What changed between the plenary report and the adopted text

Article 1 – paragraph 1 – point 21, Article 42 – paragraph 1 – subparagraph 3 – point a: (a) information referred to in Article 40(1), point (a);

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 21 a (new), Article 42 – paragraph 3 a (new): (21a) In the Article 42, the following paragraph 3a is added: / "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."

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 21 b (new), Article – 43 (new): (21b) The following Article -43 is inserted: / 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 or mixture, or of substances or mixtures, showing that hazardous properties of a substance or mixture or of substances or mixtures 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, adding 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 shown that the substance 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 shown a wide dispersive use of and/or consumer exposu…

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 21 c (new), Article – 43 a (new): (21c) The following Article -43a is added: / Article -43a / Access to justice / 1. Any natural or legal person which has submitted a 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 procedures to review their decisions, acts and omissions, in accordance with national law or practice. Decisions, acts and omissions by the Commission shall be subject to review in accordance with Regulation EU (No) 1367/2006. / 3. The procedures referred to in paragraph 2 shall be fair, equitable, timely and not prohibitively expensive while providing 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.

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 23, 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. Any advertisement for a substance for sale to the general public shall in addition indicate “always read and follow the information on the product label.

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 23, 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. Any advertisement for sale of mixtures to the general public shall, in addition, indicate “always read and follow the information on the product label.

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 25 – point -a (new), Article 50 – paragraph 2 – point a: (-a) in Article 50, paragraph 2, point a is amended as following: / "(a) provide industry with up to date technical and scientific guidance and tools where appropriate on how to comply with the obligations laid down by this Regulation;"

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 25 – point a, Article 50 – paragraph 2 – point b: (b) provide competent authorities with up to date technical and scientific guidance and tools on the operation and implementation of this Regulation and provide support to the helpdesks established by Member States under Article 44.

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 25 – point b a (new), Article 50 – paragraph 3 a (new) and 3 b (new): (ba) the following paragraphs are added: / “3a. The Agency shall be provided with adequate resources to support its work. / 3b. In order to provide adequate expertise, support, and thorough scientific evaluations, appropriate and stable funding for the Agency shall be ensured.”

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 26 – point -a (new), Article 53 – paragraph 1: (-a) In Article 53, paragraph 1 is replaced by the following: / "1. The Commission may adjust and adapt Articles 6(5), 11(3), 12, 14, 18(3)(b), 23, 25 to 29 and 35(2) second and third subparagraph and Annexes I to VII to technical and scientific progress, including the promotion of alternative methods for assessment of hazards of substances and mixtures, 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. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 54(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 54(4)."

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 26 – point a, Article 53 – paragraph 1a: 1a. The Commission is empowered to 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 population groups in the Union. When adopting those delegated acts, the Commission shall ensure a high level of protection of human health and the environment and take into account societal needs. The Commission shall make sure that information which is critical to protect human health and the environment shall be easily accessible on the label;

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 26 – point a, 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 the readiness of the necessary wireless and other technological infrastructure allowing unrestricted access to the information on chemicals;

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 26 – point b, 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 the development of criteria for immunotoxic and neurotoxic substances 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.;

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 26 – point c, Article 53 – paragraph 3: 3. The Commission shall promote and 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 three years, and adopt delegated acts in accordance with Article 53a, to update Annex I to this Regulation to reflect such technical progress, if relevant. The Commission shall adopt a delegated act in accordance with Article 53a to update Annex I to this Regulation no more than twelve months after non-animal data are included in harmonised criteria for classification and labelling at the level of the UN.

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 26 – point c a (new), Article 53 – paragraph 3 a (new): (ca) In Article 53, paragraph 3a is added as following: / "3a. The Commission shall assess the introduction of hazard criteria for immunotoxicity and neurotoxicity by 31 December 2025 and, where appropriate, adopt delegated acts in accordance with Article 53a. The Commission shall foster the rapid introduction of those hazard classes at the UNGHS."

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 27 – point a, Article 53a – paragraph 2: The power to adopt delegated acts referred to in Articles 37(5), 37(7), 37(8), 45(4), 53(1), 53(1a), 53(1b), 53(3) and 53(3a) shall be conferred on the Commission for a period of five years from [OP please insert the date = the date of entry into force of this Regulation].

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 27 – point b, Article 53a – paragraph 3: The delegations of power referred to in Articles 37(5), 37(7) and 37(8), 45(4), 53(1), 53(1a), 53(1b), 53(3) and 53(3a) may be revoked at any time by the European Parliament or by the Council.

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 27 – point c, Article 53 – paragraph 6: A delegated act adopted pursuant to Article Articles 37(5), 37(7), 37(8), 45(4), 53(1), 53(1a), 53(1b), 53(3) or 53(3a) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object.;

Regulation (EC) No 1272/2008

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 30, Article 61 – paragraph 7: Substances 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 18 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].

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 30 – point a (new), Article 61 – paragraph 7 a (new): a) In Article 61, the following paragraph 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 subparagraph, 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 subparagraph 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 24 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 48 months after th…

Article 2 – paragraph 2 – introductory part: 2. The following provisions shall apply to substances and mixtures 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]:

Article 2 – paragraph 2 a (new): 2a. The following provisions shall apply to mixtures from [OP: please insert the date = the first day of the month following 24 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.

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 may until … [OP: please insert the date = 18months after the date of entry into force of this Regulation] and mixtures 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:

Regulation (EC) No 1272/2008

Regulation (EC) No 1272/2008

Regulation (EC) No 1272/2008

Regulation (EC) No 1272/2008

Regulation (EC) No 1272/2008

Annex I – paragraph 1 – point 3 a (new), Annex I – Part 1 – Section 1.2.1.5 a (new)): (3a) In Annex I, part I, the following section is added: / Section 1.2.1.5.a For multilingual labels, the languages shall be ordered in a logical way, e.g. alphabetically.

Regulation (EC) No 1272/2008

Annex I – paragraph 1 – point 9, Annex I – Part 1 – Section 1.5.2.4.1. – point b – point iv a (new): (iva) Serious eye damage category 1/eye irritation, category 2;

Regulation (EC) No 1272/2008

Annex I – paragraph 1 – point -1 (new), 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);

Regulation (EC) No 1272/2008

Annex II – paragraph 1 – point -1 a(new), Annex II – Part 3 – Section 3.1.1.1: -1a in Part 3 of Annex II to Regulation (EC) No 1272/2008, 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."

Regulation (EC) No 1272/2008

Annex II – paragraph -1 a (new), Annex II – Part 3 – section 3.2.1: (-1a) 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 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. "