EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10028/2018 
(POOL/E2/2018/10028/10028 -EN.doc) 
D055333/02  
[…](2018) 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    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come 
into contact with food  
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 co ntact with food 
and repealing Directives 80/590/EEC and 89/109/EEC1, and in particular Article 5(1)(a), (d), 
(e), (h) and (i), Article 11(3) and Article 12(6) thereof,  
Whereas:  
(1) Annex I to Commission Regulation (EU) No 10/20112 establishes a Union list of 
authorised substances which may be used in plastic materials and articles intended to 
come into contact with food.  
(1) Since the last amendment to Regulation (EU) No 10/2011, the European Food Safety 
Authority (‘the Authority’) ha s 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 Regulation 
(EU) No 10/2011 reflects the most recen t findings of the Authority, that Regulation 
should be amended.  
(2) The Authority has adopted opinions re -evaluating perchlorate contamination in foods 
and human dietary exposure to perchlorate34. The substance perchloric acid, salts 
(perchlorate) ( FCM No 822 ) is included as an additive or polymer production aid in 
Table 1 of Annex I to Regulation (EU) No 10/2011. A  specific migration limit (SML) 
of 0,05 mg/kg applies to that substance on the basis of the conventional dietary 
exposure assumption from food conta ct materials that 1 kg of food is consumed daily 
by a person of 60 kg body weight. In re -evaluations of perchlorate, the Authority 
established a Tolerable Daily Intake (TDI) of 0 ,3 g/kg body weight per day and noted 
that both the short and long term expos ure to perchlorate of young population groups 
from all food sources exceeded the TDI whereas the short and long term exposure of 
the adult population was at the level of the TDI. To account for this, the SML should 
be calculated on the basis of the TDI and  a conventional allocation factor of 10 % of 
the TDI from FCM should be applied. Consequently, the SML of 0 ,05 mg/kg for 
perchlorate  should be lowered to 0,002 mg/kg  to ensure that migration of perchlorate 
from plastic FCM does not endanger human health.  
                                                 
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 2017;15(10):5043 . 
4 EFSA Journal 2014;12(10):3869 .  
EN 2  EN (3) The Authority adopted a favourable scientific opinion5 on the use of the substance 
phosphorous acid, mixed 2,4 -bis(1,1 -dimethylpropyl)phenyl and 4 -(1,1-
dimethylpropyl)phenyl triesters (FCM substance No 974 and CAS No 939402 -02-5). 
This substance is authoris ed with a migration limit of 5 mg/kg food. On the basis of 
new scientific evidence the Authority concluded that this substance is not of a safety 
concern for the consumer if its specific migration limit is increased from 5 to 
10 mg/kg food, where  the other  existing restrictions are  still met. Therefore the 
migration limit of this substance should be increased from 5 to 10 mg/kg, provided the 
other restrictions are retained.  
(4) The Authority adopted a favourable scientific opinion6 on the use of the substance 
1,2,3,4 -tetrahydronapht halene -2,6-dicarboxylic acid, dimethyl ester (FCM substance 
No 1066 and CAS No  23985 -75-3). The Authority concluded that the substance is not 
of a safety concern for the consumer if used as a co -monomer for the manufacture of a 
polyes ter layer intended to be used as an inner layer in a plastic  multilayer material  
intended  for contact with foods for which  food simulants A, B, C and/or D1 are 
assigned in Table 2 of Annex III  to Regulation  (EU) No 10/2011 . The migration of the 
sum of the substance and its  dimers (cyclic and open chain) should not exceed 0 ,05 
mg/kg food. That monomer should therefore be included in the Union list of 
authorised substances with the restriction that these specifications  should be met.  
(5) The Authority adopted a f avourable scientific opinion7 on the use of the substance [3-
(2,3-epoxypropoxy)propyl ]trimethoxy silane (FCM substance No 1068, CAS 
No 2530 -83-8). The Authority concluded that although the substance has genotoxic 
potential, it is not of safety concern due to its low exposure, if any, when used as a 
component of sizing agents to treat glass fibres imbedded in low diffusivity plastics 
such as in polyethylene terephthalate (PET), polycarbonate (PC), polybutylene 
terephthalate (PBTP), thermoset polyesters, and epoxy bisphenol vinyl ester intended 
for single and repeated use with long -term storage at room temperature, short -term 
repeated contact at increased or high temperature and for all foods.  As some of the 
reaction products of the substance containing the ep oxy function may also have a 
genotoxic potential, the residues of the substance and of each of the reaction products 
in the treated glass fibres should  not be detectable at 10  g/kg for the substance and 
60 g/kg for each of the reaction products (hydrolys ed monomers and epoxy -
containing cyclic dimer, trimer and tetramer).  
(6) Annex I to Regulation (EU) No 10/2011 should therefore be amended accordingly.  
(7) 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  
Annex I to Regulation (EU) No 10/2011 is amended in accordance with the Annex to this 
Regulation.  
                                                 
5 EFSA Journal 201 7;15(5):4841. 
6 EFSA Journal 201 7;15(5):4840. 
7 EFSA Journal 2017;15(10):5014 .  
EN 3  EN Article 2  
Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable 
before the entry into force of this Regulation, may be placed on the market until [enter date 
12 months after the date of entry into force of this Regulation ] and may remain on the market 
until exhaustion of stocks . 
Article 3  
This Regulation shall enter into force on the twentieth day following 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 States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER