CELEX: 32018D1622
Language: en
Date: 2018-10-29 00:00:00
Title: Commission Implementing Decision (EU) 2018/1622 of 29 October 2018 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.)

30.10.2018   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 271/26
               
            
         COMMISSION IMPLEMENTING DECISION (EU) 2018/1622
         of 29 October 2018
         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 amended by Delegated Regulation (EU) 2017/698 (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 3 February 2017.
                  
               
                     (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            For a number of active substance/product-type combinations included in that list, all the participants have withdrawn their support in a timely manner.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)
                  
                  
                     As regards some active substances generated in situ, the name of those active substances and their precursors which are supported in the review programme has been clarified in a more precise manner. This has lead in certain cases to a redefinition of the active substance in accordance with Article 13 of Delegated Regulation (EU) No 1062/2014.
                  
               
                     (4)
                  
                  
                     A notification was published inviting persons wishing to support those active substance/product-types combinations which have been redefined and currently not supported, including the generation in situ of the active substances for the product-types listed in Annex II to Delegated Regulation (EU) No 1062/2014, so that the role of participant may be taken over.
                  
               
                     (5)
                  
                  
                     For some active substance/product-type combinations no notification has been submitted or a notification has been submitted and rejected pursuant to paragraphs 4 or 5 of Article 17 of Delegated Regulation (EU) No 1062/2014.
                  
               
                     (6)
                  
                  
                     In accordance with Article 20 of Delegated Regulation (EU) No 1062/2014, those active substance/product-type combinations should not be approved for use in biocidal products.
                  
               
                     (7)
                  
                  
                     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, 29 October 2018.
            
               
                  For the Commission
               
               
                  The President
               
               Jean-Claude JUNCKER
            
         
         
            (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) 2017/698 of 3 February 2017 amending Delegated Regulation (EU) No 1062/2014 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 concerning the making available on the market and use of biocidal products (OJ L 103, 19.4.2017, p. 1).
      
      
         
            ANNEX
            Active substance/product type combinations not approved, including any nanomaterial forms:
            
                        —
                     
                     
                        the generation in situ of the active substances for the product-types listed in Annex II to Delegated Regulation (EU) No 1062/2014, except when the active substance is generated from the precursor(s) mentioned in the entry of the table of that Annex for the concerned active substance/product-type combinations;
                     
                  
                        —
                     
                     
                        the substance/product-type combinations listed in the table below, including any generation in situ of these substances using any precursor that is not mentioned in Annex II to Delegated Regulation (EU) No 1062/2014:
                        
                                    Entry Number in Annex II to Delegated Regulation (EU) No 1062/2014
                                 
                                 
                                    Substance name
                                 
                                 
                                    Rapporteur Member State
                                 
                                 
                                    EC number
                                 
                                 
                                    CAS number
                                 
                                 
                                    Product-type(s)
                                 
                              
                                    60
                                 
                                 
                                    Citric acid
                                 
                                 
                                    BE
                                 
                                 
                                    201-069-1
                                 
                                 
                                    77-92-9
                                 
                                 
                                    1
                                 
                              
                                    172
                                 
                                 
                                    Cetylpyridinium Chloride
                                 
                                 
                                    UK
                                 
                                 
                                    204-593-9
                                 
                                 
                                    123-03-5
                                 
                                 
                                    2
                                 
                              
                                    195
                                 
                                 
                                    Sodium 2-biphenylate
                                 
                                 
                                    ES
                                 
                                 
                                    205-055-6
                                 
                                 
                                    132-27-4
                                 
                                 
                                    1, 2, 3
                                 
                              
                                    288
                                 
                                 
                                    N-(Dichlorofluoromethylthio)-N′,N′-dimethyl-N-phenylsulfamide (Dichlofluanid)
                                 
                                 
                                    UK
                                 
                                 
                                    214-118-7
                                 
                                 
                                    1085-98-9
                                 
                                 
                                    7
                                 
                              
                                    365
                                 
                                 
                                    Pyridine-2-thiol 1-oxide, sodium salt (Sodium pyrithione)
                                 
                                 
                                    SE
                                 
                                 
                                    223-296-5
                                 
                                 
                                    3811-73-2
                                 
                                 
                                    3
                                 
                              
                                    401
                                 
                                 
                                    Silver
                                 
                                 
                                    SE
                                 
                                 
                                    231-131-3
                                 
                                 
                                    7440-22-4
                                 
                                 
                                    9
                                 
                              
                                    405
                                 
                                 
                                    Sulphur dioxide
                                 
                                 
                                    DE
                                 
                                 
                                    231-195-2
                                 
                                 
                                    7446-09-5
                                 
                                 
                                    4
                                 
                              
                                    424
                                 
                                 
                                    Sodium bromide
                                 
                                 
                                    NL
                                 
                                 
                                    231-599-9
                                 
                                 
                                    7647-15-6
                                 
                                 
                                    2, 11, 12
                                 
                              
                                    458
                                 
                                 
                                    Ammonium sulphate
                                 
                                 
                                    UK
                                 
                                 
                                    231-984-1
                                 
                                 
                                    7783-20-2
                                 
                                 
                                    11,12
                                 
                              
                                    1016
                                 
                                 
                                    Silver chloride
                                 
                                 
                                    SE
                                 
                                 
                                    232-033-3
                                 
                                 
                                    7783-90-6
                                 
                                 
                                    10, 11
                                 
                              
                                    515
                                 
                                 
                                    Ammonium bromide
                                 
                                 
                                    SE
                                 
                                 
                                    235-183-8
                                 
                                 
                                    12124-97-9
                                 
                                 
                                    11, 12
                                 
                              
                                    526
                                 
                                 
                                    Potassium 2-biphenylate
                                 
                                 
                                    ES
                                 
                                 
                                    237-243-9
                                 
                                 
                                    13707-65-8
                                 
                                 
                                    6, 9, 10, 13
                                 
                              
                                    529
                                 
                                 
                                    Bromine chloride
                                 
                                 
                                    NL
                                 
                                 
                                    237-601-4
                                 
                                 
                                    13863-41-7
                                 
                                 
                                    11
                                 
                              
                                    541
                                 
                                 
                                    Sodium p-chloro-m-cresolate
                                 
                                 
                                    FR
                                 
                                 
                                    239-825-8
                                 
                                 
                                    15733-22-9
                                 
                                 
                                    1, 2, 3, 6, 9, 13
                                 
                              
                                    609
                                 
                                 
                                    Mixture of cis- and trans-p-menthane-3,8 diol (Citriodiol)
                                 
                                 
                                    UK
                                 
                                 
                                    Not available
                                 
                                 
                                    Not available
                                 
                                 
                                    19
                                 
                              
                                    620
                                 
                                 
                                    Tetrakis(hydroxymethyl)phosphonium sulphate(2:1) (THPS)
                                 
                                 
                                    MT
                                 
                                 
                                    259-709-0
                                 
                                 
                                    55566-30-8
                                 
                                 
                                    2
                                 
                              
                                    673
                                 
                                 
                                    Didecyldimethylammonium chloride (DDAC (C8-10))
                                 
                                 
                                    IT
                                 
                                 
                                    270-331-5
                                 
                                 
                                    68424-95-3
                                 
                                 
                                    5
                                 
                              
                                    785
                                 
                                 
                                    6-(Phthalimido)peroxyhexanoic acid (PAP)
                                 
                                 
                                    IT
                                 
                                 
                                    410-850-8
                                 
                                 
                                    128275-31-0
                                 
                                 
                                    3, 4
                                 
                              
                                    792
                                 
                                 
                                    Tetrachlorodecaoxide complex (TCDO)
                                 
                                 
                                    DE
                                 
                                 
                                    420-970-2
                                 
                                 
                                    92047-76-2
                                 
                                 
                                    1
                                 
                              
                                    952
                                 
                                 
                                    
                                       Bacillus sphaericus other than Bacillus sphaericus 2362, strain ABTS-1743
                                 
                                 
                                    IT
                                 
                                 
                                    Micro-organism
                                 
                                 
                                    143447-72-7
                                 
                                 
                                    18
                                 
                              
                                    955
                                 
                                 
                                    
                                       Bacillus thuringiensis subsp.israelensis Serotype H14, other than strain AM65-52 and other than strain SA3A
                                 
                                 
                                    IT
                                 
                                 
                                    Micro-organism
                                 
                                 
                                    Not available
                                 
                                 
                                    18
                                 
                              
                                    957
                                 
                                 
                                    
                                       Bacillus subtilis
                                    
                                 
                                 
                                    DE
                                 
                                 
                                    Micro-organism
                                 
                                 
                                    Not available
                                 
                                 
                                    3
                                 
                              
                                    939
                                 
                                 
                                    Active Chlorine: manufactured by the reaction of hypochlorous acid and sodium hypochlorite produced in situ
                                    
                                 
                                 
                                    SK
                                 
                                 
                                    Mixture
                                 
                                 
                                    Not available
                                 
                                 
                                    2, 3, 4, 5, 11, 12
                                 
                              
                                    824
                                 
                                 
                                    Silver zinc zeolite
                                 
                                 
                                    SE
                                 
                                 
                                    Not available
                                 
                                 
                                    130328-20-0
                                 
                                 
                                    5
                                 
                              
                                    1013
                                 
                                 
                                    Silver copper zeolite
                                 
                                 
                                    SE
                                 
                                 
                                    Not available
                                 
                                 
                                    130328-19-7
                                 
                                 
                                    5
                                 
                              
                                    835
                                 
                                 
                                    Esfenvalerate/(S)-.alpha.-Cyano-3-phenoxybenzyl (S)-2-(4-chlorophenyl)-3-methylbutyrate (Esfenvalerate)
                                 
                                 
                                    PT
                                 
                                 
                                    Plant protection product
                                 
                                 
                                    66230-04-4
                                 
                                 
                                    18