CELEX: 32016R1198
Language: en
Date: 2016-07-22
Title: Commission Regulation (EU) 2016/1198 of 22 July 2016 amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance)

23.7.2016   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 198/10
            
         COMMISSION REGULATION (EU) 2016/1198
   of 22 July 2016
   amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (1), and in particular Article 31(1) thereof,
   Whereas:
   
               (1)
            
            
               Methylisothiazolinone is authorised as a preservative in cosmetic products at concentrations up to 0,01 % weight/weight (100 ppm) through entry 57 of Annex V to Regulation (EC) No 1223/2009.
            
         
               (2)
            
            
               The Scientific Committee on Consumer Safety (SCCS) adopted an opinion on the safety of methylisothiazolinone (sensitisation only) on 12 December 2013 (2).
            
         
               (3)
            
            
               The SCCS concluded that current clinical data indicate that the concentration of 100 ppm of methylisothiazolinone in cosmetic products is not safe for the consumer. For leave-on cosmetic products (including ‘wet wipes’), no safe concentrations of methylisothiazolinone for induction of contact allergy or elicitation have been adequately demonstrated.
            
         
               (4)
            
            
               In light of the SCCS opinion mentioned above, it is important to address the increased incidence of allergies induced by methylisothiazolinone and this substance should therefore be banned in leave-on products.
            
         
               (5)
            
            
               Regulation (EC) No 1223/2009 should therefore be amended accordingly.
            
         
               (6)
            
            
               The application of the above-mentioned ban should be deferred to allow the industry to make the necessary adjustments to product formulations. In particular, undertakings should be granted six months to place on the market compliant products and to withdraw from the market non-compliant products after the entry into force of this Regulation.
            
         
               (7)
            
            
               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products,
            
         HAS ADOPTED THIS REGULATION:
   Article 1
   Annex V to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this Regulation.
   Article 2
   From 12 February 2017 only cosmetic products which comply with this Regulation shall be placed and made available on the Union market.
   Article 3
   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, 22 July 2016.
      
         
            For the Commission
         
         
            The President
         
         Jean-Claude JUNCKER
      
   
   
      (1)  OJ L 342, 22.12.2009, p. 59.
   
      (2)  SCCS/1521/13 Revision of 27 March 2014.
   
      ANNEX
      In Annex V to Regulation (EC) No 1223/2009, entry 57 is replaced by the following:
      
         
                     Reference number
                  
                  
                     Substance Identification
                  
                  
                     Conditions
                  
                  
                     Wording of conditions of use and warnings
                  
               
                     Chemical name/INN
                  
                  
                     Name of Common Ingredients Glossary
                  
                  
                     CAS number
                  
                  
                     EC number
                  
                  
                     Product type, Body parts
                  
                  
                     Maximum concentration in ready for use preparation
                  
                  
                     Other
                  
                  
                      
                  
               
                     a
                  
                  
                     b
                  
                  
                     c
                  
                  
                     d
                  
                  
                     e
                  
                  
                     f
                  
                  
                     g
                  
                  
                     h
                  
                  
                     i
                  
               
                     ‘57
                  
                  
                     2-Methyl-2H-isothiazol-3-one
                  
                  
                     Methylisothiazolinone (1)
                     
                  
                  
                     2682-20-4
                  
                  
                     220-239-6
                  
                  
                     Rinse-off products
                  
                  
                     0,01 %
                  
                  
                      
                  
                  
                      
                  
               
      
         (1)  Methylisothiazolinone is also regulated in entry 39 of Annex V in a mixture with methylchloroisothiazolinone. The two entries are mutually exclusive: the use of the mixture of Methylchloroisothiazolinone (and) Methylisothiazolinone is incompatible with the use of Methylisothiazolinone alone in the same product.’