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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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This legislation may since have been updated - see the latest available (revised) version
Annex I to Regulation (EU) No 10/2011 is amended as follows:
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:
| |||
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. |
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 |
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) |
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 |
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 |
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. |
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) |
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 |
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 |
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