Commentaries: Art. 11

Without prejudice to Article 11g , a biocidal product shall be granted authorisation ALor AnLif the following conditions are met: a. It is established, according to the common principles specified in Annex VI to Regulation (EU) No 528/2012¹, that: 1. the biocidal product is sufficiently effective; 2. it has no unacceptable effects on target organisms, such as unacceptable resistance or cross-resistance, or unnecessary suffering or pain for vertebrates; 3. no immediate or delayed unacceptable effects are to be expected, from the biocidal product or its residues, on the health of humans, and in particular that of vulnerable groups, or animals, either directly or indirectly, through drinking water, food, feed, air, or through other indirect effects; and 4. no unacceptable effects are to be expected, from the biocidal product or its residues, on the environment, having particular regard to the following considerations: – the fate and distribution of the biocidal product in the environment, – contamination of surface waters (including estuarial and seawater), groundwater and drinking water, air and soil, taking into account locations distant from its use following long-range environmental transportation, – the impact of the biocidal product on non-target organisms, – the impact of the biocidal product on biodiversity and the ecosystem. b.² The chemical identity, quantity and technical equivalence of active substances in the biocidal product and, where appropriate, any toxicologically or ecotoxicologically significant and relevant impurities and non-active substances, and its residues of toxicological or environmental significance, which result from uses to be authorised, can be determined using analytical methods referred to in Annexes II and III to Regulation (EU) No 528/2012. c. The physical and chemical properties are acceptable for purposes of use, transport and storage. d. The risk to human health and the environment posed by nanomaterials used in the biocidal product has been assessed separately. e. Existing or, where appropriate, newly specified maximum concentrations, maximum residue levels or specific migration limits in or on food or feed, in accordance with the following provisions, are complied with: 1. Article 49 paragraphs 3 and 4 letter c and 10 paragraph 4 letter e FUO³; 2. Article 36 paragraph 1 of the FsO⁴.
Biocidal products with active substances listed in Annex 1 or 2 must additionally meet the requirements specified for the active substances in these lists.
If biocidal products contain active substances which are not listed in Annex 1 or 2 or included in the list of notified active substances, the active substances must meet the requirements specified in Articles 4 and 5 of Regulation (EU) No 528/2012.
Biocidal products intended for direct application to the human body may only contain non-active substances designated by the FDHA as permissible for the category concerned in accordance with Article 54 FUO.⁵This does not exclude the presence of technically unavoidable residues, provided that they do not pose a health risk.
Biocidal products consisting of or containing genetically modified organisms must meet the requirements of the RO⁶.

See footnote to Art. 1b para. 3. ↩
Amended by No I of the O of 5 June 2015, in force since 1 July 2015 (AS 2015 1985). ↩
SR 817.02 . The reference was amended on 1 May 2017 pursuant to Art. 12 para. 2 of the Publications Act of 18 June 2004 (SR 170.512 ). ↩
SR 916.307 ↩
The reference was amended on 1 May 2017 pursuant to Art. 12 para. 2 of the Publications Act of 18 June 2004 (SR 170.512 ). ↩
SR 814.911 ↩

Art. 11

Footnotes