Regulation (EU) No 528/2012 of the European Parliament and of the CouncilDangos y teitl llawn

Article 66 U.K. Confidentiality

1. Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents(1) and the rules of the Management Board of the Agency, adopted in accordance with Article 118(3) of Regulation (EC) No 1907/2006, shall apply to documents held by the Agency for the purposes of this Regulation.

2. The Agency and the competent authorities shall refuse access to information where disclosure would undermine the protection of the commercial interests or the privacy or safety of the persons concerned.

Disclosure of the following information shall normally be deemed to undermine the protection of the commercial interests or the privacy or safety of the persons concerned:

(a) details of the full composition of a biocidal product;

(b) the precise tonnage of the active substance or biocidal product manufactured or made available on the market;

(c) links between a manufacturer of an active substance and the person responsible for the placing of a biocidal product on the market or between the person responsible for the placing of a biocidal product on the market and the distributors of the product;

(d) names and addresses of persons involved in testing on vertebrates.

However, where urgent action is essential to protect human health, animal health, safety or the environment or for other reasons of overriding public interest, the Agency or the competent authorities shall disclose the information referred to in this paragraph.

3. Notwithstanding paragraph 2, after the authorisation has been granted, access to the following information shall not in any case be refused:

(a) the name and address of the authorisation holder;

(b) the name and address of the biocidal product manufacturer;

(c) the name and address of the active substance manufacturer;

(d) the content of the active substance or substances in the biocidal product and the name of the biocidal product;

(e) physical and chemical data concerning the biocidal product;

(f) any methods for rendering the active substance or biocidal product harmless;

(g) a summary of the results of the tests required pursuant to Article 20 to establish the product’s efficacy and effects on humans, animals and the environment and, where applicable, its ability to promote resistance;

(h) recommended methods and precautions to reduce dangers from handling, transport and use as well as from fire or other hazards;

(i) safety data sheets;

(j) methods of analysis referred to in Article 19(1)(c);

(k) methods of disposal of the product and of its packaging;

(l) procedures to be followed and measures to be taken in the case of spillage or leakage;

(m) first aid and medical advice to be given in the case of injury to persons.

[F1 4. Any person submitting information related to an active substance or a biocidal product to the Agency or a competent authority for the purposes of this Regulation may request that the information in Article 67(3) and (4) not be made available, including a justification as to why the disclosure of the information could be harmful for that person’s commercial interests or those of any other party concerned.]

Textual Amendments

F1 Substituted by Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014 amending Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, with regard to certain conditions for access to the market (Text with EEA relevance).

(1)

OJ L 145, 31.5.2001, p. 43.