Commission Directive 1999/91/EC of 23 November 1999 amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs (Text with EEA relevance)
4. 12. 1999 EN Official Journal of the European Communities L 310/41 COMMISSION DIRECTIVE 1999/91/EC of 23 November 1999 amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, (9) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (1) and in particular Article 3 thereof, HAS ADOPTED THIS DIRECTIVE: Article 1 Directive 90/128/EEC is amended as follows: After consulting the Scientific Committee on Food, 1. the fourth indent of Article 3(5) is deleted; Whereas: (1) (2) (3) (4) (5) (6) (7) (8) Commission Directive 90/128/EEC (2), as last amended by Directive 96/11/EC (3), provides in Article 3(2) for the revision of Annex II thereto. On the basis of the information available, certain mono- mers provisionally admitted at national level may be included in the Community list. Other monomers have been requested for use following the adoption of Directive 90/128/EEC: the technical data supplied permit their inclusion in the Community list. Annex III to Directive 90/128/EEC includes a list of additives, which should be amended so as to include other Scientific additives Committee on Food. evaluated by fully the For certain substances, the restrictions already set out should be amended according to the information avail- able. The current total list of additives is an incomplete list inasmuch as it does not contain all the substances which are currently accepted in one or more Member States; accordingly, these substances continue to be regulated by national laws pending a decision on inclusion in the Community list. This Directive establishes purity criteria for only a few substances, and therefore the other substances which may require purity criteria remain regulated in this respect by national laws pending a decision at Community level. The measures contained in this Directive do not go is necessary to achieve the objectives beyond what already provided for in Directive 89/109/EEC. (1) OJ L 40, 11. 2. 1989, p. 38. (2) OJ L 75, 21. 3. 1990, p. 19. (3) OJ L 61, 12. 3. 1996, p. 26. 2. Article 3a is replaced by the following: ‘Article 3a An incomplete list of additives which may be used for the manufacture of plastic materials and articles, together with the restrictions on their use, is set out in Annex III’; 3. the following Articles 3b and 3c are inserted: ‘Article 3b Only the products obtained by means of bacterial fermenta- tion listed in Annex IV may be used in contact with food- stuffs. Article 3c The specifications substances relating 1. appearing in Annexes II, III and IV are laid down in Annex V. to some The meaning of 2. the numbers between brackets appearing in the Column “Restrictions and/or specifications” is explained in Annex VI’; 4. Annex II is amended as shown in Annex I to this Directive; 5. Annex III Directive; is amended as shown in Annex II to this 6. the texts set out in Annex III to this Directive are added as Annexes IV, V and VI. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 2000. They shall imme- diately inform the Commission thereof. Member States shall permit, as from 1 January 2002, the trade in and use of plastic materials and articles intended to come into contact with foodstuffs and complying with this Directive. They shall prohibit, as from 1 January 2003, the manufacture and importation into the Community of plastic materials and articles intended to come into contact with foodstuffs and which do not comply with this Directive. L 310/42 EN Official Journal of the European Communities 4. 12. 1999 2. 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. This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities. Article 3 This Directive is addressed to the Member States. Article 4 Done at Brussels, 23 November 1999. For the Commission Erkki LIIKANEN Member of the Commission 4. 12. 1999 EN Official Journal of the European Communities L 310/43 ANNEX I Annex II is amended as follows: 1. The fourth indent of paragraph 5 is replaced by the following: ‘— Column 4 (Restrictions and/or specifications). These may include: — specific migration limit (SML), — maximum permitted quantity of the substance in the finished material or article (QM), — maximum permitted quantity of the substance in the finished material or article expressed as mg per 6 dm2 of the surface in contact with foodstuffs (QMA), — any other restriction specifically mentioned, — any type of specifications related to the substance or to the polymer;’ 2. The title of column 4 is modified to ‘Restrictions and/or specifications’; 3. Sections A and B are amended as shown in Appendices 1 to 5. L 310/44 EN Official Journal of the European Communities 4. 12. 1999 ‘Appendix 1 List of monomers and other starting substances inserted in Section A of Annex II to Directive 90/128/EEC PM/REF No CAS No (1) (2) Name (3) Restrictions and/or specifications (4) 12761 000693-57-2 12-Aminododecanoic acid SML = 0,05 mg/kg 13180 000498-66-8 Bicyclo[2. 2. 1]hept-2-ene nene) (= norbor- SML = 0,05 mg/kg 13210 001761-71-3 Bis(4-aminocyclohexyl)methane SML = 0,05 mg/kg 14650 000079-38-9 Chlorotrifluoroethylene QMA = 0,05 mg/6 dm2 14841 000599-64-4 4-Cumylphenol SML = 0,05 mg/kg 16694 013811-50-2 N,N -Divinyl-2-imidazolidinone QM = 5 mg/kg in FP 16704 000112-41-4 1-Dodecene SML = 0,05 mg/kg 22331 025513-64-8 Mixture of (40 % w/w) 1,6-diamino- 2,2,4-trimethylhexane and (60 % w/ w) 1,6-diamino-2,4,4-trimethyl- hexane QMA = 5 mg/6 dm2 22550 000498-66-8 Norbornene See “Bicyclo[2. 2. 1]hept-2-ene” 23175 000122-52-1 Phosphorous acid, triethyl ester QM = ND (DL = 1 mg/kg in FP) 23547 009016-00-6 063148-62-9 Polydimethylsiloxane (MW > 6800) In compliance with the specifications laid down in Annex V 25080 001120-36-1 1-Tetradecene SML = 0,05 mg/kg 25385 000102-70-5 Triallylamine 25927 027955-94-8 1,1,1-Tris(4-hydroxyphenyl)ethane In compliance with the specifications laid down in Annex V QM = 0,5 mg/kg in FP. For use only in polycarbonates 26155 001072-63-5 1-Vinylimidazole QM = 5 mg/kg in FP 26320 002768-02-7 Vinyltrimethoxysilane QM = 5 mg/kg in FP 26360 007732-18-5 Water In compliance with Directive 98/83/EC 4. 12. 1999 EN Official Journal of the European Communities L 310/45 List of monomers and other starting substances in Section A of Annex II to Directive 90/128/EEC for which the content of the column “Restriction and/or specifications” is modified Appendix 2 PM/Ref No CAS No (1) (2) Name (3) Restrictions and/or specifications (4) 10060 000075-07-0 Acetaldehyde SML(T) = 6 mg/kg (2) 13510 001675-54-3 2,2-Bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether (= BADGE) SML(T) = 1 mg/kg (9) Authorised until 1 January 2005 14200 000105-60-2 Caprolactam SML(T) = 15 mg/kg (5) 14230 002123-24-2 Caprolactam, sodium salt SML(T) = 15 mg/kg (5) (expressed as caprolactam) 15760 000111-46-6 Diethyleneglycol SML(T) = 30 mg/kg (3) 16990 000107-21-1 Ethyleneglycol SML(T) = 30 mg/kg (3) 17160 000097-53-0 Eugenol SML = ND (DL = 0,02 mg/kg, analyt- ical tolerance included) 19540 000110-16-7 Maleic acid SML(T) = 30 mg/kg (4) 19960 000108-31-6 Maleic anhydride SML(T) = 30 mg/kg (4) (expressed as maleic acid) 25360 — Trialkyl(C5-C15) epoxypropyl ester acetic acid, 2,3- QM = 1 mg/kg in FP (expressed as epoxy group, molecular weight = 43) L 310/46 EN Official Journal of the European Communities 4. 12. 1999 List of monomers and others starting substances deleted from Section B of Annex II to Directive 90/128/EEC Appendix 3 PM/Ref No CAS No (1) (2) Name (3) Restrictions and/or specifications (4) 22428 051000-52-3 Neodecanoic acid, vinyl ester List of monomers and other starting substances in Section B of Annex II to Directive 90/128/EEC for which the content of the column “Restrictions and/or specifications” is modified Appendix 4 PM/Ref No CAS No (1) (2) Name (3) Restrictions and/or specifications (4) 16690 001321-74-0 Divinylbenzene QM = 1 mg/kg in FP or SML = ND (DL = 0,02 mg/kg, analytical tolerance included) 20590 000106-91-2 Methacrylic ester acid, 2,3-epoxypropyl QM(T) = 5 mg/kg in FP (expressed as epoxy group, molecular weight = 43) 22720 000140-66-9 4-tert-Octylphenol See “4-(1,1,3,3-Tetramethylbutyl)phenol” 25185 000140-66-9 4-(1,1,3,3-Tetramethylbutyl)phenol (= 4-tert-Octylphenol) SML = ND (DL = 0,01 mgkg, analyt- ical tolerance included) 4. 12. 1999 EN Official Journal of the European Communities L 310/47 List of monomers and other starting substances transferred from Section B to Section A of Annex II to Directive 90/128/EEC Appendix 5 PM/Ref No CAS No (1) (2) Name (3) Restrictions and/or specifications (4) 11000 050976-02-8 Acrylic acid, dicyclopentadienyl ester QMA = 0,05 mg/6 dm2 11245 002156-97-0 Acrylic acid, dodecyl ester SML = 0,05 mg/kg (1) 12265 004074-90-2 Adipic acid, divinyl ester QM = 5 mg/kg in FP. For use only as comonomer 13060 004422-95-1 1,3,5-Benzenetricarboxylic trichloride acid QMA = 0,05 mg/6 dm2 (measured as 1,3,5-benzenetricarboxylic acid) 13780 002425-79-8 1,4-Butanediol bis(2,3-epoxypropyl) ether QM = 1 mg/kg in FP (expressed as epoxy group, molecular weight = 43) 14020 000098-54-4 4-tert-Butylphenol SML = 0,05 mg/kg 15130 000872-05-9 1-Decene SML = 0,05 mg/kg 16360 000576-26-1 2,6-Dimethylphenol SML = 0,05 mg/kg 16450 000646-06-0 1,3-Dioxolane SML = 0,05 mg/kg 18220 068564-88-5 N-Heptylaminoundecanoic acid SML = 0,05 mg/kg (1) 18820 000592-41-6 1-Hexene SML = 3 mg/kg 19060 000109-53-5 Isobutyl vinyl ether QM = 5 mg/kg in FP 19150 000121-91-5 Isophthalic acid SML = 5 mg/kg 19990 000079-39-0 Methacrylamide = ND (DL SML analytical tolerance included) = 0,02 mg/kg, 20050 000096-05-9 Methacrylic acid, allyl ester SML = 0,05 mg/kg 20530 002867-47-2 Methacrylic acid, 2-(dimethyla- mino)ethyl ester SML = ND (DL = 0,02 mg/kg, analytical tolerance included) 21730 000563-45-1 3-Methyl-1-butene QMA = 0,006 mg/6 dm2. For use only in polypropylene. 22937 001623-05-8 Perfluoropropyl perfluorovinyl ether SML = 0,05 mg/kg 23770 000504-63-2 1,3-Propanediol SML = 0,05 mg/kg 23920 000105-38-4 Propionic acid, vinyl ester SML(T) = 6 mg/kg (2) (expressed as acetaldehyde) 24760 026914-43-2 Styrenesulphonic acid SML = 0,05 mg/kg 26170 003195-78-6 N-Vinyl-N-methylacetamide QM = 2 mg/kg in FP’ L 310/48 EN Official Journal of the European Communities 4. 12. 1999 ANNEX II Annex III is amended as follows: 1. The fourth indent of paragraph 5 is replced by the following: ‘— Column 4 (Restrictions and/or specifications). These may include: — specific migration limit (SML), — maximum permitted quantity of the substance in the finished materil or article (QM), — maximum permitted quantity of the substance in the finished material or article expressed as mg per 6 dm2 of the surface in contact with foodstuffs (QMA), — any other restriction specifically laid down, — any type of specification related to the substance or to the polymer;’ 2. The title of the column 4 is modified into ‘Restrictions and/or specifications’; 3. ‘Incomplete list of additives’ is amended as shown in Appendices 1, 2 and 3. ‘Appendix 1 List of additives inserted in Annex III to Directive 90/128/EEC PM/REF No CAS No (1) (2) Name (3) Restrictions and/or specifications (4) 30080 004180-12-5 Acetic acid, copper salt SML(T) = 30 mg/kg (7) (expressed as copper) 30610 — 30612 — aliphatic, linear, Acids, C2-C24, monocarboxylic, from natural oils and fats, and their mono-, di- and triglycerol esters (branched fatty acids are at naturally occurring levels included) Acids, C2-C24, linear, monocarboxylic, synthetic, and their mono-, di- and triglycerol esters aliphatic, 31530 123968-25-2 Acrylic acid, 2,4-di-tert-pentyl-6-[1- (3,5-di-tert-pentyl-2-hydroxy- phenyl)ethyl]phenyl ester SML = 5 mg/kg 33801 34240 — — n-Alkyl(C10-C13)benzenesulphonic acid SML = 30 mg/kg Alkyl(C10-C20)sulphonic acid, esters with phenols SML = 6 mg/kg. Authorised until 1 January 2002 36640 000123-77-3 Azodicarbonamide For use only as a blowing agent 37360 000100-52-7 Benzaldehyde 38320 005242-49-9 4-(2-Benzoxa- zolyl)-4 -(5-methyl-2-ben- zoxazolyl)stilbene In compliance with note 10 in Annex VI In compliance with the specifications laid down in Annex V 4. 12. 1999 EN Official Journal of the European Communities L 310/49 PM/REF No CAS No (1) (2) 38510 136504-96-6 Name (3) 1,2-Bis(3-aminopropyl)ethylenedia- mine, polymer with N-butyl-2,2,6,6- tetramethyl-4-piperidinamine and 2,4,6-trichloro-1,3,5-triazine Restrictions and/or specifications (4) SML = 5 mg/kg 38515 001533-45-5 4,4-Bis(2-benzoxazolyl)stilbene SML = 0,05 mg/kg (1) 38810 080693-00-1 Bis(2,6-di-tert-butyl-4- methylphenyl)pentaerythritol diphos- phite SML = 5 mg/kg (sum of phosphite and phosphate) 38879 135861-56-2 Bis(3,4-dimethylbenzylidene)sorbitol 39200 006200-40-4 Bis(2-hydroxyethyl)-2-hydroxypropyl- 3-(dodecyloxy)methylammonium chloride SML = 1,8 mg/kg 39815 182121-12-6 9,9-Bis(metoxymethyl)fluorene QMA = 0,05 mg/6 dm2 40120 — Bis(polyethyleneglycol) hydroxymethylphosphonate SML = 0,6 mg/kg. Authorised until 1 January 2002 41680 000076-22-2 Camphor 42320 007492-68-4 Carbonic acid, copper salt In compliance with note 10 in Annex VI SML(T) = 30 mg/kg (7) expressed as copper) 43515 — Chlorides choline coconut oil fatty acids of esters of QMA = 0,9 mg/6 dm2 45195 007787-70-4 Copper bromide SML(T) = 30 mg/kg (7) (expressed as copper) 45200 001335-23-5 Copper iodide SML(T) = 30 mg/kg (7) (expressed as = 1 mg/kg copper) (expressed as iodine) SML and 45450 068610-51-5 p-Cresol-dicyclopentadiene-isobuty- lene, copolymer SML = 0,05 mg/kg (1) 46880 065140-91-2 3,5-Di-tert-butyl-4-hydroxybenzyl phosphonic acid, monoethyl ester, calcium salt SML = 6 mg/kg 47680 000111-46-6 Diethyleneglycol SML(T) = 30 mg (3) 48460 000075-37-6 1,1-Difluoroethane 49485 134701-20-5 2,4-Dimethyl-6-(1-methylpenta- decyl)phenol SML = 1 mg/kg 51700 147315-50-2 2-(4,6-Dphenyl-1,3,5-triazin-2-yl)-5- (hexyloxy)phenol SML = 0,05 mg/kg 53610 054453-03-1 Ethylenediaminetetraacetic acid, copper SML(T) = 30 mg/kg (7) (expressed as copper) L 310/50 EN Official Journal of the European Communities 4. 12. 1999 PM/REF No CAS No (1) (2) Name (3) Restrictions and/or specifications (4) 53650 000107-21-1 Ethyleneglycol SML(T) = 30 mg/kg (3) 54300 118337-09-0 2,2 Ethylidenebis(4,6-di-tert-butyl- phenyl) fluorophosphonite SML = 6 mg/kg 54930 025359-91-5 Formaldehyde-1-naphthol, copolymer [=Poly(1-hydroxynaphthyl-methane)] SML = 0,05 mg/kg 57800 018641-57-1 Glycerol tribehenate 60480 003864-99-1 2-(2-Hidroxy-3,5-di-tert-butyl- phenyl)-5- chlorobenzotriazole SML = 30 mg/kg 66560 004066-02-8 2,2 Methylenebis(4-methyl-6-cyclo- hexylphenol) SML(T) = 3 mg/kg (6) 66580 000077-62-3 2,2 Methylenebis[4-methyl-6-(1- methylcyclo-hexyl)phenol] SML(T) = 3 mg/kg (6) 66755 002682-20-4 2-Methyl-4-isothiazolin-3-one 67170 67180 — — Mixture of (80 to 100 % w/w) 5,7-di- tert-butyl-3-(3,4-dimethyphenyl)-2 (3H)-benzofuranone and (0 to 20 % w/w)5,7-di-tert-butyl-3-(2,3-di-me- thylphenyl)-2(3H)-benzofuranone Mixture of (50 % w/w) phthalic acid, n-decyl n-octyl ester, (25 % w/w) phthalic acid di-n-decyl ester, and (25 % w/w) phthalic acid di-n-decyl ester, and (25 % w/w) phthalic acid di-n-octyl ester SML = ND (LD = 0,02 mg/kg, analyt- ical tolerance included) SML = 5 mg/kg SML = 5 mg/kg (1) 68145 080410-33-9 2,2 ,2 -Nitrilo[triethyl tris(3,3 ,5,5 - tetra-tert-butyl-1,1 -bi-phenyl-2,2 - diyl)phosphite] SML = 5 mg/kg (sum of phosphite and phosphate) 71635 025151-96-6 Pentaerythritol dioleate 73720 000155-96-8 Phosphoric acid, trichloroethyl ester SML = 0,05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Directive 85/572/EEC SML = ND (LD = 0,02 mg/kg, analyt- ical tolerance included) 74010 145650-60-8 Phosphorous acid, bis butyl-6-methylphenyl) ethyl ester (2,4-di-tert- SML = 5 mg/kg (sum of phosphite and phosphate) 76721 009016-00-6 063148-62-9 Polydimethylsiloxane (MW > 6800) In compliance with the specifications laid down in Annex V 76865 — SML = 30 mg/kg Poliyesters of 1,2-propanediol and/or 1,3- and 1,4-butanediol and/or poly- propyleneglycol with adipic acid, also end-capped with acetic acid or fatty acids C10-C18 or n-octanol and/or n-decanol 4. 12. 1999 EN Official Journal of the European Communities L 310/51 PM/REF No CAS No (1) (2) Name (3) Restrictions and/or specifications (4) 77895 068439-49-6 Polyethyleneglycol(EO = 2-6) mono- alkyl(C16-C18) ether SML = 0,05 mg/kg 81515 087189-25-1 Poly(zinc glycerolate) 81760 — Powders, flakes and fibres of brass, bronze, copper, stainless steel, tin and alloys of copper, tin and iron SML(T) = 30 mg/kg (7) (expressed as copper); SML = 48 mg/kg (expressed as iron) 85360 000109-43-3 Sebacic acid, dibutyl ester 85610 — Silicates, natural, silanated (with the exception of asbestos) 85840 053320-86-8 acid, Silicic sodium salt lithium magnesium SML(T) = 0,6 mg/kg (8) (expressed s lithium) 86285 — Silicon dioxide, silanated 88640 008013-07-8 Soybean oil, epoxidised 89200 007617-31-4 Stearic acid, copper salt In compliance with the specificatins laid down in Annex V SML(T) = 30 mg/kg (7) copper) (expresed as 89440 — Stearic acid, esters with ethylene- glycol SML(T) = 30 mg/kg (3) 92030 010124-44-4 Sulphuric acid, copper salt SML(T) = 30 mg/kg (7) (expressed as copper) 92700 078301-43-6 2,2,4,4-Tetramethyl-20- (2,3-epoxypropyl)-7-oxa-3,20-diaza- dispiro[5. 1. 11. 2]-heneicosan-21-one, polymer SML = 5 mg/kg 92930 120218-34-0 Thiodiethanolbis(5-methoxycarbo- nyl-2,6-dimethyl-1,4-dihydropyri- dine-3-carboxylate) SML = 6 mg/kg 94960 000077-99-6 1,1,1-Trimethylopropane SML = 6 mg/kg 95725 110638-71-6 Vermiculite, citric acid, reaction product with lithium salt SML(T) = 0,6 mg/kg (8) (expressed as lithium) 95855 007732-18-5 Water In compliance with Directive 98/83/EC 95859 95883 — — Waxes, refined, derived from petro- leum based or synthetic hydrocarbon feedstocks In compliance with the specifications laid down in Annex V White mineral oils, paraffinic, derived from petroleum based hydrocarbon feedstocks In compliance with the specifications laid down in Annex V L 310/52 EN Official Journal of the European Communities 4. 12. 1999 List of additives in Annex III to Directive 90/128/EEC for which the content of column “CAS No” is modified Appendix 2 PM/REF No CAS No (1) (2) 39890 087826-41-3 069158-41-4 054686-97-4 081541-12-0 Name (3) Restrictions and/or specifications (4) Bis(methylbenzylidene)sorbitol 68125 037244-96-5 Nepheline syenite Appendix 3 List of additives in Annex III to Directive 90/128/EEC deleted PM/REF No CAS No (1) (2) Name (3) Restrictions and/or specifications (4) 76720 009016-00-6 063148-62-9 Polydimethylsiloxane’ 4. 12. 1999 EN Official Journal of the European Communities L 310/53 The following Annexes IV, V and VI are added: ANNEX III ‘ANNEX IV PRODUCTS OBTAINED BY MEANS OF BACTERIAL FERMENTATION PM/REf No CAS No (1) (2) Name (3) Restrictions and/or specifications (4) 18888 80181-31-3 3-hydroxybutanoic xypenta-noic acid, copolymer acid-3-hydro SML = 0,05 mg/kg for crotonic acid (as impurity) and in compliance with the specifications laid down in Annex IV. ANNEX V SPECIFICATIONS Part A: General specifications (to be fixed later) Part B: Other specifications PM/Ref No Other specifications 18888 3-HYDROXYBUTANOIC ACID-3-HYDROXYPENTANOIC ACID, COPOLYMER Definition These copolymers are produced by the controlled fermentation of Alcaligenes eutrophus using mixtures of glucose and propanoic acid as carbon sources. The organism used has not been genetically engineered and has been derived from a single wild-type organism Alcaligenes eutrophus strain H16 NCIMB 10442. Master stocks of the organism are stored as freeze-dried ampoules. A submaster/working stock is prepared from the master stock and stored in liquid nitrogen and used to prepare inocula for the fermenter. Fermenter samples will be examined daily both microscopically and for any changes in colonial morphology on a variety of agars at different temperatures. The copolymers are isolated from heat-treatment bacteria by controlled digestion of the other cellular components, washing and drying. These copolymers are normally offered as formulated, melt-formed granules containing additives such as nucleating agents, plasticisers, fillers, stabilisers and pigments which all conform to the general and individual specifications. — Chemical name Poly(3-D-hydroxybutanoate-co-3-D-hydroxypentanoate) — CAS No 80181-31-3 — Structural formula CH3 CH2 O CH3 O C-)m - ( CH-CH2- (-O- where n/(m + n) greater than 0 and less or equal to 0,25 O-CH-CH2- C-)n L 310/54 EN Official Journal of the European Communities 4. 12. 1999 PM/Ref No Other specifications — Average molecular weight Not less than 150 000 daltons (measured by gel permeation chro- matography). — Assay Description Characteristics — Identification tests: — Solubility less than Not poly(3-D-hydroxybutanoato-co-3-D- hydroxypentanoato) analysed after hydrolysis as a mixture of 3-D- hydroxybutanoic and 3-D-hydroxypentanoic acids. 98 % White to off-white powder after isolation Soluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically insoluble in ethanol, aliphatic alkanes and water. — Migration The migration of crotonic acid should not exceed 0,05 mg/kg food. — Purity Prior to granulation the raw material copolymer powder must contain: — Nitrogen Not more than 2 500 mg/kg of plastic — Zinc — Copper — Lead — Arsenic Not more than 100 mg/kg of plastic Not more than 5 mg/kg of plastic Not more than 2 mg/kg of plastic Not more than 1 mg/kg of plastic — Chromium Not more than 1 mg/kg of plastic. POLYDIMETHYLSILOXANE (Mw > 6 800) Minimum viscosity 100 × 10-6 m2/s (= 100 centistokes) at 25 °C TRIALLYLAMINE 40 mg/kg hydrogel at a ratio of 1 kg food to a maximum of 1,5 grams of hydrogel. For use only in hydrogels intended for non-direct food contact use. 4-(2-BENZOXAZOLYL)-4'-(5-METHYL-2-BENZOXAZOLYL) STILBENE Not more than 0,05 % w/w (quantity of substance used/quantity of the formulation) POLYDIMETHYLSILOXANE (Mw > 6 800) Minimum viscosity 100 × 10-6 m2/s (=100 centistokes) at 25 °C SOYBEAN OIL, EPOXIDISED Oxirane < 8 %, iodine number < 6 WAXES, REFINED, DERIVED FROM PETROLEUM BASED OR SYNTHETIC HYDROCARBON FEED- STOCKS The product should have the following specifications: — Content of mineral hydrocarbons with carbon number less than 25: not more than 5 % (w/w) — Viscosity not less than 11 × 10-6 m2/s (= 11 centistokes) at 100 °C — Average molecular weight not less than 500 WHITE MINERAL OILS, PARAFFINIC DERIVED FROM PETROLEUM BASED HYDROCARBON FEEDSTOCKS The product should have the following specifications: — Content of mineral hydrocarbons with carbon number less than 25: not more than 5 % (w/w) — Viscosity not less than 8,5 × 10-6 m2/s (= 8,5 centistokes) at 100 °C — Average molecular weight not less than 480 23547 25385 38320 76721 88640 95859 95883 4. 12. 1999 EN Official Journal of the European Communities L 310/55 ANNEX VI NOTES RELATED TO THE COLUMN “RESTRICTIONS AND/OR SPECIFICATIONS” (1) Warning: there is a risk that the SML could be exceeded in fatty food simulants. (2) (3) (4) (5) (6) (7) (8) (9) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 10060 and 23920. SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 15760, 16990, 47680, 53650, 89440. SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 19540, 19960. SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 14200, 14230. SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 66560 and 66580. SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 30080, 42320, 45195, 45200, 53610, 81760, 89200, 92030. SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 85840 and 95725. 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: (a) Badge (=2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether: (b) Badge. H O. 2 (d) Badge. HCl. (e) Badge. 2HCl (f) Badge. H 2O. HCl However in aqueous food simulants, the SML(T) should also include Badge. 2H 2O (c) unless the material or article is labelled for use in contact only with those foods and/or beverages for which it has been demonstrated that the sum of the migration levels of the five abovementioned substances (a)(b)(d)(e)(f) cannot exceed 1 mg/kg. (10) Warning: there is a risk that the migration of the substance deteriorates the organoleptic characteristics of the food in contact and then, that the finished product does not comply with the second indent of Article 2 of Directive 89/109/EEC. ’