CELEX: 32021R0345
Language: en
Date: 2021-02-25 00:00:00
Title: 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)

26.2.2021   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 68/163
               
            
         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)
         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 active chlorine generated from sodium chloride by electrolysis.
                  
               
                     (2)
                  
                  
                     Active chlorine generated from sodium chloride by electrolysis has been evaluated for use in biocidal products of 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, and product-type 5, drinking water disinfectants as defined in Annex V to Directive 98/8/EC of the European Parliament and of the Council (3), which correspond respectively to product-types 2, 3, 4 and 5 as defined in Annex V to Regulation (EU) No 528/2012.
                  
               
                     (3)
                  
                  
                     Slovakia was designated as the rapporteur Member State and its evaluating competent authority submitted the assessment reports together with its conclusions to the Commission on 19 November 2010.
                  
               
                     (4)
                  
                  
                     In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the Biocidal Products Committee adopted the opinions of the European Chemicals Agency (4) (‘the Agency’) on 16 June 2020, having regard to the conclusions of the evaluating competent authority.
                  
               
                     (5)
                  
                  
                     According to those opinions, biocidal products of product-types 2, 3, 4 and 5 using active chlorine generated from sodium chloride by electrolysis may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC, provided that certain specifications and conditions concerning their use are complied with.
                  
               
                     (6)
                  
                  
                     Taking into account the opinions of the Agency, it is appropriate to approve active chlorine generated from sodium chloride by electrolysis for use in biocidal products of product-types 2, 3, 4 and 5 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
            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
            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, 25 February 2021.
            
               
                  For the Commission
               
               
                  The President
               
               Ursula VON DER LEYEN
            
         
         
            (1)  OJ L 167, 27.6.2012, p. 1.
         
            (2)  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).
         
            (3)  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).
         
            (4)  Biocidal Products Committee Opinion on the application for approval of the active substance active chlorine generated from sodium chloride by electrolysis, Product type: 2, 3, 4 and 5, ECHA/BPC/251, 252, 253, 254, adopted on 16 June 2020.
      
      
         
            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).