BAKGRUNN (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 872/2012 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) 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 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. Those substances were identified by way of a footnote reference requiring the Authority to complete the evaluation. 

(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 is the substance of the Flavouring Group Evaluation 216 (FGE.216) 4- Methyl-2-phenylpent-2-enal (FL No 05.100). For this substance interested food business operators submitted the additional scientific data requested by the Authority. 

(6) In its scientific opinion of 29 June 20224 , the Authority evaluated the submitted data and concluded that the representative substance of the FGE.216 revision 2 (FGE.216Rev2), 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 any substance within FGE.216Rev2 and, therefore, for substance 4-Methyl-2-phenylpent-2-enal (FL No 05.100). Accordingly, the Authority indicated that further data were needed to complete the assessment. 

(7) Pending the submission of further data by interested food business operators, Commission Regulation (EU) 2024/2385 introduced restrictions on the use of 4- Methyl-2-phenylpent-2-enal (FL No 05.100). 

(8) However, interested food business operators did not submit the required data and indicated that there is no further use of this flavouring substance. 

(9) As the concern for aneugenicity cannot be ruled out, 4-Methyl-2-phenylpent-2-enal (FL No 05.100) should be removed from the Union list of flavouring substances. 

(10) Regulation (EC) No 1334/2008 should therefore be amended. 

(11) Foods to which 4-Methyl-2-phenylpent-2-enal (FL No 05.100) has been added and which have been placed on the market in the Union or which are in transit from third countries 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. The transitional measure should not apply to the substance itself and to preparations to which this substance 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. 

(12) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,