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: the active substances are 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 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; 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 of 8 February 1993 laying down Community procedures for contaminants in food OJ L 37, 13.2.1993, p. 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 OJ L 338, 13.11.2004, p. 4. , 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 OJ L 70, 16.3.2005, p. 1. , 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 OJ L 152, 16.6.2009, p. 11. or Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed OJ L 140, 30.5.2002, p. 10. ; where nanomaterials are used in that product, the risk to human health, animal health and the environment has been assessed separately.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.