COMMI SSION REGUL ATION (EU) 2021/1532 
of 17 September 2021
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-dimeth yliso xazol-4-yl)meth yl)-1H-pyrazol-4-yl)- 
1-(3-hydro xybenzyl)imidazolidine-2,4-dione in the Union list of flavour ing subst ances 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng 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 proper ties 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/EC (1), and in 
particular Article 11(3) thereof,
Havi ng regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008
establishing a common author isation procedure for food additives, food enzymes and food flavourings (2), 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 mat erials approved for 
use in and on foods and their conditions of use.
(2) Commission Implementing Regulation (EU) No 872/2012 (3)adop ted the list of flavouri ng 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 refer red to in Article 3(1) of Regulation (EC) 
No 1331/2008, either on the initiative of the Commission or followi ng an application submitted by a Member State 
or by an interest ed party.
(4) On 10 August 2012 , an application was submitted to the Commission for author isation of the use of 
3-(1-((3,5-dimethyl isoxazol-4-yl)methyl)-1H-p yrazol-4-yl)-1-(3-hyd roxybenzyl)imidazolidine-2,4-dione, (FL No 16.127), 
as a flavour ing substance in various foods falling, in substance, under a number of the food categorie s referred to in the 
Union list of flavourings and source materials. The Commission notified the application to the European Food Safe ty 
Author ity (‘the Author ity’) and requested its opinion. The Commission also made the application available to the 
Member State s pursuant to Article 4 of Regulation (EC) No 1331/2008.
(5) The Authority in its opinion adopt ed on 21 June 2016 (4)evaluated the safety of substance FL No 16.127, concluded 
that its use does not give rise to safety concer ns when limited to levels up to those specifi ed for various foods in 
differ ent food catego ries. The Author ity also noted that it is a substance with flavouring modifying proper ties.
(6) Since the use of substance FL No 16.127 as a flavouring substance does not give rise to safety concer ns with the 
specifi ed conditions of use and it is not expecte d to mislead the consumer , it is appropr iate to author ise such use in 
the light of the Opinion of the Authority.
(7) Part A of Annex I to Regulation (EC) No 1334/2008 should theref ore be amended according ly.
(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 Octo ber 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).
(4)EFSA Jour nal 2016;14(7):4334.EN Offi cial Jour nal of the European Union 20.9.2021 L 330/69  (8) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGUL ATION:
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 followi ng 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, 17 Septembe r 2021 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 330/70 20.9.2021  ANNEX 
In Annex I, Part A, Section 2, Table 1 to Regulation (EC) No 1334/2008 the follo wing entr y concer ning FL No 16.127 is inser ted, after entr y 16.126:
‘16.127 3-(1-((3,5-dimeth yliso xazol- 
4-yl)methyl) -1H-p yrazol- 
4-yl)-1-(3-h ydro xybenzyl) 
imidazolidine-2,4-dione1119831-25-2 2161 at least 99 %, assa y  
(HPL C/UV)Restr ictions of use as a flavouring substance:
In cate gory 1.4, – not more than 4 mg/kg
In cate gory 1.8,– not more than 8 mg/kg
In cate gory 3 – not more than 4 mg/kg
In cate gory 5.1. – not more than 15 mg/kg
In cate gory 5.2. – not more than 16 mg/kg
In cate gory 5.3. – not more than 30 mg/kg
In cate gory 5.4 – not more than 15 mg/kg
In cate gory 6.3. – not more than 25 mg/kg
In cate gory 12.1. – not more than 75 mg/kg
In cate gory 12.2. – not more than 100 mg/kg
In cate gory 12.3. – not more than 25 mg/kg
In cate gory 12.4. – not more than 25 mg/kg
In cate gory 12.5. – not more than 4 mg/kg
In cate gory 13.2. – not more than 4 mg/kg
In cate gory 13.3, – not more than 4 mg/kg
In catego ry 14.1.4 – not more than 4 mg/l (for dair y based 
drinks only)
In cate gory 14.1.5. – not more than 8 mg/kg
In cate gory 15.1. – not more than 20 mg/kg
In categor y 16. – not more than 4 mg/l (for dair y based deser ts 
only)EFSA ’EN Offi cial Jour nal of the European Union 20.9.2021 L 330/71  