# The Plastic Materials and Articles in Contact with Food (Amendment) Regulations 1995

S.I. 1995/360 · made 15 February 1995

These Regulations amend the Plastic Materials and Articles in Contact with Food Regulations 1992 (S.I. 1992/3145) (“the principal Regulations”) and implement Commission Directive 93/8/EEC (OJ No. L90, 14.4.93, p.22), amending Council Directive 82/711/EEC (OJ No. L297, 23.10.82, p.26) laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs, and Commission Directive 93/9/EEC (OJ No. L90, 14.4.93, p.26), amending Commission Directive 90/128/EEC (OJ No. L75, 21.3.90, p.19, to be read with corrigendum in OJ No. L349, 13.12.90, p.26) relating to plastic materials and articles intended to come into contact with foodstuffs.The Regulations—provide that the capacity of an article specified in regulation 5(4)(b)(i) of the principal Regulations is less than 500 millilitres or more than 10 litres (regulation 2(a));correct a drafting error in regulation 5(6) of the principal Regulations (regulation 2(b));correct an error and an omission in the principal Regulations (regulation 2(c) and (d) respectively);permit the use, sale or importation of plastic materials and articles manufactured using one or more of the monomers in Section D as inserted in Part I of Schedule 1 to the principal Regulations by these Regulations, until 1 April 1996 (regulation 2(e) and (i));add specified monomers to those listed in Section A of Part I to Schedule 1 of the principal Regulations (monomers authorised without time limit) (regulation 2(f));amend the restriction at item 26 (11- Aminoundecanoic acid) in Section A of Part I of Schedule 1 to the principal Regulations (regulation 2(g));substitute for Section B of Part I of Schedule 1 to the principal Regulations (monomers authorised to the end of 1996) an amended list with fewer authorised monomers (regulation 2(h));add two further requirements to paragraph 4 of Section A of Part I of Schedule 2 to the principal Regulations specifying the conditions under which verification of compliance with migration limits is to be carried out using food and simulants respectively (regulation 2(j));amend provisions relating to simulants to be used, and their use, in migration testing (regulation 2(k) and (l));amend provisions relating to time and temperature test conditions (regulation 2(m) to (r));amend the Food Safety (Sampling and Qualifications) Regulations 1990 (S.I. 1990/2463) so that those Regulations do not apply to any sample taken under the provisions of the principal Regulations (regulation 3).A copy of the Compliance Cost Assessment in relation to these Regulations has been placed in the libraries of both Houses of Parliament and further copies can be obtained from the Chemical Safety of Food Division of the Ministry of Agriculture, Fisheries and Food, Ergon House, 17 Smith Square, London SW1P 3JR.

Made under: Food Safety Act 1990 (Section 6, Section 16, Section 17, Section 26, Section 31, Section 48); European Communities Act 1972 (repealed)

## Introductory text

FOOD
Made 15th February 1995
Laid before Parliament 17th February 1995
Coming into force 10th March 1995
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 6(4), 16(2), 17(1), 26(1)(a) and (3), 31 and 48(1) of the Food Safety Act 1990 and of all other powers enabling them in that behalf; the Minister of Agriculture, Fisheries and Food and the Secretary of State being Ministers designated for the purposes of section 2(2) of the European Communities Act 1972 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 Food Safety Act 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:—

## 1 Title, commencement, extent and interpretation

(1) These Regulations may be cited as the Plastic Materials and Articles in Contact with Food (Amendment) Regulations 1995 and shall come into force on 10th March 1995.
(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 1992.

## 2 Amendment of the principal Regulations

The principal Regulations shall be amended as follows—
(a) in paragraph (4)(b)(i) of regulation 5, for the words “of not less than 500 millilitres and not more than 10 litres” there shall be substituted the words “of less than 500 millilitres or more than 10 litres”;
(b) in paragraph (6) of regulation 5, for the words “regulation 3 comprising” there shall be substituted the words “these Regulations, where it is alleged that the commission of the offence is due to”;
(c) in paragraph (2) of regulation 6, for the word “refences” there shall be substituted the word “references”;
(d) before and above regulation 12 there shall be inserted the following heading to that regulation “Use, sale and importation until 1st April 1995”;
(e) after regulation 12 there shall be inserted the following regulation—
“Use, sale and importation until 1st April 1996
13 Until 1st April 1996 a plastic material or article which has been manufactured using one or more of the monomers identified by PM/REF No. (if any), CAS No. (if any) and name respectively in columns 1, 2, 3 of Section D 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 and is used in accordance with the restrictions (if any) specified in the corresponding entry in column 4 thereof.”;
(f) the Item number and letter, PM/REF No., CAS No., 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;
(g) for the entry in column 4 (Restrictions) of Section A of Part 1 of Schedule 1, opposite and corresponding to item 26, there shall be substituted the following entry “The specific migration of this substance shall not exceed 5mg/kg.”;
(h) the contents of Schedule 2 to these Regulations shall be substituted for Section B of Part 1 of Schedule 1;
(i) the contents of Schedule 3 to these Regulations shall be inserted after Section C of Part I of Schedule 1;
(j) after paragraph 4(2) of Section A of Part 1 of Schedule 2 there shall be inserted the following sub-paragraphs—
“(3) The verification of compliance with a migration limit using food 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) The verification of compliance with a migration limit using a simulant or simulants shall be carried out in accordance with the provisions of this Schedule using the simulant or simulants and the migration test conditions which are considered to be the most severe on the basis of experience.”;
(k) in paragraph 1 of Part II of Schedule 2, in relation to Simulant D, after the words “sunflower oil.”, there shall be inserted the following sentence “If rectified olive oil, a mixture of synthetic triglycerides or sunflower oil is not appropriate, other food simulants and conditions of time and temperature may be used.”;
(l) for paragraph 1 of Part III of Schedule 2 there shall be substituted the following—
“1 (1) Subject to paragraph (2) below, the migration testing of a plastic material or article which may come into contact with any food shall be carried out using one or more of the simulants specified in Part II of this Schedule.
(2) Simulant A shall not be used in migration testing of a plastic material or article which may come into contact with any food other than where its use is specified in the Table to Part IV of this Schedule.
(3) Subject to regulations 4(1) and 5(5), the migration testing of a plastic material or article which may come into contact only with a specific food or a specific group of foods shall be carried out—
(a) where the specific food or specific group of foods is specified in the Table to this part of this Schedule, using the simulant or simulants specified in relation to that specific food or specific group of foods; or
(b) where the specific food or specific group of foods is not specified in that Table, using the simulant or simulants which correspond most closely in extractive capacity to that food or group of foods.
(4) A simulant is specified in relation to a specific food or a specific group of foods for the purposes of this paragraph 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 of this Schedule, and the Table shall be read in conjunction with the notes thereto and the following paragraphs of this Part of this Schedule.
(5) Where more than one simulant is to be used in relation to a migration test, a new sample of the plastic material or article shall be used for each such test.”;
(m) in paragraph 1 of Part IV of Schedule 2 for the words “paragraph 2” there shall be substituted the words “paragraphs 2 and 2A”;
(n) in paragraph 1(a) of Part IV of Schedule 2 after the words “most closely to” there shall be inserted the words “but which are not less than”;
(o) for sub-paragraphs (b) and (c) of paragraph 1 of Part IV of Schedule 2 there shall be substituted the following sub-paragraphs—
“(b) subject to sub-paragraph (d) below, where the intended use of a plastic material or article covers two or more combinations of time and temperature specified in column 1 of the Table to this Part of this Schedule, capability of migration shall be determined by subjecting that plastic material or article successively to each applicable test condition specified in column 2 using the same aliquot of simulant.
(c) subejct to sub-paragraph (d) below, where a plastic material or article is intended to be used under any conditions of time—
(i) if that plastic material or article may be used at any temperature not exceeding 70°C and such use is indicated by appropriate labelling or instructions, the 10 day test at 40°C shall be carried out;
(ii) if that plastic material or article may be used at a temperature exceeding 70°C and no labelling or instructions indicate the temperature expected in actual use, simulant D shall be used for 2 hours at 175°C and simulants B and C shall be used either—
(aa) at reflux temperature; or
(bb) for two hours at 100°C;
(iii) if that plastic material or article may be used at a temperature exceeding 70°C and labelling or instructions indicate conditions expected in actual use, times and temperatures shall be selected from the Table to this Part of this Schedule;”;
(p) after sub-paragraph (c) of paragraph 1 of Part IV of Schedule 2 there shall be inserted the following sub-paragraph—
“(d) where a plastic material or article is intended to be used for periods of less than 15 minutes at temperatures of not less than 70°C and not more than 100°C and this is indicated by labelling or instructions, the 2 hour test at 70°C and the 10 day test at 40°C shall be carried out separately using a different sample of the plastic material or article for each test.”;
(q) after paragraph 2 of Part IV of Schedule 2 there shall be inserted the following paragraph—
“2A Migration testing of plastic materials and articles intended for use in a microwave oven shall be carried out using a conventional oven selecting appropriate time and temperature conditions from the Table to this Part of this Schedule.”;
(r) the Table in Schedule 4 to these Regulations shall be substituted for the Table in Part IV of Schedule 2.

## 3 Amendment of the Food Safety (Sampling and Qualifications) Regulations 1990

At the end of Schedule 1 to the Food Safety (Sampling and Qualifications) Regulations 1990 (provisions to which those Regulations do not apply) there shall be added in the left hand column the title to the principal Regulations and against it in the right hand column their reference.

## Signature

Angela Browning
Parliamentary Secretary, Ministry of Agriculture, Fisheries and Food
6th February 1995
Signed by the authority of the Secretary of State for Health
Cumberlege
Parliamentary Under-Secretary of State,
Department of Health
7th February 1995
Hector Monro
Parliamentary Under-Secretary of State, Scottish Office
7th February 1995
Signed by authority of the Secretary of State for Wales
Rod Richards
Parliamentary Under-Secretary of State, Welsh Office
15th February 1995

## Schedule 1 

1
2
3
4
Item
PM/REF No.
CAS No.
Name
Restrictions
8A.
10750
002495-35-4
Acrylic acid, benzyl ester
17A.
11890
002499-59-4
Acrylic acid, n-octyl ester
66A.
15095
000334-48-5
Decanoic acid
70A.
15565
000106-46-7
1, 4-Dichlorobenzene
The specific migration of this substance shall not exceed 12 mg/kg.
72A.
15790
000111-40-0
Diethylenetriamine
The specific migration of this substance shall not exceed 5 mg/kg.
72B.
15820
000345-92-6
4, 4' Difluorobenzophenone
The specific migration of this substance shall not exceed 0.05 mg/kg.
91A.
17160
000097-53-0
Eugenol
The specific migration of this substance shall not exceed 0.01 mg/kg.
110A.
19210
001459-93-4
Isophthalic acid, dimethyl ester
The specific migration of this substance shall not exceed 0.05 mg/kg.
116A.
20080
002495-37-6
Methacrylic acid, benzyl ester
124A.
21280
002177-70-0
Methacrylic acid, phenyl ester
131A.
22390
000840-65-3
2, 6-Naphthalenedicarboxylic acid, dimethyl ester
The specific migration of this substance shall not exceed 0.05 mg/kg.
162A.
24057
000089-32-7
Pyromellitic anhydride
The specific migration of this substance shall not exceed 0.05 mg/kg (expressed as pyromellitic acid).
172A.
24475
001313-82-2
Sodium sulphide
174A.
24540
009005-25-8
Starch, edible
180A.
24888
003965-55-7
5-Sulphoisophthalic acid, monosodium salt, dimethyl ester
The specific migration of this substance shall not exceed 0.05 mg/kg.
181A.
24940
000100-20-9
Terephthalic acid dichloride
The specific migration of this substance shall not exceed 7.5 mg/kg (expressed as total of moiety or a terephthalic acid).
183A.
25120
000116-14-3
Tetrafluoroethylene
The specific migration of this substance shall not exceed 0.05 mg/kg.

## “SECTION B Monomers authorised up to the end of 1996

1
2
3
4
Item
PM/REF No.
CAS No.
Name
Restrictions
1.
As item 62
000542-02-9
Acetoguanamine
2.
10160
002206-94-2
alpha-Acetoxystyrene
3.
10162
010521-96-7
beta-Acetoxystyrene
4.
10480
Acids, aliphatic, monocarboxylic, saturated (C2-C24)
5.
10510
Acids, aliphatic, monocarboxylic, unsaturated (C3-C24)
6.
10599/70
Acids, fatty, unsaturated (C18)
7.
10599/90A
061788-89-4
Acids, fatty, unsaturated (C18), dimers, distilled
8.
10599/91
061788-89-4
Acids, fatty, unsaturated (C18), dimers, non-distilled
9.
10599/92A
068783-41-5
Acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled
10.
10599/93
068783-41-5
Acids, fatty, unsaturated (C18), dimers, hydrogenated, non-distilled
11.
10660
015214-89-8
Acrylamidomethyl-propanesulphonic acid
12.
10930
003066-71-5
Acrylic acid, cyclohexyl ester
13.
11000
050976-02-8
Acrylic acid, dicyclo-pentadienyl ester
14.
11050
001070-70-8
Acrylic acid, diester with butan-1,4-diol
15.
11180
017831-71-9
Acrylic acid, diester with tetraethyleneglycol
16.
11195
068901-05-3
Acrylic acid, diester with tripropyleneglycol
17.
11245
002156-97-0
Acrylic acid, dodecyl ester
18.
11500
000103-11-7
Acrylic acid, 2-ethylhexyl ester
19.
11520
002918-23-2
Acrylic acid, 2-hydroxy-isopropyl ester (=acrylic acid, 2-hydroxy-1-methyl-ethyl ester)
20.
11530
000999-61-1
Acrylic acid, 2-hydroxy-propyl ester
21.
11560
005888-33-5
Acrylic acid, isobornyl ester
22.
11620
001330-61-6
Acrylic acid, isodecyl ester
23.
11650
029590-42-9
Acrylic acid, isooctyl ester
24.
11695
003121-61-7
Acrylic acid, 2-methoxy-ethyl ester
25.
11740
010095-13-3
Acrylic acid, monoester with butan-1,3-diol
26.
11770
002478-10-6
Acrylic acid, monoester with butan-1,4-diol
27.
11800
013533-05-6
Acrylic acid, monoester with diethyleneglycol
28.
12010
040074-09-7
Acrylic acid, 2-sulphoethyl ester
29.
12040
039121-78-3
Acrylic acid, sulphopropyl ester
30.
12055
094160-26-6
Acrylic acid, triester with glycerol tris(2-hydroxypropyl) ether
31.
12062
075577-70-7
Acrylic acid, triester with 1,1,1-trimethylolpropane tris(2-hydroxyethyl) ether
32.
12160
002998-04-1
Adipic acid, diallyl ester
33.
12190
000105-97-5
Adipic acid, didecyl ester
34.
12220
027178-16-1
Adipic acid, diisodecyl ester
35.
12250
000123-79-5
Adipic acid, dioctyl ester
36.
12265
004074-90-2
Adipic acid, divinyl ester
37.
12370
Alcohols, aliphatic, monohydric, saturated, linear, secondary or tertiary (C4-C22)
38.
12610
000107-18-6
Allyl alcohol
39.
12700
000150-13-0
p-Aminobenzoic acid
40.
12790
000080-46-6
P-tert.-Amylphenol
41.
12850
029602-44-6
Azelaic acid, bis(2-hydroxyethyl) ester
42.
12910
001732-10-1
Azelaic acid, dimethyl ester
43.
As item 155
000528-44-9
1,2,4-Benzenetricarboxylic acid
44.
13060
004422-95-1
1,3,5-Benzenetricarboxylic acid trichloride
As item 155
45.
As item 63
000091-76-9
Benzoguanamine
46.
13328
000104-38-1
Bis(2-hydroxyethyl) ether of hydroquinone
47.
As item 71
000080-09-1
Bisphenol S
48.
13660
000584-03-2
Butan-1,2-diol
49.
13720
000110-63-4
Butan-1,4-diol
50.
13750
000513-85-9
Butan-2,3-diol
51.
13780
002425-79-8
Butan-1,-diol bis(2,3-epoxypropyl) ether
The quantity in the finished plastic material or article of any substance within, or any combination of substances within, items 51 and 115 (and 16 and 20 of section D) shall not exceed 5 mg/kg (expressed as epoxy)
52.
13810
000505-65-7
Butan-1,4-diol formal
53.
13932
000598-32-3
But-3-en-2-ol
54.
13960
001852-16-0
N-(Butoxymethyl)-acrylamide
55.
14020
000098-54-4
4-tert.-Butylphenol
56.
14260
000502-44-3
Caprolactone
57.
As item 101, Section A
000115-28-6
Chlorendic acid
As item 101, Section A.
58.
14800
003724-65-0
Crotonic acid
59.
15020
002182-05-0
Cyclohexyl vinyl ether
60.
15070
001647-16-1
Dec-1,9-diene
61.
15130
000872-05-9
Dec-1-ene
62.
15280
000542-02-9
2,4-Diamino-6-methyl-1,3,5-triazine
63.
15310
000091-76-9
2,4-Diamino-6-phenyl-1,3,5,-triazine
64.
15340
000109-76-2
1,3-Diaminopropane
65.
15370
003236-53-1
1,6-Diamino-2,2,4-trimethylhexane
66.
15400
003236-54-2
1,6-Diamino-2,4,4-trimethylhexane
67.
15490
002215-89-6
4,4'-Dicarboxydiphenyl ether
68.
15580
001653-19-6
2,3-Dichlorobuta-1,3-diene
69.
15610
000080-07-9
4,4'-Dichlorodiphenyl sulphone
70.
15730
000077-73-6
Dicyclopentadiene
71.
16090
000080-09-1
4,4'-Dihydroxydiphenyl sulphone
72.
16210
006864-37-5
3,3'-Dimethyl-4,4'-diamino-dicyclohexylmethane
73.
16270
000526-75-0
2,3-Dimethylphenol
74.
16300
000105-67-9
2,4-Dimethylphenol
75.
16330
000095-87-4
2,5-Dimethylphenol
76.
16360
000576-26-1
2,6-Dimethylphenol
77.
16390
000126-30-7
2,2-Dimethylpropan-1,3-diol
78.
16450
000646-06-0
1,3-Dioxolane
79.
16540
000102-09-0
Diphenyl carbonate
80.
16690
001321-74-0
Divinylbenzene
81.
16697
000693-23-2
Dodecanedioic acid
82.
17040
000149-57-5
2-Ethylhexanoic acid
83.
17050
000104-76-7
2-Ethylhexan-1-ol
84.
17110
016219-75-3
5-Ethylidenebicyclo-[2.2.1]hept-2-ene
85.
17350
000105-75-9
Fumaric acid, dibutyl ester
86.
18220
068564-88-5
N-Heptylaminoundecanoic acid
87.
18370
000592-45-0
Hexa-1,4-diene
88.
18400
000592-42-7
Hexa-1,5-diene
89.
18441
000085-42-7
Hexahydrophthalic anhydride
90.
18700
000629-11-8
Hexan-1,6-diol
91.
18820
000592-41-6
Hex-1-ene
92.
18905
002628-17-3
4-Hydroxystyrene
93.
18970
000078-83-1
Isobutanol
94.
19030
016669-59-3
N-(Isobutoxymethyl)-acrylamide
95.
19060
000109-53-5
Isobutyl vinyl ether
96.
19090
000078-84-2
Isobutyraldehyde
97.
19120
025339-17-7
Isodecanol
98.
19130
026896-18-4
Isononanoic acid
99.
19150
000121-91-5
Isophthalic acid
100.
19180
000099-63-8
Isophthalic acid dichloride
101.
As item 123
000078-79-5
Isoprene
102.
19270
000097-65-4
Itaconic acid
103.
19490
000947-04-6
Laurolactam
104.
19570
000999-21-3
Maleic acid, diallyl ester
105.
19600
000105-76-0
Maleic acid, dibutyl ester
106.
19936
007423-42-9
Maleic acid, mono(2-ethylhexyl) ester
107.
19990
000079-39-0
Methacrylamide
108.
20050
000096-05-9
Methacrylic acid, allyl ester
109.
20260
000101-43-9
Methacrylic acid, cyclohexyl ester
110.
20380
001189-08-8
Methacrylic acid, diester with butan-1,3-diol
111.
20410
002082-81-7
Methacrylic acid, diester with butan-1,4-diol
112.
20440
000097-90-5
Methacrylic acid, diester with ethyleneglycol
113.
20470
025852-47-5
Methacrylic acid, diester with polyethyleneglycol
114.
20530
002867-47-2
Methacrylic acid, 2-(dimethylamino)-ethyl ester
115.
20590
000106-91-2
Methacrylic acid, 2,3-epoxypropyl ester
As item 51.
116.
20740
039670-09-2
Methacrylic acid, ester with ethoxytriethyleneglycol
117.
20950
000923-26-2
Methacrylic acid, 2-hydroxypropyl ester
118.
21115
000816-74-0
Methacrylic acid, methallyl ester
119.
21220
032360-05-7
Methacrylic acid, octadecyl ester
120.
21370
010595-80-9
Methacrylic acid, 2-sulphoethyl ester
121.
21400
054276–35–6
Methacrylic acid, sulphopropyl ester
122.
21520
001561–92–8
Methallylsulphonic acid, sodium salt
The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg.
123.
21640
000078–79–5
2-Methylbut-1,3-diene
124.
21730
000563–45–1
3-Methylbut-1-ene
125.
21760
000694–91–7
5-Methylenebicyclo-[2.2.1]hept-2-ene
126.
As item 52
000505–65–7
1,4-(Methylene-dioxy)butane
127.
21837
001116–90–1
4-methylhex-1,4-diene
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).
128.
21970
000923–02–4
N-Methylolmethacrylamide
129.
22210
000098–83–9
alpha-Methylstyrene
130.
22240
000622–97–9
p-Methylstyrene
131.
22270
000107–25–5
Methyl vinyl ether
132.
22360
001141–38–4
2,6-Naphthalene-dicarboxylic acid
133.
As item 77
000126–30–7
Neopentylglycol
134.
22428
051000–52–3
Neodecanoic acid, vinyl ester
135.
22540
000104–40–5
4-Nonylphenol
136.
13180 (also used for bicyclo [2.2.1] hept-2-ene)
000498–66–8
Norbornene
As item 39 on Part I Section C.
137.
22585
003710–30–3
Octa-1,7-diene
138.
22720
000140–66–9
4-tert.-Octylphenol
139.
22900
000109–67–1
Pent-1-ene
140.
22932
001187–93–5
Perfluoromethyl perfluorovinyl ether
141.
22937
001623–05–8
Perfluoropropyl perfluorovinyl ether
142.
23530
025190–06–1
Poly(1,4-butyleneglycol) (molecular weight greater than 1000)
143.
23770
000504–63–2
Propan-1,3-diol
144.
23920
000105–38–4
Propionic acid, vinyl ester
145.
24370
000106–79–6
Sebacic acid, dimethyl ester
146.
24560
000111–63–7
Stearic acid, vinyl ester
147.
24760
026914–43–2
Styrenesulphonic acid
148.
25030
016646–44–9
Tetra(allyloxy)ethane
149.
25161
000085–43–8
1,2,3,6-Tetrahydrophthalic anhydride
150.
25300
000088–19–7
o-Toluenesulphonamide
151.
25380
Trialkyl(C5-C15) acetic acid, vinyl ester (=vinyl versatate)
152.
25390
000101–37–1
Triallyl cyanurate
153.
25450
026896–48–0
Tricyclodecanedimethanol
154.
25480
000102–71–6
Triethanolamine
155.
25540
000528–44–9
Trimellitic acid
The quantity of this substance alone or together with item 156 in the finished plastic material or article shall not exceed 5 mg/kg.
156.
25550
000552–30–7
Trimellitic anhydride
The quantity of this substance alone or together with item 155 in the finished plastic material or article shall not exceed 5 mg/kg (expressed as trimellitic acid).
157.
25810
015625–89–5
1,1,1-Trimethylolpropane triacrylate
158.
25840
003290–92–4
1,1,1-Trimethylolpropane trimethacrylate
159.
25900
000110–88–3
Trioxane
160.
As item 154
000102–71–6
Tris(2-hydroxyethyl)amine
161.
26140
000075-38-7
Vinylidene fluoride
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).
162.
26170
003195-78-6
N-Vinyl-N-methyl-acetamide
The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg.
163.
26230
000088-12-0
Vinylpyrrolidone
164.
26290
025013-15-4
Vinyltoluene
165.
As item 130
000622-97-9
p-Vinyltoluene
166.
26320
002768-02-7
Vinyltrimethoxysilane
The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg.
167.
As item 74
000105-67-9
m-Xylenol
168.
As item 73
000526-75-0
o-Xylenol
169.
As item 75
000095-87-4
p-Xylenol

## “SECTION D Monomers authorised until 1st April 1996

1
2
3
4
Item
PM/REF No.
CAS No.
Name
Restrictions
1.
10599/90
061788-89-4
Acids, fatty, unsaturated (C18), dimers
2.
10599/92
068783-41-5
Acids, fatty, unsaturated (C18), dimers, hydrogenated
3.
10600
Acids, linear, with an even number of carbon atoms (C8-C22), and the dimers and trimers of the unsaturated acids
4.
10720
000999-55-3
Acrylic acid, allyl ester
5.
10775
084100-23-2
Acrylic acid, 4-tert. butylcyclohexyl ester
6.
10990
002156-96-9
Acrylic acid, decyl ester
7.
11005
012542-30-2
Acrylic acid, dicyclopentenyl ester
8.
11010
024447-78-7
Acrylic acid, diester with 2,2-bis (4-hydroxyphenyl)-propane bis (2-hydroxyethyl) ether
9.
11020
019485-03-1
Acrylic acid, diester with butan-1,3-diol
10.
11080
004074-88-8
Acrylic acid, diester with diethyleneglycol
11.
11110
002274-11-5
Acrylic acid, diester with ethyleneglycol
12.
11140
013048-33-4
Acrylic acid, diester with hexan-1,6-diol
13.
11170
026570-48-9
Acrylic acid, diester with polyethyleneglycol
14.
11200
002426-54-2
Acrylic acid, 2-(diethylamino) ethyl ester
15.
11230
002439-35-2
Acrylic acid, 2-(dimethylamino) ethyl ester
16.
11260
000106-90-1
Acrylic acid, 2,3-epoxypropyl ester
The quantity in the finished plastic material or article of any substance within, or any combination of substances within, items 16 and 20 (and 51 and 115 of Section B) shall not exceed 5 mg/kg (expressed as epoxy).
17.
11532
002761-08-2
Acrylic acid, 3-hydroxypropyl ester
18.
11860
Acrylic acid, monoester with propyleneglycol
19.
11875
004813-57-4
Acrylic acid, octadecyl ester
20.
12640
000106-92-3
Allyl 2,3-epoxypropyl ether
As item 16.
21.
13210
001761-71-3
Bis (4-aminocyclohexyl) methane
22.
14008
000098-52-2
4-tert.-Butylcyclohexanol
23.
14035
001746-23-2
4-tert.-Butylstryrene
24.
14560
000126-99-8
2-Chlorobutan-1,3-diene
25.
14650
000079-38-9
Chlorotrifluoroethylene
The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg.
26.
14833
000623-43-8
Crotonic acid, methyl ester
27.
14980
001631-25-0
N-Cyclohexylmaleimide
The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg.
28.
15030
000931-88-4
Cyclooctene
29.
15060
000142-29-0
Cyclopentene
30.
15260
000646-25-3
1, 10-Diaminodecane
31.
15270
002783-17-7
1, 12-Diaminododecane
32.
15295
000373-44-4
1, 8-Diaminooctane
33.
16120
000110-97-4
Diisopropanolamine
34.
16180
005205-93-6
N-(Dimethylaminopropyl) methacrylamide
35.
16252
000110-03-2
2, 5-Dimethylhexan-2, 5-diol
36.
16510
000138-86-3
Dipentene
37.
16719
003813-52-3
Endomethylene tetrahydrophthalic acid
38.
16900
013036-41-4
N- (Ethoxymethyl) − acrylamide
39.
17116
005877-42-9
4-Ethyloct-l-yn-3-ol
40.
17150
000078-27-3
1-Ethynylcyclohexanol
41.
17305
000141-02-6
Fumaric acid, bis (2-ethylhexyl ester)
42.
17320
002807-54-7
Fumaric acid, diallyl ester
43.
17380
000623-91-6
Fumaric acid, diethyl ester
44.
17398
007283-68-3
Fumaric acid, dioctadecyl ester
45.
17800
Glucosides obtained from glucose and pentaerythritol
46.
17830
Glucosides obtained from glucose and polyethyleneglycol (molecular weight greater than 200)
47.
17860
Glucosides obtained from glucose and polypropyleneglycol (molecular weight greater than 400)
48.
18436
001687-30-5
Hexahydrophthalic acid
49.
18490
015511-81-6
Hexamethylenediamine adipate
50.
18610
006422-99-7
Hexamethylenediamine sebacate
51.
18850
000107-41-5
Hexyleneglycol
52.
18865
003031-66-1
Hex-3-yn-2,5-diol
53.
19140
026952-21-6
Isooctanol
54.
19480
002146-71-6
Lauric acid, vinyl ester
55.
19660
000141-05-9
Maleic acid, diethyl ester
56.
19690
014234-82-3
Maleic acid, diisobutyl ester
57.
19720
001330-76-3
Maleic acid, diisooctyl ester
58.
19750
000624-48-6
Maleic acid, dimethyl ester
59.
19915
000925-21-3
Maleic acid, monobutyl ester
60.
20095
046729-07-1
Methacrylic acid, 4-tert.-butylcyclohexyl ester
61.
20200
001888-94-4
Methacrylic acid, 2-chloroethyl ester
62.
20320
003179-47-3
Methacrylic acid, decyl ester
63.
20455
006606-59-3
Methacrylic acid, diester with hexan-1, 6-diol
64.
20560
000142-90-5
Methacrylic acid, dodecyl ester
65.
20830
Methacrylic acid, esters with propan-1, 2-diol
66.
20920
000688-84-6
Methacrylic acid, 2- ethylhexyl ester
67.
20945
004664-49-7
Methacrylic acid, 2-hydroxyisopropyl ester (=methacrylic acid, 2-hydroxy-1-methylethyl ester)
68.
20965
002761-09-3
Methacrylic acid, 3-hydroxypropyl ester
69.
20980
007534-94-3
Methacrylic acid, isobornyl ester
70.
21040
029964-84-9
Methacrylic acid, isodecyl ester
71.
21070
028675-80-1
Methacrylic acid, isooctyl ester
72.
21170
000997-46-6
Methacrylic acid, monoester with butan-1, 4-diol
73.
21250
002157-01-9
Methacrylic acid, n-octyl ester
74.
21430
004245-37-8
Methacrylic acid, vinyl ester
75.
21670
000563-46-2
2-Methylbut-l-ene
76.
21733
000115-19-5
2-Methylbut-3-yn-2-ol
77.
21736
002549-61-3
alpha-Methyl-epsilon-caprolactone
78.
21739
002549-60-2
beta-Methyl-epsilon-caprolactone
79.
21742
002549-58-8
delta-Methyl-epsilon-caprolactone
80.
21745
002549-59-9
epsilon-Methyl-epsilon-caprolactone
81.
21748
002549-42-0
gamma-Methyl-epsilon-caprolactone
82.
21850
000095-71-6
Methylhydroquinone
83.
21880
000717-27-1
Methylhydroquinone diacetate
84.
22465
000112-05-0
Nonanoic acid
85.
22690
001806-26-4
4-Octylphenol
86.
22811
000591-93-5
Pent-1, 4-diene
87.
22842
002590-16-1
Pentaerythritol diallyl ether
88.
22858
005343-92-0
Pentan-1, 2-diol
89.
22861
000111-29-5
Pentan-1, 5-diol
90.
22901
000109-68-2
Pent-2-ene
91.
22935
003823-94-7
Perfluoromethyl vinyl ether
92.
22940
006996-01-0
Perfluoropropyl vinyl ether
93.
23140
000092-69-3
4-Phenylphenol
94.
25158
000088-98-2
1, 2, 3, 6-Tetrahydrophthalic acid
95.
25630
037275-47-1
1, 1, 1-Trimethylolpropane diacrylate
96.
25645
000682-09-7
1, 1, 1-Trimethylolpropane diallyl ether
97.
25780
025723-16-4
1, 1, 1-Trimethylolpropane propoxylated
98.
25930
001067-53-4
Tris (2-methoxyethoxy) vinylsilane
The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg.
99.
26200
002867-48-3
N-Vinyl-N-methylformamide
100.
26260
001184-84-5
Vinylsulphonic acid
”

## Schedule 4 

“TABLE
Conditions of contact in actual use
Test conditions
Contact time
Test time
t ≤ 0.5 hour
0.5 hour
0.5 hour < t ≤ 1 hour
1 hour
1 hour < t ≤ 2 hours
2 hours
2 hours < t ≤ 24 hours
24 hours
t > 24 hours
10 days
Contact temperature
Test temperature
(1) Use simulant C at reflux temperature.
(2) Use simulant D at 150° or 175°C, in addition to simulants A, B and C used as appropriate at 100°C or at reflux temperature.
T ≤ 5°C
5°C
5°C < T ≤ 20°C
20°C
20°C < T ≤ 40°C
40°C
40°C < T ≤ 70°C
70°C
7°C < T ≤ 100°C
100°C or reflux temperature
100°C < T ≤ 121°C
121°C
121°C < T ≤ 130°C
130°C
130°C < T ≤ 150°C
150°C
T > 150°C
175°C
”

## Explanatory note

(This note is not part of the Regulations)
These Regulations amend the Plastic Materials and Articles in Contact with Food Regulations 1992 (S.I. 1992/3145) (“the principal Regulations”) and implement Commission Directive 93/8/EEC (OJ No. L90, 14.4.93, p.22), amending Council Directive 82/711/EEC (OJ No. L297, 23.10.82, p.26) laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs, and Commission Directive 93/9/EEC (OJ No. L90, 14.4.93, p.26), amending Commission Directive 90/128/EEC (OJ No. L75, 21.3.90, p.19, to be read with corrigendum in OJ No. L349, 13.12.90, p.26) relating to plastic materials and articles intended to come into contact with foodstuffs.
The Regulations—
(a) provide that the capacity of an article specified in regulation 5(4)(b)(i) of the principal Regulations is less than 500 millilitres or more than 10 litres (regulation 2(a));
(b) correct a drafting error in regulation 5(6) of the principal Regulations (regulation 2(b));
(c) correct an error and an omission in the principal Regulations (regulation 2(c) and (d) respectively);
(d) permit the use, sale or importation of plastic materials and articles manufactured using one or more of the monomers in Section D as inserted in Part I of Schedule 1 to the principal Regulations by these Regulations, until 1 April 1996 (regulation 2(e) and (i));
(e) add specified monomers to those listed in Section A of Part I to Schedule 1 of the principal Regulations (monomers authorised without time limit) (regulation 2(f));
(f) amend the restriction at item 26 (11- Aminoundecanoic acid) in Section A of Part I of Schedule 1 to the principal Regulations (regulation 2(g));
(g) substitute for Section B of Part I of Schedule 1 to the principal Regulations (monomers authorised to the end of 1996) an amended list with fewer authorised monomers (regulation 2(h));
(h) add two further requirements to paragraph 4 of Section A of Part I of Schedule 2 to the principal Regulations specifying the conditions under which verification of compliance with migration limits is to be carried out using food and simulants respectively (regulation 2(j));
(i) amend provisions relating to simulants to be used, and their use, in migration testing (regulation 2(k) and (l));
(j) amend provisions relating to time and temperature test conditions (regulation 2(m) to (r));
(k) amend the Food Safety (Sampling and Qualifications) Regulations 1990 (S.I. 1990/2463) so that those Regulations do not apply to any sample taken under the provisions of the principal Regulations (regulation 3).
A copy of the Compliance Cost Assessment in relation to these Regulations has been placed in the libraries of both Houses of Parliament and further copies can be obtained from the Chemical Safety of Food Division of the Ministry of Agriculture, Fisheries and Food, Ergon House, 17 Smith Square, London SW1P 3JR.

---
Source: https://www.legislation.gov.uk/uksi/1995/360 (the official version)
Page: https://openlegislation.uk/plastic-materials-and-articles-in-contact-with-food-amendment-regulations-1995
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.