COMMISSION REGUL ATION (EU) 2019/1338 
of 8 August 2019 
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 points (a), (d), (e), and (i) of Article 5(1), Article 11(3) and Article 12(3) and (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 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 a scientific opinion on the permitted uses of an already author ised substance that may be used in 
food contact mat erials (‘FCM’). In order to ensure that Regulation (EU) No 10/2011 reflects the most recent 
findings of the Auth ority, that Regulation should be amended. 
(3)  The substance poly((R)-3-hydro xybutyrate-co- (R)-3-hydro xyhexanoat e) (FCM substance No 1059, CAS number 
147398-31-0) has been author ised by Commission Regulation (EU) 2019/37 (3) to be used either alone or 
blended with other polymers in contact with dry or solid foods for which food simulant E is assigned in Table 2 
of Annex III to Regulation (EU) No 10/2011 on the basis of two scientific opinions (4) (5) published by the 
Author ity. The Auth ority has adopt ed a new favourable scientific opinion (6) extending the use of this substance 
alone or blended with other polymers in the manufacture of plastics intended to come into contact with all 
foods. In the later opinion, the Author ity concluded that this substance is not of a safety concer n for the 
consumer if it is used either alone or blended with other polymers in contact with all foods under contact 
conditions of 6 months or more at room temperature or below , including hot fill or shor t heating-up phases, 
provid ed that the migration of all oligomers with a molecular weight below 1 000 Da does not excee d 
5,0 mg/kg food or food simulant. The Author ity's conclusion is based on the worst-case migration testing 
conditions set out in point 2.1.4 of Chapt er 2 of Annex V to Regulation (EU) No 10/2011 for long term contact 
conditions (6 months or more) with food at room temperature or below . In accordance with the provisions of 
point 2.1.5 of Chapt er 2, of Annex V to that Regulation, these worst-case migration testing conditions also 
address contact conditions of less than 6 months at room temperature or below . Theref ore, the use of this 
substance alone or blended with other polymers in the manufacture of plastics intended to come into contact 
with all foods under contact conditions of less than 6 months at room temperature or below , including hot fill or 
shor t heating-up phases will also be of no safety concer n, provided that the migration of all oligomers with 
a molecular weight below 1 000 Da does not exceed 5,0 mg/kg food or food simulant. In addition, the Author ity 
also confir med in this opinion that the specifi c migration limit of 0,05 mg/kg food set for the degradation 
product croton ic acid in the previous author isation of FCM substance No 1059, should also apply under this 
exte nded use. The entr y for this substance in Table 1 of point 1 of Annex I to Regulation (EU) No 10/2011 
should theref ore include the uses of this substance with all foods and in all conditions, in column 10 of that 
Table. 
(4)  The author isation of the FCM substance No 1059 provid ed for in this Regulation, requires that the tota l 
migration of all oligomers with a molecular weight below 1 000 Da does not exce ed 5,0 mg/kg food or food 
simulant. As analytical methods to determine the migration of these oligomers are compl ex, a descr iption of 9.8.2019 L 209/5 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) 2019/37 of 10 Januar y 2019 amending and correcting Regulation (EU) No 10/2011 on plastic material s 
and articles inten ded to come into contact with food (OJ L 9, 11.1.2019, p. 88.). 
(4)EFSA Jour nal 2016;14(5):4464. 
(5)EFSA jour nal 2018;16(7):5326. 
(6)EFSA Jour nal 2019;17(1):5551. those methods is not necessar ily available to compet ent author ities. Without that 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 complies with 
the migration limit for these oligomers. Theref ore, business operat ors placing on the mark et the final article or 
mate rial containing that substance should be required to include in the suppor ting documentation referred to in 
Article 16 of Regulation (EU) No 10/2011 a descr iption of the method and a calibration sample if required by 
the method. 
(5)  Annex I to Regulation (EU) No 10/2011 should theref ore be amended according ly. 
(6)  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 intended to come into contact with food complying with Regulation (EU) No 10/2011 as 
applicable before the entr y into force of this Regulation may be placed on the market until 29 August 2020 and may 
remain on the mark et until exhaustion of stocks. 
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, 8 August 2019. 
For the Commission 
The President 
Jean-Claude JUNCK ER  9.8.2019 L 209/6 Official Jour nal of the European Union EN     ANNEX 
In Annex I to Regulation (EU) No 10/2011, the entr y of Table 1 concer ning FCM substance No 1059 is replaced by the followi ng: 
‘1059  147398-31-0 Poly((R)-3-hydr oxy­
butyrate-co-(R)-3-h y­
droxyhexanoate) no yes no  (35) Only to be used either alone or blended with other polymers 
in contact with all foods under contact conditions of up to 
6 months and/or 6 months and more, at room temperature or 
below , including hot fill or a shor t heating up phase. The mi­
gration of all oligomers with a molecular weight below 
1 000 Da shall not excee d 5,0 mg/kg food. (23)’   9.8.2019 L 209/7 Official Jour nal of the European Union EN