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 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 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 [^ntr1-L_2012267EN.01000101-E0001], and in particular Articles 3(2) and 4(1) and Article 5 thereof,

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 [^ntr2-L_2012267EN.01000101-E0002], and in particular Article 25(1) thereof,

Whereas:

• (1) Regulation (EC) No 2232/96 provides for a Community procedure for evaluation and authorisation of flavouring substances. The Member States notified to the Commission the list of flavouring substances which may be used in or on foods marketed on their territory.

• (2) Regulation (EC) No 2232/96 provides for a list of flavouring substances that are authorised to the exclusion of all others. That list is to be established on the basis of a register containing the flavouring substances notified by the Member States and on the basis of a specific evaluation programme.

• (3) The notified substances were entered in a register laid down by 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 [^ntr3-L_2012267EN.01000101-E0003].

• (4) Commission Regulation (EC) No 1565/2000 [^ntr4-L_2012267EN.01000101-E0004] has laid down the measures necessary for the adoption of an evaluation programme in application of Regulation (EC) No 2232/96. Pursuant to Article 5(2) of Regulation (EC) No 2232/96, flavouring substances not included in the register have also been included in the evaluation programme.

• (5) The European Food Safety Authority (hereinafter referred to as ‘the Authority’) evaluated a number of flavouring substances [^ntr5-L_2012267EN.01000101-E0005] through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. Those flavouring substances which do not give rise to safety concerns at their levels of dietary intakes should be included in the list referred to in Regulation (EC) No 2232/96.

• (6) Pursuant to Article 2(1) of Regulation (EC) No 1565/2000, substances that are contained in the register and have already been classified by the Scientific Committee on Food (hereinafter referred to as ‘SCF’) in Category 1 [^ntr6-L_2012267EN.01000101-E0006] or by the Council of Europe in Category A [^ntr7-L_2012267EN.01000101-E0007] or by Joint FAO/WHO Expert Committee on Food Additives (hereinafter referred to as ‘JECFA’), so as to present no safety concern, as laid down in the reports of its 46th, 49th, 51st and 53rd meeting [^ntr8-L_2012267EN.01000101-E0008], need not be re-evaluated within the evaluation programme. These substances should be included in the list referred to in Regulation (EC) No 2232/96.

• (7) Pursuant to Article 2(2) of Regulation (EC) No 1565/2000, substances contained in the register and classified by JECFA, since 2000, so as to present no safety concern on the basis of the default approach for estimation of intake, have to be considered by the Authority. Those substances, for which the Authority agreed with the JECFA conclusion, should be included in the list referred to in Regulation (EC) No 2232/96.

• (8) Flavouring substances may be used in or on foods in accordance with the good manufacturing practices or, if necessary, with specific conditions. The list referred to in Regulation (EC) No 2232/96 should contain information on the unique identification number of the substance (FL-No), the name of the substance (Chemical name), the Chemical Abstracts Service registry number, the JECFA number, the Council of Europe number, the purity, the specific conditions of use and reference to the scientific body that has carried or is carrying out the evaluation.

• (9) For the purpose of this Regulation, the food categories as laid down in Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives [^ntr9-L_2012267EN.01000101-E0009], should be referred to. When necessary, interpretation decisions can be adopted in accordance with Article 13(c) of Regulation (EC) No 1334/2008 in order to clarify whether or not a particular food belongs to a certain category of food.

• (10) Flavouring substances which did not receive a favourable assessment on their safety have been listed in Part A of Annex III to Regulation (EC) No 1334/2008 concerning substances which shall not be added as such to food or have been deleted from the register by Commission Decisions 2005/389/EC [^ntr10-L_2012267EN.01000101-E0010], 2006/252/EC [^ntr11-L_2012267EN.01000101-E0011] and 2008/478/EC [^ntr12-L_2012267EN.01000101-E0012].

• (11) Flavouring substances for which the requested information has not been provided and which, therefore, have not been evaluated by the Authority in accordance with Article 3(5) of Regulation (EC) No 1565/2000, should not be included in the list referred to in Regulation (EC) No 2232/96.

• (12) Flavouring substances for which the persons responsible for placing them on the market have withdrawn the application should not be included in the list referred to in Regulation (EC) No 2232/96.

• (13) For a number of substances, the Authority has not completed the evaluation or it has requested additional scientific data to be provided for completion of the evaluation. In accordance with the objectives of Regulations (EC) No 2232/96 and (EC) No 1334/2008 and in order to enhance legal certainty it is appropriate to include those substances in the list referred to in Regulation (EC) No 2232/96 to allow those substances which are currently placed on the market, to continue to be used in or on foods until risk assessment and authorisation procedures have been concluded.

• (14) To manage the submissions of additional scientific data requested by the Authority, time limits should be set for the persons responsible for placing flavouring substances on the market so as to comply with the Authority's requests as expressed in the published opinions. Therefore, footnotes 2 to 4 have been assigned for those substances for which the Authority has requested additional scientific data in the list referred to in Regulation (EC) No 2232/96. A time limit should be set for the Authority to evaluate the submitted data. Where the necessary information is not provided by the time requested the flavouring substance in question may not be evaluated in accordance with Article 3(5) of Regulation (EC) No 1565/2000 and therefore will be withdrawn from the Union list in accordance with the procedure laid down in Article 7 of Regulation (EC) No 1331/2008 of the European Parliament and of the Council [^ntr13-L_2012267EN.01000101-E0013].

• (15) Flavouring substances for which the Authority has not yet completed the evaluation and no request for additional information is pending, should be identified as such by footnote 1 in the list referred to in Regulation (EC) No 2232/96.

• (16) If the authorised flavouring substance is a racemate (an equal mixture of optical isomers), both the R- and S- form should also be authorised for use. If only the R-form is authorised then the S-form should not be covered by that authorisation and vice versa.

• (17) Several D- and D,L-amino acids have been evaluated as safe by the Authority for use as flavouring substances, provided that the substances are in an unchanged form when they are consumed. Therefore, the amino acids should be included in the list referred to in Regulation (EC) No 2232/96 concerning their use as flavouring substances only.

• (18) The list referred to in Regulation (EC) No 2232/96 is intended only to regulate the use of flavouring substances which are added to food in order to impart or modify odour and/or taste. Certain substances on the list may be also added to food for other purposes than flavouring and such uses remain subject to other rules. For some substances it is necessary to lay down a use level which refers to their use as a flavouring substance. These substances are caffeine (FL 16.016), theobromine (FL 16.032), neohesperidin dihydrocalcone (FL 16.061) and rebaudioside A (FL 16.113). For ammonium chloride (FL 16.048) national provisions are already in place. Therefore, for ensuring the functioning of the internal market the use levels should be harmonised.

• (19) The Authority has recommended, in its opinion adopted on 22 May 2008 [^ntr14-L_2012267EN.01000101-E0014], that for d-camphor (FL 07.215) a maximum use level should be set to ensure that exposure to d-camphor does not exceed 2 mg/kg body weight on a single day in any age group. Therefore, specific conditions of use should be set for d-camphor.

• (20) SCF concluded in its opinion adopted on 19 February 1988 [^ntr15-L_2012267EN.01000101-E0015], that it saw no objection from a toxicological point of view to the continued use at present levels (up to max 100 mg/l) of quinine in bitter drinks. The Authority does not contest this evaluation but recommends that the toxicological database on quinine should be reconsidered [^ntr16-L_2012267EN.01000101-E0016]. Pending the re-evaluation of quinine, the use of three quinine salts (FL 14.011, FL 14.152 and FL 14.155) should be restricted to non-alcoholic and alcoholic drinks.

• (21) The Authority considered glycyrrhizic acid and its ammoniated form in the opinion adopted on 22 May 2008 [^ntr17-L_2012267EN.01000101-E0017]. The Authority agreed with the evaluation by the SCF [^ntr18-L_2012267EN.01000101-E0018], which considered that the intake up to 100 mg/person/day would not give rise to safety concerns. Therefore, specific conditions of use should be set for glycyrrhizic acid (FL 16.012) and its ammoniated form (FL 16.060) as flavouring substances.

• (22) Regulation (EC) No 1334/2008 repeals Regulation (EC) No 2232/96 from the date of application of the list referred to in Article 2(2) of that Regulation. It is therefore appropriate, for reasons of legal certainty, to fix the date of application of that list. The principle of mutual recognition laid down in Regulation (EC) No 2232/96 should however continue to apply to flavouring substances included in the Annex to this Regulation for which footnotes 1 to 4 have been assigned. Regulation (EC) No 2232/96 will cease to apply and will become obsolete once the risk assessment and authorisation procedures for those flavouring substances have been concluded.

• (23) The evaluation programme provided for by Regulation (EC) No 1565/2000 was intended for the establishment of the list referred to in Article 2(2) of Regulation (EC) No 2232/96. With the establishment of that list Regulation (EC) No 1565/2000 becomes obsolete and should be repealed. It should however continue to apply to flavouring substances included in the Annex to this Regulation for which footnotes 1 to 4 have been assigned. Regulation (EC) No 1565/2000 will cease to apply and will become obsolete once the risk assessment and authorisation procedures for those flavouring substances have been concluded.

• (24) The register of flavouring substances used in or on foods adopted by Decision 1999/217/EC has become obsolete with the establishment of the list referred to in Article 2(2) of Regulation (EC) No 2232/96 and should be repealed.

• (25) Regulation (EC) No 1334/2008 provides that the Union list of flavourings and source materials shall be established by introducing the list of flavouring substances referred to in Article 2(2) of Regulation (EC) No 2232/96 into Annex I to Regulation (EC) No 1334/2008 at the time of its adoption. The list of flavouring substances referred to in Article 2(2) of Regulation (EC) No 2232/96 should be introduced into Annex I to Regulation (EC) No 1334/2008 accordingly.

• (26) The Union list of flavourings and source materials is to apply without prejudice to other provisions laid down in sector specific legislation.

• (27) The use of flavourings and source materials in infant formulae, follow-on formulae, processed cereal-based foods and baby foods and dietary foods for special medical purposes intended for infants and young children as referred to in Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses [^ntr19-L_2012267EN.01000101-E0019] will be harmonised in the future in the framework of specific rules to be adopted on the composition of foodstuffs intended for infants and young children. Meanwhile, the Member States should be able to apply national provisions in this matter stricter than the ones provided for in the list of flavouring substances referred to in Article 2(2) of Regulation (EC) No 2232/96.

• (28) Pursuant to Regulation (EC) No 1334/2008 flavouring substances not included in the Union list may be placed on the market as such and used in or on food until 18 months after the date of application of the Union list. Since flavouring substances are already on the market in the Member States, provisions have been made to ensure that the transition to a Union authorisation procedure is smooth. To this effect transitional periods have been laid down for food containing those flavouring substances in Commission Regulation (EU) No 873/2012 [^ntr20-L_2012267EN.01000101-E0020].

• (29) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

Definitions

For the purposes of this Regulation the following definitions shall apply:

• (a) ‘Union list’ means the list of flavourings and source materials set out in Annex I to Regulation (EC) No 1334/2008;

• (b) ‘evaluated flavouring substances’ means substances for which the evaluation and approval have been completed at Union level. Those substances are assigned no footnotes in Part A of the Union list of flavourings and source materials;

• (c) ‘flavouring substances under evaluation’ means substances for which the risk assessment at Union level has not been completed at the time of entry into force of this Regulation. Those substances are assigned footnotes 1 to 4 in Part A of the Union list of flavourings and source materials.

Article 2

Adoption of the list of flavouring substances referred to in Regulation (EC) No 2232/96

The list of flavouring substances referred to in Article 2(2) of Regulation (EC) No 2232/96 is hereby adopted as set out in Part A of the Annex to this Regulation.

Article 3

Introduction of the list of flavouring substances into Regulation (EC) No 1334/2008

The text in the Annex to this Regulation is introduced into Annex I to Regulation (EC) No 1334/2008.

Article 4

Flavouring substances under evaluation

Flavouring substances under evaluation may be placed on the market and used in or on foods pending their inclusion as evaluated flavouring substances in Part A of the Union list or their removal from that list.

Article 5

Updating the list

Where necessary, Part A of the Union list shall be updated in accordance with the procedure referred to in Article 7 of Regulation (EC) No 1331/2008 as from the date of entry into force of this Regulation.

Article 6

Repeal of Regulation (EC) No 2232/96

Article 7

Repeal of Regulation (EC) No 1565/2000

Regulation (EC) No 1565/2000 is hereby repealed with effect from 22 April 2013. However it shall continue to apply to flavouring substances under evaluation.

Article 8

Repeal of Decision 1999/217/EC

Decision 1999/217/EC is repealed with effect from 22 April 2013.

Article 9

Provisions for foods for infants and young children

Member States may apply national provisions which are more restrictive than Part A of the Union list as regards the use of flavouring substances in infant formulae, follow-on formulae, processed cereal-based foods and baby foods and dietary foods for special medical purposes intended for infants and young children as referred to in Directive 2009/39/EC. Those national measures must be essential to ensure that consumers are adequately protected and must be proportionate to the attainment of that objective.

Article 10

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 22 April 2013.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 1 October 2012.

For the Commission

The President

José Manuel BARROSO

[^ntr1-L_2012267EN.01000101-E0001]: OJ L 299, 23.11.1996, p. 1.

[^ntr2-L_2012267EN.01000101-E0002]: OJ L 354, 31.12.2008, p. 34.

[^ntr3-L_2012267EN.01000101-E0003]: OJ L 84, 27.3.1999, p. 1.

[^ntr4-L_2012267EN.01000101-E0004]: OJ L 180, 19.7.2000, p. 8.

[^ntr6-L_2012267EN.01000101-E0006]: Annex 6 to the minutes of the 98th meeting of the Scientific Committee on Food, 21 and 22 September 1995.

[^ntr7-L_2012267EN.01000101-E0007]: Flavouring substances and natural sources of flavourings, Volume I, Chemically-defined flavouring substances, Fourth Edition. Council of Europe, Partial agreement in the social and public health field, Strasbourg, 1992, including its subsequent loose-leaf modifications until year 1999.

[^ntr8-L_2012267EN.01000101-E0008]: Evaluation of certain food additives and contaminants. 46th Report of the Joint FAO/WHO Expert Committee on Food Additives, WHO Technical Report Series No. 868, 1997.

49th Report of the Joint FAO/WHO Expert Committee on Food Additives, WHO Technical Report Series No. 884, 1999.

51st Report of the Joint FAO/WHO Expert Committee on Food Additives, WHO Technical Report Series, No. 891, 2000.

53rd Report of the Joint FAO/WHO Expert Committee on Food Additives, WHO Technical Report Series, No. 896, 2000.

[^ntr9-L_2012267EN.01000101-E0009]: OJ L 354, 31.12.2008, p. 16.

[^ntr10-L_2012267EN.01000101-E0010]: OJ L 128, 21.5.2005, p. 73.

[^ntr11-L_2012267EN.01000101-E0011]: OJ L 91, 29.3.2006, p. 48.

[^ntr12-L_2012267EN.01000101-E0012]: OJ L 163, 24.6.2008, p. 42.

[^ntr13-L_2012267EN.01000101-E0013]: OJ L 354, 31.12.2008, p. 1.

[^ntr14-L_2012267EN.01000101-E0014]: Scientific opinion of the Panel on Food Additives, Flavourings, Processing Aids and Materials in contact with Food (AFC) on a request from the Commission on Camphor in flavourings and other food ingredients with flavouring properties. The EFSA Journal 729, 1-15.

[^ntr15-L_2012267EN.01000101-E0015]: Report of the Scientific Committee for Food on Quinine (opinion expressed on 19 February 1988). In Food - Science and techniques. Reports of the Scientific Committee for Food twenty-first series). Internal Market and Industrial Affairs Directorate-General.

[^ntr16-L_2012267EN.01000101-E0016]: Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from Commission on Flavouring Group Evaluation 35 (FGE.35). Three quinine salts from the Priority list from chemical group 30. The EFSA Journal (2008) 739, 1-18.

[^ntr17-L_2012267EN.01000101-E0017]: Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) on a request from the Commission on Flavouring Group Evaluation 36 (FGE.36). Two triterpene glycosides from the priority list. The EFSA Journal (2008) 740, 1-19.

[^ntr18-L_2012267EN.01000101-E0018]: Opinion of the Scientific Committee on Food on glycyrrhizinic acid and its ammonium salt (expressed on 4 April 2003). Scientific Committee on Food. SCF/CS/ADD/EDUL/225 Final. 10 April 2003. European Commission, Health & consumer Protection Directorate-General.

[^ntr19-L_2012267EN.01000101-E0019]: OJ L 124, 20.5.2009, p. 21.

[^ntr20-L_2012267EN.01000101-E0020]: See page 162 of this Official Journal.

ANNEX

UNION LIST OF FLAVOURINGS AND SOURCE MATERIALS

PART A

Union list of flavouring substances

SECTION 1

Content of the list

Table 1 contains the following information:

Column 1 (FL No.): the unique identification number of the substance

Column 2 (Chemical Name): the name of the substance

Column 3 (CAS No): the Chemical Abstracts Service (CAS) registry number

Column 4 (JECFA No.): The Joint FAO/WHO Expert Committee on Food additives (JECFA) number

Column 5 (CoE No.): The Council of Europe (CoE) number

Column 6 (Purity of the named substance at least 95% unless otherwise specified): The purity of the named flavouring substance has to be at least 95%. If less, the composition of the flavouring substances is given in this column.

Column 7 (Restrictions of Use): The use of flavouring substances is permitted in accordance with good manufacturing practices unless specific restriction is given in this column. Flavouring substances with restrictions of use may only be added to the listed food categories and under the specified conditions of use. For the purpose of the restrictions the following food categories, as laid down in Annex II of Regulation (EC) No 1333/2008, shall be referred to:

Column 8 (Footnotes): The footnote ‘1’ is allocated to the flavouring substances for which the evaluation has to be completed by the Authority. The footnotes ‘2’ to ‘4’ refer to time limits set for the applicants to comply with the Authority's requests as expressed in the published opinions. Where the necessary information is not provided by the time requested, the flavouring substance in question will be withdrawn from the Union list. The Authority shall evaluate the submitted data within 9 months from the receipt of such data. Substances which have already been evaluated by JECFA can be recognised from the JECFA number listed in column 4.

• (¹) evaluation to be completed by the Authority

• (²) additional scientific data shall be submitted by 31 December 2012

• (³) additional scientific data shall be submitted by 30 June 2013

• (⁴) additional scientific data shall be submitted by 31 December 2013

Column 9 (Reference): Reference to the scientific body that has carried out the evaluation.

SECTION 2

Notes

Note 1: Ammonium, sodium, potassium and calcium salts as well as chlorides, carbonates and sulphates are covered by the generic substances, providing that they have flavouring properties.

Note 2: If the authorised flavouring substance is a racemate (an equal mixture of optical isomers), both the R- and S- form shall also be authorised for use. If only the R-form has been authorised then the S-form is not covered by this authorisation and vice versa.

Note 3: Maximum levels refer to levels in or on food as marketed. By way of derogation from that principle, for dried and/or concentrated foods which need to be reconstituted the maximum levels shall apply to the food as reconstituted according to the instructions in the labelling taking into account the minimum dilution factor.

Note 4: The presence of a flavouring substance shall be permitted:

• (a) in a compound food other than as referred to in the Annex, where the flavouring substance is permitted in one of the ingredients of the compound food;

• (b) in a food which is to be used solely in the preparation of a compound food and provided that the compound food complies with this Regulation.

Table 1