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Document 32009R0975

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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)

OJ L 274, 20.10.2009, p. 3–8 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

(HR)
⏵This document has been published in a special edition(s) (HR)
Special edition in Croatian: Chapter 13 Volume 047 P. 298 - 303

Legal status of the document No longer in force, Date of end of validity: 30/04/2011; Repealed by 32011R0010

ELI: http://data.europa.eu/eli/reg/2009/975/oj

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Official Journal

20.10.2009

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:

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.’

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.’

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