813.12OBPFederal Council OrdinanceAug 1, 2005Original source
In the examination of an application for authorisation of a biocidal product containing an active substance which is a candidate for substitution, the assessment authorities shall perform a comparative assessment in accordance with Article 23 of Regulation (EU) No 528/20121as part of the evaluation specified in Article 17.
The Notification Authority, in consultation with the assessment authorities, shall prohibit or restrict the placing on the market or the professional or commercial use of a biocidal product containing an active substance which is a candidate for substitution if the comparative assessment demonstrates that:
for the uses specified in the application, another authorised biocidal product or a non-chemical control or prevention method already exists which presents a significantly lower overall risk for human health, animal health and the environment, is sufficiently effective and presents no other significant economic or practical disadvantages; and
the chemical diversity of the active substances is adequate to minimise the occurrence of resistance in the harmful organism.
By way of derogation from paragraphs 1 and 2, a biocidal product may, in exceptional cases, be authorised without a comparative assessment if it is necessary to acquire experience first through using the product in practice.