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)
Date: 2005-05-18
Institutions: European Commission
Subjects: directory, flavouring, food additive, foodstuff

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,

the Annex to Regulation (EC) No 2232/96. As a conse-
quence, propyl 4-hydroxybenzoate should be deleted
from the register.

Having regard to the Treaty
Community,

establishing the European

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)

(2)

(3)

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 notifi-
cation 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.

The European Food Safety Authority (the Authority)
concluded in its opinion of 13 July 2004 on para-hydro-
xybenzoates, 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
for this
recommend an acceptable daily intake (ADI)
substance because of
the lack of clear no-observed-
adverse-effect-level (NOAEL). The use of propyl 4-hydro-
xybenzoate 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

(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).

(4)

(5)

(6)

that

pentane-2,4-dione

The Authority concluded in its opinion of 7 December
2004 on aliphatic dialcohols, diketones and hydroxy-
ketones,
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.

07.191)

(FL

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
the
the European Parliament
2232/96 of
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.

and of

Protection for these substances,
listed in Part B of the
is limited to a maximum period of five years
register,
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
accordance with
Committee on the Food Chain and Animal Health,

in this Decision are in
Standing
the

opinion

the

of

(3) OJ L 127, 29.4.1998, p. 32.

L 128/74

EN

Official Journal of the European Union

21.5.2005

HAS ADOPTED THIS DECISION:

Article 1

The Annex to Decision 1999/217/EC is amended in accordance with the Annex to this Decision.

This Decision is addressed to the Member States.

Article 2

Done at Brussels, 18 May 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

21.5.2005

EN

Official Journal of the European Union

L 128/75

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

CAS No corresponds to
2-methylacetophenone

01.070

01.071

01.072

07.251

01.073

01.074

16.084

01.075

12.260

12.261

01.076

16.085

12.262

05.210

05.211

14.166

07.252

02.244

10.070

05.212

05.213

15.124

05.214

05.215

05.216

12.263

12.264

03.021

31

31

31

21

31

31

30

31

20

20

31

20

20

04

02

30

05

04

09

04

04

29

04

03

03

20

20

16

111-66-0

1-Octene

111-67-1

2-Octene

544-76-3

Hexadecane

577-16-2

Methylacetophenone

592-99-4

4-Octene

593-45-3

Octadecane

627-67-8

3-Methyl-1-nitrobutane

629-78-7

Heptadecane

4131-76-4

Methyl-2-methyl-3-mercaptopropionate

6725-64-0

Methanedithiol

20996-35-4

3,7-Decadiene

27959-66-6

4,4-Dimethyl-1,3-oxathiane

29414-47-9

(Methylthio)methanethiol

203-893-7

203-894-2

280-878-9

209-790-3

211-008-0

211-108-4

223-949-4

30390-51-3

4-Dodecenal

250-174-9

30689-75-9

6-Methyloctanal

32536-43-9

Indole acetic acid

33665-27-9

4-Octen-2-one

54393-36-1

4-Octen-1-ol

57681-53-5

4-Hydroxy-2-heptenoic acid lactone

260-902-7

76261-02-4

6-Dodecenal

90645-87-7

5-Nonenal

103527-75-9

3-Methyl-2-butenylthiophene

121052-28-6

8-Dodecenal

134998-59-7

2,6-Decadienal (c,c)

134998-60-0

2,6-Decadienal (t,t)

3-Mercapto-3-methylbutanal

92585-08-5

4,2-Thiopentanone

142-96-1

Dibutyl ether

205-575-3

Rose
thiophene

L 128/76

EN

Official Journal of the European Union

21.5.2005

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

CN065

CN074

CN075

CN076

Date of receipt of the notification by the Commission

Comments

26.1.2001

18.4.2003

18.4.2003

18.4.2003

6

6

6