Article 19 / Conditions for granting an authorisation
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:
the active substances are included in Annex I or approved for the relevant product-type and any conditions specified for those active substances are met;
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:
the biocidal product is sufficiently effective;
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;
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;
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 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;
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;
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 ( 29 ), Regulation (EC) No 396/2005 of the European Parliament and of the Council ( 30 ), Regulation (EC) No 470/2009 of the European Parliament and of the Council ( 31 ) or Directive 2002/32/EC of the European Parliament and of the Council ( 32 ), or specific migration limits or limits for the residual content in food contact materials have been established with respect to such active substances in accordance with Regulation (EC) No 1935/2004 of the European Parliament and of the Council ( 33 );
where nanomaterials are used in that product, the risk to human health, animal health and the environment has been assessed separately.
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:
realistic worst case conditions under which the biocidal product may be used;
the way in which treated articles treated with the biocidal product or containing the biocidal product may be used;
the consequences of use and disposal of the biocidal product;
cumulative effects;
synergistic effects.
A biocidal product shall not be authorised for making available on the market for use by the general public where:
it meets the criteria according to Directive 1999/45/EC for classification as:
it meets the criteria according to Regulation (EC) No 1272/2008 for classification as:
it consists of, contains or generates, a substance that meets the criteria for being PBT or vPvB in accordance with Annex XIII to Regulation (EC) No 1907/2006;
it has endocrine-disrupting properties; or
it has developmental neurotoxic or immunotoxic effects.
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.
A biocidal product family shall be authorised only if:
the application explicitly identifies the maximum risks to human health, animal health and the environment, and the minimum level of efficacy, on which the assessment is based, as well as the permitted variations in composition and uses referred to in point (s) of Article 3(1) together with their respective classification, hazard and precautionary statements and any appropriate risk mitigation measures; and
it can be established based on the assessment referred to in the first subparagraph of this paragraph that all the biocidal products within the family comply with the conditions set out in paragraph 1.