LegalizeCommission Implementing Regulation (EU) 2015/1729 of 28 September 2015 approving potassium sorbate as an existing active substance for use in biocidal products for product-type 8 (Text with EEA relevance)
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| 29.9.2015 | EN | Official Journal of the European Union | L 252/24 |
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 third subparagraph of Article 89(1) thereof,
Whereas:
- (1) Commission Delegated Regulation (EU) No 1062/2014 2 establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes potassium sorbate.
- (2) Potassium sorbate has been evaluated in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council 3 for use in product-type 8, wood preservatives, as defined in Annex V to that Directive, which corresponds to product-type 8, as defined in Annex V to Regulation (EU) No 528/2012.
- (3) Germany was designated as evaluating competent authority and submitted the assessment report, together with its recommendations, to the Commission on 10 October 2010 in accordance with paragraphs 4 and 6 of Article 14 of Commission Regulation (EC) No 1451/2007 4.
- (4) In accordance with Article 7(1)(b) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 4 December 2014 by the Biocidal Product Committee, having regard to the conclusions of the evaluating competent authority.
- (5) According to that opinion, biocidal products used for product-type 8 and containing potassium sorbate may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC provided that certain conditions concerning its use are complied with.
- (6) It is therefore appropriate to approve potassium sorbate for use in biocidal products for product-type 8 subject to compliance with certain specifications and conditions.
- (7) 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.
- (8) 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
Potassium sorbate is approved as an active substance for use in biocidal products for product-type 8, subject to the specifications and conditions set out in the Annex.
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, 28 September 2015.
For the Commission
The President
Jean-Claude JUNCKER
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).
Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).
ANNEX
| Common Name | IUPAC Name Identification Numbers | Minimum degree of purity of the active substance5 | Date of approval | Expiry date of approval | Product type | Specific conditions |
|---|---|---|---|---|---|---|
| Potassium sorbate | IUPAC Name: 2,4-Hexadienoic acid, potassium salt (1:1), (2E, 4E) EC No: 246-376-1 CAS No: 24634-61-5 | 990 g/kg | 1 December 2016 | 30 November 2026 | 8 | The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. The authorisations of biocidal products are subject to the following conditions: (1) For industrial or professional users, safe operational procedures and appropriate organizational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. (2) Appropriate risk mitigation measures shall be taken to protect the groundwater. In particular labels and, where provided, safety data sheets of products shall indicate that: a. industrial application shall be conducted within a contained area or on impermeable hard standing with bunding; b. freshly treated timber shall be stored after treatment under shelter or on impermeable hard standing, or both, to prevent direct losses to soil or water; c. any losses from the application of the product shall be collected for reuse or disposal. |
The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 16(2) of Directive 98/8/EC. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.
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