EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10814/2017 CIS Rev. 3 
(POOL/E2/2017/10814/10814R3 -EN 
CIS.doc)  
[…](2017) XXX  draft 
  
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come 
into contact with food  
(Text with EEA relevance)    
EN 2   EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending  Regulation (EU) No 10/2011 on plastic materials and articles intended to come 
into contact with food  
(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 1935/2004 of the European Parliament and of the 
Council of 27 October 2004 on materials and articles intended to come into contact with food 
and repealing Directives 80/590/EEC and 89/109/EEC1, and in particular Article 5(1)(a), (d), 
(e), (h) and (i), A rticle 11(3)  and Article 12(6) thereof , 
Whereas:  
(1) Commission Regulation (EU) No 10/20112 ('the Regulation') establishes a Union list 
of authorised substances which may be used in  plastic materials and articles intended 
to come into contact with food.  
(2) Since  the last amendment to Regulation (EU) No 10/2011, t he European Food Safety 
Authority (‘the Authority’) has published further  scientific opinions  on particular 
substances that may be used in food contact materials (‘FCM’) as well as on the 
permitted use of  already authorised substances. In order to ensure that the Regulation 
(EU) No 10/2011  reflects the most recent findings of the Authority, that Regulation 
should be amended.  
(3) The Authority adopted a favourable scientific opinion3 on the use of the substance  
(butadiene, styrene, methyl methacrylate, butyl acrylate) copolymer cross -linked with 
divinylbenzene or 1,3 -butanediol dimethacrylate (FCM substance No 856 and CAS 
No 25101 -28-4). The Authority concluded that the substance is not of a safety concern 
for the consumer if used as a polymeric additive at up to 40% w/w in blends of styrene 
acrylonitrile copolymer (SAN) / poly(methyl methacrylate) (PMMA) repeat -use 
articles intended for contact at room temperature with aqueous, acidic and/or low 
alcoholic (<  20%) foodstuffs for less than one day and with dry foodstuffs for any 
duration of contact including long -term storage. The current  authorisation of this 
substance  should be extended to include that use, provided that those specifications are 
met. 
(4) The Authorit y adopted a favourable scientific opinion4 on the use of the monomer 
2,4,4 -trifluorobenzophenone  (FCM substance No 1061 and CAS No 80512 -44-3). The 
Authority concluded that this substance is not of a safety concern for the consumer if 
                                                 
1 OJ L 338, 13.11.2004, p. 4.  
2 Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials 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 .  
EN 3   EN used as co -monomer up  to 0.3% w/w based on the final material in the manufacture of 
polyether ether ketone plastics. That monomer should therefore be included in the 
Union list of authorised substances with the restriction that this specification should be 
met. 
(5) The Authority adopted a favourable scientific opinion5 on the use of the monomer 
2,3,3,4,4,5,5 -heptafluoro -1-pentene (FCM substance No 1063 and CAS No 1547 -26-
8). The Authority concluded that the substance is not of a safety concern for the 
consumer if used as co -monome r together with tetrafluoroethylene and/or ethylene co -
monomers to manufacture fluorocopolymers that are only intended 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 greater 
than 30 mg/kg. That monomer should be included in the Union list of authorised 
substances with the restriction that those specifications should be met.   
(6) The Authority adopted a favourable scientific opinion6 on the use of the substance 
tungsten oxide (WO n (n = 2.72 –2.90) (FCM substance No 1064 and CAS No 39318 -
18-8). The Authority concluded that the substance is not of a safety concern for the 
consumer if the additive is used as a reheat agent in polyethylene terephthalate (PET) . 
The Authority  considered that due to the insolubility of the substance, low migration is 
expected for any foreseeable use as a reheat additive in PET. Therefore, verification of 
the migration limit is not necessary. For other technical  functions or for use in other 
polymers, the Authority  concluded that the migration should not exceed 0.05 mg/kg 
(expressed as tungsten). That substance should be included in the Union list of 
authorised substances with the restriction that those specifica tions should be met.  
(7) The Authority adopted a favourable scientific opinion7 on the use of the mixture of 
methyl -branched and linear C 14-C18 alkanamides, derived from fatty acids (FCM 
substance No 1065  and 85711 -28-0). The Authority concluded that the subst ance is 
not of a safety concern for the consumer if used in the manufacture of polyolefin 
articles intended for contact with all foodstuffs other than fatty foods (as defined by 
simulant D2) and when its migration does not exceed 5 mg/kg food. Th at mixture  
should therefore be included in the Union list of authorised substances with the 
restriction that th ese specification s should be met . 
(8) Annex I to Regulation (EU) N o 10/2011 sh ould therefore be amended accordingly.  
(9) The measures provided for in this Regulati on are in accordance with the opinion of the  
Standing Committee on Plants, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex I to Regulation (EU) No 10/2011 is amended in accordance with the Annex to this 
Regulation.  
Article 2 
This Regul ation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union.  
                                                 
5 EFSA Journal 2016;14(10):4582 . 
6 EFSA Journal 2017;15(1):4661 . 
7 EFSA Journal 2017;15(2):4724.   
EN 4   EN Article 3  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journ al of the European Union.  
Point 2 of the Annex shall apply from [ enter date 12 months after the date of entry into force 
of this Regulation ]. 
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