Statutory Instruments

1992 No. 3145

FOOD

The Plastic Materials and Articles in Contact with Food Regulations 1992

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(1), 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(2) for the purposes of section 2(2) of the European Communities Act 1972(3) 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:-

Title, commencement and extent

1.-(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.

Interpretation

2.-(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(4);

"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(5) as amended(6);

"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.

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

3.-(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.

Transfer of constituents

4.-(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.

Monomers

5.-(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.

Method of testing capability of transferring constituents

6.-(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.

Labelling

7.-(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.

Enforcement

8.-(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.

Offences

9.-(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.

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

10. 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.

Application of other provisions

11.-(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. 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).

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

Regulation 5

SCHEDULE 1

PART IAUTHORISED MONOMERS

SECTION AMonomers 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 BMonomers 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 CMonomers 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 IISUPPLEMENTARY

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.-

(1) The items identified in Part I of this Schedule-

(a)shall be taken to include-

(i)substances undergoing polymerisation (which shall be taken to include polyconden sation, polyaddition or any other similar process) to manufacture macromolecules,

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

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

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

(b)If a substance is identified in Part I of this Schedule as an . . . acid, salt and has salts of one or more of the following names (that is to say salts of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium or zinc), then the free acid corresponding to that substance is not treated as included in the specification of that substance.

Regulation 6

SCHEDULE 2

PART IPROVISIONS APPLICABLE WHEN CHECKING COMPLIANCE WITH THE MIGRATION LIMITS

A. General provisions

1. 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. 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 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.-(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.-(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. 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.

B. Special provisions relating to overall migration

6.-(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.-(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.-(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 IISIMULANTS TO BE USED IN MIGRATION TESTS

1. Subject to the provisions of this Schedule, the simulants which may be used in migration testing are as follows-

Simulant A: distilled water or water of equivalent quality;
Simulant B 3% acetic acid (w/v) in aqueous solution;
Simulant C 15% ethanol (v/v) in aqueous solution;
Simulant D: Rectified olive oil, save that if for technical reasons connected with the method of analysis it is necessary to use a different simulant, rectified olive oil shall be replaced by a mixture of synthetic triglycerides or by sunflower oil.

2. The particulars of simulant D referred to in paragraph 1 above are as hereinafter described:

(a)the characteristics of rectified olive oil shall be as follows-

Iodine value (Wijs)	=80 to 88
Refractive index at 25°C	= 1.4665 to 1.4679
Acidity (expressed as % of oleic acid)	= 0.5% maximum
Peroxide number (expressed as oxygen milliequivalents per kg of oil)	= 10 maximum

(b)the composition of the synthetic triglycerides mixture shall be as follows-

(i)fatty acid distribution

No of C-atoms in fatty acid

residue ... ... ... ...	6	8	10	12	14	16	18	others
GLC area (%) ... ... ... ...	~1	6-9	8-11	45-52	12-15	8-10	8-12	<=1

(ii)purity

Content of monoclycerides (enzymatically)	≤0.2%
Content of diglyceride(enzymatically)	≤2.0%
Unsaponifiable matter	≤0.2%
Iodine value (Wijs)	≤0.1%
Acid value	≤0.1%
Water content (K. Fischer)	≤0.1%
Melting point	28±2°C

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

Wavelength (nm)	290	310	330	350	370	390	430	470	510
Transmittance (%)	~2	~15	~37	~64	~80	~88	~95	~97	~98

At least 10% light transmittance at 310 nm (cell of 1 cm, reference: water at 35°C)
(c)
characteristics of sunflower oil shall be as follows-
Iodinevalue (Wijs) = 120 to 145
Refractive index at 20°C = 1.474 to 1.476
aponification number = 188to 193
Relative density at 20°C 0.918 to 0.925
Unsaponifiablematter = 0.5% to 1.5%

PART IIISPECIFICATION OF SIMULANTS TO BE USED

1.-(1) Subject to the provisions of this Part of this Schedule, capability of migration into food shall be treated for the purposes of these Regulations as being determined by carrying out the migration test described in this Schedule-

(a)in any case where a simultant is specified in the Table to this Schedule, either on the simulant or on the food; and

(b)in any case where the food is not specified in that table, either on the simulant which corresponds most closely in extractive capacity to the food or on the food.

(2) A simulant is specified in relation to a food for the purposes of this paragraph where -�X' is placed in the column headed by that simulant opposite the food 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.

(3) 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.

2. Where, in the Table to this Part of this Schedule, "X" is followed by an oblique stroke and a figure, the result of any migration test on the simulant shall be divided by the number indicated.

3. Where, in the Table to this Part of this Schedule, the letter "a" is shown in brackets after the "X", only one of the two simulants specified shall be used in the migration test, that is to say-

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

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

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

Table

		Simulants to be used
Reference Number	Description of food	A	B	C	D

^a If it can be demonstrated under regulation 10 or proved by means of an appropriate test that there is to be no fatty contact with the plastic material or article, simulant D shall not be used.
^b Simulant B shall not be used where the pH is more than 4.5.
01	Beverages
01.01	Non-alcoholic beverages or alcoholic beverages of an alcoholic strength lower than 5% vol.: Waters, ciders, fruit or vegetable juices of normal strength or concentrated, musts, fruit nectars, lemonades and mineral waters, syrups, bitters, infusions, coffee, tea	X(a)	X(a)
01.02	Alcoholic beverages of an alcoholic strength equal to or exceeding 5% vol.: Beverages shown under heading 01.01 but with an alcoholic strength equal to or exceeding 5% vol.: Wines, spirits and liqueurs		X(^a)	X(^b)
01.03	Miscellaneous undenatured ethyl alcohol		X(^a)	X(^b)
02	Cereals, cearal products, pastry, biscuits, cakes and other bakers' wares
02.01	Starches
02.02	Cereals, unprocessed, puffed, in flakes (including popcorn, cornflakes and the like)
02.03	Cereal flour and meal
02.04	Macaroni, spaghetti and similar products
02.05	Pastry, biscuits, cakes and other bakers' wares, dry:
	A. With fatty substances on the surface				X/5
	B. Other
02.06	Pastry, cakes and other bakers' wares, fresh:
	A. With fatty substances on the surface				X/5
	B. Other	X
03	Chocolate, sugar and products thereof, Confectionery products
03.01	Chocolate, chocolate-coated products, substitutes and products coated with substitutes				X/5
03.02	Confectionery products: In solid form:
	I.With fatty substances on the surface				X/5
	II.Other
	B. In paste form:
	I.With fatty substances on the surface				X/3
	II.Moist	X
03.03	Sugar and sugar products
	A. In solid form
	B. Honey and the like	X
	C. Molasses and sugar syrups	X
04	Fruit, vegetables and products thereof
04.01	Whole fruit, fresh or chilled
04.02	Processed fruit:
	A. Dried or dehydrated fruit, whole or in the form of flour or powder
	B. Fruit in the form of chunks, purée or paste	X(a)	X(a)
	C. Fruit preserves (jams and similar products-�whole fruit or chunks or in the form of flour or powder, preserved in a liquid medium):
	I.In an aqueous medium	X(a)	X(a)
	II.In an oily medium	X(a)	X(a)		X
	III.in an alcoholic medium (≥5% vol.)		X(^a)	X
04.03	Nuts (peanuts, chestnuts, almonds, hazalnuts, walnuts, pine kernels and others)
	A. Shelled, dried
	B. Shelled and roasted				X/5(^b)
	C. In paste or cream form	X			X/3(^b)
04.04	Whole vegetables, fresh or chilled
04.05	Processed vegetables:
	A. Dried or dehydrated vegetables whole or in the form of flour or powder
	B. Vegetables, cut, in the form of purées	X(a)	X(a)
	C. Preserved vegetables:
	I.In an aqueous medium	X(a)	X(a)
	II.In an oily medium	X(a)	X(a)		X
	III.In an alcoholic medium (≥5% vol.)		X(^a)	X
05	Fats and oils
05.01	Animal and vegetable fats and oils, whether natural or treated (including cocoa butter, lard, resolidified butter)				X
05.02	Margarine, butter and other fats and oils made from water emulsions in oil				X/2
06	Animal products and eggs
06.01	Fish:
	A. Fresh, chilled, salted, smoked	X			X/3(^a)
	B. In the form of paste	X			X/3(^a)
06.02	Crustaceans and mulluscs (including oysters,mussels, snails) not naturally protected by their shells	X
06.03	Meat of all zoological species (including poultry and game):
	A. Fresh, chilled, salted, smoked	X			X/4
	B. In the form of paste, creams	X			X/4
06.04	Processed meat products (ham, salami, bacon and other)	X			X/4
06.05	Preserved and part-preserved meat and fish:
	A. In an aqueous medium	X(a)	X(a)
	B. In an oily medium	X(a)	X(a)		X
06.06	Eggs not in shell:
	A. Powdered or dried
	B. Other	X
06.07	Egg yolks:
	A. Liquid	X
	B. Powdered or frozen
06.08	Dried white of egg
07	Milk products
07.01	Milk:
	A. Whole	X
	B. Partly dried	X
	C. Skimmed or partly skimmed	X
	D. Dried
07.02	Fermented milk such as yoghurt, buttermilk and such products in association with fruit and fruit products		X
07.03	Cream and sour cream	X(a)	X(a)
07.04	Cheeses:
	A. Whole, with rind
	B. Processed cheeses	X(a)	X(a)
	C. All others	X(a)	X(a)		X/3(^a)
07.05	Rennet:
	A. In liquid or viscous form	X(a)	X(a)
	B. Powdered or dried
08	Miscellaneous products
08.01	Vinegar		X
08.02	Fresh or roasted foods:
	A. Fried potatoes, fritters and the like				X/5
	B. Of animal origin				X/4
08.03	Preparations for soups, broths in liquid, solid or powder form (extracts, concentrates), homogenized composite food preparations, prepared dishes: Powdered or dried:
	I.With fatty substances on the surface				X/5
	II.Other
	B. Liquid or paste:
	I.With fatty substances on the surface	Z(a)	X(a)		X/3
	II.Other	X(a)	X(a)
08.04	Yeasts and raising agents:
	A. In paste form	X(a)	X(a)
	B. Dried
08.05	Salt
08.06	Sauces:
	A. Without fatty substances on the surface	X(a)	X(a)
	B. Mayonnaise, sauces derived from mayonnaise, salad creams and other oil in water emulsions	X(a)	X(a)		X/3
	C. Sauce containing oil and water forming two distinct layers	X(a)	X(a)		X
08.07	Mustard (except powdered mustard under heading 08.17)	X(a)	X(a)		X/3(^a)
08.08	Sandwichs, toasted bread and the like containing any kind of foodstuff:
	A. With fatty substances on the surface				X/5
	B. Other
08.09	Ice-cream	X
08.10	Dried foods:
	A. With fatty substances on the surface				X/5
	B. Other
08.11	Frozen or deep-frozen foods
08.12	Concentrated extracts of an alcoholic strength equal to or exceeding 5% vol.		X(^b)	X
08.13	Cocoa:
	A. Cocoa powder				X/5(^a)
	B. Cocoa paste				X/3(^a)
08.14	Coffee, whether or not roasted, decaffeinated or soluble, coffee substitutes, granulated or powdered
08.15	Liquid coffee extracts	X
08.16	Aromatic herbs and other herbs: Camomile, mallow, mint, tea, lime blossom and others
08.17	Spices and seasonings in the natural state: Cinnamons, cloves, powdered mustard, pepper, vanilla, saffron and other

PART IVTEST CONDITIONS (TIMES AND TEMPERATURES)

1. Subject to paragraph 2 below-

(a)the migration tests shall be carried out, selecting from the times and temperatures specified in the Table to this Part of this Schedule those which correspond most closely to the normal or foreseeable conditions of contact for the plastic material or article being studied;

(b)if a plastic material or article is intended to be used successively at short intervals in several of the conditions of contact referred to in column 1 of the table, migration will be determined by subjecting that plastic material or article successively to each correspond ing test condition specified in column 2, using the same simulant;

(c)where the plastic material or article may in actual use be employed under any conditions of contact time or temperature, the 10-day tests at 40°C and the two-hour tests at 70°C shall be carried out to test migration, except that, where simulant D is used (rectified olive oil or any of its substitutes), only the 10-day test at 40°C shall be carried out.

2. If it is found that carrying out the tests required by paragraph 1 above under the conditions specified in the table causes physical or other changes in the plastic material or article, the migration tests shall be carried out under conditions more appropriate to the specific case.

3. The Table to this Part of this Schedule shall be read with the footnotes to it.

Table

Test conditions to be chosen, according to conditions of contact in actual use (times (t) and temperatures (T))

	Conditions of contact in actual use	Test conditions
	1	2

^a For plastic materials in contact with foodstuffs for which a preservation temperature of less than 20°C is specified on the labelling or by law, the test conditions will be 10 days at 20°C.
^b Use only simulant D at these temperatures, in addition to simulants A, B and C as appropriate, at 100°C or at reflux temperature.
^c or reflux temperature.
1.	Contact time: t >24 hours
	1.1 T ≤5°C	10 days at 5°C
	1.2 5°C <T ≤40°C^a	10 days at 40°C
2.	Contact time: two hours ≤ t ≤24 hours
	2.1 T <5°C	24 hours at 5°C
	2.2 5°C <T ≤40°C	24 hours at 40°C
	2.3 40°C<T ≤70°C	24 hours at 70°C
	2.4 70°C <T ≤100°C	24 hours at 100°C
3.	Contact time: t <two hours
	3.1 T ≤5°C	Two hours at 5°C
	3.2 5°C <T ≤40°C	Two hours at 40°C
	3.3 40°C <T ≤70°C	Two hours at 70°C
	3.4 70°C <T ≤100°C	One hour at 100°C^c
	3.5 1000°C <T ≤121°C^b	30 minutes at 121°C
	3.6 121°C <T ≤130°C^b	30 minutes at 130°C
	3.7 130°C <T ≤150°C^b	30 minutes at 150°C
	3.8 T >150°C	30 minutes at 175°C

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).

(1)

1990 c. 16.

(2)

S.I. 1976/2141.

(3)

1972 c. 68.

(4)

S.I. 1987/1523, amended by S.I. 1990/2487, 1991/1476.

(5)

OJ No. L349, 13.12.90, p.26.

(6)

OJ No. L168, 23.6.92, p.21.

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Iodinevalue (Wijs)	= 120 to 145
Refractive index at 20°C	= 1.474 to 1.476
aponification number	= 188to 193
Relative density at 20°C	0.918 to 0.925
Unsaponifiablematter	= 0.5% to 1.5%

United Kingdom Statutory Instruments

1992 No. 3145

The Plastic Materials and Articles in Contact with Food Regulations 1992

Title, commencement and extent

Interpretation

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

Transfer of constituents

Monomers

Method of testing capability of transferring constituents

Labelling

Enforcement

Offences

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

Application of other provisions

SCHEDULE 1

PART IAUTHORISED MONOMERS

SECTION AMonomers authorised without time limit

SECTION BMonomers authorised up to the end of 1996

SECTION CMonomers authorised until 1st April 1995

PART IISUPPLEMENTARY

SCHEDULE 2

PART IPROVISIONS APPLICABLE WHEN CHECKING COMPLIANCE WITH THE MIGRATION LIMITS

A. General provisions

B. Special provisions relating to overall migration

PART IISIMULANTS TO BE USED IN MIGRATION TESTS

PART IIISPECIFICATION OF SIMULANTS TO BE USED

Table

PART IVTEST CONDITIONS (TIMES AND TEMPERATURES)

Table

Test conditions to be chosen, according to conditions of contact in actual use (times (t) and temperatures (T))

Explanatory Note