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The Plastic Materials and Articles in Contact with Food Regulations (Northern Ireland) 2006

Status:

This is the original version (as it was originally made).

Regulations 4 and 6

SCHEDULE 1

PART 1List of Monomers with Restrictions and Specifications

1

PM/REF No

2

CAS No

3

Name

4

Restrictions and specifications

110030000514-10-3Abietic acid
21006000075-07-0AcetaldehydeSML(T) = 6mg/kg (2)
310090000064-19-7Acetic acid
410120000108-05-4Acetic acid, vinyl esterThe specific migration of this substance shall not exceed 12mg/kg
510150000108-24-7Acetic anhydride
610210000074-86-2Acetylene
6A10599/90A061788-89-4Acids, fatty, unsaturated (C18), dimers, distilledQMA(T) = 0.05 mg/6 dm2 (27)
6B10599/91061788-89-4Acids, fatty, unsaturated (C18), dimers, non distilled

QMA(T) = 0.05

Mg/6 dm2 (27)

6C10599/92A068783-41-5Acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled

QMA(T) = 0.05

Mg/6 dm2 (27)

6D10599/93068783-41-5Acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled

QMA(T) = 0.05

mg/6 dm2 (27)

710630000079-06-1AcrylamideThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg)
810660015214-89-82-Acrylamido-2-methylpropane sulphonic acidThe specific migration of this substance shall not exceed 0.05 mg/kg
910690000079-10-7Acrylic acid
1010750002495-35-4Acrylic acid. benzyl ester
1110780000141-32-2Acrylic acid, n-butyl ester
1210810002998-08-5Acrylic acid, sec-butyl ester
1310840001663-39-4Acrylic acid, tert-butyl ester
13A11000050976-02-8Acrylic acid, discyclopentaidien-yl esterThe quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 m2
13B11245002156-97-0Acrylic acid, dodecyl esterThe specific migration of this substance shall not exceed 0.05 mg/kg (1)
1411470000140-88-5Acrylic acid, ethyl ester
15As item 19000818-61-1Acrylic acid, hydroxethyl ester
15A1153000999-61-1Acrylic acid, 2-hydroxypropyl esterQMA = 0.05 mg/6 dm2 for the sum of acrylic acid, 2-hydroxypropoyl ester and acrylic acid, 2-hydroxyisopropyl ester and in compliance with the specifications laid down in Schedule 4
1611590000106-63-8Acrylic acid, asobutyl ester
1711680000689-12-3Acrylic acid, isopropyl ester
1811710000096-33-3Acrylic acid, methyl ester
1911830000818-61-1Acrylic acid, monoester with ethylene gylcol
2011890002499-59-4Acrylic acid, n-octyl ester
2111980000925-60-0Acrylic acid, propyl ester
2212100000104-13-1AcrylonitrileThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included)
2312130000124-04-9Adipic acid
23A12265004074-90-2Adipic acid, divinyl esterThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg. For use only as comonomer
2412280002035-75-8Adipic anhydride
2512310Albumin
2612340Albumin, coagulated by formaldehyde
2712375Alcohols, aliphatic, monohydric, saturated, linear, primary (C4 – C22)
2812670002855-13-21-Amino-3-aminomethyl-3, 5, 5-trimethylcyclohexaneThe specific migration of this substance shall not exceed 6 mg/kg
28A12761000693-57-212-Aminododecanoic acidThe specific migration of this substance shall not exceed 0.05 mg/kg
28B1276300141-43-52-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
28C12765844354-12-8N-(2-amionoethyl)-beta-alanine, sodium saltSML – 0.05 mg/kg]
2912788002432-99-711-Aminoundecanoic acidThe specific migration of this substance shall not exceed 5mg/kg
3012789007664-41-7Ammonia
3112820000123-99-9Azelaic acid
3212970004196-95-6Azelaic anhydride
3313000001477-55-01,3-Benzenedi-methanamineThe specific migration of this substance shall not exceed 0.05 mg/kg
33A13060004422-95-11,3,5-Benzenetricarbo-xylic acid trichlorideThe quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 m2 (measured as 1,3,5- benzenetricarboxylic acid)
33B1307500091-76-9Benzoguanamine(see “2,4-Diamino-6- Phenyl-1,3,5- Triazine”
3413090000065-85-0Benzoic acid
3513150000100-51-6Benzyl alcohol
35A13180000498-66-8Bicyclo [2.2.1] hept-2-ene (= norbornene)The specific migration of this substance shall not exceed 0.05 mg/kg
35B13210001761-71-3Bis (4-aminocyclohexyl) methaneThe specific migration of this substance shall not exceed 0.05 mg/kg
36As item 79000111-46-6Bis (2-hydroxyethyl) etherAs item 79
37As item 217000077-99-62,2-Bis (hydroxymethylbutan-1-ol)As item 217
37A13323000102-40-91,3-Bis (2-hydroxyethoxy) benzeneSML = 0.05 mg/kg
3813390000105-08-81,4-Bis (hydroxymethyl) – cyclohexane
38A1339504767-03-72,2-Bis (hydroxymethyl) propionic acidQMA = 0.05 mg/6 dm2
3913480000080-05-72,2-Bis (4-hydroxyphenyl) propaneSML(T) = 0.6 mg/kg (28)
4013510001675-54-32,2-Bis (4-hydroxyphenyl) propane bis (2,3-epoxypropyl) etherUse must be in accordance with Regulation 1895/2005
4113530038103-06-92,2-Bis (4-hydroxyphenyl) propane bis (phthalic anhydride)The specific migration of this substance shall not exceed 0.05 mg/kg
42As item 93000110-98-5Bis (hydroxypropyl) ether
4313560005124-30-1Bis(4-isocyanatocyclohexyl) methaneAs item 78
4413600047465-97-43,3-Bis (3-methyl-4-hydroxyphenyl) – indolin-2-oneThe specific migration of this substance shall not exceed 1.8 mg/kg
45As item 39000080-05-7Bisphenol AAs item 39
46As item 40001675-54-3Bisphenol A bis (2,3-epoxypropyl) etherAs item 40
4713614038103-06-9Bisphenol A bis (phthalic anhydride)As item 41
47A1361700080-09-1Bisphenol SAs item 86A
47B1362010043-35-3Boric acidSML(T) – 6 mg/kg (22) (expressed as boron) without prejudice to the provisions of Directive 98/93/EC on water for human consumption
4813630000106-99-9ButadieneThe quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg or the specific migration of this substance shall not be detectable (when measured by a method with a limit of detection of 0.02mg/kg, analytical tolerance included)
4913690000107-88-01,3 Butandiol
49A1372000110-63-41,4-ButanediolSML(T) = 0.05 mg/kg (23)
49B13780002425-79-81,4-Butanediol bis 2,3-epoxypropyl) etherThe quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg (expressed as epoxy group, molecular weight equal to 43)
49C1381000505-65-71,4-Butanediol formalQMA = 0.05 mg/6dm2
5013840000071-36-3Butan-1-ol
5113870000106-98-9But-1-ene
5213900000107-01-7Bit-2-ene
52A1393200598-32-33-Buten-2-olQMA = ND (DL = 0.02 mg/6 dm2). To be used only as a co-monomer for the preparation of polymeric additive
52B14020000098-54-44-tert-ButylphenolThe specific migration of this substance shall not exceed 0.05 mg/kg
5314110000123-72-8Butyraldehyde
5414140000107-92-6Butyric acid
5514170000106-31-0Butyric acid anhydride
5614200000105-60-2CaprolactamSML(T) = 15 mg/kg (5)
5714230002123-24-2Caprolactam, sodium saltSML(T) = 15 mg/kg (5) (expressed as caprolactam)
5814320000124-07-2Caprylic acid
5914350000630-80-0Carbon monoxide
6014380000075-44-5Carbonyl chlorideThe quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg
6114411008001-79-4Caster oil
6214500009004-34-6Cellulose
6314530007782-50-5Chlorine
63A14650000079-38-9ChlorotrifluorethyleneQMA = 0.5 mg/6dm2
64As item 94000106-89-81-Chloro-2,3-epoxypropaneAs item 94
6514680000077-92-9Citric acid
6614710000108-39-4m-Cresol
6714740000095-48-7o-Cresol
6814770000106-44-5p-Cresol
68MA14800003724-65-0Crotonic acidQMA(T) = 0.05 mg/6 dm2/ (33)
68A14841000599-64-44-CumylphenolThe specific migration of this substance shall not exceed 0.05 mg/kg
69As item 38000105-08-81,4-Cyclohexanedimethanol
7014950003173-53-3Cyclohexyl isocyanateQM(T) = 1mg/kd in FP (expressed as NCO) (26)
70A1503000931-88-4CycloocteneSML = (0.05 mg/kg. For use only in polymers contacting foods for which simulant A is laid down in Council Directive 85/572/EEC
7115070001647-16-1Dec-1, 9-dieneThe specific migration of this substance shall not exceed 0.05 mg/kg
7215095000334-48-5Decanoic acid
7315100000112-30-1Decan-1-ol
73A15130000872-05-91-DeceneThe specific migration of this substance shall not exceed 0.05 mg/kg
7415250000110-60-11,4-Diaminobutane
75As item 97000107-15-31,2-DiaminoethaneAs item 97
76As item 116000124-09-41,6-DiaminohexaneAs item 116
76A1531000091-76-92,4-Diamino-6-phenyl-1,3,5-triazineQMA = 5 mg/62
7715565000106-46-71,4.-DichlorobenzeneThe specific migration of this substance shall not exceed 12 mg/kg
77A1561000080-07-94,4'-Dichlorodiphenyl sulphoneSML = 0.05 mg/kg
7815700005124-30-1Dicyclohexylmethane-4,4' – diisocyanateQM(T) = 1mg/kg (expressed as NCO (25)
7915760000111-46-6Diethylene glycolSML(T) = 30 mg/kg (3)
8015790000111-40-0DiethylenetriamineThe specific migration of this substance shall not exceed 5 mg/kg
8115820000345—92-64,4'-DifluorobenzophenoneThe specific migration of this substance shall not exceed 0.05 mg/kg
8215880000120-80-91,2-DihydroxybenzeneThe specific migration of this substance shall not exceed 6 mg/kg
8315910000108-46-31,3-DihydroxybenzeneThe specific migration of this shall not exceed 2.4 mg/kg
8415940000123-31-91,4-DihydroxybenzeneThe specific migration of this shall not exceed 0.6 mg/kg
8515970000611-99-44,4'-Dihydroxybenzophenone(SML(T) – 6 mg/kg (14)
8616000000092-88-64,4'-DihydroxybiphenylThe specific migration of this substance shall not exceed 6 mg/kg
86A1609000080-09-014,4'-Dihydroxydiphenyl sulphoneSML = 0.05 mg/kg
8716150000108-01-0DimethylaminoethanolThe specific migration of this substance shall not exceed 18 mg/kg
87A16210006864-37-53,3'-Dimethyl-4,4'-diaminodicyclohexyl methaneSML = 0.05 mg/kg (32). To be used only in polyamides
8816240000091-97-43,3'-Dimethyl-4,4'-diisocyanatobiphenylQM(T) = 1 mg/kg (expressed as NCO) (25)
88A16360000576-26-12,6-DimethylphenolThe specific migration of this substance shall not exceed 0.05 mg/kg
88B1639000126-30-72,2-Dimethyl-1,3-propanediolSML = 0.05 mg/kg
88C16450000646-06-01,3-DioxolaneThe specific migration of this substance shall not exceed 0.05 mg/kg
8916480000126-58-9Dipentaerythritol
89A16540000102-09-0Diphenyl carbonateSML = 0.05 mg/kg
9016570004128-73-8Diphenylether-4,4'-diisocyanateQM(T) = 1mg/kg (expressed as NCO) (25)
9116660005873-54-1Diphenylmethane-2,4'-diisocyanateQM(T) = 1 mg/kg (expressed as NCO) (25)
9216630000101-68-8Diphenylmethane-4,4'-diisocyanateQM(T) – 1 mg/kg (expressed as NCO) (25)
92A1665000127-63-9Diphenyl sulphoneSML(T) = 3 mg/kg (24)
9316660000110-98-5Dipropyleneglycol
93A1669001321-74-0DivinylbenzeneQMA = 0.01 mg/6 dm2 of SML = ND (DL = 0.02 mg/kg, analytical tolerance included) for the sum of divinylbenzene and ethylvinylbenzene and in compliance with the specifications laid down in Schedule 4
93B16694013811-50-2N,N'-Divinly-2-imidazolidinoneThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg
93C1669700693-23-2n-Dodecanedioic Acid
93D16704000112-41-41-DodeceneThe specific migration of this substance shall not exceed 0.05 mg/kg
9416750000106-89-8EpichlorohydrinThe quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg
9516780000064-17-5Ethanol
9616950000074-85-1Ethylene
9716960000107-15-3EthylenediamineThe specific migration of this substance shall not exceed 12 mg/kg
9816990000107-21-1Ethylene glycolSML(T) = 30 mg/kg (3)
9917005000151-56-4EthyleneimineThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg)
10017020000075-21-8Ethylene oxideThe quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg
1011705000104-76-72-Ethylhexan-1-olThe specific migration of this substance shall not exceed 30 mg/kg
101A17110016219-75-35-Ethylidenebicyclo[2,2,1] hept-2-eneQMA = 0.05 mg/6 dm2. The ratio surface/quantity of food shall be lower than 2 dm2/kg
10217160000097-53-0EugenolThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included)
10317170061688-47-4Fatty acids, coco
10417200068308-53-2Fatty acids, soya
10517230061790-12-3Fatty acids, tall oil
10617260000050-00-0FormaldehydeSML(T) = 15mg/kg (21)
10717290000110-17-8Fumaric acid
10817530000050-99-7Glucose
10918010000110-94-1Glutaric acid
11018070000108-55-4Glutaric anhydride
11118100000056-81-5Glycerol
111A18220068564-88-5N-Heptylaminound-ecanoic acidThe specific migration of this substance shall not exceed 0.05 mg/kg
11218250000115-28-6Hexachloroendomethylene-tetrahydrophthalic acidThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg)
11318280000115-27-5Hexachloroendomethylene-tetrahydrophthalic anhydrideThe specific migration of this substance shall not be detectable (when measured by a method with a limit of detection of 0.01 mg/kg)
11418310036653-82-4Hexadecan-1-ol
11518430000116-15-4HexafluoropropyleneThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg)
11618460000124-09-4HexamethylenediamineThe specific migration of this substance shall not exceed 2.4 mg/kg
11718640000822-06-0Hexamethylene diisocyanateQM(T) = 1 mg/kg (expressed as NCO) (25)
11818670000100-97-0HexamethylenetetramineSML(T) = 15 mg/kg (expressed as formaldehyde) (21)
118MA18700000629-11-81,6-HexanediolSML = 0.05 mg/kg
118A18820000592-41-61-HexeneThe specific migration of this substance shall not exceed 3 mg/kg
119As item 84000123-31-9HydroquinoneAs item 84
12018880000099-96-7p-Hydroxybenzoic acid
120ZA18896001679-51-24-(Hydroxymethyl)-1-cyclohexeneSML = 0.05 mg/kg
120A1889716712-64-46-Hydroxy-2-naphthalenecarboxylic acidSML = 0.05 mg/kg
120B18898000103-90-2N-(4-Hydroxyphenyl) acetamideSML = 0.05 mg/kg
12119000000115-11-7Isobutene
121A19060000109-53-5Isobutyl vinyl etherThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg
121B1911004098-71-91-Isocyanato-3-isocyanantomethyl-3,5,5-trimethylcyclohexaneQM(T) = 1 mg/kg (expressed as NCO (25)
121C19150000121-91-5Isophthalic acidThe specific migration of this substance shall not exceed 5 mg/kg
12219210001459-93-4Isophthalic acid, dimethyl esterThe specific migration of this substance shall not exceed 0.05 mg/kg
122A19243000780-79-5IsopreneAs item 145A
12319270000097-65-4Itaconic acid
12419460000050-21-5Lactic acid
12519470000143-07-7Lauric acid
12619480002146-71-6Lauric acid, vinyl ester
126A1949000947-04-6LaurolactamSML = 5 mg/kg
12719510011132-73-3Lignocellulose
12819540000110-16-7Maleic acidSML(T) = 30 mg/kg (4)
12919960000108-31-6Maleic anhydrideSML(T) = 30 mg/kg (4) (expressed as maleic acid)
130As item 215000108-78-1MelamineAs item 215
130A19990000079-39-0MethacrylamideThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included)
13120020000079-41-4Methacrylic acid
131A20050000096-05-9Methacrylic acid, allyl esterThe specific migration of this substance shall not exceed 0.05 mg/kg
13220080002495-37-6Methacrylic acid, benzyl ester
13320110000097-88-1Methacrylic acid, butyl ester
13420140002998-18-7Methacrylic acid, sec-butyl ester
13520170000585-07-9Methacrylic acid, tert-butyl ester
135A2026000101-43-9Methacrylic acid, cyclohexyl esterSML = 0.05 mg.kg
135B2041002082-81-7Methacrylic acid, diester with 1,4-butanediolSML = 0.05 mg/kg
135BM20440000097-90-5Methacrylic acid, diester with ethylenegycolSML = 0.05 mg/kg
135C20530002867-47-2Methacrylic acid, 2-(dimethylamino) ethyl esterThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included)
135D2059000106-91-2Methacrylic acid, 2,3-epoxypropyl esterQMA = 0.02 mg/6 dm2
13620890000097-63-2Methacrylic acid, ethyl ester
13721010000097-86-9Methacrylic acid, isobutyl ester
13821100004655-34-9Methacrylic acid, isopropyl ester
13921130000080-62-6Methacrylic acid, methyl ester
14021190000868-77-9Methacrylic acid, monoester with ethyleneglycol
14121280002177-70-0Methacrylic acid, phenyl ester
14221340002210-28-8Methacrylic acid, propyl ester
142A21400054276-35-6Methacrylic acid, sulphopropyl esterQMA = 0.05 mg/6 dm2
14321460000760-93-0Methacrylic anhydride
14421490000126-98-7MethacrylonitrileThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg., analytical tolerance included)
144A2152001561-92-8Methallylsulphonic acid, sodium saltSML = 5 mg/kg
14521550000067-56-1Methanol
145A2164000078-79-52-Methyl-1,3-butadiene

QM = 1 mg/kg in FP or SML = ND

(DL = 0.02 mg/kg, analytical tolerance included)

145B21730000563-45-13-Methyl-1-buteneThe quantity of this substance in the finished plastic material or article shall not exceed 0.006 mg/ 6 dm2. For use only in polypropylene
145C21765106246-33-74,4'-Methylenebis (3-chloro-2,6-diethylaniline)QMA = 0.05 mg/6dm2
145D2182100505-65-71,4-(Methylenedioxy) butaneAs item 49B
14621940000924-42-5N-MethylolacrylamideThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg)
14722150000691-37-24-Methyl-1-penteneSML = 0.05 mg/kg
147A22331025513-64-8Mixture of (35-45% w/w) 1,6-diamino-2,2,4-trimethylhexane and (55-65% w/w) 1,6-diamino-2,4,4-trimethylhexaneQMA = 5 mg/6 dm2
147B22332Mixture of (40% w/w) 2,,2,4-trimethylhexane-1, 6-diisocyanate and (60% w/w) 2,4,4-trimethylhexane-1,6-diisocyanateQM(T) = 1 mg/kg (expressed as NCO (26)
14822350000544-63-8Myristic acid
148A2236001141-38-42,6- Naphthalenedicarboxylic acidSML = 5 mg/kg
14922390000840-65-32,6-Naphthalenedicarboxylic acid, dimethyl esterThe specific migration of this substance shall not exceed 0.05 mg/kg
15022420003173-72-61,5-Naphthalene diisocyanateQM(T) = 1 mg/kg (expressed as NCO) (25)
150A2243700126-30-7NeopentylgycolAs item 88B
15122450009004-70-0Nitrocellulose
15222480000143-08-8Nonan-1-ol
152A22550000498-66-8NorborneneThe specific migration of this substance shall not exceed 0.05 mg/kg
15322570000112-96-9Octadecyl isocyanateQM(T) = 1mg/kg (expressed as NCO) (25)
15422600000111-87-5Octan-1-ol
15522660000111-66-0Oct-1-eneThe specific migration of this substance shall not exceed 15 mg/kg
15622763000112-80-1Oleic acid
156XA22775000144-62-7Oxalic acidSML(T) = 6 mg/kg (29)
156A2277807456-68-04,4'-Oxybis (benzenesulphonyl azideQMA = 0.05 mg/6 dm2
15722780000057-10-3Palmitic acid
15822840000115-77-5Pentaerythritol
15922870000071-41-0Pentan-1-ol
159A2290000109-67-11-PenteneSML = 5 mg/kg
159B22937001623-05-8Perfluoropropyl perfluorovinyl etherThe specific migration of this substance shall not exceed 0.05 mg/kg
16022960000108-95-2Phenol
16123050000108-45-21,3-PhenylenediamineSML = ND (DL = 0.02 mg/kg. Analytical tolerance included)
161A23070000102-39-6(1,3-Phenylenedioxy) diacetic acidQMA = 0.05 mg/6 dm2
162As item 60000075-44-5PhosgeneAs item 60
16323170007665-38-2Phosphoric acid
163A23175000122-52-1Phosphorous acid, triethyl esterThe quantity of this substance in the finished plastic material or article shall be not detectable (when measured by a method with a detection limit of 1 mg/kg
164As item 204Phthalic acidAs item 204
16523200000088-99-3o-Phthalic acid
16623230000131-17-9Phthalic acid, diallyl esterThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg)
16723380000085-44-9Phthalic anhydride
16823470000080-56-8Alpha-Pinene
16923500000127-91-3Beta-Pinene
169A23547

009016-00-6

063148-62-9

Polydimethylsiloxane (Mw >6800)In compliance with the specifications laid down in Schedule 4
17023590025322-68-3Polyethylene glycol
17123650025322-69-4Polypropylene glycol (molecular weight greater than 400)
17223651025322-69-4Polypropyleneglycol
17323740000057-55-6Propan-1,2-diol
173A23770000504-63-21,3-PropanediolThe specific migration of this substance shall not exceed 0.05 mg/kg
17423800000071-23-8Propan-1-ol
17523830000067-63-0Propan-2-ol
17623860000123-38-6Propionaldehyde
17723890000079-09-4Propionic acid
177A23920000105-38-4Propionic acid, vinyl esterSML(T) = 6 mg/kg (2) (expressed as acetaldehyde)
17823950000123-62-6Propionic anhydride
17923980000115-07-1Propylene
18024010000075-56-9Propylene oxideThe quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg
181As item 82000128-80-9PyrocatecholAs item 82
18224057000089-32-7Pyromellitic anhydrideThe specific migration of this substance shall not exceed 0.05 mg/kg (expressed as pyromellitic acid)
18324070073138-82-6Resin acids and rosin acids
184As item 83000108-46-3ResorcinolAs item 83
184A24073000101-90-6Resorcinol diglycidyl etherQMA = 0.005 mg/g dm2. 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
18524100008050-09-7Rosin
18624130008050-09-7Rosin gum
18724160008052-10-6Rosin tall oil
18824190065997-05-9Rosin wood
18924250009006-04-6Rubber, natural
19024270000069-72-7Salicylic acid
19124280000111-20-6Sebacic acid
19224430002561-88-8Sebacic anhydride
19324475001313-82-2Sodium sulphide
19424490000050-70-4Sorbitol
19524520008001-22-7Soybean oil
19624540009005-25-8Starch, edible
19724550000057-11-4Stearic acid
19824610000100-42-5Styrene
198A24760026914-43-2Styrenesulphonic acidThe specific migration of this substance shall not exceed 0.05 mg/kg
19924820000110-15-6Succinic acid
20024850000108-30-5Succinic anhydride
20124880000057-50-1Sucrose
20224887006362-79-45-Sulphoisophthalic acid, monosodium saltThe specific migration of this substance shall not exceed 5 mg/kg
20324888003965-55-75-Sulphoisophthalic acid, monosodium salt, dimethyl esterThe specific migration of this substance shall not exceed 0.05 mg/kg
20424910000100-21-0Terephthalic acidThe specific migration of this substance alone or together with item 205 shall not exceed a total of 7.5 mg/kg
20524940000100-20-9Terephthalic acid dichlorideThe specific migration of this substance along or together with item 204 shall not exceed 7.5 mg/kg (expressed as terephthalic acid)
20624970000120-61-6Terephthalic acid, dimethyl ester
206A25080001120-36-11-TetradeceneThe specific migration of this substance shall not exceed 0.05 mg/kg
20725090000112-60-7Tetraethylene glycol
20825120000116-14-3TetrafluoroethyleneThe specific migration of this substance shall not exceed 0.05 mg/kg
20925150000109-99-9TetrahydrofuranThe specific migration of this substance shall not exceed 0.6 mg/kg
21025180000102-60-3N,N,N'N'-Tetrakis (2-hydroxypropyl)- ethylenediamine
21125210000584-84-92,4-Toluene diisocyanate

QM(T) = 1 mg/kg

(expressed as NCO) (25)

21225240000091-08-72,6-Toluene diisocyanate

QM(T) = 1 mg/kg

(expressed as NCO) (25)

21325270026747-90-02,4-Toluene diisocyanate dimerQM(T) = 1 mg/kg (expressed as NCO) (25)
21425360Trialkyl (C5 -C15 ) acetic acid, 2,3-epoxypropyl esterThe quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg (expressed as epoxy group, molecular weight = 43)
214A25380Trialkyl acetic acid (C7 – C17), vinyl esters (= vinyl versatate)QMA = 0.05 mg/g dm2
214B25385000102-70-5TriallylamineIn compliance with the specifications laid down in Schedule 4
21525420000108-78-12,4,6-Triamino-1,3,5-triazineThe specific migration of this substance shall not exceed 30 mg/kg
215A2545026896-48-0Tricyclodecanedime-thanolSML = 0.05 mg/kg
21625510000112-27-6Triethylene glycol
21725600000077-99-61,1,1-TrimethylolpropaneThe specific migration of this substance shall not exceed 6 mg/kg
217A2584003290-92-41,1,1-trimethylolpropane trimethacrylateSML = 0.05 mg/kg
217B2590000110-88-3TrioxaneSML = 0.05 mg/kg
21825910024800-44-0Tripropylene glycol
218A25927027955-94-81,1,1-Tris (4-hydroxyphenyl) ethaneThe quantity of this substance in the finished plastic material or article shall not exceed 0.5 mg/kg. For use only in polycarbonates
21925960000057-13-6Urea
22026050000075-01-4Vinyl chlorideThe restrictions are those in regulation 6 (1) of the 2005 Regulations when analysed by the method referred to in regulation 7 of those Regulations
22126110000075-35-4Vinylidene chlorideThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg or the specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.05 mg/kg)
22226140000075-38-7Vinylidene fluorideThe specific migration of this substance shall not exceed 5 mg/kg
22326155001072-63-51-VinylimidazoleThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg
22426170003195-78-6N-Vinyl-N- methylacetamideThe quantity of this substance in the finished plastic material or article shall not exceed 2 mg/kg
22526320002768-02-7VinyltrimethoxysilaneThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg
22626360007732-18-5WaterIn compliance with Directive 98/83/EC on the quality of water intended for human consumption

PART 2Supplementary

1.  In regulation 4 and Part 1 of this Schedule—

(a)the PM/REF number. of any substance is its EEC packaging material reference number;

(b)the CAS number of any substance is its CAS (Chemical Abstracts Service) Registry Number;

(c)the name of any substance is its chemical name, and to the extent that there is any inconsistency between the CAS number and the name, the name shall take precedence over the CAS number; and

(d)references to specific migration are to be taken to mean specific migration as measured in accordance with Schedules 5 and 6.

2.  If a substance appearing in Part 1 of this Schedule as an individual compound also falls within a generic term which appears therein, any restriction applying to that substance shall be that indicated for the individual compound and the entry applying to the generic term shall be treated as varied to such extent as is necessary.

3.—(1) The items identified in Part 1 of this Schedule shall be taken to include—

(a)substances undergoing polymerisation (including polycondensation, polyaddition or any other similar process) to manufacture macromolecules;

(b)natural or synthetic macromolecular substances used in the manufacture of modified macromolecules, if the monomers required to synthesise them are not so identified; and

(c)substances used to modify existing natural or synthetic macromolecular substances.

(2) If a substance identified in Part 1 of this Schedule is an acid, a phenol or an alcohol and has salts (including double salts) of one or more of the following names (that is to say salts of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium or zinc) then any such salts shall be treated as included in the specification of that substance.

(3) If, as indicated in paragraph 2 of Annex II to the Directive, a substance is identified in Part 1 of this Schedule as an “… acid, salt” and has salts of one or more of the following names (that is to say salts of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium or zinc), then the free acid corresponding to that substance is not treated as included in the specification of that substance.

4.  Where an entry in column 4 of Part 1 of this Schedule (restrictions and specifications) includes a bracketed number, that entry shall be subject to a note relating to that number as follows, the following bracketed numbers corresponding with those appearing in that Part —

(1): Warning: there is a risk that the specific migration limit could be exceeded in fatty food simulants.

(2): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 10060 and 23920.

(3): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 15760, 16990, 47680, 53650 and 89440.

(4): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 19540, 19960 and 64800.

(5): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 14200, 14230 and 41840.

(14): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances of the substances having PM/REF Nos. 15970, 48640, 48720, 48880, 61280, 61360 and 61600.

(21): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 17260, 18670, 54880 and 59280].

(22): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF/Nos. 13620, 36840, 40320 and 87040.

(23): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF/Nos. 13720 and 40580.

(24): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF/Nos. 16650 and 51570.

(25): QM(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the substances having PM/REF/Nos. 14950, 15700, 16240, 16570, 16600, 16630, 18640, 19110, 22332, 22420, 22570, 25210, 25240 and 25270.

(27): QMA(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 10599/90A, 10599/91, 10599/92A and 10599/93.

(28): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 13480 and 39680.

(29): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 22775 and 69920.

(32): Compliance testing when there is a fat contact should be performed using isooctane as substitute of simulant D (unstable).

(33): QMA(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 14800 and 45600.

Regulations 5 and 7

SCHEDULE 2

PART 1Incomplete List of Additives Used in the Manufacture of Plastic Materials and Articles (not being Additives to which Paragraph 5 of Part 3 of this Schedule Applies)

Item

1

PM/REF No.

2

CAS No.

3

Name

4

Restrictions and specifications

130000000064-19-7Acetic acid
230045000123-86-4Acetic acid, butyl ester
2A30080004180-12-5Acetic acid, copper saltSML(T) = 30 mg/kg (7) (expressed as copper)
330140000141-78-6Acetic acid, ethyl ester
430280000108-24-7Acetic anhydride
530295000067-64-1Acetone
630370Acetylacetic acid, salts
730400Acetylated glycerides
7A30610Acids C2-C24 aliphatic, linear monocarboxylic, from natural oils and fats and their mono-, di- and triglycerol esters (branched fatty acids at naturally occurring levels are included)
7B30612Acids C2-C24 aliphatic linear, monocarboxylic, synthetic and their mono-, di- and triglycerol esters
830960Acids, aliphatic, monocarboxylic (C6-C22 ), esters with polyglycerol
931328Acids, fatty, from animal or vegetable foods fats and oils
9A31530123968-25-2Acrylic acid, 2,4-di-tert-pentyl-6[1(3,5-di-tert-pentyl-2- hydroxphenyl) ethyl] phenyl esterThe specific migration of this substance shall not exceed 5 mg/kg
1031730000124-04-9Adipic acid
1133120Alcohol's, aliphatic, monohydric, saturated, linear, primary (C4 -C24 )
1233350009005-32-7Algnic acid
12A33801n-Alkyl (C10 -C13) benzenesulphonic acidThe specific migration of this substance shall not exceed 30 mg/kg
1334281Alkyl (C8-C22 ) sulphuric acids, linear, primary, with an even number of carbon atoms
1434475Aluminium calcium hydroxide phosphite, hydrate
1534480Aluminium fibres, flakes and powders
1634560021645-51-2Aluminium hydroxide
1734690010978-59-9Aluminium magnesium carbonate hydroxide
1834720001344-28-1Aluminium oxide
18A34850143925-92-2Amines, bis (hydrogenated tallow alkyl) oxidised

QM = For use only:

(a)

in polyolefines at 0.1% (w/w) not in LDPE when it is in contact with foods for which Directive 85/572/EEC establishes a reduction factor less than 3;

(b)

in PET at 0.25% (w/w) in contact with foods other than those for which the simulant D is laid down in Directive 85/572/EEC SML = 0.05 mg/kg

18B34895000088-68-62-AminobenzamideTo be used only for PET for water and beverages
1935120013560-49-13-Aminocronic acid, diester with thiobis (2-hydroxyethyl) ether
19A35160006642-31-56-Amino-1,3-dimethyluracilSML = 5 mg/kg
19B35170000141-53-52-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
19C35284000111-41-1N-(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
2035320007664-41-7Ammonia
2135440012124-97-9Ammonium bromide
2235600001336-21-6Ammonium hydroxide
2335840000506-30-9Arachidic acid
2435845007771-44-0Arachidonic acid
2536000000050-81-7Ascorbic acid
2636080000137-66-6Ascorbyl palmitate
2736160010605-09-1Ascorbyl stearate
27B3684012007-55-5Barium tetraborateSML(T) = 1 mg/kg expressed as barium (11) and SML(T) = 6 mg/kg (22) (expressed as boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption
2836880008012-89-3Beeswax
2936960003061-75-4Behenamide
3037040000112-85-6Behenic acid
3137280001302-78-9Bentonite
31A37360000100-52-7Benzaldehyde(10)
3237600000065-85-0Benzoic acid
3337680000136-60-7Benzoic acid, butyl ester
3437840000093-89-0Benzoic acid, ethyl ester
3538080000093-58-3Benzoic acid, methyl ester
3638160002315-68-6Benzoic acid, propyl ester
36A38320005242-49-94-(2-benzoxazolyl)-4'- (5-methyl-2-benzoxazolyl) stilbeneIn compliance with the specifications laid down in Schedule 4
36B38510136504-96-61,2-Bis(3-aminopropyl) ethylenediamine, polymer with N-butyl-2,2,6,6-tetramethyl-4-piperidinamine and 2,4,6-trichloro-1,3,5-triazineThe specific migration of this substance shall not exceed 5 mg/kg
36C38515001533-45-54,4'-Bis(2-benzoxazolyl) stilbeneThe specific migration of this substance shall not exceed 0.05 mg/kg (1)
36D38810080693-00-1Bis(2,6-di-tert-butyl-4-methylphenyl) pentaerythritol diphosphiteThe specific migration of this substance shall not exceed 5 mg/kg (sum of phosphite and phosphate)
36E38840154862-43-8Bis(-2,4-dicumylphenyl) pentaerythritoldiphosphiteSML = 5 mg/kg (as sum of the substance itself, its oxidised form bis (2,4-dicumylphenyl) pen-taerythritol-phosphate and its hydrolysis product (2,4-dicumylphenol)
36F38879135861-56-2Bis (3,4-dimethylbenzylidene) sorbitol
3738950079072-96-1Bis(4-ethylbenzylidene) sorbitol
37A39200006200-40-4Bis (2-hydroxyethyl)-2-hydroxypropyl-3-(dodecyloxy) methylammonium chlorideThe specific migration of this substance shall not exceed 1.8 mg/kg
37AA39680000080-05-72,2-Bis(4-hydroxyphenyl) propaneSML(T) = 0.6 mg/kg (28)
37B39815182121-12-69,9-bis(methoxymethyl) fluoreneThe quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 dm2
3839890087826-41-3Bis(methylbenzylidene) sorbitol
069158-41-4“  “  “  “  “  “  “  “  “
054686-97-4“  “  “  “  “  “  “  “  “
081541-12-0“  “  “  “  “  “  “  “  “
38A39925129228-21-33,3-Bis (methoxymethyl)- 2,5-dimethyl hexaneSML = 0.05 mg./k
38B40120068951-50-8Bis(polyethyleneglycol) hydroxymethylphosphonateSML = 0.6 mg/kg
38C40320010043-35-3Boric acidSML(T) = 6 mg/kg (22) (expressed as boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption
3940400010043-11-5Boron nitride
4040570000106-97-8Butane
40A40580000110-63-41,4,-ButanediolSML(T) = 0.05 mg/kg (23)
4141040005743-36-2Calcium butyrate
41A41120010043-52-4Calcium chloride
4241280001305-62-0Calcium hydroxide
4341520001305-78-8Calcium oxide
4441600012004-14-7Calcium sulphoaluminate
037293-22-4“  “  “  “  “  “  “  “
44A41680000076-22-2Camphor(10)
45417600008006-44-8Candelilla wax
45A4184000105-60-2CaprolactamSML(T) = 15 mg/kg (5)
4641960000124-07-2Caprylic acid
4742160000124-38-9Carbon dioxide
47A42320007492-68-4Carbonic acid, copper saltSMT(L) = 30 mg/kg (7) (expressed as copper)
4842500Carbonic acid, salts
4942640009000-11-7Carboxymethylcellulose
5042720008015-86-9Carnauba wax
5142800009000-71-9Casein
51A42880008001-79-4Castor oil
5242960064147-40-6Castor oil, dehydrated
5343200Castor oil, mono- and diglycerides
5443280009004-34-6Cellulose
5543300009004-36-8Cellulose acetate butyrate
5643360068442-85-3Cellulose, regenerated
5743440008001-75-0Ceresin
57A43515Chlorides of choline esters of coconut oil fatty acidsThe quantity of this substance in the finished plastic material or article shall not exceed 0.9 mg/ 6 dm2
5844160000077-92-9Citric acid
5944640000077-93-0Citric acid, triethyl ester
59A45195007787-70-4Copper bromideSML(T) = 30 mg/kg (7) (expressed as copper)
59B45200001335-23-5Copper 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)
6045280Cotton fibres
60A45450068610-51-5p-Cresol-dicyclopentadiene- isobutylene, copolymerSML = 5 mg/kg
6145560014464-46-1Cristobalite
61A45600003724-65-0Crotonic acidQMA(T) = 0.05 mg/ 6 dm2(33)
61B45640005232-99-5

2-Cyano-3,

3-dipheneylacrylic acid, ethyl ester

SML = 0.05 mg/kg
6245760000108-91-8Cyclohexylamine
6345920009000-16-2Dammar
6445940000334-48-5n-Decanoic acid
6546070010016-20-3Alpha-Dextrin
6646080007585-39-9Beta-Dextrin
6746375061790-53-2Diatomaceous earth
6846380068855-54-9Diatomaceous earth. Soda ash flux-calcined
6946480032647-67-9Dibenzylidene sorbitol
69A46700

5,7-di-tert-Butyl-3- (3,4- and 2,3 –dimethylphenyl)-3H-benzofuran-2-one containing:

(a)

5,7-di-tert-butyl-3-(3,4-dimethylphenyl)-3H-benzofuran-2-one (80-100% w/w); and

(b)

5,7-di-tert-butyl-3-(2,3-dimethylphenyl)-3H-benzofuran-2-one (0-20% w/w)

SML = 5 mg/kg
69B46720004130-42-12,6-Di-tert-butyl-4-ethylphenolQMA = 4.8 mg/ 6 dm2
7046790004221-80-13,5-Di-tert-butyl-4-hydroxybenzoic acid, 2,4-di-tert-butylphenyl ester
7146800067845-93-63,5-Di-tert-butyl-4-hydroxybenzoic acid, hexadecyl ester
7246870003135-18-03,5-Di-tert-butyl-4-hydroxybenzylphosphonic acid, dioctadecyl ester
72A46880065140-91-23,5-Di-tert-butyl-4-hydroxybenzyl phosphonic acid, moneothyl ester, calcium saltThe specific migration of this substance shall not exceed 6 mg/kg
72B4721026427-07-6Dibutylthiostannoic acid polymer [= thiobis(butyl-tin sulphide), polymer]In compliance with this specifications laid down in Schedule 4
7347440000461-58-5Dicyanodiamide
73A47540027458-90-8Di-tert-dodecyl disulfideSML – 0.05 mg/kg
73B47680000111-46-6DiethyleneglycolSML(T) = 30 mg/kg (3)
73C48460000075-37-61,1-Difluoroethane]
73D48620000123-31-91,4-DihydroxybenzeneSML = 0.6 mg/kg
73E48720000611-99-44,4'DihydroxybenzophenoneSML(T) = 6 mg/kg (14)
73F49485134701-20-52,4-Dimethyl-6-(1-methylpentadecyl) phenolThe specific migration of this substance shall not exceed 1 mg/kg
7449540000067-68-5Dimethyl sulphoxide
7551200000126-58-9Dipentaerythritol
75A51700147315-50-22-(4,6-Diphenyl-1,3,5-triazin-2-yl)-5- (hexyloxy) phenolThe specific migration of this substance shall not exceed 0.05 mg/kg
7651760025265-71-8Dipropyleneglycol
000110-98-5“  “  “  “  “  “
7752640016389-88-1Dolomite
77A52645010436-08-5Cis-11-eicosenamide
7852720000112-84-5Erucamide
7952730000112-86-7Erucic acid
8052800000064-17-5Ethanol
8153270037205-99-5Ethylcarboxymethylcellulose
8253280009004-57-3Ethylcellulose
8353360000110-31-6N,N'-Ethylenebisoleamide
8453440005518-18-3N,N'-Ethylenebispalmitamide
8553520000110-30-5N,N'-Ethylenebisstearamide
8653600000060-00-4Ethylenediaminetetraacetic acid
86A53610054453-03-1Ethylenediaminetetraacetic acid, copper saltSML(T) = 30 mg/kg (7) (expressed as copper) (3)
86B53650000107-21-1EthyleneglycolSML(T) = 30 mg/kg
8754005005136-44-7Ethylene-N-palmitamide-N'- stearamide
8854260009004-58-4Ethylhydroxyethylcellulose
8954270Ethylhydroxymethylcellulose
9054280Ethylhydroxypropylcellulose
90A54300118337-09-02,2'-Ethylidenebis (4,6-di-tert-butylphenyl) fluorophosphoniteThe specific migration of this substance shall not exceed 6 mg/kg
9154450Fats and oils, from animal or vegetable food sources
9254480Fats and oils, hydrogenated, from animal or vegetable food sources
92A54930025359-91-5Formaldehyde-1-naphthol, copolymer [ = Poly (1-hydroxynaphthyl-methane)]The specific migration of this substance shall not exceed 0.05 mg/kg
9355040000064-18-6Formic acid
9455120000110-17-8Fumaric acid
9555190029204-02-2Gadoleic acid
9655440009000-70-8Gelatine
9755520Glass fibres
9855600Glass microballs
9955680000110-94-1Glutaric acid
10055920000056-81-5Glycerol
10156020099880-64-5Glycerol dibehenate
10256360Glycerol, esters with acetic acid
10356486Glycerol, esters with acids, aliphatic, saturated, linear, with an even number of carbon atoms C14-C18) and with acids, aliphatic, unsaturated, linear, with even number of carbon atoms (C16-C18)
10456487Glycerol, esters with butyric acid
10556490Glycerol, esters with erucic acid
10656495Glycerol, esters with 12-hydroxystearic acid
10756500Glycerol, esters with lauric acid
10856510Glycerol, esters with linoleic acid
10956520Glycerol, esters with myristic acid
109A56535Glycerol, esters with nonanoic acid
11056540Glycerol, esters with oleic acid
11156550Glycerol, esters with palmitic acid
11356570Glycerol, esters with propionic acid
11456580Glycerol, esters with ricinoleic acid
11556585Glycerol, esters with stearic acid
11656610030233-64-8Glycerol monobehenate
11756720026402-23-3Glycerol monohexanoate
11856800030899-62-8Glycerol monolaurate diacetate
11956880026402-26-6Glycerol monooctanoate
12057040Glycerol monooleate, ester with ascorbic acid
12157120Glycerol monooleate, ester with citric acid
12257200Glycerol monopalmitate, ester with ascorbic acid
12352780Glycerol monopalmitate, ester with citric acid
12457600Glycerol monostearate, ester with ascorbic acid
12557680Glycerol monostearate, ester with citric acid
125A57800018641-57-1Glycerol tribehenate
12657920000620-67-7Glycerol triheptanoate
12758300Glycine, salts
12858320007782-42-5Graphite
12958400009000-30-0Guar gum
13058480009000-01-5Gum arabic
13158720000111-14-8Heptanoic acid
131A59280000100-97-0HexamethylenetetramineSML(T) = 15 mg/kg (21) (expressed as Formaldehyde)
13259360000142-62-1Hexanoic acid
13359760019569-21-2Huntite
13459990007647-01-0Hydrochloric acid
13560030012072-90-1Hydromagnesite
13660080012304-65-3Hydrotalcite
13760160000120-47-84-Hydroxybenzoic acid, ethyl ester
13860180004191-73-54-Hydroxybenzoic acid, isopropyl ester
13960200000099-76-34-Hydroxybenzoic acid, methyl ester
14060240000094-13-34-Hydroxybenzoic acid, propyl ester
140A60480003864-99-12-(2-Hydroxy-3,5,-di-tert-butylphenyl)-5- chlorobenzotriazoleSML(T) = 30 mg/kg (18)
14160560009004-62-0Hydroxyethylcellulose
14260880009032-42-2Hydroxyethylmethylcellulose
14361120009005-27-0Hydroxyethyl starch
14461390037353-59-6Hydroxymethylcellulose
14561680009004-64-2Hydroxypropylcellulose
14661800009049-76-7Hydroxypropyl starch
14661840000106-14-912-Hydroxystearic acid
14862140006303-21-5Hypophosphorous acid
14962240001332-37-2Iron oxide
15062450000078-78-4Isopentane
15162640008001-39-6Japan wax
15262720001332-58-7Kaolin
15362800Kaolin, calcined
15462960000050-21-5Lactic acid
15563040000138-22-7Lactic acid, butyl ester
15663280000143-07-7Lauric acid
15763760008002-43-5Lecithin
15863840000123-76-2Levulinic acid
15963920000557-59-5Lignoceric acid
16064015000060-33-3Linoleic acid
16164150028290-79-1Linolenic acid
16264500Lysine, salts
16364640001309-42-8Magnesium hydroxide
16464720001309-48-4Magnesium oxide
164A6480000110-16-7Maleic acidSML(T) = 30 mg/kg(4)
16565020006915-15-7Malic acid
16665040000141-82-2Malonic acid
16765520000087-78-5Mannitol
167A65920066822-60-4N-methacryloyloxyethyl-N,N-dimethyl-N- carboxymethyl-ammonium chloride, sodium salt-octadecyl methacrylate- ethyl methacrylate –cyclohexyl methacrylate-N-vinyl-2-pyrrolidone, copolymers
16866200037206-01-2Methylcarboxymethylcellulose
16966240009004-67-5Methylcellulose
169A66560004066-02-82,2'-Methylenebis (4-methyl-6-cyclohexylphenol)SML(T) = 3 mg/kg (6)
169B66580000077-62-32,2'-Methylenebis (4-methyl-6-(1-methylcyclo-hexyl) phenol)SML(T) = 3 mg/kg (6)
17066640009004-59-5Methylethylcellulose
17166695Methylhydroxymethylcellulose
17266700009004-65-3Methylhydroxypropylcellulose
172A66755002682-20-42-Methyl-4-isothiazolin-3-oneThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included
17367120012001-26-2Mica
173B67180Mixture 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-octyl esterThe specific migration of this substance shall not exceed 5 mg/kg (1)
17467200001317-33-5Molybdenum disulphide
17567840Montanic acids and/or their esters with ethyleneglycol and/or with 1,3-butanediol and/or with glycerol
17667850008002-53-7Montan wax
17767891000544-63-8Myristic acid
17868040003333-62-87-(2H-Naphtho-(1,2-D) triazol-2-yl)-3-phenylcoumarin
178A68078027253-31-2Neodecanoic 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 Directive 85/572/EEC
17968125037244-96-5Nepheline syenite
179A68145080410-33-92,2',2'-Nitrilo (triethyl tris (3,3',5,5'- tetra-tert-butyl-1-1'-bi-phenyl-2-2-diyl) phosphite)The specific migration of this substance shall not exceed 5 mg/kg (sum of phosphite and phosphate)
18068960000301-02-0Oleamide
18169040000112-80-1Oleic acid
18269760000143-28-2Oleyl alcohol
182A69920000144-62-7Oxalic acidSML(T) = 6 mg/kg (29)
18370000070331-94-12,2'-Oxamidobis(ethyl-3-(3,5-di-tert-butyl-4- hydroxyphenyl) propionate)
18470240012198-93-5Ozokerite
18570400000057-10-3Palmitic acid
18671020000373-49-9Palmitoleic acid
18771440009000-69-5Pectin
18871600000115-77-5Pentaerythritol
188A71635025151-96-6Pentaerythritol dioleateThe specific migration of this substance shall not exceed 0.05 mg/kg. Not for use with foods for which simulant D is laid down in Directive 85/572/EEC
188B71670178671-58-4Pentaerythritol tetrakis (2-cyano-3,3-diphenylacrylate)SML(T) = 0.05 mg/kg
18971680006683-19-8Pentaerythritol tetrakis [-3-(3,5-di-tert-butyl-4- hydroxyphenyl) propionate]
19071720000109-66-0Pentane
19172640007664-38-2Phosphoric acid
191A73160Phosphoric acid, mono- and di-n-alkyl (C16 and C18) estersSML(T) = 0.05 mg/kg
191B73720000115-96-8Phosphoric acid, trichloroethylThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included
191C74010145650-60-8Phosphorous acid, bis (2,4-di-tert-butyl-6- methylphenyl) ethyl esterThe specific migration of this substance shall not exceed 5 mg/kg (covering the sum of phosphite and phosphate)
19274240031570-04-4Phosphorous acid, tris (2,4-di-tert-butylphenyl) ester
19374480000088-99-3o-Phthalic acid
19476320000085-44-9Phthalic anhydride
195A76721

009016-00-6

063148-62-9

Polydimethylsiloxane (Mw > 6800)In compliance with the specifications laid down in Schedule 4
195B76730Polydimethylsiloxane, gamma-hydroxypropylatedSML = 6 mg/kg
195D76865

Polyesters of 1,

2-propanediol and/or 1,3- and/or 1,4-butanediol and/or polypropyleneglycol with adipic acid, which may be end-capped with acetic or fatty acids C12-C18 or n-octanol and/or n-decanol

SML = 30 mg/kg
19676960025322-68-3Polyethyleneglycol
19777600061788-85-0Polyethyleneglycol ester of hydrogenated caster oil
19877702Polyethyleneglycol esters of aliphatic monocarboxylic acids (C6-C22 ), and their ammonium and sodium sulphates
198A77895068439-49-6Polyethyleneglycol (EO = 2-6) monoalkyl (C16-C18) etherSML = 0.05 mg/kg and in compliance with the specifications laid down in Schedule 4
19979040009005-64-5Polyethyleneglycol sorbitan monolaurate
20079120009005-65-6Polyethyleneglycol sorbitan monooleate
20179200009005-66-7Polyethyleneglycol sorbitan monopalmitate
20279280009005-67-8Polyethyleneglycol sorbitan monostearate
20379360009005-70-3Polyethyleneglycol sorbitan trioleate
20479440009005-71-4Polyethyleneglycol sorbitan tristearate
20580240029894-35-7Polyglycerol ricinoleate
20680640Polyoxyalkyl (C2-C4 ) dimethylpolysiloxane
20780720008017-16-1Polyphosphoric acids
20880800025322-69-4Polypropyleneglycol
208A81220192268-64-7Poly-[[6-[N-(2,2,6,6- tetramethyl-4-piperidinyl)-n-butylamino]- 1,3,5-triazine-2,4-diyl][2,2,6,6-tetramethyl-4-piperidinyl)imino]-1,6-hexanedyl[2,2,6,6- tetramethyl-4-piperidinyl) imino]] – alpha- [N,N,N',N''''-tetrabutyl-N – (2,2,6,6-tetramethyl-4- piperidinyl)-N''-[6,2,2,6,6-tetramethyl (-4-piperidinylamino)-hexyl][1,3,5-triazine-2,4,6-triamine]-omega- N,N,N',N'-tetrabutyl-1,3,5-triazine-2,4-diamineSML = 5 mg/kg
208B81515087189-25-1Poly (zinc glycerolate)]
20981520007758-02-3Potassium bromide
21081660001310-58-3Potassium hydroxide
210A81760Powders, flakes and fibres of brass, bronze, copper, stainless steel, tin and alloys of copper, tin and ironSML(T) = 30 mg/kg (7) (expressed as copper); the specific migration of this substance shall not exceed 48 mg/kg (expressed as iron)
21181840000057-55-61,2-Propanediol
21281882000067-63-02-Propanol
21382000000079-09-4Propionic acid
21482080009005-37-21,2-Propyleneglycol alginate
21582240022788-19-81,2-Propyleneglycol dilaurate
21682400000105-62-41,2-Propyleneglycol dioleate
21782560033587-20-11,2-Propyleneglycol dipalmitate
21882720006182-11-21,2-Propyleneglycol distearate
21982800027194-74-71,2-Propyleneglycol monolaurate
22082960001330-80-91,2-Propyleneglycol monooleate
22183120029013-28-31,2-Propyleneglycol monopalmitate
22283300001323-39-31,2-Propyleneglycol monostearate
22383320Propylhydroxyethylcellulose
22483325Propylhydroxymethylcellulose
22583330Propylhydroxypropylcellulose
22683440002466-09-3Pyrophosphoric acid
22783455013445-56-2Pyrophosphorous acid
22883460012269-78-2Pyrophyllite
22983470014808-60-7Quartz
229A83599068442-12-6Reaction products of oleic acid, 2-mercaptoethyl ester, with dichlorodimethyltin, sodium sulphide and trichloromethyltinSML(T) = 0.18 mg/kg (15) (expressed as tin)
23083610073138-82-6Resin acids and rosin acids
23183840008050-09-6Rosin
23284000008050-31-5Rosin, ester with glycerol
23384080008050-26-8Rosin, ester with pentaerythritol
23484210065997-06-0Rosin, hydrogenated
23584240065997-13-9Rosin, hydrogenated, ester with glycerol
23684320008050-15-5Rosin, hydrogenated, ester with methanol
23784400064365-17-9Rosin, hydrogenated, ester with pentaerythritol
23884560009006-04-6Rubber, natural
23984640000069-72-7Salicylic acid
239A85360000109-43-3Sebacic acid, dibutyl ester
240A85610Silicates, natural, silanated (with the exception of asbestos)
240ZA85601Silicates, natural, (with the exception of asbestos)
240B85680001343-98-2Silicic acid
240C85840053320-86-8Silicic acid, lithium magnesium sodium saltSML(T) = 0.6 mg/kg (8) (expressed as lithium)
24286000Silicic acid, silylated
24386160000409-21-2Silicon carbide
24486240007631-86-9Silicon dioxide
244A86285Silicon dioxide, silanated
24586560007647-15-6Sodium bromide
24686620001310-73-2Sodium hydroxide
246A87040001330-43-4Sodium tetraborateSML(T) = 6 mg/kg (22) (expressed as boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption
24787200000110-44-1Sorbic acid
24887280029116-98-1Sorbitan dioleate
24987520062568-11-0Sorbitan monobehenate
25087600001338-39-2Sorbitan monolaurate
25187680001338-43-8Sorbitan monooleate
25287760026266-57-9Sorbitan monopalmitate
25387840001338-41-6Sorbitan monostearate
25487920061752-68-9Sorbitan tetrastearate
25588080026266-58-0Sorbitan trioleate
25688160054141-20-4Sorbitan tripalmitate
25788240026658-19-5Sorbitan tristearate
25888320000050-70-4Sorbitol
25988600026836-47-5Sorbitol monstearate
259A88640008013-07-8Soybean oil, epoxidizedIn compliance with the specifications laid down in Schedule 4
26088800009005-25-8Starch, edible
26188880068412-29-3Starch, hydrolysed
26288960000125-26-5Stearamide
26389040000057-11-4Stearic acid
263A89200007617-31-4Stearic acid, copper saltSML(T) = 30 mg/kg (7) (expressed as copper)
263B89440Stearic acid, esters with ethyleneglycolSML(T) = 30 mg/kg (3)
26490720058446-52-9Stearoylbenzoylmethane
26590800005793-94-2Stearoyl-2-lactylic acid, calcium salt
26690960000110-15-6Succinic acid
26791200000126-13-6Sucrose acetate isobutyrate
26891360000126-14-7Sucrose octaacetate
26991840007704-34-9Sulphur
27091920007664-93-9Sulphuric acid
270A92030010124-44-4Sulphuric acid, copper saltSML(T) = 30 mg/kg (7) (expressed as copper)
27192080014807-96-6Talc
271A92150001401-55-4Tannic acidsAccording to the JECFA specifications
27292160000087-69-4Tartaric acid
27392195Taurine, salts
27492205057569-40-1Terephthalic acid, diester with 2,2'-methylenebis (4-methyl-6-tert-butylphenol)
27592350000112-60-7Tetraethyleneglycol
27692640000102-60-3N,N,N',N'- Tetrakis (2-hydroxypropyl) ethylenediamine
276A92700078301-43-62,2,4,4- Tetramethyl-20-(2,3- epoxypropyl)- 7-oxa-3,20-diazadispiro-[5.1.11.2]-heneicosan-21-one, polymerThe specific migration of this substance shall not exceed 5 mg/kg
276B92930120218-34-0Thiodiethanolbis (5-methoxycarbonyl-2,6-dimethyl-1,4-dihydropridine-3-carboxylate)The specific migration of this substance shall not exceed 6 mg/kg
27793440013463-67-7Titanium dioxide
27893520

000059-02-9

010191-41-0

alpha-Tocopherol

“  “  “  “  “  “

27993680009000-65-1Tragacanth gum
279A93720000108-78-12,4,6-Triamino-1,3,5-triazineSML = 30 mg/kg
28094320000112-27-6Triethyleneglycol
280A94960000077-99-61,1,1-TrimethylolpropaneThe specific migration of this substance shall not exceed 6 mg/kg
280B95000028931-67-1Trimethylolpropane trimethacrylatemethyl methacrylate copolymer]
28195200001709-70-21,3,5-Trimethyl-2,4,6-tris (3,5-di-tert-butyl-4- hydroxybenzyl) benzene
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)
281B95725110638-71-6Vermiculite, reaction product with citric acid, lithium saltSML(T) = 0.6 mg/kg (8) (expressed as lithium)
281C95855007732-18-5WaterIn compliance with Directive 98/83/EC
281D95859Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocksIn compliance with the specifications laid down in Schedule 4
281E95883White mineral oils, paraffinic, derived from petroleum based hydrocarbon deedstocksIn compliance with the specifications laid down in Schedule 4
28295905013983-17-0Wollastonite
28395920Wood flour and fibres, untreated
28495935011138-66-2Xanthan gum
28591690020427-58-1Zinc hydroxide
28696240001314-13-2Zinc oxide
28796320001314-98-3Zinc sulphide

PART 2Incomplete List of Additives Used in the Manufacture of Plastic Materials and Articles (Being Additives to which Paragraphs 5 of Part 3 of this Schedule Applies)

Item

1

PM/REFNo.

2

CAS No

3

Name

4

Restrictions and specifications

130180002180-18-9Acetic acid, manganese saltSML(T) = 0.6 mg/kg (9) (expressed as manganese)
231520061167-58-6Acrylic acid, 2-tert-butyl- 6-(3-tert- butyl- 2-hydroxy-5-methylbenzyl)-4-methylphenyl esterSML = 6 mg/kg
331920000103-23-1Adipic acid, bis (2-ethylhexyl) esterSML = 18 mg/kg (1)
434230Alkyl (C8-C22 ) sulphonic acidsSML = 6 mg/kg
4A34650151841-65-5Aluminium hydroxybis [2,2'-methylenebis (4,6-di-tert-butylphenyl) phospateSML = 5 mg/kg
535760001309-64-4Antimony trioxideSML = 0.02 mg/kg (expressed as anti-monium and analytical tolerance included)
636720017194-00-2Barium hydroxideSML(T) = 1 mg/kg (11) (expressed as barium)
736800010022-31-8Barium nitrateSML(T) = 1 mg/kg (11) (expressed as barium)
7A38000000553-54-8Benzoic acid, lithium saltSML(T) = 0.6 mg/kg (8) (expressed as lithium)
838240000119-61-9BenzophenoneSML = 0.6 mg/kg
938560007128-64-52,5-Bis (5-tert-butyl-2-benzoxazolyl) thio-pheneSML = 0.6 mg/kg
1038700063397-60-4Bis (2-carbobutoxyethyl) tin- bis (isooctylmercapto-acetate)SML = 18 mg/kg
1138800032687-78-8N,N'-Bis (3-(3,5-di-tert-butyl-4-hydroxyphenyl) pro-pionyl) hydrazideSML = 15 mg/kg
1238820026741-53-7Bis (2,4-di-tert-butylphenyl) pentaery-thritol diphosphiteSML = 0.6 mg/kg
1339060035958-30-61,1-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 tertiary amine (expressed excluding HCI)
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) hexamethy-lenediamine- 1,2- dibromoethane,copolymerSML = 2.4 mg/kg
18A40720025013-16-5Tert-butyl- 4-hydroxyanisole (= BHA)SML = 30 mg/kg
194080013003-12-84,4' – butylidene-bis (6-tert-butyl-3-methylphenyl-ditridecyl phosphite)SML = 6 mg/kg
2040908019664-95-0Butyric acid, manganese saltSML(T) = 0.6 mg/kg (9) (expressed as manganese)
214200063438-80-2(2-carbobutoxyethyl) tin-tris (isooctylmercapto-acetate)SML = 30 mg/kg
2242400010377-37-4Carbonic acid, lithium saltSML(T) = 0.6 mg/kg (8) (expressed as lithium)
2342480000584-09-8Carbonic acid, rubidium saltSML = 12 mg/kg
2443600004080-31-31- (3- Chloroallyl) – 3,5,7 – triaza-1-azoniaadamantane chlorideSML = 0.3 mg/kg
2543680000075-45-6ChlorodifluoromethaneSML = 6 mg/kg and in compliance with the specifications laid down in Schedule 4
2644960011104-61-3Cobalt oxideSML(T) = 0.05 mg/kg (13) (expressed as cobalt)
2745440Cresols, butylated, styrenatedSML = 12 mg/kg
27A4565006197-30-42-Cyano-3,3-diphenylacrylic acid, 2-ethylhexyl esterSML = 0.05 mg/kg
27B46640000128-37-02,6-di-tert-butyl-p-cresol (= BHT)SML = 3.0 mg/kg
2947600084030-61-5Di-n-dodecyltin bis (isooctyl mercaptoacetate)SML = 12 mg/kg
3048640000131-56-62,4-DihydroxybenzophenoneSML(T) = 6 mg/kg (14)
3148800000097-23-42,2'-Dihydroxy-5,5'-dichlorodiphenylmethaneSML = 12 mg/kg
3248880000131-53-32,2'Dihydroxy-4-methoxybenzophenoneSML(T) = 6 mg/kg (14)
3349600026636-01-1Dimethyltin bis (isooctyl mercaptoaecetate)SMT(T) 0.18 mg/kg (15) (expressed as tin)
3449840002500-88-1Dioctadecyl disulphideSMT = 3 mg/kg
3550160Di-n-octyltin bis(n-alkyl (C10 -C16) mercapto acetate)SML(T) = 0.04 mg/kg (16) (expressed as tin)
3650240010039-33-5Di-n-octyltin bis (2-ethylhexyl maleate)SML(T) = 0.04 mg/kg (16) (expressed as tin)
3750320015571-58-1Di-n-octyltin bis (2-ethylhexyl mercaptoaectate)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)
3950400033568-99-9Di-n-octyltin bis (isooctyl maleate)SML(T) = 0.04 mg/kg (16) (expressed as tin)
4050480026401-97-8Di-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)
4250640003648-18-8Di-n-octyltin dilaurateSML(T) = 0.04 mg/kg (16) (expressed as tin)
4350720015571-60-5Di-n-octyltin dimaleateSML(T) = 0.04 mg/kg (16) (expressed as tin)
4450800Di-n-octyltin dimaleate, esterifiedSML(T) = 0.04 mg/kg (16) (expressed as tin)
4550880Di-n-octyltin dimaleate, polymers (n = 2-4)SML(T) = 0.04 mg/kg (16) (expressed as tin)
465096069226-44-4Di-n0octyltin 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)
4951570000127-63-9Diphenyl sulphoneSML(T) = 3 mg/kg (24)
5051680000102-08-9N,N'-diphenylthioureaSML = 3 mg/kg
5152000027176-87-0Dodecylbenzenesulphonic acidSML = 30 mg/kg
5252320052047-59-32-(4-Dodecylphenyl) indoleSML = 0.06 mg/kg
5352880023676-09-74-Ethoxybenzoic acid, ethyl esterSML = 3.6 mg/kg
5453200023949-66-82-Ethoxy-2'-ethyloxanilideSML = 30 mg/kg
54A54880000050-00-0FormaldehydeSML(T) = 15 mg/kg (21 )
54B55200001166-52-5Gallic acid, dodecyl esterSML(T) = 30 mg/kg (34 )
54C55280001034-01-1Gallic acid, octyl esterSML(T) = 30 mg/kg (34 )
54D55360000121-79-9Gallic acid, propyl esterSML(T) = 30 mg/kg (34 )
5558960000057-09-0Hexadecyltrimethylammonium bromideSML = 6 mg/kg
5659120023128-74-71,6-Hexamethylene-bis (3- (3,5-di-tert-butyl-4-hydroxyphenyl) propionamide)SML = 45 mg/kg
5759200035074-77-21,6- Hexamethylene-bis (3- (3,5-di-tert-butyl-4-hydroxyphenyl) propionateSML = 6 mg/kg
5860320070321-86-72- (2-Hydroxy-3,5-bis (1,1-dimethylbenzyl) phenyl) benzotriazoleSML = 1.5 mg/kg
5960400003896-11-52- (2'-Hydroxy-3'-tert-butyl- 5'-methylphenyl) –5-chlorobenzotriazoleSML(T) = 30 mg./kg (18)
6060800065447-77-01-(2- Hydroxyethyl) –4-hydroxy- 2,2, 6,6-tetramethyl, pipe ridine-succinic acid, dimethyl ester, copolymerSML = 30 mg/kg
6161280003293-97-82-Hydroxy-4-n-hexyloxybenzophenoneSML(T) = 6 mg/kg (14)
6261360000131-57-72-Hydroxy-4-methoxybenzophenoneSML(T) = 6 mg/kg (14)
6361440002440-22-42-(2-Hydroxy-5-methylphenyl) benzotriazoleSML(T) = 30 mg/kg (18)
6461600001843-05-62-Hydroxy-4-n-octyloxybenzophenoneSML(T) = 6 mg/kg (14)
6563200051877-53-3Lactic acid, manganese saltSML(T) = 0.6 mg/kg (9) (expressed as manganese)
6664320010377-51-2Lithium iodideSML(T) = 1 mg/kg (10) (expressed as iodium) and SML(T) = 0.6 mg/kg (8 ) (expressed as lithium)
6765120007773-01-5Manganese chlorideSML(T) = 0.6 mg/kg (9) (expressed as manganese)
6865200012626-88-9Manganese hydroxideSML(T) = 0.6 mg/kg (9) (expressed as manganese
6965280010043-84-2Manganese hypophosphiteSML(T) = 0.6 mg/kg (9) (expressed as manganese
7065360011129-60-5Manganese oxideSML(T) = 0.6 mg/kg (9) (expressed as manganese
7165440Manganese pyrophosphiteSML(T) = 0.6 mg/kg (9) (expressed as manganese
7266360085209-91-22-2'-Methylene bis (4,6-di-tert-butylphenyl) sodium phosphateSML = 5 mg/kg
7366400000088-24-42-2'-Methylenbis (4-ethyl-6-tert-butylphenol)SML(T) = 1.5 mg/kg (19)
7466480000119-47-12-2'- Methylenbis (4-methyl-6-tert-butylphenol)SML(T) = 1.5 mg/kg (19)
7567360067649-65-4Mono-n-dodecyltin tris (isooctyl mercaptoacetate)SML = 24 mg/kg
7667520054849-38-6Monomethyltin tris (isooctyl mercaptoacetate)SML(T) = 0.18 mg/kg (15) (expressed as tin)
7767600Mono-n-octyltin tris (alkyl (C10 -C16) – mercaptoacetateSML(T) = 1.2 mg/kg (17) (expressed as tin)
7867680027107-89-7Mono-n-octyltin tris (2-ethylhexyl mercaptoacetateSML(T) = 1.2 mg/kg (17) (expressed as tin)
7967760026401-86-5Mono-n-octyltin tris (isooctyl mercaptoacetate)SML(T) = 1.2 mg/kg (17) (expressed as tin)
79A67896020336-96-3Myristic acid, lithium saltSML(T) = 0.6 mg/kg (8) (expressed as lithium)
8168320002082-79-3Octadecyl 3- (3,5-di-tert-butyl-4- hydroxylphenyl) propionateSML = 6 mg/kg
8268400010094-45-8OctadecylerucamideSML = 5 mg/kg
82A68860004724-48-5n-Octylphosphonic acidSML = 0.05 mg/kg
8369840016260-09-6OleylpalmitamideSML = 5 mg/kg
83A71935007601-89-0Perchloric acid, sodium salt monohydrateSML = 0.05 mg/kg (31)
8472160000948-65-22-PhenylindoleSML = 15 mg/kg
8572800001241-94-7Phosphoric acide, diphenyl 2-ethylhexyl esterSML = 2.4 mg/kg
8673040013763-32-1Phosphoric acid, lithium saltsSML(T) = 0.6 mg/kg (8) (expressed as lithium)
8773120010124-54-6Phosphoric acid, manganese saleSML(T) = 0.6 mg/kg (9) (expressed as manganese
8874400Phosphorous acid, tris (nonyl- and/or dinonylphenyl) esterSML = 30 mg/kg
88A76680068132-00-3Polycyclopentadiene, hydrogenatedSML = 5 mg/kg (1)
8977440Polyethyleneglycol diricinoleateSML = 42 mg/kg
9077520061791-12-6Polyethyleneglycol ester of caster oilSML = 42 mg/kg
9178320009004-97-1Polyethyleneglycol monoricinoleateSML – 42 mg/kg
9281200071878-19-8Poly [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) imino]SML = 3 mg/kg
9381680007681-11-0Potassium iodideSML(T) = 1 mg/kg (10) (expressed as iodium)
9482020019019-51-3Propionic 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 4
9683700000141-22-0Ricinoleic acidSML = 42 mg/kg
9784800000087-18-3Salicylic acid, 4-tert-butylphenyl esterSML = 12 mg/kg
9884880000119-36-8Salicylic acid, methyl esterSML = 30 mg/kg
9985760012068-40-5Silicic acid, lithium aluminium salt (2:1:1)SML(T) = 0.6 mg/kg (8) (expressed as lithium)
10085920012627-14-4Silicic acid, lithium saltSML(T) = 0.6 mg/kg (8) (expressed as lithium)
100A86480007631-90-5Sodium bisulphiteSML(T) = 10 mg/kg (30) (expressed as SO2)
10186800007681-82-5Sodium iodideSML(T) = 1 mg/kg (10) (expressed as iodium)
10286880Sodium monoalkyl dialkylphenoxybenzenedi-sulphonateSML = 9 mg/kg
102A86920007632-00-0Sodium nitriteSML = 0.6 mg/kg
102B86960007757-83-7Sodium sulphiteSML(T) = 10 mg/kg (30) expressed as SO2)
102C8712007772-98-7Sodium thiosulphateSML(T) = 10 mg/kg (30) expressed as SO2)
10389170013586-84-0Stearic acid, cobalt saltSML(T) = 0.05 mg/kg (13) expressed as cobalt)
10492000007727-43-7Sulphuric acid, barium saltSML(T) = 1 mg/kg (11) expressed as barium)
10592320Tetradecyl-polyethyleneglycol (EO = 3-8) ether of glycolic acidSML = 15 mg/kg
10692560038613-77-3Tetrakis (2,4- di-tert-butyl-phenyl) – 4-4' –biphenylylene diphosphoniteSML = 18 mg/kg
10792800000096-69-54,4'-Thiobis (6-tert-butyl- 3-methylphenol)SML = 0.48 mg/kg
10892880041484-35-9Thiodiethanol bis (3-(3-5-di-tert- butyl-4-hydroxyphenyl) propionateSML = 2.4 mg/kg
10993120000123-28-4Thiodipropionic acid, didodecyl esterSML(T) = 5 mg/kg (20)
11093280000693-36-7Thiodipropionic acid, dioctadecyl esterSML(T) = 5 mg/kg (20)
110A94400036443-68-2Triethyleneglycol bis[ 3-(3-tert-butyl- 4-hydroxy- 5-methylphenyl) propionate]SML = 9 mg/kg
11194560000122-20-3TriisopropanolamineSML = 5 mg/kg
11295280040601-76-11,3,5- Tris (4-tert-butyl-3-hydroxy –2,6- dimethylbenzyl)- 1,3,5-triazine-2,4,6 (1H, 3H,5H)- trioneSML = 6 mg/kg
1139536027676-62-61,3,5 – Tris (3,5-di-tert-butyl-4 hydroxybenzyl)- 1,3,5-triazine –2,4,6 (1H, 3H, 5H) – trioneSML = 5 mg/kg
1149560001843-03-41,1,3- Tris (2-methyl-4-hydroxy-5-tert-butylphenyl) butaneSML = 5 mg/kg

PART 3Supplementary

1.  In regulations 5 and 7 and Parts 1 and 2 of this Schedule—

(a)the PM/REF No of any additive is its EEC packaging material reference number,

(b)the CAS No. of any additive is its CAS (Chemical Abstracts Service) Registry Number; and

(c)the name of any additive is its chemical name, and to the extent that there is any inconsistency between the CAS No. and the name, the name shall take precedence over the CAS No.

2.  If a substance identified in Parts 1 or 2 is an acid, a phenol or an alcohol and has salts (including double salts) of one or more of the following names (that is to say salts of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium or zinc), then any such salts shall be treated as included in the specification of that substance.

3.  If, as indicated in paragraph 2 of Annex III to the Directive, a substance is identified in Parts 1 or 2 as an “… acid, salt” and has salts of one or more of the following names (that is to say, salts of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium or zinc), then the free acid corresponding to that substance is not treated as included in the specification of that substance.

4.  Where an entry in column 4 of Part 1 or Part 2 includes a bracketed number, that entry shall be subject to a note relating to that number as follows, the following bracketed numbers corresponding with those appearing in those Parts —

(1): Warning: there is a risk that the SML could be exceeded in fatty food simulants.

(2): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 10060 and 23920.

(3): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 15760, 16990, 47680, 53650 and 89440.

(4): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 19540, 19960 and 64800.

(5): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 14200, 14230 and 41840.

(6): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 66560 and 66580.

(7): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 30080, 42320, 45195, 45200, 53610, 81760, 89200 and 92030.

(8): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 38000, 42400, 64320, [67896,] 73040, 85760, 85840, 85920 and 95725.

(9): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 30180, 40980, 63200, 65120, 65200, 65280, 65360, 65440 and 73120.

(10): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels (expressed as iodine) of the substances having PM/REF Nos. 45200, 64320, 81680 and 86800.

(11): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 36720, 36800, 36840 and 92000.

(12): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 39090 and 39120.

(13): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 44960, 68078, 82020 and 89170.

(14): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 15970, 48640, 48720, 48880, 61280, 61360 and 61600.

(15): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 49600, 67520 and 83599.

(16): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 50160, 50240, 50320, 50360, 50400, 50480, 50560, 50640, 50720, 50800, 50880, 50960, 51040 and 51120.

(17): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PR/REF Nos. 67600, 67680 and 67760.

(18): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 60400, 60480 and 61440.

(19): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 66400 and 66480.

(20): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 93120 and 93280.

(21): SML(T) in this cases means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 17260, 18670, 54880 and 59280.

(22): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF/Nos. 13620, 36840, 40320 and 87040.

(23): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF/Nos. 13720 and 40580.

(24): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 16650 and 51570.

(26): QMA(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 14950, 15700, 16240, 16570, 16600, 16630, 18640, 19110, 22332, 22420, 22570, 25210, 25240 and 25270.

(27): QMA(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 10599/90A, 10599/91, 10599/92A and 10599/93.

(28): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 13480 and 39680.

(29) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 22775 and 69920.

(30): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 86480, 86960 and 87120.

(31): Compliance testing when there is a fat contact should be performed using saturated fatty food simulants as simulant D.

(32): Compliance testing when there is a fat contact should be performed using isooctane as substitute of simulant D (unstable).

(33): QMA(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 14800 and 45600.

(34): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 55200, 55280 and 55360.

5.  In this case of the substances listed in Part 2, the specific migration limits specified in column 4 of that Part (restrictions and specifications) shall have effect with effect from 1st July 2006 where the verification of compliance is carried out in simulant D or in test media of substitute tests as prescribed in Council Directive 82/711/EEC and Council Directive 85/572/EEC.

Regulation 8

SCHEDULE 3Products Obtained by Bacterial Fermentation

Item

1

PM/REF No

2

CAS No

3

Name

4

Restrictions and specifications

118888080181-31-3

3-hydroxybutanoic acid—

3-hydroxypentanoic acid, copolymer

In compliance with specifications included in Schedule 4

Schedules 1,2 & 3

SCHEDULE 4Specifications

Item

1

PM/REF No

2

Specifications

(1)

Quantity of substance used/quantity of formulation

111530Acrylic acid, 2-hydroxypropyl ester
It may contain up to 25% (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No. 002918-23-2)
216690Divinylbenzene
It may contain up to 45% (m/m) of Ethylvinylbenzene
3188883-Hydroxybutanoic acid – 3-hydroxypentanoic acid, copolymer
Definition

The 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 namePoly(3-D-hydroxybutanoate-co-3-D-hydroxypentanoate)
CAS number080181-31-3
Structural formula(This formula is currently unavailable. Please see the original.)
Average molecular weightNot less than 150 000 Daltons (measured by gel permeation chromatography)
Assay

Not less than 98% poly (3-D-hydroxybutanoate

-co-3-D-hydroxypentanoate) analysed after hydrolysis as a mixture of 3-D-hydroxybutanoic and 3-D-hydroxypentanoic acids

DescriptionWhite to off-white powder after isolation
SolubilitySoluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically insoluable in ethanol, aliphatic alkanes and water
RestrictionQMA for crotonic acid is 0.05 mg/6 dm2
PurityPrior to granulation of the raw material copolymer powder must contain:
– nitrogenNot more than 2 500 mg/g of plastic
– zincNot more than 100 mg/kg of plastic
– copperNot more than 5 mg/kg of plastic
– leadNot more than 2 mg/kg of plastic
– arsenicNot more than 1 mg/kg of plastic
– chromiumNot more than 1 mg/kg of plastic
423547Polydimethylsiloxane (Mw > 6800)
Minimum viscosity 100 × 10−6m2/s (= 100 centistokes) at 25°C
525385Triallylamine
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.
6383204-(2-Benzoxazolyl)-4'- (5-methyl-2-benzoxazolyl) stilbene
Not more than 0.05% w/w (quantity of substance used / quantity of the formulation)
743680Chlorodifluoromethane
Content of chlorofluoromethane less than 1 mg/kg of the substance
847210Dibutylthiostannoic acid polymer
Molecular unit = (C8H18S3Sn2) n (n = 1.5-2)
976721Polydimethylsiloxane (Mw > 6800)
Minimum viscosity 100 × 10 −6m2/s (= 100 centistokes) at 25° C
1077895Polyethyleneglycol (EO = 2-6) monoalkyl (C16-C18) ether
The composition of this mixture is as follows:
–polyethyleneglycol (EO = 2-6) monoalkyl (C16-C18) ether approximately 28%)
–fatty alcohols (C16-C18) (approximately 48%)
–ethyleneglycol monoalkyl (C16-C18) ether (approximately 24%)
1183595Reaction 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 biphenyl
Composition
–4,4'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 38613-77-3) (36-46% w/w)(1)
–4,3'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 118421-00-4) (17-23% w/w)(1)
–3-3'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] CAS No. 118421-01-5) (1-5% w/w )(1)
–4-Biphenylene-0,0-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 91362 – 37-7 (11-19% w/w)(1)
–Tris (2,4-di-tert-butylphenyl) phosphite (CAS No. 31570-04-4) (9-18% w/w)(1)
–4,4'-Biphenylene-0,0-bis (2,4-di-tert-butylphenyl) phosphonate-0,0-bis (2,4-di-tert-butylphenyl) phosphonite (CAS No. 112949–97-0) (<5% w/w (1))
Other specifications
–Phosphor content of minimum 5.4% to maximum 5.9%
–Acid value of maximum 10 mg KOH per gram
–Melt range of 85-110°C
1288640Soybean oil, epoxidized
Oxirane less than 8%, iodine number < 6
1395859Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks. The product should have the following specifications:
Phosphor content of minimum 5.4% to maximum 5.9%
–Content of mineral hydrocarbons with carbon number less than 25: not more than 5% (w/w)
–Viscosity not less than 11 × 10 −6m2/s (= 11 centistokes) at 100°C
–Average molecular weight not less than 500
1495883White mineral oils, paraffinic, derived from petroleum based hydrocarbon feedstocks
The product shall 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 × 10−6m2/s (= 8.5 centistokes) at 100°C
–Average molecular weight not less than 480

Regulations 9 and 11

SCHEDULE 5Provisions Applicable when Testing Compliance with the Migration Limits

General Provisions

1.  When the results of the migration tests specified in this Schedule and, where appropriate Schedule 6, are analytically determined, the specific gravity of any simulants used shall be assumed to be 1, so that milligrams of any substance released per litre of simulant will correspond numerically to milligrams of that substance released per kilogram of that simulant.

2.  Where any migration test specified in this Schedule and, where appropriate, Schedule 6 is carried out on any sample taken from any plastic material or article and the quantities of food or simulant placed in contact with the sample differ from those employed in the actual conditions under which the plastic material or article is used or is to be used, the results obtained should be corrected by applying the formula M = (( m.a2/a1.q).1000) where —

(a)M is the migration in mg/kg:

(b)m is the mass in the mg of substance released by the sample as determined by the migration test;

(c)a1 is the surface area in square decimetres of the sample in contact with the food or simulant during the migration test;

(d)a2 is the surface area in square decimetres of the plastic material or article in actual conditions of use; and

(e)q is the quantity in grams of food in contact with the plastic material or article in actual conditions of use.

3.—(1) Subject to sub-paragraph (2), any testing of migration from any plastic material or article shall be carried out on that plastic material or article.

(2) In any case where determination in accordance with sub-paragraph (1) is impracticable, such testing shall be carried out, using either specimens taken from that plastic material or article, or where appropriate, specimens representative of that plastic material or article.

(3) Any sample used for such testing shall be placed in contact with the simulant or food, as the case may be, in a manner representing the contact conditions in actual use, and for this purpose the testing shall be carried out in such a way that only those parts of the sample intended to come into contact with food in actual use will be in contact with the simulant or food.

  • Any migration testing of caps, gaskets, stoppers or similar devices for sealing shall be carried out on these articles by applying them to the containers for which they are intended in a manner which corresponds to the conditions of closing in normal or foreseeable use.

  • Any sample of plastic material or article shall be placed in contact with the appropriate simulant or the food for a period and at a temperature which are chosen by reference to the contact conditions in actual use in accordance with the provisions of this Schedule and, where appropriate, Schedule 6.

(4) At the end of the period referred to in sub-paragraph (1), analytical determination of the total quantity of substances (overall migration), each specific quantity of a substance (specific migration) or, as the case may be, both that total and that specific quantity released by the sample shall be carried out on the simulant or food, as the case may be.

(5) Verification that migration into food complies with a migration limit specified in regulation 9, Schedule 1 or Schedule 2 shall be carried out under the most extreme conditions of time and temperature foreseeable in actual use in accordance with the provisions of this Schedule.

(6) Verification that migration into food simulants complies with a migration limit specified in regulation 9, Schedule 1 or Schedule 2 shall be carried out in accordance with the provisions of this Schedule and using conventional migration tests, the basic rules for which are set out in Schedule 6.

4.  Where a plastic material or article is intended to come into repeated contact with food, any migration test shall (subject to paragraph 7 below) be carried out three times on a single sample in accordance with the conditions laid down in this Schedule and, where appropriate, Schedule 6 using separate samples of the simulant or, as the case may be food, on each occasion, and the level of the migration found in the third test shall be treated as the level relevant to that test.

Special provisions relating to overall migration

5.—(1) Subject to sub-paragraph (2), any method of analytical determination may be used to prove excess of an overall migration limit in relation to a plastic material or article.

(2) In any proceedings for an offence under these Regulations where it is alleged that a plastic material or article does not comply with regulation 9 it shall be a defence for the person charged to prove that—

(a)if an aqueous simulant specified in Schedule 6 had been used, and the analytical determination of the total quantity of substances released by a sample of the plastic material or article tested had been carried out by evaporation of the simulant and weighing of the residue; or

(b)if rectified olive oil or any of its substitutes had been used as a simulant and—

(i)a sample of the plastic material or article had been weighed before and after contact with the simulant;

(ii)the simulant absorbed by the sample had been extracted and determined quantitatively;

(iii)the quantity of simulant so found had been subtracted from the weight of the sample measured after contact with the simulant; and

(iv)the difference between the initial and corrected final weights had been determined to represent the overall migration of the sample examined,

there would have been no such excess so determined.

6.—(1) Where a plastic material or article is intended to come into repeated contact with food and it is technically impossible to carry out the test described in paragraph 5, the test shall be so modified as to enable the level of migration occurring during the third such test to be determined and, subject to sub-paragraph (2), such a determination may be used to prove excess of an overall migration limit in relation to a plastic material or article.

(2) In any proceedings for an offence under these Regulations where it is alleged, following determination under sub-paragraph (1), that a plastic material or article does not comply with regulation 9 it shall be a defence for the person charged to prove that, if—

(a)three identical samples of the plastic material or article had been procured;

(b)one of them had been subjected to the appropriate test according with paragraph 4 and the overall migration determined (M1);

(c)the second and third samples had been subjected to the same conditions of temperature but the period of contact had been two and three times that specified and overall migration had been determined in each case (M2 and M3 respectively); and

(d)the plastic material or article had been deemed to comply with the overall migration limit relevant to it provided that either M1 or M3 – M2 did not exceed that overall migration limit,

the plastic material or article would not have been deemed to exceed that limit.

7.—(1) Any plastic material or article which exceeds its overall migration limit by an amount not exceeding the analytical tolerance specified in sub-paragraph (2) shall be deemed for the purposes of these Regulations not to exceed its overall migration limit.

(2) The following analytical tolerances shall be applied for limits of overall migration—

(a)20 mg/kg or, as the case may be, 3 milligrams per square decimetre in migration tests using as a simulant rectified olive oil or substitutes;

(b)12mg/kg or, as the case may be, 2 milligrams per square decimetre in migration tests using other simulants referred to in Schedule 6.

Regulations 9 and 11

SCHEDULE 6Overall and Specific Migration Testing Using Food Simulants

PART 1Basic Rules

1.  Subject to paragraphs 2, 3 and 4 of this Part, migration tests for the determination of specific and overall migration shall be carried out using the food simulants specified in Parts 2, 3 and, where appropriate 4, and under conventional migration test conditions as specified in Part 5.

2.  Subject to paragraphs 3 and 4 of this Part, substitute tests which use test media under the conventional substitute test conditions as specified in Part 6 shall be carried out if the migration test using the fatty food simulants specified in Part 3 is not feasible for technical reasons connected with the method of analysis.

3.  Subject to paragraph 4 of this Part, alternative tests as specified in Part 7 may be used instead of the migration test with fatty food simulants specified in Part 3 but the results of such alternative tests may not be used to determine compliance with a migration limit unless the conditions specified in Part 7 are fulfilled.

4.  In migration testing it is permissible to—

(a)reduce the number of tests to be carried out to that or those which, in the specific ase under examination, is or are generally recognised to be the most severe on the basis of scientific evidence;

(b)omit the migration, the substitute or the alternative tests where —

(i)there is conclusive proof that the migration limits cannot be exceeded in any foreseeable conditions of use of the material or article, or

(ii)the conditions for non-compulsory testing set out in Article 8.2 or 8.3 of the Directive are met.

PART 2Food Simulants to be Used in Migration Testing

5.  Subject to Parts 3, 4, 5 and 7, the simulants to be used in migration testing are specified in the Table to this paragraph (referred to in this Part as “the Table”).

1

Abbreviation

2

Food Simulant

Simulant A:Distilled water or water of equivalent quality
Simulant B:3% Acetic acid (w/v) in aqueous solution
Simulant C:10% Ethanol (v/v) in aqueous solution save that the concentration of ethanol solution shall be adjusted to the actual alcoholic strength of the food if it exceeds 10% (v/v)
Simulant D:Rectified olive oil having the characteristics specified in paragraph 3 of this Part of this Schedule or, subject to paragraph 5 of this Part of this Schedule, any of the fatty food simulants specified in paragraph 4 of this Part of this Schedule

6.  For the purposes of this Schedule a reference to an abbreviation in column 1 of the Table shall mean a reference to the simulant in column 1 of that Table opposite that abbreviation.

7.  The characteristics of rectified olive oil referred to in the Table are —

(a)Iodine value (Wijs) = 80 to 88

(b)Refractive index at 25°C = 1.4665 to 1.4679

(c)Acidity (expressed as % of oleic acid) = 0.5% maximum

(d)Peroxide number (expressed as oxygen milli-equivalents per kg of oil) = 10 maximum

8.  The fatty food simulants referred to in the Table are —

(a)corn oil with standardised specifications;

(b)sunflower oil, the characteristics of which are —

(i)Iodine value (Wijs) = 120 to 145

(ii)Refractive index at 20°C = 1.474 to 1.476

(iii)Saponification number = 188 to 193

(iv)Relative density at 20°C = 0.918 to 0.925

(v)Unsaponifiable matter = 0.5% to 1.5%.

(c)a synthetic mixture of triglycerides the composition of which is as set out in the following tables:

Fatty acid distribution

No of C-atoms in fatty acid residue681012141618others
GLC area (%)~16-98-1145-5212-158-108-121

Purity

Content of monoglycerides (enzymatically)≤0.2%
Content of diglycerides (enzymatically)≤2.0%
Unsaponifiable matter≤0.2%

Iodine value

(Wijs)

≤0.1%
Acid value≤0.1%
Water content (K Fischer)≤0.1%
Melting point28 ± 2°C

Typical absorption spectrum (thickness of layer: d = 1 cm; Reference: water at 35°C)

Wavelength (nm)290310330350370390430470510
Transmittance (%)~2~15~37~64~80~88~95~97~98
At least 10% light transmittance at 310 nm

9.  Where fatty food simulant specified in paragraph 4 is used in migration testing and the result of that test shows that a plastic material or article does not comply with any migration limit specified in regulation 9 or Schedule 1, verification that the plastic material or article does not comply with the specified migration shall be carried out by testing that material or article using olive oil if such testing is technically feasible, and if such testing is not technically feasible the plastic material or article shall be deemed not to comply with the specified migration limit.

PART 3Selection of Food Simulants

Testing, reduction factors and definition of food types

10.  The testing of plastic materials and articles shall be carried out under the test conditions specified in Part 5 using a simulant or simulants selected in accordance with this Part and taking a new test specimen of the plastic material or article for each simulant used.

11.—(1) Where a test is carried out on a plastic material or article intended to come into contact with more than one food or group of foods and a reduction factor is specified for one or more of those foods or groups of foods which is not equivalent to the reduction factor specified for one or more of the other foods or groups of foods with which the plastic material or article is intended to come into contact—

(a)the reduction factor specified for each food or group of foods, as appropriate, shall be applied to the test result; and

(b)the plastic material or article shall be treated as being capable of transferring its constituents to food with which it may come into contact in excess of a migration limit specified in regulation 9 or Schedule 1 if, following application of those specified reduction factors, one or more of the results show that the material or article does not comply with that specified migration limit.

(2) For the purpose of this paragraph —

(a)a reduction factor is the figure which follows an “X” and oblique stroke in the group of columns headed “Simulants to be used” in the Table to Part 4;

(b)a reduction factor is specified for a food or group of foods where, in the Table to Part 4 —

(i)the food or group of foods is described in the column headed “Description of food”, and

(ii)“X” is placed in a column headed by a specified simulant opposite that food or group of foods followed by an oblique stroke and a reduction factor;

(c)a reduction factor shall be applied to a test result by dividing the result by that reduction factor.

12.  Food types are defined in Table 1 below as follows —

Table 1: Food types
DefinitionMeaning
Aqueous foods having a pH > 4.5Foods in relation to which simulant A only is specified in the Table to Part 4
Acidic foods having a pH ≤ 4.5Foods in relation to which simulant B only is specified in Table to Part 4
Alcoholic foodsFoods in relation to which simulant C only is specified in the Table to Part 4
Fatty foodsFoods in relation to which simulant D only is specified in the Table to Part 4
Dry FoodsFoods in relation to which no simulant is specified in the Table to Part 4

Selection of simulants for testing materials and articles intended for contact with all food types

13.  The simulants to be used in testing a plastic material or article which is intended for contact with all food types are simulant B, simulant C and simulant D which, at the test conditions specified in Part 5, are considered to be more severe.

Selection of simulants for testing materials and articles which are already in contact with a known food

14.  The simulant or simulants to be used in testing a plastic material or article which is already in contact with a known food shall be —

(a)where —

(i)the known food is a specific food or is within a specific group of foods described in column 2 of the Table to Part 4 and,

(ii)for the purposes of that Part, a simulant is, or simulants are, specified in relation to that specific food or specific group of foods,

the simulant or simulants so specified;

(b)where —

(i)the known food is neither a specific food, nor

(ii)within a specific group of foods described in the Table to Part 4 of this Schedule,

the simulant or simulants in column 2 of Table 2 opposite the description of food in column 1 of that Table which corresponds most closely to the known food.

Selection of simulants for testing materials and articles which are accompanied by a specific indication

15.  The simulant or simulants to be used in testing a plastic material or article which, pursuant to Regulation (EC) No 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food(1) (“Regulation 1935/2004”), is accompanied by a specific indication stating any type or types of food described in Table 1 with which it may or may not be used shall be the simulant or simulants in column 2 of Table 2 opposite the contact food in column 1 of that Table which corresponds most closely to the type or types of food with which it may be used, as identified by the indication which accompanies the plastic material or article.

16.  The simulant or simulants to be used in testing a plastic material or article which, pursuant to Regulation 1935/2004, is accompanied by a specific indication, expressed in accordance with paragraph 8, stating any food or group of foods described in the Table to Part 4 with which it may or may not be used shall be—

(a)where the indication states that the plastic material or article may be used with a food or group of foods described in column 2 of the Table to Part 4, the food simulant or food simulants which, for the purposes of Part 4, is or are specified in relation to that food or group of foods;

(b)where the indication states that the plastic material or article should not be used with any food or group of foods described in column 2 of Table to Part 4, a simulant other than the simulant or simulants which, for the purposes of Part 4, is or are specified in relation to that food or group of foods.

17.  A specific indication referred to in paragraph 7 is expressed in accordance with this paragraph if it is expressed—

(a)at a marketing stage other than retail, by using the reference number in column 1 of the Table to Part 4 of these Regulations or the description of food in column 2 of that Table which, in either case, corresponds to the food;

(b)at the retail stage, by using an indication which refers to only a few foods or groups of foods described in the Table to Part 4.

Table 2: Simulants to be selected for testing food contact materials in special cases
Contact foodsSimulant
Only aqueous foodsSimulant A
Only acidic foodsSimulant B
Only alcoholic foodsSimulant C
Only fatty foodsSimulant D
All aqueous and acidic foodsSimulant B
All alcoholic and aqueous foodsSimulant C
All alcoholic and acidic foodsSimulant C and B
All fatty and aqueous foodsSimulants D and A
All fatty and acidic foodsSimulants D and B
All fatty, alcoholic and aqueous foodsSimulants D and C
All fatty, alcoholic and acidic foodsSimulants D, C and B

PART 4Selection of Food Simulants

18.  For the purposes of this Schedule a simulant is specified in relation to a specific food or a specific group of foods where “X” is placed in the column headed by that simulant opposite that specific food or specific group of foods in the Table to this Part, and the Table shall be read in conjunction with the notes to it and with paragraphs 2 to 5.

19.  For the purposes of this Part —

(a)a reduction factor is the figure which follows an “X” and oblique stroke in the group of columns headed “Simulants to be used” in the Table to this Part;

(b)a reduction factor is specified in relation to a specific food or group of foods where, in the Table —

(i)the food or group of foods is described in the column headed “Description of food”; and

(ii)“X” is placed in a column headed by a specified simulant opposite that food or group of foods allowed by an oblique stroke and a reduction factor.

20.  Where a reduction factor is specified in the Table in relation to a specific food or a specific group of foods, that reduction factor shall be applied to the result of any migration test using the simulant specified in relation to that food or group of foods by dividing the result of the test by the reduction factor.

21.  Where the letter “a” is shown in brackets after the “X”, only one of the two simulants specified shall be used in the migration test, that is to say —

(a)if the pH value of the food is higher than 4.5, simulant A shall be used;

(b)if the pH value of the foodstuff is 4.5 or less, simulant B shall be used.

22.  Where a food is listed in the Table under both a specific and a general heading, the simulant relating to the specific heading is the simulant which falls to be used for the migration test.

Reference NumberDescription of foodSimulants to be used
ABCD
(1)

Simulant B shall not be used where the pH is more than 4.5.

(2)

This test shall be carried out in the case of liquids or beverages of an alcoholic strength exceeding 10% vol with aqueous solutions of ethanol of a similar strength.

(3)

If it can be demonstrated under regulation 12 or proved by means of an appropriate test that there is to be no fatty contact with the plastic material or article, simulant D shall not be used.

01Beverages
01.01Non-alcoholic beverages or alcoholic beverages of an alcoholic strength lower than 5% vol:X(a)X(a)
— Waters, ciders, fruit or vegetable juices of normal strength or concentrated, musts, fruit nectars, lemonades and mineral waters, syrups, bitters, infusions, coffee, tea, liquid chocolate, beers and other
01.02Alcoholic beverages of an alcoholic strength equal to or exceeding 5% vol.X(1)X(2)

— Beverages shown under heading 01.01 but with an alcoholic strength equal to or exceeding 5% vol.

— Wines, spirits and liqueurs

01.03Miscellaneous: undenatured ethyl alcoholX(1)X(1)X(1)
02Cereals, cereal products, pastry, biscuits, cakes and other bakers' wares
02.01Starches
02.02Cereals, unprocessed, puffed, in flakes (including popcorn, cornflakes and the like)
02.03Cereal flour and meal
02.04Macaroni, spaghetti and similar products
02.05Pastry, biscuits, cakes and other bakers' wares, dry:

A  With fatty substances on the surface

X/5

B  Other

02.06Pastry, biscuits, cakes and other bakers' wares, fresh:

A  With fatty substances on the surface

X/5

B  Other

X
03Chocolate, sugar and products thereof Confectionery products
03.01Chocolate, chocolate-coated products, substitutes and products coated with substitutesX/5
03.02Confectionery products:

A  in solid form:

— with fatty substances on the surfaceX/5
— Other

B  in paste form:

— with fatty substances on the surfaceX/3
— moistX
03.03Sugar and sugar products

A  In solid form

B  Honey and the like

X

C  Molasses and sugar syrups

X
04Fruit, vegetable and products thereof
04.01Whole fruit, fresh or chilled
04.02Processed fruit:

A  Dried or dehydrated fruit, whole or in the form of flour or powder

B  Fruit in the form of chunks, puree or paste

X(a)X(a)

C  Fruit preserves (jams and similar products – whole fruit or chunks or in the form of flour or powder, preserved in a liquid medium):

  • — i) In an aqueous medium

X(a)X(a)
  • — ii) In an oily medium

X(a)X(a)X
  • — iii) In an alcoholic medium ≥ 5% vol

X(1)X
04.03>Nuts (peanuts, chestnuts, almonds, hazelnuts, walnuts, pine kernels and others)

A  Shelled, dried

B  Shelled and roasted

X/5(3)

C  In paste or cream form

XX/3(3)
04.04Whole vegetables, fresh or chilled
04.05Processed vegetables:

A  Dried or dehydrated vegetables whole or in the form of flour or powder

B  Vegetables, cut, in the form of purees

X(a)X(a)

C  Preserved vegetables:

  • — i) In an aqueous medium

X(a)X(a)
  • — ii) In an oily medium

X(a)X(a)X
  • — iii) In an alcoholic medium (≥ 5% vol)

X(1)X
05Fats and oils
05.01Animal and vegetable fats and oils, whether natural or treated (including cocoa butter, lard, resolidified butter)X
05.02Margarine, butter and other fats and oils made from water emulsions in oilX/2
06Animal products and eggs
06.01Fish:

A  Fresh, chilled, salted, smoked

XX/3(3)

B  In the form of paste

XX/3(3)
06.02Crustaceans and molluscs (including oysters, mussels, snails) not naturally protected by their shellsX
06.03Meat of all zoological species (including poultry and game):

A  Fresh, chilled, salted, smoked

XX/4

B  In the form of paste, creams

XX/4
06.04Processed meat products (ham, salami, bacon and other)XX/4
06.05Preserved and part-preserved meat and fish:

A  In an aqueous medium

X(a)X(a)

B  In an oily medium

X(a)X(a)X
06.06Eggs not in shell:

A  Powdered or dried

B  Other

X
06.07Egg yolks:

A  Liquid

X

B  Powdered or frozen

06.08Dried white of egg
07Milk products
07.01Milk:

A  Whole

X

B  Partly dried

X

C  Skimmed or partly skimmed

X

D  Dried

Fermented milk such as yoghurt, buttermilk and such products in association with fruit and fruit productsX
07.03Cream and sour creamX(a)X(a)
07:04Cheeses:

A  Whole, with rind

B  Processed cheeses

X(a)X(a)

C  All others

X(a)X(a)X/3(3)
07:05Rennet:

A  In liquid or viscous form

X(a)X(a)

B  Powdered or dried

08Miscellaneous products
08.01VinegarX
08.02Fried or roasted foods:

A  Fried potatoes, fritters and the like

X/5

B  Of animal origin

X/4
08.03Preparations for soups, broths in liquid, solid or powder form (extracts, concentrates); homogenized composite food preparations, prepared dishes:

A  Powdered or dried

  • — i) With fatty substances on the surface

X/5
  • — ii) Other

B  Liquid or paste:

  • — i) With fatty substances on the surface

X(a)X(a)X/3
  • — ii) Other

X(a)X(a)
08.04Yeasts and raising agents:

A  In paste form

X(a)X(a)

B  Dried

08.05Salt
08.06

Sauces:

A  Without fatty substances on the surface

X(a)X(a)

B  Mayonnaise, sauces derived from mayonnaise, salad creams and other oil in water emulsions

X(a)X(a)X/3

C  Sauce containing oil and water forming two distinct layers

X(a)X(a)X
08.07Mustard (except powdered mustard under heading 08.17)X(a)X(a)X/3(3)
08.08Sandwiches, toasted bread and the like containing any kind of foodstuff:

A  With fatty substances on the surface

X/5

B  Other

08.09Ice-creamsX
08.10Dried foods:

A  With fatty substances on the surface

X/5

B  Other

08.11Frozen or deep-frozen foods
08.12Concentrated extracts of an alcoholic strength equal to or exceeding 5% volX(1)X
08.13Cocoa:

A  Cocoa powder

X/5(3)

B  Cocoa paste

X/3(3)
08.14Coffee, whether or not roasted, decaffeinated or soluble, coffee substitutes, granulated or powdered
08.15Liquid coffee extractsX
08.16

Aromatic herbs and other herbs:

Camomile, mallow, mint, tea, lime blossom and others

08.17

Spices and seasonings in the natural state:

Cinnamon, cloves, powdered mustard, pepper, vanilla, saffron and other

PART 5Migration Test Conditions (Times and Temperatures)

General criteria

23.  Subject to paragraphs 2, 4, 6 and 7 below and to paragraph 4.4 of Chapter II of the Annex to Directive 82/711, when carrying out migration tests the time and temperature used shall be the time and temperature selected from column 2 of the Table to this Part which correspond to the worst foreseeable conditions of contact specified in column 1 of that Table for the plastic material or article being tested and to any labelling information on maximum temperature for use.

24.  Where the plastic material or article being tested is intended for a food contact application covered by a combination of two or more times and temperatures specified in column 2 of the Table to this Part, the migration test shall be carried out by subjecting the test specimen successively to all the applicable worst foreseeable conditions appropriate to the sample, using the same portion of food simulant.

25.  For the purposes of this Part the worst foreseeable conditions of contact are those which are recognised to be the most severe on the basis of scientific evidence.

Volatile migrants

26.  When carrying out a test of the specific migration of volatile substances any test using a simulant shall be performed in a manner which recognises the loss of volatile migrants which may occur in the worst foreseeable conditions of use.

Special cases

27.  When carrying out a migration test of a plastic material or article which is intended for use in a microwave oven, if the appropriate time and temperature is selected from the table to this Part, either a conventional oven or a microwave oven may be used.

28.  Where the carrying out of a migration test under contact conditions specified in the Table to this Part causes any physical or other change in the test specimen which does not occur under the worst foreseeable conditions of use of the plastic material or article being tested the migration test shall be carried out in the worst foreseeable conditions of use in which such physical or other change does not occur.

29.  Where, in actual use, the plastic material or article being tested is intended to be used for periods of less than 15 minutes at any temperature of not less than 70° C and not more than 100° C and such use is indicated by appropriate labelling or instructions no test other than for 2 hours at 70° C shall be carried out on the plastic material or article unless the plastic material or article is also intended to be used or storage at room temperature in which case no test other than for 10 days test at 40° C shall be carried out.

30.  The Table to this Part shall be read with the notes to it.

Conditions of contact in worse foreseeable useTest conditions
(1)

The period of time which represents the worst foreseeable conditions of contact.

(2)

This temperature shall be used only for simulant D. For simulant A, B or C the test may be replaced by a test at 100° C or at reflux temperature for a duration of four times the time selected in accordance with paragraph 1 of this Part.

Contact time:Test time:
less than or equal to 5 minutes(1)
>5 minutes but less than or equal to 0.5 hours0.5 hours
>0.5 hours but less than or equal to 1 hour1 hour
>1 hour but less than or equal to 2 hours2 hours
>2 hours but less than or equal to 4 hours4 hours
>4 hours but less than or equal to 24 hours24 hours
>24 hours10 days
Contact temperature:Test temperature:
less than or equal to 5°C5°C
>5°C but less than or equal to 20°C20°C
>20°C but less than or equal to 40°C40°C
>40°C but less than or equal to 70°C70°C
>70°C but less than or equal to100°C100°C or reflux temperature
>100°C but less than or equal to 121°C121°C (2)
>121°C but less than or equal to 130°C130°C (2)
>130°C but less than 150°C150°C (2)
>150°C175°C (2)

PART 6Substitute Fat Test for Overall and Specific Migration

31.  Subject to paragraphs 2, 4 and 5, all the test media specified in the Table to this Part shall be used in the substitute fat test for overall or specific migration under the test conditions corresponding to the test conditions for simulant D.

32.  Test conditions other than those specified in the Table to this Part may be used in the substitute fat test if the assumptions underlying the test conditions specified in that Table and, where the plastic material or article being tested is a polymer, the existing experience of that type of polymer are taken into account.

33.  For each test—

(a)a new test specimen shall be used;

(b)the rules prescribed for simulant D in Parts 3, 4 and 5 of this Schedule shall be applied for each test medium;

(c)subject to paragraph 4, compliance with a migration limit shall be determined by selecting the highest value using all the test methods.

34.  Where carrying out a migration test causes any physical or other change in the test specimen which does not occur under the worst foreseeable conditions of use of the plastic material or article the result of that test shall not be used to ascertain compliance with a migration limit.

35.  Any test conditions in the Table to this Part which are generally recognised on the basis of scientific evidence as not being appropriate for the material or article to be tested shall not be used.

36.  The Table to this Part shall be read with the notes to it.

CONVENTIONAL CONDITIONS FOR SUBSTITUTE TESTS

Test conditions with simulant DTest conditions with isooctaneTest conditions with ethanol 95%Test conditions with MPPO(1)
(1)

MPPO = Modified polyphenylene oxide

(2)

The volatile test media are used up to a maximum temperature of 60°C. A precondition of using these tests is that the material or article will withstand the test conditions that would otherwise be used with simulant D. Immerse a test specimen in olive oil under the appropriate conditions. If the physical properties are changed (eg melting, deformation) then the material is considered unsuitable for use at that temperature. If the physical properties are not changed then proceed with the substitute tests using new specimens.

10 days at 5°C0.5 days at 5°C10 days at 5°C
10 days at 20°C1 day at 20°C10 days at 20°C
10 days at 40°C2 days at 20°C10 days at 40°C
2 hours at 70°C0.5 hours at 40°C2 hours at 60°C
0.5 hours at 100°C0.5 hours at 60°C(2)2.5 hours at 60°C0.5 hours at 100°C
1 hour at 100°C1 hour at 60°C(2)3 hours at 60°C(2)1 hour at 100°C
2 hours at 100°C1.5 hours at 60°C(2)3.5 hours at 60°C(2)2 hours at 100°C
0.5 hours at 121°C1.5 hours at 60°C(2)3.5 hours at 60°C(2)0.5 hours at 121°C
1 hour at 121°C2 hours at 60°C(2)4 hours at 60°C(2)1 hour at 121°C
2 hours at 121°C2.5 hours at 60°C4.5 hours at 60°C(2)2 hours at 121°C
0.5 hours at 130°C2 hours at 60°C(2)4 hours at 60°C(2)0.5 hours at 130°C
1 hour at 130°C2.5 hours at 60°C(2)4.5 hours at 60°C(2)1 hour at 130°C
2 hours at 150°C3 hours at 60°C(2)5 hours at 60°C(2)2 hours at 150°C
2 hours at 175°C4 hours at 60°C(2)6 hours at 60°C2 hours at 175°C

PART 7Alternative Fat Tests for Overall and Specific Migration

37.  Subject to paragraph 2 of this Part the conditions which must be fulfilled to allow the result of either test specified in paragraph 3 be used as an alternative to the result of a migration test carried out under Part 3 are that—

(a)the result obtained in a “comparison test” shows that the values are equal to or greater than those obtained in the test with simulant D; and

(b)the migration occurring in either test specified in paragraph 3 does not, after application of the appropriate reduction factor, exceed the appropriate migration limit.

38.  The condition in sub-paragraph (a) of paragraph 1 does not have to be fulfilled if it can be shown on the basis of the result of scientific experiment that the values obtained in either of the tests specified in paragraph 3 are equal to or greater than those obtained in any of the migration tests specified in Part 3.

39.  The migration tests referred to in paragraphs 2 and 3 are —

(a)a test carried out using volatile media including isooctane, ethanol 95%, other volatile solvents or a mixture of solvents at such contact conditions as would result in values equal to or greater than those obtained in a test using simulant D;

(b)other tests using media having a very strong extraction power under very severe test conditions where, on the basis of scientific evidence, it is generally recognised that the results using these tests are equal to or higher than those obtained in a test using simulant D.

(1)

OJ No. L338, 13.11.2004, p.4

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