Commission Regulation (EU) 2024/234 of 15 January 2024 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the removal of certain flavouring substances from the Union list
Commission Regulation (EU) 2024/234of 15 January 2024amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the removal of certain flavouring substances from the Union list(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/ECOJ 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 flavouringsOJ L 354, 31.12.2008, p. 1., and in particular Article 7(4) 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 872/2012Commission 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. 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.(3)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 that 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 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. However, the operators responsible for placing the following eight substances on the market as flavouring substances, for which the Authority requested additional scientific data, did not submit the required data and withdrew their respective applications: 2-Phenylpent-2-enal (FL No 05.175); 2-Phenyl-4-methyl-2-hexenal (FL No 05.222); 2-(sec-Butyl)–4,5-dimethyl-3-thiazoline (FL No 15.029); 4,5-Dimethyl-2-ethyl-3-thiazoline (FL No 15.030); 2,4-Dimethyl-3-thiazoline (FL No 15.060); 2-Isobutyl-3-thiazoline (FL No 15.119); 5-Ethyl-4-methyl-2-(2-methylpropyl)-thiazoline (FL No 15.130); 5-Ethyl-4-methyl-2-(2-butyl)-thiazoline (FL No 15.131) ("substances concerned").The substances concerned should therefore be removed from the Union list of flavouring substances.(4)Regulation (EC) No 1334/2008 should therefore be amended accordingly.(5)Foods 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.(6)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 1Amendments for Regulation (EC) No 1334/2008Annex I to Regulation (EC) No 1334/2008 is amended in accordance with the Annex to this Regulation.
Article 2Transitional measures1.Foods to which any of the flavouring substances listed in the Annex to this Regulation has been added and which were lawfully placed on the market before the entry into force of this Regulation may continue to be marketed until their date of minimum durability or use-by date.2.Foods imported into the Union to which any of the flavouring substances listed in the Annex to this Regulation has been added may be marketed until their date of minimum durability or use-by date, if the importer of such food 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 3Entry into forceThis 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 the Member States.Done at Brussels, 15 January 2024.For the CommissionThe PresidentUrsula von der LeyenANNEXIn Part A of Annex I to Regulation (EC) No 1334/2008, the following entries are deleted:
05.1752-Phenylpent-2-enal3491-63-22EFSA
05.2222-Phenyl-4-methyl-2- hexenal26643-92-52EFSA
15.0292-(sec-Butyl)-4,5-dimethyl-3-thiazoline65894-82-810592EFSA
15.0304,5-Dimethyl-2-ethyl-3-thiazoline76788-46-010582EFSA
15.0602,4-Dimethyl-3-thiazoline60755-05-72EFSA
15.1192-Isobutyl-3-thiazoline39800-92-52EFSA
15.1305-Ethyl-4-methyl-2-(2-methylpropyl)-thiazoline83418-53-517612EFSA
15.1315-Ethyl-4-methyl-2-(2-butyl)-thiazoline83418-54-617622EFSA