
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 1 January 2012 and which do not comply with this Regulation may continue to be placed on the market until 1 January 2013. 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 20th day following its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties.Done at Brussels, 28 November 2011.
For the Commission
The President
José Manuel BARROSO
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:

FCM substance No Ref. No CAS No Substance name Use as additive or polymer production aid(yes/no) Use as monomer or other starting substance or macro-molecule obtained from microbial fermentation(yes/no) FRF applicable(yes/no) SML[mg/kg] SML(T)[mg/kg](Group restriction No) Restrictions and specifications Notes on verification of compliance
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)
855 40560  (butadiene, styrene, methyl methacrylate) copolymer cross-linked with 1,3-butanediol dimethacrylate yes no no   Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below. 
856 40563  (butadiene, styrene, methyl methacrylate, butyl acrylate) copolymer cross-linked with divinylbenzene or 1,3-butanediol dimethacrylate yes no no   Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below. 
857 66765 0037953-21-2 (methyl methacrylate, butyl acrylate, styrene, glycidyl methacrylate) copolymer yes no no   Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % at room temperature or below. 
863 15260 0000646-25-3 1,10-decanediamine no yes no 0,05  Only to be used as a co-monomer for manufacturing polyamide articles for repeated use in contact with aqueous, acidic and dairy foodstuffs at room temperature or for short term contact up to 150 °C. 
873 93460  titanium dioxide reacted with octyltriethoxysilane yes no no   Reaction product of titanium dioxide with up to 2 % w/w surface treatment substance octyltriethoxysilane, processed at high temperatures. 
894 93360 0016545-54-3 thiodipropionic acid, ditetradecyl ester yes no no  (14)  
895 47060 0171090-93-0 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoic acid, esters with C13-C15 branched and linear alcohols yes no no 0,05  Only to be used in polyolefins in contact with foods other than fatty/high-alcoholic and dairy products. 
896 71958 0958445-44-8 3H-perfluoro-3-[(3-methoxy-propoxy)propanoic acid], ammonium salt yes no no   Only to be used in the polymerisation of fluoropolymers when:
— processed at temperatures higher than 280 °C for at least 10 minutes,
— processed at temperatures higher than 190 °C up to 30 % w/w for use in blends with polyoxymethylene polymers and intended for repeated use articles. 
923 39150 0000120-40-1 N,N-bis(2-hydroxyethyl)dodecanamide yes no no 5  The residual amount of diethanolamine in plastics, as an impurity and decomposition product of the substance, should not result in a migration of diethanolamine higher than 0,3 mg/kg food. (18)
924 94987  trimethylolpropane, mixed triesters and diesters with n-octanoic and n-decanoic acids yes no no 0,05  Only for use in PET in contact with all types of foods other than fatty, high-alcoholic and dairy products. 
926 71955 0908020-52-0 perfluoro[(2-ethyloxy-ethoxy)acetic acid], ammonium salt yes no no   Only to be used in the polymerisation of fluoropolymers that are processed at temperatures higher than 300 °C for at least 10 minutes. 
971 25885 0002459-10-1 trimethyl trimellitate no yes no   Only to be used as a co-monomer up to 0,35 % w/w to produce modified polyesters intended to be used in contact with aqueous and dry foodstuffs containing no free fat at the surface. (17)
972 45197 0012158-74-6 copper hydroxide phosphate yes no no    
973 22931 0019430-93-4 (perfluorobutyl)ethylene no yes no   Only to be used as a co-monomer up to 0,1 % w/w in the polymerisation of fluoropolymers, sintered at high temperatures. 
974 74050 939402-02-5 phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters yes no yes 5  SML expressed as the sum of phosphite and phosphate form of the substance and the hydrolysis product 4-t-amylphenol.The migration of the hydrolysis product 2,4-di-t-amylphenol should not exceed 0,05 mg/kg. 
((2)) in Table 1 for the following substance, the content of the columns (2), (5), (6) and (10) is replaced by the following:

FCM substance No Ref. No CAS No Substance name Use as additive or polymer production aid(yes/no) Use as monomer or other starting substance or macro-molecule obtained from microbial fermentation(yes/no) FRF applicable(yes/no) SML[mg/kg] SML(T)[mg/kg](Group restriction No) Restrictions and specifications Notes on verification of compliance
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)
438 13303 0002162-74-5 bis(2,6-diisopropylphenyl) carbodiimide no yes no 0,05  Expressed as the sum of bis(2,6-diisopropylphenyl)carbodiimide and its hydrolysis product 2,6-diisopropylaniline 
((3)) in Table 1 for the following substance, the content of the column (3) is replaced by the following:

FCM substance No Ref. No CAS No Substance name Use as additive or polymer production aid(yes/no) Use as monomer or other starting substance or macro-molecule obtained from microbial fermentation(yes/no) FRF applicable(yes/no) SML[mg/kg] SML(T)[mg/kg](Group restriction No) Restrictions and specifications Notes on verification of compliance
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)
797 76807 0073018-26-5 polyester of adipic acid with 1,3-butanediol, 1,2-propanediol and 2-ethyl-1-hexanol yes no yes  (31)(32)  
((4)) in Table 1 for the following substances, the content of the column (8) is replaced by the following:

FCM substance No Ref. No CAS No Substance name Use as additive or polymer production aid(yes/no) Use as monomer or other starting substance or macro-molecule obtained from microbial fermentation(yes/no) FRF applicable(yes/no) SML[mg/kg] SML(T)[mg/kg](Group restriction No) Restrictions and specifications Notes on verification of compliance
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)
239 19975 0000108-78-1 2,4,6-triamino-1,3,5-triazine yes yes no 2,5   
25420
93720
376 66905 0000872-50-4 N-methylpyrrolidone yes no no 60   
((5)) in Table 1 for the following substance, the content of the columns (8) and (10) is replaced by the following:

FCM substance No Ref. No CAS No Substance name Use as additive or polymer production aid(yes/no) Use as monomer or other starting substance or macro-molecule obtained from microbial fermentation(yes/no) FRF applicable(yes/no) SML[mg/kg] SML(T)[mg/kg](Group restriction No) Restrictions and specifications Notes on verification of compliance
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)
452 38885 0002725-22-6 2,4-bis(2,4-dimethylphenyl)-6-(2-hydroxy-4-n-octyloxyphenyl)-1,3,5-triazine yes no no 5   
((6)) in Table 1 for the following substances, the content of the column (10) is replaced by the following:

FCM substance No Ref. No CAS No Substance name Use as additive or polymer production aid(yes/no) Use as monomer or other starting substance or macro-molecule obtained from microbial fermentation(yes/no) FRF applicable(yes/no) SML[mg/kg] SML(T)[mg/kg](Group restriction No) Restrictions and specifications Notes on verification of compliance
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)
794 18117 0000079-14-1 glycolic acid no yes no   Only to be used for manufacture of polyglycolic acid (PGA) for (i) indirect food contact behind polyesters such as polyethylene terephthalate (PET) or polylactic acid (PLA); and (ii) direct food contact of a blend of PGA up to 3 % w/w in PET or PLA. 
812 80350 0124578-12-7 poly(12-hydroxystearic acid)-polyethyleneimine copolymer yes no no   Only to be used in plastics up to 0,1 % w/w.Prepared by the reaction of poly(12-hydroxystearic acid) with polyethyleneimine. 
((7)) in Table 1 for the following substance, the content of the columns (10) and (11) is replaced by the following:

FCM substance No Ref. No CAS No Substance name Use as additive or polymer production aid(yes/no) Use as monomer or other starting substance or macro-molecule obtained from microbial fermentation(yes/no) FRF applicable(yes/no) SML[mg/kg] SML(T)[mg/kg](Group restriction No) Restrictions and specifications Notes on verification of compliance
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)
862 15180 0018085-02-4 3,4-diacetoxy-1-butene no yes no 0,05  SML including the hydrolysis product 3,4-dihydroxy-1-buteneOnly to be used as a co-monomer for ethylvinylalcohol (EVOH) and polyvinylalcohol (PVOH) copolymers. (17)(19)
((8)) in Table 2 for the following group restriction, the content of the columns (2) and (4) is replaced by the following:

Group restriction No FCM substance No SML (T)[mg/kg] Group restriction specification
(1) (2) (3) (4)
14 294 5 Expressed as the sum of the substances and their oxidation products
368
894
((9)) in Table 3 the following notes on verification of compliance are inserted in numerical order:

Note No Notes on verification of compliance
(1) (2)
(18) There is a risk that the SML could be exceeded from low-density polyethylene (LDPE)
(19) There is a risk that the OML could be exceeded in direct contact with aqueous foods from ethylvinylalcohol (EVOH) and polyvinylalcohol (PVOH) copolymers
