813.12OBPFederal Council OrdinanceAug 1, 2005Original source
A biocidal product family must be assessed according to the common principles specified in Annex VI to Regulation (EU) No 528/20121. The assessment must consider the maximum risks to human health, animal health and the environment and the minimum level of efficacy over the whole potential range of products within the biocidal product family.
A biocidal product family shall only be authorised if:
a. the following are explicitly identified in the application:
1. the maximum risks to human health, animal health and the environment, and the minimum level of efficacy, on which the applicant’s assessment is based, and
2. the permitted variations in composition and uses referred to in Article 2 paragraph 2 letter b, together with the respective classification, hazard and precautionary statements and any appropriate risk mitigation measures; and
b. it is evident from the assessment referred to in paragraph 1 that all the biocidal products within the family comply with the conditions specified in Article 11.