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Commission Implementing Decision (EU) 2020/2124Show full title
Commission Implementing Decision (EU) 2020/2124 of 9 December 2020 not granting a Union authorisation for the biocidal product family ‘Contec Hydrogen Peroxide’ (notified under document C(2020) 8394) (Only the English text is authentic)
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Commission Implementing Decision (EU) 2020/2124
of 9 December 2020
not granting a Union authorisation for the biocidal product family ‘Contec Hydrogen Peroxide’
(notified under document C(2020) 8394)
(Only the English text is authentic)
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) thereof,
Whereas:
(1) On 25 January 2017, Contec Cleanroom (UK) Ltd. submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘Contec Hydrogen Peroxide’ of product-type 2, as described in Annex V to that Regulation, providing written confirmation that the competent authority of United Kingdom had agreed to evaluate the application. On 25 March 2019, Contec Europe took over as prospective authorisation holder, due to the withdrawal of the United Kingdom from the European Union, and the competent authority of Slovenia accepted to take over the role of the evaluating Competent Authority, as of 1 February 2020. The application was recorded under case number BC-GN057178-26 in the Register for Biocidal Products.
(2) ‘Contec Hydrogen Peroxide’ contains hydrogen peroxide, as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012.
(3) On 28 August 2019, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).
(4) On 7 April 2020, the Agency submitted to the Commission an opinion(2) on ‘Contec Hydrogen Peroxide’ in accordance with Article 44(3) of Regulation (EU) No 528/2012.
(5) The opinion concludes that ‘Contec Hydrogen Peroxide’ is a ‘biocidal product family’ within the meaning of Article 3(1)(s) of Regulation (EU) No 528/2012, but does not meet the condition laid down in Article 19(1)(b)(i) of that Regulation.
(6) According to the opinion of the Agency, the applicant has not demonstrated that ‘Contec Hydrogen Peroxide’ is sufficiently effective, due to inconsistencies within the submitted efficacy studies, which did not prove that all relevant criteria are met.
(7) The Commission concurs with the opinion of the Agency and considers it therefore appropriate not to grant a Union authorisation for ‘Contec Hydrogen Peroxide’.
(8) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products,
HAS ADOPTED THIS DECISION:
Article 1U.K.
A Union authorisation is not granted to Contec Europe for the making available on the market and use of the biocidal product family ‘Contec Hydrogen Peroxide’.
Article 2U.K.
This Decision is addressed to Contec Europe, Zl du Prat, Avenue Paul Dupleix, 56000 Vannes, France.
Done at Brussels, 9 December 2020.
For the Commission
Stella Kyriakides
Member of the Commission
(2)
ECHA opinion on the Union authorisation of the biocidal product family ‘Contec Hydrogen Peroxide’, ECHA/BPC/248/2020, adopted on 5 March 2020, https://echa.europa.eu/bpc-opinions-on-union-authorisation
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