1996 No. 694
The Plastic Materials and Articles in Contact with Food (Amendment) Regulations 1996
Made
Laid before Parliament
Coming into force
The Minister of Agriculture, Fisheries and Food, the Secretary of State for Health and the Secretary of State for Wales, acting jointly, in relation to England and Wales, and the Secretary of State for Scotland in relation to Scotland, in exercise of the powers conferred by sections 16(2), 17(1), 26(1)(a) and 48(1) of the Food Safety Act 19901, and of all other powers enabling them in that behalf; the Minister of Agriculture, Fisheries and Food and the Secretary of State being Ministers designated2 for the purposes of section 2(2) of the European Communities Act 19723 in relation to materials and articles in contact with food or drink or intended for such contact, acting jointly, in exercise of the powers conferred on them by the said section 2(2) and of all other powers enabling them in that behalf, and after consultation in accordance with section 48(4) of the Act of 1990 with such organisations as appear to them to be representative of interests likely to be substantially affected by the Regulations (in so far as the Regulations are made in exercise of the powers conferred by the said Act of 1990), hereby make the following Regulations:—
Title, commencement, extent and interpretation1
1
These Regulations may be cited as the Plastic Materials and Articles in Contact with Food (Amendment) Regulations 1996 and shall come into force on 1st April 1996.
2
These Regulations shall not extend to Northern Ireland.
3
In these Regulations “the principal Regulations” means the Plastic Materials and Articles in Contact with Food Regulations 19924.
Amendment of the principal Regulations2
The principal Regulations shall be amended as follows—
a
in regulation 2(1)—
i
after the definition of “the 1987 Regulations”, there shall be inserted the following definition—
“additive” means a substance, other than one which directly influences the formation of polymers including the catalytic system, which is—
- a
incorporated into a plastic material or article to achieve a technical effect in the finished product and is intended to be present in the finished product; or
- b
used to provide a suitable medium in which polymerization occurs including emulsifiers, surfactants and buffering agents;
ii
after the definition of “food” there shall be inserted the following definition—
“good technical quality” means good technical quality as regards the purity criteria;
b
after regulation 13 there shall be inserted the following regulations—
Use, sale and importation until 1st April 199814
Until 1st April 1998 a plastic material or article which has been manufactured using one or more of the monomers identified by PM/REF No., CASNo. and name respectively in columns 1, 2, 3 of Section E of Part I of Schedule 1—
a
may be used in the course of a business in connection with the storage, preparation, packaging, sale or serving of food for human consumption,
b
may be sold for the purpose of its being used in connection with the storage, preparation, packaging, sale or serving of food for human consumption, or
c
may be imported for the purpose of its being used in connection with the storage, preparation, packaging, sale or serving of food for human consumption,
provided that such monomer is of good technical quality.
Additives15
1
Subject to the following paragraphs of this regulation, no person shall use in the manufacture of plastic materials or articles any additive identified by PM/REF No., CASNo. (if any) and name respectively in columns 1, 2, 3 of Part I of Schedule 3 which is not of good technical quality.
2
Paragraph (1) of this regulation shall not be taken to prohibit the presence in any plastic material or article of any substance which is a mixture of additives of good technical quality identified in Part I of Schedule 3.
3
In any proceedings for an offence under these Regulations, where it is alleged that the commission of the offence is due to the manufacture of a plastic material or article with any additive identified in Part I of Schedule 3 which is not of good technical quality, it shall be a defence for the person charged to prove that each such additive is present in the finished plastic material or article as an impurity, a reaction intermediate or a decomposition product.
c
in the column headed “Item” in Section A of Part 1 of Schedule 1 for Item number and letter “66A” and “91A” there shall be substituted, respectively, “66B” and “91B”;
d
the Item number and letter, PM/REF No., CASNo., name and restriction (if any) for each monomer identified in Schedule 1 to these Regulations shall be inserted in Section A of Part 1 of Schedule 1 at the place corresponding to the number and letter specified for that monomer in the column headed “Item” in Schedule 1 to these Regulations;
e
in Section A of Part 1 of Schedule 1, opposite and corresponding to Item 57, for the entry in column 1 (PM/REF No.) there shall be substituted the entry “14411” and in column 3 (Name) the words “(food grade quality)” shall be deleted;
f
in column 4 (Restrictions) of Section A of Part 1 of Schedule 1—
i
opposite and corresponding to Item 166, there shall be inserted the following entry “see `Rosin'”; and
ii
in the entry opposite and corresponding to Item 180, for “0.05” there shall be substituted “5”;
g
in Section B of Part 1 of Schedule 1 the entries in columns 1 (PM/REF No.), 2 (CASNo.), 3 (Name) and 4 (Restrictions) (if any) opposite and corresponding to Items 11, 60, 83, 102 and 161 respectively, shall be deleted;
h
the contents of Schedule 2 to these Regulations shall be inserted after Section D of Part 1 of Schedule 1; and
i
the contents of Schedule 3 to these Regulations shall be inserted after Schedule 2.
Signed by the authority of the Secretary of State for Health
Signed by authority of the Secretary of State for Wales
SCHEDULE 1
1 | 2 | 3 | 4 | |
|---|---|---|---|---|
Item | PM/REF No. | CASNo. | Name | Restrictions |
7A. | 10660 | 015214-89-8, 2-Acrylamido-2methylpropanesulphonic acid | The specific migration of this substance shall not exceed 0.05mg/kg. | |
26A. | 12789 | 007664-41-7 | Ammonia | |
66A. | 15070 | 001647-16-1 | Dec-1,9-diene | The specific migration of this substance shall not exceed 0.05mg/kg. |
91A. | 17050 | 000104-76-7 | 2-Ethylhexan-l-ol | The specific migration of this substance shall not exceed 30mg/kg. |
110B. | 19270 | 000097-65-4 | Itaconic acid | |
197. | 26140 | 000075-38-7 | Vinylidene fluoride | The specific migration of this substance shall not exceed 5mg/kg. |
SCHEDULE 2
SECTION EMonomers authorised until 1st April 1998
1
2
3
Item
PM/REF No.
CASNo.
Name
1.
10660
015214-89-8
2-Acrylamido-2-methylpropanesulphonic acid
2.
15070
001647-16-1
Dec-1,9-diene
3.
17050
000104-76-7
2-Ethylhexan-1-o1
SCHEDULE 3
SCHEDULE 3
PART IADDITIVES
1
2
3
Item
PM/REF No.
CASNo.
Name
1
30000
000064-19-7
Acetic acid
2
30045
000123-86-4
Acetic acid, butyl ester
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
8
30960
—
Acids, aliphatic, monocarboxylic (C6-C22), esters with polyglycerol
9
31328
—
Acids, fatty, from animal or vegetable food fats and oils
10
31730
000124-04-9
Adipic acid
11
33120
—
Alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C24)
12
33350
009005-32-7
Alginic acid
13
34480
—
Aluminium fibers, flakes and powders
14
34560
021645-51-2
Aluminium hydroxide
15
34690
011097-59-9
Aluminium magnesium carbonate hydroxide
16
34720
001344-28-1
Aluminium oxide
17
35120
013560-49-1
3-Aminocrotonic acid, diester with thiobis (2-hydroxyethyl) ether
18
35320
007664-41-7
Ammonia
19
35440
012124-97-9
Ammonium bromide
20
35600
001336-21-6
Ammonium hydroxide
21
35840
000506-30-9
Arachidic acid
22
35845
007771-44-0
Arachidonic acid
23
36000
000050-81-7
Ascorbic acid
24
36080
000137-66-6
Ascorbyl palmitate
25
36160
010605-09-1
Ascorbyl stearate
26
36880
008012-89-3
Beeswax
27
36960
003061-75-4
Behenamide
28
37040
000112-85-6
Behenic acid
29
37280
001302-78-9
Bentonite
30
37600
000065-85-0
Benzoic acid
31
37680
000136-60-7
Benzoic acid, butyl ester
32
37840
000093-89-0
Benzoic acid, ethyl ester
33
38080
000093-58-3
Benzoic acid, methyl ester
34
38160
002315-68-6
Benzoic acid, propyl ester
35
38950
079072-96-1
Bis(4-ethylbenzylidene) sorbitol
36
39890
087826-41-3
Bis(methylbenzylidene) sorbitol
069158-41-4
“ “ “
054686-97-4
“ “ “
37
40400
010043-11-5
Boron nitride
38
40570
000106-97-8
Butane
39
41040
005743-36-2
Calcium butyrate
40
41280
001305-62-0
Calcium hydroxide
41
41520
001305-78-8
Calcium oxide
42
41600
012004-14-7
Calcium sulphoaluminate
037293-22-4
“ “
43
41760
008006-44-8
Candelilla wax
44
41960
000124-07-2
Caprylic acid
45
42160
000124-38-9
Carbon dioxide
46
42500
—
Carbonic acid, salts
47
42640
009000-11-7
Carboxymethylcellulose
48
42720
008015-86-9
Carnauba wax
49
42800
009000-71-9
Casein
50
42960
064147-40-6
Castor oil, dehydrated
51
43200
—
Castor oil, monoand diglycerides
52
43280
009004-34-6
Cellulose
53
43300
009004-36-8
Cellulose acetate butyrate
54
43360
068442-85-3
Cellulose, regenerated
55
43440
008001-75-0
Ceresin
56
44160
000077-92-9
Citric acid
57
44640
000077-93-0
Citric acid, triethyl ester
58
45280
—
Cotton fibers
59
45560
014464-46-1
Cristobalite
60
45760
000108-91-8
Cyclohexylamine
61
45920
009000-16-2
Dammar
62
45940
000334-48-5
n-Decanoic acid
63
46070
010016-20-3
alpha-Dextrin
64
46080
007585-39-9
beta-Dextrin
65
46375
061790-53-2
Diatomaceous earth
66
46480
032647-67-9
Dibenzylidene sorbitol
67
46790
004221-80-1
3,5-Di-tert-butyl-4-hydroxybenzoic acid, 2,4-di-tertbutylphenyl ester
68
46800
067845-93-6
3,5-Di-tert-butyl-4-hydroxybenzoic acid, hexadecyl ester
69
46870
003135-18-0
3,5-Di-tert-butyl-4-hydroxybenzylphosphonic acid, dioctadecyl ester
70
47440
000461-58-5
Dicyanodiamide
71
49540
000067-68-5
Dimethyl sulphoxide
72
51200
000126-58-9
Dipentaerythritol
73
51760
025265-71-8
Dipropyleneglycol
000110-98-5
“
74
52640
016389-88-1
Dolomite
75
52730
000112-86-7
Erucic acid
76
52800
000064-17-5
Ethanol
77
53270
037205-99-5
Ethylcarboxymethylcellulose
78
53280
009004-57-3
Ethylcellulose
79
53360
000110-31-6
N,N'-Ethylenebisoleamide
80
53440
005518-18-3
N,N'-Ethylenebispalmitamide
81
53520
000110-30-5
N,N'-Ethylenebisstearamide
82
53600
000060-00-4
Ethylenediaminetetraacetic acid
83
54005
005136-44-7
Ethylene-N-palmitamide-N1-stearamide
84
54260
009004-58-4
Ethylhydroxyethylcellulose
85
54270
—
Ethylhydroxymethylcellulose
86
54280
—
Ethylhydroxypropylcellulose
87
54450
—
Fats and oils from animal or vegetable food sources
88
54480
—
Fats and oils, hydrogenated, from animal or vegetable food sources
89
55040
000064-18-6
Formic acid
90
55120
000110-17-8
Fumaric acid
91
55190
029204-02-2
Gadoleic acid
92
55440
009000-70-8
Gelatin
93
55680
000110-94-1
Glutaric acid
94
55920
000056-81-5
Glycerol
95
56020
099880-64-5
Glycerol dibehenate
96
56360
—
Glycerol, esters with acetic acid
97
56487
—
Glycerol, esters with butyric acid
98
56490
—
Glycerol, esters with erucic acid
99
56495
—
Glycerol, esters with 12-hydroxystearic acid
100
56500
—
Glycerol, esters with lauric acid
101
56510
—
Glycerol, esters with linoleic acid
102
56520
—
Glycerol, esters with myristic acid
103
56540
—
Glycerol, esters with oleic acid
104
56550
—
Glycerol, esters with palmitic acid
105
56565
—
Glycerol, esters with nonanoic acid
106
56570
—
Glycerol, esters with propionic acid
107
56580
—
Glycerol, esters with ricinoleic acid
108
56585
—
Glycerol, esters with stearic acid
109
56610
030233-64-8
Glycerol monobehenate
110
56720
026402-23-3
Glycerol monohexanoate
111
56800
030899-62-8
Glycerol monolaurate diacetate
112
56880
026402-26-6
Glycerol monooctanoate
113
57040
—
Glycerol monooleate, ester with ascorbic acid
114
57120
—
Glycerol monooleate, ester with citric acid
115
57200
—
Glycerol monopalmitate, ester with ascorbic acid
116
57280
—
Glycerol monopalmitate, ester with citric acid
117
57600
—
Glycerol monostearate, ester with ascorbic acid
118
57680
—
Glycerol monostearate, ester with citric acid
119
57920
000620-67-7
Glycerol triheptanoate
120
58300
—
Glycine, salts
121
58320
007782-42-5
Graphite
122
58400
009000-30-0
Guar gum
123
58480
009000-01-5
Gum arabic
124
58720
000111-14-8
Heptanoic acid
125
59360
000142-62-1
Hexanoic acid
126
59760
019569-21-2
Huntite
127
59990
007647-01-0
Hydrochloric acid
128
60030
012072-90-1
Hydromagnesite
129
60080
012304-65-3
Hydrotalcite
130
60160
000120-47-8
4-Hydroxybenzoic acid, ethyl ester
131
60180
004191-73-5
4-Hydroxybenzoic acid, isopropyl ester
132
60200
000099-76-3
4-Hydroxybenzoic acid, methyl ester
133
60240
000094-13-3
4-Hydroxybenzoic acid, propyl ester
134
60560
009004-62-0
Hydroxyethylcellulose
135
60880
009032-42-2
Hydroxyethylmethylcellulose
136
61120
009005-27-0
Hydroxyethyl starch
137
61390
037353-59-6
Hydroxymethylcellulose
138
61680
009004-64-2
Hydroxypropylcellulose
139
61800
009049-76-7
Hydroxypropyl starch
140
61840
000106-14-9
12-Hydroxystearic acid
141
62140
006303-21-5
Hypophosphorous acid
142
62240
001332-37-2
Iron oxide
143
62450
000078-78-4
Isopentane
144
62640
008001-39-6
Japan wax
145
62720
001332-58-7
Kaolin
146
62800
—
Kaolin, calcined
147
62960
000050-21-5
Lactic acid
148
63040
000138-22-7
Lactic acid, butyl ester
149
63280
000143-07-7
Lauric acid
150
63760
008002-43-5
Lecithin
151
63840
000123-76-2
Levulinic acid
152
63920
000557-59-5
Lignoceric acid
153
64015
000060-33-3
Linoleic acid
154
64150
028290-79-1
Linolenic acid
155
64500
—
Lysine, salts
156
64640
001309-42-8
Magnesium hydroxide
157
64720
001309-48-4
Magnesium oxide
158
65020
006915-15-7
Malic acid
159
65040
000141-82-2
Malonic acid
160
65520
000087-78-5
Mannitol
161
66200
037206-01-2
Methylcarboxymethylcellulose
162
66240
009004-67-5
Methylcellulose
163
66640
009004-59-5
Methylethylcellulose
164
66695
—
Methylhydroxymethylcellulose
165
66700
009004-65-3
Methylhydroxypropylcellulose
166
67120
012001-26-2
Mica
167
67200
001317-33-5
Molybdenum disulphide
168
67840
—
Montanic acids and/or their esters with ethyleneglycol and/or with 1,3-butanediol and/or with glycerol
169
67850
008002-53-7
Montan wax
170
67891
000544-63-8
Myristic acid
171
68040
003333-62-8
7-[2H-Naphtho-(1,2-D)triazol-2-yl]-3-phenylcoumarin
172
68125
068187-64-4
Nepheline syenite
173
69040
000112-80-1
Oleic acid
174
69760
000143-28-2
Oleyl alcohol
175
70000
070331-94-1
2,2'-Oxamidobis[ethyl-3-(3,5-di-tert-butyl-4hydroxyphenyl)-propionate]
176
70240
012198-93-5
Ozokerite
177
70400
000057-10-3
Palmitic acid
178
71020
000373-49-9
Palmitoleic acid
179
71440
009000-69-5
Pectin
180
71600
000115-77-5
Pentaerythritol
181
71680
006683-19-8
Pentaerythritol tetrakis[3-(3,5-di-tert-butyl-4hydroxyphenyl)-propionate]
182
71720
000109-66-0
Pentane
183
72640
007664-38-2
Phosphoric acid
184
74240
031570-04-4
Phosphorous acid, tris(2,4-di-tert-butylphenyl)ester
185
74480
000088-99-3
o-Phthalic acid
186
76320
000085-44-9
Phthalic anhydride
187
76720
009016-00-6 063148-62-9
Polydimethylsiloxane
188
76960
025322-68-3
Polyethyleneglycol
189
77600
061788-85-0
Polyethyleneglycol ester of hydrogenated castor oil
190
77702
—
Polyethyleneglycol esters of aliphatic monocarboxylic acids (C6-C22), and their ammonium and sodium sulphates
191
79040
009005-64-5
Polyethyleneglycol sorbitan monolaurate
192
79120
009005-65-6
Polyethyleneglycol sorbitan monooleate
193
79200
009005-66-7
Polyethyleneglycol sorbitan monopalmitate
194
79280
009005-67-8
Polyethyleneglycol sorbitan monostearate
195
79360
009005-70-3
Polyethyleneglycol sorbitan trioleate
196
79440
009005-71-4
Polyethyleneglycol sorbitan tristearate
197
80240
029894-35-7
Polyglycerol ricinoleate
198
80640
—
Polyoxyalkyl(C2-C4)dimethylpolysiloxane
199
80720
008017-16-1
Polyphosphoric acids
200
81520
007758-02-3
Potassium bromide
201
81600
001310-58-3
Potassium hydroxide
202
81840
000057-55-6
1,2-Propanediol
203
81882
000067-63-0
2-Propanol
204
82000
000079-09-4
Propionic acid
205
82080
009005-37-2
1,2-Propyleneglycol alginate
206
82240
022788-19-8
1,2-Propyleneglycol dilaurate
207
82400
000105-62-4
1,2-Propyleneglycol dioleate
208
82560
033587-20-1
1,2-Propyleneglycol dipalmitate
209
82720
006182-11-2
1,2-Propyleneglycol distearate
210
82800
027194-74-7
1,2-Propyleneglycol monolaurate
211
82960
001330-80-9
1,2-Propyleneglycol monooleate
212
83120
029013-28-3
1,2-Propyleneglycol monopalmitate
213
83300
001323-39-3
1,2-Propyleneglycol monostearate
214
83320
—
Propylhydroxyethylcellulose
215
83325
—
Propylhydroxymethylcellulose
216
83330
—
Propylhydroxypropylcellulose
217
83440
002466-09-3
Pyrophosphoric acid
218
83455
013445-56-2
Pyrophosphorous acid
219
83460
012269-78-2
Pyrophyllite
220
83470
014808-60-7
Quartz
221
83610
073138-82-6
Resin acids and rosin acids
222
83840
008050-09-7
Rosin
223
84000
008050-31-5
Rosin, ester with glycerol
224
84080
008050-26-8
Rosin, ester with pentaerythritol
225
84210
065997-06-0
Rosin, hydrogenated
226
84240
065997-13-9
Rosin, hydrogenated, ester with glycerol
227
84320
008050-15-5
Rosin, hydrogenated, ester with methanol
228
84400
064365-17-9
Rosin, hydrogenated, ester with pentaerythritol
229
84560
009006-04-6
Rubber, natural
230
84640
000069-72-7
Salicylic acid
231
85600
—
Silicates, natural
232
85980
—
Silicic acid, salts
233
86000
—
Silicic acid, silylated
234
86160
000409-21-2
Silicon carbide
235
86240
007631-86-9
Silicon dioxide
236
86560
007647-15-6
Sodium bromide
237
86720
001310-73-2
Sodium hydroxide
238
87200
000110-44-1
Sorbic acid
239
87280
029116-98-1
Sorbitan dioleate
240
87520
062568-11-0
Sorbitan monobehenate
241
87600
001338-39-2
Sorbitan monolaurate
242
87680
001338-43-8
Sorbitan monooleate
243
87760
026266-57-9
Sorbitan monopalmitate
244
87840
001338-41-6
Sorbitan monostearate
245
87920
061752-68-9
Sorbitan tetrastearate
246
88080
026266-58-0
Sorbitan trioleate
247
88160
054140-20-4
Sorbitan tripalmitate
248
88240
026658-19-5
Sorbitan tristearate
249
88320
000050-70-4
Sorbitol
250
88600
026836-47-5
Sorbitol monostearate
251
88800
009005-25-8
Starch, edible
252
88880
068412-29-3
Starch, hydrolysed
253
89040
000057-11-4
Stearic acid
254
90720
058446-52-9
Stearoylbenzoylmethane
255
90800
005793-94-2
Stearoyl-2-lactylic acid, calcium salt
256
90960
000110-15-6
Succinic acid
257
91200
000126-13-6
Sucrose acetate isobutyrate
258
91360
000126-14-7
Sucrose octaacetate
259
91840
007704-34-9
Sulphur
260
91920
007664-93-9
Sulphuric acid
261
92080
014807-96-6
Talc
262
92160
000087-69-4
Tartaric acid
263
92195
—
Taurine, salts
264
92205
057569-40-1
Terephthalic acid, diester with 2,2'-methylenebis(4methyl-6-tert-butylphenol)
265
92350
000112-60-7
Tetraethyleneglycol
266
92640
000102-60-3
N,N,N',N'-Tetrakis(2-hydroxypropyl)ethylenediamine
267
93440
013463-67-7
Titanium dioxide
268
93520
000059-02-9
alpha-Tocopherol
“ “
269
93680
009000-65-1
Tragacanth gum
270
94320
000112-27-6
Triethyleneglycol
271
95200
001709-70-2
1,3,5-Trimethyl-2,4,6-tris(3,5-di-tert-butyl-4hydroxybenzyl)benzene
272
95905
013983-17-0
Wollastonite
273
95920
—
Wood flour and fibers, untreated
274
95935
011138-66-2
Xanthan gum
275
96190
020427-58-1
Zinc hydroxide
276
96240
001314-13-2
Zinc oxide
277
96320
001314-98-3
Zinc sulphide
PART IISUPPLEMENTARY
1
In regulation 15 and Part I of this Schedule—
a
the PM/REF No. of any additive is its EEC packaging material reference number;
b
the CASNo. 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 CASNo. and the name, the name shall take precedence over the CASNo.
2
If an additive appearing in Part I of this Schedule as an individual compound also falls within a generic term which appears therein, the restriction (if any) applying to that additive shall be that indicated for the individual compound and the entry applying to the generic term shall be treated as varied to such extent (if any) as is necessary therefor.
3
If a substance—
a
identified in Part I 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 (including double salts) of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium or zinc), then any such salts (including double salts) shall be treated as included in the specification of that substance; and
b
is identified in Part I of this Schedule as an acid salt and has salt 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.
(This note is not part of the Regulations)