Access to European Union law
<a href="https://eur-lex.europa.eu/content/help/eurlex-content/experimental-features.html" target="_blank">More about the experimental features corner</a>
Choose the experimental features you want to try
EUR-Lex
Access to European Union law

This document is an excerpt from the EUR-Lex website

You are here
Use quotation marks to search for an "exact phrase". Append an asterisk (*) to a search term to find variations of it (transp*, 32019R*). Use a question mark (?) instead of a single character in your search term to find variations of it (ca?e finds case, cane, care).
Search tips
Need more search options? Use the Advanced search

Document 32009R0975

    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)

    IO 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)

    ⏵Foilsíodh an doiciméad seo in eagrán speisialta (HR)

    Legal status of the document No longer in force, Date of end of validity: 30/04/2011; Arna aisghairm le 32011R0010

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

    Date of document:
    19/10/2009
    Date of effect:
    09/11/2009; Teacht i bhfeidhm Dáta foilsithe + 20 Féach Airt. 2
    Date of end of validity:
    30/04/2011; Arna aisghairm le 32011R0010
    Author:
    An Coimisiún Eorpach
    Form:
    Rialachán
    Additional information:
    Ábharthacht maidir le LEE
    Treaty:
    An Conradh ag bunú an Chomhphobail Eorpaigh
    Legal basis:
    Link
    Link
    Link
    Select all documents mentioning this document
    Modifies:
    Relation Act Comment Subdivision concerned From To
    Modifies 32002L0072 Leasú iarscríbhinn 3 09/11/2009
    Modifies 32002L0072 Leasú iarscríbhinn 6 09/11/2009
    Modifies 32002L0072 Leasú iarscríbhinn 4BI 09/11/2009
    Modifies 32002L0072 Leasú iarscríbhinn 5 09/11/2009
    Modifies 32002L0072 Leasú ANN3 09/11/2009
    Modifies 32002L0072 Leasú iarscríbhinn 2 09/11/2009
    Modified by:
    Relation Act Comment Subdivision concerned From To
    Repealed by 32011R0010 01/05/2011
    Link

    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.’
    Top