COMMI SSION REGUL ATION (EU) 2018/79 
of 18 Januar y 2018 
amending Regulation (EU) No 10/2011 on plas tic mater ials and articles intended to come into 
cont act with food 
(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 1935/2004 of the European Parliament and of the Council of 27 October 2004 on 
mate rials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (1), 
and in particular Article 5(1)(a), (d), (e), (h) and (i), Article 11(3) and Article 12(6) thereof, 
Whereas: 
(1)  Commission Regulation (EU) No 10/2011 (2) (‘the Regulation’) establishes a Union list of author ised substances 
whic h may be used in plastic mat erials and articles intended to come into contact with food. 
(2)  Since the last amendment to Regulation (EU) No 10/2011, the European Food Safet y Author ity (‘the Auth ority’) 
has published further scientific opinions on particular substances that may be used in food contact mater ials  
(‘FCM’) as well as on the permitted use of already author ised substances. In order to ensure that the Regulation  
(EU) No 10/2011 reflects the most recent findings of the Author ity, that Regulation should be amended. 
(3)  The Author ity adopt ed a favourable scientifi c opinion (3) on the use of the substance (butadiene, styrene, methyl 
methacr ylate, butyl acrylate) copolymer cross-linked with divin ylbenzene or 1,3-butanediol dimethacr ylate (FCM 
substance No 856 and CAS No 25101-28-4). The Author ity concluded that the substance is not of a safety 
concer n for the consumer if used as a polymer ic additive at up to 40 % w/w in blends of styrene acrylonitr ile 
copolymer (SAN)/poly( methyl methacr ylate) (PMMA) repeat-use articles intended for contact at room temperature 
with aqueous, acidic and/or low alcoholic (< 20 %) foodstuffs for less than 1 day and with dry foodstuffs for any 
duration of contact including long-t erm storag e. The current author isation of this substance should be exte nded 
to include that use, provided that those specifi cations are met. 
(4) The Auth ority adopt ed a favourable scientific opinion (4) on the use of the monomer 2,4,4′-tr ifluorobenzo ­
phenone (FCM substance No 1061 and CAS No 80512-44-3). The Authority concluded that this substance is not 
of a safet y concer n for the consumer if used as co-monomer up to 0,3 % w/w based on the final mater ial in the 
manuf acture of polye ther ether ketone plastics. That monomer should theref ore be included in the Union list of 
author ised substances with the restr iction that this specifi cation should be met. 
(5)  The Author ity adopt ed a favourable scientifi c opinion (5) on the use of the monomer 2,3,3,4,4,5,5-hepta fluoro-1- 
penten e (FCM substance No 1063 and CAS No 1547-26-8). The Author ity concluded that the substance is not of 
a safety concer n for the consumer if used as co-monomer together with tetrafluoroethylen e and/or ethylen e 
co-monomers to manuf acture fluorocopolymers that are only intende d to be applied as polymer processing aids 
at up to 0,2 % w/w of the FCM. For this application, the low molecular mass fraction below 1 500 Da in the 
fluorocopolymer should be no greate r than 30 mg/kg. That monomer should be included in the Union list of 
author ised substances with the restr iction that those specifications should be met. 
(6)  The Author ity adopt ed a favourable scientific opinion (6) on the use of the substance tungsten oxide  
(WOn (n = 2,72-2,90)) (FCM substance No 1064 and CAS No 39318-18-8). The Auth ority concluded that the 
substance is not of a safety concer n for the consumer if the additive is used as a reheat agent in polye thylene 
terephthalate (PET). The Author ity considered that due to the insolubility of the substance, low migration 19.1.2018 L 14/31 Official Jour nal of the European Union EN     
(1)OJ L 338, 13.11.2004, p. 4. 
(2)Commission Regulation (EU) No 10/2011 of 14 Januar y 2011 on plastic mat erials and articles intended to come into contact with food  
(OJ L 12, 15.1.2011, p. 1). 
(3)EFSA Journal 2016;14(11):4637. 
(4)EFSA Journal 2016;14(7):4532. 
(5)EFSA Journal 2016;14(10):4582. 
(6)EFSA Journal 2017;15(1):4661. is expecte d for any foreseeable use as a reheat additive in PET. Theref ore, verification of the migration limit is not 
necessar y. For other technical functions or for use in other polymers, the Auth ority concluded that the migration 
should not excee d 0,05 mg/kg (expressed as tungst en). That substance should be included in the Union list of 
author ised substances with the restr iction that those specifications should be met. 
(7)  The Authority adopt ed a favourable scientific opinion (1) on the use of the mixture of meth yl-branche d and linear 
C14-C18 alkanamides, derived from fatty acids (FCM substance No 1065 and CAS No 85711-28-0). The Author ity 
concluded that the substance is not of a safet y concer n for the consumer if used in the manuf acture of poly olefi n 
articles intende d for contact with all foodstuffs other than fatty foods (as defined by simulant D2) and when its 
migration does not excee d 5 mg/kg food. That mixture should theref ore be included in the Union list of 
author ised substances with the restr iction that these specifi cations should be met. 
(8)  Annex I to Regulation (EU) No 10/2011 should theref ore be amended according ly. 
(9)  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 
Annex I to Regulation (EU) No 10/2011 is amended in accordance with the Annex to this Regulation. 
Article 2 
Plastic mater ials and articles compl ying with Regulation (EU) No 10/2011 as applicable before the entr y into force of 
this Regulation, may be placed on the mark et until 8 Febr uary 2019 and may remain on the mark et until exhaustion of 
stoc ks. 
Article 3 
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union. 
This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 18 Januar y 2018. 
For the Commission 
The President 
Jean-Claude JUNCK ER  19.1.2018 L 14/32 Official Jour nal of the European Union EN     
(1)EFSA Journal 2017;15(2):4724. ANNEX 
Annex I to Regulation (EU) No 10/2011 is amended as follows:  
(1) in point 1, Table 1 is amended as follows : 
(a)  the entr y concer ning FCM substance No 856 is replaced by the followi ng: 
‘856 40563 25101-28-4 (butadiene, 
styrene, meth yl 
methacr ylate, 
butyl acrylate) 
copolymer 
cross-link ed 
with divinyl ­
benzene or  
1,3-butanediol 
dimethacr ylate yes no no   Only to be used in: 
—  rigid poly(vin yl chloride)  
(PVC) at a maximum 
level of 12 % at room 
temperature or below ; 
or 
—  at up to 40 % w/w 
in blends of styrene 
acrylonitr ile copolymer  
(SAN)/poly(methyl meth ­
acrylate) (PMMA) repeat- 
use articles at room 
temperature or below , 
and when either in con­
tact only with aqueous, 
acidic and/or low al­
coholic (< 20 %) food ­
stuffs for less than 
1 day, or when in con­
tact only with dry food ­
stuffs for any duration 
of time.’   
(b)  the following entr ies are inser ted in numer ical order of the FCM substance numbers: 
‘1061  80512-44-3 2,4,4′-tr i­
fluoroben ­
zophenone no yes no   Only to be used as a co- 
monomer in the manufacture 
of polye ther ether ketone 
plastics up to 0,3 % w/w of 
the final mat erial.  
1063  1547-26-8 2,3,3,4,4,5, 
5-hepta ­
fluoro-1- 
pentene no yes no   Only to be used together with 
tetrafluoroeth ylene and/or 
ethylene co-monomers to 
manuf acture fluorocopoly ­
mers for application as poly ­
mer processing aid at up to 
0,2 % w/w of the food con­
tact mater ial, and when the 
low-molecular mass fraction 
below 1 500 Da in the 
fluorocopolymer does not ex­
ceed 30 mg/kg.  
1064  39318-18-8 tungsten 
oxide yes no no 0,05  Stoichiometry :  
WOn, n = 2,72-2,90 (25) 19.1.2018 L 14/33 Official Jour nal of the European Union EN     1065  85711-28-0 mixture of 
methyl- 
branched 
and linear 
C14-C18 
alkanamides, 
derived 
from fatty 
acids yes no no 5  Only to be used in the manu ­
facture of articles made of 
poly olefins, and whic h do not 
come into contact with foods 
for whic h food simulant D2 
is assigned in Table 2 of 
Annex III. (26)’   
(2) in point 3, in Table 3, the following entr ies are added: 
‘(25) When used as reheat agent in polye thylene terephtha late (PET) verification of compliance with the specifi c 
migration limit is not required; in all other cases compl iance with the specifi c migration limit shall be 
verified in accordance with Article 18; the specifi c migration limit is expressed as mg tungste n/kg food. 
(26) Migration of stearamide, listed in Table 1 under FCM substance No 306 to which no specifi c migration 
limit applies, shall be excl uded from verification of the compl iance of the migration of the mixture with 
the specific migration limit laid down for the mixture.’   19.1.2018 L 14/34 Official Jour nal of the European Union EN