Activities of Anja HAZEKAMP related to 2022/0432(COD)
Plenary speeches (1)
Classification, labelling and packaging of substances and mixtures (debate)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures
Amendments (21)
Amendment 59 #
Proposal for a regulation
Recital 1
Recital 1
(1) In order to keep pace with globalisation, technological development and new means of sale, such as online sales, it is necessary to adapt Regulation (EC) No 1272/2008 of the European Parliament and of the Council. While under that Regulation it is assumed that all responsible actors in the supply chain are established in the Union, practical experience has shown that economic operators established outside the Union sell chemicals online directly to the general public in the Union. Hence, enforcement authorities are unable to enforce Regulation (EC) No 1272/2008 against economic operators not established in the Union. It is therefore appropriate to require that there is a supplier established in the Union, which ensures that the substance or the mixture in question meets the requirements set out in that Regulation when it is being placed on the market, including via distance sales. This provision would improve compliance with and enforcement of the Regulation (EC) No 12727/2008 and thereby ensure a high level of protection of human and animal health and the environment. In order to prevent situations where consumer becomes de jure and de facto an importer when buying the substance or the mixture via distance sales from the economic operators established outside the Union, it is necessary to specify that the supplier which ensures that the substance or the mixture in question meets the requirements set out in that Regulation acts in course of an industrial or professional activity.
Amendment 68 #
Proposal for a regulation
Recital 2
Recital 2
(2) From a toxicological point of view, substances with more than one constituent (‘multi-constituent substances’) are no different from mixtures composed of two or more substances. In accordance with Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council39, aimed to limitphase out, through replacement, reduction and refinement of animal testing, data on multi-constituent substances is to be generated under the same conditions as data on any other substance, while data on individual constituents of a substance is normally not to be generated, except where individual constituents are also substances registered on their own. Where data on individual constituents is available, multi- constituent substances should be evaluated and classified following the same classification rules as mixtures, unless Annex I to Regulation (EC) No 1272/2008 provides for a specific provision for those multi- constituent substances. _________________ 39 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
Amendment 100 #
Proposal for a regulation
Recital 13
Recital 13
(13) In order to adapt the label elements allowed to be provided only in a digital format to technical progress or to the level of digital readiness among all population groups in the Union, the Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union to amend the list of label elements allowed to be provided only in a digital format, taking into account societal needs and a high level of protection of human and animal health and the environment.
Amendment 108 #
Proposal for a regulation
Recital 18
Recital 18
(18) Harmonised classification and labelling proposals need not necessarily be limited to individual substances and cshould cover a group of similar substances, where such similarity allows for similar classification of all substances in the group. The purpose of such grouping is to alleviate the burden on manufacturers, importers or downstream users, the Agency and the Commission in the procedure for harmonisation of classification and labelling of substances. It also avoids testing of substances when similar substances can be classified as a group and can thereby reduce the use of animals.
Amendment 112 #
Proposal for a regulation
Recital 24
Recital 24
(24) Manufacturers and importers often notify different information for the same substance to be included in the Agency’s inventory for classification and labelling. In some cases, such divergences result from different impurities, physical states or other differentiations and may be justified. In other cases, the divergences are due to differences in data used for classification, or to disagreement between notifiers or registrants in the case of joint submission of data in accordance with Regulation (EC) No 1907/2006, or to obsolete classification entries. As a result, the classification and labelling inventory contains divergent classifications, which makes the inventory less effective as a hazard collection and communication tool and leads to incorrect classifications, ultimately hindering the ability of Regulation (EC) No 1272/2008 to protect human and animal health and the environment. Therefore, the notifiers should be required to provide reasons for divergence from the most severe classification or for introducing a more severe classification per hazard class for the same substance to the Agency. To address divergences between more recent and obsolete classifications, notifiers should be required to update their notifications within 6 months after a decision to change the classification and labelling of a substance has been taken pursuant to a review in Article 15(1) of that Regulation, and the Agency should be entitled to delete obsolete classifications. Furthermore, divergent classifications should be harmonised within 12 months to the most severe classification per hazard class.
Amendment 114 #
Proposal for a regulation
Recital 25
Recital 25
(25) In order to enhance transparency of notifications as well as to facilitate the notifiers’ duty to come to an agreed notification entry for the same substance, certainall information notified to the Agency’s classification and labelling inventory should be made publicly available, free of charge. Without prejudice to the protection of commercial interests, that information should include the identity of the notifiers as, knowing whom to contact, would facilitate the objective of coming to an agreed entry to be included in that classification and labelling inventory. In the case of notifications by a group of manufacturers or importers, it should suffice to make publicly available the identity of the notifier submitting the information on behalf of the other members of the group.
Amendment 120 #
Proposal for a regulation
Recital 33
Recital 33
(33) In accordance with Directive 2010/63/EU of the European Parliament and of the Council47, it is necessary to replace, reduce or refine testing on animals, with a view to stop using animals for testing as soon as possible. Implementation of Regulation (EC) No 1272/2008 should be based on the use of alternative test methodspromotion, development anduse of New Approach Methodologies (NAM), suitable for the assessment of health and environmental classification of chemicals, wherever possible. In order to speed up the transition to non-animal methods, with the ultimate goal of fully replacing animal testing, as well as to improve the efficiency of chemical hazard assessments, innovation in the field of non-animal methods should be supported,monitored and systematically evaluated, and the Commission and the Member States acting in the interest of the Union should promote the inclusion of harmonised criteria based on available alternative methods in UN GHS and subsequently include those criteria in Regulation (EC) No 1272/2008 without unduedelay. _________________ 47 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
Amendment 130 #
Proposal for a regulation
Article 1 – paragraph 1 – point -1 (new)
Article 1 – paragraph 1 – point -1 (new)
Regulation (EC) 1272/2008
Article 1 – paragraph 1
Article 1 – paragraph 1
(-1) In Article 1, paragraph 1 is replaced by the following: "The purpose of this Regulation is to ensure a high level of protection of human health andand animal lives and health, protection of the environment as well as the free movement of substances, mixtures and articles as referred to in Article 4(8) by: (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32008R1272)" Or. en
Amendment 197 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 a (new)
Article 1 – paragraph 1 – point 5 a (new)
Regulation (EC) 1272/2008
Article 7
Article 7
Amendment 206 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7 a (new)
Article 1 – paragraph 1 – point 7 a (new)
Regulation (EC) 1272/2008
Article 17 – paragraph 1 – point (i) (new)
Article 17 – paragraph 1 – point (i) (new)
Amendment 221 #
Proposal for a regulation
Article 1 – paragraph 1 – point 12
Article 1 – paragraph 1 – point 12
Regulation (EC) 1272/2008
Article 30 – paragraph 1
Article 30 – paragraph 1
1. In case of a change regarding the classification and labelling of a substance or a mixture, which results in the addition of a new hazard class or in a more severe classification, or which requires new supplemental information on the label in accordance with Article 25, the supplier shall ensure that the label is updated within 63 months after the results of the new evaluation referred to in Article 15(4) were obtained.
Amendment 224 #
Proposal for a regulation
Article 1 – paragraph 1 – point 12
Article 1 – paragraph 1 – point 12
2. Where a change regarding the classification and labelling of a substance or a mixture is required other than that referred to in paragraph 1, the supplier shall ensure that the label is updated within 182 months after the results of the new evaluation referred to in Article 15(4) were obtained.
Amendment 243 #
Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point a
Article 1 – paragraph 1 – point 18 – point a
Regulation (EC) 1272/2008
Article 37 – paragraph 1
Article 37 – paragraph 1
The Commission may ask the Agency or the European Food Safety Authority established in accordance with Article 1(2) of Regulation (EC) No 178/2002* to prepare a proposal for harmonised classification and labelling of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for revision thereof. The Commission may subsequently submit the proposal to the Agency. The Agency and the Authority may, on their own initiative, provide scientific advice to the Commission and Member States on substances where a harmonised classification could be necessary to protect human and animal health and the environment.
Amendment 248 #
Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point c
Article 1 – paragraph 1 – point 18 – point c
Regulation (EC) 1272/2008
Article 37 – paragraph 2a – subparagraph 2
Article 37 – paragraph 2a – subparagraph 2
Within one week from receipt of the notification, the Agency shall publish the name and, where relevant, the EC and CAS numbers of the substance(s), the status of the proposal and the name of the submitter, as well as scientific data, studies and other information supporting the proposal. The Agency shall update the information on the status of the proposal after completion of each stage of the process referred to in Article 37(4) and (5).
Amendment 260 #
Proposal for a regulation
Article 1 – paragraph 1 – point 20 a (new)
Article 1 – paragraph 1 – point 20 a (new)
Regulation (EC) 1272/2008
Article 41
Article 41
(20a) Article 41 is replaced by the following: "Agreed entries Where the notification in Article 40(1) results in different entries on the inventory referred to in Article 42 for the same substance, the notifiers and registrants shall make every effort to come to an agreed entry to be included in the inventory. The notifiers shall inform the Agency accordingly. accordingly. If after 6 months no agreement has been reached, the most severe hazard classification will apply for all concerned entries, and the Agency will change them accordingly." Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32008R1272)
Amendment 263 #
Proposal for a regulation
Article 1 – paragraph 1 – point 21
Article 1 – paragraph 1 – point 21
Regulation (EC) 1272/2008
Article 42 – paragraph 1 – subparagraph 3 – point (a)
Article 42 – paragraph 1 – subparagraph 3 – point (a)
(a) information referred to in Article 40(1), point (a), except where a notifier duly justifies why such publication is potentially harmful for its commercial interests or the commercial interests of any other concerned party;
Amendment 269 #
Proposal for a regulation
Article 1 – paragraph 1 – point 21 a (new)
Article 1 – paragraph 1 – point 21 a (new)
Regulation (EC) 1272/2008
Article 42 – paragraph 2
Article 42 – paragraph 2
(21a) Article 42, paragraph 2 is amended as follows: "The Agency shall update the inventory when it receives updated information in accordance with Article 40(2) or Article 41. The Agency shall delete entries which it considers obsolete. " Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32008R1272)
Amendment 271 #
Proposal for a regulation
Article 1 – paragraph 1 – point 22 a (new)
Article 1 – paragraph 1 – point 22 a (new)
Regulation (EC) 1272/2008
Article 46a (new)
Article 46a (new)
(22a) The following Article 46a is added: Article 46a Access to justice 1. Any natural or legal person having sufficient interest shall have access to a court or other independent and impartial public body competent to review the procedural and substantive legality of the decisions, plans, permits, acts or failure to act of the competent authority under this Regulation. Any non-governmental organisation promoting environmental protection, the protection of human or animal health or animal welfare, and meeting any requirements under national law shall be deemed to have sufficient interest. 2. Access to a court or other independent and impartial public body pursuant to paragraph 1 shall be fair, equitable, timely and not prohibitively expensive and provide adequate and effective remedies, including injunctive relief where appropriate. Member States shall ensure that practical information is made available to the public on access to administrative and judicial review procedures.
Amendment 274 #
Proposal for a regulation
Article 1 – paragraph 1 – point 23
Article 1 – paragraph 1 – point 23
Regulation (EC) 1272/2008
Article 48 – paragraph 1
Article 48 – paragraph 1
1. Any advertisement for a substance classified as hazardous shall indicate the relevant hazard pictogram, the signal word, the hazard class and the hazard statements. The use of environmental claims as defined in Article 2, point (o), of Directive 2005/29/EC is prohibited;
Amendment 276 #
Proposal for a regulation
Article 1 – paragraph 1 – point 23
Article 1 – paragraph 1 – point 23
Regulation (EC) 1272/2008
Article 48 – paragraph 2
Article 48 – paragraph 2
2. Any advertisement for a mixture classified as hazardous or covered by Article 25(6) shall indicate the hazard pictogram, the signal word, the hazard class and the hazard statements. The use of environmental claims as defined in Article 2, point (o), of Directive 2005/29/EC is prohibited;
Amendment 286 #
Proposal for a regulation
Article 1 – paragraph 1 – point 26 – point c
Article 1 – paragraph 1 – point 26 – point c
Regulation (EC) 1272/2008
Article 53 – paragraph 3
Article 53 – paragraph 3
3. The Commission shall regularly evaluate the development of alternative test mepromote and at least every two years evaluate the development of New Approach Methodologies, including thodse referred to in Article 13(1) of Regulation (EC) No 1907/2006 for classification of substances and mixtures. No later than six months after new harmonised criteria based on available NAM are included in UN GHS, the Commission shall adopt Delegated Acts in accordance with Article 53a to update Annex I of this Regulation.