Commission Regulation (EU) 2024/238of 15 January 2024amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the introduction of restrictions on the use of certain flavouring substances(Text with EEA relevance)

Commission Regulation (EU) 2024/238 of 15 January 2024 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the introduction of restrictions on the use of 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 (EC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13 OJ L 354, 31.12.2008, p. 34. , 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 OJ L 354, 31.12.2008, p. 1. , 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) By Commission Implementing Regulation (EU) No 872/2012 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). the list of flavouring substances was adopted and introduced 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 laid down in Annex I to Regulation (EC) No 1334/2008 contains, among others, a number of flavouring substances for which, at the time of adoption of the list by Regulation (EU) No 872/2012, the European Food Safety Authority (the Authority) had not been able to rule out a safety risk to the health of the consumer on the basis of the data available and had, therefore, considered that additional data was necessary to complete their evaluation. Those substances were included in the Union list of flavouring substances but on the condition that safety data addressing the concerns expressed by the Authority was submitted before the expiry of specific deadlines established in Part A of Annex I to Regulation (EC) No 1334/2008. (5) Among the substances included in the Union list of flavourings and source materials but identified by way of a footnote reference requiring the Authority to complete the evaluation, there are the following three substances of the Flavouring Group Evaluation 216 (FGE.216): 2-Phenylcrotonaldehyde (FL No 05.062), 5-Methyl-2-phenylhex-2-enal (FL No 05.099) and 4-Methyl-2-phenylpent-2-enal (FL No 05.100). For those substances the Authority requested additional scientific data that were subsequently submitted by the applicants.

(6) In its scientific opinion of 29 June 2022 Scientific Opinion on Flavouring Group Evaluation 216 Revision 2 (FGE.216Rev2): consideration of the genotoxicity potential of α,β-unsaturated 2-phenyl-2-alkenals from subgroup 3.3 of FGE.19. EFSA Journal 2022;20(8):7420, doi:10.2903/j.efsa.2022.7420. Available online: https://www.efsa.europa.eu/en/efsajournal/pub/7420 , the Authority evaluated the submitted data and concluded that the representative substance of the group, 2-Phenylcrotonaldehyde (FL No 05.062), induced an aneugenicity mode of action. As the available in vivo micronucleus studies were inconclusive, an in vivo potential aneugenicity cannot be ruled out for 2-Phenylcrotonaldehyde (FL No 05.062), 5-Methyl-2-phenylhex-2-enal (FL No 05.099) and 4-Methyl-2-phenylpent-2-enal (FL No 05.100). (7) Following this opinion and in order to further evaluate the safety of those three substances the interested business operators committed to provide further data that would allow a thorough assessment of the in vivo aneugenicity for these three substances IOFI EFFA Letter DG Sante – EFSA Opinion 216 Rev2 (EFSA Journal (2022; 20(8) 7420)) – follow-up IOFI/EFFA letter: confirmation of follow-up testing and anticipated timings. Ares(2022)8489668 . (8) It is also appropriate, pending the re-evaluation by the Authority of the additional data from the interested business operators and following on from the scientific opinion of 29 June 2022, to limit the conditions of use of 2-Phenylcrotonaldehyde (FL No 05.062), 5-Methyl-2-phenylhex-2-enal (FL No 05.099) and 4-Methyl-2-phenylpent-2-enal (FL No 05.100) to their current use. (9) Part A of Annex I to Regulation (EC) No 1334/2008 should therefore be amended accordingly. (10) Foods not complying with the new conditions set out, to which any of the substances concerned have been added and which have been placed on the market in the Union or which have been dispatched from third countries and were in transit to the Union before the entry into force of this Regulation should be allowed to be marketed in the Union until their date of minimum durability or use-by date. This transitional measure should not apply to preparations to which any of the substances concerned has been added and which are not intended to be consumed as such, as the manufacturers of food products that use those preparations as ingredients know their composition when they use them. (11) For reasons of harmonisation with Regulation (EC) No 1333/2008 of the European Parliament and the Council Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16). and in order to account for the restrictions that correspond to the food categories used by the Authority during the exposure assessment, the food categories listed in Section 1 of Part A of Annex I to Regulation (EC) No 1334/2008 should be replaced by the food categories listed in Part D of Annex II to Regulation (EC) No 1333/2008.

(12) A new footnote should be added to column 8 in the Union list, under Section 1 of Part A of Annex I to Regulation (EC) No 1334/2008 to indicate the need for additional data where additional data are expected in order to fully complete the assessment of the Authority. (13) 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

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

Article 2

Transitional measures

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, 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 in transit to the Union before the entry into force of this Regulation.
3. The transitional measures provided for in paragraphs 1 and 2 shall not apply to preparations, not intended to be consumed as such, to which any of the flavouring substances listed in the Annex to this Regulation has been added.
4. For the purposes of this Regulation, preparations shall be understood as mixtures of one or more flavourings to which other food ingredients such as food additives, enzymes or carriers may be also incorporated to facilitate their storage, sale, standardisation, dilution or dissolution.

Article 3

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. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 15 January 2024. For the Commission The President Ursula von der Leyen

Annex

ANNEX Part A of Annex I to Regulation (EC) No 1334/2008 is amended as follows: (1) Section 1 is amended as follows: (a) the table containing the list of food categories is replaced with the following: OJ L 401, 30.12.2006, p. 1. OJ L 339, 6.12.2006, p. 16. OJ L 91, 7.4.1999, p. 29. OJ L 16, 21.1.2009, p. 3. Category numberFood Category0.All categories of foods01.Dairy products and analogues01.1Unflavoured pasteurised and sterilised (including UHT) milk01.2Unflavoured fermented milk products, including natural unflavoured buttermilk (excluding sterilised buttermilk) non-heat-treated after fermentation01.3Unflavoured fermented milk products, heat-treated after fermentation01.4Flavoured fermented milk products including heat-treated products01.5Dehydrated milk as defined by Directive 2001/114/EC01.6Cream and cream powder01.6.1Unflavoured pasteurised cream (excluding reduced fat creams)01.6.2Unflavoured live fermented cream products and substitute products with a fat content of less than 20 %01.6.3Other creams01.7Cheese and cheese products01.7.1Unripened cheese excluding products falling in category 1601.7.2Ripened cheese01.7.3Edible cheese rind01.7.4Whey cheese01.7.5Processed cheese01.7.6Cheese products (excluding products falling in category 16)01.8Dairy analogues, including beverage whiteners01.9Edible caseinates02.Fats and oils and fat and oil emulsions02.1Fats and oils essentially free from water (excluding anhydrous milkfat)02.2Fat and oil emulsions mainly of type water-in-oil02.2.1Butter and concentrated butter and butter oil and anhydrous milkfat02.2.2Other fat and oil emulsions including spreads as defined by Regulation (EC) No 1234/2007 and liquid emulsions02.3Vegetable oil pan spray03.Edible ices04.Fruit and vegetables

04.1Unprocessed fruit and vegetables04.1.1Entire fresh fruit and vegetables04.1.2Peeled, cut and shredded fruit and vegetables04.1.3Frozen fruit and vegetables04.2Processed fruit and vegetables04.2.1Dried fruit and vegetables04.2.2Fruit and vegetables in vinegar, oil, or brine04.2.3Canned or bottled fruit and vegetables04.2.4Fruit and vegetable preparations, excluding products covered by 5.404.2.4.1Fruit and vegetable preparations excluding compote04.2.4.2Compote, excluding products covered by category 1604.2.5Jam, jellies and marmalades and similar products04.2.5.1Extra jam and extra jelly as defined by Directive 2001/113/EC04.2.5.2Jam, jellies and marmalades and sweetened chestnut puree as defined by Directive 2001/113/EC04.2.5.3Other similar fruit or vegetable spreads04.2.5.4Nut butters and nut spreads04.2.6Processed potato products05.Confectionery05.1Cocoa and chocolate products as covered by Directive 2000/36/EC05.2Other confectionery including breath refreshening microsweets05.3Chewing gum05.4Decorations, coatings and fillings, except fruit based fillings covered by category 4.2.406.Cereals and cereal products06.1Whole, broken, or flaked grain06.2Flours and other milled products and starches06.2.1Flours06.2.2Starches06.3Breakfast cereals06.4Pasta06.4.1Fresh pasta06.4.2Dry pasta06.4.3Fresh pre-cooked pasta06.4.4Potato gnocchi06.4.5Fillings of stuffed pasta (ravioli and similar)06.5Noodles06.6Batters 06.7Pre-cooked or processed cereals07.Bakery wares07.1Bread and rolls07.1.1Bread prepared solely with the following ingredients: wheat flour, water, yeast or leaven, salt07.1.2Pain courant français; Friss búzakenyér, fehér és félbarna kenyerek07.2Fine bakery wares08.Meat08.1Fresh meat, excluding meat preparations as defined by Regulation (EC) No 853/200408.2Meat preparations as defined by Regulation (EC) No 853/200408.3Meat products08.3.1Non-heat-treated meat products08.3.2Heat-treated meat products08.3.3Casings and coatings and decorations for meat08.3.4Traditional and traditionally cured meat products with specific provisions concerning nitrites and nitrates08.3.4.1Traditional immersion cured products (Meat products cured by immersion in a curing solution containing nitrites and/or nitrates, salt and other components)08.3.4.2Traditional dry cured products. (Dry curing process involves dry application of curing mixture containing nitrites and/or nitrates, salt and other components to the surface of the meat followed by a period of stabilisation/maturation)08.3.4.3Other traditional and traditionally cured products (including immersion and dry cured processes used in combination or where nitrite and/or nitrate is included in a compound product or where the curing solution is injected into the product prior to cooking)09.Fish and fisheries products09.1Unprocessed fish and fisheries products09.1.1Unprocessed fish09.1.2Unprocessed molluscs and crustaceans09.2Processed fish and fishery products including mollusks and crustaceans09.3Fish roe10.Eggs and egg products10.1Unprocessed eggs10.2Processed eggs and egg products11.Sugars, syrups, honey and table-top sweeteners11.1Sugars and syrups as defined by Directive 2001/111/EC11.2Other sugars and syrups11.3Honey as defined in Directive 2001/110/EC11.4Table-top sweeteners11.4.1Table-top sweeteners in liquid form11.4.2Table-top sweeteners in powder form11.4.3Table-top sweeteners in tablets12.Salts, spices, soups, sauces, salads and protein products

12.1Salt and salt substitutes12.1.1Salt12.1.2Salt substitutes12.2Herbs, spices, seasonings12.2.1Herbs and spices12.2.2Seasonings and condiments12.3Vinegars and diluted acetic acid (diluted with water to 4–30 % by volume)12.4Mustard12.5Soups and broths12.6Sauces12.7Salads and savoury based sandwich spreads12.8Yeast and yeast products12.9Protein products, excluding products covered in category 1.813.Foods intended for particular nutritional uses as defined by Directive 2009/39/EC13.1Foods for infants and young children13.1.1Infant formulae as defined by Commission Directive 2006/141/EC13.1.2Follow-on formulae as defined by Directive 2006/141/EC13.1.3Processed cereal-based foods and baby foods for infants and young children as defined by Commission Directive 2006/125/EC13.1.4Other foods for young children13.1.5Dietary foods for infants and young children for special medical purposes as defined by Commission Directive 1999/21/EC and special formulae for infants13.1.5.1Dietary foods for infants for special medical purposes and special formulae for infants13.1.5.2Dietary foods for babies and young children for special medical purposes as defined in Directive 1999/21/EC13.2Dietary foods for special medical purposes defined in Directive 1999/21/EC (excluding products from food category 13.1.5)13.3Dietary foods for weight control diets intended to replace total daily food intake or an individual meal (the whole or part of the total daily diet)13.4Foods suitable for people intolerant to gluten as defined by Commission Regulation (EC) No 41/200914.Beverages14.1Non-alcoholic beverages 14.1.1Water, including natural mineral water as defined in Directive 2009/54/EC and spring water and all other bottled or packed waters14.1.2Fruit juices as defined by Directive 2001/112/EC and vegetable juices14.1.3Fruit nectars as defined by Directive 2001/112/EC and vegetable nectars and similar products14.1.4Flavoured drinks14.1.5Coffee, tea, herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products14.1.5.1Coffee, coffee extracts14.1.5.2Other14.2Alcoholic beverages, including alcohol-free and low-alcohol counterparts14.2.1Beer and malt beverages14.2.2Wine and other products defined in Part II of Annex VII to Regulation (EU) No 1308/201314.2.3Cider and perry14.2.4Fruit wine and made wine14.2.5Mead14.2.6Spirit drinks as defined in Regulation (EU) 2019/78714.2.7Aromatised wine products as defined by Regulation (EU) No 251/201414.2.7.1Aromatised wines14.2.7.2Aromatised wine-based drinks14.2.7.3Aromatised wine-product cocktails14.2.8Other alcoholic beverages including mixtures of alcoholic beverages with non-alcoholic beverages and other alcoholic beverages based on distilled alcohol with alcoholic strength by volume less than 15 %15.Ready-to-eat savouries and snacks15.1Potato-, cereal-, flour- or starch-based snacks15.2Processed nuts16.Desserts excluding products covered in categories 1, 3 and 417.Food supplements as defined in Directive 2002/46/EC17.1Food supplements supplied in a solid form, excluding food supplements for infants and young children17.2Food supplements supplied in a liquid form, excluding food supplements for infants and young children18.Processed foods not covered by categories 1 to 17, excluding foods for infants and young children

(b) under Column 8 (footnotes), the following footnote is added: (5) additional scientific data shall be submitted in a timeframe agreed with the Commission Services, for the evaluation to be completed by the Authority. (2) in Table 1 in Section 2, entries 05.062, 05.099 and 05.100 are replaced by the following: 05.0622-Phenylcrotonaldehyde4411-89-61474670 In category 1.4 – not more than 0,50 mg/kg In category 1.7 – not more than 1,40 mg/kg In category 1.8 – not more than 1,30 mg/kg In category 2.1, 2.2, 2.3 – not more than 1,60 mg/kg In category 3.0 – not more than 1,15 mg/kg In category 4.2 – not more than 0,05 mg/kg In category 4.2.2 – not more than 0,20 mg/kg In category 4.2.5 – not more than 0,30 mg/kg In category 5.1 – not more than 2,00 mg/kg In category 5.2 – not more than 2,00 mg/kg In category 5.3 – not more than 2,00 mg/kg In category 5.4 – not more than 1,10 mg/kg In category 6.3 – not more than 2,00 mg/kg In category 6.4 – not more than 0,04 mg/kg In category 6.6 – not more than 0,30 mg/kg In category 6.7 – not more than 0,60 mg/kg In category 7.1 – not more than 2,00 mg/kg In category 7.2 – not more than 2,00 mg/kg In category 8.2, 8.3 – not more than 0,80 mg/kg In category 9.2, 9.3 – not more than 0,50 mg/kg In category 10.2, – not more than 0,20 mg/kg In category 11.2 – not more than 1,5 mg/kg In category 12.2 – not more than 0,60 mg/kg In category 12.3 – not more than 1,80 mg/kg In category 12.4 – not more than 0,20 mg/kg In category 12.5 – not more than 0,40 mg/kg In category 12.6 – not more than 1,90 mg/kg In category 12.7 – not more than 0,20 mg/kg In category 12.9 – not more than 2,00 mg/kg In category 13.2, 13.3, 13.4 – not more than 2,00 mg/kg In category 14.1 – not more than 2,00 mg/kg In category 14.2.1 – not more than 0,20 mg/kg In category 14.2.2 – not more than 0,30 mg/kg In category 14.2.5 – not more than 0,50 mg/kg In category 14.2.6 – not more than 1,50 mg/kg In category 15.0 – not more than 2,00 mg/kg In category 16 – not more than 2,00 mg/kg In category 18.0 – not more than 0,40 mg/kg 5EFSA 05.0995-Methyl-2-phenylhex-2-enal21834-92-4147210365 In category 1.4 – not more than 5,00 mg/kg In category 1.7 – not more than 3,20 mg/kg In category 1.8 – not more than 5,00 mg/kg In category 2.1, 2.2, 2.3 – not more than 5,00 mg/kg In category 3.0 – not more than 5,00 mg/kg In category 4.2 – not more than 1,10 mg/kg In category 4.2.2 – not more than 0,50 mg/kg In category 4.2.5 – not more than 2,70 mg/kg In category 5.1 – not more than 5,00 mg/kg In category 5.2 – not more than 5,00 mg/kg In category 5.3 – not more than 5,00 mg/kg In category 5.4 – not more than 5,00 mg/kg In category 6.3 – not more than 2,10 mg/kg In category 6.4 – not more than 0,30 mg/kg In category 6.6 – not more than 3,00 mg/kg In category 6.7 – not more than 0,06 mg/kg In category 7.1 – not more than 5,00 mg/kg In category 7.2 – not more than 5,00 mg/kg In category 8.2, 8.3 – not more than 0,20 mg/kg In category 9.2, 9.3 – not more than 5,00 mg/kg In category 10.2 – not more than 0,50 mg/kg

In category 11.1 – not more than 2,40 mg/kg In category 11.2 – not more than 5 mg/kg In category 11.4 – not more than 0,02 mg/kg In category 12.2 – not more than 5,00 mg/kg In category 12.3 – not more than 3,00 mg/kg In category 12.4 – not more than 5,00 mg/kg In category 12.5 – not more than 0,20 mg/kg In category 12.6 – not more than 1,60 mg/kg In category 12.7 – not more than 0,60 mg/kg In category 12.9 – not more than 5,00 mg/kg In category 13.2, 13.3, 13.4 – not more than 1,10 mg/kg In category 14.1 – not more than 5,00 mg/kg In category 14.2.1 – not more than 1,25 mg/kg In category 14.2.2 – not more than 5,00 mg/kg In category 14.2.5 – not more than 5,00 mg/kg In category 14.2.6 – not more than 5,00 mg/kg In category 15.0 – not more than 5,00 mg/kg In category 16 – not more than 5,00 mg/kg In category 17 – not more than 5,00 mg/kg In category 18.0 – not more than 2,30 mg/kg 5EFSA 05.1004-Methyl-2-phenylpent-2-enal26643-91-4147310366 In category 1.4 – not more than 0,60 mg/kg In category 1.7 – not more than 5,00 mg/kg In category 1.8 – not more than 0,50 mg/kg In category 2.1, 2.2, 2.3 – not more than 5,00 mg/kg In category 3.0 – not more than 0,60 mg/kg In category 4.2 – not more than 0,09 mg/kg In category 4.2.2 – not more than 1,50 mg/kg In category 4.2.5 – not more than 0,20 mg/kg In category 5.1 – not more than 2,00 mg/kg In category 5.2 – not more than 5,00 mg/kg In category 5.3 – not more than 5,00 mg/kg In category 5.4 – not more than 5,00 mg/kg In category 6.3 – not more than 5,00 mg/kg In category 6.4 – not more than 1,50 mg/kg In category 6.6 – not more than 3,00 mg/kg In category 6.7 – not more than 0,20 mg/kg In category 7.1 – not more than 5,00 mg/kg In category 7.2 – not more than 5,00 mg/Kg In category 8.2, 8.3 – not more than 1,50 mg/kg In category 9.2, 9.3 – not more than 1,50 mg/kg In category 10.2 – not more than 1,50 mg/kg In category 11.2 – not more than 0,10 mg/kg In category 12.2 – not more than 0,90 mg/kg In category 12.3 – not more than 1,50 mg/kg In category 12.4 – not more than 1,50 mg/kg In category 12.5 – not more than 0,80 mg/kg In category 12.6 – not more than 1,50 mg/kg In category 12.7 – not more than 1,50 mg/kg In category 12.9 – not more than 5,00 mg/kg In category 13.2, 13.3, 13.4 – not more than 5,00 mg/kg In category 14.2.1 – not more than 0,08 mg/kg In category 14.2.2 – not more than 0,08 mg/kg In category 14.2.5 – not more than 0,08 mg/kg In category 14.2.6 – not more than 0,08 mg/kg In category 15.0 – not more than 1,8 mg/kg In category 16 – not more than 4,00 mg/kg In category 17 – not more than 0,60 mg/kg 5EFSA