EN   EN  
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11793/2016 
(POOL/E2/2016/11793/11793 -EN.docx)  
D073140/03  
[…](2021) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of 
the Council as regards the inclusion of 3 -(1-((3,5 -dimethylisoxazol -4-yl)methyl) -1H-
pyrazol -4-yl)-1-(3-hydroxybenzyl)imidazolidine -2,4-dione in the Union list of flavouring 
substances  
(Text with EEA relevance)  
 EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of 
the Council as regards the inclusion of 3 -(1-((3,5 -dimethylisoxazol -4-yl)methyl) -1H-
pyrazol -4-yl)-1-(3-hydroxybenzyl)imidazolidine -2,4-dione in the Union list of flavouring 
substances  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning o f 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 Regula tion (E EC) No 1601/91, 
Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC1, 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 esta blishing a common authorisation procedure for food 
additives, food enzymes and food flavourings2, 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 872/2012
3 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 10 August  2012, an application was submitted to the Commission for authorisation 
of the use of 3- (1-((3,5- dimethylisoxazol -4-yl)methyl)- 1H-pyrazol -4-yl)-1-(3-
hydroxybenzyl)imidazolidine -2,4-dione, (FL No 16.127) , as a flavouring substance in 
various foods falling, in substance, under a number of the food categories referred to 
in the Union list of flavourings and source materials . The Commission notified the 
application to the European Food Safety Authority ( ‘the Authority ’) and requested its 
                                                 
1 OJ L 354, 31.12.2008, p. 34.  
2 OJ L 354, 31.12.2008, p. 1.  
3 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 ). EN 2  EN 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 opinion adopted on 21 June 20164 evaluated the safety of  
substance FL No 16.127, concluded that its use does not give rise to safety concern s 
when limited to levels up to those specified  for various foods in different food 
categories. The Authority also noted that it is a substance with flavouring modifying 
properties . 
(6) Since the use of substance FL No 16.127 as a flavouring substance does not give rise 
to safety concerns with the specified conditions of use  and it is not expected to mislead 
the consumer, it is appropriate to authorise s uch use  in the light of the Opinion of the 
Authority . 
(7) Part A of Annex I 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:  
Article 1  
Annex I , Part A  to Regulation (EC)  No 1334/2008 is amended in accordance with the Annex 
to this Regulation.  
Article 2  
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,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN  
                                                 
4 EFSA Journ al 2016;14(7):4334 .