EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10224/2019 
(POOL/E2/2019/10224/10224 -EN.doc) 
D061326/03  
[…](2019) 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  
(Text with EEA relevance)    
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  
(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), 
and (i) of Article 5(1), Article 11(3) and Article 12 (3) and (6) thereof,  
Whereas:  
(1) Annex I to Commission Regulatio n (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.  
(2) Since the last amendment to Regulation (EU) No 10/2011, the European Food Safety 
Authority (‘the Authority’) has published a scientific opinion on the permitted use s of 
an already authorised substance  that may be used in food contact materials (‘FCM’). 
In order to ensure that Regulation (EU) No 10/2011 reflects the most recent findings 
of the Authority, that Regulation should be amended .  
(3) The s ubstance poly(( R)-3-hydroxybutyrate -co-(R)-3-hydroxyhexanoate) (FCM 
substance No 1059, CAS number 147398 -31-0) has been authorised  by Commission 
Regulation (EU) 2019/373 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 opinions4,5 
published by the Authority . The Authority has  adopted a  new favourable scientific 
opinion6 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 th e later  
opinion, the Authority concluded that this substanc e is not of a safety concern 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 short heating -up phases, prov ided that the migration of all 
                                                 
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) 2019/37 of 10 January 2019 amending and correcting Regulation (EU) 
No 10/2011 o n plastic materials and articles intended to come into contact with food  (OJ L 9, 
11.01.2019, p. 88. ). 
4 EFSA Journal 2016;14(5):4464 . 
5 EFSA journal 2018; 16(7):5326.  
6 EFSA Journal 2019;17(1):5551.   
EN 2  EN oligomers with a molecular weight below 1 000 Da does not exceed 5,0 mg/kg food or 
food simulant. The Authority’s conclusion is based on the worst -case migration testing 
conditions set out in point 2.1.4 of Chapter 2 of Annex  V to Regulation (EU) 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 Chapter 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. Therefore, 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 short heating -up phases 
will also be of no safety concern, provided that the migration of all oligomers with a 
mole cular weight below 1 000 Da does not exceed 5,0 mg/kg food or food simulant.  In 
addition, t he Authority also confirmed in this opinion that the specific migration limit 
of 0,05 mg/kg food set for the degradation product crotonic acid in the previous 
author isation of FCM substance No 1059, should also apply under this extended use.  
The entry for this substance in Table  1 of point 1 of Annex I to Regulation (EU) 
No 10/2011 should  therefore include the uses of this substance with all foods and in all 
condition s, in column 10 of that Table . 
(4) The authorisation of the FCM substance No 1059 provided for in this Regulation, 
requires that the total migration of all oligomers with a molecular weight below 1 000 
Da does not exceed 5,0 mg/kg food  or food simulant . As a nalytical methods to 
determine the migration of these oligomers are complex , a description of those 
methods is not necessarily available to competent authorities. Without that description,  
it is not possible for the competent authority to verify that the mig ration 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 include  in the support ing 
documentation referred to in Article 16 of Regulation (EU) 10/2011 a description of 
the method and a calibration sample if required by the method.   
(5) Annex I to Regulation (EU) No 10/2011 should therefore be amended accordingly.  
(6) 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.  
Article 2  
Plastic materials and articles intended to come into contact with food  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.   
EN 3  EN 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