Activities of Stanislav POLČÁK related to 2022/0432(COD)
Plenary speeches (1)
Classification, labelling and packaging of substances and mixtures (A9-0271/2023 - Maria Spyraki)
Amendments (27)
Amendment 98 #
Proposal for a regulation
Recital 12
Recital 12
(12) Regulation (EC) No 1272/2008 needs to be adjusted to technological and societal changes in the field of digitalisation and be prepared for future developments. Digital labelling could improve the efficiency of hazard communication, especially for vulnerable population groups and people who do not speak the national language of a Member State. Therefore, it is necessary to provide for voluntary digitmandatory digital labelling supplementing, but not replacing, the existing physical labelling and to lay down technical requirements for such labelling. In order to provide for legal certainty, it is appropriate to specify the label elements that are allowed to be provided in a digital format only. That possibility should only exist for information which is not instrumental for the safety of the user or the protection of the environment.
Amendment 101 #
Proposal for a regulation
Recital 16
Recital 16
(16) Regulation (EC) No 1272/2008 does not lay down rules on the labelling of chemicals supplied to the general public without packaging except for ready mixed cement and concrete in a wet state. In order to enhance legal clarity and ensure a better protection of citizens, it is appropriate to provide for the labelling elements of other chemicals supplied without packaging, such as fuels supplied at filling stations and intended to be pumped into receptacles from where they are normally not intended to be removed.
Amendment 102 #
Proposal for a regulation
Recital 17
Recital 17
(17) As the new hazard classes and criteria introduced by Commission Delegated Regulation 41 allow for the harmonised classification and labelling of substances of the highest concern with regard to health and environment, they should normally under normal circumstances be subject to harmonised classification and labelling and added to the list of hazard classes which includes respiratory sensitisation, germ cell mutagenicity, carcinogenicity and reproductive toxicity. Sub-categorisation of the hazard class for respiratory sensitisation in sub-category 1A or 1B should be performed where sufficient information to classify in those hazard sub- categories is available, in order to avoid over- or under-classification. In view of the rapid development of scientific knowledge and the long-standing expertise of the European Chemicals Agency (the ‘Agency’) and the European Food Safety Authority (the ‘Authority’) on the one hand, and the limited resources of Member States’ competent authorities to develop harmonised classification proposals on the other, the Commission should have the right to request the Agency and the Authority to develop a harmonised classification and labelling proposal. _________________ 41 [Commission Delegated Regulation amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures, OJ XX of XX p XX.]
Amendment 111 #
Proposal for a regulation
Recital 21
Recital 21
(21) As the criteria for substances to qualify as endocrine disruptor for human health or the environment included in sections 3.6.5. and 3.8.2. of Annex II to Regulation (EC) No 1107/2009 and in Commission Delegated Regulation (EU) 2017/2100, and those to qualify as endocrine disruptor for human health or the environment included in Annex I to Regulation (EC) No 1272/2008, are equivalent, substances which qualify as meeting the criteria for endocrine disruptor properties in accordance with Commission Regulation (EU) 2018/605 and Commission Delegated Regulation (EU) 2017/2100 should be included as endocrine disruptors category 1 for human health or endocrine disruptors category 1 for the environment in Table 3 in Part 3 of Annex VI to Regulation (EC) No 1272/2008.(Does not affect the English version.)
Amendment 115 #
(25) In order to enhance transparency of notifications as well as to facilitate the notifiers’ fulfilment of their duty to come to an agreed notification entryof data to be listed for the same substance, certain 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, tThat information should include the identity of the notifiers also as, knowing whom to contact, would facilitate the objective of coming to an agreed entry of data 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 117 #
Proposal for a regulation
Recital 30
Recital 30
(30) Regulation (EC) No 1272/2008 does not explicitly refer togulate offers, let alone to distance sales offers. Consequently, it does not address specific problems arising from distance sales, such as online sales. Whereas advertisements is understood as being at the pre-stage of offers, notably as information designed to promote messages of a natural or legal person, whether or not against remuneration, offers are understood as invitations by a natural or legal person to conclude a purchase contract. This differentiation should justify the requirement of providing more hazard information in offers than in advertisements. In order to keep pace with technological development and new means of sale, the compliance by design obligations laid down for providers of online marketplaces in Article 31 of Regulation (EU) 2022/2065 of the European Parliament and of the Council 44[1] should apply for the purpose of labelling information required by Article 17 of Regulation (EC) No 1272/2008. The enforcement of those obligations is subject to the rules laid down in Chapter IV of Regulation (EU) 2022/2065. _________________ 44 Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act) (OJ L 277, 27.10.2022, p. 1).
Amendment 118 #
Proposal for a regulation
Recital 31
Recital 31
(31) Apart from providing industry with technical and scientific tools on how to comply with Regulation (EC) No 1272/2008, the Agency should also provide competent authorities with such tools, for example databases, in order to foster its implementation. Regulation (EC) No 12727/2008 should more in detail set out the Agency’s remit in this regard. Furthermore, the Agency, actingif it acts as a body appointed by a Member State competent authority for receiving information for emergency health response, should provide the relevant national appointed body of that Member State access to that information.
Amendment 119 #
Proposal for a regulation
Recital 33
Recital 33
(33) In accordance with Directive 2010/63/EU of the European Parliament and of the Council 47[1], it is necessary to replace, reduce or refine testing on animals. Implementation of Regulation (EC) No 1272/2008 should be based on the use of alternative test methods, suitable for the assessment of health and environmental classification of chemicals, such as in vitro tests (using cells or tissues), computational models and high- throughput screening methods, which offer many advantages, including being faster, cheaper and often more accurate, 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 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 undue delay. _________________ 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 125 #
Proposal for a regulation
Recital 37
Recital 37
(37) To ensure that suppliers of substances and mixtures have time to adapt to new rules on classification, labelling and packaging, the application of some provisions of this Regulation should be deferred. Substances and mixtures which are already placed on the market before the end of that deferral period, should be allowed to continue being placed on the market without being re-classified and re- labelled in accordance with this Regulation, to avoid additional burden on suppliers of substances and mixtures.
Amendment 127 #
Proposal for a regulation
Recital 38 a (new)
Recital 38 a (new)
(38a) In line with the new tasks that will arise for the Agency as a result of the amendment of Regulation (EC) No 1272/2008, it is essential that the Agency is provided with additional resources to enable it to fully carry out these new tasks.
Amendment 128 #
Proposal for a regulation
Recital 38 b (new)
Recital 38 b (new)
Amendment 165 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EU) 1272/2008
Article 5 – paragraph 3 – point 4
Article 5 – paragraph 3 – point 4
Relevant available information on the multi-constituent substance itself showing absence of certain properties or less severe properties shall not override the relevant available information on each of the constituents in the substance.
Amendment 194 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EU) 1272/2008
Article 6 – paragraph 4a (new)
Article 6 – paragraph 4a (new)
4a. However, where available test data on the mixture itself demonstrate biodegradability, persistence, mobility and bioaccumulation properties that have not been identified from the relevant available information on the individual substance referred to in the first subparagraph, those data shall also be taken into account for the purposes of the evaluation of the mixture referred to in the first subparagraph.
Amendment 195 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 a (new)
Article 1 – paragraph 1 – point 5 a (new)
Regulation (EU) 1272/2008
Article 7 – paragraph 1
Article 7 – paragraph 1
(5a) Article 7, paragraph 1 is replaced by the following: 1. Where new tests are carried out for the purposes of this Regulation, animal testing within the meaning of Directive 2010/63/EU shall only be carried out if there are no other alternatives providing adequate reliability and quality of data at the time they are carried out. These tests should gradually be fully replaced by alternative methods in accordance with the current state of scientific knowledge.
Amendment 218 #
Proposal for a regulation
Article 1 – paragraph 1 – point 12
Article 1 – paragraph 1 – point 12
Regulation (EU) 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 6 months after the results of the new evaluation referred to in Article 15(4) were obtained. Where the supplier is a micro, small or medium-sized enterprise within the meaning of the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises, it shall ensure that the label is updated within 12 months of receiving the results of the reassessment referred to in Article 15(4).
Amendment 227 #
Proposal for a regulation
Article 1 – paragraph 1 – point 13
Article 1 – paragraph 1 – point 13
Regulation (EU) 1272/2008
Article 31 – paragraph 3
Article 31 – paragraph 3
3. The label elements referred to in Article 17(1) shallmust be clearly and indelibly marked. They shall stand out clearly from the background and they shall be of such size and spacing as to be easily read. They shall be formatted in accordance with section 1.2.1 of Annex I.’
Amendment 230 #
Proposal for a regulation
Article 1 – paragraph 1 – point 15
Article 1 – paragraph 1 – point 15
Regulation (EU) 1272/2008
Chapter 3 - header
Chapter 3 - header
Amendment 231 #
Proposal for a regulation
Article 1 – paragraph 1 – point 15
Article 1 – paragraph 1 – point 15
Regulation (EU) 1272/2008
Article 34a – paragraph 1 – point a)
Article 34a – paragraph 1 – point a)
(a) on a label in a physical form (‘physical label’); orand
Amendment 232 #
Proposal for a regulation
Article 1 – paragraph 1 – point 15
Article 1 – paragraph 1 – point 15
Regulation (EU) 1272/2008
Article 34a – paragraph 1 – point b)
Article 34a – paragraph 1 – point b)
(b) both on a physical label and on a label in a digital form (‘digital label’).
Amendment 234 #
Proposal for a regulation
Article 1 – paragraph 1 – point 15
Article 1 – paragraph 1 – point 15
Regulation (EU) 1272/2008
Article 34b – paragraph 1
Article 34b – paragraph 1
1. The digital label for substances and mixtures shallmust satisfy the following general rules and technical requirements:
Amendment 235 #
Proposal for a regulation
Article 1 – paragraph 1 – point 15
Article 1 – paragraph 1 – point 15
Regulation (EU) 1272/2008
Article 34b – paragraph 1 – point d)
Article 34b – paragraph 1 – point d)
(d) the digital label shall be accessible free of charge, without the need to register, download or install applications, or to provide a password, in a user-friendly and harmonised format;
Amendment 240 #
Proposal for a regulation
Article 1 – paragraph 1 – point 16
Article 1 – paragraph 1 – point 16
Regulation (EU) 1272/2008
Article 35 – paragraph 2a
Article 35 – paragraph 2a
2a. Hazardous substances or mixtures may be supplied to consumers and professionalsubsequent users via refill stations only if, in addition to the requirements set out in Titles III and IV, the conditions laid down in section 3.4 of Annex II are fulfilled.’;
Amendment 262 #
Proposal for a regulation
Article 1 – paragraph 1 – point 21
Article 1 – paragraph 1 – point 21
Regulation (EU) 1272/2008
Article 42 – paragraph 1
Article 42 – paragraph 1
The following information shall be made publicly available free of charge online in a user-friendly format:
Amendment 264 #
Proposal for a regulation
Article 1 – paragraph 1 – point 21
Article 1 – paragraph 1 – point 21
Regulation (EU) 1272/2008
Article 42 – paragraph 1 – point a)
Article 42 – paragraph 1 – 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 275 #
Proposal for a regulation
Article 1 – paragraph 1 – point 23
Article 1 – paragraph 1 – point 23
Regulation (EU) 1272/2008
Article 48 – paragraph 1
Article 48 – paragraph 1
1. Any advertisement for a substance classified as hazardous shallmust indicate the relevant hazard pictogram, the signal word, the hazard class and the hazard statements.
Amendment 277 #
Proposal for a regulation
Article 1 – paragraph 1 – point 23
Article 1 – paragraph 1 – point 23
Regulation (EU) 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) shallmust indicate the hazard pictogram, the signal word, the hazard class and the hazard statements.
Amendment 279 #
Proposal for a regulation
Article 1 – paragraph 1 – point 24
Article 1 – paragraph 1 – point 24
Regulation (EU) 1272/2008
Article 48a
Article 48a
Suppliers placing substances or mixtures on the market through distance sales shall clearly indicate the label elements referred to in Article 17 as part of the offer of these substances or mixtures.