Changes from plenary report to adopted text

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 5, Article 6 – paragraph 3 – subparagraph 1: 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.

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 5, 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, 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.

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 5, 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 demonstrate a lack of biodegradation, persistency, mobility and bioaccumulation properties that have not been identified from the relevant available information on the individual substance referred to in the first subparagraph, such data shall also be taken into account for the purpose of evaluating the mixture referred to in the first subparagraph.

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 5 a (new), Article 7: (5 a) Article 7 is replaced by the following: / "Article 7 / Non-animal, animal, and human testing / 4. Tests using new approach methodologies shall also be considered."

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 6, Article 9 – paragraph 3: 3. Where the criteria referred to in paragraph 1 cannot be applied directly to available identified information, or where properties are defined by multiple criteria, 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.

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 7 a (new), Article 17: (7a) Article 17 is replaced by the following : / "Article 17 / (ha) where applicable, a link to the digital label where further information can be found. / Suppliers may use more languages on their labels than those required by the Member States, provided that the same details appear in all languages used. / The information in points (h) and (ha) in paragraph 1 may be provided on the inner pages of a fold-out label."

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 7 b (new), Article 18 – paragraph 3 – subparagraph 1– point b: (7b) 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."

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 8 a (new), Article 25 – paragraphs 2 and 3: (8a) In Article 25, paragraphs 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 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 7, 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."

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 9, Article 25 – paragraph 6 – subparagraph 1: The specific labelling rules set out in Part 2 of Annex II shall apply to mixtures containing substances referred to in that Annex. 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.

Article 1 – paragraph 1 – point 13 – introductory part: (13) in Article 31, paragraph 1, the following sentence is added:

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 13, Article 31 – paragraph 1: "1. Labels shall be firmly affixed to one or more surfaces of the packaging immediately containing the substance or mixture and shall be readable horizontally when the package is set down normally. / The label may also be presented in a form of a fold out label."

Regulation (EC) 1272/2008

Article 1 – paragraph 1 – point 13, 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.

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 13 a (new), Article 32 – paragraph 6: (13a) In Article 32, paragraph 6 is replaced by the following: / "6. Where the label elements referred to in Article 17(1) are 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), (f) and (g) in all official languages of the Member State where the product is put on the market along with a reference to the additional information provided on the inside page or pages."

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 15, 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;

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 16, 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).

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 18 – point a, Article 37 – paragraph 1 – subparagraph 1: A competent authority may submit to the Agency a proposal for harmonised classification and labelling of a substance or a group of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for revision thereof.

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 18 – point a, 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 a substance or a group 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 or a group of substances where a harmonised classification could be necessary to protect human and animal health and the environment.

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 18 – point a, Article 37 – paragraph 1 – subparagraph 3: The proposals for harmonised classification and labelling of a substance or a group 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.

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 18 – point a, Article 37 – paragraph 1 – subparagraph 3 a (new): 'Whenever considered scientifically justified and possible by a competent authority or the Commission, proposals for harmonised classification and labelling shall prioritise groups of substances rather than individual substances.'

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 18 – point c, Article 37 – paragraph 2a – subparagraph 2: Within one week from receipt of the notification, the Agency shall publish the name, the EC and CAS numbers of the substance(s), and where relevant, the status of the proposal and the name of the submitter. 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).

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 18 – point e, Article 37 – paragraph 5 – subparagraph 1: The Commission, within twelve months of the publication of the opinion of the Committee for Risk Assessment, shall 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.

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 18 – point e, Article 37 – paragraph 6: 6. Manufacturers, importers and downstream users who have new information which may lead to 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.

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 18 – point f, Article 37 – paragraph 7 – subparagraph 1: By 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, 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 1 January 2025, those substances have been included in the candidate list referred to in Article 59(1) of Regulation (EC) No 1907/2006.

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 20 – point a – point ii, Article 40 – paragraph 1 – subparagraph 1 – point g: (g) where applicable, and without needing to acquire new data or new studies being necessary, the reason for divergence from the most severe classification per hazard class included in the inventory referred to in Article 42;

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 20 – point a – point ii, Article 40 – paragraph 1 – subparagraph 1 – point h: (h) where applicable and without needing to acquire new data or new studies being necessary, the reason for introducing a more severe classification per hazard class compared to those included in the inventory referred to in Article 42;

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 20 a (new), Article 41: (20a) Article 41 is replaced by the following: / "Article 41 / 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.'"

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 21, Article 42 – paragraph 1 – subparagraph 3 – introductory part: The following information shall be made publicly available free of charge online in a user-friendly format:

Regulation (EC) No 1272/2008