Regulations 9(2), (6) and (10), 10(2), (6) and (11), 11(4) and (7), 12(4) and (9), 13(2) and (7), 14(2) and (8), 19(2) and (6) and 20(3) and Schedules 6 and 7
SCHEDULE 3Determinations of the Executive
1. Subject to paragraph 2, the Executive has determined that the biocidal product satisfies the following requirements, namely—
(a)the biocidal product is sufficiently effective;
(b)the biocidal product has no unacceptable effects on the target organisms, such as unacceptable resistance, cross-resistance, or unnecessary suffering and pain for vertebrates;
(c)the biocidal product and its residues, have no unacceptable effects on human or animal health, surface water or groundwater, whether directly or indirectly; and
(d)the biocidal product and its residues, have no unacceptable effects on the environment, having particular regard to—
(i)its fate and distribution in the environment, including in particular contamination of surface water (including estuarian and sea water), ground water and drinking water, and
(ii)its impact on non-target organisms.
2. In making the determinations referred to in paragraph 1, the Executive shall have regard to—
(a)current scientific and technical knowledge;
(b)the evaluation, according to the common principles for the evaluation of dossiers laid down in Annex VI, of the dossiers submitted with the application in question;
(c)all normal conditions under which the biocidal product may be used;
(d)the ways in which any material treated with the biocidal product may be used; and
(e)the consequences of use and disposal of the biocidal product.
3. The Executive has determined, according to the relevant requirements in Annexes IIA, IIB, IIIA, IIIB, IVA and IVB—
(a)the nature and quantity of—
(i)the active substance; and
(ii)where appropriate, any toxicologically or ecotoxicologically significant impurities and co-formulants,
contained in the biocidal product; and
(b)the nature and quantity of the residues of toxicological or environmental significance which would result from the uses of the biocidal product if such biocidal product were authorised or registered.
4. The Executive has determined—
(a)the physical and chemical properties of the biocidal product; and
(b)that such properties are acceptable for the purposes of the intended use, storage and transport of the biocidal product.