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Commission Implementing Regulation (EU) 2024/247 of 16 January 2024 approving trihydrogen pentapotassium di(peroxomonosulfate) di(sulfate) as an existing active substance for use in biocidal products of product-types 2, 3, 4 and 5 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Type Implementing Regulation

Publication 2024-01-17

State In force

Text As published

Department European Commission, SANTE

Source EUR-Lex

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Image omitted; see official source	Official Journal of the European Union	EN Series L

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	2024/247	17.1.2024

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 Article 89(1), third subparagraph, 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 pentapotassium bis(peroxymonosulfate)bis(sulfate) (CAS No: 70693-62-8) for product-types 2, 3, 4 and 5.

(2) Pentapotassium bis(peroxymonosulfate)bis(sulfate) has been evaluated for use in biocidal products of product-types 2 (disinfectants and algaecides not intended for direct application to humans or animals), 3 (veterinary hygiene), 4 (food and feed area) and 5 (drinking water), as described in Annex V to Regulation (EU) No 528/2012.

(3) Slovenia was designated as the rapporteur Member State and its evaluating competent authority submitted the assessment reports together with their conclusions to the European Chemicals Agency (‘the Agency’) on 23 September 2022. The Agency discussed the assessment reports and the conclusions in technical meetings.

(4) During the examination of pentapotassium bis(peroxymonosulfate)bis(sulfate), the name of that active substance has been corrected by the Agency to trihydrogen pentapotassium di(peroxomonosulfate) di(sulfate).

(5) In accordance with Article 75(1), second subparagraph, point (a), of Regulation (EU) No 528/2012, the Biocidal Products Committee prepares the opinion of the Agency regarding the applications for approval of active substances. In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014 read in conjunction with Article 75(1) and (4) of Regulation (EU) No 528/2012, the Biocidal Products Committee adopted the opinions of the Agency on 6 June 2023 ³, having regard to the conclusions of the evaluating competent authority. In those opinions, the Agency concludes that biocidal products of product-types 2, 3, 4 and 5 containing trihydrogen pentapotassium di(peroxomonosulfate) di(sulfate) may be expected to satisfy the criteria laid down in Article 19(1), point (b), of Regulation (EU) No 528/2012, provided that certain conditions concerning their use are complied with.

(6) Taking into account the opinions of the Agency, it is appropriate to approve trihydrogen pentapotassium di(peroxomonosulfate) di(sulfate) as an active substance for use in biocidal products of product-types 2, 3, 4 and 5 subject to compliance with certain 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

Trihydrogen pentapotassium di(peroxomonosulfate) di(sulfate) is approved as an active substance for use in biocidal products of product-types 2, 3, 4 and 5, subject to the 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, 16 January 2024.

For the Commission

The President

Ursula VON DER LEYEN

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).

Biocidal Products Committee Opinions on the application for approval of the active substance trihydrogen pentapotassium di(peroxomonosulfate) di(sulfate), Product-types 2, 3, 4 and 5; ECHA/BPC/377/2023, ECHA/BPC/378/2023, ECHA/BPC/379/2023 and ECHA/BPC/380/2023, adopted on 6 June 2023.

ANNEX

Common Name	IUPAC Name Identification Numbers	Minimum degree of purity of the active substance⁴	Date of approval	Expiry date of approval	Product type	Specific conditions
Trihydrogen pentapotassium di(peroxomonosulfate) di(sulfate)	Pentapotassium bis((hydroperoxysulfonyl)oxidanide) hydrogen sulfate sulfate EC No: 274-778-7 CAS No: 70693-62-8	≥ 890 g/kg (≥ 89 % w/w) dipotassium peroxydisulphate (relevant impurity): ≤ 20 g/kg (≤ 2 % w/w)	1 July 2025	30 June 2035	2	The authorisation of biocidal products is subject to the following conditions: (1) 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; (2) the product assessment shall pay particular attention to: (i) professional users; (ii) non-professional users; (iii) surface water due to chronic emission following private swimming pool disinfection.
Trihydrogen pentapotassium di(peroxomonosulfate) di(sulfate)	Pentapotassium bis((hydroperoxysulfonyl)oxidanide) hydrogen sulfate sulfate EC No: 274-778-7 CAS No: 70693-62-8	≥ 890 g/kg (≥ 89 % w/w) dipotassium peroxydisulphate (relevant impurity): ≤ 20 g/kg (≤ 2 % w/w)	1 July 2025	30 June 2035	3	The authorisation of biocidal products is subject to the following conditions: (1) 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; (2) the product assessment shall pay particular attention to professional users.
Trihydrogen pentapotassium di(peroxomonosulfate) di(sulfate)	Pentapotassium bis((hydroperoxysulfonyl)oxidanide) hydrogen sulfate sulfate EC No: 274-778-7 CAS No: 70693-62-8	≥ 890 g/kg (≥ 89 % w/w) dipotassium peroxydisulphate (relevant impurity): ≤ 20 g/kg (≤ 2 % w/w)	1 July 2025	30 June 2035	4	The authorisation of biocidal products is subject to the following conditions: (1) 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; (2) the product assessment shall pay particular attention to professional users.
Trihydrogen pentapotassium di(peroxomonosulfate) di(sulfate)	Pentapotassium bis((hydroperoxysulfonyl)oxidanide) hydrogen sulfate sulfate EC No: 274-778-7 CAS No: 70693-62-8	≥ 890 g/kg (≥ 89 % w/w) dipotassium peroxydisulphate (relevant impurity): ≤ 20 g/kg (≤ 2 % w/w)	1 July 2025	30 June 2035	5	The authorisation of biocidal products is subject to the following conditions: (1) 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; (2) the product assessment shall pay particular attention to professional users.

The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.

ELI: http://data.europa.eu/eli/reg_impl/2024/247/oj

ISSN 1977-0677 (electronic edition)

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