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

Type Scottish-Statutory-Instrument
Publication 2006-06-07
State In force
Jurisdiction Scotland
Department Queen's Printer for Scotland
Source legislation.gov.uk
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articles Not indexed
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  • (3) If, as indicated in paragraph 2 of Annex II, a substance is identified in Part 1 of this Schedule as an “… acid, salt” and has salts of one or more 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.

SCHEDULE 2 — Authorised Additives

PART 1 — Incomplete 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 2 3 4
PM/REF No. CAS No. Name Restrictions and specifications
1 30000 000064-19-7 Acetic acid
2 30045 000123-86-4 Acetic acid, butyl ester
2A 30080 004180-12-5 Acetic acid, copper salt SML(T) = 30 mg/kg (7) (expressed as copper)
3 30140 000141-78-6 Acetic acid, ethyl ester
4 30280 000108-24-7 Acetic anhydride
5 30295 000067-64-1 Acetone
6 30370 – Acetylacetic acid, salts
7 30400 – Acetylated glycerides
7A 30610 – Acids 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)
7B 30612 – Acids C2–C24 aliphatic linear, monocarboxylic, synthetic and their mono-, di- and triglycerol esters
8 30960 – Acids, aliphatic, monocarboxylic (C6–C22), esters with polyglycerol
9 31328 – Acids, fatty, from animal or vegetable foods fats and oils
9A 31530 123968-25-2 Acrylic acid, 2,4-di-tert-pentyl-6[1(3,5-di-tert-pentyl-2- hydroxyphenyl) ethyl] phenyl ester The specific migration of this substance shall not exceed 5 mg/kg
10 31730 000124-04-9 Adipic acid
11 33120 – Alcohol's, aliphatic, monohydric, saturated, linear, primary (C4–C24)
12 33350 009005-32-7 Alginic acid
12A 33801 – n-Alkyl (C10–C13) benzenesulphonic acid The specific migration of this substance shall not exceed 30 mg/kg
13 34281 – Alkyl (C8–C22) sulphuric acids, linear, primary, with an even number of carbon atoms
14 34475 – Aluminium calcium hydroxide phosphite, hydrate
15 34480 – Aluminium fibres, flakes and powders
16 34560 021645-51-2 Aluminium hydroxide
17 34690 011097-59-9 Aluminium magnesium carbonate hydroxide
18 34720 001344-28-1 Aluminium oxide
18A 34850 143925-92-2 Amines, bis (hydrogenated tallow alkyl) oxidised QM = For use only: 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; 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
18B 34895 000088-68-6 2-Aminobenzamide SML – 0.5 mg/kg To be used only for PET for water and beverages
19 35120 013560-49-1 3-Aminocronic acid, diester with thiobis (2-hydroxyethyl) ether
19A 35160 006642-31-5 6-Amino-1,3-dimethyluracil SML = 5 mg/kg
19B 35170 000141-53-5 2-Aminoethanol SML = 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
19C 35284 000111-41-1 N-(2-aminoethyl) ethanolamine SML = 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
20 35320 007664-41-7 Ammonia
21 35440 001214-97-9 Ammonium bromide
22 35600 001336-21-6 Ammonium hydroxide
23 35840 000506-30-9 Arachidic acid
24 35845 007771-44-0 Arachidonic acid
25 36000 000050-81-7 Ascorbic acid
26 36080 000137-66-6 Ascorbyl palmitate
27 36160 010605-09-1 Ascorbyl stearate
27B 36840 12007-55-5 Barium tetraborate SML(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
28 36880 008012-89-3 Beeswax
29 36960 003061-75-4 Behenamide
30 37040 000112-85-6 Behenic acid
31 37280 001302-78-9 Bentonite
31A 37360 000100-52-7 Benzaldehyde (10)
32 37600 000065-85-0 Benzoic acid
33 37680 000136-60-7 Benzoic acid, butyl ester
34 37840 000093-89-0 Benzoic acid, ethyl ester
35 38080 000093-58-3 Benzoic acid, methyl ester
36 38160 002315-68-6 Benzoic acid, propyl ester
36A 38320 005242-49-9 4-(2-benzoxazolyl)-4'- (5-methyl-2-benzoxazolyl) stilbene In compliance with the specifications laid down in Schedule 4
36B 38510 136504-96-6 1,2-Bis(3-aminopropyl) ethylenediamine, polymer with N-butyl-2,2,6,6-tetramethyl-4-piperidinamine and 2,4,6-trichloro-1,3,5-triazine The specific migration of this substance shall not exceed 5 mg/kg
36C 38515 001533-45-5 4,4'-Bis(2-benzoxazolyl) stilbene The specific migration of this substance shall not exceed 0.05 mg/kg (1)
36D 38810 080693-00-1 Bis(2,6-di-tert-butyl-4-methylphenyl) pentaerythritol diphosphite The specific migration of this substance shall not exceed 5 mg/kg (sum of phosphite and phosphate)
36E 38840 154862-43-8 Bis(2,4-dicumylphenyl) pentaerythritoldiphosphite SML = 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)
36F 38879 135861-56-2 Bis (3,4-dimethylbenzylidene) sorbitol
37 38950 079072-96-1 Bis(4-ethylbenzylidene) sorbitol
37A 39200 006200-40-4 Bis (2-hydroxyethyl)-2-hydroxypropyl-3-(dodecyloxy) methylammonium chloride The specific migration of this substance shall not exceed 1.8 mg/kg
37AA 39680 000080-05-7 2,2-Bis(4-hydroxyphenyl) propane SML(T) = 0.6 mg/kg (28)
37B 39815 182121-12-6 9,9-Bis(methoxymethyl) fluorene The quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 dm²
38 39890 087826-41-3 Bis(methylbenzylidene) sorbitol
069158-41-4 Ditto
054686-97-4 Ditto
081541-12-0 Ditto
38A 39925 129228-21-3 3,3-Bis (methoxymethyl)- 2,5-dimethyl hexane SML = 0.05 mg/kg
38B 40120 068951-50-8 Bis(polyethyleneglycol) hydroxymethylphosphonate SML = 0.6 mg/kg
38C 40320 010043-35-3 Boric acid SML(T) = 6 mg/kg (22) (expressed as boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption
39 40400 010043-11-5 Boron nitride
40 40570 000106-97-8 Butane
40A 40580 000110-63-4 1,4,-Butanediol SML(T) = 0.05 mg/kg (23)
41 41040 005743-36-2 Calcium butyrate
41A 41120 010043-52-4 Calcium chloride
42 41280 001305-62-0 Calcium hydroxide
43 41520 001305-78-8 Calcium oxide
44 41600 012004-14-7 Calcium sulphoaluminate
037293-22-4 Ditto
44A 41680 000076-22-2 Camphor (10)
45 41760 008006-44-8 Candelilla wax
45A 41840 000105-60-2 Caprolactam SML(T) = 15 mg/kg (5)
46 41960 000124-07-2 Caprylic acid
47 42160 000124-38-9 Carbon dioxide
47A 42320 007492-68-4 Carbonic acid, copper salt SML(T) = 30 mg/kg (7) (expressed as copper)
48 42500 – Carbonic acid, salts
49 42640 009000-11-7 Carboxymethylcellulose
50 42720 008015-86-9 Carnauba wax
51 42800 009000-71-9 Casein
51A 42880 008001-79-4 Castor oil
52 42960 064147-40-6 Castor oil, dehydrated
53 43200 – Castor oil, mono- and diglycerides
54 43280 009004-34-6 Cellulose
55 43300 009004-36-8 Cellulose acetate butyrate
56 43360 068442-85-3 Cellulose, regenerated
57 43440 008001-75-0 Ceresin
57A 43515 – Chlorides of choline esters of coconut oil fatty acids The quantity of this substance in the finished plastic material or article shall not exceed 0.9 mg/ 6 dm²
58 44160 000077-92-9 Citric acid
59 44640 000077-93-0 Citric acid, triethyl ester
59A 45195 007787-70-4 Copper bromide SML(T) = 30 mg/kg (7) (expressed as copper)
59B 45200 001335-23-5 Copper iodide SML(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)
60 45280 – Cotton fibres
60A 45450 068610-51-5 p-Cresol-dicyclopentadiene-isobutylene, copolymer SML = 5 mg/kg
61 45560 014464-46-1 Cristobalite
61A 45600 003724-65-0 Crotonic acid QMA(T) = 0.05 mg/ 6 dm²(33)
61B 45640 005232-99-5 2-Cyano-3, 3-dipheneylacrylic acid, ethyl ester SML = 0.05 mg/kg
62 45760 000108-91-8 Cyclohexylamine
63 45920 009000-16-2 Dammar
64 45940 000334-48-5 n-Decanoic acid
65 46070 010016-20-3 Alpha-Dextrin
66 46080 007585-39-9 Beta-Dextrin
67 46375 061790-53-2 Diatomaceous earth
68 46380 068855-54-9 Diatomaceous earth. Soda ash flux-calcined
69 46480 032647-67-9 Dibenzylidene sorbitol
69A 46700 – 5,7-di-tert-Butyl-3- (3,4- and 2,3-dimethylphenyl)-3H-benzofuran-2-one containing: 5,7-di-tert-butyl-3-(3,4-dimethylphenyl)-3H-benzofuran-2-one (80–100% w/w); and 5,7-di-tert-butyl-3-(2,3-dimethylphenyl)-3H-benzofuran-2-one (0–20% w/w) SML = 5 mg/kg
69B 46720 004130-42-1 2,6-Di-tert-butyl-4-ethylphenol QMA = 4.8 mg/ 6 dm²
70 46790 004221-80-1 3,5-Di-tert-butyl-4-hydroxybenzoic acid, 2,4-di-tert-butylphenyl ester
71 46800 067845-93-6 3,5-Di-tert-butyl-4-hydroxybenzoic acid, hexadecyl ester
72 46870 003135-18-0 3,5-Di-tert-butyl-4-hydroxybenzylphosphonic acid, dioctadecyl ester
72A 46880 065140-91-2 3,5-Di-tert-butyl-4-hydroxybenzyl phosphonic acid, monoethyl ester, calcium salt The specific migration of this substance shall not exceed 6 mg/kg
72B 47210 26427-07-6 Dibutylthiostannoic acid polymer [= thiobis(butyl-tin sulphide), polymer] In compliance with this specifications laid down in Schedule 4
73 47440 000461-58-5 Dicyanodiamide
73A 47540 027458-90-8 Di-tert-dodecyl disulfide SML – 0.05 mg/kg
73B 47680 000111-46-6 Diethyleneglycol SML(T) = 30 mg/kg (3)
73C 48460 000075-37-6 1,1-Difluoroethane
73D 48620 000123-31-9 1,4-Dihydroxybenzene SML = 0.6 mg/kg
73E 48720 000611-99-4 4,4'Dihydroxybenzophenone SML(T) = 6 mg/kg (14)
73F 49485 134701-20-5 2,4-Dimethyl-6-(1-methylpentadecyl) phenol The specific migration of this substance shall not exceed 1 mg/kg
74 49540 000067-68-5 Dimethyl sulphoxide
75 51200 000126-58-9 Dipentaerythritol
75A 51700 147315-50-2 2-(4,6-Diphenyl-1,3,5-triazin-2-yl)-5- (hexyloxy) phenol The specific migration of this substance shall not exceed 0.05 mg/kg
76 51760 025265-71-8 Dipropyleneglycol
000110-98-5 Ditto
77 52640 016389-88-1 Dolomite
77A 52645 010436-08-5 Cis-11-eicosenamide
78 52720 000112-84-5 Erucamide
79 52730 000112-86-7 Erucic acid
80 52800 000064-17-5 Ethanol
81 53270 037205-99-5 Ethylcarboxymethylcellulose
82 53280 009004-57-3 Ethylcellulose
83 53360 000110-31-6 N,N'-Ethylenebisoleamide
84 53440 005518-18-3 N,N'-Ethylenebispalmitamide
85 53520 000110-30-5 N,N'-Ethylenebisstearamide
86 53600 000060-00-4 Ethylenediaminetetraacetic acid
86A 53610 054453-03-1 Ethylenediaminetetraacetic acid, copper salt SML(T) = 30 mg/kg (7) (expressed as copper) (3)
86B 53650 000107-21-1 Ethyleneglycol SML(T) = 30 mg/kg
87 54005 005136-44-7 Ethylene-N-palmitamide-N'-stearamide
88 54260 009004-58-4 Ethylhydroxyethylcellulose
89 54270 – Ethylhydroxymethylcellulose
90 54280 – Ethylhydroxypropylcellulose
90A 54300 118337-09-0 2,2'-Ethylidenebis (4,6-di-tert-butylphenyl) fluorophosphonite The specific migration of this substance shall not exceed 6 mg/kg
91 54450 – Fats and oils, from animal or vegetable food sources
92 54480 – Fats and oils, hydrogenated, from animal or vegetable food sources
92A 54930 025359-91-5 Formaldehyde-1-naphthol, copolymer [ = Poly (1-hydroxynaphthyl-methane)] The specific migration of this substance shall not exceed 0.05 mg/kg
93 55040 000064-18-6 Formic acid
94 55120 000110-17-8 Fumaric acid
95 55190 029204-02-2 Gadoleic acid
96 55440 009000-70-8 Gelatine
97 55520 – Glass fibres
98 55600 – Glass microballs
99 55680 000110-94-1 Glutaric acid
100 55920 000056-81-5 Glycerol
101 56020 099880-64-5 Glycerol dibehenate
102 56360 – Glycerol, esters with acetic acid
103 56486 – Glycerol, 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)
104 56487 – Glycerol, esters with butyric acid
105 56490 – Glycerol, esters with erucic acid
106 56495 – Glycerol, esters with 12-hydroxystearic acid
107 56500 – Glycerol, esters with lauric acid
108 56510 – Glycerol, esters with linoleic acid
109 56520 – Glycerol, esters with myristic acid
109A 56535 – Glycerol, esters with nonanoic acid
110 56540 – Glycerol, esters with oleic acid
111 56550 – Glycerol, esters with palmitic acid
113 56570 – Glycerol, esters with propionic acid
114 56580 – Glycerol, esters with ricinoleic acid
115 56585 – Glycerol, esters with stearic acid
116 56610 030233-64-8 Glycerol monobehenate
117 56720 026402-23-3 Glycerol monohexanoate
118 56800 030899-62-8 Glycerol monolaurate diacetate
119 56880 026402-26-6 Glycerol monooctanoate
120 57040 – Glycerol monooleate, ester with ascorbic acid
121 57120 – Glycerol monooleate, ester with citric acid
122 57200 – Glycerol monopalmitate, ester with ascorbic acid
123 52780 – Glycerol monopalmitate, ester with citric acid
124 57600 – Glycerol monostearate, ester with ascorbic acid
125 57680 – Glycerol monostearate, ester with citric acid
125A 57800 018641-57-1 Glycerol tribehenate
126 57920 000620-67-7 Glycerol triheptanoate
127 58300 – Glycine, salts
128 58320 007782-42-5 Graphite
129 58400 009000-30-0 Guar gum
130 58480 009000-01-5 Gum arabic
131 58720 000111-14-8 Heptanoic acid
131A 59280 000100-97-0 Hexamethylenetetramine SML(T) = 15 mg/kg (21) (expressed as Formaldehyde)
132 59360 000142-62-1 Hexanoic acid
133 59760 019569-21-2 Huntite
134 59990 007647-01-0 Hydrochloric acid
135 60030 012072-90-1 Hydromagnesite
136 60080 012304-65-3 Hydrotalcite
137 60160 000120-47-8 4-Hydroxybenzoic acid, ethyl ester
138 60180 004191-73-5 4-Hydroxybenzoic acid, isopropyl ester
139 60200 000099-76-3 4-Hydroxybenzoic acid, methyl ester
140 60240 000094-13-3 4-Hydroxybenzoic acid, propyl ester
140A 60480 003864-99-1 2-(2-Hydroxy-3,5,-di-tert-butylphenyl)-5-chlorobenzotriazole SML(T) = 30 mg/kg (18)
141 60560 009004-62-0 Hydroxyethylcellulose
142 60880 009032-42-2 Hydroxyethylmethylcellulose
143 61120 009005-27-0 Hydroxyethyl starch
144 61390 037353-59-6 Hydroxymethylcellulose
145 61680 009004-64-2 Hydroxypropylcellulose
146 61800 009049-76-7 Hydroxypropyl starch
146 61840 000106-14-9 12-Hydroxystearic acid
148 62140 006303-21-5 Hypophosphorous acid
149 62240 001332-37-2 Iron oxide
150 62450 000078-78-4 Isopentane
151 62640 008001-39-6 Japan wax
152 62720 001332-58-7 Kaolin
153 62800 – Kaolin, calcined
154 62960 000050-21-5 Lactic acid
155 63040 000138-22-7 Lactic acid, butyl ester
156 63280 000143-07-7 Lauric acid
157 63760 008002-43-5 Lecithin
158 63840 000123-76-2 Levulinic acid
159 63920 000557-59-5 Lignoceric acid
160 64015 000060-33-3 Linoleic acid
161 64150 028290-79-1 Linolenic acid
162 64500 – Lysine, salts
163 64640 001309-42-8 Magnesium hydroxide
164 64720 001309-48-4 Magnesium oxide
164A 64800 00110-16-7 Maleic acid SML(T) = 30 mg/kg(4)
165 65020 006915-15-7 Malic acid
166 65040 000141-82-2 Malonic acid
167 65520 000087-78-5 Mannitol
167A 65920 066822-60-4 N-methacryloyloxyethyl-N,N-dimethyl-N- carboxymethyl-ammonium chloride, sodium salt-octadecyl methacrylate-ethyl methacrylate -cyclohexyl methacrylate-N-vinyl-2-pyrrolidone, copolymers
168 66200 037206-01-2 Methylcarboxymethylcellulose
169 66240 009004-67-5 Methylcellulose
169A 66560 004066-02-8 2,2'-Methylenebis (4-methyl-6-cyclohexylphenol) SML(T) = 3 mg/kg (6)
169B 66580 000077-62-3 2,2'-Methylenebis (4-methyl-6-(1-methylcyclo-hexyl) phenol) SML(T) = 3 mg/kg (6)
170 66640 009004-59-5 Methylethylcellulose
171 66695 – Methylhydroxymethylcellulose
172 66700 009004-65-3 Methylhydroxypropylcellulose
172A 66755 002682-20-4 2-Methyl-4-isothiazolin-3-one The 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
173 67120 012001-26-2 Mica
173B 67180 – Mixture of (50% w/w) phthalic acid n-decyl n-octyl ester, (25% w/w) phthalic acid di-n-decyl ester, and (25% w/w) phthalic acid di-n-octyl ester The specific migration of this substance shall not exceed 5 mg/kg (1)
174 67200 001317-33-5 Molybdenum disulphide
175 67840 – Montanic acids and/or their esters with ethyleneglycol and/or with 1,3-butanediol and/or with glycerol
176 67850 008002-53-7 Montan wax
177 67891 000544-63-8 Myristic acid
178 68040 003333-62-8 7-(2H-Naphtho-(1,2-D) triazol-2-yl)-3-phenylcoumarin
178A 68078 027253-31-2 Neodecanoic acid, cobalt salt SML(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
179 68125 037244-96-5 Nepheline syenite
179A 68145 080410-33-9 2,2',2"-Nitrilo(triethyl tris (3,3',5,5'- tetra-tert-butyl-1-1'-bi-phenyl-2-2-diyl) phosphite) The specific migration of this substance shall not exceed 5 mg/kg (sum of phosphite and phosphate)
180 68960 000301-02-0 Oleamide
181 69040 000112-80-1 Oleic acid
182 69760 000143-28-2 Oleyl alcohol
182A 69920 000144-62-7 Oxalic acid SML(T) = 6 mg/kg (29)
183 70000 070331-94-1 2,2'-Oxamidobis(ethyl-3-(3,5-di-tert-butyl-4- hydroxyphenyl) propionate)
184 70240 012198-93-5 Ozokerite
185 70400 000057-10-3 Palmitic acid
186 71020 000373-49-9 Palmitoleic acid
187 71440 009000-69-5 Pectin
188 71600 000115-77-5 Pentaerythritol
188A 71635 025151-96-6 Pentaerythritol dioleate The 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
188B 71670 178671-58-4 Pentaerythritol tetrakis (2-cyano-3,3-diphenylacrylate) SML = 0.05 mg/kg
189 71680 006683-19-8 Pentaerythritol tetrakis [-3-(3,5-di-tert-butyl-4- hydroxyphenyl) propionate]
190 71720 000109-66-0 Pentane
191 72640 007664-38-2 Phosphoric acid
191A 73160 Phosphoric acid, mono- and di-n-alkyl (C16 and C18) esters SML = 0.05 mg/kg
191B 73720 000115-96-8 Phosphoric acid, trichloroethyl ester The 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
191C 74010 145650-60-8 Phosphorous acid, bis (2,4-di-tert-butyl-6- methylphenyl) ethyl ester The specific migration of this substance shall not exceed 5 mg/kg (covering the sum of phosphite and phosphate)
192 74240 031570-04-4 Phosphorous acid, tris (2,4-di-tert-butylphenyl) ester
193 74480 000088-99-3 o-Phthalic acid
194 76320 000085-44-9 Phthalic anhydride
195A 76721 009016-00-6 063148-62-9 Polydimethylsiloxane (Mw > 6800) In compliance with the specifications laid down in Schedule 4
195B 76730 Polydimethylsiloxane, gamma-hydroxypropylated SML = 6 mg/kg
195D 76865 – 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
196 76960 025322-68-3 Polyethyleneglycol
197 77600 061788-85-0 Polyethyleneglycol ester of hydrogenated caster oil
198 77702 – Polyethyleneglycol esters of aliphatic monocarboxylic acids (C6–C22), and their ammonium and sodium sulphates
198A 77895 068439-49-6 Polyethyleneglycol (EO = 2–6) monoalkyl (C₁₆–C₁₈) ether SML = 0.05 mg/kg and in compliance with the specifications laid down in Schedule 4
199 79040 009005-64-5 Polyethyleneglycol sorbitan monolaurate
200 79120 009005-65-6 Polyethyleneglycol sorbitan monooleate
201 79200 009005-66-7 Polyethyleneglycol sorbitan monopalmitate
202 79280 009005-67-8 Polyethyleneglycol sorbitan monostearate
203 79360 009005-70-3 Polyethyleneglycol sorbitan trioleate
204 79440 009005-71-4 Polyethyleneglycol sorbitan tristearate
205 80240 029894-35-7 Polyglycerol ricinoleate
206 80640 – Polyoxyalkyl (C2–C4) dimethylpolysiloxane
207 80720 008017-16-1 Polyphosphoric acids
208 80800 025322-69-4 Polypropyleneglycol
208A 81220 192268-64-7 Poly-[[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-diamine SML = 5 mg/kg
208B 81515 087189-25-1 Poly (zinc glycerolate)
209 81520 007758-02-3 Potassium bromide
210 81660 001310-58-3 Potassium hydroxide
210A 81760 – Powders, flakes and fibres of brass, bronze, copper, stainless steel, tin and alloys of copper, tin and iron SML(T) = 30 mg/kg (7) (expressed as copper); the specific migration of this substance shall not exceed 48 mg/kg (expressed as iron)
211 81840 000057-55-6 1,2-Propanediol
212 81882 000067-63-0 2-Propanol
213 82000 000079-09-4 Propionic acid
214 82080 009005-37-2 1,2-Propyleneglycol alginate
215 82240 022788-19-8 1,2-Propyleneglycol dilaurate
216 82400 000105-62-4 1,2-Propyleneglycol dioleate
217 82560 033587-20-1 1,2-Propyleneglycol dipalmitate
218 82720 006182-11-2 1,2-Propyleneglycol distearate
219 82800 027194-74-7 1,2-Propyleneglycol monolaurate
220 82960 001330-80-9 1,2-Propyleneglycol monooleate
221 83120 029013-28-3 1,2-Propyleneglycol monopalmitate
222 83300 001323-39-3 1,2-Propyleneglycol monostearate
223 83320 – Propylhydroxyethylcellulose
224 83325 – Propylhydroxymethylcellulose
225 83330 – Propylhydroxypropylcellulose
226 83440 002466-09-3 Pyrophosphoric acid
227 83455 013445-56-2 Pyrophosphorous acid
228 83460 012269-78-2 Pyrophyllite
229 83470 014808-60-7 Quartz
229A 83599 068442-12-6 Reaction products of oleic acid, 2-mercaptoethyl ester, with dichlorodimethyltin, sodium sulphide and trichloromethyltin SML(T) = 0.18 mg/kg (15) (expressed as tin)
230 83610 073138-82-6 Resin acids and rosin acids
231 83840 008050-09-6 Rosin
232 84000 008050-31-5 Rosin, ester with glycerol
233 84080 008050-26-8 Rosin, ester with pentaerythritol
234 84210 065997-06-0 Rosin, hydrogenated
235 84240 065997-13-9 Rosin, hydrogenated, ester with glycerol
236 84320 008050-15-5 Rosin, hydrogenated, ester with methanol
237 84400 064365-17-9 Rosin, hydrogenated, ester with pentaerythritol
238 84560 009006-04-6 Rubber, natural
239 84640 000069-72-7 Salicylic acid
239A 85360 000109-43-3 Sebacic acid, dibutyl ester
240A 85610 – Silicates, natural, silanated (with the exception of asbestos)
240ZA 85601 – Silicates, natural, (with the exception of asbestos)
240B 85680 001343-98-2 Silicic acid
240C 85840 053320-86-8 Silicic acid, lithium magnesium sodium salt SML(T) = 0.6 mg/kg (8) (expressed as lithium)
242 86000 – Silicic acid, silylated
243 86160 000409-21-2 Silicon carbide
244 86240 007631-86-9 Silicon dioxide
244A 86285 – Silicon dioxide, silanated
245 86560 007647-15-6 Sodium bromide
246 86720 001310-73-2 Sodium hydroxide
246A 87040 001330-43-4 Sodium tetraborate SML(T) = 6 mg/kg (22) (expressed as boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption
247 87200 000110-44-1 Sorbic acid
248 87280 029116-98-1 Sorbitan dioleate
249 87520 062568-11-0 Sorbitan monobehenate
250 87600 001338-39-2 Sorbitan monolaurate
251 87680 001338-43-8 Sorbitan monooleate
252 87760 026266-57-9 Sorbitan monopalmitate
253 87840 001338-41-6 Sorbitan monostearate
254 87920 061752-68-9 Sorbitan tetrastearate
255 88080 026266-58-0 Sorbitan trioleate
256 88160 054141-20-4 Sorbitan tripalmitate
257 88240 026658-19-5 Sorbitan tristearate
258 88320 000050-70-4 Sorbitol
259 88600 026836-47-5 Sorbitol monostearate
259A 88640 008013-07-8 Soybean oil, epoxidized In compliance with the specifications laid down in Schedule 4
260 88800 009005-25-8 Starch, edible
261 88880 068412-29-3 Starch, hydrolysed
262 88960 000124-26-5 Stearamide
263 89040 000057-11-4 Stearic acid
263A 89200 007617-31-4 Stearic acid, copper salt SML(T) = 30 mg/kg (7) (expressed as copper)
263B 89440 – Stearic acid, esters with ethyleneglycol SML(T) = 30 mg/kg (3)
264 90720 058446-52-9 Stearoylbenzoylmethane
265 90800 005793-94-2 Stearoyl-2-lactylic acid, calcium salt
266 90960 000110-15-6 Succinic acid
267 91200 000126-13-6 Sucrose acetate isobutyrate
268 91360 000126-14-7 Sucrose octaacetate
269 91840 007704-34-9 Sulphur
270 91920 007664-93-9 Sulphuric acid
270A 92030 010124-44-4 Sulphuric acid, copper salt SML(T) = 30 mg/kg (7) (expressed as copper)
271 92080 014807-96-6 Talc
271A 92150 001401-55-4 Tannic acids According to the JECFA specifications
272 92160 000087-69-4 Tartaric acid
273 92195 – Taurine, salts
274 92205 057569-40-1 Terephthalic acid, diester with 2,2'-methylenebis (4-methyl-6-tert-butylphenol)
275 92350 000112-60-7 Tetraethyleneglycol
276 92640 000102-60-3 N,N,N',N'- Tetrakis (2-hydroxypropyl) ethylenediamine
276A 92700 078301-43-6 2,2,4,4- Tetramethyl-20-(2,3- epoxypropyl)- 7-oxa-3,20-diazadispiro-[5.1.11.2]-heneicosan-21-one, polymer The specific migration of this substance shall not exceed 5 mg/kg
276B 92930 120218-34-0 Thiodiethanolbis (5-methoxycarbonyl-2,6-dimethyl-1,4-dihydropridine-3-carboxylate) The specific migration of this substance shall not exceed 6 mg/kg
277 93440 013463-67-7 Titanium dioxide
278 93520 000059-02-9 alpha-Tocopherol
010191-41-0 Ditto
279 93680 009000-65-1 Tragacanth gum
279A 93720 000108-78-1 2,4,6-Triamino-1,3,5-triazine SML = 30 mg/kg
280 94320 000112-27-6 Triethyleneglycol
280A 94960 000077-99-6 1,1,1-Trimethylolpropane The specific migration of this substance shall not exceed 6 mg/kg
280B 95000 028931-67-1 Trimethylolpropane trimethacrylatemethyl methacrylate copolymer
281 95200 001709-70-2 1,3,5-Trimethyl-2,4,6-tris (3,5-di-tert-butyl-4- hydroxybenzyl) benzene
281A 95270 161717-32-4 2,4,6-Tris(tert-butyl) phenyl 2-butyl-2-ethyl-1,3-propanediol phosphite SML = 2 mg/kg (as sum of phosphite, phosphate and the hydrolysis product = TTBP)
281B 95725 110638-71-6 Vermiculite, reaction product with citric acid, lithium salt SML(T) = 0.6 mg/kg (8) (expressed as lithium)
281C 95855 007732-18-5 Water In compliance with Directive 98/83/EC
281D 95859 – Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks In compliance with the specifications laid down in Schedule 4
281E 95883 – White mineral oils, paraffinic, derived from petroleum based hydrocarbon feedstocks In compliance with the specifications laid down in Schedule 4
282 95905 013983-17-0 Wollastonite
283 95920 – Wood flour and fibres, untreated
284 95935 011138-66-2 Xanthan gum
285 91690 020427-58-1 Zinc hydroxide
286 96240 001314-13-2 Zinc oxide
287 96320 001314-98-3 Zinc sulphide

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

Item 1 2 3 4
PM/REF No. CAS No Name Restrictions and specifications
1 30180 002180-18-9 Acetic acid, manganese salt SML(T) = 0.6 mg/kg (9) (expressed as manganese)
2 31520 061167-58-6 Acrylic acid, 2-tert-butyl- 6-(3-tert- butyl- 2-hydroxy-5-methylbenzyl)-4-methylphenyl ester SML = 6 mg/kg
3 31920 000103-23-1 Adipic acid, bis (2-ethylhexyl) ester SML = 18 mg/kg (1)
4 34230 Alkyl (C8-C22) sulphonic acids SML = 6 mg/kg
4A 34650 151841-65-5 Aluminium hydroxybis [2,2'-methylenebis (4,6-di-tert-butylphenyl)] phosphate SML = 5 mg/kg
5 35760 001309-64-4 Antimony trioxide SML = 0.02 mg/kg (expressed as anti-monium and analytical tolerance included)
6 36720 017194-00-2 Barium hydroxide SML(T) = 1 mg/kg (11) (expressed as barium)
7 36800 010022-31-8 Barium nitrate SML(T) = 1 mg/kg (11) (expressed as barium)
7A 38000 000553-54-8 Benzoic acid, lithium salt SML(T) = 0.6 mg/kg (8) (expressed as lithium)
8 38240 000119-61-9 Benzophenone SML = 0.6 mg/kg
9 38560 007128-64-5 2,5-Bis (5-tert-butyl-2-benzoxazolyl) thiophene SML = 0.6 mg/kg
10 38700 063397-60-4 Bis (2-carbobutoxyethyl) tin-bis (isooctylmercaptoacetate) SML = 18 mg/kg
11 38800 032687-78-8 N,N'-Bis (3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionyl) hydrazide SML = 15 mg/kg
12 38820 026741-53-7 Bis (2,4-di-tert-butylphenyl) pentaery-thritol diphosphite SML = 0.6 mg/kg
13 39060 035958-30-6 1,1-Bis (2-hydroxy-3, 5-di-tert-butylphenyl) ethane SML = 5 mg/kg
14 39090 N,N-bis (2-hydroxyethyl) alkyl (C8–C18) amine SML(T) = 1.2 mg/kg (12)
15 39120 N,N-bis (2-hydroxyethyl)-alkyl (C8–C18) amine hydrochlorides SML(T) = 1.2 mg/kg (12) expressed as tertiary amine (expressed excluding HCI)
16 40000 00991-84-4 2,4-Bis (octylmercapto)-6- (4-hydroxy- 3,5,di-tert-butylanilino) - 1,3,5-triazine SML = 30 mg/kg
17 40020 110553-27-0 2,4-Bis (octylthiomethyl) - 6-methylphenol SML = 6 mg/kg
18 40160 61269-61-2 N,N'-bis (2,2,6,6-tetramethyl-4-piperidyl) hexamethy-lenediamine- 1,2-dibromoethane, copolymer SML = 2.4 mg/kg
18A 40720 025013-16-5 Tert-butyl- 4-hydroxyanisole (= BHA) SML = 30 mg/kg
19 40800 13003-12-8 4,4'-butylidene-bis (6-tert-butyl-3-methylphenyl-ditridecyl phosphite) SML = 6 mg/kg
20 409080 19664-95-0 Butyric acid, manganese salt SML(T) = 0.6 mg/kg (9) (expressed as manganese)
21 42000 63438-80-2 (2-carbobutoxyethyl) tin-tris (isooctylmercaptoacetate) SML = 30 mg/kg
22 42400 010377-37-4 Carbonic acid, lithium salt SML(T) = 0.6 mg/kg (8) (expressed as lithium)
23 42480 000584-09-8 Carbonic acid, rubidium salt SML = 12 mg/kg
24 43600 004080-31-3 1- (3- Chloroallyl) - 3,5,7 -triaza-1-azoniaadamantane chloride SML = 0.3 mg/kg
25 43680 000075-45-6 Chlorodifluoromethane SML = 6 mg/kg and in compliance with the specifications laid down in Schedule 4
26 44960 011104-61-3 Cobalt oxide SML(T) = 0.05 mg/kg (13) (expressed as cobalt)
27 45440 – Cresols, butylated, styrenated SML = 12 mg/kg
27A 45650 06197-30-4 2-Cyano-3,3-diphenylacrylic acid, 2-ethylhexyl ester SML = 0.05 mg/kg
27B 46640 000128-37-0 2,6-di-tert-butyl-p-cresol (= BHT) SML = 3.0 mg/kg
29 47600 084030-61-5 Di-n-dodecyltin bis (isooctyl mercaptoacetate) SML = 12 mg/kg
30 48640 000131-56-6 2,4-Dihydroxybenzophenone SML(T) = 6 mg/kg (14)
31 48800 000097-23-4 2,2'-Dihydroxy-5,5'-dichlorodiphenylmethane SML = 12 mg/kg
32 48880 000131-53-3 2,2'-Dihydroxy-4-methoxybenzophenone SML(T) = 6 mg/kg (14)
33 49600 026636-01-1 Dimethyltin bis (isooctyl mercaptoaecetate) SMT(T) 0.18 mg/kg (15) (expressed as tin)
34 49840 002500-88-1 Dioctadecyl disulphide SMT = 3 mg/kg
35 50160 Di-n-octyltin bis(n-alkyl (C10-C16) mercapto acetate) SML(T) = 0.04 mg/kg (16) (expressed as tin)
36 50240 010039-33-5 Di-n-octyltin bis (2-ethylhexyl maleate) SML(T) = 0.04 mg/kg (16) (expressed as tin)
37 50320 015571-58-1 Di-n-octyltin bis (2-ethylhexyl mercaptoaectate) SML(T) = 0.04 mg/kg (16) (expressed as tin)
38 50360 Di-n-octyltin bis (ethyl maleate) SML(T) = 0.04 mg/kg (16) (expressed as tin)
39 50400 033568-99-9 Di-n-octyltin bis (isooctyl maleate) SML(T) = 0.04 mg/kg (16) (expressed as tin)
40 50480 026401-97-8 Di-n-octyltin bis (isooctyl mercaptoacetate) SML(T) = 0.04 mg/kg (16) (expressed as tin)
41 50560 Di-n-octyltin 1,4-butanediol bis (mercaptoacetate) SML(T) = 0.04 mg/kg (16) (expressed as tin)
42 50640 003648-18-8 Di-n-octyltin dilaurate SML(T) = 0.04 mg/kg (16) (expressed as tin)
43 50720 015571-60-5 Di-n-octyltin dimaleate SML(T) = 0.04 mg/kg (16) (expressed as tin)
44 50800 – Di-n-octyltin dimaleate, esterified SML(T) = 0.04 mg/kg (16) (expressed as tin)
45 50880 – Di-n-octyltin dimaleate, polymers (n = 2-4) SML(T) = 0.04 mg/kg (16) (expressed as tin)
46 50960 69226-44-4 Di-n-octyltin ethyleneglycol bis (mercaptoacetate) SML(T) = 0.04 mg/kg (16) (expressed as tin)
47 51040 15535-79-2 Di-n-octyltin mercaptoacetate SML(T) = 0.04 mg/kg (16) (expressed as tin)
48 51120 Di-n-octyltin thiobenzoate 2-ethyl-hexyl mercaptoacetate SML(T) = 0.04 mg/kg (16) (expressed as tin)
49 51570 000127-63-9 Diphenyl sulphone SML(T) = 3 mg/kg (24)
50 51680 000102-08-9 N,N'-diphenylthiourea SML = 3 mg/kg
51 52000 027176-87-0 Dodecylbenzenesulphonic acid SML = 30 mg/kg
52 52320 052047-59-3 2-(4-Dodecylphenyl) indole SML = 0.06 mg/kg
53 52880 023676-09-7 4-Ethoxybenzoic acid, ethyl ester SML = 3.6 mg/kg
54 53200 023949-66-8 2-Ethoxy-2'-ethyloxanilide SML = 30 mg/kg
54A 54880 000050-00-0 Formaldehyde SML(T) = 15 mg/kg (²¹)
54B 55200 001166-52-5 Gallic acid, dodecyl ester SML(T) = 30 mg/kg (³⁴)
54C 55280 001034-01-1 Gallic acid, octyl ester SML(T) = 30 mg/kg (³⁴)
54D 55360 000121-79-9 Gallic acid, propyl ester SML(T) = 30 mg/kg (³⁴)
55 58960 000057-09-0 Hexadecyltrimethylammonium bromide SML = 6 mg/kg
56 59120 023128-74-7 1,6-Hexamethylene-bis (3- (3,5-di-tert-butyl-4-hydroxyphenyl) propionamide) SML = 45 mg/kg
57 59200 035074-77-2 1,6- Hexamethylene-bis (3- (3,5-di-tert-butyl-4-hydroxyphenyl) propionate SML = 6 mg/kg
58 60320 070321-86-7 2- (2-Hydroxy-3,5-bis (1,1-dimethylbenzyl) phenyl) benzotriazole SML = 1.5 mg/kg
59 60400 003896-11-5 2- (2'-Hydroxy-3'-tert-butyl- 5'-methylphenyl) -5-chlorobenzotriazole SML(T) = 30 mg./kg (18)
60 60800 065447-77-0 1-(2- Hydroxyethyl) -4-hydroxy- 2,2, 6,6-tetramethyl, piperidine-succinic acid, dimethyl ester, copolymer SML = 30 mg/kg
61 61280 003293-97-8 2-Hydroxy-4-n-hexyloxybenzophenone SML(T) = 6 mg/kg (14)
62 61360 000131-57-7 2-Hydroxy-4-methoxybenzophenone SML(T) = 6 mg/kg (14)
63 61440 002440-22-4 2-(2-Hydroxy-5-methylphenyl) benzotriazole SML(T) = 30 mg/kg (18)
64 61600 001843-05-6 2-Hydroxy-4-n-octyloxybenzophenone SML(T) = 6 mg/kg (14)
65 63200 051877-53-3 Lactic acid, manganese salt SML(T) = 0.6 mg/kg (9) (expressed as manganese)
66 64320 010377-51-2 Lithium iodide SML(T) = 1 mg/kg (10) (expressed as iodium) and SML(T) = 0.6 mg/kg (⁸) (expressed as lithium)
67 65120 007773-01-5 Manganese chloride SML(T) = 0.6 mg/kg (9) (expressed as manganese)
68 65200 012626-88-9 Manganese hydroxide SML(T) = 0.6 mg/kg (9) (expressed as manganese
69 65280 010043-84-2 Manganese hypophosphite SML(T) = 0.6 mg/kg (9) (expressed as manganese
70 65360 011129-60-5 Manganese oxide SML(T) = 0.6 mg/kg (9) (expressed as manganese
71 65440 Manganese pyrophosphite SML(T) = 0.6 mg/kg (9) (expressed as manganese
72 66360 085209-91-2 2-2'-Methylene bis (4,6-di-tert-butylphenyl) sodium phosphate SML = 5 mg/kg
73 66400 000088-24-4 2-2'-Methylene bis (4-ethyl-6-tert-butylphenol) SML(T) = 1.5 mg/kg (19)
74 66480 000119-47-1 2-2'- Methylene bis (4-methyl-6-tert-butylphenol) SML(T) = 1.5 mg/kg (19)
75 67360 067649-65-4 Mono-n-dodecyltin tris (isooctyl mercaptoacetate) SML = 24 mg/kg
76 67520 054849-38-6 Monomethyltin tris (isooctyl mercaptoacetate) SML(T) = 0.18 mg/kg (15) (expressed as tin)
77 67600 Mono-n-octyltin tris (alkyl (C10–C16) - mercaptoacetate SML(T) = 1.2 mg/kg (17) (expressed as tin)
78 67680 027107-89-7 Mono-n-octyltin tris (2-ethylhexyl mercaptoacetate SML(T) = 1.2 mg/kg (17) (expressed as tin)
79 67760 026401-86-5 Mono-n-octyltin tris (isooctyl mercaptoacetate) SML(T) = 1.2 mg/kg (17) (expressed as tin)
79A 67896 020336-96-3 Myristic acid, lithium salt SML(T) = 0.6 mg/kg (8) (expressed as lithium)
81 68320 002082-79-3 Octadecyl 3- (3,5-di-tert-butyl-4- hydroxylphenyl) propionate SML = 6 mg/kg
82 68400 010094-45-8 Octadecylerucamide SML = 5 mg/kg
82A 68860 004724-48-5 n-Octylphosphonic acid SML = 0.05 mg/kg
83 69840 016260-09-6 Oleylpalmitamide SML = 5 mg/kg
83A 71935 007601-89-0 Perchloric acid, sodium salt monohydrate SML = 0.05 mg/kg (31)
84 72160 000948-65-2 2-Phenylindole SML = 15 mg/kg
85 72800 001241-94-7 Phosphoric acid, diphenyl 2-ethylhexyl ester SML = 2.4 mg/kg
86 73040 013763-32-1 Phosphoric acid, lithium salts SML(T) = 0.6 mg/kg (8) (expressed as lithium)
87 73120 010124-54-6 Phosphoric acid, manganese salt SML(T) = 0.6 mg/kg (9) (expressed as manganese
88 74400 Phosphorous acid, tris (nonyl- and/or dinonylphenyl) ester SML = 30 mg/kg
88A 76680 068132-00-3 Polycyclopentadiene, hydrogenated SML = 5 mg/kg (1)
89 77440 Polyethyleneglycol diricinoleate SML = 42 mg/kg
90 77520 061791-12-6 Polyethyleneglycol ester of caster oil SML = 42 mg/kg
91 78320 009004-97-1 Polyethyleneglycol monoricinoleate SML – 42 mg/kg
92 81200 071878-19-8 Poly [6- [1,1,3,3-tetramethylbutyl) - amino]-1,3,5-triazine-2,4-diyl]-[(2,2,6,6-tetramethyl- 4-piperidyl)-imino] hexamethylene- [2,2,6,6-tetramethyl-4-piperidyl) limino] SML = 3 mg/kg
93 81680 007681-11-0 Potassium iodide SML(T) = 1 mg/kg (10) (expressed as iodium)
94 82020 019019-51-3 Propionic acid, cobalt salt SML(T) = 0.05 mg/kg (13) (expressed as cobalt)
95 83595 119345-01-6 Reaction 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 SML = 18 mg/kg and in compliance with the specifications in Schedule 4
96 83700 000141-22-0 Ricinoleic acid SML = 42 mg/kg
97 84800 000087-18-3 Salicylic acid, 4-tert-butylphenyl ester SML = 12 mg/kg
98 84880 000119-36-8 Salicylic acid, methyl ester SML = 30 mg/kg
99 85760 012068-40-5 Silicic acid, lithium aluminium salt (2:1:1) SML(T) = 0.6 mg/kg (8) (expressed as lithium)
100 85920 012627-14-4 Silicic acid, lithium salt SML(T) = 0.6 mg/kg (8) (expressed as lithium)
100A 86480 007631-90-5 Sodium bisulphite SML(T) = 10 mg/kg (30) (expressed as SO₂)
101 86800 007681-82-5 Sodium iodide SML(T) = 1 mg/kg (10) (expressed as iodium)
102 86880 Sodium monoalkyl dialkylphenoxybenzenedi-sulphonate SML = 9 mg/kg
102A 86920 007632-00-0 Sodium nitrite SML = 0.6 mg/kg
102B 86960 007757-83-7 Sodium sulphite SML(T) = 10 mg/kg (30) expressed as SO₂)
102C 87120 07772-98-7 Sodium thiosulphate SML(T) = 10 mg/kg (30) expressed as SO₂)
103 89170 013586-84-0 Stearic acid, cobalt salt SML(T) = 0.05 mg/kg (13) expressed as cobalt)
104 92000 007727-43-7 Sulphuric acid, barium salt SML(T) = 1 mg/kg (11) expressed as barium)
105 92320 Tetradecyl-polyethyleneglycol (EO = 3–8) ether of glycolic acid SML = 15 mg/kg
106 92560 038613-77-3 Tetrakis (2,4- di-tert-butyl-phenyl) - 4-4'-biphenylylene diphosphonite SML = 18 mg/kg
107 92800 000096-69-5 4,4'-Thiobis (6-tert-butyl- 3-methylphenol) SML = 0.48 mg/kg
108 92880 041484-35-9 Thiodiethanol bis (3-(3-5-di-tert- butyl-4-hydroxyphenyl) propionate) SML = 2.4 mg/kg
109 93120 000123-28-4 Thiodipropionic acid, didodecyl ester SML(T) = 5 mg/kg (20)
110 93280 000693-36-7 Thiodipropionic acid, dioctadecyl ester SML(T) = 5 mg/kg (20)
110A 94400 036443-68-2 Triethyleneglycol bis[ 3-(3-tert-butyl- 4-hydroxy- 5-methylphenyl) propionate] SML = 9 mg/kg
111 94560 000122-20-3 Triisopropanolamine SML = 5 mg/kg
112 95280 040601-76-1 1,3,5- Tris (4-tert-butyl-3-hydroxy -2,6- dimethylbenzyl)-1,3,5-triazine-2,4,6 (1H, 3H,5H)- trione SML = 6 mg/kg
113 95360 027676-62-6 1,3,5 - Tris (3,5-di-tert-butyl-4 hydroxybenzyl)- 1,3,5-triazine - 2,4,6 (1H, 3H, 5H) - trione SML = 5 mg/kg
114 95600 01843-03-4 1,1,3- Tris (2-methyl-4-hydroxy-5-tert-butylphenyl) butane SML = 5 mg/kg

PART 3 — Supplementary

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 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 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 the 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 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.

SCHEDULE 3 — Products Obtained by Bacterial Fermentation

Item 1 2 3 4
PM/REF No CAS No Name Restrictions and specifications
1 18888 080181-31-3 3-hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer In compliance with specifications included in Schedule 4

SCHEDULE 4 — Specifications

Item 1 2 2
PM/REF No Specifications Specifications
(1) Quantity of substance used/quantity of formulation (1) Quantity of substance used/quantity of formulation (1) Quantity of substance used/quantity of formulation (1) Quantity of substance used/quantity of formulation
1 11530 Acrylic acid, 2-hydroxypropyl ester Acrylic acid, 2-hydroxypropyl ester
It may contain up to 25% (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No. 002918-23-2) It may contain up to 25% (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No. 002918-23-2)
2 16690 Divinylbenzene Divinylbenzene
It may contain up to 45% (m/m) of Ethylvinylbenzene It may contain up to 45% (m/m) of Ethylvinylbenzene
3 18888 3-Hydroxybutanoic acid - 3-hydroxypentanoic acid, copolymer 3-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 name Poly(3-D-hydroxybutanoate-co-3-D-hydroxypentanoate)
CAS number 080181-31-3
Structural formula As set out in Part B of Annex V to the Directive
Average molecular weight Not less than 1050 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
Description White to off-white powder after isolation
Solubility Soluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically insoluable in ethanol, aliphatic alkanes and water
Restriction QMA for crotonic acid is 0.05 mg/6 dm²
Purity Prior to granulation of the raw material copolymer powder must not contain more than:
– nitrogen 2 500 mg/g of plastic
– zinc 100 mg/kg of plastic
– copper 5 mg/kg of plastic
– lead 2 mg/kg of plastic
– arsenic 1 mg/kg of plastic
– chromium 1 mg/kg of plastic
4 23547 Polydimethylsiloxane (Mw > 6800) Polydimethylsiloxane (Mw > 6800)
Minimum viscosity 100 × 10 -⁶m²/s (= 100 centistokes) at 25°C Minimum viscosity 100 × 10 -⁶m²/s (= 100 centistokes) at 25°C
5 25385 Triallylamine Triallylamine
40 mg/kg hydrogel at a ratio of 1 kg food to a maximum of 1.5 grams of hydrogel. For use only in hydrogels intended for non-direct food contact use. 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.
6 38320 4-(2-Benzoxazolyl)-4'- (5-methyl-2-benzoxazolyl) stilbene 4-(2-Benzoxazolyl)-4'- (5-methyl-2-benzoxazolyl) stilbene
Not more than 0.05% w/w (quantity of substance used/quantity of the formulation) Not more than 0.05% w/w (quantity of substance used/quantity of the formulation)
7 43680 Chlorodifluoromethane Chlorodifluoromethane
Content of chlorofluoromethane less than 1 mg/kg of the substance Content of chlorofluoromethane less than 1 mg/kg of the substance
8 47210 Dibutylthiostannoic acid polymer Dibutylthiostannoic acid polymer
Molecular unit = (C₈H&₁&₈S₃Sn₂) n (n = 1.5-2) Molecular unit = (C₈H&₁&₈S₃Sn₂) n (n = 1.5-2)
9 76721 Polydimethylsiloxane (Mw > 6800) Polydimethylsiloxane (Mw > 6800)
Minimum viscosity 100 × 10 -⁶m²/s (= 100 centistokes) at 25°C Minimum viscosity 100 × 10 -⁶m²/s (= 100 centistokes) at 25°C
10 77895 Polyethyleneglycol (EO = 2–6) monoalkyl (C₁₆–C₁₈) ether Polyethyleneglycol (EO = 2–6) monoalkyl (C₁₆–C₁₈) ether
The composition of this mixture is as follows: The composition of this mixture is as follows:
–polyethyleneglycol (EO = 2–6) monoalkyl (C₁₆–C₁₈) ether approximately 28%) –polyethyleneglycol (EO = 2–6) monoalkyl (C₁₆–C₁₈) ether approximately 28%)
–fatty alcohols (C₁₆–C₁₈) (approximately 48%) –fatty alcohols (C₁₆–C₁₈) (approximately 48%)
–ethyleneglycol monoalkyl (C₁₆–C₁₈) ether (approximately 24%)
11 83595 Reaction 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 Reaction 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 Composition
-4,4'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 38613-77-3) (36–46% w/w)[^f01000] -4,4'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 38613-77-3) (36–46% w/w)[^f01000]
-4,3'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 118421-00-4) (17 –23% w/w) [^f01000] -4,3'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 118421-00-4) (17 –23% w/w) [^f01000]
-3-3'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] CAS No. 118421-01-5) (1–5% w/w)[^f01000] -3-3'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] CAS No. 118421-01-5) (1–5% w/w)[^f01000]
-4-Biphenylene-0,0-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 91362 - 37-7 (11–19% w/w)[^f01000] -4-Biphenylene-0,0-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 91362 - 37-7 (11–19% w/w)[^f01000]
-Tris (2,4-di-tert-butylphenyl) phosphite (CAS No. 31570-04-4) (9–18% w/w)[^f01000] -Tris (2,4-di-tert-butylphenyl) phosphite (CAS No. 31570-04-4) (9–18% w/w)[^f01000]
-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)[^f01000] -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)[^f01000]
Other specifications Other specifications
– Phosphor content of minimum 5.4% to maximum 5.9% – Phosphor content of minimum 5.4% to maximum 5.9%
– Acid value of maximum 10 mg KOH per gram – Acid value of maximum 10 mg KOH per gram
– Melt range of 85-110°C – Melt range of 85-110°C
12 88640 Soybean oil, epoxidized Soybean oil, epoxidized
Oxirane less than 8%, iodine number < 6 Oxirane less than 8%, iodine number < 6
13 95859 Waxes, 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 Waxes, 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
14 95883 White 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 White 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

SCHEDULE 5 — Provisions 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) above 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.
  • (4) 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.

4

  • (1) 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.
  • (2) 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.
  • (3) 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.
  • (4) 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.

5

Where a plastic material or article is intended to come into repeated contact with food, any migration test shall (subject to paragraph 7) 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

6

  • (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.

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