Commission Regulation (EC) No 975/2009 of 19 October 2009 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs (Text with EEA relevance)
Date: 2009-10-19
Institutions: European Commission
Subjects: adjuvant, chemical product, food safety, foodstuff, foodstuffs legislation, packaging product, plastics








L_2009274EN.01000301.xml










20.10.2009   


EN


Official Journal of the European Union


L 274/3








            COMMISSION REGULATION (EC) No 975/2009
of 19 October 2009
         
amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs
(Text with EEA relevance)


THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,


Having regard to Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (1), and in particular Article 5(2) thereof,

Whereas:







(1)


Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs (2) establishes a Community list of monomers and other starting substances, which may be used for the manufacture of plastic materials and articles. Recently additional monomers and starting substances have received a favourable scientific evaluation by the European Food Safety Authority (the Authority) and should now be added to the existing list.












(2)


Directive 2002/72/EC also contains a Community list of additives which may be used for the manufacture of plastic materials and articles. Recently additional additives have received a favourable scientific evaluation by the Authority and should now be added to the existing list.












(3)


Directive 2002/72/EC should therefore be amended accordingly.












(4)


According to Article 4(1) of Directive 2002/72/EC, the Community list of additives contained in Annex III to that Directive will become a positive list from 1 January 2010. Consequently, the titles in Annex III to that Directive should no longer refer to an ‘incomplete’ list of additives.












(5)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,





HAS ADOPTED THIS REGULATION:



Article 1
Annexes II, III, IVa, V and VI to Directive 2002/72/EC are amended in accordance with Annexes I to V to this Regulation.


Article 2
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 all Member States.
Done at Brussels, 19 October 2009.


For the Commission

Androulla VASSILIOU
            

Member of the Commission






(1)  
            OJ L 338, 13.11.2004, p. 4.

(2)  
            OJ L 220, 15.8.2002, p. 18.




ANNEX I
In section A to Annex II to Directive 2002/72/EC the following lines are inserted in the table in numerical order:









Ref. No


CAS No


Name


Restrictions and/or specifications




(1)


(2)


(3)


(4)




‘14627


0000117-21-5


3-chlorophthalic anhydride


SML = 0,05 mg/kg expressed as 3-chlorophthalic acid




14628


0000118-45-6


4-chlorophthalic anhydride


SML = 0,05 mg/kg expressed as 4-chlorophthalic acid




14876


0001076-97-7


1,4-cyclohexanedicarboxylic acid


SML = 5 mg/kg
Only to be used for manufacture of polyesters




18117


0000079-14-1


glycolic acid


For indirect food contact only, behind a polyethylene terephthalate (PET) layer




19965


0006915-15-7


malic acid


Only to be used as a co-monomer in aliphatic polyesters up to maximum level of 1 % on a molar basis




21498


0002530-85-0


[3-(methacryloxy) propyl]trimethoxysilane


SML = 0,05 mg/kg
Only to be used as a surface treatment agent of inorganic fillers’










ANNEX II
Annex III to Directive 2002/72/EC is amended as follows:






(1)


The word ‘incomplete’ is deleted from the general title of Annex III as well as from the titles of Sections A and B.










(2)


In section A the following lines are inserted in numerical order:








Ref. No


CAS No


Name


Restrictions and/or specifications




(1)


(2)


(3)


(4)




‘30607


—


acids, C2-C24, aliphatic, linear, monocarboxylic, from natural oils and fats, lithium salt


SML(T) = 0,6 mg/kg (expressed as Lithium) (8)




33105


0146340-15-0


alcohols, C12-C14 secondary, β-(2-hydroxyethoxy), ethoxylated


SML = 5 mg/kg (44)




33535


0152261-33-1


α-alkenes(C20-C24) copolymer with maleic anhydride, reaction product with 4-amino-2,2,6,6-tetramethylpiperidine


Not to be used for articles in contact with fatty foods for which simulant D is laid down
Not to be used in contact with alcoholic foods




38550


0882073-43-0


bis(4-propylbenzylidene)propylsorbitol


SML = 5 mg/kg (including the sum of its hydrolysis products)




40155


0124172-53-8


N,N'-bis(2,2,6,6-tetramethyl-4-piperidyl)-N,N'-diformylhexamethylenediamine


SML = 0,05 mg/kg (1) (44)




49080


0852282-89-4


N-(2,6-Diisopropylphenyl)-6-[4-(1,1,3,3-tetramethylbutyl)phenoxy]-1H-benzo[de]isoquinolin-1,3(2H)-dione


SML = 0,05 mg/kg (39) (45) (46)
Only for use in polyethylene terephthalate (PET)




60027


—


hydrogenated homopolymers and/or copolymers made of 1-hexene and/or 1-octene and/or 1-decene and/or 1-dodecene and/or 1-tetradecene (Mw: 440-12 000 )


Not to be used for articles in contact with fatty foods for which simulant D is laid down.
In compliance with the specification laid down in Annex V




62215


0007439-89-6


iron


SML = 48 mg/kg




68119


—


neopentyl glycol, diesters and monoesters with benzoic acid and 2-ethylhexanoic acid


SML = 5 mg/kg
Not to be used for articles in contact with fatty foods for which simulant D is laid down.




72141


0018600-59-4


2,2'-(1,4-phenylene)bis[4H-3,1-benzoxazin-4-one]


SML = 0,05 mg/kg (including the sum of its hydrolysis products)




76807


00073018-26-5


polyester of adipic acid with 1,3-butanediol, 1,2-propanediol and 2-ethyl-1-hexanol


SML = 30 mg/kg




77708


—


polyethyleneglycol (EO = 1-50) ethers of linear and branched primary (C8-C22) alcohols


SML = 1,8 mg/kg
In compliance with the specification laid down in Annex V




80077


0068441-17-8


polyethylene waxes, oxidised


SML = 60 mg/kg




80350


0124578-12-7


poly(12-hydroxystearic acid)-polyethyleneimine copolymer


Only to be used in polyethylene terephthalate (PET), polystyrene (PS), high impact polystyrene (HIPS) and polyamide (PA) up to 0,1 % w/w.
In compliance with the specification laid down in Annex V




80480


0090751-07-8; 0082451-48-7


poly(6-morpholino-1,3,5-triazine-2,4-diyl)-[(2,2,6,6-tetramethyl-4-piperidyl)imino)]-hexamethylene-[(2,2,6,6-tetramethyl-4-piperidyl)imino)]


SML = 5 mg/kg (47)
In compliance with the specification laid down in Annex V




80510


1010121-89-7


poly(3-nonyl-1,1-dioxo-1-thiopropane-1,3-diyl)-block-poly(x-oleyl-7-hydroxy-1,5-diiminooctane-1,8-diyl), process mixture with x = 1 and/or 5, neutralised with dodecylbenzenesulfonic acid


Only to be used as a polymerisation production aid in polyethylene (PE), polypropylene (PP) and polystyrene (PS)




91530


—


sulphosuccinic acid alkyl (C4-C20) or cyclohexyl diesters, salts


SML = 5 mg/kg




91815


—


sulphosuccinic acid monoalkyl (C10-C16) polyethyleneglycol esters, salts


SML = 2 mg/kg




92200


0006422-86-2


terephthalic acid, bis(2-ethylhexyl)ester


SML = 60 mg/kg




92470


0106990-43-6


N,N',N',N'-tetrakis(4,6-bis(N-butyl-(N-methyl-2,2,6,6-tetramethylpiperidin-4-yl)amino)triazin-2-yl)-4,7-diazadecane-1,10-diamine


SML = 0,05 mg/kg




92475


0203255-81-6


3,3',5,5'-tetrakis(tert-butyl)-2,2'-dihydroxybiphenyl, cyclic ester with [3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propyl]oxyphosphonous acid


SML = 5 mg/kg (expressed as the sum of phosphite and phosphate form of the substance and the hydrolysis products)




93450


—


titanium dioxide, coated with a copolymer of n-octyltrichlorosilane and [aminotris(methylenephosphonic acid), penta sodium salt]


In compliance with the specification laid down in Annex V




94000


0000102-71-6


triethanolamine


SML = 0,05 mg/kg (including the hydrochloride adduct)




94425


0000867-13-0


triethyl phosphonoacetate


Only for use in polyethylene terephthalate (PET)




94985


—


trimethylolpropane, mixed triesters and diesters with benzoic acid and 2-ethylhexanoic acid


SML = 5 mg/kg
Not to be used for articles in contact with fatty food for which simulant D is laid down’













ANNEX III
In Annex IVa to Directive 2002/72/EC the following lines are inserted in numerical order:








Ref. No


CAS No


Name




‘49080


852282-89-4


N-(2,6-Diisopropylphenyl)-6-[4-(1,1,3,3-tetramethylbutyl)phenoxy]-1H-benzo[de]isoquinolin-1,3(2H)-dione




72141


0018600-59-4


2,2′-(1,4-phenylene)bis[4H-3,1-benzoxazin-4-one]




76807


0007308-26-5


polyester of adipic acid with 1,3-butanediol, 1,2-propanediol and 2-ethyl-1-hexanol




92475


0203255-81-6


3,3′,5,5′-tetrakis(tert-butyl)-2,2′-dihydroxybiphenyl, cyclic ester with [3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propyl]oxyphosphonous acid’










ANNEX IV
In Part B of Annex V to Directive 2002/72/EC the following lines are inserted in numerical order:







Ref. No


Other specifications




‘60027


hydrogenated homopolymers and/or copolymers made of 1-hexene and/or 1-octene and/or 1-decene and/or 1-dodecene and/or 1-tetradecene (Mw: 440-12 000 )
Average molecular weight not less than 440 Da
Viscosity at 100 °C not less than 3,8 cSt (3,8 x 10-6 m2/s)




77708


polyethyleneglycol (EO = 1-50) ethers of linear and branched primary (C8-C22) alcohols
Maximum residual quantity of ethylene oxide in the material or article = 1 mg/kg




80350


poly(12-hydroxystearic acid)-polyethyleneimine copolymer
Prepared by the reaction of poly(12-hydroxystearic acid) with polyethyleneimine




80480


poly(6-morpholino-1,3,5-triazine-2,4-diyl)-[(2,2,6,6-tetramethyl-4-piperidyl)imino)]-hexamethylene-[(2,2,6,6-tetramethyl-4-piperidyl)imino)]
Average molecular weight not less than 2 400  Da
Residual content of morpholine ≤ 30 mg/kg, of N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine < 15 000  mg/kg, and of 2,4-dichloro-6-morpholino-1,3,5-triazine ≤ 20 mg/kg




93450


titanium dioxide, coated with a copolymer of n-octyltrichlorosilane and [aminotris(methylenephosphonic acid), penta sodium salt]
The content of the surface treatment copolymer of the coated titanium dioxide is less than 1 % w/w’










ANNEX V
Annex VI to Directive 2002/72/EC is amended as follows:






1.


The note (8) is replaced by the following:






‘(8)


SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 24886, 62020, 30607, 38000, 42400, 64320, 66350, 67896, 73040, 85760, 85840, 85920 and 95725.’














2.


The following notes are added:






‘(44)


The SML could be exceeded from polyolefins.










(45)


The SML could be exceeded from plastics containing more than 0,5 % w/w of the substance.










(46)


The SML could be exceeded in contact with foods with high alcoholic content.










(47)


The SML could be exceeded from low-density polyethylene (LDPE) containing more than 0,3 % w/w of the substance when in contact with fatty foods.’