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Commission Implementing Regulation (EU) 2021/345 of 25 February 2021 approving active chlorine generated from sodium chloride by electrolysis as an active substance for use in biocidal products of product types 2, 3, 4 and 5 (Text with EEA relevance)

Implementing Regulation (EU) 2021/345 · Regulation · 3 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

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Active chlorine generated from sodium chloride by electrolysis is approved as an active substance for use in biocidal products of product-types 2, 3, 4 and 5 subject to the specifications and conditions set out in the Annex.

Article 2

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

Supplementary provisions

ANNEXSupplementary provisions

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ANNEX Common Name IUPAC Name Identification Numbers Minimum degree of purity of the active substance ( 1 ) Date of approval Expiry date of approval Product type Specific conditions Active chlorine generated from sodium chloride by electrolysis IUPAC name: not applicable EC No: not applicable CAS No: not applicable Precursor: IUPAC Name: Sodium Chloride EC No 231-598-3 CAS No 7647-14-5 The specification for active chlorine generated in situ is dependent on the precursor sodium chloride which must comply with purity requirements of one of the following standards: NF Brand, EN 973 A, EN 973 B, EN 14805 Type 1, EN 14805 Type 2, EN 16370 Type 1, EN 16370 Type 2, EN 16401 Type 1, EN 16401 Type 2, CODEX STAN 150-1985 or European Pharmacopoeia 9.0. 1 July 2022 30 June 2032 2 The authorisations of biocidal products are subject to the following conditions: (a) 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; (b) the product assessment shall pay particular attention to the protection of professional users for hard surface disinfection via mopping or wiping. 3 The authorisations of biocidal products are subject to the following conditions: (a) 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; (b) for products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 ( 2 ) or Regulation (EC) No 396/2005 ( 3 ) shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded. 4 The authorisations of biocidal products are subject to the following conditions: (a) 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; (b) for products that may lead to residues in food or feed, the need to set new or to amend existing MRLs in accordance with Regulation (EC) No 470/2009 or Regulation (EC) No 396/2005 shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded. 5 The authorisations of biocidal products are subject to the following conditions: (a) 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; (b) for products that may lead to residues in food or feed, the need to set new or to amend existing MRLs in accordance with Regulation (EC) No 470/2009 or Regulation (EC) No 396/2005 shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded. ( 1 ) The purity requirements for the precursor indicated in this column are those provided in the application for the approval of the active substance evaluated. ( 2 ) Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council ( OJ L 152, 16.6.2009, p. 11 ). ( 3 ) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC ( OJ L 70, 16.3.2005, p. 1 ).

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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