CELEX: 32013R0985
Language: en
Date: 2013-10-14 00:00:00
Title: Commission Regulation (EU) No 985/2013 of 14 October 2013 amending and correcting Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards certain flavouring substances  Text with EEA relevance

15.10.2013   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 273/18
            
         COMMISSION REGULATION (EU) No 985/2013
   of 14 October 2013
   amending and correcting Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards certain flavouring substances
   (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 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (1), and in particular Article 11(3) thereof,
   Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (2), and in particular Article 7(5) thereof,
   Whereas:
   
               (1)
            
            
               Annex I to Regulation (EC) No 1334/2008 lays down a Union list of flavourings and source materials for use in food and their conditions of use.
            
         
               (2)
            
            
               Part A of the Union list contains both evaluated flavouring substances, which are assigned no footnotes and flavourings substances under evaluation, which are identified by footnote references 1 to 4 in that list.
            
         
               (3)
            
            
               The European Food Safety Authority has completed the assessment of 23 substances which are currently listed as flavouring substances under evaluation. Those flavouring substances were assessed by the EFSA in the following flavouring group evaluations: evaluation FGE.06rev4 (3) (substances FL Nos 02.229, 05.137, 09.562 and 09.854), evaluation FGE.07rev4 (4) (substances FL Nos 02.145, 02.194, 02.211, 07.198 and 07.204), evaluation FGE.08rev5 (5) (substance FL No 15.134), evaluation FGE.09rev4 (6) (substances FL Nos 07.202 and 07.255), evaluation FGE.12rev3 (7) (substance FL No 05.182), evaluation FGE.20rev4 (8) (substances FL Nos 05.026, 05.028, 05.029 and 09.858), evaluation in FGE.23rev4 (9) (substance FL No 13.170), evaluation in FGE.63rev1 (10) (substances FL Nos 02.252, 07.190 and 09.936), evaluation FGE.94rev1 (11) (substance FL No 16.095) and evaluation FGE.304 (12) (substance FL No 16.123). The EFSA concluded that those flavouring substances do not give rise to safety concerns at the estimated levels of dietary intakes.
            
         
               (4)
            
            
               Therefore, the flavouring substances assessed in those flavouring group evaluations should be listed as evaluated substances by deleting footnote references 1 to 4 in the relevant entries of the Union list.
            
         
               (5)
            
            
               After publication of the Union list, certain errors have been identified in that list. Those errors are related to names, CAS-numbers, JECFA-numbers or secondary components of the followings substances: FL Nos 02.093, 02.110, 05.085, 08.004, 09.016, 09.131, 09.132, 09.266, 09.578, 09.596, 09.880, 12.075, 12.086, 12.273, 13.028, 13.190, 14.067 and 17.015. The errors should be corrected.
            
         
               (6)
            
            
               Part A of Annex I to Regulation (EC) No 1334/2008 should therefore be amended and corrected accordingly.
            
         
               (7)
            
            
               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
            
         HAS ADOPTED THIS REGULATION:
   Article 1
   Part A of Annex I to Regulation (EC) No 1334/2008 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, 14 October 2013.
      
         
            For the Commission
         
         
            The President
         
         José Manuel BARROSO
      
   
   
      (1)  OJ L 354, 31.12.2008, p. 34.
   
      (2)  OJ L 354, 31.12.2008, p. 1.
   
      (3)  EFSA Journal 2013; 11(2):3091.
   
      (4)  EFSA Journal 2012; 10(10):2899.
   
      (5)  EFSA Journal 2012; 10(7):2837.
   
      (6)  EFSA Journal 2012; 10(7):2836.
   
      (7)  EFSA Journal 2012; 10(12):2993.
   
      (8)  EFSA Journal 2012; 10(12):2994.
   
      (9)  EFSA Journal 2013; 11(2):3092.
   
      (10)  EFSA Journal 2012; 10(10):2900.
   
      (11)  EFSA Journal 2012; 10(6):2747.
   
      (12)  EFSA Journal 2012; 10(10):2903.
   
      ANNEX
      Part A of Annex I to Regulation (EC) No 1334/2008 is amended as follows:
      
                  (1)
               
               
                  the entry concerning FL No 02.093 is replaced by the following:
                  
                              ‘02.093
                           
                           
                              (Z)-Non-6-en-1-ol
                           
                           
                              35854-86-5
                           
                           
                              324
                           
                           
                              10294
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              JECFA’
                           
                        
            
                  (2)
               
               
                  the entry concerning FL No 02.110 is replaced by the following:
                  
                              ‘02.110
                           
                           
                              2,6-Dimethylhept-6-en-1-ol
                           
                           
                              36806-46-9
                           
                           
                              348
                           
                           
                               
                           
                           
                              At least 90 %; secondary component 5-10 % 2,6-dimethyl-5-hepten-1-ol
                           
                           
                               
                           
                           
                               
                           
                           
                              JECFA’
                           
                        
            
                  (3)
               
               
                  the entry concerning FL No 02.145 is replaced by the following:
                  
                              ‘02.145
                           
                           
                              2,6-Dimethylocta-1,5,7-trien-3-ol
                           
                           
                              29414-56-0
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (4)
               
               
                  the entry concerning FL No 02.194 is replaced by the following:
                  
                              ‘02.194
                           
                           
                              Octa-1,5-dien-3-ol
                           
                           
                              83861-74-9
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (5)
               
               
                  the entry concerning FL No 02.211 is replaced by the following:
                  
                              ‘02.211
                           
                           
                              Undeca-1,5-dien-3-ol
                           
                           
                              56722-23-7
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (6)
               
               
                  the entry concerning FL No 02.229 is replaced by the following:
                  
                              ‘02.229
                           
                           
                              (-)-3,7-Dimethyl-6-octen-1-ol
                           
                           
                              7540-51-4
                           
                           
                               
                           
                           
                               
                           
                           
                              At least 90 % cis-isomer; secondary components 2-6 % di-unsaturated and saturated C10 alcohols, 2-4 % citronellyl acetate and 2-3 % citronellal
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (7)
               
               
                  the entry concerning FL No 02.252 is replaced by the following:
                  
                              ‘02.252
                           
                           
                              4,8-Dimethyl-3,7-nonadien-2-ol
                           
                           
                              67845-50-5
                           
                           
                              1841
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (8)
               
               
                  the entry concerning FL No 05.026 is replaced by the following:
                  
                              ‘05.026
                           
                           
                              o-Tolualdehyde
                           
                           
                              529-20-4
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (9)
               
               
                  the entry concerning FL No 05.028 is replaced by the following:
                  
                              ‘05.028
                           
                           
                              m-Tolualdehyde
                           
                           
                              620-23-5
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (10)
               
               
                  the entry concerning FL No 05.029 is replaced by the following:
                  
                              ‘05.029
                           
                           
                              p-Tolualdehyde
                           
                           
                              104-87-0
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (11)
               
               
                  the entry concerning FL No 05.085 is replaced by the following:
                  
                              ‘05.085
                           
                           
                              (Z)-Hept-4-enal
                           
                           
                              6728-31-0
                           
                           
                              320
                           
                           
                              2124
                           
                           
                              At least 93 % of Z-form of hept-4-enal; secondary component 2-5 % of E-form of hept-4-enal.
                           
                           
                               
                           
                           
                               
                           
                           
                              JECFA’
                           
                        
            
                  (12)
               
               
                  the entry concerning FL No 05.137 is replaced by the following:
                  
                              ‘05.137
                           
                           
                              Dec-4(cis)-enal
                           
                           
                              21662-09-9
                           
                           
                               
                           
                           
                               
                           
                           
                              At least 90 %; secondary component at least 5 % trans-isomer
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (13)
               
               
                  the entry concerning FL No 05.182 is replaced by the following:
                  
                              ‘05.182
                           
                           
                              2,6,6-Trimethylcyclohex-2-ene-1-carboxaldehyde
                           
                           
                              432-24-6
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (14)
               
               
                  the entry concerning FL No 07.190 is replaced by the following:
                  
                              ‘07.190
                           
                           
                              Octa-1,5-dien-3-one
                           
                           
                              65213-86-7
                           
                           
                              1848
                           
                           
                               
                           
                           
                              Mixture of stereoisomers: 60-90 % E-form and 10-40 % Z-form
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (15)
               
               
                  the entry concerning FL No 07.198 is replaced by the following:
                  
                              ‘07.198
                           
                           
                              Pseudo-ionone
                           
                           
                              141-10-6
                           
                           
                               
                           
                           
                              11191
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (16)
               
               
                  the entry concerning FL No 07.202 is replaced by the following:
                  
                              ‘07.202
                           
                           
                              2,6,6-Trimethylcyclohex-2-en-1-one
                           
                           
                              20013-73-4
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (17)
               
               
                  the entry concerning FL No 07.204 is replaced by the following:
                  
                              ‘07.204
                           
                           
                              3,3,6-Trimethylhepta-1,5-dien-4-one
                           
                           
                              546-49-6
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (18)
               
               
                  the entry concerning FL No 07.255 is replaced by the following:
                  
                              ‘07.255
                           
                           
                              l-Piperitone
                           
                           
                              4573-50-6
                           
                           
                              1856
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (19)
               
               
                  the entry concerning FL No 08.004 is replaced by the following:
                  
                              ‘08.004
                           
                           
                              Lactic acid
                           
                           
                              50-21-5
                           
                           
                              930
                           
                           
                              4
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (20)
               
               
                  the entry concerning FL No 09.016 is replaced by the following:
                  
                              ‘09.016
                           
                           
                              Menthyl acetate
                           
                           
                              16409-45-3
                           
                           
                              431
                           
                           
                              206
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              JECFA’
                           
                        
            
                  (21)
               
               
                  the entry concerning FL No 09.131 is replaced by the following:
                  
                              ‘09.131
                           
                           
                              DL-Isobornyl propionate
                           
                           
                              2756-56-1
                           
                           
                              1391
                           
                           
                              412
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (22)
               
               
                  the entry concerning FL No 09.132 is replaced by the following:
                  
                              ‘09.132
                           
                           
                              Benzyl propionate
                           
                           
                              122-63-4
                           
                           
                              842
                           
                           
                              413
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (23)
               
               
                  the entry concerning FL No 09.266 is replaced by the following:
                  
                              ‘09.266
                           
                           
                              Hexyl 2-butenoate
                           
                           
                              19089-92-0
                           
                           
                              1807
                           
                           
                              10688
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (24)
               
               
                  the entry concerning FL No 09.562 is replaced by the following:
                  
                              ‘09.562
                           
                           
                              trans-3-Hexenyl formate
                           
                           
                              56922-80-6
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (25)
               
               
                  the entry concerning FL No 09.578 is replaced by the following:
                  
                              ‘09.578
                           
                           
                              Hexyl (E)-but-2-enoate
                           
                           
                              1617-25-0
                           
                           
                               
                           
                           
                              10688
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (26)
               
               
                  the entry concerning FL No 09.596 is replaced by the following:
                  
                              ‘09.596
                           
                           
                              Isopentyl-(Z)-but-2-enoate
                           
                           
                              10482-55-0
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (27)
               
               
                  the entry concerning FL No 09.854 is replaced by the following:
                  
                              ‘09.854
                           
                           
                              cis-3-Hexenyl 2-methylbutanoate
                           
                           
                              53398-85-9
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (28)
               
               
                  the entry concerning FL No 09.858 is replaced by the following:
                  
                              ‘09.858
                           
                           
                              Phenylmethyl 2-methyl-2-butenoate
                           
                           
                              67674-41-3
                           
                           
                               
                           
                           
                               
                           
                           
                              Mixture of stereoisomers: 60-90 % E-form and 10-40 % Z-form
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (29)
               
               
                  the entry concerning FL No 09.880 is replaced by the following:
                  
                              ‘09.880
                           
                           
                              (Z)-Hept-4-en-2-yl butanoate
                           
                           
                              94088-12-7
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (30)
               
               
                  the entry concerning FL No 09.936 is replaced by the following:
                  
                              ‘09.936
                           
                           
                              4,8-Dimethyl-3,7-nonadien-2-yl acetate
                           
                           
                              91418-25-6
                           
                           
                              1847
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (31)
               
               
                  the entry concerning FL No 12.075 is replaced by the following:
                  
                              ‘12.075
                           
                           
                              Methyl prop-1-enyl disulfide
                           
                           
                              5905-47-5
                           
                           
                              569
                           
                           
                              11712
                           
                           
                              At least 90 %; secondary components 3-4 % dimethyl disulfide and 3-4 % di-1-propenyl disulfide
                           
                           
                               
                           
                           
                               
                           
                           
                              JECFA’
                           
                        
            
                  (32)
               
               
                  the entry concerning FL No 12.086 is replaced by the following:
                  
                              ‘12.086
                           
                           
                              S-Methyl 2-methylbutanethioate
                           
                           
                              42075-45-6
                           
                           
                              486
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              JECFA’
                           
                        
            
                  (33)
               
               
                  the entry concerning FL No 12.273 is replaced by the following:
                  
                              ‘12.273
                           
                           
                              3-(Methylthio)heptanal
                           
                           
                              51755-70-5
                           
                           
                              1692
                           
                           
                               
                           
                           
                              At least 92 %; secondary component 5-7 % (E)-hept-2-enal
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (34)
               
               
                  the entry concerning FL No 13.028 is replaced by the following:
                  
                              ‘13.028
                           
                           
                              2-Butyl-5 or 6-keto-1,4-dioxane
                           
                           
                              65504-95-2
                           
                           
                              1484
                           
                           
                              2206
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (35)
               
               
                  the entry concerning FL No 13.170 is replaced by the following:
                  
                              ‘13.170
                           
                           
                              2S-cis-Tetrahydro-4-methyl-2-(2-methyl-1-propenyl)-2H-pyran
                           
                           
                              3033-23-6
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (36)
               
               
                  the entry concerning FL No 13.190 is replaced by the following:
                  
                              ‘13.190
                           
                           
                              3-((2-methyl-3-furyl)thio)-2-butanone
                           
                           
                              61295-44-1
                           
                           
                              1525
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (37)
               
               
                  the entry concerning FL No 14.067 is replaced by the following:
                  
                              ‘14.067
                           
                           
                              2-Ethoxy-3-methylpyrazine
                           
                           
                              32737-14-7
                           
                           
                              793
                           
                           
                              11921
                           
                           
                              At least 82 % 2-ethoxy-3-methylpyrazine. Secondary components 15 % 2–ethoxy-5-methylpyrazine (CAS no 67845-34-5) or 2-ethoxy-6-methylpyrazine (CAS no 53163-97-6)
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (38)
               
               
                  the entry concerning FL No 15.134 is replaced by the following:
                  
                              ‘15.134
                           
                           
                              2,5-Dihydroxy-1,4-dithiane
                           
                           
                              40018-26-6
                           
                           
                              550
                           
                           
                               
                           
                           
                              Mixture of diastereoisomers: 25-30 % of (2S,5S and 2R,5R) and 70-75 % (2S,5R and 2R,5S)
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (39)
               
               
                  the entry concerning FL No 16.095 is replaced by the following:
                  
                              ‘16.095
                           
                           
                              Cyclopropanecarboxamide, N-[(2E)-3,7-dimethyl-2,6-octadien-1-yl]-
                           
                           
                              744251-93-2
                           
                           
                              1779
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (40)
               
               
                  the entry concerning FL No 16.123 is replaced by the following:
                  
                              ‘16.123
                           
                           
                              (1R,2S,5R)-N-(4-Methoxyphenyl)-5-methyl-2-(1-methylethyl)cyclohexanecarboxamide
                           
                           
                              68489-09-8
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’
                           
                        
            
                  (41)
               
               
                  the entry concerning FL No 17.015 is replaced by the following:
                  
                              ‘17.015
                           
                           
                              DL-Methylmethioninesulphonium chloride
                           
                           
                              3493-12-7
                           
                           
                              1427
                           
                           
                              761
                           
                           
                               
                           
                           
                               
                           
                           
                               
                           
                           
                              EFSA’