EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10349/2018 
(POOL/E2/2018/10349/10349 -EN.doc) 
D056135/03  
[…](2018) 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 pyroligneous distillate in the Union list of 
flavourings  
(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 pyroligneous distillate in the Union list of 
flavourings  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on th e 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 2000/131, 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 Decembe r 2008 establishing 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 872/20123 adopt ed the list of 
flavouring substances and introduced  that list  in Part A of Annex I to Regulation (EC) 
No 1334/2008.  Regulation  (EU) No 872/2012 also introduced Part B ( 'Flavouring 
preparations '), Part C ('Thermal process flavourings'), Part D ('Flavour precursors'), 
Part E ('Other flavourings') and Part F ('Source materials') in Annex I to Regulation 
(EC) No 1334/2008 . Parts B to  F of Annex I correspond to the categories of 
flavourings and source materials referred to in Article 9(b) to (f) of the Regulation 
(EC) 1334/2008. Parts B to F contain no entries.  
(3) Commission Regulation (EU) No 873/20124 lays down transitional measures 
concerning the Union list of flavourings and source materials set out in Annex I of 
Regulation (EC) No 1334/2008 .  
                                                 
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 o f 
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 Commission Regul ation (EU) No 873/2012 of 1 October 2012 on transitional measures concerning the 
Union list of flavourings and source materials set out in Annex I to Regulation (EC) No 1334/2008 of 
the European Parliament and of the Council (OJ L 267, 2.10.2012, p. 162).  
EN 2  EN (4) Article 4 of Regulation  (EU) No 873/2012 la ys down a transitio nal period for foods to 
which flavourings belonging to the Parts B to F of Annex I  to Regulation (EC) No 
1334/2008 have been added and which have been the object of an application before 
22 October 2015  pursuan t to Article 3 thereof . Article 4 lays down that the end of the 
transiti onal period for placing on the market of such foods is 22 April 2018.  
(5) Annex I  of Regulation (EC) No 1334/2008 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 . 
(6) On 16 October 2012, an application was submitted to the Commission for the 
authorisation of the pro duct pyroligneous distillate [FL  no. 21.001] with the name 'rum 
ether' under the category 'other flavourings'. The applicant requested this flavouring to 
be used in edible ices , confectionery , chewing gum , cereal and cereal products derived 
from cereal grains, roots and tubers and pulses and legumes , bakery wares , meat and 
meat products , salts, spices , soups , sauces, sa lads, non-alcoholic  beverages , and 
alcoholic beverages  up to certain levels . 
(7) The application was sent to the European Food Safety Authority ('the Authority') for 
its opinion. The application was also made available to the Member States pursuant to 
Article 4 of Regulation (EC) No 1331/2008.  
(8) On 24 August 2017, t he Authority  adopted its 'Scientific Opinion of Flavouring Group 
Evaluation 500 (FGE.500): rum ether', concerning the evaluation of the safety of  
pyroligneous distillate [FL  no. 21.001]  when used as a flavouring under the category 
'other flavourings'5. This product is a complex mixture composed of more than eighty 
individual constituents. The Authority  concluded that according to the overall strategy 
for the risk assessment of flavouring substances, the  presence of genotoxic substances 
as constituents of rum ether is of safety concern. It indicated serious safety concerns 
relating to a number of constituents like furans and derivatives, and other constituents, 
associated with genotoxicity  and carcinogen icity, and also mentioned the 
carcinogenicity risks involved in the presence of ethanol .  
(9) Czech Republic and Slovak Republic have informed the Commission about the use of 
pyroligneous distillate [FL  no. 21.001]  in the traditional spirit drinks tuzemak  and 
tuzemský  and asked to maintain this use for th ese specific spirit drinks .  
(10) According to Recital 7 of the Regulation (EC) No 1334/2008 the approval of 
flavourings should  also take into account other factors relevant to the matter under 
consideration, includ ing societal and traditional factors.  Since the  use of this 
flavouring is currently necessary for maintaining the speci fic traditional organoleptic 
characteristics of the spirit drinks tuzemak  and tuzemský  in Czech Republic and Slovak 
Republic , it is appropriate to authorise this substance under the conditions of use laid 
down in the Annex to this Regulation .  
(11) Those spirit drinks, like all spirit drinks  and alcoholic beverages in general , are not 
intended to be consumed by children or other vulnerable parts of the population . In 
addition to existing labelling requirements, Member States should  require additional 
information to be provided regarding the specific risks linked to the presence of 
pyroligneous distillate (Fl no. 21.001] in th ose traditional alcoholic beverages.  
                                                 
5 EFSA Journal 2017;15( 8):4897 .  
EN 3  EN (12) The spirit drinks to which pyroligneous distil late [FL  no. 21.001] has been added 
should not be used in the manufacture of other foodstuffs.   
(13) When reference is made to the flavouring in the labelling of the spirit  drinks  tuzemak  
and tuzemský , the name o r the FL  number should be used . 
(14) In addition to the requirements of Article 15 of Regulation (EU) No 1334/2008 , when 
pyroligneous distillate  [FL no. 21.001] is marketed as such not intended for the sale to 
the ultimate consumer , it should  be indicated in the labelling that this flavouring  may 
only be used for the manufacture of the spirit  drinks tuzemak  and tuzemský . 
(15) In order to ensure legal certainty , this  Regulation should be applicable as from 23 
April 2018 .  
(16) This Regulation should be in force for a period of  5 years in order to allow for 
alternatives to pyroligneous distillate  [FL no. 21.001] to be developed for the use in 
traditional spirit  drinks tuzemak  and tuzemský . 
(17) Part E of Annex I to Regulation (EC) No 1334/2008 should therefore  be amended 
accordingly.  
(18) 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  
Part E of Annex I to Regulation (EC) No 1334/2008 i s amended in accordance with the 
Annex to this Regulation.  
The pro duct pyroligneous distillate [FL  no.21.001] is authorized in traditional spirit drinks 
tuzemak  and tuzemský  subject to restrictions of use laid in 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.  
It shall apply from 23 April 2018  until [Office of Publications : Please insert the date 
corresponding to 5 years af ter the date of publication of the text in the OJ] . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER