EN    EN   
  EUROPEAN COMMISSION   
Brussels, XXX  
[…](2011) XXX draft   
  
Draft COMMISSION REGULATION (EU) No …/..   
of XXX  
 on transitional measures concerning the Union list of flavourings and source 
materials  set out in Annex I to Regulation (EC) No 1334/2008  
(Text with EEA relevance)  
 EN 2   EN Draft COMMISSION REGULATION (EU) No …/.. 
of XXX 
on transitional measures concerning the Unio n list of flavourings and source materials  
set out in Annex I of Regulation (EC) No 1334/2008 
(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 am ending Council Regulation (EEC) No 1601/91, 
Regulations (EC) No 2232/96 and (E C) No 110/2008 and Directive 2000/13/EC
1 and in 
particular Article 25(3) thereof, 
Whereas: 
(1) Article 9 of Regulation (EC)  No 1334/2008 lays down the type of flavourings and 
source materials for which an eval uation and approval is required.  
(2) Article 10 of Regulation (EC) No 1334/2008 provides that, of the flavourings and 
source materials referred to in Article 9, only those included in the Union list may be placed on the market as such and used in or on foods under the conditions of use specified therein, where applicable.  
(3) Article 30 of Regulation (EC) No 1334/2008 specifies that Article 10 is to apply 
from 18 months after the date of  application of the Union list. 
(4) It is therefore appropriate to  fix that date of application of the Union list for the 
purposes of third paragraph of Artic le 30 of Regulation (EC) No 1334/2008. 
(5) As a first step, a Union list of flavouring substances referred to in point (a) of 
Article 9 of Regulation  (EC) No 1334/ 2008 has been established by Regulation 
(EU) …  by introducing the list of fla vouring substances referred to in Regulation 
(EC) No 2232/96 into Annex I to Regul ation (EC) No 1334/2008 and by fixing the 
dates of application of that list. 
(6) Pursuant to Regulation (E C) No 1334/2008 flavouring s ubstances not included in 
the Union list may be placed on the market as such and used in or on food until 18 
                                                
 
1  OJ L 354, 31.12.2008, p. 34. EN 3   EN months after the date of application of the Union list. Since flavouring substances 
are already on the market in the Member St ates, provision should be made to ensure 
that the transition to a Union authorisa tion procedure is smooth. To increase legal 
certainty, a transitional period should be  provided also for food containing those 
flavouring substances. 
(7) As a second step, the flavourings and source ma terials referred to in Article 9 (b) to 
(f) must be evaluated. The interested par ties are to submit applications for updating 
the Union list by adding a substance to the list pursu ant to Regulation (EC) No 
1331/2008 and are to follow Commission Regulation (EU) No 234/2011 of 10 
March 2011 implementing Regulation (EC) No 1331/2008 of the European 
Parliament and of the Council establishi ng a common authorisation procedure for 
food additives, food enzymes and food flavourings2 as to the data required and as to 
the content, drafting and presentation of the applications for authorisation of flavourings and source materials listed in Ar ticle 9(b) to (f) of  Regulation (EC) No 
1334/2008.  
(8) In accordance with the objectives of Regulation (EC) No 1334/2008, in order to 
enhance legal certainty and non-discriminati on it is appropriate to adopt transitional 
measures to allow the time for evaluation a nd authorisation of those flavourings and 
source materials.  
(9) The date of application of Parts B to  F of Annex I to Regulation (EC) No 
1334/2008, concerning flavourings a nd source materials listed in Article 9(b) to (f) 
of that Regulation, should be postponed to allow the time for evaluation and authorisation of those flavour ings and source materials. 
(10) The interested parties should submit applications for authorisations within a set time 
limit  as regards flavourings and source materials listed in Article 9 (b) to (f) of Regulation (EC) No 1334/ 2008 that are currently placed on the market.  
(11) Pursuant to Regulation (EC)  No 1334/2008 flavourings a nd source materials listed 
in Article 9 (b) to (f) not included in the Union list may be placed on the market as 
such and used in or on food until 18 months  after the date of application of the 
Union list. Since flavourings and source mate rials listed in Article 9 (b) to (f) of 
Regulation (EC) No 1334/2008 are already on the market  in the Member States, 
provision should be made to ensure that the transition to a Union authorisation 
procedure is smooth. To increase legal cer tainty, a transitional period should be 
provided also for food containi ng those flavouring substances. 
(12) Article 30 of Regulation (EC) No 1334/ 2008 specifies that Articles 26 and 28 of 
Regulation (EC) No 1334/2008 concerning  amendments to Council Regulation 
(EEC) No 1601/91 of 10 June 1991 laying down general rules on the definition, description and presentation of  aromatised wines, aromatised wine-based drinks and 
aromatised wine-product cocktails
3 and to Regulation (EC) No 110/2008 of the 
European Parliament and of the Council of 15 January 2008 on the definition, description, presentation, labe lling and the protection of geographical indications of 
                                                
 
2  OJ L 64, 11.3.2011, p.15. 
3  OJ L 149, 14.6.1991, p. 1. EN 4   EN spirit drinks4 are to apply from the date of application of the Union list. It is 
therefore appropriate to fix that date of application fo r the purposes of the fourth 
paragraph of Article 30 of Regulation (EC) No 1334/2008. 
(13) The measures provided for in this Regulat ion are in accordance with the opinion of 
the Standing Committee on the Food Chain and Animal Health and neither the 
European Parliament nor the Council have opposed them, 
HAS ADOPTED THIS REGULATION: 
Chapter I 
Flavouring substances referred to in Arti cle 9 (a) of Regulation (EC) No 1334/2008 
Article 1 
Transitional measures for food c ontaining flavouring substances 
Foods containing flavouring substances, which ar e lawfully placed on the market or labelled 
prior to  [18 months after the da te of application of Part A of  the Union list as set out in 
Regulation (EU) …] but which do not comply w ith Part A of Annex I to Regulation (EC) No 
1334/2008 may be marketed until their date of minimum durability or use-by-date. 
 
Chapter II  
Flavourings and source materials referred to in Article 9 (b) to (f) of  Regulation (EC) No 
1334/2008 
Article 2 
Date of application of Parts B to F of the Un ion list of flavourings  and source materials  
For the purposes of the third paragraph of Ar ticle 30 in conjunction  with Article 10 of 
Regulation (EC) No 1334/2008, Part s B to F of the Union list of flavourings and source 
materials set out in Annex I to that Regulation, shall apply from …[4 year s after the entry into 
force of this Regulation]. 
Article 3 
Time limit for submissions 
Interested parties shall submit applications for authorisation of flavourings and source 
materials referred to in Artic le 9 (b) to (f) of Regulati on (EC) No 1334/2008 placed on the 
market at the time of entry into force of this Regulation to the Commission in accordance with the Regulation (EU) No 1331/2008 at the latest by [ 36 months from the entry into force of this 
Regulation].  
                                                
 
4  OJ L 39, 13.2.2008 EN 5   EN Article 4  
Transitional measure for food containing flavouri ngs and source materials referred to in 
Article 9 (b) to (f) of Regulation (EC) No 1334/2008  
Foods containing flavourings and source material s referred to in Article 9 (b) to (f) of 
Regulation (EC) No 1334/2008 which are lawfully placed on the market or labelled prior to 
[date XX][4 years + 18 months af ter the date of entry into for ce of this Regulation] but which 
do not comply with Parts B to F of Anne x I to Regulation (EC) No 1334/2008, may be 
marketed until their date of mini mum durability or use-by-date. 
Chapter III  
Final provisions 
Article 5 
Amendments to Regulations (E C) No 1601/91 and (EC) No 110/2008 
For the purposes of the fourth paragraph of  Article 30 of Regula tion (EC) No 1334/2008, 
concerning amendments to Regulations (EC)  No 1601/91 and (EC) No 110/2008, the date of 
application of the Union list of flavouri ngs and source materials shall be the [ 6 months after 
the date of entry into force of this Regulation] . 
Article 6 
Entry into force 
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 a nd directly applicable in the Member States in 
accordance with the Treaties. 
Done at Brussels, […] 
 For the Commission 
 José Manuel BARROSO  The President