Regulation (EC) No 1272/2008 of the European Parliament and of the CouncilShow full title

Article 38 U.K. Content of opinions and decisions for [F1 mandatory] classification and labelling in [F1 the GB mandatory classification and labelling list]; accessibility of information

[F2 A1. Any opinion of the Agency referred to in Article 37 must specify the reasons for the opinion.]

1. Any opinion [F3 of the Agency referred to in Article 37A] 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.

[F4 2. When making publicly available an opinion or a decision as referred to in Article 37 or Article 37A, the Agency must not publish any information in relation to which paragraph 3 applies.]

[F5 3. This paragraph applies to information which has been made available to the Agency in relation to which a person has submitted a justification, accepted by the Agency as valid, as to why publication of the information is potentially harmful to the commercial interests of that person or any other person.]

Textual Amendments

F1 Words in Art. 38 heading substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 35(a) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 9(a)); 2020 c. 1, Sch. 5 para. 1(1)

F2 Art. 38(A1) inserted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 35(b); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 38(1) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 35(c); 2020 c. 1, Sch. 5 para. 1(1)

F4 Art. 38(2) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 35(d); 2020 c. 1, Sch. 5 para. 1(1)

F5 Art. 38(3) inserted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 35(e); 2020 c. 1, Sch. 5 para. 1(1)