CELEX: 32020D1036
Language: en
Date: 2020-07-15 00:00:00
Title: Commission Implementing Decision (EU) 2020/1036 of 15 July 2020 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)

16.7.2020   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 227/68
               
            
         COMMISSION IMPLEMENTING DECISION (EU) 2020/1036
         of 15 July 2020
         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), as last amended by Commission Delegated Regulation (EU) 2019/227 (3), 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            For a number of active substance/product-type combinations included in that list, all the participants have withdrawn their support in a timely manner.
                  
               
                     (3)
                  
                  
                     The Commission was informed, in accordance with Article 12(3) of Delegated Regulation (EU) No 1062/2014, of those active substance/product-type combinations for which all participants made a timely withdrawal and for which the role of participant had previously been taken over. In accordance with point (a) of the first paragraph of Article 20 of Delegated Regulation (EU) No 1062/2014, those active substance/product-type combinations should not be approved for use in biocidal products.
                  
               
                     (4)
                  
                  
                     An open invitation was published 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 a notification has been submitted and rejected pursuant to paragraph 4 or paragraph 5 of Article 17 of Delegated Regulation (EU) No 1062/2014. In accordance with point (b) of the first paragraph of Article 20 of Delegated Regulation (EU) No 1062/2014, those active substance/product-type combinations should not be approved for use in biocidal products.
                  
               
                     (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, 15 July 2020.
            
               
                  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)  Commission Delegated Regulation (EU) 2019/227 of 28 November 2018 amending Delegated Regulation (EU) No 1062/2014 as regards certain active substances/product-type combinations for which the competent authority of the United Kingdom has been designated as the evaluating competent authority (OJ L 37, 8.2.2019, p. 1).
      
      
         
            ANNEX
            Active substance/product-type combinations not approved, including any nanomaterial forms:
            
                        Entry Number in Annex II to Regulation (EU) No 1062/2014
                     
                     
                        Substance name
                     
                     
                        Rapporteur Member State
                     
                     
                        EC number
                     
                     
                        CAS number
                     
                     
                        Product-type(s)
                     
                  
                        37
                     
                     
                        Formic acid
                     
                     
                        BE
                     
                     
                        200-579-1
                     
                     
                        64-18-6
                     
                     
                        11, 12
                     
                  
                        1025
                     
                     
                        Performic acid generated from formic acid and hydrogen peroxide
                     
                     
                        BE
                     
                     
                        n/a
                     
                     
                        n/a
                     
                     
                        3, 5, 6
                     
                  
                        1027
                     
                     
                        Peracetic acid generated from 1,3- diacetyloxypropan-2-yl acetate and hydrogen peroxide
                     
                     
                        AT
                     
                     
                        n/a
                     
                     
                        n/a
                     
                     
                        4
                     
                  
                        1028
                     
                     
                        Peracetic acid generated from tetraacetylethylenediamine (TAED) and sodium perborate monohydrate
                     
                     
                        AT
                     
                     
                        n/a
                     
                     
                        n/a
                     
                     
                        3
                     
                  
                        1029
                     
                     
                        Peracetic acid generated by perhydrolysis of N-acetylcaprolactam by hydrogen peroxide in alkaline conditions
                     
                     
                        AT
                     
                     
                        n/a
                     
                     
                        n/a
                     
                     
                        2
                     
                  
                        85
                     
                     
                        Symclosene
                     
                     
                        DE
                     
                     
                        201-782-8
                     
                     
                        87-90-1
                     
                     
                        12
                     
                  
                        195
                     
                     
                        Sodium 2-biphenylate
                     
                     
                        ES
                     
                     
                        205-055-6
                     
                     
                        132-27-4
                     
                     
                        4, 6, 7, 9, 10, 13
                     
                  
                        253
                     
                     
                        Tetrahydro-3,5-dimethyl-1,3,5-thiadiazine-2-thione (Dazomet)
                     
                     
                        BE
                     
                     
                        208-576-7
                     
                     
                        533-74-4
                     
                     
                        6, 12
                     
                  
                        346
                     
                     
                        Sodium dichloroisocyanurate dihydrate
                     
                     
                        DE
                     
                     
                        220-767-7
                     
                     
                        51580-86-0
                     
                     
                        12
                     
                  
                        345
                     
                     
                        Troclosene sodium
                     
                     
                        DE
                     
                     
                        220-767-7
                     
                     
                        2893-78-9
                     
                     
                        12
                     
                  
                        359
                     
                     
                        Formaldehyde released from (Ethylenedioxy)dimethanol (Reaction products of ethylene glycol with paraformaldehyde (EGForm))
                     
                     
                        PL
                     
                     
                        222-720-6
                     
                     
                        3586-55-8
                     
                     
                        2
                     
                  
                        382
                     
                     
                        Tetrahydro-1,3,4,6-tetrakis(hydroxymethyl)imidazo[4,5-d]imidazole-2,5 (1H,3H)-dione (TMAD)
                     
                     
                        ES
                     
                     
                        226-408-0
                     
                     
                        5395-50-6
                     
                     
                        2
                     
                  
                        1035
                     
                     
                        Active bromine generated from ozone and bromide of natural water and sodium bromide
                     
                     
                        NL
                     
                     
                        n/a
                     
                     
                        n/a
                     
                     
                        2
                     
                  
                        1036
                     
                     
                        Hydrogen peroxide released from sodium percarbonate
                     
                     
                        FI
                     
                     
                        n/a
                     
                     
                        n/a
                     
                     
                        5
                     
                  
                        473
                     
                     
                        Pyrethrins and Pyrethroids
                     
                     
                        ES
                     
                     
                        232-319-8
                     
                     
                        8003-34-7
                     
                     
                        18, 19
                     
                  
                        1041
                     
                     
                        Chlorine dioxide generated from sodium chloride by electrolysis
                     
                     
                        DE
                     
                     
                        n/a
                     
                     
                        n/a
                     
                     
                        2, 3, 4, 5, 11, 12
                     
                  
                        1044
                     
                     
                        Chlorine dioxide generated from sodium chlorite and sodium persulfate
                     
                     
                        DE
                     
                     
                        n/a
                     
                     
                        n/a
                     
                     
                        12
                     
                  
                        597
                     
                     
                        1-[2-(Allyloxy)-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole (Imazalil)
                     
                     
                        DE
                     
                     
                        252-615-0
                     
                     
                        35554-44-0
                     
                     
                        3
                     
                  
                        939
                     
                     
                        Active chlorine generated from sodium chloride by electrolysis
                     
                     
                        SK
                     
                     
                        n/a
                     
                     
                        n/a
                     
                     
                        12
                     
                  
                        1052
                     
                     
                        Active chlorine generated from magnesium chloride hexahydrate by electrolysis
                     
                     
                        FR
                     
                     
                        n/a
                     
                     
                        n/a
                     
                     
                        2
                     
                  
                        1053
                     
                     
                        Active chlorine generated from potassium chloride by electrolysis
                     
                     
                        DK
                     
                     
                        n/a
                     
                     
                        n/a
                     
                     
                        2, 4
                     
                  
                        1055
                     
                     
                        Active chlorine generated from sodium chloride and pentapotassium bis(peroxymonosulfate)bis(sulfate) (KPMS) and sulfamic acid
                     
                     
                        SI
                     
                     
                        n/a
                     
                     
                        n/a
                     
                     
                        2, 3
                     
                  
                        1056
                     
                     
                        Active chlorine generated from hydrochloric acid by electrolysis
                     
                     
                        SI
                     
                     
                        n/a
                     
                     
                        n/a
                     
                     
                        2, 4, 5
                     
                  
                        731
                     
                     
                        
                           Chrysanthemum cinerariaefolium, ext.
                     
                     
                        ES
                     
                     
                        289-699-3
                     
                     
                        89997-63-7
                     
                     
                        18
                     
                  
                        811
                     
                     
                        Silver sodium hydrogen zirconium phosphate
                     
                     
                        SE
                     
                     
                        422-570-3
                     
                     
                        265647-11-8
                     
                     
                        1
                     
                  
                        1014
                     
                     
                        Silver zeolite
                     
                     
                        SE
                     
                     
                        n/a
                     
                     
                        n/a
                     
                     
                        5
                     
                  
                        868
                     
                     
                        Polyhexamethylene biguanide hydrochloride with a mean number-average molecular weight (Mn) of 1415 and a mean polydispersity (PDI) of 4,7 (PHMB(1415;4,7))
                     
                     
                        FR
                     
                     
                        Polymer
                     
                     
                        1802181-67-4/32289-58-0
                     
                     
                        3, 9, 11