2022/0432(COD) | [ParlTrack]

Proposal for a regulation
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 101 #

Proposal for a regulation
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

(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 103 #

Proposal for a regulation
Recital 17 a (new)

(17a) The process of classification of a substance or mixture under this Regulation should identify, assess and communicate the regulatory links between this Regulation and the relevant EU legislation.

Amendment 104 #

Proposal for a regulation
Recital 18

(18) Harmonised classification and labelling proposals need not necessarily be limited to individual substances and could 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 groupbased on scientific justification (taking into account all available data on physico-chemical, ecotoxicological and toxicological properties as specified in REACH Annex XI (1.5)) using a weight of evidence approach, allows for similar classification of all substances in the group. The grouping process should be scientifically robust, coherent and transparent for all stakeholders. 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. The similarity of a group of substances should be given for the specific endpoint and the severity of the effect, which results in the same classification for the respective hazard class. To ensure that all submitters of dossiers for harmonised classification and labelling apply the same scientific principles to justify the grouping approach, there is a need for ECHA to develop guidance clarifying the principles from which a harmonised classification for a group of substances can be derived.

Amendment 105 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Susana SOLÍS PÉREZ

Proposal for a regulation
Recital 18

Amendment 106 #

Proposal for a regulation
Recital 18

Amendment 107 #

Christian DOLESCHAL, Christine SCHNEIDER, Dennis RADTKE

Proposal for a regulation
Recital 18

(18) Harmonised classification and labelling proposals need not necessarily be limited to individual substances and could cover a group of similar substances, where such similarity based on a scientific evidence approach and justification 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.

Amendment 108 #

Proposal for a regulation
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 109 #

Proposal for a regulation
Recital 19

(19) To increase transparency and predictability of the proposals submitted to the Agency, the Member States’ competent authorities, manufacturers, importers or downstream users should be required to notify the Agency of their intention to submit a proposal for harmonised classification and labelling, while the Commission should be required to notify the Agency of its request to the Agency or to the Authority to prepare such proposal. Stakeholders should have better acces to CARACAL and the platform should provide a higher transparency. to include among others meeting minutes, discussions and decisions related to CLP classification proposals. Furthermore, the Agency should be required to publish information on such intention or request and update the information regarding the submitted proposal at each stage of the procedure for the harmonised classification and labelling of substances. The proposals should be based on socio- economic assessments. For the same reason, a competent authority that receives a proposal for revision of a harmonised classification and labelling submitted by a manufacturer, importer or downstream user should be required to communicate its decision to accept or refuse the proposal for revision to the Agency, which should share that information with the other competent authorities. receives a proposal for revision of a harmonised classification and labelling submitted by a manufacturer, importer or downstream user should be required to communicate its decision to accept or refuse the proposal for revision to the Agency, which should share that information with the other competent authorities.

Amendment 110 #

Proposal for a regulation
Recital 19

(19) To increase transparency and predictability of the proposals submitted to the Agency, the Member States’ competent authorities, manufacturers, importers or downstream users should be required to notify the Agency of their intention to submit a proposal for harmonised classification and labelling, while the Commission should be required to notify the Agency of its request to the Agency or to the Authority to prepare such proposal. Furthermore, the Agency should be required to publish information on such intention or request and update the information regarding the submitted proposal at each stage of the procedure for the harmonised classification and labelling of substances. For the same reason, a competent authority that receives a proposal for revision of a harmonised classification and labelling submitted by a manufacturer, importer or downstream user should be required to communicate its decision to accept or refuse the proposal for revision to the Agency, which should share that information with the other competent authorities. receives a proposal for revision of a harmonised classification and labelling submitted by a manufacturer, importer or downstream user should be required to communicate its decision to accept or refuse the proposal for revision to the Agency, which should share that information with the other competent authorities. Moreover, to increase the efficiency of the harmonised classification and labelling process, a 6 months deadline should be fixed for the Commission to amend Annex VI after the adoption of an opinion on any proposals submitted to the Agency.

Amendment 111 #

Proposal for a regulation
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 112 #

Proposal for a regulation
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 113 #

Proposal for a regulation
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 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. Moreover, the Agency should be able to remove incomplete, incorrect or obsolete notifications from the inventory after having informed the notifier.

Amendment 114 #

Proposal for a regulation
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, ~~certain~~all 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 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 ~~entry~~of 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, t~~That 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 116 #

Proposal for a regulation
Recital 29

(29) Regulation (EC) No 1272/2008 regulates advertisement of hazardous substances and mixtures in a general manner and provides that an advertisement for a substance classified as hazardous is to mention the hazard classes or hazard categories concerned, and an advertisement for a mixture classified as hazardous or a mixture containing a classified substance is to mention the types of hazards indicated on the label where such advertisement allows concluding a contract for purchase without first having sight of the label. This obligation should be changed to ensure that the advertisement of hazardous substances and mixtures contains all the information which is most important in terms of safety and protection of human health and the environment. Therefore, the advertisement should contain the hazard pictogram, the signal word, the hazard class and the hazard statements. The hazard category should not be provided, as it is reflected by the hazard statement.

Amendment 117 #

Proposal for a regulation
Recital 30

(30) Regulation (EC) No 1272/2008 does not explicitly re~~fer to~~gulate 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

(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, ~~acting~~if 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

(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 120 #

Proposal for a regulation
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 methods~~promotion, 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 ~~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 121 #

(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. 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, 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 , including new approach methodologies,should be monitored and systematically and periodicallyevaluated, 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, including new approach 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 122 #

Proposal for a regulation
Recital 35 a (new)

(35a) Where the Agency deems it necessary, it should provide further guidance for the application of the provisions associated with the revision of this Regulation.

Amendment 123 #

Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS

Proposal for a regulation
Recital 35 b (new)

(35b) The revision of this regulation expands the tasks and remit of the Agency. In order to provide adequate expertise, support, and thorough scientific evaluations, a sustainable funding for the Agency should be ensured under the framework of the upcoming ECHA Founding Regulation.

Amendment 124 #

Proposal for a regulation
Recital 37

~~(37)~~ To ensure that suppliers of ~~(37)~~ substances and mixtures have time to adapt to 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. In addition, differentiated dates for substances and mixtures should be maintained.

Amendment 125 #

Proposal for a regulation
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 126 #

Nathalie COLIN-OESTERLÉ

Proposal for a regulation
Recital 37 a (new)

(37a) An assessment of the costs incurred by micro, small and medium- sized enterprises, especially producers of essential oils, in implementing this regulation should be carried out by the European Commission. This should be carried out with a view to providing financial support to these entities, if necessary.

Amendment 127 #

Proposal for a regulation
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)

(38b) Following the adoption of this Regulation, the Agency should explore ways to further simplify the notification procedure, in particular taking into account the needs of small and medium- sized enterprises, so that they are not disproportionately burdened by new obligations.

Amendment 129 #

Proposal for a regulation
Article 1 – paragraph 1 – point -1 (new)

Regulation (EC) 1272/2008
Article 1 – paragraph 1

-1 In Article 1 ~~Purpose and Scope~~ , paragraph 1 is replaced by the following: "1. The purpose of this Regulation is to ensure a high level of protection of human health and the environment as well as the free movement of substances, mixtures and articles as referred to in Article 4(8) by: (a) harmonising the criteria for classification of substances and mixtures, and the rules on labelling and packaging for hazardous substances and mixtures;b) providing an obligation for: (i) manufacturers, importers and downstream users to classify substances and mixtures placed on the market; (ii) suppliers to label and package substances and mixtures placed on the market; (iii) manufacturers, producers of articles and importers to classify those substances not placed on the market that are subject to registration or notification under Regulation (EC) No 1907/2006; (iv) the Commission to ensure, prior to introducing new hazard classes or classification criteria, that such classes or criteria can be fully satisfied with existing data aligned with the EU’s goal of using alternative test methods, and thus avoiding animal testing where feasible." Or. en (Regulation 1272/2008)

Amendment 130 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Susana SOLÍS PÉREZ

Proposal for a regulation
Article 1 – paragraph 1 – point -1 (new)

Regulation (EC) 1272/2008
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 and~~and 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 131 #

Proposal for a regulation
Article 1 – paragraph 1 – point 1 a (new)

Regulation (EC) 1272/2008
Article 1 – paragraph 5 – point c

(1a) In Article 1, paragraph 5, point c is replaced by the following: "(c) cosmetic products as defined in Directive 76/768/EEC; for human health hazard classes;" Or. en (32008R1272)

Amendment 132 #

Proposal for a regulation
Article 1 – paragraph 1 – point 1 a (new)

Regulation (EC) 1272/2008
Article 1 – paragraph 5

(1a) In Article 1, paragraph 5 is replaced by the following: "This Regulation shall not apply to human health hazard classes for substances and mixtures in the following forms, which are in the finished state, intended for the final user: '" Or. en (Regulation (EC) 1272/2008)

Amendment 133 #

Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS

Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a

Regulation (EC) 1272/2008
Article 2 – point 7a

~~(a) the following point is inserted: ‘7a. ‘multi-constituent substance’ means a substance that contains more than one constituent.’~~deleted

Amendment 134 #

Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a

Regulation (EC) 1272/2008
Article 2 – point 7a

~~(a) the following point is inserted: ‘7a. ‘multi-constituent substance’ means a substance that contains more than one constituent.’~~ deleted (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Art 2 point 7a (new))

Amendment 135 #

Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a

Regulation (EC) No 1272/2008
Article 2 – paragraph 7a

~~(a) the following point is inserted: ‘7a. ‘multi-constituent substance’ means a substance that contains more than one constituent.’~~deleted

Amendment 136 #

Irène TOLLERET, Max ORVILLE, Giuseppe FERRANDINO, Atidzhe ALIEVA-VELI, Iskra MIHAYLOVA, Ilhan KYUCHYUK

Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a

Regulation (EC) No 1272/2008
Article 2 – point 7a

~~(a) the following point is inserted: ‘7a. ‘multi-constituent substance’ means a substance that contains more than one constituent.’~~deleted

Amendment 137 #

Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a

Regulation (EC) No 1272/2008
Article 2 – paragraph 7a

~~(a) the following point is inserted: ‘7a. ‘multi-constituent substance’ means a substance that contains more than one constituent.’~~deleted

Amendment 138 #

Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a

Regulation (EC) No 1272/2008
Article 2 – paragraph 7a

~~7a. ‘multi-constituent substance’ means a substance that contains more than one constituent.~~deleted

Amendment 139 #

Martin HOJSÍK, Irène TOLLERET, Atidzhe ALIEVA-VELI, Iskra MIHAYLOVA, Ilhan KYUCHYUK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Max ORVILLE, Susana SOLÍS PÉREZ

Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a

Regulation (EC) 1272/2008
Article 2 – paragraph 7a

~~7a. ‘multi-constituent substance’ means a substance that contains more than one constituent.~~deleted

Amendment 140 #

Christian DOLESCHAL, Christine SCHNEIDER, Dennis RADTKE

Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a

Regulation (EC) 1272/2008
Article 5 – paragraph 7a

~~7a. ‘multi-constituent substance’ means a substance that contains more than one constituent.~~deleted

Amendment 141 #

Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a

Regulation (EC) 1272/2008
Article 2 – point 7a

7a. ‘~~multi-constituent~~ substance’ means a substance that contains more than one constituent. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article 2, point 7a)

Amendment 142 #

Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point b a (new)

Regulation (EC) 1272/2008
Article 2 – paragraph 1 – point 38 a (new)

(ba) In Article 2, the following point 38 a is added: '38a. refill’ means an operation by which a consumer or a professional user fills its own container, which fulfils the packaging function, with a hazardous substance or mixture offered by a supplier in the context of a commercial transaction;'

Amendment 143 #

Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point b b (new)

Regulation (EC) 1272/2008
Article 2 – paragraph 1 – point 38 b (new)

(bb) In Article 2, the following point 38 b is added: '38b. refill station’ means a place where a supplier offers to consumers or professional users hazardous substances or mixtures that can be purchased through refill;'

Amendment 144 #

Proposal for a regulation
Article 1 – paragraph 1 – point 2 a (new)

Regulation (EC) 1272/2008
Article 3 – paragraph 1

(2a) In Article 3, paragraph 1 is replaced by the following: "A substance or a mixture fulfilling the criteria relating to physical hazards, health hazards or environmental hazards, laid down in Parts 2 to 5 of Annex I is hazardous and shall be classified in relation to the respective hazard classes provided for in that Annex. Gender differences with regard to the susceptibility to chemicals shall be taken into consideration, where relevant." Or. en (Regulation (EC) 1272/2008)

Amendment 145 #

Andrey NOVAKOV, Asim ADEMOV, Andrey KOVATCHEV, Emil RADEV, Eva MAYDELL, Alexander ALEXANDROV YORDANOV, Radan KANEV, Ivo HRISTOV, Tsvetelina PENKOVA, Petar VITANOV, Elena YONCHEVA, Atidzhe ALIEVA-VELI, Ilhan KYUCHYUK, Iskra MIHAYLOVA, Marc ANGEL

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008
Article 5 – paragraph 3

~~[...] [...] [...]~~d e [...] l e t e d

Amendment 146 #

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3

[...] d e [...] l e t e d

Amendment 147 #

Irène TOLLERET, Max ORVILLE, Giuseppe FERRANDINO, Atidzhe ALIEVA-VELI, Iskra MIHAYLOVA, Ilhan KYUCHYUK

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3

[...] d e [...] l e t e d

Amendment 148 #

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008
Article 5 – paragraph 3

[...] d e [...] l e t e d

Amendment 149 #

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 1

A ~~multi-constituent~~ substance containing ~~at least~~more than one constituent, in the form of an individual constituent, an identified impurity or an additive for which relevant information referred to in paragraph 1 is available, shall be examined in accordance with the criteria set out in this paragraph, using the available information on those constituents as well as on the substance~~, unless Annex I lays down a specific provision. (This amendment is linked to amendments by the same author to the fourth and seventh sub-~~. (The first part of this amendment is a horizontal amendment: all references in the Commission proposal to "multi- constituent substance(s)" - other than the deletion of the definition - should be replaced with the wording provided here) Or. en paragraph of this paragraph.)

Amendment 150 #

Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3

A ~~multi-constituent~~ substance containing at least one constituent, ~~in the form of an individual constituent,~~ an identified impurity or an additive for which relevant information referred to in paragraph 1 is available, shall be examined in accordance with the criteria set out in this paragraph, using the available information on those constituents as well as on the substance, unless Annex I lays down a specific provision. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Amendment 151 #

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3

Amendment 152 #

Christian DOLESCHAL, Christine SCHNEIDER, Dennis RADTKE

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3

A ~~multi-constituent~~ substance containing at least one constituent, in the form of an individual constituent, an identified impurity or an additive for which relevant information referred to in paragraph 1 is available, shall be examined in accordance with the criteria set out in this paragraph, using the available information on those constituents as well as on the substance, unless Annex I lays down a specific provision.

Amendment 153 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Max ORVILLE, Susana SOLÍS PÉREZ

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3

~~A multi-constituent s~~Substances containing ~~at least~~more than one constituent, in the form of an individual constituent, an identified impurity or an additive for which relevant information referred to in paragraph 1 is available, shall be examined in accordance with the criteria set out in this paragraph, using the available information on those constituents as well as on the substance, unless Annex I lays down a specific provision.

Amendment 154 #

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 1

Amendment 155 #

Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 2

For the evaluation of ~~multi-~~substances containing more than one constituent ~~substances~~ pursuant to Chapter 2 of this Title in relation to the ‘germ cell mutagenicity’, ‘carcinogenicity’, ‘reproductive toxicity’, ‘endocrine disrupting property for human health’ and ‘endocrine disrupting property for the environment’ hazard classes referred to in sections 3.5.3.1, 3.6.3.1, 3.7.3.1, 3.11.3.1. and 4.2.3.1. of Annex I, the manufacturer, importer or downstream user shall use the relevant available information referred to in paragraph 1 for each of the individual constituents in the substance.

Amendment 156 #

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 2

For the evaluation of ~~multi-constituent~~these substances pursuant to Chapter 2 in relation to the ‘germ cell mutagenicity’, ‘carcinogenicity’, ‘reproductive toxicity’, ~~‘endocrine disrupting property for human health’ and ‘endocrine disrupting property for the environment’ hazard classes~~and ‘hazardous to the aquatic environment’ referred to in sections 3.5.~~3.1~~, 3.6.~~3.1~~, 3.7.~~3.1, 3.11.3~~, and 4.1. and 4.2.3.1. of Annex I, where relevant information referred to in paragraph 1 is not available on the substance itself, the manufacturer, importer or downstream user shall use the relevant available information referred to in paragraph 1 for each of the individual constituents ~~in the substance.~~ , impurities and additives in the substance. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Art 5 §3 (new))

Amendment 157 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Max ORVILLE, Susana SOLÍS PÉREZ

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 paragraph 3 – subparagraph 2

For the evaluation of ~~multi-constituent substances~~substances containing more than one constituent pursuant to Chapter 2 in relation to the ‘germ cell mutagenicity’, ‘carcinogenicity’, ‘reproductive toxicity’, ‘endocrine disrupting property for human health’ and ‘endocrine disrupting property for the environment’ hazard classes referred to in sections 3.5.3.1, 3.6.3.1, 3.7.3.1, 3.11.3.1. and 4.2.3.1. of Annex I, the manufacturer, importer or downstream user shall use the relevant available information referred to in paragraph 1 for each of the individual constituents in the substance.

Amendment 158 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Max ORVILLE, Susana SOLÍS PÉREZ

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 2

For the evaluation of ~~multi-constituent~~these substances pursuant to Chapter 2 in relation to the ‘germ cell mutagenicity’, ‘carcinogenicity’, ‘reproductive toxicity’~~, ‘endocrine disrupting property for human health’ and ‘endocrine disrupting property for the environment’ hazard classes~~ and ‘hazardous to the aquatic environment’ referred to in sections 3.5~~.3.1~~, 3.6~~.3.1~~, 3.7~~.3.1, 3.11.3.1.~~ and 4.~~2.3.1.~~1 of Annex I, where relevant information referred to in paragraph 1 is not available on the substance itself, the manufacturer, importer or downstream user shall use the relevant available information referred to in paragraph 1 for each of the individual constituents ~~in the substance.~~ , impurities and additives in the substance. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Art, 5 - paragraph 3 (new))

Amendment 159 #

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 3

Relevant available information on the ~~multi-constituent substance~~substances containing more than one constituent itself shall be taken into account where one of the following conditions are met, unless Annex I lays down a specific provision:

Amendment 160 #

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008
Article 5 – paragraph 3 – subparagraph 3

Relevant available information on the ~~multi-~~substance containing more than one constituent ~~substance~~ itself shall be taken into account where one of the following conditions are met:

Amendment 161 #

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008
Article 5 – paragraph 3 – subparagraph 3 – point b a (new)

(ba) the information conforms to the derogation criteria established in Annex I in accordance with paragraph 4.

Amendment 162 #

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 4

Relevant available information on the ~~multi-~~substance containing more than one constituent ~~substance~~ itself showing absence of certain properties or less severe properties shall not override the relevant available information on the constituents in the substance, unless Annex I lays down a specific provision.

Amendment 163 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Max ORVILLE, Susana SOLÍS PÉREZ

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008
Article 5 – paragraph 3 – subparagraph 4

Relevant available information on the ~~multi-constituent substance~~substance containing more than one constituent itself showing absence of ~~certain~~the properties referred to in point (a) or less severe properties shall not override the relevant available information on the constituents in the substance.

Amendment 164 #

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 4

Relevant available information on the ~~multi-constituent substance~~substances containing more than one constituent itself showing absence of certain properties or less severe properties shall not override the relevant available information on the constituents in the substance.

Amendment 165 #

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EU) 1272/2008
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 166 #

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 5

For the evaluation of ~~multi-constituent~~these substances pursuant to Chapter 2 in relation to the ~~‘biodegradation, persistence, mobility and bioaccumulation’ properties within the ‘hazardous to the aquatic environment’~~ ‘persistent, bioaccumulative and toxic’, ‘very persistent and very bioaccumulative’, ‘persistent, mobile and toxic’ and ‘very persistent and very mobile’ hazard classes referred to in sections 4.~~1.2.8 4.1.2.9, 4.3.2.3.1, 4.3.2.3.2, 4.4.2.3.1~~3 and 4.4~~.2.3.2~~ of Annex I, where relevant information referred to in paragraph 1 is not available on the substance itself, the manufacturer, importer or downstream user shall use the relevant available information referred to in paragraph 1 for each of the individual constituents ~~in the substance.~~ , impurities or additives in the substance (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article 5 - paragraph 3 (new))

Amendment 167 #

Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS

Proposal for a regulation
Article 1 – paragraph 1 – point 4 Regulation (EC) No 1272/2008

For the evaluation of ~~multi-~~substances containing more than one constituent ~~substances~~ pursuant to Chapter 2 of this Title in relation to the ‘biodegradation, persistence, mobility and bioaccumulation’ properties within the ‘hazardous to the aquatic environment’ ‘persistent, bioaccumulative and toxic’, ‘very persistent and very bioaccumulative’, ‘persistent, mobile and toxic’ and ‘very persistent and very mobile’ hazard classes referred to in sections 4.1.2.8 4.1.2.9, 4.3.2.3.1, 4.3.2.3.2, 4.4.2.3.1 and 4.4.2.3.2 of Annex I, the manufacturer, importer or downstream user shall use the relevant available information referred to in paragraph 1 for each of the individual constituents in the substance.

Amendment 168 #

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 5

For the evaluation of ~~multi-constituent~~these substances pursuant to Chapter 2 in relation to the ~~‘biodegradation, persistence, mobility and bioaccumulation’ properties within the ‘hazardous to the aquatic environment’~~ ‘persistent, bioaccumulative and toxic’, ‘very persistent and very bioaccumulative’, ‘persistent, mobile and toxic’ and ‘very persistent and very mobile’ hazard classes referred to in sections 4.~~1.2.8 4.1.2.9, 4.3.2.3.1, 4.3.2.3.2, 4.4.2.3.1 and 4.4.2.3.2 of Annex I~~3 and 4.4 of Annex I, where relevant information referred to in paragraph 1 is not available on the substance itself, the manufacturer, importer or downstream user shall use the relevant available information referred to in paragraph 1 for each of the individual constituents ~~in the substance.~~ , impurities or additives in the substance. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Art 5 §3 (new))

Amendment 169 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Max ORVILLE, Susana SOLÍS PÉREZ

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 5

For the evaluation of ~~multi-constituent substances~~substances containing more than one constituent pursuant to Chapter 2 in relation to the ‘biodegradation, persistence, mobility and bioaccumulation’ properties within the ‘hazardous to the aquatic environment’ ‘persistent, bioaccumulative and toxic’, ‘very persistent and very bioaccumulative’, ‘persistent, mobile and toxic’ and ‘very persistent and very mobile’ hazard classes referred to in sections 4.1.2.8 4.1.2.9, 4.3.2.3.1, 4.3.2.3.2, 4.4.2.3.1 and 4.4.2.3.2 of Annex I, the manufacturer, importer or downstream user shall use the relevant available information referred to in paragraph 1 for each of the individual constituents in the substance.

Amendment 170 #

Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 6

Rdele~~vant available information on the multi-constituent substance itself shall be taken into acc~~ted (This amendment applies throughount wthere one of the following conditions are met: (a) the information demonstrates biodegradation, persistence, mobility and bioaccumulation properties. (b) the information supports the conclusions based on the relevant available information on the constituents in the substance. text. Adopting it will necessitate corresponding changes throughout.) Or. en (Art 5 §3 (new))

Amendment 171 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Max ORVILLE, Susana SOLÍS PÉREZ

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 6

Amendment 172 #

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008
Article 5 – paragraph 3 – subparagraph 6

Relevant available information on the ~~multi-~~substance containing more than one constituent ~~substance~~ itself shall be taken into account where one of the following conditions are met:

Amendment 173 #

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 6 – point a

(a) the information demonstrates lack of biodegradation, or persistence, mobility ~~and~~or bioaccumulation properties.

Amendment 174 #

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008
Article 5 – paragraph 3 – subparagraph 6 – point a

(a) the information demonstrates ~~biodegradation,~~ persistence, mobility and bioaccumulation properties., or lack of biodegradation

Amendment 175 #

Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008
Article 5 – paragraph 3 – subparagraph 6 – point b a (new)

(ba) the information conforms to the derogation criteria established in Annex I in accordance with paragraph 4.

Amendment 176 #

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 7

Rdelevant 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 the constituents in the substance. ted (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Art 5 §3 (new))

Amendment 177 #

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 7

Amendment 178 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Max ORVILLE, Susana SOLÍS PÉREZ

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008
Article 5 – paragraph 3 – subparagraph 7

Relevant available information on the ~~multi-constituent substance~~substance containing more than one constituent itself showing absence of ~~certain~~the properties referred to in (a) or less severe properties shall not override the relevant available information on the constituents in the substance.

Amendment 179 #

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 7

Amendment 180 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Max ORVILLE, Susana SOLÍS PÉREZ

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008
Article 5 – paragraph 3 a (new)

In Article 5, the following paragraph 3a is added: 'The Commission is empowered to adopt delegated acts in accordance with the procedure referred to in Article 53 in order to amend Annex I to lay down derogation criteria referred to in paragraph 3, subparagraphs 3(ba) and 5(ba) on the basis of the opinion of the Committee for Risk Assessment of the Agency set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006. The opinion of the Committee for Risk Assessment shall be based on reliable and updated scientific information, particularly when it demonstrates the occurrence of antagonistic effects among constituents impacting the hazard of the substance.'

Amendment 181 #

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3a (new)

In Article 5, the following paragraph 3a is added: 'The European Commission shall, where appropriate and scientifically justified, amend Annex I in accordance with the procedure referred to in Article 53, to lay down specific provisions granting derogation from the criteria set out in this Article for a substance containing more than one constituent. The Committee for Risk Assessment of the Agency set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006 shall, where necessary, adopt an opinion on the scientific argumentation for a derogation from the rules for substances containing more than one constituent provided under this article.'

Amendment 182 #

Eric ANDRIEU, Nora MEBAREK, Sylvie GUILLAUME

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 a (new)

In Article 5, paragraph 3a is added as follows: ‘For substances which occur in nature, as defined in Article 3(39) of the REACH Regulation, and substances obtained directly from plants of renewable origin such as essential oils, the determination of classification should be based solely on data obtained from an analysis of the substance as a whole and not from an analysis of its components taken separately.’

Amendment 183 #

Cristian-Silviu BUŞOI, Salvatore DE MEO, Aldo PATRICIELLO

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 a (new)

In Article 5, the following paragraph 3a is added: 'Substances which occur in nature, as defined under article 3.39 of REACH, as well as substances obtained directly from plants occurring from renewable origin, intrinsically sustainable, justify that the determination of the classification can take into account data obtained on the whole substance.'

Amendment 184 #

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 7 a (new)

In Article 5, paragraph 3, the following subparagraph 7a is added: 'The Commission shall use the procedure in Article 53 to lay down specific provisions in Annex I.'

Amendment 185 #

Billy KELLEHER, Ilhan KYUCHYUK, Iskra MIHAYLOVA, Atidzhe ALIEVA-VELI

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 a (new)

In Article 5, the following paragraph 3a is added: '3a. Paragraph 3 shall not apply to UVCB substances of biological origin.'

Amendment 186 #

Petar VITANOV, Tsvetelina PENKOVA, Ilhan KYUCHYUK, Iskra MIHAYLOVA, Atidzhe ALIEVA-VELI, Radan KANEV, Eva MAYDELL, Andrey KOVATCHEV, Andrey NOVAKOV, Emil RADEV, Asim ADEMOV

In Article 5, the following paragraph 3a is added: 'Paragraph 3 shall not apply to UVCB substances of biological origin.'

Amendment 187 #

Andrey SLABAKOV, Andrey NOVAKOV, Angel DZHAMBAZKI, Emil RADEV, Andrey KOVATCHEV, Tsvetelina PENKOVA, Atidzhe ALIEVA-VELI, Ilhan KYUCHYUK, Iskra MIHAYLOVA, Radan KANEV, Petar VITANOV, Alexander ALEXANDROV YORDANOV

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 a (new)

In Article 5, the following paragraph 3a is added: 'Paragraph 3 shall not apply to UVCB substances of biological origin.'

Amendment 188 #

Radan KANEV, Emil RADEV, Andrey NOVAKOV, Andrey KOVATCHEV, Asim ADEMOV, Petar VITANOV, Angel DZHAMBAZKI

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 a (new)

In Article 5, the following paragraph 3a is added: 'Paragraph 3 shall not apply to UVCB substances of biological origin.'

Amendment 189 #

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 a (new)

In Article 5, the following paragraph 3a is added: 'Paragraph 3 shall not apply to UVCB substances of biological origin.'

Amendment 190 #

Proposal for a regulation
Article 1 – paragraph 1 – point 5

Regulation (EC) No 1272/2008
Article 6 – paragraph 3

For the evaluation of mixtures pursuant to chapter 2 of this Title in relation to the ‘germ cell mutagenicity’, ‘carcinogenicity’, ‘reproductive toxicity’, ‘endocrine disrupting property for human health’ and ‘endocrine disrupting property for the environment’ hazard classes referred to in sections 3.5.3.1, 3.6.3.1, 3.7.3.1, 3.11.3.1 and 4.2.3.1 of Annex I, the manufacturer, importer or downstream user shall only use the relevant available information referred to in paragraph 1 for the substances in the mixture and not for the mixture itself .

Amendment 191 #

Proposal for a regulation
Article 1 – paragraph 1 – point 5

In Article 6, paragraph 4a is added: 'The Agency shall develop robust and timely guidance to support the above mentioned evaluations. All guidance should be adopted before the entry into force of this Regulation.' Or. en (See paragraph 4, Article 6, Regulation 1272/2008)

Amendment 192 #

Proposal for a regulation
Article 1 – paragraph 1 – point 5

Regulation (EC) 1272/2008
Article 6 – paragraph 3 – subparagraph 2

However, for the one plant protection product or the one biocidal product for which the approval criteria of Regulation (EC) No 1107/2009 or Regulation (EU) No 528/2012 need to be met, respectively, for the approval of the corresponding active substance, or where the available test data on the mixture itself demonstrates germ cell mutagenic, carcinogenic or toxic to reproduction properties, or endocrine disrupting properties for human health or the environment which have not been identified from the relevant available information on the individual substance referred to in the first subparagraph, ~~that data~~data on the mixture as a whole shall also be taken into account for the purposes of the evaluation of the mixture referred to in the first subparagraph.

Amendment 193 #

Proposal for a regulation
Article 1 – paragraph 1 – point 5

Regulation (EC) No 1272/2008
Article 6 – paragraph 4

4. For the evaluation of mixtures pursuant to Chapter 2 of this Title in relation to the ‘biodegradation, persistency, mobility and bioaccumulation’ properties within the ‘hazardous to the aquatic environment’, ‘persistent, bioaccumulative and toxic’, ‘very persistent and very bioaccumulative’, ‘persistent, mobile and toxic’ and ‘very persistent and very mobile’ hazard classes referred to in sections 4.1.2.8, 4.1.2.9, 4.3.2.3.1, 4.3.2.3.2, 4.4.2.3.1 and 4.4.2.3.2 of Annex I, the manufacturer, importer or downstream user shall only use the relevant available information referred to in paragraph 1 for the substances in the mixture and not for the mixture itself ; However, where the available test data on the mixture itself demonstrates persistent, mobile, or bioaccumulation properties which have not been identified from the relevant available information on the individual substance referred to in the first subparagraph, that data shall also be taken into account for the purposes of the evaluation of the mixture referred to in the first subparagraph.

Amendment 194 #

Proposal for a regulation
Article 1 – paragraph 1 – point 5

Regulation (EU) 1272/2008
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)

Regulation (EU) 1272/2008
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 196 #

Proposal for a regulation
Article 1 – paragraph 1 – point 5 a (new)

Regulation (EC) 1272/2008
Article 7

(5a) Article 7 is replaced by the following: "Article 7 Article 7 Animal and human testing 1. Where new tests are carried out for the purposes of this Regulation, tests on animals within the meaning of Directive 86/ 609/EEC shall be undertaken only where no other alternatives, which provide adequate reliability and quality of data, are possible. 2. Tests on non-human primates shall be prohibited for the purposes of this Regulation. 3. Tests on humans shall not be performed for the purposes of this Regulation. Data obtained from other sources, such as clinical studies, can however be used for the purposes of this Regulation. All data shall be evaluated comparably and according to their biological relevance, mechanistic understanding, and ability to provide information suitable for meeting the requirements of this Regulation." Or. en (Regulation 1272/ 2008)

Amendment 197 #

Proposal for a regulation
Article 1 – paragraph 1 – point 5 a (new)

Regulation (EC) 1272/2008
Article 7

A(5a) Article 7 is replaced by the following: "'New Approach Methodologies, animal and human testing 1. Where new tests are carried out for the purposes of this Regulation, tNew Approach methodologies (NAM) shall be used as the norm. Tests on animals within the meaning of Directive 86/609/EEC shall be undertaken only where it is demonstrated that no other alternatives, which provide adequate reliability and quality of data, ~~are possible~~exist. 2. Tests on non-human primates shall be prohibited for the purposes of this Regulation, as well as the use of data derived from tests on non-human primates. 3. Tests on humans shall not be performed for the purposes of this Regulation. Data obtained from other sources, such as clinical studies, can however be used for the purposes of this Regulation. '" Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32008R1272)

Amendment 198 #

Proposal for a regulation
Article 1 – paragraph 1 – point 5 a (new)

Regulation (EC) 1272/2008
Article 7 – paragraph 1 a (new)

(5a) In Article 7, the following paragraph 1a is added: '1a. Tests using new approach methodologies shall also be considered'.

Amendment 199 #

Proposal for a regulation
Article 1 – paragraph 1 – point 6

Regulation (EC) 1272/2008
Article 9 – paragraph 3

3. Where the criteria referred to in paragraph 1 cannot be applied directly to all available identified information, manufacturers, importers and downstream users shall carry out an evaluation by applying a weight of evidence determination using expert judgement in accordance with section 1.1.1 of Annex I to this Regulation, weighing all available information having a bearing on the determination of the hazards of the substance or the mixture, and in accordance with section 1.2 of Annex XI to Regulation (EC) No 1907/2006. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (in Article 9, paragraphs 3 and 4 are replaced by the following:)

Amendment 200 #

Proposal for a regulation
Article 1 – paragraph 1 – point 7 a (new)

Regulation (EC) 1272/2008
Article 10 a (new)

(7a) The following Article 10 a is added: The proposed classification of a substance or mixture shall be accompanied by a socio-economic impact assessment. The assessment shall evaluate potential social and economic impacts associated with the proposed classification. This report is to be conducted by the party submitting the classification proposal and by the industry whose substance is subject to classification. The socio-economic impact assessment shall include, but not be limited to, the following: a) Economic implications, including potential effects on jobs, the competitive position of the EU industry, and the cost of compliance with the proposed classification and who will bear such cost. b) Social implications, including potential effects on consumer/industry access to goods and services, job loss and competitivity. A third party shall review the socio- economic impact assessment as part of the classification process for a comprehensive and neutral review. Parts of the socio- economic impact assessment could be made publicly available, subject to the protection of confidential business information (CBI).

Amendment 201 #

Proposal for a regulation
Article 1 – paragraph 1 – point 7 b (new)

Regulation (EC) 1272/2008
Article 10 b (new)

(7b) The following Article 10 b is added: In the process of classifying a substance or mixture under CLP regulation, it shall be necessary to identify, assess, and clearly communicate the regulatory links between the CLP Regulation and other relevant pieces of EU legislation. This is to ensure consistent and effective risk management across all relevant regulatory contexts and prevent double regulation. The downstream impact assessment shall take into account case- specific factors. For example, in cases where a substance is present as an impurity in other substances or mixtures, the impact assessment should consider the socio-economic implications for industries relying on the recycling of these substances or mixtures. This is specially relevant for special mixtures such as metals and inorganics. The European Chemicals Agency (ECHA), in cooperation with relevant national authorities, shall ensure that the consequences of proposed classifications, including the regulatory links and downstream impacts, are clearly communicated to all relevant stakeholders to prevent classifications from existing in a vacuum disconnected from the other pieces of legislation affecting the substance or mixture in question. The assessment of regulatory links and downstream impacts, and the communication of these links and impacts, shall be regularly reviewed and updated as part of the continuous evolution of the CLP regulation and in light of new scientific evidence or changes in socio-economic conditions.

Amendment 202 #

Proposal for a regulation
Article 1 – paragraph 1 – point 7 c (new)

Regulation (EC) 1272/2008
Article 10 c (new)

(7c) The following Article 10 c is added: When calculating the concentration of a classified substance in a special mixture, such as those containing metals and other inorganic substances, specific considerations shall apply. This is in recognition of the fact that these mixtures may have distinct properties and behaviours compared to mixtures of organic chemical substances. Rather than calculating the concentration of a classified substance in a special mixture using the full mixture weight, a different method shall be employed. This method shall be based on a scientifically valid approach that considers the specific physical, chemical, and toxicological properties of the classified substance and the nature of the special mixture. The European Chemicals Agency (ECHA) and steered by the Commission shall provide detailed guidance on the adjusted calculation method for special mixtures. This guidance shall be developed in consultation with relevant scientific experts and industry stakeholders, steered by the European Commission, and shall be regularly reviewed and updated in light of new evidence. The adjusted calculation method for special mixtures, and the associated guidance from ECHA, shall be taken into account when implementing and enforcing other relevant pieces of EU legislation, including but not limited to the SEVESO Directive. This is to ensure a consistent and fair approach to the classification and management of special mixtures across all regulatory contexts.

Amendment 203 #

Proposal for a regulation
Article 1 – paragraph 1 – point 7 d (new)

Regulation (EC° 1272/2008
Article 10 d (new)

(7d) The following Article 10 d is added: The Competent Authorities for REACH and CLP (CARACAL) platform shall enhance its transparency beyond meeting agendas. This includes making meeting minutes, including discussions and decisions related to CLP classification proposals, publicly available. All such information shall be made accessible in a user-friendly manner to facilitate understanding by non-expert stakeholders. In recognition of the specific interests and expertise of industry stakeholders, special measures shall be taken to ensure their informed participation in the CLP classification process. This includes, but is not limited to, providing clear and comprehensive information on the classification process and its implications for industry, and facilitating industry representation in CARACAL discussions.

Amendment 204 #

Christian DOLESCHAL, Christine SCHNEIDER, Dennis RADTKE

Proposal for a regulation
Article 1 – paragraph 1 – point 7 a (new)

Regulation (EC) 1272
Article 17

(7a) Article 17 is replaced by the following: "1. A substance or mixture classified as hazardous and contained in packaging shall bear a label or fold-out label including the following elements: (a) the name, address and telephone number of the supplier(s); (b) the nominal quantity of the substance or mixture in the package made available to the general public, unless this quantity is specified elsewhere on the package; (c) product identifiers as specified in Article 18; (d) where applicable, hazard pictograms and signal words in accordance with Article 19 and 20; (e) where applicable, signal words in accordance with Article 20; (f) where applicable, hazard statements in accordance with Article 21; (g) where applicable, the appropriate precautionary statements in accordance with Article 22; (h) where applicable, a section for a statement indicating that supplemental information in accordance with Article 25, and other sector specific labelling information, can be found online. 2. The label shall be written in the official language(s) of the Member State(s) where the substance or mixture is placed on the market, unless the Member State(s) concerned provide(s) otherwise. Suppliers may use more languages on their labels or fold-out labels than those required by the Member States, provided that the same details appear in all languages used. The information in paragraph 1 (e), (f), (g) and (h) may be provided on the inner pages of a fold-out label. For multilingual fold-out labels, the languages shall be ordered in a logical way, e.g. alphabetically. The Commission shall develop clear guidance to outline further the details of the criteria in this article prior to the entry into force of this Regulation." Or. en (32008R1272)

Amendment 205 #

Proposal for a regulation
Article 1 – paragraph 1 – point 7 a (new)

Regulation (EC) 1272/2008
Article 17 – paragraph 1

(7a) In Article 17, paragraph 1 is replaced by the following: "1. A substance or mixture classified as hazardous and contained in packaging shall bear a label or fold-out label including the following elements: " Or. en (Regulation 1272/2008)

Amendment 206 #

Christian DOLESCHAL, Christine SCHNEIDER, Dennis RADTKE

Proposal for a regulation
Article 1 – paragraph 1 – point 7 a (new)

Regulation (EC) 1272/2008
Article 17 – paragraph 1 – point (i) (new)

(7a) In Article 17, paragraph 1, the following point (i) is added: '(i) where relevant, the species and number of animals used in tests;'

Amendment 207 #

Proposal for a regulation
Article 1 – paragraph 1 – point 7 b (new)

Regulation (EC) 1272/2008
Article 17 paragraph 1 – point a

(7b) In Article 17, in paragraph 1, point a is replaced by the following: "(a) the name, address and telephone number of the supplier(s); distributers who do not change the product or packaging may use the provided label unchanged." Or. en (Regulation 1272/2008/EC)

Amendment 208 #

Christian DOLESCHAL, Christine SCHNEIDER, Dennis RADTKE

Proposal for a regulation
Article 1 – paragraph 1 – point 7 b (new)

Regulation (EC) 1272/2008
Article 17 – paragraph 2

(7b) In Article 17, paragraph 2 is replaced by the following: "2. The label shall be written in the official language(s) of the Member State(s) where the substance or mixture is placed on the market, unless the Member State(s) concerned provide(s) otherwise.Suppliers may use more languages on their labels or fold-out labels than those required by the Member States, provided that the same details appear in all languages used. " Or. en (Regulation 1272/2008)

Amendment 209 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Susana SOLÍS PÉREZ

Proposal for a regulation
Article 1 – paragraph 1 – point 7 a (new)

Regulation (EC) 1272/2008
Article 18 – paragraph 3 – point b

(7a) In Article 18, paragraph 3, point (b) is replaced by the following: "‘(b) the identity of all substances in the mixture that contribute to the classification of the mixture as regards acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, endocrine disruption for human health, endocrine disruption for the environment, respiratory or skin sensitisation, specific target organ toxicity (STOT) or aspiration hazard. , persistent, bioaccumulative and toxic (PBT), very persistent, very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), very persistent, very mobile (vPvM) properties.’;" Or. en (Regulation 1272/2008)

Amendment 210 #

(7a) In Article 18, paragraph 3, point b is replaced by the following: "(b) the identity of all substances in the mixture that contribute to the classification of the mixture as regards acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, endocrine disruption for human health, endocrine disruption for the environment, respiratory or skin sensitisation, specific target organ toxicity (STOT) or aspiration hazard. , persistent, bioaccumulative and toxic (PBT), very persistent, very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), very persistent, very mobile (vPvM)." Or. en (32008R1272)

Amendment 211 #

Proposal for a regulation
Article 1 – paragraph 1 – point 7 a (new)

Regulation (EC) 1272/2008
Article 18 – paragraph 3 – point b

(7a) In Article 18, paragraph 3, point (b) is replaced by the following: "the identity of all substances in the mixture that contribute to the classification of the mixture as regards acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or skin sensitisation, specific target organ toxicity (STOT) ~~or aspiration hazard.~~ , aspiration hazard, endocrine disruption for human health, endocrine disruption for the environment, persistent, bioaccumulative and toxic, very persistent and very bioaccumulative, persistent, mobile and toxic, or very persistent and very mobile properties." Or. en (Regulation (EC) 1272/2008)

Amendment 212 #

Proposal for a regulation
Article 1 – paragraph 1 – point 8

Regulation 1272/2008
Article 23 – paragraph 1 – point e a (new)

In Article 23, the following point ea is added: '(ea) disposable electronic cigarettes, single use cartridges and refill containers as defined in Directive 2014/40/EU.'

Amendment 213 #

In ~~the case of a bespoke paint~~Article 25, paragraph 8 is replaced by the following: "In the case of a bespoke paint or an on- site formulated mixture for which no submission in accordance with Annex VIII has been made and no corresponding unique formula identifier has been created, the unique formula identifiers of all the mixtures contained in the bespoke paint or the on-site formulated mixture in a concentration exceeding 0,1 % which themselves are subject to notification under Article 45 shall be included in the supplemental information on the label of the bespoke paint or the on-site formulated mixture, located together and listed in descending order of the mixtures’ concentration in the bespoke paint or the on-site formulated mixture, in accordance with the provisions of Section 5 of Part A of Annex VIII. In a case falling within the first subparagraph, where the concentration of a mixture with a unique formula identifier in the bespoke paint or the on- site formulated mixture exceeds 5 %, the concentration of that mixture shall also be included in the supplemental information on the label of the bespoke paint or the on- site formulated mixture next to its unique formula identifier, in accordance with Section 3.4 of Part B of Annex VIII. For the purposes of this paragraph, ‘bespoke paint’ means a paint that is formulated in limited amounts on a tailor-made basis for an individual consumer or professional user at the point of sale by tinting or colour mixing~~. (Regulation (EU) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures.Art. 25, para. 1)~~ and ‘on-site formulated mixture’ means a mixture that is formulated in a volume less than 10 ml on a tailor-made basis for an individual consumer or professional user at the point of supply." Or. en

Amendment 214 #

Christian DOLESCHAL, Christine SCHNEIDER, Dennis RADTKE

Proposal for a regulation
Article 1 – paragraph 1 – point 9

Regulation (EC) 1272/2008
Article 25 – paragraph 2 and 3

In article 25, paragraph 2 and 3 are replaced by the following: "2. A statement shall be included in the section for supplemental information on the label where a substance or mixture classified as hazardous falls within the scope of ~~Directive 91/414/EEC~~Regulation (EC) No 1107/2009 or Regulation (EU) No 528/2012 .The statement shall be worded in accordance with Part 4 of Annex II and Part 3 of Annex III to this Regulation. 3. The supplier may include supplemental information in the section for supplemental information on the label other than that referred to in paragraphs 1, 2 and 27, provided that that information does not make it more difficult to identify the label elements referred to in Article 17(1) (a) to (g) and that it provides further details and does not contradict or cast doubt on the validity of the information specified by those elements. " Or. en (Regulation 1272/2008)

Amendment 215 #

Proposal for a regulation
Article 1 – paragraph 1 – point 10 a (new)

Regulation (EC) 1272/2008
Article 25 – paragraph 6

(10a) In Article 25, paragraph 6 is replaced by the following: "6. Where a mixture contains any substance classified as hazardous, it shall be labelled in accordance with Part 2 of Annex II.The statements shall be worded in accordance with Part 3 of Annex III and shall be placed in the supplemental information section of the label.The label shall also include the product identifier referred to in Article 18 and the name, address and telephone number of the supplier of the mixture. Distributers who do not change the product or its packaging may use the provided label unchanged." Or. en (Regulation 1272/2008/EC)

Amendment 216 #

Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS

Proposal for a regulation
Article 1 – paragraph 1 – point 11 – point a

Regulation (EC) 1272/2008
Article 29 – paragraph 1

1. Where the packaging of a substance or a mixture is either in such a shape or form or is so small that it is impossible to meet the requirements laid down in Article 31 for a label or a fold-out label in the languages of the Member States in which the substance or mixture is placed on the market, the label elements set out in Article 17(1), shall be provided in accordance with sections 1.5.1.1. and 1.5.1.2. of Annex I.; (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article 29 paragraph 1)

Amendment 217 #

Proposal for a regulation
Article 1 – paragraph 1 – point 11 – point a

Regulation (EC) 1272/2008
Article 29 – paragraph 1

1. Where the packaging of a substance or a mixture is either in such a shape or form or is so small that it is impossible to meet the requirements laid down in Article 31 for a label or a fold-out label in the languages of the Member ~~State~~ in which the substance or mixture is placed on the market, the label elements set out in Article 17(1), shall be provided in accordance with sections 1.5.1.1. and 1.5.1.2. of Annex I.; (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article 29 - paragraph 1)

Amendment 218 #

Proposal for a regulation
Article 1 – paragraph 1 – point 12

Regulation (EU) 1272/2008
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 219 #

Proposal for a regulation
Article 1 – paragraph 1 – point 12

Regulation (EC) 1272/2008
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 618 months after the results of the new evaluation referred to in Article 15(4) were obtained. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article 30 - paragraph 1)

Amendment 220 #

Proposal for a regulation
Article 1 – paragraph 1 – point 12

Regulation (EC) No 1272/2008
Article 30 – paragraph 1

Amendment 221 #

Christian DOLESCHAL, Christine SCHNEIDER, Dennis RADTKE

Proposal for a regulation
Article 1 – paragraph 1 – point 12

Regulation (EC) 1272/2008
Article 30 – paragraph 1

Amendment 222 #

Proposal for a regulation
Article 1 – paragraph 1 – point 12

Regulation (EC) 1272/2008
Article 30 – paragraph 1

Amendment 223 #

Christian DOLESCHAL, Christine SCHNEIDER, Dennis RADTKE

Proposal for a regulation
Article 1 – paragraph 1 – point 12

Regulation (EC) 1272/2008
Article 30 – paragraph 2

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, t~~The supplier shall ensure that the label is updated within 18 months after the ~~results of~~supplier has received the new evaluation referred to in Article 15(4) ~~were obtained~~.

Amendment 224 #

Christian DOLESCHAL, Christine SCHNEIDER, Dennis RADTKE

Proposal for a regulation
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 225 #

Proposal for a regulation
Article 1 – paragraph 1 – point 12

Regulation (EC) 1272/2008
Article 30 – paragraph 3a new

3a. Paragraphs 1 and 2 shall not be applicable to distributers who do not modify the product, its packaging or label.

Amendment 226 #

Proposal for a regulation
Article 1 – paragraph 1 – point 13

Regulation (EC) 1272/2008
Article 31– paragraph 3

3. The label elements referred to in Article 17(1) shall 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. (Th~~ey shall be formatted in accordance with section 1.2.1 of Annex I.;~~ is amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article 31- paragraph 3Justification)

Amendment 227 #

Christian DOLESCHAL, Christine SCHNEIDER, Dennis RADTKE

Proposal for a regulation
Article 1 – paragraph 1 – point 13

Regulation (EU) 1272/2008
Article 31 – paragraph 3

3. The label elements referred to in Article 17(1) ~~shall~~must 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 228 #

Proposal for a regulation
Article 1 – paragraph 1 – point 13 a (new)

Regulation (EC) 1272/2008
Article 31 – title

~~General rules for the application of labels~~ (13a) In Article 31, the title is changed as following: "General rules for the application of labels and fold-out labels" Or. en (Regulation 1272/2008)

Amendment 229 #

Proposal for a regulation
Article 1 – paragraph 1 – point 14

Regulation (EC) No 1272/2008
Article 32 – paragraph 6

(14) in Article 32, paragraph 6 is deleted; and replaced by the following; ´6. Where the label elements referred to in Article 17(1) is provided by means of a fold-out label, the front page shall contain at least the information provided in accordance with Article 17(1)(e) in all languages of the label along with a reference to the additional information provided on the inside page(s).'

Amendment 230 #

Proposal for a regulation
Article 1 – paragraph 1 – point 15

Regulation (EU) 1272/2008
Chapter 3 - header

~~Formats of the labelling~~(Does not affect the English version.)

Amendment 231 #

Proposal for a regulation
Article 1 – paragraph 1 – point 15

Regulation (EU) 1272/2008
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

Regulation (EU) 1272/2008
Article 34a – paragraph 1 – point b)

(b) ~~both on a physical label and~~ on a label in a digital form (‘digital label’).

Amendment 233 #

Proposal for a regulation
Article 1 – paragraph 1 – point 15

Regulation (EC) No 1272/2008
Article 34a – paragraph 2a (new)

2a. In Article 34a, the following paragraph 2a is added: 'The Commission shall document in full transparency the decision process to determine what information is not instrumental for the safety of the user or the protection of the environment.'

Amendment 234 #

Proposal for a regulation
Article 1 – paragraph 1 – point 15

Regulation (EU) 1272/2008
Article 34b – paragraph 1

1. The digital label for substances and mixtures ~~shall~~must satisfy the following general rules and technical requirements:

Amendment 235 #

Proposal for a regulation
Article 1 – paragraph 1 – point 15

Regulation (EU) 1272/2008
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 236 #

Proposal for a regulation
Article 1 – paragraph 1 – point 15

Regulation (EC) 1272/2008
Article 34b – paragraph 1 – point d

(d) the digital label shall be accessible free of charge, without the need to register, download or install specific applications, or to provide a password; (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article 34)

Amendment 237 #

Proposal for a regulation
Article 1 – paragraph 1 – point 15

Regulation (EC) 1272/2008
Article 34b – paragraph 1 – point f

~~(f) the information on the digital label shall be accessible with no more than two clicks;~~ deleted (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article 34)

Amendment 238 #

Proposal for a regulation
Article 1 – paragraph 1 – point 15

Regulation (EC) 1272/2008
Article 34b – paragraph 1 – point h

(h) when the digital label is available in more than one language, the choice of language shall not be ~~conditioned on the geographical location;~~ restricted by geographical location; (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article 34)

Amendment 239 #

Proposal for a regulation
Article 1 – paragraph 1 – point 16

Regulation (EC) No 1272/2008
Article 35 – paragraph 2a

2a. Hazardous substances or mixtures may be supplied to consumers and professional 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. This paragraph shall not apply to hazardous substances or mixtures supplied to the general public without packaging in accordance with Article 29(3).;

Amendment 240 #

Proposal for a regulation
Article 1 – paragraph 1 – point 16

Regulation (EU) 1272/2008
Article 35 – paragraph 2a

2a. Hazardous substances or mixtures may be supplied to consumers and ~~professional~~subsequent 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 241 #

Proposal for a regulation
Article 1 – paragraph 1 – point 16 a (new)

"HARMONISATION OF CLASSIFICATION AND LABELLING OF SUBSTANCES AND MIXTURES AND THE CLASSIFICATION AND LABELLING INVENTORY " (Horizontal amendment that should apply throughout the text.) Or. en (Regulation (EC) 1272/2008)

Amendment 242 #

Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point a

Regulation (EC) 1272/2008
Article 37 – paragraph 1 – first subparagraph

A competent authority may submit to the Agency a proposal for harmonised classification and labelling of ~~substances~~a substance or a group of substances or a mixture and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for revision thereof.

Amendment 243 #

Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point a

Regulation (EC) 1272/2008
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 244 #

Sirpa PIETIKÄINEN

Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point a

Regulation (EC) No 1272/2008
Article 37 – paragraph 1 – subparagraph 2

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. Whenever considered scientifically justified and possible by a competent authority or the European Commission, proposals for classification should prioritise groups of substances rather than individual substances.

Amendment 245 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Susana SOLÍS PÉREZ

Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point a

Regulation (EC) 1272/2008
Article 37 – paragraph 1 – subparagraph 2

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~~a substance or a group of substances or a mixture 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. Or. en (Linked to the amendment on the first subparagraph of this Article by the same author.)

Amendment 246 #

Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point a

Regulation (EC) 1272/2008
Article 37 – paragraph 1 – subparagraph 3

The proposals for harmonised classification and labelling of a substance and also groups of substances referred to in the first and the second subparagraphs shall follow the format set out in Part 2 of Annex VI and contain the relevant information provided for in Part 1 of Annex VI.

Amendment 247 #

Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point a

Regulation (EC) No 1272/2008
Article 37 – paragraph 1 – subparagraph 3 a (new)

In Article 37, the following subparagraph 3a is added: 'Whenever considered scientifically justified and possible by a competent authority or the Commission, proposals for harmonised classification and labelling should prioritise groups of rather than individual substances.'

Amendment 248 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Susana SOLÍS PÉREZ

Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point c

Regulation (EC) 1272/2008
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 249 #

Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point d a (new)

Regulation (EC) 1272/2008
Article 37 – paragraph 4

(da) In Article 37, paragraph 4 is replaced by the following "4. The Committee for Risk Assessment of the Agency set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006 shall adopt an opinion on any proposal submitted pursuant to paragraphs 1 or 2 within 18 months of receipt of the proposal, giving the parties concerned the opportunity to comment. The Agency shall forward this opinion and any comments to the Commission. The Agency may provide further guidance on the development of harmonised classification proposal for group(s) of substances and take into consideration the complexity of the proposal to allow sufficient time for the relevant stakeholders to provide comments." Or. en (32008R1272)

Amendment 250 #

Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point e

Regulation (EC) 1272/2008
Article 37 – paragraph 5

The Commission shall adopt with~~out undue delay~~in 6 months after the adoption of an opinion by the Committee for Risk Assessment of the Agency in accordance with paragraph 4, delegated acts in accordance with Article 53a to amend Annex VI by inclusion of substances together with the relevant classification and labelling elements and, where appropriate, the specific concentration limits, M-factors or acute toxicity estimates in Table 3 of Part 3 of Annex VI.

Amendment 251 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Susana SOLÍS PÉREZ

Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point e

Regulation (EC) 1272/2008
Article 37 – paragraph 5

The Commission shall ~~adopt without undue delay,~~within nine months following the receipt of the opinion of the Committee for Risk Assessment adopt delegated acts in accordance with Article 53a to amend Annex VI by inclusion of substances or mixtures together with the relevant classification and labelling elements and, where appropriate, the specific concentration limits, M-factors or acute toxicity estimates in Table 3 of Part 3 of Annex VI.

Amendment 252 #

Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point e

Regulation (EC) 1272/2008
Article 37 – paragraph 6

6. Manufacturers, importers and downstream users who have new information which may lead to a change of the harmonised classification and labelling elements of substances in Part 3 of Annex VI shall submit a proposal in accordance with paragraph 2, second subparagraph, to the competent authority in one of the Member States in which the substances are placed on the market. The manufacturer, importer or downstream user that has, after refusal of submission to adapt classification to a less severe hazard class or category by a competent authority in one of the Member States, resorted to submitting the proposal to a competent authority in another Member States, shall be rejected and contribute with a fee to compensate for the costs borne by the competent authorities;

Amendment 253 #

Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point e Regulation (EC) 1272/2008

6. Manufacturers, importers and downstream users who have new information which may lead to a change of the harmonised classification and labelling elements of substances in Part 3 of Annex VI shall submit a proposal in accordance with paragraph 2, second subparagraph, to the competent authority in one of the Member States in which the substances are placed on the market. A proposal of a manufacturer, importer or downstream user for a change of the harmonised classification and labelling elements of substances in Part 3 of Annex VI to a less severe harmonised classification and labelling shall be accompanied by the fee determined by the Commission in accordance with the procedure referred to in Article 54(2);

Amendment 254 #

Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point e

Regulation (EC) No 1272/2008
Article 37 – paragraph 6

6. Manufacturers, importers and downstream users who have new information which may lead to a change of the harmonised classification and labelling elements of substances in Part 3 of Annex VI shall submit a proposal in accordance with paragraph 2, second subparagraph, to the competent authority in one of the Member States in which the substances are placed on the market.; Any proposal referred to in the first subparagraph shall be accompanied by a fee determined by the Commission in accordance with the regulatory procedure referred to in Article 54(2) of this Regulation.

Amendment 255 #

Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point f

Regulation (EC) 1272/2008
Article 37 – paragraph 7

The Commission shall adopt delegated acts in accordance with Article 53a to amend Table 3 of Part 3 of Annex VI to this Regulation by inclusion of substances as endocrine disruptor category 1 for human health properties, endocrine disruptor category 1 for environment properties, as persistent, bioaccumulative and toxic or as very persistent and very bioaccumulative, as persistent, mobile and toxic or as very persistent, very mobile, together with relevant classification and labelling elements where, on … [OP: please insert the date = the date of entry into force of Commission Delegated Regulation (EU) …i.e. delegated act on the new hazard classes - reference to be added once adopted], those substances have been included in the candidate list referred to in Article 59(1) of Regulation (EC) No 1907/2006.

Amendment 256 #

Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point f

Regulation (EC) 1272/2008
Article 37 – paragraph 7

TBy 1 January 2026, the Commission shall adopt delegated acts in accordance with Article 53a to amend Table 3 of Part 3 of Annex VI to this Regulation by inclusion of substances as endocrine disruptor category 1 for human health properties, endocrine disruptor category 1 for environment properties, as persistent, bioaccumulative and toxic or, as very persistent and very bioaccumulative, as persistent, mobile and toxic, or very persistent and very mobile together with relevant classification and labelling elements where, on ~~… [OP: please insert the date = the date of entry into force of Commission Delegated Regulation (EU) …i.e. delegated act on the new hazard classes - reference to be added once adopted]~~1 January 2025, those substances have been included in the candidate list referred to in Article 59(1) of Regulation (EC) No 1907/2006.

Amendment 257 #

Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point f

Regulation (EC) 1272/2008
Article 37 – paragraph 8

TBy 1 January 2026, the Commission shall adopt delegated acts in accordance with Article 53a to amend Table 3 of Part 3 of Annex VI by inclusion of substances together with relevant classification and labelling elements where, on ~~… [OP: please insert the date = the date of entry into force of Commission Delegated Regulation (EU) …i.e. the delegated act on the new hazard classes - reference to be added once adopted]~~1 January 2025 those substances have not been approved, under Regulation (EC) No 1107/2009 or Regulation (EU) No 528/2012 or have been approved with derogation in accordance with the relevant provisions of those Regulations, due to either of the following characteristics:

Amendment 258 #

Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point f

Regulation (EC) 1272/2008
Article 37 – paragraph 8 a (new)

In Article 37, the following paragraph 8a is added: '8a. Without prejudice to paragraphs 1 to 5, in the case that additional classification criteria relating to physical hazards, health hazards or environmental hazards, laid down in Parts 2 to 5 of Annex I, are integrated to this regulation, new data in relation to those criteria and available to manufacturers, importers and downstream users, not having been previously submitted for evaluation under the processes of Regulation (EC) No. 1107/2009 or Regulation (EU) No 528/2012 or Regulation (EU) No 2017/2100, shall be evaluated at minimum through a simplified process by the Risk Assessment Committee of the Agency before inclusion in Table 3.2 of Part 3 of Annex VI of conclusions on classification and labelling relating to the criteria concerned.' (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Amendment 259 #

Proposal for a regulation
Article 1 – paragraph 1 – point 20 a (new) Regulation (EC) 1272/2008

(20a) The 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. In case where notifiers and registrants cannot come to an agreed entry because of divergences about the level of scientific evidence supporting a classification and labelling of the same substance, the most protective classification shall prevail.'" Or. en (32008R1272)

Amendment 260 #

Proposal for a regulation
Article 1 – paragraph 1 – point 20 a (new)

Regulation (EC) 1272/2008
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 261 #

Proposal for a regulation
Article 1 – paragraph 1 – point 21

Regulation (EC) 1272/2008
Article 42 – paragraph 1 – subparagraph 3

(21) in Article 42(1), the third subparagraph is replaced by the following: ‘The following information shall be made publicly available free of charge online: (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; (b) in the case of group notifications, the identity of the importer or manufacturer submitting the information on behalf of the other members of the group; (c) information in the inventory which corresponds to the information referred to in Article 119(1) of Regulation (EC) No 1907/2006. The Agency shall grant access to the information in the inventory that concerns a substance and is not referred to in the first subparagraph to other parties subject to Article 118 of Regulation (EC) No 1907/2006.;’deleted (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Amendment 262 #

Proposal for a regulation
Article 1 – paragraph 1 – point 21

Regulation (EU) 1272/2008
Article 42 – paragraph 1

The following information shall be made publicly available free of charge online in a user-friendly format:

Amendment 263 #

Proposal for a regulation
Article 1 – paragraph 1 – point 21

Regulation (EC) 1272/2008
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 264 #

Proposal for a regulation
Article 1 – paragraph 1 – point 21

Regulation (EU) 1272/2008
Article 42 – paragraph 1 – point a)

Amendment 265 #

Proposal for a regulation
Article 1 – paragraph 1 – point 21

Regulation (EC) 1272/2008
Article 42 – paragraph 3 a (new)

In the Article 42, the following paragraph 3a is added: 'The Agency shall remove inactive entries from the inventory. An entry is considered inactive, when the notifier has not updated the entry within 2 years and after this period has not reacted on a request of the Agency to confirm the correctness of the entry.'

Amendment 266 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Susana SOLÍS PÉREZ

Proposal for a regulation
Article 1 – paragraph 1 – point 21

Regulation (EC) 1272/2008
Article 42 – paragraph 3 a (new)

In Article 42, the following paragraph 3a is inserted: 3a. Where the Agency considers that an entry is incomplete, incorrect or obsolete it shall delete the corresponding entry from the inventory after having informed the notifier .

Amendment 267 #

Proposal for a regulation
Article 1 – paragraph 1 – point 21

Regulation (EC) 1272/2008
Article 42 – paragraph 2 – subparagraph 1 a (new)

In Article 42, paragraph 2, the following subparagraph 1a is added: 'The Agency may, where appropriate, delete obsolete and out-of-date information from the inventory;'

Amendment 268 #

Proposal for a regulation
Article 1 – paragraph 1 – point 21 a (new)

(21a) The following Article -43 is added: Article -43 – Right to request action from competent authorities and the Commission 1. Any natural or legal person, individually or in association, shall be entitled to submit substantiated evidence to competent authorities as referred to in Article 43 or the Commission, such as peer reviewed studies, human biomonitoring data, or environmental monitoring data, on the hazardous properties of a substance(s) or mixture(s) showing that hazardous properties of a substance(s) or mixture(s) may not have been sufficiently considered in the classification or labelling process. 2. The competent authorities or the Commission shall diligently and impartially assess the information submitted in accordance with paragraph 1, integrating the evidence submitted to all other available evidence using a weight of evidence approach. 3. Where the evidence submitted shows non-compliance with one or several of the requirements on the classification, labelling and packaging of substances and mixtures, enforcement measures shall be initiated in accordance with Article 47. 4. Where the assessment has showed that the substance(s) meets the criteria for classification in any of the hazard classes referred to in Article 36(1), the competent authority or the Commission shall initiate a process of harmonised classification and labelling. Where the assessment has showed a wide dispersive use of and/or consumer exposure to the substance or mixture concerned, the competent authority or the Commission shall initiate a risk management process under Article 59, Article 69, or Article 68(2) of Regulation (EU) No 1907/2006. Where the assessment has showed a lack of information on the risk to health or the environment posed by a hazardous substance or mixture, the competent authority or the Commission shall require companies or any other relevant actor to provide more information, with a view to take risk management measures under Titles VI, VII or VIII of Regulation (EU) 1907/2006, where necessary. 5. Where the evidence submitted should have been included in the registration dossier submitted under Regulation (EU) No 1907/2006 but was omitted by the registrant, enforcement measure should be initiated under Article 126 of Regulation (EU) No 1907/2006 against registrants which registration is non- compliant. 6. The competent authority or the Commission, shall, within 6 months, inform the natural or legal persons referred to in paragraph 1, of its opinion on the evidence and concerns so submitted, and of any steps it plans to take to address these concerns, providing the reasons for both the opinion reached and the steps proposed. 7. Competent authorities and the Commission shall publish an annual report on the requests received and their treatment.

Amendment 269 #

Proposal for a regulation
Article 1 – paragraph 1 – point 21 a (new)

Regulation (EC) 1272/2008
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 270 #

Proposal for a regulation
Article 1 – paragraph 1 – point 21 b (new)

Regulation (EC) 1272/2008
Article –43 a (new)

(21b) The following Article -43a is added: Article -43a – Access to justice 1. Any natural or legal person which has submitted substantiated concern in accordance with Article -43a shall have access to an administrative or judicial procedure to review the procedural and substantive legality of the decisions, acts or omissions of the relevant competent authority under this Regulation. 2. Member States shall ensure access to administrative or judicial procedure to review their decisions, acts and omissions, in accordance with national legislation or practice. Decisions, acts and omissions by the Commission shall be submitted to review according to the provisions of Regulation EU (No) 1367/2006. 3. Any such procedure shall be fair, equitable, timely and not prohibitively expensive as well as provide adequate and effective remedies, including injunctive relief where necessary. Member States shall ensure that practical information is made available to the public on access to administrative and judicial review procedures.

Amendment 271 #

Proposal for a regulation
Article 1 – paragraph 1 – point 22 a (new)

Regulation (EC) 1272/2008
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 272 #

Proposal for a regulation
Article 1 – paragraph 1 – point 23

Regulation (EC) 1272/2008
Article 48

(23) Article 48 is replaced by the following: ‘Article 48 Advertisement 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. 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.’ deleted (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article 48)

Amendment 273 #

Proposal for a regulation
Article 1 – paragraph 1 – point 23

Regulation (EC) 1272/2008
Article 48 – paragraph 1

1. Any advertisement ofor a substance classified as hazardous shall indicate the relevant hazard pictogram, the signal word, the hazard class and the hazard statements and request the user to always read and follow product label information.

Amendment 274 #

Proposal for a regulation
Article 1 – paragraph 1 – point 23

Regulation (EC) 1272/2008
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 275 #

Proposal for a regulation
Article 1 – paragraph 1 – point 23

Regulation (EU) 1272/2008
Article 48 – paragraph 1

1. Any advertisement for a substance classified as hazardous ~~shall~~must indicate the relevant hazard pictogram, the signal word, the hazard class and the hazard statements.

Amendment 276 #

Proposal for a regulation
Article 1 – paragraph 1 – point 23

Regulation (EC) 1272/2008
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 277 #

Proposal for a regulation
Article 1 – paragraph 1 – point 23

Regulation (EU) 1272/2008
Article 48 – paragraph 2

2. Any advertisement for a mixture classified as hazardous or covered by Article 25(6) ~~shall~~must indicate the hazard pictogram, the signal word, the hazard class and the hazard statements.

Amendment 278 #

Proposal for a regulation
Article 1 – paragraph 1 – point 24

Regulation (EC) 1272/2008
Article 48 a

~~(24) the following Article 48a is added: ‘Article 48a Distance sales offers Su~~deleted (This amendment appliers ~~placing substances or mixtures on the market through distance sales shall clearly indicate the label elements referred to i~~throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article ~~17.;’~~ 48 a)

Amendment 279 #

Proposal for a regulation
Article 1 – paragraph 1 – point 24

Regulation (EU) 1272/2008
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.

Amendment 280 #

Proposal for a regulation
Article 1 – paragraph 1 – point 25 a (new)

Regulation (EC) 1272/2008
Article 53 – paragraph 1

(25 a) In Article 53, paragraph 1 is replaced by the following: "'The Commission is empowered to adopt delegated acts in accordance with Article 53a amending Article 6(5), Article 11(3), Articles 12 and 14, point (b) of Article 18(3), Article 23, Articles 25 to 29, the second and third subparagraphs of Article 35(2) and Annexes I to VIII in order to adapt them to technical and scientific progress, taking due account of the further development of the GHS, in particular any UN amendments relating to the use of information on similar mixtures, and considering the developments in internationally recognised chemical programmes and of the data from accident databases. , and to adopt specific provisions in Annex I for substances containing more than one constituent." Or. en (Regulation (EC) 1272/2008)

Amendment 281 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Susana SOLÍS PÉREZ

Proposal for a regulation
Article 1 – paragraph 1 – point 26 – point -a (new)

Regulation (EC) 1272/2008
Article 53 – paragraph 1– subparagraph 1 a (new)

(-a) In Article 53, paragraph 1, the following subparagraph 1a is added: 'The Commission shall, no later than 2025, adopt delegated acts in accordance with Article 53a to propose the development of hazard criteria for immunotoxicity and neurotoxicity;'

Amendment 282 #

Proposal for a regulation
Article 1 – paragraph 1 – point 26 – point a

Regulation (EC) 1272/2008
Article 53 – paragraph 1a

~~1a.~~ The Commission is empowered to ~~1a.~~ adopt delegated acts in accordance with Article 53a to amend section 1.6. of Annex I in order to adapt the label elements referred to in Article 34a(2) to technical progress or to the level of digital readiness among ~~all~~different population groups in the Union. When adopting those delegated acts, the Commission shall ~~take into account the societal needs and a high level of~~ensure high level of protection of human health and the environment and take into account the societal needs. The Commission shall make sure that information which is critical to protect~~ion of~~ human health and ~~the~~ environment shall remain easily accessible on physical label;

Amendment 283 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Susana SOLÍS PÉREZ

Proposal for a regulation
Article 1 – paragraph 1 – point 26 – point a

Regulation (EC) 1272/2008
Article 53 – paragraph 1b – point d

(d) take into account the level of digital readiness among all population groups in the Union, as well as readiness of the necessary wireless and other technological infrastructure allowing unrestricted access to the information on chemicals;

Amendment 284 #

Proposal for a regulation
Article 1 – paragraph 1 – point 26 – point b

Regulation (EC) 1272/2008
Article 53 – paragraph 2

2. The Commission or the Member States acting in the interest of the Union shall, in the manner appropriate to their role in the relevant UN fora, promote the harmonisation of the criteria for classification and labelling of endocrine disruptors for human health, endocrine disruptors for the environment, persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile and toxic (PMT) and very persistent and very mobile (vPvM) substances as well ~~as alternative test methods at the level of the UN.;~~the development of criteria for immunotoxic and neurotoxic substances and as well as alternative test methods, including new approach methods and in particular non- animal methods at the level of the UN to address existing and emerging hazard classes.

Amendment 285 #

Proposal for a regulation
Article 1 – paragraph 1 – point 26 – point c

Regulation (EC) 1272/2008
Article 53 – paragraph 3

3. The Commission shall ~~regularly~~ evaluate the development of alternative test methods referred to in Article 13(1) of Regulation (EC) No 1907/2006 for classification of substances and mixtures, including new approach methods and in particular non- animal test methods, at least every two years, and update Annex I of this Regulation to reflect such technical progress, if relevant. The Commission shall update Annex I of this Regulation no more than six months after non- animal data are taken up into harmonised criteria for classification and labelling at the level of the UN.

Amendment 286 #

Proposal for a regulation
Article 1 – paragraph 1 – point 26 – point c

Regulation (EC) 1272/2008
Article 53 – paragraph 3

3. The Commission shall ~~regularly evaluate the development of alternative test me~~promote 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.

Amendment 287 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Susana SOLÍS PÉREZ

Proposal for a regulation
Article 1 – paragraph 1 – point 26 – point c

Regulation (EC) No 1272/2008
Article 53 – paragraph 3

3. The Commission shall regularly evaluate the development of alternative test methods referred to in Article 13(1) of Regulation (EC) No 1907/2006 for classification of substances and mixtures. Where validated alternative test methods are not available for the endpoint in discussion, the expert judgement of competent authorities on the type of data necessary to decide on the classification of substances and mixtures shall prevail.

Amendment 288 #

Proposal for a regulation
Article 1 – paragraph 1 – point 26 – point c

Regulation (EC) 1272/2008
Article 53 – paragraph 3 a (new)

3a. In Article 53, the following paragraph 3a is added: 'The Commission shall by December 2024 assess hazard criteria for immunotoxicity and neurotoxicity and, where appropriate, adopt delegated acts in accordance with Article 53;'

Amendment 289 #

Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS

Proposal for a regulation
Article 1 – paragraph 1 – point 30

Regulation (EC) 1272/2008
Article 61 – paragraph 7

Substances ~~and mixtures~~ which have been classified, labelled and packaged in accordance with Article 1(1), Article 4(10), Article 5, Article 6(3) and (4), Article 9(3) and (4), Article 25(6) and (9), Articles 29, 30 and 35, Article 40(1) and (2), Article 42(1), third sub-paragraph, Article 48, section 1.2.1. of Annex I, section 1.5.1.2 of Annex I, section 1.5.2.4.1 of Annex I, Parts 3 and 5 of Annex II, Part A, the first sub- paragraph of section 2.4, of Annex VIII, Part B, section 1, of Annex VIII, Part B, the third paragraph of section 3.1, of Annex VIII , Part B, section 3.6, of Annex VIII, Part B, the first row of Table 3 of Section 3.7, of Annex VIII, Part B, the first paragraph of Section 4.1, of Annex VIII, Part C, sections 1.2 and 1.4, of Annex VIII, and Part D, sections 1, 2 and 3, of Annex VIII as applicable on … [OP: please insert the date = the day before the entry into force of this Regulation] and which were placed on the market before [OP: please insert the date = the first day of the month following 1824 months after the date of entry into force of this Regulation ] are not required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation …/… of the European Parliament and of the Council* [OP: please complete the reference in the footnote – it should be the reference to this Regulation] until … [OP: please insert the date = the first day of the month following 42 months after the date of entry into force of this Regulation]. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article 61 – paragraph 7))

Amendment 290 #

Proposal for a regulation
Article 1 – paragraph 1 – point 30

Regulation (EC) 1272/2008
Article 61 – paragraph 7

Amendment 291 #

Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS

Proposal for a regulation
Article 1 – paragraph 1 – point 30

In the Article 61, the following paragraph 7a is added: ‘7a. Mixtures which have been classified, labelled and packaged in accordance with Article 1(1), Article 4(10), Article 5, Article 6(3) and (4), Article 9(3) and (4), Article 25(6) and (9), Articles 29, 30 and 35, Article 40(1) and (2), Article 42(1), third sub-paragraph, Article 48, section 1.2.1. of Annex I, section 1.5.1.2 of Annex I, section 1.5.2.4.1 of Annex I, Parts 3 and 5 of Annex II, Part A, the first sub- paragraph of section 2.4, of Annex VIII, Part B, section 1, of Annex VIII, Part B, the third paragraph of section 3.1, of Annex VIII, Part B, section 3.6, of Annex VIII, Part B, the first row of Table 3 of Section 3.7, of Annex VIII, Part B, the first paragraph of Section 4.1, of Annex VIII, Part C, sections 1.2 and 1.4, of Annex VIII, and Part D, sections 1, 2 and 3, of Annex VIII as applicable on … [OP: please insert the date = the day before the entry into force of this Regulation] and which were placed on the market before [OP: please insert the date = the first day of the month following 36 months [VC1] after the date of entry into force of this Regulation] are not required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation …/… of the European Parliament and of the Council* [OP: please complete the reference in the footnote – it should be the reference to this Regulation] until … [OP: please insert the date = the first day of the month following 60 months after the date of entry into force of this Regulation].’ (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Amendment 292 #

Proposal for a regulation
Article 1 – paragraph 1 – point 30

Regulation (EC) 1272/2008
Article 61 – paragraph 7 a (new)

In Article 61, the following paragraph 7a is added: '7a. Mixtures which have been classified, labelled and packaged in accordance with Article 1(1), Article 4(10), Article 5, Article 6(3) and (4), Article 9(3) and (4), Article 25(6) and (9), Articles 29, 30 and 35, Article 40(1) and (2), Article 42(1), third sub-paragraph, Article 48, section 1.2.1. of Annex I, section 1.5.1.2 of Annex I, section 1.5.2.4.1 of Annex I, Parts 3 and 5 of Annex II, Part A, the first sub- paragraph of section 2.4, of Annex VIII, Part B, section 1, of Annex VIII, Part B, the third paragraph of section 3.1, of Annex VIII, Part B, section 3.6, of Annex VIII, Part B, the first row of Table 3 of Section 3.7, of Annex VIII, Part B, the first paragraph of Section 4.1, of Annex VIII, Part C, sections 1.2 and 1.4, of Annex VIII, and Part D, sections 1, 2 and 3, of Annex VIII as applicable on … [OP: please insert the date = the day before the entry into force of this Regulation] and which were placed on the market before [OP: please insert the date = the first day of the month following 36 months [VC1] after the date of entry into force of this Regulation] are not required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation …/… of the European Parliament and of the Council* [OP: please complete the reference in the footnote – it should be the reference to this Regulation] until … [OP: please insert the date = the first day of the month following 60 months after the date of entry into force of this Regulation].' (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article 61 – paragraph 7 a (new))

Amendment 293 #

Proposal for a regulation
Article 2 – paragraph 2 – introductory part

2. The following provisions shall apply to substances from [OP: please insert the date = the first day of the month following 18 months after the date of entry into force of this Regulation]:

Amendment 294 #

Proposal for a regulation
Article 2 – paragraph 2 – point d a (new)

(da) 2a. The following provisions shall apply to mixtures from [OP: please insert the date = the first day of the month following 36 months after the date of entry into force of this Regulation]: (a) Article 1, points (1), (4), (5), (6), (7), (10), (11), (12), (15), (16), (20), (21), (23) and (24); (b) points (2), (3), (7), (9) and (10) of Annex I; (c) Annex II; (d) points (1)(c), (2), (3) and (4) of Annex III.

Amendment 295 #

Proposal for a regulation
Article 2 – paragraph 3 – introductory part

3. By way of derogation from Article 1(1), Article 4(10), Article 5, Article 6(3) and (4), Article 9(3) and (4), Article 25(6) and (9), Articles 29, 30 and 35, Article 40(1) and (2), Article 42(1), third sub- paragraph, Article 48, section 1.2.1. of Annex I, section 1.5.1.2 of Annex I, section 1.5.2.4.1 of Annex I, Parts 3 and 5 of Annex II, Part A, the first sub-paragraph of section 2.4, of Annex VIII, Part B, section 1, of Annex VIII, Part B, the third paragraph of section 3.1, of Annex VIII , Part B, section 3.6, of Annex VIII, Part B, the first row of Table 3 of Section 3.7, of Annex VIII, Part B, the first paragraph of Section 4.1, of Annex VIII, Part C, sections 1.2 and 1.4, of Annex VIII, and Part D, sections 1, 2 and 3, of Annex VIII to Regulation (EC) No 1272/2008 as applicable on [OP: please insert the date = the day before the date of entry into force of this Regulation], substances and mixtures may until … [OP: please insert the date = the last day of the month following 17 months after the date of entry into force of this Regulation] and mixture may until … [OP: please insert the date = the last day of the month following 35 months after the date of entry into force of this Regulation] be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as amended by the following provisions of this Regulation:

Amendment 296 #

Proposal for a regulation
Annex I – paragraph 1 – point 1

Regulation (EC) No 1272/2008
Annex I – Part 1 – point 1.1.1.3

1.1.1.3. A weight of evidence determination means that all available information bearing on the determination of hazard is considered together, such as the results of suitable in vitro tests, results of adequate non-mammalian embryo models such as aquatic eleutheroembryos as well as invertebrate species, relevant animal data, human experience such as occupational data and data from accident databases, epidemiological and clinical studies and well-documented case reports and observations. For substances, information from the application of the category approach (grouping, read-across) ~~and~~, (Q)SAR, and omics' results are also considered. The quality and consistency of the data shall be given appropriate weight. Information on substances related to the substance being classified shall be considered, as appropriate. Information on substances or mixtures related to the mixture being classified shall be considered in accordance with Article 9(4). Information on the site of action and the mechanism or mode of action study results shall also be considered. Both positive and negative results shall be assembled together in a single weight of evidence determination.;

Amendment 297 #

Proposal for a regulation
Annex I – paragraph 1 – point 2

Regulation (EC) No 1272/2008
Annex I – part 1 – section 1.2.1.4

The dimensions of the label and of each pictogram~~, and the font size of letters shall be as follows:~~ shall be as follows: (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Annex I, 1.2.1.4)

Amendment 298 #

Proposal for a regulation
Annex I – paragraph 1 – point 2

Regulation (EC) No 1272/2008
Annex I – part 1 – section 1.2.1.4. – Table 1.3 – title

Minimum dimensions of labels, and pictograms ~~and font size~~ (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Annex I, 1.2.1.4)

Amendment 299 #

Danilo Oscar LANCINI, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS, Rosanna CONTE

Proposal for a regulation
Annex I – Paragraph 1 – point 2

Regulation (EU) No 1272/2008
Annex I – Part 1 – Section 1.2.1.4. – Table 1.3

Capacity of the Dimensions of the Dimensions of each ~~Minimum font-size~~ package label (in pictogram (in millimetres) for the millimetres) information required by Article 17 Not exceeding 3 If possible, at least Not smaller than ~~8pt~~ litres: 52x74 10x10 If possible, at least ~~16x16~~ 16x16 Greater than 3 At least 74x105 At least 23x23 ~~12pt~~ litres but not exceeding 50 litres: Greater than 50 At least 105x148 At least 32x32 ~~16pt~~ litres but not exceeding 500 litres: Greater than 500 At least 148x210 At least 46x46 ~~20pt’;~~ litres:

Amendment 300 #

Proposal for a regulation
Annex I – Paragraph 1 – point 2

Regulation (EU) No 1272/2008
Annex I – Part 1 – Section 1.2.1.4. – Table 1.3

Capacity of the Dimensions of the Dimensions of each ~~Minimum font-size~~ package label (in pictogram (in millimetres) for the millimetres) information required by Article 17 Not exceeding 3 If possible, at least Not smaller than ~~8pt~~ litres: 52x74 10x10 If possible, at least 16x16 Greater than 3 At least 74x105 At least 23x23 ~~12pt~~ litres but not exceeding 50 litres: Greater than 50 At least 105x148 At least 32x32 ~~16pt~~ litres but not exceeding 500 litres: Greater than 500 At least 148x210 At least 46x46 ~~20pt’;~~ litres:

Amendment 301 #

Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS

Proposal for a regulation
Annex I – paragraph 1 – point 3

Regulation (EU) No 1272/2008
Annex I – Part 1 – Section 1.2.1.5

~~1.2.1.5. The text on the label shall have the following characteristics: (a) be white; (b) shall be equal or above 120 % of the font size; (c) easily legible and without serifs; (d) appropriate for th~~deleted the background of the label shall the distance between two lines a single font shall be use~~lected font to be comfortably legible. For the labelling of inn~~d that is the letter spac~~kag~~ing where the contents do not exceed 10 ml, the font size may be smaller than indicated in Table 1.3, as long as it remains legible for a person with average eyesight, where itis deemed important to place the most critical hazard statement and where the outer packaging meets the requirements of Article 17.shall be (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Amendment 302 #

Proposal for a regulation
Annex I – paragraph 1 – point 3

Regulation (EC) No 1272/2008
Annex I – Part 1 – point 2– Section 1.2.1.5

1.2.1.5. The text on the label shall have the following characteristics: (a) the background of the label shall be white; (b) shall be equal or above 120 % of the font size; (c) easily legible and without serifs; (d) the letter spacing shall be appropriate for the selected font to be comfortably legible. For the labelling of inner packaging where the contents do not exceed 10 ml, the font size may be smaller than indicated in Table 1.3, as long as it remains legible for a person with average eyesight, where itis deemed important to place the most critical hazard statement and where the outer packaging meets the requirements of Article 17.deleted the distance between two lines a single font shall be used that is (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Amendment 303 #

Proposal for a regulation
Annex I – paragraph 1 – point 3

Regulation (EC) No 1272/2008
Annex I – Part 1 – Section 1.2.1.5

The text on the label shall have the following characteristics: (a) be white; (b) shall be equal or above 120 % of the font size; (c) easily legible and without serifs; (d) appropriate for the selected font to be comfortably legible.deleted the background of the label shall the distance between two lines a single font shall be used that is the letter spacing shall be (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Amendment 304 #

Proposal for a regulation
Annex I – paragraph 1 – point 3

Regulation (EC) No 1272/2008
Annex I – Part 1 – Section 1.2.1.5. – point a a (new)

(aa) there is a significant contrast between the print and the background;

Amendment 305 #

Proposal for a regulation
Annex I – paragraph 1 – point 3

Regulation (EC) No 1272/2008
Annex I – Part 1 – Section 1.2.1.5. – point d a (new)

(da) the label elements provided in accordance with Articles 18, 20 and 21 shall be emphasised through a typeset that clearly distinguishes it from the rest of the text for example by means of the colour or style.

Amendment 306 #

Proposal for a regulation
Annex I – paragraph 1 – point 3

Regulation (EC) No 1272/2008
Annex I – Part 1 – Section 1.2.1.5 – paragraph 2

For the labelling of inner packaging where the contents do not exceed 10 ml, the font size may be smaller than indicated in Table 1.3, as long as it remains legible for a person with average eyesight, where itis deemed important to place the most critical hazard statement and where the outer packaging meets the requirements of Article 17. deleted (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Amendment 307 #

Proposal for a regulation
Annex I – paragraph 1 – point 4 a (new)

Regulation (EC) No 1272/2008
Annex I – Part 1 – Section 1.3.7 a (new)

(4a) In Part 1 of Annex I, the following Section 1.3.7.a is added: 1.3.7.a Mixtures designed to be inhaled via electronic cigarettes and contained in refill containers The labelling elements referred to in Article 17(1) shall only be provided on the outer packaging of disposable electronic cigarettes and single use cartridges. The elements referred to in Article 17(1) (d) to (g) shall only apply if the mixture contained is classified as having respiratory sensitisation and/or acute inhalation toxicity properties. This applies accordingly to the application of Articles 48 and 48a. For refill containers, the label elements in accordance with the first subparagraph of Article 17(2) shall be provided in accordance with sections 1.5.1 and 1.5.1.2 of Annex I. A tie-on tag shall not be used.

Amendment 308 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Susana SOLÍS PÉREZ

Proposal for a regulation
Annex I – paragraph 1 – point 4 a (new)

Regulation (EC) No 1272/2008
Annex I – Part 1 – Section 1.3.7. a (new)

(4a) In Point 1 of Annex I, the following Section 1.3.7.a is added: 1.3.7.a By derogation from Article 5(3), hydrocarbon substances with more than one constituent, impurity or additive, can be classified using all available reliable whole substance or constituent data in a weight of evidence approach according to Regulation (EC) No 1907/2006 (Annex XI section 1.5 Grouping of substances and read-across approach).

Amendment 309 #

Proposal for a regulation
Annex I – paragraph 1 – point 9

Regulation (EC) No 1272/2008
Annex I – Part 1 – Section 1.5.2.4.1. – point b – point iv a (new)

(iva) Serious eye damage/irritation, category 1;

Amendment 310 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Susana SOLÍS PÉREZ

Proposal for a regulation
Annex I – paragraph 1 – point 9

Regulation (EC) No 1272/2008
Annex I – Part 1 – Section 1.5.2.4.1 – point b – point v a (new)

(va) Skin sensitisation, category 1 (sub- categories 1A and 1B);

Amendment 311 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Susana SOLÍS PÉREZ

Proposal for a regulation
Annex II – paragraph 1 – point -1 (new)

Regulation (EC) No 1272/2008
Annex II – Part 3 – Section 3.1.1.1

~~3.1.1.1.~~-1. In in Part 3 of Annex II, point 3.1.1.1. is amended as following: ‘3.1.1.1. Packaging of whatever capacity containing a substance or mixture supplied to the general public and classified for acute toxicity, categories 1 to 3, STOT — single exposure category 1, STOT — repeated exposure category 1, or skin corrosion category 1, or serious eye damage category 1 shall be fitted with child-resistant fastenings.’

Amendment 312 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Susana SOLÍS PÉREZ

Proposal for a regulation
Annex II – paragraph 1 – point -1 (new)

Regulation (EC) No 1272/2008
Annex II – part 3 – section 3.1.1.1

(-1) In in Part 3 of Annex II, section 3.1.1.1 is replaced by the following: ‘Packaging of whatever capacity containing a substance or mixture supplied to the general public and classified for acute toxicity, categories 1 to 3, STOT — single exposure category 1, STOT — repeated exposure category 1, or skin corrosion category 1, or serious eye damage category 1 shall be fitted with child- resistant fastenings.’

Amendment 313 #

Proposal for a regulation
Annex II – paragraph 1 – point -1 a (new)

Regulation (EC) No 1272/2008
Annex II – Part 3 – section 3.2.1.

-1a. In in Part 3 of Annex II, section 3.2.1. is replaced by the following: ‘3.2.1. Packaging to be fitted with a tactile warning Where substances or mixtures are supplied to the general public and classified for acute toxicity, skin corrosion/skin irritation, serious eye damage/eye irritation, endocrine disruption for human health category 2, endocrine disruption for the environment category 2, germ cell mutagenicity category 2, carcinogenicity category 2, reproductive toxicity category 2, respiratory or skin sensitiszation, ~~or Stot,~~STOT categories 1 ~~and~~or 2, aspiration hazard, or flammable gases, ~~liquids and solids in categories 1 and 2~~flammable liquids categories 1 or 2, or flammable solids, the packaging of whatever capacity, shall be fitted with a tactile warning of danger.’

Amendment 314 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Susana SOLÍS PÉREZ

Proposal for a regulation
Annex II – paragraph 1 – point -1 a (new)

Regulation (EC) No 1272/2008
Annex II – part 3 – section 3.2.1.1

(-1a) In in Part 3 of Annex II, section 3.2.1.1 is replaced by the following: ‘Where substances or mixtures are supplied to the general public and classified for acute toxicity, skin corrosion/skin irritation, serious eye damage/eye irritation, germ cell mutagenicity category 2, carcinogenicity category 2, reproductive toxicity category 2, ~~respiratory sensitis~~endocrine disruption for human health category 2, endocrine disruption for the environment category 2, respiratory or skin sensitization, STOT categories 1 or 2, aspiration hazard, flammable gases, flammable liquids categories 1 or 2, or flammable solids, the packaging of whatever capacity, shall be fitted with a tactile warning of danger.’

Amendment 315 #

Proposal for a regulation
Annex II – paragraph 1 – point 1

Regulation (EC) No 1272/2008
Annex II – Part 3 – section 3.4. – point b

(b) a label is firmly affixed on a visible place of the refill station and with a font size that is easily legible and without serifs and is provided free of charge by suppliers;

Amendment 316 #

Proposal for a regulation
Annex II – paragraph 1 – point 1

Regulation (EC) No 1272/2008
Annex II – Part 3 – Section 3.4 – point b

(b) a label is firmly affixed on a visible place of the refill station and ~~with a font size that is easily legible and without serifs~~fulfils the requirements in Article 31;

Amendment 317 #

Proposal for a regulation
Annex II – paragraph 1 – point 1

Regulation (EC) No 1272/2008
Annex II – Part 3 – Section 3.4 – point b a (new)

(ba) a label that fulfils the requirements in Article 31 is available at the refill station, free-of-charge for consumers in a self-adhesive sticker form to be affixed on the container used by the consumer. Where refill stations provide several substances or mixtures, labels should easily and clearly identify which substance or mixture provided at the refill station they correspond to.

Amendment 318 #

Proposal for a regulation
Annex II – paragraph 1 – point 1

Regulation (EC) No 1272/2008
Annex II – Part 3 – Section 3.4 – point e

(e) overfilling packaging is ~~technically prevented;~~prevented by technical or organisational means (f) filling a substance or mixture into unsuitable packaging is prevented by technical or organisational means; (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Amendment 319 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Susana SOLÍS PÉREZ

Proposal for a regulation
Annex II – paragraph 1 – point 1

Regulation (EC) No 1272/2008
Annex II – Part 3 – Section 3.4 – point ii

(ii) Specific target organ toxicity – Single exposure, categories 1~~, 2 and 3;~~ and 2; (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Amendment 320 #

Proposal for a regulation
Annex II – paragraph 1 – point 1

Regulation (EC) No 1272/2008
Annex II – Part 3 – Section 3.4. – point iv a (new)

(iva) Serious eye damage/irritation, category 1;

Amendment 321 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Susana SOLÍS PÉREZ

Proposal for a regulation
Annex II – paragraph 1 – point 1

Regulation (EC) No 1272/2008
Annex II – Part 3 – Section 3.4 – point iv a (new)

(iva) Serious eye damage/irritation category 1;

Amendment 322 #

Proposal for a regulation
Annex II – paragraph 1 – point 1

Regulation (EC) No 1272/2008
Annex II – Part 3 – Section 3.4. – point v a (new)

(va) Skin sensitisation, category 1 (sub- categories 1A and 1B);

Amendment 323 #

Proposal for a regulation
Annex II – paragraph 1 – point 1

Regulation (EC) No 1272/2008
Annex II – Part 3 – Section 3.4 – point v a (new)

(va) Skin sensitisation category 1 (sub- categories 1A, 1B);

Amendment 324 #

Proposal for a regulation
Annex II – paragraph 1 – point 2

Regulation (EC) No 1272/2008
Annex II – Part 5 – paragraph 2

‘For a substance or a mixture supplied at a f~~illing~~uel service station and directly pumped into a receptacle, thate forms an integral part of a vehicle and from where the substance or mixture is normally not intended to be removed, the label elements referred to in Article 17 shall be provided on the respective pump.;llowing label elements shall be provided on or next to the respective pump: Product identifier for the substance or trade name or designation of the mixture; Hazard pictogram; Hazard and precautionary statements; Signal word. Fuel service stations shall not be considered as refill stations in the sense of Annex II part 3.4.’ (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Amendment 325 #

Proposal for a regulation
Annex II a (new)

In Annex VI, Part 2 is replaced by the following: ‘2. PART 2: DOSSIERS FOR HARMONISED CLASSIFICATION AND LABELLING This Part lays down general principles for preparing dossiers to propose and justify harmonised classification and labelling. The relevant parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006 shall be used for the methodology and format of any dossier. For all dossiers any relevant information from registration dossiers shall be considered and other available information may be used. For hazard information which has not been previously submitted to the Agency, a robust study summary shall be included in the dossier. A dossier for harmonised classification and labelling shall contain the following: — Proposal The proposal shall include the identity of the substance or substances concerned and the harmonised classification and labelling proposed. — Justification for the proposed harmonised classification and labelling A comparison of the available information with the criteria contained in Parts 2 to 5, taking into account the general principles in Part 1, of Annex I to this Regulation shall be completed and documented in the format set out in Part B of the Chemical Safety Report in Annex I to Regulation (EC) No 1907/2006. — Justification for the proposed grouping of substances to harmonized classification and labelling Where a harmonised classification and labelling proposal is made for group(s) of substances, the dossier shall include scientific justification (based on assessment of available data on physico-chemical, ecotoxicological and toxicological properties as specified in REACH Annex XI (1.5)) using a weight of evidence approach, for the grouping of substances and for applying a similar classification. — Justification for other effects at Community level For other effects than carcinogenity, mutagenicity, reprotoxicity and respiratory sensitisation a justification shall be provided that there is a need for action demonstrated at Community level. This does not apply for an active substance in the meaning of Directive 91/414/EEC or Directive 98/8/EC.’.

Amendment 326 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Susana SOLÍS PÉREZ

Proposal for a regulation
Annex II a (new)

Regulation (EC) No 1272/2008
Annex VI – Part 2

In Annex VI, part 2 is replaced by the following: ‘PART 2: DOSSIERS FOR HARMONISED CLASSIFICATION AND LABELLING This Part lays down general principles for preparing dossiers to propose and justify harmonised classification and labelling. The relevant parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006 shall be used for the methodology and format of any dossier. For all dossiers any relevant information from registration dossiers shall be considered and other available information may be used. For hazard information which has not been previously submitted to the Agency, a robust study summary shall be included in the dossier. A dossier for harmonised classification and labelling shall contain the following: — Proposal The proposal shall include the identity of the substance or substances concerned and the harmonised classification and labelling proposed. — Justification for the proposed harmonised classification and labelling A comparison of the available information with the criteria contained in Parts 2 to 5, taking into account the general principles in Part 1, of Annex I to this Regulation shall be completed and documented in the format set out in Part B of the Chemical Safety Report in Annex I to Regulation (EC) No 1907/2006. — Justification for other effects at Community level For other effects than carcinogenity, mutagenicity, reprotoxicity, endocrine disruption for human health and the environment, persistent bioaccumulative and toxic (PBT), very persistent, very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), very persistent, very mobile (vPvM), and respiratory sensitisation a justification shall be provided that there is a need for action demonstrated at Community level. This does not apply for an active substance in the meaning of ~~Directive 91/414/EEC or Directive 98/8/EC.~~Regulation (EU) No 1107/2009 or Regulation (EU) No 528/2012.’

Amendment 327 #

Proposal for a regulation
Annex II a (new)

Annex VI Part 2 is replaced by the following: ‘2. PART 2: DOSSIERS FOR HARMONISED CLASSIFICATION AND LABELLING This Part lays down general principles for preparing dossiers to propose and justify harmonised classification and labelling. The relevant parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006 shall be used for the methodology and format of any dossier. For all dossiers any relevant information from registration dossiers shall be considered and other available information may be used. For hazard information which has not been previously submitted to the Agency, a robust study summary shall be included in the dossier. A dossier for harmonised classification and labelling shall contain the following: —Proposal The proposal shall include the identity of the substance or substances concerned and the harmonised classification and labelling proposed. —Justification for the proposed harmonised classification and labelling A comparison of the available information with the criteria contained in Parts 2 to 5, taking into account the general principles in Part 1, of Annex I to this Regulation shall be completed and documented in the format set out in Part B of the Chemical Safety Report in Annex I to Regulation (EC) No 1907/2006. For dossier for harmonised classification and labelling of groups of substances, justification for the grouping. —Justification for other effects at Community level For other effects than carcinogenity, mutagenicity, reprotoxicity and respiratory sensitisation a justification shall be provided that there is a need for action demonstrated at Community level. This does not apply for an active substance in the meaning of Directive 91/414/EEC or Directive 98/8/EC.’

Amendment 328 #

Proposal for a regulation
Annex III – paragraph 1 a (new)

Regulation (EC) No 1272/2008
Annex VIII – Part A – section 2.2 a

In ~~the case of bespoke paint~~Annex VIII, in part A, section 2.2a is replaced by the following: ‘In the case of bespoke paints or on-site formulated mixtures, submitters may, without prejudice to Article 25(8), opt not to submit information and not to create a Unique Formula Identifier in accordance with this Annex.’

Amendment 329 #

Proposal for a regulation
Annex III – paragraph 1

Regulation (EC) No 1272/2008
Annex VIII - Part A, section 2.4 – subparagraph 1 – point 6 a (new)

In Annex VIII, in part A, Section 2.4, the following point 6a is added: ‘6a. ‘on-site formulated mixture’ means a mixture that is formulated in a volume less than 10 ml on a tailor-made basis for an individual consumer or professional user at the point of supply.’

Amendment 58 #

Proposal for a regulation
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, together with requirements in Regulation (EU) No xxx/xxx [reference to adopted act to be inserted] on General Product Safety, Regulation (EU) No 2022/2065, and Regulation (EU) 2019/1020 would improve compliance with and enforcement of the Regulation (EC) No 12727/2008 and thereby ensure a high level of protection of human 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 59 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Susana SOLÍS PÉREZ

Proposal for a regulation
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 60 #

Proposal for a regulation
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~~necessary 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 wshould improve compliance with and enforcement of the Regulation (EC) No 12727/2008 and thereby ensure a high level of protection of human 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 61 #

Proposal for a regulation
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 limit 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).deleted

Amendment 62 #

Proposal for a regulation
Recital 2

Amendment 63 #

Irène TOLLERET, Max ORVILLE, Giuseppe FERRANDINO, Atidzhe ALIEVA-VELI, Iskra MIHAYLOVA, Ilhan KYUCHYUK

Proposal for a regulation
Recital 2

Amendment 64 #

Proposal for a regulation
Recital 2

Amendment 65 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Max ORVILLE, Susana SOLÍS PÉREZ

Proposal for a regulation
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 limit animal testing, data on ~~multi-~~substances containing more than one 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-~~substances containing more than one 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-constituentsubstances~~substances containing more than one constituenton the basis of sufficient and reliable scientific argumentation. Such derogations would be warranted where using data on constituents and calculation rules would result in a less appropriate classification of the complexsubstances than by using data on the substance itself. This could be the case for example when a complex substance like essential oil contains only structurally similar constituents or when there is proof of antagonistic effects among constituents. The Committee for Risk Assessment of the Agency set up pursuant to Article 76/1/(c) of Regulation (EC) no 1907/2006 should provide an assessment of the derogations when needed.This regulatory approach should contribute to the objectives of the EU Chemical Strategy for Sustainability to better protect citizens and the environment and to boost innovation for safe and sustainable chemicals by ensuring implementation of existing legal provisions of Regulation 1272/2008 and corresponding Guidance on the Application of the CLP criteria. _________________ 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 66 #

Proposal for a regulation
Recital 2

(2) From a toxicological point of view, substances ~~with~~containing 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 limit 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-~~substances containing more than one 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-constituentsubstances.~~ substances. Specific provisions could be provided into Annex I on the basis of adequate and reliable scientific argumentation. Such derogations would be needed for cases where using data on constituents and calculation rules would result in a less appropriate classification of a substance with more than one constituent than by using data on the substance itself. This could be the case for example when a substance with more than one constituent contains constituents interacting with each other. Such interactions could have an impact on the hazard of the whole substance, notably when antagonistic effects occur. The scientific criteria to derogate to the mixture rule should be established by the Risk Assessment Committee. This committee should also be consulted for specific cases where appropriate. _________________ 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 67 #

Proposal for a regulation
Recital 2

(2) From a toxicological point of view, substances with more than one constituent ~~(‘multi-constituent substances’) are~~are normally 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 lminimitseanimal testing, data on ~~multi-~~substances with more than one 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-~~substances containing more than one 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 aspecific provision f~~. However,specific provisions should be provided into Annex I forsubstances containing more than one constituent on the basis of robust scientific argumentation for cases where using data on constituents and calculation rules could result in a false classification as compared to using data on the substance containing more th~~ose multi-constituentsubstances~~an one constituent as a whole. This could be the case for example when there is proof of antagonistic effects among constituents. At the same time, it must be ensured that any such differences are not due to dilution effects. In such cases, the Commisson should ask the Risk Assessment Committee for an opinion. _________________ 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 68 #

Proposal for a regulation
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 ~~limit~~phase 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 69 #

Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS

Proposal for a regulation
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. I~~and in accordance with Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council39, aimed to limit animal testing, data on ~~multi-~~substances with more than one 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~~the substance with more than one constituents is not available~~, multi- constituent~~ and where relevant data on individual constituents is available, these 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-constituentsubstances. _________________ 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)substances.

Amendment 70 #

Proposal for a regulation
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. I~~and in accordance with Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council39, aimed to limit animal testing, data on ~~multi-constituent~~substances is to be generated under the same conditions as data on any other substance with more than one costituent, 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~~the substance with more than one constituents is not available~~, multi- constituent~~ and where relevant data onindividual constituents is available, thesesubstances 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 71 #

Christian DOLESCHAL, Christine SCHNEIDER, Dennis RADTKE

Proposal for a regulation
Recital 2

(2) From a toxicological point of view, substances with more than one constituent ~~(‘multi-constituent substances’)~~s for which the information is available for this constituent 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 limit animal testing, data ~~on multi- constituentsubstances is to be generated under the same conditions as data on any other~~is to be developpedon substances, 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 72 #

Agnès EVREN

Proposal for a regulation
Recital 2 a (new)

(2a) Whereas the European Parliament resolution of 14 December 2022 on the implementation of the new European agenda for culture and the EU strategy for international cultural relations (2022/2047(INI)) noted that the EU must ensure that Europe’s cultural heritage is safeguarded and insists that upholding the required level of protection for human health and the environment does not conflict with the preservation of European heritage, avoiding the closure of many craft enterprises and any negative impact on the restoration, maintenance and conservation of the vast heritage of the EU. European institutions should consult and involve the heritage sector in all discussions related to regulatory or legislative changes with a direct impact on their activities. Products such as essential oils and natural complexes made from plants and landscapes, which are part of a cultural heritage, must be preserved.

Amendment 73 #

Martin HOJSÍK, Atidzhe ALIEVA-VELI, Iskra MIHAYLOVA, Ilhan KYUCHYUK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Max ORVILLE, Susana SOLÍS PÉREZ

Proposal for a regulation
Recital 2 a (new)

(2a) Essential oils are derived from various sections of plants and are obtained by distillation, steam distillation or expression. They are complex substances that should warrant a tailored approach to their identification, including by providing for scientifically justified derogations from the rules applicable to the substances with more than one constituent under Article 5(3) of this Regulation. The European Commission and the Agency should assist the sector, particularly micro and small companies, that intends to benefit from the derogation, including by ensuring expeditious assessment of the dossier. This Regulation does not regulate safe use of essential oils in consumer products.

Amendment 74 #

Eric ANDRIEU, Nora MEBAREK, Sylvie GUILLAUME

Proposal for a regulation
Recital 2 a (new)

(2a) The development of safe and sustainable products by design should contribute to achieving Green Deal objectives. In this context, natural and renewable products, which are inherently sustainable, could play a key role in the development of a circular and sustainable economy.

Amendment 75 #

Cristian-Silviu BUŞOI, Aldo PATRICIELLO, Salvatore DE MEO

Proposal for a regulation
Recital 2 a (new)

(2a) The development of products that are safe and sustainable by design must help to achieve the objectives of the green deal. In that context, the products of natural and renewable origin, by essence sustainable, could play a key role in facilitating the development of a circular and sustainable economy.

Amendment 76 #

Eric ANDRIEU, Nora MEBAREK, Sylvie GUILLAUME

Proposal for a regulation
Recital 2 b (new)

(2b) Essential oils are natural, renewable products of agricultural and plant origin, made up of heterogeneous components that cannot be formulated or pre-calibrated. An essential oil cannot be chemically reproduced by combining its individual components. An essential oil is therefore intrinsically a substance, like vegetable oils, and not a mixture of ingredients, since the identification of an essential oil is incomplete if the ingredients are considered separately. In addition, the scientific evidence on essential oils shows that specific ingredients considered in isolation may have hazardous properties that are not expressed when naturally present in an essential oil assessed as a whole substance.

Amendment 77 #

Cristian-Silviu BUŞOI, Aldo PATRICIELLO, Salvatore DE MEO

Proposal for a regulation
Recital 2 b (new)

(2b) Essential oils are natural and renewable products, of agricultural and plants origin, of heterogeneous components that cannot be formulated or dosed. An essential oil cannot be reproduced chemically by the addition of its individual components. An essential oil is therefore intrinsically a substance, similarly to vegetal oils, and not a mixture of ingredients, that taken separately could not enable its full identification. In addition, scientific evidences on essential oils show that specific ingredients considered in isolation can have hazardous properties that are not expressed when they are naturally present in an essential oil assessed as a whole substance.

Amendment 78 #

Cristian-Silviu BUŞOI, Nathalie COLIN-OESTERLÉ

Proposal for a regulation
Recital 2 c (new)

(2c) Considering that the European Parliament resolution of 14 December 2022 on the implementation of the New European Agenda for Culture and the EU Strategy for International Cultural Relations (2022/2047(INI)) recalled that the EU must ensure that Europe’s cultural heritage is safeguarded and insisted on the fact that upholding the required level of protection for human health and the environment does not conflict, where appropriate, with the preservation of European heritage, avoiding the closure of many craft enterprises and any negative impact on the restoration, maintenance and conservation of the vast heritage of the EU. The European institutions should consult and involve the heritage sector in all discussions related to regulatory or legislative changes with a direct impact on their activities. The products such as essential oils and natural complex substances, obtained from plants and landscapes, which are part of a cultural heritage, should be preserved.

Amendment 79 #

Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS

Proposal for a regulation
Recital 3

(3) It is normally not possible to sufficiently assess the endocrine disrupting properties for human health and the environment and the persistent, bioaccumulative and mobile properties of a mixture or of a multi-constituent substance on the basis of data on that mixture or substance. The data for the individual substances of the mixture or for the individual constituents of the multi-constituent substance should therefore normally be used as the basis for hazard identification of those multi- constituent substances or mixtures. However, in certain cases, data on those multi-constituent substances themselves may also be relevant. This is the case in particular where that data demonstrates endocrine disrupting properties for human health and the environment, as well as persistent, bioaccumulative and mobile properties, or where it supports data on the individual constituents. Therefore, it is appropriate that data on multi-constituent substances are used in those cases.deleted

Amendment 80 #

Proposal for a regulation
Recital 3

(3) ~~It is normally not possible to sufficiently assess the~~For the assessment of endocrine disrupting properties for human health and the environment and the persistent, bioaccumulative and mobile properties of a mixture or of a multi-constituent substance on the basis of data on that mixture or substance. The data for the individual substances of the mixture or for the individual constituents of the multi- constituent substance should therefore normally be used as the basis for hazard identification of those multi-constituent substances or mixtures. However, in certain cases, data on those multi- constituent substances themselves may also be relevant. This is the case in particular where that data demonstrates endocrine disrupting properties for human health and the environment, as well as persistent, bioaccumulative and mobile properties, or where it supports data on the individual constituents. Therefore, it is appropriate that data on multi-constituent substances are used in those casboth whole substance data and data for the individual constituents of the substance with more than one constituent, impurity or additive should be used as the basis for hazard classification of those substances.

Amendment 81 #

Proposal for a regulation
Recital 3

(3) It is normally not possible to sufficiently assess the endocrine disrupting properties for human health and the environment and the persistent, bioaccumulative and mobile properties of a mixture ~~or of a multi-constituent substance~~ on the basis of data on that mixture ~~or substance~~. The data for the individual substances of the mixture ~~or for the individual constituents of the multi- constituent substance~~ should therefore normally be used as the basis for hazard identification of those multi-constituent substances or mixtures. However, in certain cases, data on those multi- constituent substances themselves may also be relevant. This is the case in particular where that data demonstrates endocrine disrupting properties for human health and the environment, as well as persistent, bioaccumulative and mobile properties, or where it supports data on the individual constituents. Therefore, it is appropriate that data on multi-constituent substances are used in those casixtures.

Amendment 82 #

Irène TOLLERET, Max ORVILLE, Giuseppe FERRANDINO, Atidzhe ALIEVA-VELI, Iskra MIHAYLOVA, Ilhan KYUCHYUK

Proposal for a regulation
Recital 3

Amendment 83 #

Proposal for a regulation
Recital 3

(3) ~~It is normally not possible~~Under the current state of science, it may be difficult to sufficiently assess the endocrine disrupting properties for human health and the environment and the persistent, bioaccumulative and mobile properties of a mixture or of a ~~multi-constituent~~ substance on the basis of data on that mixture or substance. The data for the individual substances of the mixture or for the individual constituents of the ~~multi- constituent~~ substance should therefore normally be used as the basis for hazard identification of those ~~multi-constituent~~ substances or mixtures. However, in certain cases, data on those ~~multi- constituent~~ substances themselves may also be relevant. This is the case in particular where that data demonstrates endocrine disrupting properties for human health and the environment, as well as persistent, bioaccumulative and mobile properties, or where it supports data on the individual constituents. Therefore, it is appropriate that data on multi-constituent substances are used in those cases.

Amendment 84 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Max ORVILLE, Susana SOLÍS PÉREZ

Proposal for a regulation
Recital 3

(3) It is normally not possible to sufficiently assess the endocrine disrupting properties for human health and the environment and the persistent, bioaccumulative and mobile properties of a mixture or of a ~~multi-constituent substance~~substance containing more than one constituent on the basis of data on that mixture or substance. The data for the individual substances of the mixture or for the individual constituents of the ~~multi-~~substance containing more than one constituent ~~substance~~ should therefore normally be used as the basis for hazard identification of those ~~multi-constituent substances~~substances containing more than one constituent or mixtures. However, in certain cases, data on ~~those multi- constituent substances themselves may also be relevant. This is the case in particular where that data demonstrates~~mixtures or on substances containing more than one constituent may also be relevant. This is the case in particular for the one plant protection product or the one biocidal product relevant for approval decisions of the corresponding active substance, or where data on mixtures or on substances containing more than one constituent demonstrate endocrine disrupting properties for human health and the environment, ~~as well as~~or persistent, bioaccumulative and mobile properties, or where it supports data on the individual constituents. Therefore, it is appropriate that data on m~~ulti-constituent substances are used~~ixtures or on substances containing more than one constituent are taken into consideration in those cases.

Amendment 85 #

Proposal for a regulation
Recital 3

(3) It is normally not possible to sufficiently assess the endocrine disrupting properties for human health and the environment and the persistent, bioaccumulative and mobile properties of a mixture or of a ~~multi-~~substance containing more than one constituent ~~substance~~ on the basis of data on that mixture or substance. The data for the individual substances of the mixture or for the individual constituents of the ~~multi- constituent substance~~substance containing more than one constituent should therefore normally be used as the basis for hazard identification of those ~~multi-constituent substances~~substances containing more than one constituent or mixtures. However, in certain cases, data on those ~~multi-~~substance containing more than one constituent ~~substances~~ themselves may also be relevant. This is the case in particular where that data demonstrates endocrine disrupting properties for human health and the environment, as well as persistent, bioaccumulative and mobile properties, or where it supports data on the individual constituents. Therefore, it is appropriate that data on ~~multi-constituent substances~~substances containing more than one constituent are used in those cases.

Amendment 86 #

Christian DOLESCHAL, Christine SCHNEIDER, Dennis RADTKE

Proposal for a regulation
Recital 3

(3) It is normally not possible to sufficiently assess the endocrine disrupting properties for human health and the environment and the persistent, bioaccumulative and mobile properties of a mixture or of a ~~multi-~~substance containing more than one constituent ~~substance~~ on the basis of data on that mixture or substance. The data for the individual substances of the mixture or for the individual constituents of the multi- constituent substance should therefore normally be used as the basis for hazard identification of those multi-constituent substances or mixtures. However, in certain cases, data on those ~~multi-~~substances containing more than one constituent ~~substances~~ themselves may also be relevant. This is the case in particular where that data demonstrates endocrine disrupting properties for human health and the environment, as well as persistent, bioaccumulative and mobile properties, or where it supports data on the individual constituents. Therefore, it is appropriate that data on ~~multi-constituent substances~~substances containing more than one constituent are used in those cases.

Amendment 87 #

Proposal for a regulation
Recital 3

Amendment 88 #

Proposal for a regulation
Recital 4

(4) In order to improve legal certainty and implementation with regard to the evaluation of hazard information for mixtures where no or inadequate test data are available for the mixture itself, the interaction between the application of the bridging principles and a weight of evidence determination using expert judgement should be clarified. Such clarification should ensure that the weight of evidence determination complements but does not substitute the application of the bridging principles. It should also be clarified that if bridging principles cannot be applied to evaluate a mixture, manufacturers, importers and downstream users should use the calculation method or other methods described in Parts 3 and 4 of Annex I to Regulation (EC) No 1272/2008. Commission shall provide detailed guidance regarding adjusted calculation method for special mixture. It should also be clarified which criteria, when not met, determine when a weight of evidence determination using expert judgment is to be carried out.

Amendment 89 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Susana SOLÍS PÉREZ

Proposal for a regulation
Recital 7 a (new)

(7a) Disposable electronic cigarettes and single use cartridges may contain a nicotine-containing mixture classified as having acute oral and/or acute dermal toxicity properties. However, the mixtures contained in these products cannot directly be ingested or touched. Therefore, it is appropriate to provide for labelling exemptions for these products, unless the mixtures contained are classified as having acute inhalation toxicity and/or respiratory sensitisation properties. This is without prejudice to specific EU and national legislation on the marketability of the mixtures contained.

Amendment 90 #

Proposal for a regulation
Recital 10

(10) To increase enforceability of the obligation placed on suppliers to update their labels after a change in the classification and labelling of their substance or mixture, a deadline should be laid down as regards that obligation. A similar obligation placed on registrants is set out in Commission Implementing Regulation (EU) 2020/143540. Where the new hazard class is additional to an existing hazard class or represents a more severe hazard class or category, or where new supplemental labelling elements are required under Article 25, the deadline to update the labelling information in the case of adaptation of the classification in accordance with the result of a new evaluation should be set at maximum6 months from the day on which the results of a new evaluation on the classification of that substance or that mixture were obtained. In case where a classification is updated to a less severe hazard class or category without triggering classification in an additional hazard class or new supplemental labelling requirements, the deadline for updating the labels should remain at 18 months from the day on which the results of a new evaluation on the classification of that substance or that mixture were obtained. It should also be clarified that, in cases of harmonised classification and labelling, the deadlines to update the labelling information should be set at the date of application of the provisions setting out the new or amended classification and labelling of the substance concerned, which is usually 18 months from the date of entry into force of those provisions. The same applies in case of changes triggered by other delegated acts adopted in light of the adaptation to technical and scientific progress, for instance as a result of the implementation of new or amended provisions of the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS). _________________ 40 Commission Implementing Regulation (EU) 2020/1435 of 9 October 2020 on the duties placed on registrants to update their registrations under Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 331, 12.10.2020, p.24.)

Amendment 91 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Susana SOLÍS PÉREZ

Proposal for a regulation
Recital 10

(10) To increase enforceability of the obligation placed on suppliers to update their labels after a change in the classification and labelling of their substance or mixture, a deadline should be laid down as regards that obligation. A similar obligation placed on registrants is set out in Commission Implementing Regulation (EU) 2020/143540. Where the new hazard class is additional to an existing hazard class or represents a more severe hazard class or category, or where new supplemental labelling elements are required under Article 25, the deadline to update the labelling information in the case of adaptation of the classification in accordance with the result of a new evaluation should be set at 63months from the day on which the results of a new evaluation on the classification of that substance or that mixture were obtained. In case where a classification is updated to a less severe hazard class or category without triggering classification in an additional hazard class or new supplemental labelling requirements, the deadline for updating the labels should remain at 18 months from the day on which the results of a new evaluation on the classification of that substance or that mixture were obtained. It should also be clarified that, in cases of harmonised classification and labelling, the deadlines to update the labelling information should be set at the date of application of the provisions setting out the new or amended classification and labelling of the substance concerned, which is usually 18 months from the date of entry into force of those provisions. The same applies in case of changes triggered by other delegated acts adopted in light of the adaptation to technical and scientific progress, for instance as a result of the implementation of new or amended provisions of the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS). _________________ 40 Commission Implementing Regulation (EU) 2020/1435 of 9 October 2020 on the duties placed on registrants to update their registrations under Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 331, 12.10.2020, p.24.)

Amendment 92 #

Proposal for a regulation
Recital 11

(11) Regulation (EC) No 1272/2008 only allows for the use of fold-out labels if the general rules for the application of labels cannot be met due to the shape or form of the packaging or its small size, whilst it does not provide for a minimum font size of labels that would ensure readability. As a result of advancements in labelling technologies, more flexibility should be given to suppliers by providing for a broader use of fold-out labels, while durability and good readability of all physical labels should be ensured, including by laying down minimum font size ~~and formatting requirement~~, using optimal typesets and contrasts between the print and the background and other formatting requirements. In order to ensure compatibility between bigger flexibility and minimum consumers safety, the front page of a fold-out label should display at least signal words, precautionary statement and hazard pictograms.

Amendment 93 #

Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS

Proposal for a regulation
Recital 11

Amendment 94 #

Proposal for a regulation
Recital 11

Amendment 95 #

Martin HOJSÍK, Billy KELLEHER, María Soraya RODRÍGUEZ RAMOS, Michal WIEZIK, Susana SOLÍS PÉREZ

Proposal for a regulation
Recital 11

Amendment 96 #

Sirpa PIETIKÄINEN

Proposal for a regulation
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 digital 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. The decision about what part of the information is not instrumental for the safety of the user or the protection of the environment needs to be transparently documented. Hazard labels shall always remain excluded from this option.

Amendment 97 #

Proposal for a regulation
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 digital 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. Unique Formula Identifier, the hazard statement, the signal word, and the hazard pictogram should always remain at the on-pack label to ensure they are in sight of consumers.

Amendment 98 #