EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
[…](2013) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending and correcting Commission Regulati on (EU) No 10/2011 on  plastic materials 
and articles intended to come into contact with food 
(Text with EEA relevance) 
 EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending and correcting Commission Regulati on (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/EEC 
1, and in particular points (a) and (e) of 
Article 5(1), Article 11(3) and Article 12 (6) thereof, 
Whereas: (1)
 Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and 
articles intended to come into contact with food2  establishes a Union list of 
monomers, other starting substances and additives which may be used in the 
manufacture of plastic mate rials and articles. Recently the European Food Safety 
Authority (‘the Authority’) issued favourab le scientific evaluations for additional 
substances which should now be  added to the current list 
(2) Annex I to Regulation (EU) No 10/2011 s hould therefore be amended accordingly. 
(3) From the scientific evaluation of the subs tance1,3-bis(isocyanatomethyl)benzene with 
FCM number 988 it follows that migrat ion of its hydrolysis product, 1,3-
benzenedimethanamine should be controlled. 1,3-benzenedimethanamine is already an 
authorised starting substance with FCM num ber 421. As the migration of substance 
421 and 988 is controlled in the same manner a group rest riction which includes both 
substances should be introduced. Therefore the authorisation of substance 421 should 
be amended and the group restriction introduced to table 2 of Annex I. 
(4) The substance with FCM Substance Number  340 and the name dicyanodiamide is 
authorised to be used as an  additive in plastics in Ta ble 1 of Annex I to Regulation 
(EU) No 10/2011 without a specific migrati on limit. The Opinion reported in the 33rd 
series of the Scientific Committee for Food3 established a TDI of 1 mg/kg b.w. 
resulting in an SML of 60 mg/kg food. This limit coincides with the generic specific 
migration limit established in  Article 11(2) of Regulatio n (EU) No 10/2011, however 
if the SML of 60 mg/kg is derived from a t oxicological threshold such as the TDI the 
SML should be specifically mentioned in  Annex I, which should therefore be 
corrected accordingly. 
                                                 
1 OJ L 338, 13.11.2004, p. 4 
2 OJ L 12, 15.1.2011, p. 1 
3 Reports of the Scientific Committee for Food, 33rd series, p. 31, Office for Of ficial publications of the 
European Communities, Luxembour g, 1995, ISBN 92-826-9275-2 EN 3   EN (5) In order to limit the admini strative burden to business opera tors, plastic materials and 
articles which have been lawfully placed on the market based on the requirements set 
out in Regulation (EU) No 10/2011 and whic h do not comply with  this Regulation 
should be able to be placed on the market until one year after entry into force of this Regulation. They should be able to remain  on the market until exhaustion of stocks. 
(6)
 The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Anim al Health, and neither the European 
Parliament nor the Council has opposed them. 
HAS ADOPTED THIS REGULATION: 
Article 1 
Annex I to Regulation (EU) No 10/2011 is ame nded in accordance with the Annex to this 
Regulation. 
Article 2 
Plastic materials and articles which have been lawfully first placed on the market before 
{estimated date of entry into force + 1 year } and which do not comply with this Regulation 
may remain on the market after that date until the exhaus tion of stocks. 
Article  
This Regulation shall enter into force on the 20th 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. 
This Regulation shall be binding in its entirety and directly applicable in the Member States in 
accordance with the Treaties. 
Done at Brussels, 
 For the Commission 
 The President   
  
 On behalf of the President    [Position] EN 4   EN ANNEX  
Annex I to Regulation (EU) No 10/2011 is amended as follows: 
(1) In Table 1 the following lines are inserted in numerical order of the FCM Substance 
numbers: 
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
872  0006607-
41-6 2-phenyl-3,3-bis(4-
hydroxyphenyl)phthalimidine No Yes No 0.05  To be used only as a 
co-monomer in 
polycarbonate 
copolymers 20 
988  3634-83-
1 1,3-
bis(isocyanatomethyl)benzene No Yes No  (34) SML(T) applies to the 
migration of its 
hydrolysis product, 1,3-
benzenedimethanamine 
To be used only as co-
monomer in the 
manufacture of a 
middle layer coating on a poly(ethylene 
terephthalate) polymer 
film in a multilayer film  
 
(2) In Table 1 for the following substance, the co ntent of the column (8) is replaced by 
the following: 
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
340 47440 0000461-
58-5 dicyanodiamide Yes No No 60    
 
(3) In Table 1 for the following substance, the content of the column (8) is deleted and to 
column (9) "(34)" is added: 
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
421 13000 0001477-
55-0 1,3-
benzenedimethanamine No Yes No  (34)   
 
(4) in Table 2 the following line is inserted in numerical order of  the group restriction 
numbers: 
(1) (2) (3) (4) 
Group 
Restric-tion No FCM 
substance No SML (T) 
[mg/kg] Group restriction specification EN 5   EN (1) (2) (3) (4) 
34 421 
988 0.05 Expressed as 1,3-benzenedimethanamine 
 
(5) In Table 3 the following line is inserted  in numerical order of the notes on 
verification of compliance: 
(1) (2) 
Note No. Note on verification of compliance 
20 The substance contains aniline as an impurity; verification of compliance 
with the restriction set for primary aroma tic amines in Annex II (2) is necessary.