COMMISSION REGUL ATION (EU) 2018/1246 
of 18 September 2018 
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 flavour ings 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d 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 flavouri ng 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, 
Having 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 mater ials appro ved 
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 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 (‘Fla vouri ng preparations’) , Part C (‘Ther mal process flavouri ngs’), Part D (‘Flav our precursors’ ), 
Part E (‘Other flavourings ’) and Part F (‘Source mater ials’) in Annex I to Regulation (EC) No 1334/2008. Parts B 
to F of Annex I correspond to the cate gories of flavourings and source mater ials refer red to in Article 9(b) to (f) 
of the Regulation (EC) No 1334/2008. Parts B to F contain no entr ies. 
(3)  Commission Regulation (EU) No 873/2012 (4) lays down transitional measures concer ning the Union list of 
flavourings and source mat erials set out in Annex I of Regulation (EC) No 1334/2008. 
(4)  Article 4 of Regulation (EU) No 873/2012 lays down a transitional 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 which have been the 
object of an application before 22 October 2015 pursuant to Article 3 thereof. Article 4 lays down that the end 
of the transitional period for placing on the mark et of such foods is 22 Apr il 2018. 
(5)  Annex I of Regulation (EC) No 1334/2008 may be update d 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 submitte d by a Member State or by an interest ed party. 
(6)  On 16 October 2012, an application was submitte d to the Commission for the author isation of the product 
pyroligneous distillat e [FL no. 21.001] with the name ‘rum ether ’ under the categor y ‘other flavourings’. The 
applicant request ed this flavouri ng to be used in edible ices, confect ioner y, chewing gum, cereals and cereal 
products derived from cereal grains, roots and tubers and pulses and legumes, baker y wares, meat and meat 
products, salts, spices, soups, sauces, salads, non-alcoholic beverages, and alcoholic beverages up to certain levels. 19.9.2018 L 235/3 Official Jour nal of the European Union EN     
(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). 
(4)Commission Regulation (EU) No 873/2012 of 1 October 2012 on transitional measures concer ning 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). (7)  The application was sent to the European Food Safety Author ity (‘the Author ity’) for its opinion. The application 
was also made available to the Member State s pursuant to Article 4 of Regulation (EC) No 1331/2008. 
(8)  On 24 August 2017, the Auth ority adopt ed its ‘Scientif ic Opinion of Flavouring Group Evaluation 500 
(FGE.500): rum ether ’, concer ning the evaluation of the safet y of pyroligneous distillat e [FL no. 21.001] when 
used as a flavouri ng under the categor y ‘other flavouri ngs’ (1). This product is a compl ex mixture compo sed of 
more than eighty individual constituents. The Author ity concluded that according to the overall strateg y for the 
risk assessment of flavouri ng substances, the presence of genoto xic substances as constituents of rum ether is of 
safety concer n. It indicate d serious safety concer ns relating to a number of constituents like furans and 
derivatives, and other constituents, associated with genot oxicity and carcinog enicity , and also mentioned the 
carcinog enicity risks involved in the presence of ethanol. 
(9)  Czec h Republic and Slovak Republic have informed the Commission about the use of pyroligneous distillate 
[FL no. 21.001] in the traditional spirit drinks tuzemák and tuzemský and aske d to maintain this use for these 
specific spirit drinks. 
(10)  According to Recital 7 of the Regulation (EC) No 1334/2008 the approval of flavouri ngs should also take into 
account other factors relevant to the matte r under consideration, including societal and traditional factors. Since 
the use of this flavouring is currently necessar y for maintaining the specifi c traditional organolep tic charact eristics 
of the spirit drinks tuzemák and tuzemský in Czec h Republic and Slovak Republic, it is appropr iate to author ise 
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 regar ding the specific risks linked to the presence of 
pyroligneous distillate (FL no. 21.001] in those traditional alcoholic beverages. 
(12)  The spirit drinks to whic h pyroligneous distillate [FL no. 21.001] has been added should not be used in the 
manuf acture of other foodstuffs. 
(13)  When referen ce is made to the flavouri ng in the labelling of the spirit drinks tuzemák and tuzemský, the name or 
the FL number should be used. 
(14)  In addition to the requirements of Article 15 of Regulation (EC) No 1334/2008, when pyroligneous distillat e 
[FL no. 21.001] is mark eted as such not intende d for the sale to the ultimat e consumer , it should be indicate d in 
the labelling that this flavouring may only be used for the manuf acture of the spirit drinks tuzemák and tuzemský. 
(15)  In order to ensure legal certainty , this Regulation should be applicable as from 23 Apr il 2018. 
(16)  This Regulation should be in force for a period of 5 years in order to allow for alternatives to pyroligneous 
distillat e [FL no. 21.001] to be developed for the use in traditional spirit drinks tuzemák and tuzemský. 
(17)  Part E of Annex I to Regulation (EC) No 1334/2008 should theref ore be amended according ly. 
(18)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
Part E of Annex I to Regulation (EC) No 1334/2008 is amended in accordance with the Annex to this Regulation. 
The product pyroligneous distillat e [FL no.21.001] is author ized in traditional spirit drinks tuzemák and tuzemský subject 
to restr ictions of use laid in the Annex to this Regulation. 19.9.2018 L 235/4 Official Jour nal of the European Union EN     
(1)EFSA Jour nal 2017;15(8):4897. 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. 
It shall apply from 23 Apr il 2018 until 19 Sept ember 2023. 
This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 18 September 2018. 
For the Commission 
The President 
Jean-Claude JUNCK ER  19.9.2018 L 235/5 Official Jour nal of the European Union EN     ANNEX 
In Part E of Annex I to Regulation (EC) No 1334/2008 the followi ng entr y concer ning pyroligneous distillat e [FL no: 21.001] is added: 
FL no. Name CAS no JECF A No. CoE No. Purity of the named flavouring Restr ictions of use Footnote Reference 
‘21.001 Pyroligneous 
distillat e — — — Com plex mixture of substances, obtained by 
distillation of reaction products of pyrolig ­
neous acid and ethanol. Liquid with rum-like 
tasting odour and taste . 
Constituents: 
—Ethanol (deter mined by Gas Chromat o­
graphy/Flame Ionization Detect or): more 
than 40 % w/w) 
—  Ethyl acetate: less than 25 % w/w) 
—  Ethyl formate: less than 2 % w/w) 
—  Ethyl propionate: less than 4 % w/w) 
—  Ethyl butyrate: less than 1,5 % w/w) 
—  Methyl acetate : less than 3,5 % w/w) 
—  Furan equivalents (furan and 2 meth yl 
furan) expressed as furan: less than 8 mg/l 
—Methanol and methanol derivatives, ex­
pressed as methanol equivalents: less than 
2 % (w/w) 
—  Benzop yrene: less than 1 µg/l 
—  Benz(a)anthra-cene: less than 2 µg/l 
—  acids (expressed as acetic acid): less than 
1,00 g/l  In the followi ng spirit drinks only: 
tuzemák and tuzemský falling under Regulation 
(EC) No 110/2008 when mark eted in the 
final packag e intended only for the final 
consumer , 3 800 mg/l. 
1.  When reference is made in the labelling 
to the flavouring pyroligneous distillate 
[FL no: 21.001] in the spirit drinks 
tuzemák and tuzemský, the name or the 
FL number shall be used. 
2.Tuzemák and tuzemský to whic h pyrolig ­
neous distillate [FL no: 21.001] has been 
added shall not be used in the manufa c­
ture of other foodstuffs. 
3.  In addition to the requirements of 
Article 15 of Regulation (EC) 
No 1334/2008, when this flavouring is 
market ed as such, it shall be indicate d in 
the labelling that this flavouri ng may only 
be used for the manufa cture of the spirit 
drinks tuzemák and tuzemský. 
Member States shall require additional la­
belling, informing consumers about the 
specific risks linked to the presence of pyro­
ligneous distillate [FL no. 21.001] in the spirit 
drinks tuzemák and tuzemský.  EFSA ’   19.9.2018 L 235/6 Official Jour nal of the European Union EN