COMMI SSION REGUL ATION (EU) 2019/37 
of 10 Januar y 2019 
amending and correcting Regulation (EU) No 10/2011 on plastic mater ials and articles intended to 
come into contact 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 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 10/2011 (2) establishes a Union list of author ised substances whic h 
may be used in the manufacture of plastic mater ials and articles intende d to come into contact with food. 
Annex III to that Regulation assigns food simulants to be used for tests to demonstrate compl iance of plastic 
mate rials and articles not yet in contact with food with the migration limits refer red to in Articles 11 and 12 of 
that Regulation. 
(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 addition, certain textual errors and 
ambiguities were identif ied. In order to ensure that Regulation (EU) No 10/2011 reflects the most recent findings 
of the Auth ority and in order to remo ve any doubt as regar ds its correct application, that Regulation should be 
amended and corrected. 
(3)  The name of the substance 1,2,3,4-tetrah ydronaphthalene-2,6-dicarbo xylic acid, dimeth yl ester (FCM substance 
No 1066 and CAS No 23985-75-3) author ised by Commission Regulation (EU) 2018/831 (3) as listed in Table 1 
of point 1 of Annex I to Regulation (EU) No 10/2011 contains a typographical error in the English version of 
the document. It is theref ore necessar y to correct this entr y in Table 1 of point 1 of Annex I to Regulation (EU) 
No 10/2011. 
(4)  On the basis of the favourable scientifi c opinion of the Auth ority (4), on the use of substance [3-(2,3- 
epoxypropo xy)prop yl]tr imetho xy silane (FCM substance No 1068, CAS No 2530-83-8) as a compo nent of sizing 
agents to treat glass fibres imbedded in low diffusivity plastics such as in poly ethylene terephthalat e (PET), 
poly carbonate (PC), polybutylene terephthalat e (PBTP), ther moset polyest ers, and epoxy bisphenol vinyl ester 
intende d for sing le and repeated use with long-ter m storag e at room temperature, shor t-term repeated contact at 
increased or high temperature and for all foods, the substance was author ised by Regulation (EU) 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 polymer ic backbon e of the plastic mate rial and may 
become part of it, it should be considered as a starting mate rial or monomer in the manuf acture of sizing agents 
to treat glass fibres imbedded in low diffusivity plastics such as in polyet hylene terephthalat e (PET), poly carbonate 
(PC), polybutylene terephthalate (PBTP), ther moset polyest ers, and epoxy bisphenol vinyl ester. It is theref ore 
necessar y to amend this entr y 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 order to clarify its intende d uses. 
(5) The Author ity adopt ed two favourable scientific opinions (5) (6) on the use of the substance poly((R)-3-hydr oxybu ­
tyrate -co-(R)-3-hydro xyhexanoat e) (FCM substance No 1059, CAS number 147398-31-0), which is 11.1.2019 L 9/88 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)Commission Regulation (EU) 2018/831 of 5 June 2018 amending Regulation (EU) No 10/2011 on plastic mat erials and articles 
inten ded to come into contact with food (OJ L 140, 6.6.2018, p. 35). 
(4)EFSA Jour nal 2017;15(10):5014. 
(5)EFSA Jour nal 2016;14(5):4464. 
(6)EFSA jour nal 2018;16(7):5326 a biodegradable (co)polymer obtained from microbial fermentation used in the manuf acture of packag ing articles 
intende d to be in contact with whole fruit and vegetables. In those two opinions, the Author ity concluded that 
this substance is not of a safet y concer n 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 shor t heating up phases. The Author ity further concluded that the specifi c migration of the 
degradation product croton ic acid should not exceed 0,05 mg/kg food. That substance should theref ore be 
included in the Union list of author ised substances with the restr iction that these specifications should be met. 
(6)  Croton ic acid (FCM substance No 467 and CAS No 3724-65-0) is author ised as an additive or a monomer in the 
manuf acture of plastics intended to come into contact with foods. A specific migration limit of 0,05 mg/kg food 
was introduced in the entr y for this substance in Table 1 of point 1 of Annex I to Regulation (EU) No 10/2011 
by Commission Regulation (EU) 2017/752 (7) replacing the previous compliance verification by residual content 
per food contact surface area (QMA). Com pliance verification of crot onic acid by QMA with a limit of 0,05 mg/6 
dm2 is also included in the entr y of the substance 3-hydro xybutanoic acid-3-h ydro xypentanoic 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 specifi c migration limit for crot onic acid is to be applicable for FCM substances 467, 744, and 1059, it is 
appropr iate to introduce a group restr iction for croton ic 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 entr ies in Tables 1 and 4 of 
that Annex. 
(7)  The Author ity adopt ed a favourable scientific opinion (8) on the use of the substance dimethyl carbonate (FCM 
substance No 1067 and CAS No 616-38-6) as a monomer in the manuf acture of plastics intended to come into 
contact with foods. The Author ity concluded that the substance is not of a safety concer n for the consumer if 
used as co-monomer together with 1,6-hexanediol for making a poly carbonate pre-polymer and then reacted 
with 4,4′-methy lenediphenyldiisocyanat e and diols such as polyprop ylene glycol and 1,4-butanediol to form 
a ther moplastic polyurethane. The use of this mate rial should be further restr icted to contain up to 30 % of the 
poly carbonate pre-polymer and to be used only for repeated use articles in shor t–ter m contact (≤ 30 min) at 
room temperature with foods for whic h simulants A and B are assigned in Table 2 of Annex III to Regulation 
(EU) No 10/2011. Theref ore, the substance should be included in the Union list of author ised substances 
provid ed these restr ictions are met. 
(8)  The Author ity also noted that the FCM substance No 1067 may also be used for the manufacture of other 
poly carbonates or under other conditions. In those cases, the Author ity concluded that use of the substance is 
not of a safety concer n for the consumer if the migration of dimeth yl carbonate does not exceed 0,05 mg/kg 
food and the total migration of poly carbonate oligomers with a molecular weight below 1 000 Da does not 
excee d 0,05 mg/kg food. Theref ore, those uses of the substance should be author ised provid ed those restr ictions 
are met. 
(9)  The author isation of the FCM substance No 1067 provided for in this Regulation for the manufacture of other 
poly carbonates or under other conditions, requires that the total migration of poly carbonate 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 compl ex. A descr iption of those methods is not necessar ily available to 
compet ent author ities. Without a descr iption it is not possible for the compet ent author ity to verify that the 
migration of oligomers from the mater ial or article compl ies with the migration limit for these 
oligomers. Theref ore, business operators placing on the market the final article or mate rial containing that 
substance should be required to provide a descr iption of the method and a calibration sample if required by the 
method. 
(10)  The Auth ority adopt ed a favour able scientific opinion (9) on the use of the substance isobutane (CAS 
number 75-28-5, FCM substance No 1069) as a foaming agent for plastics intende d to come into contact with 
food. In that opinion, the Author ity concluded that this substance is not of a safety concer n for the consumer if 
it is used as a foaming agent in plastics intended to come into contact with food. Theref ore, this use of the 
substance should be author ised. The class of compo unds collectively term ed ‘foaming agents ’ also includes 11.1.2019 L 9/89 Official Jour nal of the European Union EN     
(7)Commission Regulation (EU) 2017/752 of 28 Apr il 2017 amending and correcting Regulation (EU) No 10/2011 on plastic materials 
and articles inten ded to come into contact with food (OJ L 113, 29.4.2017, p. 18). 
(8)EFSA Jour nal 2017;15(7):4901. 
(9)EFSA Jour nal 2018:16(1):5116. surfactants and are often understood to be surfactants only . To avoid poten tial confusion and in line with the 
function of this substance which was evaluated by the Author ity, the synonymous term ‘blowing agent’ should be 
used in the entr y 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 
compl iance of plastic mate rials 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 provid es for 
the use of food simulant D1 (50 % ethanol). The fourth row refers to aqueous, acidic and alcoholic foods and 
milk products and provides for the use of food simulant D1 and of food simulant B (3 % acetic acid). Food 
simulant 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 rang es 
between 4,0 and 4,5. This dichotom y 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 theref ore appropr iate 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)  Annex es I and III to Regulation (EU) No 10/2011 should theref ore be amended and corrected according ly. 
(13)  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 es I and III to Regulation (EU) No 10/2011 are 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 31 Januar y 2020 and may remain on the market 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, 10 Januar y 2019. 
For the Commission 
The President 
Jean-Claude JUNCK ER  11.1.2019 L 9/90 Official Jour nal of the European Union EN     ANNEX 
Annex es I and III to Regulation (EU) No 10/2011 are amended as follows :  
(1) in Annex I, Table 1 is amended as follows: 
(a)  the entr ies concer ning FCM substances No 467, 744, 1066, and 1068 are replaced by the followi ng: 
‘467 14800 3724-65-0 croton ic acid yes yes no  (35)’   
45600 
‘744 18888 080181-31-3 3-hydro xybutanoic 
acid-3- hydro xypen ­
tanoic acid, copoly ­
mer no yes no  (35) The substance is used as product obtained by bacterial fermenta ­
tion. In compliance with the specifi cations mentioned in the Ta­
ble 4 of Annex I.’  
‘1066  23985-75-3 1,2,3,4-t etrahydro ­
naphthalene-2,6-di ­
carbo xylic acid, di­
meth yl ester no yes no 0,05  Only to be used as a co-monomer in the manufacture of a polye ­
ster non-f ood contact layer in a plastic multila yer mater ial, which 
is to be used only in contact with foods for which food simulants 
A, B, C and/or D1 are assigned in Table 2 of Annex III. The 
specif ic migration limit in column 8 refers to the sum of the sub­
stance and of its dimers (cyclic and open chain). ’  
‘1068  2530-83-8 [3-(2,3-epo xypro ­
poxy)prop yl]tr i­
metho xy silane no yes no   Only to be used as a compo nent of a sizing agent to treat glass fi­
bres to be embedded in glass-fibre-reinf orced low diffusivity plas ­
tics (polyeth ylene terephthalat e (PET), poly carbonate (PC), polybu ­
tylene terephthalate (PBT), ther moset polyest ers 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 re­
action products (hydrolysed monomers and epoxy-containing 
cyclic dimer , trimer and tetramer).’   
(b)  the follo wing entr ies are inser ted in numer ical order of the FCM substance numbers: 
‘1059  147398-31-0 poly((R)-3-hydr oxy­
butyrate -co-(R)-3-hy ­
droxyhexanoat e) no yes no  (35) Only to be used alone or blended with other polymers in contact 
with foods for whic h food simulant E is assigned in Table 2 of 
Annex III.’  11.1.2019 L 9/91 Official Jour nal of the European Union EN     ‘1067  616-38-6 dimeth yl carbonate no yes no   Only to be used: 
a)  with 1,6-hexanediol in the manuf acture of poly carbonat e pre- 
polymers that are used at up to 30 % to manuf acture ther mo­
plastic polyurethanes with 4,4′-methy lenediphen yldiisocya ­
nate and diols, such as polyprop ylene glycol and 1,4-butane ­
diol. The resulting mater ial shall only be applied in repeate d 
use articles intended to come into shor t–term contact 
(≤ 30 min at room temperature) with food for which simu ­
lants A and/or B are assigned in Table 2 of Annex III; or 
b)  for the production of other poly carbonates and/or under 
other conditions provided that the migration of dimeth yl car­
bonate does not exceed 0,05 mg/kg food and that the migra ­
tion of all poly carbonate oligomers with a molecular weight 
below 1 000 Da together does not exceed 0,05 mg/kg food. (27)’ 
‘1069  75-28-5 isobutane yes no no   Only to be used as a blowing agent.’     11.1.2019 L 9/92 Official Jour nal of the European Union EN     (2) in Table 2 of Annex I, the following entr y is added: 
‘35 467 
744 
1059 0,05 expressed as crotonic acid’   
(3) in Table 3 of Annex I, the following entr y is added: 
‘(27) When a final mater ial or article containing this substance and produced under conditions other than those 
descr ibed in point (a) column 10 of Table 1 is placed on the market, a well descr ibed method to determi ne 
whether the oligomer migration compl ies with the restr ictions specified in point (b) column 10 of Table 1 
shall form part of the suppor ting documentation refer red to in Article 16. This method shall be suitable for 
use by a compet ent author ity to verify compl iance. If an adequat e method is publicly available, reference 
shall be made to that method. If the method requires a calibration sam ple, a sufficient sample shall be sup­
plied to the compet ent author ity on its request.’   
(4) in Table 4 of Annex I, the row concer ning restr iction of the entr y concer ning substance FCM No 744 is replaced by 
the following: 
‘Restr iction Specifi c migration limit for croton ic acid is 0,05 mg/kg food’   
(5) in table 3 of point 4 of Annex III, the third and fourth rows are replaced by the following: 
‘all aqueous and alcoholic foods and milk products 
with a pH ≥ 4,5 food simulant D1 
all aqueous and alcoholic foods and milk products with 
a pH < 4,5 food simulant D1 and food simulant B’   11.1.2019 L 9/93 Official Jour nal of the European Union EN