CELEX: 32009R0975
Language: en
Date: 2009-10-19 00:00:00
Title: 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)

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.’