CELEX: 32021D1283
Language: en
Date: 2021-08-02 00:00:00
Title: Commission Implementing Decision (EU) 2021/1283 of 2 August 2021 on the non-approval of certain active substances in biocidal products pursuant to Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)

3.8.2021   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 279/32
               
            
         COMMISSION IMPLEMENTING DECISION (EU) 2021/1283
         of 2 August 2021
         on the non-approval of certain active substances in biocidal products pursuant to Regulation (EU) No 528/2012 of the European Parliament and of the Council
         (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 in its Annex II a list of active substance/product-type combinations included in the review programme of existing active substances in biocidal products on 30 March 2019.
                  
               
                     (2)
                  
                  
                     For a number of active substance/product-type combinations included in that list, all the participants have withdrawn or are considered to have withdrawn their support in a timely manner.
                  
               
                     (3)
                  
                  
                     In accordance with Article 14(1) of Delegated Regulation (EU) No 1062/2014, the European Chemicals Agency (‘the Agency’) published an open invitation to take over the role of participant for those active substance/product-type combinations for which the role of participant had not previously been taken over. For some of those combinations no notification has been submitted or the notification has been rejected pursuant to Article 17(4) or (5) of that Regulation. Those active substance/product-type combinations which, in accordance with Article 20, first paragraph, point (b), of Delegated Regulation (EU) No 1062/2014, should not be approved for use in biocidal products are the following: metam-sodium (product-types 9 and 11); thiram (product-type 9); bronopol (product-type 9); peroxyoctanoic acid (product-type 2, 3, 4); Malt, ext. – Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Hordeum, Gramineae (product-type 19); 2,2-Dibromo-2-cyanoacetamide (product-type 13).
                  
               
                     (4)
                  
                  
                     In addition, in accordance with Article 12(3) of Delegated Regulation (EU) No 1062/2014, the Agency informed the Commission of those active substance/product-type combinations for which all participants have withdrawn or are considered to have withdrawn their support in a timely manner, and for which the role of participant had previously been taken over. Those active substance/product-type combinations which, in accordance with Article 20, first paragraph, point (a), of that Regulation, should not be approved for use in biocidal products are the following: silver, as a nanomaterial (product-types 2, 4, 9); Eucalyptus citriodora oil and citronellal, hydrated, cyclized (product-type 19); 2-Hydroxy-α,α,4-trimethylcyclohexanemethanol (product-type 19); chlorine dioxide generated from sodium chlorite and sodium persulfate (product-types 2, 3, 4, 5, 11); amines, C10-16-alkyldimethyl, N-oxides (product-type 4); Capsicum oleoresin (product-type 19); Capsicum annuum, ext. (product-type 19); reaction mass of (6E)-N-(4-hydroxy-3-methoxy-2-methylphenyl)-8-methylnon-6-enamide and N-(4-hydroxy-3-methoxy-2-methylphenyl)-8- methylnonanamide (product-type 19).
                  
               
                     (5)
                  
                  
                     The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products,
                  
               HAS ADOPTED THIS DECISION:
         
            Article 1
            The active substances listed in the Annex are not approved for the product-types indicated therein.
         
         
            Article 2
            This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
         
         
            Done at Brussels, 2 August 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).
      
      
         
            ANNEX
            Active substance/product-type combinations not approved:
            
                        Entry Number in Annex II to Regulation (EU) No 1062/2014
                     
                     
                        Substance name
                     
                     
                        Rapporteur Member State
                     
                     
                        EC number
                     
                     
                        CAS number
                     
                     
                        Product-type(s)
                     
                  
                        9
                     
                     
                        Bronopol
                     
                     
                        ES
                     
                     
                        200-143-0
                     
                     
                        52-51-7
                     
                     
                        9
                     
                  
                        206
                     
                     
                        Thiram
                     
                     
                        BE
                     
                     
                        205-286-2
                     
                     
                        137-26-8
                     
                     
                        9
                     
                  
                        210
                     
                     
                        Metam-sodium
                     
                     
                        BE
                     
                     
                        205-293-0
                     
                     
                        137-42-8
                     
                     
                        9, 11
                     
                  
                        1023
                     
                     
                        Silver, as a nanomaterial
                     
                     
                        SE
                     
                     
                        231-131-3
                     
                     
                        7440-22-4
                     
                     
                        2, 4, 9
                     
                  
                        494
                     
                     
                        2,2-Dibromo-2-cyanoacetamide (DBNPA)
                     
                     
                        DK
                     
                     
                        233-539-7
                     
                     
                        10222-01-2
                     
                     
                        13
                     
                  
                        1047
                     
                     
                        
                           Eucalyptus citriodora oil and citronellal, hydrated, cyclized
                     
                     
                        CZ
                     
                     
                        n/a
                     
                     
                        n/a
                     
                     
                        19
                     
                  
                        609
                     
                     
                        2-Hydroxy-α,α,4-trimethylcyclohexanemethanol
                     
                     
                        CZ
                     
                     
                        255-953-7
                     
                     
                        42822-86-6
                     
                     
                        19
                     
                  
                        813
                     
                     
                        Peroxyoctanoic acid
                     
                     
                        FR
                     
                     
                        n/a
                     
                     
                        33734-57-5
                     
                     
                        2, 3, 4
                     
                  
                        1044
                     
                     
                        Chlorine dioxide generated from sodium chlorite and sodium persulfate
                     
                     
                        DE
                     
                     
                        n/a
                     
                     
                        n/a
                     
                     
                        2, 3, 4, 5, 11
                     
                  
                        1064
                     
                     
                        Malt, ext. Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Hordeum, Gramineae
                        
                     
                     
                        AT
                     
                     
                        232-310-9
                     
                     
                        8002-48-0
                     
                     
                        19
                     
                  
                        692
                     
                     
                        Amines, C10-16-alkyldimethyl, N-oxides
                     
                     
                        PT
                     
                     
                        274-687-2
                     
                     
                        70592-80-2
                     
                     
                        4
                     
                  
                        1059
                     
                     
                        
                           Capsicum oleoresin
                        
                        Extractives and their physically modified derivatives. It is a product which may contain resin acids and their esters, terpenes, and oxidation or polymerization products of these terpenes. (Capsicum frutescens, Solanaceae)
                     
                     
                        BE
                     
                     
                        Not available
                     
                     
                        8023-77-6
                     
                     
                        19
                     
                  
                        1060
                     
                     
                        
                           Capsicum annuum, ext.
                        Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Capsicum annuum, Solanaceae.
                     
                     
                        BE
                     
                     
                        283-403-6
                     
                     
                        84625-29-6
                     
                     
                        19
                     
                  
                        1061
                     
                     
                        Reaction mass of (6E)-N-(4-hydroxy-3-methoxy-2-methylphenyl)-8-methylnon-6-enamide and N-(4-hydroxy-3- methoxy-2-methylphenyl)-8- methylnonanamide
                     
                     
                        BE
                     
                     
                        Not available
                     
                     
                        Not available
                     
                     
                        19