CELEX: 32005D0389
Language: en
Date: 2005-05-18 00:00:00
Title: 2005/389/EC: Commission Decision of 18 May 2005 amending Decision 1999/217/EC as regards the register of flavouring substances used in or on foodstuffs (notified under document number C(2005) 1437)   (Text with EEA relevance)

21.5.2005   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 128/73
            
         
      COMMISSION DECISION
   
   of 18 May 2005
   amending Decision 1999/217/EC as regards the register of flavouring substances used in or on foodstuffs
   (notified under document number C(2005) 1437)
   (Text with EEA relevance)
   (2005/389/EC)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Regulation (EC) No 2232/96 of the European Parliament and of the Council of 28 October 1996 laying down a Community procedure for flavouring substances used or intended for use in or on foodstuffs (1), and in particular Article 3(2) and Article 4(3) thereof,
   Whereas:
   
               (1)
            
            
               Regulation (EC) No 2232/96 lays down the procedure for the establishment of rules in respect of flavouring substances used or intended to be used in foodstuffs. That Regulation provides for the adoption of a register of flavouring substances (the register) following notification by the Member States of a list of the flavouring substances which may be used in or on foodstuffs marketed in their territory and on the basis of scrutiny by the Commission of that notification. That register was adopted by Commission Decision 1999/217/EC (2).
            
         
               (2)
            
            
               In addition, Regulation (EC) No 2232/96 provides for a programme for the evaluation of flavouring substances in order to check whether they comply with the general criteria for the use of flavouring substances set out in the Annex to that Regulation.
            
         
               (3)
            
            
               The European Food Safety Authority (the Authority) concluded in its opinion of 13 July 2004 on para-hydroxybenzoates, that propyl 4-hydroxybenzoate (FL 09.915) had effects on sex hormones and the male reproductive organs in juvenile rats. The Authority was unable to recommend an acceptable daily intake (ADI) for this substance because of the lack of clear no-observed-adverse-effect-level (NOAEL). The use of propyl 4-hydroxybenzoate as a flavouring substance in food is not acceptable, as it does not comply with the general criteria for the use of flavouring substances set out in the Annex to Regulation (EC) No 2232/96. As a consequence, propyl 4-hydroxybenzoate should be deleted from the register.
            
         
               (4)
            
            
               The Authority concluded in its opinion of 7 December 2004 on aliphatic dialcohols, diketones and hydroxyketones, that pentane-2,4-dione (FL 07.191) is genotoxic in vitro and in vivo. Accordingly, its use as a flavouring substance is not acceptable, because it does not comply with the general criteria for the use of flavouring substances set out in the Annex to Regulation (EC) No 2232/96. As a consequence, pentane-2,4-dione should be deleted from the register.
            
         
               (5)
            
            
               In application of Regulation (EC) No 2232/96 and Commission Recommendation 98/282/EC of 21 April 1998 on the ways in which the Member States and the signatory States to the Agreement on the European Economic Area should protect intellectual property in connection with the development and manufacture of flavouring substances referred to in Regulation (EC) No 2232/96 of the European Parliament and of the Council (3), for a number of substances, the notifying Member States requested that they should be registered in such a way as to protect the intellectual property rights of the manufacturer.
            
         
               (6)
            
            
               Protection for these substances, listed in Part B of the register, is limited to a maximum period of five years following the date of receipt of the notification. That period has now expired for 28 substances which should consequently be transferred to Part A of the register.
            
         
               (7)
            
            
               Decision 1999/217/EC should therefore be amended accordingly.
            
         
               (8)
            
            
               The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
            
         HAS ADOPTED THIS DECISION:
   Article 1
   The Annex to Decision 1999/217/EC is amended in accordance with the Annex to this Decision.
   Article 2
   This Decision is addressed to the Member States.
   
      Done at Brussels, 18 May 2005.
      
         
            For the Commission
         
         Markos KYPRIANOU
         
         
            Member of the Commission
         
      
   
   
      (1)  OJ L 299, 23.11.1996, p. 1. Regulation as amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).
   
      (2)  OJ L 84, 27.3.1999, p. 1. Decision as last amended by Decision 2004/357/EC (OJ L 113, 20.4.2004, p. 28).
   
      (3)  OJ L 127, 29.4.1998, p. 32.
   
      ANNEX
      The Annex to Decision 1999/217/EC is amended as follows:
      
                  1.
               
               
                  Part A is amended as follows:
                  
                              (a)
                           
                           
                              The rows set out in the table for the substances attributed with FL-numbers 07.191 (pentane-2,4-dione) and 09.915 (propyl 4-hydroxybenzoate) are deleted.
                           
                        
                              (b)
                           
                           
                              The following rows are inserted in the table:
                              
                                          FL No
                                       
                                       
                                          Chemical group
                                       
                                       
                                          CAS
                                       
                                       
                                          Name
                                       
                                       
                                          Fema
                                       
                                       
                                          Einecs
                                       
                                       
                                          Synonyms
                                       
                                       
                                          Comments
                                       
                                    
                                          01.070
                                       
                                       
                                          31
                                       
                                       
                                          111-66-0
                                       
                                       
                                          1-Octene
                                       
                                       
                                           
                                       
                                       
                                          203-893-7
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          01.071
                                       
                                       
                                          31
                                       
                                       
                                          111-67-1
                                       
                                       
                                          2-Octene
                                       
                                       
                                           
                                       
                                       
                                          203-894-2
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          01.072
                                       
                                       
                                          31
                                       
                                       
                                          544-76-3
                                       
                                       
                                          Hexadecane
                                       
                                       
                                           
                                       
                                       
                                          280-878-9
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          07.251
                                       
                                       
                                          21
                                       
                                       
                                          577-16-2
                                       
                                       
                                          Methylacetophenone
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                          CAS No corresponds to 2-methylacetophenone
                                       
                                    
                                          01.073
                                       
                                       
                                          31
                                       
                                       
                                          592-99-4
                                       
                                       
                                          4-Octene
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          01.074
                                       
                                       
                                          31
                                       
                                       
                                          593-45-3
                                       
                                       
                                          Octadecane
                                       
                                       
                                           
                                       
                                       
                                          209-790-3
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          16.084
                                       
                                       
                                          30
                                       
                                       
                                          627-67-8
                                       
                                       
                                          3-Methyl-1-nitrobutane
                                       
                                       
                                           
                                       
                                       
                                          211-008-0
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          01.075
                                       
                                       
                                          31
                                       
                                       
                                          629-78-7
                                       
                                       
                                          Heptadecane
                                       
                                       
                                           
                                       
                                       
                                          211-108-4
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          12.260
                                       
                                       
                                          20
                                       
                                       
                                          4131-76-4
                                       
                                       
                                          Methyl-2-methyl-3-mercaptopropionate
                                       
                                       
                                           
                                       
                                       
                                          223-949-4
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          12.261
                                       
                                       
                                          20
                                       
                                       
                                          6725-64-0
                                       
                                       
                                          Methanedithiol
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          01.076
                                       
                                       
                                          31
                                       
                                       
                                          20996-35-4
                                       
                                       
                                          3,7-Decadiene
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          16.085
                                       
                                       
                                          20
                                       
                                       
                                          27959-66-6
                                       
                                       
                                          4,4-Dimethyl-1,3-oxathiane
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          12.262
                                       
                                       
                                          20
                                       
                                       
                                          29414-47-9
                                       
                                       
                                          (Methylthio)methanethiol
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          05.210
                                       
                                       
                                          04
                                       
                                       
                                          30390-51-3
                                       
                                       
                                          4-Dodecenal
                                       
                                       
                                           
                                       
                                       
                                          250-174-9
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          05.211
                                       
                                       
                                          02
                                       
                                       
                                          30689-75-9
                                       
                                       
                                          6-Methyloctanal
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          14.166
                                       
                                       
                                          30
                                       
                                       
                                          32536-43-9
                                       
                                       
                                          Indole acetic acid
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          07.252
                                       
                                       
                                          05
                                       
                                       
                                          33665-27-9
                                       
                                       
                                          4-Octen-2-one
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          02.244
                                       
                                       
                                          04
                                       
                                       
                                          54393-36-1
                                       
                                       
                                          4-Octen-1-ol
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          10.070
                                       
                                       
                                          09
                                       
                                       
                                          57681-53-5
                                       
                                       
                                          4-Hydroxy-2-heptenoic acid lactone
                                       
                                       
                                           
                                       
                                       
                                          260-902-7
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          05.212
                                       
                                       
                                          04
                                       
                                       
                                          76261-02-4
                                       
                                       
                                          6-Dodecenal
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          05.213
                                       
                                       
                                          04
                                       
                                       
                                          90645-87-7
                                       
                                       
                                          5-Nonenal
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          15.124
                                       
                                       
                                          29
                                       
                                       
                                          103527-75-9
                                       
                                       
                                          3-Methyl-2-butenylthiophene
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                          Rose thiophene
                                       
                                       
                                           
                                       
                                    
                                          05.214
                                       
                                       
                                          04
                                       
                                       
                                          121052-28-6
                                       
                                       
                                          8-Dodecenal
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          05.215
                                       
                                       
                                          03
                                       
                                       
                                          134998-59-7
                                       
                                       
                                          2,6-Decadienal (c,c)
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          05.216
                                       
                                       
                                          03
                                       
                                       
                                          134998-60-0
                                       
                                       
                                          2,6-Decadienal (t,t)
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          12.263
                                       
                                       
                                          20
                                       
                                       
                                           
                                       
                                       
                                          3-Mercapto-3-methylbutanal
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          12.264
                                       
                                       
                                          20
                                       
                                       
                                          92585-08-5
                                       
                                       
                                          4,2-Thiopentanone
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          03.021
                                       
                                       
                                          16
                                       
                                       
                                          142-96-1
                                       
                                       
                                          Dibutyl ether
                                       
                                       
                                           
                                       
                                       
                                          205-575-3
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                        
            
                  2.
               
               
                  The table of part B is replaced by the following:
                  Flavouring substances notified in application of Article 3(2) of Regulation (EC) No 2232/96, for which the protection of the intellectual property rights of the manufacturer has been requested
                  
                              Code
                           
                           
                              Date of receipt of the notification by the Commission
                           
                           
                              Comments
                           
                        
                              CN065
                           
                           
                              26.1.2001
                           
                           
                               
                           
                        
                              CN074
                           
                           
                              18.4.2003
                           
                           
                              6
                           
                        
                              CN075
                           
                           
                              18.4.2003
                           
                           
                              6
                           
                        
                              CN076
                           
                           
                              18.4.2003
                           
                           
                              6