
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 distillate [FL no.21.001] is authorized in traditional spirit drinks tuzemák 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 19 September 2023.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 18 September 2018.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX

In Part E of Annex I to Regulation (EC) No 1334/2008 the following entry concerning pyroligneous distillate [FL no: 21.001] is added:

FL no. Name CAS no JECFA No. CoE No. Purity of the named flavouring Restrictions of use Footnote Reference
‘21.001 Pyroligneous distillate — — — Complex mixture of substances, obtained by distillation of reaction products of pyroligneous acid and ethanol. Liquid with rum-like tasting odour and taste.Constituents:
— Ethanol (determined by Gas Chromatography/Flame Ionization Detector): 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 methyl furan) expressed as furan: less than 8 mg/l
— Methanol and methanol derivatives, expressed as methanol equivalents: less than 2 % (w/w)
— Benzopyrene: 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 following spirit drinks only:tuzemák and tuzemský falling under Regulation (EC) No 110/2008 when marketed in the final package 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 which pyroligneous distillate [FL no: 21.001] has been added shall not be used in the manufacture of other foodstuffs.

3. In addition to the requirements of Article 15 of Regulation (EC) No 1334/2008, when this flavouring is marketed as such, it shall be indicated in the labelling that this flavouring may only be used for the manufacture of the spirit drinks tuzemák and tuzemský.
Member States shall require additional labelling, informing consumers about the specific risks linked to the presence of pyroligneous distillate [FL no. 21.001] in the spirit drinks tuzemák and tuzemský.  EFSA’
