COD)
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1 – point f a (new)
Article 9 – paragraph 1 – subparagraph 1 – point f a (new)
(fa) The system shall ensure the protection of value chain operators’ confidential information.
Amendment 833 #
2022/0095(COD)
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. The economic operator placing the product on the market shall provide dealers with a digital copy ofproduct identifier, related to the data carrier to allow the dealer to make it accessible to customers the relevant information of the DPP where they cannot physically access the product. The economic operator shall provide that digital copyidentifier free of charge and within 5 working days of the dealer’s request.
Amendment 851 #
2022/0095(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point f
Article 10 – paragraph 1 – point f
(f) the rights to access and to introduce, modify or update information in product passport shall be restricted based on the access rights specified in delegated acts adopted pursuant to Article 4, with specific consideration of information that constitutes trade secrets or proprietary;
Amendment 900 #
2022/0095(COD)
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
The Commission shall ensure that when it conducts its activities, it observes a balanced participation of Member States’ representatives and all interested parties involved with the product or product group in question, such as industrya broad representation of industry across their value chains (especially those that are in the scope of the working plan mentioned in Art. 16-2), including SMEs and, craft industry, trade unions, traders, retailers, importers, environmental protection groups and consumer organisations. These parties shall contribute in particular to preparing ecodesign requirements, examining the effectiveness of the established market surveillance mechanisms and assessing self-regulation measures. To that end, the Commission shall establish an expert group, in which those parties shall meet, referred to as the ‘Ecodesign Forum’. The Forum shall advise the Commission on the delegated acts referred to in Article 4. The Forum shall carry out its tasks in accordance with the principle of transparency. The Commission shall publish the minutes of the meetings of the Forum and other relevant documents on the Commission website.
Amendment 959 #
2022/0095(COD)
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1 – introductory part
Article 20 – paragraph 1 – subparagraph 1 – introductory part
An economic operator that discards unsold consumer products directly, or on behalf of another economic operator, shall disclosemake available, upon request of competent national authorities and the European Commission, the following information:
Amendment 965 #
2022/0095(COD)
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1 – point a
Article 20 – paragraph 1 – subparagraph 1 – point a
(a) the numberamount in weight (tons) of unsold consumer products discarded per year, differentiated per type or category of products;
Amendment 973 #
2022/0095(COD)
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1 – point b
Article 20 – paragraph 1 – subparagraph 1 – point b
(b) the reasons for the discarding of products;, including but not limited to whether products are discarded due to:
Amendment 974 #
2022/0095(COD)
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1 – point b a (new)
Article 20 – paragraph 1 – subparagraph 1 – point b a (new)
(ba) health and safety concerns, including of counterfeit goods;
Amendment 975 #
2022/0095(COD)
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1 – point b b (new)
Article 20 – paragraph 1 – subparagraph 1 – point b b (new)
(bb) damage to products as a result of their handling or detected after a product has been returned by a consumer;
Amendment 976 #
2022/0095(COD)
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1 – point b c (new)
Article 20 – paragraph 1 – subparagraph 1 – point b c (new)
(bc) fitness of the product for the purpose for which it is intended, taking into account, where applicable, Union and national law and technical standards;
Amendment 977 #
2022/0095(COD)
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1 – point b d (new)
Article 20 – paragraph 1 – subparagraph 1 – point b d (new)
(bd) refusal of products for donation, preparing for re-use or remanufacturing;
Amendment 986 #
2022/0095(COD)
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 2
Article 20 – paragraph 1 – subparagraph 2
The economic operator shall disclose that information on a freely accessible website or otherwise make it publicly available,provide the competent national authority with that information until a delegated act adopted pursuant to paragraph 3 starts applying to the category of unsold consumer products discarded by the operator in question.
Amendment 153 #
2022/0089(COD)
Proposal for a regulation
Article 17 – paragraph 5
Article 17 – paragraph 5
5. The Commission shall be empowered to adopt delegated acts in accordance with Article 84 supplementing this Regulation by ruleentrust EUIPO with the purly administrative tasks onf entrusting EUIPO with the tasks set out in this Articlexamining applications for registration.
Amendment 184 #
2022/0089(COD)
Proposal for a regulation
Article 19 – paragraph 10
Article 19 – paragraph 10
10. The Commission shall be empowered to adopt delegated acts, in accordance with Article 84 supplementing this Regulation by detailed procedures and deadlines for the opposition procedure, for the official submission of comments by national authorities and persons with a legitimate interest, which will not trigger the opposition procedure and by rules on entrusting its tasks set out in this Article to EUIPO. The Commission is empowered to entrust EUIPO with the purely administrative tasks of the Union opposition procedure.
Amendment 222 #
2022/0089(COD)
Proposal for a regulation
Article 23 – paragraph 7
Article 23 – paragraph 7
7. The Commission shall be empowered to adopt delegated acts in accordance with Article 84 supplementing this Regulation by rules on entrusting EUIPO to operate the Union register of geographical indications.
Amendment 229 #
2022/0089(COD)
Proposal for a regulation
Article 25 – paragraph 1
Article 25 – paragraph 1
1. A producer group having a legitimate interest may apply for the approval of an amendment to the product specification of a registeredrecognised producer group may apply for the approval of an amendment to the product specification of a registered geographical indication. Where such a group does not exist, a producer group having a legitimate interest or, in exceptional and duly justified cases, any an individual producer which is the only producer of the geographical indication may submit an application to amend a product specification. Producers may only submit an application to amend the specification for the geographical indication product they produce.
Amendment 265 #
2022/0089(COD)
10. The Commission shall be empowered to adopt delegated acts in accordance with Article 84 supplementing this Regulation by provisions entrustingentrust EUIPO with the publication of standthe ordinardy amendments referred to in paragraph (9).
Amendment 286 #
2022/0089(COD)
Proposal for a regulation
Article 26 – paragraph 6
Article 26 – paragraph 6
6. The Commission shall be empowered to adopt delegated acts in accordance with Article 84 supplementing this Regulation by rules entrustdefining EUIPO with the tasks set out in paragraph (5)'s administrative tasks.
Amendment 296 #
2022/0089(COD)
Proposal for a regulation
Article 27 – paragraph 1 a (new)
Article 27 – paragraph 1 a (new)
1 a. Where a designation of origin or a geographical indication is registered under this Regulation, the application for registration of a traditional term the use of which would contravene Article 103(2) shall be refused.
Amendment 393 #
2022/0089(COD)
Proposal for a regulation
Article 46 – paragraph 1
Article 46 – paragraph 1
The Commission shall be empowered to adopt delegated acts in accordance with Article 84 supplementing this Regulation by rules on entrusting EUIPO with the scrutiny of third countryentrust EUIPO with the purely administrative task of examining geographical indications of third countries, other than geographical indications under the Geneva Act of the Lisbon Agreement on Appellations of Origin and Geographical Indications, proposed for protection pursuant to international negotiations or international agreements.
Amendment 398 #
2022/0089(COD)
Proposal for a regulation
Article 47 – paragraph 1 – introductory part
Article 47 – paragraph 1 – introductory part
1. Where tThe Commission exercises any of the empowerments provided for in this Regulation to entrust tasks to EUIPO, it shall also be empowered to adopt delegated acts in accordance with Article 84 to supplement this Regulation byshall define criteria for monitoring performance in the execution of suchthe tasks. Such entrusted to EUIPO. These criteria mayshall include in particular:
Amendment 410 #
2022/0089(COD)
Proposal for a regulation
Article 47 – paragraph 2
Article 47 – paragraph 2
2. No later than 53 years after the first delegation of any tasks to EUIPO, the Commission shall prepare and submit a report to the European Parliament and to the Council on the results and experience of the exercise of these tasks by EUIPO. Should the findings reveal shortcomings in the management by EUIPO of the tasks entrusted to it, in accordance with the law of the European Parliament and of the Council, those tasks shall be reallocated to DG AGRI.
Amendment 56 #
2022/0066(COD)
Proposal for a directive
Recital 6
Recital 6
(6) Due to their vulnerability, children who witness violence against women or domestic violence suffer a direct emotional harm, which impacts their development. Therefore, such children should be considered victims and benefit from targeted protection measur. Such “Witnessed violence”, i.e. experiencing any form of ill-treatment, carried out through acts of physical, verbal, psychological, sexual and economic violence against reference figures or other affectively significant figures, has very serious consequences on the psychological and emotional development of the child, and can generate traumas that are sometimes permanent on the ability to interact socially during childhood and adulthood. Therefore, such children should be considered victims and benefit from targeted protection measures. It is essential to give due attention to this type of violence in separations and parental custody arrangements, taking into account the best interest of the child, in particular in order to determine custody and visitation rights in separation cases.
Amendment 64 #
2022/0066(COD)
Proposal for a directive
Recital 9
Recital 9
(9) Victims are often still unable to fully exercise their rights in the EU and access to support services is critical to women exposed violence. Victims often face difficulties in obtaining justice due to lack of information and insufficient support and protection and often face secondary victimisation and when claiming compensation. In light of the specificities related to these types of crime it is necessary to lay down a comprehensive set of rules, which addresses the persisting problem of violence against women and domestic violence in a targeted manner and caters to the specific needs of victims of such violence. The existing provisions at Union and national levels have proven to be insufficient to effectively combat and prevent violence against women and domestic violence. In particular, Directives 2011/36/EU and 2011/93/EU concentrate on specific forms of such violence, while Directive 2012/29/EU of the European Parliament and of the Council38 lays down the general framework for victims of crime. While providing some safeguards for victims of violence against women and domestic violence, it is not set out to address their specific needs. _________________ 38 Directive 2012/29/EU of the European Parliament and of the Council of 25 October 2012 establishing minimum standards on the rights, support and protection of victims of crime, and replacing Council Framework Decision 2001/220/JHA (OJ L 315, 14.11.2012, p. 57).
Amendment 74 #
2022/0066(COD)
Proposal for a directive
Recital 17
Recital 17
(17) Gender-based violence against women have been amplified or facilitated by technology, in particular the technology used in online and digital environments. It is necessary to provide for harmonised definitions of offences and penalties regarding certain forms of cyber violence. Cyber violence particularly targets and impacts women politicians, journalists and human rights defenders. It can have the effect of silencing women and hindering their societal participation on an equal footing with men. Cyber violence also disproportionately affects women and girls in educational settings, such as schools and universities, with detrimental consequences to their further education and to their mental health, which may, in extreme cases, lead to suicide.
Amendment 76 #
2022/0066(COD)
Proposal for a directive
Recital 18
Recital 18
(18) The use of information and communication technologies bears the risk of easy, fast and wide-spread amplification of certain forms of cyber violence with the effect of creating or enhancing profound and long-lasting harm for the victim. Cyber violence has severe implications for women’s participatory rights online. The hateful abuse to which women are subjected in online environments causes many women to withdraw from participating online, including from expressing their views on online platforms. Violence against women in the digital sphere thus silences their voices and reduces their perspectives in public debate. The potential for such amplification, which is a pre-requisite for the perpetration of several offences of cyber violence defined under this Directive, should be reflected by the element of making certain material accessible, through information and communication technologies, to a ‘multitude’ of end-users. The term ‘multitude’ should be understood as referring to reaching a significant number of end-users of the technologies in question, thus allowing for significant access to, and potential further distribution of that material. That term should be interpreted and applied having regard to the relevant circumstances, including the technologies used to make that material accessible and the means these technologies offer for amplification.
Amendment 79 #
2022/0066(COD)
Proposal for a directive
Recital 26
Recital 26
(26) In order to tackle underreporting in the cases when the victim is a child, safe and child-friendly reporting procedures should be established. This can include questioning by competent authorities in simple and accessible language. Participation in court proceedings should take place in a comfortable environment so as not to cause additional trauma or stress for the child and to minimise the psychological and emotional impact of such circumstances, and be appropriate for the age, maturity and language skills of the child in terms of language and content.
Amendment 82 #
2022/0066(COD)
Proposal for a directive
Recital 27
Recital 27
(27) Delays in processing complaints of violence against women and domestic violence can bear particular risks to victims thereof, given that they might still be in immediate danger given that offenders might often be close family members or spouses. Therefore, the competent authorities should have the sufficient expertise and effective investigative tools to investigate and prosecute such crimes. Member States should make sufficient resources available to ensure that proceedings involving children are handled with utmost compliance with the standards of child-friendly justice, with appropriate respect for child’s emotional and physical integrity, and without undue delay. Member States should ensure that child and family courts function as an essential service, continuing to hold emergency hearings and executing court orders for the care and protection of children who are at an immediate risk of neglect or abuse.
Amendment 84 #
2022/0066(COD)
Proposal for a directive
Recital 27 a (new)
Recital 27 a (new)
(27 a) In many cases the close connection between criminal, civil and other legal proceedings need to be recognized in order to coordinate the judicial and other legal responses to child and intimate partner violence. Member States should adopt measures to link criminal and civil cases involving an individual family and children in order ot effectively prevent any discrepancies between judicial and other legal decisions that are harmful to children. The best interests of the child should always be the primary consideration in all decisions concerning children.
Amendment 94 #
2022/0066(COD)
Proposal for a directive
Recital 50
Recital 50
(50) The traumatic nature of sexual violence, including rape, requires a particularly sensitive response by trained and specialised staff. Victims of this type of violence need immediate medical care, services operated by gynaecologists and obstetricians where needed, and trauma support combined with immediate forensic examinations to collect the evidence needed for prosecution. Rape crisis centres or sexual violence referral centres should be available in sufficient numbers and adequately spread over the territory of each Member State. Similarly, victims of female genital mutilation, who are often girls, typically are in need of targeted support. Therefore, Member States should ensure they provide dedicated support tailored to these victims.
Amendment 96 #
2022/0066(COD)
Proposal for a directive
Recital 53
Recital 53
(53) Shelters play a vital role in protecting victims from acts of violence. Beyond providing a safe place to stay, shelters should provide the necessary support concerning interlocking problems related to victims’ health, financial situation and the well-being of their children, ultimately preparing victims for an autonomous life. Member States should guarantee support for women and their children who are victims of violence by means of community, educational and financial support, in order to ensure these women have the necessary means to care for their children. Victims of violence should have access to psychological support and counselling at every stage of their legal procedures.
Amendment 97 #
2022/0066(COD)
Proposal for a directive
Recital 54
Recital 54
(54) Growing up in a violent domestic environment has very negative implications for the child’s physical, emotional and social development and subsequent behaviour as an adult. Exposure to violence as a child, either through experiencing maltreatment and/or witnessing partner violence, constitutes a risk factor for becoming vulnerable to victimisation, committing violence as an adult or experiencing behavioural, physical or mental health problems. To effectively address negative consequences for child victims, support measures to children should include age- appropriate psychological counselling, together with paediatric care where necessary, and be provided as soon as competent authorities have reasonable grounds to believe that children might have been victims, including child witnesses of violence. In the provision of support to child victims, the rights of the child, as laid down in Article 24 of the Charter, should be a primary consideration. Cooperation between competent authorities and venues the child visits frequently, such as school, should be ensured, both to support the child and provide due support for other children and parents.
Amendment 107 #
2022/0066(COD)
Proposal for a directive
Recital 60
Recital 60
(60) In order to ensure victims of violence against women and domestic violence are identified and receive appropriate support, Member States should ensure that professionals likely to come into contact with victims receiveof violence, child abuse and, in general, all forms of violence and its mechanisms, including manipulation, psychological violence and coercive control, receive mandatory specific and continuous training and targeted information. Trainings should cover the risk and prevention of intimidation, repeat and secondary victimisation and the availability of protection and support measures for victims, and should therefore be intended for the judiciary, law enforcement officers, specialised legal practitioners, forensic medical personnel, healthcare professionals, including gynaecologists and obstetricians, social workers, teachers and child carers, as well as public servants working in these fields. The training should be conducted by primarily focusing on the needs and concerns of victims as a priority. To prevent and appropriately address instances of sexual harassment at work, persons with supervisory functions should also receive training. These trainings should also cover assessments regarding sexual harassment at work and associated psychosocial safety and health risks as referred to under Directive 89/391/EEC of the European Parliament and of the Council45 . Training activities should also cover the risk of third party violence. Third party violence refers to violence which staff may suffer at the workplace, not at the hands of a co-worker, and includes cases, such as nurses sexually harassed by a patient. _________________ 45 Council Directive 89/391/EEC of the European Parliament and of the Council of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (OJ L 183, 29.6.1989, p. 1).
Amendment 115 #
2022/0066(COD)
Proposal for a directive
Recital 65
Recital 65
(65) In order to address the issue of the eradication of gender-based violence, it is necessary to rely on consistent and comparable administrative data, based on a robust and coordinated framework for data collection. Member States should ensure that the data collected are limited to what is strictly necessary in relation to supporting the monitoring of the prevalence and trends of violence against women and domestic violence and design new policy strategies in this field. When sharing the data collected, no personal data should be included.
Amendment 127 #
2022/0066(COD)
Proposal for a directive
Article 4 – paragraph 1 – point c
Article 4 – paragraph 1 – point c
(c) “victim” means any person, regardless of sex or, gender, or age, unless specified otherwise, who has suffered harm, which was directly caused by acts of violence covered under this Directive, including child witnesses of such violence;
Amendment 132 #
2022/0066(COD)
Proposal for a directive
Article 4 – paragraph 1 – point j a (new)
Article 4 – paragraph 1 – point j a (new)
(ja) "witnessed violence" means the experience by a child of one of the forms of abuse through acts of violence referred to in points (a) and (b) against reference figures or other figures of significance in the household;
Amendment 157 #
2022/0066(COD)
Proposal for a directive
Article 16 – paragraph 4
Article 16 – paragraph 4
4. Member States shall take the necessary measures to encourage and simplify the possibility for minors to report to the competent authorities. Where children report criminal offences of violence against women or domestic violence, Member States shall ensure that the reporting procedures are safe, confidential, designed and accessible in a child-friendly manner and language, in accordance with their age and maturity. Such reporting procedures must be conducted by trained professionals, such as doctors or psychologists, including professionals qualified in child neuropsychiatry, in order to take into account of the harmonious development of the child and to avoid deepening their trauma and victimisation. If the offence involves the holder of parental responsibility, Member States should ensure reporting is not conditional upon this person’s consent.
Amendment 162 #
2022/0066(COD)
Proposal for a directive
Article 17 – paragraph 4
Article 17 – paragraph 4
4. The competent authorities shall promptly refer victims to relevant health care professionals or support services referred to in Articles 27, 28 and 29 to assist in securing evidence, in particular in cases of sexual violence, where the victim wishes to bring charges and make use of such services. Professionals dealing with such cases should be trained in a targeted way to be able to approach all forms of violence and its mechanisms, focusing on the needs and concerns of victims as a priority.
Amendment 164 #
2022/0066(COD)
Proposal for a directive
Article 18 – paragraph 2
Article 18 – paragraph 2
2. This individual assessment shall be initiated upon the first contact of the victim with the competent authorities also in order to ensure the safety and protection of victims. The competent judicial authorities shall verify at the latest at the initiation of criminal proceedings whether an assessment has been conducted. If this has not been the case, they shall remedy the situation by undertaking an assessment as soon as possible.
Amendment 166 #
2022/0066(COD)
Proposal for a directive
Article 18 – paragraph 3
Article 18 – paragraph 3
3. The individual assessment shall focus on the risk emanating from the offender or suspect, including the risk of repeated violence, the risk of bodily harm, the use of weapons, the offender or suspect living with the victimlikelihood of the victim returning to the offender or suspect, the degree of control exercised by the offender or suspect on the victim and its potential effect on the evidence, the risk of bodily harm, the use of weapons, the offender or suspect living with the victim, the involvement of children, the economic dependence of the victim on the offender or suspect, an offender or suspect’s drug or alcohol misuse, child abuse, mental health issues or behaviour of stalking.
Amendment 168 #
2022/0066(COD)
Proposal for a directive
Article 18 – paragraph 6
Article 18 – paragraph 6
6. The individual assessment shall be undertaken in collaboration with all relevant competent authorities depending on the stage of the proceedings, and relevant support services, such as victim protection centres and women’s and children’s specialised services, shelters, social services and healthcare professionals. Psychophysical support must be provided to the victim, particularly during and after questioning procedures, taking into account the emotional tensions associated with the circumstances, and designed to prevent risk factors which could lead to further violent offences.
Amendment 181 #
2022/0066(COD)
Proposal for a directive
Article 23 – paragraph 1 – point c a (new)
Article 23 – paragraph 1 – point c a (new)
(ca) how to adopt the best measures for a child who witnessed violence;
Amendment 183 #
2022/0066(COD)
Proposal for a directive
Article 24 – paragraph 1 – subparagraph 1 – point b
Article 24 – paragraph 1 – subparagraph 1 – point b
(b) publish independent reports and make recommendations on any issue relating to such forms of violence, including identifying existing best practices;
Amendment 192 #
2022/0066(COD)
Proposal for a directive
Article 27 – paragraph 1 – point b
Article 27 – paragraph 1 – point b
(b) referrals to medical and psychological expertise, and medical forensic examinations;
Amendment 193 #
2022/0066(COD)
Proposal for a directive
Article 27 – paragraph 1 – point b a (new)
Article 27 – paragraph 1 – point b a (new)
(ba) the additional specific support needed when a child witnessed the violence;
Amendment 195 #
2022/0066(COD)
Proposal for a directive
Article 27 – paragraph 3
Article 27 – paragraph 3
3. Member States shall ensure sufficient human and financial resources to provide the services referred to in paragraph 1, especially those referred to in point (b) and (c) of that paragraph, including where such services are provided by non- governmental organisations.
Amendment 198 #
2022/0066(COD)
Proposal for a directive
Article 27 – paragraph 5
Article 27 – paragraph 5
5. Member States shall issue guidelines and protocols for healthcare and social service professionals, drawn from a set of data and best practices at EU level, on identifying and providing appropriate support to victims of all forms of violence against women and domestic violence, including on referring victims to the relevant support services. Such guidelines and protocols shall also indicate how to address the specific needs of victims who are at an increased risk of such violence as a result of their experiencing discrimination based on a combination of sex and other grounds of discrimination.
Amendment 201 #
2022/0066(COD)
Proposal for a directive
Article 28 – paragraph 1
Article 28 – paragraph 1
1. Member States shall provide for appropriately equipped, easily accessible rape crisis or sexual violence referral centres to ensure effective support to victims of sexual violence, including assisting in the preservation and documentation of evidence. These centres should have adequate human and financial resources and shall provide for medical and forensic examinations, trauma support and psychological counselling, after the offence has been perpetrated and for as long as necessary thereafter. Where the victim is a child, such services shall be provided in a child-friendly manner.
Amendment 206 #
2022/0066(COD)
Proposal for a directive
Article 31 – paragraph 1
Article 31 – paragraph 1
1. Member States shall set up state- wide round-the-clock (24/7) telephone helplines, free of charge, to provide advice for victims of violence against women and domestic violence. Such helplines should be able to direct the victim to the necessary medical, legal, and security services. Advice shall be provided confidentially or with due regard for their anonymity. Member States shall ensure the provision of such service also through other information and communication technologies, including online applications.
Amendment 211 #
2022/0066(COD)
Proposal for a directive
Article 31 – paragraph 2
Article 31 – paragraph 2
2. Member States shall take appropriate measures to ensure the accessibility of services referred to in paragraph 1 for children and end-users with disabilities, including providing support in easy to understand language. Those services shall be accessible in line with the accessibility requirements for electronic communications services set in Annex I to Directive 2019/882/EU of the European Parliament and of the Council52 . _________________ 52 Directive (EU) 2019/882 of the European Parliament and of the Council of 17 April 2019 on the accessibility requirements for products and services, OJ L 151, 7.6.2019, p. 70–115.
Amendment 217 #
2022/0066(COD)
Proposal for a directive
Article 32 – paragraph 1
Article 32 – paragraph 1
1. The shelters and other appropriate interim accommodations as provided for in Article 9(3), point (a), of Directive 2012/29/EU shall address the specific needs of women victims of domestic violence and sexual violence. They shall assist them in their recovery, providing adequate and appropriate living conditions with a view on a return to independent living. Shelters should be able to direct victims to all necessary services, such as medical or legal assistance.
Amendment 225 #
2022/0066(COD)
Proposal for a directive
Article 33 – paragraph 2
Article 33 – paragraph 2
2. Child victims, including victims of witnessed violence, shall be provided with age-appropriate medical care, emotional, psychosocial, psychological and educational support, as well as any other appropriate support tailored in particular to situations of domestic violence.
Amendment 229 #
2022/0066(COD)
Proposal for a directive
Article 33 – paragraph 3 a (new)
Article 33 – paragraph 3 a (new)
3 a. Member States should ensure that the best interests of the child are always the primary consideration in all decisions concerning children, in particular in order to determine custody and visitation rights in separation cases concerning violence.
Amendment 232 #
2022/0066(COD)
Proposal for a directive
Article 34 – paragraph 1
Article 34 – paragraph 1
Member States shall establish and maintain safe places which allow a safe contact between a child and a holder of parental responsibilities who is an offender or suspect of violence against women or domestic violence, to the extent that the latter has rights of access, this right of access may be curtailed or adapted in the best interests of the child. Member States shall ensure supervision by trained professionals, as appropriate, and in the best interests of the child.
Amendment 241 #
2022/0066(COD)
Proposal for a directive
Article 36 – paragraph 2
Article 36 – paragraph 2
2. Preventive measures shall include awareness-raising campaigns targeting all ages, research and education programmes, where appropriate developed in cooperation with relevant civil society organisations, social partners, impacted communities and other stakeholders.
Amendment 249 #
2022/0066(COD)
Proposal for a directive
Article 36 – paragraph 5
Article 36 – paragraph 5
5. Preventive measures shall in particular aim at challenging harmful gender stereotypes, promoting equality between women and men, encouraging all, including men and boys, to act as positive role models to support corresponding behaviour changes across society as a whole in line with the objectives of this directive. Preventive measures shall also aim at remove, as far as possible, any economic barriers that might induce a woman not to report the violence she has suffered.
Amendment 255 #
2022/0066(COD)
Proposal for a directive
Article 37 – paragraph 1
Article 37 – paragraph 1
1. Member States shall ensure that professionals likely to come into contact with victims, including law enforcement authorities, court staff, judges and prosecutors, lawyers, providers of victim support and restorative justice services, child and healthcare professionals, social serviceforensic doctors, social services, as well as volunteer workers, civil society organisations working with and for children and victims, educational and other relevant staff, receive both general and specialist training which is mandatory and continuous and targeted information to a level appropriate to their contacts with victims, to enable them to identify, prevent and address instances of violence against women or all forms of domestic violence and its mechanisms, including manipulation, psychological violence and coercive control, and to treat victims in a trauma-, gender- and child- sensitive manner.
Amendment 269 #
2022/0051(COD)
Proposal for a directive
Recital 4
Recital 4
(4) The behaviour of companies across all sectors of the economy is key to success in the Union’s sustainability objectives as Union companies, especially large ones, rely on global valuesupply chains. It is also in the interest of companies to respect and protect human rights and the environment, in particular given the rising concern of consumers and investors regarding these topics. Several initiatives fostering enterprises which support value-oriented transformation already exist on Union77 , as well as national78 level. Further, binding due diligence legislation has been implemented in several Member States such as France and Germany, which gives rise to the need for a level playing field for companies in order to avoid fragmentation and to provide legal certainty for businesses operating in the single market. _________________ 77 ‘Enterprise Models and the EU agenda’, CEPS Policy Insights, No PI2021-02/ January 2021. 78 E.g. https://www.economie.gouv.fr/entreprises/ societe-mission
Amendment 273 #
2022/0051(COD)
Proposal for a directive
Recital 5
Recital 5
(5) EWell-established existing international standards on responsible business conduct such as the United Nations Guiding Principles on Business and Human Rights and the OECD Guidelines for Multinational Enterprises clarified in the OECD Due Diligence Guidance for Responsible Business Conduct specify that companies should respect and protect human rights and set out how they should address the protection of the environment across their operations and valuesupply chains. The United Nations Guiding Principles on Business and Human Rights79 recognise the responsibility of companies to exercise human rights due diligence by identifying, preventing and mitigating the adverse impacts of their operations on human rights and by accounting for how they address those impacts. Those Guiding Principles state that businesses should avoid infringing human rights and should address adverse human rights impacts that they have caused, contributed to or are linked with in their own operations, subsidiaries and through their direct and indirect business relationships. These international standards should be the basis for this Directive. _________________ 79 United Nations’ “Guiding Principles on Business and Human Rights: Implementing the United Nations ‘Protect, Respect and Remedy’ Framework”, 2011, available at https://www.ohchr.org/documents/publicati ons/guidingprinciplesbusinesshr_en.pdf.
Amendment 278 #
2022/0051(COD)
Proposal for a directive
Recital 6
Recital 6
(6) The concept of human rights due diligence was specified and further developed in the OECD Guidelines for Multinational Enterprises80 which extended the application of due diligence to environmental and governance topics. The OECD Guidance on Responsible Business Conduct and sectoral guidance81 are internationally recognised frameworks setting out practical due diligence steps to help companies identify, prevent, mitigate and account for how they address actual and potential impacts in their operations, valuesupply chains and other business relationships. The concept of due diligence is also embedded in the recommendations of the International Labour Organisation (ILO) Tripartite Declaration of Principles concerning Multinational Enterprises and Social Policy.82, which should form the basis for this Directive. _________________ 80 OECD Guidelines for Multinational Enterprises, 2011 updated edition, available at http://mneguidelines.oecd.org/guidelines/.h ttps://mneguidelines.oecd.org/mneguidelin es/ 81 OECD Guidance on Responsible Business Conduct, 2018, and sector- specific guidance, available at https://www.oecd.org/investment/due- diligence-guidance-for-responsible- business-conduct.htm. 82 The International Labour Organisation’s “Tripartite Declaration of Principles concerning Multinational Enterprises and Social Policy, Fifth Edition, 2017, available at: https://www.ilo.org/empent/Publications/ WCMS_094386/lang--en/index.htm.
Amendment 285 #
2022/0051(COD)
Proposal for a directive
Recital 8
Recital 8
(8) International agreements under the United Nations Framework Convention on Climate Change, to which the Union and the Member States are parties, such as the Paris Agreement84 and the recent Glasgow Climate Pact85 , set out precise avenues to address climate change and keep global warming within 1.5 C degrees for states as signatory parties. Besides specific actions being expected from all signatory Parties, the role of the private sector, in particular its investment strategies, is also considered central to achieve these objectives. _________________ 84 https://unfccc.int/files/essential_backgroun d/convention/application/pdf/english_paris _agreement.pdf. 85 Glasgow Climate Pact, adopted on 13 November 2021 at COP26 in Glasgow, https://unfccc.int/sites/default/files/resourc e/cma2021_L16_adv.pdf.https://unfccc.int/ sites/default/files/resource/cma2021_L16_ adv.pdf.
Amendment 293 #
2022/0051(COD)
Proposal for a directive
Recital 10
Recital 10
(10) According to the Commission Communication on forging a climate- resilient Europe89 presenting the Union Strategy on Adaptation to climate change, new investment and policy decisions should be climate-informed and future- proof, including for larger businesses managing valuesupply chains. This Directive should be consistent with that Strategy. Similarly, there should be consistency with the Commission Directive […] amending Directive 2013/36/EU as regards supervisory powers, sanctions, third-country branches, and environmental, social and governance risks (Capital Requirements Directive)90 , which sets out clear requirements for banks’ governance rules including knowledge about environmental, social and governance risks at board of directors level. _________________ 89 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on Forging a climate-resilient Europe – the new EU Strategy on Adaptation to Climate Change (COM/2021/82 final), available at https://eur-lex.europa.eu/legal- content/EN/TXT/?uri=COM:2021:82:FIN. 90 OJ C […], […], p. […].
Amendment 295 #
2022/0051(COD)
Proposal for a directive
Recital 11
Recital 11
Amendment 296 #
2022/0051(COD)
Proposal for a directive
Recital 12
Recital 12
(12) This Directive is in coherence with the EU Action Plan on Human Rights and Democracy 2020-202499 . This Action Plan defines as a priority to strengthen the Union’s engagement to actively promote the global implementation of the United Nations Guiding Principles on Business and Human Rights and other relevant international guidelines such as the OECD Guidelines for Multinational Enterprises, including by advancing relevant due diligence standards OECD Guidelines for Multinational Enterprises as clarified in the OECD Due Diligence Guidance for Responsible Business Conduct as the relevant guidelines, including by advancing relevant due diligence standards. Therefore, these international standards should form the basis for the obligations on due diligence for companies set out in this Directive. _________________ 99 Joint Communication to the European Parliament and the Council on the EU Action Plan on Human Rights and Democracy 2020-2024 (JOIN/2020/5 final).
Amendment 299 #
2022/0051(COD)
Proposal for a directive
Recital 13
Recital 13
(13) The European Parliament, in its resolution of 10 March 2021 calls upon the Commission to propose Union rules for a comprehensive corporate due diligence obligation100 . The Council Conclusions on Human Rights and Decent Work in Global Supply Chains of 1 December 2020 called upon the Commission to table a proposal for a Union legal framework on sustainable corporate governance, including cross- sector corporate due diligence obligations along global supply chains.101 The European Parliament also calls for clarifying directors` duties in its own initiative report adopted on 2 December 2020 on sustainable corporate governance. In their Joint Declaration on EU Legislative Priorities for 2022102 , the European Parliament, the Council of the European Union and the Commission have committed, to deliver on an economy that works for people, and to improve the regulatory framework on sustainable corporate governance. _________________ 100 European Parliament resolution of 10 March 2021 with recommendations to the Commission on corporate due diligence and corporate accountability (2020/2129(INL)), P9_TA(2021)0073, available at https://oeil.secure.europarl.europa.eu/oeil/p opups/ficheprocedure.do?lang=en&referen ce=2020/2129(INL). 101 Council Conclusions on Human Rights and Decent Work in Global Supply Chains, 1 December 2020 (13512/20). 102 Joint declaration of the European Parliament, the Council of the European Union and the European Commission on EU Legislative Priorities for 2022, available at https://ec.europa.eu/info/sites/default/files /joint_declaration_2022.pdf.
Amendment 304 #
2022/0051(COD)
Proposal for a directive
Recital 14
Recital 14
(14) This Directive aims to ensure that companies active in the internal market contribute to sustainable development and the sustainability transition of economies and societies through the identification, prevention and mitigation, bringing to an end and minimisation of potential or actual adverse human rights and environmental impacts connected with companies’ own operations, subsidiaries and value chainssupply chains. This Directive is without prejudice to the responsibility of Member States to respect and protect human rights and the environment under international law.
Amendment 307 #
2022/0051(COD)
Proposal for a directive
Recital 14 a (new)
Recital 14 a (new)
(14a) In line with relevant EU and national law, all companies in the EU need to adhere to the protection of human rights and environmental standards. If that is not the case, Member States and their relevant authorities are required to enforce the legislation. Thus, there is no need for companies within the EU to control each other’s conduct. The goal of due diligence is to tackle risks in cases where human rights and environmental standards are not or cannot be enforced. Thus, tracing activities in the supply chain shall be focused on upstream level business relationships outside the EU.
Amendment 309 #
2022/0051(COD)
Proposal for a directive
Recital 14 b (new)
Recital 14 b (new)
(14b) This Directive is without prejudice to obligations in the areas of human rights, protection of the environment and climate change under other Union legislative acts. If the provisions of this Directive conflict with a provision of another Union legislative act pursuing the same objectives and providing for more extensive or more specific obligations, the provisions of the other Union legislative act should prevail to the extent of the conflict and should apply to those specific obligations. Examples of these obligations in Union legislative acts include obligations in the Conflict Minerals Regulation, the proposal for a Batteries Regulation or the proposal for a Regulation on deforestation-free supply chains.
Amendment 310 #
2022/0051(COD)
Proposal for a directive
Recital 15
Recital 15
(15) Companies should take appropriate steps within their means to set up and carry out risk-based due diligence measures, with respect to their own operations, their subsidiaries, as well as their established direct anddirect business relationships outside the EU and in case of substantiated knowledge of risks, indirect business relationships throughoutoutside the EU in their valuesupply chains in accordance with the provisions of this Directive. This Directive should not require companies to guarantee, in all circumstances, that adverse impacts will never occur or that they will be stopped. For example with respect to business relationships where the adverse impact results from State intervention, the company might not be in a position to arrive at such results. Therefore, the main obligations in this Directive should be ‘obligations of means’. The company should take the appropriate measureMoreover, administering information on a large number of business relationships is difficult. Therefore, the main obligations in this Directive should be ‘obligations of means’. In addition, while companies can be asked to prevent or mitigate adverse impacts that they caused or contributed to, it is still the responsibility of states to combat human rights violations worldwide. Companies should take the appropriate proportionate and commensurate measures within their means which can reasonably be expected to result in prevention or minimisation of the adverse impact under the circumstances of the specific case. Account should be taken of the specificities of the respective company’s valuesupply chain, sector or geographical area in which its value chain partners operate, the company’s power to influence its direct and indirect business relationships,ize, risk factors including the sector and geographical area of activity, the likelihood and severity of the company's potential or actual adverse impacts and its specific circumstances, the company’s power, resources and leverage to influence its business relationships, whether they caused or contributed to the adverse impact or are directly linked to it and whether the company could increase its power of influencleverage.
Amendment 317 #
2022/0051(COD)
(16) The risk-based due diligence process set out in this Directive should cover the six steps defined by the OECD Due Diligence Guidance for Responsible Business Conduct, which include due diligence measures for companies to identify and address adverse human rights and environmental impacts. This encompasses the following steps: (1) integrating due diligence into policies and management systems, (2) identifying and, assessing and prioritising adverse human rights and environmental impacts, (3) preventing, ceasing or minimising actual and potential adverse human rights, and environmental impacts, (4) assessing the effectiveness of measures, (5) communicating, (6) providing remediation.
Amendment 321 #
2022/0051(COD)
Proposal for a directive
Recital 17
Recital 17
(17) Adverse human rights and environmental impact occur in companies’ own operations, subsidiaries, products, and in their value chains, in particulaaspects particularly occur at the level of raw material sourcing, and manufacturing, or at the level of product or waste disposal in the upstream supply chain operating outside the EU. In order for the due diligence to have a meaningful impact, it should cover human rights and environmental adverse impacts generated throughout the life-cycle of production and use and disposal of product or provision of servicthe level of companies’ own operations, operations of their subsidiaries, atnd the level of own operations, subsidiaries and in valueir business relationships outside the EU in their upstream supply chains.
Amendment 323 #
2022/0051(COD)
Proposal for a directive
Recital 17 a (new)
Recital 17 a (new)
(17a) Secondary raw materials can only be traced until the point where the recycled material is returned to the immediate supplier of the recycler and where the information is obtained and retained to demonstrate that the material is recycled. Therefore, due diligence obligations should not go beyond that point.
Amendment 330 #
2022/0051(COD)
Proposal for a directive
Recital 18
Recital 18
(18) The valuesupply chain should cover activities related to the production of a good or provision of services by a company, including the development of the product or the service and the use and disposal of the product as well as the related activities of established business relationships of the company. It should encompass upstream established direct anddirect and, in cases of substantiated knowledge of adverse impacts, indirect business relationships, both outside the EU that design, extract, manufacture, transport, store and supply raw material, products, parts of products, or provide services to the company that are necessary to carry out the company’s activities, and also downstream relationships, including established direct and indirect business relationships, that use or receive products, parts of products or services from the company up to the end of life of the product, including inter alia the distribution of the product to retailers, the transport and storage of the product, dismantling of the product, its recycling, composting or landfilling.directly necessary to carry out the company’s activities;
Amendment 332 #
2022/0051(COD)
Proposal for a directive
Recital 18
Recital 18
(18) The valuesupply chain should cover activities related to the production of a good or provision of services by a company, including the development of the product or the service and the use and disposal of the product as well as the related activities of established business relationships of the company. It should encompass upstream established direct and indirect business relationships that design, extract, manufacture, transport, store and supply raw material, products, parts of products, or provide services to the company that are necessary to carry out the company’s activities, and also downstream relationships, including established direct and indirect business relationships, that use or receive products, parts of products or services from the company up to the end of life of the product, including inter alia the distribution of the product to retailers, the transport and storage of the product, dismantling of the product, its recycling, composting or landfilling.
Amendment 336 #
2022/0051(COD)
Proposal for a directive
Recital 19
Recital 19
Amendment 341 #
2022/0051(COD)
Proposal for a directive
Recital 20
Recital 20
(20) In order to allow companies to properly identify the adverse impacts in their value chainsupply chain that it caused or contributed to and to make it possible for them to exercise appropriate leverage, the due diligence obligations should be limited in this Directive to establisheddirect business relationships. For the purpose of this Directive, established business relationships should mean such direct and indirect business relationships which are, or which are expected to be lasting, in view of their intensity and duration and which do not represent a negligible or ancillary part of the value chain. The nature of business relationships as “established” should be reassessed periodically, and at least every 12 months. If the direct business relationship of a company is established, then all linked indirect business relationships should also be considered as established regarding that company outside the EU. In cases when there is substantiated knowledge of adverse impacts and the company has the means and leverage to influence those, meaning being directly linked to the adverse impact, companies should include indirect business relationships outside the EU.
Amendment 347 #
2022/0051(COD)
Proposal for a directive
Recital 20 a (new)
Recital 20 a (new)
(20a) The concept of a company’s involvement in an adverse impact should clarify that the actions to be taken to address potential or actual adverse impacts depend on the level of involvement of a company in an adverse impact. The company’s involvement in an adverse impact should be in the form of the company causing the adverse impact, contributing to the adverse impact, or the company being directly linked to the adverse impact, meaning it was caused by its direct or indirect business relationship in the company’s supply chain without the company causing or contributing to it. Although the concepts of the company’s involvement in an adverse impact of ‘contributing to’ and ‘being directly linked to’ also exist in international standards, they should receive an autonomous definition in the Directive. With a view to ensure an effective protection of human rights and the environment, ‘causing’ should be understood as the companies own sole activities, and ‘contributing to’ should be understood as a company’s own activities in combination with or intervention of the activities of business relationships or facilitating or incentivising a business relationship to cause an adverse impact.
Amendment 349 #
2022/0051(COD)
Proposal for a directive
Recital 21
Recital 21
(21) Under this Directive, EU companies established in the Union with more than 53000 employees on average and a worldwide net turnover exceeding EUR 150 million in the financial year preceding the last financial year should be required to comply with due diligence. As regards companies which do not fulfil those criteria, but which had more than 250 employees on average and more than EUR 40 million worldwide net turnover in the financial year preceding the last financial year and which operate in one or more high-impact sectors, due diligence should apply 2 years after the end of the transposition period of this directive, in order to provide for a longer adaptation period. In order to ensure a proportionate burden, companies operating in such high-impact sectors should be required to comply with more targeted due diligence focusing on severe adverse impacts900 million in the financial year preceding the last financial year should be required to comply with due diligence. Temporary agency workers, including those posted under Article 1(3), point (c), of Directive 96/71/EC, as amended by Directive 2018/957/EU of the European Parliament and of the Council103 , should be included in the calculation of the number of employees in the user company. Posted workers under Article 1(3), points (a) and (b), of Directive 96/71/EC, as amended by Directive 2018/957/EU, should only be included in the calculation of the number of employees of the sending company. _________________ 103 Directive (EU) 2018/957 of the European Parliament and of the Council of 28 June 2018 amending Directive 96/71/EC concerning the posting of workers in the framework of the provision of services (OJ L 173, 9.7.2018, p. 16).
Amendment 353 #
2022/0051(COD)
Proposal for a directive
Recital 22
Recital 22
Amendment 358 #
2022/0051(COD)
Proposal for a directive
Recital 23
Recital 23
(23) In order to fully achieve fully the objectives of this Directive addressing human rights and adverse environmental impacts with respect to companies’ operations, subsidiaries and valuesupply chains, third-country companies with significant operations in the EU should also be covered. More specifically, the Directive should apply to third-country companies which generated a net turnover of at least EUR 150 million in the Union in the financial year preceding the last financial year or a net turnover of more than EUR 40 million but less thanhave a branch or subsidiary in the EU, had 3000 employees on average and generated a net worldwide turnover of at least EUR 15900 million in the last financial year preceding the last financial year in one or more of the high- impact sectors, as of 2 years after the end of the transposition period of this Directive.
Amendment 361 #
2022/0051(COD)
Proposal for a directive
Recital 24
Recital 24
(24) For defining the scope of application in relation to non-EUthird-country companies the describcompany in question needs turnover criterion should be choseno have a branch or subsidiary in the EU as it creates a territorial connection between the third- country companies and the Union territory. TIn addition, turnover is a proxy for the effects that the activities of those companies could have on the internal market. In accordance with international law, such effects justify the application of Union law to third-country companies. To ensure identification of the relevant turnover of companies concerned, the methods for calculating net turnover for non-EUthird-country companies as laid down in Directive (EU) 2013/34 as amended by Directive (EU) 2021/2101 should be used. To ensure effective enforcement of this Directive, an employee threshold should, in turn, not be applied also be applied as a benchmark to determine which third-country companies fall under this Directive, as to create a level- playing field, while taking into account that the notion of “employees” retained for the purposes of this Directive is based on Union law and could not be easily transposed outside of the Union. In the absence of a clear and consistent methodology, including in accounting frameworks, to determine the employThat is why the nexus to the EU needs of third-country companies, such employee threshold would therefore create legal uncertainty and would be difficult to apply for supervisory authoritiesto be ensured through having a branch or subsidiary in the EU. The definition of turnover should be based on Directive 2013/34/EU which has already established the methods for calculating net turnover for non-Union companies, as turnover and revenue definitions are similar in international accounting frameworks too. With a view to ensuring that the supervisory authority knows which third country companies generate the required turnover in the Union to fall under the scope of this Directive, this Directive should require that a supervisory authority in the Member State where the third country company’s authorised representative is domiciled or established and, where it is different, a supervisory authority in the Member State in which the company generated most of its net turnover in the Union in the financial year preceding the last financial year are informed that the company is a company falling under the scope of this Directive.
Amendment 363 #
2022/0051(COD)
Proposal for a directive
Recital 25
Recital 25
(25) In order to achieve a meaningful contribution to the sustainability transition, due diligence under this Directive should be carried out with respect to adverse human rights impact on protected persons resulting from the violation of one of the rights and prohibitions as enshrined in the international conventions as listed in the Annex to this Directive. In order to ensure a comprehensive coverage of human rights, a violation of a prohibition or right not specifically listed in that Annex which directly impairs a legal interest protected in those conventions should also form part of the adverse human rights impact covered by this Directive, provided that the company concerned could have reasonably established the risk of such impairment and any appropriate measures to be taken in order to comply with the due diligence obligations under this Directive, taking into account all relevant circumstances of their operations, such as the sector and operational contextOECD Due Diligence Guidelines for Multinational Enterprises as clarified in the OECD Guidance for Responsible Business Conduct, as well as the UN Guiding Principles for Business and Human Rights. Due diligence should further encompass adverse environmental impacts resulting from the violation of one of the prohibitions and obligations pursuant to the international environmental conventions listed in the Annex to this DirectiveOECD Due Diligence Guidelines for Multinational Enterprises as clarified in the Guidance for Responsible Business Conduct as regards the environment.
Amendment 365 #
2022/0051(COD)
Proposal for a directive
Recital 26
Recital 26
(26) Companies should have guidance at their disposal that illustrates how their activities may impact human rights and which corporate behaviour is prohibited in accordance with internationally recognised human rights. Such guidance is included for instance in The United Nations Guiding Principles Reporting Framework104 and the United Nations Guiding Principles Interpretative Guide105 . Using relevant international guidelines and standards as a and should be made easily accessible to companies. Therefeorence, the Commission should be able to issue additionalissue guidance that will serve as a practical tool for companies. _________________ 104 https://www.ungpreporting.org/wp- content/uploads/UNGPReportingFramewor k_withguidance2017.pdf. 105 https://www.ohchr.org/Documents/Issues/ Business/RtRInterpretativeGuide.pdf.https: //www.ohchr.org/Documents/Issues/Busine ss/RtRInterpretativeGuide.pdf.
Amendment 367 #
2022/0051(COD)
Proposal for a directive
Recital 27
Recital 27
(27) In order to conduct appropriate human rights, and environmental due diligence with respect to their operations, their subsidiaries, and their valuesupply chains, companies covered by this Directive should integrate due diligence into corporate policies, identify, prevent and mitigate as well as bring to an end and minimise the extent of potential and actual adverse human rights and environmental impacts that they cause or contribute to, establish and maintain a complaintsnotification procedure, monitor the effectiveness of the taken measures in accordance with the requirements that are set up in this Directive and communicate publicly on their due diligence in line with competition law. In order to ensure clarity for companies, in particular the steps of preventing and mitigating potential adverse impacts and of bringing to an end, or when this is not possible, minimising actual adverse impacts should be clearly distinguished in this Directive.
Amendment 372 #
2022/0051(COD)
(28) In order to ensure that due diligence forms part of companies’ corporate policies, and in line with the relevant international framework, companies should integrate due diligence into all their relevant corporate policies and have in place a risk- based due diligence policy. The due diligence policy should contain a description of the company’s approach, including in the long term, to due diligence, a code of conduct describing the rules and principles to be followed by the company’s employees and subsidiaries; a description of the processes put in place to implement due diligence, including the measures taken to verify compliance with the code of conduct and to extend its application to establishedits direct business relationships outside the EU. The code of conduct should apply in all relevant corporate functions and operations, including procurement and purchasing decisions. Companies should also update their due diligence policy annuallwhen relevant, meaning after a significant change occurs, such as operating in or sourcing from a new country.
Amendment 377 #
2022/0051(COD)
Proposal for a directive
Recital 29
Recital 29
(29) To comply with due diligence obligations, companies need to take appropriate measures with respect to identification, prevention and bringing to an end adverse impacts that it caused or contributed to. An ‘appropriate measure’ should mean a measure that is capable of achieving the objectives of due diligence, commensurate with the degree of severity and the likelihood of the adverse impact, and reasonably available to the company, taking into account the circumstances of the specific case, including characteristics of the economic sector and of the specific business relationship and the company’s influence thereof, and the need to ensure prioritisation of action. In this context, in line with international frameworks, the company’s influencleverage over a business relationship should include, on the one hand its ability to persuade the business relationship to take action to bring to an end or prevent adverse impacts (for example through ownership or factual control, market power, pre-qualification requirements, linking business incentives to human rights and environmental performance, etc.) and, on the other hand, the degree of influence or leverage that the company could reasonably exercise, for example through cooperation with the business partner in question or engagement with another company which is the direct business partner of the business relationship associated with adverse impact.
Amendment 379 #
2022/0051(COD)
Proposal for a directive
Recital 30
Recital 30
(30) Under the due diligence obligations set out by this Directive, a company should identify actual or potential adverse human rights and environmental impacts. In order to allow for a comprehensive identification of adverse impacts, such identification should be based on meaningful stakeholder engagement and quantitative and qualitative information. For instance, as regards adverse environmental impacts, the company should obtain information about baseline conditions at higher risk sites or facilities in valuesupply chains. Identification of adverse impacts should include assessing the human rights, and environmental context in a dynamic way and in regular intervals: prior to a new activity or relationship, prior to major decisions or changes in the operation; in respoWhen identifying adverse impacts that they caused or contributed to, the company should be able to first map areas of their operations, the operations of their subsidiaries and, where related to their supply chainse, to or anticipation of changesheir direct business relationships outside the EU inf they operating environment; and periodically, at least every 12 me in risk areas, and based on ths, throughout the life of an activity or relationship. Regulated financial undertakings providing loan, credit, or other financial services should identify the adverse impacts only at the inception of the contract. When identifying adverse impacts, companies should also identify and assess the impact of ae results, carry out an in-depth risk assessment prioritising the areas where the adverse impacts are most likely to be present or most significant. Indirect business relationship’s business model and strategies, including trading, procurement and pricing pshall be taken into account then there is substantiated knowledge of risks in those operactices. Whereons that the company cannot prevent, bring to an end or minimize all its adverse impacts at the same time, it should be able to prioritize its action, provided it takes the measures reasonably available to the company, taking into account the specific circumstancesis directly linked to, e.g. based on information gathered in the notification procedure. Identification of adverse impacts should include assessing the human rights, and environmental context in a dynamic way after a significant change occurs, throughout the life of an activity or relationship.
Amendment 384 #
2022/0051(COD)
Proposal for a directive
Recital 30 a (new)
Recital 30 a (new)
(30a) Where the company cannot prevent, mitigate, bring to an end or minimise all the identified actual and potential adverse impacts at the same time to the full extent, it should be allowed to prioritise them based on the severity and likelihood of the adverse impact. In line with the relevant international framework, the severity of an adverse impact should be assessed based on its gravity (scale of the adverse impact), the number of persons or the extent of the environment affected (scope of the adverse impact), its irreversibility, and difficulty to restore the situation prevailing prior to the impact (irremediable character of the adverse impact).
Amendment 385 #
2022/0051(COD)
Proposal for a directive
Recital 31
Recital 31
Amendment 388 #
2022/0051(COD)
Proposal for a directive
Recital 32
Recital 32
(32) Where the company cannot prevent, mitigate, bring to an end or minimise all the identified actual and potential adverse impacts at the same time to the full extent, it should be allowed to prioritise them based on the severity and likelihood of the adverse impact. In line with the relevant international framework, the severity of an adverse impact should be assessed based on its gravity (scale of the adverse impact), the number of persons or the extent of the environment affected (scope of the adverse impact), its irreversibility, and difficulty to restore the situation prevailing prior to the impact (irremediable character of the adverse impact). In line with international standards, prevention and mitigation as well as bringing to an end and minimisation of adverse impacts should take into account the interests of those adversely impacted. In order to enable continuous engagement with the valuesupply chain business partner instead of termination of business relations (disengagement) and possibly exacerbating adverse impacts, this Directive should ensure that disengagement is a last-resort action, used only in cases of severe or repeated misconduct, after repeated attempts of bringing an actual adverse impact to an end have failed and only if it is in the best interest of those impacted (responsible disengagement), also in line with the Union`s policy of zero-tolerance on child labour. Terminating a business relationship in which child labour was found could expose the child to even more severe adverse human rights impacts. This should therefore be taken into account when deciding on the appropriate action to take. Moreover, responsible disengagement should also take into account possible impacts for those depending on the product or affected by disruptions of supply chains.
Amendment 392 #
2022/0051(COD)
Proposal for a directive
Recital 33
Recital 33
(33) Under the due diligence obligations set out by this Directive, if a company identifies potential adverse human rights or environmental impacts, it should take appropriate measureproportionate and commensurate measures within their means to prevent andor adequately mitigate them. To provide companies with legal clarity and certainty, this Directive should set out the actions companies should becan be reasonably expected to take for prevention and mitigation of potential adverse impacts where relevant depending on the circumstances. and leverage. Companies should be obliged to take measures within their means to prevent or mitigate the adverse impacts that they cause or to which they contribute. When companies are not causing nor contributing to the adverse impacts occurring in their supply chain (so called ‘being directly linked to’ the adverse impact), they should use their influence to prevent or mitigate the adverse impact caused by their subsidiaries or business partners or to increase their influence to do so.
Amendment 397 #
2022/0051(COD)
Proposal for a directive
Recital 34
Recital 34
(34) So as to comply with the prevention and mitigation obligation under this Directive, companies should be required to take the following actions, where relevant depending on the circumstances and their leverage. Where necessary due to the complexity of prevention measures, companies should develop and implement a prevention action plan. Companies shouldmay seek to obtain contractual or other assurances from a direct partner with whom they have an established direct business relationship outside the EU that it will ensure compliance with the code of conduct or the prevention action plan, including by seeking corresponding contractual assurances from its partners to the extent that their activities are part of the companies’ value chain. The contractual assurances should besupply chain where possible. The assurances may be, where appropriate, accompanied by appropriate measures to verify compliance. To ensure comprehensive prevention of actual and potential adverse impacts, companies should also make investments which aim to prevent adverse impacts, and, where appropriate, collaborate with other companies to that extent. Companies should also provide targeted and proportionate support for an SME with which they have an established direct business relationship outside the EU such as financing, for example, through direct financing, low-interest loans, guarantees of continued sourcing, and assistance in securing financing, to help implement the code of conduct or prevention action plan, or technical guidance such as in the form of training, management systems upgrading, and collaborate with other companies.
Amendment 402 #
2022/0051(COD)
Proposal for a directive
Recital 35
Recital 35
(35) In order to reflect the full range of options for the company in cases where potential impacts could not be addressed by the described prevention or minimisation measuresthere is substantiated knowledge of severe adverse impacts in indirect business relationships outside the EU, this Directive should also refer to the possibility for the company to seek to conclude a contract with the indirect business partnerrelationship, with a view to achieving compliance with the company’s code of conduct or a prevention action plan, and conduct appropriate measures to verify compliance of the indirect business relationship with the contract. This possibility should be taken into account on an ad-hoc basis and following the engagement with stakeholders.
Amendment 405 #
2022/0051(COD)
Proposal for a directive
Recital 36
Recital 36
Amendment 409 #
2022/0051(COD)
Proposal for a directive
Recital 37
Recital 37
(37) As regards direct andor where applicable indirect business relationships, industry cooperation, industry schemes and multi- stakeholder initiatives can help create additional leverage to identify, mitigate, and prevent adverse impacts. Therefore, it should be possible for companies to rely on such initiatives to support the implementation of their due diligence obligations laid down in this Directive to the extent that such schemes and initiatives are appropriate to support the fulfilment of those obligations. CompaniMember States cshould assess, at their own initiative, the alignment of these schemes and initiatives with the obligations under this Directive and assess their feasibility. However, membership of such schemes should complement, not replace company due diligence efforts. In order to ensure full information on such initiatives, the Directive should also refer to the possibilityquire for the Commission and the Member States to facilitate the dissemination of information on such schemes or initiatives and their outcomes. The Commission, in collaboration with Member States, may should issue guidance for assessing the fitness of industry schemes and multi-stakeholder initiatives.
Amendment 413 #
2022/0051(COD)
Proposal for a directive
Recital 38
Recital 38
(38) Under the due diligence obligations set out by this Directive, if a company identifies actual human rights or environmental adverse impacts that it caused or contributed to, it should take appropriate measures to bring those to an end. It can be expected that a company is able to bring to an end actual adverse impacts in theirits own operations and inthose of its subsidiaries. However, it should be clarified that, as regards established business relationships, where adverse impacts cannot be brought to an end, companies should minimise the extent of such impacts. Minimisation of the extent of adverse impacts should require an outcome that is the closest possible to bringing the adverse impact to an end. To provide companies with legal clarity and certainty, this Directive should define which actions companies shcould be reasonably required to take within their means for bringing actual human rights and environmental adverse impacts to an end and minimisation of their extent, where relevant depending on the circumstances. When companies are neither causing nor contributing to the adverse impacts, meaning they are directly linked to the adverse impact, they should be obliged to use their influence to bring to an end or minimise the extent of the adverse impact caused by their subsidiaries or business relationships or to increase their influence to do so.
Amendment 418 #
2022/0051(COD)
Proposal for a directive
Recital 39
Recital 39
(39) So as to comply with the obligation of bringing to an end and minimising the extent of actual adverse impacts under this Directive, companies should be required to take the following actions, where relevant within their means, where relevant depending on the circumstances. They should neutralise the adverse impact or minimise its extent, with an action proportionate to the significance and scale of the adverse impact and to the contribution of the company’s conduct to the adverse impact. Where necessary due to the fact that the adverse impact cannot be immediately brought to an end, companies should develop and implement a corrective action plan with reasonable and clearly defined timelines for action and qualitative and quantitative indicators for measuonitoring improvement. Companies should alsomay also, where possible and where deemed necessary following engagement with stakeholders, seek to obtain contractual or other assurances from a direct business partner with whom they have an established business relationship that they will ensure compliance with the company’s code of conduct and, as necessary, a prevention action plan, including by seeking corresponding contractual assurances from its partners, to the extent that their activities are part of the company’s valuesupply chain. The contractual assurances should beassurances may be, where appropriate, accompanied by the appropriate measures to verify compliance. Finally, companies should also make investments aiming at ceasing or minimising the extent of adverse impact, provide targeted and proportionate support for an SMEs with which they have an established direct business relationship and collaborate with other entities, including through industry initiatives, where relevant, to increase the company’s ability to bring the adverse impact to an end.
Amendment 423 #
2022/0051(COD)
Proposal for a directive
Recital 40
Recital 40
(40) In order to reflect the full range of options for the company in cases where actual impacts could not be addressed by the described measures, this Directive should also refer to the possibility for the company to seek to conclude a contract with the indirect business partner, where appropriate, with a view to achieving compliance with the company’s code of conduct or a corrective action plan, and conduct appropriate measures to verify compliance of the indirect business relationship with the contract.
Amendment 425 #
2022/0051(COD)
Proposal for a directive
Recital 41
Recital 41
(41) In order to ensure that bringing actual adverse impacts to an end or minimising them is effective, companies should prioritize engagement with business relationships in the valuesupply chain, instead of terminating the business relationship, as a last resort action after attempting ato bringing actual adverse impacts to an end or minimising them without success. However, this Directive should also, for cases where actual adverse impacts could not be brought to an end or adequately mitigated by the described measures, refer to the obligation for companies to refrain from entering into new or extending existing relations with the partner in question and, where the law governing their relations so entitles them to, to either temporarily suspend commercialbusiness relationships with the partner in question, while pursuing efforts to bring to an end or minimise the extent of the adverse impact, or terminate the business relationship with respect to the activities concerned, if the adverse impact is considered severe and only if this is in the best interest of those impacted (responsible disengagement). In order to allow companies to fulfil that obligation, Member States should provide for the availability of an option to terminate the business relationship in contracts governed by their laws.
Amendment 426 #
2022/0051(COD)
Proposal for a directive
Recital 42
Recital 42
(42) Companies should provide the possibility for persons and organisations to submit complaintsinformation directly to them in case of legitimate concerns regarding actual or potential human rights and environmental adverse impacts. Organisations who could submit such complaintsinformation should include trade unions and other workers’ representatives representing individuals working in the valuesupply chain concerned and civil society organisations active in the areas related to the valuesupply chain concerned where they have substantiated and documented knowledge about a potential or actual adverse impact. Companies should establish a procedure for dealing with those complaintnotifications and inform workers, trade unions and other workers’ representatives, where relevant, about such processes. Recourse to the complaints and remedinotification mechanism should not prevent the complaininformant from having recourse to judicial remedies. In accordance with international standards, complaiinformants should be entitled to request from the company appropriate follow-up on the complaint andnotification. This can include to meet with the company’s representatives at an appropriate level to discuss potential or actual severe adverse impacts that are the subject matter of the complaintnotification. This access should not lead to unreasonable solicitations of companies nor to sanctions. Companies may deal with notifications as a group, for example within an industry initiative.
Amendment 431 #
2022/0051(COD)
Proposal for a directive
Recital 43
Recital 43
(43) Companies should monitor the implementation and effectiveness of their due diligence measures. They should carry out periodiccontinuous assessments of their own operations, those of their subsidiaries and, where related to the valuesupply chains of the company, those of their established business relationships outside the EU, to monitor the effectiveness of the identification, prevention, minimisation, bringing to an end and mitigation of human rights and environmental adverse impacts. Such assessments should verify that adverse impacts are properly identified, due diligence measures are implemented and if adverse impacts have actually been prevented or brought to an end. In order to ensure that such assessments are up-to- date, they should be carried out at least every 12 months and be revised in- betweenwhen deemed necessary after a significant change occurs, such as operating in or sourcing from a new country or if there are reasonable grounds to believe that significant new risks of adverse impact could have arisen.
Amendment 439 #
2022/0051(COD)
Proposal for a directive
Recital 44
Recital 44
(44) Like in the existing international standards set by the United Nations Guiding Principles on Business and Human Rights and the OECD framework, it forms part of the due diligence requirement to communicate externally relevant information on due diligence policies, processes and activities conducted to identify and address actual or potential adverse impacts, including the findings and outcomes of those activities. The proposal to amend Directive 2013/34/EU as amended regardsing corporate sustainability reporting sets out relevant reporting obligations for the companies covered by this directive. In order to avoid duplicating reporting obligations, this Directive should therefore not introduce any new reporting obligations in addition to those under Directive 2013/34/EU for the companies covered by that Directive as well as the reporting standards that should be developed under it. As regards companies that are within the scope of this Directive, but do not fall under Directive 2013/34/EU, in order to comply with their obligation of communicating as part of the due diligence under this Directive, they should publish on their website an annual statement in a language customary in the sphere of international businessone of the official languages of the Union.
Amendment 442 #
2022/0051(COD)
Proposal for a directive
Recital 45
Recital 45
(45) In order to facilitate companies’ compliance with their due diligence requirements throughas regards their valuesupply chain and limiting shifting compliance burden on SME business partners, in particular SMEs, the Commission should provide guidance on model contractual clauses.
Amendment 448 #
2022/0051(COD)
Proposal for a directive
Recital 47
Recital 47
(47) Although SMEs are not included in the scope of this Directive, they could be heavily impacted by its provisions as contractors or subcontractors to the companies which are in the scope. The aim is nevertheless to mitigate the immense financial or administrative burden on SMEs, many of which are already struggling in the context of the global economic and sanitary crisis. In order to support companies in the implementation, including SMEs, Member States should set up and operate, either individually or jointly, dedicated websites, portals or platforms, to provide information and support to companies, and Member States cshould also financially support SMEs specifically and help them build capacity. Such support should also be made accessible, and where necessary adapted and extended to upstream economic operators in third countries. Companies whose business partner is an SME, are also encouraged tshould also support them to comply with due diligence measures, in case such requirements would jeopardize the viability of the SME and use fair, reasonable, non-discriminatory and proportionate requirements vis-a-vis the SMEs.
Amendment 450 #
2022/0051(COD)
Proposal for a directive
Recital 48
Recital 48
(48) In order to complement Member State support to companies in their implementation, including SMEs, the Commission mayshould build on existing EU tools, projects and other actions helping with the due diligence implementation in the EU and in third countries. It may set up new support measures that provide help to companies, including SMEs on due diligence requirements, including an observatory for valuesupply chain transparency and the facilitation and assessment of joint stakeholder initiatives.
Amendment 452 #
2022/0051(COD)
Proposal for a directive
Recital 49
Recital 49
(49) The Commission and Member States should continue to work in partnership with third countries to support upstream economic operators build the capacity to effectively prevent and mitigate adverse human rights and environmental impacts of their operations and business relationships, paying specific attention to the challenges faced by smallholders. They should use their neighbourhood, development and international cooperation instruments, including Free Trade Agreements, to support third country governments and upstream economic operators in third countries addressing adverse human rights and environmental impacts of their operations and upstream business relationships. This could include working with partner country governments, the local private sector and stakeholders on addressing the root causes of adverse human rights and environmental impacts.
Amendment 457 #
2022/0051(COD)
Proposal for a directive
Recital 51
Recital 51
Amendment 460 #
2022/0051(COD)
Proposal for a directive
Recital 53
Recital 53
(53) In order to ensure the monitoring of the correct implementation of companies’ due diligence obligations and ensure the proper enforcement of this Directive, Member States should designate one or more national supervisory authorities. These supervisory authorities should be of a public nature, independent from the companies falling within the scope of this Directive or other market interests, and free of conflicts of interest. In accordance with national law, Member States should ensure appropriate financing of the competent authority. They should be entitled to carry out investigations, on their own initiative or based on complaints or substantiated concerns raised under this Directive. Where competent authorities under sectoral legislation exist, Member States could identify those as responsible for the application of this Directive in their areas of competence. They could designate authorities for the supervision of regulated financial undertaking also as supervisory authorities for the purposes of this Directive.
Amendment 461 #
2022/0051(COD)
Proposal for a directive
Recital 53
Recital 53
(53) In order to ensure the monitoring of the correct implementation of companies’ due diligence obligations and ensure the proper enforcement of this Directive, Member States should designate one or more national supervisory authorities to oversee compliance with the obligations laid down in national provisions pursuant to due diligence processes outlined in this Directive. These supervisory authorities should be of a public nature, independent from the companies falling within the scope of this Directive or other market interests, and free of conflicts of interest. In accordance with national law, Member States should ensure appropriate financing of the competent authority. They should be entitled to carry out investigations, on their own initiative or based on complaints or substantiated concerns raised under this Directive. Where competent authorities under sectoral legislation exist, Member States could identify those as responsible for the application of this Directive in their areas of competence. They could designate authorities for the supervision of regulated financial undertaking also as supervisory authorities for the purposes of this Directive.
Amendment 462 #
2022/0051(COD)
Proposal for a directive
Recital 54
Recital 54
(54) In order to ensure effective enforcement of national measures implementing this Directive, Member States should provide for dissuasive, proportionate and effective administrative sanctions for infringements of those measures. In order for such sanction regime to be effective, administrative sanctions to be imposed by the national supervisory authorities should include pecuniary sanctions. Where the legal system of a Member State does not provide for administrative sanctions as foreseen in this Directive, the rules on administrative sanctions should be applied in such a way that the sanction is initiated by the competent supervisory authority and imposed by the judicial authority. Therefore, it is necessary that those Member States ensure that the application of the rules and sanctions has an equivalent effect to the administrative sanctions imposed by the competent supervisory authorities.
Amendment 464 #
2022/0051(COD)
Proposal for a directive
Recital 55
Recital 55
(55) In order to ensure consistent application and enforcement of national provisions adopted pursuant to this Directive, national supervisory authorities should actively cooperate and coordinate their action. For that purpose a European Network of Supervisory Authorities should be set up by the Commission and the supervisory authorities should assist each other in performing their tasks and provide mutual assistance.
Amendment 470 #
2022/0051(COD)
Proposal for a directive
Recital 56
Recital 56
(56) In order to ensure effective compensation of victims of adverse impacts, Member States should be required to lay down rules governing the civil liability of companies for damages arising due to its intentional or gross negligent failure to comply with the due diligence process. The company should be liable for damages if thethat they directly caused if they intentionally or gross negligently failed to comply with the obligations to prevent and mitigate potential adverse impacts or to bring actual impacts to an end and minimise their extent, and as a result of this failure an adverse impact that it directly caused and that should have been identified, prevented, mitigated, brought to an end or its extent minimised through the appropriate measures occurred and led to damage.
Amendment 474 #
2022/0051(COD)
Proposal for a directive
Recital 57
Recital 57
Amendment 479 #
2022/0051(COD)
Proposal for a directive
Recital 59
Recital 59
(59) As regards civil liability rules, the civil liability of a company for damages arising due to its failure to carry out adequate due diligencethat it directly caused should be without prejudice to civil liability of its subsidiaries or the respective civil liability of direct and indirect business partnerbusiness in the valuesupply chain. Also, the civil liability rules under this Directive should be without prejudice to Union or national rules on civil liability related to adverse human rights impacts or to adverse environmental impacts that provide for liability in situations not covered by or providing for stricter liability than this Directive.
Amendment 483 #
2022/0051(COD)
Proposal for a directive
Recital 61
Recital 61
Amendment 484 #
2022/0051(COD)
Proposal for a directive
Recital 62
Recital 62
Amendment 485 #
2022/0051(COD)
Proposal for a directive
Recital 63
Recital 63
Amendment 486 #
2022/0051(COD)
Proposal for a directive
Recital 64
Recital 64
Amendment 493 #
2022/0051(COD)
Proposal for a directive
Recital 70
Recital 70
Amendment 495 #
2022/0051(COD)
Proposal for a directive
Recital 71
Recital 71
(71) The objective of this Directive, namely better exploiting the potential of the single market to contribute to the transition to a sustainable economy and contributing to sustainable development through the prevention and mitigation of potential or actual human rights and environmental adverse impacts in companies’ value chains, cannot be sufficiently achieved by the Member States acting individually or in an uncoordinated manner, but can rather, by reason of the scale and effects of the actions, be better achieved at Union level. In particular, addressed problems and their causes are of a transnational dimension, as many companies are operating Union wide or globally and value chains expand to other Member States and to third countries. Moreover, individuala growing number of individual and different Member States’ measures risk being ineffective, unworkable for companies to comply with, and lead to fragmentation of the internal market. Therefore, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.
Amendment 501 #
2022/0051(COD)
Proposal for a directive
Article 1 – paragraph 1 – subparagraph 1 – introductory part
Article 1 – paragraph 1 – subparagraph 1 – introductory part
This DirectiveRegulation lays down rules
Amendment 506 #
2022/0051(COD)
Proposal for a directive
Article 1 – paragraph 1 – subparagraph 1 – point a
Article 1 – paragraph 1 – subparagraph 1 – point a
(a) on obligations for companies regarding actual and potential human rights adverse impacts and environmental adverse impacts that they caused, contributed to or are directly linked to, with respect to their own operations, the operations of their subsidiaries, and the valuesupply chain operations carried out by entities with whom the company has an establishedtheir business relationships outside the EU and
Amendment 512 #
2022/0051(COD)
Proposal for a directive
Article 1 – paragraph 1 – subparagraph 1 – point b
Article 1 – paragraph 1 – subparagraph 1 – point b
(b) on liability for violations of the obligations mentioned abovedamages that occurred in the operations described above which a company directly intentionally or gross negligently caused.
Amendment 519 #
2022/0051(COD)
Proposal for a directive
Article 1 – paragraph 1 – subparagraph 2
Article 1 – paragraph 1 – subparagraph 2
Amendment 528 #
2022/0051(COD)
2a. Member States shall not introduce, in their national law, more stringent provisions than those laid down in this Directive, unless otherwise provided for in this Directive.
Amendment 536 #
2022/0051(COD)
Proposal for a directive
Article 2 – paragraph 1 – introductory part
Article 2 – paragraph 1 – introductory part
1. This Directive shall apply to companies which are formed in accordance with the legislation of a Member State and which fulfil one of the following conditions:had more than 3000 employees on average and had a net worldwide turnover of more than EUR 900 million in the last financial year for which annual financial statements have been prepared;
Amendment 540 #
2022/0051(COD)
Proposal for a directive
Article 2 – paragraph 1 – point a
Article 2 – paragraph 1 – point a
Amendment 549 #
2022/0051(COD)
Proposal for a directive
Article 2 – paragraph 1 – point b
Article 2 – paragraph 1 – point b
Amendment 596 #
2022/0051(COD)
Proposal for a directive
Article 2 – paragraph 2 – introductory part
Article 2 – paragraph 2 – introductory part
2. This Directive shall also apply to companies which are formed in accordance with the legislation of a third country, and fulfil one of the following conditions:have a domestic branch office or subsidiary in a Member State and which had at least 3000 employees and had a net worldwide turnover of more than EUR 900million in the last financial year for which annual financial statements have been prepared;.
Amendment 602 #
2022/0051(COD)
Proposal for a directive
Article 2 – paragraph 2 – point a
Article 2 – paragraph 2 – point a
Amendment 611 #
2022/0051(COD)
Proposal for a directive
Article 2 – paragraph 2 – point b
Article 2 – paragraph 2 – point b
Amendment 632 #
2022/0051(COD)
Proposal for a directive
Article 2 – paragraph 4 a (new)
Article 2 – paragraph 4 a (new)
4a. In case of group of companies: (a) the parent company, whether or not it meets the thresholds mentioned in paragraphs 1 or 2,may perform the obligations laid down in Article 4 as well as in Article 15 and16 on behalf of any or all its subsidiaries which meet the said thresholds; (b) any subsidiary shall be deemed in compliance with the obligations laid down in Article 4 where their parent company includes those subsidiaries in its due diligence corporate policy, and shall be deemed in compliance with the obligations laid down in Article 15 where their parent company includes those subsidiaries in the plan mentioned in Article 15(1). In this case, subsidiaries shall not be subject to Article 16
Amendment 635 #
2022/0051(COD)
Proposal for a directive
Article 2 – paragraph 4 a (new)
Article 2 – paragraph 4 a (new)
4a. In case of a group of companies: (a) the parent company, whether or not it meets the thresholds mentioned in paragraphs 1 or 2, may perform the Due Diligence obligations laid down in this Directive on behalf of any or all its subsidiaries which meet the thresholds in paragraph 1 or 2; (b) any subsidiary shall be deemed in compliance with the obligations laid down in this Directive where their parent company includes those subsidiaries in its due diligence corporate policy.
Amendment 649 #
Amendment 667 #
2022/0051(COD)
Proposal for a directive
Article 3 – paragraph 1 – point b
Article 3 – paragraph 1 – point b
(b) ‘adverse environmental impact’ means an adverse impact on the environment resulting from the violation of one of the prohibitions and obligations pursuant to the international environmental conventions listed in the Annex, Part II; inciples set out in the OECD Due Diligence Guidelines for Multinational Enterprises as clarified in the OECD Guidance for Responsible Business Conduct as regards the environment and climate.;
Amendment 676 #
2022/0051(COD)
(c) ‘adverse human rights impact’ means an adverse impact on protected persons that may impair the full enjoyment of human rights resulting from the violation of one of the prights or prohibitions listed in the Annex, Part I Section 1, as enshrined in the international conventions listed in the Annex, Part I Section 2nciples set out in the OECD Due Diligence Guidelines for Multinational Enterprises as clarified in the OECD Guidance for Responsible Business Conduct and the UN Guiding Principles on Business and Human Rights;
Amendment 682 #
2022/0051(COD)
Proposal for a directive
Article 3 – paragraph 1 – point c a (new)
Article 3 – paragraph 1 – point c a (new)
(ca) ‘adverse impact’ means an adverse environmental impact and adverse human rights impact;
Amendment 684 #
2022/0051(COD)
Proposal for a directive
Article 3 – paragraph 1 – point c b (new)
Article 3 – paragraph 1 – point c b (new)
(cb) ‘to cause an adverse impact’ means a company’s own actions that directly led to the adverse impact.
Amendment 685 #
2022/0051(COD)
Proposal for a directive
Article 3 – paragraph 1 – point c c (new)
Article 3 – paragraph 1 – point c c (new)
(cc) ‘to contribute to an adverse impact’ means a company’s own actions in combination with the activities of other entities cause an adverse impact, or if the activities of a company cause, facilitate or incentivise another entity to cause an adverse impact. Contribution must be substantial, meaning that it does not include minor or trivial contributions. The substantial nature of the contribution and understanding when the actions of the enterprise may have caused, facilitated or incentivised another entity to cause an adverse impact may involve the consideration of multiple factors. The following factors can be taken into account: – the extent to which an enterprise may encourage or motivate an adverse impact by another entity, i.e. the degree to which the activity increased the risk of the impact occurring. – the extent to which an enterprise could or should have known about the adverse impact or potential for adverse impact, i.e. the degree of foreseeability. – the degree to which any of enterprise’s activities actually mitigated the adverse impact or decreased the risk of the impact occurring. The mere existence of a business relationship or activities which create the general conditions in which it is possible for adverse impacts to occur does not necessarily represent a relationship of contribution. The activity in question should substantially increase the risk of adverse impact.
Amendment 687 #
2022/0051(COD)
Proposal for a directive
Article 3 – paragraph 1 – point c d (new)
Article 3 – paragraph 1 – point c d (new)
(cd) being ‘directly linked to an adverse impact’ means that there is a relationship between the adverse impact and the company’s products, services or operations through another business relationship. Directly linked is not defined by direct contractual relationships. Also, a direct linkage does not imply that the responsibility shifts from the entity causing an adverse impact to the enterprise with which it has a linkage.
Amendment 690 #
2022/0051(COD)
Proposal for a directive
Article 3 – paragraph 1 – point e – introductory part
Article 3 – paragraph 1 – point e – introductory part
(e) ‘direct business relationship’ means a business relationship with a direct contractor, subcontractor or any other legal entities (‘partner’)ual relation for the supply of goods or the provision of services whose supplies are necessary for the production of the enterprise’s product or the provision and use of the relevant service, which is relevant based on the severity and likelihood of adverse impacts and is outside the European Union.
Amendment 697 #
2022/0051(COD)
Proposal for a directive
Article 3 – paragraph 1 – point e – point i
Article 3 – paragraph 1 – point e – point i
Amendment 700 #
2022/0051(COD)
Proposal for a directive
Article 3 – paragraph 1 – point e – point ii
Article 3 – paragraph 1 – point e – point ii
Amendment 711 #
2022/0051(COD)
Proposal for a directive
Article 3 – paragraph 1 – point f
Article 3 – paragraph 1 – point f
(f) ‘establishedindirect business relationship’ means a business relationship, whether direct or indirect, which is, or which is expected to be lasting, in view of its intensity or duration and which does not represent a negligible or merely ancillary part of the value chaiich is not a direct supplier and whose supplies are necessary for the production of the enterprise’s product or the provision and use of the relevant service, which is relevant based on the severity and likelihood of adverse impacts and is outside the European Union;
Amendment 713 #
2022/0051(COD)
Proposal for a directive
Article 3 – paragraph 1 – point f
Article 3 – paragraph 1 – point f
(f) ‘establisheddirect business relationship’ means a business relationship, whether direct oich has been lasting for more than one year iandirect, which is, or which is expected to be lasting, in view of its intensity or duration and which does not represent a negligible or merely ancillary part of the value chaisignificant for the company’s operations or turnover based on the criteria indicated by the Commission;
Amendment 718 #
2022/0051(COD)
Proposal for a directive
Article 3 – paragraph 1 – point f a (new)
Article 3 – paragraph 1 – point f a (new)
Amendment 727 #
2022/0051(COD)
Proposal for a directive
Article 3 – paragraph 1 – point g
Article 3 – paragraph 1 – point g
(g) ‘valuesupply chain’ means activities related to the production and supply of goods or the provision of services by a company, including the development of the product or the service and the use and disposal of the product as well as the related activities of upstream and downstream established business relationships of the company. As regards companies within the meaning of point (a)(iv), ‘value chain’ with respect to the provision of these specific services shall only include the activities of the clients receiving such loan, c as far as these activities are dit, and other financial services and of other companies belonging to the same group whose activities are linked to the contract in question. The value chain of such regulated financial undertakings does not cover SMEs receiving loan, credit, financing, insurance or reinsurance of such entities;rectly necessary for the production of the goods or the provision of the services.
Amendment 734 #
2022/0051(COD)
Proposal for a directive
Article 3 – paragraph 1 – point g a (new)
Article 3 – paragraph 1 – point g a (new)
(ga) ‘leverage’ means the ability of a company, depending on size and importance to supplier’s revenue or the functioning of its business operations, to affect change in the wrongful practices of the entity that causes or contributes to the adverse impact in the supply chain;
Amendment 746 #
2022/0051(COD)
Proposal for a directive
Article 3 – paragraph 1 – point h a (new)
Article 3 – paragraph 1 – point h a (new)
(ha) For the purposes of point (h), the Commission shall adopt a delegated act in accordance with Article 28 to specify the minimum standards for the independent third-party verification;
Amendment 753 #
2022/0051(COD)
Proposal for a directive
Article 3 – paragraph 1 – point j a (new)
Article 3 – paragraph 1 – point j a (new)
(ja) For the purposes of point (j), the Commission shall adopt a delegated act in accordance with Article 14b and 28 to specify the minimum standards for the industry initiative to be recognised by one Member States as feasible;
Amendment 754 #
2022/0051(COD)
Proposal for a directive
Article 3 – paragraph 1 – point l
Article 3 – paragraph 1 – point l
Amendment 765 #
2022/0051(COD)
Proposal for a directive
Article 3 – paragraph 1 – point n
Article 3 – paragraph 1 – point n
(n) ‘stakeholders’ means the company’s employees, the employees of its subsidiaries, employees within its supply chain and other relevant individuals, groups, communities or entities whose rights or vested interests are or could be directly affected by the potential and actual adverse environmental and human rights impacts connected to the products, services and operations of that company, its subsidiaries and its business relationships;
Amendment 776 #
2022/0051(COD)
Proposal for a directive
Article 3 – paragraph 1 – point o
Article 3 – paragraph 1 – point o
Amendment 781 #
2022/0051(COD)
Proposal for a directive
Article 3 – paragraph 1 – point p
Article 3 – paragraph 1 – point p
Amendment 785 #
2022/0051(COD)
Proposal for a directive
Article 3 – paragraph 1 – point q
Article 3 – paragraph 1 – point q
(q) ‘appropriate measure’ means a measure that is capable of achieving the objectives of due diligence, commensurate with the degree of severity and the likelihood of the adverse impact, and proportionate to the size, reasonably available tources and capacities of the company, taking into account the circumstances of the specific case, including characteristics of the economic sector and of the specific business relationship and the company’s influence thereof, and the need to ensure prioritisation of actionleverage in that relationship, and the principle of risk-based prioritisation of action. Companies are not required to guarantee, in all circumstances, that adverse impacts will never occur or that they will be stopped. The main obligations in this Directive are obligations of means;
Amendment 787 #
2022/0051(COD)
Proposal for a directive
Article 3 – paragraph 1 – point q a (new)
Article 3 – paragraph 1 – point q a (new)
(qa) ‘Group’ means a parent company and all its subsidiary undertakings as defined by Article 2 of the Directive 2013/34/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 June 2013 on the annual financial statements, consolidated financial statements and related reports of certain types of undertakings, amending Directive 2006/43/EC of the European Parliament and of the Council and repealing Council Directives 78/660/EEC and83/349/EE;
Amendment 795 #
2022/0051(COD)
Proposal for a directive
Article 3 – paragraph 1 – point q c (new)
Article 3 – paragraph 1 – point q c (new)
(qc) ‘risk factors’ means enterprise- level risk factors, geographic risk factors, and sectoral risk factors. The Commission shall prepare a list of risk factors with accompanying guidance as described in Article 13;
Amendment 796 #
2022/0051(COD)
Proposal for a directive
Article 3 – paragraph 1 – point q d (new)
Article 3 – paragraph 1 – point q d (new)
(qd) ‘Group’ means a parent company and all its subsidiary undertakings as defined by Article 2 of the Directive 2013/34/EU of 26 June 2013 on the annual financial statements, consolidated financial statements and related reports of certain types of undertakings, amending Directive 2006/43/EC of the European Parliament and of the Council and repealing Council Directives 78/660/EEC and83/349/EE;
Amendment 802 #
2022/0051(COD)
Proposal for a directive
Article 4 – paragraph 1 – introductory part
Article 4 – paragraph 1 – introductory part
1. Member States shall ensure that companies conduct risk-based human rights and environmental due diligence as laid down in Articles 5 to 11 (‘due diligence’) by carrying out the following actions:
Amendment 804 #
2022/0051(COD)
Proposal for a directive
Article 4 – paragraph 1 – point b
Article 4 – paragraph 1 – point b
(b) identifying and prioritising actual or potential adverse impacts that they caused or contributed to or are directly linked to in accordance with Article 6;
Amendment 808 #
2022/0051(COD)
Proposal for a directive
Article 4 – paragraph 1 – point c
Article 4 – paragraph 1 – point c
(c) preventing andor mitigating potential adverse impacts that they caused or contributed to, and bringing actual adverse impacts to an end andhat they caused or contributed to an end or minimising their extent in accordance with Articles 7 and 8;
Amendment 812 #
2022/0051(COD)
Proposal for a directive
Article 4 – paragraph 1 – point d
Article 4 – paragraph 1 – point d
(d) establishing and maintaining a complaintsnotification procedure in accordance with Article 9;
Amendment 825 #
2022/0051(COD)
Proposal for a directive
Article 4 – paragraph 2
Article 4 – paragraph 2
2. Member States shall ensure thatThe Commission shall provide indications, for the purposes of due diligence, on how and to which extent companies are entitled to share resources and information within their respective groups of companies and with other legal entities in compliance with applicable competition law.
Amendment 835 #
2022/0051(COD)
Proposal for a directive
Article 5 – paragraph 1 – introductory part
Article 5 – paragraph 1 – introductory part
1. Member States shall ensure that companies integrate due diligence into all their relevant corporate policies and have in place a due diligence policy. The due diligence policy shall contain all of the following:
Amendment 848 #
2022/0051(COD)
Proposal for a directive
Article 5 – paragraph 1 – point c
Article 5 – paragraph 1 – point c
(c) a description of the processes put in place to implement due diligence, including, where relevant, the measures taken to verify compliance with the code of conduct and to extend its application to established business relationships;
Amendment 860 #
2022/0051(COD)
Proposal for a directive
Article 5 – paragraph 2
Article 5 – paragraph 2
2. Member States shall ensure that the companies continuously update their due diligence policy annuallywhen significant changes occur.
Amendment 865 #
2022/0051(COD)
Proposal for a directive
Article 5 – paragraph 2 a (new)
Article 5 – paragraph 2 a (new)
2a. Companies shall carry out a due diligence policy which is proportionate and commensurate to the likelihood and severity of their potential or actual adverse impacts and their specific circumstances and risk factors, particularly their sector and location of activity, the size and length of their supply chain, the size of the company, its capacity, resources and leverage.
Amendment 872 #
2022/0051(COD)
Proposal for a directive
Article 6 – title
Article 6 – title
Identifying and prioritising actual and potential adverse impacts
Amendment 876 #
2022/0051(COD)
Proposal for a directive
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Member States shall ensure that companies take appropriate measures to identifywithin their means to identify whether they cause or contribute to or are directly linked to actual and potential adverse human rights impacts and adverse environmental impacts arising from their own operations or those of their subsidiaries and, w in their business relationships. Where related to their valuesupply chains, from their established business relationships, in accordance with paragraph 2, 3 and 4companies shall assess adverse impacts arising from their direct business relationships located outside the EU that they cause or contribute to. In case of substantiated knowledge, companies shall assess adverse impacts arising from their indirect business relationships outside the EU that they are directly linked to, in accordance with paragraph 2, 3 and 4. In cases where an enterprise has structured a direct business relationship in an improper manner or has engaged in a transaction in order to circumvent the due diligence obligations with regard to the direct supplier, an indirect business relationship is deemed to be a direct business relationship.
Amendment 884 #
2022/0051(COD)
Proposal for a directive
Article 6 – paragraph 1 a (new)
Article 6 – paragraph 1 a (new)
1a. Companies shall identify whether they cause, contribute to or are directly linked to actual and potential adverse human rights impacts and adverse environmental impacts based on a risk assessment and risk-based monitoring methodology, taking into account the likelihood, severity and urgency of adverse impacts, the nature and context of their operations, including sector and geographic location based on the Commission guidelines set out in Article 13. Companies only need to assess business relationships outside the EU and only where risk factors are likely.
Amendment 885 #
2022/0051(COD)
Proposal for a directive
Article 6 – paragraph 1 a (new)
Article 6 – paragraph 1 a (new)
1a. Member States shall ensure that companies are allowed to prioritise adverse human rights impacts and adverse environmental impacts arising from their own operations, those of their subsidiaries or those of their established business partners identified pursuant to paragraph 1 for fulfilling the obligations laid down in Articles 7 or 8, where it is not feasible to address all identified adverse impacts at the same time to the full extent.
Amendment 888 #
2022/0051(COD)
Proposal for a directive
Article 6 – paragraph 1 b (new)
Article 6 – paragraph 1 b (new)
1b. Where a company is not in a position to identify all potential or actual adverse impacts that it caused, contributed to or is directly linked to at the same time, it shall prioritise risk factors based on their severity. Risk assessments under this article shall take into account the perspective of stakeholders where relevant.
Amendment 889 #
2022/0051(COD)
Proposal for a directive
Article 6 – paragraph 1 b (new)
Article 6 – paragraph 1 b (new)
1b. The prioritisation of adverse impacts shall be based on severity and likelihood of the adverse impact. Severity of an adverse impact shall be assessed based on its scale, scope and irremediable character.
Amendment 891 #
2022/0051(COD)
Proposal for a directive
Article 6 – paragraph 1 c (new)
Article 6 – paragraph 1 c (new)
1c. If a company concludes that it does not cause, contribute to, or that it is not directly linked to any potential or actual adverse impact, it shall publish a statement to that effect on its website (in accordance with Art. 11) and shall thus be considered in compliance with the Directive. In particular, that company may conclude that it has encountered no adverse impacts on human rights or the environment if its impacts identification determines that its direct suppliers perform due diligence in line with this directive. That statement shall be reviewed in the event that new risks emerge or in the event of that company entering into new business relationships that can pose risks.
Amendment 892 #
2022/0051(COD)
Proposal for a directive
Article 6 – paragraph 1 d (new)
Article 6 – paragraph 1 d (new)
1d. Companies are encouraged to take these measures in cooperation with industry initiatives.
Amendment 893 #
2022/0051(COD)
Proposal for a directive
Article 6 – paragraph 2
Article 6 – paragraph 2
Amendment 895 #
2022/0051(COD)
Proposal for a directive
Article 6 – paragraph 2
Article 6 – paragraph 2
Amendment 902 #
2022/0051(COD)
Proposal for a directive
Article 6 – paragraph 3
Article 6 – paragraph 3
Amendment 909 #
2022/0051(COD)
Proposal for a directive
Article 6 – paragraph 4
Article 6 – paragraph 4
4. Member States shall ensure that, for the purposes of identifying and prioritising the adverse impacts referred to in paragraph 1 based on, where appropriate, quantitative and qualitative information, companies are entitled to make use of appropriate resources, including independent reports and information gathered through the complaintsnotification procedure provided for in Article 9. Companies shall, where relevant, also carry out consultations engage with potentially affected groups including workers and other relevant stakeholders to gather information on actual or potential adverse impacts.
Amendment 916 #
2022/0051(COD)
Proposal for a directive
Article 6 – paragraph 4 a (new)
Article 6 – paragraph 4 a (new)
4a. In the event that not all the necessary information regarding its supply chain is available, the parent company shall explain the efforts made to obtain the necessary information about its supply chain, the reasons why not all of the necessary information could be obtained, and its plans to obtain the necessary information in the future.
Amendment 925 #
2022/0051(COD)
Proposal for a directive
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Member States shall ensure that companies take appropriate proportionate and commensurate measures to prevent, or where prevention is not possible or not immediately possible, adequately mitigate potential adverse human rights impacts and adverse environmental impacts that have been, or shouldthey cause or contribute to and that have been, identified pursuant to Article 6, in accordance with paragraphs 2, 3, 4 and 5 of this Article. Companies that are directly linked to potential adverse impacts without causing or contributing to them are required to make use of their leverage to the extent possible to mitigate adverse impacts.
Amendment 933 #
2022/0051(COD)
Proposal for a directive
Article 7 – paragraph 2 – point a
Article 7 – paragraph 2 – point a
(a) where necessary due to the nature or complexity of the measures required for prevention, develop and implement a prevention action plan, with reasonable and clearly defined timelines for action and qualitative and quantitative indicators for measuonitoring improvement. The prevention action plan shall be developed in consultationmeaningful engagement with affected stakeholders where relevant; companies are encouraged to develop their action plans in cooperation with industry initiatives;
Amendment 937 #
2022/0051(COD)
Proposal for a directive
Article 7 – paragraph 2 – point a a (new)
Article 7 – paragraph 2 – point a a (new)
Amendment 940 #
2022/0051(COD)
Proposal for a directive
Article 7 – paragraph 2 – point a b (new)
Article 7 – paragraph 2 – point a b (new)
(ab) Companies shall apply best efforts to develop and use purchase policies that do not encourage potential adverse impacts on human rights the environment.
Amendment 945 #
2022/0051(COD)
Proposal for a directive
Article 7 – paragraph 2 – point b
Article 7 – paragraph 2 – point b
(b) seekmay seek, where appropriate, contractual or other assurances, from a business partner with whom it has a direct business relationship located outside the EU that it will ensure compliance with the company’s code of conduct and, as necessary, a prevention action plan, including by seeking corresponding contractual assurances from its partners, to the extent that their activities are part of the company’s value chain ( and by requesting information on their suppliers if possible; Member States shall ensure that the general due diligence duty prevails over contractual cascading).surances; When such contractual assurances are obtained, paragraph 4 shall apply;
Amendment 956 #
2022/0051(COD)
Proposal for a directive
Article 7 – paragraph 2 – point d
Article 7 – paragraph 2 – point d
(d) provide targeted and proportionate supportfinancial and administrative support, especially for an SME with which the company has an established business relationship, where compliance with the code of conduct or the prevention action plan would jeopardise the viability of the SME outside the EU;
Amendment 962 #
2022/0051(COD)
Proposal for a directive
Article 7 – paragraph 2 – point e
Article 7 – paragraph 2 – point e
(e) in compliance with Union law including competition law, collaborate with other entities, sectoral approaches or industry initiatives, including, where relevant, to increase the company’s ability to bring the adverse impact to an end, in particular where no other action is suitable or effective;
Amendment 972 #
2022/0051(COD)
Proposal for a directive
Article 7 – paragraph 3
Article 7 – paragraph 3
3. As regards potential adverse impacts that could not be prevented or adequately mitigated by the measures in paragraph 2, the company that is directly linked to the adverse impact may seek to conclude a contract with a partner with whom it has an indirect relationship outside the EU that was identified in accordance with Article 6 due to substantiated knowledge of potential adverse impacts, with a view to achieving compliance with the company’s code of conduct or a prevention action plan. When such a contract is concluded, paragraph 4 shall apply.
Amendment 979 #
2022/0051(COD)
Proposal for a directive
Article 7 – paragraph 4 – subparagraph 1
Article 7 – paragraph 4 – subparagraph 1
Amendment 980 #
2022/0051(COD)
Proposal for a directive
Article 7 – paragraph 4 – subparagraph 1
Article 7 – paragraph 4 – subparagraph 1
The contractual assurances or the contract shall be accompanied by thempany shall endeavour to include, within the contractual assurances or the contract, appropriate measures to verify compliance. For the purposes of verifying compliance, the company may refer to suitable industry initiatives or independent third-party verification.
Amendment 984 #
2022/0051(COD)
Proposal for a directive
Article 7 – paragraph 4 – subparagraph 2
Article 7 – paragraph 4 – subparagraph 2
When contractual assurancesassurances, including contractual, are obtained from, or a contract is entered into, with an SME outside the EU, the terms used shall be fair, reasonable and non-discriminatory. Where measures are carried out to verify compliance are carried out in relation to SMEs, the company shall bearof assurances obtained from SMEs outside the EU, the cost of the independent third- party verification should be provided by public funds.
Amendment 990 #
2022/0051(COD)
Proposal for a directive
Article 7 – paragraph 5
Article 7 – paragraph 5
Amendment 1015 #
2022/0051(COD)
Proposal for a directive
Article 7 – paragraph 6
Article 7 – paragraph 6
Amendment 1019 #
2022/0051(COD)
Proposal for a directive
Article 8 – paragraph 1
Article 8 – paragraph 1
1. Member States shall ensure that companies take appropriate measures to bring actual adverse impacts that have been, or shouldproportionate and commensurate measures within their means to bring actual adverse impacts that they have caused or contributed to and that have been, identified pursuant to Article 6 to an end, in accordance with paragraphs 2 to 6 of this Article. Companies that are directly linked to the actual adverse impact without causing or contributing to it are required to make use of their leverage to the extent possible to bring actual adverse impacts to an end.
Amendment 1021 #
2022/0051(COD)
Proposal for a directive
Article 8 – paragraph 1 a (new)
Article 8 – paragraph 1 a (new)
1a. When domestic laws requirements are in conflict with international conventions listed in the annex, the company should seek ways to respect these conventions to the extent possible which does not place it in violation of domestic law and should take all reasonable steps to avoid human rights violations. In case of adverse impacts resulting from such conflict, this shall be taken into account by the authorities in assessing the measures taken by companies under the Directive.
Amendment 1027 #
2022/0051(COD)
Proposal for a directive
Article 8 – paragraph 2
Article 8 – paragraph 2
2. Where the adverse impact cannot be brought to an end, Member States shall ensure that companies take measures within their means to minimise the extent of such an impact.
Amendment 1037 #
2022/0051(COD)
Proposal for a directive
Article 8 – paragraph 3 – point a
Article 8 – paragraph 3 – point a
(a) neutralise the adverse impact or minimise its extent, including by the payment of damages to the affected persons and of financial compensation to the affected communities. The action shall be proportionate and commensurate to the significance and scale of the adverse impact and to the contribution of the company’s conduct to the adverse impact, as well as to its resources and leverage;
Amendment 1045 #
2022/0051(COD)
Proposal for a directive
Article 8 – paragraph 3 – point b
Article 8 – paragraph 3 – point b
(b) where necessary due to the fact that the adverse impact cannot be immediately brought to an end, develop and implement a corrective action plan with reasonable and clearly defined timelines for action and qualitative and quantitative indicators for measuonitoring improvement. Where relevant, tThe corrective action plan shall be developed in consultationthrough meaningful engagement with stakeholders;
Amendment 1047 #
2022/0051(COD)
Proposal for a directive
Article 8 – paragraph 3 – point b a (new)
Article 8 – paragraph 3 – point b a (new)
(ba) set up a prioritisation strategy on the basis of Principle 17 of the UN Guiding Principles on Business and Human Rights based on risk factors. Companies shall consider the level of severity, likelihood and urgency of the different actual adverse impacts on human rights or the environment, the nature and context of their operations, including geographic, the scope of the risks, their scale and how irremediable they might be, and use the prioritisation policy in dealing with them. When prioritising their response to risks to human rights, companies shall treat the severity of an adverse impact, such as where a delayed response would make the impact irremediable, as the predominant factor.
Amendment 1052 #
2022/0051(COD)
Proposal for a directive
Article 8 – paragraph 3 – point c
Article 8 – paragraph 3 – point c
(c) seekmay seek, where appropriate, contractual or other assurances from a direct partner with whom it has an established direct business relationship outside the EU that it will ensure compliance with the code of conduct and, as necessary, a corrective action plan, including by seeking corresponding contractual assurances from its partners, to the extent that they are part of the value chain ( and by requesting information on their suppliers if possible. Member States shall ensure that the general due diligence duty prevails over contractual cascading)surances. When such contractual assurances are obtained, paragraph 5 shall apply.
Amendment 1057 #
2022/0051(COD)
Proposal for a directive
Article 8 – paragraph 3 – point d
Article 8 – paragraph 3 – point d
(d) make necessary, where appropriate, investments, such as into management or production processes and infrastructures to comply with paragraphs 1, 2 and 3;
Amendment 1063 #
2022/0051(COD)
Proposal for a directive
Article 8 – paragraph 3 – point e
Article 8 – paragraph 3 – point e
(e) provide targeted and proportionate supportfinancial and administrative support, especially for an SME with which the company has an established direct business relationship, where compliance with the code of conduct or the corrective action plan would jeopardise the viability of the SME outside the EU;
Amendment 1069 #
2022/0051(COD)
Proposal for a directive
Article 8 – paragraph 3 – point f
Article 8 – paragraph 3 – point f
(f) in compliance with Union law including competition law, collaborate with other entities, sectoral approaches or industry initiatives, including, where relevant, to increase the company’s ability to bring the adverse impact to an end, in particular where no other action is suitable or effective.
Amendment 1076 #
2022/0051(COD)
Proposal for a directive
Article 8 – paragraph 4
Article 8 – paragraph 4
4. As regards actual adverse impacts that could not be brought to an end or adequately mitigated by the measures in paragraph 3, the company that is directly linked to the impact may seek to conclude a contract, where appropriate, with a partner with whom it has an indirect relationship outside the EU that was identified in accordance with Article 6 due to substantiated knowledge of actual adverse impacts, with a view to achieving compliance with the company’s code of conduct or a corrective action plan. When such a contract is concluded, paragraph 5 shall apply.
Amendment 1080 #
2022/0051(COD)
Proposal for a directive
Article 8 – paragraph 5 – subparagraph 1
Article 8 – paragraph 5 – subparagraph 1
Amendment 1084 #
2022/0051(COD)
Proposal for a directive
Article 8 – paragraph 5 – subparagraph 2
Article 8 – paragraph 5 – subparagraph 2
When contractual assurancesassurances, including contractual, are obtained from, or a contract is entered into, with an SMEother company, the terms used shall be fair, reasonable and non- discriminatory. Where measures to verify compliance are carried out in relation to SMEs, the company shall bear the cost of the independent third- party verification should be provided by public funds.
Amendment 1089 #
2022/0051(COD)
Proposal for a directive
Article 8 – paragraph 6 – subparagraph 1 – introductory part
Article 8 – paragraph 6 – subparagraph 1 – introductory part
As regards actual adverse impacts within the meaning of paragraph 1 that could not be brought to an end or the extent of which could not be minimised by the measures provided for in paragraphs 3, 4 and 5, the company shall refrain from entering into new or extending existing relations with the partner in connection to or in the value chain of which the impact has arisen and shall, where the law governing their relations so entitles them tomay, after having taken into account potential social and economic adverse impacts and having evaluated actual and potential human rights impact related to its decision, take oneany of the following actions:
Amendment 1091 #
2022/0051(COD)
Proposal for a directive
Article 8 – paragraph 6 – subparagraph 1 – introductory part
Article 8 – paragraph 6 – subparagraph 1 – introductory part
As regards actual adverse impacts within the meaning of paragraph 1 that the company caused or contributed to and that could not be brought to an end or the extent of which could not be minimised by the measures provided for in paragraphs 3, 4 and 5 and despite repeated efforts, the company shall refrain from entering into new or extending existing relations with the partner in connection to or in the valuesupply chain of which the impact has arisen and shall, as a measure of last resort, where the law governing their relations so entitles them to, take one of the following actions and where the impact is considered extremely severe or irreversible, take the following actions, in line with responsible disengagement, taking into account the best interest of those impacted:
Amendment 1097 #
2022/0051(COD)
Proposal for a directive
Article 8 – paragraph 6 – subparagraph 1 – point b
Article 8 – paragraph 6 – subparagraph 1 – point b
(b) terminate the business relationship with respect to the activities concerned, if the adverse impact is considered severe.;
Amendment 1098 #
2022/0051(COD)
Proposal for a directive
Article 8 – paragraph 6 – subparagraph 1 – point b
Article 8 – paragraph 6 – subparagraph 1 – point b
(b) if suspension does not lead to a sufficient result, terminate the business relationship with respect to the activities concerned, if the adverse impact is consid. Member States shall provide for the availability of an option to terminate the business relationship in contracts governed severeby their laws.
Amendment 1102 #
2022/0051(COD)
Proposal for a directive
Article 8 – paragraph 6 – subparagraph 1 – point b a (new)
Article 8 – paragraph 6 – subparagraph 1 – point b a (new)
(ba) refrain from entering into new or extending existing relations with the partner in connection to or in the value chain of which the impact has arisen.
Amendment 1111 #
2022/0051(COD)
Proposal for a directive
Article 8 – paragraph 6 – subparagraph 2
Article 8 – paragraph 6 – subparagraph 2
Amendment 1118 #
2022/0051(COD)
Proposal for a directive
Article 8 – paragraph 7
Article 8 – paragraph 7
Amendment 1134 #
2022/0051(COD)
Proposal for a directive
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Member States shall ensure that companies provide the possibility for persons and organisations listed in paragraph 2 to submit complaints tonotify them where they have legitimate concernsinformation regarding actual or potential adverse human rights impacts and adverseand environmental impacts with respect to their own operations, the operations of their subsidiaries and their valuesupply chains. This can be done in cooperation with industry initiatives.
Amendment 1142 #
2022/0051(COD)
Proposal for a directive
Article 9 – paragraph 1 a (new)
Article 9 – paragraph 1 a (new)
1a. Member States shall ensure that notification procedures are legitimate, accessible, predictable, equitable, transparent, rights compatible and a source of continuous learning based on engagement and dialogue.
Amendment 1154 #
2022/0051(COD)
Proposal for a directive
Article 9 – paragraph 2 – introductory part
Article 9 – paragraph 2 – introductory part
2. Member States shall ensure that the complaintnotifications may be submitted by:
Amendment 1164 #
2022/0051(COD)
Proposal for a directive
Article 9 – paragraph 2 – point b
Article 9 – paragraph 2 – point b
(b) trade unions and other workers’ representatives representing individuals working in the valuesupply chain concerned,
Amendment 1171 #
2022/0051(COD)
Proposal for a directive
Article 9 – paragraph 2 – point c
Article 9 – paragraph 2 – point c
(c) civil society organisations active in the areas related to the valuesupply chain concerned.
Amendment 1177 #
2022/0051(COD)
Proposal for a directive
Article 9 – paragraph 3
Article 9 – paragraph 3
3. Member States shall ensure that the companies establish a procedure for dealing with complaintnotifications referred to in paragraph 1, including a procedure when the company considers the complaintinformation to be unfounded, and inform the relevant workers and trade unions of those procedures. Member States shall ensure that where the complaintinformation is well- founded, the adverse impact that is the subject matter of the complaintnotification is deemed to be identified within the meaning of Article 6. This can be done in cooperation with industry initiatives.
Amendment 1183 #
2022/0051(COD)
Proposal for a directive
Article 9 – paragraph 4 – introductory part
Article 9 – paragraph 4 – introductory part
4. Member States shall ensure that complainants are entitledIn case the notification proves to be well founded, Member States shall ensure that informants are entitled to request appropriate follow-up on the notification from the company with which they have filed a notification pursuant to paragraph 1.
Amendment 1192 #
2022/0051(COD)
Proposal for a directive
Article 9 – paragraph 4 – point a
Article 9 – paragraph 4 – point a
Amendment 1195 #
2022/0051(COD)
Proposal for a directive
Article 9 – paragraph 4 – point b
Article 9 – paragraph 4 – point b
Amendment 1214 #
2022/0051(COD)
Proposal for a directive
Article 10 – paragraph 1
Article 10 – paragraph 1
Member States shall ensure that companies carry out periodiccontinuous assessments of their own operations and measures, those of their subsidiaries and, where related to the valuesupply chains of the company, those of their established business relationships, to monitor the effectiveness of the identification, prevention, mitigation, bringing to an end and minimisation of the extent of human rights and environmental adverse impacts. Such assessments shall be based, where appropriate, on qualitative and quantitative indicators and be carried out at least every 12 monthscontinuously and whenever there are reasonable grounds to believe that significant new risks of the occurrence of those adverse impacts may arise. The due diligence policy shall be updated in accordance with the outcome of those assessments.
Amendment 1223 #
2022/0051(COD)
Proposal for a directive
Article 11 – paragraph 1
Article 11 – paragraph 1
Member States shall ensure that companies that are not subject to reporting requirements under Articles 19a and 29a of Directive 2013/34/EU report on the matters covered by this Directive by publishing on their website an annual statement in a language customary in tone of the official languages of the Union. When sphere of international business. The statement shall be published by 30 April each year, covering the previous calendar yearignificant changes occur, the statement shall be updated.
Amendment 1230 #
2022/0051(COD)
Proposal for a directive
Article 11 – paragraph 1 a (new)
Article 11 – paragraph 1 a (new)
The companies referred to in paragraph 1 may rely on the consolidated reporting of the group to which they belong in order to fulfil their reporting requirements under this Article.
Amendment 1238 #
2022/0051(COD)
Proposal for a directive
Article 11 – paragraph 2
Article 11 – paragraph 2
The Commission shall adopt delegated acts in accordance with Article 14b and 28 concerning the content and criteria for such reporting under paragraph 1, specifying information on the description of due diligence, potential and actual adverse impacts and actions taken on those.
Amendment 1262 #
2022/0051(COD)
Proposal for a directive
Article 13 – paragraph 1
Article 13 – paragraph 1
In order to provide support to companies or 1. to Member State authorities on how companies should fulfil their due diligence obligations, the Commission, in consultation with Member States and relevant stakeholders, including from third countries, the European Union Agency for Fundamental Rights, the European Environment Agency, the External Action Service, the European Innovation Council and Small and Medium-sized Enterprises Executive Agency (EISMEA) and where appropriate with the OECD and other international bodies having expertise in due diligence, may issue guidelines, including for specific sectors or specific adverse impacts. shall issue clear and easily understandable guidelines in the form of targeted guidance where applicable to facilitate compliance in a practical manner: (a) in digital, free of charge and easily accessible format; (b) including on existing digital solutions to be used for the due diligence process and on the development of digital solutions; (c) including on the implementation of the human rights and environmental standards applicable to businesses based on the OECD Guidelines for Multinational Enterprises as clarified in the Due Diligence Guidance as well as the UNGPs; (d) including lists of risk factors and accompanying guidance, including enterprise-level risk factors, geographic risk factors and sectoral risk factors; (e) including an overview on applicable industry initiatives; (f) including practical guidance on how proportionality and prioritisation, in terms of impacts, sectors and geographical areas, may be applied to due diligence obligations depending on the size and sector of the company; (g) including taking into account SMEs needs. 2. The guidelines shall be made available no later than ... [18 months after the date of entry into force of this Directive]. The Commission shall periodically review the relevance of its guidelines and adapt them to new best practices. 3. Country fact-sheets shall be updated regularly by the Commission and made publicly available in order to provide up-to-date information on the international Conventions and Treaties ratified by each of the Union’s trading partners. The Commission shall collect and publish trade and customs data on origins of raw materials, and intermediate and finished products, and publish information on human rights, environmental and governance potential or actual adverse impacts risks associated with certain countries or regions, sectors and sub-sectors, and products.
Amendment 1278 #
2022/0051(COD)
Proposal for a directive
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The Commission in cooperation with Member States shall, in order to provide information and support to companies and the partners with whom they have established business relationships in their valuesupply chains in their efforts to fulfil the obligations resulting from this Directive, set up and operate individually or jointly dedicated websites, platforms or portals. Specific consideration shall be given, in that respect, to the SMEs that are present in the valuesupply chains of companies.
Amendment 1282 #
2022/0051(COD)
Proposal for a directive
Article 14 – paragraph 1 a (new)
Article 14 – paragraph 1 a (new)
1a. The Commission in cooperation with Member States shall undertake efforts in order to provide information and support to stakeholders and their representatives to exercise their involvement in due diligence. This shall include setting up and operating individually or jointly dedicated websites, platforms or portals.
Amendment 1288 #
2022/0051(COD)
Proposal for a directive
Article 14 – paragraph 3
Article 14 – paragraph 3
3. The Commission mayshall complement Member States’ support measures building on existing Union action to support due diligence in the Union and in third countries and may devise new measures, including facilitation of joint stakeholder initiatives to help companies fulfil their obligations.
Amendment 1290 #
2022/0051(COD)
Proposal for a directive
Article 14 – paragraph 3 a (new)
Article 14 – paragraph 3 a (new)
3a. The Commission may rely on its cooperation and trade instruments to support the development of the enabling environment in third countries, through capacity building and expertise that will reinforce their economic sector to comply with due diligence obligations as set out in this Directive.
Amendment 1299 #
2022/0051(COD)
4. Companies may rely on industry schemes and multi-stakeholder initiatives to support the implementation of their obligations referred to in Articles 5 to 11 of this Directive to the extent that such schemes and initiatives are appropriate to support the fulfilment of those obligations. The Commission and the Member States mayshall facilitate the dissemination of information on such schemes or initiatives and their outcome. The Commission, in collaboration with Member States, may and the OECD as well as relevant stakeholders, shall issue guidance for assessing the fitness of industry schemes and multi-stakeholder initiativesinitiatives in line with Article 14c.
Amendment 1307 #
2022/0051(COD)
Proposal for a directive
Article 14 a (new)
Article 14 a (new)
Article 14a Single Point of Contact 1. Each Member State shall designate a national single point of contact on corporate sustainability due diligence. Member States may assign this role to an existing authority. Where a Member State designates only one competent authority, that competent authority may also be the single point of contact. 2. Companies may seek additional guidance and obtain further support and information about how best to fulfil their due diligence obligations through this point of contact. 3. The single point of contact may also exercise a liaison function to ensure cross-border cooperation of Member State authorities and with the relevant authorities in other Member States via cooperation with the European Supervisory Network established in Article 21.
Amendment 1309 #
2022/0051(COD)
Proposal for a directive
Article 14 c (new)
Article 14 c (new)
Amendment 1313 #
2022/0051(COD)
Proposal for a directive
Article 15
Article 15
Amendment 1344 #
2022/0051(COD)
Proposal for a directive
Article 17 – paragraph 3 – subparagraph 1
Article 17 – paragraph 3 – subparagraph 1
As regards companies referred to in Article 2(2), the competent supervisory authority shall be that of the Member State in which the company has a branch. If the company does not have a branch in any Member State, or has branches located in different Member States, the competent supervisory authority shall be the supervisory authority of the Member State in which the company generated most of its net turnover in the Union in the financial year preceding the last financial year before the date indicated in Article 30 or the date on which the company first fulfils the criteria laid down in Article 2(2), whichever comes last or subsidiary.
Amendment 1391 #
2022/0051(COD)
Proposal for a directive
Article 18 – paragraph 6
Article 18 – paragraph 6
Amendment 1400 #
2022/0051(COD)
Proposal for a directive
Article 19 – paragraph 1
Article 19 – paragraph 1
1. Member States shall ensure that natural and legal personsstakeholders as referred to in Article 9 para.2 are entitled to submit substantiated concerns to any supervisory authority when they have reasons to believe, on the basis of objective circumstances, that a company is failing to comply with the national provisions adopted pursuant to this Directive (‘substantiated concerns’)Articles 6 to 11 and Article 15(1) and (2) of this Directive (‘substantiated concerns’), if the notification procedure referred to in Article 9 did not have a satisfactory outcome.
Amendment 1402 #
2022/0051(COD)
Proposal for a directive
Article 19 – paragraph 1
Article 19 – paragraph 1
1. Member States shall ensure that natural and legal persons are entitled to submit substantiated concerns to any supervisory authority when they have reasons to believe, on the basis of objective circumstances, that a company is failing to comply with the national provisions adopted pursuant to Articles 4 to 14 of this Directive (‘substantiated concerns’).
Amendment 1417 #
Amendment 1419 #
2022/0051(COD)
Proposal for a directive
Article 20 – paragraph 1
Article 20 – paragraph 1
1. Member States shall lay down the rules on administrative sanctions applicable to infringements of national provisions adopted pursuant to this Directive, and shall take all measures necessary to ensure that they are implemented. The sanctions provided for shall be effective, proportionate and dissuasive. At least the following administrative measures and sanctions shall be provided for: (a) a public statement indicating company responsible and the nature of the infringement; (b) an order requiring the company responsible to cease the conduct constituting the infringement and to desist from any repetition of that conduct; (c) administrative pecuniary sanctions.
Amendment 1423 #
2022/0051(COD)
Proposal for a directive
Article 20 – paragraph 1
Article 20 – paragraph 1
1. Member States shall lay down the rules on sanctions applicable to infringements of national provisions adopted pursuant to this Directive, and shall take all measures necessary to ensure that they are implemented. The sanctions provided for shall be effective, proportionate and, dissuasive and based on a gradual approach.
Amendment 1430 #
2022/0051(COD)
Proposal for a directive
Article 20 – paragraph 2
Article 20 – paragraph 2
2. In deciding whether to impose sanctions and, if so, in determining their nature and appropriate level, due account shall be taken of the legal framework applicable in the country where the adverse impact may occur or has occurred, the gravity and duration of the infringement, the importance of profits gained or losses avoided by the company, in so far as they can be determined the company’s efforts to comply with any remedial action required of them by a supervisory authority, any investments made and any targeted support provided pursuant to Articles 7 and 8, any previous infringements, cumulative effects of the different measures and sanctions already imposed on the company as well as the collaboration with other entities to address adverse impacts in its valuesupply chains, as the case may be.; any other aggravating or mitigating factors applicable to the circumstances of the case;
Amendment 1431 #
2022/0051(COD)
Proposal for a directive
Article 20 – paragraph 2
Article 20 – paragraph 2
2. In deciding whether to impose sanctions and, if so, in determining their nature and appropriate level, due account shall be taken of, inter alia: (a) the severity of the negative impact; (b) the company’s efforts to comply with any remedial action required of them by a supervisory authority, any investments made and any targeted support provided pursuant to Articles 7 and 8, as well as collaboration with other entities to address adverse impacts in its value chains, as the case may be; (c) previous infringements; (d) preventive measures adopted to avoid the repetition of a certain infringement.
Amendment 1462 #
2022/0051(COD)
Proposal for a directive
Article 21 – paragraph 2 a (new)
Article 21 – paragraph 2 a (new)
2a. Supervisory authorities shall share relevant information with the single point of contact as a means of ensuring that the single point of contact has the necessary information to perform its tasks.
Amendment 1463 #
2022/0051(COD)
Proposal for a directive
Article 21 – paragraph 2 b (new)
Article 21 – paragraph 2 b (new)
2b. The ENSA shall also support the Commission in developing the Single- Reporting-Instrument.
Amendment 1471 #
2022/0051(COD)
Proposal for a directive
Article 22 – paragraph 1 – introductory part
Article 22 – paragraph 1 – introductory part
1. Member States shall ensure thatoutline rules for providing cases in which, according to the national rules on civil liability, companies are liable for damages if:
Amendment 1476 #
2022/0051(COD)
Proposal for a directive
Article 22 – paragraph 1 – point a
Article 22 – paragraph 1 – point a
(a) they intentionally or gross negligently failed to comply with the obligations laid down in Articles 7 and 8 and;
Amendment 1483 #
2022/0051(COD)
Proposal for a directive
Article 22 – paragraph 1 – point b
Article 22 – paragraph 1 – point b
(b) as a result of this failure an actual adverse impact that they caused and that should have been identified, prevented, mitigated, brought to an end or its extent minimised through the appropriate measures laid down in Articles 7 and 8 occurred and led to damage.
Amendment 1495 #
2022/0051(COD)
Proposal for a directive
Article 22 – paragraph 2 – subparagraph 1
Article 22 – paragraph 2 – subparagraph 1
Amendment 1505 #
2022/0051(COD)
Proposal for a directive
Article 22 – paragraph 2 – subparagraph 2
Article 22 – paragraph 2 – subparagraph 2
Amendment 1509 #
2022/0051(COD)
Proposal for a directive
Article 22 – paragraph 2 – subparagraph 2
Article 22 – paragraph 2 – subparagraph 2
In the assessment of the existence and extent of liability under this paragraph, due account shall be taken of the company’s efforts, insofar as they relate directly to the damage in question, to comply with any remedial action required of them by a supervisory authority, any investments made and any targeted support provided pursuant to Articles 7 and 8, as well as any collaboration with other entities to address adverse impacts in its valuesupply chains.
Amendment 1512 #
2022/0051(COD)
Proposal for a directive
Article 22 – paragraph 2 a (new)
Article 22 – paragraph 2 a (new)
2a. Member States shall ensure that where a company prioritised adverse impacts in accordance with Article 6 and the damage stems from the less significant adverse impact that was not yet addressed, it shall not be liable for any the damage occurred, unless it was unreasonable, in the circumstances of the case, to expect that the action actually taken, including as regards verifying compliance, would be adequate to prevent, mitigate, bring to an end or minimise the extent of the adverse impact.
Amendment 1528 #
2022/0051(COD)
Proposal for a directive
Article 22 – paragraph 4
Article 22 – paragraph 4
4. The civil liability rules under this Directive shall be without prejudice to Union or national rules on civil liability related to adverse human rights impacts or to adverse environmental impacts that provide for liability in situations not covered by or providing for stricter liability than this Directive.
Amendment 1535 #
2022/0051(COD)
Proposal for a directive
Article 22 – paragraph 5
Article 22 – paragraph 5
5. Member States shall ensure that the liability provided for in provisions of national law transposing this Article is of overriding mandatory application in cases whmitation period for bringing civil liability claims concerning harm arising out of adverse the law applicable to claims to that effect is not the law of a Member Stateimpacts on human rights and the environment is five years.
Amendment 1551 #
2022/0051(COD)
Proposal for a directive
Article 24
Article 24
Amendment 1559 #
2022/0051(COD)
Proposal for a directive
Article 25
Article 25
Amendment 1571 #
2022/0051(COD)
Proposal for a directive
Article 26
Article 26
Amendment 1596 #
2022/0051(COD)
Proposal for a directive
Article 29 – paragraph 1 – introductory part
Article 29 – paragraph 1 – introductory part
No later than … [OP please insert the date = 78 years after the date of entry into force of this Directive], the Commission shall submit a report to the European Parliament and to the Council on the implementation of this Directive. The report shall evaluate the effectiveness of this Directive in reaching its objectives and assess the following issues:
Amendment 1598 #
2022/0051(COD)
Proposal for a directive
Article 29 – paragraph 1 – point a
Article 29 – paragraph 1 – point a
(a) whether the thresholds regarding the number of employees and net turnover laid down in Article 2(1) need to be loweredimpact of the Directive was justified and reached the targeted goals, including the associated indirect costs and the economic, social and environmental benefits thereof, including on SMEs;
Amendment 1600 #
2022/0051(COD)
Proposal for a directive
Article 29 – paragraph 1 – point a a (new)
Article 29 – paragraph 1 – point a a (new)
(aa) whether the thresholds regarding the number of employees and net turnover laid down in Article 2(1) need to be modified;
Amendment 1607 #
2022/0051(COD)
Proposal for a directive
Article 29 – paragraph 1 – point c
Article 29 – paragraph 1 – point c
Amendment 1620 #
2022/0051(COD)
Proposal for a directive
Article 30 – paragraph 1 – subparagraph 1
Article 30 – paragraph 1 – subparagraph 1
Member States shall adopt and publish, by … [OJ to insert: 25 years from the entry into force of this Directive] at the latest, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
Amendment 1622 #
2022/0051(COD)
Proposal for a directive
Article 30 – paragraph 1 – subparagraph 2 – introductory part
Article 30 – paragraph 1 – subparagraph 2 – introductory part
They shall apply those provisions as follows:from four years after national transposition as regards companies referred to in Article 2(1), point (a), and Article 2(2), point (a);
Amendment 1626 #
2022/0051(COD)
Proposal for a directive
Article 30 – paragraph 1 – subparagraph 2 – point a
Article 30 – paragraph 1 – subparagraph 2 – point a
Amendment 1632 #
2022/0051(COD)
Proposal for a directive
Article 30 – paragraph 1 – subparagraph 2 – point b
Article 30 – paragraph 1 – subparagraph 2 – point b
Amendment 1635 #
Amendment 127 #
2022/0047(COD)
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13 a) This Regulation is without prejudice to Union and national legal acts providing for the protection of intellectual property rights, including Directive 2001/29/EC, Directive 2004/48/EC, and Directive (EU) 2019/790.
Amendment 133 #
2022/0047(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) Data generated by the use of a product or related service include data recorded intentionally by the user. Such data include also data generated as a by- product of the user’s action, such as diagnostics data, and without any action by the user, such as when the product is in ‘standby mode’, and data recorded during periods when the product is switched off. Such data should include data accessible to the data holder in the form and format in which they are generated by the product, but not pertain to data resulting from any software process that calculates derivative data from such data as such software process may be subject to intellectual property rights.
Amendment 140 #
2022/0047(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) This Regulation imposes the obligation on data holders to make data available in certain circumstances. Insofar as personal data are processed, the data holder should be a controller under Regulation (EU) 2016/679. Where users are data subjects, data holders should be obliged to provide them access to their data and to make the data available to third parties of the user’s choice in accordance with this Regulation. However, this Regulation does not create a legal basis under Regulation (EU) 2016/679 for the data holder to provide access to personal data or make it available to a third party when requested by a user that is not a data subject and should not be understood as conferring any new right on the data holder to use data generated by the use of a product or related service. This applies in particular where the manufacturer is the data holder. In that case, the basis for the manufacturer to use non-personal data should be a contractual agreement between the manufacturer and the user. This agreement may be part of the sale, rent or lease agreement relating to the product. Any contractual term in the agreement stipulating that the data holder may use the data generated by the user of a product or related service should be transparent to the user, including as regards the purpose for which the data holder intends to use the data. This Regulation should not prevent contractual conditions, whose effect is to exclude or limit the use of the data, or certain categories thereof, by the data holder, whenever that is justified, in line with the principle of good faith, in light of the legitimate interests of the user that would otherwise be disproportionately harmed. This Regulation should also not prevent sector-specific regulatory requirements under Union law, or national law compatible with Union law, which would exclude or limit the use of certain such data by the data holder on well- defined public policy grounds.
Amendment 145 #
2022/0047(COD)
Proposal for a regulation
Recital 28 a (new)
Recital 28 a (new)
(28 a) As regards trade secrets, this Regulation should be interpreted in a manner that preserves the protection awarded to trade secrets under Directive (EU) 2016/943. For this reason, data holders are entitled to require that the user or third parties of the user’s choice take all necessary measures to ensure that confidentiality of data considered as trade secrets, including through technical means, is preserved.
Amendment 147 #
2022/0047(COD)
Proposal for a regulation
Recital 29
Recital 29
(29) A third party to whom data is made available may be an enterprise, a research organisation or a not-for-profit organisation. In making the data available to the third party, neither the data holder nor the third party should not abuse its position to seek a competitive advantage in markets where the data holder and third party may be in direct competition. The data holderBoth parties should not therefore use any data generated by the use of the product or related service in order to derive insights about the economic situation of the othirder party or its assets or production methods or the use in any other way that could undermine the commercial position of the othirder party on the markets it is active on.
Amendment 151 #
2022/0047(COD)
Proposal for a regulation
Recital 37
Recital 37
(37) Given the current state of technology, it is overly burdensome to impose further design obligations in relation to products manufactured or designed and related services provided by micro and small enterprises. That is not the case, however, where a micro or small enterprise is sub-contracted to manufacture or design a product. In such situations, the enterprise, which has sub-contracted to the micro or small enterprise, is able to compensate the sub-contractor appropriately. A micro or small enterprise may nevertheless be subject to the requirements laid down by this Regulation as data holder, where it is not the manufacturer of the product or a provider of related services. In order to increase the participation of micro and small enterprises in the data economy, Member States should provide digital training and guidance to such enterprises.
Amendment 152 #
2022/0047(COD)
Proposal for a regulation
Recital 51
Recital 51
(51) Where one party is in a stronger bargaining position, there is a risk that that party could leverage such position to the detriment of the other contracting party when negotiating access to data and make access to data commercially less viable and sometimes economically prohibitive. Such contractual imbalances can in particularly harm micro, small and medium-sized enterprises withoutenterprises that, due to their comparatively smaller size, may not have a meaningful ability to negotiate the conditions for access to data, who and, therefore, may have no other choice than to accept ‘take- it-or-leave-it’ contractual terms. Therefore, in those cases where such imbalances of negotiation power are present, unfair contract terms regulating the access to and use of data or the liability and remedies for the breach or the termination of data related obligations should not be binding on micro, small or medium-sizedthose enterprises when they have been unilaterally imposed on them.
Amendment 153 #
2022/0047(COD)
Proposal for a regulation
Recital 52
Recital 52
(52) Rules on contractual terms should take into account the principle of contractual freedom as an essential concept in business-to-business relationships. Therefore, not all contractual terms should be subject to an unfairness test, but only to those terms that are unilaterally imposed oin micro, small and medium-sized enterprissituations where an imbalance of negotiation power exists between the contracting parties. This concerns ‘take-it- or- leave-it’ situations where one party supplies a certain contractual term and the micro, small or medium-sized enterpriseother cannot influence the content of that term despite an attempt to negotiate it. A contractual term that is simply provided by one party and accepted by the micro, small or medium-sized enterpriseother or a term that is negotiated and subsequently agreed in an amended way between contracting parties should not be considered as unilaterally imposed.
Amendment 161 #
2022/0047(COD)
Proposal for a regulation
Recital 58
Recital 58
(58) An exceptional need may also arise when a public sector body can demonstrate that the data are necessary either to prevent a public emergency, or to assist recovery from a public emergency, in circumstances that are reasonably proximate to the public emergency in question. Where the exceptional need is not justified by the need to respond to, prevent or assist recovery from a public emergency, the public sector body or the Union institution, agency or body should demonstrate that the lack of timely access to and the use of the data requested prevents it from effectively fulfilling a specific task in the public interest that has been explicitly provided in law. Such exceptional need may also occur in other situations, for example in relation to the timely compilation of official statistics when data is not otherwise available or when the burden on statistical respondents will be considerably reduced. At the same time, the public sector body or the Union institution, agency or body should, outside the case of responding to, preventing or assisting recovery from a public emergency, demonstrate that no alternativeit has exhausted all other means forto obtaining the data requested exists and that the data cannot be obtained in a timely manner, including through the laying down of the necessary data provision obligations in new legislation.
Amendment 176 #
2022/0047(COD)
Proposal for a regulation
Recital 80
Recital 80
(80) To promote the interoperability of smart contracts in data sharing applications, it is necessary to lay down essential requirements for smart contracts for professionals who create smart contracts for others or integrate such smart contracts in applications that support the implementation of agreements for sharing data. Specific training programmes on smart contracts for businesses, in particular SMEs, should be provided. In order to facilitate the conformity of such smart contracts with those essential requirements, it is necessary to provide for a presumption of conformity for smart contracts that meet harmonised standards or parts thereof in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council.
Amendment 180 #
2022/0047(COD)
Proposal for a regulation
Recital 84
Recital 84
(84) In order to eliminate the risk that holders of data in databases obtained or generated by means of physical components, such as sensors, of a connected product and a related service claim the sui generis right under Article 7 of Directive 96/9/EC where such databases do not qualify for the sui generis right, and in so doing hinder the effective exercise of the right of users to access and use data and the right to share data with third parties under this Regulation, this Regulation should clarify that the sui generis right does not apply to such databases as the requirements for protection would not be fulfilledshould not be invoked to refuse access to those data generated by the use of a product or a related service.
Amendment 233 #
2022/0047(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. Products shall be designed and manufactured, and related services shall be provided, in such a manner that data generated by their use that are accessible to the data holder are, by default, easily, safely, securely and, where relevant and appropriate, directly accessible to the user. Data shall be provided in the raw form in which they have been generated by the product, with only the minimal adaptations necessary to make them useable by a third party, including related metadata necessary to interpret and use the data.
Amendment 241 #
2022/0047(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point a
Article 3 – paragraph 2 – point a
(a) the nature antype of data and the estimated volume of the data likely to be generated by the use of the product or related service;
Amendment 260 #
2022/0047(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Where data cannot be directly accessed by the user from the product, the data holder shall make available to the user the data generated by its use of a product or related service that are accessible to the data holder without undue delay, free of charge and, where applicable, continuously and in real-time. This shall be done on the basis of a simple request through electronic means where technically feasible. Data shall be provided in the raw form in which they have been generated by the product, with only the minimal adaptations necessary to make them useable by the user, including related metadata necessary to interpret and use the data.
Amendment 265 #
2022/0047(COD)
Proposal for a regulation
Article 4 – paragraph 3
Article 4 – paragraph 3
3. Trade secrets shall only be disclosed provided that all specific necessary measures are taken by the user prior to the disclosure to preserve the confidentiality of trade secrets in particular with respect to third parties. TWhere such measures are not sufficient, the data holder and the user canshall agree measuresadditional measures, such as technical and organisational measures, to preserve the confidentiality of the shared data, in particular in relation to third parties, through contractual instruments such as confidentiality agreements. The data holder shall identify the data which are protected as trade secrets. When no agreement is reached regarding the necessary measures to preserve the confidentiality of trade secrets or the user fails to implement those measures, the data holder is entitled to refuse the user’s access to data which are protected as trade secrets.
Amendment 273 #
2022/0047(COD)
Proposal for a regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
4. The user shall not use the data obtained pursuant to a request referred to in paragraph 1 to develop a product or related service that competes with the product or related service from which the data originate.
Amendment 276 #
2022/0047(COD)
Proposal for a regulation
Article 4 – paragraph 4 a (new)
Article 4 – paragraph 4 a (new)
4 a. The user shall not deploy coercive means or abuse gaps in the technical infrastructure of the data holder designed to protect the data in order to obtain access to data.
Amendment 279 #
2022/0047(COD)
Proposal for a regulation
Article 4 – paragraph 6
Article 4 – paragraph 6
6. The data holder shall only use any non-personal data generated by the use of a product or related service on the basis of a contractual agreement with the user. The data holduser shall authorise the use of non- personal data generated by the use of a product or related service at the request of the data holder if no legitimate interest of the user is disproportionately harmed. The data holder and the user shall not use such data generated by the use of the product or related service to derive insights about the economic situation, assets and production methods of or the use by the userother party that could undermine the commercial position of the userother party in the markets in which the userother party is active.
Amendment 282 #
2022/0047(COD)
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. Upon request by a user, or by a party acting on behalf of a user, the data holder shall make available the data generated by the use of a product or related service that are accessible to the data holder to a third party, without undue delay, free of charge to the user, of the same quality as is available to the data holder and, where applicable, continuously and in real-time. Data shall be provided in the raw form in which they have been generated by the product, with only the minimal adaptations necessary to make them useable by a third party, including related metadata necessary to interpret and use the data.
Amendment 293 #
2022/0047(COD)
Proposal for a regulation
Article 5 – paragraph 4
Article 5 – paragraph 4
4. The third party shall not deploy coercive means or abuse evident gaps in the technical infrastructure of the data holder designed to protect the data in order to obtain access to data.
Amendment 294 #
2022/0047(COD)
Proposal for a regulation
Article 5 – paragraph 5
Article 5 – paragraph 5
5. The data holder shall not use any non-personal data generated by the use of the product or related service to derive insights about the economic situation, assets and production methods of or use by the third party that could undermine the commercial position of the third party on the markets in which the third party is active, unless the third party has consented to such use and has the technical possibility to withdraw that consent at any time.
Amendment 302 #
2022/0047(COD)
Proposal for a regulation
Article 5 – paragraph 8
Article 5 – paragraph 8
8. Trade secrets shall only be disclosed to third parties to the extent that they are strictly necessary to fulfil the purpose agreed between the user and the third party and all specific necessary measures agreed, including technical and organisational measures, specified in the agreement between the data holder and the third party are taken by the third party prior to the disclosure to preserve the confidentiality of the trade secret. In such a case, the nature of the data as trade secrets and theThe data holder shall identify the data which are protected as trade secrets. When no agreement is reached regarding the necessary measures forto preservinge the confidentiality shall bof trade specified in the agreement between the data holder and the third partyrets or the third party fails to implement those measures, the data holder is entitled to refuse the third party’s access to data which are protected as trade secrets.
Amendment 314 #
2022/0047(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point e
Article 6 – paragraph 2 – point e
(e) use the data it receives to develop a product or related service that competes with the product or related service from which the accessed data originate or share the data with another third party for that purpose;
Amendment 315 #
2022/0047(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point e a (new)
Article 6 – paragraph 2 – point e a (new)
(e a) use the data it receives to cause substantial damage to the data holder by misuse of the data or to derive insights about the economic situation, assets and production methods of or use by the data holder that could undermine the commercial position of the data holder on the markets in which the data holder is active;
Amendment 321 #
2022/0047(COD)
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. A data holder shall not discriminate between comparable categories of data recipients, including partner enterprises or linked enterprises, as defined in Article 3 of the Annex to Recommendation 2003/361/EC, of the data holder, when making data available. Where a data recipient has reasonable grounds to considers that the conditions under which data has been made available to it to be discriminatory, it shall be for the data holder to demonstrate that there has been no discrimination.
Amendment 324 #
2022/0047(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Where the data recipient is a micro, small or medium enterprise, as defined in Article 2 of the Annex to Recommendation 2003/361/EC, any compensation agreed shall not exceed the costs directly related to making the data available to the data recipient and which are attributable to the requestprovided those enterprises do not have partner enterprises or linked enterprises as defined in Article 3 of the Annex to Recommendation 2003/361/EC which do not qualify as micro, small or medium enterprises, any compensation agreed shall not exceed the costs directly related to making the data available to the data recipient and which are attributable to the request, unless the data holder is also a micro, small or medium enterprise, as defined in Article 2 of the Annex to Recommendation 2003/361/EC, and no imbalance exists between the parties. Article 8(3) shall apply accordingly.
Amendment 334 #
2022/0047(COD)
Proposal for a regulation
Article 11 – paragraph 2 – introductory part
Article 11 – paragraph 2 – introductory part
2. A data recipient that has, for the purposes of obtaining data, provided inaccurate or false information to the data holder, deployed deceptive or coercive means or abused evident gaps in the technical infrastructure of the data holder designed to protect the data, has used the data made available for unauthorised purposes or has disclosed those data to another party without the data holder’s authorisation, shall without undue delay, unless the data holder or the user instruct otherwise:
Amendment 346 #
2022/0047(COD)
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
1. A contractual term, concerning the access to and use of data or the liability and remedies for the breach or the termination of data related obligations which has been unilaterally imposed by an enterprise on a micro, small or medium-sized enterprise as defined in Article 2 of the Annex to Recommendation 2003/361/ECnother enterprise that has no meaningful ability to negotiate due to the imbalance of power between the parties shall not be binding on the latter enterprise if it is unfair.
Amendment 347 #
2022/0047(COD)
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. A contractual term is unfair if it is of such a nature that its use grossly deviates from good commercial practice in data access and use, contrary to good faith and fair dealing, and it causes a significant imbalance in the party's rights and obligations arising under the contract.
Amendment 369 #
2022/0047(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point b
Article 15 – paragraph 1 – point b
(b) where the data request is limited in time and scope and necessary to prevent an imminent public emergency or to assist the recovery from a public emergency, and alternative means to obtain such data are either unavailable or would be inappropriate;
Amendment 375 #
2022/0047(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point c – point 1
Article 15 – paragraph 1 – point c – point 1
(1) the public sector body or Union institution, agency or body has been unable to obtain such data by alternative meansexhausted all other means at its disposal to obtain such data, including bythe purchasinge of the data on the market at market rates or by, relying on existing obligations to make data available, andor the adoption of new legislative measures cannotwhich could ensure the timely availability of the data; orand
Amendment 382 #
2022/0047(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point e
Article 17 – paragraph 1 – point e
(e) specify an appropriathe deadline by which the data are to be made available or within which the data holder may request the public sector body, Union institution, agency or body to modify or withdraw the request.
Amendment 387 #
2022/0047(COD)
Proposal for a regulation
Article 17 – paragraph 2 – point d a (new)
Article 17 – paragraph 2 – point d a (new)
(d a) where applicable, specify the measures to be taken pursuant to Article 19(2) to preserve the confidentiality of trade secrets, in particular with respect to third parties;
Amendment 390 #
2022/0047(COD)
Proposal for a regulation
Article 17 – paragraph 4 – subparagraph 1
Article 17 – paragraph 4 – subparagraph 1
Paragraph 3 does not preclude a public sector body or a Union institution, agency or body to exchange data obtained pursuant to this Chapter with another public sector body, Union institution, agency or body, in view of completing the tasks in Article 15 or to make the data available to a third party in cases where it has outsourced, by means of a publicly available agreement, technical inspections or other functions to this third party. The obligations on public sector bodies, Union institutions, agencies or bodies pursuant to Article 19 apply also to those third parties.
Amendment 391 #
2022/0047(COD)
Proposal for a regulation
Article 17 – paragraph 4 – subparagraph 1 a (new)
Article 17 – paragraph 4 – subparagraph 1 a (new)
Those third parties shall not use the data they receive from a public sector body or a Union institution, agency or body under this paragraph to develop a product or a service that competes with the product or service of the data holder from whom the data was received, nor share the data with another third party for that purpose.
Amendment 394 #
2022/0047(COD)
Proposal for a regulation
Article 17 – paragraph 4 – subparagraph 2
Article 17 – paragraph 4 – subparagraph 2
Where a public sector body or a Union institution, agency or body transmits or makes data available under this paragraph, it shall notify without undue delay the data holder from whom the data was received.
Amendment 406 #
2022/0047(COD)
Proposal for a regulation
Article 19 – paragraph 2
Article 19 – paragraph 2
2. Disclosure of trade secrets or alleged trade secrets to a public sector body or to a Union institution, agency or body shall only be required to the extent that it is strictly necessary to achieve the purpose of the request. In such a case, the public sector body or the Union institution, agency or body shall take appropriate measures, prior to the disclosure, take all the necessary and appropriate measures, such as technical and organisational measures, agreed with the data holder to preserve the confidentiality of those trade secrets.
Amendment 409 #
2022/0047(COD)
Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 1 (new)
Article 19 – paragraph 2 – subparagraph 1 (new)
Where a public sector body or a Union institution, agency or body transmits or makes data available to third parties pursuant to Article 17 (4), trade secrets shall only be disclosed to third parties to the extent that they are strictly necessary for the third party to perform the tasks that have been outsourced to it and provided that all specific necessary measures, including technical and organisational measures, agreed between the data holder and the third party are taken by the third party to preserve the confidentiality of the trade secret.
Amendment 410 #
2022/0047(COD)
Proposal for a regulation
Article 19 – paragraph 2 a (new)
Article 19 – paragraph 2 a (new)
2 a. The data holder shall identify the data which are protected as trade secrets. When no agreement is reached regarding the necessary measures to preserve the confidentiality of trade secrets or those measures are not implemented, the data holder is entitled to refuse access to data which are protected as trade secrets.
Amendment 415 #
2022/0047(COD)
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
1. DFor making data made available to respond to a public emergency pursuant to Article 15, point (a), shall be provided free of chargethe data holder is entitled to claim a compensation, which shall not exceed the technical and organisational costs incurred to comply with the request.
Amendment 417 #
2022/0047(COD)
Proposal for a regulation
Article 20 – paragraph 2
Article 20 – paragraph 2
2. Where tThe data holder claims compensshall be entitled to a fair remuneration for making data available in compliance with a request made pursuant to Article 15, points (b) or (c), s. Such compensation shall not exceedat the least cover the technical and organisational costs incurred to comply with the request including, where necessary, the costs of anonymisation and of technical adaptation, plus a reasonable margin. Upon request of the public sector body or the Union institution, agency or body requesting the data, the data holder shall provide information on the basis for the calculation of the costs and the reasonable margin.
Amendment 421 #
2022/0047(COD)
Proposal for a regulation
Article 21 – paragraph 4
Article 21 – paragraph 4
4. Where a public sector body or a Union institution, agency or body transmits or makes data available under paragraph 1, it shall notify without undue delay the data holder from whom the data was received, and provide all necessary information regarding the identity of the data recipient and the activities that will be carried out by the data recipient based on the data received pursuant to paragraph 1.
Amendment 468 #
2022/0047(COD)
Proposal for a regulation
Article 34 – paragraph 1
Article 34 – paragraph 1
The Commission shall develop and recommend non-binding model contractual terms on data access and use to assist parties in drafting and negotiating contracts with balanced contractual rights and obligations, as well as model contractual terms on the necessary protection of trade secrets and the preservation of their confidentiality.
Amendment 471 #
2022/0047(COD)
Proposal for a regulation
Article 35 – paragraph 1
Article 35 – paragraph 1
In order not to hinder the exercise of the right of users to access and use such data in accordance with Article 4 of this Regulation or of the right to share such data with third parties in accordance with Article 5 of this Regulation, the sui generis right provided for in Article 7 of Directive 96/9/EC does not apply to databases containing data obtained from or, shall not be invoked to refuse access to data generated by the use of a product or a related service.
Amendment 1 #
2021/2166(INI)
Motion for a resolution
Citation 6 a (new)
Citation 6 a (new)
— having regard to the Commission Communication entitled ‘Updating the 2020 New Industrial Strategy: Building a stronger Single Market for Europe’s recovery’ (COM/2021/350 final),
Amendment 2 #
2021/2166(INI)
Motion for a resolution
Citation 6 b (new)
Citation 6 b (new)
— having regard to the European Parliament report entitled ‘A New Industrial Strategy for Europe’ (2020/2076(INI)),
Amendment 3 #
2021/2166(INI)
Motion for a resolution
Citation 7
Citation 7
— having regard to the better regulation toolbox, which complements the Better regulation guidelines, both from November 2021,
Amendment 5 #
2021/2166(INI)
Motion for a resolution
Citation 10 a (new)
Citation 10 a (new)
— having regard to the latest EP resolution “Regulatory Fitness, subsidiarity and proportionality- report on Better Law Making 2017, 2018 and 2019, adopted 24.6.20211a, _________________ 1a P9_TA (2021) 0316.
Amendment 8 #
2021/2166(INI)
Motion for a resolution
Citation 11 a (new)
Citation 11 a (new)
— having regard to its report ‘on a new strategy for European SMEs’(2020/2131(INI))
Amendment 10 #
2021/2166(INI)
Motion for a resolution
Citation 12
Citation 12
Amendment 11 #
2021/2166(INI)
Motion for a resolution
Citation 12 a (new)
Citation 12 a (new)
Amendment 14 #
2021/2166(INI)
Motion for a resolution
Recital A
Recital A
A. whereas better law-making is a common goal for all EU Institutions, and should be achieved by increasing transparency, accountability and cooperation between the institutions and Member States, citizens and stakeholders, ensuring full respect of all fundamental European values, including democracy, the rule of law and human rights; whereas legislation should be fit for purpose, balanced, clear, transparent and comprehensive in order to benefit citizens and stakeholders;
Amendment 21 #
2021/2166(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
A a. whereas European union and national legislation should always be fit for purpose, proportionate, clear and comprehensive, in order to benefit the relevant addressees
Amendment 22 #
2021/2166(INI)
Motion for a resolution
Recital A b (new)
Recital A b (new)
A b. whereas better regulation tools should be applied in an ever-changing world, where challenges and policy priorities are constantly evolving and the achievement of European objectives and targets across sectors is increasingly urgent; whereas, therefore, it will be increasingly important toback up regulatory proposals with evidence based on the most appropriate assessments;
Amendment 23 #
2021/2166(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
B a. whereas high quality regulation serves the public interest as directly conditions the competitiveness of the European Union, territories and businesses, as well as the degree of democracy and participation of the various legal systems, including the national and regional ones; whereas better law-making primarily means guaranteeing citizens the principle of legal certainty;
Amendment 24 #
2021/2166(INI)
Motion for a resolution
Recital B b (new)
Recital B b (new)
B b. whereas there is a need for regulatory review and simplification to remove obstacles to the implementation of legislation, including across borders, and to make laws more effective, transparent and comprehensive to the end user, be it citizen or business;
Amendment 25 #
2021/2166(INI)
Motion for a resolution
Recital B c (new)
Recital B c (new)
B c. whereas the better regulation principles and tools should remain policy- neutral to guarantee an objective problem definition and real alternative policy options to be considered by the European Commission, the Council and the European Parliament;
Amendment 27 #
2021/2166(INI)
Motion for a resolution
Recital C
Recital C
C. whereas better law-making must aim to serve the EU’s political ambitions, especially its long-term objectives, such as generating economy and growth, boosting investment and job creation, taking care of a more competitive and democratic Europe and fighting terrorism, while aiming social progress and the binding objective of Union climate neutrality by 2050, and the long-term priority objective for 2050 that citizens live well, within the limits of our planet; whereas a sustainability should be at the heart ofperspective should also be considered for an high quality law- making, placing social, environmental and economic considerations on an equal footing;
Amendment 35 #
2021/2166(INI)
Motion for a resolution
Recital D
Recital D
D. whereas well carried out ex ante and ex post impact assessments and, public consultations and the "evaluate first principle" are essential tools for well- informed, better, efficient, accountable and transparent law-making;
Amendment 37 #
2021/2166(INI)
Motion for a resolution
Recital E
Recital E
E. whereas the ‘Have Your Say’ web portal aims to boost involvement in EU policy-making; whereas the European Court of Auditors published a special report in 20192 with a set of recommendations to even improve this portal, especially the use ando make it more user- friendly, including with regard to the availability of translations; _________________ 2 European Court of Auditors special report no 14/2019: ‘‘Have your say!’: Commission’s public consultations engage citizens, but fall short of outreach activities’.
Amendment 38 #
2021/2166(INI)
Motion for a resolution
Recital F
Recital F
F. whereas the Regulatory Scrutiny Board assesses the quality of impact assessments as well as of fitness checks and major evaluations to support politicalhigh- quality decision-making;
Amendment 39 #
2021/2166(INI)
Motion for a resolution
Recital F a (new)
Recital F a (new)
F a. whereas publicly available European Union websites for funding and tender opportunities within the framework of the EU programs are published in English Language first; whereas the translation of those websites can take several months; whereas the availability of those websites in all official languages of the EU is crucial for fair competition;
Amendment 40 #
2021/2166(INI)
Motion for a resolution
Recital F a (new)
Recital F a (new)
F a. whereas the Regulatory Scrutiny Board (RSB) Plays an important role in improving European legislation and it assessed that around 1/3 of impact assessments in 20211a have been negative in their first assessment; _________________ 1a https://ec.europa.eu/transparency/docume nts-register/
Amendment 43 #
2021/2166(INI)
Motion for a resolution
Recital G
Recital G
G. whereas the aim of the regulatory fitness and performance (REFIT) programme is to simplify and reduce regulatory burden of EU laws and reduce unnecessary administrative burdens with a view to improve regulatory complianceand unnecessary regulatory costs, while achieving the underlying policy objectives;
Amendment 46 #
2021/2166(INI)
Motion for a resolution
Recital H
Recital H
H. whereas in 2021 the Commission introduced the ‘one in, one out’ approach with the intention of offsetting new burdens resulting from the Commission’s legislative proposals by removing already existing burdens in the same policy area;
Amendment 47 #
2021/2166(INI)
Motion for a resolution
Recital H a (new)
Recital H a (new)
H a. whereas the ‘one-in, one-out’ principle strengthens the REFIT programme, by extending the programme beyond the burdens from individual pieces of existing legislation to include also burdens from new legislation as well as managing the accumulative burden in each policy area; whereas, at the same time, the ‘one in, one out’ principle needs a clarification concerning its application in practice, as this should always benefit to the interests of businesses, workers, citizens and consumers;
Amendment 50 #
2021/2166(INI)
Motion for a resolution
Recital H b (new)
Recital H b (new)
H b. whereas achieving the benefits of simplification efforts at European level also depends on the maintenance of the relevant provisions by the co-legislators and on the choices made by the Member States when transposing them into national law, and a greater effort of coordination and consultation with them and also with the local and regional authorities is therefore required;
Amendment 56 #
2021/2166(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the Commission’s commitment to making better use of strategic foresight, mainstreaming the Sustainable Development Goals in all its legislative proposals, in line with the UN’s 2030 Sustainable Development Agenda, to paying greater attention to gender equality and equality for all, and to ensuring that the ‘do no significant harm’ and precautionary principles are applied across all policy areas; calls forsince it plays a key role in helping to future-proof EU policy- making by ensuring that short-term initiatives are grounded in a longer-term perspective; acknowledges that ‘foresight elements’ are fully integrated into the Commission to clearly define the ‘do no significant harm’ principle in order to ensure its consist’s better regulation agenda, and calls for its integration in impact assessments applicnd evaluations; welcomnotes, the proposal that sustainability and digitalisation should be better taken into account in law-making; calls on the Commission to implement a ‘sustainabiloo, that ‘strategic foresight’ will support the REFIT programme, which identifies opportunities to reduce regulatory burdens and ensure that existing EU laws remain ‘fity first’ approachor the future’;
Amendment 62 #
2021/2166(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Highlights that there are 1.28 million1c small and medium-sized enterprises (SMEs) in the EU and therefore the Commission should not just perform the SME test more systematically, but shall foresee a mandatory SME test to be performed for all legislative proposals; _________________ 1c https://www.statista.com/statistics/878412/ number-of-smes-in-europe-by-size/
Amendment 63 #
2021/2166(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. welcomes the Commissions intentions to improve the analysis and reporting of proposals’ impacts, for example on competitiveness and SMEs, territoriality, sustainability,equality, subsidiarity and proportionality;
Amendment 65 #
2021/2166(INI)
Motion for a resolution
Paragraph 1 b (new)
Paragraph 1 b (new)
Amendment 66 #
2021/2166(INI)
Motion for a resolution
Paragraph 1 b (new)
Paragraph 1 b (new)
1 b. welcomes that in line with the 2030 Digital Compass Communication, better regulation will promote the ‘digital by default’ principle in forthcoming EU legislationas an important tool to support digital transformation;
Amendment 67 #
2021/2166(INI)
Motion for a resolution
Paragraph 1 c (new)
Paragraph 1 c (new)
1 c. welcomes the intention of the Commission to create an interinstitutional database – the so-called Joint Legislative Portal - whose functioning should make sure to provide themost intuitive layout and user-friendly experience possible in order to avoid information overload;
Amendment 72 #
2021/2166(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Welcomes the Commission’s commitment to more actively publicising consultations in order to reach more citizens, and stakeholders and encourages to do so through local and regional authorities and the Committee of the Regions;
Amendment 73 #
2021/2166(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Welcomes the Commission’s commitment to more actively publicising consultations in order to reach more citizens, stakeholders, in particular SMEs, and local and regional authorities;
Amendment 86 #
2021/2166(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Calls for all European Union websites on funding and tender opportunities to be translated into all official languages of the EU immediately, as the initial exclusive availability in English language putsnon-English speaking member states at disadvantage;
Amendment 88 #
2021/2166(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls for impact assessments to be performed on all acts, without exception;legislative proposals, deeply regrets that this was not the case for several politically sensitive proposals in the past; recalls that on several occasions Parliament has carried out its own impact assessments in replacement of the Commission’s, mainly because of a lack of a necessary impact assessment; notes that this could be avoided by a proper coverage from the Commissions site before their publication of a legislative proposal; nevertheless, recalls that impact assessments help to inform but do not replace political decision-making;
Amendment 93 #
2021/2166(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Recalls that the application of the ‘Think Small First’ principle enshrined in the Small Business Act is an essential element for the proportionality test, prior to any legislative proposal and should aim at ensuring that SMEs’ voices are heard and that their interests are taken on board as early as possible, in order to create a favourable business environment for the development of SMEs, which are the backbone of our European economy;
Amendment 95 #
2021/2166(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Underlines that if an impact assessment has not been performed than the Commission should publish the staff working document at the same time as the legislative proposal;
Amendment 99 #
2021/2166(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Encourages greater account of feedback resulting from evaluations and assessments should be taken, and highlights the positive and widely recognised role of the Regulatory Scrutiny Committee in increasing the quality of legislative proposals; therefore, calls to make better use of its expertise and experience within the Commission;
Amendment 100 #
2021/2166(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. ESupports the Commission’s commitment to policy reviews and encourages the Commission to make greater use of ex post assessments to evaluate the effectiveness and benefits of legislation which in turn can help inform future policy developmentand improve regulation approaches; stresses the importance of the ‘evaluate first’ principle for ensuring that lessons learnt from the past informluence future policy cycle action; is seriously concerned about the increasing trend of evaluations and impact assessments being carried out in parallel, although evaluation results should feed into any revision of legislation;
Amendment 103 #
2021/2166(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7 a. Stresses that ex post evaluations are also an important tool to assess the impact of legislation on citizens and businesses, whereby special attention should be given as to the impact on SMEs;
Amendment 118 #
2021/2166(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Takes note of the use of instruments such as the regulatory fitness and performance programme (REFIT) and the ‘Fit for Future’ Platform to identify opportunities for simplification and reducing unnecessary costs before the Commission proposes a revision, while ensuring the highest standards of protection and enhancing compliance with EU law; recalls that the ‘Fit for Future’ platform’s role is also to assess whether specific Union legislation and its objectives remain future-proof proportionate and adapted to new challenges;
Amendment 127 #
2021/2166(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10 a. Outlines that the Commission should better align and combine its better regulation and strategic foresight activates in order to better integrate both processes;
Amendment 129 #
2021/2166(INI)
Motion for a resolution
Paragraph 10 c (new)
Paragraph 10 c (new)
10 c. Points out that the quality of the replies to parliaments questions for oral answer, such as for example O- 000003/2020 and O-000028/2021 concerning the implementation of the better Regulation, are very poor, calls therefore for an immediate and structural significant improvement of the Commissions answer to parliamentary questions;
Amendment 132 #
2021/2166(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Takes note of the involvement of the Regulatory Scrutiny Board in impact assessments, fitness checks, and major evaluations of current legislation; notemphasises, however, that the independence of the board could be further improved; notes, that the transparency of the Regulatory Scrutiny Board on meetings with stakeholders, reviews, recommendations and opinions should be significantly improved; underlines that the work of the Board should not ultimately affect the Commission’s capacity to propose legislation or unduly delay the adoption of legislative proposals; considers that all the Board’s opinions should always be made public immediately after adoption without any exception;
Amendment 140 #
2021/2166(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Takes note of the ‘one in, one out’ approachprinciple, which is based on stake holder involvement, and by which the Commission aims to offset newly introduced burdens especially for micro- enterprises and SMEs by relieving citizens and businesses of equivalent burdens at EU level in the same policy area; regrets the unilateral introduction of this approach by the Commission, without a prior impact assessment or consultation; underlines that the implementation of this approach should not affect political imperatives or the objectives of better regulation, and emphasises that it should not lead to mechanical or mathematical decisions to repeal legislation, lower its standard or resuls and that int a chilling effect on legislationim should be to modernise and reform EU legislation to face new challenges; recalls that the need for new legislation should not automatically imply that current legislation is no longer needed; calls for this approach to be based on a transparent and evidence-based methodology giving balanced consideration to all sustainability aspects, both in terms of bestresses at the same time that, while additional unnecessary administrative burdens should be avoided when designing, transposing and implementing EU acts, this should nefits and costs, including the costs of non-compliance and inaction; calls on the Commission, in this regard, to make its ‘one in, one out’ calculator public before applying this approachher be translated into deregulation or ‘no regulation’, nor should it prevent Member States’ parliaments from maintaining or taking more ambitious measures in cases where only minimum standards are defined by Union law;
Amendment 142 #
2021/2166(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Calls on the Commission to introduce a digital single reporting instrument, consolidation reporting requirements arising from the revision of the non-financial reporting directive (NFRD), the taxonomy, but also the reporting requirements from the Fit for 55 package in a single tool, which is designed with specific requirements and ready-made Key Performance Indicators (KPls) and standards, accessible in a modular and digital way for companies and other organisations
Amendment 143 #
2021/2166(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Stresses that, in applying the ‘one in, one out’ principle, all compliance costs, both administrative and adjustment costs, should be offset, since they both concur to burden businesses in particular; stresses the need that the principle is applied by the Member States as well as by local and regional authorities during the transposition process concerned; encourages the exchange of best practices on compensatory measures, methodologies and data collected;
Amendment 145 #
2021/2166(INI)
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12 b. Underlines that systematic review of legislation plays an increasingly important role for achieving better regulation; stresses in this regard the importance of the European Parliament, the Council and the Commission engaging in a more structured cooperation in order to assess the application and effectiveness of Union law with a view to its improvement; points out the need for the swift, timely and correct application of Union legislation by the Member States inorder to properly assess the need for further legislation;
Amendment 146 #
2021/2166(INI)
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12 b. Highlights that the Better Regulation Guidelines and Toolbox need to be improved with regards to the effects of costs added by co-legislators in the course of negotiations and Member States “gold-plating” legislation when transposing it into the national laws since "gold-plating" practices are one of the main sources of administrative burden;
Amendment 148 #
2021/2166(INI)
Motion for a resolution
Paragraph 12 c (new)
Paragraph 12 c (new)
12 c. Reiterates the specificity of local and regional authorities and the need to tailor consultations; recommends that the Commission consult the Committee of Regions in the development of open consultations and roadmaps for proposals that significantly affect sub-national levels of government;
Amendment 149 #
2021/2166(INI)
Motion for a resolution
Paragraph 12 d (new)
Paragraph 12 d (new)
12 d. Recalls the importance of the Territorial Impact Assessment for the CoR, including rural impact assessment, urban impact assessment and cross- border impact assessment, for the achievement of the objective of evidence- based policy making;
Amendment 150 #
2021/2166(INI)
Motion for a resolution
Paragraph 12 e (new)
Paragraph 12 e (new)
12 e. Stresses that better law-making objectives need to be regularly reviewed and evaluate dagainst the criteria of the better law-making agenda, including monitoring and reporting; underlines that the objectives need to be well balanced, proportionate and evaluated in terms of their effectiveness; recalls the importance of comparable EU-wide data for the purpose of this evaluation and calls on the Commission to examine whether the use of the better regulationtools have served to achieve objectives such as improved policy outcomes;
Amendment 9 #
2021/2046(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. affirms the importance of developing and investing in a mobility that is affordable and accessible to all, safer and more sustainable; Calls on the Commission and the Member States to take these objectives into account in the implementation of an operational multimodal trans-European transport network, equipped for sustainable and intelligent transport; not only in environmental terms, but also in terms of social accessibility and competitiveness of the European industrial sector;
Amendment 11 #
2021/2046(INI)
Draft opinion
Paragraph 1 c (new)
Paragraph 1 c (new)
1c Observes that the same level of ambition to achieve social sustainability as for environmental sustainability is needed; that price is a key element in ensuring the environmental and social performance of the sector; however, it has to be noted that often the logic of low cost comes as a result of social dumping and business practice which allows companies keep their costs artificially low to the detriment of workers of the transport sector;
Amendment 12 #
2021/2046(INI)
Draft opinion
Paragraph 1 d (new)
Paragraph 1 d (new)
1d Emphasizes the need to develop plans that are consistent with the specificities of each country in order to consider national needs, expectations of workers and passengers, and previous investments carried out in the field of energy and mobility;
Amendment 13 #
2021/2046(INI)
Draft opinion
Paragraph 1 e (new)
Paragraph 1 e (new)
1e Notes that exploitation of resources is not uniform among Member States; stresses the importance of diversifying energy strategies considering technological neutrality and the exploitation of national resources; stresses that in order to maintain the competitiveness of the European market it is necessary to enhance the contribution of alternative solutions for which the EU industrial sector is a world leader, while waiting for the development of expertise in technological contexts that are not yet mature or exclusive prerogative of non- EU companies;
Amendment 16 #
2021/2046(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Emphasises that in a sector such as mobility, exclusivity over data rights can produce a barrier to market entry, increased transaction costs, and a barrier to innovation that is harmful to operators, SMEs, and the public; Highlight the importance of a discussion with stakeholders to move forward on the issue of access to machine-generated data, with the aim of achieving the objective of a proper sharing of data and data- integration between, underpinned by strong cyber-resilience, and of a cooperation based on mutual and fair data exchange between all (public and private) actors involved;
Amendment 32 #
2021/2046(INI)
Draft opinion
Paragraph 3 d (new)
Paragraph 3 d (new)
3d. Highlights, in this context, the risks of the use of AI for the safety of users and operators in the transport sector, classified as "high-risk" by the Commission according to the requirements outlined in the proposal for a Regulation for harmonized rules on Artificial Intelligence (Artificial Intelligence Act); Stresses how these risks may result from possible design defects or poor data quality or availability; Points out in this regard the need for specific and coordinated adjustments to the liability regimes in this area, in order to ensure a high level of certainty for travelers and companies operating in the sector, with particular reference to the regime of civil liability, the compensability of damages and the distribution and satisfaction of the burden of proof on the parties, in cases where there is the involvement of AI systems in human decisions and events involving damage to persons or property;
Amendment 34 #
2021/2046(INI)
Draft opinion
Paragraph 3 f (new)
Paragraph 3 f (new)
3f. Recalls the need to comply with the General Data Protection Regulation (GDPR) when collecting and interpreting data from smart devices and mobility- related AI; Emphasizes the need to enable systems to protect against hacking and cyber-attacks; Highlights that clear privacy and security measures should be in place when consumer data is being collected and used;
Amendment 36 #
2021/2046(INI)
Draft opinion
Paragraph 3 h (new)
Paragraph 3 h (new)
3h. Highlights that, given their experience and their central role as integrator, their local knowledge, and their legitimacy, any regulation or policy initiative should recognise the context specificity of mobility and the instrumental role of public authorities and should strengthen their capacity to achieve Europe’s green and digital objectives;
Amendment 37 #
2021/2046(INI)
Draft opinion
Paragraph 3 i (new)
Paragraph 3 i (new)
3i. Deplores the fact that the Commission's Strategy does not contain any concrete commitments or actions towards workers; Underlines the necessity of concrete policy actions to eliminate the existing obstacles for women to join and remain in the transport sector and urgent measures to ensure that the ecological and digital transitions are just to workers;
Amendment 38 #
2021/2046(INI)
Draft opinion
paragraph 3 j (new)
paragraph 3 j (new)
3j. Stresses the importance of supporting Research and Innovation for the development of innovative mobility technologies, as well as competitive, sustainable and circular products and services to ensure that EU businesses remain world leaders in the sector; considers, in addition, that the strategy should further aim to create safeguards for workers in the sector and economic sustainability of investments for EU industry;
Amendment 39 #
2021/2046(INI)
Draft opinion
Paragraph 3 k (new)
Paragraph 3 k (new)
3k. Emphasizes the importance of strengthening digital supply chain-related industrial capabilities in the European space, including the design and manufacture of components, software platforms, and Internet of Things (IoT) technology to further electrify and automate transportation and mobility;
Amendment 40 #
2021/2046(INI)
Draft opinion
Paragraph 3 l (new)
Paragraph 3 l (new)
3l. Calls on the Commission and Member States to ensure a regulatory framework that makes the EU a fertile ground for SMEs and start-ups to develop new technologies for the design and production of components, but also through the identification of new contractual forms that protect companies and facilitate the safe sharing of licences;
Amendment 41 #
2021/2046(INI)
Draft opinion
Paragraph 3 m (new)
Paragraph 3 m (new)
3m. Calls on the Commission and the Member States to provide support for SMEs in the sector by simplifying access to credit; draws attention to the importance in the field of new technologies of the time factor, and therefore calls for the simplification and rationalisation of approval systems for verification and control procedures relating to innovative ideas;
Amendment 42 #
2021/2046(INI)
Draft opinion
Paragraph 3 n (new)
Paragraph 3 n (new)
3n. Emphasizes that technological advances in the transport sector can facilitate trade and make certain geographical areas more accessible, thereby reducing disparities and promoting economic growth and the creation of new employment; Recalls the potential of intelligent transport for social inclusion, especially for the benefit of people with disabilities and reduced mobility;
Amendment 43 #
2021/2046(INI)
Draft opinion
Paragraph 3 o (new)
Paragraph 3 o (new)
3o. Calls on the Commission to allocate specific funds for the connection of geographically disadvantaged areas in order to promote the creation of multi- modal infrastructure and offer a transport service that does not discriminate against any of the Union's citizens;
Amendment 44 #
2021/2046(INI)
Draft opinion
Paragraph 3 p (new)
Paragraph 3 p (new)
3p. Recalls the importance of identifying specific actions to support investment in sustainable local transport in densely populated areas and/or areas with a high seasonal and touristic value, as well as in rural, insular and mountainous regions;
Amendment 50 #
2021/2046(INI)
Draft opinion
Paragraph 4 c (new)
Paragraph 4 c (new)
4c. Calls on the Commission and the Member States to rationalize, in the light of new technological opportunities, the regulatory framework concerning the rights and obligations of rail passengers as set out in Regulation (EC) No 1371/2007, as well as the common rules on compensation and assistance to passengers in the event of denied boarding and of cancellation or long delay of flights as set out in Regulation (EC) No 261/2004 and Regulation (EC) No 2027/97 on air carrier liability in respect of the carriage of passengers and their baggage by air; Calls also for clarification of the cases in which carriers are liable, in order to avoid cases of strict liability without reasonable support;
Amendment 54 #
2021/2046(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Emphasizes the centrality of the action of Member States in allocating national resources to complement EU funds, in order to ensure adequate operation and maintenance of their public transport networks; stresses how the presence of transport lines that are not always technically interoperable between Member States may act as a limitation to the implementation of European indications at territorial level;
Amendment 5 #
2021/2037(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Notes that in 2020 China for the first time ranked as the EU’s largest partner for trade in goods, with the trade balance further deteriorating to the EU’s detriment, having the latter a trade deficit with China; highlights that the current EU- China Strategy in place has clearly resulted limited;
Amendment 11 #
2021/2037(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
Amendment 27 #
2021/2037(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Is concerned about the increasingly unbalanced EU-China bilateral economic and trade relationship, which are marked by an asymmetry in market access and the absence of an effective level playing-field able to ensure fair access to the Chinese market for these EU producers and exporters as well as by the opposed social and environmental standards; stresses that rebalancing and a more level playing field are vital to EU interests;
Amendment 34 #
2021/2037(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Regrets that the efforts and the tools used by the EU have not resulted in tangible progress on human rights in China, not contributing in the ceasing of the prompt and negative evolution and deterioration of China as an international actor;
Amendment 39 #
2021/2037(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Repeats its deep concern about the many barriers that European businesses face when accessing and operating on the Chinese market as well as the unfair trading practices imposed by state-owned enterprises; is worried that China’s ‘dual circulation strategy’ referred to in its 14th Five Year Plan will further deteriorate the business environment for EU companies; highlights again its particular concern about the market distorting practices of Chinese state-owned enterprises, forced technology transfers and data localisation, industrial overcapacity in sectors such as steel and the related dumping of exports, and other unfair trading practices as well as the interferences in the democratic life of the EU by the attempts of Chinese state and non-state actors;
Amendment 47 #
2021/2037(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Welcomes the adoption of a proposal for a Regulation on foreign subsidies distorting the internal market; hopes that that this instrument can secure a strong and competitive single market, strengthening the position of the EU and tackling the distortions caused by third countries-especially China- by increasing the level-playing field;
Amendment 54 #
2021/2037(INI)
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4 b. Recalls that China has not ratified four of the eight core ILO Conventions; condemns the continuous breaches of human and labour rights practiced by China, especially those related to Uighur abuses in Xinjiang region;
Amendment 68 #
2021/2037(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. WelcomesTakes note with big concern of the conclusion at the political level of the EU- China Comprehensive Agreement on Investment (CAI); recalls that the CAI has to be considered in the context of a strengthened EU toolbox of unilateral measureswelcomes the suspension of the ratification of the such investment agreement and expects the Commission to consult with the Parliament before taking further steps towards its conclusion; underlines it will thoroughly scrutinise the agreement, including its sustainable development section, and take stock of the human rights context, before determining its position;
Amendment 73 #
2021/2037(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. In this sense, recalls the arbitrary and unlawful sanctions adopted by the People’s Republic of China against five members of the European Parliament, entities and think tanks, meant as a tool of intimidation; highlights that, due the latter Chinese sanctions, the role of the European Parliament for duly analysing the CAI has been jeopardised and further states that trade and investment relations need to be within the scope of human rights and the broader political relations;
Amendment 94 #
2021/2037(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Welcomes the entry into force of the EU-China Agreement on geographical indications, and reiterates the importance of effective implementation of the Agreement.; regrets, nevertheless, that the Commission did not pursue from the beginning a more ambitious agenda by trying to cover a broader number of Geographical Indications;
Amendment 99 #
2021/2037(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Is highly concerned about the global high dependence on Chinese supply chain that the current COVID19 pandemic has shown; further highlights the need for the EU to swift towards the reshoring and near shoring some strategical productions 1b; _________________ 1b“PostCovid-19 value chains: options for reshoring production back to Europe in a globalised economy”, published in 2020
Amendment 102 #
2021/2037(INI)
Draft opinion
Paragraph 6 b (new)
Paragraph 6 b (new)
6 b. Takes note of the important role that China is taking in the Asia-Pacific region, which has increased even more thanks to the Regional Comprehensive Economic Partnership (RCEP); underlines the fact that the RCEP is causing significant geopolitical shifts, challenging also the global position of the EU, by creating the world's largest trading bloc, covering nearly a third of the global economy;
Amendment 2 #
2021/2013(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Stresses the importance of developing a new EU pharmaceutical strategy which is consistent with the Union’s competences under the Treaties and with the principles of proportionality and subsidiarity, as a means of stimulating the development of European enterprises and making them competitive at global level, of paving the way for scientific progress and of guaranteeing better prevention and preparedness and more effective responses to future health emergencies; stresses the need to draw up future European framework provisions for regulatory approval, access and incentives for innovation, accompanied by vigorous industrial policies, with attractiveness and predictable rules being regarded as the key to innovation, and to facilitate patients’ access to medicines; notes that EU pharmaceutical strategy and legislative measures must support European developers and producers in guiding scientific progress and remaining globally competitive; draws attention to the need to develop production chains within Europe through the formulation of rational regulatory framework provisions that are compatible between the Member States, thereby ensuring the supply of medicines by safeguarding the entire production process;
Amendment 25 #
2021/2013(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Emphasises the key importance of intellectual property protection in the EU, which is essential if the EU is not to be dependent on third countries and is to enhance its strategic autonomy in the field of medicines; calls for a joint review process involving European, national and regional institutions, along with health professionals, industry representatives and stakeholders, with a view to identifying shared approaches, in particular to the challenges posed by the COVID-19 pandemic; stresses that compulsory licensing should only be possible in exceptional cases, where no other solution can be found and where it appears to be justified and necessary to increase production capacity effectively;
Amendment 31 #
2021/2013(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Stresses that intellectual property plays a pivotal role in the expansion and growth of SMEs, which are penalised by a lack of knowledge of procedures and by inadequate or non-existent information regarding opportunities available to them;
Amendment 32 #
2021/2013(INI)
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Stresses the need for the Commission, the Member States and the holders of marketing authorisations for medicines to work together in order to identify and address the root causes of the shortfall in medicines on EU markets and to find appropriate ways of addressing the remaining barriers to timely and effective patient access; stresses that affordability of medicines remains a challenge for national health systems;
Amendment 33 #
2021/2013(INI)
Draft opinion
Paragraph 2 c (new)
Paragraph 2 c (new)
2c. Stresses the importance of building adequate legal and operational frameworks that give industry the necessary agility and flexibility to quickly rebuild stockpiles based on patients’ needs in each country and using regional supply strategies; underscores the need for regulatory solutions that encourage flexible and adaptable production and distribution strategies; highlights the need for dialogue with industry to find viable solutions that increase common capacity to prevent shortages;
Amendment 45 #
2021/2013(INI)
3. Stresses the importance of investment and supporting for research in the EU, not least in order to increase the number of patents filed in the Member States; stresses that one of the priorities should be to develop medicines in areas where needs have been met only insufficiently or not at all or where commercial interest is low, to be decided in close collaboration with interested parties, that is to say patients, consumers, healthcare professionals and not-for- profit researchers, and based on the added value to the patient, taking into account the severity of the disease, the costs and the alternative treatments possible; notes that public research should focus particularly on areas of low commercial interest; draws attention, in that connection, to the key role played by AI and its potential as a driver of research and development in the health and pharmaceutical sector;
Amendment 50 #
2021/2013(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Stresses that full realisation of the potential of new technologies also depends on the proper use of health data; stresses the importance of using the potential of digital technologies and health data to expedite access to innovative technologies and to help Member States develop the infrastructure necessary to better assess safety data, health benefits and outcomes; notes that the current COVID-19 crisis has already highlighted the usefulness of data sharing in expediting research, and stepping up public health surveillance systems across the EU with the intention of saving lives;
Amendment 51 #
2021/2013(INI)
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Calls on the Commission to draw up guidelines to resolve problems relating to the interpretation of GDPR provisions on sharing health data for scientific purposes and a code of conduct for the processing of personal data in the health sector in accordance with Article 40 of the GDPR; recommends that appropriate consultations be carried out with the Member States and the scientific community in the implementation of these actions, so that the future health data space can truly fulfil its ambition to support scientific and medical research in Europe;
Amendment 73 #
2021/2013(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Calls on the Commission to use all the means at its disposal to prevent counterfeit products from entering the market and so protect intellectual property rights holders and European citizens, as these products are often of low quality and pose a danger to health; notes that this is compounded by the heavy economic impact, estimated at a loss of at least EUR 10 billion for the European pharmaceutical industry and 37 000 jobs; notes that it is necessary to provide technical assistance to the Member States for the proper implementation of the EMVS;
Amendment 77 #
2021/2013(INI)
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Stresses the need to relocate the production of the most essential medicines into the EU; calls, therefore, on the Commission to prioritise the pharmaceutical production of vaccines in the EU, enabling Member States to conclude public contracts with the various European pharmaceutical laboratories producing vaccines in order to avoid a shortage of doses and ensure the safety of European citizens in the face of such a crisis;
Amendment 569 #
2021/2013(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Emphasises that the term medical device means any instrument, device, item of equipment, software package, implant, reagent, material or other article intended by the manufacturer for use on human beings. If the medical device is to be used alone or in combination with other substances, the Commission is asked to refer to rule 21 in Annex VIII to Regulation 745/2017 on the classification of medical devices;
Amendment 4 #
2021/2003(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. WPoints out that, according to the report 'Women and trade: the role of trade in promoting gender equality', published jointly by the World Trade Organization (WTO) and the World Bank, trade supports the economic and social empowerment of women in the workplace, marketplace and home, and also women make up, on average, 33% of the labour force in exporting firms versus 24% in non-exporting firms, meaning that countries that are more open to trade, as measured by the trade-to-gross domestic product ratio, have higher levels of gender equality; welcomes the fact that the new EU Gender Action Plan 2021-2025 (GAP III) calls for the promotion of gender equality through the EU’s trade policy and recalls the necessary support for the inclusion of a specific gender chapter in EU trade and investment agreements;
Amendment 21 #
2021/2003(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Notes that trade policy is not always gender neutral and that better collection of gender-disaggregated data, together with clear indicators, is needed to adequately assess the different impacts of trade policy on women and men, as well as a careful analysis of specific local sectors and contexts, in order to avoid replicating or exacerbating existing gender imbalances; reiterates its call for the EU and its Member States to include in ex ante and ex post impact assessments the country-specific and sector-specific gender impact of EU trade policy and agreements;
Amendment 28 #
2021/2003(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Stresses the importance of cooperation activities aimed at improving women's access to education and skills development in the fields of business and management, science, technology, engineering and mathematics, and in other areas that could lead to fair pay and decent working conditions for women;
Amendment 29 #
2021/2003(INI)
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Notes the obstacles that working mothers face in the world, especially single mothers, who are particularly economically vulnerable, including the difficulties linked to pregnancy; calls on the Commission and Member States to promote a trade policy that protects mothers;
Amendment 30 #
2021/2003(INI)
Draft opinion
Paragraph 2 c (new)
Paragraph 2 c (new)
2c. Calls on the Commission and Member States to pay particular attention when entering into international trade agreements to all forms of violence against women, including female trafficking and exploitation; notes also that the burden of (unpaid) domestic and care work falls heavily on women, and that this has major implications on their educational and professional choices;
Amendment 35 #
2021/2003(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Points out that gender inequality in trade can be seriously detrimental to economic development since, in the long term, it can disincentivise skills development and technical innovation, and that unequal access to productive resources and markets can stifle the range of products on offer;
Amendment 38 #
2021/2003(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Recognises the disproportionate impact of the COVID-19 pandemic on the participation in trade of female entrepreneurs and women; calls for COVID-19 recovery strategies to pay special attention to micro, small and medium-sized enterprises (MSMEs), which are often run by women, and burdened with taxation, often in connection with the cost of doing business in a country, that leaves them unable to compete on the foreign market and excludes them from certain economic opportunities, and to sectors with higher female participation (agriculture, tourism, garment and retail);
Amendment 46 #
2021/2003(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Notes with concern the persistent gender gap in digital access and digital skills; calls for the Commission and the Member States to support female entrepreneurs in acquiring the necessary skills through development cooperation and Aid for Trade; stresses that policies promoting female participation in science, technology, engineering and mathematics provide an opportunity for the European Union to establish itself in these sectors in which third countries are increasingly advancing, and to stimulate the economic recovery;1a _________________ 1a https://eige.europa.eu/sites/default/files/do cuments/2017.2082_mh0217177enn_pdfw eb_20170803123353.pdf
Amendment 55 #
2021/2003(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Stresses the need to verify whether third-country operators participating in public tenders or procedures launched by the Union and Member States comply with EU law with regard to human rights, in particular as regards discrimination against women;
Amendment 57 #
2021/2003(INI)
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Notes with concern the difficulties that women face in many countries around the world in accessing education, professional training and, therefore, the world of work;
Amendment 60 #
2021/2003(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Calls on the Commission to ensure that sufficient resources are available to promote the core value ofa gender equality perspective in its trade and investment policies, through dialogue and an exchange of good practices with trade partners in order to create an environment in which women have access to decent work and genuinely equal pay, and to ensure that the secretariats of the EU institutions responsible for trade policy and negotiations have the knowledge and technical capacity to incorporate the gender perspective.
Amendment 66 #
2021/2003(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Considers that in order to pursue the aim of promoting gender equality through trade policy, trade policy must ensure that women play a greater role in negotiating and implementing trade agreements;
Amendment 219 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point c
Article 1 – paragraph 1 – point 1 – point c
Directive (EU) 2018/2001
Article 2 – paragraph 2 – point 22 a (new)
Article 2 – paragraph 2 – point 22 a (new)
“(22a) ‘renewable fuels’ means biofuels, bioliquids, biogas, biomass fuels and renewable fuels of non-biological origin;”
Amendment 633 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 16 – point e – point i
Article 1 – paragraph 1 – point 16 – point e – point i
Directive (EU) 2018/2001
Article 27 – paragraph 3 – subparagraphs 1, 2 and 3
Article 27 – paragraph 3 – subparagraphs 1, 2 and 3
(i) the first, second and third subparagraphs are deleted; replaced by the following: ‘For the calculation of the share of renewable electricity Member States shall refer to the two-year period before the year in which the electricity is supplied in their territory. In order to ensure that the expected increase in demand for electricity beyond the current baseline is met with additional renewable energy generation capacity, the Commission shall develop a framework on additionality and shall develop different options with a view to determining the baseline of Member States and measuring additionality.’
Amendment 640 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 16 – point e – point iii a (new)
Article 1 – paragraph 1 – point 16 – point e – point iii a (new)
Directive (EU) 2018/2001
Article 27 – paragraph 3 – subparagraph 6
Article 27 – paragraph 3 – subparagraph 6
Amendment 816 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 19
Article 1 – paragraph 1 – point 19
Directive (EU) 2018/2001
Article 29a – paragraph 3
Article 29a – paragraph 3
3. The Commission is empowered to adopt delegated acts in accordance with Article 35 to supplement this Directive by specifying the methodology for assessing greenhouse gas emissions savings from renewable fuels of non-biological origin and from recycled carbon fuels. The methodology shall ensure that credit for avoided emissions is not given for CO2 the capture of which has already received an emission credit under other provisions of law.; In any case, the methodology for assessing greenhouse gas emissions savings from recycled carbon fuels shall consider, in a life-cycle approach, the avoided emissions compared to the traditional alternatives of fossil fuels production and of waste treatment or disposal.
Amendment 820 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 19
Article 1 – paragraph 1 – point 19
Directive (EU) 2018/2001
Article 29a – paragraph 3a (new)
Article 29a – paragraph 3a (new)
the following paragraph 3a is added: “3a. Pending the adoption of the delegated acts referred to in paragraph 3, Member States may define the methodology for assessing the reductions of greenhouse gas emissions along the life cycle of the fuels referred to in the previous paragraph.”;
Amendment 825 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 19 a (new)
Article 1 – paragraph 1 – point 19 a (new)
Directive (EU) 2018/2001
Article 29b (new)
Article 29b (new)
(19a) The following Article is inserted: Article 29b Greenhouse gas emissions saving criteria for low carbon fuels 1.Fuels can qualify as low carbon fuels only if the greenhouse gas emissions savings from the use of those fuels are at least 65%. 2.The Commission is empowered to adopt delegated acts in accordance with Article 35 to supplement this Directive by specifying the methodology for assessing greenhouse gas emissions savings from low carbon fuels. The methodology shall ensure that credit for avoided emissions is not given for CO2, the capture of which has already received an emission credit under other provisions of law.
Amendment 172 #
2021/0214(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) Existing mechanisms to address the risk of carbon leakage in sectors or sub- sectors at risk of carbon leakage are the transitional free allocation of EU ETS allowances and financial measures to compensate for indirect emission costs incurred from GHG emission costs passed on in electricity prices respectively laid down in Articles 10a(6) and 10b of Directive 2003/87/EC. However, free allocation under the EU ETS weakens the price signal that the system provides for the installations receiving it compared to full auctioning and thus affects the incentives for investment into further abatement of emissions.
Amendment 196 #
2021/0214(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) The CBAM seeks to replacecomplement and conceivably replace, after 2030, these existing mechanisms by addressing the risk of carbon leakage in a different way, namely by ensuring equivalent carbon pricing for imports and domestic products. To ensure a gradual transition from the current systemthat this new mechanism achieves the above objective, and prior to any gradual phasing-out of free EU ETS allowances to the CBAM, the CBAM should be progressively phased in while free allowances in sectors covered by the CBAM are phased out, there is a need to assess a fully-operational CBAM based on the data gathered by the European Commission in the period 2026-2028, and to evaluate the impacts on value chains. Furthermore, before any reduction in the free allowances allocated is contemplated, an effective export protection mechanism must be established to ensure that the environmental objectives of the CBAM are not undermined by carbon leakage arising from the cancellation of European exports. The combined and transitional application of EU ETS allowances allocated free of charge and of the CBAM should in no case result in more favourable treatment for Union goods compared to goods imported into the customs territory of the Union.
Amendment 229 #
2021/0214(COD)
Proposal for a regulation
Recital 11 a (new)
Recital 11 a (new)
(11a) The mechanism in Article 10a(6) of Directive 2003/87/EC should remain outside the scope of CBAM given the unique characteristics of price formation on the Union electricity market, that are not existing in third countries.
Amendment 287 #
2021/0214(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) In order to exclude from the CBAM third countries or territories fully integrated into, or linked, to, the EU ETS in the event of future agreements, the power to adopt acts in accordance with Article 290 of TFEU should be delegated to the Commission in respect of amending the list of countries in Annex IIand only when the carbon costs passed on in the products imported are completely equivalent to those under the ETS within the EU, and when there is a free energy market, the European Commission should submit a proposal to the European Parliament and the Council to amend the current Regulation. Conversely, those third countries or territories should be excluded from the list in Annex II and be subject to CBAM whereby they do not effectively charge the ETS price on goods exported to the Union.
Amendment 411 #
2021/0214(COD)
Proposal for a regulation
Recital 40
Recital 40
(40) An authorised declarant should be allowed to claim a reduction in the number of CBAM certificates to be surrendered corresponding to the carbon price already paid for those emissions in other jurisdictions, but only if such jurisdictions make provision for a free energy market.
Amendment 558 #
2021/0214(COD)
Proposal for a regulation
Article 1 – paragraph 3
Article 1 – paragraph 3
3. The mechanism willcould progressively become, after 2030 and only if the data gathered in the period 2026- 2028 show the CBAM to effectively protect against carbon leakage and if an export protection mechanism has been successfully introduced, an alternative to the mechanisms established under Directive 2003/87/EC to prevent the risk of carbon leakage, notably the allocation of allowances free of charge in accordance with Article 10a of that Directive.
Amendment 594 #
2021/0214(COD)
Proposal for a regulation
Article 2 – paragraph 5 – point b a (new)
Article 2 – paragraph 5 – point b a (new)
(ba) The carbon costs of imported products are completely equivalent to those under the EU’s ETS;
Amendment 618 #
2021/0214(COD)
Proposal for a regulation
Article 2 – paragraph 11
Article 2 – paragraph 11
11. The Commission is empowered to adopt delegated acts in accordance with Article 28should submit a proposal to the European Parliament and the EU Council to amend the lists in Annex II, Sections A or B, depending on whether the conditions in paragraphs 5, 7 or 9 are satisfied. Before that proposal is submitted, the European Commission should conduct a detailed consultation with stakeholders.
Amendment 637 #
2021/0214(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 3
Article 3 – paragraph 1 – point 3
(3) ‘emissions’ mean the release of greenhouse gases into the atmosphere from the production of goods, in accordance with the provisions of the MRR;
Amendment 695 #
2021/0214(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point c a (new)
Article 6 – paragraph 2 – point c a (new)
(ca) the emissions verification report, including the details of the verifier;
Amendment 700 #
2021/0214(COD)
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Embedded emissions in goods other than electricity shall be determined based on the actual emissions in accordance with the methods set out in Annex III, points 2 and 3. When the actual emissions cannot be adequately determined, the embedded emissions shall be determined by reference to default valuesse shall be determined in conjunction with the parties concerned by reference to default values which must be high enough to ensure preferential use of the real data in the emissions declaration in accordance with the methods set out in Annex III, point 4.1.
Amendment 719 #
2021/0214(COD)
Proposal for a regulation
Article 7 – paragraph 6
Article 7 – paragraph 6
6. The Commission is empowered to adopt delegated implementing acts concerning detailed rules regarding the elements of the calculation methods set out in Annex III, including determining system boundaries of production processes, emission factors, installation-specific values of actual emissions and default values and their respective application to individual goods as well as laying down methods to ensure the reliability of data on the basis of which the default values shall be determined, including the level of detail and the verification of the data. Where necessary, those acts shall provide that the default values can be adapted to particular areas, regions or countries to take into account specific objective factors such as geography, natural resources, market conditions, prevailing energy sources, or industrial processes. The delegated implementing acts shall build upon existing legislation for the verification of emissions and activity data for installations covered by Directive 2003/87/EC, in particular Implementing Regulation (EU) No 2018/2067.
Amendment 724 #
2021/0214(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. The authorised declarant shall ensure that the total embedded emissions declared in the CBAM declaration submitted pursuant to Article 6 are verified by a verifier accredited pursuant to Article 18, based on the verification principles set out in Annex V. The competent authority is authorised to verify the accuracy of the information in the CBAM declaration.
Amendment 743 #
2021/0214(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. An authorised declarant may claim in its CBAM declaration a reduction in the number of CBAM certificates to be surrendered in order for the carbon price paid in the country of origin for the declared embedded emissions to be taken into account. The reduction may only be granted to countries operating in a free energy market, so as to ensure a genuine level playing field.
Amendment 758 #
2021/0214(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The authorised declarant shall keep records of the documentation, certified by an independent personaccredited verifier, required to demonstrate that the declared embedded emissions were subject to a carbon price in the country of origin of the goods and keep evidence of the proof of the actual payment for that carbon price, which should not have been subject to an export rebate or any other form of compensation on exportation.
Amendment 762 #
2021/0214(COD)
Proposal for a regulation
Article 9 – paragraph 4
Article 9 – paragraph 4
4. The Commission is empowered to adopt implementing acts establishing the methodology for calculating the reduction in the number of CBAM certificates to be surrendered, regarding the verification methodology, regarding the conversion of the carbon price paid in foreign currency into euro at yearly average exchange rate in accordance with paragraph 1, and regarding the qualifications of the independent person certifying the information as well as elements of proof of the carbon price paid and the absence of export rebates or other forms of compensation on exportation being applied as referred to in paragraph 2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 29(2).
Amendment 775 #
2021/0214(COD)
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. The Commission shall, upon request by a register the information on operators of an installations located in a third country, register the information on that operator and on itsies and on their installations in athe central database referred to in Article 14(4).
Amendment 777 #
2021/0214(COD)
Proposal for a regulation
Article 10 – paragraph 6
Article 10 – paragraph 6
6. The records referred to in paragraph 5, point (c), shall be sufficiently detailed to enable the verification in accordance with paragraph 5, point (b), and to enable any competent authority to conduct audits and review, in accordance with Article 19(1), the CBAM declaration made by an authorised declarant to whom the relevant information was disclosed in accordance with paragraph 8.
Amendment 784 #
2021/0214(COD)
Proposal for a regulation
Article 10 – paragraph 7
Article 10 – paragraph 7
7. An operator mayust disclose the information on the verification of embedded emissions referred to in paragraph 5 to an authorised declarant. The authorised declarant shall be entitled to avail itself of that disclosed information to fulfil the obligation referred to in Article 8.
Amendment 1186 #
2021/0214(COD)
Proposal for a regulation
Article 30 a (new)
Article 30 a (new)
Article 30a The Commission shall review the functioning of the CBAM on the basis of the data gathered in the period 2026-2028 with a view to assessing its effectiveness in protecting industries against the risk of carbon leakage and its impact on the security of national supply and on value chains. In 2029, the Commission shall submit a report to the European Parliament and the Council on the effectiveness of the CBAM on the basis of the impact assessment conducted on the data gathered in the period 2026-2028, and shall also do so whenever the assessment of the effectiveness of the CBAM in addressing carbon leakage dictates that EU ETS allowances should continue to be allocated free of charge pursuant to Article 10a of Directive 2003/87/EC in order to prevent the risk of carbon leakage post-2030. The report shall also cover the mechanism established to protect exports.
Amendment 1210 #
2021/0214(COD)
Proposal for a regulation
Article 31 – paragraph 2 a (new)
Article 31 – paragraph 2 a (new)
2a. The CBAM is complemented by a WTO compatible offsetting mechanism granting free allowances to exporters for an amount linked to the emissions embedded in EU products exported to third countries, which do not impose carbon cost. The Commission adopts implementing acts laying down a calculation methodology for the amount of free allowances to be granted pursuant to subparagraph 1.
Amendment 1239 #
2021/0214(COD)
Proposal for a regulation
Article 36 – paragraph 3 – point d
Article 36 – paragraph 3 – point d
d) Articles 4, 6, 7, 8, 9, 10, 14, 15, 16, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 31 shall apply from 1 January 2026.
Amendment 1282 #
2021/0214(COD)
Proposal for a regulation
Annex III – point 4 – paragraph 2
Annex III – point 4 – paragraph 2
For the purpose of determining default values, only actual values shall be used for the determination of embedded emissions. In the absence of actual data, literature values may be used. The Commission shall publish guidance for the approach taken to correct for waste gases or greenhouse gases used as process input, before collecting the data required to determine the relevant default values for each type of goods listed in Annex I. Default values shall be determined based on the best available data. They shall be revised periodically through implementing acts based on the most up-to-date and reliable information, including on the basis of information provided by stakeholders, a third country or group of third countries.
Amendment 1290 #
2021/0214(COD)
Proposal for a regulation
Annex III – point 4 – point 4.1 – paragraph 1
Annex III – point 4 – point 4.1 – paragraph 1
When actual emissions cannot be adequately determined by the authorised declarant, default values shall be used. These values shall be set at the average emission intensity of each exporting country and for each of the goods listed in Annex I other than electricity, increased by a mark-up, the latter to be determined in the implementing acts of this Regulation. When reliable data for the exporting country cannot be applied for a type of goods, the default values shall be based on the average emission intensity of the 10 per cent worst performing EU installations for that type of goods and to be high enough to facilitate production of the statement of actual emissions data.
Amendment 74 #
2021/0202(COD)
Proposal for a decision
Article 1
Article 1
Decision (EU) 2015/1814
Article 1 – paragraph 5 – subparagraph 1
Article 1 – paragraph 5 – subparagraph 1
Amendments to Decision (EU) 2015/1814 In Article 1(5), first subparagraph, of Decision (EU) 2015/1814, the last sentence is replaced by the following: By way of derogation from the first and second sentences, until 31 December 2030, the percentages and the 100 million allowances referred to in those sentences shall be doubled.rticle 1 deleted
Amendment 141 #
2020/2273(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the new EU Biodiversity Strategy for 2030 and its level of ambition; recognises, however, the need to set balanced targets in each Member State, given the diversity of farming and forestry practices and the efforts made to date to observe the principles of economic, environmental and social sustainability;
Amendment 253 #
2020/2273(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Expresses strong support for the targets of protecting at least 30 % of the Union’s marine and terrestrial areas, and of strictly protecting at least 10 % of these areas, including primary and old-growth forests and other carbon-rich ecosystems; stresses that these should be binding and implemented by Member States in accordance with science-based criteria and biodiversitythat are specific to each site and biodiversity needs at local and regional level, as well as climate needs; underlines that in addition to increasing protected areas, the quality of protected areas should be ensured and clear conservation plans, specific to each site, implemented;
Amendment 272 #
2020/2273(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Emphasises that successful conservation of protected areas, including strictly protected areas, requires decision- making at the level of, and based on the needs of, the individual sites, taking into account the regional, socio-economic and cultural characteristics of the areas within the EU, with a view to promoting community-based conservation;
Amendment 338 #
2020/2273(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Welcomes the upcoming legislative proposal on the EU Nature Restoration Plan and reiterates its call for a restoration target of at least 30 % of the EU’s land and seas, which should be implemented by each Member State consistently throughout their territory, which should be based on scientific assessments; considers that in addition to an overall restoration target, ecosystem-specific targets should be set, with a particular emphasis on ecosystems for the dual purposes of biodiversity restoration and climate change mitigation and adaptation; stresses that after restoration, no ecosystem degradation should be allowed;
Amendment 407 #
2020/2273(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Stresses the need for the active involvement of all stakeholders at European, national, regional and local level so that they can take concrete action to effectively implement the Biodiversity Strategy for 2030 and to address any implementation gaps in the Habitats and Birds Directives;
Amendment 491 #
2020/2273(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Calls on the Commission to develop environmental regeneration processes by restoring natural areas in built-up zones, thereby encouraging the removal of unused, outdated or dilapidated buildings and infrastructure by private and public bodies; notes that this process would also help to improve the landscape and relieve citizens and local authorities of the tax burdens potentially involved in maintaining such properties;
Amendment 520 #
2020/2273(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Expresses its support for the 2030 targets of bringing at least 25 % of agricultural land under organic farm management, which should become the norm in the long term, and ensuring that at least 10 % of agricultural land consists of high-diversity landscape features, which should be implemented at farm level, targets which should both be incorporated into EU legislation; considers it imperative that farmers receive support and training in the transition towards agroecological practices; supporting the development of organic farming in line with market trends, and ensuring, on a voluntary basis, that 10 % of agricultural land consists of high-diversity landscape features, which should be implemented at farm level; considers it imperative that farmers receive financial and other support as well as training in the transition towards more sustainable practices, and that products obtained in this way are properly promoted; notes, too, that all available production techniques should be used to ensure that there is sufficient supply to meet market demands;
Amendment 625 #
2020/2273(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Points out that the maintenance and development of open areas for permanent grassland and pasture should be made a priority in order to protect at- risk species of wild birds and pollinators, which are primarily connected with this type of environment, including by clearing woodland in degraded areas consisting of matter of little environmental value;
Amendment 653 #
2020/2273(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Underlines that the new EU Forest Strategy must be fully aligned with the Climate Law and the Biodiversity Strategy; calls for the inclusion in the Nature Restoration Plan of specific bindingpolicy targets for the protection and restoration of forest ecosystems, which should also be incorporated into the Forest Strategy;
Amendment 689 #
2020/2273(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
Amendment 771 #
2020/2273(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Welcomes the Commission’s targets of reducing the use of more hazardous and chemical pesticides by 50 %, the use of fertilisers by at least 20 % and nutrient losses by at least 50 % by 2030, which should be made bindingand nutrient losses by 2030; recognises that these targets could have a significant negative impact on the economic sustainability of the sector, on farmers’ incomes and on food safety, and should therefore be subject to an impact assessment before a targeted reduction is set; takes the view that farmers should be put in a position where they are able to use fewer products, or optimise their use, through greater investment and greater development in the areas of research, innovation and tools and precision agriculture techniques; considers that the derogation envisaged in Article 53(1) of Regulation (EC) No 1107/2009 should be clarified and must only be applied for health and environmental reasoso as to respond to farmers’ actual needs with regard to the most dangerous pathogens;
Amendment 799 #
2020/2273(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Takes the view that a reduction in plant protection chemicals should be accompanied by a clear framework that would allow for the development and use of innovative technologies, including biotechnologies, provided that they are safe for consumers and the environment and widely accessible to farmers; calls for clarity on the ever-growing world of new plant-breeding techniques (NBTs) in order to regulate their areas of application and prospective use and thereby provide the necessary legal basis for their development in the field;
Amendment 813 #
2020/2273(INI)
Motion for a resolution
Paragraph 18 b (new)
Paragraph 18 b (new)
18b. Looks forward to reading the Commission’s study on the potential of new genomic techniques, which should ultimately lead to an appropriate legal framework based on state-of-the-art scientific expertise and evidence;
Amendment 874 #
2020/2273(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Regrets that the list of Union concern represents less than 6 % of IAS present in Europe; cCalls on the Commission to ensure proper coverage of IAS affecting threatened species on the EU list and to reinforce prevention by introducing mandatory risk assessments prior to the first import of non-native speci, while taking due account of the implementation costs for Member States and the socioeconomic aspects of using IAS for income purposes, and by adopting white lists by 2030 at the latests well as reinforcing prevention in the context of imports;
Amendment 887 #
2020/2273(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Calls on the Commission to give stakeholders all the power they need to take sweeping and concrete action to tackle invasive alien species as a matter of priority, both in terms of time and resources;
Amendment 892 #
2020/2273(INI)
Motion for a resolution
Paragraph 21 b (new)
Paragraph 21 b (new)
21b. Calls on the Commission to equip Member States with urgent intervention measures to control general predatory species whose conservation status is favourable or on the rise and whose prominence in many environments, just as with IAS, is putting the populations of priority species at risk, for example many bird species that nest on the ground in open or cultivated areas or wetlands;
Amendment 909 #
2020/2273(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Calls on the Commission to ensure effective biodiversity mainstreaming and proofing across EU spending and programmes on the basis of the EU Taxonomy and the ‘do no significant harm’ principle; calls on the Commission to provide a comprehensive assessment of how the EUR 20 billion per yearresources needed for nature could be mobilised, to make corresponding proposals for the Union’s annual budget and to examine the need for a dedicated funding instrument for TEN-N; considers that efforts should be made to reach 10 %earmark a proportion of annual spending on biodiversity under the multiannual financial framework (MFF) as soon as possible from 2021 onwards; calls on the Commission to draw up a legislative proposal that includes sufficient financial resources to compensate farmers for the increased costs and/or loss of income due to new practices designed to pursue the objectives of the biodiversity strategy;
Amendment 928 #
2020/2273(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
Amendment 965 #
2020/2273(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Highlights the need for a legally binding biodiversity governance framework, similar to the Climate Law, which steers a path to 2050 through a set of binding objectives, including targets for 2030 and the COP15 commitments, and which establishes a monitoring mechanism with smart indicators; calls on the Commission to submit a legal proposal to this end in 2022 which establishes a monitoring mechanism with smart indicators;
Amendment 1138 #
2020/2273(INI)
Motion for a resolution
Paragraph 29 a (new)
Paragraph 29 a (new)
29a. Stresses the importance of including respect for biodiversity in trade agreements in order to halt global deforestation and prevent the overexploitation of fishery and marine resources; urges developing countries to support biodiversity and alignment with European standards on sustainability, and to prevent the exploitation of workers; calls on the Commission to ensure that imported products meet the same standards required of European producers in order to protect biodiversity;
Amendment 119 #
2020/2260(INI)
Motion for a resolution
Citation 24 a (new)
Citation 24 a (new)
- having regard to Decision 5.COM 6.41 of 16 November 2010 of the UNESCO Intergovernmental Committee for the Safeguarding of the Intangible Cultural Heritage, recognising the value of the Mediterranean Diet in terms of its many different elements, and having regard to the fact that this step has been recognised as fundamental by the FAO and the WHO for the contribution it can make to the Farm to Fork Strategy and EU food policies,
Amendment 231 #
2020/2260(INI)
Motion for a resolution
Recital B
Recital B
B. whereas Europe’s food system shouldagri-food and fishing system delivers food and nutrition security in a way that, contributesing to social well- being and maintainsing and restoresing ecosystem health; whereas currently, the food system is responsible for a range ofhas an impacts on human and animal health and on the environment, the climate and biodiversity; whereas the way in which we produce and consume food needs to transform in orderadapt in order to continue to ensure coherence with the SDGs, the Paris Agreement, the Convention on Biological Diversity and EU policies, particularly in the areas of sustainability, the environment, climate, public health, animal welfare, food and economic sustainability for farmerall operators in the agro-food and fishing supply chains;
Amendment 280 #
2020/2260(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the European model of a multifunctional agricultural sector, mainly driven by family and small-scale farms, continues to ensure high-quality food production, short and local supply chains, good agriculture practices, high environmental standards and vibrant rural areas throughout the EU, despite an arsenal of restrictive regulations and trade globalisation that affect their competitiveness; whereas the European agricultural model is facing serious difficulties, such as fewer workers, generational and vocational renewal, low incomes and income inequality, extensive regulation and red tape, and international market pressures;
Amendment 359 #
2020/2260(INI)
Motion for a resolution
Recital D
Recital D
D. whereas it is important that consumers are informed and enabled to take responsibility for the consequences of their choice of food stuffs on the whole food system, from production to processing and distribution; whereas this requires a healthy and sound food environment which ensures that the healthy and sustainable choice is also the easy and affordable choice, and fosters and encourages consumption patterns that supportthat a safe and varied supply of agri-food products is ensured, benefiting human health while ensuring the sustainable use of natural and human resources and animal welfare;
Amendment 421 #
2020/2260(INI)
Motion for a resolution
Recital E
Recital E
E. whereas the European food system has played a crucial role during the COVID-19 pandemic, demonstrating its resilience with farmers and fisheries operators, processors and retailers working together under difficult conditions, including lockdowns, to ensure that European consumers continue to have access to safe, affordable, and high quality products without impediment;
Amendment 427 #
2020/2260(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Amendment 463 #
2020/2260(INI)
Motion for a resolution
Recital E b (new)
Recital E b (new)
Eb. whereas the Farm to Fork commitments should protect and make the most of centuries of European food culture, and promote nutritional patterns that are well-established in the traditions and history of the European continent;
Amendment 488 #
2020/2260(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the farm to fork strategy as an important step in ensuring a sovereign, sustainable, fair and resilient food system, which is central to achievingcalls for a paradigm shift, particularly given the numerous agricultural imports that do not meet the goals set out in the European Green Deal and in the SDGs; emphasises the inextricable links between healthy people, healthy societies, healthy rural life and a healthy planet, encourages the Commission to translate the strategy into concrete legislative and non-legislative action as soon as possible and in consultation with stakeholders;
Amendment 496 #
2020/2260(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. WelcomNotes the farm to fork strategy as an important step in ensuring a sustainable, fair and resilient food system, which is central to achieving the goals set out in the European Green Deal and in the SDGs; emphasises the inextricable links between healthy people, healthy societies and a healthy planet, encourages the Commission to translate the strategy into concrete legislative and non-legislative action as soon as possible, following an impact assessment that takes into account the economic, environmental and social sustainability of the measures planned;
Amendment 585 #
2020/2260(INI)
2. WelcomNotes the announcement of an impact-assessed proposal forpreparatory to the drafting of a legislative framework for sustainable food systems; invites the Commission to use this proposal to set out a holistic common food policy aimed at reducassess, together with the other institutions of the EU and the actors ing the environmental and climate footprint of the EU foodagri-food sector, the effectiveness of a European approach to syustemainability and self-sufficiency in food in order to make Europe the first climate- neutral continent by 2050 and strengthen its resilience to ensure food security, quantity and quality in the face of climate change and biodiversity loss, leading a global transition towards sustainability from farm to fork, based on the principle of a multifunctional agricultural sector; stresses the importance of ensuring adequate support tools for the multifunctional agricultural sector during the energy transition phase, while ensuring consistency between policies by taking into account the existing legislation in order to enable all actors in the European food system to develop long- term plans based on realistic, achievable and transparent objectives; suggests that the respective base lines and progress achieved in each Member State be taken into account, while promoting the exchange of know-how and best practices between Member States; stresses the need to include the entire food and beverage chains including processing, marketing, distribution and retail;
Amendment 638 #
2020/2260(INI)
2a. Urges the Commission not to forget the key role that young farmers play, and must continue to play, in accomplishing this much-needed transition to sustainable farming; calls for measures designed to support income, generational renewal and training to create a space enabling the inclusion and retention of young people in agriculture;
Amendment 708 #
2020/2260(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
Amendment 910 #
2020/2260(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Emphasises the importance of recognising the significantcorrectly assessing, recognising the positive role that agriculture already plays in carbon sequestration in soils, the impact of agriculture and especially animal production on greenhouse gas (GHG) emissions and land use, given the extent of these activities in relation to other production activities; stresses the need to enhance natural carbon sinks and reduce agricultural emissions of carbon dioxide, methane and nitrous oxide, in particular in the feed and livestock sectors; calls for regulatory measures and targets to ensure progressive reductions in all GHG emissions in these sectorsemissions and calls on the Commission to present a legislative proposal that includes adequate financial resources to compensate farmers for the increased costs incurred or the loss of income they suffer in pursuing the decontamination target and to ensure more ambitious action on carbon sequestration and the use of products that biodegrade in the soil;
Amendment 967 #
2020/2260(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Calls on the Commission and the Member States to use solutions based on the circular economy, particularly biogas such as biomethane, in order to reduce the impact of agriculture and livestock production on air quality;
Amendment 1025 #
2020/2260(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Points out that extensive and permanent grassland-based or organic animal husbandry is a feature ofthat meets animal welfare standards is essential for the European food system and a defining element of many traditional rural communities, and that it has multiplehas positive effects for the environment and against climate change, and contributes significantly to a circular economy;
Amendment 1047 #
2020/2260(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Calls for appropriate investment incentives for modern indoor livestock rearing facilities and techniques that comply fully with animal welfare standards, which ensure the supply of foodstuffs of animal origin required by the EU population while also contributing to reducing emissions and combating climate change;
Amendment 1050 #
2020/2260(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Calls on the Commission and the Member States to explore local slaughter solutions, with smaller units and better staff training on how to avoid animal suffering, and to make it compulsory to stun animals before they are slaughtered;
Amendment 1121 #
2020/2260(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Welcomes the notion of rewarding carbon sequestration in soils; stresses, however, that intensive and industrial agriculture and farming models with negative impacts on biodiversity should not receive climate funding or be incentivised; calls for th the need for a system of incentives that promotes biodiversity and the achievement of ambitious sustainability objectives, offering rewards that are proposrtionals to be in line with the environmental objectives and the ‘do no harm’ principle of the Green Dealthe scale of the commitments that farmers and processing companies wish to assume, individually or collectively;
Amendment 1179 #
2020/2260(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Calls on the Commission to guarantee a new regulatory approach requiring that new plant breeding techniques (NBTs) undergo specific case- by-case assessments to verify their agricultural, economic and environmental viability, in order to provide farmers in the EU with further directly available tools to address the reduction of inputs and ensure greater resilience and adaptation to climate change;
Amendment 1249 #
2020/2260(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Calls for CAP National Strategic Plans to ensure adequate financial support and incentives to promote new ecological ‘green’ business modelecological production models such as organic and integrated production and other recognised systems for agriculture and artisanal food production, notably through fostering shortlocal supply chains and quality food production;
Amendment 1314 #
2020/2260(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Recalls that the European foodagri-food and fisheries system delivers a sufficient and varied supply of safe, nutritious, affordable and sustainable food to people at all times and underlines that increasing the economic, environmental and social sustainability of food producers will ultimately increase their resilience; encourages the Commission to consider the food supply chain and its workers as a strategic asset for the safety and well-being of all Europeans;
Amendment 1333 #
2020/2260(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Underlines that robust and reliable legal frameworks for the fisheries and aquaculture sector should provide the basis for better protection measures with subsequent increases in fish populations and more clarity regarding the use of space and licenses in aquaculture, allowing for greater predictability for investments; stresses that good traceability mechanisms and high sustainability standards for all products sold on EU markets are essential to ensure transparency for consumers, the sector and the different administrations, and to achieve the targets of the Green Deal and the SDGs; development of projects able to incentivise the collection of maritime waste by operators in the fisheries sector, by recognising the strategic role they already play and could play further in terms of cleaning up the sea. Initiatives should be supported by strategies to improve the economic conditions for producers through policies to support, protect and maximise the value of fishery products, so as to enable operators to support environmental policies. Recognition of organic production could become a valuable support for sustainable growth;
Amendment 1367 #
2020/2260(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Expresses its deep concern about the emergence of zoonotic diseases that are transferred from animals to humans (anthropozoonoses), such as Q fever, avian influenza and the new strain of influenza A (H1N1), which is exacerbated by anthropogenic climate change, the destruction of biodiversity, environmental degradation and our current food production systemsthe importing of agri-food products from third countries that do not apply the same high standards in terms of quality, safety, and respect for the environment and human rights required for producers in the EU;
Amendment 1399 #
2020/2260(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Expresses its deep concern about the emergence of zoonotic diseases that are transferred from animals to humans (anthropozoonoses), such as Q fever, avian influenza and the new strain of influenza A (H1N1), which is exacerbated by faster trade around the world, anthropogenic climate change, the destruction of biodiversity, and environmental degradation and our current food production systems;
Amendment 1406 #
2020/2260(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Expresses its deep concern about the increasing number of imported diseases and invasive species that are threatening entire sectors of European agriculture, such as Xylella fastidiosa, the coffee berry borer, the Asian hornet, the western conifer seed bug and the brown marmorated stink bug;
Amendment 1421 #
2020/2260(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Calls for primary producers to be supported in making the transition to greater sustainability through the encouragement of cooperation and collective actions as well as through competition rules and the enhancement of possibilities for cooperation among the various actors involved in the supply chain within the common market organisations for agricultural, fishery and aquaculture products, and thus for farmers’ and fishers’ position in the supply chain to be strengthened in order to enable them to capture a fair share of the added value of sustainable production; takes the view that supply chain agreements should be implemented and supported to ensure a fair distribution of value to farmers and fishing contractors and to guarantee greater transparency and traceability in the supply chain as a whole;
Amendment 1472 #
2020/2260(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Urges the Commission to follow up on Directive (EU) 2019/633 on unfair trading practices22 and the EU code of conduct on responsible business and marketing practices by producing a monitoring framework for the food and retail sectors and providing for legal action if progress in integrating economic, environmental and social sustainability into corporate strategies is insufficient, and in so doing promoting and rewarding the efforts of sustainable agricultural producers while increasing the availability and affordability of healthy, sustainable food options and reducing the overall environmental footprint of the food system; stresses the importance of halting and addressing consolidation and concentration in the grocery retail sector in order to ensure fair prices for farmers; notes the importance of timely application of the directive on unfair trading practices to combat fraud in the agri-food chain, and the right of consumers to cater to their own protein needs in full awareness of the plant or animal origin of a given name used in the sale of a food product; _________________ 22 OJ L 111, 25.4.2019, p. 59.
Amendment 1478 #
2020/2260(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Urges the Commission to follow up on Directive (EU) 2019/633 on unfair trading practices22 and the EU code of conduct on responsible business and marketing practices by producing a monitoring framework for the food and retail sectors and providing for legal action if progress in integrating economic, environmental and social sustainability into corporate strategies is insufficient, and in so doing promoting and rewarding the efforts of sustainable agricultural producers while increasing the availability and affordability of healthy, sustainable food options and reducing the overall environmental footprint of the food systemsales channels use the nutritional labelling system as a direct tool for commercial promotion; stresses the importance of halting and addressing consolidation and concentration in the grocery retail sector in order to ensure fair prices for farmers; _________________ 22 OJ L 111, 25.4.2019, p. 59.
Amendment 1497 #
2020/2260(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Supports the Commission in its efforts to combat food fraud, which misleads consumers and distorts competition in the internal market; regards it as essential to make the penalties imposed on fraudsters more dissuasive, to earmark sufficient resources so that checks can be stepped up and to establish a legal definition at EU level of the concepts of ‘food fraud and crime’ and ‘counterfeiting’;
Amendment 1509 #
2020/2260(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Urges the Commission to meet its commitments in terms of health security, protection of biodiversity and prevention of unfair competition when it sets the maximum residue limits for pesticides in agricultural products authorised for import under free trade agreements, and particularly when those products contain residues of pesticides banned in the EU;
Amendment 1571 #
2020/2260(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Calls on the Commission to identify practical ways of encouraging short supply chains, such as an exemption from VAT for products sold less than 100 km from their production site, and providing public spaces for the regular or seasonal sale of products from micro- enterprises or regional cooperatives;
Amendment 1605 #
2020/2260(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Recalls the need to promote effective, innovative and flexible Agricultural Knowledge and Innovation Systems (AKIS), enabling agricultural enterprises to stay on the market in a competitive and sustainable way, ensuring vitality in rural areas, and enabling all food chain actors to become sustainable by speeding up innovation and accelerating knowledge transfer; recalls, in addition, the need for a farm sustainability data network to set benchmarks for farm performance and document the uptake of sustainable farming practices, while allowing for the precise and tailored application of new production approaches at farm level by providing farmers with access to fast broadband connections;
Amendment 1617 #
2020/2260(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Stresses the need to better inform consumers through mandatory labelling of all foods in relation to country of origin, providing a clear and transparent tool for the entire agri-food chain that is applied uniformly throughout the European market;
Amendment 1641 #
2020/2260(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls for measures to reduce the burden that highly processed foods with high salt, sugar and fat content place on public health;regrets that the introduction of nutrient profiles is greatland consumer information campaigns to promote healthier diets that provide information on the importance of a varied and balanced diet that does not exclude any food, provided that it is consumed in the right amount and frequency and is accompanied by adelayed and stresses that a robust set of nutrient profiles must be developed to restrict or prohibit the use of false nutritional claims on foods high in fats, sugars and/or salt; calls for a mandatoryquate physical activity; welcomes efforts to harmonise EU-wide front-of-pack nutrition labelling systems, provided that they are voluntary, and based on the portions actually consumed and on independent science, eschewing simplistic solutions that could influence consumers’ decisions, as opposed to providing them with information on actual nutritional intake and balanced diets; believes that the instruments to harmonise EU-wide front- of- pack nutrition labelling system based on independent sciencehould exclude the use of simplified categories and/or categories represented by colour schemes or traffic lights, such as the ‘Nutriscore’ model;
Amendment 1642 #
2020/2260(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls for measures to reduce the burden that highly processed foods with high salt, sugar and fat content place on public health;regrets that the introduction of nutrient profiles is greatland consumer information campaigns to promote healthier diets that provide information on the importance of a varied and balanced diet that does not exclude any food, provided that it is consumed in the right amount and frequency, and is accompanied by adelayed and stresses that a robust set of nutrient profiles must be developed to restrict or prohibit the use of false nutritional claims on foods high in fats, sugars and/or salt;calls for a mandatoryquate physical activity; welcomes efforts to harmonise EU-wide front-of-pack nutrition labelling systems, provided that they are voluntary, and based on the portions actually consumed and on independent science, eschewing simplistic solutions that could influence consumers’ decisions, as opposed to providing them with information on actual nutritional intake and balanced diets; believes that a harmonised EU-wide front- of-pack nutrition labelling system based on independent sciencemust meet the requirements laid down in Article 35 of Regulation (EU) No 1169/2011;
Amendment 1687 #
2020/2260(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Stresses the importance of the Commission’s proposal to introduce a harmonised front-of-pack (FOP) labelling system based on sound scientific evidence and supported by accurate impact assessments; calls on the Commission to take into account the actual daily intake of food and drink to avoid sending misleading messages to the consumer; takes the view that a harmonised scheme at EU level must be easy to understand and must not be misleading, and therefore advises against the use of colours that would convey a simplistic message without providing details of the method used to attribute them; expresses its concern that products protected by PDO and PGI labels might be penalised, since they are governed by production rules laying down the raw materials and production methods to be used, and as such cannot be changed;
Amendment 1725 #
2020/2260(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Welcomes the Commission’s commitment to revise the EU legislation on food contact materials (FCM); reiterates its call to revise the legislation on FCM in line with the regulation on the registration, evaluation, authorisation and restriction of chemicals (REACH), as well as classification, labelling and packaging regulations, and to insert, without further delay, specific provisions to substitute endocrine disrupting chemicals; stresses that the introduction of more sustainable materials could lead to additional costs for producers and that new obligations should take proper account of the time needed for introduction and actual availability of alternative packaging materials and solutions;
Amendment 1785 #
2020/2260(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Welcomes the fact that the strategy rightly recognises the role and influence of the food environment in shaping consumption patterns and the need to make it easier for consumers to chooseAcknowledges that the strategy must make the most of the role of the agri- food chain in allowing the products offered on the domestic market to stand out and emphasise the need to provide correct information to consumers to enable them to plan healthy and sustainable diets; reiterates the importance of promoting sustainablebalanced diets by raising consumer awareness of the impacts of consumption patterns and providing information on diets that are better for human health and have a lower environmental footprint; underlines that food prices must send the right signal to consumers; welcomes, therefore, the strategy’s objective that the healthy and suthrough a voluntary system of indications with a sound scientific basis and based on actual portions consumed; underlines that food prices must adequately support the supply chain in its efforts to deliver high standards of food safety, quality and the distainable choice should become the most affordable onective character of European products on the markets;
Amendment 1838 #
2020/2260(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Reaffirms its belief that policy measures that are dependent solely on consumer choice unduly shift the responsibility to purchase sustainable and local products to consumers; notes that third- party certification and labelling alone are not effective in ensuring sustainable production and consumption;
Amendment 1857 #
2020/2260(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Highlights the recognition in the strategy that Europeans’ diets are not in line with recommendations for healthy eating, and that a population-wide shift in consumption patterns is needed towards more healthy and plant-based foods and less red and processed meat, sugars, salt, and fats, which will also benefit the environment; eEmphasises that EU-wide guidelines for sustainable and healthy diets would bring clarity to consumers on what constitutes a healthy and sustainable diet and inform Member States’ own efforts to integrate sustainability elements in national dietary advice; calls on the Commission to develop such guidelines and specific actions to effectively promote healthy plant-based diets;
Amendment 1881 #
2020/2260(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Highlights the recognition in the strategy that Europeans’ diets are not in line with recommendations for healthy eating, and that a population-wide shift in consumption patterns is needed towards more healEmphasises that the strategy must be taken as a starting point for building a framework of rules to ensure that consumers are given complete and scientifically correct information to enable them to plan healthy diets; notes that food safety and quality are also crucial for the value they and plant-based foods and less red and processed meat, sugars, salt, and fats, which will also benefit the environment; emphasises that EU-wide guidelines for sustainable and healthy diets would bring clarity to consumers on what constitutes a healthy and sustainable diet and inform Member States’ own efforts to integrate sustainability elements in national dietary advice; calls on the Commission to develop such guidelines and specific actions to effectively promote healthy plant-based dietsdeliver to the supply chain, and that Europe’s agricultural production must guarantee the variety and quality of all the major nutrients that contribute to good human health; stresses that any public initiative involving information messages on food diets must not be used for promotional or commercial purposes; notes the input of the Member States on national dietary advice and invites them to integrate environmental sustainability elements as necessary; calls on the Commission to develop a proper information campaign on balanced and healthy diets and to promote physical exercise as another essential component of human well-being;
Amendment 1916 #
2020/2260(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Encourages the Member States to promote food education through their culinary traditions, understanding of their land and learning to cook from a very young age and in school;
Amendment 1918 #
2020/2260(INI)
Motion for a resolution
Paragraph 20 b (new)
Paragraph 20 b (new)
20b. Points out that artificial food made in laboratories has little taste and few nutritional qualities, always contains additives, and has not been properly assessed in terms of its toxicity; emphasises, in this respect, that artificial food is an aberration and an attempt by laboratories to pre-empt the food sector, which could have long-term consequences on prices and agricultural jobs;
Amendment 1942 #
2020/2260(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Considers that the further development of plant protein production and alternative sources of protein in the EU is a way of effectively addressing many of the environmental and climate challenges that EU agriculture is facing, as well as preventing deforestation in countries outside the EU and reducing Europe’s current dependence regarding its supply of plant proteins;
Amendment 1957 #
2020/2260(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Considers that the European food system is among the best in the world, and that the added value for the supply chain is based on food production that cannot be significantly replaced or provided by edible insects, which are alien to European food traditions;
Amendment 2106 #
2020/2260(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Underlines the importance EU funding for research and innovation as a key driver in accelerating the transition to a more sustainable, healthy and inclusivelocal European food system while facilitating investments needed to encourage agro- ecological practices in both social and technological innovation, and the crucial role of farm advisory services in ensuring the transfer of knowledge to the farming community, drawing on the existing specialised training systems for farmers in Member States; points out the need to take account of the accumulated delay due to the COVID-19 pandemic, which is hindering the economic recovery efforts aimed at continental and overseas farmers and fishers, with those overseas particularly suffering from their remoteness and island location;
Amendment 2124 #
2020/2260(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Underlines the importance EU funding for research and innovation as a key driver in accelerating the transition to a more sustainable, healthy and inclusive European food system while facilitating investments needed to encourage agro- ecologicalsustainable practices in both social and technological innovation, and the crucial role of farm advisory services for all actors in the agri-food chain in ensuring the transfer of knowledge to the farming communitysector, drawing on the existing specialised training systems for farmers in Member States for farmers and all actors in the supply chain, without introducing additional administrative burdens;
Amendment 2193 #
2020/2260(INI)
Motion for a resolution
Paragraph 26
Paragraph 26
26. Recalls the global responsibility of European food systems and their key role in setting global standards for food safety, environmental protection and animal welfare; calls on the Commission and the Member States to ensure that all food and feed products imported to the EU fully meet relevant EU regulations and standards and to provide development assistance to support primary producers from developing countries in meeting, to never lower our requirements to meet import conditions defined in free trade agreements, and to make those standards strictly mandatory for gaining access to the European market, so that European continental or overseas producers and producers outside Europe are subject to those standardame market conditions; welcomes the Commission’s intention to take the environmental impacts of requested import tolerances into account; calls on the Commission to revise the free trade agreements, given the environmental impact that some agricultural products imported from third countries may have;
Amendment 2213 #
2020/2260(INI)
Motion for a resolution
Paragraph 26
Paragraph 26
26. Recalls the global responsibility of European food systems and their key role in setting global standards for food safety, environmental protection and animal welfare; calls on the Commission and the Member States to ensure that the farm to fork objectives are implemented gradually, taking account of the level of overall agreement on them, and to ensure that all food and feed products imported to the EU fully meet relevant EU regulations and standards and to provide development assistance to support primary producers from developing countries in meeting those standards; welcomes the Commission’s intention to take the environmental impacts of requested import tolerances into account;
Amendment 2220 #
2020/2260(INI)
Motion for a resolution
Paragraph 26
Paragraph 26
26. Recalls the global responsibility of European food systems and their key role in setting global standards for food safety, environmental protection and animal welfare; calls on the Commission and the Member States to ensure that all farm, food and feed products imported to the EU, including the raw materials needed to produce them, fully meet the relevant EU regulations and the Union’s high standards and to provide development assistance to support primary producers from developing countries in meeting those standards; welcomes the Commission’s intention to take the environmental impacts of requested import tolerances into account;
Amendment 2239 #
2020/2260(INI)
Motion for a resolution
Paragraph 26 a (new)
Paragraph 26 a (new)
26a. Believes that environmental, social and economic sustainability must be at the heart of the future EU trade policy and every bilateral trade agreement, adopting an approach to trade policies with third countries that safeguards the value of European farmers’ environmental sustainability efforts;
Amendment 26 #
2020/2071(INI)
Motion for a resolution
Recital A
Recital A
A. whereas the increase in global demand has aggravated shortages of medicines in the EU, undermining health services in the Member States and exposing patients to considerable risks; whereas these include the progression of the disease and/or worsening of symptoms, increased exposure to falsified medicines, medication errors or adverse events which occur when the missing medicine is replaced by another, avoidable transmission of infectious diseases and significant psychological distress; whereas the Member States have a duty to find swift and effective solutions through closer European integration;
Amendment 37 #
2020/2071(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas shortages of medicines are a symptom of unsustainable policies, and there is abundant scientific evidence that demonstrates that medicines shortages have multi factorial root causes: namely economic causes, increasing regulatory burden, unforeseen surges in demand, supply chain interdependencies and manufacturing and quality challenges;
Amendment 70 #
2020/2071(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas medicine shortages may lead to delays in the treatment of patients, the need to use alternative therapies that could be less effective and, accordingly, to adverse effects and even a danger to life where a shortage concerns vital medicines;
Amendment 89 #
2020/2071(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the loss of European sovereignty and independence in the health sector is linked to the relocation of production, with 40 % of medicinal end products marketed in the EU now originating in third countries; whereas the onlya way tof saveing money and maximising profit is to rely heavily on subcontractors to produce pharmaceutical raw materials in Asia, where labour costs and environmental standards are lower, with the result that 80 % of active ingredients are manufactured outside the EU, mainly in China and India;
Amendment 104 #
2020/2071(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas the EU has an important existing manufacturing footprint and it is important to secure it through sustainable economic, regulatory and industrial incentives and policies;
Amendment 135 #
2020/2071(INI)
Motion for a resolution
Recital F
Recital F
F. whereas there are no price harmonisation arrangements tocurrent internal market rules facilitate ‘parallel exports’ to countriMember States where the medicine in question is more expensive; whereas, however, in a market economy, price planning is inconceivable;
Amendment 154 #
2020/2071(INI)
Motion for a resolution
Recital G
Recital G
G. whereas, in the absence of a regulatory authority, stockpiling in some Member States is leading to a market imbalancesome Member States, stockpiling can further contribute to actual medicine shortages;
Amendment 163 #
2020/2071(INI)
Motion for a resolution
Recital G a (new)
Recital G a (new)
Ga. whereas the combination of cost containment measures, lack of market predictability, combined with an onerous and rigid regulatory framework are challenging sustainable and equitable access to medicines, especially for very old inexpensive essential drugs, as well as the competitiveness of the EU pharmaceutical industry;
Amendment 165 #
2020/2071(INI)
Motion for a resolution
Recital G b (new)
Recital G b (new)
Gb. whereas the coronavirus pandemic has demonstrated that a pan-European coordination and dialogue is needed between authorities, industry and relevant stakeholders of the healthcare supply chain;
Amendment 166 #
2020/2071(INI)
Motion for a resolution
Recital H
Recital H
Amendment 172 #
2020/2071(INI)
Motion for a resolution
Recital I
Recital I
I. whereas the greater number, geographical spread and impact of epidemics is partly attributable to climate change, in combination with globalisation and increased travelglobalisation is a decisive factor as regards the increased geographical spread and impact of epidemics, not to mention the speed at which the infection spreads;
Amendment 181 #
2020/2071(INI)
Motion for a resolution
Recital J
Recital J
J. whereas the destruction of biodiversity, the proliferation of man-made habitats and damage to natural areas densely populated by humans are potentially facilitating the propagation of zoonoses, i.e. the transmission to humans and rapid spread of animal pathogens;
Amendment 185 #
2020/2071(INI)
Motion for a resolution
Recital J a (new)
Recital J a (new)
Ja. whereas health is not a commodity, and making it subject to internal market rules as if it were, has done nothing but discourage research and the production of new medicines, as well as promote the establishment of a parallel market in medicines and an oligopoly of multinationals;
Amendment 204 #
2020/2071(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses the geostrategic imperative that the UnionMember States regain itstheir sovereignty and independence with regard to health care and secure itstheir supply of medicines and medical equipment;
Amendment 212 #
2020/2071(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Urges Member States to avoid to take measures such as artificial stockpiling, as recommended by the Commission in its Guidelines on the optimal and rational supply of medicines of 8 April 2020 in the context of the COVID-19 crisis; also discourages Member States to apply unproportioned and unnecessary penalties, which create even further unsustainability and increase the possibility to generate medicines shortage;
Amendment 230 #
2020/2071(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Urges the Commission to propose in the upcoming Pharmaceutical Strategy the creation of a High Level pharmaceutical Forum, together with policy-makers, regulators, payers, patients, industry representatives and other actors of the healthcare supply chain to set a clear plan to address pharmaceutical sustainability issues, and ensure the competitiveness of the pharmaceutical industry sector in Europe;
Amendment 232 #
2020/2071(INI)
Motion for a resolution
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Calls on the Commission to preserve a competitive research-based pharmaceutical industry taking into account that EU remains by far the world leader manufacturing region of active ingredients for on patent medicines;
Amendment 285 #
2020/2071(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission and the Member States to take whatever action is needed to restore European health sovereigntythe medical and pharmaceutical self-sufficiency of the Union and local pharmaceutical manufacturing, giving priority to essential and strategic medicines; calls on the Commission to map out potential production sites in the EU;
Amendment 346 #
2020/2071(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Urges the Commission and the Member States to define and propose sustainable, economic, industrial and regulatory policies to maintain and secure existing manufacturing operations, to introduce tax and financial incentives in return for appropriate commitments and to authorise state aid to encourage producers to maintain or locate their operations in Europe, from compound manufacturing to packaging and distribution; emphasises the strategic significance of this sector and the importance of investing in European companies, in the interests of resource diversification;
Amendment 399 #
2020/2071(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Notes that procurement procedures with only one successful tenderer may exacerbate vulnerability should supplies be disrupted; calls on the Commission and the Member States to introduce procurement procedures under which contracts may be awarded to a number of successful tenderers, in order to maintain market competition and reduce the risk of shortages, while guaranteeing high-quality and affordable treatment for patients;
Amendment 447 #
2020/2071(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Stresses the importance of research and innovation, and calls for the establishment of a genuine European network, given that the price of relocation must not be a deterioration in the quality of medical research; calls for medical research to be encouraged in Europe, to support the relocation and renewed competitiveness of the sector;
Amendment 490 #
2020/2071(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Recommends the introduction of centralised managementa European database to bring about greater transparency in the distribution chain and the creation of a European supply management unit tasked with developing a European strategy to prevent and resolve breaks in supplyan early warning system on shortages of existing and planned medicines to ensure that breaks in supply are better managed;
Amendment 530 #
2020/2071(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Calls on the Commission to develop European health strategies on the basis of a common basket of drugs for the treatment of cancer and infections whose prices are harmonisedtailored to the purchasing power of each Member State, in a bid to counter recurrent shortages and ensure that patients have access to treatment;
Amendment 544 #
2020/2071(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls on the Commission to create, as part of the ‘RescEU’ mechanism, a European contingencystrategic reserve of medicines of strategic importance for health care, supplies of which are critical, along the lines of the ‘RescEU’ mechanism, in order to alleviate shortages outside crisis permajor therapeutic importance and at high risk of shortage, to act as a contingency stock for Member States in critical situatiodns;
Amendment 566 #
2020/2071(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls on the Commission and the Member States to adopt a joint definition of ‘medicines of strategic importance for health carmajor therapeutic importance’ and of ‘criticality’, emphasising the value of these medicines for public health, the lack of alternatives and the vulnerability of the production chain; calls for a European regulatory authority to be designated to carry out the task of setting quotas for the allocation of medicines from that reserve to the Member States;
Amendment 590 #
2020/2071(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls on the Commission and Member States to develop innovative and coordinated strategies and to step up exchanges of good practice in the area of stock management; considers that the European Medicines Agency (EMA) could be designated as the regulatory authority tasked with preventing shortages of essential medicines, with a correspondingly wider remit and more staffat no additional cost to the Union budget;
Amendment 622 #
2020/2071(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Calls on the Commission to encourage producers, on a voluntary basis, to introduce a labelling system - visible to and identifiable by patients / consumers - concerning the place of origin and production of medical products and active ingredients, in order to avoid the risks of falsified medicines and to meet consumers' expectations;
Amendment 655 #
2020/2071(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to set up an innovative centralised digital platform, which can be consulted by the public, for sharing information provided by national agencies and all stakeholders regarding shortages of medicines and medical equipment; welcomes the introduction by the EMA of the SPOC and i-SPOC systems; calls for existing information systems to be improved so as to provide a clear overview of difficulties, shortages and requirements in each Member State, with a view to preventing stockpiling;
Amendment 696 #
2020/2071(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Calls for the paper information notice to be supplemented by an electronic information notice to be drawn up in all the official Union languages for every medicine on the EU marketsold in the Union itself, in order to facilitate sales of medicines between Member States; recommends the provision of more comprehensive information on the origin of medicines;
Amendment 709 #
2020/2071(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Stresses the need to use state-of- the-art track-and-trace systems and technologies for medicines, from when the active ingredients are produced, in order to improve the reliability of the entire production, packaging and distribution chain and ensure a high quality of medicines;
Amendment 724 #
2020/2071(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Calls on the Commission, EMA and relevant regulatory authorities to ensure that regulatory flexibilities continue to be applied in the efforts to mitigate medicines shortage from occurring;
Amendment 727 #
2020/2071(INI)
Motion for a resolution
Paragraph 21 b (new)
Paragraph 21 b (new)
21b. Calls on the Commission and EMA to optimise the regulatory framework by implementing its telematics strategy and amending Regulation (EC) No 1234/2008 (Variations Regulation) and the Variations Classification Guidelines; this will contribute to the prevention of medicines shortage and align with the progress in technology;
Amendment 734 #
2020/2071(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Takes the view that the introduction of stress tests by the Member States to assess the resilience of respective health systems in emergencies would provide an effective means of countering shortages in the event of pandemics and of identifying structural risk factors which go to create shortages;
Amendment 20 #
2020/2043(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Supports, in the absence of a global carbon price and a multilateral solution, a market-based EU carbon border adjustment mechanism (CBAM) on condition that it is, notes that this has been the Commission’s intention for a number of years, but that it has only very recently engaged with stakeholders to set such a mechanism in motion and has yet to flesh it out with any real substance, stresses that this mechanism must be compatible with EU free trade agreements (FTAs) and WTO rules (by being non- discriminatory and not constituting a disguised restriction on international trade), and that it is proportionate, based on the polluter pays principle and fit for purpose in delivering the climate, environment and social objectives;
Amendment 40 #
2020/2043(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Notes that the general exception clause of Article XX of the General Agreement on Tariffs and Trade (GATT) should be the basis for any CBAM design and its onlymain rationale should be: an environmental one – reducing global CO2 emissions and preventing carbon leakage by reducing logistics chains, slowing down global flows and promoting local production and consumption circuits; recommends that the price per tonne of CO2 take account of the real environmental cost of a product, encompassing not only production costs but also transportation costs, which should include a coefficient for actual distance travelled; stresses that this real cost must not only offset the environmental cost of products, but also contribute to bolstering the internal market and providing impetus for reducing the carbon footprint and volume of world trade;
Amendment 63 #
2020/2043(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Calls for thorough impact assessments and for the utmost transparency of the process leading to the CBAM, as well as engagement with the EU’s trading partners to build coalitions and avoid any possible retaliastresses that this must be accompanied by robust and coherent diplomacy on the part of the European Union and Member States in accordance with their respective competences, with a view to preventing and countering any possible retaliations, by means, inter alia, of engagement with the EU’s trading partners to build coalitions;
Amendment 12 #
2020/2041(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. WelcomNotes the announcement from the G20 on a temporary moratorium on debt repayments for the weakest developing countries and encourages private creditors to take part in this operation;
Amendment 22 #
2020/2041(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Highlights that the European Union still has important economic ties with African states, and that China has intensified its economic engagement in Africaincluding Economic Partnership Agreements (EPAs), which have not turned out to be the most appropriate tools for pursuing the development process for which they were intended and which, on the contrary, are threatening existing local production and are liable to hamper the establishment of new job- and wealth-creating businesses;
Amendment 32 #
2020/2041(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Is of the view that Chinese presence and investments in Africa have increased considerably and that there is a need to remain vigilant as to the economic, social and environmental impact of the Chinese approach in Africa, in order to preserve the commercial interests of African states and of EU Member States;
Amendment 35 #
2020/2041(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Underlines that the role of many African states in the international division of labour does not promote theireconomic development in those states that is sustainable developmentover time;
Amendment 57 #
2020/2041(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Calls on the Commission to support Africa in its ambitions for a continental free trade area by making the necessary adjustments in order to implement itsto the Economic Partnership Agreements (EPAs) and make them fit the project of the Continental Free Trade Area;
Amendment 65 #
2020/2041(INI)
Draft opinion
Paragraph 7
Paragraph 7
7. Underlines that the fragmented implementation of EPAs hasinadequacy of the EPAs has undermined the already delicate process of continental integration and resulted in a lack of substantial progress in supporting regional integration, capacity-building on border cooperation, and improvements in investment climates and good governance;
Amendment 76 #
2020/2041(INI)
Draft opinion
Paragraph 8
Paragraph 8
8. Calls for a concrete proposal that establishes common initiatives on a renewablen energy supply on thethat is suited to the specific territorial, geographic and demographic features and needs of African countinentries;
Amendment 84 #
2020/2041(INI)
Draft opinion
Paragraph 9
Paragraph 9
9. Emphasises the need for substantial sustainable investments that enable leapfrogging in the African states; African states to promote job creation, develop their production and processing sectors in situ and manage their resources more effectively, in order to achieve the objectives of greater 'economic autonomy';
Amendment 99 #
2020/2041(INI)
Draft opinion
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Highlights the need to promote, support and encourage female and youth entrepreneurship;
Amendment 6 #
2020/2017(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Underlines that artificial intelligence (AI) and related technologies are acan be tools to serve the people, provided they are properly regulated, and that algorithmic systems can enable access to information, including listings of different kinds of cultural objects; notes the risks of intellectual property rights (IPR) infringement when blending AI and different technologies with a multiplicity of sources (documents, photos, films);
Amendment 30 #
2020/2017(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Notes that AI-improved image recognition software could vastly enhance the ability of educational facilities and relevant actors to provide and develop modern and innovative schooling methods while ensuring quality sources and respecting the protection of IPRs, provided that this does not serve as a pretext for doing away with schooling methods based on human intervention by a teacher who is physically present;
Amendment 6 #
2020/2016(INI)
Draft opinion
Recital A
Recital A
A. whereas the right to fair trial is a fundamental right which also applies to enforcement of the lawmust be upheld in all circumstances, in particular in the context of the use of AI;
Amendment 21 #
2020/2016(INI)
Draft opinion
Recital B
Recital B
B. whereas technologies such as artificial intelligence (AI) and related technologies willmay contribute to the reducing of crime rates, through the use of statistical data analytics in crime analysis and prevention, and the operation of criminal justice systems;
Amendment 65 #
2020/2016(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Emphasises the need to draw up strict rules to govern the use of facial recognition technologies in connection with criminal matters; suggests that a recommendation be issued banning their use temporarily pending the drafting of those rules;
Amendment 74 #
2020/2016(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Considers it necessary to clarify whether law enforcement decisions can be delegated to AIWarns against the temptation to delegate to AI the power to take decisions under the criminal law, and stresses the need to develop codes of conduct for the design and use of AI to help law enforcers and judicial authorities; refers to the ongoing work in the Committee on Legal Affairs.
Amendment 4 #
2020/2015(INI)
Motion for a resolution
Recital A
Recital A
A. whereas the European legal framework for intellectual property aims to promote innovation, creativity and access to knowledge and information and that copyright in particular seeks to protect authors and their ability to earn a living from the proceeds of their works;
Amendment 18 #
2020/2015(INI)
Motion for a resolution
Recital E
Recital E
E. whereas a human-centred approach to AI is needed if the technology is to remain a tool that serves people and the common good, particularly in the field of biomedical engineering, medical advancement and health;
Amendment 21 #
2020/2015(INI)
Motion for a resolution
Recital F
Recital F
F. whereas legal certainty fosters technological development, and whereasstrengthens the international competitiveness of European industry and SMEs, as well as fostering public confidence in new technologies, which is essential for the development of this sector;
Amendment 25 #
2020/2015(INI)
Motion for a resolution
Recital G
Recital G
G. whereas the EU is the appropriate level at which to regulate AI technologies in order to avoid fragmentation of the single market, while taking due account of the varying levels of digitalisation of the Member States; whereas the EU regulatory framework in the field of AI will have the potential to become a legislative benchmark at international level;
Amendment 50 #
2020/2015(INI)
Motion for a resolution
Recital L
Recital L
L. whereas AI technologies are heavily dependent on data, a blanket term for information falling into a range of categories that requires protection and tailored governance; whereas increased access to certain data and databases in the European Union, especially for SMEs and start-ups, will play a crucial role in advancing the development of European AI;
Amendment 57 #
2020/2015(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. WelcomesTakes note of the Commission White Paper on ‘Artificial Intelligence - A European approach to excellence and trust’ and of the European Data Strategy; stresses thatconsiders the approaches outlined therein are likely to contribute toto be a starting point for the deployment of the potential of human- centered AI in the EU; notes, however, that the issue of the protection of IPRs in the context of the development of AI technologies does not seem to have been addressed by the Commission, despite the importance of these rights and the role played by innovation and creativity in the EU economy;
Amendment 67 #
2020/2015(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses the importance of protecting IPRs in relation to AI technologies, in order to create the legal certainty and build the trust needed to encourage investment in these technologies, in particular for SMEs and start-ups; considers that the EU can be a frontrunner in the creation of AI technologies if it adopts an operational regulatory framework that is regularly assessed in the light of technological developments and implements proactive public policies, particularly as regards training programmes and financial support for research;
Amendment 105 #
2020/2015(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Takes the view that consideration must be given to protecting technical and artistic creations generated by AI, in order to encourage this form of creation; considers that certain works generated by AI canould be regarded as equivalent to intellectual works and could therefore be protected by copyright;, and recommends that ownership of rights be assigned to the person who prepares and publishes a work lawfully, provided that the technology designer has not expressly reserved the right to use the work in that waythe issue of copyright on such works be carefully assessed;
Amendment 117 #
2020/2015(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Notes that AI makes it possible to process a large quantity of data relating to the state of the art or the existence of IPRs; notes, at the same time, that the use of AI technology cannot be a substitute for human verification in relation to the granting of IPRs and the determination of liability for infringements of IPRs and of damage occasioned by AI technologies;
Amendment 5 #
2020/2014(INL)
Motion for a resolution
Citation 23 a (new)
Citation 23 a (new)
- having regard to Council Directive 2000/78/EC of 27 November 2000 establishing a general framework for equal treatment in employment and occupation1a, ____________________ 1a OJ L 303, 2.12.2000, p. 16.
Amendment 6 #
2020/2014(INL)
Motion for a resolution
Citation 23 b (new)
Citation 23 b (new)
- having regard to the directives on equal treatment of men and women with regard to employment and access to goods and services,
Amendment 7 #
2020/2014(INL)
Motion for a resolution
Citation 23 c (new)
Citation 23 c (new)
- having regard to various consumer protection rules such as the Unfair Commercial Practices Directive (Directive 2005/29/EC) and the Consumer Rights Directive (Directive 2011/83/EC),
Amendment 8 #
2020/2014(INL)
Motion for a resolution
Citation 23 d (new)
Citation 23 d (new)
- having regard to Directive 2009/48/EC on the safety of toys,
Amendment 9 #
2020/2014(INL)
Motion for a resolution
Citation 23 e (new)
Citation 23 e (new)
- having regard to European Council Decision 2017/745 on medical devices amending Directive 2001/83/EC and applicable from 26 May 2020,
Amendment 43 #
2020/2014(INL)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Considers that the challenge related to the introduction of AI-systems into society and the economy is one of the most important questions on the current political agenda; whereas technologies based on A I could improve our lives in almost every sector, from the personal sphere (e.g. personalised education, fitness programs, credit provision and court orders) to global challenges (e.g. climate change, hunger and starvation);
Amendment 89 #
2020/2014(INL)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Considers it appropriate to define the deployer as the person who decides on the use of the AI-system, who exercises control over the risk and who benefits from its operation; considers that exercising control means any action of the deployer that affects the manner of the operation from start to finish or that changes specific functions or processes within the AI- system; takes the view that those tasked with deployment should monitor the good intentions of the developers throughout the value chain in order to ensure the protection of consumers through trustworthy AI;
Amendment 112 #
2020/2014(INL)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Recommends that all high-risk AI- systems be listed in an Annex to the proposed Regulation; recognises that, given the rapid technological change and the required technical expertise, it should be up to the Commission to review that Annex every six months and if necessary, amend it through a delegated act; believes that the Commission should closely cooperate with a newly formed standing committee similar to the existing Standing Committee on Precursors or the Technical Committee on Motor Vehicles, which include national experts of the Member States and stakeholders; considers that the balanced membership of the ‘High-Level Expert Group on Artificial Intelligence’ could serve as an example for the formation of the group of stakeholders, with the addition of ethics experts and anthropologists, sociologists and mental- health specialists;
Amendment 157 #
2020/2014(INL)
Motion for a resolution
Annex I – part A – paragraph 1 – indent 6
Annex I – part A – paragraph 1 – indent 6
- Citizens need to be entitled to the same level of protection and rights, no matter if the harm is caused by an AI- system or not, or if it takes place physically or virtually. , or if it is material or non- material. As set out in the Commission Communication of 19 February 2020 on the safety and liability implications of AI and robotics, ‘explicit obligations for producers, among others, of humanoid AI to explicitly take into account the non- material damage that their products could cause to users, in particular vulnerable users such as elderly people in care settings’ should be taken into account in this EU legislation.
Amendment 164 #
2020/2014(INL)
Motion for a resolution
Annex I – part B – recital 1
Annex I – part B – recital 1
(1) The concept of ‘liability’ plays an important double role in our daily life: on the one hand, it ensures that a person who has suffered harm or damage is entitled to claim compensation from the party proven to be liable for that harm or damage, and on the other hand, it provides the economic incentives for persons to avoid causing harm or damage, whether material or non- material, in the first place. Any liability framework should strive to strike a balance between efficiently protecting potential victims of damage and at the same time, providing enough leeway to make the development of new technologies, products or services possible.
Amendment 170 #
2020/2014(INL)
Motion for a resolution
Annex I – part B – recital 3
Annex I – part B – recital 3
(3) The rise of Artificial intelligence (AI) however presents a significant challenge for the existing liability frameworks. Using AI-systems in our daily life will lead to situations in which their opacity (“black box” element) makes it extremely expensive or even impossible to identify who was in control of the risk of using the AI-system in question or which code or input has caused the harmful operation. This difficulty is even compounded by the connectivity between an AI-system and other AI-systems and non-AI-systems, by its dependency on external data, by its vulnerability to cybersecurity breaches as well as by the increasing autonomy of AI-systems triggered by machine-learning and deep- learning capabilities. Besides these complex features and potential vulnerabilities, AI-systems could also be used to cause severe harm, such as compromising our human dignity, our values and freedoms by tracking individuals against their will, by introducing Social Credit Systems or by constructing lethal autonomous weapon systems, or to take biased decisions in matters of health insurance, credit provision, court orders or recruitment or employment decisions.
Amendment 248 #
2020/2014(INL)
Motion for a resolution
Annex I – part B – recital 20
Annex I – part B – recital 20
(20) Despite missing historical claim data for reasons such as updating algorithms or anonymising data, there are already insurance products that are developed area-by-area and cover- by-cover as technology develops. Many insurers specialise in certain market segments (e.g. SMEs) or in providing cover for certain product types (e.g. electrical goods), which means that there will usually be an insurance product available for the insured. If a new type of insurance is needed, the insurance market will develop and offer a fitting solution and thus, will close the insurance gap. In exceptional cases, in which the compensation significantly exceeds the maximum amounts set out in this Regulation, Member States should be encouraged to set up a special compensation fund for a limited period of time that addresses the specific needs of those cases.
Amendment 31 #
2020/2012(INL)
Motion for a resolution
Recital E
Recital E
E. whereas such questions should be addressed through a comprehensive and future-proof legal framework reflecting the Union’s principles and values as enshrined in the Treaties and the Charter of Fundamental Rights that would bring legal certainty to businesses and citizenall citizens and businesses alike;
Amendment 55 #
2020/2012(INL)
Motion for a resolution
Recital K
Recital K
K. whereas each Member State should establish a national supervisory authoritysystem responsible for ensuring, assessing and monitoring compliance, and for enabling discussion and exchange of points of view in close cooperation with the concerned stakeholders and the civil society;
Amendment 58 #
2020/2012(INL)
Motion for a resolution
Recital L
Recital L
Amendment 115 #
2020/2012(INL)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Affirms that possible bias in and discrimination by software, algorithms and data should be addressed by setting rules for the processes through which they are designed and used, as this approach would have the potential to turn software, algorithms and data into a considerable counterbalance to bias and discrimination, and a positive force for social change;
Amendment 125 #
2020/2012(INL)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Emphasises that socially responsible artificial intelligence, robotics and related technologies should safeguard and promote fundamental values of our society such as democracy, freedom of expression and political pluralism, diverse and independent media and objective and freely available information, health and economic prosperity, equality of opportunity, workers’ and social rights, quality education, cultural and linguistic diversity, gender balance, digital literacy, innovation and creativity;
Amendment 187 #
2020/2012(INL)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Notes the added value of having national supervisory authoritiesystems in each Member State responsible for ensuring, assessing and monitoring compliance with ethical principles for the development, deployment and use of artificial intelligence, robotics and related technologies;
Amendment 192 #
2020/2012(INL)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Indicates that such authoritienational supervisory systems should liaise not only among themselves but also with the European Commission and other relevant institutions, bodies, offices and agencies of the Union in order to guarantee coherent cross-border action;
Amendment 198 #
2020/2012(INL)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Calls for such authoritienational supervisory systems to be tasked with promoting regular exchanges with civil society and innovation within the Union by providing assistance to concerned stakeholders, in particular small and medium-sized enterprises or start-ups;
Amendment 206 #
2020/2012(INL)
Motion for a resolution
Paragraph 22
Paragraph 22
Amendment 211 #
2020/2012(INL)
Motion for a resolution
Paragraph 23
Paragraph 23
Amendment 225 #
2020/2012(INL)
Motion for a resolution
Paragraph 24
Paragraph 24
Amendment 238 #
2020/2012(INL)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Suggests that the European Agency for Artificial Intelligence develops common criteriae creation of a European certificate of compliance and an application process relating to the granting of a European certificate of ethical compliance following a request by any developer, deployer or user seeking to certify the positive assessment of compliance carried out by the respective national supervisory authoritysystem;
Amendment 251 #
2020/2012(INL)
Motion for a resolution
Paragraph 28
Paragraph 28
Amendment 262 #
2020/2012(INL)
Motion for a resolution
Paragraph 29
Paragraph 29
29. Concludes, following the above reflections on aspects related to the ethical dimension of artificial intelligence, robotics and related technologies, that the ethical dimension should be framed as a series of principles resulting in a legal framework at Union level supervised by national competent authoritiesystems, coordinated and enhanced by a European Agency for Artificial Intelligenceby the European Commission and duly respected and certified within the internal market;
Amendment 272 #
2020/2012(INL)
Motion for a resolution
Paragraph 32
Paragraph 32
Amendment 104 #
2020/0361(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) Such a substantial connection to the Union should be considered to exist where the service provider has an establishment in the Union or, in its absence, on the basis of the existence of a significant number of users in one or more Member States, or the targeting of activities towards one or more Member States. The targeting of activities towards one or more Member States canshould be determined on the basis of all relevant circumstances, including factors such as the use of a language or a currency generally used in that Member State, or the possibility of ordering products or services, or using a national top level domain. The targeting of activities towards a Member State could also be derived from the availability of an application in the relevant national application store, from the provision of local advertising or advertising in the language used in that Member State, or from the handling of customer relations such as by providing customer service in the language generally used in that Member State. A substantial connection should also be assumed where a service provider directs its activities to one or more Member State as set out in Article 17(1)(c) of Regulation (EU) 1215/2012 of the European Parliament and of the Council27 . On the other hand, mere technical accessibility of a website from the Union cannot, on that ground alone, be considered as establishing a substantial connection to the Union. _________________ 27 Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (OJ L351, 20.12.2012, p.1).
Amendment 115 #
2020/0361(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) It should be clarified that this Regulation is without prejudice to the rules of Union law on copyright and related rights, which establish specific rules and procedures that should remain unaffected and are lex specialis, prevailing over this Regulation.
Amendment 123 #
2020/0361(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) In order to achieve the objective of ensuring a safe, predictable and trusted online environment, for the purpose of this Regulation the concept of “illegal content” should be defined broadly and also covers information relating to illegal content, products, services and activities. In particular, that concept should be understood to refer to information, irrespective of its form, that under the applicable law is either itself illegal, such as illegal hate speech or terrorist content and unlawful discriminatory content, or that relates to activities that are illegal, such as the sharing of images depicting child sexual abuse, unlawful non- consensual sharing of private images, online stalking, the sale of non-compliant, dangerous or counterfeit products, the non-authorised use of copyright protected material or activities involving infringements of consumer protection law. In this regard, it is immaterial whether the illegality of the information or activity results from Union law or from national law that is consistent with Union law and what the precise nature or subject matter is of the law in question.
Amendment 131 #
2020/0361(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Considering the particular characteristics of the services concerned and the corresponding need to make the providers thereof subject to certain specific obligations, it is necessary to distinguish, within the broader category of providers of hosting services as defined in this Regulation, the subcategory of online platforms. Online platforms, such as social networks or online marketplaces, should be defined as providers of hosting services that not only store information provided by the recipients of the service at their request, but that also disseminate that information to the public, again at their request. However, in order to avoid imposing overly broad obligations, providers of hosting services should not be considered as online platforms where the dissemination to the public is merely a minor and purely ancillary feature of anotherthe principal service and that feature cannot, for objective technical reasons, be used without that other, principal service, and the integration of that feature is not a means to circumvent the applicability of the rules of this Regulation applicable to online platforms. For example, the comments section in an online newspaper could constitute such a feature, where it is clear that it is ancillary to the main service represented by the publication of news under the editorial responsibility of the publisher.
Amendment 141 #
2020/0361(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) The exemptions from liability established in this Regulation should not apply where, instead of confining itself to providing the services neutrally, by a merely technical and automatic processing of the information provided by the recipient of the service, the provider of intermediary services plays an active role of such a kind as to give it knowledge of, or control over, that information. A provider of intermediary services plays an active role when assistance is given to the recipient of the service, notably for the optimizing and the promotion of the content offered. Those exemptions should accordingly not be available in respect of liability relating to information provided not by the recipient of the service but by the provider of intermediary service itself, including where the information has been developed under the editorial responsibility of that provider.
Amendment 144 #
2020/0361(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) AThe provider should not be able to benefit from exemptions from liability provided for in this Regulation where the main purpose is to engage in or facilitate illegal activities or where a provider of intermediary services that deliberately collaborates with a recipient of the services in order to undertake illegal activities and does not provide its service neutrally and should therefore not be able to benefit from the exemptions from liability provided for in this Regulation.
Amendment 153 #
2020/0361(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) In order to ensure the effective protection of consumers when engaging in intermediated commercial transactions online, certain providers of hosting services, namely, online platforms that allow consumers to conclude distance contracts with traders on the platforms, should not be able to benefit from the exemption from liability for hosting service providers established in this Regulation, in so far as those online platforms present the relevant information relating to the transactions at issue in such a way that it leads consumers to believe that the information was provided by those online platforms themselves or by recipients of the service acting under their authority or control, and that those online platforms thus have knowledge of or control over the information, even if that may in reality not be the case. In that regard, is should be determined objectively, on the basis of all relevant circumstances, whether the presentation could lead to such a belief on the side of an average and reasonably well- informed consumer.
Amendment 181 #
2020/0361(COD)
Proposal for a regulation
Recital 32
Recital 32
(32) The orders to provide information regulated by this Regulation concern the production of specific information about individual recipients of the intermediary service concerned who are identified in those orders for the purposes of determining compliance by the recipients of the services with applicable Union or national rules. Therefore, ois information, which should include the relevant email addresses, telephone numbers, IP addresses and other contact details necessary to ensure such compliance, should be available in respect of all types orders. Orders about information on a group of recipients of the service who are not specifically identified, including orders to provide aggregate information required for statistical purposes or evidence-based policy-making, should remain unaffected by the rules of this Regulation on the provision of information.
Amendment 196 #
2020/0361(COD)
Proposal for a regulation
Recital 40
Recital 40
Amendment 204 #
2020/0361(COD)
Proposal for a regulation
Recital 41
Recital 41
Amendment 213 #
2020/0361(COD)
Proposal for a regulation
Recital 42
Recital 42
(42) Where a hosting service provider decides to remove or disable information provided by a recipient of the service, for instance following receipt of a notice or acting on its own initiative, including through the use of automated means, that provider should inform the recipient of its decision, the reasons for its decision and the available redress possibilities to contest the decision, in view of the negative consequences that such decisions may have for the recipient, including as regards the exercise of its fundamental right to freedom of expression. That obligation should apply irrespective of the reasons for the decision, in particular whether the action has been taken because the information notified is considered to be illegal content or incompatible with the applicable terms and conditions. Available recourses to challenge the decision of the hosting service provider should always include judicial redress.
Amendment 218 #
2020/0361(COD)
Proposal for a regulation
Recital 43 a (new)
Recital 43 a (new)
(43 a) Providers of hosting services play a particularly important role in tackling illegal content online, as they store information provided by and at the request of the recipients of the service and typically give other recipients access thereto, sometimes on a large scale. It is important that all providers of hosting services, regardless of their size, put in place user-friendly notice and action mechanisms that facilitate the notification of specific items of information that the notifying party considers to be illegal content to the provider of hosting services concerned ('notice'), pursuant to which that provider can decide, based on its own assessment, whether or not it agrees with that assessment and wishes to remove or disable access to that content ('action'). Provided the requirements on notices are met, it should be possible for individuals or entities to notify multiple specific items of allegedly illegal content through a single notice. The obligation to put in place notice and action mechanisms should apply, for instance, to file storage and sharing services, web hosting services, advertising servers and paste bins, in as far as they qualify as providers of hosting services covered by this Regulation.
Amendment 219 #
2020/0361(COD)
Proposal for a regulation
Recital 43 b (new)
Recital 43 b (new)
(43 b) The rules on such notice and action mechanisms should be harmonised at Union level, so as to provide for the timely, diligent and objective processing of notices on the basis of rules that are uniform, transparent and clear and that provide for robust safeguards to protect the right and legitimate interests of all affected parties, in particular their fundamental rights guaranteed by the Charter, irrespective of the Member State in which those parties are established or reside and of the field of law at issue. The fundamental rights include, as the case may be, the right to freedom of expression and information, the right to respect for private and family life, the right to protection of personal data, the right to non-discrimination and the right to an effective remedy of the recipients of the service; the freedom to conduct a business, including the freedom of contract, of service providers; as well as the right to human dignity, the rights of the child, the right to protection of property, including intellectual property, and the right to non-discrimination of parties affected by illegal content.
Amendment 245 #
2020/0361(COD)
Proposal for a regulation
Recital 52
Recital 52
(52) Online advertisement plays an important role in the online environment, including in relation to the provision of the services of online platforms. However,Online advertising is a significant source of financing for many digital business models and an effective tool to reach new costumers, not least for small- and medium sized companies. However, there are some instances when online advertisement can contribute to significant risks, ranging from advertisement that is itself illegal content, to contributing to financial incentives for the publication or amplification of illegal or otherwise harmful content and activities online, or the discriminatory display of advertising with an impact on the equal treatment and opportunities of citizens. In addition toBased on the requirements resulting from Article 6 of Directive 2000/31/EC, online platforms should therefore be required to ensure that the recipients of the service have certain individualised information necessary for them to understand when and on whose behalf the advertisement is displayed. In addition, recipients of the service should have information on the main parameters used for determining that specific advertising is to be displayed to them, providing meaningful explanations of the logic used to that end, including when this is based on profiling. The requirements of this Regulation on the provision of information relating to advertisement is without prejudice to the application of the relevant provisions of Regulation (EU) 2016/679, in particular those regarding the right to object, automated individual decision-making, including profiling and specifically the need to obtain consent of the data subject prior to the processing of personal data for targeted advertising. Similarly, it is without prejudice to the provisions laid down in Directive 2002/58/EC in particular those regarding the storage of information in terminal equipment and the access to information stored therein.
Amendment 265 #
2020/0361(COD)
Proposal for a regulation
Recital 58
Recital 58
(58) Very large online platforms should deploy the necessary and proportionate means to diligently mitigate the systemic risks identified in the risk assessment. Very large online platforms should under such mitigating measures consider, for example, enhancing or otherwise adapting the design and functioning of their content moderation, algorithmic recommender systems and online interfaces, so that they discourage and limit the dissemination of illegal content, adapting their decision- making processes, or adapting their terms and conditions. They may also include corrective measures, such as discontinuing advertising revenue for specific content, or other actions, such as improving the visibility of authoritative information sources. Very large online platforms may reinforce their internal processes or supervision of any of their activities, in particular as regards the detection of systemic risks. They may also initiate or increase cooperation with trusted flaggers, organise training sessions and exchanges with trusted flagger organisations, and cooperate with other service providers, including by initiating or joining existing codes of conduct or other self-regulatory measures. Any measures adopted should respect the due diligence requirements of this Regulation and be effective and appropriate for mitigating the specific risks identified, in the interest of safeguarding public order, protecting privacy and fighting fraudulent and deceptive commercial practices, and should be proportionate in light of the very large online platform’s economic capacity and the need to avoid unnecessary restrictions on the use of their service, taking due account of potential negative effects on the fundamental rights of the recipients of the service.
Amendment 277 #
2020/0361(COD)
Proposal for a regulation
Recital 62
Recital 62
(62) A core part of a very large online platform’s business is the manner in which information is prioritised and presented on its online interface to facilitate and optimise access to information for the recipients of the service. This is done, for example, by algorithmically suggesting, ranking and prioritising information, distinguishing through text or other visual representations, or otherwise curating information provided by recipients. Such recommender systems can have a significantn impact on the ability of recipients to retrieve and interact with information online. They also play an important role in the amplification of certain messages, the viral dissemination of information and the stimulation of online behaviour. Consequently, very large online platforms should ensure that recipients are appropriately informed, and can influence the information presented to them. They should clearly present the main parameters for such recommender systems in an easily comprehensible manner to ensure that the recipients understand how information is prioritised for them. They should also ensure that the recipients enjoy alternative options for the main parameters, including options that are not based on profiling of the recipient.
Amendment 279 #
2020/0361(COD)
Proposal for a regulation
Recital 63
Recital 63
(63) Advertising systems used by very large online platforms could pose particular risks and require further public and regulatory supervision on account of their scale and ability to target and reach recipients of the service based on their behaviour within and outside that platform’s online interface. Very large online platforms should ensure public access to repositories of advertisements displayed on their online interfaces to facilitate supervision and research into emerging risks brought about by the distribution of advertising online, for example in relation to illegal advertisements or manipulative techniques and disinformation with a real and foreseeable negative impact on public health, public security, civil discourse, political participation and equality. Repositories should include the content of advertisements and related data on the advertiser and the delivery of the advertisement, in particular where targeted advertising is concerned.
Amendment 282 #
2020/0361(COD)
Proposal for a regulation
Recital 64
Recital 64
(64) In order to appropriately supervise the compliance of very large online platforms with the obligations laid down by this Regulation, the Digital Services Coordinator of establishment or the Commission may require access to or reporting of specific data. Such a requirement may include, for example, the data necessary to assess the risks and possible harms brought about by the platform’s systems, data on the accuracy, functioning and testing of algorithmic systems for content moderation, recommender systems or advertising systems, or data on processes and outputs of content moderation or of internal complaint-handling systems within the meaning of this Regulation. Investigations by researchers on the evolution and severity of online systemic risks are particularly important for bridging information asymmetries and establishing a resilient system of risk mitigation, informing online platforms, Digital Services Coordinators, other competent authorities, the Commission and the public. This Regulation therefore provides a framework for providing information or compelling access to data from very large online platforms to vetted researchers. All requirements f where relevant to a research project. All requests for providing information or access to data under that framework should be proportionate and appropriately protect the rights and legitimate interests, including trade secrets and other confidential information, of the platform and any other parties concerned, including the recipients of the service.
Amendment 301 #
2020/0361(COD)
Proposal for a regulation
Recital 69
Recital 69
(69) The rules on codes of conduct under this Regulation could serve as a basis for already established self-regulatory efforts at Union level, including the Product Safety Pledge, the Memorandum of Understanding against counterfeit goods, the Code of Conduct against illegal hate speech as well as the Code of practice on disinformation. In particular for the latter, the Commission will issue guidance for strengthening the Code of practice on disinformation as announced in the European Democracy Action Plan.
Amendment 305 #
2020/0361(COD)
Proposal for a regulation
Recital 70
Recital 70
(70) The provision of online advertising generally involves several actors, including intermediary services that connect publishers of advertising with advertisers. Codes of conducts should support and complement the transparency obligations relating to advertisement for online platforms and very large online platforms set out in this Regulation in order to provide for flexible and effective mechanisms to facilitate and enhance the compliance with those obligations, notably as concerns the modalities of the transmission of the relevant information. The involvement of a wide range of stakeholders should ensure that those codes of conduct are widely supported, technically sound, effective and offer the highest levels of user-friendliness to ensure that the transparency obligations achieve their objectives.
Amendment 373 #
2020/0361(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point d – indent 1
Article 2 – paragraph 1 – point d – indent 1
— a significant number of users in relation to their population in one or more Member States; or
Amendment 388 #
2020/0361(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point h
Article 2 – paragraph 1 – point h
(h) ‘online platform’ means a provider of a hosting service which, at the request of a recipient of the service, stores and disseminates to the public information, unless that activity is a minor and purely ancillary feature of anotherthe principal service and, for objective and technical reasons cannot be used without that otherprincipal service, and the integration of the feature into the other service is not a means to circumvent the applicability of this Regulation.
Amendment 389 #
2020/0361(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point h a (new)
Article 2 – paragraph 1 – point h a (new)
(h a) ‘editorial platform’ means an intermediary service which is in connection with a press publication within the meaning of Article 2(4) of Directive (EU) 2019/790 or another editorial media service and which allows users to discuss topics generally covered by the relevant media or to comment editorial content and which is under the supervision of the editorial team of the publication or other editorial media.
Amendment 397 #
2020/0361(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point i a (new)
Article 2 – paragraph 1 – point i a (new)
(i a) 'live streaming platform services' means an information society service which main or one the main purposes is to give the public access to live broadcasted audio or video material and which it organises and promotes for profit-making purposes;
Amendment 400 #
2020/0361(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point o
Article 2 – paragraph 1 – point o
(o) ‘recommender system’ means a fully or partially automated system, used by an very large online platform to suggest in its online interface specific information to recipients of the service, including as a result of a search initiated by the recipient or otherwise determining the relative order or prominence of information displayed;
Amendment 419 #
2020/0361(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
(b) upon obtaining such knowledge or awareness, acts expeditiouslyaccording within the deadlines of Article 5Ia new when it comes to remove or toing or disableing access to the illegal content.
Amendment 421 #
2020/0361(COD)
Proposal for a regulation
Article 5 – paragraph 1 a (new)
Article 5 – paragraph 1 a (new)
Amendment 423 #
2020/0361(COD)
Proposal for a regulation
Article 5 – paragraph 2 a (new)
Article 5 – paragraph 2 a (new)
2 a. Paragraph 1 shall not apply when the main purpose of the information society service is to engage in or facilitate illegal activities or when the provider of the information society service deliberately collaborates with a recipient of the services in order to undertake illegal activities.
Amendment 425 #
2020/0361(COD)
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Paragraph 1 shall not apply with respect to liability under consumer protection law of online platforms allowing consumers to conclude distance contracts with traders on the platform, where such an online platform presents the specific item of information or otherwise enables the specific transaction at issue in a way that would lead an average and reasonably well-informed consumer to believe that the information, or the product or service that is the object of the transaction, is provided either by the online platform itself or by a recipient of the service who is acting under its authority or control.
Amendment 430 #
2020/0361(COD)
Proposal for a regulation
Article 5 a (new)
Article 5 a (new)
Article 5 a The exemptions from liability established in Articles 3, 4 and 5 shall not apply where the information society service plays an active role of such a kind as to give it knowledge of, or control over the information provided by the recipient of the service.
Amendment 503 #
2020/0361(COD)
Proposal for a regulation
Article 9 – paragraph 2 – point b
Article 9 – paragraph 2 – point b
(b) the order only requires the provider to provide information already collected for the purposes of providing the service and which lies within its control, including email addresses, telephone numbers, IP addresses and other contact details necessary to determine the compliance referred to in (a);
Amendment 525 #
2020/0361(COD)
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
1. Providers of intermediary services which do not have an establishment in the Union but which offer services in the Union shall designate, in writing, a legal or natural person as their legal representative in one of the Member States where the provider offers its services. The Member States may require very large online platforms to designate a legal representative in their Member State.
Amendment 528 #
2020/0361(COD)
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. Providers of intermediary services shall mandate their legal representatives to be addressed in addition to or instead of the provider by the Member States’ authorities, the Commission and the Board on all issues necessary for the receipt of, compliance with and enforcement of decisions issued in relation to this Regulation. Providers of intermediary services shall provide their legal representative with the necessary powers and resource to guarantee the proper and timely cooperateion with the Member States’ authorities, the Commission and the Board and comply with those decisions.
Amendment 531 #
2020/0361(COD)
Proposal for a regulation
Article 11 a (new)
Article 11 a (new)
Article 11 a Exclusions Articles 12 and 13 of Section 1,and the provisions of Section 2, and Section 3 of Chapter III shall not apply to: (a) editorial platforms within the meaning of Article 2(h a) of this Regulation; (b) online platforms that qualify as micro and medium-sized enterprises within the meaning of the Annex to Recommendation 2003/361/EC. (c) an intermediary service, except very large online platforms, where it would constitute a disproportionate burden in view of its size, the nature of its activity and the risk posed to users.
Amendment 537 #
2020/0361(COD)
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
1. Providers of intermediary services shall include information on any restrictions that they impose in relation to the use of their service in respect of information provided by the recipients of the service, in their terms and conditions, which have to respect European and national law. That information shall include information on any policies, procedures, measures and tools used for the purpose of content moderation, including algorithmic decision-making and human review. It shall be set out in clear and unambiguous language and shall be publicly available in an easily accessible format.
Amendment 545 #
2020/0361(COD)
Proposal for a regulation
Article 12 – paragraph 2 a (new)
Article 12 – paragraph 2 a (new)
2a. Where very large online platforms within the meaning of Article 25 of this Regulation otherwise allow for the dissemination to the public of press publications within the meaning of Article 2(4) of Directive (EU) 2019/790, such platforms shall not remove, disable access to, suspend or otherwise interfere with such content or the related service or suspend or terminate the related account on the basis of the alleged incompatibility of such content with its terms and conditions, unless it is illegal content
Amendment 564 #
2020/0361(COD)
Proposal for a regulation
Article 13 – paragraph 1 – point a
Article 13 – paragraph 1 – point a
(a) the number of orders received from Member States’ authorities, categorised, where possible, by the type of illegal content concerned, including orders issued in accordance with Articles 8 and 9, and the average time needed for taking the action specified in those orders;.
Amendment 566 #
2020/0361(COD)
Proposal for a regulation
Article 13 – paragraph 1 – point b
Article 13 – paragraph 1 – point b
(b) the number of notices submitted in accordance with Article 14, categorised by the type of alleged illegal content concerned, any action taken pursuant to the notices by differentiating whether the action was taken on the basis of the law or the terms and conditions of the provider, and the average time needed for taking the action;
Amendment 570 #
2020/0361(COD)
Proposal for a regulation
Article 13 – paragraph 1 – point d
Article 13 – paragraph 1 – point d
(d) the number of complaints received through the internal complaint-handling system referred to in Article 17, where identifiable, the basis for those complaints, decisions taken in respect of those complaints, the average time needed for taking those decisions and the number of instances where those decisions were reversed.
Amendment 575 #
2020/0361(COD)
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. Paragraph 1 shall not apply to providers of intermediary services that qualify as micro or small enterprises within the meaning of the Annex to Recommendation 2003/361/EC. In addition, paragraph 1 shall not apply to enterprises that previously qualified for the status of a small or microenterprise within the meaning of the Annex to Recommendation2003/361/EC during the twelve months following their loss of that status.
Amendment 586 #
Amendment 634 #
2020/0361(COD)
Proposal for a regulation
Article 15 – paragraph 4
Article 15 – paragraph 4
4. Providers of hostingaragraphs 2, 3 and 4 shall not apply to providers of intermediary services sthall publish the decisions and the statements of reast qualify as micro or small enterprises within the meaning of the Annex to Recommendation 2003/361/EC. In additions, referred to in paragraph 1 in a publicly accessible database managed by the Commission. That information shall not contain personal datathose paragraphs shall not apply to enterprises that previously qualified for the status of a micro or small enterprise within the meaning of the Annex to Recommendation 2003/361/EC during the twelve months following their loss of that status.
Amendment 647 #
2020/0361(COD)
Proposal for a regulation
Article 16 a (new)
Article 16 a (new)
Amendment 680 #
2020/0361(COD)
Proposal for a regulation
Article 18 – paragraph 1 – introductory part
Article 18 – paragraph 1 – introductory part
1. RAfter internal complaint handling mechanisms are exhausted, recipients of the service addressed by the decisions referred to in Article 17(1), shall be entitled to select any out-of- court dispute that has been certified in accordance with paragraph 2 in order to resolve disputes relating to those decisions, including complaints that could not be resolved by means of the internal complaint-handling system referred to in that Article. Online platforms shall engage, in good faith, with the body selected with a view to resolving the dispute and shall be bound by the decision taken by the body.
Amendment 710 #
2020/0361(COD)
Proposal for a regulation
Article 19 – paragraph 1
Article 19 – paragraph 1
1. Online platforms shall take the necessary technical and organisational measures to ensure that notices submitted by trusted flaggers through the mechanisms referred to in Article 14, are processed and decided upon with priority and without delayimmediately processed without prejudice to the implementation of a complaint and redress mechanism.
Amendment 743 #
2020/0361(COD)
Proposal for a regulation
Article 19 – paragraph 7 a (new)
Article 19 – paragraph 7 a (new)
7a. Online platforms shall, where possible, provide trusted flaggers with access to technical means that help them detect illegal content on a large scale.
Amendment 760 #
2020/0361(COD)
(d) where identifiable, the intention of the recipient, individual, entity or complainant.
Amendment 781 #
2020/0361(COD)
Proposal for a regulation
Article 22 – paragraph 1 – introductory part
Article 22 – paragraph 1 – introductory part
1. Where an online platform allows consumers to conclude distance contracts with professional traders, it shall ensure that traders can only use its services to promote messages on or to offer products or services to consumers located in the Union if, prior to the use of its services, the online platform has obtained the following information:
Amendment 782 #
2020/0361(COD)
Proposal for a regulation
Article 22 – paragraph 1 – point c
Article 22 – paragraph 1 – point c
Amendment 822 #
2020/0361(COD)
Proposal for a regulation
Article 24
Article 24
Amendment 865 #
2020/0361(COD)
Proposal for a regulation
Article 26 – paragraph 1 – point b
Article 26 – paragraph 1 – point b
(b) any negative effects for the exercise of the fundamental rights to respect for private and family life, freedom of expression and information, freedom and pluralism of the media, the prohibition of discrimination and the rights of the child, as enshrined in Articles 7, 11, 21 and 24 of the Charter respectively caused by an illegal activity;
Amendment 870 #
2020/0361(COD)
Proposal for a regulation
Article 26 – paragraph 1 – point c
Article 26 – paragraph 1 – point c
(c) intentional manipulation of their service, including by means of inauthentic use or automated exploitation of the service, with an actual or foreseeable negative and illegal effect on the protection of public health, minors, civic discourse, or actual or foreseeable effects related to electoral processes and public security.
Amendment 873 #
2020/0361(COD)
Proposal for a regulation
Article 26 – paragraph 2
Article 26 – paragraph 2
2. When conducting risk assessments, very large online platforms shall take into account, in particular, how their content moderation systems, recommender systems and systems for selecting and displaying advertisement influence any of the systemic risks referred to in paragraph 1, including the potentially rapid and wide dissemination of illegal content and of information that is incompatible with their terms and conditions.
Amendment 918 #
2020/0361(COD)
Proposal for a regulation
Article 28 – paragraph 1 – point b
Article 28 – paragraph 1 – point b
(b) any commitmentof voluntary measures undertaken pursuant to the codes of conduct referred to in Articles 35 and 36 and the crisis protocols referred to in Article 37.
Amendment 931 #
2020/0361(COD)
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
1. Very large online platforms that use recommender systems shall set out in their terms and conditions, in a clear, accessible and easily comprehensible manner, the mainshall base the parameters used inof their recommender systems, as well as any options for the recipients of the service to modify or influence those main parameters that they may have made available, including at least one option which is not based on profiling, within the meaning of Article 4 (4) of Regulation (EU) 2016/679 on Regulation (EU) 2019/1150 of the European Parliament and of the Council of 20 June 2019 on promoting fairness and transparency for business users of online intermediation services (P2B) and set them out in their terms and conditions.
Amendment 935 #
2020/0361(COD)
Proposal for a regulation
Article 29 – paragraph 1 a (new)
Article 29 – paragraph 1 a (new)
1a. The parameters used in recommender systems shall always be fair and non-discriminatory.
Amendment 938 #
2020/0361(COD)
Proposal for a regulation
Article 29 – paragraph 2
Article 29 – paragraph 2
Amendment 946 #
2020/0361(COD)
Proposal for a regulation
Article 30 – paragraph 1
Article 30 – paragraph 1
1. Very large online platforms that display advertising on their online interfaces shall compile and make publicly available through application programming interfaces a repository containing the information referred to in paragraph 2, until one yearfor advertisements that have been seen by more than 5000 recipients of the service and until six months after the advertisement was displayed for the last time on their online interfaces. They shall ensure that the repository does not contain any personal data of the recipients of the service to whom the advertisement was or could have been displayed.
Amendment 953 #
2020/0361(COD)
Proposal for a regulation
Article 30 – paragraph 2 – point d
Article 30 – paragraph 2 – point d
Amendment 954 #
2020/0361(COD)
Proposal for a regulation
Article 30 – paragraph 2 – point e
Article 30 – paragraph 2 – point e
Amendment 966 #
2020/0361(COD)
Proposal for a regulation
Article 31 – paragraph 1
Article 31 – paragraph 1
1. Very large online platforms shall provide the Digital Services Coordinator of establishment or the Commission, upon their reasoned request and within a reasonable period, specified in the request, provide information and access to data that are necessary to properly monitor and assess compliance with this Regulation. That Digital Services Coordinator and the Commission shall only use that data for those purposes.
Amendment 969 #
2020/0361(COD)
Proposal for a regulation
Article 31 – paragraph 2
Article 31 – paragraph 2
2. Upon a reasoned request from the Digital Services Coordinator of establishment or the Commission, very large online platforms shall, within a reasonable period, as specified in the request, provide access toinformation and access to relevant data to vetted researchers who meet the requirements in paragraphs 4 of this Article, for the sole purpose of conducting research that contributes to the identification and understanding of systemic risks as set out in Article 26(1).
Amendment 973 #
2020/0361(COD)
Proposal for a regulation
Article 31 – paragraph 3
Article 31 – paragraph 3
3. Very large online platforms shall provide access to data pursuant to paragraphs 1 and 2 for a limited time and through online databases or application programming interfaces, as appropriate.
Amendment 1009 #
2020/0361(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point f
Article 34 – paragraph 1 – point f
Amendment 1016 #
2020/0361(COD)
Proposal for a regulation
Article 35 – paragraph 2
Article 35 – paragraph 2
2. Where significant systemic risk within the meaning of Article 26(1) in relation to the dissemination of illegal content emerge and concern several very large online platforms, the Commission may invite the very large online platforms concerned, other very large online platforms, other online platforms and other providers of intermediary services, as appropriate, as well as civil society organisations and other interested parties, to participate in the drawing up of codes of conduct, including by setting out commitments to take specific risk mitigation measures, as well as a regular reporting framework on any measures taken and their outcomes.
Amendment 1019 #
2020/0361(COD)
Proposal for a regulation
Article 35 – paragraph 2
Article 35 – paragraph 2
2. Where significant systemic risk within the meaning of Article 26(1) emerge and concern several very large online platforms, the Commission may invite the very large online platforms concerned, other very large online platforms, other online platforms and other providers of intermediary services, as appropriate, as well as civil society organisations and other interested partierelevant stakeholders, to participate in the drawing up of codes of conduct, including by setting out commitments to take specific risk mitigation measures, as well as a regular reporting framework on any measures taken and their outcomes.
Amendment 1024 #
2020/0361(COD)
Proposal for a regulation
Article 35 – paragraph 3
Article 35 – paragraph 3
3. When giving effect to paragraphs 1 and 2, the Commission and the Board shall aim to ensure that the codes of conduct clearly set out their objectives in relation to the dissemination of illegal content, contain key performance indicators to measure the achievement of those objectives and take due account of the needs and interests of all interested partiethe relevant stakeholders, including citizens, at Union level. The Commission and the Board shall also aim to ensure that participants report regularly to the Commission and their respective Digital Service Coordinators of establishment on any measures taken and their outcomes, as measured against the key performance indicators that they contain.
Amendment 1032 #
2020/0361(COD)
Proposal for a regulation
Article 36 – paragraph 1
Article 36 – paragraph 1
1. The Commission shall encourage and facilitate the drawing up of codes of conduct at Union level between, online platforms and other relevant service providers, such as providers of online advertising intermediary services or organisations representing recipients of the service and civil society organisations or relevant authorities to contribute to further transparency in online advertising beyond the requirements of Articles 24 30 and 30Article 6 of Directive 2000/31/EC.
Amendment 1034 #
2020/0361(COD)
Proposal for a regulation
Article 36 – paragraph 2 – introductory part
Article 36 – paragraph 2 – introductory part
2. The Commission shall aim to ensure that the codes of conduct pursue an effective transmission of information, in full respect for the rights and interests of all parties involved, and a competitive, transparent and fair environment in online advertising, in accordance with Union and national law, in particular on competition and the protection of personal data. The Commission shall aim to ensure that the codes of conduct address at least: the transmission of information held by providers of online advertising intermediaries to the repositories pursuant to Article 30.
Amendment 1035 #
2020/0361(COD)
Proposal for a regulation
Article 36 – paragraph 2 – point a
Article 36 – paragraph 2 – point a
Amendment 1036 #
2020/0361(COD)
Proposal for a regulation
Article 36 – paragraph 2 – point b
Article 36 – paragraph 2 – point b
Amendment 1044 #
Amendment 1058 #
2020/0361(COD)
Proposal for a regulation
Article 41 – paragraph 2 – point e
Article 41 – paragraph 2 – point e
(e) the power to proportionate adopt interim measures to avoid the risk of serious harm.
Amendment 1060 #
2020/0361(COD)
1. Member States shall lay down the rules on penalties including administrative fines applicable to infringements of this Regulation by providers of intermediary services under their jurisdiction and shall take all the necessary measures to ensure that they are properly and effectively implemented in accordance with Article 41.
Amendment 1061 #
2020/0361(COD)
Proposal for a regulation
Article 42 – paragraph 2
Article 42 – paragraph 2
2. Penalties shall be effective, proportionate and dissuasive. They shall take into particular account the interest of small scale providers and start ups and their economic viability. Member States shall notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendments affecting them.
Amendment 1103 #
2020/0361(COD)
Proposal for a regulation
Article 47 – paragraph 2 – point a a (new)
Article 47 – paragraph 2 – point a a (new)
(aa) contributing to the effective application of Directive 2000/31/EC Article 3 to prevent fragmentation of the digital single market and the obligations of very large platforms of Article 5 of the Platform to Business Regulation 2019/1150
Amendment 1132 #
2020/0361(COD)
Proposal for a regulation
Article 55 – paragraph 1
Article 55 – paragraph 1
1. In the context of proceedings which may lead to the adoption of a decision of non-compliance pursuant to Article 58(1), where there is an urgency due to the risk of serious damage for the recipients of the service, the Commission may, by decision, order proportionate interim measures against the very large online platform concerned on the basis of a prima facie finding of an infringement.
Amendment 1135 #
2020/0361(COD)
Proposal for a regulation
Article 57 – paragraph 1
Article 57 – paragraph 1
1. For the purposes of carrying out the tasks assigned to it under this Section, the Commission may take the necessary actions to monitor the effective implementation and compliance with this Regulation by the very large online platform concerned. The Commission may also order that platform to provide access to, and explanations relating to, and, where necessary access to its databases and algorithms.
Amendment 1138 #
2020/0361(COD)
Proposal for a regulation
Article 59 – paragraph 2 – introductory part
Article 59 – paragraph 2 – introductory part
2. The Commission may by decision and in compliance with the proportionality principle impose on the very large online platform concerned or other person referred to in Article 52(1) fines not exceeding 1% of the total turnover in the preceding financial year, where they intentionally or negligently:
Amendment 1151 #
2020/0361(COD)
Proposal for a regulation
Article 74 – paragraph 2 – introductory part
Article 74 – paragraph 2 – introductory part
2. It shall apply from [date - threesix months after its entry into force].
Amendment 7 #
2020/0108(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) The CovidOVID-19 pandemic is a major shock to the global and Union economy. Due to the necessary containment measures, economic activity in the EU dropped significantly. The contraction in EUMember States' GDP in 2020 is expected to be around 7.5%the worst since the Great Depression, far deeper than during the financial crisis in 2009. The outbreak of the pandemic has shown the interconnectivity of global supply chains and exposed some vulnerabilities such as the over-reliance of strategic industries on non-diversified external supply sources. Such vulnerabilities need to be addressed, to improve the Union’s emergency response as well as the resilience of the entire economy, while maintaining its openness to competition and trade in line with its rules. Investment activity is expected to have dropped significantly. Even before the pandemic, while a recovery in investment-to-GDP ratios in the Union could be observed, it remained below what might be expected in a strong recovery and was insufficient to compensate for years of underinvestment following the 2009 crisis. More importantly, the current investment levels and forecasts do not cover the Union’s needs for structural investment to restart and sustain long-term growth in the face of technological change and global competitiveness, including for innovation, skills, infrastructure, small and medium- sized enterprises (SMEs) and the need to address key societal challenges such as sustainability or population ageing. Consequently, in order to achieve the Union's policy objectives and to support a swift, inclusive and healthy economic recovery, support is necessary to address market failures and sub-optimal investment situations and to reduce the investment gap in targeted sectors.
Amendment 12 #
2020/0108(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) In the last years, the Union has adopted ambitious strategies to complete the Single Mternal market and to stimulate sustainable and inclusive growth and jobs, such as 'Europe 2020 - A strategy for smart, sustainable and inclusive growth' of 3 March 2010, 'Action Plan on Building a Capital Markets Union' of 30 September 2015, 'A new European Agenda for Culture' of 22 May 2018, 'Clean Energy for all Europeans' of 30 November 2016, 'Closing the loop - An EU action plan for the Circular Economy' of 2 December 2015, 'A European Strategy for Low- Emission Mobility' of 20 July 2016, ‘European Defence Action Plan’ of 30 November 2016, 'Launching the European Defence Fund' of 7 June 2017, 'Space Strategy for Europe' of 26 October 2016, the Interinstitutional Proclamation on the European Pillar of Social Rights of 13 December 2017, the ‘European Green Deal’ of 11 December 2019, the ‘European Green Deal Investment Plan’ of 14 January 2020, the ‘Strong Social Europe for Just Transitions’ of 14 January 2020, the ‘Strategy for shaping Europe’s digital future’, the ‘Data Strategy’ and the ‘Artificial Intelligence Communication’ of 19 February 2020, ‘A New Industrial Strategy for Europe’ of 10 March 2020 and ‘SME Strategy for a sustainable and digital Europe’ of 10 March 2020. The InvestEU Fund should exploit and reinforce synergies between those mutually reinforcing strategies through providing support to investment and access to financing. (This amendment applies throughout the text.)
Amendment 13 #
2020/0108(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) At Union level, the European Semester of economic policy coordination is the framework to identify national reform priorities and monitor their implementation. Member States, where appropriate in cooperation with local and regional authorities, develop their own national multiannual investment strategies in support of those reform priorities. Those strategies should be presented alongside the yearly national reform programmes as a way of outlining and coordinating priority investment projects that are to be supported by national funding, Union funding, or both. Those strategies should also use Union funding in a coherent manner and maximise the added value of the financial support to be received notably from the European structural and investment funds, the Recovery and Resilience Facility and the InvestEU Programme. However, country-specific recommendations have often had counterproductive macro- economic effects; notably, in the field of public health they have recommended the weakening of public health systems in several Member States, which therefore found themselves less equipped to deal with the COVID-19 outbreak.
Amendment 16 #
2020/0108(COD)
Proposal for a regulation
Recital 8
Recital 8
Amendment 21 #
2020/0108(COD)
Proposal for a regulation
Recital 9
Recital 9
Amendment 23 #
2020/0108(COD)
Proposal for a regulation
Recital 10
Recital 10
Amendment 33 #
2020/0108(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) The contribution of the InvestEU Fund to the achievement of the climate target will be tracked through a Union climate tracking system to be developed by the Commission in cooperation with potential implementing partners, appropriately using the criteria established by [Regulation on the establishment of a framework to facilitate sustainable investment25 ] for determining whether an economic activity is environmentally sustainable. The InvestEU Programme should also contribute to the implementation of other dimensions of the SDGs. _________________ 25. COM(2018)353.
Amendment 41 #
2020/0108(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Investment projects that receive substantial Union support, in particular in the area of infrastructure, should be screened by the implementing partner to determine whether they have an environmental, climate or social impact. Investment projects that have such an impact should be subject to sustainability proofing in accordance with guidance that should be developed by the Commission in close cooperation with potential implementing partners under the InvestEU Programme. This guidance should appropriately use the criteria established by [Regulation on establishment of a framework to facilitate sustainable investment] for determining whether an economic activity is environmentally sustainable and consistent with the guidance developed for other programmes of the Union. Consistent with the principle of proportionality, such guidance should include adequate provisions for avoiding undue administrative burdens, and projects below a certain size as to be defined in the guidance should be excluded from the sustainability proofing. Where the implementing partner concludes that no sustainability proofing is to be carried out, it should provide a justification to the Investment Committee established for the InvestEU Fund. Operations that are inconsistent with the achievement of the climate objectives should not be eligible for support under this Regulation.
Amendment 96 #
2020/0108(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point b
Article 3 – paragraph 1 – point b
(b) growth and employment in the Union economy, the sustainability of the Union economy and its environmental and climate dimension contributing to the achievement of the SDGs and the objectives of the Paris Agreement on Climate Change and to the creation of high-quality jobs;
Amendment 167 #
2020/0108(COD)
Proposal for a regulation
Article 7 – paragraph 6 – introductory part
Article 7 – paragraph 6 – introductory part
6. Implementing partners shall apply a target of at least 60 % of the investment under the sustainable infrastructure policy window contributing to meeting the Union objectives on climate and environment.deleted
Amendment 194 #
2020/0108(COD)
Proposal for a regulation
Annex II – point 1 – introductory part
Annex II – point 1 – introductory part
1. The development of the energy sector in accordance with the Energy Union priorities, including security of energy supply, clean energy transition and the commitments taken under the 2030 Agenda for Sustainable Development and the Paris Agreement on Climate Change, in particular through:
Amendment 206 #
2020/0108(COD)
Proposal for a regulation
Annex II – point 3 – point f
Annex II – point 3 – point f
(f) climate change actions, climate adaptation and mitigadaptation, including natural hazard disaster risk reduction;
Amendment 209 #
2020/0108(COD)
Proposal for a regulation
Annex II – point 3 – point j
Annex II – point 3 – point j
(j) projects that promote sustainable culturalcultural and landscape heritage.
Amendment 236 #
2020/0108(COD)
Proposal for a regulation
Annex V – part 2 – paragraph 1 – point 12 – point c
Annex V – part 2 – paragraph 1 – point 12 – point c
(c) projects equipped with carbon capture and storage or carbon capture and utilisation installations; industrial or research projects that lead to substantial reductions of greenhouse gas emissions as compared with the applicable EU Emission Trading System benchmarks
Amendment 238 #
2020/0108(COD)
Proposal for a regulation
Annex V – part 2 – paragraph 1 – point 15 – point b
Annex V – part 2 – paragraph 1 – point 15 – point b
(b) existing plants, where the investment is for the purpose of increasing energy efficiency, capturing exhaust gases for storage or use or recovering materials from incineration ashes, provided such investments do not result in an increase of the plants' waste processing capacity.
Amendment 4 #
2020/0104(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) At Union level, the European Semester of economic policy coordination (‘European Semester’), including the principles of the European Pillar of Social Rights, is the framework to identify national reform priorities and monitor their implementation. Member States develop their own national multiannual investment strategies in support of those reforms. Those strategies should be presented alongside the yearlyon a three-year basis as an annex to the National Reform Programmes as a way to outline and coordinate priority investment projects to be supported by national and/or Union funding.
Amendment 9 #
2020/0104(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) The implementation of the investments and reforms contributing to achieve a high degree of resilience of domestic economies, allowing constraints flexibility, strengthening adjustment capacity and unlocking growth potential without involving pro-cyclical effects are among the Union’s policy priorities. They are therefore crucial to set the recovery on a sustainable path and support the process of upward economic and social convergence. This is even more necessary in the aftermath of the pandemic crisis to pave the way for a swift recovery.
Amendment 18 #
2020/0104(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) Currently, nNo instrument should foresees direct financial support linked to the achievement of results and to implementation of reforms and public investments of the Member States in response to challenges identified in the European Semester, and with a view to having a lasting impact on the productivity and resilience of the economy of the Member States.
Amendment 27 #
2020/0104(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) Against this background, it is necessary to strengthenadapt the current framework for the provision of support to Member States and provide direct financial support to Member States through an innovative tool. To that end, a Recovery and Resilience Facility (the ‘Facility’) should be established under this Regulation to provide effective financial and significant support to step up the implementation of counter-cyclical reforms and related public investments in the Member States. The Facility should be comprehensive and should also benefit from the experience gained by the Commission and the Member States from the use of the other instruments and programmes.
Amendment 31 #
2020/0104(COD)
Proposal for a regulation
Recital 11
Recital 11
Amendment 43 #
2020/0104(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) In order to implement these overall objectivesboost economical recovery, relevant actions will be identified during the Facility’s preparation and implementation, and reassessed in the context of the relevant evaluations and review processes. Also, due attention should be paid to the impact of the national plans submitted under this Regulation on fostering not only the green transition, but also the digital transformation. They will both play a priority role in relaunching and modernising our economy.
Amendment 45 #
2020/0104(COD)
Proposal for a regulation
Recital 13
Recital 13
Amendment 54 #
2020/0104(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) The Facility’s general objective should be the promotion of economic, social and territorial cohesion. For that purpose, it should contribute to improving the resilience and adjustment capacity of the Member States, mitigating the social and economic impact of the crisis, and supporting the green and digital transitions aimed at achieving a climate neutral Europe by 2050, thereby restoring the growth potential of the economies of the Union in the aftermath of the crisis, fostering employment creation and to promoting sustainable growth.
Amendment 59 #
2020/0104(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) The specific objective of the Facility should be to provide financial support with a view to achieving the milestones and targets of countercyclical reforms and investments as set out in recovery and resilience plans. That specific objective should be pursued in close cooperation with the Member States concerned.
Amendment 62 #
2020/0104(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) To ensure its contribution to the objectives of the Facility, the recovery and resilience plan should comprise measures for the implementation of reforms and public investment projects through a coherent recovery and resilience plan. The recovery and resilience plan should be consistent with the relevant country- specific challenges and priorities identified in the context of the European Semester, with the national reform programmes, the national energy and climate plans, the just transition plans, and the partnership agreements and operational programmes adopted under the Union funds. To boost actions that fall within the priorities of the European Green Deal and the Digital Agenda, the plan should also set out measures that are relevant for the green and digital transitions. The measures should enable a swift deliver of targets, objectives and contributions set out in national energy and climate plans and updates thereofby the Member States in the aftermath of the COVID-19 outbreak. All supported activities should be pursued in full respect of the climate and environmental prioritiestandards of the Union.
Amendment 68 #
2020/0104(COD)
Proposal for a regulation
Recital 17
Recital 17
Amendment 72 #
2020/0104(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) To inform the preparation and the implementation of the recovery and resilience plans by Member States, the Council should be able to discuss, within the European Semester, the state of recovery, resilience, cohesion and adjustment capacity in the Union. To ensure appropriate evidence, this discussion should be based on the Commission’s strategic and analytical information available in the context of the European Semester and, if available, on the basis of the information on the implementation of the plans in the preceding years.
Amendment 74 #
2020/0104(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) In order to ensure a meaningful financial contribution commensurate to the actual needs of Member States to undertake and complete the reforms and investments included in the recovery and resilience plan, it is appropriate to establish a maximum financial contribution available to them under the Facility as far as the financial support (i.e. the non- repayable financial support) is concerned. That maximum contribution should be calculated on the basis of the demographic trend (taking into account the depopulation rate), the inversempact of the per capitaCOVID-19 outbreak on the Gross Domestic Product (GDP) and the relative unemployment rate of each Member State.
Amendment 76 #
2020/0104(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) In order to ensure the national ownership and a focus on relevant reforms and investments, Member States wishing to receive support should submit to the Commission a recovery and resilience plan that is duly reasoned and substantiated. The recovery and resilience plan should set out the detailed set of measures for its implementation, including targets and milestones, and the expected impact of the recovery and resilience plan on growth potential, job creation and economic and social resilience; it should also include measures that are relevant for the green and the digital transitions; it should also include an explanation of the consistency of the proposed recovery and resilience plan with the relevant country-specific challenges and priorities identified in the context of the European Semesterbe ecologically responsible. Close cooperation between the Commission and the Member States should be sought and achieved throughout the process.
Amendment 83 #
2020/0104(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) The Commission should assess the recovery and resilience plan proposed by the Member States and should act in close cooperation with the Member State concerned. The Commission will fully respect the national ownership of the process and will therefore take into account the justification and elements provided by the Member State concerned and assess whether the recovery and resilience plan proposed by the Member State is expected to contribute to effectively address challenges identified in the relevant country-specific recommendation addressed to the Member State concerned or in other relevant documents officially adopted by the Commission in the European Semester; whether the plan contains measures that effectively contribute to the green and the digital transitions and to addressing the challenges resulting from them; whether the plan is expected to have a lasting impact in the Member State concerned; whether the plan is expected to effectively contribute to strengthen the growth potential, job creation and economic and social resilience of the Member State, mitigate the economic and social impact of the crisis and contribute to enhancing economic, social and territorial cohesion; whether the justification provided by the Member State of the estimated total costs of the recovery and resilience plan submitted is reasonable and plausible and is commensurate to the expected impact on the economy and employment; whether the proposed recovery and resilience plan contains measures for the implementation of reforms and public investment projects that represent coherent actions; and whether the arrangement proposed by the Member State concerned are expected to ensure effective implementation of the recovery and resilience plan, including the proposed milestones and targets, and the related indicators.
Amendment 94 #
2020/0104(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) To ensure that the financial support is frontloaded in the initial years after the crisis, and to ensure compatibility with the available funding for this instrument, the allocation of funds to the Member States should be made available until 31 December 2024. To this effect, at least 670 percent of the amount available for non- repayable support should be legally committed by 31 December 2022. The remaining amount should be legally committed by 31 December 2024.
Amendment 97 #
2020/0104(COD)
Proposal for a regulation
Recital 29
Recital 29
(29) The request for a loan should be justified by the financial needs linked to additional countercyclical reforms and investments included in the recovery and resilience plan, notably relevant for the green and digital transitions, and by therefore, by a higher cost of the plan than the maximum financial contribution (to be) allocated via the non-repayable contribution. It should be possible to submit the request for a loan together with the submission of the plan. In case the request for loan is made at a different moment in time, it should be accompanied by a revised plan with additional milestones and targets. To ensure frontloading of resources, Member States should request a loan support at the latest by 31 August 2024. For the purposes of sound financial management, the total amount of all the loans granted under this Regulation should be capped. In addition, the maximum volume of the loan for each Member State should not exceed 4.7% of its Gross National Income. An increase of the capped amount should be possible in exceptional circumstances subject to available resources. For the same reasons of sound financial management, it should be possible to pay the loan in instalments against the fulfilment of results.
Amendment 100 #
2020/0104(COD)
Proposal for a regulation
Recital 30
Recital 30
(30) A Member State should have the possibility to make a reasoned request to amend the recovery and resilience plan within the period of implementation, where objective circumstances justify such a course of action. The Commission should assess the reasoned request and take a new decision within fourthree months.
Amendment 102 #
2020/0104(COD)
Proposal for a regulation
Recital 32
Recital 32
(32) For the purpose of sound financial management, specific rules should be laid down for budget commitments, payments, suspension, cancellation and recovery of funds. To ensure predictability, it should be possible for Member States to submit requests for payments on a biannual basis. Payments should be made in instalments and be based on a positive assessment by the Commission of the implementation of the recovery and resilience plan by the Member State. Suspension and cancellation of the financial contribution should be possible when the recovery and resilience plan has not been implemented in a satisfactory manner by the Member State. Appropriate contradictory procedures should be established to ensure that the decision by the Commission in relation to suspension, cancellation and recovery of amounts paid respects the right of Member States to provide observations.
Amendment 105 #
2020/0104(COD)
Proposal for a regulation
Recital 33
Recital 33
(33) For effective monitoring of implementation, the Member States should report on a quarteyearly basis within the European Semester process on the progress made in the achievement of the recovery and resilience plan. Such reports prepared by the Member States concerned should be appropriately reflected in the National Reform Programmes, which should be used as a tool for reporting on progress towards completion of recovery and resilience plans.
Amendment 110 #
2020/0104(COD)
Proposal for a regulation
Recital 40
Recital 40
(40) In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council14 , Council Regulation (Euratom, EC) No 2988/9515and ,Council Regulation (Euratom, EC) No 2185/9616 and Council Regulation (EU) 2017/193917 , the financial interests of the Union are to be protected through proportionate measures, including the prevention, detection, correction and investigation of irregularities and fraud, the recovery of funds lost, wrongly paid or incorrectly used and, where appropriate, the imposition of administrative sanctions. In particular, in accordance with Regulation (EU, Euratom) No 883/2013 and Regulation (Euratom, EC) No 2185/96, the European Anti-Fraud Office (OLAF) may carry out administrative investigations, including on- the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. In accordance with Regulation (EU) 2017/1939, the European Public Prosecutor's Office (EPPO) may investigate and prosecute fraud and other criminal offences affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council18 . In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the Union’s financial interests, to grant the necessary rights and access to the Commission, OLAF, the EPPO and the European Court of Auditors and to ensure that any third parties involved in the implementation of Union funds grant equivalent rights to the Commission, OLAF, the EPPO and the European Court of Auditors. _________________ 14Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999,(OJ L248, 18.9.2013, p. 1) 15 Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.95, p.1) 16 Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities (OJ L292,15.11.96, p.2) 17 Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor’s Office (‘the EPPO’) (OJ L283, 31.10.2017,, p.1) 18 Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union's financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29)
Amendment 113 #
2020/0104(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
Amendment 124 #
2020/0104(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
The scope of application of the Recovery and Resilience Facility established by this Regulation shall refer to policy areas related to economic, social and territorial cohesion, the green and digital transitions, health, competitiveness, resilience, productivity, education and skills, research and innovation, smart, sustainable and inclusive growth, jobs and investment, and the stability of the financial systems.
Amendment 134 #
2020/0104(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The general objective of the Recovery and Resilience Facility shall be to promote the Union’s economic, social and territorial cohesion by improving the resilience and adjustment capacity of the Member States, mitigating the social and economic impact of the crisis, and supporting the green and digital transitions, thereby contributing to restoring the growth potential of the economies of the Union, fostering employment creation in the aftermath of the COVID-19 crisis, and promoting sustainable growth.
Amendment 140 #
2020/0104(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. To achieve that general objective, the specific objective of the Recovery and Resilience Facility shall be to provide Member States with financial support with a view to achieving the milestones and targets of countercyclical reforms and investments as set out in their recovery and resilience plans. That specific objective shall be pursued in close cooperation with the Member States concerned.
Amendment 146 #
2020/0104(COD)
2. The amounts referred to in paragraph 1(a) may also cover expenses pertaining to preparatory, monitoring, control, audit and evaluation activities, which are required for the management of each instrument and the achievement of its objectives, in particular studies, meetings of experts, information and communication actions, including corporate communication of the political priorities of the Union, in so far as they are related to the objectives of this Regulation, expenses linked to IT networks focusing on information processing and exchange, corporate information technology tools, and all other technical and administrative assistance expenses incurred by the Commission for the management of each instrument. EThe same amount of expenses may also cover the costs of other supporting activities such as quality control and monitoring of projects on the ground and the costs of peer counselling and experts for the assessment and implementation of countercyclical reforms and investments.
Amendment 148 #
2020/0104(COD)
Proposal for a regulation
Article 6
Article 6
Amendment 153 #
2020/0104(COD)
Proposal for a regulation
Article 9 – paragraph 1 – introductory part
Article 9 – paragraph 1 – introductory part
1. In the event of significant non- compliance in relation to any of the cases laid down in Article 15(7) of the Regulation laying down common provisions on the […)][CPR], the Council shallmay, on a proposal from the Commission, adopt a decision by means of an implementing act to suspend the time period for the adoption of the decisions referred to in Articles 17(1) and 17(2) or to suspend payments under the Recovery and Resilience Facility.
Amendment 156 #
2020/0104(COD)
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
A maximum financial contribution shall be calculated for each Member State for the allocation of the amount referred to in Article 5(1)(a), using the methodology set out in Annex I, based on the demographic trend (taking into account the depopulation rate), the inverse of the per capitampact of COVID- 19 outbreak on the Gross Domestic Product (GDP) and the relative unemployment rate of each Member State.
Amendment 158 #
2020/0104(COD)
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. For a period starting after 31 December 2022 until 31 December 2024, where financial resources are available, the Commission may organise calls in line with the calendar of the European Semester. To that effect, it shall publish an indicative calendar of the calls to be organised in that period, and shall indicate, at each call, the amount available for allocation. Each Member State may propose to receive up to a maximum amount corresponding to its allocation share of the available amount for allocation, as referred to in Annex I, to implement the recovery and resilience plan.
Amendment 159 #
2020/0104(COD)
Proposal for a regulation
Article 12 – paragraph 3 – point a
Article 12 – paragraph 3 – point a
(a) the reasons for the loan support, justified by the higher financial needs linked to additional countercyclical reforms and investments;
Amendment 160 #
2020/0104(COD)
Proposal for a regulation
Article 12 – paragraph 3 – point b
Article 12 – paragraph 3 – point b
(b) the additional countercyclical reforms and investments in line with Article 15;
Amendment 163 #
2020/0104(COD)
Proposal for a regulation
Article 13 – paragraph 1 – point b
Article 13 – paragraph 1 – point b
(b) the additional countercyclical reforms and investments comply with the criteria set out in Article 16(3.
Amendment 164 #
2020/0104(COD)
Proposal for a regulation
Article 13 – paragraph 2 – point e
Article 13 – paragraph 2 – point e
(e) the other elements needed for the implementation of the loan support in relation to the countercyclical reforms and the investment projects concerned in line with the decision referred to in Article 17(2).
Amendment 175 #
2020/0104(COD)
Proposal for a regulation
Article 14 – paragraph 2
Article 14 – paragraph 2
2. The recovery and resilience plans shall be consistent with the relevant country-specific challenges and priorities identified in the context of the European Semester, in particular those relevant for or resulting from the green and digital transitionby the Member States. The recovery and resilience plans shall also be consistent with the information included by the Member States in the national reform programmes under the European Semester, in their national energy and climate plans and updates thereof under the Regulation (EU)2018/199921 , in the territorial just transition plans under the Just Transition Fund22 , and in the partnership agreements and operational programmes under the Union funds. _________________ 21Regulation (EU)2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action. 22 […]
Amendment 183 #
2020/0104(COD)
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
Amendment 188 #
2020/0104(COD)
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
2. The recovery and resilience plan presented by the Member State concerned shall constitute an annex to its National Reform Programme and shall be officially submitted on a three-year basis at the latest by 30 April. A draft plan may be submitted by Member State starting from 15 October of the preceding year, together with the draft budget of the subsequent year.
Amendment 189 #
2020/0104(COD)
Proposal for a regulation
Article 15 – paragraph 3 – point a
Article 15 – paragraph 3 – point a
Amendment 195 #
2020/0104(COD)
Proposal for a regulation
Article 15 – paragraph 3 – point c
Article 15 – paragraph 3 – point c
Amendment 215 #
2020/0104(COD)
Proposal for a regulation
Article 15 – paragraph 3 – point d
Article 15 – paragraph 3 – point d
Amendment 221 #
2020/0104(COD)
Proposal for a regulation
Article 15 – paragraph 3 – point f
Article 15 – paragraph 3 – point f
(f) the estimated total cost of the countercyclical reforms and investments covered by the recovery and resilience plan submitted (also referred as ‘estimated total cost of the recovery and resilience plan’) backed up by appropriate justification and how it is commensurate to the expected impact on the economy and employment;
Amendment 230 #
2020/0104(COD)
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. When assessing the recovery and resilience plan and in the determination of the amount to be allocated to the Member State concerned, the Commission shall take into account the analytical information on the Member State concerned available in the context of the European Semester as well as the justification and the elements provided by the Member State concerned, as referred to in Article 15(3), and any other relevant information including, in particular, the one contained in the National Reform Programme and the National Energy and Climate Plan of the Member State concerned and, if relevant, information from technical support received via the Technical Support Instrument.
Amendment 233 #
2020/0104(COD)
Proposal for a regulation
Article 16 – paragraph 3 – introductory part
Article 16 – paragraph 3 – introductory part
3. The Commission shall assess the importance and coherence of the recovery and resilience plan and its contribution to the green and digital transitions, and for that purpose, shall take into account the following criteria:
Amendment 237 #
2020/0104(COD)
Proposal for a regulation
Article 16 – paragraph 3 – point a
Article 16 – paragraph 3 – point a
Amendment 239 #
2020/0104(COD)
Proposal for a regulation
Article 16 – paragraph 3 – point b
Article 16 – paragraph 3 – point b
Amendment 259 #
2020/0104(COD)
Proposal for a regulation
Article 16 – paragraph 3 – point e
Article 16 – paragraph 3 – point e
(e) whether the justification provided by the Member State on the amount of the estimated total costs of the recovery and resilience plan submitted is reasonable and plausible and is commensurate to the expected impact on the economy and employment;
Amendment 262 #
2020/0104(COD)
Proposal for a regulation
Article 16 – paragraph 3 – point f
Article 16 – paragraph 3 – point f
(f) whether the recovery and resilience plan contains measures for the implementation of countercyclical reforms and public investments projects that represent coherent actions;
Amendment 269 #
2020/0104(COD)
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
1. The Commission shall adopt a decision within four months of the official submission of the recovery and resilience plan by the Member State, by means of an implementing act. In the event that the Commission gives a positive assessment to a recovery and resilience plan, that decision shall set out the countercyclical reforms and investment projects to be implemented by the Member State, including the milestones and targets, and the financial contribution allocated in accordance with Article 11.
Amendment 272 #
2020/0104(COD)
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
2. In case the Member State concerned requests a loan support, the decision shall also set out the amount of the loan support as referred to in Article 12(4) and (5) and the additional countercyclical reforms and investment projects to be implemented by the Member State covered by that loan support, including the additional milestones and targets.
Amendment 277 #
2020/0104(COD)
Proposal for a regulation
Article 17 – paragraph 4 – point b
Article 17 – paragraph 4 – point b
(b) the description of the countercyclical reforms and of the investment projects and the amount of the estimated total cost of the recovery and resilience plan;
Amendment 278 #
2020/0104(COD)
Proposal for a regulation
Article 17 – paragraph 4 – point c – point 2
Article 17 – paragraph 4 – point c – point 2
Amendment 279 #
2020/0104(COD)
Proposal for a regulation
Article 17 – paragraph 4 – point e
Article 17 – paragraph 4 – point e
Amendment 283 #
2020/0104(COD)
Proposal for a regulation
Article 17 – paragraph 5
Article 17 – paragraph 5
5. Where the Commission gives a negative assessment to a recovery and resilience plan, it shall communicate a duly justified assessment within fourthree months of the submission of the proposal by the Member State.
Amendment 284 #
2020/0104(COD)
Proposal for a regulation
Article 17 – paragraph 6
Article 17 – paragraph 6
6. The arrangements and timetable for implementation as referred to in point (d), the relevant indicators relating to the fulfilment of the envisaged milestones and targets referred to in point (e), the arrangements for providing access by the Commission to the underlying data referred to in point (f), and, where appropriate, the additional milestones and targets related to the disbursement of the loan support referred to in point (g) of paragraph 4 shall be further illustrated in an operational arrangement to be agreed by the Member State concerned and the Commission after the adoption of the decision referred to in paragraph 1.
Amendment 286 #
2020/0104(COD)
Proposal for a regulation
Article 18 – paragraph 2
Article 18 – paragraph 2
2. Where the Commission considers that the reasons put forward by the Member State concerned justify an amendment of the relevant recovery and resilience plan, the Commission shall assess the new plan in accordance with the provisions of Article 16 and shall take a new decision in accordance with Article 17 within fourthree months of the official submission of the request.
Amendment 287 #
2020/0104(COD)
Proposal for a regulation
Article 18 – paragraph 3
Article 18 – paragraph 3
Amendment 290 #
2020/0104(COD)
Proposal for a regulation
Article 19 – paragraph 3 – introductory part
Article 19 – paragraph 3 – introductory part
3. Upon completion of the relevant agreed milestones and targets indicated in the recovery and resilience plan as approved in the implementing act of the Commission, the Member State concerned shall submit to the Commission a duly justified request for payment of the financial contribution and, where relevant, of the loan tranche. Such requests for payment may be submitted by the Member States to the Commission on a biannual basis. The Commission shall assess, within two months of receiving the request, whether the relevant milestones and targets set out in the decision referred to in Article 17(1) have been satisfactorily implemented. For the purpose of the assessment, the operational arrangement referred to in Article 17(6) shall also be taken into account. The Commission may be assisted by experts.
Amendment 295 #
2020/0104(COD)
Proposal for a regulation
Article 19 – paragraph 6
Article 19 – paragraph 6
Amendment 298 #
2020/0104(COD)
Proposal for a regulation
Article 19 – paragraph 7
Article 19 – paragraph 7
Amendment 300 #
2020/0104(COD)
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
The Member State concerned shall report on a quarterly basis within the European Semester procesyearly basis on the progress made in the achievement of the recovery and resilience plans, including the operational arrangement referred to in Article 17(6). To that effect, the quarterly reports of the Member States shall be appropriately reflected in the National Reform Programmes, which shall be used as a tool for reporting on progress towards completion of the recovery and resilience plans.
Amendment 302 #
2020/0104(COD)
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
1. The Commission shall transmit the recovery and resilience plans as approved in the implementing act of the Commission in accordance with Article 17 to the European Parliament and the Council without undue delay. The Member State concerned may request the Commission to redact sensitive or confidential information, the disclosure of which would jeopardise public interests of the Member State.
Amendment 304 #
2020/0104(COD)
Proposal for a regulation
Article 21 – paragraph 2
Article 21 – paragraph 2
Amendment 311 #
2020/0104(COD)
Proposal for a regulation
Article 24 – paragraph 4
Article 24 – paragraph 4
Amendment 312 #
2020/0104(COD)
Proposal for a regulation
Article 25 – paragraph 2
Article 25 – paragraph 2
2. The evaluation report shall, in particular, assess to which extent the objectives have been achieved, and the efficiency of the use of resources and the European added value. It shall also consider the continued relevance of all objectives and actions.
Amendment 315 #
2020/0104(COD)
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
Amendment 317 #
2020/0104(COD)
Proposal for a regulation
Article 26 – paragraph 2
Article 26 – paragraph 2
Amendment 318 #
2020/0104(COD)
Proposal for a regulation
Annex I – paragraph 2 – indent 1
Annex I – paragraph 2 – indent 1
— PopulationDemographic trend;
Amendment 324 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 1 – introductory part
Annex II – point 2 – paragraph 1 – introductory part
In accordance with Article 16(3), the Commission shall assess the importance and coherence of the recovery and resilience plans, and its contribution to the green and digital transitions, and for that purpose, it shall take into account the following criteria:
Amendment 326 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 1 – point a
Annex II – point 2 – paragraph 1 – point a
Amendment 328 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 1 – point b
Annex II – point 2 – paragraph 1 – point b
Amendment 338 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 1 – point e
Annex II – point 2 – paragraph 1 – point e
(e) whether the justification provided by the Member State on the amount of the estimated total costs of the recovery and resilience plan submitted is reasonable and plausible and is commensurate to the expected impact on the economy and employment;
Amendment 340 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 1 – point f
Annex II – point 2 – paragraph 1 – point f
(f) whether the recovery and resilience plan contains measures for the implementation of countercyclical reforms and public investment projects that represent coherent actions;
Amendment 344 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 3 – point 2.1 – introductory part
Annex II – point 2 – paragraph 3 – point 2.1 – introductory part
2.1 The recovery and resilience plan is expected to contribute to effectively address challenges identified in the relevant country-specific recommendations addressspecific reports prepared toby the Member State concerned or in other relevant documents officially adopted by the Commission in the European Semester.
Amendment 346 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 3 – point 2.1 – paragraph 1 – subparagraph 1 – indent 1
Annex II – point 2 – paragraph 3 – point 2.1 – paragraph 1 – subparagraph 1 – indent 1
— The recovery and resilience plan is expected to contribute to effectively address challenges identified in the relevant country-specific recommendations, including fiscal aspects, or in other relevant documents officially adopted by the Commission in the European Semester addressed to the Member States concernedMember States' specific reports, including fiscal aspects,
Amendment 348 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 3 – point 2.1 – paragraph 1 – subparagraph 6
Annex II – point 2 – paragraph 3 – point 2.1 – paragraph 1 – subparagraph 6
A – The recovery and resilience plan contributes to effectively address challenges identified in the CSRs, or in other relevant documents officially adopted by the Commission in the European Semester,specific reports proposed by the Member State concerned and the plan represents an adequate response to the economic and social situation of the Member State concerned.
Amendment 349 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 3 – point 2.1 – paragraph 1 – subparagraph 7
Annex II – point 2 – paragraph 3 – point 2.1 – paragraph 1 – subparagraph 7
B – The recovery and resilience plan contributes to partially address challenges identified in the CSRs, or in other relevant documents officially adopted by the Commission in the European Semesterspecific reports proposed by the Member State concerned and the plan represents a partially adequate response to the economic and social situation of the Member State concerned.
Amendment 350 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 3 – point 2.1 – paragraph 1 – subparagraph 8
Annex II – point 2 – paragraph 3 – point 2.1 – paragraph 1 – subparagraph 8
C – The recovery and resilience plan does not contribute to address any challenges identified in the CSRs, or in other relevant documents officially adopted by the Commission in the European Semesterspecific reports proposed by the Member State concerned and the plan does not represent an adequate response to the economic and social situation of the Member State concerned.
Amendment 351 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 3 – point 2.2
Annex II – point 2 – paragraph 3 – point 2.2
Amendment 384 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 3 – point 2.4 – paragraph 1 – subparagraph 1 – indent 1
Annex II – point 2 – paragraph 3 – point 2.4 – paragraph 1 – subparagraph 1 – indent 1
— the recovery and resilience plan contains measures that aim at addressing weaknesses of the economy of the Member States and at boosting the growth potential of the economy of the Member State concerned, stimulating job creation and mitigating the adverse effects of the crisis, while avoiding adverse impacts of those measures on climate and environment.
Amendment 388 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 3 – point 2.5 – introductory part
Annex II – point 2 – paragraph 3 – point 2.5 – introductory part
2.5 The justification provided by the Member State on the amount of the estimated total costs of the recovery and resilience plan is reasonable and plausible and is commensurate to the expected impact on the economy and employment;
Amendment 389 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 3 – point 2.5 – paragraph 1 – subparagraph 1 – indent 1
Annex II – point 2 – paragraph 3 – point 2.5 – paragraph 1 – subparagraph 1 – indent 1
Amendment 390 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 3 – point 2.5 – paragraph 1 – subparagraph 2 – indent 1
Annex II – point 2 – paragraph 3 – point 2.5 – paragraph 1 – subparagraph 2 – indent 1
Amendment 189 #
2020/0102(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) With a view to protecting people in vulnerable situations, including those suffering from mental illnesses, non- communicable diseases and chronic diseases, the Programme should also promote actions which address the collateral impacts of the health crisis on people belonging to such vulnerable groups. With a view to guaranteeing continued high standards of essential healthcare services, the Programme should, especially in times of crisis and pandemics, encourage a transition to telemedicine, home administration of medication, and implementation of preventative and self-care plans, where possible and appropriate, while ensuring that access to healthcare services is provided to chronic patients, taking into account the respective levels of digitisation of the Member States and problems of access to digital solutions in remote areas or for certain population groups.
Amendment 197 #
2020/0102(COD)
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
(12a) Correlations have been observed between health and/or economic crises and a worrying increase in depressive tendencies resulting from the effects of reduced disposable income, uncertainty about the future and growing unemployment. The Programme should therefore provide support for national actions aimed at integrating mental health into all policies and promoting mental health in all areas, including school and work, and for preventive actions to combat depression and suicide.
Amendment 241 #
2020/0102(COD)
Proposal for a regulation
Recital 16 a (new)
Recital 16 a (new)
(16a) The Programme should provide for equal access to healthcare. ‘Socioeconomic health inequalities’ cover situations ranging from unequal access to treatment, fragmented access across regions and differences in health status based on economic conditions, to the distribution of health determinants between different population groups. The individual Member States are responsible for developing social and health polices to tackle the national challenges linked to health inequalities.
Amendment 255 #
2020/0102(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) Non-communicable diseases are a result of a combination of genetic, physiological, environmental and behavioural factors. Such non- communicable diseases as cardiovascular diseases, cancer, neurological disorders, chronic respiratory diseases, and diabetes, represent major causes of disability, ill- health, health- related retirement, and premature death in the Union, resulting in considerable social and economic impacts. To decrease the impact of non- communicable diseases on individuals and society in the Union and reach goal 3 of the Sustainable Development Goals, Target 3.4, to reduce premature mortality from non- communicable diseases by one third by 2030, it is key to provide an integrated response focusing on prevention across sectors and policy fields, combined with efforts to strengthen health systems.
Amendment 299 #
2020/0102(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) Cancer is the second leading cause of mortality in the Member States after cardiovascular diseases. It is also one of non-communicable diseases that share common risk factors and the prevention and control of which would benefit the majority of citizens. In 2020 the Commission announced the ‘Europe’s Beating Cancer Plan’ which would cover the entire cycle of the disease starting from prevention and early diagnosis to treatment and quality of life of patients and survivors. The measures should benefit from the Programme and from Horizon Europe’s Mission on Cancer. The actions on cancer should also address its common risk factors and synergies with other major non-communicable diseases, such as neurological diseases, and consider devising a template for other major disease areas based on the ‘Europe’s Beating Cancer Plan’.
Amendment 312 #
2020/0102(COD)
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
(19a) Heart attacks and strokes often occur in people previously undiagnosed with cardiovascular diseases. Many of these are due to undetected genetic conditions, such as familial hypercholesterolaemia, arrhythmias, congenital heart disease and cardiomyopathies, and conditions such as hypertension. The Programme should support the development of policies and interventions to identify and manage individuals at high risk of developing cardiovascular disease in order to prevent the onset of the disease and reduce mortality.
Amendment 345 #
2020/0102(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) The Programme should therefore support actions to monitor shortages of medicines, medical devices and other healthcare products and to ensure greater availability and affordability of those products while limiting the dependency of their supply chains on third countries, in particular actions, where necessary in synergy with other programmes, to encourage local production of medicinal plants in the Member States, and to encourage and support production of active ingredients and generics within the European Union. In particular, in order to address unmet medical needs, the Programme should provide support to clinical trials so as to speed up the development, authorisation and access to innovative and effective medicines, promote incentives to develop such medicinal products as antimicrobials and foster the digitial transformation of healthcare products and platforms for monitoring and collecting information on medicines.
Amendment 568 #
2020/0102(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 6
Article 4 – paragraph 1 – point 6
(6)support action for the surveillance, prevention, diagnosis and treatment and care of non-communicable diseases, and notably of cancer, while addressing its synergies with other major non- communicable diseases, such as neurological disorders;
Amendment 640 #
2020/0102(COD)
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
The Commission shall consult the health authorities of the Member States in the Steering Group on Health Promotion, Disease Prevention and Management of Non-Communicable Diseases on the work plans established for the Programme and its priorities and strategic orientations and its implementation. Consideration should be given to promoting synergies between European funds and national funds/resources to ensure long-term effectiveness and sustainability of the actions.
Amendment 666 #
2020/0102(COD)
Proposal for a regulation
Annex I – point a – point ii a (new)
Annex I – point a – point ii a (new)
(iia.) Local production of medicinal plants in the Member States;
Amendment 668 #
2020/0102(COD)
Proposal for a regulation
Annex I – point a – point ii b (new)
Annex I – point a – point ii b (new)
(iib.) Production of active ingredients and generics within the European Union to reduce the Member States’ dependence on certain third countries.
Amendment 740 #
2020/0102(COD)
Proposal for a regulation
Annex I – point d a (new)
Annex I – point d a (new)
(da.)Development of the capacity and resources of patients’ organisations to increase patients’ contribution to health policy planning and implementation.
Amendment 765 #
2020/0102(COD)
Proposal for a regulation
Annex I – point f – point v
Annex I – point f – point v
(v) Actions to address the collateral health consequences of a health crisis, in particular those on mental health, onin addition to social exclusion and financial hardship, often experienced by patients suffering from chronic diseases and other vulnerable groups;
Amendment 768 #
2020/0102(COD)
Proposal for a regulation
Annex I – point f – point v a (new)
Annex I – point f – point v a (new)
(va.) With patient safety as a top priority, actions to facilitate the availability of accessible and affordable telemedicine services for all patients throughout Europe, and to support digital literacy and a transition to telemedicine, home administration of treatment and medication, and implementation of preventative and self-care plans, while involving patients’ organisations in evaluating, identifying and implementing the best possible solutions in terms of continued access to high-quality care and treatment;
Amendment 809 #
2020/0102(COD)
Proposal for a regulation
Annex I – point g – point vi a (new)
Annex I – point g – point vi a (new)
(via.) Support actions promoting mental health in the workplace and in schools; promote actions to combat depression and suicide; develop socially inclusive forms of mental health care;
Amendment 819 #
2020/0102(COD)
Proposal for a regulation
Annex I – point g – point ix a (new)
Annex I – point g – point ix a (new)
(ixa.) Support the establishment and implementation of evidence-based programmes assisting Member States and their actions to improve health promotion, health literacy and disease prevention (for communicable and non-communicable diseases);
Amendment 910 #
2020/0102(COD)
Proposal for a regulation
Annex I – point h – point x a (new)
Annex I – point h – point x a (new)
(xa.) Support actions to tackle common, shared risk factors and synergies between cancer and other major non- communicable diseases, such as neurological disorders, and to render the European cancer plan a template for other major disease areas;
Amendment 918 #
2020/0102(COD)
Proposal for a regulation
Annex I – point h – point x b (new)
Annex I – point h – point x b (new)
(xb) Building on Europe’s cancer plan, support the creation of a template for other major disease areas, such as neurological disorders;
Amendment 944 #
2020/0102(COD)
Proposal for a regulation
Annex I – point i – point iv a (new)
Annex I – point i – point iv a (new)
(iva) Foster a supportive environment for meaningful patient and public involvement in clinical trials, starting with the design phase and ending with dissemination;
Amendment 5 #
2020/0100(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) The Commission adopted a Communication on the European Green Deal on 11 December 20199 , drawing its roadmap towards an allegedly new growth policy for Europe and setting ambitious objectives to counter climate change and for environmental protection. In line with the objective to achieve climate neutrality in the Union by 2050 in an effective and fair manner, the European Green Deal announced a Just Transition Mechanism to provide means for facing the climate challengetransition towards a climate-neutral economy while leaving no one behind. The most vulnerable regions and people are the most exposed to the harmful effects of climate change and environmental degradation. At the same time, managing the transition requires significant structural changes. _________________ 9 COM(2019) 640 final.
Amendment 12 #
2020/0100(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) The proposal for establishing the Just Transition Fund was adopted by the Commission on 14 January 202011 . For the better programming and implementation of the Fund, territorial just transition plans are to be adopted, setting out the key steps and timeline of the transition process and identifying the territories most negatively affected by the transition towards a climate neutral economy and with less capacity to deal with the transition challendamages. _________________ 11 COM(2020) 22 final
Amendment 20 #
2020/0100(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) A public sector loan facility (the ‘Facility’) should be provided. It constitutes the third pillar of the Just Transition Mechanism, supporting public sector entities in their investments. Such investments should meet the development needs resulting from the transition challendamages described in the territorial just transition plans as adopted by the Commission. The activities envisaged for support should be consistent with and complement those supported under the other two pillars of the Just Transition Mechanism.
Amendment 26 #
2020/0100(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) In order to enhance the economic diversification of territories impacted by the transition, the Facility should cover a wide range of investments, on condition that they contribute to meet the development needs in the transition towards a climate neutral economy, as described in the territorial just transition plans. The investments supported may cover energy and transport infrastructure, district heating networks, green mobility, smalocal public transport, waste management, clean energy and energy efficiency measures including renovations and conversions of buildings, support to transition to a circular economy, land restoration and decontamination, as well as up- and re- skilling, training and social infrastructure, including social housing. Infrastructure developments may also include solutions leading to their enhanced resilience to withstand disasters. Comprehensive investment approach should be favoured in particular for territories with important transition needs. Investments in other sectors could also be supported if they are consistent with the adopted territorial just transition plans. By supporting investments that do not generate sufficient revenues, the Facility aims at providing public sector entities with additional resources necessary to address the social, economic and environmental challendamages resulting from the adjustment to climathe transition. In order to help identify investments with a high positive environmental impact eligible under the Facility, the EU taxonomy on environmentally sustainable economic activities may be used towards a climate-neutral economy.
Amendment 45 #
2020/0100(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) The objective of this Regulation, namely to leverage public investment in territories, most impacted by the transition towards climate neutrality by addressing the corresponding development needs, cannot be sufficiently achieved by the Member States alone. The main reasons in this regard are the difficulties for public entities to support investments, which do not generate sufficient streams of own revenues and benefit the territories most negatively impacted by climathe transition, without EU grant support towards a climate-neutral economy, due to the Union's restrictive economic and budgetary policies and the need for a coherent implementation framework under direct management. Since those objectives can be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,
Amendment 54 #
2020/0100(COD)
Proposal for a regulation
Article 1 – paragraph 2
Article 1 – paragraph 2
The Facility shall provide support benefitting Union territories facing serious social, environmental and economic challendamages deriving from the transition process towards a climate-neutral economy of the Union by 2050.
Amendment 63 #
2020/0100(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. The general objective of the Facility is to address serious socio- economic challendamages deriving from the transition process towards a climate-neutral economy for the benefit of the Union territories identified in the territorial just transition plans prepared by the Member States in accordance with Article 7 of Regulation [JTF Regulation].
Amendment 84 #
2020/0100(COD)
Proposal for a regulation
Article 8 – paragraph 1 – point a
Article 8 – paragraph 1 – point a
(a) the projects achieve measurable impact in addressing serious social, economic or environmental challendamages deriving from the transition process towards a climate-neutral economy and benefit territories identified in a territorial just transition plan, even if they are not located in those territories;
Amendment 113 #
2020/0100(COD)
Proposal for a regulation
Annex II – point 6 – point 6.3
Annex II – point 6 – point 6.3
6.3 Public utilities (water, wastewater, district heating, energy, waste management, local transport)
Amendment 115 #
Amendment 116 #
2020/0100(COD)
Proposal for a regulation
Annex II – point 7
Annex II – point 7
7. GPolluting and greenhouse gas emission reduced
Amendment 51 #
2019/2816(RSP)
Recital D a (new)
Da. whereas there is a lack of studies on the mutual potentiation of the different molecules and the interaction of their natural metabolic degradation products;
Amendment 194 #
2019/2816(RSP)
Paragraph 24 a (new)
24a. Asks the Commission and the Member States quickly to address the lack of studies on the mutual potentiation of the different molecules and the interaction of natural metabolic degradation products;
Amendment 43 #
2019/2166(INI)
Motion for a resolution
Recital A
Recital A
A. whereas gender equality between men and women is a fundamental value and an objective of the EU; whereas gender-based violenceviolence based on a person's sex is an extreme form of discrimination against women and one of the biggest obstacles to achieving gender equality of the sexes;
Amendment 52 #
2019/2166(INI)
Motion for a resolution
Recital B
Recital B
B. whereas, in spite of numerous instances of formal recognition and progress having been made on gender equality of the sexes, women and men do not enjoy the same rights in practice and social, economic and cultural inequalities persist;
Amendment 83 #
2019/2166(INI)
Motion for a resolution
Recital E
Recital E
E. whereas children may suffer ‘witnessed violence’ when they witness acts of violence in the family environment, through experiencing any form of ill- treatment, carried out through acts of physical, verbal, psychological, sexual and economic violence against reference figures or other affectively significant figures; whereas such violence has very serious consequences for the psychological and emotional development of the child, and whereas it is therefore essential to pay due attention to this type of violence in separations and parental custody arrangements, taking the best interests of the child into account, in particular in order to determine custody and visitation rights in separation cases;
Amendment 89 #
2019/2166(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas, in the light of the COVID-19 pandemic, court officials in all countries have been advised to stay at home and hearings have, in many cases, been postponed; whereas staff reductions in the courts are likely to cause delays in issuing restraining orders, in separation and divorce proceedings and in child custody hearings, including separation and divorce hearings, which women victims of intimate partner violence rely on in order to make it easier for them to distance or estrange themselves from their violent partners;
Amendment 90 #
2019/2166(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Amendment 96 #
2019/2166(INI)
Motion for a resolution
Recital F
Recital F
F. whereas, in order to address the issue of the eradication of gender-based violenceviolence based on a person's sex, it is necessary to rely on consistent and comparable administrative data, based on a robust and coordinated framework of data collection; whereas the current available data collected by the Member States’ law enforcement and justice authorities fail to reflect the full extent of intimate partner violence, as most Member States neither collect gendersex- segregated comparable data on gender- based violenceviolence based on a person's sex nor do they recognise intimate partner violence as a specific offence;
Amendment 99 #
2019/2166(INI)
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas witnessed violence is not always easily recognisable, especially in the case of young children, and it is essential that operators who are called upon to decide on the right measures to protect and care for the children know how to interpret the situation and the actions of the mother, whilst being aware that the perpetrator and victim of violence are not equally responsible, in order not to make hasty diagnostic and prognostic judgements that do not take account of post-traumatic symptomatology, while facilitating an assessment in a protective and caring setting;
Amendment 107 #
2019/2166(INI)
Motion for a resolution
Recital G a (new)
Recital G a (new)
Ga. whereas in situations of marital or relationship breakdown, allegations of interpersonal violence should be addressed before custody and visitation issues can be addressed; whereas in order to assess allegations of interpersonal violence in custody cases, the professionals involved must have specialist knowledge;
Amendment 147 #
2019/2166(INI)
Motion for a resolution
Recital N a (new)
Recital N a (new)
Na. whereas children who are victims of or witnesses to intimate partner violence have more health problems (stunting, allergies, ENT and dermatological problems, headaches, stomach aches, sleeping and eating disorders, etc.), adjustment disorders (school phobia, hyperactivity, irritability, learning difficulties) and problems with concentration and behaviour;
Amendment 191 #
2019/2166(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Notes that, in principle, shared custody and unsupervised visits are desirable in order to ensure that parents enjoy equal rights and responsibilities, as well as to safeguard the best interests of the child; underlines, however, that intimate partner violence is clearly incompatible withcan justify the withdrawal of shared custody and care, owing to its severe consequences for women and children, including the risk of extreme acts of femicide and infanticide; stresses that when establishing the arrangements for custody allocation and visitation rights, the protection of women and children from violence and the best interests of the child must be paramount and should take precedence over other criteria; stresses, therefore, that awarding exclusive custody to the non-violent partner, most frequently the mother, often represents the best alternative in order to prevent further violence and secondary victimisation of the victims;
Amendment 218 #
2019/2166(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Stresses the need for appropriate legal assistance for victims in terms of legal advice and representation by a lawyer before the court; emphasises, in addition, the need for prior preparation of victims for criminal proceedings, including through a system of psychosocial support - particularly during and after questioning procedures - which takes into account the emotional tensions associated with the circumstances, and designed to prevent risk factors which could lead to further violent offences;
Amendment 222 #
2019/2166(INI)
Motion for a resolution
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Recommends that national authorities take action, in particular, to draft and disseminate a set of guidelines for professionals involved in cases relating to intimate partner violence and custody rights, including consideration of risk factors (risk factors relating to children or family members, environmental or social concerns, or potential repetition of violent offences), to enable the intimate partner violence to be assessed, in support of children's and women's rights;
Amendment 237 #
2019/2166(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Notes that such guidelines and guidance should be geared, inter alia, towards the management and storage of medical files and evidentiary items by the forensic expert and medical professionals, as appropriate, but in any case such as to enable women to take subsequent legal action and to enable the judicial authority to carry out specific investigations;
Amendment 247 #
2019/2166(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Calls on the Commission and the Member States to provide quality, gendersex- segregated and comparable EU-wide data on the prevalence, causes, consequences and management of intimate partner violence and custody rights, making full use of the capacity and expertise of the EIGE;
Amendment 253 #
2019/2166(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Suggests that such guidelines and guidance should include measures to promote safe, respectful and non-guilt- inducing out-patient and in-patient treatment programmes for women who have suffered violence, including intimate partner violence, and to support research to develop and evaluate the best treatments for women who have suffered violence, and for their children;
Amendment 266 #
2019/2166(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Expresses its concern about the fact that discriminatory gendersex bias often leads to a lack of trust in women, in particular concerning presumed false allegations of child abuse and of domestic violence;
Amendment 269 #
2019/2166(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Notes that such guidelines and guidance should support health professionals in raising public awareness in their professional environment of the crucial impact of violence against women, including intimate partner violence, on their mental health;
Amendment 280 #
2019/2166(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Notes that, for clinical and legal purposes, the specific skills of the forensic expert make him or her the most suitable professional for the protection of women who are victims of violence, and children, also to assist specialists (paediatricians, gynaecologists, psychologists) in their work, having the appropriate training and technical expertise to be able to recognise the signs of violence and, where there are grounds to do so, to comply with reporting obligations and liaise with judicial and health authorities;
Amendment 292 #
2019/2166(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Stresses the importance for the forensic expert, or any other professional involved, to provide the relevant national authority with information relating to violence within the couple, when he or she believes that such violence puts the life of the adult victim or child in immediate danger and that the victim is unable to protect him/herself because of the moral or economic coercion resulting from the hold exercised by the perpetrator, seeking to obtain the adult victim's consent where appropriate;
Amendment 298 #
2019/2166(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Strongly recommends that Member States put in place systematic procedures for monitoring, including psychological monitoring, of children who are victims of and witnesses to domestic violence, in order to respond to the troubles this causes in their lives and to prevent them from repeating such violence as adults;
Amendment 305 #
2019/2166(INI)
Motion for a resolution
Paragraph 10 b (new)
Paragraph 10 b (new)
10b. Stresses the need to eliminate any economic barriers that might induce a woman not to report the violence she has suffered; notes that this could be done by giving courts the option of awarding government benefits to support the victims, once the circumstances of the domestic violence have been established;
Amendment 318 #
2019/2166(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Calls on the Commission to promote EU-wide public awareness campaigns and exchange of good practice as a necessary measure in the prevention of domestic violence and the creation of a climate of zero tolerance towards violence;
Amendment 325 #
2019/2166(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Calls on the Commission and the Member States to allocate more funds to national territorial authorities, including through projects and calls for funding, for the establishment and expansion of shelters, in order to increase, improve and ensure adequate reception and protection services for women who are victims of domestic violence and any children involved;
Amendment 342 #
2019/2166(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Emphasises that hearing from the child is important to establish what is in the best interests of the child while examining custody and foster care cases; points out nevertheless that in every case, but crucially in cases where intimate partnership violence is suspected, such hearings should be conducted in a child- friendly environment, with no pressure or influence from parents or relatives, by trained professionals, including those qualified in child neuropsychiatry, to avoid deepening the trauma and victimisation;
Amendment 353 #
2019/2166(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Calls on the Member States to provide effective instruments for the judicial accompaniment of children and to ensure that the operators in charge are adequately trained;
Amendment 363 #
2019/2166(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Calls on the competent authorities of the Member States to promote, in the best interests of the child and the female victim, a procedure whereby, with the intervention of accredited professionals, an assessment of the child's psychological state can be carried out at every stage of the procedure, in order to decide whether a meeting with the allegedly or declaredly violent parent is appropriate;
Amendment 366 #
2019/2166(INI)
Motion for a resolution
Paragraph 14 b (new)
Paragraph 14 b (new)
14b. Calls on the competent national authorities to improve coordination between courts by fostering contacts between prosecutors' offices to enable issues of parental responsibility to be resolved urgently and to ensure that family courts are able to consider all issues relating to violence against women when determining custody and visitation rights and to assess whether such violence justifies a limitation of custody and visitation rights;
Amendment 367 #
2019/2166(INI)
Motion for a resolution
Paragraph 14 c (new)
Paragraph 14 c (new)
14c. Encourages Member States, especially in view of the current situation in which there are still frequent periods of quarantine owing to the COVID-19 pandemic, to increase the number of violence prevention and response hotlines and invest in shelters and family centres and other appropriate measures, providing women who are victims of violence and are isolated, with confidentiality and a safe and local environment;
Amendment 369 #
2019/2166(INI)
Motion for a resolution
Paragraph 14 d (new)
Paragraph 14 d (new)
14d. Calls on Member States to explore virtual options for helping victims of violence, including mental health and counselling options, paying attention to existing inequalities in access to information technology services;