COMMISSION REGULATION (EU) No 202/2014  
of 3 March 2014  
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/EEC (  1 ), 
and in particular 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 substances which may be used 
in the manufacture of plastic materials and articles 
(‘Union list of authorised substances’).  
(2) On 24 July 2012 the European Food Safety Authority 
issued favourable scientific evaluations for two additional 
substances, namely 2-phenyl-3,3-bis(4-hydroxyphe ­
nyl)phthalimidine (  3 ) and 1,3-bis(isocyanatomethyl)ben ­
zene (  4 ). Those substances should now be added to the 
Union list of authorised substances as food contact 
material (FCM) substances Nos 872 and 988.  
(3) From the scientific evaluation of FCM substance No 988 
it follows that migration of its hydrolysis product, 1,3- 
benzenedimethanamine should be controlled. 1,3- 
benzenedimethanamine is already authorised as FCM 
substance No 421. As the migration of FCM substances 
Nos 421 and 988 is controlled on the basis of the 
migration of FCM substance No 421, a group restriction 
including both substances should be introduced. 
Therefore, the authorisation of FCM substance No 421 
should be amended and the group restriction introduced 
in Table 2 of Annex I to Regulation (EU) No 10/2011.  (4) FCM substance No 340 (dicyanodiamide) is authorised as 
an additive in plastics in Table 1 of Annex I to Regu ­
lation (EU) No 10/2011 without a specific migration 
limit. The Opinion reported in the 33rd series of the 
Scientific Committee for Food (  5 ) established a tolerable 
daily intake (TDI) of 1 mg/kg body weight resulting in a 
specific migration limit (SML) of 60 mg/kg food. This 
limit coincides with the generic specific migration limit 
established in Article 11(2) of Regulation (EU) No 
10/2011. However, since the SML of 60 mg/kg is 
derived from a toxicological threshold such as the TDI, 
the SML should be specifically mentioned in Annex I to 
Regulation (EU) No 10/2011.  
(5) In order to limit the administrative burden to business 
operators, 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 which do 
not comply with this Regulation should be able to be 
placed on the market until 24 March 2015. They should 
be able to remain on the market until exhaustion of 
stocks.  
(6) Regulation (EU) No 10/2011 should therefore be 
amended accordingly.  
(7) The measures provided for in this Regulation are in 
accordance with the opinion of the Standing 
Committee on the Food Chain and Animal Health,  
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 which have been lawfully placed on 
the market before 24 March 2014 and which do not comply 
with this Regulation may be placed on the market until 
24 March 2015. Those plastic materials and articles may 
remain on the market after that date until the exhaustion of 
stocks.EN 4.3.2014 Official Journal of the European Union L 62/13  
( 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 ) EFSA Journal 2012; 10(7):2825.  
( 4 ) EFSA Journal 2012;10(7):2824.  ( 5 ) Reports of the Scientific Committee for Food, 33rd series, p. 31, 
Office for Official publications of the European Communities, 
Luxembourg, 1995, ISBN 92-826-9275-2.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, 3 March 2014.  
For the Commission  
The President  
José Manuel BARROSOEN L 62/14 Official Journal of the European Union 4.3.2014ANNEX  
Annex I to Regulation (EU) No 10/2011 is amended as follows:  
(1) Table 1 is amended as follows:  
(a) the entry concerning FCM substance No 340 (dicyanodiamide) is replaced by the following: 
‘340  47440  0000461-58-5  dicyanodiamide  Yes  No  No  60’  
(b) the entry concerning FCM substance No 421 (1,3-benzenedimethanamine) is replaced by the following: 
‘421  13000  0001477-55-0  1,3-benzenedimethanamine  No  Yes  No  (34)’  
(c) the following entry is inserted in accordance with the numerical order: 
‘872  0006607-41-6  2-phenyl-3,3-bis(4-hydro ­
xyphenyl)phthalimidine  No Yes  No  0,05  To be used only as a co-monomer 
in polycarbonate copolymers  (20)’  
(d) the following entry is added: 
‘988  3634-83-1  1,3-bis(isocyanato ­
methyl)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 2, the following entry is added: 
‘34 421 
988  0,05  Expressed as 1,3-benzenedimethanamine’  
(3) In Table 3, the following entry is added: 
‘(20)  The substance contains aniline as an impurity; verification of compliance with the restriction set for primary aromatic amines  in Annex II (2) is necessary.’EN 4.3.2014 Official Journal of the European Union L 62/15