EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/2759 
(POOL/E2/2023/2759/2759 -EN.docx)  
D096634/03  
[…](2024) 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 removal of the flavouring substance Benzene -1,2-diol (FL No. 
04.029) from the Union list  
(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 removal of the flavouring substance Benzene -1,2-diol (FL No. 
04.029) from the Union list  
(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 (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 establishing a common authorisation procedure for food 
additives, food enzymes and food flavouring s2, and in particular Article 7(4) 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 872/20123 adopted the Union list of 
flavouring substances and introduce d 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 Re gulation (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 1334/20 08 contains  Benzene -1,2-diol (FL No. 04.029) , which was  listed on 
the basis of a safety assessment by the Scientific Committee for Food .  
(5) On 28 September 2023 , the European Food Safety Authority (‘the Authority’) , 
adopted opinions on the renewal of the authorisation s for  Zesti Smoke code 10  (SF‐
 
1 OJ L 354, 31.12.2008, p. 34 , ELI: http://data.europa.eu/eli/reg/2008/1334/oj . 
2 OJ L 354, 31.12.2008, p. 1 , ELI: http://data.europa.eu/eli/reg/2008/1331/oj . 
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 , ELI: http://data.europa.eu/eli/reg_impl/2012/872/oj ).  
EN 2  EN 002)4, Smoke Concentrate 809045 (SF‐003)5, SmokEz C‐10 (SF‐005)6 and SmokEz 
Enviro‐23 (SF‐006)7 as smoke flavouring primary product s contain ing Benzene -1,2-
diol (FL No. 04.029) . In its opinions, the Authority considered that Benzene -1,2-diol 
(FL No. 04.029) raises a safety concern as its  genotoxicity was identified in vivo  upon 
oral administration . 
(6) In accordance with  Article 4 , point (a), of Regulation  (EC) No  1334/2008 , only 
flavourings that , based  on available scientific evidence, do not pose a safety risk to 
consumer health may be placed on the market . Benzene -1,2-diol (FL No. 04.029)  
should therefore be removed from the Union list of flavouring substances . 
(7) Regulation (EC) No 1334/2008 should therefore be amended.  
(8) Taking into consideration the low  use of this flavouring substance and i n order to 
ensure a smooth transition  from the rules existing prior to this Regulation , foods to 
which Benzene -1,2-diol (FL No. 04.029) 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 unt il their date of minimum durability or use -by date. Th e 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 .  
(9) 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  
 Amendments to Regulation (EC) No 1334/2008  
Annex I to Regulation (EC) No 1334/2008 is amended in accordance with the Annex to this 
Regulation.  
Article 2  
Transitional measures  
1. Foods to which Benzene -1,2-diol (FL No. 04.029)  has b een added and which were 
lawfully placed on the market before the entry into force of this Regulation may 
continue to be marketed until their date of minimum durability or use-by date .  
 
4 Scientific opinion on the renewal of the authorisation of Zesti Smoke Code  10 (SF‐002) as a smoke 
flavouring Primary Product . EFSA Journal 2023;21(11):836 4. 
5 Scientific opinion on the renewal of the authorisation of Smoke Concentrate 809045 (SF -003) as a 
smoke flavouring Primary Product. EFSA Journal 2023  ;21(11)  :8365 . 
6 Scientific opinion on the renewal of the autorisation of SmokEz C‐10 (SF‐005) as a smoke f lavouring 
Primary Product. EFSA Journal 2023  ;21(11)  :8367 . 
7 Scientific opinion on the renewal of the autorisation of SmokEz Enviro‐23 (SF‐006) as a smoke 
flavouring Primary Product. EFSA Journal 2023;21(11):8368 .  
EN 3  EN 2. Foods imported into the Union to which Benzene -1,2-diol (FL No. 04.029 ) has been 
added may be marketed until their date of minimum durability or use -by date, if the 
importer of such food can demonstrate that they were dispatched from the third 
country concerned  and were in transit to the Union before the entry into force of this 
Regulation . 
3. Paragraphs  1 and 2 shall not apply to Benzene -1,2-diol and to preparations 
containing this substance  not intended to be consum ed as such .  
For the purposes of this paragraph, ‘ preparations ’ means mixtures of flavourings  or 
mixtures of one or more flavourings with other food ingredients , such as food 
additives, enzymes or carriers , to facilitate their storage, sale, standardisation, 
dilution or dissolution .  
Article 3  
This Regulation shall enter into force on the twentieth da y 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 the Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN