Activities of Francesca PEPPUCCI
Plenary speeches (15)
Fighting cyberbullying of young people across the EU (debate)
Social and economic costs of climate change in light of the floods in Emilia Romagna, Marche and Toscana and the urgent need for European solidarity (debate)
Delivering on the Green Deal: risk of compromising the EU path to the green transition and its international commitments (debate)
SME Relief Package (debate)
The 10th consecutive increase in reference interest rates decided by the ECB and its consequences (debate)
Need for a speedy adoption of the asylum and migration package (debate)
Type-approval of motor vehicles and engines with respect to their emissions and battery durability (Euro 7) (debate)
International day for the elimination of violence against women (debate)
Addressing urgent skills shortages and finding the right talents to boost job creation (European Year of Skills) (debate)
Instant payments in euro (debate)
Quality traineeships in the EU (debate)
Empowering farmers and rural communities - a dialogue towards sustainable and fairly rewarded EU agriculture (debate)
Detergents and surfactants (debate)
Union code relating to medicinal products for human use - Union procedures for the authorisation and supervision of medicinal products for human use and rules governing the European Medicines Agency (joint debate - Pharmaceutical package)
European Disability Card and European Parking Card for persons with disabilities - European Disability Card and European Parking Card for persons with disabilities for third country nationals legally residing in a Member State (joint debate - Disability cards)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on detergents and surfactants, amending Regulation (EU) 2019/1020 and repealing Regulation (EC) No 648/2004
Oral questions (1)
Medicine shortages and strategic healthcare autonomy in the EU
Written questions (7)
Commission action against adulterated honey
Extreme weather emergency in Italy
Areas being left without bank branches
Azeri community in Iran – inequality and discrimination
Proposal for a packaging and packaging waste regulation: transparency and impartiality of the impact assessment
Recognising firefighters among the occupational categories at risk of contamination with asbestos and PFAS
Threat posed by the Asian hornet to biodiversity and European honey
Amendments (435)
Amendment 32 #
2023/2081(INI)
F. whereas, in its 2021 resolution on the Farm to Fork Strategy, Parliament explicitly welcomed the announcement of a legislative proposal to establish nutrient profiles in order to prohibit the use of nutrition and health claims on foods high in fat, sugar and/or salt and called for particular attention to be given to food for children and other special purpose foods;
Amendment 35 #
2023/2081(INI)
Motion for a resolution
Recital G
Recital G
G. whereas consumers continue to be exposed to positive nutrition or health claims on foods high in fat, salt or sugaroverall unhealthy foods, which is incompatible with the objective of high- level consumer protection;
Amendment 72 #
2023/2081(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
Amendment 76 #
2023/2081(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Reminds that claims should not mislead consumers about the true nutrient value of a product; highlights that, in the absence of nutrient profiles, claims can, for example by stressing a positive aspect of an overall unhealthy product; underlines that the development of nutrient profiles is necessary in order to achieve the consumer protection objective of the NHCR; calls for the swift publication of a Commission proposal on nutrient profiles to limit the use of nutrition and health claims on unhealthy foods;
Amendment 80 #
2023/2081(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Stresses the relevance of an approach aimed at promoting a balanced diet that includes a proper intake of all nutrients; recalls that a restrictive and superficial approach of excluding categories of food from nutrition and health claims would lead to a de facto market segregation that is not justified from a health perspective; stresses that such segregation would lead consumers to consider only those products bearing such claims as healthy, and to consider many products that are essential within a varied and balanced diet as unhealthy;
Amendment 83 #
2023/2081(INI)
Motion for a resolution
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Highlights that, when considering the use of nutrition or health claims on food products, portions consumed, the overall contribution of such food on the diet, the level of processing and ultra- processing, and the health and nutrition positive contributions of such food products should be taken into account;
Amendment 188 #
2023/2075(INI)
Motion for a resolution
Recital H a (new)
Recital H a (new)
Ha. whereas thanks to research knowledge about the biology of many types of non-communicable diseases, such as neurodegenerative ones, has grown exponentially, but has not yet been translated into decisive therapeutic interventions, and is still limited to purely symptomatic interventions;
Amendment 367 #
2023/2075(INI)
Motion for a resolution
Paragraph 7 – point b
Paragraph 7 – point b
b. Promote evidence-based and proportionate measures aimed at reducing and preventing alcohol-related harm within the revised EU alcohol strategy;
Amendment 405 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 – point a
Paragraph 8 – point a
a. encourage and help consumers to make informed and healthy choices about food products, empowering them to follow healthy, varied and balanced diets; promote behavioural changes via communication and mass media campaigns for healthy diets; encourage public food procurement and service policies for healthy and sustainable diets;
Amendment 411 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 – point a a (new)
Paragraph 8 – point a a (new)
aa. implement a comprehensive strategy to combat eating disorders, through allocation of resources, data collection, prevention campaigns as well as support systems and coordination with existing bodies in individual Member States;
Amendment 589 #
2023/2075(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. stresses the complexity of diagnosis in certain non-communicable diseases in childhood, such as Multiple Sclerosis, whose onset may be similar to that found in other inflammatory diseases of the central nervous system, stresses that diagnosis is crucial for the delivery of targeted and effective therapies;
Amendment 732 #
2023/2075(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Welcomes the pharmaceutical package and calls for the strengthening of the European medicines market to ensure access to medicines and alleviate medicine shortages, reduce barriers to cross-border business, while strengthening incentives for investment in innovation; underlines that in many cases the immediate availability of precise and appropriate medicines can hinder the irreversible degeneration of certain diseases; underlines that data protection and intellectual property rights are crucial to ensure competitiveness in the EU by incentivising innovators to develop new products and further ongoing research efforts;
Amendment 6 #
2023/2015(INI)
Motion for a resolution
Citation 7 a (new)
Citation 7 a (new)
– having regard to the FAO’s 2022 report entitled ‘Thinking about the future of food safety and food allergies with regard to certain types of novel foods and protein sources’,
Amendment 10 #
2023/2015(INI)
Motion for a resolution
Citation 8 a (new)
Citation 8 a (new)
– having regard to the study by the Joint Research Centre (JRC) from July 2020 on the future of EU livestock: how to contribute to a sustainable agricultural sector?
Amendment 11 #
2023/2015(INI)
– having regard to the Dublin Declaration of 2022 on the societal role of meat,
Amendment 41 #
2023/2015(INI)
Motion for a resolution
Recital B
Recital B
B. whereas the COVID-19 pandemic and the Russian invasion of Ukraine have had dramatic effects on global trade and have made it more apparent that the EU needs to diversify its food supply chains and increase its production;
Amendment 69 #
2023/2015(INI)
Motion for a resolution
Recital D
Recital D
D. whereas plant-based proteins are crucialan important factor for the transition towards more sustainable food systems with a reduced climate impact;
Amendment 81 #
2023/2015(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas proteins of animal origin are essential in ensuring a balanced and healthy diet and protecting rural areas and their development;
Amendment 110 #
2023/2015(INI)
Motion for a resolution
Recital G
Recital G
G. whereas the market for plant-based and alternative sources ofsustainable production of animal and plant-based protein is steadily increasing due to consumer demand;
Amendment 127 #
2023/2015(INI)
Motion for a resolution
Recital I
Recital I
Amendment 151 #
2023/2015(INI)
Motion for a resolution
Recital J
Recital J
J. whereas interest in insects for human and in particular animal consumption is growing, as is the desire and right of consumers to have easy access to clear information about the presence of insects in various end products;
Amendment 169 #
2023/2015(INI)
Motion for a resolution
Recital K
Recital K
K. whereas research and innovation on plantsustainable production of all sources of proteins needs to be scaled up;
Amendment 185 #
2023/2015(INI)
Motion for a resolution
Recital L
Recital L
L. whereas it is important to adopt a value chain approach in order to create added value for plant-based protein sourcessustainable protein production;
Amendment 200 #
2023/2015(INI)
1. Calls on the Commission to urgently present a comprehensive EU protein strategy covering the sustainable production of all protein types, both animal and plant-based, within the EU, and introducing effective measures to increase the EU’s production of protein in the short, medium and long term;
Amendment 221 #
2023/2015(INI)
Motion for a resolution
Paragraph 2 – point 1 a (new)
Paragraph 2 – point 1 a (new)
1a. The principles of a circular economy;
Amendment 245 #
2023/2015(INI)
Motion for a resolution
Paragraph 2 – point 3
Paragraph 2 – point 3
3. The development of plant-based and alternative protein for food and feed;
Amendment 259 #
2023/2015(INI)
Motion for a resolution
Paragraph 2 – point 5 a (new)
Paragraph 2 – point 5 a (new)
5a. The innovation, research and development of sustainably produced plant-based and animal protein;
Amendment 293 #
2023/2015(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Points out that the protein strategy should acknowledge thesupport environmental transition through sustainable development of all possibleagricultural protein sources and/or those from the fisheries and aquaculture sectors;
Amendment 330 #
2023/2015(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Considers that developing the production of plant and alternative sources ofsustainably produced proteins in the EU is an effective way of addressing many of the social, environmental and climate challenges that the EU faces;
Amendment 339 #
2023/2015(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. stresses that the EU’s protein strategy should encourage the transition to increasingly sustainable animal protein production, to avoid the relocation of animal production where environmental standards are lower than in the EU and to maintain the vitality of rural areas;
Amendment 390 #
2023/2015(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Calls on the Commission to propose medium- and long-term policy measures to close the nutrient loop, such as enabling the use of alternative organic products such as recovered nitrogen from manure (RENURE) productsor digestate;
Amendment 401 #
2023/2015(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Recalls that the production of biomethane, biogas, biofuels or other bio- based chemicals that use biowaste streams is a key factor contributing to more sustainable production and a source of important revenue to enhance and capture the value of protein-rich crops and strengthen their business case for farmers;
Amendment 414 #
2023/2015(INI)
Motion for a resolution
Subheading 4
Subheading 4
Amendment 428 #
2023/2015(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Highlights the big potential of sustainably produced animal and plant- based protein and the fact that the development of the sectors with their essential role that will benefit European farmers, the circular economy, soil quality, biodiversity, the climate and human health;
Amendment 453 #
2023/2015(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Stresses the importance of grasslands and their combined role with livestock production as a protein source; highlights the relevance of projects that extract high- quality protein as well as biomethanol from grasslands through biorefining;
Amendment 475 #
2023/2015(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
Amendment 504 #
2023/2015(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Stresses that insects should be considered as alternative sources of protein, particularly for animal nutrition;
Amendment 522 #
2023/2015(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Is of the opinion that authorisations made solely through novel food legislation should be based on the safety of the product and its impact on human health;
Amendment 536 #
2023/2015(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls for more research and development into plant-based and alternative proteinsfor the sustainable production of animal and plant-based proteins in the EU;
Amendment 581 #
2023/2015(INI)
Motion for a resolution
Paragraph 26 a (new)
Paragraph 26 a (new)
26a. calls on the Commission to present an analytical study on the space available on the market for proteins;
Amendment 620 #
2023/2015(INI)
Motion for a resolution
Paragraph 32 – point ii
Paragraph 32 – point ii
Amendment 672 #
2023/2015(INI)
Motion for a resolution
Paragraph 32 – point ix
Paragraph 32 – point ix
Amendment 701 #
2023/2015(INI)
Motion for a resolution
Paragraph 32 – point xiii
Paragraph 32 – point xiii
xiii. A clear research and development funding strategy to promote and stimulate the market uptake of plant-based proteins for food and feed in the EUinvest in food and feed in the EU and their sustainable production;
Amendment 155 #
2023/0373(COD)
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
2. Economic operators, EU carriers and non-EU carriers shall notify the competent authority, in the manner determined by the latter, of each installation they operate and oif wtheny engaginge in the transport of plastic pellets, as applicable.
Amendment 156 #
2023/0373(COD)
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. Economic operators, EU carriers and non-EU carriers shall notify the competent authorities of the Member State in which they are established of any significant change in their installations and activities related to handling of plastic pellets, including of any closure of an existing installation.
Amendment 158 #
2023/0373(COD)
Proposal for a regulation
Article 3 – paragraph 4
Article 3 – paragraph 4
4. Competent authorities shall establish and maintain a public register containing the information they have received in accordance with paragraphs 3 and 42 and 3. The register shall avoid duplication with other existing EU and national environmental registration systems and protect confidential business information.
Amendment 187 #
2023/0373(COD)
Proposal for a regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
4. Competent authorities shall establish, maintain, and update a register containing the risk assessment plans and self-declarations of conformity notified in accordance with paragraphs 1 and 2 of this Article. The register shall be publicly available on a websiteavoid duplication with other existing EU and national environmental registration systems and protect confidential business information.
Amendment 314 #
2023/0373(COD)
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
2. The penalties referred to in paragraph 1 shall include fines proportionate to the turnover of the legal person or to the income of the natural person having committed the infringement, 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 infringements of the economic benefits derived from those infringements. The level of the fines shall be gradually increased for repeated infringements. In the case of an infringement committed by a legal person, the maximum amount of such fines shall be at least 4 % of the economic operator’s annual turnover in the Member State concerned in the business year preceding the fining decision of the same nature.
Amendment 323 #
2023/0373(COD)
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
Amendment 328 #
2023/0373(COD)
Proposal for a regulation
Article 16 – paragraph 4
Article 16 – paragraph 4
Amendment 330 #
2023/0373(COD)
Proposal for a regulation
Article 16 – paragraph 5
Article 16 – paragraph 5
5. Member States shall ensure thatmay establish the limitation periods for bringing claims for compensation referred to in paragraph 1 are not shorter than 5 years. Such periods shall not begin to run before the infringement has ceased and the person claiming the compensation knows or can reasonably be expected to know that he or she suffered damage from a infringement pursuant to paragraph 1.
Amendment 345 #
2023/0311(COD)
Proposal for a directive
Article 7 – paragraph 7 a (new)
Article 7 – paragraph 7 a (new)
7 a. The Commission shall establish a publicly accessible database, available in all EU official languages, containing information concerning the European Parking Card for persons with disabilities, as defined at local, regional or national level.
Amendment 352 #
2023/0311(COD)
Proposal for a directive
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Member States shall make the conditions and rules, practices, and procedures to issue, renew or withdraw a European Disability Card and a European Parking Card for persons with disabilities publicly available in accessible formats, including in digital formats, and upon request in assistive formats requested by persons with disabilities. The Commission ensures that such informations are available in all EU official languages on an EU-level website.
Amendment 366 #
2023/0311(COD)
Proposal for a directive
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Commission and Member States shall take appropriate measures to raise awareness among the public and inform persons with disabilities, including in accessible ways, about the existence and conditions to obtain, use, or renew the European Disability Card and the European Parking Card for persons with disabilities.
Amendment 389 #
2023/0311(COD)
Proposal for a directive
Article 9 – paragraph 7 a (new)
Article 9 – paragraph 7 a (new)
7 a. The Commission ensures that Member States have adequate funding to cover the costs of implementing the above provisions.
Amendment 397 #
2023/0311(COD)
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making, as well as persons with disabilities and their representative organisations.
Amendment 409 #
2023/0311(COD)
Proposal for a directive
Article 12 – paragraph 1
Article 12 – paragraph 1
1. The Commission shall be assisted by a committee and involve persons with disabilities and their representative organisations. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
Amendment 182 #
2023/0232(COD)
Proposal for a directive
Recital 38
Recital 38
(38) Economic instruments, including those under the Common Agricultural Policy (CAP) that provide support to farmers, have a crucial role in the transition to the sustainable management of agricultural soils and, to a lesser extent, forest soils. The CAP aims to supports soil health through the implementation of conditionality, eco-schemes and rural development measures. Financial support for farmers and foresters who apply sustainable soil management practices can also be generated by the private sector. Voluntary sustainability labels in the food, wood, bio-based, and energy industry, for example, established by private stakeholders, can take into account the sustainable soil management principles set out in this Directive. This can enable food, wood, and other biomass producers that follow those principles in as part of sustainable soil management practices without additional burdens on farmers. Any additional burdens on farmers will have to be supported by adequate resources. Financial support for farmers and foresters who apply sustainable soil management practices can also be generated by their production to reflect these in the value of their productsivate sector. Additional funding for a network of real-life sites for testing, demonstrating and upscaling of solutions, including on carbon farming, will be provided through the Soil Mission’s living labs and lighthouses. Without prejudice to the polluter pays principle, support and advice should be provided by Member States to help landowners and land users affected by action taken under this Directive taking into account, in particular, the needs and limited capacities of small and medium sized enterprises.
Amendment 251 #
2023/0232(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 4
Article 3 – paragraph 1 – point 4
(4) ‘soil health’ means the physical, chemical and biological condition of the soil determining its capacity to function as a vital living system and to provide ecosystem services taking into consideration the land use and its purpose;
Amendment 301 #
2023/0232(COD)
Proposal for a directive
Article 4 – paragraph 1 – subparagraph 2
Article 4 – paragraph 1 – subparagraph 2
The number of soil districts for each Member State shall as a minimum correspond tobe in line with the political, administrative and legal territorial governance structure already established within the nuMember of NUTS 1 territorial units established under Regulation (EC) No 1059/2003State, also trying to match soil types, climatic conditions, environmental zones and territorial areas as much as possible. The number of soil districts must be limited to avoid fragmentation.
Amendment 305 #
2023/0232(COD)
Proposal for a directive
Article 4 – paragraph 1 a (new)
Article 4 – paragraph 1 a (new)
1 a. When establishing the geographic extent of soil districts, Member States shall identify national and international coordination bodies based on the political, administrative and legal territorial governance structures already established within the Member State, which will communicate directly with the European Commission in order to ensure the most effective implementation of monitoring and reporting on heterogeneous soil types, climatic conditions, environmental zones and land uses.
Amendment 306 #
2023/0232(COD)
Proposal for a directive
Article 4 – paragraph 2
Article 4 – paragraph 2
Amendment 322 #
2023/0232(COD)
Proposal for a directive
Article 4 – paragraph 2 a (new)
Article 4 – paragraph 2 a (new)
2 a. Member States shall designate the competent authorities responsible for the appropriate political, administrative and legal territorial body to perform the tasks provided for in this Directive.
Amendment 344 #
2023/0232(COD)
Proposal for a directive
Article 6 – paragraph 3 – point d
Article 6 – paragraph 3 – point d
(d) the relevant remote sensing data that is approved scientifically and products referred to in paragraph 5 of this Article, if any;
Amendment 345 #
2023/0232(COD)
Proposal for a directive
Article 6 – paragraph 3 – subparagraph 1 (new)
Article 6 – paragraph 3 – subparagraph 1 (new)
For the purposes of monitoring activities, no economic burden should be placed on the landowner and land manager.
Amendment 353 #
2023/0232(COD)
Proposal for a directive
Article 6 – paragraph 4
Article 6 – paragraph 4
4. The Commission shall, subject to agreement from Member States concerned, carry out regular soil measurements on soil samples taken in-situ, based on the relevant descriptors and methodologies referred to in Articles 7 and 8, to support Member States’ monitoring of soil health. Where a Member State provides agreement in accordance with this paragraph, it shall ensure that the Commission can carry out such in-situ soil sampling, only with the express permission of the landowner and land manager.
Amendment 368 #
2023/0232(COD)
Proposal for a directive
Article 6 – paragraph 8
Article 6 – paragraph 8
8. The Commission shall adopt implementing acts to establish formats or methods for sharing or collecting the data referred to in paragraph 7 or for integrating those data in the digital soil health data portal. Those implementing actensures that all data collected are aggregated and anonymised to ensure full protection of the private property of land owners and managers. Data collected and analysed for future academic or scientific use must recognise historical land use, production and recultivation activities sthall be adopted in accordance with the examination procedure referred to in Article 21t will have an impact on this and any future representation of the analysed soil data.
Amendment 369 #
2023/0232(COD)
Proposal for a directive
Article 7 – paragraph 1 – subparagraph 1
Article 7 – paragraph 1 – subparagraph 1
When monitoring and assessing soil health, Member States shall apply that least five soil descriptors and soil health criteria listed in Annex I that best illustrate soil characteristics in each soil type on a national level.
Amendment 374 #
2023/0232(COD)
Proposal for a directive
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Member States may adapt the soil descriptors and the soil health criteria referred to in part A of Annex I, in accordance with the national specifications referred to in the second and third columns in part A of Annex Ion soil health.
Amendment 377 #
2023/0232(COD)
Proposal for a directive
Article 7 – paragraph 3
Article 7 – paragraph 3
Amendment 379 #
2023/0232(COD)
Proposal for a directive
Article 7 – paragraph 4
Article 7 – paragraph 4
Amendment 383 #
2023/0232(COD)
Proposal for a directive
Article 7 – paragraph 5
Article 7 – paragraph 5
Amendment 385 #
2023/0232(COD)
Proposal for a directive
Article 7 – paragraph 6
Article 7 – paragraph 6
Amendment 424 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 2
Article 9 – paragraph 2
Amendment 459 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 2 a (new)
Article 9 – paragraph 2 a (new)
2 a. Soil is considered healthy in accordance with this Directive where the values for all soil descriptors listed in part A and B of Annex I, meet the criteria set in accordance of the Soil Health Index referred to Article 9, paragraph 2, subparagraph 3. Artificial land shall be excluded from applying the conditions for healthy soil.
Amendment 460 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 2 b (new)
Article 9 – paragraph 2 b (new)
2 b. The European Commission shall define the Soil Health Index through a delegated act during the monitoring period of this Directive. The Soil Health Index shall serve as a comprehensive metric for assessing the overall health and quality of soil, taking into consideration multiple indicators and reflect the overall health and quality of the soil, considering its physical, chemical, and biological properties. Member States shall integrate the Soil Health Index into their national monitoring and reporting systems as required by this Directive.
Amendment 465 #
2023/0232(COD)
4. Based on the assessment of soil health carried out in accordance with this Article, the competent authority shall, where relevant in coordination with local, regional, national authorities, identify, in each soil district, the areas which present unareas in different degrees of soil healthy soilstatus, and inform the public in accordance with Article 19landowner and land manager within these areas.
Amendment 471 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 5
Article 9 – paragraph 5
Amendment 486 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 6
Article 9 – paragraph 6
6. Member States shall communicate soil health data and assessment referred to in Articles 6 to 9 to the relevant land owners and land managers upon their request, in particular to support the development of the advice referred to in Article 10(3)within 3 weeks of soil samples being taken.
Amendment 490 #
2023/0232(COD)
Proposal for a directive
Article 10 – paragraph 1 – subparagraph 1 – introductory part
Article 10 – paragraph 1 – subparagraph 1 – introductory part
From (OP: please insert the date = 4 years after date of entry into force of the Directive), Member States shall take at least the following measures, taking into accountpromote the adoption of sustainable soil management practices that respect the principles listed in Annex III , taking into account the active productive agricultural, forestry, or industrial model, crop rotation, the type, use and condition of soil:.
Amendment 495 #
2023/0232(COD)
Proposal for a directive
Article 10 – paragraph 1 – subparagraph 1 – point a
Article 10 – paragraph 1 – subparagraph 1 – point a
Amendment 504 #
2023/0232(COD)
Amendment 510 #
2023/0232(COD)
Proposal for a directive
Article 10 – paragraph 1 – subparagraph 1 a (new)
Article 10 – paragraph 1 – subparagraph 1 a (new)
Member States identify soil management practices and other practices affecting negatively the soil health to be avoided by soil managers.
Amendment 528 #
2023/0232(COD)
Proposal for a directive
Article 10 – paragraph 4
Article 10 – paragraph 4
Amendment 603 #
2023/0232(COD)
Proposal for a directive
Article 14 – paragraph 3
Article 14 – paragraph 3
Amendment 620 #
2023/0232(COD)
Proposal for a directive
Article 16 – paragraph 1
Article 16 – paragraph 1
1. By … (OP : please insert date = 4 years after entry into force of the Directive), Member States shall, in accordance with paragraph 2, draw up a register of contaminated sites and potentially contaminated sites.
Amendment 700 #
2023/0232(COD)
Proposal for a directive
Article 24 – paragraph 1 – introductory part
Article 24 – paragraph 1 – introductory part
1. By (OP :please insert the date = 615 years after the date of entry into force of the Directive), the Commission shall carry out an evaluation of this Directive to assess the progress towards its objectives and the need to amend its provisions in order to set more specific requirements to ensure that unhealthy soils are regenerated and that all soils will be healthyin a good ecological stat by 2050. This evaluation shall take into account, inter alia, the following elements:
Amendment 706 #
2023/0232(COD)
Proposal for a directive
Article 24 – paragraph 1 – point d
Article 24 – paragraph 1 – point d
(d) an analysis of the gap towards achieving healthy soilssoils in a good ecological state by 2050;
Amendment 713 #
2023/0232(COD)
Proposal for a directive
Article 24 – paragraph 1 – point e
Article 24 – paragraph 1 – point e
Amendment 758 #
2023/0232(COD)
Proposal for a directive
Annex I – Part B
Annex I – Part B
Amendment 765 #
2023/0232(COD)
Proposal for a directive
Annex I – Part C -Row 2
Annex I – Part C -Row 2
Part C: soil descriptors without criteria Aspect of soil degradation Soil descriptor Excess nutrient content in soiland deficient nutrient Nitrogen in soil (mg g-1) content in soil Extractable phosphorus (mg per kg)
Amendment 154 #
2023/0226(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) NGT plants that could also occur naturally or be produced by conventional breeding techniques and their progeny obtained by conventional breeding techniques (‘category 1 NGT plants’) should be treated as plants that have occurred naturally or have been produced by conventional breeding techniques, given that they are equivalent and that their risks are comparable, thereby derogating in full from the Union GMO legislation and GMO related requirements in sectoral legislation. In order to ensure legal certainty, this Regulation should set out the criteria to ascertain if a NGT plant is equivalent to naturally occurring or conventionally bred plants and lay down a procedure for competent authorities to verify and take a decision on the fulfillment of those criteria, prior to the release or placing on the market of NGT plants or NGT products. Those criteria should be objective and based on science. They should cover the type and extent of genetic modifications that can be observed in nature or in organisms obtained with conventional breeding techniques and should include thresholds for both size and number of genetic modifications to the genome of NGT plants. Since scientific and technical knowledge evolves rapidly in this area, the Commission should be empowered in accordance with Article 290 of the Treaty on the Functioning of the European Union to update these criteria in light of scientific and technical progress as regards the type and, extent, size and number of genetic modifications that can occur in nature or through conventional breeding.
Amendment 186 #
2023/0226(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) Since the criteria for considering that a NGT plant is equivalent to naturally occurring or conventionally bred plants are unrelated to the type of activity that requires the deliberate release of the NGT plant, a declaration of the category 1 NGT plant status made prior to its deliberate release for any other purpose than placing on the market in the territory of the Union should also be valid for the placing on the market of related NGT products. In view of the high uncertainty existing at the field trial stage about the product reaching the market and the likely involvement of smaller operators in such releases, the verification procedure of category 1 NGT plant status prior to field trials should be conducted by national competent authorities as this would be less administratively burdensome for operators, and a decision should be taken at Union level only in case there are comments to the verification report by other national competent authorities. Where the verification request is submitted prior to the placing on the market of NGT products, the procedure should be conducted at Union levelin consultation with the Commission and EFSA, only if there are reasoned objections from other Member States, in order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.
Amendment 189 #
2023/0226(COD)
Proposal for a regulation
Recital 18 a (new)
Recital 18 a (new)
(18a) In order to effectively select new varieties that help the agricultural sector increase food security, as well as sustainability, adaptation and resilience to the consequences of climate change, it is necessary to consider the specificity of polyploid plants, i.e. those that contain more than two genomes. For such plants, the maximum number of genetic modifications allowed for inclusion in category 1 NGT should be proportionate to the number of genomes they contain.
Amendment 228 #
2023/0226(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) Regulation (EU) 2018/848 of the European Parliament and the Council on organic production and labelling of organic products and repealing Council Regulation (EC) 834/2007(47 ) prohibits the use of GMOs and products from and by GMOs in organic production. It defines GMOs for the purposes of that Regulation by reference to Directive 2001/18/EC, excluding from the prohibition GMOs which have been obtained through the techniques of genetic modification listed in Annex 1.B of Directive 2001/18/EC. As a result, category 2 NGT plants will be banned in organic production. However, it is necessary to clarify the status of category 1 NGT plants for the purposes of organic production. The use of new genomic techniques is currently incompatible with the concept of organic production in the Regulation (EC) 2018/848 and with consumers’ perception of organic products. The use of category 1 NGT plants should therefore be also prohibited in organic production. This prohibition, in any case, should not hinder the application of Category 1 NGT. _________________ 47 Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1).
Amendment 278 #
2023/0226(COD)
Proposal for a regulation
Recital 29 a (new)
Recital 29 a (new)
(29a) Once a category 1 NGT plant has been granted authorisation on the basis of scientific criteria, the authorisation should be valid for an unlimited period.
Amendment 285 #
2023/0226(COD)
Proposal for a regulation
Recital 30
Recital 30
(30) For reasons of proportionality, after a first renewal of the authorisation, the authorisation should be valid for an unlimited period. In the case of a category 2 NGT plant, unless decided differently at the time of that renewal based on the risk assessment and the available information on the NGT plant concerned, subject to reassessment when new information has become available.
Amendment 336 #
2023/0226(COD)
Proposal for a regulation
Recital 40
Recital 40
(40) Given the novelty of the NGTs, it will be important to monitor closely the development and presence on the market of NGT plants and products and evaluate any accompanying impact on human and animal health, the environment and environmental, economic and social sustainability. IWith reference to category 2 NGT plants, information should be collected regularly and within five years after the adoption of the first decision allowing the deliberate release or the marketing of NGTsuch plants or NGTsuch products in the Union, the Commission should carry out an evaluation of this Regulation to measure the progress made towards the availability of NGTsuch plants containing such characteristics or properties on the EU market.
Amendment 413 #
2023/0226(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 6 a (new)
Article 3 – paragraph 1 – point 6 a (new)
Amendment 497 #
2023/0226(COD)
Proposal for a regulation
Article 5 – paragraph 2 a (new)
Article 5 – paragraph 2 a (new)
2a. Category 1 NGT plants and products from such plants are not subject to the provisions laid down in Article 24 of this Regulation or Regulation 1829/2003.
Amendment 507 #
2023/0226(COD)
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. The Commission is empowered to adopt delegated acts in accordance with Article 26 amending the criteria of equivalence of NGT plants to conventional plants laid down in Annex I in order to adapt them to scientific and technological progress as regards the types and, extent, size and number of modifications which can occur naturally or through conventional breeding.
Amendment 568 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 7
Article 6 – paragraph 7
7. The other Member States and the Commission may make commentreasoned objections to the verification report with regard to compliance with the criteria in the Annex I within 20 days from the date of receipt of that report.
Amendment 578 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 8
Article 6 – paragraph 8
8. In the absence of any commentreasoned objections from a Member State or the Commission, within 10 working days from the expiry of the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall adopt a decision declaring whether the NGT plant is a category 1 NGT plant. It shall transmit the decision without undue delay to the requester, the other Member States and to the Commission.
Amendment 588 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 9
Article 6 – paragraph 9
9. In cases where a commentreasoned objections is made by another Member State or by the Commission by the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall forward the comment(s)objections and their justifications to Member States to the Commission without undue delay.
Amendment 597 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 10
Article 6 – paragraph 10
10. The Commission, after having consulted the European Food Safety Authority (‘the Authority’), shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 45 working days from the date of receipt of the comment(s)reasoned objections and their justifications, taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).
Amendment 655 #
2023/0226(COD)
Proposal for a regulation
Article 7 a (new)
Article 7 a (new)
Article 7a Freedom of movement Member States do not prohibit or restrict the intentional release or placing on the market of Category 1 NGT plants and Category 1 NGT products.
Amendment 809 #
2023/0226(COD)
Proposal for a regulation
Article 16
Article 16
Amendment 844 #
2023/0226(COD)
Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 2
Article 19 – paragraph 2 – subparagraph 2
In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the applicant or concluded by the European Union Reference Laboratory referred to in Article 32 of Regulation (EC) No 1829/2003 during the procedure referred to in Article 20(4), the modalities to comply with analytical method requirements shall be adapted as specified in the implementing act adopted in accordance with Article 27, point (e) and the guidance referred to in Article 29(2)application for authorisation is accompanied by such justification;
Amendment 912 #
2023/0226(COD)
Proposal for a regulation
Article 23
Article 23
Amendment 931 #
2023/0226(COD)
Proposal for a regulation
Article 24 – paragraph 1
Article 24 – paragraph 1
Amendment 935 #
2023/0226(COD)
Proposal for a regulation
Article 24 – paragraph 1 a (new)
Article 24 – paragraph 1 a (new)
Amendment 962 #
2023/0226(COD)
Proposal for a regulation
Article 26 – paragraph 3
Article 26 – paragraph 3
3. The delegations of power referred to in Article 5(3) and Article 22(8) may only be exercised to adapt to scientific and technological progress, and the non- regression clause must be applied. Delegations of power may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Amendment 1056 #
2023/0226(COD)
Proposal for a regulation
Annex I – paragraph 1
Annex I – paragraph 1
A NGT plant is considered equivalent to conventional plants when it differs from the recipient/parental plant by no more than 20 genetic modifications per haploid of the types referred to in points 1 to 5, in any DNA sequence sharing sequence similarity with the targeted site that can be predicted by bioinformatic tools.
Amendment 1062 #
2023/0226(COD)
Proposal for a regulation
Annex I – point 1
Annex I – point 1
(1) substitution or insertion of no more than 20 nucleotides per haploid;
Amendment 1077 #
2023/0226(COD)
Proposal for a regulation
Annex I – point 3 – point a
Annex I – point 3 – point a
(a) targeted insertion of a contiguous DNA sequence existing in the breeder’s gene pool for reproductive purposes;
Amendment 1087 #
2023/0226(COD)
Proposal for a regulation
Annex I – point 3 – point b
Annex I – point 3 – point b
(b) targeted substitution of an endogenous DNA sequence with a contiguous DNA sequence existing in the breeder’s gene pool for reproductive purposes;
Amendment 1102 #
2023/0226(COD)
Proposal for a regulation
Annex I – point 5
Annex I – point 5
(5) any other targeted modification of any size, on the condition that the resulting DNA sequences already occur (possibly with modifications as accepted under points (1) and/or (2)) in a species from the breeders’ gene pool for reproductive purposes.
Amendment 529 #
2023/0132(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 36 a (new)
Article 4 – paragraph 1 – point 36 a (new)
(36 a) 'Quality Master File' means a comprehensive document provided by the manufacturer of an active substance, excluding chemical active substances. This document includes a thorough description of the manufacturing process, quality control procedures throughout production, and the validation process. It is mandated by Annex II and is prepared as a distinct document, encompassing details about the active substance or any other substances utilized in the production of a medicinal product.
Amendment 1218 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 1 – introductory part
Article 84 – paragraph 1 – introductory part
1. A non-cumulative period of regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic indicationoption, including a new indication, posology, pharmaceutical form, method or route of administration or any other way in which the medical product may be used, not previously authorised in the Union, provided that:
Amendment 1224 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 1 – point a
Article 84 – paragraph 1 – point a
(a) adequate non-clinical or clinical studies were carried outevidence was provided in relation to the therapeutic indicaoption demonstrating that it is of significant clinical benefit, and
Amendment 1235 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 1 – point b
Article 84 – paragraph 1 – point b
(b) the medicinal product is authorised in accordance with Articles 9 to 12 and has notdoes not fall in the same global marketing authorisation as a medical product that has previously benefitted from data protection or market exclusivity, or 25 years have passed since the granting of the initial marketing authorisation of the medicinal product concerned.
Amendment 1238 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 3
Article 84 – paragraph 3
3. During the data protection period referred to in paragraph 1, the marketing authorisation shall indicate that the medicinal product is an existing medicinal product authorised in the Union that has been authorised with an additional therapeutic indicationedicinal product shall be appointed as a value added medicinal product.
Amendment 1548 #
2023/0132(COD)
Proposal for a directive
Article 195 – paragraph 2
Article 195 – paragraph 2
2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend, revoke or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder via conditions specified in Articles 44(h) or 87(c).
Amendment 1557 #
2023/0132(COD)
Proposal for a directive
Article 196 – paragraph 1 – point f
Article 196 – paragraph 1 – point f
(f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder via conditions specified in Articles 44(h) or 87(c).
Amendment 528 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 7
Article 2 – paragraph 2 – point 7
(7) ‘significant benefit’ means a clinically relevant advantage or a major contribution to patient care of an orphan medicinal product if such an advantage or contribution benefits a substantial part of the target population;
Amendment 658 #
2023/0131(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point d
Article 15 – paragraph 1 – point d
Amendment 665 #
2023/0131(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point d
Article 15 – paragraph 1 – point d
(d) the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant;re is no agreement on the content or timing of post-authorisation studies to further explain environmental risk assessment, as stated by article 20(c).
Amendment 886 #
2023/0131(COD)
Proposal for a regulation
Article 40 a (new)
Article 40 a (new)
Article40a AMR designation All AMR medicinal products designed to combat a priority pathogen should receive an AMR designation through a transparent and open Community procedure. An AMR medicinal product will be identified as such when its sponsor can demonstrate: a) That it is intended for the diagnosis, prevention or treatment of a pathogen included in the ‘WHO priority pathogens list for R&D of new antibiotics’, or a comparable list established at Union level. b) that there is no approved method within the community for diagnosing, preventing, or treating the specified condition that is deemed satisfactory. If such a method does exist, the medicinal product must provide substantial benefits to individuals suffering from the condition. 3. To secure the classification of a pharmaceutical product as an AMR medicinal product, the sponsor must submit an application to the Agency either prior to, or concurrently, with the submission for marketing authorization. The application should include the specified details and accompanying documents: a) name or corporate name and permanent address of the sponsor; b) active ingredients of the medicinal product; c) proposed therapeutic indication; d) verification of compliance with the criteria specified in Article x(y), confirmation of anticipated indications, and review of pertinent preclinical and clinical information constitute the rationale for the approval process. The Agency is responsible for validating the application's legitimacy and issuing an opinion within 90 days of receiving a valid application.
Amendment 890 #
2023/0131(COD)
Proposal for a regulation
Article 40 a (new)
Article 40 a (new)
Article40a Any product receiving AMR Designation shall be considered as meeting the criteria for Unmet Need outlined in the [revised Directive 2001/83/EC].
Amendment 1078 #
2023/0131(COD)
Proposal for a regulation
Article 66 – paragraph 1
Article 66 – paragraph 1
Amendment 1087 #
2023/0131(COD)
Proposal for a regulation
Article 66 – paragraph 2
Article 66 – paragraph 2
Amendment 1089 #
2023/0131(COD)
Proposal for a regulation
Article 66 – paragraph 3
Article 66 – paragraph 3
Amendment 1093 #
2023/0131(COD)
Proposal for a regulation
Article 66 – paragraph 4
Article 66 – paragraph 4
4. An orphan designation ceases to be valid once an orphan medicine sponsor has obtained a marketing authorisation for the relevant medicinal product in accordance with Article 13(2). However, when the original marketing authorization only addresses part of the population affected by the designated orphan condition, the orphan designation shall remain valid.
Amendment 1123 #
2023/0131(COD)
Proposal for a regulation
Article 70
Article 70
Amendment 1160 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point a
Article 71 – paragraph 2 – point a
(a) nintwelve years for orphan medicinal products other than those referred to in points (b) and (c);
Amendment 1176 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point b
Article 71 – paragraph 2 – point b
(b) thirteen years for orphan medicinal products addressing a high unmetwhich satisfy any of the following criteria: i. there is no medicinal product authorised in the Union for such condition or where ii. even though the Union has authorized medicinal need as referred to in Article 70; products for such condition, the applicant demonstrates that the orphan medicinal product, in addition to having a significant benefit, will result in exceptional therapeutic advancement or iii. the condition affects not more than 0,5 in 10,000 persons in the Union when the application for an orphan designation is submitted.
Amendment 1199 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point c
Article 71 – paragraph 2 – point c
(c) fiseven years for orphan medicinal products which have been authorised in accordance with Article 13 of [revised Directive 2001/83/EC].
Amendment 1229 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 1 – subparagraph 1
Article 72 – paragraph 1 – subparagraph 1
Amendment 1239 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 1 – subparagraph 2
Article 72 – paragraph 1 – subparagraph 2
Amendment 1246 #
2023/0131(COD)
The period of market exclusivity shall be prolonged by an additional 124 months for orphan medicinal products referred to in Article 71(2), points (a) and (b), if at least two years before the end of the exclusivity period, the orphan marketing authorisation holder obtains a marketing authorisation for one or more new therapeutic indications for a different orphan condition. If the recently approved therapeutic indication satisfies one of the criteria mentioned in Article 71(2) point (b) and a period of market exclusivity was not granted for the first orphan marketing authorization as mentioned in Article 71(2) point (b), the period of market exclusivity shall be extended by a total of 36 months.
Amendment 1255 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 2
Article 72 – paragraph 2 – subparagraph 2
Amendment 1261 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 2 a (new)
Article 72 – paragraph 2 – subparagraph 2 a (new)
After the orphan medical product in question first receives an authorization as stated in Article 69, the holder of an orphan marketing authorization shall be entitled to a maximum of [15] years of orphan marketing exclusivity.
Amendment 1262 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 2 b (new)
Article 72 – paragraph 2 – subparagraph 2 b (new)
If requested by the applicant as an option instead of the stipulated reward in Article 86 of the revised Directive, the duration of market exclusivity for orphan medicinal products, as specified in Article 71(2), points (a) and (b), will be extended by an extra 24 months. This extension applies when an application for orphan marketing authorization is submitted for a designated orphan medicinal product under the Revised Regulation, and the application incorporates the findings of all studies conducted in adherence to an agreed-upon paediatric investigation plan. The first subparagraph shall also be applicable where fulfilment of the stipulated paediatric investigation plan does not result in the approval of a pediatric indication. However, the findings from the conducted studies should be incorporated into the summary of product characteristics and, if deemed suitable, into the package leaflet of the respective medicinal product. The extension of the market exclusivity period by 24 months will be acknowledged in the marketing authorization.
Amendment 1271 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 3 a (new)
Article 72 – paragraph 3 a (new)
3 a. The restriction mentioned in paragraph 3 shall not apply when the orphan marketing exclusivity period is prolonged as outlined in paragraph 4 concerning that extension.
Amendment 1272 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 3 b (new)
Article 72 – paragraph 3 b (new)
3 b. The extended market exclusivity mentioned in paragraph 2 does not apply to orphan medicinal products, and they will not receive the extra period of data protection outlined in Article 81(2), point (d) of the revised Directive 2001/83/EC.
Amendment 1356 #
2023/0131(COD)
Proposal for a regulation
Article 91 – paragraph 1
Article 91 – paragraph 1
1. Any clinical study which involves the use in the paediatric population of a medicinal product covered by a marketing authorisation and is sponsored by the marketing authorisation holder, whether or not it is conducted in compliance with an agreed paediatric investigation plan, shall be submitted to the Agency or to the Member States which have previously authorised the medicinal product concerned within six12 months of completion of the studies concerned.
Amendment 1362 #
2023/0131(COD)
Proposal for a regulation
Article 94 – paragraph 2 – subparagraph 2
Article 94 – paragraph 2 – subparagraph 2
Irrespective of the outcome of a clinical trial within 612 months from the end of the trial the clinical trial sponsor, the addressee of the Agency's decision on a paediatric investigation plan or the marketing authorisation holder as appropriate, shall submit to the EU database a summary of the results of the trial shall be uploaded in the database.
Amendment 1363 #
2023/0131(COD)
Proposal for a regulation
Article 94 – paragraph 2 – subparagraph 3
Article 94 – paragraph 2 – subparagraph 3
Amendment 1415 #
2023/0131(COD)
Proposal for a regulation
Article 113 – paragraph 3
Article 113 – paragraph 3
3. The Agency shall monitor the field of emerging medicinal products and may shall request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and mayshall engage with them in preliminary discussions, where appropriate referring to the consultation mechanism provided in Article 162.
Amendment 1422 #
2023/0131(COD)
Proposal for a regulation
Article 113 – paragraph 4 – subparagraph 1
Article 113 – paragraph 4 – subparagraph 1
Where the Agency considers it appropriate to set up a regulatory sandbox for medicinal products which are likely to fall under the scope of this Regulation, it shall provide a recommendation to the Commissionproducts, which might be regulated as medicinal products (including advanced therapy medicines), medical equipment, in-vitro diagnostics, substances of human origin, it shall provide a recommendation to the Commission, where appropriate after invoking the consultation mechanism of Article 162. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1.
Amendment 1446 #
2023/0131(COD)
Proposal for a regulation
Article 113 – paragraph 9
Article 113 – paragraph 9
9. Where after the Decision to establish the regulatory sandbox in accordance with paragraph 6, risks to health are identified but these risks can be fully mitigated by the adoption of supplementary conditionsadapting the relevant requirements and conditions set out in paragraphs 6 and 7, the Commission may, after consultation of the Agency, amend its decision by means of implementing acts. The Commission may also prolong the duration of a regulatory sandbox by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2).
Amendment 1453 #
2023/0131(COD)
Proposal for a regulation
Article 114 – paragraph 3
Article 114 – paragraph 3
3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation and [revised Directive 2001/83/EC], Regulation (EC) 1394/2007 and other relevant Union legislation . Thoese derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation.
Amendment 1460 #
2023/0131(COD)
Proposal for a regulation
Article 115 – paragraph 1 – subparagraph 1
Article 115 – paragraph 1 – subparagraph 1
The regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. In case of identification of risks to public health or safety concerns associated with the use of products covered by a sandbox, competent authorities shall take immediate and adequate temporary measures in order to suspend or restrict their use and inform the Commission in accordance with Article 113(2).
Amendment 1479 #
2023/0131(COD)
Proposal for a regulation
Article 116 – paragraph 1 – point d
Article 116 – paragraph 1 – point d
(d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than sixtwo months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).
Amendment 1497 #
2023/0131(COD)
Proposal for a regulation
Article 117 – paragraph 1
Article 117 – paragraph 1
1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the marketUnion list of critical medicinal products mentioned in Article 131 . To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.
Amendment 82 #
2023/0124(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) The conditions for placing and making available on the market of detergents and surfactants for detergents have been harmonised through Regulation (EC) No 648/2004 of the European Parliament and of the Council29 . _________________ 29 Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (OJ L 104, 8.4.2004, p. 1).
Amendment 83 #
2023/0124(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) The Fitness Check of the most relevant chemicals legislation31 (excluding Regulation (EC) No 1907/2006 of the European Parliament and of the Council32 ) highlighted the complexity of the Union regulatory framework for chemicals and attributed it to the large number of product and sector specific pieces of legislation with embedded links with each other. It also pointed out that there is room for simplification in the communication of information of overcrowded labels to product users, and found that the use of innovative tools for communicating product information is currently not being taken advantage of. It is, therefore, necessary that the current rules are simplified to reduce burden for economic operators, improve consumer understanding and facilitate market surveillance. Regulation (EC) No 648/2004 should therefore be replaced, but, in order to achieve regulatory consistency, any amendment that may be introduced to the rules on registration, evaluation, authorisation and restriction of chemicals contained in detergents, such as restriction of hazardous substances, must only be undertaken within the appropriate framework of Regulation (EC) No 1907/2006. _________________ 31 Fitness Check of the most relevant chemicals legislation (excluding REACH), SWD(2019)199 32 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH),establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing CouncilRegulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as CouncilDirective 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and2000/21/EC (OJ L 396, 30.12.2006, p. 1).
Amendment 94 #
2023/0124(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) In order to safeguard the functioning of the internal market and to ensure that the objective of providing a high level of protection of health and the environment is achieved, it is necessary to establish that detergents and surfactants from third countries entering the Union market also comply with this Regulation. In particular, it is necessary to ensure that appropriate conformity assessment procedures have been carried out by manufacturers with regard to those products. It is also necessary to lay down rules for importers to ensure that the detergents and surfactants they place on the market comply with those requirements and that the documentation drawn up by manufacturers and, where relevant, the CE marking areis available for inspection by the competent national authorities. Provision should also be made for importers to ensure that a product passport is available for those products.
Amendment 100 #
2023/0124(COD)
Proposal for a regulation
Recital 24
Recital 24
Amendment 108 #
2023/0124(COD)
Proposal for a regulation
Recital 31
Recital 31
(31) Digital labelling could improve the communication of labelling information both by avoiding overcrowded physical labels and by allowing users to rely on various reading options available only for digital formats, such as increased font, automatic search, loud speakers or translation into other languages. Providing digital labels could also lead to a more efficient management of the labelling obligations by economic operators, by facilitating the update of labelling information, reducing labelling costs and permitting a more targeted information of users. Therefore, economic operators should be allowed to provide certain labelling information only through the digital label subject to certain conditions to ensure a high level of protection of detergents’ users.
Amendment 110 #
2023/0124(COD)
Proposal for a regulation
Recital 32
Recital 32
(32) To avoid imposing an unnecessary administrative burden for economic operators and since, in most cases, the digital label is onlyften complementary to the physical one, economic operators should be able to decide whether to use digital labels or provide all the information on a physical label only. The choice to provide a digital label should rest with manufacturers and importers, who are responsible for providing the accurate set of labelling information.
Amendment 115 #
2023/0124(COD)
Proposal for a regulation
Recital 33
Recital 33
(33) Digital labelling could also create challenges for the vulnerable population groups with no or insufficient digital skills and lead to an accentuation of the digital divide. For this reason, the specific information to be provided only in a digital label should reflect the current state of the digitalisation of the society and the particular situation of detergents users. In addition, all the labelling information concerning the protection of health and the environment, as well as minimum use instructions of detergents, should remain on the physical label, to enable all end- users to make informed choices before buying the detergent and to ensure its safe handling.
Amendment 117 #
2023/0124(COD)
Proposal for a regulation
Recital 34
Recital 34
Amendment 120 #
2023/0124(COD)
Proposal for a regulation
Recital 36
Recital 36
(36) Given the current development of the digital skills, economic operators should also provide the labelling information by alternative means to end- users when they cannot access the digital label. This obligation should be imposed as a safety measure to reduce any potential risks by the unavailability of the labelling information, in particular as regards refilled detergents, where all the information may be provided in a digital label.
Amendment 123 #
2023/0124(COD)
Proposal for a regulation
Recital 37
Recital 37
(37) Since detergents have the same use and present the same risks irrespective of the format in which they are made available on the market, economic operators making detergents available on the market in a refill format should ensure that these comply with the same requirements as the pre-packaged ones. In addition, consumers should receive the required labelling information also when opting for refilled detergents. A physical copy of the label should always be present at the refill station. The refill sale of detergents should, therefore, be explicitly covered by this Regulation in order to ensure a high level of protection of health and the environment and a level playing field for economic operators.
Amendment 125 #
2023/0124(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) Manufacturers should create a product passport to provide information on the conformity of detergents and surfactants with this Regulation, as well as with any other legislation that the detergent or surfactant must comply with, without jeopardising the protection of confidential business information. In order to facilitate checks on detergents or surfactants and to allow the actors in the supply chain and end-users to access necessary information such as ingredients and use instructions, the information on the product passport should be provided digitally and in a directly accessible manner, through a data carrier affixed to the label of the detergent or surfactant, its packaging or the accompanying documentation. Market surveillance authorities, economic operators and end- users should, therefore, have immediate access to compliance or other information on the detergent or surfactant through the data carrier.
Amendment 126 #
2023/0124(COD)
Proposal for a regulation
Recital 39 a (new)
Recital 39 a (new)
(39 a) To avoid costs to companies and the public that are disproportionate to the wider benefits, the product passport should, by default, be specific to the product model which includes a combination of the product name together with the unique formula of the product.
Amendment 129 #
2023/0124(COD)
Proposal for a regulation
Recital 44
Recital 44
(44) It is crucial to make clear to both manufacturers and users that by creating the product passport for detergent or surfactant and, where relevant, by affixing the CE marking, the manufacturer declares that the detergent or surfactant is in conformity with all applicable requirements and that the manufacturer takes full responsibility thereof.
Amendment 132 #
2023/0124(COD)
Proposal for a regulation
Recital 45
Recital 45
(45) Where certain information is provided only digitally, it is necessary to clarify that this information needs to be provided separately and clearly distinguished from each other but through a single data carrier. This will facilitate the work of market surveillance authorities but also provide clarity to end users regarding the different pieces of information that are available to them in a digital format.
Amendment 138 #
2023/0124(COD)
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This Regulation establishes rules for the free movement of detergents and surfactants in the internal market while, at the same time, ensuring a high degree of protection of health and the environment.
Amendment 141 #
2023/0124(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 6
Article 2 – paragraph 1 – point 6
(6) ‘cleaning’ means the process by which an undesirable deposit is dislodged from a substrate or from within a substrate and brought into a state of solution or dispersion, or is digested or degraded by an active substance or a micro-organism;
Amendment 142 #
2023/0124(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 11 – introductory part
Article 2 – paragraph 1 – point 11 – introductory part
(11) ‘surfactant’ means any surface- active organic substance or mixture used in detergents, which has surface-active properties and which consists of one or more hydrophilic and one or more hydrophobic groups of such a nature and size that it is capable to perform all ofboth the following actions:
Amendment 145 #
2023/0124(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 11 – indent 2
Article 2 – paragraph 1 – point 11 – indent 2
Amendment 148 #
2023/0124(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 11 – indent 3
Article 2 – paragraph 1 – point 11 – indent 3
– to form emulsions and/or microemulsions and/or micelles;a clear micellar solution or a translucent microemulsion or a stable emulsion without separation of insoluble matter when mixed with water at a concentration of 0.5 wt% and left to stand for one hour at 20°C
Amendment 150 #
2023/0124(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 11 – indent 4
Article 2 – paragraph 1 – point 11 – indent 4
Amendment 157 #
2023/0124(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 34
Article 2 – paragraph 1 – point 34
Amendment 176 #
2023/0124(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 34 a (new)
Article 2 – paragraph 1 – point 34 a (new)
(34 a) ‘model’ means a specific type of product which includes a combination of the product name together with the unique formula;
Amendment 207 #
2023/0124(COD)
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 2 – point c
Article 7 – paragraph 2 – subparagraph 2 – point c
Amendment 212 #
2023/0124(COD)
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
3. Manufacturers shall keep the technical documentation and the product passport for 105 years after the detergent or the surfactant covered by that documentation or product passport has been placed on the market.
Amendment 221 #
2023/0124(COD)
Proposal for a regulation
Article 8 – paragraph 3 – subparagraph 2 – point b
Article 8 – paragraph 3 – subparagraph 2 – point b
(b) keep the product passport and technical documentation at the disposal of national market surveillance authorities for 105 years after the detergent or surfactant covered by those documents has been placed on the market;
Amendment 227 #
2023/0124(COD)
Proposal for a regulation
Article 9 – paragraph 2 – point b
Article 9 – paragraph 2 – point b
Amendment 234 #
2023/0124(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point b
Article 10 – paragraph 2 – point b
Amendment 242 #
2023/0124(COD)
Proposal for a regulation
Article 10 – paragraph 5
Article 10 – paragraph 5
5. Distributors that consider or have reason to believe that a detergent or a surfactant which they have made available on the market is not in conformity with this Regulation shall make immediately inform the manufacturer or importer, as appropriate, and cooperate with the manufacturer or importer and the competent authorities to ensure that the corrective measures necessary to bring that detergent or surfactant into conformity, to withdraw it or to recall it, as appropriate, are taken. Furthermore, where distributors consider or have reason to believe that a detergent or surfactant which they have made available on the market presents a risk to health or to the environment, they shall immediately inform the competent national authorities of the Member States in which they made the detergent or surfactant available on the market to that effect, giving details, in particular, of any non-compliance and of any corrective measures taken.
Amendment 254 #
2023/0124(COD)
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
2. An economic operator making a detergent available on the market directly to an end-user in a refill format shall provide the physical label orand the data carrier through which the digital label is accessible to the end-user at the refill station.
Amendment 260 #
2023/0124(COD)
Proposal for a regulation
Article 16 – paragraph 1 – subparagraph 1 – introductory part
Article 16 – paragraph 1 – subparagraph 1 – introductory part
Where detergents or surfactants are made available on the market, they shall be accompanied by the label elements set out in Article 15(3) and, where applicable, Article 15(4) in the following form:
Amendment 261 #
2023/0124(COD)
Proposal for a regulation
Article 16 – paragraph 1 – subparagraph 1 – point a
Article 16 – paragraph 1 – subparagraph 1 – point a
(a) on a physical label; with the elements set out in Article 15(3) points (b), (c) and (e) and, where applicable, the dosage information, as set out in Article 15(4); and
Amendment 264 #
2023/0124(COD)
Proposal for a regulation
Article 16 – paragraph 1 – subparagraph 1 – point b
Article 16 – paragraph 1 – subparagraph 1 – point b
(b) on a digital label and duplicated on a physical labelwith all the remaining label elements set out in Article 15(3) and other relevant information, such as safe disposal ways and best practices.
Amendment 265 #
2023/0124(COD)
Proposal for a regulation
Article 16 – paragraph 1 – subparagraph 2
Article 16 – paragraph 1 – subparagraph 2
Amendment 272 #
2023/0124(COD)
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. By way of derogation from paragraph 1, wWhere detergents are made available on the market directly to anthe end- user in a refill format, the label elements set out in Article 15(3) and (4) may be provided in a digital label only, with the exception of dosage information for consumer laundry detergents as set out in point 1 and 2 of part B of Annex V, which needs to be provided also on a physical labela leaflet or sticker containing the physical label information referred to in Article 16(1) shall be provided to the end-user.
Amendment 274 #
2023/0124(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point a
Article 17 – paragraph 1 – point a
(a) all label elements referred to in Article 15(3) and, where applicable,in accordance with Article 15(4)6(1), shall be provided in one place and separated from other information;
Amendment 279 #
2023/0124(COD)
Proposal for a regulation
Article 17 – paragraph 3
Article 17 – paragraph 3
Amendment 281 #
2023/0124(COD)
Proposal for a regulation
Article 17 – paragraph 4
Article 17 – paragraph 4
4. Economic operators providing a digital label shall not track, analyse or use any usage information for purposes other than what is absolutely necessary for providing the information on the digital label online.
Amendment 283 #
2023/0124(COD)
Proposal for a regulation
Article 17 – paragraph 5 – subparagraph 1 – introductory part
Article 17 – paragraph 5 – subparagraph 1 – introductory part
Economic operators providing a digital label shall provide the information present in the digital label by other means in any of the following cases:
Amendment 286 #
2023/0124(COD)
Proposal for a regulation
Article 18 – paragraph 2 – point a
Article 18 – paragraph 2 – point a
(a) it shall correspond to a specific batchmodel of the detergent or surfactant;
Amendment 292 #
2023/0124(COD)
Proposal for a regulation
Article 18 – paragraph 2 – point c
Article 18 – paragraph 2 – point c
(c) it shall contain at least the information included in Annex VI, taking into account the need to protect confidential business information and trade secrets in accordance with Directive (EU) 2016/943;
Amendment 296 #
2023/0124(COD)
Proposal for a regulation
Article 18 – paragraph 2 – point f
Article 18 – paragraph 2 – point f
(f) it shall be accessible to end-users, market surveillance authorities, customs authorities, the Commission and other economic operators, taking into account the need to protect confidential business information and trade secrets in accordance with Directive (EU) 2016/943;
Amendment 300 #
2023/0124(COD)
Proposal for a regulation
Article 18 – paragraph 2 – point g
Article 18 – paragraph 2 – point g
(g) it shall be available for a period of 105 years after the detergent or surfactant is placed on the market, also in cases of an insolvency, a liquidation or a cessation of activity in the Union of the economic operator that created the product passport;
Amendment 306 #
2023/0124(COD)
Proposal for a regulation
Article 18 – paragraph 4
Article 18 – paragraph 4
4. Where economic operators provide a digital label, aA single data carrier shall be used to access the product passportdigital label and the digital labelproduct passport.
Amendment 307 #
2023/0124(COD)
Proposal for a regulation
Article 18 – paragraph 9 – subparagraph 1 a (new)
Article 18 – paragraph 9 – subparagraph 1 a (new)
Products placed on the market before 60 months after the entry into force of the implementing act may be made available without a product passport and without uploading to the register in accordance with Article 20(1) until stocks are exhausted.
Amendment 309 #
2023/0124(COD)
Proposal for a regulation
Article 19 – paragraph 1 – point a
Article 19 – paragraph 1 – point a
(a) product passports created under this Regulation shall be fully interoperable with product passports required by other Union legislation in relation to the technical, semantic and organisational aspects of end- to-end communication and data transfer, whenever feasible and relevant;
Amendment 310 #
2023/0124(COD)
Proposal for a regulation
Article 19 – paragraph 1 – point b
Article 19 – paragraph 1 – point b
(b) all information included in the product passport shall be based on open standards developed with an interoperable format and shall be machine readable, structured and searchable, taking into account the need to protect confidential business information and trade secrets in accordance with Directive (EU) 2016/943;
Amendment 312 #
2023/0124(COD)
Proposal for a regulation
Article 19 – paragraph 1 – point b a (new)
Article 19 – paragraph 1 – point b a (new)
(b a) product passports shall be designed and operated so that they are user-friendly
Amendment 329 #
2023/0124(COD)
Proposal for a regulation
Article 25 – paragraph 1 – point a
Article 25 – paragraph 1 – point a
Amendment 332 #
2023/0124(COD)
Proposal for a regulation
Article 26 – paragraph 7
Article 26 – paragraph 7
7. Where individual risk-based concentration limits for fragrance allergens are established in Regulation (EC) No 1223/2009 of the European Parliament and of the Council46 , the Commission shall adopt delegated acts in accordance with Article 27 amending Annex V in order to adapt the limit of the allergenic fragrances listed in Annex III to that Regulation accordingly. Products under this Regulation are subject to the transition periods laid down in Regulation (EC) No 1223/2009. _________________ 46 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).
Amendment 337 #
2023/0124(COD)
Proposal for a regulation
Annex II – point 1 – paragraph 1 – point a
Annex II – point 1 – paragraph 1 – point a
(a) shall have an American Type Culture Collection (ATCC) number, belong to a collection of an International Depository Authority (IDA) or have had their DNA identified in accordance with a “Strain identification protocol” (using 16S ribosomal DNA sequencing or an equivalent method);
Amendment 339 #
2023/0124(COD)
Proposal for a regulation
Annex II – point 1 – paragraph 1 – point b – introductory part
Annex II – point 1 – paragraph 1 – point b – introductory part
(b) shall belong to both of the following:Risk Group I as defined by Directive 2000/54/EC – biological agents at work;
Amendment 340 #
2023/0124(COD)
Proposal for a regulation
Annex II – point 1 – paragraph 1 – point b – point i
Annex II – point 1 – paragraph 1 – point b – point i
Amendment 343 #
2023/0124(COD)
Proposal for a regulation
Annex II – point 1 – paragraph 1 – point b – point ii
Annex II – point 1 – paragraph 1 – point b – point ii
Amendment 344 #
2023/0124(COD)
Proposal for a regulation
Annex II – point 1 – paragraph 1 – point b a (new)
Annex II – point 1 – paragraph 1 – point b a (new)
(b a) shall have a safety assessment carried out by the placer on the market and made available to the authorities.
Amendment 346 #
2023/0124(COD)
Proposal for a regulation
Annex II – point 3
Annex II – point 3
3. Intentionally added micro- organisms shall not be genetically modified microorganisms as defined in Directive 2001/18/EC.
Amendment 347 #
2023/0124(COD)
Proposal for a regulation
Annex II – point 5
Annex II – point 5
5. When placed on the market, detergents containing micro-organisms shall have a standard plate count equal to or greater than 1x105 colony-forming units (CFUs) per ml in accordance with ISO 4833-1:2014, but not limited to, ISO 4833-1:2014, ISO 21149 method or equivalent.
Amendment 349 #
2023/0124(COD)
Proposal for a regulation
Annex II – point 6
Annex II – point 6
6. The minimum shelf life of a dDetergent containing micro- organisms shall not be lower than 24 months and the microbial count shall not decrease by more than 10 % every 12 months in accordance with ISO 4833-1:2014be stable for the declared shelf life .
Amendment 352 #
2023/0124(COD)
Proposal for a regulation
Annex II – point 7
Annex II – point 7
7. Micro-organisms contained in detergentDetergents containing micro- organisms that are placed on the market in a spray format shall pass the acute inhbe evaluation toxicity test in accordance with the test method B.2., described in Part B of the Annex to Regulation (EC) No 440/2008ed through the appropriate tests to ensure consumer safety of the end product, such as particle size distribution measurements.
Amendment 354 #
2023/0124(COD)
Proposal for a regulation
Annex II – point 8
Annex II – point 8
8. Detergents containing micro- organisms shall not be placed on the market in a refill format, unless consumer safety is ensured.
Amendment 355 #
2023/0124(COD)
Proposal for a regulation
Annex II – point 9
Annex II – point 9
Amendment 358 #
2023/0124(COD)
Proposal for a regulation
Annex II – point 11
Annex II – point 11
Amendment 363 #
2023/0124(COD)
Proposal for a regulation
Annex V – Part A – point 4
Annex V – Part A – point 4
4. If added at concentrations exceeding 0,01 % by weight, the allergenic fragrances that are listed in entries 45, 67- 92 and [X] to [X] of Annex III to Regulation (EC) No 1223/2009, shall be labelled using the system referred to in Article 33 of that Regulation. The first sentence shall not apply to allergenic fragrances that meet the labelling thresholds under Regulation (EC) No 1272/2008. The transitional periods for cosmetic products as defined in Regulation (EC) No 1223/2009 shall also apply to the placing and making available on the market of detergents.
Amendment 364 #
2023/0124(COD)
Proposal for a regulation
Annex V – Part A – point 6 – point a
Annex V – Part A – point 6 – point a
Amendment 367 #
2023/0124(COD)
Proposal for a regulation
Annex V – Part B – point 1 – point a
Annex V – Part B – point 1 – point a
(a) the recommended quantities and/or dosage instructions expressed in millilitres or grams appropriate to a standard washing machine load, for soft, medium and hard water hardness levels and making provision for one or two cycle washing processes, or the recommended dosage instructions expressed in number of units corresponding to a standard washing machine load, where necessary adapted to soft, medium and hard water hardness,
Amendment 374 #
2023/0124(COD)
Proposal for a regulation
Annex V – Part B – point 3
Annex V – Part B – point 3
3. The label of consumer automatic dishwasher detergents shall indicate the standard dosage expressed in grams or millilitres or number of tableunits for the main washing cycle for normally soiled tableware in a fully loaded 12 place settings dishwasher, adjusting the standard dosage, where relevant, for soft, medium, and hard water hardness.
Amendment 377 #
2023/0124(COD)
Proposal for a regulation
Annex V – Part D – paragraph 1 – point b
Annex V – Part D – paragraph 1 – point b
(b) the recommended quantities based on medium/average water hardness and different degrees of fabric soiling; and
Amendment 379 #
2023/0124(COD)
Proposal for a regulation
Annex V – Part D – paragraph 1 – point c
Annex V – Part D – paragraph 1 – point c
(c) an indication of the washing machinreference load.
Amendment 53 #
2023/0105(COD)
Proposal for a directive
Recital 3 a (new)
Recital 3 a (new)
(3a) The reports of DG SANTE, JRC and OLAF on honey counterfeiting "EU Coordination Action "Out of the Hives" and "EU Coordination Action to Prevent Certain Fraudulent Practices in the Honey Sector - Analysis Results of Imported Honey" highlight that a high percentage of imported honey is suspected of counterfeiting and confirm a number of fraud cases in the honey sector. Therefore, measures and provisions should be taken to limit the possibilities of fraud, facilitate controls and allow better traceability and analysis of the quality and origin of honey. In this context, the proposed mandatory requirements to indicate the countries of origin with their respective percentages on the label should create the conditions for the implementation of a complete traceability system. Access to detailed and complete information on the origin and composition of the honey will make it easier for the honey analysis laboratories to verify the geographical indication on the honey packaging and to detect fraud.
Amendment 231 #
2023/0105(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 1 – point b a (new)
Article 2 – paragraph 1 – point 1 – point b a (new)
Directive 2001/112/EC
Article 3 – paragraph 3 a (new)
Article 3 – paragraph 3 a (new)
(ba) The following paragraph 3a is added: "3a.The country of origin of the fruit used to manufacture the juice shall be indicated on the front-label. If the fruit used originates in more than one country, the countries of origin shall be indicated on the label in descending order according to their proportion in the fruit juice. If a fruit juice consists of two or more different fruits, the country of origin of all the fruits must be indicated in descending order according to their proportion in the fruit juice. Labelling is obligatory for all categories of fruit juice defined in Annexes I and III. If two countries together account for at least 95% of the fruit juice of a type of fruit, it is not necessary to indicate the country of origin of the remaining quantities on the label."
Amendment 246 #
2023/0105(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 1 – point b a (new)
Article 3 – paragraph 1 – point 1 – point b a (new)
Directive 2001/113/EC
Article 2 – paragraph 4 a (new)
Article 2 – paragraph 4 a (new)
Amendment 254 #
2023/0105(COD)
Proposal for a directive
Article 5 – paragraph 1 – subparagraph 1
Article 5 – paragraph 1 – subparagraph 1
Member States shall adopt and publish, by [OP please insert the date = 182 months after the date of entry into force of this Directive] at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
Amendment 258 #
2023/0105(COD)
Proposal for a directive
Article 5 – paragraph 1 – subparagraph 2
Article 5 – paragraph 1 – subparagraph 2
They shall apply those provisions from [OP please insert the date = 2418 months after the date of entry into force of this Directive].
Amendment 261 #
2023/0105(COD)
Proposal for a directive
Article 6 – paragraph 1
Article 6 – paragraph 1
Products which are placed on the market or labelled before [OP please insert the date = 2418 months after the date of entry into force of this Directive], in accordance with Directives 2001/110/EC, 2001/112/EC, 2001/113/EC and 2001/114/EC, may continue to be marketed until the exhaustion of stocks.
Amendment 68 #
2023/0085(COD)
Proposal for a directive
Recital 10 a (new)
Recital 10 a (new)
(10 a) This proposal does not address business-to-business environmental claims or sustainability reporting.
Amendment 124 #
2023/0085(COD)
Proposal for a directive
Recital 32
Recital 32
(32) The Commission Recommendation (EU) 2021/2279 contains guidance on how to measure the life cycle environmental performance of specific products or organisations and how to develop Product Environmental Footprint Category Rules (PEFCRs) and Organisation Environmental Footprint Sectorial Rules (OEFSRs) that allow comparison of products to a benchmark. Such category rules for specific products or traders can be used to support the substantiation of claims in line with the requirements of this Directive. Therefore, the Commission should be empowered to adopt delegated acts to establish product group or sector specific rules where this may have added value. However, in case the Product Environmental Footprint method does not yet cover an impact category, which is relevant for a product group, the adoption of PEFCR may take place only once these new relevant environmental impact categories have been added. For example, as regards marine fisheries, the PEFCR should for example reflect the fisheries- specific environmental impact categories, in particular the sustainability of the targeted stock. Concerning space, the PEFCR should reflect defence and space- specific environmental impact categories, including the orbital space use. As regards food and agricultural products, biodiversity and nature protection, as well as farming practices, including positive externalities of extensive farming and animal welfare, should, for example, also be integrated before the adoption of PEFCR could be considered. As regards textiles, the PEFCR should for example reflect the microplastics release, before the adoption of PEFCR could be considered. In order to facilitate a clear, transparent and collaborative process, the Commission should publish a communication outlining the path towards further development of the PEF methodology. This should include regular updates of the rules to promote scientific advancements and engagement of affected stakeholders.
Amendment 186 #
2023/0085(COD)
Proposal for a directive
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This Directive applies to explicit environmental claims made by traders about products or traders in business-to- consumer commercial practices as outlined in Directive 2005/29/EC.
Amendment 270 #
2023/0085(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 19 a (new)
Article 2 – paragraph 1 – point 19 a (new)
(19 a) "Widely recognized scientific evidence" means evidence based in international or European standards or grounded in scientifically valid reasoning that has been either peer-reviewed and published or widely embraced by a relevant scientific community.
Amendment 282 #
2023/0085(COD)
Proposal for a directive
Article 3 – paragraph 1 – point b
Article 3 – paragraph 1 – point b
(b) rely on widely recognised scientific evidence, use accurate information and take into account relevant international standards; the references of which have been included in Annex I of this Directive. The Commission may amend Annex I by adopting delegated acts that determine standards and methodologies covering specific environmental aspects, environmental performance, or environmental impacts, to ensure that explicit environmental claims conforming to these standards satisfy the substantiation requirement outlined in Article 3. These delegated acts shall be adopted in accordance with the procedure referred to in Article 18.
Amendment 321 #
2023/0085(COD)
Proposal for a directive
Article 3 – paragraph 1 – point f
Article 3 – paragraph 1 – point f
Amendment 472 #
2023/0085(COD)
Proposal for a directive
Article 5 – paragraph 6 – subparagraph 2 – introductory part
Article 5 – paragraph 6 – subparagraph 2 – introductory part
That information shall include at least the following:
Amendment 474 #
2023/0085(COD)
Proposal for a directive
Article 5 – paragraph 6 – subparagraph 2 – point a
Article 5 – paragraph 6 – subparagraph 2 – point a
Amendment 477 #
2023/0085(COD)
Proposal for a directive
Article 5 – paragraph 6 – subparagraph 2 – point b
Article 5 – paragraph 6 – subparagraph 2 – point b
Amendment 479 #
2023/0085(COD)
Proposal for a directive
Article 5 – paragraph 6 – subparagraph 2 – point c
Article 5 – paragraph 6 – subparagraph 2 – point c
Amendment 485 #
2023/0085(COD)
Proposal for a directive
Article 5 – paragraph 6 – subparagraph 2 – point d
Article 5 – paragraph 6 – subparagraph 2 – point d
Amendment 486 #
2023/0085(COD)
Proposal for a directive
Article 5 – paragraph 6 – subparagraph 2 – point e
Article 5 – paragraph 6 – subparagraph 2 – point e
Amendment 488 #
2023/0085(COD)
Proposal for a directive
Article 5 – paragraph 6 – subparagraph 2 – point f
Article 5 – paragraph 6 – subparagraph 2 – point f
Amendment 631 #
2023/0085(COD)
Proposal for a directive
Article 10 – paragraph 4
Article 10 – paragraph 4
4. The verification of environmental labeling schemes shall be undertaken by a verifier fulfilling the requirements set out in Article 11, in accordance with the procedures referred to in paragraphs 1 and 2, before the environmental claim is made public or the environmental label is displayed by a trader. The verification of explicit environmental claims shall satisfy the conditions outlined in Article 12, according to the protocols outlined in paragraphs 1, before the environmental claim is made public or a trader displays the environmental label.
Amendment 715 #
2023/0085(COD)
Proposal for a directive
Article 12 a (new)
Article 12 a (new)
Article12a Presumption of conformity with substantiation requirement 1. In the context of this Directive, an explicit environmental statement will be considered compliant with the substantiation requirement outlined in Article 3 of this Directive if it aligns with applicable standards or methodologies related to the environmental aspect, performance, or impact covered by those standards mentioned in Annex I to this Directive. Environmental statements meeting these criteria are not subject to the pre-verification requirement specified in Article 10. 2. The Commission can implement changes to Annex I by adopting delegated acts that establish standards and procedures covering specific environmental aspects, environmental performance, or environmental impacts. This will guarantee that specific environmental claims that comply with those standards and procedures meet the requirements for substantiation outlined in Article 3. The delegated acts shall be approved using the process mentioned in Article 18. 3. Member States shall guarantee that a trader submitting an explicit environmental claim in line with this Article shall prepare supporting documentation demonstrating that the claim is complying with this Article. 4. It is the responsibility of the Member States to guarantee that the substantiation documentation mentioned in paragraph 3 is updated. The Member States bear the duty of ensuring the relevance of the substantiation documentation referred to in paragraph 3. 5. Member States are responsible for ensuring that traders implement procedures that allow items made in bulk and with an explicit environmental claim continue complying with the Article 3 substantiation requirement.
Amendment 796 #
2023/0085(COD)
Proposal for a directive
Article 21 – paragraph 3 – point b
Article 21 – paragraph 3 – point b
(b) facilitating transition towards toxic free environment by considering introducing, on the basis of an impact assessment, a prohibition of environmental claims for products containing hazardous substances of significant concern, except where their use is considered essential for the society in line with the criteria to be developed by the Commissionsafe and improves the sustainability of the product;
Amendment 814 #
2023/0085(COD)
Proposal for a directive
Article 25 – paragraph 1 – subparagraph 2
Article 25 – paragraph 1 – subparagraph 2
They shall apply those measures from [OP please insert the date = 2436 months after the date of entry into force of this Directive].
Amendment 61 #
2022/0432(COD)
Proposal for a regulation
Recital 2
Recital 2
Amendment 138 #
2022/0432(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a
Article 1 – paragraph 1 – point 2 – point a
Regulation (EC) No 1272/2008
Article 2 – paragraph 7a
Article 2 – paragraph 7a
Amendment 220 #
2022/0396(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) In line with the Green Deal33, the new Circular Economy Action Plan (CEAP)34commits to reinforcing the essential requirements for packaging in view of making all packaging reusable or recyclable by 2030, and to consider other measures to reduce (over)packaging and packaging waste, drive design for re-use and recyclability of packaging, reduce the complexity of packaging materials and introduce requirements for recycled content in plastic packaging. The new CEAP also commits to reduce food waste and encourages circular approaches to the use of water.It commits the Commission to assess the feasibility of Union-wide labelling that facilitates the correct separation of packaging waste at source. _________________ 33 https://eur-lex.europa.eu/legal- content/EN/TXT/?uri=COM%3A2019%3 A640%3AFIN 34 https://eur-lex.europa.eu/legal- content/EN/TXT/?uri=COM:2020:98:FIN &WT.mc_id=Twitter
Amendment 223 #
2022/0396(COD)
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) Plastic is a widely used material for the packaging of agri-food products, as it ensures their safety while keeping their quality and conformity throughout the supply chain, including transport, as well as contributing to increasing the shelf life of fresh and highly perishable products. Most non-plastic food contact materials are not currently covered by specific European legislation and recycling technologies currently available do not always guarantee a high quality recycled plastic. For this reason, any initiative aimed at substituting single-use packaging, including plastic products, in the food sector, should be done in a technically and economically feasible way. Chemical recycling constitutes a complementary option to mechanical recycling to achieve the targets set in this Regulation, especially for plastic packaging in contact with food.
Amendment 227 #
2022/0396(COD)
Proposal for a regulation
Recital 7
Recital 7
Amendment 230 #
2022/0396(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) The European Parliament’s Resolution of 10 February 2021 on the New Circular Economy Action Plan39reiterated the objective of making all packaging reusable or recyclable in an economically viable way by 2030 and called on the Commission to present a legislative proposal including waste reduction measures and targets and ambitious essential requirements in the Packaging and Packaging Waste Directive to reduce excessive packaging, including in e-commerce, improve recyclability and minimise the complexity of packaging, increase recycled content, phase out hazardous and harmful substances, and promote re-use. At the same time, it underlined the need to comply with food hygiene and food safety standards. _________________ 39 https://www.europarl.europa.eu/doceo/doc ument/TA-9-2021-0040_EN.html
Amendment 234 #
2022/0396(COD)
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8a) In its resolution of 15 September 2022 on the consequences of drought, fire, and other extreme weather phenomena: increasing the EU’s efforts to fight climate change, the European Parliament stressed how water is an increasingly valuable yet scarce resource and underlined the importance of sustainable water management for guaranteeing food security, calling on the Commission to refrain from proposing further EU legislation that endangers or risks endangering EU food security. In light of its scarcity, the use of water should be prioritised in sectors where it is essential, such as agriculture.
Amendment 241 #
2022/0396(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) An item, which is an integral part of a product and is necessary to contain, support or preserve that product throughout its lifetime and where all elements are intended to be used, consumed or disposed of together, should not be considered as being packaging given that its functionality is intrinsically linked to it being part of the product. However, in light of the disposal behaviour of consumers regardingefforts to establish appropriate recycling and composing streams, tea and coffee bags as well as coffee or tea system single-serve units, which in practice are disposed of together with the product residue leading to the contamination of compostable and recycling streams, those specific items, should be treated as packaging. This is in line with the objective to increase the separate collection of bio-waste, as required by Article 22 of Directive 2008/98/EC of the European Parliament and of the Council41. Furthermore, to ensure coherence regarding end-of-life financial and operational obligations, also all coffee or tea system single-serve units necessary to contain coffee or tea should be treated as packaging. _________________ 41 Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3).
Amendment 246 #
2022/0396(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) In line with the waste hierarchy set out in Article 4(21) of Directive 2008/98/EC, and with the requirement set in paragraph 2 of Article 4 of the same Directive, which foresees that specific waste streams may depart from the hierarchy where this is in line with life- cycle thinking to deliver the best overall environmental outcome, the measures provided for under this Regulation aim at reducing the amount of packaging placed on the market in terms of its volume and weight, and preventing the generation of packaging waste, especially through packaging minimisation, avoiding packaging where it is not needed, and increased re-use of packagingand recycling of packaging while delivering the best environmental outcome. In addition, the measures aim at increasing the use of recycled content in packaging, especially in plastic packaging where the uptake of recycled content is very low, as well as higher recycling rates for all packaging and high quality of the resulting secondary raw materials while reducing other forms of recovery and final disposal.
Amendment 257 #
2022/0396(COD)
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
(12a) It is estimated that 88 million tonnes of food waste are generated in the Union each year and over 50 % of food waste is estimated to come from households and consumers. Packaging can play an important role in reducing food waste as it preserves essential elements of food, so that its composition and organoleptic properties are not compromised, it ensures food protection from mechanical damage and physical shocks, and it is an effective barrier against microbiological degradation, oxygen or loss of aromas, therefore increasing the shelf life of agri-food products. Packaging for fresh vegetables and fruit can ensure that consumers have access to fresh, healthy products that last longer, therefore encouraging their consumption and healthy eating habits. According to the European Food Safety Agency (EFSA), food packaging protects food from microorganisms and makes it easier to store and to prolong the shelf life of food. Packaging and other articles such as containers also improve hygiene and make it more convenient for people to buy, sell and handle food. Any initiative to reduce the amount of packaging placed on the market and packaging waste should not outweigh the Union's ambitions of food waste reduction and carefully consider the food safety of the products concerned.
Amendment 291 #
2022/0396(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) Designing packaging with the objective of its recycling, once it becomes packaging waste, is one the most efficient measures to improve the packaging circularity and raise packaging recycling rates and the use of recycled content in packaging, while assuring marketing and consumer acceptance and preserving all its functions. Packaging design for recycling criteria have been established for a number of packaging formats under voluntary industry schemes or by some Member States for the purpose of the modulation of extended producer responsibility fees. In order to prevent barriers to the internal market and provide industry with a level playing field, and with the objective to promote the sustainability of packaging assuring marketing and consumer acceptance and preserving all its functions, it is important to set mandatory requirements regarding the recyclability of packaging, by harmonising the criteria and the methodology for assessing packaging recyclability based on a design for recycling methodology at the Union level. In order to meet the objective set out in the CEAP that, by 2030, all packaging should be recyclable or reusable, in an economically viable manner, packaging recyclability performance grades should be established based on design for recycling criteria for packaging categories as listed in Annex II. However, packaging should comply with them only as of 1 January 2030 in order to give sufficient time to the economic operators to adapt.
Amendment 297 #
2022/0396(COD)
Proposal for a regulation
Recital 20 a (new)
Recital 20 a (new)
(20a) Careful consideration should be given to situations when the packaging's technical and qualitative characteristics conflict with total recyclability when determining the design for recycling criteria. The product's performance and its effects on the environment, particularly in terms of hygiene, healthiness and food safety, must then be carefully considered.
Amendment 300 #
2022/0396(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) As design for recycling assessment in itself does not ensure that packaging is recycled in practice, it is necessary to establish a uniform methodology and criteria for assessing the recyclability of packaging in practice based on the state-of- the-art separate collection, sorting and recycling processes and infrastructure actually available in the Union. Related reporting from Member States and, where relevant, economic operators should support establishing the recyclability “at scale” thresholds and update, on this basis, the recyclability performance grades with respect to the specific packaging materials and categories, preserving the added value conveyed to the final consumer with the packaging.
Amendment 303 #
2022/0396(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) In order to establish harmonised rules on packaging design to ensure its recyclability while ensuring packaging performs all its functions and assuring marketing and consumer acceptance, the power to adopt delegated acts should be delegated to the Commission to set out detailed criteria for packaging design for recycling per packaging materials and categories, as well as for the assessment of the packaging recyclability at scale including for categories of packaging not listed in this Regulation. These criteria shall not conflict with the quality requirements and technical functionality that the packaging shall ensure. In order to give economic operators and Member States sufficient time to collect and report the necessary data to establish the “at scale” recycling methodology, the manufacturers should ensure that packaging is recycled at scale as of 2035. That should ensure that packaging complies with the design for recycling criteria, and is also recycled in practice on the basis of the state of the art processes for separate collection, sorting and recycling.
Amendment 321 #
2022/0396(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) Some Member States are taking action to encourage recyclability of packaging through modulation of extended producer responsibility fees; such initiatives taken at the national level may create regulatory uncertainty for the economic operators, in particular where they supply packaging in several Member States. At the same time, modulation of extended producer responsibility fees is an effective economic instrument to incentivise more sustainable packaging design leading to better recyclable packaging while improving the functioning of the internal market. It is therefore necessary to harmonise criteria for the modulation of extended producer responsibility fees based on the recyclability performance grade obtained through recyclability assessment, while not setting the actual amounts of such fees, and to ensure that such fees are earmarked to finance the net cost of collection, sorting and recycling of packaging. As the criteria should be related to the criteria on packaging recyclability, it is appropriate to empower the Commission to adopt such harmonised criteria at the same time as establishing the detailed design for recycling criteria per packaging categories.
Amendment 328 #
2022/0396(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) To ensure packaging circularity, packaging should be designed and manufactured in such a way as to allow for the increased substitution of virgin materials with recycled materials. The increased use of recycled materials supports the development of the circular economy with well-functioning markets for recycled materials, reduces costs, dependencies and negative environmental impacts related to the use of primary raw materials, and allows for a more resource- efficient use of materials. In relation to the different packaging materials, the lowest input of recycled materials is in plastic packaging. In order to address these concerns in the most appropriate manner, it is necessary to increase the uptake of recycled plastics, by establishing mandatory targets for recycled content in plastic packaging at different levels depending on the contact-sensitivity54of different plastic packaging applications, the availability, prices and market volumes of recycled plastic,and ensuring that the targets become binding byfrom2030. In order to incrementally ensure packaging circularity, increased targets should apply as of 2040. _________________ 54 Contact sensitive packaging refers to plastic packaging of products covered by Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29), 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 (OJ L 338 13.11.2004, p. 4), Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC (OJ L 229, 1.9.2009, p. 1), Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (OJ L 342, 22.12.2009, p. 59), Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1), 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), Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (OJ L 4, 7.1.2019, p. 1), Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43), Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67) and Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ L 260, 30.9.2008, p. 13–59).
Amendment 337 #
2022/0396(COD)
Proposal for a regulation
Recital 29
Recital 29
(29) In order to prevent barriers to the internal market and ensure the efficient implementation of the obligations, economic operators should ensure that the plastic part of each unit of packaging contains a certain minimum percentage of recycled content recovered from post- consumer plastic waste calculated as an average of the plastic packaging placed by a producer on the Union market. This provision should not apply to food or feed contact plastic packaging in those cases when the recycled content risks affecting human and animal health and/or compromising the food safety of products.
Amendment 352 #
2022/0396(COD)
Proposal for a regulation
Recital 31
Recital 31
(31) In order to ensure uniform conditions for the implementation of the rules on calculationg and verifying, per unit of post-consumer plastic waste in packaging,ication of the share of recycled content recovered from post-consumer plastic waste present and establishing the format for technical documentation, the Commission should be empowered to adopt implementing provisions, in accordance with Article 5 of Regulation (EU) No 182/2011 of the European Parliament and of the Council55. _________________ 55 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Amendment 364 #
2022/0396(COD)
Proposal for a regulation
Recital 35
Recital 35
(35) The bio-waste waste stream is oftencould be contaminated with conventional plastics and the material recycling streams are oftencould be contaminated with compostable plastics. This cross-contamination could leads to waste of resources, lower quality secondary raw materials and should be prevented at source. As the proper disposal route for compostable plastic packaging is becoming increasingly confusing for consumers, it is justified andTherefore, it is necessary to lay down clear and common rules on the use of compostableand disposal of plastic packaging, mandating it only when its use brings a clear benefit for the environment or for human healthlabeled as compostable, including the possibility to mandating applications. This is particularly the case when the use of compostable packaging helps collect or disposrecycle of bio-waste. All plastic packaging labeled as compostable should not go into material recycling.
Amendment 376 #
2022/0396(COD)
Proposal for a regulation
Recital 36
Recital 36
(36) For limited packaging applications made of biodegradable plastic polymers, tThere is a demonstrable environmental benefit of using compostable packaging, which enters composting plants, including anaerobic digestion facilities under controlled conditions. Furthermore, where appropriate waste collection schemes and waste treatment infrastructures are available in a Member State, there should be a limited flexibility in deciding whether to mandate the use of compostable plastics for lightweight plastic carrier bags on its territory. In order to avoid consumer confusion about the correct disposal and considering the environmental benefit of circularity of the carbon, all other plastic packaging not labeled as compostable should go into material recycling and the design of such packaging should ensure that it does not affect the recyclability of other waste streams.
Amendment 378 #
2022/0396(COD)
Proposal for a regulation
Recital 37
Recital 37
Amendment 383 #
2022/0396(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) In order to facilitate conformity assessment with requirements on compostable packaging, it is necessary to provide for presumption of conformity for compostable packaging which is in conformity with harmonised standards adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council56for the purpose of expressing detailed technical specifications of those requirements and take into account, in line with the latest scientific and technological developments, the parameters, including composting times and admissible levels of contamination, which reflect the actual conditions in bio- waste treatment facilities, including anaerobic digestion processes. quality of the output,composting proper processingtimes and admissible levels of contamination. _________________ 56 Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council Text with EEA relevance (OJ L 316, 14.11.2012, p. 12).
Amendment 389 #
2022/0396(COD)
Proposal for a regulation
Recital 40
Recital 40
(40) Packaging should be designed, where relevant for a given shape, so as to minimise its volume and weight while maintaining its ability to perform the packaging functions. The manufacturer of packaging should assess the packaging against the performance criteria, as listed in Annex IV of this Regulation. In view of the objective of this Regulation to reduce packaging and packaging waste generation and to improve circularity of packaging across the internal market, it is appropriate to further specify the existing criteria and to make them more stringent. The list of the packaging performance criteria, as listed in the existing harmonised standard EN 13428:200057, should therefore be modified. While marketing and consumer acceptance remain relevant for packaging designpresentation,design and differentiation functionality, they should not be part ofthe mainperformance criteria justifying on their own additional packaging weight and volume. However, this should not compromise product or packagingspecifications for craft and industrial products and food , beveragesand agricultural products that are registered aundprotected under theEU geographical indication protection schemeer or otherwiseprotected by the Union intellectual property law orEU geographical indication protection schemes, including third country geographical indication that have been given distinctive recognition by the Union, as part of the Union’s objective to protect Intellectual property rights,cultural heritage and traditional know- how.Traditional packaging associated with products that have been granted distinctive recognition or that are subject to geographical indication of origin protection shall, however, seek to reduce packaging weight to the smallest amount possible while protecting the shape of the packaging in accordance with the overall ambitions of this proposal. On the other hand, recyclability, the use of recycled content, and re-use may justify additional packaging weight or volume, and should be added to the performance criteria. Packaging with double walls, false bottoms and other characteristics only aimed to increase the perceived product volume should not be placed on the market, as it does not meet the requirement for packaging minimisation. The same rule should apply to superfluous packaging not necessary for ensuring packaging functionality. _________________ 57 Packaging – Requirements specific to manufacturing and composition – Prevention by source reduction.
Amendment 397 #
2022/0396(COD)
Proposal for a regulation
Recital 42
Recital 42
(42) In order to facilitate conformity assessment with requirements on packaging minimisation, it is necessary to provide presumption of conformity for packaging which is in conformity with harmonised standards adopted in accordance with Regulation (EU) No 1025/2012 for the purpose of expressing detailed technical specifications of those requirements and specify measurable design criteria, including where appropriate, maximum weight or empty space limits for specific packaging formats as well as by-default, standardised packaging designs that comply with the packaging minimisation requirement. Packaging design and minimisation should not compromise the requirements specified under EU rules on food contact materials and they should not affect the food safety of the products.
Amendment 399 #
2022/0396(COD)
Proposal for a regulation
Recital 43
Recital 43
(43) To promote the circularity and sustainable use of packaging, reusable packaging and systems for re-use should be incentivised without prejudice to Article 4(2) of Directive 2008/98/EC and where re-use does not pose risks to the quality of food and/or compromises food safety of the products. For that purpose, it is necessary to clarify the notion of reusable packaging and to ensure that it is linked not only to the packaging design, which should enable a maximum number of trips or rotations and maintaining the safety, quality and hygiene requirements when being emptied, unloaded, refilled or reloaded, but also to the setting up of systems for re-use respecting minimum requirements as set out in this Regulation. In order to facilitate conformity assessment with requirements on reusable packaging, it is necessary to provide for presumption of conformity for packaging which is in conformity with harmonised standards adopted in accordance with Regulation (EU) No 1025/2012 for the purpose of expressing detailed technical specifications of those requirements and define reusable packaging criteria and formats, including minimum number of trips or rotations, standardised designs, as well as requirements for systems for re-use, including hygiene requirements. In light of the significant amount of water needed to implement a re-use system, especially for food and beverages and at industrial level, Member States should maintain a level of flexibility in adopting such provision. The Commission should produce a risk assessment of the implementation of reusable packaging vis-à-vis EU water management strategy and European water waste reduction targets.
Amendment 407 #
2022/0396(COD)
Proposal for a regulation
Recital 44
Recital 44
(44) It is necessary to inform consumers and to enable them to appropriately dispose of packaging waste, including compostable lightweight and very lightweight plastic carrier bags. The most appropriate manner to do this is to establish a harmonised labelling system based on the material composition of packaging for sorting of waste, and to pair it with corresponding labels on waste receptacles. To this end, the Commission and Member States shall provide the necessary tools and incentives, including economic ones, with special attention to micro and small enterprises.
Amendment 417 #
2022/0396(COD)
Proposal for a regulation
Recital 47
Recital 47
(47) In order to inform end-users about reusability, availability of systems for re- use and location of collection points as regards reusable packaging, such packaging should bear a QR code or other data carrier that provides such information. The QR code should also facilitate tracking and the calculation of trips and rotations. In addition, reusable sales packaging should be clearly identified at the point of sale.
Amendment 427 #
2022/0396(COD)
Proposal for a regulation
Recital 54
Recital 54
(54) In order to safeguard the functioning of the internal market, it is necessary to ensure that packaging from third countries entering the Union market comply with this Regulation, whether imported as self-standing packaging or in a packaged product. In particular, it is necessary to ensure that appropriate conformity assessment procedures have been carried out by manufacturers with regard to that packaging. Importers should therefore ensure that the packaging they place on the market comply with those requirements and that documentation drawn up by manufacturers are available for inspection by the competent national authorities. To comply with these obligations, adequate support should be provided to non-professional importers, especially to micro and SMEs.
Amendment 438 #
2022/0396(COD)
Proposal for a regulation
Recital 61
Recital 61
Amendment 447 #
2022/0396(COD)
Proposal for a regulation
Recital 63
Recital 63
(63) Reusable packaging has to be safe for its users. Therefore, economic operators offering their products in reusable packaging have to ensure that, before a reusable packaging is used again, it is subject to a reconditioning process, for which requirements should be laid down. For foodstuffs reusable packaging should guarantee that food safety is not compromised.
Amendment 448 #
2022/0396(COD)
Proposal for a regulation
Recital 64
Recital 64
(64) Reusable packaging becomes waste, in the sense of the Article 3(1) of Directive 2008/98/EC, when its holder discards it, intends to discard it or is obligated to discard it. Reusable packaging in a reconditioning process is normally not t considered to be waste.
Amendment 462 #
2022/0396(COD)
Proposal for a regulation
Recital 67
Recital 67
(67) In order to reduce the increasing proportion of packaging that is single use and the growing amounts of packaging waste generated, it is necessary to establish quantitative re-use and refill targets on packaging in sectors, which have been assessed as having the greatest potential for packaging waste reduction, namely food and beverages for take-away, large-white goods and transport packaging. This was appraised based on factors such as existing systems for re-use, necessity of using packaging and the possibility of fulfilling the functional requirements in terms of containment, tidiness, health, hygiene and safety. Differences of the products and their production and distribution systems, were also taken into account. The setting of the targets is expected to support the innovation and increase the proportion of re-use and refill solutions. The use ofIn acccording with Article 4(2) of Directive 2008/98/EC, restrictions shall not apply to single -use packaging for food and beverages filled and consumed within the premises in the HORECA sector should not be allowedthat provides a better overall environmental outcome supported by life cycle thinking, as well as a better overall economic and health impact.
Amendment 469 #
2022/0396(COD)
Proposal for a regulation
Recital 68
Recital 68
(68) To increase their effectiveness and ensure the equal treatment of economic operators, the re-use and refill targets should be placed on the economic operators. In cases of targets for beverages, they should be additionally placed also on the manufacturers, as these actors are able to control the packaging formats used for the products they offer. The targets should be calculated as a percentage of sales in reusable packaging within a system for re-use or through refill or, in case of transport packaging, as a percentage of uses. The targets should be material neutral. A detailed assessment should be conducted to ensure that reuse targets can be met in a safe, economically feasible, and environmentally sustainable manner that would bring concrete benefits compared to recyclable alternatives. Moreover, the targets should be realistic and feasible, giving economic operators sufficient time to adapt. In order to ensure uniform conditions for the implementation of targets for re-use and refill, the power to adopt an implementing act in accordance with Article 291 of the Treaty on the methodology for their calculation, should be delegated to the Commission.
Amendment 474 #
2022/0396(COD)
Proposal for a regulation
Recital 69
Recital 69
(69) Certain uses of single use transport packaging formats are not necessary, as there is a wide range of well-functioning reusable alternatives. In order to ensure that such alternatives are effectively used, it is appropriate to require economic operators, when transporting products between different sites of the same economic operator or between the economic operator and the linked or partner enterprises, to use only reusable transport packaging with respect to packaging formats such as pallets, foldable plastic boxes, and plastic crates, intermediate bulk containers, both rigid and flexible, or drums. The same obligation should, for the same reasons, apply to economic operators transporting products within one Member State. Pursuant to Article 4(2) of Directive 2008/98/EC, exceptions must be possible if, according to a life cycle assessment, the use of easily recyclable single-use packaging is more suitable than the use of reusable packaging.
Amendment 490 #
2022/0396(COD)
Proposal for a regulation
Recital 90
Recital 90
(90) Waste prevention is the most efficient way to improve resource efficiency and to reduce the environmental impact of waste. It is important therefore that economic operators take appropriate measures to reduce the waste generation by eliminating excessive packaging and restrict the uses of certain packaging formats, extending the life span of packaging, re-designing products so that no packaging or less packaging can be used, including bulk sales, and by shifting from single use packaging to reusable packaging where it make sense from a climate and environmental standpoint considering the whole life cycle of packaging.
Amendment 499 #
2022/0396(COD)
Proposal for a regulation
Recital 91
Recital 91
(91) To achieve an ambitious and sustained reduction in the overall packaging waste generation, targets should be laid down for the reduction of packaging waste per capitamaterial to be achieved by 20340. Meeting a target of 5 % reduction in 2030 compared to 2018 should entail an overall absolute reduction of approximately 19 % on average across the Union in 2030 compAccording to the existing harmonised standared to the 2030 baseline. Member States should reduce packaging waste generation by 10 %, compared to 2018, by 2035; this is estimated to reduce packaging waste by 29 % compared to the 2030 baseline. In order to ensure that the reduction efforts continue beyond 2030, a reduction target of 10 % from 2018, which would mean a reduction of 29 % compared to baseline, should be set for 2035 and, for 2040, a reduction target of 15 % from 2018, which means a reduction of 37 % compared to baselineEN 13428:200030, waste prevention through material reduction should be a core guiding principle, whereby the substitution of one packaging material for another is not a basis for should be establishedrce reduction.
Amendment 505 #
2022/0396(COD)
Proposal for a regulation
Recital 92
Recital 92
Amendment 524 #
2022/0396(COD)
Proposal for a regulation
Recital 101 a (new)
Recital 101 a (new)
(101a) The first stage in ensuring recycling and creating a robust Union market for secondary raw materials is the separate collection of packaging. A national incentive to create effective and targeted collection systems is the implementation of collection obligations, which will increase the amount of waste sorted and recycled at scale.
Amendment 528 #
2022/0396(COD)
Proposal for a regulation
Recital 103
Recital 103
(103) Deposit and return systems should be obligatory for single use plastic beverage bottles and metal beverage containers. Member States might also decide to include other packaging in these systems, in particular single use glass bottles, and should ensure that deposit and return systems for single-use packaging formats, in particular for single use glass beverage bottles, are equally available for reusable packaging, where technically and economically feasible. They should consider establishing deposit and return systems also for reusable packaging. In such situations, a Member State should be allowed, while observing the general rules laid down in the Treaty and complying with the provisions set out in this Regulation, adopt provisions which go beyond the minimum requirements set out in this Regulation.
Amendment 544 #
2022/0396(COD)
(108) As a specific packaging waste generation prevention measure, Member States should actively encourage the re-use and refill solutions. They should support the establishment of systems for re-use and refill and monitor their functioning and compliance with the hygiene standards. Member States are encouraged to take also other measures, such as setting up deposit and return systems covering reusable packaging formats, or using economic incentives or establishing requirements for final distributors to make available a certain percentage of other products than those covered by re- use and refill targets in reusable packaging or through refill provided that such requirements will not result in fragmentation of single market and creation of trade barriers.
Amendment 567 #
2022/0396(COD)
Proposal for a regulation
Recital 136
Recital 136
(136) The Commission should carry out an evaluation of this Regulation. Pursuant to paragraph 22 of the Inter-institutional Agreement on Better Law-Making, that evaluation should be based on the five criteria of efficiency, effectiveness, relevance, coherence and Union value added and should provide the basis for impact assessments of possible further measures. The evaluation should have a dedicated part to, inter alia, the impact of this Regulation on the agri-food system. The Commission should submit to the European Parliament, to the Council, the European Economic and Social Committee, and to the Committee of the Regions a report on the implementation of this Regulation and its impact on the environmental sustainability of packaging and the functioning of the internal market.
Amendment 582 #
2022/0396(COD)
Proposal for a regulation
Article 2 – paragraph 1
Article 2 – paragraph 1
1. This Regulation applies to all packaging, with the exception of packaging approved for the transport of dangerous goods regardless of the material used, and to all packaging waste, whether such waste is used in or originates from industry, other manufacturing, retail or distribution, offices, services or households.
Amendment 590 #
2022/0396(COD)
2. This Regulation applies without prejudice to Union regulatory requirements for packaging such as those regarding safety, quality, the protection of health and the hygiene of the packed products, or to transport requirements, as well as without prejudice to the provisions of the Directive 2008/98/EC as regards the management of hazardous waste and the requirements provided for in paragraph 2 of Article 4 of Directive 2008/98/EC.
Amendment 597 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point f
Article 3 – paragraph 1 – point 1 – point f
(f) tea or coffee bagcompostable coffee bags and system single-serve units and permeable tea or coffee single-serve units necessary to contain a tea or coffee product and intended to be used and disposed of together with the product;
Amendment 618 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point g
Article 3 – paragraph 1 – point 1 – point g
(g) coffee or tea systemprotective beverage single-serve unit necessary to contain a coffee or tea product and intended to be used and disposed of together with the product;
Amendment 635 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 18 a (new)
Article 3 – paragraph 1 – point 18 a (new)
(18a) ‘plastic packaging’ means a packaging that is wholly or predominantly made of plastic.
Amendment 640 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 19
Article 3 – paragraph 1 – point 19
(19) ‘composite packaging’ means a unit of packaging made of two or more different materials, excluding materials used for labels, closures and sealing, which cannot be separated manually and therefore form a single integraloatings, linings, paints, inks, adhesives, closures, sealing and lacquers, which are considered as part of the weight of the main packaging material, which cannot be separated manually and therefore form a single integral unit, unless a given material constitutes an insignificant part of the packaging unit and in no case more than 10% of the total mass of the packaging unit;
Amendment 686 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 32 b (new)
Article 3 – paragraph 1 – point 32 b (new)
(32b) ‘'recyclability' means the compatibility of packaging with the management and processing of waste, based on separate collection, sorting in separate streams, recycling at scale, and use of recycled materials to replace primary raw materials;
Amendment 690 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 32
Article 3 – paragraph 1 – point 32
(32) ‘recycled at scale’ means collected, sorted and recycled through installed state-of-the-art infrastructure and processesthat the packaging meets the requirements of Article 6(2)(a) and is accepted for recycling by packaging responsibility organisations in the majority of Member States, where the packaging is placed on the market and the producer is registered under the obligations set out in Article 39, covering at least 75 % of the Union population, including packaging waste exported from the Union that meets the requirements of Article 47(5);
Amendment 708 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 32 a (new)
Article 3 – paragraph 1 – point 32 a (new)
(32a) 'high quality recycling’ means any recovery operation, as defined in Article 3, point (17), of Directive 2008/98/EC, that ensures that the distinct quality of the waste collected and sorted is preserved or recovered during that recovery operation, so that the resulting recycled materials are of sufficient quality to substitute primary raw materials;
Amendment 717 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 34
Article 3 – paragraph 1 – point 34
(34) ‘integrated component’ means a packaging component that may be distinct from the main body of the packaging unit, and may be of a different material, but is integral to the packaging unit and its functioning and does not need to be separated from the main packaging unit in order to consume the product and is typically discarded at the same time as the packaging unit, although not necessarily in the same disposal routeis recommended to be disposed together with the main body of the packaging;
Amendment 722 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 35
Article 3 – paragraph 1 – point 35
(35) ‘separate component’ means a packaging component that is distinct from the main body of the packaging unit, which may be of a different material, that needs to becan be manually disassembled completely and permanently from the main packaging unit in order to access the product, and that is typically discarded prior to anby the end consumer, and that is recommended to be disposed separately from the packaging unit;
Amendment 737 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 38
Article 3 – paragraph 1 – point 38
(38) ‘secondary raw materials’ means materials that have been obtaineundergone all necessary checking, sorting and othrough recycling processeser preliminary operations to remove waste materials that are not targeted by the subsequent reprocessing and can substitute primary raw materials;
Amendment 743 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 39 a (new)
Article 3 – paragraph 1 – point 39 a (new)
(39a) "recycled content in plastic packaging" refers to the quantity of material contained in the packaging derived through any recycling process or pre- and post-consumer waste, whether mechanically, physically, or chemically recycled.
Amendment 747 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 39 b (new)
Article 3 – paragraph 1 – point 39 b (new)
(39b) 'pre-consumer plastic waste' means plastic waste that is generated from production and converting of plastic material.
Amendment 797 #
2022/0396(COD)
Proposal for a regulation
Article 4 – paragraph 5
Article 4 – paragraph 5
Amendment 811 #
2022/0396(COD)
Proposal for a regulation
Article 4 – paragraph 6 a (new)
Article 4 – paragraph 6 a (new)
6a. Medicinal products, as defined in Article 1, point (2) of Directive 2001/83/EC, that have been lawfully placed on the market before the date of application referred to in Article 65 of this Regulation or the date of entry into force of specific measures, and that have not been repackaged or relabelled after these dates, may be further made available on the market until their expiry date without being required to comply with the specific rules laid down in Articles 6, 7, 11 and 13.
Amendment 817 #
2022/0396(COD)
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. Packaging shall be so manufactured that the presence and concentration of substances of concernthat meet the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1% weight by weight (w/w) as laid down the Regulation (EC) No 1907/2006 as constituents of the packaging material or of any of the packaging components is minimised, including with regard to their presence in emissions and any outcomes of waste management, such as secondary raw materials, ashes or other material for final disposal.
Amendment 822 #
2022/0396(COD)
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
2. WOher than the substances criteria laid down in Article 5(1) and without prejudice to the restrictions on chemicals set out in Annex XVII of Regulation (EC) No 1907/2006 or, where applicable, to the restrictions and specific measures on food contact packaging in Regulation (EC) No 1935/2004, the sum of concentration levels of lead, cadmium, mercury and hexavalent chromium resulting from substances present in packaging or packaging components shall not exceed 100 mg/kg.
Amendment 844 #
2022/0396(COD)
Proposal for a regulation
Article 5 – paragraph 4
Article 5 – paragraph 4
4. Recyclability requirements established in delegated acts adopted pursuant to Article 6(5)by CEN - European Committee for Standardization shall not restrict the presence of substances in packaging or packaging components for reasons relating primarily to chemical safety. They shall address, as appropriate, substances of concern that negatively affect the re-use and recycling of materials in the packaging in which they are present, and shall, as appropriate, identify the specific substances concerned and their associated criteria and limitations.
Amendment 868 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. All packaging shall be recyclable from 1 January 2030.
Amendment 873 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1 – point a
Article 6 – paragraph 2 – subparagraph 1 – point a
(a) it is designed for recycling or, for compostable packaging, is compliant with point a), b) and c) of Annex III;
Amendment 881 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1 – point b
Article 6 – paragraph 2 – subparagraph 1 – point b
Amendment 885 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1 – point c
Article 6 – paragraph 2 – subparagraph 1 – point c
Amendment 890 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1 – point d
Article 6 – paragraph 2 – subparagraph 1 – point d
Amendment 899 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1 – point e – point i (new)
Article 6 – paragraph 2 – subparagraph 1 – point e – point i (new)
i) it is effectively and efficiently separately collected in accordance with Article 43(1) and (2);
Amendment 900 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1 – point e – point ii (new)
Article 6 – paragraph 2 – subparagraph 1 – point e – point ii (new)
ii) it is sorted into defined waste streams without affecting the recyclability of other waste streams;
Amendment 901 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1 – point e – point iii (new)
Article 6 – paragraph 2 – subparagraph 1 – point e – point iii (new)
iii) except for compostable plastics, it can be recycled so that the resulting secondary raw materials are of sufficient quality to substitute primary raw materials;
Amendment 917 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 2
Article 6 – paragraph 2 – subparagraph 2
Point (a) shall apply from 1 January 2030 and point (eb) shall apply from 1 January 2035.
Amendment 926 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. Recyclable packaging shall, from 1 January 2030, comply with the design for recycling criteria as laid down in the delegated acts adopted pursuant to paragraph 4 and, from 1 January 2035, also with the recyclability at scale requirements laid down in the delegated acts adopted pursuant to paragraph 6. Where such packaging complies with those delegated acts, it shall be considered to comply with paragraph 2, points (a) and (e).:
Amendment 940 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 3 – point a (new)
Article 6 – paragraph 3 – point a (new)
(a) from either 1 January 2030 or 36 months years after the publication in the Official Journal of the European Union of the harmonised standard developed by CEN-European Committee for Standardisation referred to in paragraph 4, whichever is the latest, comply with design for recycling criteria, and,
Amendment 941 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 3 – point b (new)
Article 6 – paragraph 3 – point b (new)
Amendment 944 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1
Article 6 – paragraph 4 – subparagraph 1
The Commission is empowered to adopt delegated acts in accordance with Article 58 to supplement this Regulation in ordershall request the CEN European Committee for Standardisation, to develop, at the latest by 31 December 2026, harmonised standards to establish design for recycling criteria and recycling performance grades based on th, as appropriate, on the indicative criteria and parameters listed in Table 2 and 3 of Annex II for the packaging categories listed in Table 1 of that Annex, as well as. From the date of publication of the references to harmonised standards in the Official Journal of the European Union, packaging which is in conformity with those standards shall be presumed to be in conformity with the requirement laid down in paragraph 1. The Commission is empowered to adopt delegated acts in accordance with Article 58 to supplement this Regulation in order to establish rules concerning the modulation of financial contributions to be paid by producers to comply with their extended producer responsibility obligations set out in Article 40(1), based on the packaging recycling performance grade, and for plastic packaging, the percentage of recycled content. Design-for-recycling criteria shall consider state of the art collection, marketing and consumer acceptance criteria, existing industry commitments, sorting and recycling processes and shall cover all packaging components.
Amendment 973 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 2
Article 6 – paragraph 4 – subparagraph 2
The Commission is empowered to adopt delegated acts, in close cooperation with stakeholders, in accordance with Article 58 to amend Table 1 of Annex II in order to adapt it to scientific and technical development in material and product design, collection, sorting and recycling infrastructure.
Amendment 978 #
2022/0396(COD)
From either 1 January 2030, or 36 months after the publication in the Official Journal of the European Union of the harmonised standard developed by CEN referred to in paragraph 4, packaging shall not be considered recyclable if it corresponds to performance grade E under the design for recycling criteria established in the delegated act adopted pursuant to paragraph 4 for the packaging category, to which the packaging belongs.
Amendment 990 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 5 – subparagraph 2
Article 6 – paragraph 5 – subparagraph 2
These criteria shall be based at least onould consider as appropriate the parameters as listed in Table 23 of Annex II.
Amendment 1013 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 6 – point d a (new)
Article 6 – paragraph 6 – point d a (new)
(da) specific provisions should be approved for inert packaging placed on the market in very small quantities (i.e., approximately 0,1 % by weight) in the Union.
Amendment 1024 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 7 – point a
Article 6 – paragraph 7 – point a
(a) the manner in which to express the result of the recyclability assessment in recyclability performance grades from A to E, as described in Table 3 of Annex II, based on the percentage of the packaging unit, in weight, which is recyclable according to paragraph 1;
Amendment 1044 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 8 – subparagraph 4 a (new)
Article 6 – paragraph 8 – subparagraph 4 a (new)
Small components (50 mm in two dimensions) provide a specific challenge to current packaging material recycling facility capabilities. Small components may be placed on the market in derogation of paragraphs 2 and 3 until the Delegated Act defining the Design for Recycling standards is implemented. The Design for Recycling criteria shall take into account the needs for small components and be compatible with the state of the art collection, sorting, and recycling procedures.
Amendment 1058 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 10 – introductory part
Article 6 – paragraph 10 – introductory part
10. Until 31 December 2034, tThis Article shall not apply to the following:
Amendment 1060 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 10 – point b
Article 6 – paragraph 10 – point b
(b) contact sensitive plastic packaging of medical devices covered by Regulation (EU) 2017/745 and by Regulation (EU) 2019/6;
Amendment 1064 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 10 – point c
Article 6 – paragraph 10 – point c
(c) contact sensitive plastic packaging of in vitro diagnostics medical devices covered by Regulation (EU) 2017/746.
Amendment 1068 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 10 – point c a (new)
Article 6 – paragraph 10 – point c a (new)
(ca) outer packaging as defined in Article 1, point (24), of Directive 2001/83/EC and in Article 4, point (26), of Regulation (EU) 2019/6.
Amendment 1073 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 10 – point c b (new)
Article 6 – paragraph 10 – point c b (new)
(cb) items that are sold along with the product with the objective to be used for the application or dispensing of the product by the end user and will therefore be in contact with the products covered under points (a), (b), (ba) or (c);
Amendment 1076 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 11
Article 6 – paragraph 11
11. The financial contributions to be paid by producers to comply with their extended producer responsibility obligations as referred to in Article 40 shall be modulated on the basis of the recyclability performance grade, as determined in accordance with the delegated acts referred to in paragraphs 4 and 6 of this Article and, as regards plastic packaging, also in accordance with the Article 7(6). Financial contributions shall, in line with Article 8a of Directive 2008/98/EC, be destined to finance the net cost of collection, sorting and recycling infrastructures of the packaging type it is paid for, following the categories set in Annex II, Table 1.
Amendment 1093 #
2022/0396(COD)
1. From 1 January 2030, the plastic part inprovided technical feasibility, availability of the material and compliance with food safety national and European requirements, plastic packaging shall contain the following minimum percentage of recycled content recovered from pre-consumer or post-consumer plastic waste, per unit of packaging:
Amendment 1120 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point a
Article 7 – paragraph 1 – point a
(a) 30 % for contact sensitive plastic packaging made from polyethylene terephthalate (PET) as the major component;
Amendment 1128 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point b
Article 7 – paragraph 1 – point b
(b) 10 % for contact sensitive plastic packaging made from plastic materials other than PET, except single use plastic beverage bottles;
Amendment 1147 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 (new)
Article 7 – paragraph 1 – subparagraph 1 (new)
Targets shall be calculated as an avarage of the plastic packaging placed by a producer on the Union market.
Amendment 1172 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 2 – introductory part
Article 7 – paragraph 2 – introductory part
2. From 1 January 2040, the plastic part in packaging shall contain the following minimum percentage of recycled content recovered from pre-consumer or post- consumer plastic waste, per unit of packaging:
Amendment 1190 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 1 (new)
Article 7 – paragraph 2 – subparagraph 1 (new)
Targets shall be calculated as an avarage of the plastic packaging placed by a producer on the Union market.
Amendment 1223 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 4
Article 7 – paragraph 4
4. Paragraphs 1 and 2 shall not apply to compostable plastic packaging as well as to bio-based plastic packaging, inks, adhesives, varnishes and coatings used on packaging.
Amendment 1239 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 6
Article 7 – paragraph 6
6. ByFrom 1 January 2030, the financial contributions paid by producers to comply with their extended producer responsibility obligations as laid down in Article 40 shall be modulated based on the percentage of recycled content used in the packagingtaking into account the cost of packaging waste management and the revenues from sales of secondary materials. The non-use of recycled contents as authorized by a derogation from this Article shall be considered in the modulation of the financial contributions.
Amendment 1262 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 7
Article 7 – paragraph 7
7. By 31 December 2026, the Commission is empowered toshall adopt implementing acts establishing the methodology for the calculation and verification of the percentage of recycled content recovered from post-consumer plastic waste, per unit of plastic packaging, and the format for the technical documentation referred to in Annex VII. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(3).
Amendment 1274 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 7 a (new)
Article 7 – paragraph 7 a (new)
7a. Paragraphs 1 and 2 shall apply not earlier than 36 months after the adoption of the implementing acts pursuant to paragraph 7.
Amendment 1290 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 9 – subparagraph 1
Article 7 – paragraph 9 – subparagraph 1
By 31 JanuaryDecember 20285, the Commission shall assess the need for derogations from the minimum percentage laid down in paragraph 1, points b and d, for specific plastic packaging, or for the revision of the derogation established under paragraph 3 for specific plastic packaging.
Amendment 1296 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 9 – subparagraph 1 a (new)
Article 7 – paragraph 9 – subparagraph 1 a (new)
By 31 December 2035, the Commission shall assess the need for derogations from the minimum percentages laid down in paragraph 2 point a, b and c for specific plastick packaging.
Amendment 1298 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 9 – subparagraph 1 b (new)
Article 7 – paragraph 9 – subparagraph 1 b (new)
These assessments shall be based on market availability and prices of recycled plastics on an annual basis from the year of entry into force of this Regulation. These assessments shall consider Eurostat data for the EU-27 achieved plastic packaging recycling levels, recycled plastic price indices and annual rates of price change based on a monitoring tool to be established by the European Commission, and be based on the uptake of new recycling technologies and their impact on available market volumes.
Amendment 1302 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 9 – subparagraph 2 – introductory part
Article 7 – paragraph 9 – subparagraph 2 – introductory part
Based on this assessment, the Commission is empowered toshall, at the latest by 31 December 2026 and by 31 December 2036 respectively, adopt delegated acts in accordance with Article 58 to amend this Regulation in order to:
Amendment 1307 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 9 – subparagraph 2 – point a
Article 7 – paragraph 9 – subparagraph 2 – point a
(a) provide for derogations from the scope, timing or level of minimum percentage laid down in paragraph 1, points a, b and d, and in paragraph 2, points a, b and c for specific plastic packaging, and, as appropriate,.
Amendment 1311 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 9 – subparagraph 2 – point b
Article 7 – paragraph 9 – subparagraph 2 – point b
Amendment 1357 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. By [OP: please insert the date = 24 months from the entry into force of this Regulation]2030, packaging referred to in Article 3(1), points (f) and (g), sticky labels attached to fruit and vegetables and very lightweight plastic carrier bags shall be compostable in industrially controlled conditions in bio-waste treatment facilities and therefore allowed to be collected in bio-waste receptacles.
Amendment 1364 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
Amendment 1375 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. By [OP: Please insert the date = 24 months from the date of entry into force of this Regulation], packaging other than that referred to in paragraphs 1 and 2, including packaging made of biodegradshall comply with the criteria listed in Annex III. Packaging made with compostable material that is not labele plastic polymers,d as compostable shall be allowed to material recycling where appropriate waste collection schemes and waste treatment infrastructure are available to ensure they enter the bio-waste waste management stream without affecting the recyclability of other waste streams.
Amendment 1385 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 5
Article 8 – paragraph 5
5. TAfter an assessment of the Expert Group, the Commission shall be empowered to adopt delegated acts in accordance with Article 58 to amend paragraphs 1 and 2 of this Article by adding other types of packaging to the types of packaging covered by those paragraphs when it is justified and appropriate due to technological and regulatory developments impacting the disposal of compostable packaging and under the conditions set out in Annex III. A public register containing the lists of such applications should be established and updated by the Commission.
Amendment 1392 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 5 a (new)
Article 8 – paragraph 5 a (new)
5a. By 1 January 2030, the financial contributions paid by producers to comply with their extended producer responsibility obligations as laid down in Article 40 shall be collected and managed by dedicated extended producer responsibility scheme.
Amendment 1393 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 5 b (new)
Article 8 – paragraph 5 b (new)
5b. Compostable packaging can be placed on the market providing the presence of a minimum content of renewable raw material determined as percentage of carbon of biological origin present in packaging compared to the total carbon present therein. For this purposes, the current European standard on the subject based on radiocarbon methods EN 16640 shall be used. Agricultural biomass used for the manufacture of compostable packaging complies with the criteria laid down in Article 29, paragraphs 2 to 5, of Directive (EU) 2018/2001. Forest biomass used for the manufacture compostable packaging complies with the criteria laid down in Article 29, paragraphs 6 and 7 of that Directive.
Amendment 1395 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 5 c (new)
Article 8 – paragraph 5 c (new)
5c. By [OP: please insert the date = 12 months from the entry into force of this Regulation] compostable packaging shall contain a minimum content of renewable raw material of at least 60%.
Amendment 1403 #
2022/0396(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. PBy January 2030, packaging shall be designed so that its weight and volume is reduced to the minimum necessary for ensuring its functionalitys, as listed in the definition of packaging in Article 3(1), taking account of the material that the packaging is made of. and its design, for a given material and a given shape.
Amendment 1423 #
2022/0396(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. PBy January 2030, packaging not necessary to comply with any of the performance criteria set out in Annex IV and packaging with characteristics that are only aimed to increase the perceived volume of the product, including double walls, false bottoms, and unnecessary layers, shall not be placed on the market, unless the packaging design is subject to geographical indications of originshall not be placed on the market, unless the product or packaging design is subject to intellectual property protection or benefits from the Union’s geographical indications of origin protection or have been given distinctive product recognition by the Union, in each case protected under Union legislation.
Amendment 1430 #
2022/0396(COD)
Proposal for a regulation
Article 9 – paragraph 3 – subparagraph 1 – introductory part
Article 9 – paragraph 3 – subparagraph 1 – introductory part
Amendment 1438 #
2022/0396(COD)
Proposal for a regulation
Article 9 – paragraph 3 – subparagraph 2
Article 9 – paragraph 3 – subparagraph 2
For the purpose of assessing the compliance with this paragraph, space filled by paper cuttings, air cushions, bubble wraps, sponge fillers, foam fillers, wood wool, polystyrene, styrofoam chips or other filling materials shall be considered as empty space unless required to protect and to transport the goods.
Amendment 1447 #
2022/0396(COD)
Proposal for a regulation
Article 9 – paragraph 4 – subparagraph 1 – point b
Article 9 – paragraph 4 – subparagraph 1 – point b
(b) the identification of the design requirements, including those related to intellectual property rights, which prevent further reduction of the packaging weight or volume, for each of these performance criteria;
Amendment 1451 #
2022/0396(COD)
Proposal for a regulation
Article 9 – paragraph 4 – subparagraph 1 – point c
Article 9 – paragraph 4 – subparagraph 1 – point c
(c) any test results, studies such as modelling and simulation studies or other relevant sources used to assess the minimum necessary volume or weight of the packaging.
Amendment 1457 #
2022/0396(COD)
Proposal for a regulation
Article 9 – paragraph 4 a (new)
Article 9 – paragraph 4 a (new)
4a. Packaging produced or imported prior the deadlines listed in paragraphs 1, 2 and 3, may be commercialised until 36 months after entry into force of this Regulation.
Amendment 1458 #
2022/0396(COD)
Proposal for a regulation
Article 9 – paragraph 4 b (new)
Article 9 – paragraph 4 b (new)
4b. Space necessary to comply with the performance criteria in Annex IV, shall not be considered as empty space.
Amendment 1472 #
2022/0396(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point d
Article 10 – paragraph 1 – point d
(d) it is capable of being emptied, unloaded, refilled or reloaded, reloaded or re-used as tableware or kitchenware, while ensuring compliance with the applicable safety and hygiene requirements;
Amendment 1475 #
2022/0396(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point e
Article 10 – paragraph 1 – point e
(e) it is capable of being reconditioned in accordance with Part B of Annex VI, whilst maintaining its ability to perform its intended function; or, if it is originally designed to be reused as tableware or kitchenware, it is proven by design characteristics such as washability, repairability, durability without losing product functionality, economic benefit for the consumer, and general consumer perception.
Amendment 1479 #
2022/0396(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point f
Article 10 – paragraph 1 – point f
(f) it can be emptied, unloaded, refilled or reloaded, reloaded or re-used as tableware or kitchenware while maintaining the quality and safety of the packaged product and allowing for the attachment of labelling, and the provision of information on the properties of that product and on the packaging itself, including any relevant instructions and information for ensuring safety, adequate use, traceability and shelf- life of the product;
Amendment 1483 #
2022/0396(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point g
Article 10 – paragraph 1 – point g
(g) it can be emptied, unloaded, refilled or reloaded, reloaded or re-used as tableware or kitchenware without risk to the health and safety of those responsible for doing so;
Amendment 1491 #
2022/0396(COD)
Proposal for a regulation
Article 10 – paragraph 2
Article 10 – paragraph 2
2. Compliance with the requirements set out in paragraph 1, including the minimum indicative number of trips or rotation per packaging application, shall be demonstrated in the technical information concerning the packaging referred to in Annex VII.
Amendment 1499 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 1
Article 11 – paragraph 1 – subparagraph 1
From [OP: Please insert the date = 4236 months after the entry into force of this Regulation], packaging shall be marked with a label containing information on its material composition. This obligation does not apply to transport packaginge delegated act referred to in paragraph 5, information to facilitate consumer sorting shall be marked on the packaging or shall be available through digital means according to Article 11(4). This obligation does not apply to transport packaging, to packaging mentioned in Article 7(3), retail packaging subject to final packaging, as in te case of over-the counter food sales, and to reusable gas receptacles. However, it applies to e- commerce packaging.
Amendment 1518 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 2
Article 11 – paragraph 1 – subparagraph 2
Packaging subject to deposit and return systems referred to in Article 44(1) shall, in addition to the labelling referred to in the first subparagraph, be marked with a harmonised label established in the relevant implementing act adopted pursuant to paragraph 5.
Amendment 1521 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. From [OP: Please insert the date = 48 months after the date of entry into force of this Regulation],e implementing act referred to in paragraph 5, reusable packaging shall bear a label on packaging reusability andor shall be available through a QR code or other type of digital data carrier that provides further information on packaging reusability including the availability of a system for re-use and of collection points, and that facilitates the tracking of the packaging and the calculation of trips and rotations. In addition, reusable sales packaging shall be clearly identified and distinguished from single use packaging at the point of sale. The marketing authorisation holder is permitted to transmit the package leaflet's information via a digital data carrier for medicinal products as defined in Article 1, point (2) of Directive 2001/83/EC and as required by Articles 59 and 52 of that same Directive.
Amendment 1533 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 3
Article 11 – paragraph 3
3. Where a unit ofplastic packaging covered by Article 7 is marked with a label containing information consumer relevant information on the share of recycled content, that label from post-consumer plastic waste, that label or a QR code or other type of digital data carrier shall comply with the specifications laid down in the relevant implementing act adopted pursuant to Article 11(5) and shall be based on the methodology pursuant to Article 7(7). Where a unit of plastic packaging is marked with a label containing information on the share of biobased plastic content, that label shall comply with the specifications laid down in the relevant implementing act adopted pursuant to Article 11(5).
Amendment 1538 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 4 – subparagraph 1
Article 11 – paragraph 4 – subparagraph 1
Labels referred to in paragraphs 1 to 3 and the QR code or other type of digital data carrier referred to in paragraph 2 shall be placed, printed or engraved visibly, clearly legibly and indelibly on the packaging. Where this is not possible or not warranted on account of the nature and size of the packaging, they shall be affixed to the grouped packaging information should be conveyed to consumers via digital means of communication as QR code or they shall be affixed to the grouped packaging. Information must be provided through the outer packaging, as defined in Article 1, Point (24), of Directive 2001/83/EC, for all immediate packaging, as defined in Article 1, Point (23), of Directive 2001/83/EC. From [Please insert the date = 24 months after the entry into force of this Regulation] the Commission shall adopt guidance regarding provision of information by digital means.
Amendment 1555 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 4 a (new)
Article 11 – paragraph 4 a (new)
4a. The information referred to in paragraphs 1 through 3 may, as a derogation from paragraph 4, be provided by electronic means that are specified on the package or on a label that is attached to it.In such cases, the following requirements apply: a) no user data shall be collected or tracked; b) the information shall not be displayed with other information intended for sales or marketing purposes.
Amendment 1558 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 5
Article 11 – paragraph 5
5. By [OP: Please insert the date = 182 months after the date of entry into force of this Regulation], the Commission shall adopt implementing acts to establish a harmonised label and specifications for the labelling requirements and formats for the labelling of packaging referred to in paragraphs 1 to 3 and the labelling of waste receptacles referred to in Article 12. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(3).
Amendment 1560 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 6
Article 11 – paragraph 6
6. By [OP: Please insert the date = 124 months after the date of entry into force of this Regulation], the Commission shall adopt implementing acts to establish the methodology for identifying the material composition of packaging referred to in paragraph 1packaging materials by means of digital marking technologies. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(3).
Amendment 1565 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 7
Article 11 – paragraph 7
7. Without prejudice to requirements concerning other harmonised EU labels, Member States shall not require economic operators shall noto provide or display labels, marks, symbols or inscriptions that are likely to mislead or confuse consumers or other end users with respect to the sustainability requirements for packaging, other packaging characteristics or packaging waste management options, for which harmonised labelling has been laid down in this Regulation. From [Please insert the date = 24 months after the entry into force of this Regulation] the Commission shall adopt guidance regarding aspects that are likely to mislead or confuse consumers or other end users.
Amendment 1576 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 8
Article 11 – paragraph 8
8. Packaging included in an extended producer responsibility scheme or covered by a deposit and return system other than that referred to in Article 44(1) mayshall be identified by means of a corresponding symbol throughout the territory in which that scheme or system applies. That symbol shall be clear and unambiguous and shall not mislead consumers or users as to the recyclability or reusability of the packagingharmonised symbol to be designed via an implementing act by the Commission in accordance with the examination procedure referred to in Article 59(3).
Amendment 1579 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 8 a (new)
Article 11 – paragraph 8 a (new)
8a. Packaging produced or imported prior the deadlines referred to in paragraphs 1, 2 and 3, may be put into the market until 36 months after the entry into force of this Regulation.
Amendment 1587 #
2022/0396(COD)
Proposal for a regulation
Article 12 a (new)
Article 12 a (new)
Article12a Packaging and Packaging Waste Forum The Commission shall ensure that it maintains a balanced participation of Member States’ representatives and all interested parties involved with the packaging industry, including waste treatment industry representatives, manufacturers and packaging suppliers, distributors, retailers, craft industry representatives, importers, SMEs, environmental protection groups, and others when it defines the sustainability requirements and other requirements and criteria established in this Regulation. These parties shall contribute in particular to preparing design for recycling criteria for different packaging and recycling performance grades based on the criteria and parameters listed in Table 2 of Annex II for packaging categories listed in Table 1 of that Annex. To that end, the Commission shall establish an expert group, in which those parties shall meet, referred to as “Packaging and Packaging Waste Forum”.
Amendment 1590 #
2022/0396(COD)
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
By 1 January 202836 months from the date of entry into force of the delegated act referred to in Article 11(5), labels that enable the separate collection of each material specific fraction of packaging waste that is intended to be discarded in separate receptacles shall be affixed, printed or engraved visibly, legibly and indelibly on all waste receptacles for collection of packaging waste.
Amendment 1611 #
2022/0396(COD)
Proposal for a regulation
Article 13 – paragraph 6 a (new)
Article 13 – paragraph 6 a (new)
6a. With regard to this Regulation, for medicinal products, as defined in Article 1, point (2), of the Directive 2001/83/EC, the information provided shall be of the marketing authorisation holder, as provided by Article 6.1a of the Directive 2001/83/EC.
Amendment 1618 #
2022/0396(COD)
Proposal for a regulation
Article 13 – paragraph 9 a (new)
Article 13 – paragraph 9 a (new)
9a. The provisions of paragraphs 1 to 6 shall not apply to custom transport packaging for configurable devices and systems, that are destined to be used use in industrial and healthcare environments.
Amendment 1636 #
2022/0396(COD)
Proposal for a regulation
Article 16 – paragraph 10 a (new)
Article 16 – paragraph 10 a (new)
10a. To fulfil the obligations under this article, Member States shall provide support tools for non professional importers, especially micro and SME importers.
Amendment 1659 #
2022/0396(COD)
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
1. EBy January 2030, economic operators who supply products to a final distributor or an end user in grouped packaging, transport packaging or e- commerce packaging, shall ensure that the empty space ratio is maximum 40 %inimised, under the restrictions outlined in Part I of Annex IV. The packaging minimisation shall take into careful consideration the protection of the goods and its transport.
Amendment 1674 #
2022/0396(COD)
Proposal for a regulation
Article 21 – paragraph 2 – subparagraph 1
Article 21 – paragraph 2 – subparagraph 1
Amendment 1676 #
2022/0396(COD)
Proposal for a regulation
Article 21 – paragraph 2 – subparagraph 1 – point a
Article 21 – paragraph 2 – subparagraph 1 – point a
Amendment 1678 #
2022/0396(COD)
Proposal for a regulation
Article 21 – paragraph 2 – subparagraph 1 – point b
Article 21 – paragraph 2 – subparagraph 1 – point b
Amendment 1701 #
2022/0396(COD)
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
1. EFrom 1 January 2030 economic operators shall not place on the market packaging in the formats and for the purposes listed in Annex V. unless: a) such placing on the market is in line with paragraph 2 of Article 4 of Directive 2008/98/EC;and b) they can show effective collection and recycling of these packaging formats, on the basis of the predominant packaging material, with the following percentages: - 75% by weight by 2026 - 80% by weight by 2028 - 90% by weight by 2030
Amendment 1707 #
2022/0396(COD)
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
1. EFrom 1 January 2030 economic operators shallould not place on the market packaging in the formats and for the purposes listed in Annex V.
Amendment 1712 #
2022/0396(COD)
Proposal for a regulation
Article 22 – paragraph 2
Article 22 – paragraph 2
Amendment 1714 #
2022/0396(COD)
Proposal for a regulation
Article 22 – paragraph 2
Article 22 – paragraph 2
Amendment 1733 #
2022/0396(COD)
Proposal for a regulation
Article 22 – paragraph 3
Article 22 – paragraph 3
3. Member States may exempt economic operators fromEconomic operators shall be exempted from the application of point 3 of Annex V if they comply withmeet the definition of micro-company in accordance wienterprise according to the rules set out in the Commission Recommendation 2003/361, as applicable on [OP: Please insert the date = the date of entry into force of this Regulation], and. In addition, Member States shall grant an exemption where it is not technically feasible not to use packaging or to obtain access to the infrastructure that is necessary for the functioning of a re-use system or when duly justified by concerns related to public health, food hygiene and safety, product integrity or environmental issues.
Amendment 1734 #
2022/0396(COD)
Proposal for a regulation
Article 22 – paragraph 3
Article 22 – paragraph 3
3. Member States may exempt economic operators from point 3 of Annex V if they comply withEconomic operators shall be exempted if they meet the definition of micro-company in accordance wienterprise according to the rules set out in the Commission Recommendation 2003/361, as applicable on [OP: Please insert the date = the date of entry into force of this Regulation], and. In addition, Member States shall grant an exemption where it is not technically feasible not to use packaging or to obtain access to the infrastructure that is necessary for the functioning of a reuse system or when duly justified by concerns related to public health, food hygiene and food safety, product integrity or environmental issues.
Amendment 1745 #
2022/0396(COD)
Proposal for a regulation
Article 22 – paragraph 4
Article 22 – paragraph 4
Amendment 1746 #
2022/0396(COD)
Proposal for a regulation
Article 22 – paragraph 4
Article 22 – paragraph 4
4. The Commission shall be empowered to adopt delegated acts in accordance with Article 58 to amend Annex V in order to adapt it to technical and scientific progress with the objective to reducing packaging waste. When adopting those delegated acts, the Commission shall consider the potential of the restrictions on the use of specific packaging formats to reduce the packaging waste generated while ensuring an overall positive environmental impact, and shall take into account the availability of alternative packaging solutions that meet requirements set out in legislation applicable to contact sensitive packaging, as well as their capability to prevent microbiological contamination of the packaged productBy [OP: Please insert the date = 8 years after the date of entry into force of this Regulation], the Commission shall assess the results of such restrictions on the reduction of packaging waste generated as well as on their overall environmental impact, and submit a report to the European Parliament and to the Council.
Amendment 1761 #
2022/0396(COD)
Proposal for a regulation
Article 23 – paragraph 1
Article 23 – paragraph 1
1. Economic operators who place reusable packaging on the market shall ensure that a system for re-use of such packaging is in place, which meets the requirements laid down in Article 24 and Annex VI., except in cases where packaging is re-used as tableware or kitchenware
Amendment 1767 #
2022/0396(COD)
Proposal for a regulation
Article 24 – paragraph 2
Article 24 – paragraph 2
2. Economic operators making use of reusable packaging shall recondition such packaging in compliance with Part B of Annex VI, prior to offering it again for use by end users. Packaging made to be re-used, as kitchenware or tableware, is exempt from this obligation.
Amendment 1773 #
2022/0396(COD)
Proposal for a regulation
Article 24 – paragraph 2 a (new)
Article 24 – paragraph 2 a (new)
2a. Conveying reusable packaging to reconditioning is not considered to be waste.
Amendment 1784 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
Amendment 1800 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 2
Article 26 – paragraph 2
Amendment 1829 #
2022/0396(COD)
Amendment 1864 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 4
Article 26 – paragraph 4
Amendment 1892 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 5
Article 26 – paragraph 5
Amendment 1915 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 6
Article 26 – paragraph 6
Amendment 1952 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 7 – point b
Article 26 – paragraph 7 – point b
Amendment 1956 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 7 – subparagraph 1 (new)
Article 26 – paragraph 7 – subparagraph 1 (new)
This obligation does not apply to food businesses as defined in Article 3, point (2), of Regulation (EC) No 178/2002, which are engaged in logistics and wholesale B2B distribution and large scale industrial production and processing.
Amendment 1968 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 8 – point b
Article 26 – paragraph 8 – point b
Amendment 1983 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 9 – point a
Article 26 – paragraph 9 – point a
(a) from 1 January 20305 years after publication of the implementing acts pursuant to Article 27 (4), 10 % of such packaging used is reusable packaging within a system for re- use;
Amendment 1993 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 9 – point b
Article 26 – paragraph 9 – point b
Amendment 2023 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 10 – point b
Article 26 – paragraph 10 – point b
Amendment 2057 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 12 – subparagraph 2
Article 26 – paragraph 12 – subparagraph 2
This obligation applies to pallets, boxes, excluding cardboard, trays, plastic crates, intermediate bulk containers, drums and canisters, of all sizes and materials, excluding cardboard and including flexible formats.
Amendment 2081 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 13 – subparagraph 2
Article 26 – paragraph 13 – subparagraph 2
This obligation applies to pallets, boxes, excluding cardboard, plastic crates intermediate bulk containers, and drumplastic crates, of all sizes and materials, excluding cardboard, including flexible formats.
Amendment 2107 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 15
Article 26 – paragraph 15
15. Economic operators shall be exempted from the obligation to meet the targets in paragraphs 2 to 6 if, during a calendar year, they have a sales area of not more than 100 m2, including also all storage and dispatch areas and if it is not technically feasible to use reusable packaging or to obtain access to the infrastructure necessary for the functioning of a re-use system.
Amendment 2117 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 15 a (new)
Article 26 – paragraph 15 a (new)
15a. Economic operators shall be exempted from the obligation to meet the targets in this article when duly justified by concerns related to public health, food hygiene and safety, product integrity or environmental issues.
Amendment 2121 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 15 b (new)
Article 26 – paragraph 15 b (new)
15b. Economic operators shall be exempted from the obligation to meet the targets in this article if, in accordance with paragraph 2 of Article 4 of Directive 2008/98/EC, they can show that alternative packaging formats deliver a better overall environmental outcome justified by life-cycle thinking, as well as a better overall economic and human health impact.
Amendment 2126 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 15 c (new)
Article 26 – paragraph 15 c (new)
15c. Economic operators shall be exempted from the obligation to meet the targets in this article for specific packaging formats if, by 2025 and for at least three consecutive calendar years, the Member State in which they operate has already attained the recycling target of the respective packaging material set for 2030, as required under article 46(1) point (d).
Amendment 2133 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 16 – point a
Article 26 – paragraph 16 – point a
Amendment 2145 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 16 – point c
Article 26 – paragraph 16 – point c
Amendment 2216 #
2022/0396(COD)
Proposal for a regulation
Article 38 – paragraph 1 – introductory part
Article 38 – paragraph 1 – introductory part
1. Each Member State shall reduce the packaging waste generated per capita, as compared to the packaging waste generated per capita in 2018the year of entry into force of this Regulation as reported to the Commission in accordance with Decision 2005/270/EC, for each of the different materials contained in packaging waste detailed in Article 46, by
Amendment 2223 #
Amendment 2229 #
Amendment 2241 #
Amendment 2264 #
2022/0396(COD)
Proposal for a regulation
Article 38 – paragraph 5
Article 38 – paragraph 5
Amendment 2300 #
2022/0396(COD)
Proposal for a regulation
Article 43 – paragraph 1
Article 43 – paragraph 1
1. By 2030, Member States shall ensure that systems and infrastructures are set up to provide for the return and separate collection of 90% of all packaging waste from the end users in a given year for each packaging format listed in Table 1 of Annex II, in order to ensure that it is treated in accordance with Articles 4 and 13 of Directive 2008/98/EC, and to facilitate its preparation for re-use and high quality recycling. Packaging that comply with Design for Recycling criteria, as defined in the standards resulting from Article 6(4), shall be collected to ensure recycling.
Amendment 2346 #
2022/0396(COD)
Proposal for a regulation
Article 43 – paragraph 1
Article 43 – paragraph 1
1. By 2030, Member States shall ensure that systems and infrastructures are set up to provide for the return and separate collection of 90% of all packaging waste from the end users in a given year for each packaging format listed in Table 1 of Annex II, in order to ensure that it is treated in accordance with Articles 4 and 13 of Directive 2008/98/EC, and to facilitate its preparation for re-use and high quality recycling. Packaging that comply with Design for Recycling criteria, as defined in the standards resulting from Article 6(4), shall be collected to ensure recycling.
Amendment 2692 #
2022/0396(COD)
Proposal for a regulation
Annex II – Table 2 – row 1
Annex II – Table 2 – row 1
Recyclability Assessment of recyclability per unit, in weight Performance Grade
Amendment 2694 #
2022/0396(COD)
Proposal for a regulation
Annex II – Table 2 – row 2
Annex II – Table 2 – row 2
Grade A hHigher or equal to 95 % st compatibility with design for recycling
Amendment 2697 #
2022/0396(COD)
Proposal for a regulation
Annex II – Table 2 – row 3
Annex II – Table 2 – row 3
Grade B hHigher or equal to 90 % to medium compatibility with design for recycling
Amendment 2700 #
2022/0396(COD)
Proposal for a regulation
Annex II – Table 2 – row 4
Annex II – Table 2 – row 4
Amendment 2703 #
2022/0396(COD)
Proposal for a regulation
Annex II – Table 2 – row 5
Annex II – Table 2 – row 5
Grade D higher or equal to 70 % Medium to low compatibility with design for recycling
Amendment 2706 #
2022/0396(COD)
Proposal for a regulation
Annex II – Table 2 – row 6
Annex II – Table 2 – row 6
Grade E lower than 70 % Not compatible with design for recycling
Amendment 2710 #
2022/0396(COD)
Indicative parameters that may be considered, as appropriate, when establishing design criteria for recycling under Article 6 Indicative parameters that may be considered when developing design criteria for recycling under Article 6: 1. Additives 2. Labels 3. Closure systems and small parts 4. Adhesives 5. Printing inks 6. Colours 7. Material composition 8. Barriers / coatings Ease of dismantling
Amendment 2720 #
2022/0396(COD)
Proposal for a regulation
Annex V – row 2
Annex V – row 2
Amendment 2727 #
2022/0396(COD)
Proposal for a regulation
Annex V – row 3
Annex V – row 3
Amendment 2731 #
2022/0396(COD)
Proposal for a regulation
Annex V – row 4
Annex V – row 4
Amendment 2735 #
2022/0396(COD)
Proposal for a regulation
Annex V – row 5
Annex V – row 5
Shampoo bottles, hand Single use and body Single use For cosmetics, hygiene and toiletry products 5. hotel miniature lotion bottles, hotel miniature of less than 50 ml for liquid products or less plastic sachets packaging than 100 g for non-liquid products packaging around miniature bar soap