EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10747/2018 CIS 
(POOL/E2/2018/10747/10747 -EN.doc)  
[…](2018) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles 
intended to come into contact with food  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending and correcting 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 points (a), (d), (e), 
(h) and (i)  of Article 5(1) , 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 the manufacture of plastic materials and 
articles intended to come into contact with food.  Annex III to that Regulation assigns 
food simulants to be used for tests to demonstrate compliance of plastic materials and 
articles not yet in contact with food with the migration limits referred to in Articles 11 
and 12 of that Regulation.   
(2) Since the last amendment to Regulation (EU) No 10/2011, the European Food Sa fety 
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 addition, certain textual errors an d 
ambiguities were identified.  In order to ensure that Regulation (EU) No 10/2011 
reflects the most recent findings of the Authority and in order to remove any doubt as 
regards its correct application, that Regulation should be amended and corrected.  
(3) The name of the substance 1,2,3,4 -tetrahydronaphthalene -2,6-dicarboxylic acid, 
dimethyl ester (FCM substance No 1066 and CAS No 23985 -75-3) authorised by 
Commission Regulation (EU) No 2018/8313 as listed in Table 1 of point 1 of Annex I 
to Regulation (EU) No 10/2011 contains a typographical error.  It is therefore 
necessary to correct this entry in Table 1 of  point 1 of Annex I to Regulation (EU) No 
10/2011 .  
(4) On the basis of the favourable  scientific opinion  of the Authority4, on the use of 
substance [3-(2,3-epoxypropoxy) propyl]trimethoxy silane (FCM substance No 1068, 
CAS No 2530 -83-8) as a component of sizing agents to treat  glass ﬁbres imbedded in 
low diffusivity plastics such as in polyethylene terephthalate (PET), polycarbonate 
                                                 
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 Commission Regulation  (EU) 2018/831 of 5 June 2018 amending Regulation (EU) No 10/2011 on 
plastic materials and articles intended to com e into contact with food (OJ L 140, 6.6.2018, p. 35 ).  
4 EFSA Journal 2017;15(10):5014 .  
EN 2  EN (PC), polybutylene terephthalate (PBTP), thermoset polyesters, and epoxy bisphenol 
vinyl ester intended for single and repeated use with long -term stor age at room 
temperature, short -term repeated contact at increased or high temperature and for all 
foods , the substance was a uthorised by Regulation (EU) No  2018/831 as an additive or 
polymer production aid in column 5 of Table 1 of point 1 of Annex I to Regulation 
(EU) No 10/2011 .  As this substance is intended to react with the polymeric backbone 
of the plastic material and may become part of it, it should be considered  as a star ting 
material or monomer in the manufacture of sizing agents to treat glass fibres imbedded 
in low diffusivity plastics such as in polyethylene terephthalate (PET), polycarbonate 
(PC), polybutylene tere phthalate (PBTP), thermoset polyesters, and epoxy bisphenol 
vinyl ester.   It is therefore necessary to amend this entry in Table 1 of point 1 of 
Annex I to Regulation (EU) No 10/2011 to include this substance in column 6 of 
Annex I to that Regulation in or der to clarify its intended uses.  
(5) The Authority adopted two favourable scientific opinions56 on the use of the substance 
Poly(( R)-3-hydroxybutyrate -co-(R)-3-hydroxyhexanoate)  (FCM substance No 1059, 
CAS number 147398 -31-0), which is a biodegradable (co)polymer obtained from 
microbial fermentation  used in the manufacture of packaging articles intended to be in 
contact with whole fruit and vegetables .  In those  two opinions, the Authority 
concluded that this substance is not of a safety c oncern for the consumer if it is used 
either alone or blended with other polymers in contact with (dry/solid) foods for which 
food simulant E is assigned in Table 2 of Annex III to Regulation (EU) No 10/2011 , 
under contact conditions up to 6 months or more  at room temperature or below, 
including hot -ﬁll or short heating up phase s.  The Authority further concluded that the 
specific migration of the degradation product cr otonic acid should not exceed 0, 05 
mg/kg food.   That substance should therefore be included in the Union list of 
authorised substances with the restriction that these specifications should be met.  
(6) Crotonic acid (FCM substance No 467 and CAS No 3724 -65-0) is authorised as an 
additive or a monomer in the  manufacture of plastics intended to come into contact 
with foods . A specific migration limit of 0,05 mg/kg food was introduced  in the entry 
for this substance in Table 1 of point 1 of Annex I to Regulation (EU) No 10/2011 by 
Commission Regulation (EU) No 2017/7527 replacing the previous compliance 
verification by residual content per food contact surface area (QMA) .  Compliance 
verification of crotonic acid by QMA with a limit of 0, 05 mg/ 6 dm2 is also included in 
the entry of the substance 3-hydroxybutanoic acid -3- hydroxypentanoic acid, 
copolymer (FCM substance No 744 , CAS No  80181 -31-3) in Table 4 of Annex I  to 
Regulation (EU) No 10/2011  and should also be replaced by the specific migration 
limit assigned to FCM substance No 467 . In light of the fact that the same specific 
migration limit for crotonic acid is to be applicable for FCM substances 467, 744 , and 
1059 , it is appropriate to introduce a group restriction for crotonic acid for FCM 
substances 467, 744 , and 1059 in Table 2  of Annex I  to Regulation (EU) No 10/2011 , 
and amend the corresponding individual entries in Tables 1 and 4 of that Annex .  
(7) The Authority adopted a favourable scientific opinion8 on the use of the substance 
dimethyl carbonate (FCM substance No 1067 and CAS No 616 -38-6) as a monomer in 
                                                 
5 EFSA Journal 2016;14(5):4464 . 
6 EFSA journal 2018 ;16(7):5326  
7 Commission Regulation  (EU) 2017/752 of 28 April 2017 amending and correcting Regulation (EU) No  
10/2011 on plastic materials and articles intended to come into contact with food (OJ L 113, 29.4.2017, 
p. 18 ). 
8 EFSA Journal 2017;15(7):4901.   
EN 3  EN the manufacture of plastics intended to come into contact with foods .  The Authority 
concluded that the substance is not of a safety concern for the  consumer if used as co -
monomer together with 1,6 -hexanediol for making a polycarbonate pre -polymer and 
then reacted with 4,4 '-methylenediphenyldiisocyanate  and diols such as polypropylene 
glycol and 1,4 -butanediol to form a thermoplastic polyurethane.  The use of this 
material should be further restricted to contain up to 30% of the polycarbonate pre-
polymer and to be used only for repeated use articles in short –term contact ( ≤ 30 min) 
at room temperature with foods for which simulants A and B are assigned  in Table 2 
of Annex III to Regulation (EU) No 10/2011.  Therefore, the substance should be 
included in the Union list of authorised substances provided these restrictions are met.  
(8) The Authority also noted that the FCM substance No 1067 may also be used fo r the 
manufacture of other polycarbonates or under other conditions. In those cases, the 
Authority concluded that use of the substance is not of a safety concern for the 
consumer if the migration of dimethyl carbonate does not exceed 0,05 mg/kg food and 
the total migration of polycarbonate oligomers with a molecular weight below 1 000 
Da does not exceed 0,05  mg/kg food. Therefore, th ose uses of the substance should be 
authorised provided th ose restrictions are met.   
(9) The authorisation of the FCM substance  No 1067  provided for in this Regulation for 
the manufacture of other polycarbonates or under other conditions , requires that the 
total migration of polycarbonate oligomers with a molecular weight below 1 000 Da 
does not exceed 0,05 mg/kg food .  Analytical methods to determine the migration of 
these oligomers  are complex.  A description of those methods is not necessarily 
available to competent authorities.  Without a description it is not possible for the 
competent authority to verify that the migration of oligomers from the material or 
article complies with the migration limit for these oligomers.  Therefore, business 
operators placing on the market the final article or material containing that substance 
should be required to provide a description of the me thod and a calibration sample if 
required by the method.  
(10) The Authority adopted a favourable scientific opinion9 on the use of the substance 
isobutane (CAS number 75 -28-5, FCM substance No 1069) as a foaming agent for 
plastics intended to come into contact with food. In that opinion, the Authority 
concluded that this substance is not of a safety concern for the consumer if it is used as 
a foaming agent in plastics intended to come into contact with food.  Therefore, th is 
use of the substance should be author ised.  The class of compounds collectively 
termed ‘foaming agents’ also includes surfactants and are often understood to be 
surfactants only.  To avoid potential confusion and in line with the function of this 
substance which was evaluated by the Authority , the synonymous term ‘blowing 
agent’ should be used in the entry for this substance in Table 1 of Annex I to 
Regulation (EU) No 10/2011.  
(11) Table 3 of Annex III to Regulation (EU) No 10/2011 assigns food simulants to be used 
for tests to demonstrate complia nce of plastic materials and articles not yet in contact 
with food  with the overall migration limit laid down to in Article 12 of that 
Regulation.  There is an ambiguity between rows 3 and 4 in their reference to the food 
simulants which are to be used for  the overall migration testing of the products listed, 
and in particular  of milk products.  The third row refers to aqueous and alcoholic foods 
and milk products in general and provides for the use of food simulant D1 (50% 
ethanol). The fourth row refers t o aqueous, acidic and alcoholic foods and milk 
                                                 
9 EFSA Journal 201 8 :16(1):5116.   
EN 4  EN products and provides for the use of food simulant D1 and of food simulant B (acetic 
acid 3%).  Food s imulant B is to be used for acidic products with a pH value below 4.5 
as laid down in point 2 of Annex III to Regulation (EU) No 10/2011.  Milk products 
are mentioned in both rows because although milk itself has a relatively neutral pH 
(pH 6.5 -6.8), certain processed (fermented or soured) milk products have acidic pH 
ranges between 4.0 and 4.5. This dichotomy could erroneously be interpreted to mean 
that acidic milk products are also included in the third row and thus could be tested 
only with food simulant D1 instead of with food simulant B as laid down in the fourth 
row. It is therefore appropriate to clarify  the third and fourth rows of Table 3 by 
specifying the pH of the listed milk products using the pH value of 4.5 as the cut -off 
value.  
(12) Annexes I and III to Regulation (EU) No 10/2011 should therefore be amended and 
corrected accordingly.  
(13) The measures pro vided 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 es I and III to Regulation (EU) No 10/2011 are amended in accordance with the Annex 
to this Regulation.  
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