Commission Regulation (EU) 2021/1916 of 3 November 2021 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the inclusion of 4-amino-5-(3-(isopropylamino)-2,2-dimethyl-3oxopropoxy)-2-methylquinoline-3-carboxylic acid in the Union list of flavourings (Text with EEA relevance)
Commission Regulation (EU) 2021/1916of 3 November 2021amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the inclusion of 4-amino-5-(3-(isopropylamino)-2,2-dimethyl-3oxopropoxy)-2-methylquinoline-3-carboxylic acid in the Union list of flavourings(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(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 872/2012Commission 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). adopted the 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)On 24 February 2015, an application was submitted to the Commission for authorisation of the use of the substance 4-amino-5-(3-(isopropylamino)-2,2-dimethyl-3oxopropoxy)-2-methylquinoline-3-carboxylic acid (FL No 16.130) and one of its salts, namely, its hemisulfate monohydrate salt, as flavouring substances in various foods falling, in substance, under a number of the food categories referred to in the Union list of flavourings and source materials. According to the application, only that substance and its hemisulfate monohydrate salt, but not other salts of that substance, are intended to be added to food as flavourings. The Commission notified to the European Food Safety Authority ("the Authority") and requested its opinion. The Commission also made the application available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.(5)The Authority, in its opinionEFSA Journal 2017;15(1):4660. adopted on 30 November 2016, evaluated the safety of substance and of its hemisulfate monohydrate salt both under the FL No 16.130. It noted that this substance is a substance with flavouring modifying properties and concluded that its use and also that of only its hemisulfate monohydrate salt do not give rise to safety concerns when used at the estimated levels of dietary intake.(6)In light of the opinion of the Authority, it is appropriate to authorise the use of substance FL No 16.130 and its hemisulfate monohydrate salt as flavouring substances under the specified conditions of use since their use under these conditions does not give rise to safety concerns and it is not expected to mislead the consumer Since only the hemisulfate monohydrate salt of the concerned substance is also intended to be added to food as flavouring, it is also appropriate, for the sake of clarity, to explicitly indicate that Part A, Section 2, Note 1 of Annex I to Regulation (EC) No 1334/2008 does not apply to this substance.(7)Annex I, Part A to Regulation (EC) No 1334/2008 should therefore be amended accordingly.(8)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: