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

Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (Text with EEA relevance)

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When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.

Changes over time for: Article 66

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Point in time view as at 31/12/2020.

Changes to legislation:

There are currently no known outstanding effects for the Regulation (EU) No 528/2012 of the European Parliament and of the Council, Article 66. Help about Changes to Legislation

Article 66U.K.Confidentiality

F11.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.The [F2competent authority] 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 [F3competent authority] 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.

[F44.Any person submitting information related to an active substance or a biocidal product to the F5... 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.]

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