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

Article 19 Conditions for granting an authorisation

1. A biocidal product other than those eligible for the simplified authorisation procedure in accordance with Article 25 shall be authorised provided the following conditions are met:

(a) the active substances are approved for the relevant product-type and any conditions specified for those active substances are met;

(b) it is established, according to the common principles for the evaluation of dossiers for biocidal products laid down in Annex VI, that the biocidal product, when used as authorised and having regard to the factors referred to in paragraph 2 of this Article, fulfils the following criteria:

(i)

the biocidal product is sufficiently effective;

(ii)

the biocidal product has no unacceptable effects on the target organisms, in particular unacceptable resistance or cross-resistance or unnecessary suffering and pain for vertebrates;

(iii)

the biocidal product has no immediate or delayed unacceptable effects itself, or as a result of its residues, on the health of humans, including that of vulnerable groups, or animals, directly or through drinking water, food, feed, air, or through other indirect effects;

(iv)

the biocidal product has no unacceptable effects itself, or as a result of its residues, on the environment, having particular regard to the following considerations:

• the fate and distribution of the biocidal product in the environment,

• contamination of surface waters (including estuarial and seawater), groundwater and drinking water, air and soil, taking into account locations distant from its use following long-range environmental transportation,

• the impact of the biocidal product on non-target organisms,

• the impact of the biocidal product on biodiversity and the ecosystem;

(c) the chemical identity, quantity and technical equivalence of active substances in the biocidal product and, where appropriate, any toxicologically or ecotoxicologically significant and relevant impurities and non-active substances, and its residues of toxicological or environmental significance, which result from uses to be authorised, can be determined according to the relevant requirements in Annexes II and III;

(d) the physical and chemical properties of the biocidal product have been determined and deemed acceptable for the purposes of the appropriate use and transport of the product;

(e) where appropriate, maximum residue limits for food and feed have been established with respect to active substances contained in a biocidal product in accordance with Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food(1), Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food(2), Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin(3), Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin(4) or Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed(5);

(f) where nanomaterials are used in that product, the risk to human health, animal health and the environment has been assessed separately.

2. The evaluation of whether a biocidal product fulfils the criteria set out in point (b) of paragraph 1 shall take into account the following factors:

(a) realistic worst case conditions under which the biocidal product may be used;

(b) the way in which treated articles treated with the biocidal product or containing the biocidal product may be used;

(c) the consequences of use and disposal of the biocidal product;

(d) cumulative effects;

(e) synergistic effects.

3. A biocidal product shall only be authorised for uses for which relevant information has been submitted in accordance with Article 20.

4. A biocidal product shall not be authorised for making available on the market for use by the general public where:

(a) it meets the criteria according to Directive 1999/45/EC for classification as:

• (a) toxic or very toxic,

• a category 1 or 2 carcinogen,

• a category 1 or 2 mutagen, or

• toxic for reproduction category 1 or 2;

(b) it meets the criteria according to Regulation (EC) No 1272/2008 for classification as:

• (b) acute oral toxicity category 1 or 2 or 3,

• acute dermal toxicity category 1 or 2 or 3,

• acute inhalation toxicity (gases and dust/mist) category 1 or 2 or 3,

• acute inhalation toxicity (vapours) category 1 or 2,

• a category 1A or 1B carcinogen,

• a category 1A or 1B mutagen, or

• toxic for reproduction category 1A or 1B;

(c) it meets the criteria for being PBT or vPvB in accordance with Annex XIII to Regulation (EC) No 1907/2006;

(d) it has endocrine-disrupting properties; or

(e) it has developmental neurotoxic or immunotoxic effects.

5. Notwithstanding paragraphs 1 and 4, a biocidal product may be authorised when the conditions laid down in paragraph 1(b)(iii) and (iv) are not fully met, or may be authorised for making available on the market for use by the general public when the criteria referred to in paragraph 4(c) are met, where not authorising the biocidal product would result in disproportionate negative impacts for society when compared to the risks to human health, animal health or the environment arising from the use of the biocidal product under the conditions laid down in the authorisation.

The use of a biocidal product authorised pursuant to this paragraph shall be subject to appropriate risk mitigation measures to ensure that exposure of humans and the environment to that biocidal product is minimised. The use of a biocidal product authorised pursuant to this paragraph shall be restricted to Member States in which the condition of the first subparagraph is met.

6. In the case of a biocidal product family, a reduction in the percentage of one or more active substances may be allowed, and/or a variation in percentage of one or more non-active substances, and/or the replacement of one or more non-active substances by other specified substances presenting the same or lower risk. The classification, hazard and precautionary statements for each product within the biocidal product family shall be the same (with the exception of a biocidal product family comprising a concentrate for professional use and ready-for-use products obtained through dilution of that concentrate).

A biocidal product family shall be authorised only if all the biocidal products within it, taking into account the permitted variations referred to in the first subparagraph, are expected to comply with the conditions set out in paragraph 1.

7. Where appropriate, the prospective authorisation holder or its representative shall apply for the establishment of maximum residue limits with respect to active substances contained in a biocidal product in accordance with Regulation (EEC) No 315/93, Regulation (EC) No 1935/2004, Regulation (EC) No 396/2005, Regulation (EC) No 470/2009 or Directive 2002/32/EC.

8. Where, for active substances covered by Article 10(1)(a) of Regulation (EC) No 470/2009, no maximum residue limit has been established in accordance with Article 9 of that Regulation at the time of the approval of the active substance, or where a limit established in accordance with Article 9 of that Regulation needs to be amended, the maximum residue limit shall be established or amended in accordance with the procedure referred to in Article 10(1)(b) of that Regulation.

9. Where a biocidal product is intended for direct application to the external parts of the human body (epidermis, hair system, nails, lips and external genital organs), or to the teeth and the mucous membranes of the oral cavity, it shall not contain any non-active substance that may not be included in a cosmetic product pursuant to Regulation (EC) No 1223/2009.

(1)

OJ L 37, 13.2.1993, p. 1.

(2)

OJ L 338, 13.11.2004, p. 4.

(3)

OJ L 70, 16.3.2005, p. 1.

(4)

OJ L 152, 16.6.2009, p. 11.

(5)

OJ L 140, 30.5.2002, p. 10.