BETA

Activities of Benedek JÁVOR related to 2018/0106(COD)

Shadow opinions (2)

OPINION on the proposal for a directive of the European Parliament and of the Council on the protection of persons reporting on breaches of Union law
2016/11/22
Committee: CONT
Dossiers: 2018/0106(COD)
Documents: PDF(345 KB) DOC(167 KB)
OPINION on the proposal for a Directive of the European Parliament and of the Council on the protection of persons reporting on breaches of Union law
2016/11/22
Committee: ENVI
Dossiers: 2018/0106(COD)
Documents: PDF(421 KB) DOC(202 KB)

Amendments (110)

Amendment 88 #
Proposal for a directive
Recital 1
(1) Persons who work for an organisation or are in contact with it in the context of their work-related activities are often the first to know about threats or harm to the public interest which arise in this context. The purpose of this Directive is to create a climate of trust that enables whistleblowers to report observed or suspected breaches of law, wrongdoing, misconduct and threats to the public interest. By ‘blowing the whistle’ they play a key role in exposing and preventing breaches of the law and in safeguarding the welfare of society. However, potential whistleblowers are often discouraged from reporting their concerns or suspicions for fear of retaliation.
2018/09/14
Committee: CONT
Amendment 91 #
Proposal for a directive
Recital 5
(5) Accordingly, common minimum standards ensuring effective whistleblower protection should apply in those acts and policy areas where i) there is a need to strengthen enforcement; ii) under-reporting by whistleblowers is a key factor affecting enforcement, and iii) breaches of Union law cause serious harm toundermine the public interest.
2018/09/14
Committee: CONT
Amendment 96 #
Proposal for a directive
Recital 19
(19) Each time a new Union act for which whistleblower protection is relevant and can contribute to more effective enforcement is adopted, consideration should be given to whether to amendit should be added to the Annex to the present Directive in order to place it under its scope.
2018/09/14
Committee: CONT
Amendment 97 #
Proposal for a directive
Recital 20
(20) This Directive should be without prejudiceis a complement to the protection afforded to employees when reporting on breaches of Union employment law. In particular, in the area of occupational safety and health, Article 11 of Framework Directive 89/391/EEC already requires Member States to ensure that workers or workers' representatives shall not be placed at a disadvantage because of their requests or proposals to employers to take appropriate measures to mitigate hazards for workers and/or to remove sources of danger. Workers and their representatives are entitled to raise issues with the competent national authorities if they consider that the measures taken and the means employed by the employer are inadequate for the purposes of ensuring safety and health.
2018/09/14
Committee: CONT
Amendment 98 #
Proposal for a directive
Recital 22
(22) Persons who report information, particularly about threats or harm to the public interest obtained in the context of their work- related activities, make use of their right to freedom of expression. The right to freedom of expression, enshrined in Article 11 of the Charter of Fundamental Rights of the European Union (‘the Charter’) and in Article 10 of the European Convention on Human Rights (ECHR), encompasses freedom of information as well as media freedom and pluralism.
2018/09/14
Committee: CONT
Amendment 99 #
Proposal for a directive
Recital 24
(24) Persons need specific legal protection where they acquire the information they report through their work-related activities and theand their decision to refpore run thet it results in a risk of work-related or other retaliation (for instance, for breaching the duty of confidentiality or loyaltyEU legislation on trade secrets). The underlying reason for providing them with protection is their position of economic vulnerability vis-à-vis the person on whom they de facto depend for work. When there is no such work-related power imbalance (for instance in the case of ordinary complainants or citizen bystanders) there is no need for protection against retaliationare reporting or on whom they de facto depend for work.
2018/09/14
Committee: CONT
Amendment 102 #
Proposal for a directive
Recital 25
(25) Effective enforcement of Union law requires that protection is granted to the broadest possible range of categories of persons, who, irrespective of whether they are EU citizens or third-country nationals, by virtue of work-related activities (irrespective of the nature of these activities, whether they are paid or not), have privilegedhave access to information about breaches that would be in the public’s interest to report and who may suffer retaliation if they report them. Member States should ensure that the need for protection is determined by reference to all the relevant circumstances and not merely by reference to the nature of the relationship, so as to cover the whole range ofall persons connected in a broad sense to the organisation where the breach has occurredto the report.
2018/09/14
Committee: CONT
Amendment 104 #
Proposal for a directive
Recital 28
(28) Effective whistleblower protection implies protecting also further categories of persons who, whilst not relying on their work-related activities economically, may nevertheless suffer retaliation for exposing breaches. Retaliation against volunteers and unpaid trainees may take the form of no longer making use of their services, or of giving a negative reference for future employment or otherwise damaging their reputation. Retaliation against investigators or reporters could take the form of strategic litigation suits, for example regarding libel or defamation.
2018/09/14
Committee: CONT
Amendment 105 #
Proposal for a directive
Recital 30
(30) Effective prevention of breaches of Union law requires that protection is also granted to persons who provide information about potential breaches, which have not yet materialised, but are likely to be committed. For the same reasons, protection is warranted also for persons who do not provide positive evidence but raise reasonable concerns or suspicions. At the same time, protection should not apply to the reporting of informaunsubstantiated rumours and hearsay. Protection should be given to individuals working at institutions which is already in the public domain or of unsubstantiated rumours and hearsay. ithin the Union, but also to individuals working in European entities located outside Union territory. It should also apply to officials as well as other employees and interns working at the institutions, agencies and bodies of the Union.
2018/09/14
Committee: CONT
Amendment 112 #
Proposal for a directive
Recital 42
(42) Provided the anonymity or confidentiality of the identity of the reporting person is ensured, it is up to each individual private and public legal entity to define the kind of reporting channels to set up, such as in person, by post, by physical complaint box(es), by telephone hotline or through an online platform (intranet or internet). However, reporting channels should not be limited to those amongst the tools, such as in-person reporting and complaint box(es), which do not guarantee anonymity nor confidentiality of the identity of the reporting person.
2018/09/14
Committee: CONT
Amendment 113 #
Proposal for a directive
Recital 43
(43) Third parties may also be authorised to receive reports on behalf of private and public entities, provided they offer appropriate guarantees of respect for independence, confidentiality, the possibility for anonymity data protection and secrecy. These can be external reporting platform providers, external counsel or auditors or trade union representatives.
2018/09/14
Committee: CONT
Amendment 114 #
Proposal for a directive
Recital 44
(44) Internal reporting procedures should enable private legal entities to receive and investigate in full confidentiality and with respect of anonymity if appropriate reports by the employees of the entity and of its subsidiaries or affiliates (the group), but also, to any extent possible, by any of the group’s agents and suppliers and by any person who acquires information through his/her work-related activities with the entity and the group.
2018/09/14
Committee: CONT
Amendment 116 #
Proposal for a directive
Recital 47
(47) Persons who are considering reporting breaches of Union law should be able to make an informed decision on whether, how and when to report. Private and public entities having in place internal reporting procedures shall provide information on these procedures as well as on procedures to report externally to relevant competent authorities. They should also provide information on rights guaranteed to whistleblowers, particularly their right to disclosure guaranteed by this Directive, and their right to turn to civil society organisations involved in whistleblower protection to this end, in particular those who provide strategic and legal advice to whistleblowers .Such information must be easily understandable and easily accessible, including, to any extent possible, also to other persons, beyond employees, who come in contact with the entity through their work-related activities, such as service-providers, distributors, suppliers and business partners. For instance, such information may be posted at a visible location accessible to all these persons and to the web of the entity and may also be included in courses and trainings on ethics and integrity.
2018/09/14
Committee: CONT
Amendment 117 #
Proposal for a directive
Recital 48
(48) Effective detection and prevention of breaches of Union law requires ensuring that potential whistleblowers can easily and in full confidentiality and anonymity bring the information they possess to the attention of the relevant competent authorities which are able to investigate and to remedy the problem, where possible.
2018/09/14
Committee: CONT
Amendment 118 #
Proposal for a directive
Recital 48 a (new)
(48a) In all cases, the reporting person should be informed of the investigation’s progress and should be able to access the draft report at least once so as to be able to revise it, comment on it and correct it if necessary, albeit with no obligation to do so. These comments must be incorporated and taken into account in the monitoring of the investigation. The reporting person should be informed of the investigation's outcome and should be able to revise and comment on the final report of the investigation. These comments must be included in the final report.
2018/09/14
Committee: CONT
Amendment 122 #
Proposal for a directive
Recital 58
(58) Protection of personal data of the reporting and concerned person, as well as of the report itself is crucial in order to avoid unfair treatment or reputational damages due to disclosure of personal data, in particular data revealing the identity of a person concerned. Hence, in line with the requirements of Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation, hereinafter also referred to as 'GDPR'), competent authorities should establish adequate data protection procedures specifically geared to the protection of the reporting person, the concerned person and any third person referred to in the report that should include a secure system within the competent authority with restricted access rights for authorised staff only.
2018/09/14
Committee: CONT
Amendment 123 #
Proposal for a directive
Recital 59
(59) The regular review of the procedures of competent authorities and the exchange of good practices between them and competent civil society organisations should guarantee that those procedures are adequate and thus serving their purpose.
2018/09/14
Committee: CONT
Amendment 125 #
Proposal for a directive
Recital 61
(61) The requirement of a tiered use of reporting channels, as a general rule, is necessary to ensure that the information gets to the persons who can contribute to the early and effective resolution of risks to the public interest as well as to prevent unjustified reputational damage from public disclosure. At the same time, some exceptions to its application are necessary, allowing the reporting person to choose the most appropriate channel depending on the individual circumstances of the case. Moreover, iIt is necessary to protect public disclosures taking into account democratic principles such as transparency and accountability, and fundamental rights such as freedom of expression and media freedom, whilst balancing the interest of employers to manage their organisations and to protect their interests with the interest of the public to be protected from harm, in line with the criteria developed in the case-law of the European Court of Human Rights57 . _________________ 57 One of the criteria for determining whether retaliation against whistleblowers making public disclosures interferes with freedom of expression in a way which is not necessary in a democratic society, is whether the persons who made the disclosure had at their disposal alternative channels for making the disclosure; see, for instance, Guja v. Moldova [GC], no 14277/04, ECHR 2008.
2018/09/14
Committee: CONT
Amendment 126 #
Proposal for a directive
Recital 62
(62) As a rule, reporting persons should first use the internal channels at their disposal and report to their employer. However, it may be the case that internal channels do not exist (in case of entities which are not under an obligation to establish such channels by virtue of this Directive or applicable national law) or that their use is not mandatory (which may be the case for persons who are not in an employment relationship), or that they were used but did not function properly (for instance the report was not dealt with diligently or within a reasonable timeframe, or no action was taken to address the breach of law despite the positive results of the enquiry).deleted
2018/09/14
Committee: CONT
Amendment 129 #
Proposal for a directive
Recital 63
(63) In other cases, internal channels could not reasonably be expected to function properly, for instance, where the reporting persons have valid reasons to believe that they would suffer retaliation in connection with the reporting; that their confidentiality would not be protected; that the ultimate responsibility holder within the work-related context is involved in the breach; that the breach might be concealed; that evidence may be concealed or destroyed; that the effectiveness of investigative actions by competent authorities might be jeopardised or that urgent action is required (for instance because of an imminent risk of a substantial and specific danger to the life, health and safety of persons, or to the environment. In all such cases, persons reporting externally to the competent authorities and, where relevant, to bodies, offices or agencies of the Union shall be protected. Moreover, protection is also to be granted in cases where Union legislation allows for the reporting person to report directly to the competent national authorities or bodies, offices or agencies of the Union, for example in the context of fraud against the Union budget, prevention and detection of money laundering and terrorist financing or in the area of financial services.deleted
2018/09/14
Committee: CONT
Amendment 132 #
Proposal for a directive
Recital 65
(65) Reporting persons should be protected against any form of retaliation, whether direct or indirect, taken by their employer or customer/recipient of services and by persons working for or acting on behalf of the latter, including co-workers and managers in the same organisation or in other organisations with which the reporting person is in contact in the context of his/her work-related activities, where retaliation is recommended or tolerated by the concerned person. Protection should be provided against retaliatory measures taken vis-à-vis the reporting person him/herself but also those that may be taken vis-à-vis the legal entity he/she represents, such as denial of provision of services, blacklisting or business boycotting. Protection against retaliation should also be granted to natural or legal persons closely linked to the reporting person, irrespective of the nature of the activities, and whether they are paid or not. Indirect retaliation also includes actions taken against relatives of the reporting person who are also in a work-related connection with the latter’s employer or customer/recipient of services and workers’ representatives who have provided support to the reporting person.
2018/09/14
Committee: CONT
Amendment 134 #
Proposal for a directive
Recital 67
(67) Potential whistleblowers who are not sure about how to report or whether they will be protected in the end may be discouraged from reporting. Member States should ensure that relevant information is provided in a user-friendly way and is easily accessible to the general public and support the work of CSOs providing this information. Individual, impartial and confidential advice, free of charge, should be available on, for example, whether the information in question is covered by the applicable rules on whistleblower protection, which reporting channel may best be used and which alternative procedures are available in case the information is not covered by the applicable rules (‘signposting’). Access to such advice can help ensure that reports are made through the appropriate channels, in a responsible manner and that breaches and wrongdoings are detected in a timely manner or even prevented.
2018/09/14
Committee: CONT
Amendment 138 #
Proposal for a directive
Recital 74
(74) Action taken against reporting persons outside the work-related context, through proceedings, for instance, related to defamation, breach of copyright, trade secrets, confidentiality and personal data protection, can also pose a serious deterrent to whistleblowing. The protection of whistleblowers provided for in this Directive shall prevail over Directive (EU) 2016/943 of the European Parliament and of the Council58 exempts reporting persons from the civil redress measures, procedures and remedies it provides for that, in case the alleged acquisition, use or disclosure of the trade secret was carried out for revealingcan reasonably be assumed to serve as proof of actual misconduct, wrongdoing or illegal activity, provided that the respondent acted for the purpose of protecting the general public interest. Also in other proceedings, reporting persons should be able to rely on having made a report or disclosure in accordance with this Directive as a defence. In such cases, the person initiating the proceedings should carry the burden to prove any intent on the part of the reporting person to violate the law. _________________ 58 Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1).
2018/09/14
Committee: CONT
Amendment 140 #
Proposal for a directive
Recital 78
(78) Penalties are necessary to ensure the effectiveness of the rules on whistleblower protection. Penalties against those who take retaliatory or other adverse actions against reporting persons can discourage further such actions. Penalties against persons who make a report or disclosure demonstrated to be knowingly false are necessary to deter further malicious reporting and preserve the credibility of the system. The proportionality of such penalties should ensure that they do not have a dissuasive effect on potential whistleblowers.
2018/09/14
Committee: CONT
Amendment 144 #
Proposal for a directive
Article 1 – paragraph 1 – introductory part
1. With a view to enhancing the enforcement of Union law and policies in specific areas, this Directive lays down common minimum standards for the protection of persons reporting on the following unlawful activities or, abuse of law or threats to the public interest, including:
2018/09/14
Committee: CONT
Amendment 146 #
Proposal for a directive
Article 1 – paragraph 1 – point a – introductory part
(a) breaches falling within the scope of the Union acts set out in the Annex (Part I and Part II) as regards, including but not limited to the following areas:
2018/09/14
Committee: CONT
Amendment 148 #
Proposal for a directive
Article 1 – paragraph 1 – point a – point ii
(ii) financial services, prevention of money laundering and terrorist financing;, corruption and organised crime
2018/09/14
Committee: CONT
Amendment 149 #
Proposal for a directive
Article 1 – paragraph 1 – point a – point v
(v) protection of the environment, sustainable development, waste management, sea, air and noise pollution, protection and management of water and soils, protecting the natural world and biodiversity as well as combating climate change and wildlife crime;
2018/09/14
Committee: CONT
Amendment 150 #
Proposal for a directive
Article 1 – paragraph 1 – point a – point viii
(viii) public health or public safety;
2018/09/14
Committee: CONT
Amendment 151 #
Proposal for a directive
Article 1 – paragraph 1 – point a – point x a (new)
(xa) employment and working conditions;
2018/09/14
Committee: CONT
Amendment 152 #
Proposal for a directive
Article 1 – paragraph 1 – point a – point x b (new)
(xb) tax fraud, tax evasion and tax optimisation
2018/09/14
Committee: CONT
Amendment 153 #
Proposal for a directive
Article 1 – paragraph 1 – point a – point x c (new)
(xc) violations of human rights or of the rights enshrined in the European Charter of Fundamental Rights;
2018/09/14
Committee: CONT
Amendment 154 #
Proposal for a directive
Article 1 – paragraph 1 – point a – point x d (new)
(xd) company law;
2018/09/14
Committee: CONT
Amendment 155 #
Proposal for a directive
Article 1 – paragraph 1 – point a – point x e (new)
(xe) asylum and migration law
2018/09/14
Committee: CONT
Amendment 156 #
(b) competition law, especially breaches of Articles 101, 102, 106, 107 and 108 TFEU and breaches falling within the scope of Council Regulation (EC) No 1/2003 and Council Regulation (EU) No 2015/1589;
2018/09/14
Committee: CONT
Amendment 157 #
Proposal for a directive
Article 1 – paragraph 1 – point d
(d) breaches relating to the internal market, as referred to in Article 26(2) TFEU, particularly as regards acts which breach the rules of corporate tax or arrangements whose purpose is to obtain a tax advantage that defeats the object or purpose of the applicable corporate tax law.
2018/09/14
Committee: CONT
Amendment 159 #
Proposal for a directive
Article 1 – paragraph 2
2. Where specific rules on the reporting of breaches are provided for in sector-specific Union acts listed in Part 2 of the Annex, those rules shall apply. The provisions of this Directive shall be applicable for all matters relating to the protection of reporting persons not regulated in those sector-specific Union acts. This paragraph shall apply only in cases where the protection foreseen in sector-specific acts is higher than the one guaranteed by this directive.
2018/09/14
Committee: CONT
Amendment 162 #
Proposal for a directive
Article 2 – paragraph 1 – point d a (new)
(da) any person fitting the descriptions in a-d presenting new information on a breach.
2018/09/14
Committee: CONT
Amendment 166 #
Proposal for a directive
Article 3 – paragraph 1 – point 1
(1) ‘breaches’ means actual or potential unlawful activities, omissions or abuse of law relating to the Union acts and, notably in areas falling within the scope referred to in Article 1 and in the Annex;
2018/09/14
Committee: CONT
Amendment 167 #
Proposal for a directive
Article 3 – paragraph 1 – point 5
(5) ‘report’ means the provision of information relating to a breach which has occurred or is likely to occur in the organisation at which the reporting person works or has worked or in another organisation with which he or she is or was in contact through his or her work;and/or in the event of a serious, imminent threat or where there is a risk of irreversible damage to human life, the environment and/or public health
2018/09/14
Committee: CONT
Amendment 168 #
Proposal for a directive
Article 3 – paragraph 1 – point 9
(9) ‘reporting person’ means a natural or legal person who reports or discloses information on breaches acquired in the context of his or her work-related activiti, or who contributes, assists or aids to reveal or make public information on breaches;
2018/09/14
Committee: CONT
Amendment 170 #
Proposal for a directive
Article 3 – paragraph 1 – point 12
(12) ‘retaliation’ means any threatened or actual act or omission prompted by the internal or, external reporting which occurs in a work-related context andor disclosure and which causes or may cause unjustified detriment to the reporting person, suspected reporting person or their family members, relatives and facilitators;
2018/09/14
Committee: CONT
Amendment 173 #
Proposal for a directive
Article 4 – paragraph 2
2. Such channels and procedures shall 2. allow for reporting by employees of the entity. They mayshall allow for reporting by other persons who are in contact with the entity in the context of their work-related activities, referred to in Article 2(1)(b),(c) and (d), but the use of internal channels for reporting shall not be mandatory for these categories of persons.
2018/09/14
Committee: CONT
Amendment 174 #
Proposal for a directive
Article 4 – paragraph 3 – point c a (new)
(ca) private legal entities of any size whose conducted activities are likely to constitute a danger to the environment or to public health
2018/09/14
Committee: CONT
Amendment 176 #
(da) European Union institutions, agencies and bodies.
2018/09/14
Committee: CONT
Amendment 179 #
Proposal for a directive
Article 5 – paragraph 1 – point c
(c) diligent follow up to the report by the designated person or department and appropriate and timely action if needed;
2018/09/14
Committee: CONT
Amendment 182 #
Proposal for a directive
Article 5 – paragraph 2 – subparagraph 1 – point a
(a) written reports in electronic or paper format and/or oral report through telephone lines, whether recorded or unrecorded; in case the phone conversation is recorded, the prior consent of the reporting person is necessary;
2018/09/14
Committee: CONT
Amendment 183 #
Proposal for a directive
Article 5 – paragraph 2 – subparagraph 1 – point b
(b) physical meetings with the person or department designated to receive reports accompanied, if the reporting person requests it, by a union representative, by a representative of civil society or his/her legal representative.
2018/09/14
Committee: CONT
Amendment 184 #
Proposal for a directive
Article 5 – paragraph 3 a (new)
3a. Member States shall ensure the protection of report to an employer other than his or her direct employer where there are multiple organisations or employers involved and the worker reasonably believes the information relates solely or mainly to the conduct of that person or organisation, or is a matter for which that person or organisation has legal responsibility. Any such disclosure shall be treated as internal reporting.
2018/09/14
Committee: CONT
Amendment 185 #
Proposal for a directive
Article 6 – paragraph 2 – point a
(a) establish independent and autonomous external reporting channels, which are both secure and ensure confidentiality, for receiving and handling information provided by the reporting person and allow for anonymous reporting;
2018/09/14
Committee: CONT
Amendment 186 #
Proposal for a directive
Article 6 – paragraph 2 – point b
(b) acknowledge receipt of the report within 5 working days, give feedback to the reporting person about the follow-up of the report within a reasonable timeframe not exceeding three months or six months in duly justified casewo months;
2018/09/14
Committee: CONT
Amendment 187 #
Proposal for a directive
Article 6 – paragraph 4
4. Member States shall ensure that any authority which has received a report but does not have the competence to address the breach reported transmits it to the competent authority and that the reporting person is informed. Member States shall ensure that competent authorities receiving reports they do not have competence to address have clear procedures for handling all disclosed information securely with due regard to confidentiality or anonymity.
2018/09/14
Committee: CONT
Amendment 188 #
Proposal for a directive
Article 7 – paragraph 1 – point c a (new)
(ca) they guarantee free and independent advice and legal support for reporting persons and intermediaries.
2018/09/14
Committee: CONT
Amendment 189 #
Proposal for a directive
Article 7 – paragraph 2 – point c
(c) physical meeting with dedicated staff members of the competent authority accompanied, if the reporting person requests it, by a union representative by a representative of civil society or his/her legal representative.
2018/09/14
Committee: CONT
Amendment 190 #
Proposal for a directive
Article 7 – paragraph 4
4. Member States and EU Bodies shall establish procedures to ensure that, where a report being initially addressed to a person who has not been designated as responsible handler for reports that person is refrained from disclosing any information that might identify the reporting or the concerned person.
2018/09/14
Committee: CONT
Amendment 191 #
Proposal for a directive
Article 8 – paragraph 1
1. Member States shall ensure that competent authorities have an adequate number of competent staff members dedicated to handling reports. Dedicated staff members shall receive specific training for the purposes of handling reports.
2018/09/14
Committee: CONT
Amendment 193 #
Proposal for a directive
Article 13 – paragraph 1
1. A reporting person shall qualify for protection under this Directive provided he or she has reasonable grounds to believe that the information reported was true at the time of reporting and that this information falls within the scope of this Directive, regardless of the reporting channel chosen.
2018/09/14
Committee: CONT
Amendment 195 #
Proposal for a directive
Article 13 – paragraph 2 – introductory part
2. A person reporting externallywho anonymously disclosed information that falls within the scope of this directive and whose identity was revealed shall also qualify for protection under this Ddirective where one of the following conditions is fulfilled :.
2018/09/14
Committee: CONT
Amendment 196 #
Proposal for a directive
Article 13 – paragraph 2 – point a
(a) he or she first reported internally but no appropriate action was taken in response to the report within the reasonable timeframe referred in Article 5;deleted
2018/09/14
Committee: CONT
Amendment 197 #
Proposal for a directive
Article 13 – paragraph 2 – point b
(b) internal reporting channels were not available for the reporting person or the reporting person could not reasonably be expected to be aware of the availability of such channels;deleted
2018/09/14
Committee: CONT
Amendment 198 #
Proposal for a directive
Article 13 – paragraph 2 – point c
(c) the use of internal reporting channels was not mandatory for the reporting person, in accordance with Article 4(2);deleted
2018/09/14
Committee: CONT
Amendment 199 #
Proposal for a directive
Article 13 – paragraph 2 – point d
(d) he or she could not reasonably be expected to use internal reporting channels in light of the subject-matter of the report;deleted
2018/09/14
Committee: CONT
Amendment 201 #
Proposal for a directive
Article 13 – paragraph 2 – point e
(e) he or she had reasonable grounds to believe that the use of internal reporting channels could jeopardise the effectiveness of investigative actions by competent authorities;deleted
2018/09/14
Committee: CONT
Amendment 202 #
Proposal for a directive
Article 13 – paragraph 2 – point f
(f) he or she was entitled to report directly through the external reporting channels to a competent authority by virtue of Union law.deleted
2018/09/14
Committee: CONT
Amendment 203 #
Proposal for a directive
Recital 1
(1) Persons who work for an organisation or are in contact with it in the context of their work-related activities are often the first to know about threats or harm to the public interest which arise in this context. By ‘blowing the whistle’ they play a key role in exposing and preventing breaches of the law and in safeguarding the welfare of society. However, potential whistleblowers are often discouraged from reporting their concerns or suspicions for fear of retaliation. The purpose of this Directive is to create a climate of trust that enables whistleblowers to report observed or suspected breaches of law, as well as threats to the public interest.
2018/07/04
Committee: ENVI
Amendment 204 #
Proposal for a directive
Article 13 – paragraph 4
4. A person publicly disclosing information on breaches falling within the scope of this Directive shall qualify for protection under this Directive where: (a) and/or externally in accordance with Chapters II and III and paragraph 2 of this Article, but no appropriate action was taken in response to the report within the timeframe referred to in Articles 6(2)(b) and 9(1)(b); or (b) expected to use internal and/or external reporting channels due to imminent or manifest danger for the public interest, or to the particular circumstances of the case, or where there is a risk of irreversible damage.deleted he or she first reported internally he or she could not reasonably be
2018/09/14
Committee: CONT
Amendment 207 #
Proposal for a directive
Recital 3
(3) In certain policy areas, breaches of Union law may cause serious harm to the public interest, in the sense of creating significant risks for the welfare of society. Where weaknesses of enforcement have been identified in those areas, and whistleblowers are in a privileged position to disclose breaches, it is necessary to enhance enforcement by ensuring effective protection of whistleblowers from retaliation and introducingto ensure that there are effective reporting channels.
2018/07/04
Committee: ENVI
Amendment 210 #
Proposal for a directive
Article 15 – paragraph 7
7. In addition to the exemption from measures, procedures and remedies provided for in Directive (EU) 2016/943, in judicial proceedings, including for defamation, breach of copyright, breach of secrecy or for compensation requests based on private, public, or on collective labour law, reporting persons shall have the right to rely on having made a report or disclosure in accordance with this Directive to seek dismissal. The reporting persons shall benefit from the best protective measures in Member States where the entity in question, or the group of which it is a subsidiary, are located wherever relevant.
2018/09/14
Committee: CONT
Amendment 211 #
Proposal for a directive
Article 16 a (new)
Article 16a Rights of Persons Implicated Member States shall ensure that any findings or reports resulting from an assessment or an investigation of, or prompted by, one or more protected disclosure(s) does not unjustly prejudice any individual, whether directly or indirectly. The right to a fair hearing or trial shall also be fully respected.
2018/09/14
Committee: CONT
Amendment 212 #
Proposal for a directive
Article 17 – paragraph 1 – point d
(d) breach the duty of maintaining the confidentiality or the anonymity of the identity of reporting persons.
2018/09/14
Committee: CONT
Amendment 213 #
Proposal for a directive
Recital 10
(10) Evidence-gathering, detecting and addressing environmental crimes and unlawful conduct or omission as well as potential breaches against the protection of the environment remain a challenge and need to be reinforced as acknowledged in the Commission Communication "EU actions to improve environmental compliance and governance" of 18 January 201840 . Whilst whistleblower protection rules exist at present only in one sectorial instrument on environmental protection41 , the introduction of such protection appears necessary to ensure effective enforcement of the Union environmental acquis, whose breaches can cause serious harm to the public interest with possible spill-over impacts across national borders. This is also relevant in cases where unsafe products can cause environmental harm. _________________ 40 COM(2018) 10 final. COM(2018) 10 final. 41 Directive 2013/30/EU of the European Parliament and of the Council, of 12 June 2013, on safety of offshore oil and gas operations (OJ L 178, p. 66).
2018/07/04
Committee: ENVI
Amendment 217 #
Proposal for a directive
Article 17 – paragraph 2
2. Member States shall provide for effective, proportionate and dissuasive penalties applicable to persons making malicious or abusive reports or disclosures, including measures for compensating persons who have suffered damage from malicious or abusive reports or disclosures by retaining the protection and applying the rules of general law.
2018/09/14
Committee: CONT
Amendment 218 #
Proposal for a directive
Article 17 a (new)
Article 17a No Waiver of Rights and Remedies The rights and remedies provided for under this Directive may not be waived or limited by any agreement, policy, form or condition of employment, including by any pre-dispute arbitration agreement. Any attempt to waive or limit these rights and remedies shall be considered void and unenforceable and may be subject to penalty or sanction.
2018/09/14
Committee: CONT
Amendment 220 #
Proposal for a directive
Article 22 a (new)
Article 22a Updating the Annexes Whenever a new EU legal act falls into the material scope laid down in Article 1 (1) (a) or Article 1 (2), the Commission shall update the Annexes accordingly via a delegated act.
2018/09/14
Committee: CONT
Amendment 224 #
Proposal for a directive
Recital 47
(47) Persons who are considering reporting breaches of Union law should be able to make an informed decision on whether, how and when to report. Private and public entities having in place internal reporting procedures shall provide information on these procedures as well as on procedures to report externally to relevant competent authorities. Such information must be easily understandable and easily accessible, including, to any extent possible, also to other persons, beyond employees, who come in contact with the entity through their work-related activities, such as service-providers, distributors, suppliers and business partners. For instance, such information may be posted at a visible location accessible to all these persons and to the web of the entity and may also be included in courses and trainings on ethics and integrity. They should also provide information on rights guaranteed to whistleblowers, particularly their right to disclosure guaranteed by this Directive, and their right to turn to civil society organisations involved in whistleblower protection to this end, in particular those who provide strategic and legal advice to whistleblowers .
2018/07/04
Committee: ENVI
Amendment 225 #
Proposal for a directive
Recital 48 a (new)
(48 a) In all cases, the reporting person should be informed of the investigation’s progress and should be able to access the draft report at least once so as to be able to revise it, comment on it and correct it if necessary, albeit with no obligation to do so. These comments must be incorporated and taken into account in the monitoring of the investigation. The reporting person should be informed of the investigation's outcome and should be able to revise and comment on the final report of the investigation. These comments must be included in the final report.
2018/07/04
Committee: ENVI
Amendment 228 #
Proposal for a directive
Recital 62
(62) As a rule, reporting persons should first use the internal channels at their disposal and report to their employer. However, it may be the case that internal channels do not exist (in case of entities which are not under an obligation to establish such channels by virtue of this Directive or applicable national law) or that their use is not mandatory (which may be the case for persons who are not in an employment relationship), or that they were used but did not function properly (for instance the report was not dealt with diligently or within a reasonable timeframe, or no action was taken to address the breach of law despite the positive results of the enquiry).deleted
2018/07/04
Committee: ENVI
Amendment 229 #
Proposal for a directive
Recital 63
(63) In other cases, internal channels could not reasonably be expected to function properly, for instance, where the reporting persons have valid reasons to believe that they would suffer retaliation in connection with the reporting; that their confidentiality would not be protected; that the ultimate responsibility holder within the work-related context is involved in the breach; that the breach might be concealed; that evidence may be concealed or destroyed; that the effectiveness of investigative actions by competent authorities might be jeopardised or that urgent action is required (for instance because of an imminent risk of a substantial and specific danger to the life, health and safety of persons, or to the environment. In all such cases, persons reporting externally to the competent authorities and, where relevant, to bodies, offices or agencies of the Union shall be protected. Moreover, protection is also to be granted in cases where Union legislation allows for the reporting person to report directly to the competent national authorities or bodies, offices or agencies of the Union, for example in the context of fraud against the Union budget, prevention and detection of money laundering and terrorist financing or in the area of financial services.deleted
2018/07/04
Committee: ENVI
Amendment 230 #
Proposal for a directive
Recital 65
(65) Reporting persons should be protected against any form of retaliation, whether direct or indirect, taken by their employer or customer/recipient of services and by persons working for or acting on behalf of the latter, including co-workers and managers in the same organisation or in other organisations with which the reporting person is in contact in the context of his/her work-related activities, where retaliation is recommended or tolerated by the concerned person. Protection should be provided against retaliatory measures taken vis-à-vis the reporting person him/herself but also those that may be taken vis-à-vis the legal entity he/she represents, such as denial of provision of services, blacklisting or business boycotting. Protection against retaliation should also be granted to natural or legal persons closely linked to the reporting person, irrespective of the nature of the activities, and whether they are paid or not. Indirect retaliation also includes actions taken against relatives of the reporting person who are also in a work-related connection with the latter’s employer or customer/recipient of services and workers’ representatives who have provided support to the reporting person.
2018/07/04
Committee: ENVI
Amendment 233 #
Proposal for a directive
Article 1 – paragraph 1 – point a – introductory part
a) breaches falling within the scope of the Union acts, and especially those set out in the Annex (Part I and Part II) as regards the following areas:
2018/07/04
Committee: ENVI
Amendment 235 #
Proposal for a directive
Article 1 – paragraph 1 – point a – point v
(v) protection of the environment, sustainable development, waste management, sea, air and noise pollution, protection and management of water and soils, protecting the natural world and biodiversity as well as combating climate change and wildlife crime;
2018/07/04
Committee: ENVI
Amendment 236 #
Proposal for a directive
Article 1 – paragraph 2
2. Where specific rules on the reporting of breaches are provided for in sector-specific Union acts listed in Part 2 of the Annex, those rules shall apply. The provisions of this Directive shall be applicable for all matters relating to the protection of reporting persons not regulated in those sector-specific Union acts. This paragraph shall apply only in cases where the protection foreseen in sector-specific acts is higher than the one guaranteed by this directive.
2018/07/04
Committee: ENVI
Amendment 238 #
Proposal for a directive
Article 3 – paragraph 1 – point 3
(3) ‘abuse of law’ means acts or omissions falling within the scope of Union law which do not appear to be unlawful in formal terms but defeat the object or the purpose pursued by the applicable rules, or represent a danger or a potential danger to the public interest;
2018/07/04
Committee: ENVI
Amendment 241 #
Proposal for a directive
Article 3 – paragraph 1 – point 5
(5) ‘report’ means the provision of information relating to a breach which has occurred or is likely to occur in the organisation at which the reporting person works or has worked orand/or in the event of a serious, imminent threat or where there ins another organisation with which he or she is or was in contact through his or her work risk of irreversible damage to the environment and/or public health;
2018/07/04
Committee: ENVI
Amendment 242 #
Proposal for a directive
Article 3 – paragraph 1 – point 9
(9) ‘reporting person’ means a natural or legal person who reports or discloses information on breaches acquired in the context of his or her work-related activities; who contributes, assists or aids to reveal or make public information on breaches; as well as persons representing the reporting person and family and relatives of the reporting person;
2018/07/04
Committee: ENVI
Amendment 243 #
Proposal for a directive
Article 4 – paragraph 6 – point d a (new)
d a) European Union institutions, agencies and bodies;
2018/07/04
Committee: ENVI
Amendment 244 #
Proposal for a directive
Article 5 – paragraph 1 – point c
c) diligent follow up to the report by the designated person or department and appropriate and timely action if needed;
2018/07/04
Committee: ENVI
Amendment 245 #
Proposal for a directive
Article 5 – paragraph 1 – point d
d) a reasonable timeframe, not exceeding 30 days or three months following the report,in duly justified cases following the report, with an acknowledgement of the report within 30 days to provide feedback to the reporting person about the follow-up to the report;
2018/07/04
Committee: ENVI
Amendment 249 #
Proposal for a directive
Article 13 – paragraph 2
2. A person reporting externally shall qualify for protection under this Directive where one of the following conditions is fulfilled : a) he or she first reported internally but no appropriate action was taken in response to the report within the reasonable timeframe referred in Article 5; b) internal reporting channels were not available for the reporting person or the reporting person could not reasonably be expected to be aware of the availability of such channels; c) the use of internal reporting channels was not mandatory for the reporting person, in accordance with Article 4(2); d) he or she could not reasonably be expected to use internal reporting channels in light of the subject-matter of the report; e) he or she had reasonable grounds to believe that the use of internal reporting channels could jeopardise the effectiveness of investigative actions by competent authorities; f) he or she was entitled to report directly through the external reporting channels to a competent authority by virtue of Union law.deleted
2018/07/04
Committee: ENVI
Amendment 250 #
Proposal for a directive
Article 13 – paragraph 2 a (new)
2 a. A person who anonymously disclosed information that falls within the scope of this directive and whose identity was revealed shall also qualify for protection under this Directive.
2018/07/04
Committee: ENVI
Amendment 251 #
Proposal for a directive
Article 13 – paragraph 3
3. A person reporting to relevant bodies, offices or agencies of the Union on breaches falling within the scope of this Directive shall qualify for protection as laid down in this Directive under the same conditions as a person who reported externally in accordance with the conditions set out in paragraph 2.deleted
2018/07/04
Committee: ENVI
Amendment 252 #
Proposal for a directive
Article 13 – paragraph 4 – point b
b) he or she could not reasonably be expected to use internal and/or external reporting channels due, for instance, to imminent or manifest danger for the public interest, or to the particular circumstances of the case, or where there is a risk of irreversible damage.
2018/07/04
Committee: ENVI
Amendment 260 #
Proposal for a directive
Article 22 a (new)
Article 22 a Delegated acts to update the annex Whenever a new EU legal act falls into the material scope laid down in Article 1 (1) (a) or Article 1 (2), the Commission shall update the Annexes accordingly via a delegated act.
2018/07/04
Committee: ENVI
Amendment 261 #
Proposal for a directive
Annex I – part I – subpart A – point 1 – introductory part
1. Procedures for procurement relating to supplies contracts for defence products and supplies and services contracts for water, energy, transport and postal services and any other contract or service as regulated in particular under Union legislation:
2018/07/04
Committee: ENVI
Amendment 262 #
Proposal for a directive
Annex I – part I – subpart A – point 2 – introductory part
2. Review procedures regulated in particular by:
2018/07/04
Committee: ENVI
Amendment 263 #
Proposal for a directive
Annex I – part I – subpart C – point 1 – introductory part
1. General safety requirements of products placed in the Union market as defined and regulated in particular by:
2018/07/04
Committee: ENVI
Amendment 264 #
Proposal for a directive
Annex I – part I – subpart D – point 3 – introductory part
3. Safety requirements in the road sector as regulated in particular by:
2018/07/04
Committee: ENVI
Amendment 265 #
Proposal for a directive
Annex I – part I – subpart E – title
E Article 1(a)(v) – protection of the environment:, sustainable development, waste management, sea, air and noise pollution, protection and management of water and soils, protecting the natural world and biodiversity as well as combating climate change and wildlife crime;
2018/07/04
Committee: ENVI
Amendment 266 #
Proposal for a directive
Annex I – part I – subpart E – point ix a (new)
(ix a) Other legislative acts relevant to the protection of the environment, sustainable development, waste management, sea, air and noise pollution, protection and management of water and soils, protecting the natural world and biodiversity as well as combating climate change and wildlife crime, in particular: Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein Commission Regulation (EC) No 865/2006 of 4 May 2006laying down detailed rules concerning the implementation of Council Regulation(EC) No 338/97 on the protection of species of wild fauna and flora by regulating trade therein Council Regulation (EC) No 1005/2008 of 29 September2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing, amending Regulations (EEC) No 2847/93,(EC) No 1936/2001 and (EC) No 601/2004 and repealing Regulations (EC)No 1093/94 and (EC) No 1447/1999 Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7) Directive2009/147/EC of the European Parliament and of the Council of 30 November 2009on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7) Regulation(EU) No 1143/2014 of the European Parliament and of the Council of 22 October2014 on the prevention and management of the introduction and spread of invasive alien species (OJ L 317, 4.11.2014, p. 35) Council Regulation (EC) No 1936/2001 of 27 September 2001 laying down control measures applicable to fishing for certain stocks of highly migratory fish (OJ L 263,3.10.2001, p. 1) Council Regulation (EC) No 1239/98 of 8 June 1998 amending Regulation (EC) No 894/97laying down certain technical measures for the conservation of fishery resources Council Regulation (EC) No 708/2007 of 11 June 2007 concerning use of alien and locally absent species in aquaculture (OJ L 168, 28.6.2007, p. 1) Council Directive 83/129/EC of 28 March 1983 concerning the importation into Member States of skins of certain seal pups and products derived therefrom (OJ L 91,9.4.1983, p. 30) Regulation(EC) No 1007/2009 of the European Parliament and of the Council of 16 September2009 on trade in seal products (OJ L 286, 31.10.2009, p. 36) Council Regulation (EC) No 734/2008 of 15 July 2008 on the protection of vulnerable marine ecosystems in the high seas from the adverse impacts of bottom fishing gears (OJ L 201, 30.7.2008, p. 8) Council Regulation (EC) No 812/2004 of 26 April 2004 laying down measures concerning bycatches of cetaceans in fisheries and amending Regulation (EC) No 88/98 (OJ L150, 30.4.2004, p. 12) Regulation(EC) No 1523/2007 of the European Parliament and of the Council of 11 December2007 banning the placing on the market and the import to, or export from, the Community of cat and dog fur, and products containing such fur (OJ L 343,27.12.2007, p. 1) Council Directive 1999/22/EC of 29 March 1999 relating to the keeping of wild animals in zoos (OJ L 94, 9.4.1999, p. 24) Council Regulation (EC) No 2173/2005 of 20 December 2005 on the establishment of a FLEGT licensing scheme for imports of timber into the European Community (OJ L347, 30.12.2005, p. 1) Commission Regulation (EU) No 1307/2014 of 8 December 2014 on defining the criteria and geographic ranges of highly biodiverse grassland for the purposes of Article7b(3)(c) of Directive 98/70/EC of the European Parliament and of the Council relating to the quality of petrol and diesel fuels and Article 17(3)(c) of Directive 2009/28/EC of the European Parliament and of the Council on the promotion of the use of energy from renewable sources (OJ L 351, 9.12.2014, p.3) Directive2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive90/313/EEC Regulation(EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001regarding public access to European Parliament, Council and Commission documents Regulation(EC) No 1367/2006 of the European Parliament and of the Council of 6 September2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies Directive 2003/35/EC of the European Parliament and of the Council of 26 May 2003 providing for public participation in respect of the drawing up of certain plans and programmes relating to the environment and amending with regard to public participation and access to justice Council Directives 85/337/EEC and 96/61/EC Directive 2007/2/EC of the European Parliament and of the Council of 14 March 2007establishing an Infrastructure for Spatial Information in the European Community (INSPIRE) Regulation(EU) No 1293/2013 of the European Parliament and of the Council of 11 December2013 on the establishment of a Programme for the Environment and Climate Action(LIFE) and repealing Regulation (EC) No 614/2007 Directive2009/28/EC of the European Parliament and of the Council of 23 April 2009 on the promotion of the use of energy from renewable sources and amending and subsequently repealing Directives 2001/77/EC and 2003/30/EC Directive2009/29/EC of the European Parliament and of the Council of 23 April 2009 amending Directive 2003/87/EC so as to improve and extend the greenhouse gas emission allowance trading scheme of the Community (OJ L 140, 5.6.2009, p. 63), and all related Regulations; Regulation(EU) No 421/2014 of the European Parliament and of the Council of 16 April 2014amending Directive 2003/87/EC establishing a scheme for greenhouse gas emission allowance trading within the Community, in view of the implementation by 2020of an international agreement applying a single global market-based measure to international aviation emissions (OJ L 129, 30.4.2014, p. 1); Directive2009/31/EC of the European Parliament and of the Council of 23 April 2009 on the geological storage of carbon dioxide and amending Council Directive85/337/EEC, European Parliament and Council Directives 2000/60/EC, 2001/80/EC,2004/35/EC, 2006/12/EC, 2008/1/EC and Regulation (EC) No 1013/2006 (OJ L 140,5.6.2009, p. 114); Regulation(EU) No 525/2013 of the European Parliament and of the Council of 21 May 2013on a mechanism for monitoring and reporting greenhouse gas emissions and for reporting other information at national and Union level relevant to climate change and repealing Decision No 280/2004/EC (OJ L 165, 18.6.2013, p. 13); Regulation(EU) No 517/2014 of the European Parliament and of the Council of 16 April 2014on fluorinated greenhouse gases and repealing Regulation (EC) No 842/2006 (OJ L150, 20.5.2014, p. 195) Council Directive 2003/96/EC of 27 October 2003 restructuring the Community framework for taxation of energy products and electricity (OJ L 283 of 31.10.2003 p. 51) Directive2012/27/EU of the European Parliament and of the Council of 25 October 2012 on energy efficiency, amending Directives 2009/125/EC and 2010/30/EU and repealing Directives 2004/8/EC and 2006/32/EC (OJ L 315, 14.11.2012, p. 1) Directive2008/98/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) Commission Regulation (EU) No 1357/2014 of 18 December 2014 replacing Annex III to Directive 2008/98/EC of the European Parliament and of the Council on waste and repealing certain Directives (OJ L 365, 19.12.2014, p. 89–96) Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste (OJ L 182, 16.7.1999,p. 1) Regulation(EC) No 1013/2006 of the European Parliament and of the Council of 14 June 2006on shipments of waste (OJ L 190, 12.7.2006, p. 1) European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (OJ L 365, 31.12.1994, p. 10) Directive(EU) 2015/720 of the European Parliament and of the Council of 29 April 2015amending Directive 94/62/EC as regards reducing the consumption of light weight plastic carrier bags (OJ L 115, 6.5.2015, p. 11) Directive2012/19/EU on waste electrical and electronic equipment (WEEE) (OJ L 197,24.7.2012, p. 38) Directive2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC (OJ L 266, 26.9.2006, p. 1) Directive2011/65/EU of the European Parliament and the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88) Directive2000/53/EC of the European Parliament and of the Council of 18 September 2000on end-of life vehicles (OJ L 269, 21.10.2000, p. 34) Directive2005/64/EC of the European Parliament and of the Council of 26 October 2005 on the type-approval of motor vehicles with regard to their reusability, recyclability and recoverability and amending Council Directive 70/156/EEC (OJL 310, 25.11.2005, p. 10); Council Directive 96/59/EC of 16 September 1996 on the disposal of polychlorinatedbiphenyls and polychlorinated terphenyls (PCB/PCT) (OJ L 243, 24.9.1996, p. 31) Directive2011/65/EU of the European Parliament and the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88) Council Regulation (Euratom) No 1493/93 of 8 June 1993 on shipments of radioactive substances between Member States (OJ L 148, 19.6.1993, p. 1) Directive2001/42/EC of the European Parliament and of the Council of 27 June 2001 on the assessment of the effects of certain plans and programmes on the environment(OJ L 197, 21.7.2001, p. 30) Regulation(EC) No 66/2010 of the European Parliament and of the Council of 25 November2009 on the EU Ecolabel (OJ L 27, 30.1.2010, p. 1) Directive2008/50/EC of the European Parliament and of the Council of 21 May 2008 on ambient air quality and cleaner air for Europe (OJ L 152, 11.6.2008, p. 1) Directive2004/107/EC of the European Parliament and of the Council of 15 December 2004relating to arsenic, cadmium, mercury, nickel and polycyclic aromatichydrocarbons in ambient air Regulation(EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004on persistent organic pollutants and amending Directive 79/117/EEC (OJ L 158,30.4.2004, p. 7) Regulation(EC) No 1005/2009 of the European Parliament and of the Council of 16 September2009 on substances that deplete the ozone layer (OJ L 286, 31.10.2009, p. 1) Directive2001/81/EC of the European Parliament and of the Council of 23 October 2001 on national emission ceilings for certain atmospheric pollutants (OJ L 309,27.11.2001, p. 22) European Parliament and Council Directive 94/63/EC of 20 December 1994 on the control of volatile organic compound (VOC) emissions resulting from the storage of petrol and its distribution from terminals to service stations (OJ L 365, 31.12.1994,p. 24) Directive98/70/EC of the European Parliament and of the Council of 13 October 1998relating to the quality of petrol and diesel fuels and amending Council Directive 93/12/EEC Directive2009/126/EC of the European Parliament and of the Council of 21 October 2009 on Stage II petrol vapour recovery during refuelling of motor vehicles at service stations (OJ L 285, 31.10.2009, p. 36) Regulation(EC) No 715/2007 of the European Parliament and of the Council of 20 June 2007on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information (OJ L 171, 29.6.2007, p. 1) Regulation(EC) No 595/2009 of the European Parliament and of the Council of 18 June 2009on type-approval of motor vehicles and engines with respect to emissions from heavy duty vehicles (Euro VI) and on access to vehicle repair and maintenance information and amending Regulation (EC) No 715/2007 and Directive 2007/46/EC and repealing Directives 80/1269/EEC, 2005/55/EC and 2005/78/EC (OJ L 188,18.7.2009, p. 1) Directive2014/94/EU of the European Parliament and of the Council of 22 October 2014 on the deployment of alternative fuels infrastructure (OJ L 307, 28.10.2014, p. 1) Regulation(EC) No 443/2009 of the European Parliament and of the Council of 23 April 2009setting emission performance standards for new passenger cars as part of the Community's integrated approach to reduce CO2 emissions from light-duty vehicles (OJ L 140, 5.6.2009, p. 1) Directive1999/94/EC relating to the availability of consumer information on fuel economy and CO2 emissions in respect of the marketing of new passenger cars (OJ L 12,18.1.2000, p. 16) Regulation(EU) No 510/2011 of the European Parliament and of the Council of 11 May 2011setting emission performance standards for new light commercial vehicles as part of the Union's integrated approach to reduce CO2 emissions from light-duty vehicles (OJ L 145, 31.5.2011, p. 1) Directive2006/40/EC of the European Parliament and of the Council of 17 May 2006relating to emissions from air conditioning systems in motor vehicles and amending Council Directive 70/156/EEC (OJ L 161, 14.6.2006, p. 12) Directive2009/33/EC of the European Parliament and of the Council of 23 April 2009 on the promotion of clean and energy-efficient road transport vehicles (OJ L 120,15.5.2009, p. 12) Regulation(EU) 2016/1628 of the European Parliament and of the Council of 14 September2016 on requirements relating to gaseous and particulate pollutant emission limits and type- approval for internal combustion engines for non-road mobile machinery, amending Regulations (EU) No 1024/2012 and (EU) No 167/2013, and amending and repealing Directive 97/68/EC (OJ L 252, 16.9.2016, p. 53) Directive2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (OJ L 334,17.12.2010, p. 17) Directive2008/101/EC of the European Parliament and of the Council of 19 November 2008amending Directive 2003/87/EC so as to include aviation activities in the scheme for greenhouse gas emission allowance trading within the Community (OJ L8, 13.1.2009, p. 3) Directive2006/38/EC of the European Parliament and of the Council of 17 May 2006amending Directive 1999/62/EC on the charging of heavy goods vehicles for the use of certain infrastructures (OJ L 157, 9.6.2006, p. 8) Regulation(EC) No 549/2004 of the European Parliament and of the Council of 10 March 2004laying down the framework for the creation of the single European sky (the framework Regulation) (OJ L 96, 31.3.2004, p. 1) Directive2002/84/EC of the European Parliament and of the Council of 5 November 2002amending the Directives on maritime safety and the prevention of pollution from ships (OJ L 324, 29.11.2002, p. 53) Regulation(EU) No 546/2014 of the European Parliament and of the Council of 15 May 2014amending Council Regulation (EC) No 718/1999 on a Community-fleet capacity policy to promote inland waterway transport Directive2009/30/EC of the European Parliament and of the Council of 23 April 2009amending Directive 98/70/EC as regards the specification of petrol, diesel and gas-oil and introducing a mechanism to monitor and reduce greenhouse gas emissions and amending Council Directive 1999/32/EC as regards the specification of fuel used by inland waterway vessels and repealing Directive93/12/EEC (OJ L 140, 5.6.2009, p. 88) Regulation(EC) No 782/2003 of the European Parliament and of the Council of 14 April 2003on the prohibition of organotin compounds on ships (OJ EU L 115, 9.5.2003, p.1) Directive2002/49/EC of the European Parliament and of the Council of 25 June 2002relating to the assessment and management of environmental noise (OJ L 189,18.7.2002, p. 12) Directive2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors (OJ L 162, 3.7.2000, p. 1) Directive2002/49/EC of the European Parliament and the Council of 25 June 2002 relating to the assessment and management of environmental noise Directive2000/60/EC of the European Parliament and of the Council of 23 October 2000establishing a framework for Community action in the field of water policy Directive2008/105/EC of the European Parliament and of the Council of 16 December 2008on environmental quality standards in the field of water policy, amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC,84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council (OJ L 348, 24.12.2008, p. 84) Directive2006/118/EC of the European Parliament and of the Council of 12 December 2006on the protection of groundwater against pollution and deterioration (OJ L 372,27.12.2006, p. 19) Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJL 135, 30.5.1991, p. 40) Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption Regulation(EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004on detergents (OJ L 104, 8.4.2004, p. 1) Council Directive 91/676/EEC of 12 December 1991 concerning the protection of waters against pollution caused by nitrates from agricultural sources (OJ L 375,31.12.1991, p. 1) Directive2007/60/EC of the European Parliament and of the Council of 23 October 2007 on the assessment and management of flood risks (OJ L 288, 6.11.2007, p. 27) Directive2014/52/EU of the European Parliament and of the Council of 16 April 2014amending Directive 2011/92/EU on the assessment of the effects of certain public and private projects on the environment (OJ L 124, 25.4.2014, p. 1) Directive2011/92/EU of the European Parliament and of the Council of 13 December 2011 on the assessment of the effects of certain public and private projects on the environment Text with EEA relevance
2018/07/04
Committee: ENVI
Amendment 270 #
Proposal for a directive
Annex I – part I – subpart F – paragraph 1 – introductory part
Rules on nuclear safety as regulated in particular by:
2018/07/04
Committee: ENVI
Amendment 271 #
Proposal for a directive
Annex I – part I – subpart F – paragraph 1 – point i
(i) Council Directive 2009/71/Euratom of 25 June 2009 establishing a Community framework for the nuclear safety of nuclear installations (OJ L 172, 2.7.2009, p. 18) as well as Council Directive2014/87/Euratom of 8 July 2014 amending Directive 2009/71/Euratom establishing a Community framework for the nuclear safety of nuclear installations (OJ L 219, 25.7.2014, p.42–52);
2018/07/04
Committee: ENVI
Amendment 272 #
Proposal for a directive
Annex I – part I – subpart G – title
G Article 1(a)(vii) – food and feed safety, animal health and animal welfare: Rules on food and feed safety, as regulated in particular by:
2018/07/04
Committee: ENVI
Amendment 273 #
Proposal for a directive
Annex I – part I – subpart G – point 3 a (new)
3 a. Other legislative acts relevant to food and feed safety, in particular: Regulation (EC) No 2003/2003 of the European Parliament and of the Council relating to fertilisers Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market and repealing Council Directives 91/414/EEC and 79/117/EEC Directive 2009/128/EC establishing a framework for Community action to achieve the sustainable use of pesticides Regulation (EC) No 396/2005 on maximum residue levels (MRLs)of pesticides in or on food and feed of plant and animal origin Council Regulation (Euratom) 3954/87 laying down maximum permitted levels of radioactive contamination of foodstuffs and of feedingstuffs following a nuclear accident or any other case of radiological emergency Council Regulation (Euratom) 944/89 laying down maximum permitted levels of radioactive contamination in minor foodstuffs following a nuclear accident or any other case of radiological emergency Council Regulation (EURATOM) 770/90 laying down maximum permitted levels of radioactive contamination of feedingstuffs following a nuclear accident or any other case of radiological emergency Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms Regulation (EC) No 1829/2003 on genetically modified food and feed Regulation (EC) No 1830/2003 on the traceability and labelling of GMOs and the traceability of food and feed products produced from GMOs and amending Directive 2001/18/EC Council Decision 2002/628/EC concerning the conclusion, on behalf of the European Community, on the Cartagena Protocol on Biosafety(2002). Official Journal of the European Communities, L 201/48 Directive2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (recast) (OJ L 125,21.5.2009, p. 75) Regulation(EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003on trans boundary movements of genetically modified organisms (OJ L 287,5.11.2003, p. 1) Regulation(EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012concerning the making available on the market and use of biocidal products Directive 2001/82/EC on the Community code relating to veterinary medicinal products Regulation (EC) No 470/2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin (repealing Regulation (EEC) No 2377/90) Directive 96/23/EC on measures to monitor certain substances and residues thereof in live animals and animal products Council Directive 96/22/EC concerning the prohibition on the use in stock- farming of certain active substances having a hormonal or thyrostatic action and of beta-agonists Regulation (EC) No 852/2004 of the European Parliament and of the Council on the hygiene of foodstuffs Regulation (EC) No 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin Regulation (EC) No 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption Council Directive 2002/99/EC on products of animal origin Commission Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs Regulation (EC) No 2160/2003 on the control of Salmonella and other specified food-borne zoonotic agents Directive 2003/99/EC of the European Parliament and of the Council on the monitoring of zoonoses and zoonotic agents Regulation (EC) No 1331/2008 on a common authorisation procedure for food additives, enzymes and flavourings Regulation (EC) No 1333/2008 on food additives Regulation (EC) No 1332/2008 on food enzymes Regulation (EC) No 1334/2008 on food flavourings Regulation (EC) No 2065/2003 on smoke flavourings Directive 2009/32/EC on extraction solvents used in the production of foods and food ingredients Council Regulation (EEC) No 315/93 laying down Community procedures for contaminants in food Commission Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants in foodstuffs Directive 1999/2/EC of the European Parliament and of the Council on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation Regulation (EC) No 258/97 concerning novel foods and novel food ingredients Regulation (EC) No 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food Council Directive 82/711/EEC laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs Regulation (EU) No 609/2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption 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 Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and(EC) No 1234/2007 Regulation (EU) No 1305/2013 of the European Parliament and of the Council of 17 December 2013 on support for rural development by the European Agricultural Fund for Rural Development(EAFRD) and repealing Council Regulation (EC) No 1698/2005 Regulation (EU) No 1307/2013 of the European Parliament and of the Council of 17 December 2013 establishing rules for direct payments to farmers under support schemes within the framework of the common agricultural policy and repealing Council Regulation (EC) No637/2008 and Council Regulation (EC) No 73/2009 Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and(EC) No 1234/2007 Regulation(EC) No 1831/2003 of the European Parliament and of the Council of 22 September2003 on additives for use in animal nutrition Council Directive 90/167/EEC of26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community coderelating to veterinary medicinal products Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed 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 (Text with EEA relevance) Commission Directive 2008/38/EC of 5 March 2008 establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes Regulation (EC) No 183/2005 oft he European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene
2018/07/04
Committee: ENVI
Amendment 274 #
Proposal for a directive
Annex I – part I – subpart G – point 4 – introductory part
4. Protection of animal health and welfare as regulated in particular by:
2018/07/04
Committee: ENVI
Amendment 275 #
Proposal for a directive
Annex I – part I – subpart G – point 4 – point iii a (new)
(iii a) Other legislative acts relevant to animal health and welfare, in particular: Council Directive 74/577/EEC of 18 November 1974 on stunning of animals befores laughter Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra- Community trade in certain live animals and products with a view to the completion of the internal market Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC Council Directive 91/628/EEC of 19 November 1991 on the protection of animals during transport and amending Directives 90/425/EEC and 91/496/EEC Council Directive 95/29/EC of 29 June 1995 amending Directive 91/628/EEC concerning the protection of animals during transport Council Regulation (EC) No 411/98 of 16 February 1998 on additional animal protection standards applicable to road vehicles used for the carriage of livestock on journeys exceeding eight hours Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations and amending Directives 64/432/EEC and93/119/EC and Regulation (EC) No 1255/97 Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing (Text with EEA relevance) Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes Council Directive 1999/22/EC of 29 March1999 relating to the keeping of wild animals in zoos Commission Regulation (EC) No 1739/2005 of21 October 2005 laying down animal health requirements for the movement of circus animals between Member States (Text with EEA relevance) Commission Regulation (EC) No 318/2007 of 23 March 2007 laying down animal health conditions for imports of certain birds into the Community and the quarantine conditions thereof (Text with EEA relevance) Regulation(EC) No 1523/2007 of the European Parliament and of the Council of 11 December2007 banning the placing on the market and the import to, or export from, the Community of cat and dog fur, and products containing such fur (Text with EEA relevance ) Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7) Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein Council Regulation(EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein Regulation (EU) No 1143/2014 of the European Parliament and of the Council of 22 October 2014 on the prevention and management of the introduction and spread of invasive alien species (OJ L 317, 4.11.2014, p. 35) Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products Directive2010/63/EU of the European Parliament and of the Council of 22 September 2010on the protection of animals used for scientific purposes (OJ L 276,20.10.2010, p. 33) and Directive 86/609/EEC Directive 86/609/EEC(no longer in force)Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes Council Directive 88/320/EEC of 9 June 1988 on the inspection and verification of Good Laboratory Practice (GLP) 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 Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No1234/2007 Regulation (EU) No 1305/2013 of the European Parliament and of the Council of 17 December 2013 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) and repealing Council Regulation (EC) No 1698/2005 Regulation (EU) No 1307/2013 of the European Parliament and of the Council of 17 December 2013 establishing rules for direct payments to farmers under support schemes within the framework of the common agricultural policy and repealing Council Regulation (EC) No 637/2008 and Council Regulation (EC) No 73/2009 Council Regulation (EEC) No 1906/90 of 26 June 1990 on certain marketing standards for poultry Council Regulation (EEC) No 1907/90 of 26 June 1990 on certain marketing standards for eggs Commission Regulation (EEC) No 1538/91 of 5 June1991 introducing detailed rules for implementing Regulation (EEC) No 1906/90 on certain marketing standards for poultry meat Regulation (EU) 2016/1012 of the European Parliament and of the Council of 8 June 2016 on zootechnical and genealogical conditions for the breeding, trade in and entry into the Union of pure bred breeding animals, hybrid breeding pigs and the germinal products thereof and amending Regulation (EU) No 652/2014, Council Directives 89/608/EEC and90/425/EEC and repealing certain acts in the area of animal breeding (‘Animal Breeding Regulation’) (Text with EEA relevance) Council Directive 2008/73/EC of 15 July 2008simplifying procedures of listing and publishing information in the veterinary and zootechnical fields and amending Directives 64/432/EEC, 77/504/EEC,88/407/EEC, 88/661/EEC, 89/361/EEC, 89/556/EEC, 90/426/EEC, 90/427/EEC,90/428/EEC, 90/429/EEC, 90/539/EEC, 91/68/EEC, 91/496/EEC, 92/35/EEC,92/65/EEC, 92/66/EEC, 92/119/EEC, 94/28/EC, 2000/75/EC, Decision 2000/258/EC and Directives 2001/89/EC, 2002/60/EC and 2005/94/EC (Text with EEA relevance) Council Regulation (EC) No 1255/97 of 25 June1997 concerning Community criteria for staging points and amending the route plan referred to in the Annex to Directive 91/628/EEC Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products Directives 2009/156/EC Council Regulation (EC) No 21/2004 Commission Decision 2006/968/EC Council Decision 1999/879/EC: Council Decision of 17 December 1999 concerning the placing on the market and administration of bovine somatotrophin (BST) and repealing Decision 90/218/EEC Council Directive 1999/74/EC of 19 July 1999laying down minimum standards for the protection of laying hens Directives 86/113/EEC and 88/166/EEC Laying down minimum standards for the protection of laying hens kept in battery cages Council Directive 2007/43/EC of 28 June 2007laying down minimum rules for the protection of chickens kept for meat production Council Directive 2008/119/EC of 18 December2008 laying down minimum standards for the protection of calves Council Directive 2008/120/EC of 18 December2008 laying down minimum standards for the protection of pigs Council Regulation (EEC) No 3254/91 of 4November 1991 prohibiting the use of leghold traps in the Community and the introduction into the Community of pelts and manufactured goods of certain wild animal species originating in countries which catch them by means of legholdtraps or trapping methods which do not meet international humane trapping standards Regulation (EU) 2016/429 Transmissible animal diseases and amending and repealing certain acts in the area of animal health (Animal Health Law) and other legislation aimed at minimising animal Directive 2013/31/EU of the European Parliament and of the Council of 12 June 2013 amending Council Directive92/65/EEC as regards the animal health requirements governing intra- Union trade in and imports into the Union of dogs, cats and ferrets Regulation (EU) No 576/2013 of the European Parliament and of the Council of 12 June 2013 on the non-commercial movement of pet animals and repealing Regulation (EC) No 998/2003 Council Directive 2009/156/EC of 30 November2009 on animal health conditions governing the movement and importation from third countries of equidae Council Directive 92/35/EEC of 29 April 1992laying down control rules and measures to combat African horse sickness Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC Council Regulation (EC) No 1239/98 of 8 June 1998 amending Regulation (EC) No 894/97laying down certain technical measures for the conservation of fishery resources Council Directive 83/129/EC of 28 March 1983 concerning the importation into Member States of skins of certain seal pups and products derived therefrom (OJ L 91,9.4.1983, p. 30) Regulation(EC) No 1007/2009 of the European Parliament and of the Council of 16 September2009 on trade in seal products (OJ L 286, 31.10.2009, p. 36)
2018/07/04
Committee: ENVI
Amendment 276 #
Proposal for a directive
Annex I – part I – subpart H – point 1 – introductory part
1. Measures setting high standards of quality and safety of organs and substances of human origin, as regulated in particular by:
2018/07/04
Committee: ENVI
Amendment 277 #
Proposal for a directive
Annex I – part I – subpart H – point 2 – introductory part
2. Measures setting high standards of quality and safety for medicinal products and devices of medical use as regulated in particular by:
2018/07/04
Committee: ENVI
Amendment 278 #
Proposal for a directive
Annex I – part I – subpart H – point 5
5. Manufacture, presentation and sale of tobacco and related products regulated by Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (OJ L 127, 29.4.2014, p. 1), and the advertising and sponsorship of tobacco products as regulated by Directive 2003/33/EC of the European Parliament and of the Council of 26 May 2003 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products.
2018/07/04
Committee: ENVI
Amendment 279 #
Proposal for a directive
Annex I – part I – subpart H – point 5 a (new)
5 a. Other legislative acts relating to public health, in particular: Commission Directive (EU)2016/1214 of 25 July 2016 amending Directive 2005/62/EC as regards quality system standards and specifications for blood establishments (OJ L 199,26.7.2016, p. 14) Commission Directive2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events (OJ L 256, 1.10.2005, p.32) Commission Directive2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components (OJ L 91, 30.3.2004, p. 25) Commission Directive2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments (OJ L 256,1.10.2005, p. 41) Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation 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) No1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC 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 Regulation (EC) No 1223/2009of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
2018/07/04
Committee: ENVI
Amendment 280 #
Proposal for a directive
Annex I – part I – subpart I – paragraph 1 – introductory part
Consumer rights and consumer protection as regulated in particular by:
2018/07/04
Committee: ENVI