Commission Implementing Regulation (EU) 2016/672
of 29 April 2016
approving peracetic acid as an existing active substance for use in biocidal products for product-types 1, 2, 3, 4, 5 and 6
(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 , and in particular the third subparagraph of Article 89(1) thereof,
Whereas:
(1)
Commission Delegated Regulation (EU) No 1062/2014 establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes peracetic acid.
(2)
Peracetic acid has been evaluated in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council for use in product-type 1, human hygiene biocidal products, product-type 2, private area and public health area disinfectants and other biocidal products, product-type 3, veterinary hygiene biocidal products, product-type 4, food and feed area disinfectants, product-type 5, drinking water disinfectants, and product-type 6, in-can preservatives, as defined in Annex V to that Directive, which correspond respectively to product-types 1, 2, 3, 4, 5 and 6 as defined in Annex V to Regulation (EU) No 528/2012.
(3)
Finland was designated as evaluating competent authority and submitted the assessment reports together with its recommendations on 16 January 2013.
(4)
In accordance with Article 7(1)(b) of Delegated Regulation (EU) No 1062/2014, the opinions of the European Chemicals Agency were formulated on 30 September 2015 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.
(5)
According to those opinions, biocidal products used for product-types 1, 2, 3, 4, 5 and 6 and containing peracetic acid may be expected to satisfy the requirements of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain conditions concerning its use are complied with.
(6)
It is therefore appropriate to approve peracetic acid for use in biocidal products for product-types 1, 2, 3, 4, 5 and 6 subject to compliance with certain specifications and conditions.
(7)
For the use in product-type 4, the evaluation did not address the incorporation of biocidal products containing peracetic acid in materials and articles intended to come into contact directly or indirectly with food within the meaning of Article 1(1) of Regulation (EC) No 1935/2004 of the European Parliament and of the Council . Such materials may require the establishment of specific limits on the migration into food, as referred to in Article 5(1)(e) of that Regulation. The approval should therefore not cover such use unless the Commission has established such limits or it has been established pursuant to that Regulation that such limits are not necessary.
(8)
Peracetic acid is in an aqueous solution containing acetic acid and hydrogen peroxide. Due to the presence of hydrogen peroxide, which can be used in the production of explosive precursors, Regulation (EU) No 98/2013 of the European Parliament and of the Council should continue to apply to hydrogen peroxide.
(9)
A reasonable period should be allowed to elapse before an active substance is approved, in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.
(10)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,
HAS ADOPTED THIS REGULATION:
OJ L 167, 27.6.2012, p. 1.
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, 10.10.2014, p. 1).
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).
Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).
Regulation (EU) No 98/2013 of the European Parliament and of the Council of 15 January 2013 on the marketing and use of explosives precursors (OJ L 39, 9.2.2013, p. 1).