
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 2013 and which do not comply with this Regulation 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 applicable in all Member States.Done at Brussels, 30 November 2012.
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 for the following substance, the content of column (3) is replaced by the following:

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)
257 13550 0000110-98-5 dipropyleneglycol yes yes no    
16660 0025265-71-8
51760 
((2)) in Table 1 for the following substance, the content of 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 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 content of 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 methacrylate) copolymer yes no no   Only to be used in:
((a)) rigid poly(vinyl chloride) (PVC) at a maximum 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 paragraph 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 no yes no 0,05 (33) Only to be used as comonomer in siloxane modified polycarbonate.The oligomeric mixture shall be characterised by the formulaC24H38Si2O5(SiOC2H6)n (50 > n ≥ 26). 
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 231/2012. 
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. 

((6)) in Table 2 the following line is inserted in numerical order of the group restriction numbers:

(1) (2) (3) (4)
Group Restriction No FCM substance No SML (T) [mg/kg] Group restriction specification
33 180874 ND expressed as eugenol
((7)) in Table 3 on verification of compliance the content of Note No (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.
