Regulation (EU) No 528/2012 of the European Parliament and of the CouncilShow full title

Article 5 Exclusion criteria

1. Subject to paragraph 2, the following active substances shall not be approved:

(a) active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, carcinogen category 1A or 1B;

(b) active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, mutagen category 1A or 1B;

(c) active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, toxic for reproduction category 1A or 1B;

(d) active substances which, on the basis of the criteria specified pursuant to the first subparagraph of paragraph 3 or, pending the adoption of those criteria, on the basis of the second and third subparagraphs of paragraph 3, are considered as having endocrine-disrupting properties that may cause adverse effects in humans or which are identified in accordance with Articles 57(f) and 59(1) of Regulation (EC) No 1907/2006 as having endocrine disrupting properties;

(e) active substances which meet the criteria for being PBT or vPvB according to Annex XIII to Regulation (EC) No 1907/2006.

2. Without prejudice to Article 4(1), active substances referred to in paragraph 1 of this Article may be approved if it is shown that at least one of the following conditions is met:

(a) the risk to humans, animals or the environment from exposure to the active substance in a biocidal product, under realistic worst case conditions of use, is negligible, in particular where the product is used in closed systems or under other conditions which aim at excluding contact with humans and release into the environment;

(b) it is shown by evidence that the active substance is essential to prevent or control a serious danger to human health, animal health or the environment; or

(c) not approving the active substance would have a disproportionate negative impact on society when compared with the risk to human health, animal health or the environment arising from the use of the substance.

When deciding whether an active substance may be approved in accordance with the first subparagraph, the availability of suitable and sufficient alternative substances or technologies shall be a key consideration.

The use of a biocidal product containing active substances approved in accordance with this paragraph shall be subject to appropriate risk-mitigation measures to ensure that exposure of humans, animals and the environment to those active substances is minimised. The use of the biocidal product with the active substances concerned shall be restricted to Member States in which at least one of the conditions set out in this paragraph is met.

3. No later than 13 December 2013, the Commission shall adopt delegated acts in accordance with Article 83 specifying scientific criteria for the determination of endocrine-disrupting properties.

Pending the adoption of those criteria, active substances that are classified in accordance with Regulation (EC) No 1272/2008 as, or meet the criteria to be classified as, carcinogen category 2 and toxic for reproduction category 2, shall be considered as having endocrine-disrupting properties.

Substances such as those that are classified in accordance with Regulation (EC) No 1272/2008 as, or that meet the criteria to be classified as, toxic for reproduction category 2 and that have toxic effects on the endocrine organs, may be considered as having endocrine-disrupting properties.