Commission Regulation (EU) 2017/378Show full title

Commission Regulation (EU) 2017/378

of 3 March 2017

amending 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 approved for use in and on foods and their conditions of use.

(2) Commission Implementing Regulation (EU) No 872/2012(3) adopted a list of flavouring substances and introduced that list in Part A of Annex I to Regulation (EC) No 1334/2008.

(3) That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application submitted by a Member State or by an interested party.

(4) The Union list of flavourings and source materials contains a number of substances for which the European Food Safety Authority (‘the Authority’) has requested additional scientific data to be provided for completion of the evaluation before the deadlines established in Part A of Annex I to Regulation (EC) No 1334/2008.

(5) In the case of the substances belonging to the Flavouring Group Evaluation (‘FGE 203’) rev.1: the deadline of 31 December 2012 was established in the Union list for the submission of requested additional scientific data. The substances belonging to this FGE203 rev.1 are: deca-2,4-dien-1-ol (FL No 02.139), hepta-2,4-dien-1-ol (FL No 02.153), hexa-2,4-dien-1-ol (FL No 02.162), nona-2,4-dien-1-ol (FL No 02.188), hexa-2(trans),4(trans)-dienal (FL No 05.057), trideca-2(trans),4(cis),7(cis)-trienal (FL No 05.064), nona-2,4-dienal (FL No 05.071), 2,4-decadienal (FL No 05.081), hepta-2,4-dienal (FL No 05.084), penta-2,4-dienal (FL No 05.101), undeca-2,4-dienal (FL No 05.108), dodeca-2,4-dienal (FL No 05.125), octa-2(trans),4(trans)-dienal (FL No 05.127), deca-2(trans),4(trans)-dienal (FL No 05.140), deca-2,4,7-trienal (FL No 05.141), nona-2,4,6-trienal (FL No 05.173), 2,4-octadienal (FL No 05.186), tr-2,tr-4-nonadienal (FL No 05.194), tr-2,tr-4-undecadienal (FL No 05.196), and hexa-2,4-dienyl acetate (FL No 09.573). Such data has been submitted by the applicant.

(6) That chemical group includes hexa-2(trans),4(trans)-dienal (FL No 05.057) and deca-2(trans),4(trans)-dienal (FL No 05.140) which were used as representative substances for the group and for which toxicity data were submitted.

(7) The Authority has evaluated the genotoxicity of these two representative substances in its scientific opinion of 26 March 2014(4).

(8) For hexa-2(trans),4(trans)-dienal (FL No 05.057) it confirmed safety concerns based on the evidence from publications reporting the induction of DNA adducts in different systems in vitro and in vivo, the IARC classification as possible carcinogen to humans, considering the conclusion drawn by IARC that mechanistic data provide additional support for the relevance of the animal carcinogenicity data to humans and that there is a moderate evidence that tumour induction occurs via a genotoxic mechanism.

(9) For deca-2(trans),4(trans)-dienal (FL No 05.140) it came to the conclusion that a non-threshold mechanism of genotoxicity cannot be excluded on the basis that there is some indication for genotoxicity in vivo and considering the evidence from in vitro studies for the induction of different types of DNA damage (oxidised DNA bases and bulky adducts).

(10) Overall, the Authority concluded that the safety concern regarding genotoxicity cannot be ruled out for both representative substances of the group and that this conclusion is likewise applicable to the other substances of the FGE group 203.

(11) The parties concerned have indicated that they are undertaking a variety of toxicity studies on the substances in FGE group 203 responding to the concerns expressed by the Authority. In addition, the Commission has requested further information in order to fully evaluate the safety of those substances.

(12) The supporting parties submitted the studies and information on 26 September 2016.

(13) Pending the evaluation by the Authority of the substances in group FGE, the eventual full evaluation of these substances according to the EFSA CEF panel procedure and the completion of the subsequent regulatory process, it is appropriate to limit the conditions of use of those substances to their current use.

(14) Due to technical reasons, transitional periods should be laid down to cover food not complying with the conditions set out in the Annex, which has been placed on the Union market or dispatched from third countries for the Union before the entry into force of this Regulation.

(15) Part A of Annex I to Regulation (EC) No 1334/2008 should therefore be amended accordingly.

(16) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1 U.K.

Part A of Annex I to Regulation (EC) No 1334/2008 is amended in accordance with the Annex to this Regulation.

Article 2 U.K.

1. Foods to which any of the flavouring substances listed in the Annex to this Regulation have been added which do not comply with the conditions set out in that Annex and which have been lawfully placed on the market before the entry into force of this Regulation, may be marketed until their date of minimum durability or use by date.

2. Foods to which any of the flavouring substances listed in the Annex to this Regulation have been added, and which do not comply with the conditions set out in that Annex and which have been imported into the Union from a third country may be marketed until their date of minimum durability or use by date where the importer of such foods can demonstrate that they were dispatched from the third country concerned and were en route to the Union before the entry into force of this Regulation.

3. The transitional periods provided in paragraphs 1 and 2 shall not apply to mixtures of flavourings.

Article 3 U.K.

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, 3 March 2017.

For the Commission

The President

Jean-Claude Juncker

ANNEX U.K.

Table 1 of Section 2 of Part A of Annex I to Regulation (EC) No 1334/2008 is amended as follows:

(a)

the entry for FL No 02.139 is replaced by the following:

‘02.139

Deca-2,4-dien-1-ol

18409-21-7

1189

11748

Restrictions of use as a flavouring substance: In category 2 — not more than 1,5 mg/kg, in category 3 — not more than 5 mg/kg, in category 5 — not more than 9 mg/kg, in category 7 — not more than 15 mg/kg, in category 8 — not more than 5 mg/kg, in category 12 — not more than 3 mg/kg, in category 14.1 — not more than 2 mg/kg, in category 14.2 — not more than 1 mg/kg, in category 16 — not more than 2 mg/kg.

1

EFSA’

(b)

the entry for FL No 02.153 is replaced by the following:

‘02.153

Hepta-2,4-dien-1-ol

33467-79-7

1784

Restrictions of use as a flavouring substance: In category 1 — not more than 35 mg/kg, in category 2 — not more than 25 mg/kg, in category 3 — not more than 30 mg/kg, in category 4.2 — not more than 50 mg/kg, in category 5 — not more than 50 mg/kg, in category 6 — not more than 25 mg/kg, in category 7 — not more than 50 mg/kg, in category 8 — not more than 10 mg/kg, in category 9 — not more than 10 mg/kg, in category 12 — not more than 100 mg/kg, in category 14.1 — not more than 25 mg/kg, in category 15 — not more than 50 mg/kg, in category 16 — not more than 25 mg/kg.

1

EFSA’

(c)

the entry for FL No 02.162 is replaced by the following:

‘02.162

Hexa-2,4-dien-1-ol

111-28-4

1174

Restrictions of use as a flavouring substance: In category 3 — not more than 4 mg/kg, in category 4.2 — not more than 2 mg/kg, in category 5 — not more than 2 mg/kg, in category 12 — not more than 4 mg/kg, in category 14.1 — not more than 4 mg/kg, in category 14.2 — not more than 1 mg/kg, in category 15 — not more than 1 mg/kg, in category 16 — not more than 2 mg/kg.

1

EFSA’

(d)

the entry for FL No 02.188 is replaced by the following:

‘02.188

Nona-2,4-dien-1-ol

62488-56-6

1183

11802

At least 92 %; secondary component 3-4 % 2-nonen-1-ol

Restrictions of use as a flavouring substance: In category 1 — not more than 2 mg/kg, in category 2 — not more than 5 mg/kg, in category 3 — not more than 5 mg/kg, in category 4.2 — not more than 5 mg/kg, in category 5 — not more than 10 mg/kg, in category 6 — not more than 1 mg/kg, in category 7 — not more than 14,5 mg/kg, in category 8 — not more than 5 mg/kg, in category 12 — not more than 10 mg/kg, in category 14.1 — not more than 2 mg/kg, in category 14.2 — not more than 5 mg/kg, in category 15 — not more than 5 mg/kg, in category 16 — not more than 2,5 mg/kg.

1

EFSA’

(e)

the entry for FL No 05.057 is replaced by the following:

‘05.057

Hexa-2(trans),4(trans)-dienal

142-83-6

1175

640

Restrictions of use as a flavouring substance: In category 1 — not more than 10 mg/kg, in category 3 — not more than 10 mg/kg, in category 4.2 — not more than 15 mg/kg, in category 5 — not more than 20 mg/kg, in category 6 — not more than 0,05 mg/kg, in category 7 — not more than 15 mg/kg, in category 8 — not more than 15 mg/kg, in category 9 — not more than 20 mg/kg, in category 11 — not more than 50 mg/kg, in category 12 — not more than 4 mg/kg, in category 14.1 — not more than 15 mg/kg, in category 14.2 — not more than 1 mg/kg, in category 16 — not more than 10 mg/kg.

1

EFSA’

(f)

the entry for FL No 05.064 is replaced by the following:

‘05.064

Trideca-2(trans),4(cis),7(cis)-trienal

13552-96-0

1198

685

At least 71 %; secondary components 14 % 4-cis-7-cis-tridecadienol; 6 % 3-cis-7-cis-tridecadienol; 5 % 2-trans-7-cis-tridecadienal; 3 % 2-trans-4-trans-7-cis-tridecatrienal

Restrictions of use as a flavouring substance: In category 2 — not more than 1 mg/kg, in category 8 — not more than 2 mg/kg, in category 9 — not more than 1 mg/kg, in category 12 — not more than 1 mg/kg, in category 15 — not more than 1 mg/kg.

1

EFSA’

(g)

the entry for FL No 05.071 is replaced by the following:

‘05.071

Nona-2,4-dienal

6750-03-4

1185

732

At least 89 %; secondary components 5-6 % 2,4-nonadien-1-ol and 1-2 % 2-nonen-1-ol

Restrictions of use as a flavouring substance: In category 1 — not more than 1,5 mg/kg, in category 2 — not more than 5 mg/kg, in category 3 — not more than 1 mg/kg, in category 4.2 — not more than 1 mg/kg, in category 5 — not more than 5 mg/kg, in category 6 — not more than 1 mg/kg, in category 7 — not more than 5 mg/kg, in category 8 — not more than 5 mg/kg, in category 9 — not more than 5 mg/kg, in category 10 — not more than 1 mg/kg, in category 11 — not more than 1 mg/kg, in category 12 — not more than 10 mg/kg, in category 14.1 — not more than 1 mg/kg, in category 14.2 — not more than 1 mg/kg, in category 15 — not more than 5 mg/kg, in category 16 — not more than 1 mg/kg.

1

EFSA’

(h)

the entry for FL No 05.081 is replaced by the following:

‘05.081

2,4-Decadienal

2363-88-4

3135

2120

At least 89 %; secondary components mixture of the (cis, cis)-; (cis, trans)- and (trans, cis)- 2,4-decadienals (sum of all isomers 95 %); acetone and isopropanol

Restrictions of use as a flavouring substance: In category 1 — not more than 1,5 mg/kg, in category 2 — not more than 5 mg/kg, in category 3 — not more than 1,5 mg/kg, in category 4.2 — not more than 5 mg/kg, in category 5 — not more than 5 mg/kg (except in category 5.3 — not more than 10 mg/kg), in category 6 — not more than 5 mg/kg, in category 7 — not more than 5 mg/kg, in category 8 — not more than 10 mg/kg, in category 9 — not more than 3 mg/kg, in category 10 — not more than 1 mg/kg, in category 11 — not more than 7,5 mg/kg, in category 12 — not more than 10 mg/kg, in category 14.1 — not more than 1 mg/kg, in category 14.2 — not more than 1 mg/kg, in category 15 — not more than 20 mg/kg, in category 16 — not more than 1,5 mg/kg.

1

EFSA’

(i)

the entry for FL No 05.084 is replaced by the following:

‘05.084

Hepta-2,4-dienal

4313-03-5

1179

729

At least 92 %; secondary components 2-4 % (E,Z)-2,4-heptadienal and 2-4 % 2,4-heptadienoic acid

Restrictions of use as a flavouring substance: In category 1 — not more than 5 mg/kg, in category 2 — not more than 10 mg/kg, in category 3 — not more than 1 mg/kg, in category 4.2 — not more than 1 mg/kg, in category 5 — not more than 5 mg/kg, in category 6 — not more than 0,5 mg/kg, in category 7 — not more than 10 mg/kg, in category 8 — not more than 6 mg/kg, in category 9 — not more than 6 mg/kg, in category 10 — not more than 1 mg/kg, in category 11 — not more than 1 mg/kg, in category 12 — not more than 2 mg/kg, in category 14.1 — not more than 1 mg/kg, in category 14.2 — not more than 1 mg/kg, in category 15 — not more than 3 mg/kg, in category 16 — not more than 1 mg/kg

1

EFSA’

(j)

the entry for FL No 05.101 is replaced by the following:

‘05.101

Penta-2,4-dienal

764-40-9

1173

11695

Restrictions of use as a flavouring substance: In category 1 — not more than 1 mg/kg, in category 3 — not more than 1 mg/kg, in category 5 — not more than 1 mg/kg, in category 6 — not more than 1 mg/kg, in category 7 — not more than 1 mg/kg, in category 8 — not more than 1 mg/kg, in category 12 — not more than 1 mg/kg, in category 14.1 — not more than 1 mg/kg, in category 14.2 — not more than 1 mg/kg, in category 16 — not more than 1 mg/kg.

1

EFSA’

(k)

the entry for FL No 05.108 is replaced by the following:

‘05.108

Undeca-2,4-dienal

13162-46-4

1195

10385

Restrictions of use as a flavouring substance: In category 1 — not more than 1 mg/kg, in category 2 — not more than 5 mg/kg. In category 3 — not more than 1 mg/kg. In category 4.2 — not more than 1 mg/kg, in category 5 — not more than 1 mg/kg (except in category 5.3 — not more than 10 mg/kg), in category 6 — not more than 1 mg/kg, in category 7 — not more than 5 mg/kg, in category 8 — not more than 3 mg/kg, in category 9 — not more than 3 mg/kg, in category 10 — not more than 1 mg/kg, in category 11 — not more than 1 mg/kg, in category 12 — not more than 1 mg/kg, in category 14.1 — not more than 1 mg/kg, in category 14.2 — not more than 1 mg/kg, in category 15 — not more than 3 mg/kg, in category 16 — not more than 1 mg/kg.

1

EFSA’

(l)

the entry for FL No 05.125 is replaced by the following:

‘05.125

Dodeca-2,4-dienal

21662-16-8

1196

11758

At least 85 %; secondary component 11-12 % 2-trans-4-cis isomer

Restrictions of use as a flavouring substance: In category 1 — not more than 1 mg/kg, in category 2 — not more than 5 mg/kg, in category 3 — not more than 1 mg/kg, in category 4.2 — not more than 1 mg/kg, in category 5 — not more than 1 mg/kg (except in category 5.3 — not more than 10 mg/kg), in category 6 — not more than 1 mg/kg, in category 7 — not more than 3 mg/kg, in category 8 — not more than 3 mg/kg, in category 9 — not more than 3 mg/kg, in category 10 — not more than 1 mg/kg, in category 11 — not more than 1 mg/kg, in category 12 — not more than 1 mg/kg, in category 14.1 — not more than 1 mg/kg, in category 14.2 — not more than 1 mg/kg, in category 15 — not more than 3 mg/kg, in category 16 — not more than 1 mg/kg.

1

EFSA’

(m)

the entry for FL No 05.127 is replaced by the following:

‘05.127

Octa-2(trans),4(trans)-dienal

30361-28-5

1181

11805

Restrictions of use as a flavouring substance: In category 1 — not more than 1 mg/kg, in category 3 — not more than 1 mg/kg, in category 5 — not more than 10 mg/kg, in category 6 — not more than 5 mg/kg, in category 7 — not more than 2 mg/kg, in category 8 — not more than 2 mg/kg, in category 12 — not more than 2 mg/kg, in category 14.1 — not more than 3 mg/kg, in category 15 — not more than 1 mg/kg, in category 16 — not more than 2 mg/kg.

1

EFSA’

(n)

the entry for FL No 05.140 is replaced by the following:

‘05.140

Deca-2(trans),4(trans)-dienal

25152-84-5

1190

2120

At least 89 %; secondary components 3-4 % mixture of (cis-cis)-; (cis-trans)- and (trans-cis)- 2,4-decadienals; 3-4 % acetone and trace of isopropanol

Restrictions of use as a flavouring substance: In category 1 — not more than 1,5 mg/kg, in category 2 — not more than 5 mg/kg, in category 3 — not more than 1,5 mg/kg, in category 4.2 — not more than 5 mg/kg, in category 5 — not more than 5 mg/kg, (except in category 5.3 — not more than 10 mg/kg), in category 6 — not more than 5 mg/kg, in category 7 — not more than 5 mg/kg In category 8 — not more than 10 mg/kg, in category 9 — not more than 3 mg/kg, in category 10 — not more than 1 mg/kg, in category 11 — not more than 7,5 mg/kg, in category 12 — not more than 10 mg/kg, in category 14.1 — not more than 1 mg/kg, in category 14.2 — not more than 1 mg/kg, in category 15 — not more than 20 mg/kg, in category 16 — not more than 1,5 mg/kg.

1

EFSA’

(o)

the entry for FL No 05.141 is replaced by the following:

‘05.141

Deca-2,4,7-trienal

51325-37-2

1786

Restrictions of use as a flavouring substance: In category 1 — not more than 1 mg/kg, in category 2 — not more than 1 mg/kg, in category 3 — not more than 1 mg/kg, in category 4.2 — not more than 1 mg/kg, in category 5 — not more than 1 mg/kg, in category 6 — not more than 1 mg/kg, in category 7 — not more than 1 mg/kg, in category 8 — not more than 1 mg/kg, in category 9 — not more than 1 mg/kg, in category 10 — not more than 1 mg/kg, in category 11 — not more than 1 mg/kg, in category 12 — not more than 1 mg/kg, in category 14.1 — not more than 1 mg/kg, in category 14.2 — not more than 1 mg/kg, in category 15 — not more than 1 mg/kg, in category 16 — not more than 1 mg/kg.

1

EFSA’

(p)

the entry for FL No 05.173 is replaced by the following:

‘05.173

Nona-2,4,6-trienal

57018-53-8

1785

Restrictions of use as a flavouring substance: In category 1 — not more than 15 mg/kg, in category 2 — not more than 10 mg/kg, in category 3 — not more than 15 mg/kg, in category 4.2 — not more than 15 mg/kg, in category 5 — not more than 20 mg/kg, in category 6 — not more than 10 mg/kg, in category 7 — not more than 25 mg/kg, in category 8 — not more than 5 mg/kg, in category 9 — not more than 5 mg/kg, in category 12 — not more than 25 mg/kg, in category 14.1 — not more than 10 mg/kg, in category 15 — not more than 15 mg/kg, in category 16 — not more than 15 mg/kg.

1

EFSA’

(q)

the entry for FL No 05.186 is replaced by the following:

‘05.186

2,4-Octadienal

5577-44-6

11805

Restrictions of use as a flavouring substance: In category 1 — not more than 1 mg/kg, in category 3 — not more than 1 mg/kg, in category 5 — not more than 10 mg/kg, in category 6 — not more than 5 mg/kg, in category 7 — not more than 2 mg/kg, in category 8 — not more than 2 mg/kg, in category 12 — not more than 2 mg/kg, in category 14.1 — not more than 3 mg/kg, in category 15 — not more than 1 mg/kg, in category 16 — not more than 2 mg/kg.

1

EFSA’

(r)

the entry for FL No 05.194 is replaced by the following:

‘05.194

tr-2, tr-4-Nonadienal

5910-87-2

732

At least 89 %; secondary components at least 5 % 2,4-nonadien-1-ol and 2-nonen-1-ol and other isomers of 2,4-nonadienal

Restrictions of use as a flavouring substance: In category 1 — not more than 1,5 mg/kg, in category 2 — not more than 5 mg/kg, in category 3 — not more than 1 mg/kg, in category 4.2 — not more than 1 mg/kg, in category 5 — not more than 5 mg/kg, in category 6 — not more than 1 mg/kg, in category 7 — not more than 5 mg/kg, in category 8 — not more than 5 mg/kg, in category 9 — not more than 5 mg/kg, in category 10 — not more than 1 mg/kg, in category 11 — not more than 1 mg/kg, in category 12 — not more than 10 mg/kg, in category 14.1 — not more than 1 mg/kg, in category 14.2 — not more than 1 mg/kg, in category 15 — not more than 5 mg/kg, in category 16 — not more than 1 mg/kg.

1

EFSA’

(s)

the entry for FL No 05.196 is replaced by the following:

‘05.196

tr-2, tr-4-Undecadienal

30361-29-6

10385

Restrictions of use as a flavouring substance: In category 1 — not more than 1 mg/kg, in category 2 — not more than 5 mg/kg, in category 3 — not more than 1 mg/kg, in category 4.2 — not more than 1 mg/kg, in category 5 — not more than 1 mg/kg (except in category 5.3 — not more than 10 mg/kg), in category 6 — not more than 1 mg/kg, in category 7 — not more than 5 mg/kg, in category 8 — not more than 3 mg/kg, in category 9 — not more than 3 mg/kg, in category 10 — not more than 1 mg/kg, in category 11 — not more than 1 mg/kg, in category 12 — not more than 1 mg/kg, in category 14.1 — not more than 1 mg/kg, in category 14.2 — not more than 1 mg/kg, in category 15 — not more than 3 mg/kg, in category 16 — not more than 1 mg/kg.

1

EFSA’

(t)

the entry for FL No 09.573 is replaced by the following:

‘09.573

Hexa-2,4-dienyl acetate

1516-17-2

1780

10675

Restrictions of use as a flavouring substance: In category 1 — not more than 25 mg/kg, in category 3 — not more than 20 mg/kg, in category 4.2 — not more than 25 mg/kg, in category 5 — not more than 25 mg/kg, in category 6 — not more than 10 mg/kg, in category 7 — not more than 25 mg/kg, in category 12 — not more than 10 mg/kg, in category 14.1 — not more than 20 mg/kg, in category 14.2 — not more than 20 mg/kg, in category 15 — not more than 25 mg/kg, in category 16 — not more than 25 mg/kg.

1

EFSA’

(1)

OJ L 354, 31.12.2008, p. 34.

(2)

OJ L 354, 31.12.2008, p. 1.

(3)

Commission Implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council and repealing Commission Regulation (EC) No 1565/2000 and Commission Decision 1999/217/EC (OJ L 267, 2.10.2012, p. 1).

(4)

Scientific Opinion on Flavouring Group Evaluation 203 Rev 1 (FGE.203 Rev1): alpha,beta-unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.4 of FGE.19 with two or more conjugated double-bonds and with or without additional non-conjugated double-bonds. EFSA Journal 2014;12(4):3626, 31 pp. doi:10.2903/j.efsa.2014.3626. Available online: www.efsa.europa.eu/efsajournal