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