Regulation (EC) No 1272/2008 of the European Parliament and of the CouncilDangos y teitl llawn

CHAPTER 1 Establishing harmonised classification and labelling of substances

Article 36 Harmonisation of classification and labelling of substances

1. A substance that fulfils the criteria set out in Annex I for the following shall normally be subject to harmonised classification and labelling in accordance with Article 37:

(a) respiratory sensitisation, category 1 (Annex I, section 3.4);

(b) germ cell mutagenicity, category 1A, 1B or 2 (Annex I, section 3.5);

(c) carcinogenicity, category 1A, 1B or 2 (Annex I, section 3.6);

(d) reproductive toxicity, category 1A, 1B or 2 (Annex I, section 3.7).

2. A substance that is an active substance in the meaning of Directive 91/414/EEC or Directive 98/8/EC shall normally be subject to harmonised classification and labelling. For such substances, the procedures set out in Article 37, paragraphs 1, 4, 5 and 6 shall apply.

3. Where a substance fulfils the criteria for other hazard classes or differentiations than those referred to in paragraph 1 and does not fall under paragraph 2, a harmonised classification and labelling in accordance with Article 37 may also be added to Annex VI on a case-by-case basis, if justification is provided demonstrating the need for such action at Community level.

Article 37 Procedure for harmonisation of classification and labelling of substances

1. A competent authority may submit to the Agency a proposal for harmonised classification and labelling of substances and, where appropriate, specific concentration limits or M-factors, or a proposal for a revision thereof.

The proposal 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.

2. A manufacturer, importer or downstream user of a substance may submit to the Agency a proposal for harmonised classification and labelling of that substance and, where appropriate, specific concentration limits or M-factors, provided that there is no entry in Part 3 of Annex VI for such a substance in relation to the hazard class or differentiation covered by that proposal.

The proposal shall be drawn up in accordance with the relevant Parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006 and it shall follow the format set out in Part B of the Chemical Safety Report of section 7 of that Annex. It shall contain the relevant information provided for in Part 1 of Annex VI to this Regulation. Article 111 of Regulation (EC) No 1907/2006 shall apply.

3. Where the proposal of the manufacturer, importer or downstream user concerns the harmonised classification and labelling of a substance in accordance with Article 36(3), it shall be accompanied by the fee determined by the Commission in accordance with the regulatory procedure referred to in Article 54(2).

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.

5. Where the Commission finds that the harmonisation of the classification and labelling of the substance concerned is appropriate, it shall, without undue delay, submit a draft decision concerning the inclusion of that substance together with the relevant classification and labelling elements in Table 3.1 of Part 3 of Annex VI and, where appropriate, the specific concentration limits or M-factors.

A corresponding entry shall be included in Table 3.2 of Part 3 of Annex VI subject to the same conditions, until 31 May 2015.

That measure, 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).

6. Manufacturers, importers and downstream users who have new information which may lead to a change of the harmonised classification and labelling elements of a substance in Part 3 of Annex VI shall submit a proposal in accordance with the second subparagraph of paragraph 2 to the competent authority in one of the Member States in which the substance is placed on the market.

Article 38 Content of opinions and decisions for harmonised classification and labelling in Part 3 of Annex VI; accessibility of information

1. Any opinion referred to in Article 37(4) and any decision according to Article 37(5) shall at least specify for each substance:

(a) the identity of the substance as specified in sections 2.1 to 2.3.4 of Annex VI to Regulation (EC) No 1907/2006;

(b) the classification of the substance referred to in Article 36, including a statement of reasons;

(c) the specific concentration limits or M-factors, where applicable;

(d) the label elements specified in points (d), (e) and (f) of Article 17(1) for the substance, together with any supplemental hazard statements for the substance, determined in accordance with Article 25(1);

(e) any other parameter enabling an assessment to be made of the health or environmental hazard of mixtures containing the hazardous substance in question or of substances containing such hazardous substances as identified impurities, additives and constituents, if relevant.

2. When making publicly available an opinion or a decision as referred to in Article 37(4) and (5) of this Regulation, Article 118(2) and Article 119 of Regulation (EC) No 1907/2006 shall apply.