Directive 98/8/EC of the European Parliament and of the Council (repealed)Show full title

Article 5 Conditions for issue of an authorisation

1. Member States shall authorise a biocidal product only if

(a) the active substance(s) included therein are listed in Annex I or IA and any requirements laid down in these Annexes are fulfilled;

(b) it is established, in the light of current scientific and technical knowledge, and is shown from appraisal of the dossier provided for in Article 8, according to the common principles for the evaluation of dossiers as laid down in Annex VI, that, when used as authorised and having regard to:

• (b) all normal conditions under which the biocidal product may be used,

• how the material treated with it may be used,

• the consequences from use and disposal,

the biocidal product:

(i)

(b) is sufficiently effective,

(ii)

has no unacceptable effects on the target organisms, such as unacceptable resistance or cross-resistance or unnecessary suffering and pain for vertebrates,

(iii)

has no unacceptable effects itself or as a result of its residues, on human or animal health, directly or indirectly (e.g. through drinking water, food or feed, indoor air or consequences in the place of work) or on surface water and groundwater,

(iv)

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

• its fate and distribution in the environment; particularly contamination of surface waters (including estuarian and seawater), groundwater and drinking water,

• its impact on non-target organisms;

(c) the nature and quantity of its active substances and, where appropriate, any toxicologically or ecotoxicologically significant impurities and co-formulants, and its residues of toxicological or environmental significance, which result from authorised uses, can be determined according to the relevant requirements in Annex IIA, IIB, IIIA, IIIB, IVA or IVB;

(d) its physical and chemical properties have been determined and deemed acceptable for purposes of the appropriate use, storage and transport of the product.

2. A biocidal product classified according to Article 20(1) as toxic, very toxic or as a category 1 or 2 carcinogen, or as a category 1 or 2 mutagen or classified as toxic for reproduction category 1 or 2, shall not be authorised for marketing to, or use by the general public.

3. Authorisation may be conditional on, and must stipulate the conditions relating to marketing and use necessary to ensure compliance with the provisions of paragraph 1.

4. Where other Community provisions impose requirements relevant to the conditions for the issue of an authorisation and for use of the biocidal product, and particularly where these are intended to protect the health of distributors, users, workers and consumers or animal health or the environment, the competent authority shall take these into account when issuing an authorisation and where necessary shall issue the authorisation subject to those requirements.