Commentaries: Art. 7

The following types of authorisation exist for biocidal products: a.¹ authorisation A L based on a comprehensive evaluation of the biocidal product: for biocidal products which: 1. contain at least one active substance listed in Annex 2, and otherwise contain only active substances that are listed in Annex 1, or 2. contain only active substances listed in Annex 1 but are not eligible for the simplified authorisation procedure under Article 25 letters c and d of Regulation (EU) No 528/2012²; b.³ authorisation A nL based on a comprehensive evaluation of the biocidal product and its active substances: for biocidal products containing at least one active substance which is not listed either in Annex 1 or in Annex 2 or included in the list of notified active substances for use in biocidal products referred to in Annex II of Regulation (EU) No 1062/2014⁴(list of notified active substances); c. authorisation A N : for biocidal products: 1. containing at least one active substance included in the list of notified active substances but for which a decision on listing in Annex 1 or 2 is still outstanding, and 2. whose other active substances are included in one of these lists; d. authorisation A C (confirmation) based on a summary procedure: for biocidal products: 1. containing at least one active substance included in the list of notified active substances but for which a decision on listing in Annex 1 or 2 is still outstanding, 2. whose other active substances are included in one of these lists, 3. for which an application for authorisation ACwas submitted to the Notification Authority no later than 31 July 2006, and 4. which are still on the market when the Amendment of 20 June 2014 to this Ordinance comes into force; e.⁵ derogations : for biocidal products used to deal with exceptional situations; f. simplified authorisation : for biocidal products which are eligible for the simplified procedure in accordance with Article 25 of Regulation (EU) No 528/2012⁶; g. recognition : for biocidal products: 1.⁷ which have been authorised in an EU or EFTA Member State in accordance with Article 33 of Regulation (EU) No 528/2012, or 2. for which an application has been submitted in accordance with Article 34 of Regulation (EU) No 528/2012; h. recognition of a Union authorisation : for biocidal products for which a Union authorisation has been granted by the European Commission; i. authorisation of the same biocidal products : for biocidal products which: 1. are identical to biocidal products already authorised, and 2. are placed on the market by the authorisation holder or by third parties under the same terms and conditions as the biocidal products already authorised; j.⁸ authorisation for parallel trade : for biocidal products : 1. that are authorised in an EU or EFTA member state and are identical to a biocidal product that has been granted authorisation ZLor recognition in Switzerland, or 2. that are placed on the market in an EU or EFTA member state in accordance with the national provisions and are identical to a biocidal product that has been granted authorisation ZNor ZBin Switzerland.
Unless otherwise indicated by a provision of this Ordinance,authorisation in this Ordinance is to be understood as referring to all the types of authorisation listed in paragraph 1.

Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817). ↩
See footnote to Art. 1b para. 3. ↩
Amended by No I of the FOPH O of the of 5 Sept. 20232019, in force since 1 Oct. 2023 (AS 2023 518). ↩
Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council, OJ L 294 of 10 October 2014, p. 1; last amended by Delegated Regulation (EU) 2022/825, OJ L 147 of 30.5.2022, p. 3. ↩
Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817). ↩
See footnote to Art. 1b para. 3. ↩
Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817). ↩
Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817). ↩

Art. 7

Footnotes