EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX   
[…](2012) 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 
 EN 2   EN COMMISSION REGULATION (EU) No […]/[…] 
of […] 
amending and correcting 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 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 food
2 establishes a Union list of monomers, 
other starting substances and additives wh ich may be used in the manufacture of 
plastic materials and articles. Recently the European Food Safety Authority (‘the Authority’) issued favourable scientific ev aluations for additional substances which 
should now be added to the current list. 
(2) For certain other substances, the restrictions and/or specifications already established 
at the EU level should be amended on th e basis of a new favourable scientific 
evaluation by the Authority. 
(3) Annex I to Regulation (EU) No 10/2011 s hould therefore be amended accordingly. 
(4) The substance with FCM Substance Number  257 and the name dipropyleneglycol is 
authorised to be used as an  additive in plastics in Ta ble 1 of Annex I to Regulation 
(EU) No 10/2011 and listed with the CAS No 0000110-98-5. In Commission Directive 
2002/72/EC of 6 August 2002 rela ting to plastic materials and articles intended to 
come into contact with foodstuffs
3 this substance was referred to by CAS No 
0025265-71-8. That reference was deleted upon the entry into force of Regulation 
(EU) No 10/2011, replacing Directive 2002/ 72/EC, because it was considered 
superfluous. However, taking into account  that CAS No 0025265- 71-8 refers to the 
commercially used mixture of isomers rather than to the pure substance, it should be 
reinserted in Regulation(EU) No 10/ 2011. CAS No 0000110-98-5 should remain in 
Table 1. 
                                                 
1 OJ L 338, 13.11.2004, p. 4. 
2 OJ L 12, 15.1.2011, p. 1. 
3 OJ L 220, 15.8.2002, p. 18. EN 3   EN (5) Compliance Note No (4) in Table 3 of A nnex I to Regulation (EU) No 10/2011 gives 
an ambiguous reference to simulant D, where a reference to simulant D2 is intended. 
Therefore, the Note No (4) should refer to simulant D2. 
(6) Annex I to Regulation (EU) No 10/2011 shoul d therefore be corrected accordingly. 
(7) 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. 
(8) 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 placed on the ma rket before 1 January 
2013 and which do not comply with this Regulati on may continue to be placed on the market 
until 1 January 2014. Those plastic materials and articles may remain on the market until the 
exhaustion of stocks. 
Article 3 
This Regulation shall enter into force on the twentieth day following its publication in the 
Official Journal of the European Union . 
This Regulation shall be binding in  its entirety and directly app licable in the Member States.  
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 for the following substance, the co ntent of the column (3) is replaced by 
the following: 
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
257 13550 
16660 
51760 0000110-
98-5 
0025265-
71-8 dipropyleneglycol yes yes no     
 
(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) 
449 49840 0002500-
88-1 dioctadecyl 
disulphide yes no yes 0.05    
 
(3) In Table 1 for the following substance, the content of the columns (8) and (9) is 
replaced by the following: 
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
180 17160 0000097-
53-0 eugenol no yes no  (33)   
 
(4) In Table 1 for the following substances, the co ntent of the column (10) is replaced by 
the following: 
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
807 93485 — titanium 
nitride, 
nanoparticles yes no no   No migration of titanium 
nitride nanoparticles 
Only to be used in 
polyethylene terephthalate 
(PET) up to 20 mg/kg 
In the PET, the agglomerates 
have a diameter of 100 – 500 
nm consisting of primary 
titanium nitride nanoparticles; 
primary particles have a 
diameter of approximately 20 
nm.  
865 40619 0025322-
99-0 (butyl 
acrylate, 
methyl 
methacrylate, 
butyl yes no no   Only to be used in: 
(a) rigid poly(vinyl chloride) 
(PVC) at a maximum  EN 5   EN methacrylate) 
copolymer level of 1% w/w; 
(b) polylactic acid (PLA) at 
a maximum level of 5 % 
w/w. 
868 53245 0009010-
88-2 (ethyl 
acrylate, 
methyl 
methacrylate) 
copolymer yes no no   Only to be used in: 
(a) rigid poly(vinyl chloride) 
(PVC) at a maximum 
level of 2% w/w; 
(b) polylactic acid (PLA) at 
a maximum level of 5 % 
w/w; 
(c) polyethylene 
terephthalate (PET) at a 
maximum level of 5 % 
w/w.  
 
(5) 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) 
858  38565   0090498-
90-1 3,9-bis[2-(3-(3-tert-butyl-4-
hydroxy-5-
methylphenyl)propionyloxy)-1,1-dimethylethyl]-2,4,8,10-
tetraoxaspiro[5,5]undecane yes no yes 0.05   SML expressed as the sum of 
the substance and its 
oxidation product 3-[(3-(3-tert-butyl-4-hydroxy-5-
methylphenyl)prop-2-
enoyloxy)-1,1-
dimethylethyl]-9-[(3-(3-tert-
butyl-4-hydroxy-5-
methylphenyl)propionyloxy)-
1,1-dimethylethyl]-2,4,8,10-
tetraoxaspiro[5,5]-undecane 
in equilibrium with its para 
quinone methid tautomer 
   
(2) 
874 16265 0156065-
00-8 α-dimethyl-3-(4'-hydroxy-3'-
methoxyphenyl)propylsilyloxy, 
ω-3-dimethyl-3-(4'-hydroxy-3'-
methoxyphenyl)propylsilyl 
polydimethylsiloxane, n=26-50 no yes no  (33) Only to be used as 
comonomer in siloxane 
modified polycarbonate  
902  0000128-
44-9 1,2-benzisothiazol-3(2H)-one 
1,1-dioxide, sodium salt yes no no   The substance shall comply 
with the specific purity 
criteria as set out in 
Commission Regulation 
(EU) No 231/20124  
979 79987 - (polyethylene terephthalate, 
hydroxylated polybutadiene, 
pyromellitic anhydride) 
copolymer yes no no   Only to be used in 
polyethylene terephthalate 
(PET) at a maximum level of 
5% w/w  
                                                 
4 OJ L 83, 22.3.2012, p. 1. EN 6   EN  
(6) 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 
33 180 
874 ND  expressed as eugenol 
 
(7) In Table 3 on verification of compliance th e content of note (4) is replaced by the 
following: 
(1) (2) 
Note No. Note on verification of compliance 
(4) Compliance testing when there is a fat contact should be performed using
saturated fatty food simulants as simulant D2.