COMMISSION REGUL ATION (EU) 2018/831 
of 5 June 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)  Annex I to Commission Regulation (EU) No 10/2011 (2) establishes a Union list of author ised substances whic h 
may be used in plastic mater ials 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 Regulation (EU) 
No 10/2011 reflects the most recent findings of the Author ity, that Regulation should be amended. 
(3)  The Auth ority has adopt ed opinions re-evaluating perc hlorate contamination in foods and human dietar y 
exposure to perchlor ate (3) (4). The substance perchloric acid, salts (perchlor ate) (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 specifi c migration 
limit (SML) of 0,05 mg/kg applies to that substance on the basis of the conventional dietar y exposure assump tion 
from food contact mater ials that 1 kg of food is consumed daily by a person of 60 kg body weight. In re- 
evaluations of perchlor ate, the Author ity established a Tolerable Daily Intake (TDI) of 0,3 μg/kg body weight per 
day and note d that both the shor t and long term exposure to perch lorate of young population groups from all 
food sources exceed ed the TDI whereas the shor t and long term exposure of the adult population was at the level 
of the TDI. To account for this, the SML should be calculat ed 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 
perc hlorate should be lowe red to 0,002 mg/kg to ensure that migration of perc hlorate from plastic FCM does not 
endange r human health. 
(4)  The Authority adopt ed a favourable scientific opinion (5) on the use of the substance phosphorous acid, mixe d 
2,4-bis(1,1-dimeth ylprop yl)phenyl and 4-(1,1-dimeth ylprop yl)phen yl trieste rs (FCM substance No 974 and CAS 
No 939402-02-5). This substance is author ised with a migration limit of 5 mg/kg food. On the basis of new 
scientific evidence the Author ity concluded that this substance is not of a safety concer n for the consumer if its 
specific migration limit is increased from 5 to 10 mg/kg food, where the other existing restr ictions are still met. 
Theref ore the migration limit of this substance should be increased from 5 to 10 mg/kg, provid ed the other 
restr ictions are retained. 
(5) The Auth ority adopt ed a favourable scientific opinion (6) on the use of the substance 1,2,3,4-t etrahy dro­
naphthalene-2,6-dicarbo xylic acid, dimethyl ester (FCM substance No 1066 and CAS No 23985-75-3). The 
Author ity concluded that the substance is not of a safety concer n for the consumer if used as a co-monomer for 
the manufa cture of a poly ester layer intende d to be used as an inner layer in a plastic multila yer mat erial intended 
for contact with foods for whic h 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 exce ed 0,05 mg/kg food. That monomer should theref ore be included in the Union list of author ised 
substances with the restr iction that these specifi cations should be met. 6.6.2018 L 140/35 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 2017;15(10):5043. 
(4)EFSA Journal 2014;12(10):3869. 
(5)EFSA Journal 2017;15(5):4841. 
(6)EFSA Journal 2017;15(5):4840. (6)  The Auth ority adopt ed a favourable scientifi c opinion (1) on the use of the substance [3-(2,3-epo xypropo xy) 
prop yl]tr imetho xy silane (FCM substance No 1068, CAS No 2530-83-8). The Author ity concluded that although 
the substance has genoto xic poten tial, it is not of safety concer n due to its low exposure, if any, when used as 
a compo nent of sizing agents to treat glass fibre s imbedded in low diffusivity plastics such as in polye thylene 
terephthalate (PET), poly carbonate (PC), polybutylene terephthalate (PBTP), ther moset polyes ters, and epoxy 
bisphenol vinyl ester intended for sing le and repeated use with long-t erm storag e at room temperature, shor t- 
term repeate d contact at increased or high temperature and for all foods. As some of the reaction products of the 
substance containing the epoxy function may also have a genot oxic poten tial, the residues of the substance and 
of each of the reaction products in the treated glass fibres should not be detectable at 10 μg/kg for the substance 
and 60 μg/kg for each of the reaction products (hydroly sed monomers and epoxy-containing cyclic dimer , trimer 
and tetramer). 
(7)  Annex I to Regulation (EU) No 10/2011 should theref ore be amended according ly. 
(8)  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 26 June 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, 5 June 2018. 
For the Commission 
The President 
Jean-Claude JUNCK ER  6.6.2018 L 140/36 Official Jour nal of the European Union EN     
(1)EFSA Journal 2017;15(10):5014. 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 ies concer ning FCM substances No 822 and No 974 are replaced by the follo wing: 
‘822 71938  Perc hlor ic acid, salts yes no no 0,002   (4)’ 
‘974 74050 939402-02-5 phosphorous acid, mixed 
2,4-bis(1,1- dimethylpro ­
pyl)phenyl and 4-(1,1-  
dimethylprop yl)phenyl 
triesters yes no yes 10  SML expressed as the sum of the phosphite and phosphat e 
forms of the substance, 4-tert-amy lphenol and 2,4-di-ter t- 
amy lphenol. The migration of 2,4-di-ter t- amy lphenol 
shall not exceed 1 mg/kg food.’   
(b)  the follo wing entr ies are added in numer ical order of the FCM substance numbers: 
‘1066  23985-75-3 1,2,3,4-tetrah ydronaphta ­
lene-2,6-dicarbo xylic acid, 
dimethyl ester no yes no 0,05  Only to be used as a co-monomer in the manufacture of 
a polyest er non-f ood contact layer in a plastic multila yer 
mater ial, whic h is to be used only in contact with foods 
for whic h food simulants A, B, C and/or D1 are assigned 
in Table 2 of Annex III. The specifi c migration limit in 
column 8 refers to the sum of the substance and of its 
dimers (cyclic and open chain).  
1068  2530-83-8 [3-(2,3-epo xypropo xy) 
prop yl]tr imetho xy silane yes no no   Only to be used as a compo nent of a sizing agent to treat 
glass fibres to be embedded in glass-fibre-reinf orced low 
diffusivity plastics (polyeth ylene terephthalate (PET), poly ­
carbonate (PC), polybutylene terephthalat e (PBT), ther mo­
set poly esters and epoxy bisphenol vinylester) in contact 
with all foodstuffs. 
In treated glass fibres, residues of the substance must not 
be detec table at 0,01 mg/kg for the substance and 
0,06 mg/kg for each of the reaction products (hydroly sed 
monomers and epoxy-containing cyclic dimer , trimer and 
tetramer).’    6.6.2018 L 140/37 Official Jour nal of the European Union EN