Regulation 5 Applications concerning new active substances
A person who applies to the Ministers for the inclusion of a new active substance in Annex I, IA or IB shall submit to the Ministers—
(a)
a dossier relating to the new active substance satisfying the requirements of—
(i)
Annex IVA, where the new active substance in question is a micro-organism, or
(ii)
Annexes IIA and IIIA, where the new active substance in question is not a micro-oganism;
(b)
a dossier satisfying the requirements of regulation 9(4) to (6) for at least one biocidal product containing the new active substance; and
(c)
a declaration that the new active substance is intended for inclusion in a biocidal product.