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Commission Directive 92/39/EEC of 14 May 1992 amending Directive 90/128/EEC relating to plastics materials and articles intended to come into contact with foodstuffs Official Journal L 168 , 23/06/1992 P. 0021 - 0029 Finnish special edition: Chapter 13 Volume 23 P. 0067 Swedish special edition: Chapter 13 Volume 23 P. 0067

COMMISSION DIRECTIVE 92/39/EEC of 14 May 1992 amending Directive 90/128/EEC relating to plastics materials and articles intended to come into contact with foodstuffs THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic 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, Whereas Commission Directive 90/128/EEC (2) of 23 February 1990, and in particular Article 3 (4), provides for the revision of Annex II and particularly section B; Whereas, on the basis of the available information, certain substances provisionally admitted at national level may be included in the Community list, while others must be definitively prohibited; Whereas certain substances provisionally admitted at national level may continue to be permitted for a further specified period since the data requested by the Scientific Committee for Food are not yet available but the required studies are ongoing or are planned; Whereas other substances have been requested for use following the adoption of the Directive, and the technical data supplied permit their inclusion in the Community list; Whereas, for certain substances, the restrictions already set out should be amended according to the available information; Whereas it is necessary to permit the continued use of certain well-defined substances contained in those groups of substances which are not well-defined and are now deleted, pending a decision on their inclusion in the Community list; Whereas the Scientific Committee for Food has been consulted; Whereas the measures laid down by this Directive comply with the opinion of the Standing Committee on Foodstuffs, HAS ADOPTED THIS DIRECTIVE: Article 1 Directive 90/128/EEC is hereby amended as follows: 1. Article 3 (4) is replaced by the following: '4. As from 1 January 1997, only those monomers and other starting substances listed in Annex II, Section A, shall be used for the manufacture of plastic materials and articles, subject to the restrictions specified therein. However, the substances listed in Annex II, Section B may be deleted before the abovementioned date if the data requested for inclusion in Section A are not supplied in time to permit their evaluation by the Scientific Committee for Food. Moreover, before 1 January 1996 it may be decided that, in some justified cases, for certain substances listed in Annex II, Section B, this time-limit will be postponed.' 2. Annex II of Directive 90/128/EEC is amended as follows: (a) Section A: - the substances appearing in Annex I to this Directive are added; - the content of the column 'Restrictions' for the substances appearing in Annex II of this Directive is modified as indicated therein. (b) Section B: - the substances appearing in Annex III to this Directive are added, as a replacement for those groups of substances which are not well-defined and which are deleted by this Directive; - the substances appearing in Annex IV to this Directive are deleted; - the content of the column 'Restrictions' for the substance appearing in Annex V to this Directive is modified as indicated therein. (c) The substances appearing in Annex VI to this Directive are transferred from Section B to A and are now subject to the restrictions, if any, specified. (d) Point 8 is hereby amended as follows: - the following text is inserted after 'NCO = isocyanate moiety;' 'ND = not detectable. For the purpose of this Directive "not detectable" means that the substance should not be detected by a validated method of analysis which should detect it at the detection limit (DL) specified. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the detection limit may be used, pending the development of a validated method.' - the following text is inserted after 'SML = specific migration limit in food or in food stimulant, unless it is specified otherwise.' 'For the purpose of this Directive "SML" means that the specific migration of the substance should be determined by a validated method of analysis at the specified limit. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit may be used, pending the development of a validated method.' Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 1992. They shall immediately inform the Commission thereof. Member States should: - permit trade in and use of plastic materials and articles complying with this Directive by 31 March 1994; - prohibit trade in and use of plastic materials and articles intended to come into contact with foodstuffs and which do not comply with this Directive with effect from 1 April 1995. 2. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive is addressed to the Member States. Done at Brussels, 14 May 1992. For the Commission Martin BANGEMANN Vice-President (1) OJ No L 40, 11. 2. 1989, p. 38. (2) OJ No L 75, 21. 3. 1990, p. 19, rectified by OJ No L 349, 13. 12. 1990, p. 26. ANNEX I LIST OF MONOMERS AND OTHER STARTING SUBSTANCES ADDED TO SECTION A PM/Ref No CAS No Name Restrictions (1) (2) (3) (4) 12788 002432-99-7 11-Aminoundecanoic acid SML = ND (DL = 0,01 mg/kg) 13530 038103-06-9 2,2-Bis(4-hydroxyphenyl)propane bis(phtalic anhydride) SML = 0,05 mg/kg 13614 038103-06-9 Bisphenol A bis(phtalic anhydride) See 13530 19470 000143-07-7 Lauric acid 22350 000544-63-8 Myristic acid 22763 000112-80-1 Oleic acid 24270 000069-72-7 Salicylic acid 24887 006362-79-4 5-Sulphoisophthalic acid, monosodium salt SML = 0,05 mg/kg 25910 024800-44-0 Tripropyleneglycol ANNEX II LIST OF MONOMERS AND OTHER STARTING SUBSTANCES IN SECTION A FOR WHICH THE CONTENT OF THE COLUMN 'RESTRICTIONS' IS MODIFIED PM/Ref No CAS No Name Restrictions (1) (2) (3) (4) 17005 000151-56-4 Ethyleneimine SML = ND (DL = 0,01 mg/kg) 18670 000100-97-0 Hexamethylenetetramine SML (T) = 15 mg/kg (expressed as formaldehyde) 22150 000691-37-2 4-Methyl-1-pentene SML = 0,02 mg/kg ANNEX III LIST OF MONOMERS AND OTHER STARTING SUBSTANCES ADDED TO SECTION B PM/Ref No CAS No Name Restrictions (1) (2) (3) (4) 10160 002206-94-2 alpha-Acetoxystyrene 10162 010521-96-7 beta-Acetoxystyrene 10599/70 Acids, fatty, unsaturated (C 18) 10599/90 061788-89-4 Acids, fatty, unsaturated (C18), dimers 10599/92 068783-41-5 Acids, fatty, unsaturated (C18), dimers, hydrogenated 10775 084100-23-2 Acrylic acid, 4-tert-butylcyclohexyl ester 11000 050976-02-8 Acrylic acid, dicyclopentadienyl ester 11005 012542-30-2 Acrylic acid, dicyclopentenyl ester 11010 024447-78-7 Acrylic acid, diester with 2,2-bis(4-hydroxyphenyl)propane bis(2-hydroxyethyl) ether 11180 017831-71-9 Acrylic acid, diester with tetraethyleneglycol 11195 068901-05-3 Acrylic acid, diester with tripropyleneglycol 11245 002156-97-0 Acrylic acid, dodecyl ester 11520 002918-23-2 Acrylic acid, 2-hydroxyisopropyl ester (= acrylic acid, 2-hydroxy-1-methylethyl ester) 11532 002761-08-2 Acrylic acid, 3-hydroxypropyl ester 11695 003121-61-7 Acrylic acid, 2-methoxyethyl ester 11875 004813-57-4 Acrylic acid, octadecyl ester 12055 094160-26-6 Acrylic acid, triester with glycerol tris(2-hydroxypropyl) ether 12062 075577-70-7 Acrylic acid, triester with 1,1,1-trimethylolpropane tris (2-hydroxyethyl) ether 12265 004074-90-2 Adipic acid, divinyl ester 13328 000104-38-1 Bis(2-hydroxyethyl) ether of hydroquinone 13932 000598-32-3 3-Buten-2-ol 14008 000098-52-2 4-tert-Butylcyclohexanol 14035 001746-23-2 4-tert-Butylstyrene 14833 000623-43-8 Crotonic acid, methyl ester 15020 002182-05-0 Cyclohexyl vinyl ether 15030 000931-88-4 Cyclooctene 15060 000142-29-0 Cyclopentene 15095 000334-48-5 Decanoic acid 15260 000646-25-3 1,10-Diaminodecane 15270 002783-17-7 1,12-Diaminododecane 15295 000373-44-4 1,8-Diaminooctane 16252 000110-03-2 2,5-Dimethyl-2,5-hexanediol 16697 000693-23-2 Dodecanedioic acid 16719 003813-52-3 Endomethylenetetrahydrophthalic acid 17040 000149-57-5 2-Ethylhexanoic acid 17116 005877-42-9 4-Ethyl-1-octyn-3-ol 17150 000078-27-3 1-Ethynylcyclohexanol 17305 000141-02-6 Fumaric acid, bis(2-ethylhexyl) ester 17398 007283-68-3 Fumaric acid, dioctadecyl ester 18436 001687-30-5 Hexahydrophthalic acid 18441 000085-42-7 Hexahydrophthalic anhydride 18865 003031-66-1 3-Hexyn-2,5-diol 18905 002628-17-3 4-Hydroxystyrene 19130 026896-18-4 Isononanoic acid 19490 000947-04-6 Laurolactam 19915 000925-21-3 Maleic acid, monobutyl ester 19936 007423-42-9 Maleic acid, mono(2-ethylhexyl) ester 20095 046729-07-1 Methacrylic acid, 4-tert-butylcyclohexyl ester 20455 006606-59-3 Methacrylic acid, diester with 1,6-hexanediol 20945 004664-49-7 Methacrylic acid, 2-hydroxyisopropyl ester (= methacrylic acid, 2-hydroxy-1-methylethyl ester) 20965 002761-09-3 Methacrylic acid, 3-hydroxypropyl ester 21115 000816-74-0 Methacrylic acid, methallyl ester 21170 000997-46-6 Methacrylic acid, monoester with 1,4-butanediol 21733 000115-19-5 2-Methyl-3-butyn-2-ol 21736 002549-61-3 alpha-Methyl-epsilon-caprolactone 21739 002549-60-2 beta-Methyl-epsilon-caprolactone 21742 002549-58-8 delta-Methyl-epsilon-caprolactone 21745 002549-59-9 epsilon-Methyl-epsilon-caprolactone 21748 002549-42-0 gamma-Methyl-epsilon-caprolactone 21837 001116-90-1 4-Methyl-1,4-hexadiene SML = ND (DL = 0,05 mg/kg) 22428 051000-52-3 Neodecanoic acid, vinyl ester 22465 000112-05-0 Nonanoic acid 22585 003710-30-3 1,7-Octadiene 22811 000591-93-5 1,4-Pentadiene 22842 002590-16-1 Pentaerythritol diallyl ether 22858 005343-92-0 1,2-Pentanediol 22861 000111-29-5 1,5-Pentanediol 22901 000109-68-2 2-Pentene 22932 001187-93-5 Perfluoromethyl perfluorovinyl ether 22935 003823-94-7 Perfluoromethyl vinyl ether 22937 001623-05-8 Perfluoropropyl perfluorovinyl ether 22940 006996-01-6 Perfluoropropyl vinyl ether 24560 000111-63-7 Stearic acid, vinyl ester 25158 000088-98-2 1,2,3,6-Tetrahydrophalic acid 25161 000085-43-8 1,2,3,6-Tetrahydrophalic anhydride 25380 Trialkyl (C5-C15) acetic acid, vinyl ester (= vinyl versatate) 25645 000682-09-7 1,1,1-Trimethylolpropane diallyl ether ANNEX IV LIST OF MONOMERS AND OTHER STARTING SUBSTANCES DELETED PM/Ref No CAS No Name (1) (2) (3) 10180 000556-08-1 p-(Acetylamino)benzoic acid 10240 Acids, aliphatic, dicarboxylic, esters with alcohols, aliphatic, monohydric 10270 Acids, aliphatic, dicarboxylic (C3-C12), esters with alcohols, unsaturated (C3-C18) 10300 Acids, aliphatic, dicarboxylic, saturated (C4-C18) 10330 Acids, aliphatic, dicarboxylic, unsaturated (C4-C12) 10360 Acids, aliphatic, dicarboxylic, unsaturated, esters with polyethyleneglycol 10390 Acids, aliphatic, dicarboxylic, unsaturated, esters with polypropyleneglycol 10420 Acids, aliphatic, mono- and dicarboxylic (C2-C20), vinyl esters 10450 Acids, aliphatic, monocarboxylic (C3-C12), esters with alcohols, unsaturated (C3-C18) 10540 Acids, aliphatic, monocarboxylic, unsaturated (C3-C8), esters with alcohols, aliphatic, monohydric, saturated (C2-C12) 10570 Acids, aliphatic, monocarboxylic, unsaturated, esters with polypropyleneglycol 10870 002206-89-5 Acrylic acid, 2-chloroethyl ester 10900 Acrylic acid, cyclohexylaminoethyl ester 10960 016868-13-6 Acrylic acid, cyclopentyl ester 11290 Acrylic acid, esters with alcohols, aliphatic, monohydric, saturated (C1-C21) 11320 Acrylic acid, esters with alcohols, aliphatic, monohydric, unsaturated (C4-C18) 11350 Acrylic acid, esters with alcohols, aliphatic, polyhydric (C2-C21) 11380 Acrylic acid, esters with etheralcohols 11410 Acrylic acid, esters with glycolethers obtained from mono- and/or digylcols with alcohols, aliphatic, monohydric (C1-C18) 11440 044992-01-0 Acrylic acid, ester with trimethylethanolammonium chloride 11920 005048-82-8 Acrylic acid, phenylaminoethyl ester 11950 000937-41-7 Acrylic acid, phenyl ester 12070 002177-18-6 Acrylic acid, vinyl ester 12400 Alcohols, aliphatic, monohydric, unsaturated (up to C18) 12430 Alcohols, aliphatic, polyhydric (up to C18) 12460 Alcohols, cycloaliphatic, mono- and/or polyhydric, substituted (up to C18) 12490 Aldehydes (C4) 12520 Alkadienes 12550 n-Alkenes (up to C16) 12580 p-Alkyl(C4-C9) phenols 12730 000060-32-2 6-Aminocaproic acid 12760 omega-Aminocarboxylic acids, alphatic, linear (C6-C12) 12880 000123-98-8 Azelaic acid dichloride 12940 004080-88-0 Azelaic acid, diphenyl ester 13030 000539-48-0 1,4-Benzenedimethanamine 13120 000769-78-8 Benzoic acid, vinyl ester 13180 000498-66-8 Bicyclo[2.2.1]hept-2-ene 13240 003377-24-0 2,2-Bis(4-aminocyclohexyl)propane 13300 038050-97-4 1,4-Bis(4,4"-dihydroxytriphenylmethyl)benzene 13330 Bis(2-hydroxyethyl) ether of hydroquinone and its condensation products with propylene oxide 13360 001620-68-4 2,6-Bis(2-hydroxy-5-methylbenzyl)-4-methylphenol 13420 000843-55-0 1,1-Bis(4-hydroxyphenyl)cyclohexane 13450 000125-13-3 3,3-Bis(4-hydroxyphenyl)-2-indolinone 13570 000141-07-1 1,3-Bis(methoxymethyl)urea 13930 006117-91-5 2-Buten-1-ol 13990 005153-77-5 N-(Butoxymethyl)methacrylamide 14050 000111-34-2 Butyl vinyl ether 14080 000926-02-3 tert-Butyl vinyl ether 14290 Caprolactone, substituted 14440 064147-40-6 Castor oil, dehydrated 14470 008001-78-3 Castor oil, hydrogenated 14590 000615-67-8 Chlorohydroquinone 14620 057981-99-4 Chlorohydroquinone diacetate 14830 Crotonic acid, esters with alcohols, mono- and polyhydric 14860 Cycloalkenes 14920 002842-38-8 2-(Cyclohexylamino)ethanol 15010 001131-60-8 p-Cyclohexylphenol 15040 000542-92-7 1,3-Cyclopentadiene 15160 000765-05-9 Decyl vinyl ether 15190 Diamines, aliphatic, linear (C2-C12) 15430 003749-77-7 4,4-Dicarboxydiphenoxybutane 15460 003753-05-7 4,4-Dicarboxydiphenoxyethane 15520 004919-48-6 4,4-Dicarboxydiphenyl sulphide 15550 002449-35-6 4,4-Dicarboxydiphenyl sulphone 15640 000156-59-2 cis-1,2-Dichloroethylene 15670 000156-60-5 trans-1,2-Dichloroethylene 16030 001965-09-9 4,4-Dihydroxydiphenyl ether 16060 002664-63-3 4,4-Dihydroxydiphenyl sulphide 16420 000123-91-1 Dioxane 16720 000826-62-0 Endomethylenetetrahydrophthalic anhydride 16810 Ether alcohols 16840 Ethers of N-methylolacrylamide 16870 Ethers of N-methylolmethacrylamide 16930 000075-00-3 Ethyl chloride 17080 000103-44-6 2-Ethylhexyl vinyl ether 17140 000109-92-2 Ethyl vinyl ether 17410 Fumaric acid, esters with alcohols, aliphatic, monohydric, saturated (C1-C18) 17440 Fumaric acid, esters with alcohols, aliphatic, monohydric, unsaturated (C3-C18) 17470 Fumaric acid, esters with alcohols, polyhydric 17500 000098-01-0 Furfural 17560 Glucosides obtained from glucose and 1,3-butanediol 17590 Glucosides obtained from glucose and 1,4-butanediol 17620 Glucosides obtained from glucose and diethyleneglycol 17650 Glucosides obtained from glucose and 2,2-dimethyl-1,3-propanediol 17680 Glucosides obtained from glucose and ethyleneglycol 17710 Glucosides obtained from glucose and glycerol 17740 Glucosides obtained from glucose and 1,6-hexanediol 17770 Glucosides obtained from glucose and 1,2,6-hexanetriol 17890 Glucosides obtained from glucose and propanediol 17920 Glucosides obtained from glucose and sorbitol 17950 Glucosides obtained from glucose and sucrose 17980 Glucosides obtained from glucose and 1,1,1-trimethylolpropane 18040 029733-18-4 Glutaric acid, diisodecyl ester 18130 004371-64-6 1,1-Heptadecanedicarboxylic acid 18160 025339-56-4 Heptene 18190 000592-76-7 1-Heptene 18340 000822-28-6 Hexadecyl vinyl ether 18520 038775-37-0 Hexamethylenediamine azelate 18550 Hexamethylenediamine dodecanedicarboxylate 18580 Hexamethylenediamine heptadecanedicarboxylate 18730 002935-44-6 2,5-Hexanediol 18760 000106-69-4 1,2,6-Hexanetriol 18790 025264-93-1 Hexene 18910 000288-32-4 Imidazole 18940 000095-13-6 Indene 19240 000744-45-6 Isophthalic acid, diphenyl ester 19300 002155-60-4 Itaconic acid, dibutyl ester 19330 007748-43-8 Itaconic acid, 2,3-epoxypropyl diester 19360 Itaconic acid, 2,3-epoxypropyl monoester 19390 Itaconic acid, esters with alcohols, aliphatic, monohydric, saturated (C1-C18) 19420 Itaconic acid, esters with alcohols, polyhydric 19450 Lactams of omega-aminocarboxylic acids, aliphatic, linear (C7-C12) 19630 071550-61-3 Maleic acid, diester with 1,2-propanediol 19780 002915-53-9 Maleic acid, dioctyl ester 19810 Maleic acid, esters with alcohols, aliphatic, saturated (C1-C18) 19840 Maleic acid, esters with alcohols, polyhydric 19870 Maleic acid, ester with 1,3-butanediol 19900 002424-58-0 Maleic acid, monoallyl ester 19930 Maleic acid, monoesters with alcohols, aliphatic, monohydric, unsaturated (C3-C18) 20230 Methacrylic acid, cyclohexylaminoethyl ester 20290 016868-14-7 Methacrylic acid, cyclopentyl ester 20350 Methacrylic acid, (di-tert-butylamino)ethyl ester 20500 000105-16-8 Methacrylic acid, 2-(diethylamino)ethyl ester 20620 Methacrylic acid, esters with alcohols, aliphatic, monohydric, saturated (C1-C21) 20650 Methacrylic acid, esters with alcohols, aliphatic, monohydric, unsaturated (C4-C18) 20680 Methacrylic acid, esters with alcohols, polyhydric (C2-C21) 20710 Methacrylic acid, esters with etheralcohols 20770 Methacrylic acid, esters with glycolethers obtained from mono- and/or diglycols with alcohols, aliphatic, monohydric (C1-C18) 20800 024493-59-2 Methacrylic acid, ester with methoxytriethyleneglycol 20860 Methacrylic acid, ester with trimethylethanolammonium chloride 21160 Methacrylic acid, monoester with 1,3-butanediol 21310 003683-12-3 Methacrylic acid, phenylethyl ester 21580 003644-11-9 N-(Methoxymethyl)acrylamide 21610 003644-12-0 N-(Methoxymethyl)methacrylamide 21700 000513-35-9 2-Methyl-2-butene 21790 000110-26-9 Methylenebiscarylamide 21820 013093-19-1 Methylenebiscaprolactam 21910 000814-78-8 Methyl isopropenyl ketone 22000 001118-58-7 2-Methyl-1,3-pentadiene 22030 001115-08-8 3-Methyl-1,4-pentadiene 22060 000926-56-7 4-Methyl-1,3-pentadiene 22090 000763-29-1 2-Methyl-1-pentene 22120 000760-20-3 3-Methyl-1-pentene 22180 004461-48-7 4-Methyl-2-pentene 22300 000078-94-4 Methyl vinyl ketone 22330 001822-74-8 Methyl vinyl thioether 22510 027215-95-8 Nonene 22580 000930-02-9 Octadecyl vinyl ether 22630 025377-83-7 Octene (except 1-octene) 22750 000929-62-4 Octyl vinyl ether 22810 000504-60-9 1,3-Pentadiene 22930 Perfluoroalkyl(C1-C3)vinyl ethers 22990 Phenols, mono- and dihydric, alkoxylated or hydrogenated 23020 028994-41-4 alpha-Phenyl-o-cresol 23080 001079-21-6 Phenylhydroquinone 23110 058244-28-3 Phenylhydroquinone diacetate 23260 000088-95-9 o-Phthalic acid dichloride 23290 Phthalic acids, halogenated derivatives 23320 Phthalic acids, hydrogenated 23350 Phthalic acids, hydrogenated, substituted, endosubstituted, and their halogenated derivatives 23410 Phthalic anhydride, hydrogenated 23440 000111-16-0 Pimelic acid 23560 Polyethers based on ethylene oxide, propylene oxide and/or tetrahydrofuran, containing free hydroxyl groups 23620 Polyols derived from phenols and bisphenols, hydrogenated and/or condensed with epoxyalkanes and/or arylepoxyalkanes possibly halogenated, alkoxylated, aryloxylated 23680 009002-89-5 Polyvinylalcohols 23710 063148-65-2 Polyvinylbutyrals 24040 000764-47-6 Propyl vinyl ether 24220 009006-03-5 Rubber, chlorinated 24310 000111-19-3 Sebacic acid, dichloride 24340 002432-89-5 Sebacic acid, didecyl ester 24400 002918-18-5 Sebacic acid, diphenyl ester 24640 Styrene, substituted by alkyl groups (alpha) 24670 Styrene, substituted in the benzene ring 24700 Styrene, substituted by halogens (alpha or beta) 24730 Styrene, substituted in the vinyl group 24790 000505-48-6 Suberic acid 25000 001539-04-4 Terephthalic acid, diphenyl ester 25060 000632-58-6 Tetrachlorophthalic acid 25330 000070-55-3 P-Toluenesulphonamide 25570 000067-48-1 Trimethylethanolammonium chloride 25660 019727-16-3 1,1,1-Trimethylolpropane dimethacrylate 25690 1,1,1-Trimethylolpropane maleates 25720 007024-08-0 1,1,1-Trimethylolpropane monoacrylate 25750 007024-09-1 1,1,1-Trimethylolpropane monomethacrylate 25870 000107-39-1 2,4,4-Trimethyl-1-pentene 25990 000689-97-4 Vinylacetylene 26020 001484-13-5 N-Vinylcarbazole 26080 Vinyl ethers of alcohols, aliphatic, monohydric, saturated (C2-C18) ANNEX V LIST OF MONOMERS AND OTHER STARTING SUBSTANCES IN SECTION B FOR WHICH THE CONTENT OF THE COLUMN 'RESTRICTIONS' IS MODIFIED PM/Ref No CAS No Name Restrictions (1) (2) (3) (4) 26140 000075-38-7 Vinylidene fluoride SML = ND (DL = 0,05 mg/kg) ANNEX VI LIST OF MONOMERS AND OTHER STARTING SUBSTANCES TRANSFERRED TO SECTION A PM/Ref No CAS No Name Restrictions (1) (2) (3) (4) 10630 000079-06-1 Acrylamide SML = ND (DL = 0,01 mg/kg) 12280 002035-75-8 Adipic anhydride 12670 002855-13-2 1-Amino-3-aminomethyl-3,5,5-trimethylcyclohexane SML = 6 mg/kg 12970 004196-95-6 Azelaic anhydride 15250 000110-60-1 1,4-Diaminobutane 18070 000108-55-4 Glutaric anhydride 18250 000115-28-6 Hexachloroendomethylenetetrahydrophthalic acid SML = ND (DL = 0,01 mg/kg) 18280 000115-27-5 Hexachloroendomethylenetetrahydrophthalic anhydride SML = ND (DL = 0,01 mg/kg) 18430 000116-15-4 Hexafluoropropylene SML = ND (DL = 0,01 mg/kg) 21190 000868-77-9 Methacrylic acid, monoester with ethyleneglycol 21940 000924-42-5 N-Methylolacrylamide SML = ND (DL = 0,01 mg/kg) 23200 000088-99-3 o-Phthalic acid 23230 000131-17-9 Phthalic acid, diallyl ester SML = ND (DL = 0,01 mg/kg) 24430 002561-88-8 Sebacic anhydride 24850 000108-30-5 Succinic anhydride

COMMISSION DIRECTIVE 92/39/EEC of 14 May 1992 amending Directive 90/128/EEC relating to plastics materials and articles intended to come into contact with foodstuffs

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic 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,

Whereas Commission Directive 90/128/EEC (2) of 23 February 1990, and in particular Article 3 (4), provides for the revision of Annex II and particularly section B;

Whereas, on the basis of the available information, certain substances provisionally admitted at national level may be included in the Community list, while others must be definitively prohibited;

Whereas certain substances provisionally admitted at national level may continue to be permitted for a further specified period since the data requested by the Scientific Committee for Food are not yet available but the required studies are ongoing or are planned;

Whereas other substances have been requested for use following the adoption of the Directive, and the technical data supplied permit their inclusion in the Community list;

Whereas, for certain substances, the restrictions already set out should be amended according to the available information;

Whereas it is necessary to permit the continued use of certain well-defined substances contained in those groups of substances which are not well-defined and are now deleted, pending a decision on their inclusion in the Community list;

Whereas the Scientific Committee for Food has been consulted;

Whereas the measures laid down by this Directive comply with the opinion of the Standing Committee on Foodstuffs,

HAS ADOPTED THIS DIRECTIVE:

Directive 90/128/EEC is hereby amended as follows:

1. Article 3 (4) is replaced by the following:

'4. As from 1 January 1997, only those monomers and other starting substances listed in Annex II, Section A, shall be used for the manufacture of plastic materials and articles, subject to the restrictions specified therein. However, the substances listed in Annex II, Section B may be deleted before the abovementioned date if the data requested for inclusion in Section A are not supplied in time to permit their evaluation by the Scientific Committee for Food. Moreover, before 1 January 1996 it may be decided that, in some justified cases, for certain substances listed in Annex II, Section B, this time-limit will be postponed.'

2. Annex II of Directive 90/128/EEC is amended as follows:

(a) Section A:

- the substances appearing in Annex I to this Directive are added;

- the content of the column 'Restrictions' for the substances appearing in Annex II of this Directive is modified as indicated therein.

(b) Section B:

- the substances appearing in Annex III to this Directive are added, as a replacement for those groups of substances which are not well-defined and which are deleted by this Directive;

- the substances appearing in Annex IV to this Directive are deleted;

- the content of the column 'Restrictions' for the substance appearing in Annex V to this Directive is modified as indicated therein.

(c) The substances appearing in Annex VI to this Directive are transferred from Section B to A and are now subject to the restrictions, if any, specified.

(d) Point 8 is hereby amended as follows:

- the following text is inserted after 'NCO = isocyanate moiety;'

'ND = not detectable.

For the purpose of this Directive "not detectable" means that the substance should not be detected by a validated method of analysis which should detect it at the detection limit (DL) specified.

If such a method does not currently exist, an analytical method with appropriate performance characteristics at the detection limit may be used, pending the development of a validated method.'

- the following text is inserted after 'SML = specific migration limit in food or in food stimulant, unless it is specified otherwise.'

'For the purpose of this Directive "SML" means that the specific migration of the substance should be determined by a validated method of analysis at the specified limit. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit may be used, pending the development of a validated method.'

Article 2

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 1992. They shall immediately inform the Commission thereof.

Member States should:

- permit trade in and use of plastic materials and articles complying with this Directive by 31 March 1994;

- prohibit trade in and use of plastic materials and articles intended to come into contact with foodstuffs and which do not comply with this Directive with effect from 1 April 1995.

2. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.

This Directive is addressed to the Member States. Done at Brussels, 14 May 1992. For the Commission

Martin BANGEMANN

Vice-President

(1) OJ No L 40, 11. 2. 1989, p. 38. (2) OJ No L 75, 21. 3. 1990, p. 19, rectified by OJ No L 349, 13. 12. 1990, p. 26.

ANNEX I

LIST OF MONOMERS AND OTHER STARTING SUBSTANCES ADDED TO SECTION A

PM/Ref No CAS No Name Restrictions (1) (2) (3) (4)

12788 002432-99-7 11-Aminoundecanoic acid SML = ND (DL = 0,01 mg/kg) 13530 038103-06-9 2,2-Bis(4-hydroxyphenyl)propane bis(phtalic anhydride) SML = 0,05 mg/kg 13614 038103-06-9 Bisphenol A bis(phtalic anhydride) See 13530 19470 000143-07-7 Lauric acid 22350 000544-63-8 Myristic acid 22763 000112-80-1 Oleic acid 24270 000069-72-7 Salicylic acid 24887 006362-79-4 5-Sulphoisophthalic acid, monosodium salt SML = 0,05 mg/kg 25910 024800-44-0 Tripropyleneglycol

ANNEX II

LIST OF MONOMERS AND OTHER STARTING SUBSTANCES IN SECTION A FOR WHICH THE CONTENT OF THE COLUMN 'RESTRICTIONS' IS MODIFIED

PM/Ref No CAS No Name Restrictions (1) (2) (3) (4)

17005 000151-56-4 Ethyleneimine SML = ND (DL = 0,01 mg/kg) 18670 000100-97-0 Hexamethylenetetramine SML (T) = 15 mg/kg (expressed as formaldehyde) 22150 000691-37-2 4-Methyl-1-pentene SML = 0,02 mg/kg

ANNEX III

LIST OF MONOMERS AND OTHER STARTING SUBSTANCES ADDED TO SECTION B

PM/Ref No CAS No Name Restrictions

(1) (2) (3) (4)

10160 002206-94-2 alpha-Acetoxystyrene 10162 010521-96-7 beta-Acetoxystyrene 10599/70 Acids, fatty, unsaturated (C 18) 10599/90 061788-89-4 Acids, fatty, unsaturated (C18), dimers 10599/92 068783-41-5 Acids, fatty, unsaturated (C18), dimers, hydrogenated 10775 084100-23-2 Acrylic acid, 4-tert-butylcyclohexyl ester 11000 050976-02-8 Acrylic acid, dicyclopentadienyl ester 11005 012542-30-2 Acrylic acid, dicyclopentenyl ester 11010 024447-78-7 Acrylic acid, diester with 2,2-bis(4-hydroxyphenyl)propane bis(2-hydroxyethyl) ether 11180 017831-71-9 Acrylic acid, diester with tetraethyleneglycol 11195 068901-05-3 Acrylic acid, diester with tripropyleneglycol 11245 002156-97-0 Acrylic acid, dodecyl ester 11520 002918-23-2 Acrylic acid, 2-hydroxyisopropyl ester (= acrylic acid, 2-hydroxy-1-methylethyl ester) 11532 002761-08-2 Acrylic acid, 3-hydroxypropyl ester 11695 003121-61-7 Acrylic acid, 2-methoxyethyl ester 11875 004813-57-4 Acrylic acid, octadecyl ester 12055 094160-26-6 Acrylic acid, triester with glycerol tris(2-hydroxypropyl) ether 12062 075577-70-7 Acrylic acid, triester with 1,1,1-trimethylolpropane tris (2-hydroxyethyl) ether 12265 004074-90-2 Adipic acid, divinyl ester 13328 000104-38-1 Bis(2-hydroxyethyl) ether of hydroquinone 13932 000598-32-3 3-Buten-2-ol 14008 000098-52-2 4-tert-Butylcyclohexanol 14035 001746-23-2 4-tert-Butylstyrene 14833 000623-43-8 Crotonic acid, methyl ester 15020 002182-05-0 Cyclohexyl vinyl ether 15030 000931-88-4 Cyclooctene 15060 000142-29-0 Cyclopentene 15095 000334-48-5 Decanoic acid 15260 000646-25-3 1,10-Diaminodecane 15270 002783-17-7 1,12-Diaminododecane 15295 000373-44-4 1,8-Diaminooctane 16252 000110-03-2 2,5-Dimethyl-2,5-hexanediol 16697 000693-23-2 Dodecanedioic acid 16719 003813-52-3 Endomethylenetetrahydrophthalic acid 17040 000149-57-5 2-Ethylhexanoic acid 17116 005877-42-9 4-Ethyl-1-octyn-3-ol 17150 000078-27-3 1-Ethynylcyclohexanol 17305 000141-02-6 Fumaric acid, bis(2-ethylhexyl) ester 17398 007283-68-3 Fumaric acid, dioctadecyl ester 18436 001687-30-5 Hexahydrophthalic acid 18441 000085-42-7 Hexahydrophthalic anhydride 18865 003031-66-1 3-Hexyn-2,5-diol 18905 002628-17-3 4-Hydroxystyrene 19130 026896-18-4 Isononanoic acid 19490 000947-04-6 Laurolactam 19915 000925-21-3 Maleic acid, monobutyl ester 19936 007423-42-9 Maleic acid, mono(2-ethylhexyl) ester 20095 046729-07-1 Methacrylic acid, 4-tert-butylcyclohexyl ester 20455 006606-59-3 Methacrylic acid, diester with 1,6-hexanediol 20945 004664-49-7 Methacrylic acid, 2-hydroxyisopropyl ester (= methacrylic acid, 2-hydroxy-1-methylethyl ester) 20965 002761-09-3 Methacrylic acid, 3-hydroxypropyl ester 21115 000816-74-0 Methacrylic acid, methallyl ester 21170 000997-46-6 Methacrylic acid, monoester with 1,4-butanediol 21733 000115-19-5 2-Methyl-3-butyn-2-ol 21736 002549-61-3 alpha-Methyl-epsilon-caprolactone 21739 002549-60-2 beta-Methyl-epsilon-caprolactone 21742 002549-58-8 delta-Methyl-epsilon-caprolactone 21745 002549-59-9 epsilon-Methyl-epsilon-caprolactone 21748 002549-42-0 gamma-Methyl-epsilon-caprolactone 21837 001116-90-1 4-Methyl-1,4-hexadiene SML = ND (DL = 0,05 mg/kg) 22428 051000-52-3 Neodecanoic acid, vinyl ester 22465 000112-05-0 Nonanoic acid 22585 003710-30-3 1,7-Octadiene 22811 000591-93-5 1,4-Pentadiene 22842 002590-16-1 Pentaerythritol diallyl ether 22858 005343-92-0 1,2-Pentanediol 22861 000111-29-5 1,5-Pentanediol 22901 000109-68-2 2-Pentene 22932 001187-93-5 Perfluoromethyl perfluorovinyl ether 22935 003823-94-7 Perfluoromethyl vinyl ether 22937 001623-05-8 Perfluoropropyl perfluorovinyl ether 22940 006996-01-6 Perfluoropropyl vinyl ether 24560 000111-63-7 Stearic acid, vinyl ester 25158 000088-98-2 1,2,3,6-Tetrahydrophalic acid 25161 000085-43-8 1,2,3,6-Tetrahydrophalic anhydride 25380 Trialkyl (C5-C15) acetic acid, vinyl ester (= vinyl versatate) 25645 000682-09-7 1,1,1-Trimethylolpropane diallyl ether

ANNEX IV

LIST OF MONOMERS AND OTHER STARTING SUBSTANCES DELETED

PM/Ref No CAS No Name (1) (2) (3) 10180 000556-08-1 p-(Acetylamino)benzoic acid 10240 Acids, aliphatic, dicarboxylic, esters with alcohols, aliphatic, monohydric 10270 Acids, aliphatic, dicarboxylic (C3-C12), esters with alcohols, unsaturated (C3-C18) 10300 Acids, aliphatic, dicarboxylic, saturated (C4-C18) 10330 Acids, aliphatic, dicarboxylic, unsaturated (C4-C12) 10360 Acids, aliphatic, dicarboxylic, unsaturated, esters with polyethyleneglycol 10390 Acids, aliphatic, dicarboxylic, unsaturated, esters with polypropyleneglycol 10420 Acids, aliphatic, mono- and dicarboxylic (C2-C20), vinyl esters 10450 Acids, aliphatic, monocarboxylic (C3-C12), esters with alcohols, unsaturated (C3-C18) 10540 Acids, aliphatic, monocarboxylic, unsaturated (C3-C8), esters with alcohols, aliphatic, monohydric, saturated (C2-C12) 10570 Acids, aliphatic, monocarboxylic, unsaturated, esters with polypropyleneglycol 10870 002206-89-5 Acrylic acid, 2-chloroethyl ester 10900 Acrylic acid, cyclohexylaminoethyl ester 10960 016868-13-6 Acrylic acid, cyclopentyl ester 11290 Acrylic acid, esters with alcohols, aliphatic, monohydric, saturated (C1-C21) 11320 Acrylic acid, esters with alcohols, aliphatic, monohydric, unsaturated (C4-C18) 11350 Acrylic acid, esters with alcohols, aliphatic, polyhydric (C2-C21) 11380 Acrylic acid, esters with etheralcohols 11410 Acrylic acid, esters with glycolethers obtained from mono- and/or digylcols with alcohols, aliphatic, monohydric (C1-C18) 11440 044992-01-0 Acrylic acid, ester with trimethylethanolammonium chloride 11920 005048-82-8 Acrylic acid, phenylaminoethyl ester 11950 000937-41-7 Acrylic acid, phenyl ester 12070 002177-18-6 Acrylic acid, vinyl ester 12400 Alcohols, aliphatic, monohydric, unsaturated (up to C18) 12430 Alcohols, aliphatic, polyhydric (up to C18) 12460 Alcohols, cycloaliphatic, mono- and/or polyhydric, substituted (up to C18) 12490 Aldehydes (C4) 12520 Alkadienes 12550 n-Alkenes (up to C16) 12580 p-Alkyl(C4-C9) phenols 12730 000060-32-2 6-Aminocaproic acid 12760 omega-Aminocarboxylic acids, alphatic, linear (C6-C12) 12880 000123-98-8 Azelaic acid dichloride 12940 004080-88-0 Azelaic acid, diphenyl ester 13030 000539-48-0 1,4-Benzenedimethanamine 13120 000769-78-8 Benzoic acid, vinyl ester 13180 000498-66-8 Bicyclo[2.2.1]hept-2-ene 13240 003377-24-0 2,2-Bis(4-aminocyclohexyl)propane 13300 038050-97-4 1,4-Bis(4,4"-dihydroxytriphenylmethyl)benzene 13330 Bis(2-hydroxyethyl) ether of hydroquinone and its condensation products with propylene oxide 13360 001620-68-4 2,6-Bis(2-hydroxy-5-methylbenzyl)-4-methylphenol 13420 000843-55-0 1,1-Bis(4-hydroxyphenyl)cyclohexane 13450 000125-13-3 3,3-Bis(4-hydroxyphenyl)-2-indolinone 13570 000141-07-1 1,3-Bis(methoxymethyl)urea 13930 006117-91-5 2-Buten-1-ol 13990 005153-77-5 N-(Butoxymethyl)methacrylamide 14050 000111-34-2 Butyl vinyl ether 14080 000926-02-3 tert-Butyl vinyl ether 14290 Caprolactone, substituted 14440 064147-40-6 Castor oil, dehydrated 14470 008001-78-3 Castor oil, hydrogenated 14590 000615-67-8 Chlorohydroquinone 14620 057981-99-4 Chlorohydroquinone diacetate 14830 Crotonic acid, esters with alcohols, mono- and polyhydric 14860 Cycloalkenes 14920 002842-38-8 2-(Cyclohexylamino)ethanol 15010 001131-60-8 p-Cyclohexylphenol 15040 000542-92-7 1,3-Cyclopentadiene 15160 000765-05-9 Decyl vinyl ether 15190 Diamines, aliphatic, linear (C2-C12) 15430 003749-77-7 4,4-Dicarboxydiphenoxybutane 15460 003753-05-7 4,4-Dicarboxydiphenoxyethane 15520 004919-48-6 4,4-Dicarboxydiphenyl sulphide 15550 002449-35-6 4,4-Dicarboxydiphenyl sulphone 15640 000156-59-2 cis-1,2-Dichloroethylene 15670 000156-60-5 trans-1,2-Dichloroethylene 16030 001965-09-9 4,4-Dihydroxydiphenyl ether 16060 002664-63-3 4,4-Dihydroxydiphenyl sulphide 16420 000123-91-1 Dioxane 16720 000826-62-0 Endomethylenetetrahydrophthalic anhydride 16810 Ether alcohols 16840 Ethers of N-methylolacrylamide 16870 Ethers of N-methylolmethacrylamide 16930 000075-00-3 Ethyl chloride 17080 000103-44-6 2-Ethylhexyl vinyl ether 17140 000109-92-2 Ethyl vinyl ether 17410 Fumaric acid, esters with alcohols, aliphatic, monohydric, saturated (C1-C18) 17440 Fumaric acid, esters with alcohols, aliphatic, monohydric, unsaturated (C3-C18) 17470 Fumaric acid, esters with alcohols, polyhydric 17500 000098-01-0 Furfural 17560 Glucosides obtained from glucose and 1,3-butanediol 17590 Glucosides obtained from glucose and 1,4-butanediol 17620 Glucosides obtained from glucose and diethyleneglycol 17650 Glucosides obtained from glucose and 2,2-dimethyl-1,3-propanediol 17680 Glucosides obtained from glucose and ethyleneglycol 17710 Glucosides obtained from glucose and glycerol 17740 Glucosides obtained from glucose and 1,6-hexanediol 17770 Glucosides obtained from glucose and 1,2,6-hexanetriol 17890 Glucosides obtained from glucose and propanediol 17920 Glucosides obtained from glucose and sorbitol 17950 Glucosides obtained from glucose and sucrose 17980 Glucosides obtained from glucose and 1,1,1-trimethylolpropane 18040 029733-18-4 Glutaric acid, diisodecyl ester 18130 004371-64-6 1,1-Heptadecanedicarboxylic acid 18160 025339-56-4 Heptene 18190 000592-76-7 1-Heptene 18340 000822-28-6 Hexadecyl vinyl ether 18520 038775-37-0 Hexamethylenediamine azelate 18550 Hexamethylenediamine dodecanedicarboxylate 18580 Hexamethylenediamine heptadecanedicarboxylate 18730 002935-44-6 2,5-Hexanediol 18760 000106-69-4 1,2,6-Hexanetriol 18790 025264-93-1 Hexene 18910 000288-32-4 Imidazole 18940 000095-13-6 Indene 19240 000744-45-6 Isophthalic acid, diphenyl ester 19300 002155-60-4 Itaconic acid, dibutyl ester 19330 007748-43-8 Itaconic acid, 2,3-epoxypropyl diester 19360 Itaconic acid, 2,3-epoxypropyl monoester 19390 Itaconic acid, esters with alcohols, aliphatic, monohydric, saturated (C1-C18) 19420 Itaconic acid, esters with alcohols, polyhydric 19450 Lactams of omega-aminocarboxylic acids, aliphatic, linear (C7-C12) 19630 071550-61-3 Maleic acid, diester with 1,2-propanediol 19780 002915-53-9 Maleic acid, dioctyl ester 19810 Maleic acid, esters with alcohols, aliphatic, saturated (C1-C18) 19840 Maleic acid, esters with alcohols, polyhydric 19870 Maleic acid, ester with 1,3-butanediol 19900 002424-58-0 Maleic acid, monoallyl ester 19930 Maleic acid, monoesters with alcohols, aliphatic, monohydric, unsaturated (C3-C18) 20230 Methacrylic acid, cyclohexylaminoethyl ester 20290 016868-14-7 Methacrylic acid, cyclopentyl ester 20350 Methacrylic acid, (di-tert-butylamino)ethyl ester 20500 000105-16-8 Methacrylic acid, 2-(diethylamino)ethyl ester 20620 Methacrylic acid, esters with alcohols, aliphatic, monohydric, saturated (C1-C21) 20650 Methacrylic acid, esters with alcohols, aliphatic, monohydric, unsaturated (C4-C18) 20680 Methacrylic acid, esters with alcohols, polyhydric (C2-C21) 20710 Methacrylic acid, esters with etheralcohols 20770 Methacrylic acid, esters with glycolethers obtained from mono- and/or diglycols with alcohols, aliphatic, monohydric (C1-C18) 20800 024493-59-2 Methacrylic acid, ester with methoxytriethyleneglycol 20860 Methacrylic acid, ester with trimethylethanolammonium chloride 21160 Methacrylic acid, monoester with 1,3-butanediol 21310 003683-12-3 Methacrylic acid, phenylethyl ester 21580 003644-11-9 N-(Methoxymethyl)acrylamide 21610 003644-12-0 N-(Methoxymethyl)methacrylamide 21700 000513-35-9 2-Methyl-2-butene 21790 000110-26-9 Methylenebiscarylamide 21820 013093-19-1 Methylenebiscaprolactam 21910 000814-78-8 Methyl isopropenyl ketone 22000 001118-58-7 2-Methyl-1,3-pentadiene 22030 001115-08-8 3-Methyl-1,4-pentadiene 22060 000926-56-7 4-Methyl-1,3-pentadiene 22090 000763-29-1 2-Methyl-1-pentene 22120 000760-20-3 3-Methyl-1-pentene 22180 004461-48-7 4-Methyl-2-pentene 22300 000078-94-4 Methyl vinyl ketone 22330 001822-74-8 Methyl vinyl thioether 22510 027215-95-8 Nonene 22580 000930-02-9 Octadecyl vinyl ether 22630 025377-83-7 Octene (except 1-octene) 22750 000929-62-4 Octyl vinyl ether 22810 000504-60-9 1,3-Pentadiene 22930 Perfluoroalkyl(C1-C3)vinyl ethers 22990 Phenols, mono- and dihydric, alkoxylated or hydrogenated 23020 028994-41-4 alpha-Phenyl-o-cresol 23080 001079-21-6 Phenylhydroquinone 23110 058244-28-3 Phenylhydroquinone diacetate 23260 000088-95-9 o-Phthalic acid dichloride 23290 Phthalic acids, halogenated derivatives 23320 Phthalic acids, hydrogenated 23350 Phthalic acids, hydrogenated, substituted, endosubstituted, and their halogenated derivatives 23410 Phthalic anhydride, hydrogenated 23440 000111-16-0 Pimelic acid 23560 Polyethers based on ethylene oxide, propylene oxide and/or tetrahydrofuran, containing free hydroxyl groups 23620 Polyols derived from phenols and bisphenols, hydrogenated and/or condensed with epoxyalkanes and/or arylepoxyalkanes possibly halogenated, alkoxylated, aryloxylated 23680 009002-89-5 Polyvinylalcohols 23710 063148-65-2 Polyvinylbutyrals 24040 000764-47-6 Propyl vinyl ether 24220 009006-03-5 Rubber, chlorinated 24310 000111-19-3 Sebacic acid, dichloride 24340 002432-89-5 Sebacic acid, didecyl ester 24400 002918-18-5 Sebacic acid, diphenyl ester 24640 Styrene, substituted by alkyl groups (alpha) 24670 Styrene, substituted in the benzene ring 24700 Styrene, substituted by halogens (alpha or beta) 24730 Styrene, substituted in the vinyl group 24790 000505-48-6 Suberic acid 25000 001539-04-4 Terephthalic acid, diphenyl ester 25060 000632-58-6 Tetrachlorophthalic acid 25330 000070-55-3 P-Toluenesulphonamide 25570 000067-48-1 Trimethylethanolammonium chloride 25660 019727-16-3 1,1,1-Trimethylolpropane dimethacrylate 25690 1,1,1-Trimethylolpropane maleates 25720 007024-08-0 1,1,1-Trimethylolpropane monoacrylate 25750 007024-09-1 1,1,1-Trimethylolpropane monomethacrylate 25870 000107-39-1 2,4,4-Trimethyl-1-pentene 25990 000689-97-4 Vinylacetylene 26020 001484-13-5 N-Vinylcarbazole 26080 Vinyl ethers of alcohols, aliphatic, monohydric, saturated (C2-C18)

ANNEX V

LIST OF MONOMERS AND OTHER STARTING SUBSTANCES IN SECTION B FOR WHICH THE CONTENT OF THE COLUMN 'RESTRICTIONS' IS MODIFIED

PM/Ref No CAS No Name Restrictions

(1) (2) (3) (4)

26140 000075-38-7 Vinylidene fluoride SML = ND (DL = 0,05 mg/kg)

ANNEX VI

LIST OF MONOMERS AND OTHER STARTING SUBSTANCES TRANSFERRED TO SECTION A

PM/Ref No CAS No Name Restrictions

(1) (2) (3) (4)

10630 000079-06-1 Acrylamide SML = ND (DL = 0,01 mg/kg) 12280 002035-75-8 Adipic anhydride 12670 002855-13-2 1-Amino-3-aminomethyl-3,5,5-trimethylcyclohexane SML = 6 mg/kg 12970 004196-95-6 Azelaic anhydride 15250 000110-60-1 1,4-Diaminobutane 18070 000108-55-4 Glutaric anhydride 18250 000115-28-6 Hexachloroendomethylenetetrahydrophthalic acid SML = ND (DL = 0,01 mg/kg) 18280 000115-27-5 Hexachloroendomethylenetetrahydrophthalic anhydride SML = ND (DL = 0,01 mg/kg) 18430 000116-15-4 Hexafluoropropylene SML = ND (DL = 0,01 mg/kg) 21190 000868-77-9 Methacrylic acid, monoester with ethyleneglycol 21940 000924-42-5 N-Methylolacrylamide SML = ND (DL = 0,01 mg/kg) 23200 000088-99-3 o-Phthalic acid 23230 000131-17-9 Phthalic acid, diallyl ester SML = ND (DL = 0,01 mg/kg) 24430 002561-88-8 Sebacic anhydride 24850 000108-30-5 Succinic anhydride