(Utkast) Kommisjonsforordning (EU) .../... om endring av vedlegg I til europaparlaments- og rådsforordning (EF) nr. 1334/2008 med hensyn til oppføring av 3-[3-(2-isopropyl-5-metyl-cykloheksyl)-ureido]-butansyre etylester på EU-listen over aromaer og retting av visse CAS-nummer
Aromaforordningen: oppføring av stoffet 3-[3-(2-isopropyl-5-metyl-cykloheksyl)-ureido]-butansyre etylester i EU-listen
Utkast til kommisjonsforordning sendt til Europaparlamentet og Rådet for klarering og publisert i EUs komitologiregister 23.10.2025
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(fra kommisjonsforordningen)
(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 872/20123 adopted the Union 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 16 March 2020, an application was submitted to the Commission for the authorisation of 3-[3-(2-isopropyl-5-methyl-cyclohexyl)-ureido]-butyric acid ethyl ester (FL No. 16.136), as a flavouring substance to be used in various foods falling under a number of food categories referred to in the Union list of flavourings and source materials. The application was notified to the European Food Safety Authority (‘the Authority’) for its opinion. The Commission also made the application available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.
(5) In its opinion adopted on 16 December 20244 , the Authority evaluated the safety of 3- [3-(2-isopropyl-5-methyl-cyclohexyl)-ureido]-butyric acid ethyl ester (FL No. 16.136) when used as a flavouring substance and concluded that such use under the proposed conditions of use does not raise a safety concern.
(6) In the light of the opinion of the Authority, since the use of 3-[3-(2-isopropyl-5- methyl-cyclohexyl)-ureido]-butyric acid ethyl ester (FL No. 16.136) as a flavouring substance does not give rise to safety concerns under the specified conditions of use and it is not expected to mislead the consumer, it is appropriate to authorise such use.
(7) In addition, the Chemical Abstracts Service registry numbers (CAS Nos) listed in Annex I to Regulation (EC) No 1334/2008 for the flavouring substances FL Nos 08.017, 08.127, 16.041 and 16.132 are incorrect and should be corrected.
(8) Annex I to Regulation (EC) No 1334/2008 should therefore be amended and corrected accordingly to include 3-[3-(2-isopropyl-5-methyl-cyclohexyl)-ureido]-butyric acid ethyl ester (FL No. 16.136) in the Union list of flavourings and to correct the CAS Nos for the flavouring substances FL Nos 08.017, 08.127, 16.041 and 16.132.
(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,