Commission Implementing Regulation (EU) 2021/977 of 7 June 2021 amending Implementing Regulation (EU) 2019/1844 to make administrative changes to the Union authorisation of the biocidal product family ‘BPF_Iodine_VET’ (Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the first subparagraph of Article 44(5) and Article 50(2) thereof,

Whereas:

(1) On 22 October 2019, Commission Implementing Regulation (EU) 2019/1844 (2) granted a Union authorisation with authorisation number EU-0020540-0000 to Applied Biocide GmbH for the making available on the market and use of the biocidal product family ‘BPF_Iodine_VET’.

(2) On 10 April 2020, Applied Biocide GmbH submitted a notification to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013 (3), regarding administrative changes to the Union authorisation for the biocidal product family ‘BPF_Iodine_VET’ as referred to in Sections 1 and 2 of Title 1 of the Annex to that Regulation.

(3) Applied Biocide GmbH proposed the changes in the names of the manufacturers of the biocidal products in the first information level, administrative information, the changes in the names of one product in the third information level in meta-SPC 2 and one product in meta-SPC 6 and the addition of trade names for the individual products in meta SPCs 2 and 5, in the summary of the product characteristics for the biocidal product family ‘BPF_Iodine_VET’ as set out in the Annex to Implementing Regulation (EU) 2019/1844. The notification was recorded under the case number BC-VD058524-35 in the Register for Biocidal Products.

(4) On 9 June 2020, the Agency submitted an opinion (4) on the proposed changes to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013. The opinion concludes that the amendments to the existing authorisation sought by the authorisation holder fall under Article 50(3)(a) of Regulation (EU) No 528/2012, and that after the implementation of the changes the conditions of Article 19 of that Regulation are still met. On the same date, the Agency transmitted to the Commission the revised summary of the biocidal product characteristics in all the official languages of the Union in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.

(5) The Commission concurs with the opinion of the Agency and therefore considers it appropriate to amend the Union authorisation of the biocidal product family ‘BPF_Iodine_VET’.

(6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Implementing Regulation (EU) 2019/1844 is replaced by the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 7 June 2021.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 167, 27.6.2012, p. 1.

(2) Commission Implementing Regulation (EU) 2019/1844 of 22 October 2019 granting a Union authorisation for the biocidal product family BPF_Iodine_VET (OJ L 283, 5.11.2019, p. 1).

(3) Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4).

(4) ECHA opinion of 9 June 2020 on the administrative change of the Union authorisation of the biocidal product family ‘BPF_Iodine_VET’, https://echa.europa.eu/documents/10162/22836226/opinion_for_ua-admin_changes_bc-vd058524-35_en.pdf/b95474e7-89d4-a601-8d02-b42d95cecde5