CELEX: 32005L0079
Language: en
Date: 2005-11-18 00:00:00
Title: Commission Directive 2005/79/EC of 18 November 2005 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food   (Text with EEA relevance)

19.11.2005   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 302/35
            
         
      COMMISSION DIRECTIVE 2005/79/EC
   of 18 November 2005
   amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food
   (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,
   After consulting the European Food Safety Authority,
   Whereas:
   
               (1)
            
            
               Commission Directive 2002/72/EC (2) establishes a list of monomers and other starting substances, which may be used for the manufacture of plastic materials and articles. On the basis of new information related to the risk assessment of such substances, certain monomers provisionally admitted at national level as well as new monomers should be included in the Community list of permitted substances in that Directive.
            
         
               (2)
            
            
               Directive 2002/72/EC also contains an incomplete list of additives which may be used in the manufacture of plastic materials and articles. That list should be amended so as to include other additives evaluated by the European Food Safety Authority (the Authority).
            
         
               (3)
            
            
               For certain substances, the restrictions already established at Community level should be amended on the basis of the new information available. In particular for epoxidised soybean oil (ESBO) the Authority recommended to decrease its specific migration limit (SML) for PVC gaskets containing that substance which are used to seal glass jars containing infant formulae and follow-on formulae or containing processed cereal-based foods and baby foods for infants and young children. In fact the Authority noted that the exposure of infants who regularly eat such foods may exceed the TDI. Therefore the SML for ESBO is decreased for these particular applications from 60 to 30 mg/kg of food or food simulant while it remains unchanged for all other applications.
            
         
               (4)
            
            
               A transitional period should be provided for in respect of PVC gaskets containing epoxidised soybean oil, used to seal glass jars, which are brought into contact with food before the 19 November 2006.
            
         
               (5)
            
            
               Directive 2002/72/EC should therefore be amended accordingly.
            
         
               (6)
            
            
               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
            
         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annexes II, III, V and VI of Directive 2002/72/EC are amended in accordance with Annexes I to IV to this Directive.
   Article 2
   PVC gaskets containing epoxidised soybean oil, with reference number 88640 in section A of Annex III to Directive 2002/72/EC, which are used to seal glass jars containing infant formulae and follow-on formulae as defined by Commission Directive 91/321/EEC (3) or containing processed cereal-based foods and baby foods for infants and young children as defined by Commission Directive 96/5/EC (4), filled before 19 November 2006 and which comply with the restrictions and/or specifications provided for in Section A of Annex III to Directive 2002/72/EC as amended by Directive 2004/19/EC, may continue to be placed on the market provided that the date of filling appears on the materials and articles.
   The date of filling may be replaced by another indication, provided that that indication permits the identification of the date of filling. Upon request the date of filling shall be made available to the competent authorities and any person enforcing the requirements of this Directive.
   The first and second subparagraphs shall apply without prejudice to Directive 2000/13/EC of the European Parliament and of the Council (5).
   Article 3
   1.   Member States shall adopt and publish, by 19 November 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions in such a way as to:
   
               (a)
            
            
               permit the trade in and use of plastic materials and articles intended to come into contact with food and complying with this Directive, from 19 November 2006;
            
         
               (b)
            
            
               prohibit the manufacture and importation into the Community of plastic materials and articles intended to come into contact with food and which do not comply with this Directive, from 19 November 2007.
            
         When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 4
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 5
   This Directive is addressed to the Member States.
   
      Done at Brussels, 18 November 2005.
      
         
            For the Commission
         
         Markos KYPRIANOU
         
         
            Member of the Commission
         
      
   
   
      (1)  OJ L 338, 13.11.2004, p. 4.
   
      (2)  OJ L 220, 15.8.2002, p. 18. Directive as last amended by Directive 2004/19/EC (OJ L 71, 10.3.2004, p. 8).
   
      (3)  OJ L 175, 4.7.1991, p. 35. Directive as last amended by Directive 2003/14/EC (OJ L 41, 14.2.2003, p. 37).
   
      (4)  OJ L 49, 28.2.1996, p. 17. Directive as last amended by Directive 2003/13/EC (OJ L 41, 14.2.2003, p. 33).
   
      (5)  OJ L 109, 6.5.2000, p. 29. Directive as last amended by Directive 2003/89/EC (OJ L 308, 25.11.2003, p. 15).
   
      ANNEX I
      Annex II to Directive 2002/72/EC is amended as follows:
      
                  1.
               
               
                  point 2 of the general introduction is replaced by the following:
                  
                              ‘2.
                           
                           
                              The following substances are not included even if they are intentionally used and are authorised:
                              
                                          (a)
                                       
                                       
                                          salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium and sodium of authorised acids, phenols or alcohols. However, names containing “… acid(s), salts” appear in the lists, if the corresponding free acid(s) is (are) not mentioned;
                                       
                                    
                                          (b)
                                       
                                       
                                          salts (including double salts and acid salts) of zinc of authorised acids, phenols or alcohols. For these salts a Group SML = 25 mg/kg (expressed as Zn) apply. The same restriction for Zn applies to:
                                          
                                                      (i)
                                                   
                                                   
                                                      substances whose name contains “… acid(s), salts” which appear in the lists, if the corresponding free acid(s) is (are) not mentioned,
                                                   
                                                
                                                      (ii)
                                                   
                                                   
                                                      substances referred to in note 38 of Annex VI.’;
                                                   
                                                
                                    
                        
            
                  2.
               
               
                  section A is amended as follows:
                  
                              (a)
                           
                           
                              the following lines are inserted in the table in numerical order:
                              
                                          Reference No
                                       
                                       
                                          CAS No
                                       
                                       
                                          Name
                                       
                                       
                                          Restrictions and/or specifications
                                       
                                    
                                          (1)
                                       
                                       
                                          (2)
                                       
                                       
                                          (3)
                                       
                                       
                                          (4)
                                       
                                    
                                          ‘11005
                                       
                                       
                                          012542-30-2
                                       
                                       
                                          Acrylic acid, dicyclopentenyl ester
                                       
                                       
                                          QMA = 0,05 mg/6 dm2
                                          
                                       
                                    
                                          11500
                                       
                                       
                                          000103-11-7
                                       
                                       
                                          Acrylic acid, 2-ethylhexyl ester
                                       
                                       
                                          SML = 0,05 mg/kg
                                       
                                    
                                          12786
                                       
                                       
                                          000919-30-2
                                       
                                       
                                          3-Aminopropyltriethoxysilane
                                       
                                       
                                          Residual extractable content of 3-aminopropyltriethoxysilane to be less than 3 mg/kg filler. To be used only for the reactive surface treatment of inorganic fillers
                                       
                                    
                                          13317
                                       
                                       
                                          132459-54-2
                                       
                                       
                                          N,N′-Bis[4-(ethoxycarbonyl)phenyl]-1,4,5,8-naphthalenetetracarboxydiimide
                                       
                                       
                                          SML = 0,05 mg/kg. Purity > 98,1 % (w/w). To be used only as co-monomer (max 4 %) for polyesters (PET, PBT)
                                       
                                    
                                          14260
                                       
                                       
                                          000502-44-3
                                       
                                       
                                          Caprolactone
                                       
                                       
                                          SML = 0,05 mg/kg (expressed as the sum of caprolactone and 6-hydroxyhexanoic acid)
                                       
                                    
                                          16955
                                       
                                       
                                          000096-49-1
                                       
                                       
                                          Ethylene carbonate
                                       
                                       
                                          Residual content = 5 mg/kg of hydrogel at a maximum ratio of 10 g of hydrogel to 1 kg of food. The hydrolysate contains ethyleneglycol having an SML = 30 mg/kg
                                       
                                    
                                          21370
                                       
                                       
                                          010595-80-9
                                       
                                       
                                          Methacrylic acid, 2-sulphoethyl ester
                                       
                                       
                                          QMA = ND (DL = 0,02 mg/6 dm2)
                                       
                                    
                                          22210
                                       
                                       
                                          000098-83-9
                                       
                                       
                                          alpha-Methylstyrene
                                       
                                       
                                          SML = 0,05 mg/kg
                                       
                                    
                                          22932
                                       
                                       
                                          001187-93-5
                                       
                                       
                                          Perfluoromethyl perfluorovinyl ether
                                       
                                       
                                          SML = 0,05 mg/kg. Only to be used for anti-stick coatings
                                       
                                    
                                          24903
                                       
                                       
                                          068425-17-2
                                       
                                       
                                          Syrups, hydrolysed starch, hydrogenated
                                       
                                       
                                          In compliance with the specifications laid down in Annex V
                                       
                                    
                                          25540
                                       
                                       
                                          000528-44-9
                                       
                                       
                                          Trimellitic acid
                                       
                                       
                                          SML(T) = 5 mg/kg (35)
                                       
                                    
                                          25550
                                       
                                       
                                          000552-30-7
                                       
                                       
                                          Trimellitic anhydride
                                       
                                       
                                          SML(T) = 5 mg/kg (35) (expressed as trimellitic acid)’
                                       
                                    
                        
                              (b)
                           
                           
                              in the following lines the content of the columns ‘CAS No’ or ‘Restrictions and/or specifications’ is replaced by the following:
                              
                                          Reference No
                                       
                                       
                                          CAS No
                                       
                                       
                                          Name
                                       
                                       
                                          Restrictions and/or specifications
                                       
                                    
                                          (1)
                                       
                                       
                                          (2)
                                       
                                       
                                          (3)
                                       
                                       
                                          (4)
                                       
                                    
                                          ‘10690
                                       
                                       
                                          000079-10-7
                                       
                                       
                                          Acrylic acid
                                       
                                       
                                          SML(T) = 6 mg/kg (36)
                                       
                                    
                                          10750
                                       
                                       
                                          002495-35-4
                                       
                                       
                                          Acrylic acid, benzyl ester
                                       
                                       
                                          SML(T) = 6 mg/kg (36)
                                       
                                    
                                          10780
                                       
                                       
                                          000141-32-2
                                       
                                       
                                          Acrylic acid, n-butyl ester
                                       
                                       
                                          SML(T) = 6 mg/kg (36)
                                       
                                    
                                          10810
                                       
                                       
                                          002998-08-5
                                       
                                       
                                          Acrylic acid, sec-butyl ester
                                       
                                       
                                          SML(T) = 6 mg/kg (36)
                                       
                                    
                                          10840
                                       
                                       
                                          001663-39-4
                                       
                                       
                                          Acrylic acid, tert-butyl ester
                                       
                                       
                                          SML(T) = 6 mg/kg (36)
                                       
                                    
                                          11470
                                       
                                       
                                          000140-88-5
                                       
                                       
                                          Acrylic acid, ethyl ester
                                       
                                       
                                          SML(T) = 6 mg/kg (36)
                                       
                                    
                                          11590
                                       
                                       
                                          000106-63-8
                                       
                                       
                                          Acrylic acid, isobutyl ester
                                       
                                       
                                          SML(T) = 6 mg/kg (36)
                                       
                                    
                                          11680
                                       
                                       
                                          000689-12-3
                                       
                                       
                                          Acrylic acid, isopropyl ester
                                       
                                       
                                          SML(T) = 6 mg/kg (36)
                                       
                                    
                                          11710
                                       
                                       
                                          000096-33-3
                                       
                                       
                                          Acrylic acid, methyl ester
                                       
                                       
                                          SML(T) = 6 mg/kg (36)
                                       
                                    
                                          11830
                                       
                                       
                                          000818-61-1
                                       
                                       
                                          Acrylic acid, monoester with ethyleneglycol
                                       
                                       
                                          SML(T) = 6 mg/kg (36)
                                       
                                    
                                          11890
                                       
                                       
                                          002499-59-4
                                       
                                       
                                          Acrylic acid, n-octyl ester
                                       
                                       
                                          SML(T) = 6 mg/kg (36)
                                       
                                    
                                          11980
                                       
                                       
                                          000925-60-0
                                       
                                       
                                          Acrylic acid, propyl ester
                                       
                                       
                                          SML(T) = 6 mg/kg (36)
                                       
                                    
                                          13720
                                       
                                       
                                          000110-63-4
                                       
                                       
                                          1,4-Butanediol
                                       
                                       
                                          SML(T) = 5 mg/kg (24)
                                       
                                    
                                          20020
                                       
                                       
                                          000079-41-4
                                       
                                       
                                          Methacrylic acid
                                       
                                       
                                          SML(T) = 6 mg/kg (37)
                                       
                                    
                                          20080
                                       
                                       
                                          002495-37-6
                                       
                                       
                                          Methacrylic acid, benzyl ester
                                       
                                       
                                          SML(T) = 6 mg/kg (37)
                                       
                                    
                                          20110
                                       
                                       
                                          000097-88-1
                                       
                                       
                                          Methacrylic acid, butyl ester
                                       
                                       
                                          SML(T) = 6 mg/kg (37)
                                       
                                    
                                          20140
                                       
                                       
                                          002998-18-7
                                       
                                       
                                          Methacrylic acid, sec-butyl ester
                                       
                                       
                                          SML(T) = 6 mg/kg (37)
                                       
                                    
                                          20170
                                       
                                       
                                          000585-07-9
                                       
                                       
                                          Methacrylic acid, tert-butyl ester
                                       
                                       
                                          SML(T) = 6 mg/kg (37)
                                       
                                    
                                          20890
                                       
                                       
                                          000097-63-2
                                       
                                       
                                          Methacrylic acid, ethyl ester
                                       
                                       
                                          SML(T) = 6 mg/kg (37)
                                       
                                    
                                          21010
                                       
                                       
                                          000097-86-9
                                       
                                       
                                          Methacrylic acid, isobutyl ester
                                       
                                       
                                          SML(T) = 6 mg/kg (37)
                                       
                                    
                                          21100
                                       
                                       
                                          004655-34-9
                                       
                                       
                                          Methacrylic acid, isopropyl ester
                                       
                                       
                                          SML(T) = 6 mg/kg (37)
                                       
                                    
                                          21130
                                       
                                       
                                          000080-62-6
                                       
                                       
                                          Methacrylic acid, methyl ester
                                       
                                       
                                          SML(T) = 6 mg/kg (37)
                                       
                                    
                                          21190
                                       
                                       
                                          000868-77-9
                                       
                                       
                                          Methacrylic acid, monoester with ethyleneglycol
                                       
                                       
                                          SML(T) = 6 mg/kg (37)
                                       
                                    
                                          21280
                                       
                                       
                                          002177-70-0
                                       
                                       
                                          Methacrylic acid, phenyl ester
                                       
                                       
                                          SML(T) = 6 mg/kg (37)
                                       
                                    
                                          21340
                                       
                                       
                                          002210-28-8
                                       
                                       
                                          Methacrylic acid, propyl ester
                                       
                                       
                                          SML(T) = 6 mg/kg (37)
                                       
                                    
                                          21460
                                       
                                       
                                          000760-93-0
                                       
                                       
                                          Methacrylic anhydride
                                       
                                       
                                          SML(T) = 6 mg/kg (37)
                                       
                                    
                                          24190
                                       
                                       
                                          008050-09-7
                                       
                                       
                                          Rosin wood
                                       
                                       
                                          See “Rosin” (Reference No 24100)’
                                       
                                    
                        
                              (c)
                           
                           
                              the following line is deleted:
                              
                                          Reference No
                                       
                                       
                                          CAS No
                                       
                                       
                                          Name
                                       
                                       
                                          Restrictions and/or specifications
                                       
                                    
                                          (1)
                                       
                                       
                                          (2)
                                       
                                       
                                          (3)
                                       
                                       
                                          (4)
                                       
                                    
                                          ‘11000
                                       
                                       
                                          050976-02-8
                                       
                                       
                                          Acrylic acid, dicyclopentadienyl ester
                                       
                                       
                                          QMA = 0,05 mg/6 dm2’
                                       
                                    
                        
            
                  3.
               
               
                  in section B the following lines are deleted:
                  
                              Reference No
                           
                           
                              CAS No
                           
                           
                              Name
                           
                           
                              Restrictions and/or specifications
                           
                        
                              (1)
                           
                           
                              (2)
                           
                           
                              (3)
                           
                           
                              (4)
                           
                        
                              ‘11500
                           
                           
                              000103-11-7
                           
                           
                              Acrylic acid, 2-ethylhexyl ester
                           
                           
                               
                           
                        
                              14260
                           
                           
                              000502-44-3
                           
                           
                              Caprolactone
                           
                           
                               
                           
                        
                              21370
                           
                           
                              010595-80-9
                           
                           
                              Methacrylic acid, 2-sulphoethyl ester
                           
                           
                               
                           
                        
                              22210
                           
                           
                              000098-83-9
                           
                           
                              alpha-Methylstyrene
                           
                           
                               
                           
                        
                              25540
                           
                           
                              000528-44-9
                           
                           
                              Trimellitic acid
                           
                           
                              QM(T) = 5 mg/kg in FP
                           
                        
                              25550
                           
                           
                              000552-30-7
                           
                           
                              Trimellitic anhydride
                           
                           
                              QM(T) = 5 mg/kg in FP (expressed as trimellitic acid)’
                           
                        
            
   
      ANNEX II
      Annex III to Directive 2002/72/EC is amended as follows:
      
                  1.
               
               
                  point 2 is replaced by the following:
                  
                              ‘2.
                           
                           
                              The following substances are not included even if they are intentionally used and are authorised:
                              
                                          (a)
                                       
                                       
                                          salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium and sodium of authorised acids, phenols or alcohols. However, names containing “… acid(s), salts” appear in the lists, if the corresponding free acid(s) is (are) not mentioned;
                                       
                                    
                                          (b)
                                       
                                       
                                          salts (including double salts and acid salts) of zinc of authorised acids, phenols or alcohols. For these salts a Group SML = 25 mg/kg (expressed as Zn) apply. The same restriction for Zn applies to:
                                          
                                                      (i)
                                                   
                                                   
                                                      substances whose name contains “… acid(s), salts” which appear in the lists, if the corresponding free acid(s) is (are) not mentioned,
                                                   
                                                
                                                      (ii)
                                                   
                                                   
                                                      substances referred to in note 38 of Annex VI.’;
                                                   
                                                
                                    
                        
            
                  2.
               
               
                  section A is amended as follows:
                  
                              (a)
                           
                           
                              the following lines are inserted in numerical order:
                              
                                          Reference No
                                       
                                       
                                          CAS No
                                       
                                       
                                          Name
                                       
                                       
                                          Restrictions and/or specifications
                                       
                                    
                                          (1)
                                       
                                       
                                          (2)
                                       
                                       
                                          (3)
                                       
                                       
                                          (4)
                                       
                                    
                                          ‘30340
                                       
                                       
                                          330198-91-9
                                       
                                       
                                          12-(Acetoxy)stearic acid, 2,3-bis(acetoxy)propyl ester
                                       
                                       
                                           
                                       
                                    
                                          30401
                                       
                                       
                                          —
                                       
                                       
                                          Acetylated mono- and diglycerides of fatty acids
                                       
                                       
                                           
                                       
                                    
                                          31542
                                       
                                       
                                          174254-23-0
                                       
                                       
                                          Acrylic acid, methyl ester, telomer with 1-dodecanethiol, C16-C18 alkyl esters
                                       
                                       
                                          QM = 0,5 % (w/w) in FP
                                       
                                    
                                          43480
                                       
                                       
                                          064365-11-3
                                       
                                       
                                          Charcoal, activated
                                       
                                       
                                          In compliance with the specifications laid down in Annex V, Part B
                                       
                                    
                                          62245
                                       
                                       
                                          012751-22-3
                                       
                                       
                                          Iron phosphide
                                       
                                       
                                          For PET polymers and copolymers only
                                       
                                    
                                          64990
                                       
                                       
                                          025736-61-2
                                       
                                       
                                          Maleic anhydride-styrene, copolymer, sodium salt
                                       
                                       
                                          In compliance with specifications laid down in Annex V
                                       
                                    
                                          66905
                                       
                                       
                                          000872-50-4
                                       
                                       
                                          N-Methylpyrrolidone
                                       
                                       
                                           
                                       
                                    
                                          66930
                                       
                                       
                                          068554-70-1
                                       
                                       
                                          Methylsilsesquioxane
                                       
                                       
                                          Residual monomer in methylsilsesquioxane: < 1 mg methyltrimethoxysilane/kg of methylsilsesquioxane
                                       
                                    
                                          67155
                                       
                                       
                                          —
                                       
                                       
                                          Mixture of 4-(2-Benzoxazolyl)-4′-(5-methyl-2-benzoxazolyl)stilbene, 4,4′-bis(2-benzoxazolyl) stilbene and 4,4′-bis(5-methyl-2-benzoxazolyl)stilbene)
                                       
                                       
                                          Not more than 0,05 % w/w (quantity of substance used/quantity of the formulation). In compliance with the specifications laid down in Annex V
                                       
                                    
                                          76415
                                       
                                       
                                          019455-79-9
                                       
                                       
                                          Pimelic acid, calcium salt
                                       
                                       
                                           
                                       
                                    
                                          76815
                                       
                                       
                                          —
                                       
                                       
                                          Polyester of adipic acid with glycerol or pentaerythritol, esters with even numbered, unbranched C12-C22 fatty acids
                                       
                                       
                                          In compliance with the specifications laid down in Annex V
                                       
                                    
                                          76845
                                       
                                       
                                          031831-53-5
                                       
                                       
                                          Polyester of 1,4-butanediol with caprolactone
                                       
                                       
                                          In compliance with the specifications laid down in Annex V
                                       
                                    
                                          77370
                                       
                                       
                                          070142-34-6
                                       
                                       
                                          Polyethyleneglycol-30 dipolyhydroxystearate
                                       
                                       
                                           
                                       
                                    
                                          79600
                                       
                                       
                                          009046-01-9
                                       
                                       
                                          Polyethyleneglycol tridecyl ether phosphate
                                       
                                       
                                          SML = 5 mg/kg. For materials and articles intended for contact with aqueous foods only. In compliance with the specification laid down in Annex V
                                       
                                    
                                          80000
                                       
                                       
                                          009002-88-4
                                       
                                       
                                          Polyethylene wax
                                       
                                       
                                           
                                       
                                    
                                          81060
                                       
                                       
                                          009003-07-0
                                       
                                       
                                          Polypropylene wax’
                                       
                                       
                                           
                                       
                                    
                        
                              (b)
                           
                           
                              in the following lines the content of the columns ‘Name’ and ‘Restrictions and/or specifications’ is replaced by the following:
                              
                                          Reference No
                                       
                                       
                                          CAS No
                                       
                                       
                                          Name
                                       
                                       
                                          Restrictions and/or specifications
                                       
                                    
                                          (1)
                                       
                                       
                                          (2)
                                       
                                       
                                          (3)
                                       
                                       
                                          (4)
                                       
                                    
                                          ‘30080
                                       
                                       
                                          004180-12-5
                                       
                                       
                                          Acetic acid, copper salt
                                       
                                       
                                          SML(T) = 5 mg/kg (7) (expressed as Copper)
                                       
                                    
                                          35760
                                       
                                       
                                          001309-64-4
                                       
                                       
                                          Antimony trioxide
                                       
                                       
                                          SML = 0,04 mg/kg (39) (expressed as Antimony)
                                       
                                    
                                          40580
                                       
                                       
                                          000110-63-4
                                       
                                       
                                          1,4-Butanediol
                                       
                                       
                                          SML(T) = 5 mg/kg (24)
                                       
                                    
                                          42320
                                       
                                       
                                          007492-68-4
                                       
                                       
                                          Carbonic acid, copper salt
                                       
                                       
                                          SML(T) = 5 mg/kg (7) (expressed as Copper)
                                       
                                    
                                          45195
                                       
                                       
                                          007787-70-4
                                       
                                       
                                          Copper bromide
                                       
                                       
                                          SML(T) = 5 mg/kg (7) (expressed as Copper)
                                       
                                    
                                          45200
                                       
                                       
                                          001335-23-5
                                       
                                       
                                          Copper iodide
                                       
                                       
                                          SML(T) = 5 mg/kg (7) (expressed as Copper)
                                       
                                    
                                          53610
                                       
                                       
                                          054453-03-1
                                       
                                       
                                          Ethylenediaminetetraacetic acid, copper salt
                                       
                                       
                                          SML(T) = 5 mg/kg (7) (expressed as Copper)
                                       
                                    
                                          81515
                                       
                                       
                                          087189-25-1
                                       
                                       
                                          Poly(zinc glycerolate)
                                       
                                       
                                          SML(T) = 25 mg/kg (38) (as Zinc)
                                       
                                    
                                          81760
                                       
                                       
                                          —
                                       
                                       
                                          Powders, flakes and fibers of brass, bronze, copper, stainless steel, tin and alloys of copper, tin and iron
                                       
                                       
                                          SML(T) = 5 mg/kg (7) (expressed as Copper)
                                       
                                    
                                          88640
                                       
                                       
                                          008013-07-08
                                       
                                       
                                          Soybean oil, epoxidised
                                       
                                       
                                          SML = 60 mg/kg. However in the case of PVC gaskets used to seal glass jars containing infant formulae and follow-on formulae as defined by Commission Directive 91/321/EEC or containing processed cereal-based foods and baby foods for infants and young children as defined by Directive 96/5/EC, the SML is lowered to 30 mg/kg
                                       
                                    
                                          89200
                                       
                                       
                                          007617-31-4
                                       
                                       
                                          Stearic acid, copper salt
                                       
                                       
                                          SML(T) = 5 mg/kg (7) (expressed as Copper)
                                       
                                    
                                          92030
                                       
                                       
                                          010124-44-4
                                       
                                       
                                          Sulphuric acid, copper salt
                                       
                                       
                                          SML(T) = 5 mg/kg (7) (expressed as Copper)
                                       
                                    
                                          96190
                                       
                                       
                                          020427-58-1
                                       
                                       
                                          Zinc hydroxide
                                       
                                       
                                          SML(T) = 25 mg/kg (38) (as Zinc)
                                       
                                    
                                          96240
                                       
                                       
                                          001314-13-2
                                       
                                       
                                          Zinc oxide
                                       
                                       
                                          SML(T) = 25 mg/kg (38) (as Zinc)
                                       
                                    
                                          96320
                                       
                                       
                                          001314-98-3
                                       
                                       
                                          Zinc sulphide
                                       
                                       
                                          SML(T) = 25 mg/kg (38) (as Zinc)’
                                       
                                    
                        
                              (c)
                           
                           
                              the following lines are deleted:
                              
                                          Reference No
                                       
                                       
                                          CAS No
                                       
                                       
                                          Name
                                       
                                       
                                          Restrictions and/or specifications
                                       
                                    
                                          (1)
                                       
                                       
                                          (2)
                                       
                                       
                                          (3)
                                       
                                       
                                          (4)
                                       
                                    
                                          ‘30400
                                       
                                       
                                          —
                                       
                                       
                                          Acetylated glycerides
                                       
                                       
                                           
                                       
                                    
                                          38320
                                       
                                       
                                          005242-49-9
                                       
                                       
                                          4-(2-Benzoxazolyl)-4′-(5-methyl-2-benzoxazolyl)stilbene
                                       
                                       
                                          In compliance with the specifications laid down in Annex V’
                                       
                                    
                        
            
                  3.
               
               
                  section B is amended as follows:
                  
                              (a)
                           
                           
                              the following lines are inserted in numerical order:
                              
                                          Reference No
                                       
                                       
                                          CAS No
                                       
                                       
                                          Name
                                       
                                       
                                          Restrictions and/or specifications
                                       
                                    
                                          (1)
                                       
                                       
                                          (2)
                                       
                                       
                                          (3)
                                       
                                       
                                          (4)
                                       
                                    
                                          ‘31500
                                       
                                       
                                          025134-51-4
                                       
                                       
                                          Acrylic acid, acrylic acid, 2-ethylhexyl ester, copolymer
                                       
                                       
                                          SML(T) = 6 mg/kg (36) (expressed as acrylic acid) and SML = 0,05 mg/kg (expressed as acrylic acid, 2-ethylhexyl ester)
                                       
                                    
                                          38505
                                       
                                       
                                          351870-33-2
                                       
                                       
                                          cis-endo-Bicyclo[2.2.1]heptane-2,3-dicarboxylic acid, disodium salt
                                       
                                       
                                          SML = 5 mg/kg. Not to be used with polyethylene in contact with acidic foods. Purity ≥ 96 %
                                       
                                    
                                          38940
                                       
                                       
                                          110675-26-8
                                       
                                       
                                          2,4-Bis(dodecylthiomethyl)-6-methylphenol
                                       
                                       
                                          SML(T) = 5 mg/kg (40)
                                       
                                    
                                          49595
                                       
                                       
                                          057583-35-4
                                       
                                       
                                          Dimethyltin bis(ethylhexyl mercaptoacetate)
                                       
                                       
                                          SML(T) = 0,18 mg/kg (16) (expressed as Tin)
                                       
                                    
                                          63940
                                       
                                       
                                          008062-15-5
                                       
                                       
                                          Lignosulphonic acid
                                       
                                       
                                          SML = 0,24 mg/kg and to be used only as dispersant for plastics dispersions
                                       
                                    
                                          66350
                                       
                                       
                                          085209-93-4
                                       
                                       
                                          2,2′-Methylenebis(4,6-di-tert-butylphenyl) lithium phosphate
                                       
                                       
                                          SML = 5 mg/kg and SML(T) = 0,6 (8) (expressed as Lithium)
                                       
                                    
                                          67515
                                       
                                       
                                          057583-34-3
                                       
                                       
                                          Monomethyltin tris(ethylhexyl mercaptoacetate)
                                       
                                       
                                          SML(T) = 0,18 mg/kg (16) (expressed as Tin)
                                       
                                    
                                          69160
                                       
                                       
                                          014666-94-5
                                       
                                       
                                          Oleic acid, cobalt salt
                                       
                                       
                                          SML(T) = 0,05 mg/kg (14) (expressed as Cobalt)
                                       
                                    
                                          76681
                                       
                                       
                                          —
                                       
                                       
                                          Polycyclopentadiene, hydrogenated
                                       
                                       
                                          SML = 5 mg/kg (1)
                                       
                                    
                                          85950
                                       
                                       
                                          037296-97-2
                                       
                                       
                                          Silicic acid, magnesium-sodium-fluoride salt
                                       
                                       
                                          SML = 0,15 mg/kg (expressed as fluoride). Only to be used in layers of multilayers materials not coming into direct contact with food
                                       
                                    
                                          95265
                                       
                                       
                                          227099-60-7
                                       
                                       
                                          1,3,5-Tris(4-benzoylphenyl) benzene
                                       
                                       
                                          SML = 0,05 mg/kg’
                                       
                                    
                        
                              (b)
                           
                           
                              in the following lines the content of the columns ‘Name’ and ‘Restrictions and/or specifications’ is replaced by the following:
                              
                                          Reference No
                                       
                                       
                                          CAS No
                                       
                                       
                                          Name
                                       
                                       
                                          Restrictions and/or specifications
                                       
                                    
                                          (1)
                                       
                                       
                                          (2)
                                       
                                       
                                          (3)
                                       
                                       
                                          (4)
                                       
                                    
                                          ‘40020
                                       
                                       
                                          110553-27-0
                                       
                                       
                                          2,4-Bis(octylthiomethyl)-6-methylphenol
                                       
                                       
                                          SML(T) = 5 mg/kg (40)
                                       
                                    
                                          50160
                                       
                                       
                                          —
                                       
                                       
                                          Di-n-octyltin bis(n-alkyl(C10-C16) mercaptoacetate)
                                       
                                       
                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)
                                       
                                    
                                          50240
                                       
                                       
                                          010039-33-5
                                       
                                       
                                          Di-n-octyltin bis(2-ethylhexyl maleate)
                                       
                                       
                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)
                                       
                                    
                                          50320
                                       
                                       
                                          015571-58-1
                                       
                                       
                                          Di-n-octyltin bis(2-ethylhexyl mercaptoacetate)
                                       
                                       
                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)
                                       
                                    
                                          50360
                                       
                                       
                                          —
                                       
                                       
                                          Di-n-octyltin bis(ethyl maleate)
                                       
                                       
                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)
                                       
                                    
                                          50400
                                       
                                       
                                          033568-99-9
                                       
                                       
                                          Di-n-octyltin bis(isooctyl maleate)
                                       
                                       
                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)
                                       
                                    
                                          50480
                                       
                                       
                                          026401-97-8
                                       
                                       
                                          Di-n-octyltin bis(isooctyl mercaptoacetate)
                                       
                                       
                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)
                                       
                                    
                                          50560
                                       
                                       
                                          —
                                       
                                       
                                          Di-n-octyltin 1,4-butanediol bis(mercaptoacetate)
                                       
                                       
                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)
                                       
                                    
                                          50640
                                       
                                       
                                          003648-18-8
                                       
                                       
                                          Di-n-octyltin dilaurate
                                       
                                       
                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)
                                       
                                    
                                          50720
                                       
                                       
                                          015571-60-5
                                       
                                       
                                          Di-n-octyltin dimaleate
                                       
                                       
                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)
                                       
                                    
                                          50800
                                       
                                       
                                          —
                                       
                                       
                                          Di-n-octyltin dimaleate, esterified
                                       
                                       
                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)
                                       
                                    
                                          50880
                                       
                                       
                                          —
                                       
                                       
                                          Di-n-octyltin dimaleate, polymers (n = 2-4)
                                       
                                       
                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)
                                       
                                    
                                          50960
                                       
                                       
                                          069226-44-4
                                       
                                       
                                          Di-n-octyltin ethyleneglycol bis(mercaptoacetate)
                                       
                                       
                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)
                                       
                                    
                                          51040
                                       
                                       
                                          015535-79-2
                                       
                                       
                                          Di-n-octyltin mercaptoacetate
                                       
                                       
                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)
                                       
                                    
                                          51120
                                       
                                       
                                          —
                                       
                                       
                                          Di-n-octyltin thiobenzoate 2-ethylhexyl mercaptoacetate
                                       
                                       
                                          SML(T) = 0,006 mg/kg (17) (expressed as Tin)
                                       
                                    
                                          67180
                                       
                                       
                                          —
                                       
                                       
                                          Mixture of (50 % w/w) phthalic acid n-decyl n-octyl ester, (25 % w/w) phthalic acid di-n-decyl ester, (25 % w/w) phthalic acid di-n-octyl ester
                                       
                                       
                                          SML = 5 mg/kg (1)’
                                       
                                    
                        
                              (c)
                           
                           
                              The following line is deleted:
                              
                                          Reference No
                                       
                                       
                                          CAS No
                                       
                                       
                                          Name
                                       
                                       
                                          Restrictions and/or specifications
                                       
                                    
                                          (1)
                                       
                                       
                                          (2)
                                       
                                       
                                          (3)
                                       
                                       
                                          (4)
                                       
                                    
                                          ‘76680
                                       
                                       
                                          068132-00-3
                                       
                                       
                                          Polycyclopentadiene, hydrogenated
                                       
                                       
                                          SML = 5 mg/kg (1)’
                                       
                                    
                        
            
   
      ANNEX III
      In Part B of Annex V, the following lines are inserted in numerical order:
      
         
                     Reference No
                  
                  
                     OTHER SPECIFICATIONS
                  
               
                     ‘24903
                  
                  
                     Syrups, hydrolysed starch, hydrogenated
                     In compliance with the purity criteria for maltitol syrup E 965(ii) (Commission Directive 95/31/EC (OJ L 178, 28.7.1995, p. 1) as last amended by 2004/46/EC (OJ L 114, 21.04.2004, p. 15))
                  
               
                     43480
                  
                  
                     Charcoal, activated
                     To be used only in PET at maximum 10 mg/kg of polymer. Same purity requirements as for Vegetable Carbon (E 153) set out by Commission Directive 95/45/EC ((OJ L 226, 22.9.1995, p. 1). Directive as last amended by Directive 2004/47/EC (OJ L 113, 20.4.2004, p. 24)) with exception of ash content which can be up to 10 % (w/w).
                  
               
                     64990
                  
                  
                     Maleic anhydride-styrene, copolymer, sodium salt
                     MW fraction < 1 000 is less than 0,05 % (w/w)
                  
               
                     67155
                  
                  
                     Mixture of 4-(2-Benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl)stilbene, 4,4'-bis(2-benzoxazolyl) stilbene and 4,4'-bis(5-methyl-2-benzoxazolyl)stilbene
                     Mixture obtained from the manufacturing process in the typical ratio of (58-62 %):(23-27 %): (13-17 %).
                  
               
                     76845
                  
                  
                     Polyester of 1,4-butanediol with caprolactone
                     MW fraction < 1 000 is less than 0,05 % (w/w)
                  
               
                     76815
                  
                  
                     Polyester of adipic acid with glycerol or pentaerythritol, esters with even numbered, unbranched C12-C22 fatty acids
                     MW fraction < 1 000 is less than 5 % (w/w)
                  
               
                     79600
                  
                  
                     Polyethyleneglycol tridecyl ether phosphate
                     Polyethyleneglycol (EO ≤ 11) tridecyl ether phosphate (mono-and dialkyl ester) with a maximum 10 % content of polyethyleneglycol (EO ≤ 11) tridecylether’
                  
               
   
   
      ANNEX IV
      Annex VI is amended as follows:
      
                  1.
               
               
                  the notes (8), (14) and (16) are 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 Reference Nos 38000, 42400, 64320, 66350, 67896, 73040, 85760, 85840, 85920 and 95725.
                           
                        
                              (14)
                           
                           
                              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 Reference Nos 44960, 68078, 69160, 82020 and 89170.
                           
                        
                              (16)
                           
                           
                              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 Reference Nos 49595, 49600, 67520, 67515 and 83599.’;
                           
                        
            
                  2.
               
               
                  the following notes are added:
                  
                              ‘(35)
                           
                           
                              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 Reference Nos 25540 and 25550.
                           
                        
                              (36)
                           
                           
                              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 Reference Nos 10690, 10750, 10780, 10810, 10840, 11470, 11590, 11680, 11710, 11830, 11890, 11980 and 31500.
                           
                        
                              (37)
                           
                           
                              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 Reference Nos 20020, 20080, 20110, 20140, 20170, 20890, 21010, 21100, 21130, 21190, 21280, 21340 and 21460.
                           
                        
                              (38)
                           
                           
                              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 Reference Nos 81515, 96190, 96240 and 96320 as well as of salts (including double salts and acid salts) of zinc of authorised acids, phenols or alcohols. The same restriction for Zn applies to the names containing “… acid(s), salts” which appear in the lists, if the corresponding free acid(s) is (are) not mentioned.
                           
                        
                              (39)
                           
                           
                              Migration limit might be exceeded at very high temperature.
                           
                        
                              (40)
                           
                           
                              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 Reference Nos 38940 and 40020.’