Commission Regulation (EU) No 1282/2011 of 28 November 2011 amending and correcting Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food  Text with EEA relevance

ANNEX
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-butene
Only 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
Commission Regulation (EU) No 1282/2011 of 28 November 2011 amending and correcting Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food Text with EEA relevance

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