2004/357/EC: Commission Decision of 7 April 2004 amending Decision 1999/217/EC as regards the register of flavouring substances (Text with EEA relevance) (notified under document number C(2004) 1273)
Date: 2004-04-07
Institutions: European Commission
Subjects: directory, flavouring, food additive, foodstuff

L 113/28

EN

Official Journal of the European Union

20.4.2004

II

(Acts whose publication is not obligatory)

COMMISSION

COMMISSION DECISION

of 7 April 2004

amending Decision 1999/217/EC as regards the register of flavouring substances

(notified under document number C(2004) 1273)

(Text with EEA relevance)

(2004/357/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), as amended by Regu-
lation (EC) No 1882/2003 (2), and in particular Article 3(2)
thereof,

Whereas:

(1)

(2)

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 notifica-
tion 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.

In addition, Regulation (EC) No 2232/96 provides for a
programme of evaluation of the flavouring substances
contained in the register (‘the evaluation programme’) in
order to check if those substances comply within the
general criteria for their use set out in the Annex to that
Regulation. Regulation (EC) No 2232/96 provides that
the persons
responsible for placing the flavouring
substances on the market are to forward data necessary

(1) OJ L 299, 23.11.1996, p. 1.
(2) OJ L 284, 31.10.2003, p. 1.

for their evaluation to the Commission. That Regulation
also provides that following completion of the evalua-
tion programme, the list of flavouring substances the use
of which is to be authorised to the exclusion of others,
is to be adopted.

Pursuant to Regulation (EC) No 2232/96, Commission
Decision 1999/217/EC of 23 February 1999 adopting a
register of flavouring substances used in or on foodstuffs
drawn up in application of Regulation (EC) No 2232/96
of the European Parliament and of the Council of 28
October 1996 (3), as last amended by Decision 2002/
113/EC (4), adopted a register of flavouring substances
used in or on foodstuffs.

Commission Regulation (EC) No 1565/2000 of 18 July
2000 laying down the measures necessary for the adop-
tion of an evaluation programme in application of Regu-
lation (EC) No 2232/96 of the European Parliament and
of the Council (5), provides for certain information to be
submitted by the person responsible for placing certain
flavouring substances contained in the register on the
market in order to enable the evaluation of the substance
to be carried out.

Commission Regulation (EC) No 622/2002 of 11 April
2002 establishing deadlines for the submission of infor-
mation for
chemically defined
evaluation of
flavouring substances used in or on foodstuffs (6), estab-
lished time limits for the submission of information for
required
the evaluation of

flavouring substances as

the

(3)

(4)

(5)

(3) OJ L 84, 27.3.1999, p. 1.
(4) OJ L 49, 20.2.2002, p. 1.
(5) OJ L 180, 19.7.2000, p. 8.
(6) OJ L 95, 12.4.2002, p. 10.

20.4.2004

EN

Official Journal of the European Union

L 113/29

pursuant to Regulation (EC) No 1565/2000. However,
for a number of substances for which the deadline of 31
December 2002 had been established, no information
has been submitted nor has the Commission been
informed about any intention to still submit information.
these substances cannot be evaluated in
Therefore,
respect of their compliance with the general criteria for
the use of flavouring substances set out in Regulation
(EC) No 2232/96 before the completion of the evalua-
tion programme. Accordingly, it is appropriate to delete
these substances from the register.

(10)

(11)

It is not appropriate to maintain the confidential code of
substances that otherwise have been notified with their
full name and were on the market at the moment the
register was elaborated.

The industry has now provided information concerning
certain substances which are indicated with the number
4 in the column ‘comments’ of part A of the Annex to
Decision 1999/217/EC and for which additional infor-
mation was required under that Decision. In particular,
evidence was provided that
are
flavouring substances. Accordingly, that Annex should
be amended to delete the reference to number 4.

substances

those

(6)

(7)

(8)

Scrutiny of
listed in the
the flavouring substances
register revealed inconsistencies concerning the names of
certain substances (FL No 06.100, and FL No 06.131)
and also concerning certain chemical numbers (FL No
02.027, FL No 07.033, FL No 07.153, and FL No
In addition, cases were identified where the
09.578).
same
chemical
names in the register (FL No 02.228 and FL No 02.027;
FL No 07.221 and FL No 07.033). Those inconsistencies
should be rectified.

substance appeared under different

(12)

It is appropriate to make a correction to the register by
giving a Flavis number to some substances that were on
the market at the moment the register was elaborated to
ensure that they are correctly taken up in the evaluation
programme.

(13) Member States have notified new flavouring substances
to be included in the evaluation programme and they
should therefore be incorporated into the register.

Scrutiny by the Commission also revealed that of the
different forms of quinine only quinine hydrochloride
(FL No 14.011), quinine monohydrochloride dihydrate
(FL No 14.155) and quinine sulphate (FL No 14.152) are
used as
forms of
flavouring substances. The other
quinine (FL No 14.146 and FL No 14.154) should there-
fore be deleted from the register.

The Scientific Committee on Food concluded in its
opinion of 26 February 2002 that N-(4-hydroxy-3-meth-
oxybenzyl)-8-methylnon-6-enamide (capsaicin, FL No
16.014) is genotoxic. Capsaicin is naturally present in
Capsicum species (e.g. chilli, cayenne pepper, red pepper).
High consumption of chillies has been reported to be a
risk factor for cancer. Although the maximum daily
intake in the European Union is much lower than the
the addition of
intake levels associated with cancer,
capsaicin as such to food should be avoided, 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. Accordingly, that substance should be
deleted from the register.

(14)

in application of
For some newly notified substances,
Regulation (EC) No 2232/96 and Commission Recom-
mendation 98/282/EC of 21 April 1998 on the ways in
which the Member States and signatory States to the
Agreement on the European Economic Area should
intellectual property in connection with the
protect
development and manufacture of flavouring substances
referred to in Regulation (EC) No 2232/96 of the Euro-
pean Parliament and of the Council (1), the notifying
Member State requested designation in such a way as to
protect the intellectual property rights of their manufac-
turer. Those substances should therefore be listed in part
B of the Annex to Decision 1999/217/EC.

(15) Decision 1999/217/EC should therefore be amended

accordingly.

(16)

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

(9)

For two substances listed in the register (CN060 and
CN061), the notifying Member State has withdrawn its
should therefore be
substances
notification. Those
deleted from the register.

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

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

L 113/30

EN

Official Journal of the European Union

20.4.2004

This Decision is addressed to the Member States.

Article 2

Done at Brussels, 7 April 2004.

For the Commission

David BYRNE

Member of the Commission

20.4.2004

EN

Official Journal of the European Union

L 113/31

ANNEX

The Annex to Decision 1999/217/EC is amended as follows:

1.

in the list in the third paragraph of the introductory part of the Annex which precedes part A, the following point 6
is added:

‘6. Substance which may not be used in and on food, unless lawfully placed on the market in the Member State(s)

concerned.’;

2. part A is amended as follows:

(a) the entries for the substances attributed with the FL-Nos referred to in points (i) to (vi) are amended as follows:

(i) for FL No 02.027, the entry ‘141-25-3’ in the column ‘CAS’ is replaced by the entry ‘6812-78-8’ and the

entry ‘205-473-9’ in the column ‘Einecs’ shall be replaced by ‘229-887-4’;

(ii) for FL No 06.100, the entry ‘Acetaldehyde dipentyl acetal’ in the column ‘Name’ is replaced by the entry

‘1,1-dipentyloxyethane’;

(iii) for FL No 06.131, the entry ‘1-Ethoxy-3-methyl-1-isopentyloxybutane’ in the column ‘Name’ is replaced by

the entry ‘1-ethoxy-1-(3-methylbutoxy)-3-methylbutane’;

(iv) for FL No 07.033, the entry ‘95-41-0’ in the column ‘CAS’ is replaced by the entry ‘11050-62-7’;
(v) for FL No 07.153, the entry ‘1803-39-0’ in the column ‘CAS’ is replaced by the entry ‘20489-53-6’;
(vi) for FL No 09.578, the entry ‘19089-92-0’ in the column ‘CAS’ is replaced by the entry ‘1617-25-0’;
(vii) for FL No 12.201, the entry ‘57074-34-7’ in the column ‘CAS’ is replaced by the entry ‘94293-57-9’;

(b) the rows set out in the table for the substances attributed with the following FL-numbers are deleted:

‘02.046

02.143

02.158

02.161

02.169

02.179

02.220

02.225

02.228

02.241

05.086

05.138

05.145

05.151

05.161

05.162

05.163

05.165

05.168

05.181

05.206

06.056

06.093

06.110

06.112

07.006

07.037

07.073

07.155

07.166

07.186

07.197

07.209

07.218

07.221

07.222

07.227

08.077

08.084

08.091

08.105

08.106

08.118

08.122

08.124

08.125

09.172

09.175

09.190

09.224

09.226

09.320

09.322

09.336

09.338

09.343

09.344

09.359

09.361

09.366

09.373

09.376

09.378

09.393

09.497

09.577

09.591

09.597

09.610

09.622

09.627

09.628

09.630

09.653

09.828

09.849

09.856

09.863

09.868

09.883

09.889

09.890

12.011

12.090

12.091

12.105

12.119

12.131

12.133

12.140

12.144

12.160

12.184

12.185

12.190

12.204

12.213

12.215

12.219

12.220

12.225

12.229

14.146

14.154

16.014

16.077

17.004

17.011

17.016

17.030’

(c) for the substances attributed with the following FL-Nos, the number ‘4’ in the column ‘comments’ in the table is

deleted:

‘02.004

02.121

02.216

02.217

09.016

09.034

09.367

09.712

16.009

16.017’

(d) the following rows are inserted in the table:

FL No

Chemical group

CAS

Name

Einecs

Synonyms

Comments

‘02.243

04.095

04.096

05.207

05.208

05.209

06.132

05.217

05.218

07.239

07.240

07.241

07.242

07.243

07.244

07.245

07.246

07.247

04

25

18

04

04

04

23

04

04

05

05

05

21

21

05

08

08

05

FEMA

3884

278-518-3

208-419-2

209-444-1

56805-23-3

(E)-3-(Z)-6-Nonadien-1-ol

527-60-6

2,4,6-Trimethyl phenol

579-60-2

2-Methoxy-6-(2-propenyl)phenol

105683-99-6

6-Decenal, cis

169054-69-7

Z-8-Tetradecenal

147159-48-6

6-Decenal, trans

63253-24-7

Vanillin butan-2,3-diol acetal (mixture of
stereo isomers)

4023

Vanillin erythro and threo-butan-2,3-
diol acetal

21662-08-8

5-Decenal

56554-87-1

16-Octadecenal

2278-53-7

[R-(E)]-5-Isopropyl-8-methylnona-6,8-
dien-2-one

218-907-7

13019-20-0

2-Methylheptan-3-one

4000

235-877-0

1635-02-5

3,4-Dimethylhex-3-en-2-one

216-656-8

5355-63-5

3-Hydroxy-4-phenylbutane-2-one

99-93-4

4-Hydroxy acetophenone

202-802-8

20859-10-3

Trans-6-Methyl-3-hepten-2-one

4001

71048-82-3

Trans-delta-damascone

275-156-8

(1alpha(E),2beta) – 1-(2,6,6-trimethyl-
cyclohex-3-en-1-yl)but-2-en-1-one

25304-14-7

Dimethyl cyclohexyl methyl ketone

246-799-1

30086-02-3

Octadien-2-one/3,5- (E,E)

4008

L

1
1
3
/
3
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
0
4
2
0
0
4

6

6

6

6

6

6

6

6

6

6

6

6

6

6

6

6

FL No

Chemical group

CAS

Name

FEMA

Einecs

Synonyms

Comments

07.248

07.249

07.253

09.917

09.918

09.919

09.920

09.921

09.922

09.923

09.924

09.925

09.926

09.927

09.928

10.069

10.070

12.238

12.239

12.240

10

05

05

04

04

09

08

04

04

05

05

05

05

04

04

09

09

20

20

20

585-25-1

Octan-2,3-dione

209-552-9

927-49-1

Undecan-6-one

4022

213-150-9

30086-02-3

3,5-Octadiene-2-one

1576-85-8

4-Pentenyl acetate

4011

216-413-6

67452-27-1

Cis-4-decenyl acetate

3967

139564-43-5

Ethyl 3-acetoxy-2-methylbutyrate

156324-82-2

2-Isopropyl-5-methylcyclohexyl oxycarbo-
nyloxy-2-hydroxypropane

3992

417-420-9

54653-25-7

Ethyl 5-hexenoate

3976

39924-27-1

Ethyl cis-4-heptenoate

3975

254-702-9

39026-94-3

Hept-2-yl butyrate

3981

5921-83-5

(+/-)-3-Heptyl acetate

3980

203-932-8

60826-15-5

Nonan-3-yl acetate

4007

262-444-3

84434-65-1

Octan-3-yl formate

4009

282-866-1

141-15-1

Rhodinyl butyrate

2982

205-462-9

3681-82-1

Trans-3-hexenyl acetate

222-962-2

67663-01-8

3-Methyl gamma-decalactone

3999

1073-11-6

4-Methyl-5-hexen-1,4-olide

214-024-6

227456-27-1

3-Mercapto-2-methylpentan-1-ol

227456-28-2

3-Mercapto-2-methylpentanal

3996

3994

6540-86-9

2,4,6-Trithiaheptane

6

6

6

6

6

6

6

6

6

6

6

6

6

6

6

6

6

6

6

.

.

2
0
4
2
0
0
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

L

1
1
3
/
3
3

FL No

Chemical group

CAS

Name

FEMA

3995

258823-39-1

2-Mercapto-2-methylpentan-1-ol

29414-47-9

Methylthiomethylmercaptan

6725-64-0

Dimercaptomethane

12.241

12.242

12.243

12.244

12.245

12.246

12.247

12.248

12.249

12.250

12.251

12.252

12.253

12.254

12.255

12.256

12.257

12.259

13.191

13.192

20

20

20

20

20

20

20

20

20

20

20

20

20

20

20

20

20

20

14

14

14109-72-9

1-Methylthio-2-propanone

3882

7529-06-8

1,3-Dimercapto-2-thiapropane

1-(Methylthio) hexan-3-one

61837-77-2

1-(Methylthio) octan-3-one

5862-47-5

2-(Methylthio) ethyl acetate

227456-27-1

3-Mercapto-2-methylpentanol (mixture of
stereo isomers)

3996

51755-72-7

3-Mercaptohexanal

136954-22-8

3-Mercaptohexyl hexanoate

3853

31539-84-1

4-Mercapto-4-methyl-2-pentanol

72437-68-4

Amyl methyl disulfide

63986-03-8

Butyl ethyl disulfide

156472-94-5

Ethyl 3-mercaptobutyrate

3977

31499-70-4

Ethyl propyl trisulfide

104228-51-5

Ethyl 4-(acetylthio) butyrate

3974

29725-66-4

p-menthan-3-one, 1 mercapto

376595-42-5

O-Ethyl S-(2-furylmethyl)thiocarbonate

109537-55-5

Furfuryl 2-methyl-3-furyldisulfide

Einecs

Synonyms

Comments

6

6

6

6

6

6

6

6

6

6

6

6

6

6

6

6

6

6

6

L

1
1
3
/
3
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
0
4
2
0
0
4

FL No

Chemical group

CAS

Name

13.193

13.194

13.195

13.196

13.197

14.162

14.163

14.164

14.165

15.123

16.082

14

14

30

14

14

28

28

28

28

20

30

26486-21-5

2,5-Dimethyltetrahydro-3-furanthiol

252736-39-3

2,5-Dimethyltetrahydro-3-furyl
acetate

thio

26131-91-9

2-Isobutyl-4,5-dimethyl oxazole

180031-78-1

4-(Furfurylthio) pentan-2-one

252736-36-0

Furyl propyldisulfide

98-79-3

L-2-Pyrrolidone-5-carboxylic acid

1192-58-1

1-Methylpyrrole-2-carboxaldehyde

622-39-9

2-Propylpyridine

2168-14-8

N-ethyl-2-formylpyrrole

53897-58-5

2,4,6-Triethyl-1,3,5-trithiane

21018-84-8

Amarogentin

FEMA

3971

3972

3840

3979

Einecs

Synonyms

Comments

214-755-0

210-732-4

6

6

6

6

6

6

6

6

6

6

6’

.

.

2
0
4
2
0
0
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

L

1
1
3
/
3
5

L 113/36

EN

Official Journal of the European Union

20.4.2004

3. 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

CN003

CN004

CN009

CN010

CN012

CN013

CN014

CN016

CN019

CN022

CN023

CN030

CN033

CN035

CN036

CN037

CN042

CN045

CN048

CN049

CN050

CN052

CN053

CN054

CN057

CN058

CN059

CN064

CN065

CN074

CN075

CN076

Date of receipt of the notification by the Commission

Comments

17.10.1998

17.10.1998

17.10.1998

17.10.1998

17.10.1998

17.10.1998

17.10.1998

17.10.1998

17.10.1998

17.10.1998

17.10.1998

17.10.1998

17.10.1998

17.10.1998

17.10.1998

17.10.1998

17.10.1998

17.10.1998

17.10.1998

17.10.1998

17.10.1998

17.10.1998

17.10.1998

17.10.1998

17.10.1998

30.10.1998

18.9.1998

3.2.1999

26.1.2001

18.4.2003

18.4.2003

18.4.2003

6

6

6’