Commission Regulation (EU) No 1282/2011Show full title

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)

(1)

in Table 1 the following lines are inserted in numerical order of the FCM substance numbers:

FCM substance NoRef. NoCAS NoSubstance nameUse 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 specificationsNotes on verification of compliance
(1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)
85540560(butadiene, styrene, methyl methacrylate) copolymer cross-linked with 1,3-butanediol dimethacrylateyesnonoOnly to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below.
85640563(butadiene, styrene, methyl methacrylate, butyl acrylate) copolymer cross-linked with divinylbenzene or 1,3-butanediol dimethacrylateyesnonoOnly to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below.
857667650037953-21-2(methyl methacrylate, butyl acrylate, styrene, glycidyl methacrylate) copolymeryesnonoOnly to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % at room temperature or below.
863152600000646-25-31,10-decanediaminenoyesno0,05Only 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.
87393460titanium dioxide reacted with octyltriethoxysilaneyesnonoReaction product of titanium dioxide with up to 2 % w/w surface treatment substance octyltriethoxysilane, processed at high temperatures.
894933600016545-54-3thiodipropionic acid, ditetradecyl esteryesnono(14)
895470600171090-93-03-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoic acid, esters with C13-C15 branched and linear alcoholsyesnono0,05Only to be used in polyolefins in contact with foods other than fatty/high-alcoholic and dairy products.
896719580958445-44-83H-perfluoro-3-[(3-methoxy-propoxy)propanoic acid], ammonium saltyesnono

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.

923391500000120-40-1N,N-bis(2-hydroxyethyl)dodecanamideyesnono5The 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)
92494987trimethylolpropane, mixed triesters and diesters with n-octanoic and n-decanoic acidsyesnono0,05Only for use in PET in contact with all types of foods other than fatty, high-alcoholic and dairy products.
926719550908020-52-0perfluoro[(2-ethyloxy-ethoxy)acetic acid], ammonium saltyesnonoOnly to be used in the polymerisation of fluoropolymers that are processed at temperatures higher than 300 °C for at least 10 minutes.
971258850002459-10-1trimethyl trimellitatenoyesnoOnly 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)
972451970012158-74-6copper hydroxide phosphateyesnono
973229310019430-93-4(perfluorobutyl)ethylenenoyesnoOnly to be used as a co-monomer up to 0,1 % w/w in the polymerisation of fluoropolymers, sintered at high temperatures.
97474050939402-02-5phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triestersyesnoyes5

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 NoRef. NoCAS NoSubstance nameUse 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 specificationsNotes on verification of compliance
(1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)
438133030002162-74-5bis(2,6-diisopropylphenyl) carbodiimidenoyesno0,05Expressed 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 NoRef. NoCAS NoSubstance nameUse 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 specificationsNotes on verification of compliance
(1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)
797768070073018-26-5polyester of adipic acid with 1,3-butanediol, 1,2-propanediol and 2-ethyl-1-hexanolyesnoyes

(31)

(32)

(4)

in Table 1 for the following substances, the content of the column (8) is replaced by the following:

FCM substance NoRef. NoCAS NoSubstance nameUse 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 specificationsNotes on verification of compliance
(1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)
239199750000108-78-12,4,6-triamino-1,3,5-triazineyesyesno2,5
25420
93720
376669050000872-50-4N-methylpyrrolidoneyesnono60
(5)

in Table 1 for the following substance, the content of the columns (8) and (10) is replaced by the following:

FCM substance NoRef. NoCAS NoSubstance nameUse 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 specificationsNotes on verification of compliance
(1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)
452388850002725-22-62,4-bis(2,4-dimethylphenyl)-6-(2-hydroxy-4-n-octyloxyphenyl)-1,3,5-triazineyesnono5
(6)

in Table 1 for the following substances, the content of the column (10) is replaced by the following:

FCM substance NoRef. NoCAS NoSubstance nameUse 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 specificationsNotes on verification of compliance
(1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)
794181170000079-14-1glycolic acidnoyesnoOnly 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.
812803500124578-12-7poly(12-hydroxystearic acid)-polyethyleneimine copolymeryesnono

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 NoRef. NoCAS NoSubstance nameUse 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 specificationsNotes on verification of compliance
(1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)
862151800018085-02-43,4-diacetoxy-1-butenenoyesno0,05

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 NoFCM substance NoSML (T)[mg/kg]Group restriction specification
(1)(2)(3)(4)
142945Expressed 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 NoNotes 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