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Regulation 16(a) and (b)

SCHEDULE 2

PART ILIST OF ADDITIVES TO BE ADDED TO PART I OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS

ItemPM/REF No.CAS No.NameRestrictions and specifications
19A3516006642-31-56-Amino-1, 3-dimethyluracilSML = 5 mg/kg
19B3517000141-43-52-AminoethanolSML = 0.05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC and for indirect food contact only, behind the PET layer
19C3528400111-41-1N-(2-aminoethyl) ethanolamineSML = 0.05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC and for indirect food contact only, behind the PET layer
36E38840154862-43-8Bis(-2,4-dicumylphenyl) pentaerythritoldiphosphiteSML = 5 mg/kg (as sum of the substance itself, its oxidised form bis(2,4-dicumylphenyl) pentaerythritol-phosphate and its hydrolysis product (2,4-dicumylphenol)
38A39925129228-21-33,3-Bis(methoxymethyl)-2,5-dimethyl hexaneSML = 0.05 mg/kg
41A4112010043-52-4Calcium chloride
45A4184000105-60-2CaprolactamSML(T) = 15 mg/kg (5)
72B4721026427-07-6Dibutylthiostannoic acid polymer [= thiobis(butyl-tin sulphide), polymer]In compliance with the specifications laid down in Schedule 2B
73A4754027458-90-8Di-tert-dodecyl disulfideSML = 0.05 mg/kg
73D4862000123-31-91,4-DihydroxybenzeneSML = 0.6 mg/kg
73E4872000611-99-44,4'-DihydroxybenzophenoneSML(T) = 6 mg/kg (14)
77A5264510436-08-5Cis-11-eicosenamide
164A6480000110-16-7Maleic acidSML(T) = 30 mg/kg (4)
167A6592066822-60-4[N-methacryloyloxyethyl-N,N-dimethyl-N-carboxymethyl-ammonium chloride, sodium salt-octadecyl methacrylate-ethyl methacrylate-cyclohexyl methacrylate-N-vinyl-2-pyrrolidone, copolymers
191A73160Phosphoric acid, mono-and di-n-alkyl (C16 and C18) estersSML = 0.05 mg/kg
195B76730Polydimethylsiloxane, gamma-hydroxypropylatedSML = 6 mg/kg
240B8568001343-98-2Silicic acid
271A9215001401-55-4Tannic acidsAccording to the JECFA specifications
279A9327000108-78-12,4,6-Triamino-1,3, 5-triazineSML = 30 mg/kg
281A95270161717-32-42,4,6-Tris(tert-butyl) phenyl 2-butyl-2-ethyl-1, 3-propanediol phosphiteSML = 2 mg/kg (as sum of phosphite, phosphate and the hydrolysis product = TTBP)

PART IILIST OF ADDITIVES FOR WHICH THE ENTRY CONTAINED IN THE FIRST COLUMN (ITEM) OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS IS TO BE AMENDED

ItemName
36FBis(3-4-dimethylbenzylidene)sorbitol
38BBis(polyethyleneglycol)hydroxymethyl-phosphonate
73BDiethyleneglycol
73C1,1-Difluoroethane
73F2,4-Dimethyl-6-(1-methylpentadecyl)phenol
191BPhosphoric acid, trichloroethyl ester
195CPolyesters of 1,2-propanediol and/or 1,3-and/or polypropyleneglycol with adipic acid, also end-capped with acetic acid or fatty acids C10-C18 or n-octanol and/or n-decanol
208BPoly (zinc glycerolate)
240CSilicic acid, lithium, magnesium, sodium salt
281BVermiculite, reaction product with citric acid, lithium salt
281CWater
281DWaxes, refined, derived from petroleum based or synthetic hydrocarbon feed stocks
281EWhite mineral oils, paraffinic, derived from petroleum based hydrocarbon feed stocks

PART IIILIST OF ADDITIVES FOR WHICH THE ENTRY CONTAINED IN COLUMN 4 (RESTRICTIONS AND SPECIFICATIONS) OF PART I OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS IS TO BE AMENDED

NameRestrictions and specifications
Bis(polyethylenelycol)hydroxymethyl-phosphonateSML = 0.6 mg/kg. Authorised until 1st January 2004
Copper iodideSML(T) = 30 mg/kg (7) (expressed as copper) and the specific migration of this substance shall not exceed 1 mg/kg (10) (expressed as iodine)
2'-(2-Hydroxy-3,5'-di-tert-butylphenyl)-5-chlorobenzotriazoleSML(T) = 30 mg/kg (18)

PART IVPROVISIONS INSERTED AFTER PART I OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS

PART II:INCOMPLETE LIST OF ADDITIVES USED IN THE MANUFACTURE OF PLASTIC MATERIALS AND ARTICLES (BEING ADDITIVES TO WHICH PARAGRAPH 5 OF PART III OF THIS SCHEDULE APPLIES)

ItemPM/REF No. CAS No. NameRestrictions and specifications
13018002180-18-9Acetic acid, manganese saltSML(T) = 0.6 mg/kg (9) (expressed as manganese)
23152061167-58-6Acrylic acid, 2-tert-butyl-6-(3-tert-butyl-2-hydroxy-5- methylbenzyl)-4-methylphenyl esterSML = 6 mg/kg
33192000103-23-1Adipic acid, bis(2-ethyllhexyl) esterSML = 18 mg/kg (1)
434230Alkyl(C8-C22)sulphonic acidsSML = 6 mg/kg
53576001309-64-4Antimony trioxideSML = 0.02 mg/kg (expressed as anti-monium and analytical tolerance included)
63672017194-00-2Barium hydroxideSML(T) = 1 mg/kg (11) (expressed as barium)
73680010022-31-8Barium nitrateSML(T) = 1 mg/kg (11) (expressed as barium)
83824000119-61-9BenzophenoneSML = 0.6 mg/kg
93856007128-64-52,5-Bis(5-tert-butyl-2-benzoxazolyl)thiopheneSML = 0.6 mg/kg
103870063397-60-4Bis(2-carbobutoxyethyl)tin-bis(isooctylmercaptoacetate)SML = 18 mg/kg
113880032687-78-8N,N'-Bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionyl)hydrazideSML = 15 mg/kg
123882026741-53-7Bis(2,4-di-tert-butylphenyl) pentaery-thritol diphosphiteSML = 0.6 mg/kg
133906035958-30-61,1-Bis(2-hydroxy-3,5-di-tert-butylphenyl)ethaneSML = 5 mg/kg
1439090N,N-bis(2-hydroxyethyl)alkyl (C8-C18)amineSML(T) = 1.2 mg/kg (12)
1539120N,N-bis(2-hydroxyethyl)alkyl (C8-C18)amine hydrochloridesSML(T) = 1.2 mg/kg (12) (expressed as N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amine)
164000000991-84-42,4-Bis(octylmercapto)-6-(4-hydroxy-3,5-di-tert-butylanilino)-1,3,5-triazineSML = 30 mg/kg
1740020110553-27-02,4-Bis(octylthiomethyl)-6-methylphenolSML = 6 mg/kg
184016061269-61-2N,N'-bis(2,2,6,6-tetramethyl-4-piperidyl)hexamethylenediamine-1,2-dibromoethane, copolymerSML = 2.4 mg/kg
194080013003-12-84,4'-Butylidene-bis(6-tert-butyl-3-methylphenyl-ditridecyl phosphite)SML = 6 mg/kg
204098019664-95-0Butyric acid, manganese saltSML(T) = 0.6 mg/kg (9) (expressed as manganese)
214200063438-80-2(2-Carbobutoxyethyl)tin-tris (isooctylmercaptoacetate)SML = 30 mg/kg
224240010377-37-4Carbonic acid, lithium saltSML(T) = 0.6 mg/kg (8) (expressed as lithium)
234248000584-09-8Carbonic acid, rubidium saltSML = 12 mg/kg
244360004080-31-31-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chlorideSML = 0.3 mg/kg
254368000075-45-6ChlorodifluoromethaneSML = 6 mg/kg and in compliance with the specifications laid down in Schedule 2B
264496011104-61-3Cobalt oxideSML(T) = 0.05 mg/kg (13) (expressed as cobalt)
2745440Cresols, butylated, styrenatedSML = 12 mg/kg
284672004130-42-12,6-Di-tert-butyl-4-ethylphenolQMA = 4.8 mg/6 dm2
294760084030-61-5Di-n-dodecyltin bis (isooctyl mercaptoacetate)SML = 12 mg/kg
304864000131-56-62,4-DihydroxybenzophenoneSML(T) = 6 mg/kg (14)
314880000097-23-42,2'-Dihydroxy-5,5'-dichlorodiphenylmethaneSML = 12 mg/kg
324888000131-53-32,2'-Dihydroxy-4-methoxybenzophenoneSML(T) = 6 mg/kg (14)
334960026636-01-1Dimethyltin bis(isooctyl mercaptoacetate)SML(T) 0.18 mg/kg (15) (expressed as tin)
344984002500-88-1Dioctadecyl disulphideSML = 3 mg/kg
3550160Di-n-octylin bis(n-alkyl(C10-C16) mercapto acetate)SML(T) = 0.04 mg/kg (16) (expressed as tin)
365024010039-33-5Di-n-octyltin bis(2-ethyllhexyl maleate)SML(T) = 0.04 mg/kg (16) (expressed as tin)
375032015571-58-1Di-n-octyltin bis(2-ethylhexyl mercaptoacetate)SML(T) = 0.04 mg/kg (16) (expressed as tin)
3850360Di-n-octyltin bis(ethyl maleate)SML(T) = 0.04 mg/kg (16) (expressed as tin)
395040033568-99-9Di-n-octyltin bis(isooctyl maleate)SML(T) = 0.04 mg/kg (16) (expressed as tin)
405048026401-97-8Di-n-octyltin bis(isooctyl mercaptoacetate)SML(T) = 0.04 mg/kg (16) (expressed as tin)
4150560Di-n-octyltin 1,4-butanediol bis (mercaptoacetate)SML(T) = 0.04 mg/kg (16) (expressed as tin)
425064003648-18-8Di-n-octyltin dilaurateSML(T) = 0.04 mg/kg (16) (expressed as tin)
435072015571-60-5Di-n-octyltin dimaleateSML(T) = 0.04 mg/kg (16) (expressed as tin)
465096069226-44-4Di-n-octyltin ethyleneglycol bis (mercaptoacetate)SML(T) = 0.04 mg/kg (16) (expressed as tin)
475104015535-79-2Di-n-octyltin mercaptoacetateSML(T) = 0.04 mg/kg (16) (expressed as tin)
4851120Di-n-octyltin thiobenzoate 2-ethyl-hexyl mercaptoacetateSML(T) = 0.04 mg/kg (16) (expressed as tin)
495157000127-63-9Diphenyl sulphoneSML = 3 mg/kg
505168000102-08-9N,N'-diphenylthioureaSML = 3 mg/kg
515200027176-87-0Dodecylbenzenesulphonic acidSML = 30 mg/kg
525232052047-59-32-(4-Dodecylphenyl)indoleSML = 0.06 mg/kg
535288023676-09-74-Ethoxybenzoic acid, ethyl esterSML = 3.6 mg/kg
545320023949-66-82-Ethoxy-2'-ethyloxanilideSML = 30 mg/kg
555896000057-09-0Hexadecyltrimethylammonium bromideSML = 6 mg/kg
565912023128-74-71,6-Hexamethylene-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionamide)SML = 45 mg/kg
575920035074-77-21,6-Hexamethylene-bis(3-(3, 5-di-tert-butyl-4-hydroxyphenyl) propionate)SML = 6 mg/kg
586032070321-86-72-(2-Hydroxy-3,5-bis(1,1-dimethylbenzyl)phenyl) benzotriazoleSML = 1.5 mg/kg
596040003896-11-52-(2'-Hydroxy-3'-tert-butyl-5'-methylphenyl)-5-chlorobenzotriazoleSML(T) = 30 mg/kg (18)
606080065447-77-01-(2-Hydroxyethyl)-4-hydroxy-2,2,6,6-tetramethyl, piperidine-succinic acid, dimethyl ester, copolymerSML = 30 mg/kg
616128003293-97-82-Hydroxy-4-n-hexyloxybenzophenoneSML(T) = 6 mg/kg (14)
626136000131-57-72-Hydroxy-4-methoxybenzophenoneSML(T) = 6 mg/kg (14)
636144002440-22-42-(2-Hydroxy-5-methylphenyl) benzotriazoleSML(T) = 30 mg/kg (18)
646160001843-05-62-Hydroxy-4-n-octyloxybenzophenoneSML(T) = 6 mg/kg (14)
656320051877-53-3Lactic acid, manganese saltSML(T) = 0.6 mg/kg (9) (expressed as manganese)
666432010377-51-2Lithium iodideSML(T) = 1 mg/kg (10) (expressed as iodium) and SML(T) = 0.6 mg/kg (8) (expressed as lithium)
676512007773-01-5Manganese chlorideSML(T) = 0.6 mg/kg (9) (expressed as manganese)
686520012626-88-9Manganese hydroxideSML(T) = 0.6 mg/kg (9) (expressed as manganese)
696528010043-84-2Manganese hypophosphiteSML(T) = 0.6 mg/kg (9) (expressed as manganese)
706536011129-60-5Manganese oxideSML(T) = 0.6 mg/kg (9) (expressed as manganese)
7165440Manganese pyrophosphiteSML(T) = 0.6 mg/kg (9) (expressed as manganese)
726636085209-91-22-2'-Methylene bis(4,6-di-tert-butylphenyl)sodium phosphateSML = 5 mg/kg
736640000088-24-42-2'-Methylenebis(4-ethyl-6-tert-butylphenol)SML(T) = 1.5 mg/kg (19)
746648000119-47-12-2'-Methylenebis(4-methyl-6-tert -butylphenol)SML(T) = 1.5 mg/kg (19)
756736067649-65-4Mono-n-dodecyltin tris(isooctyl mercaptoacetate)SML = 24 mg/kg
766752054849-38-6Monomethyltin tris(isooctyl mercaptoacetate)SML(T) = 0.18 mg/kg (15) (expressed as tin)
7767600Mono-n-octyltin tris(alkyl(C10-C16)-mercaptoacetate)SML(T) = 1.2 mg/kg (17) (expressed as tin)
786768027107-89-7Mono-n-octyltin tris(2-ethylhexyl mercaptoacetate)SML(T) = 1.2 mg/kg (17) (expressed as tin)
796776026401-86-5Mono-n-octyltin tris(isooctyl mercaptoacetate)SML(T) = 1.2 mg/kg (17) (expressed as tin)
806807827253-31-2Neodecanoic acid, cobalt saltSML(T) = 0.05 mg/kg (expressed as neodecanoic acid) and SML(T) = 0.05 mg/kg (13) (expressed as cobalt). Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC
816832002082-79-3Octadecyl 3-(3,5-di-tert-butyl-4-hydroxylphenyl)propionateSML = 6 mg/kg
826840010094-45-8OctadecylerucamideSML = 5 mg/kg
836984016260-09-6OleylpalmitamideSML = 5 mg/kg
847216000948-65-22-PhenylindoleSML = 15 mg/kg
857280001241-94-7Phosphoric acid, diphenyl 2-ethylhexyl esterSML = 2.4 mg/kg
867304013763-32-1Phosphoric acid, lithium saltsSML(T) = 0.6 mg/kg (8) (expressed as lithium)
877312010124-54-6Phosphoric acid, manganese saltSML(T) = 0.6 mg/kg (9) (expressed as manganese)
8874400Phosphorous acid, tris(nonyl-and /or dimonylphenyl) esterSML = 30 mg/kg
8977440Polyethyleneglycol diricinoleateSML = 42 mg/kg
907752061791-12-6Polyethyleneglycol ester of castor oilSML = 42 mg/kg
917832009004-97-1Polyethyleneglycol monoricinoleateSML = 42 mg/kg
928120071878-19-8Poly[6-[(1,1,3,3-tetramethylbutyl) amino]-1,3,5-triazine-2,4-diyl]-[(2,2,6,6-tetramethyl-4-piperidyl)-imino]hexamethylene[(2,2,6,6-tetramethyl-4-piperidyl)limino]SML = 3 mg/kg
938168007681-11-0Potassium iodideSML(T) = 1 mg/kg (10) (expressed as iodium)
948202019019-51-3Propionic acid, cobalt saltSML(T) = 0.05 mg/kg (13) (expressed as cobalt)
9583595119345-01-6Reaction product of di-tert-butylphosphonite with biphenyl, obtained by condensation of 2, 4-di-tert-butylphenol with friedel craft reaction product of phosphorus trichloride and biphenylSML = 18 mg/kg and in compliance with the specifications in Schedule 2B
968370000141-22-0Ricinoleic acidSML = 42 mg/kg
978480000087-18-3Salicylic acid, 4-tert-butylphenyl esterSML = 12 mg/kg
988488000119-36-8Salicylic acid, methyl esterSML = 30 mg/kg
998576012068-40-5Silicic acid, lithium aluminium salt (2:1:1)SML(T) = 0.6 mg/kg (8) (expressed as lithium)
1008592012627-14-4Silicic acid, lithium saltSML(T) = 0.6 mg/kg (8) (expressed as lithium)
1018680007681-82-5Sodium iodideSML(T) = 1 mg/kg (10) (expressed as iodium)
10286880Sodium monoalkyl dialkylphenoxybenzenedi-sulphonateSML = 9 mg/kg
1038917013586-84-0Stearic acid, cobalt saltSML(T) = 0.05 mg/kg (13) (expressed as cobalt)
1049200007727-43-7Sulphuric acid, barium saltSML(T) = 1 mg/kg (11) (expressed as barium)
10592320Tetradecyl-polyethyleneglycol (EO = 3-8) ether of glycolic acidSML = 15 mg/kg
1069256038613-77-3Tetrakis(2,4-di-tert-butyl-phenyl)-4-4'-biphenylylene diphosphoniteSML = 18 mg/kg
1079280000096-69-54,4'-Thiobis(6-tert-butyl-3-methylphenol)SML = 0.48 mg/kg
1089288041484-35-9Thiodiethanol bis(3-(3-5-di-tert-butyl-4-hydroxyphenyl)propionate)SML = 2.4 mg/kg
1099312000123-28-4Thiodipropionic acid, didodecyl esterSML(T) = 5 mg/kg (20)
1109328000693-36-7Thiodipropionic acid, dioctadecyl esterSML(T) = 5 mg/kg (20)
1119456000122-20-3TriisopropanolamineSML = 5 mg/kg
1129528040601-76-11,3,5-Tris(4-tert-butyl-3-hydroxy-2,6-dimethylbenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trioneSML = 6 mg/kg
1149560001843-03-41,1,3-Tris(2-methyl-4-hydroxy-5-tert-butylphenyl)butaneSML = 5 mg/kg