CELEX: 32020R1684
Language: en
Date: 2020-11-12 00:00:00
Title: Commission Regulation (EU) 2020/1684 of 12 November 2020 amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance)

13.11.2020   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 379/42
               
            
         COMMISSION REGULATION (EU) 2020/1684
         of 12 November 2020
         amending Annex VI 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(2) thereof,
         Whereas:
         
                     (1)
                  
                  
                     The Scientific Committee on Consumer Safety (SCCS) concluded in its opinion of 13 December 2019 (2) (‘the SCCS opinion’) that the use of Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate as a UV filter in cosmetic products at a maximum concentration of 3 % is safe. Inhalation toxicity was not assessed in the SCCS opinion because no data were provided. Hence, the SCCS opinion is not applicable to any cosmetic product in form of spray that could lead to exposure of the end-user’s lungs by inhalation.
                  
               
                     (2)
                  
                  
                     The SCCS also concluded in its opinion that Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate is a secondary amine, and thus is prone to nitrosation and formation of nitrosamine. It should not be used in combination with nitrosating substances. The nitrosamine content should be less than 50 ppb.
                  
               
                     (3)
                  
                  
                     In light of the SCCS opinion and in order to take into account technical and scientific progress, the use of Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate as a UV filter in cosmetic products should be authorised at a maximum concentration of 3 %, except in applications that may lead to exposure of the end-user’s lungs by inhalation.
                  
               
                     (4)
                  
                  
                     Annex VI to Regulation (EC) No 1223/2009 should therefore be amended accordingly.
                  
               
                     (5)
                  
                  
                     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 VI to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this Regulation.
         
         
            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, 12 November 2020.
            
               
                  For the Commission
               
               
                  The President
               
               Ursula VON DER LEYEN
            
         
         
            (1)  OJ L 342, 22.12.2009, p. 59.
         
            (2)  SCCS/1605/19.
      
      
         
            ANNEX
            In Annex VI to Regulation (EC) No 1223/2009, the following entry is added:
            
               
                           Reference number
                        
                        
                           Substance identification
                        
                        
                           Conditions
                        
                        
                           Wording of conditions of use and warnings
                        
                     
                           Chemical name/INN/XAN
                        
                        
                           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
                        
                     
                           ‘32
                        
                        
                           2-ethoxyethyl (2Z)-2-cyano-2-[3-(3-methoxypropylamino) cyclohex-2-en-1-ylidene]acetate
                        
                        
                           Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate
                        
                        
                           1419401-88-9
                        
                        
                           700-860-3
                        
                        
                            
                        
                        
                           3 %
                        
                        
                           
                                       —
                                    
                                    
                                       Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation
                                    
                                 
                                       —
                                    
                                    
                                       Do not use with nitrosating agents – Maximum nitrosamine content: 50 μg/kg
                                    
                                 
                                       —
                                    
                                    
                                       Keep in nitrite-free containers’