# The Plastic Materials and Articles in Contact with Food Regulations 1992

S.I. 1992/3145 · made 10 December 1992

These Regulations implement Commission Directive (EEC) 90/128 (OJ No. L349, 13.12.90, p.26) as amended by Commission Directive (EEC) 92/39 (OJ No. L168, 23.6.92, p.21) relating to plastic materials and articles intended to come into contact with foodstuffs, as read with Council Directives (EEC) 82/711 and 85/572 (OJ Nos. L297, 23.10.82, p.26 and L372, 30.12.85, p.14 respectively) which between them lay down the basic rules necessary, and the list of simulants to be used, for testing migration of certain constituents of plastic materials and articles intended to come into contact with foodstuffs. The Regulations prescribe limits both in relation to content of the materials and articles in question and migration of constituents into food, and the tests by which migration is to be established. The materials and articles to which these Regulations relate are also subject to the Materials and Articles in Contact with Food Regulations 1987.

Made under: Food Safety Act 1990 (Section 4, Section 6, Section 16, Section 17, Section 26, Section 31, Section 48); European Communities Act 1972 (repealed)

## Introductory text

FOOD
Made 10th December 1992
Laid before Parliament 11th December 1992
Coming into force 1st January 1993
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 4(1), 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 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 and extent

(1) These Regulations may be cited as the Plastic Materials and Articles in Contact with Food Regulations 1992 and shall come into force on 1st January 1993.
(2) These Regulations shall not extend to Northern Ireland.

## 2 Interpretation

(1) In these Regulations, unless the context otherwise requires—
“the Act” means the Food Safety Act 1990;
“the 1987 Regulations” means the Materials and Articles in Contact with Food Regulations 1987;
“business” has the same meaning as it has in the Act;
“capable” means capable as established under regulation 6;
“the Directive” means Commission Directive (EEC) No. 90/128 relating to plastics materials and articles intended to come into contact with foodstuffs as amended;
“food” has the same meaning as it has in the Act;
“human consumption” has the same meaning as it has in the Act;
“import” means import in the course of a business;
“monomer” means anything which is included for the purposes of the Directive among monomers and other starting substances;
“person charged” includes, in Scotland, the accused;
“plastic material or article” means anything which for the purposes of the Directive is included among those plastics materials and articles and parts thereof to which the Directive applies;
“preparation” has the same meaning as it has in the Act;
“sell” includes offer or expose for sale or have in possession for sale, and “sale” shall be construed accordingly.
(2) For the purposes of these Regulations the supply of any plastic material or article, otherwise than on sale, in the course of a business shall be deemed to be a sale of the plastic material or article.
(3) Any reference in these Regulations to a numbered regulation or Schedule shall unless the context otherwise requires be construed as a reference to the regulation or Schedule bearing that number in these Regulations.

## 3 Restriction on sale etc., and importation of plastic materials and articles

(1) No person shall use any plastic material or article which does not comply with these Regulations in the course of a business in connection with the storage, preparation, packaging, sale or serving of food for human consumption.
(2) No person shall sell any plastic material or article which does not comply with these Regulations for the purpose of its being used in connection with the storage, preparation, packaging, sale or serving of food for human consumption.
(3) No person shall import from any place other than a member State of the European Economic Community any plastic material or article which does not comply with these Regulations for the purpose of its being used in connection with the storage, preparation, packaging, sale or serving of food for human consumption.
(4) In any proceedings for an offence under this regulation it shall be a defence for the person charged to prove that the plastic material or article in respect of which the offence is alleged to have been committed was intended for export and complied with the importing country’s domestic legislation relevant to the alleged offence.

## 4 Transfer of constituents

(1) No plastic material or article shall be capable of transferring its constituents to food with which it may come into contact in quantities exceeding the appropriate limit provided that a plastic material or article shall not be considered capable of transferring its constituents to food with which it may come into contact, in quantities exceeding the appropriate limit, if the only food which that plastic material or article may come into contact with is a food or foods specified in the Table to Part III of Schedule 2 in relation to which no simulant is specified.
(2) For the purposes of this regulation and regulation 5(5) no simulant is specified in relation to a food specified in the Table to Part III of Schedule 2 where there is no ‘X’ placed in the column headed "Simulants to be used' opposite that food.
(3) For the purposes of this regulation the appropriate limit is—
(a) an overall migration limit of 60 milligrams of constituents released per kilogram of food in the case of any plastic material or article comprising—
(i) an article which is a container or is comparable to a container or which can be filled, with a capacity of not less than 500 millilitres and not more than 10 litres;
(ii) an article which can be filled and for which it is impracticable to estimate the surface area in contact with food;
(iii) a cap, gasket, stopper or similar device for sealing, and
(b) in the case of any other plastic material or article, an overall migration limit of 10 milligrams per square decimetre of the surface area of the plastic material or article.

## 5 Monomers

(1) Subject to the following paragraphs of this regulation, no plastic material or article shall be manufactured with any monomer other than a monomer which is of good technical quality and is identified by PM/REF No. (if any), CAS No. (if any) and name respectively in columns 1, 2, 3 of the relevant fraction of Part I of Schedule 1 and used in accordance with the restrictions (if any) specified in the corresponding entry in column 4 thereof, and for the purposes of this regulation the relevant fraction of Part I comprises—
(a) in the case of a plastic material or article manufactured before 1st January 1997, Sections A and B of Part I, and
(b) in the case of a plastic material or article manufactured after 31st December 1996, Section A of Part I.
(2) Paragraph (1) of this regulation does not apply to plastic materials or articles comprising—
(a) surface coatings obtained from resinous or polymerized products in liquid, powder or dispersion form, including, but not limited to, varnishes, lacquers and paints;
(b) silicones;
(c) epoxy resins;
(d) products obtained by means of bacterial fermentation;
(e) adhesives and adhesion promoters;
(f) printing inks.
(3) Paragraph (1) of this regulation shall not be taken to prohibit the presence in any plastic material or article of any substance if the substance is a mixture of monomers of good technical quality identified in the relevant fraction of Part I of Schedule 1.
(4) Subject to the proviso in paragraph (5) of this regulation, where column 4 of the relevant fraction of Part I of Schedule 1 expresses a migration limit of mg/kg in relation to any monomer, no plastic material or article manufactured from that monomer shall be capable of transferring constituents of that monomer to food with which that plastic material or article may come into contact in quantities exceeding the appropriate limit, and for the purposes of this paragraph the appropriate limit is—
(a) in the case of any plastic material or article other than one specified in subparagraph (b) below, the number of milligrams expressed therein released per kilogram of food, and
(b) if the plastic material or article comprises—
(i) an article which is a container or is comparable to a container or which can be filled, with a capacity of not less than 500 millilitres and not more than 10 litres, or
(ii) sheet, film or other material which cannot be filled or for which it is impracticable to estimate the relationship between the surface area of that material and the quantity of food in contact with that surface area,
one sixth of the number of milligrams expressed therein per square decimetre of surface area of the plastic material or article.
(5) A plastic material or article manufactured from any monomer in respect of which column 4 of the relevant fraction of Part I of Schedule 1 expresses a migration limit of mg/kg shall not be considered capable of transferring constituents of that monomer to food with which that plastic material or article may come into contact in quantities exceeding the appropriate limit in paragraph (4) of this regulation if the only food which that plastic material or article may come into contact with is a food or foods specified in the Table to Part III of Schedule 2 in relation to which no simulant is specified.
(6) In any proceedings for an offence under regulation 3 comprising the manufacture of a plastic material or article with any monomer (whether or not of good technical quality) other than those identified in the relevant fraction of Part I of Schedule 1, it shall be a defence for the person charged to prove that—
(a) each such monomer is present in the finished plastic material as an impurity, a reaction intermediate or a decomposition product,
(b) each such monomer is an oligomer or a natural or synthetic macromolecular substance or a mixture thereof and every monomer required to synthesise it is of good technical quality and identified in the relevant fraction of Part I of Schedule 1, or
(c) each such monomer falls within either sub-paragraph (a) or sub-paragraph (b) above.
(7) Part II of Schedule 1 shall have effect to supplement this regulation and Part I of Schedule 1.

## 6 Method of testing capability of transferring constituents

(1) Plastic material, for the purposes of these Regulations, shall be treated as being capable of transferring constituents to food with which it may come into contact to the extent that it is established for those purposes—
(a) in any case other than one to which sub-paragraph (b) below relates, by the verification methods specified in Schedule 2, and
(b) in any case where the extent to which vinyl chloride, as identified in Section A of Part I of Schedule 1, is capable of such transfer falls to be established, by the method referred to in regulation 14(2) of the 1987 Regulations.
(2) In Schedule 2 refences to migration or release of a substance shall be construed as references to the transfer of constituents to the simulant representing the food or, as the case may be, food with which it may come into contact.

## 7 Labelling

(1) Subject to paragraph (2) below, any plastic material or article which is intended to be placed in contact with food and is at a marketing stage other than the retail stage shall be accompanied by a written declaration attesting that it complies with the legislation applicable to it.
(2) Paragraph (1) above shall not apply to any plastic material or article which by its nature is clearly intended to come into contact with food.

## 8 Enforcement

(1) Each authority which is the enforcement authority for the 1987 Regulations shall enforce and execute in its area the provisions of these Regulations.
(2) Nothing in this regulation shall be taken as authorising in Scotland an enforcement authority to institute proceedings for an offence against these Regulations.

## 9 Offences

(1) If any person contravenes or fails to comply with any of the provisions of these Regulations he shall be guilty of an offence.
(2) Any person who—
(a) intentionally obstructs any person acting in the execution of these Regulations, or
(b) without reasonable cause, fails to give to any person acting in the execution of these Regulations any assistance or information which that person may reasonably require of him for the performance of his functions under these Regulations,
shall be guilty of an offence, but nothing in sub-paragraph (b) above shall be construed as requiring any person to answer any question or give any information if to do so might incriminate him.
(3) Any person who, in purported compliance with any such requirement as is mentioned in paragraph (2)(b) above—
(a) furnishes information which he knows to be false or misleading in a material particular, or
(b) recklessly furnishes information which is false or misleading in a material particular,
shall be guilty of an offence.
(4) Where an offence under these Regulations which has been committed by a body corporate is proved to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of—
(a) any director, manager, secretary or other similar officer of the body corporate, and in Scotland, any partner of a partnership, or
(b) any person who was purporting to act in any such capacity,
he as well as the body corporate shall be deemed to be guilty of that offence and shall be liable to be proceeded against and punished accordingly.
(5) For the purposes of these Regulations “body corporate” shall in Scotland include a partnership.
(6) Where the commission by any person of an offence under these Regulations is due to an act or default of some other person, that other person shall be guilty of the offence; and a person may be charged with and convicted of the offence by virtue of this paragraph whether or not proceedings are taken against the first mentioned person.
(7) In any proceedings for an offence under these Regulations it shall, subject to paragraph (11) below, be a defence for the person charged to prove that he took all reasonable precautions and exercised all due diligence to avoid the commission of the offence by himself or by a person under his control.
(8) Without prejudice to the generality of paragraph (7) above, a person charged with an offence under these Regulations who neither—
(a) prepared the plastic material or article in respect of which the offence is alleged to have been committed, nor
(b) imported it into Great Britain,
shall be taken to have established the defence provided by that paragraph if he satisfies the requirements of paragraph (9) or (10) below.
(9) A person satisfies the requirements of this paragraph if he proves—
(a) that the commission of the offence was due to an act or default of another person who was not under his control, or to reliance on information supplied by such a person;
(b) that he carried out all such checks of the plastic material or article in question as were reasonable in all the circumstances, or that it was reasonable in all the circumstances for him to rely on checks carried out by the person who supplied the plastic material or article to him; and
(c) that he did not know and had no reason to suspect at the time of the commission of the alleged offence that his act or omission would amount to an offence under these Regulations.
(10) A person satisfies the requirements of this paragraph if the offence is one of sale and he proves—
(a) that the commission of the offence was due to an act or default of another person who was not under his control, or to reliance on information supplied by such a person;
(b) that the sale of which the alleged offence consisted was not a sale under his name or mark; and
(c) that he did not know, and could not reasonably have been expected to know, at the time of the commission of the alleged offence that his act or omission would amount to an offence under these Regulations.
(11) If in any case the defence provided by paragraph (7) above involves the allegation that the commission of the offence was due to an act or default of another person, or to reliance on information supplied by another person, the person charged shall not, without leave of the court, be entitled to rely on that defence unless—
(a) at least seven clear days before the hearing, and
(b) where he has previously appeared before a court in connection with the alleged offence, within one month of his first such appearance,
he has served on the prosecutor a notice in writing giving such information identifying or assisting in the identification of that other person as was then in his possession, and in this paragraph any reference to appearing before a court shall be construed as including a reference to being brought before a court.
(12) Any person guilty of an offence under these Regulations shall be liable on summary conviction to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding three months or to both and on conviction on indictment to a fine or to imprisonment for a term not exceeding two years or both.

## 10 Presumption as to food with which a plastic material or article is to come into contact

In establishing which descriptions of food a plastic material or article may come into contact with it shall be assumed for the purposes of these Regulations, until the contrary is proved, that, if particulars are shown in relation to that plastic material or article in accordance with the 1987 Regulations, those particulars are accurate and that, unless the particulars so indicate, there are no restrictions on the intended conditions of contact.

## 11 Application of other provisions

(1) The following provisions of the 1987 Regulations shall apply in relation to plastic materials or articles as they apply to materials and articles for the purposes of those Regulations, as if those provisions formed part of these Regulations—
(a) regulation 12 (powers of authorised officers);
(b) regulation 13 (analysis, examination and testing);
(c) regulation 16 (confidentiality);
(d) regulation 17 (authorised officer acting in good faith);
(e) regulation 20 (evidence of analysis); and
(f) regulation 21 (analysis by Government chemist).
(2) Section 3(4) of the Act (relating to the presumption of intention for human consumption) shall apply for the purposes of these Regulations as it applies for the purposes of the Act.
(3) Sections 29 and 30 of the Act (which deal with procurement and analysis of samples) shall, in so far as they relate to plastic materials or articles, be modified to the extent necessary for the purposes of these Regulations.

## 12 Application of other provisions

Until 1st April 1995 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 C of Part I of Schedule 1—
(a) may be used in the course of a business in connection with the storage, preparation, packing, 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 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 and where column 4 expresses a migration limit of mg/kg in relation to any such monomer that monomer shall comply with the appropriate migration limit in regulation 5(4).

## Signature

In Witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 10th December 1992.
L.S.
John Selwyn Gummer
Minister of Agriculture, Fisheries and Food
Signed by the authority of the Secretary of State for Health
Tom Sackville
Parliamentary Under Secretary of State,
Department of Health
8th December 1992
David Hunt
Secretary of State for Wales
10th December 1992
Hector Monro
Parliamentary Under Secretary of State, Scottish Office
9th December 1992

### Part I: AUTHORISED MONOMERS

## SECTION A Monomers authorised without time limit

1
2
3
4
Item
PM/REF No.
CAS No.
Name
Restrictions
1.
10030
000514-10-3
Abietic acid
2.
10060
000075-07-0
Acetaldehyde
3.
10090
000064-19-7
Acetic acid
4.
10120
000108-05-4
Acetic acid, vinyl ester
The specific migration of this substance shall not exceed 12 md/kg.
5.
10150
000108-24-7
Acetic anhydride
6.
10210
000074-86-2
Acetylene
7.
10630
000079-06-1
Acrylamide
The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection 0.01 mg/kg.
8.
10690
000079-10-7
Acrylic acid
9.
10780
000141-32-2
Acrylic acid, n-butyl ester
10.
10810
002998-08-5
Acrylic acid, sec. butyl
11.
10840
001663-39-4
Acrylic acid, tert. butyl
12.
11470
000140-88-5
Acrylic acid, ethyl ester
13.
As item 17
000818-61-1
Acrylic acid, hydroxyethyl exter
14.
11590
000106-63-8
Acrylic acid, isobutyl ester
15.
11680
000689-12-3
Acrylic acid, isopropyl ester
16.
11710
000096-33-3
Acrylic acid, methyl ester
17.
11830
000818-61-1
Acrylic acid, monoester with ethylene glycol
18.
11980
000925-60-0
Acrylic acid, propyl ester
19.
12100
000107-13-1
Acrylonitrile
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)
20.
12130
000124-04-9
Adipic acid
21.
12280
002035-75-8
Adipic anhydride
22.
12310
Albumin
23.
12340
Albumin, coagulated by formaldehyde
24.
12375
Alcohols, aliphatic, monohydric, saturated, linear, prinmary (C4-C22)
25.
12670
002855-13-2
1-Amino-3-aminomethyl-3,5,5-trimethylcyclohexane
The specific migration of this substance shall not exceed 6 mg/kg.
26.
12788
002432-99-7
11-aminoundecanoic acid
The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg.
27.
12820
000123-99-9
Azalaid acid
28.
12970
004196-95-6
Azelaic anhydride
29.
13000
001477-55-0
1,3-Benzenedimethanamine
The specific migration pof this substance shall not exceed 0.05 mg/kg.
30.
13090
000065-85-0
Benzolic acid
31.
13150
000100-51-6
Benzyl alcohol
32.
As item 72
000111-46-6
Bis(2-hydroxyethyl) ether
As item 72.
33.
As item 192
000077-99-6
2,2-Bis(hydroxymethyl)-butan-1-ol
As item 192.
34.
13390
000105-08-8
1,4-Bis(hydroxymethyl)-cyclohexane
35.
13480
000080-05-7
2,2-Bis(4-hydroxyphenyl)-propane
The specific migration of this substance shall not exceed 3 mg/kg.
36.
13510
001675-54-3
2,2-Bis(4-hydroxyphenyl)-propane bis(2,3-epoxypropyl) ether
The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg or the specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg. analytical tolerance included).
37.
As item 84
000110-98-5
Bis(hydroxypropyl) ether
38.
As item 71
005124-30-1
Bis(4-isocyanatocyclohexyl)methane
As item 71.
39.
13530
038103-06-9
2,2-Bis(4-hydroxyphenyl)-propane bis(phthalic anhydride)
The specific migration of this substance shall not exceed 0.05 mg/kg.
40.
13600
047465-97-4
3,3-Bis(3-methyl-4-hydroxyphenyl)indolin-2-one
The specific migration of this substance shall not exceed 1.8 mg/kg.
41.
As item 35
000080-05-7
Bisphenol A
As item 35.
42.
As item 36
001675-54-3
Bisphenol A bis(2,3-epoxypropyl) ether
As item 36.
43.
13614
038103-06-9
Bisphenol A bis(phthalic anhydride)
As item 39.
44.
13630
000106-99-0
Butadiene
The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg or the specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg. analytical tolerance included).
45.
13690
000107-88-0
Butan-1,3-diol
46.
13840
000071-36-3
Butan-1-ol
47.
13870
000106-98-9
But-1-ene
48.
13900
000107-01-7
But-2-ene
49.
14110
000123-72-8
Butyraldehyde
50.
14140
000107-92-6
Butyric acid
51.
14170
000106-31-0
Butyric anhydride
52.
14200
000105-60-2
Caprolactam
The specific migration of this substance alone or together with item 53 shall not exceed a total of 15 mg/kg.
53.
14230
002123-24-2
Caprolactam, sodium salt
The specific migration of this substance alone or together with item 52 shall not exceed a total of 15 mg/kg (expressed as caprolactam).
54.
14320
000124-07-2
Caprylic acid
55.
14350
000630-08-0
Carbon monoxide
56.
14380
000075-44-5
Carbonyl chloride
The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg.
57.
14410
008001-79-4
Castor oil (food grade quality)
58.
14500
009004-34-6
Cellulose
59.
14530
007782-50-5
Chlorine
60.
As item 85
000106-89-8
1-Chloro-2,3-epoxypropane
As item 85.
61.
14680
000077-92-9
Citric acid
62.
14710
000108-39-4
m-Cresol
63.
14740
000095-48-7
o-Cresol
64.
14770
000106-44-5
p-Crresol
65.
As item 34
000105-08-8
1,4-Cyclohexanedimethanol
66.
14950
003175-53-3
Cyclohexyl isocyanate
The quantity in the finished plastic material or article of any substance within, or any combination of substances within, items 66, 71, 79, 81, 82, 83, 106, 132, 135, 186, 187 and 188 shall not exceed 1 mg/kg (expressed as isocyanate moiety).
67.
15100
000112-30-1
Decan-1-ol
68.
As item 88
000107-15-3
1,2-Diaminoethane
As item 88.
69.
As item 105
000124-09-4
1,6-Diaminohexane
As item 105.
70.
15250
000110-60-1
1,4-Diaminobutane
71.
15700
005124-30-1
Dicyclohexylmethane-4,4'-diisocyanate
As item 66.
72.
15760
000111-46-6
Diethylene glycol
The specific migration of this substance alone or together with item 89 shall not exceed a total of 30 mg/kg.
73.
15880
000120-80-9
1,2-Dihydroxybenzene
The specific migration of this substance shall not exceed 6 mg/kg.
74.
15910
000108-46-3
1,3-Dihydroxybenzene
The specific migration of this substance shall not exceed 2.4 mg/kg.
75.
15940
000123-31-9
1,4-Dihydroxybenzene
The specific migration of this substance shall not exceed 0.6 mg/kg.
76.
15970
000611-99-4
4,4'-Dihydroxybenzophenone
The specific migration of this substance shall not exceed 6 mg/kg.
77.
16000
000092-88-6
4,4'-Dihydroxybiphenyl
The specific migration of this substance shall not exceed 6 mg/kg.
78.
16150
000108-01-0
Dimethylaminoethanol
The specific migration of this substance shall not exceed 18 mg/kg.
79.
16240
000091-97-4
3,3'-Dimethyl-4,4'-diisocyanatobiphenyl
As item 66.
80.
16480
000126-58-9
Dipentaerythritol
81.
16570
004128-73-8
Diphenylether-4,4'-diisocyanaate
As item 66.
82.
16600
005873-54-1
Diphenylmethane-2,4'-diisocyanate
As item 66.
83.
16630
000101-68-8
Diphenylmethane-4-4'-diisocyanate
As item 66.
84.
16660
000110-98-3
Dipropylene glycol
85.
16750
000106-89-8
Epichlorohydrin
The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg.
86.
16780
000064-17-5
Ethanol
87.
16950
000074-85-1
Ethylene
88.
16960
000107-15-3
Ethylenediamine
The specific migration of this substance shall not exceed 12 mg/kg.
89.
16990
000107-21-1
Ethylene glycol
The specifi c migration opf this substance alone or together with item 72 shall not exceed a total of 30 mg/kg.
90.
17005
000151-56-4
Ethyleneimine
The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg).
91.
17020
000075-21-8
Ethylene oxide
The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg.
92.
17170
061788-47-4
Fatty acids, coco
93.
17200
068308-53-2
Fatty acids, soya
94.
17230
061790-12-3
Fatty acids, tall oil
95.
17260
000050-00-0
formaldehyde
The specific migration of this substance shall not exceed 15 mg/kg.
96.
17290
000110-17-8
Fumaric acid
97.
17530
000050-99-7
Glucose
98.
18010
000110-94-1
Glutaric acid
99.
18070
000108-55-4
Glutaric anhydride
100.
18100
000056-81-5
Glycerol
101.
18250
000115-28-6
Hexachloroendomethylenetetrahydrophthalic acid
The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg).
102.
18280
000115-27-5
Hexachloroendomethylenetetrahydrophthalic anhydride
The specific migration of this substance shallb be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg).
103.
18310
036653-82-4
Hexadecan-1-ol
104.
18430
000116-15-4
Hexafluoropropylene
The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg).
105.
18460
000124-09-4
Hexamethylenediamine
The specific migration pof this substance shall not exceed 2.4 mg/kg.
106.
18640
000822-06-0
Hexamethylene diisocyanate
As item 66.
107.
18670
000100-97-0
Hexamethylenetetramine
The specific migration of this substance shall not exceed 1.5 mg/kg (expressed as formaldahyde).
108.
As item 75
000123-31-9
Hydroquinone
As item 75.
109.
18880
000099-96-7
p-Hydroxybenzoic acid
110.
19000
000115-11-7
Isobutene
111.
19470
000143-07-7
Lauric acid
112.
19510
011132-73-3
Lignocellulose
113.
19540
000110-16-7
maleic acid
The specific migration of this substance alone or together with item 114 shall not exceed a total of 30 mg/kg.
114.
19960
000108-31-6
Maleic anhydride
The specific migration of this substance alone or together with item 113 shall not exceed a total of 30 mg/kg (expressed as maleic acid).
115.
As item 190
000108-78-1
Melamine
As item 190.
116.
20020
000079-41-4
Methacrylic acid
117.
20110
000097-88-1
Methacrylic acid, butyl ester
118.
20140
002998-18-7
Methacrylic acid, sec. butyl
119.
20170
000585-07-9
Methacryhlic acid, tert. butyl ester
120.
20890
000097-63-2
Methacrylic acid, ethyl ester
121.
21010
000097-86-9
Methacrylic acid, isobutyl ester
122.
21100
004655-34-9
Methacrylic acid, isopropyl ester
123.
21130
000080-62-6
Methacrylic acid, methyl ester
124.
21190
000868-77-9
Methacrylic acid, monoester with ethyleneglycol
125.
21340
002210-28-8
Methacrylic acid, propyl ester
126.
21460
000760-93-0
Methacrylic anhydride
127.
21490
000126-98-7
Methacrylonitrile
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).
128.
21550
000067-56-1
Methanol
129.
21940
000924-42-5
N-Methylolacrylamide
The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg).
130.
22150
000691-37-2
4-Methylpent-1-ene
The specific migration of this substance shall not exceed 0.02 mg/kg.
131.
22350
000544-63-8
Myristic acid
132.
22420
003173-72-6
1,5-Naphthalene diisocyanate
As item 66.
133.
22450
009004-70-0
Nitrocellulose
134.
22480
000143-08-8
Nonan-1-ol
135.
22570
000112-96-9
Octadecyl isocyanate
As item 66.
136.
22600
000111-87-5
Octan-1-ol
137.
22660
000111-66-0
Oct-1-ene
The specific migration of this substance shall not exceed 15 mg/kg.
138.
22763
000112-80-1
Oleic acid
139.
22780
000057-10-3
Palmitic acid
140.
22840
000115-77-5
Pentaerythritol
141.
22870
000071-41-0
Pentan-1-ol
142.
22960
000108-95-2
Phenol
143.
23050
000108-45-2
1,3-Phenylenediamine
The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg.
144.
As item 56
000075-44-5
Phosgene
As item 56.
145.
23170
007644-38-2
Phosphoric acid
146.
As item 181
Phthalic acid
As item 181.
147.
232500
000088-99-3
o-Phthalic Acid
148.
23230
000131-17-9
Phthalic acid diallyl ester
The specific migration of this sustance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg).
149.
23380
000085-44-9
Phthalic anhydride
150.
23470
000080-56-8
alpha-Pinene
151.
23500
000127-91-3
beta-Pinene
152.
23590
025322-68-3
Polyethylene glycol
153.
23650
025322-69-4
Polypropylene glycol (molecular weight greater than 400)
154.
23740
000057-55-6
Propan-1,2-diol
155.
23800
000071-23-8
Propan-1-ol
156.
23830
000067-63-0
Propan-2-ol
157.
23860
000123-38-6
Propionaldehyde
158.
23890
000079-09-4
Propionic acid
159.
23950
000123-62-6
Propionic anhydride
160.
23980
000115-07-1
Propylene
161.
24010
000075-56-9
Propylene oxide
The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg.
162.
As item 73
000120-80-9
Pyrocatechol
As item 73.
163.
24070
073138-82-6
Resin acids and rosin acids
164.
As item 74
000108-46-3
Resorcinol
As item 74.
165.
24100
008050-09-7
Rosin
166.
24130
008050-09-7
Rosin gum
167.
24160
008052-10-6
Rosin tall oil
168.
24190
009014-63-5
Rosin wood
169.
24250
009006-04-6
Rubber, natural
170.
24270
000069-72-7
Salicyclic acid
171.
24280
000111-20-6
Sebacic acid
172.
24430
002561-88-8
Sebacic anhydride
173.
24490
000050-70-4
Sorbitol
174.
24520
008001-22-7
Soybean oil
175.
24550
000057-11-4
Stearic acid
176.
24610
000100-42-5
Styrene
177.
24820
000110-15-6
Succinic acid
178.
24850
000108-30-5
Succinic anhydride
179.
24880
000057-50-1
Sucrose
180.
24887
006326-79-4
5-Sulphoisophthalic acid, monosodium sale
The specific migration of this substance shall not exceed 0.05 mg/kg.
181.
24910
000100-21-0
Terephthalic acid
The specific migration of this substance shall not exceed 7.5 mg/kg.
182.
24970
000120-61-6
Terephthalic acid, dimethyl ester
183.
25090
000112-60-7
Tetraethylene glycol
184.
25150
000109-99-9
Tetrahydrofuran
The specific migration of this substance shall not exceed 0.6 mg/kg.
185.
25180
000102-60-3
N,N,N',N'-Tetrakis(2-hydroxypropyl)ethylenediamine
186.
25210
000584-84-9
2,4-Toluene diisocyanate
As item 66.
187.
25240
000091-08-7
2,6-Toluene diisocyanate
As item 66.
188.
25270
026747-90-0
2,4-Toluene diisocyanate dimer
As item 66.
189.
25360
Trialdyl(C5-C15)acitic acid, 2,3-epoxypropyl ester
The specific migration of this substance shall not exceed 0.6 mg/kg.
190.
25420
000108-78-1
2,4,6-Triamino-1,3,5-triazine
The specific migration of this substance shall not exceed 30 mg/kg.
191.
25510
000112-27-6
Triethylene glycol
192.
25600
000077-99-6
1,1,1-Trimethylolpropane
The specific migration of this substance shall not exceed 6 mg/kg.
193.
25910
024800-44-0
Tripropylene glycol
194.
25960
000057-13-6
Urea
195.
26050
000075-01-4
Vinyl chloride
The restrictions are those in regulation 5(1)(a) and (b) of the 1987 Regulations when analysed by the method referred to in regulation 14 of those regulations.
196.
26110
000075-35-4
Vinylidene chloride
The quantity of this substance in the finishedplastic material or article shall not exceed 5 mg/kg or the specific migration pof this substance shall be not detectable (when measured by a method with a limit of detection of 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 92
00542-02-9
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.
10599/70
061788-89-4
Acids, fatty, unsaturated (C18), dimers
8.
10599/92
068783-41-5
Acids, fatty, unsaturated (C18), dimers, hydrogenated
9.
10600
Acids, linear, with an even number of carbon atoms (C8-C22), and the dimers and trimers of the unsaturated acids
10.
10660
015214-89-8
Acrylamidomethylpropanesulphonic acid
11.
10720
000999-55-3
Acrylic acid, allyl ester
12.
10750
002495-35-4
Acrylic acid, benzyl ester
13.
10775
084100-23-2
Acrylic acid, 4-tert.-butylcyclohexyl ester
14.
10930
003066-71-5
Acrylic acid, cyclohyxyl ester
15.
10990
002156-96-9
Acrylic acid, decyl ester
16.
11000
050967-02-8
Acrylic acid, dicyclopentadienyl ester
17.
11005
012542-30-2
Acrylic acid, dicyclopentenyl ester
18.
11010
024447-78-7
Acrylic acid, diester with 2,2-bis(4-hydroxyphenyl)-propane bis(2-hydroxyethyl) ether
19.
11020
019485-03-1
Acrylic acid, diester with butan-1,3-diol
20.
11050
001070-70-8
Acrylic acid, diester with butan-1,4-diol
21.
11080
004074-88-8
Acrylic acid, diester with diethyleneglycol
22.
11110
002274-11-5
Acrylic acid, diester with ethyleneglycol
23.
11140
013048-33-4
Acrylic acid, diester with hexan-1,6-diol
24.
11170
026570-48-9
Acrylic acid, diester with polyethyleneglycol
25.
11180
017831-71-9
acrylic acid, diester with tetraethyleneglycol
26.
11195
068901-05-3
Acrylic acid, diester with tripropyleneglycol
27.
11200
002426-54-2
Acrylic acid, 2-(diethylamino)ethyl ester
28.
11230
002439-35-2
Acrylic acid, 2-(dimethylamino)ethyl ester
29.
11245
002156-97-0
Acryhlic acid, dodecyl ester
30.
11260
000106-90-1
Acrylic acid, 2,3-epoxypropyl ester
The quantity in the finished plastic material or articleof any substance within, or any combination of substances within, items 30, 56, 70 and 181 shall not exceed 5 mg/kg (expressed as epoxy).
31.
11500
000103-11-7
Acrylic acid, 2-ethylhexyl ester
32.
11520
002918-23-2
Acrylic acid, 2-hydroxyisopropyl ester(=acrylic acid, 2-hydroxy-1-methylethyl ester)
33.
11530
000999-61-1
Acrylic acid, 2-hydroxypropyl ester
34.
11532
002761-08-2
Acrylic acid, 3-hydroxypropyl ester
35.
11560
005888-33-5
Acrylic acid, isobornyl ester
36.
11620
001330-61-6
Acrylic acid, isodecyl ester
37.
11695
003121-61-7
Acrylic acid, 2-methoxyethyl ester
38.
11650
029590-42-9
Acrylic acid, isooctyl ester
39.
11740
010095-13-3
Acrylic acid, monoester with butan-1,3-diol
40.
11770
002478-10-6
Acrylic acid, monoester with butan-1,4-diol
41.
11800
013533-05-6
Acrylic acid, monoester with diethyleneglycol
42.
11860
Acrylic acid, monoester with propyleneglycol
43.
11875
004813-57-4
Acrylic acid, octadecyl ester
44.
11890
002499-59-4
Acrylic acid, octadecyl ester
Acrylic acid, n-octyl ester
45.
12010
040074-09-7
Acrylic acid, 2-sulphoethyl ester
46.
12040
039121-78-3
Acrylic acid, sulphopropyl ester
47.
12055
094160-26-6
Acrylic acid, triester with glycerol tris(2-hydroxypropyl) ether
48.
12062
075577-70-7
Acrylic acid, triester with 1,1,1-trimethylolpropane tris(2-hydroxyethyl) ether
49.
12160
002998-04-1
Adipic acid, diallyl ester
50.
12190
000105-97-5
Adipic acid, didecyl ester
51.
12220
027178-16-1
Adipic acid, diisodecyl ester
52.
12250
000123-79-5
Adipic acid, dioctyl ester
53.
12265
004074-90-2
Adipic acid, divinyl ester
54.
12370
Alcohols, aliphatic, monohydric, saturated, linear, secondary or tertiary (C4-C22)
55.
12610
000107-18-6
Allyl alcohol
56.
12640
000106-92-3
Allyl 2,3-epoxypropyl ether
As item 30.
57.
12700
000150-13-0
p-Aminobenzoic acid
58.
12790
000080-46-6
p-tert.-Amylphenol
59.
12850
029602-44-6
Azelaic acid, bis(2-hydroxyethyl) ester
60.
12910
001732-10-1
Azelaic acid, dimethyl ester
61.
As item 255
000528-44-9
1,2,4-Benzenetricarboxylic acid
As item 255.
62.
13060
004422-95-1
1,3,5-Benzenetricarboxylic acid trichloride
63.
As item 94
000091-76-9
Benzoguanamine
64.
13210
001761-71-3
Bis(4-aminocyclohexyl)-methane
65.
13328
000104-38-1
Bis(2-hydroxyethyl) ether of hydroquinone
66.
As item 103
000080-09-1
Bisphenol S
67.
13660
000584-03-2
Butan-1,2-diol
68.
13720
000110-63-4
Butan-1,4-diol
69.
13750
000513-85-9
Butan-2,3-diol
70.
13780
002425-79-8
Butan-1,4-diol bis(2,3-epoxypropyl) ether
As item 30.
71.
13810
000505-65-7
Butan-1,4-diol formal
72.
13932
000598-32-3
Butan-3-en-2-ol
73.
13960
001852-16-0
N-(Butoxymethyl)-acrylamide
74.
14008
000098-52-2
4-tert.-Butylcyclohexanol
75.
14020
000098-54-4
4-tert.-Butylphenol
76.
14035
001746-23-2
4-tert.-Butylstyrene
77.
14260
000502-44-3
Caprolactone
78.
As item 101, Section A
000115-28-6
Chlorendic acid
As item 101, Section A.
79.
14560
000126-99-8
2-Chlorobutan-1,3-diene
80.
14650
000079-38-9
Chlorotrifluoroethylene
The quantity of this substance in the finished platic material or article shall not exceed 5 mg/kg.
81.
14800
003724-65-0
Crotonic acid
82.
14833
000623-43-8
Crotonic acid, methyl ester
83.
14980
001631-25-0
N-Cyclohexylmaleimide
The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg.
84.
15020
002182-05-0
Cyclohexyl vinyl ether
85.
15030
000931-88-4
Cyclooctene
86.
15060
000142-29-0
Cyclopentene
87.
15070
001647-16-1
Dec-1,9-diene
88.
15095
000334-48-5
Decanoic acid
89.
15120
000872-05-9
Dec-1-ene
90.
15260
000646-25-3
1,10-Diaminodecane
91.
15270
002783-17-7
1,12-Diaminododecane
92.
15280
000542-02-9
2,4-Diamino-6-methyl-1,3,5-triazine
93.
15295
000373-44-4
1,8-Diaminooctane
94.
15310
000091-76-9
2,4-Diamino-6-phenyl-1,3,5,-triazine
95.
15340
000109-76-2
1,3-Diaminopropane
96.
15370
003236-53-1
1,6-Diamino-2,2,4-trimethylhexane
97.
15400
003236-54-2
1,6-Diamino-2,4,4-trimethylhexane
98.
15490
002215-89-6
4,4'-Dicarboxydiphenyl ether
99.
15580
001653-19-6
2,3-Dichlorobuta-1,3-diene
100.
15610
000080-07-9
4,4'-Dichlorodiphenyl sulphone
101.
15730
000077-73-6
Dicyclopentadiene
102.
15790
000111-40-0
Diethylenetriamine
103.
16090
000080-09-1
4,4'-Dihydroxydiphenyl sulpone
104.
16120
000110-97-4
Diisopropanolamine
105.
16180
005205-93-6
N-(Dimethylaminopropyl)methacrylamide
106.
16210
006864-37-5
3,3'-Dimethyl-4,4'-diaminodicyclohexylmethane
107.
16252
000110-03-2
2,5-Dimethylhexane-2,5-diol
108.
16270
000526-75-0
2,3-Dimethylphenol
109.
16300
000105-67-9
2,4-Dimethylphenol
110.
16330
000095-87-4
2,5-Dimethylphenol
111.
16360
000576-26-1
2,6-Dimethylphenol
112.
16390
000126-30-7
2,2-Dimethylpropan-1,3-diol
113.
16450
000646-06-0
1,3-Dioxolane
114.
16510
000138-86-3
Dipentene
115.
16540
000102-09-0
Diphenyl carbonate
116.
16690
001321-74-0
Divinylbenzene
117.
16697
000693-23-2
Dodecanedioic acid
118.
16719
003813-52-3
Endomethylenetetrahydrophthalic acid
119.
16900
013036-41-4
N-(Ethoxymethyl)-acryhlamide
120.
17040
000149-57-5
2-Ethylhexanoic acid
121.
17050
000104-76-7
2-Ethylhexan-1-ol
122.
17110
016219-75-3
5-Ethylidenebicyclo-[2.2.1]hept-2-ene
123.
17116
005877-42-9
4-Ethyloct-1-yn-3-ol
124.
17150
000078-27-3
1-Ethynylcyclohexanol
125.
17305
000141-02-6
Fumeric acid, bis(2-ethylhexyl ester)
126.
17320
002807-54-7
Fumaric acid, diallyl ester
127.
17350
000105-75-9
Fumaric acid, dibutyl ester
128.
17380
000623-91-6
Fumaric acid, diethyl ester
129.
17398
007283-68-3
Fumaric acid, dioctadecyl ester
130.
17800
Glucosides obtained from glucose and pentaerythritol
131.
17830
Glucosides obtained from glucose and polyethyleneglycol (molecular weight greater than 200)
132.
17860
Glucosides obtained from glucose and polypropyleneglycol (molecular weight greater than 400)
133.
18220
068564-88-5
N-Heptylaminoundecanoid acid
134.
18370
000592-45-0
Hexa-1,4-diene
135.
18400
000592-42-7
Hexa-1,5-diene
136.
18436
001687-30-5
Hexadydrophthalic acid
137.
18441
000085-42-7
Hexahydrophthalic anhydride
138.
18490
015511-81-6
Hexamethylenediamine adipate
139.
18610
006422-99-7
Hexamethylenediamine sebacate
140.
18700
000629-11-8
Hexan-1,6-diol
141.
18820
000592-41-6
Hex-1-ene
142.
18850
000107-41-5
Hexyleneglycol
143.
18865
003031-66-1
Hex-3-yn-2,5-diol
144.
18905
002628-17-3
4-Hydroxystyrene
145.
18970
000078-83-1
Isobutanol
146.
19030
016669-59-3
N-(Isobutoxymethyl)-acrylamide
147.
19060
000109-53-5
Isobutyl vinyl ether
148.
19090
000079-84-2
Isobutyraldehyde
149.
19120
025339-17-7
Isodecanol
150.
19130
026896-18-4
Isononanoic acid
151.
19140
026952-21-6
Isooctanol
152.
19150
000121-91-5
Isophthalic acid
153.
19180
000099-63-8
Isophthalic acid dichloride
154.
19210
001459-93-4
Isophthalic acid, dimethyl ester
155.
As item 200
000078-79-5
Isoprene
156.
19270
000097-65-4
Itaconic acid
157.
19480
002146-71-6
Lauric acid, vinyl ester
158.
19490
000947-04-6
Laurolactam
159.
19570
000999-21-3
Maleic acid, diallyl ester
160.
19600
000105-76-0
Maleic acid, dibutyl ester
161.
19660
000141-05-9
Maleic acid, diethyl ester
162.
19690
014234-82-3
Maleic acid, diisobutyl ester
163.
19720
001330-76-3
Maleic acid, diisooctyl ester
164.
19750
000624-48-6
Maleic acid, dimethyl ester
165.
19915
000925-21-3
Maleic acid, monobutyl ester
166.
19936
007423-42-9
Maleic acid, mono(2-ethylhexyl) ester
167.
19990
000079-39-0
Methacrylamide
168.
20050
000096-05-9
Methacrylic acid, allyl ester
169.
20080
002495-37-6
Methacrylic acid, benzyl ester
170.
20095
046729-07-1
Methacrylic acid, 4-tert.-butylcyclohexyl ester
171.
20200
001888-94-4
Methacrylic acid, 2-chloroethyl ester
172.
20260
000101-43-9
Methacrylic acid, cyclohexyl ester
173.
20320
003179-47-3
Methacrylic acid, decyl ester
174.
20380
001189-08-8
Methacrylic acid, diester with butan-1,3-diol
175.
20410
002028-81-7
Methacrylic acid, diester with butan-1,4-diol
176.
20440
000097-90
Methacryl5ic acid, diester with ethyleneglycol
177.
20455
006606-59-3
Methacrylic acid, diester with hexan-1,6-diol
178.
20470
025852-47-5
Methacrylic acid, diester with polyethyleneglycol
179.
20530
002867-47-2
Methacrylic acid, 2-(dimethylamino)-ethyl ester
180.
20560
000142-90-5
Methacrylic acid, dodecyl ester
181.
20590
000106-91-2
Methacrylic acid, 2,3-epoxypropyl ester
As item 30.
182.
20740
039670-09-2
Methacrylic acid, ester with ethoxytriethyleneglycol
183.
20830
Methacrylic acid, esters with propan-1,2-diol
184.
20920
000688-84-6
Methacrylic acid, 2-ethylhexyl ester
185.
20945
004664-49-7
Methacrylic acid, 2-hydroxyisopropyl ester (=methacrylic acid, 2-hydroxy-1-methylethyl ester)
186.
20950
000923-26-2
Methacrylic acid, 2-hydroxypropyl ester
187.
20965
002761-09-3
Methacrylic acid, 3-hydroxypropyl ester
188.
20980
007534-94-3
Methacrylic acid, isobornyl ester
189.
21040
029964-84-9
Methacrylic acid, isodecyl ester
190.
21070
028675-80-1
Methacrylic acid, isooctyl ester
191.
21115
000816-74-0
Methacrylic acid, methallyl ester
192.
21170
000997-46-6
Methacrylic acid, monoester with butan-1,4-diol
193.
21220
032360-05-7
Methacrylic acid, octadecyl ester
194.
21250
002157-01-9
Methacrylic acid, n-octyl ester
195.
21280
002177-70-0
Methacrylic acid, phenyl ester
196.
21370
010595-80-9
Methacrylic acid, 2-sulphoethyl ester
197.
21400
054276-35-6
Methacrylic acid, sulphopropyl ester
198.
21430
004245-37-8
Methacrylic acid, vinyl ester
199.
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.
200.
21640
000078-79-5
2-Methylbut-1,3-diene
201.
21670
000563-46-2
2-Methylbut-1-ene
202.
21730
000563-45-1
3-Methylbut-1-ene
203.
21733
000115-19-5
2-Methylbut-3-yn-2-ol
204.
21736
002549-61-3
alpha-Methyl-epsilon-caprolactone
205.
21739
002549-60-2
beta-Methyl-epsilon-caprolactone
206.
21742
002549-58-8
delta-Methyl-epsilon-caprolactone
207.
21745
002549-59-9
epsilon-Methyl-epsilon-caprolactone
208.
21748
002549-42-0
gamma-Methyl-epsilon-caprolactone
209.
21760
000694-91-7
5-Methylenebicyclo-[2.2.2]hept-2-ene
210.
As item 71
000506-65-7
1,4-(Methylenedioxy)butane
211.
21867
001116-90-1
4-methylhex-1,4-diene
The specific migration pof this substance shall be not detectable (when measured by a method with a limit of detection of 0.05 mg/kg).
212.
21850
000095-71-6
Methylhydroquinone
213.
21880
000717-27-1
Methylhydroquinone diacetate
214.
21970
000923-02-4
N-Methylolmethacrylamide
215.
22210
000098-86-9
alpha-Methylstyrene
216.
22240
000622-97-9
p-Methylstyrene
217.
22270
000107-25-5
Methyl vinyl ether
218.
22360
001141-38-4
2,6-Naphthalenedicarboxylic acid
219.
As item 112
000126-30-7
Neopentylglycol
220.
22428
051000-52-3
Neodecanoic acid, vinyl ester
221.
22465
000112-05-0
Nonanoic acid
222.
22540
000104-40-5
4-Nonylphenol
223.
13180 (also used for bicyclo[2.2.2]hept-2-ene)
000498-66-8
Norbornene
As item 39 on Part I Section C.
224.
22585
003710-30-3
Octa-1,7-diene
225.
22690
001806-26-4
4-Octylphenol
226.
22720
000140-66-9
4-tert.-Octylphenol
227.
22811
000591-93-5
Pent-1,4-diene
228.
22842
002590-16-1
Pentaerythritol diallyl ether
229.
22858
005343-92-0
Pentan-1,2-diol
230.
22861
000111-29-5
Pentan-1,5-diol
231.
22900
000109-67-1
Pent-1-ene
232.
22901
000109-68-2
Pent-2-ene
233.
22932
001187-93-5
Perfluoromethyl perfluorovinyl ether
234.
22935
003823-94-7
Perfluoromethyl vinyl ether
235.
22937
001623-05-8
Perfluoropropyl perfluorovinyl ether
236.
22940
006996-01-06
Perfluoropropyl vinyl ether
237.
23140
000092-69-3
4-Phenylphenol
239.
23530
025190-06-1
Poly(1,4-butyleneglycol) (molecular weight greater than 1000)
240.
23770
000504-63-2
Propan-1,3-diol
241.
23920
000105-38-4
Propionic acid, vinyl ester
242.
24370
000106-79-6
Sebacic acid, dimethyl ester
243.
24560
000111-63-7
Stearic acid, vinyl ester
244.
24760
026914-43-2
Styrenesulphonic acid
245.
24940
000100-20-9
Terephthalic acid dichloride
246.
25030
016646-44-9
Tetra(allyloxy)ethane
247.
25120
000116-14-3
Tetrafluoroethylene
248.
25158
000088-98-2
1,2,3,6-Tetrahydrophthalic acid
249.
25161
000085-43-8
1,2,3,6-Tetrahydrophthalic anhydride
250.
25300
000088-19-7
o-Toluenesulphonamide
251.
25380
Trialkyl(C5-C15) acetic acid vinyl ester (=vinyl versatate)
252.
25390
000101-37-1
Triallyl cyanurate
253.
25450
026896-48-0
Tricyclodecadedimethanol
254.
25480
000102-71-6
Triethanolamine
255.
25540
000528-44-9
Trimellitic acid
The quantity of this substance alone or together with item 256 in the finished plastic material or article shall not exceed 5 mg/kg.
256.
25550
000552-30-7
Trimellitic anhydride
The quantity of this substance alone or together with item 255 in the finished plastic material or article shall not exceed 5 mg/kg (expressed as trimellitic acid).
257.
25630
037275-47-1
1,1,1-Trimethylolpropane diacrylate
258.
25645
000682-09-7
1,1,1-Trimethylolpropane diallyl ether
259.
25780
025723-16-4
1,1,1-Trimethylolpropane propoxylated
260.
25810
015625-89-5
1,1,1-Trimethyololpropane triacrylate
261.
25840
003290-92-4
1,1,1-Trimethylolpropane trimethacrylate
262.
25900
000110-88-3
Trioxane
263.
As item 254
000102-71-6
Tris(2-hydroxyethyl)amine
264.
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.
265.
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).
266.
26170
003195-78-6
N-Vinyl-N-methylacetamide
The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg.
267.
26200
002867-48-3
N-Vinyl-N-methylformamide
268.
26230
000088-12-0
Vinylpyrrolidone
269.
26260
001184-84-5
Vinylsulphonic acid
270.
26290
025013-15-4
Vinyhltoluene
271.
As item 216
000622-97-9
p-Vinyltoluene
272.
26320
002768-02-7
Vinyltrimethoxysilane
The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg.
273.
As item 109
000105-67-9
m-Xylenol
274.
As item 108
000526-75-0
o-Xylenol
275.
As item 110
000095-87-4
p-Xylenol

## SECTION C Monomers authorised until 1st April 1995

1
2
3
4
Item
PM/REF No.
CAS No.
Name
Restrictions
1.
10180
000556-08-1
p-(Acetylamino)benzoic acid
2.
10240
Acids, aliphatic, dicarboxylic, esters with alcohols, aliphatic, monohydric
3.
10270
Acids, aliphatic, dicarboxylic (C3-C12), esters with alcohols, unsaturated (C3-C18)
4.
10300
Acids, aliphatic, dicarboxylic, saturated (C4-C18)
5.
10330
Acids, aliphatic, dicarboxylic, unsaturated (C4-C12)
6.
10360
Acids, aliphatic, dicarboxylic, unsaturated, esters with polyethyleneglycol
7.
10390
Acids, aliphatic, dicarboxylic, unsaturated, esters with polypropyleneglycol
8.
10420
Acids, aliphatic, mono- and dicarboxylic (C2-C20), vinyl esters
9.
10450
Acids, aliphatic, monocarboxylic (C3-C12), esters with alcohols, unsaturated (C3-C18)
10.
10540
Acids, aliphatic, monocarboxylic, unsaturated (C3-C8), esters with alcohols, aliphatic, monohydric, saturated (C2-C12)
11.
10570
Acids, aliphatic, monocarboxylic, unsaturated, esters with polypropyleneglycol
12.
10630
000079-06-1
Acrylamide
13.
10870
002206-89-5
Acrylic acid, 2-chloroethyl ester
14.
10900
Acrylic acid, cyclohexylaminoethyl ester
15.
10960
016868-13-6
Acrylic acid, cyclopentyl ester
16.
11290
Acrylic acid, esters with alcohols, aliphatic, monohydric, saturated (C1-C21)
17.
11320
Acrylic acid, esters with alcohols, aliphatic, monohydric, unsaturated (C4-C18)
18.
11350
Acrylic acid, esters with alcohols, aliphatic, polyhydric (C2-C21)
19.
11380
Acrylic acid, esters with etheralcohols
20.
11410
Acrylic acid, esters with glycolethers obtained from mono- and/or diglycols with alcohols, aliphatic, monohydric (C1-C18)
21.
11440
044992-01-0
Acrylic acid, ester with trimethylethanolammonium chloride
22.
11920
005048-82-8
Acrylic acid, phenylaminoethyl ester
23.
11950
000937-41-7
Acrylic acid, phenyl ester
24.
12070
002177-18-6
Acrylic acid, vinyl ester
25.
12400
Alcohols, aliphatic, monohydric, unsaturated (up to C18)
26.
12430
Alcohols, aliphatic, polyhydric (up to C18)
27.
12460
Alcohols, cycloaliphatic, mono- and/or polyhydric, substituted (up to C18)
28.
12490
Aldehydes (C4)
29.
12520
Alkadienes
30.
12550
n-Alkenes (up to C16)
31.
12580
p-Alkyl (C4-C9) phenols
32.
12670
002855-13-2
1-Amino-3-aminomethyl-3,5,5-trimethylcyclohexane
33.
12730
000060-32-2
6-Aminocaproic acid
34.
12670
omega-Aminocarboxylic acids, aliphatic, linear (C6-C12)
35.
12880
000123-98-8
Azelaic acid dichloride
36.
12940
004080-88-0
Azelaic acid, diphenyl ester
37.
13030
000539-48-0
1,4-Benzenedimethanamine
38.
13120
000769-78-8
Benzoic acid, vinyl ester
39.
13180
000498-66-8
Bicyclo[2.2.1]hept-2-ene
40.
13240
003377-24-0
2,2-Bis(4-aminocyclohexyl)propane
41.
13300
038050-97-4
1,4-Bis(4',4'-dihydroxytriphenylmethyl)benzene
42.
13330
Bis(2-hydroxyethyl) ether of hydroquinone and its condensation products with propylene oxide
43.
13360
001620-68-4
2,6-Bis(2-hydrowy-5-methylbenzyl)-4-methylphenol
44.
13420
000843-55-0
1,1-Bis(4-hydroxyphenyl)cyclohexane
45.
13450
000125-13-3
3,3-Bis(4-hydroxyphenyl)-2-indolinone
46.
13570
000141-07-1
1,3-Bis(methoxymethyl)urea
47.
13930
006117-91-5
But-2-en-1-ol
48.
13990
005153-77-5
N-(Butoxymethyl)methacrylamide
49.
14050
000111-34-2
Butyl vinyl ether
50.
14080
000926-02-3
tert.-Butyl vinyl ether
51.
14290
Caprolactone, substituted
52.
14440
064147-40-6
Castor oil, dehydrated
53.
14470
008001-78-3
Castor oil, hydrogenated
54.
14590
000615-67-8
Chlorohydroquinone
55.
14620
057981-99-4
Chlorohydroquinone diacetate
56.
14830
Crotonic acid, esters with alcohols, mono- and polyhydric
57.
14860
Cycloalkenes
58.
14920
002842-38-8
2-(Cyclohexylamino)ethanol
59.
15010
001131-60-8
p-Cyclohexylphenol
60.
15040
000542-92-7
Cyclopenta-1,3-diene
61.
15160
000765-05-9
Decyl vinyl ether
62.
15190
Diamines, aliphatic, linear (C2-C12)
63.
15430
003749-77-7
4,4'-Dicarboxydiphenoxybutane
64.
15460
003753-05-7
4,4'-Dicarboxydiphenoxyethane
65.
15520
004919-48-6
4,4'-Dicarboxydiphenyl sulphide
66.
15550
002449-35-6
4,4'-Dicarboxydiphenyl sulphone
67.
15640
000156-59-2
cis-1,2-Dichloroethylene
68.
15670
000156-60-5
trans-1,2-Dichloroethylene
69.
16030
001965-09-9
4,4'-Dihydroxydiphenyl ether
70.
16060
002664-63-3
4,4'-Dihydroxydiphenyl sulphide
71.
16420
000123-91-1
Dioxane
72.
16720
000826-62-0
Endomethylenetetrahydrophthalic anhydride
73.
16810
Ether alcohols
74.
16840
Ethers of N-methylolacrylamide
75.
16870
Ethers of N-methylolmethacrylamide
76.
16930
000075-00-3
Ethyl chloride
77.
17080
000103-44-6
2-Ethylhexyl vinyl ether
78.
17140
000109-92-2
Ethyl vinyl ether
79.
17410
Fumaric acid, esters with alcohols, aliphatic, monohydric, saturated (C1-C18)
80.
17440
Fumaric acid, esters with alcohols, aliphatic, monohydric, unsaturated (C1-C18)
81.
17470
Fumaric acid, esters with alcohols, polyhydric
82.
17500
000098-01-0
Furfural
83.
17560
Glucosides obtained from glucose and butan-1,3-diol
84.
17590
Glucosides obtained from glucose and butan-1,4-diol
85.
17620
Glucosides obtained from glucose and diethyleneglycol
86.
17650
Glucosides obtained from glucose and 2,2-dimethylpropan-1,3-diol
87.
17680
Glucosides obtained from glucose and ethyleneglycol
88.
17710
Glucosides obtained from glucose and glycerol
89.
17740
Glucosides obtained from glucose and hexan-1,6-diol
90.
17770
Glucosides obtained from glucose and hexan-1,2,6-triol
91.
17890
Glucosides obtained from glucose and propanediol
92.
17920
Glucosides obtained from glucose and sorbitol
93.
17950
Glucosides obtained from glucose and sucrose
94.
17980
Glucosides obtained from glucose and 1,1,1-trimethylolpropane
95.
18040
029733-18-4
Glutaric acid, diisodecyl ester
96.
18130
004371-64-6
1,1-Heptadecanedicarboxylic acid
97.
18160
025339-56-4
Heptene
98.
18190
000592-76-7
Hept-1-ene
99.
18250
000115-28-6
Hexachloroendomethylenetetrahydrophthalic acid
The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg.
100.
18280
000115-27-5
Hexachloroendomethylenetetrahydrophthalic anhydride
101.
18340
000822-28-6
Hexadecyhl vinyl ether
102.
18430
000116-15-4
Hexafluoropropylene
103.
18520
038775-37-0
Hexamethylenediamine azelate
104.
18550
Hexamethylenediamine dodecanedicarboxylate
105.
18580
Hexamethylenediamine heptadecanedicarboxylate
106.
18670
000100-97-0
Hexamethylenetetramine
107.
18730
002935-44-6
Hexan-2,5-diol
108.
18760
000106-69-4
Hexan-1,2,6-triol
109.
18790
025264-93-1
Hexene
110.
18910
000288-32-4
Imidazole
111.
18940
000095-13-6
Indene
112.
19240
000744-45-6
Isophthalic acid, diphenyl ester
113.
19300
002155-60-4
Itaconic acid, dibutyl ester
114.
19330
007748-43-8
Itaconic acid, 2,3-eposypropyl diester
The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg.
115.
19360
Itaconic acid, 2,3-epoxypropyl monoester
The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg.
116.
19390
Itaconic acid, esters with alcohols, aliphatic, monohydric, saturated (C1-C18)
117.
19420
Itaconic acid, esters with alcohols, polyhydric
118.
19450
Latcams of omega-aminocarboxylic acids, aliphatic, linear (C7-C12)
119.
19630
071550-61-3
Maleic acid, diester with propan-1,2-diol
120.
19780
002915-53-9
Maleic acid, dioctyl ester
121.
19810
Maleic acid, esters with alcohols, aliphatic, saturated (C1-C18)
122.
19840
Maleic acid, esters with alcohols, polyhydric
123.
19870
Maleic acid, ester with butan-1,3-diol
124.
19900
002424-58-0
Maleic acid, monoallyl ester
125.
19930
Maleic acid, monoesters with alcohols, aliphatic, monohydric, unsaturated (C3-C18)
126.
20230
Methacrylic acid, cyclohexylaminoethyl ester
127.
20290
016868-14-7
Methacrylic acid, cyclopentyl ester
128.
20350
Methacrylic acid, (di-tert.-butylamino)ethyl ester
129.
20500
000105-16-8
Methacrylic acid, 2-(diethylamino)ethyl ester
130.
20620
Methacrylic acid, esters with alcohols, aliphatic, monohydric, saturated (C1-C21)
131.
20650
Methacrylic acid, esters with alcohols, aliphatic, monohydric, unsaturated (C4-C18)
132.
20680
Methacrylic acid, esters with alcohols, polyhydric (C2-C21)
133.
20710
Methacrylic acid, esters with etheralcohols
134.
20770
Methacrylic acid, esters with glycolethers obtained from mono- and/or diglycols with alcohols, aliphatic, monohydric (C1-C18)
135.
20800
024493-59-2
Methacrylic acid, ester with methoxytriethyleneglycol
136.
20860
Methacrylic acid, ester with trimethylethanolammonium chloride
137.
21160
Methacrylic acid, monoester with butan-1,3-diol
138.
21310
003683-12-3
Methacrylic acid, phenylethyl ester
139.
21580
003644-11-9
N-(Methoxymethyl)-acrylamide
140.
21610
003644-12-0
N-(Methoxymethyl)-metharcylamide
141.
21700
000513-35-9
2-Methylbut-2-ene
142.
21790
000110-26-9
Methylenebisacrylamide
143.
21820
013093-19-1
Methylenebiscaprolactam
144.
21910
000814-78-8
Methyl isopropenyl ketone
145.
21940
000924-42-5
N-Methylolacrylamide
146.
22000
001118-58-7
2-Methylpent-1,3-diene
147.
22030
001115-08-8
3-Methylpent-1,4-diene
148.
22060
000926-56-7
4-Methylpent-1,3-diene
149.
22090
000763-29-1
2-Methylpent-1-ene
150.
22120
000760-20-3
3-Methylpent-1-ene
151.
22150
000691-37-2
4-Methylpent-1-ene
152.
22180
004461-48-7
4-Methylpent-2-ene
153.
22300
000078-94-4
Methyl vinyl ketone
The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg.
154.
22330
001822-74-8
Methyl vinyl thioether
155.
22510
027215-95-8
Nonene
156.
22580
000930-02-9
Octadecyl vinyl ether
157.
22630
025377-83-7
Octene (except oct-1-ene)
158.
22750
000929-62-4
Octyl vinyl ether
159.
22810
000504-60-9
Pent-1,3-diene
160.
22930
Perfluoroalkyl(C1-C3)vinyl ethers
161.
22990
Phenols, mono- and dihydric, alkoxylated or hydrogenated
162.
23020
028994-41-4
alpha-Penyl-o-cresol
163.
23080
001079-21-6
Phenylhydroquinone
164.
23110
058244-28-3
Phenylhydroquinone diacetate
165.
23230
000131-17-9
Phthalic acid, diallyl ester
166.
23260
000088-95-9
o-Phthalic acid dichloride
167.
23290
Phthalic acids, halogenated derivatives
168.
23320
Phthalic acids, hydrogenated
169.
23350
Phthalic acids, hydrogenated, substituted, endosubstituted, and their halogenated derivatives
170.
23410
Phthalic anhydride, hydrogenated
171.
23440
000111-16-0
Pimelic acid
172.
23560
Polyethers based on ethylene oxide, propylene oxide and/or tetrahydrofuran, containing free hydroxyl groups
173.
23620
Polyols derived from phenols and bisphenols hydrogenated and/or condensed with epoxyalkanes and/or arylepoxyalkanes possibly halogenated, alkoxylated, aryloxylated
174.
23680
009002-89-5
Polyvinylalcohols
175.
23710
063148-65-2
Polyvinylbutyrals
176.
24040
000764-47-6
Propyl vinyl ether
177.
24220
009006-03-5
Rubber, chlorinated
178.
24310
000111-19-3
Sebacic acid, dichloride
179.
24340
002432-89-5
Sebacic acid, didecyl ester
180.
24400
002918-18-5
Sebacic acid, diphenyl ester
181.
24640
Styrene, substituted by alkyl groups (alpha)
182.
24670
Styrene, substituted in the benzene ring
183.
24700
Styrene, substituted by halogens (alpha or beta)
184.
24730
Styrene, substituted in the vinyl group
185.
24790
000505-48-6
Suberic acid
186.
25000
001539-04-4
Terephthalic acid, diphenyl ester
187.
25060
000632-58-6
Tetrachlorophthalic acid
188.
25330
000070-55-3
p-Toluenesulphonamide
189.
25570
000067-48-1
Trimethylethanolammonium chloride
190.
25660
019727-16-3
1,1,1-Trimethylolpropane dimethacrylate
191.
25690
1,1,1-Trimethylolpropane maleates
192.
25720
007024-08-0
1,1,1-Trimethylolpropane monoacrylate
193.
25750
007024-09-1
1,1,1-Trimethylolpropane monomethacrylate
194.
25870
000107-39-1
2,4,4-Trimethylpent-1-ene
195.
25990
000689-97-4
Vinylacetylene
The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg.
196.
26020
001484-13-5
N-Vinylcarbazole
The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg.
197.
26080
Vinyl ethers of alcohols, aliphatic, monohydric, saturated (C2-C18)
198.
26140
000075-38-7
Vinylidene fluoride

### Part II: SUPPLEMENTARY

## 1 

In regulation 5 and Part I of this Schedule—
(a) the PM/REF No. of any substance is its EEC packaging material reference number,
(b) the CAS No. of any substance is its CAS (Chemical Abstracts Service) Registry Number, and
(c) the name of any substance 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 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 substance shall be that indicated for the individual compound and the entry applying to the generic term shall be treated as varied to such extent (if any) as is necessary therefor.

## 3 



### Part I: PROVISIONS APPLICABLE WHEN CHECKING COMPLIANCE WITH THE MIGRATION LIMITS

## 1 A. General provisions

When the results of the migration tests specified in this Schedule 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 A. General provisions

Where any migration test specified in this Schedule 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 following formula:
M=m.a2a1.q×.1000 M is the migration in mg/kg;
m is the mass in mg of substance released by the sample as determined by the migration test;
a1 is the surface area in square decimetres of the sample in contact with the food or simulant during the migration test;
a2 is the surface area in square decimetres of the plastic material or article in actual conditions of use;
q is the quantity in grams of food in contact with the plastic material or article in actual conditions of use.

## 3 A. General provisions

(1) Subject to sub-paragraph (2) below, 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 impracti-cable, 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 A. General provisions

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

## 5 A. General provisions

Where a plastic material or article is intended to come into repeated contact with food, any migration test shall (subject to paragraph 7 below) be carried out three times on a single sample in accordance with the conditions laid down in this Schedule 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.

## 6 B. Special provisions relating to overall migration

(1) Subject to the following sub-paragraphs of this paragraph, any method of analytical determination may be used to prove excess of an overall migration limit in relation to a plastic material or article.
(2) In any proceedings for an offence under regulation 3 comprising excess of an overall migration limit, it shall be a defence for the person charged to prove that—
(a) if an aqueous simulant specified in this Schedule had been used, and the analytical determination of the total quantity of substances released by a sample of the plastic material or article tested had been carried out by evaporation of the simulant and weighing of the residue, or
(b) if rectified olive oil or any of its substitutes had been used as a simulant and—
(i) a sample of the plastic material or article had been weighed before and after contact with the simulant,
(ii) the simulant absorbed by the sample had been extracted and determined quantitatively,
(iii) the quantity of simulant so found had been subtracted from the weight of the sample measured after contact with the simulant, and
(iv) the difference between the initial and corrected final weights had been determined to represent the overall migration of the sample examined,
there would have been no such excess so determined.

## 7 B. Special provisions relating to overall migration

(1) Where a plastic material or article is intended to come into repeated contact with food and it is technically impossible to carry out the test described in paragraph 5 above, the test shall be so modified as to enable the level of migration occurring during the third such test to be determined and, subject to sub-paragraph (2) below, such a determination may be used to prove excess of an overall migration limit in relation to a plastic material or article.
(2) In any procedures for an offence under regulation 3 comprising excess of an overall migration limit as determined under sub-paragraph (1) above, it shall be a defence for the person charged to prove that, if—
(a) three identical samples of the plastic material or article had been procured,
(b) one of them had been subjected to the appropriate test according with paragraph 4 above and the overall migration determined (M1),
(c) the second and third samples had been subjected to the same conditions of temperature but the period of contact had been two and three times that specified and overall migration had been determined in each case (M2 and M3, respectively), and
(d) the plastic material or article had been deemed to comply with the overall migration limit relevant to it provided that either M1 or M3 − M2 did not exceed that overall migration limit,
the plastic material or article would not have been deemed to exceed that limit.

## 8 B. Special provisions relating to overall migration

(1) Any plastic material or article which exceeds its overall migration limit by an amount not exceeding the analytical tolerance specified in sub-paragraph (2) below shall be deemed for the purposes of these Regulations not to exceed its overall migration limit.
(2) The following analytical tolerances shall be applied for limits of overall migration—
(a) 20 mg/kg or, as the case may be, 3 milligrams per square decimetre in migration tests using as a simultant rectified olive oil or substitutes,
(b) 6 mg/kg or, as the case may be, 1 milligram per square decimetre in migration tests using other simulants referred to in this Schedule.

### Part II: SIMULANTS TO BE USED IN MIGRATION TESTS

### Part III: SPECIFICATION OF SIMULANTS TO BE USED

### Part IV: TEST CONDITIONS (TIMES AND TEMPERATURES)

## Explanatory note

(This note is not part of the Regulations)
These Regulations implement Commission Directive (EEC) 90/128 (OJ No. L349, 13.12.90, p.26) as amended by Commission Directive (EEC) 92/39 (OJ No. L168, 23.6.92, p.21) relating to plastic materials and articles intended to come into contact with foodstuffs, as read with Council Directives (EEC) 82/711 and 85/572 (OJ Nos. L297, 23.10.82, p.26 and L372, 30.12.85, p.14 respectively) which between them lay down the basic rules necessary, and the list of simulants to be used, for testing migration of certain constituents of plastic materials and articles intended to come into contact with foodstuffs. The Regulations prescribe limits both in relation to content of the materials and articles in question and migration of constituents into food, and the tests by which migration is to be established. The materials and articles to which these Regulations relate are also subject to the Materials and Articles in Contact with Food Regulations 1987.
Plastic materials and articles manufactured before the coming into force of these Regulations containing certain constituents which by these Regulations can no longer be used in manufacture may be used for the purposes of storage etc and may be sold for such purposes until 1st April 1995 (regulation 12).

---
Source: https://www.legislation.gov.uk/uksi/1992/3145 (the official version)
Page: https://openlegislation.uk/plastic-materials-and-articles-in-contact-with-food-regulations-1992
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.