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)
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Address https://gelex.eu/eli/EU/decision/2005/389@2005-05-18/en
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, 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) 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, 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
ANNEX
ANNEX
The Annex to Decision 1999/217/EC is amended as follows:
1. Part A is amended as follows:
1.
(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. 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
The table of part B is replaced by the following: 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