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The Plastic Materials and Articles in Contact with Food Regulations 1992

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

Original text. legislation.gov.uk does not revise statutory instruments, so later amendments are not shown here. Changes made to it are listed under each provision when known.

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 1990f1, and of all other powers enabling them in that behalf; the Minister of Agriculture, Fisheries and Food and the Secretary of State being Ministers designatedf2 for the purposes of section 2(2) of the European Communities Act 1972f3 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:—

Annotations to the whole text

Footnotes

f1

1990 c. 16.

f2

S.I. 1976/2141.

f3

1972 c. 68.

Contents

  1. 1Title, commencement and extent
  2. 2Interpretation
  3. 3Restriction on sale etc., and importation of plastic materials and articles
  4. 4Transfer of constituents
  5. 5Monomers
  6. 6Method of testing capability of transferring constituents
  7. 7Labelling
  8. 8Enforcement
  9. 9Offences
  10. 10Presumption as to food with which a plastic material or article is to come into contact
  11. 11Application of other provisions
  12. 12Application of other provisions
  13. Signature
  14. Schedule 1
  15. Part I: AUTHORISED MONOMERS
  16. SECTION AMonomers authorised without time limit
  17. SECTION BMonomers authorised up to the end of 1996
  18. SECTION CMonomers authorised until 1st April 1995
  19. Part II: SUPPLEMENTARY
  20. 1Paragraph 1
  21. 2Paragraph 2
  22. 3Paragraph 3 Repealed
  23. Schedule 2
  24. Part I: PROVISIONS APPLICABLE WHEN CHECKING COMPLIANCE WITH THE MIGRATION LIMITS
  25. 1A. General provisions
  26. 2A. General provisions
  27. 3A. General provisions
  28. 4A. General provisions
  29. 5A. General provisions
  30. 6B. Special provisions relating to overall migration
  31. 7B. Special provisions relating to overall migration
  32. 8B. Special provisions relating to overall migration
  33. Part II: SIMULANTS TO BE USED IN MIGRATION TESTS
  34. Part III: SPECIFICATION OF SIMULANTS TO BE USED
  35. Part IV: TEST CONDITIONS (TIMES AND TEMPERATURES)
  36. Explanatory note

1Title, 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.

2Interpretation

(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 1987f1;

  • “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 foodstuffsf2 as amendedf3;

  • “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.

3Restriction 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.

4Transfer 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.

5Monomers

(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.

6Method 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.

7Labelling

(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.

8Enforcement

(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.

9Offences

(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.

10Presumption 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.

11Application 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.

12Application 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

SECTION AMonomers authorised without time limit

1234
ItemPM/REF No.CAS No.NameRestrictions
1.10030000514-10-3Abietic acid
2.10060000075-07-0Acetaldehyde
3.10090000064-19-7Acetic acid
4.10120000108-05-4Acetic acid, vinyl esterThe specific migration of this substance shall not exceed 12 md/kg.
5.10150000108-24-7Acetic anhydride
6.10210000074-86-2Acetylene
7.10630000079-06-1AcrylamideThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection 0.01 mg/kg.
8.10690000079-10-7Acrylic acid
9.10780000141-32-2Acrylic acid, n-butyl ester
10.10810002998-08-5Acrylic acid, sec. butyl
11.10840001663-39-4Acrylic acid, tert. butyl
12.11470000140-88-5Acrylic acid, ethyl ester
13.As item 17000818-61-1Acrylic acid, hydroxyethyl exter
14.11590000106-63-8Acrylic acid, isobutyl ester
15.11680000689-12-3Acrylic acid, isopropyl ester
16.11710000096-33-3Acrylic acid, methyl ester
17.11830000818-61-1Acrylic acid, monoester with ethylene glycol
18.11980000925-60-0Acrylic acid, propyl ester
19.12100000107-13-1AcrylonitrileThe 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)
20.12130000124-04-9Adipic acid
21.12280002035-75-8Adipic anhydride
22.12310Albumin
23.12340Albumin, coagulated by formaldehyde
24.12375Alcohols, aliphatic, monohydric, saturated, linear, prinmary (C4-C22)
25.12670002855-13-21-Amino-3-aminomethyl-3,5,5-trimethylcyclohexaneThe specific migration of this substance shall not exceed 6 mg/kg.
26.12788002432-99-711-aminoundecanoic acidThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg.
27.12820000123-99-9Azalaid acid
28.12970004196-95-6Azelaic anhydride
29.13000001477-55-01,3-BenzenedimethanamineThe specific migration pof this substance shall not exceed 0.05 mg/kg.
30.13090000065-85-0Benzolic acid
31.13150000100-51-6Benzyl alcohol
32.As item 72000111-46-6Bis(2-hydroxyethyl) etherAs item 72.
33.As item 192000077-99-62,2-Bis(hydroxymethyl)-butan-1-olAs item 192.
34.13390000105-08-81,4-Bis(hydroxymethyl)-cyclohexane
35.13480000080-05-72,2-Bis(4-hydroxyphenyl)-propaneThe specific migration of this substance shall not exceed 3 mg/kg.
36.13510001675-54-32,2-Bis(4-hydroxyphenyl)-propane bis(2,3-epoxypropyl) etherThe 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 84000110-98-5Bis(hydroxypropyl) ether
38.As item 71005124-30-1Bis(4-isocyanatocyclohexyl)methaneAs item 71.
39.13530038103-06-92,2-Bis(4-hydroxyphenyl)-propane bis(phthalic anhydride)The specific migration of this substance shall not exceed 0.05 mg/kg.
40.13600047465-97-43,3-Bis(3-methyl-4-hydroxyphenyl)indolin-2-oneThe specific migration of this substance shall not exceed 1.8 mg/kg.
41.As item 35000080-05-7Bisphenol AAs item 35.
42.As item 36001675-54-3Bisphenol A bis(2,3-epoxypropyl) etherAs item 36.
43.13614038103-06-9Bisphenol A bis(phthalic anhydride)As item 39.
44.13630000106-99-0ButadieneThe 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).
45.13690000107-88-0Butan-1,3-diol
46.13840000071-36-3Butan-1-ol
47.13870000106-98-9But-1-ene
48.13900000107-01-7But-2-ene
49.14110000123-72-8Butyraldehyde
50.14140000107-92-6Butyric acid
51.14170000106-31-0Butyric anhydride
52.14200000105-60-2CaprolactamThe specific migration of this substance alone or together with item 53 shall not exceed a total of 15 mg/kg.
53.14230002123-24-2Caprolactam, sodium saltThe specific migration of this substance alone or together with item 52 shall not exceed a total of 15 mg/kg (expressed as caprolactam).
54.14320000124-07-2Caprylic acid
55.14350000630-08-0Carbon monoxide
56.14380000075-44-5Carbonyl chlorideThe quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg.
57.14410008001-79-4Castor oil (food grade quality)
58.14500009004-34-6Cellulose
59.14530007782-50-5Chlorine
60.As item 85000106-89-81-Chloro-2,3-epoxypropaneAs item 85.
61.14680000077-92-9Citric acid
62.14710000108-39-4m-Cresol
63.14740000095-48-7o-Cresol
64.14770000106-44-5p-Crresol
65.As item 34000105-08-81,4-Cyclohexanedimethanol
66.14950003175-53-3Cyclohexyl isocyanateThe 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).
67.15100000112-30-1Decan-1-ol
68.As item 88000107-15-31,2-DiaminoethaneAs item 88.
69.As item 105000124-09-41,6-DiaminohexaneAs item 105.
70.15250000110-60-11,4-Diaminobutane
71.15700005124-30-1Dicyclohexylmethane-4,4'-diisocyanateAs item 66.
72.15760000111-46-6Diethylene glycolThe specific migration of this substance alone or together with item 89 shall not exceed a total of 30 mg/kg.
73.15880000120-80-91,2-DihydroxybenzeneThe specific migration of this substance shall not exceed 6 mg/kg.
74.15910000108-46-31,3-DihydroxybenzeneThe specific migration of this substance shall not exceed 2.4 mg/kg.
75.15940000123-31-91,4-DihydroxybenzeneThe specific migration of this substance shall not exceed 0.6 mg/kg.
76.15970000611-99-44,4'-DihydroxybenzophenoneThe specific migration of this substance shall not exceed 6 mg/kg.
77.16000000092-88-64,4'-DihydroxybiphenylThe specific migration of this substance shall not exceed 6 mg/kg.
78.16150000108-01-0DimethylaminoethanolThe specific migration of this substance shall not exceed 18 mg/kg.
79.16240000091-97-43,3'-Dimethyl-4,4'-diisocyanatobiphenylAs item 66.
80.16480000126-58-9Dipentaerythritol
81.16570004128-73-8Diphenylether-4,4'-diisocyanaateAs item 66.
82.16600005873-54-1Diphenylmethane-2,4'-diisocyanateAs item 66.
83.16630000101-68-8Diphenylmethane-4-4'-diisocyanateAs item 66.
84.16660000110-98-3Dipropylene glycol
85.16750000106-89-8EpichlorohydrinThe quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg.
86.16780000064-17-5Ethanol
87.16950000074-85-1Ethylene
88.16960000107-15-3EthylenediamineThe specific migration of this substance shall not exceed 12 mg/kg.
89.16990000107-21-1Ethylene glycolThe specifi c migration opf this substance alone or together with item 72 shall not exceed a total of 30 mg/kg.
90.17005000151-56-4EthyleneimineThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg).
91.17020000075-21-8Ethylene oxideThe quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg.
92.17170061788-47-4Fatty acids, coco
93.17200068308-53-2Fatty acids, soya
94.17230061790-12-3Fatty acids, tall oil
95.17260000050-00-0formaldehydeThe specific migration of this substance shall not exceed 15 mg/kg.
96.17290000110-17-8Fumaric acid
97.17530000050-99-7Glucose
98.18010000110-94-1Glutaric acid
99.18070000108-55-4Glutaric anhydride
100.18100000056-81-5Glycerol
101.18250000115-28-6Hexachloroendomethylenetetrahydrophthalic acidThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg).
102.18280000115-27-5Hexachloroendomethylenetetrahydrophthalic anhydrideThe specific migration of this substance shallb be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg).
103.18310036653-82-4Hexadecan-1-ol
104.18430000116-15-4HexafluoropropyleneThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg).
105.18460000124-09-4HexamethylenediamineThe specific migration pof this substance shall not exceed 2.4 mg/kg.
106.18640000822-06-0Hexamethylene diisocyanateAs item 66.
107.18670000100-97-0HexamethylenetetramineThe specific migration of this substance shall not exceed 1.5 mg/kg (expressed as formaldahyde).
108.As item 75000123-31-9HydroquinoneAs item 75.
109.18880000099-96-7p-Hydroxybenzoic acid
110.19000000115-11-7Isobutene
111.19470000143-07-7Lauric acid
112.19510011132-73-3Lignocellulose
113.19540000110-16-7maleic acidThe specific migration of this substance alone or together with item 114 shall not exceed a total of 30 mg/kg.
114.19960000108-31-6Maleic anhydrideThe 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 190000108-78-1MelamineAs item 190.
116.20020000079-41-4Methacrylic acid
117.20110000097-88-1Methacrylic acid, butyl ester
118.20140002998-18-7Methacrylic acid, sec. butyl
119.20170000585-07-9Methacryhlic acid, tert. butyl ester
120.20890000097-63-2Methacrylic acid, ethyl ester
121.21010000097-86-9Methacrylic acid, isobutyl ester
122.21100004655-34-9Methacrylic acid, isopropyl ester
123.21130000080-62-6Methacrylic acid, methyl ester
124.21190000868-77-9Methacrylic acid, monoester with ethyleneglycol
125.21340002210-28-8Methacrylic acid, propyl ester
126.21460000760-93-0Methacrylic anhydride
127.21490000126-98-7MethacrylonitrileThe 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).
128.21550000067-56-1Methanol
129.21940000924-42-5N-MethylolacrylamideThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg).
130.22150000691-37-24-Methylpent-1-eneThe specific migration of this substance shall not exceed 0.02 mg/kg.
131.22350000544-63-8Myristic acid
132.22420003173-72-61,5-Naphthalene diisocyanateAs item 66.
133.22450009004-70-0Nitrocellulose
134.22480000143-08-8Nonan-1-ol
135.22570000112-96-9Octadecyl isocyanateAs item 66.
136.22600000111-87-5Octan-1-ol
137.22660000111-66-0Oct-1-eneThe specific migration of this substance shall not exceed 15 mg/kg.
138.22763000112-80-1Oleic acid
139.22780000057-10-3Palmitic acid
140.22840000115-77-5Pentaerythritol
141.22870000071-41-0Pentan-1-ol
142.22960000108-95-2Phenol
143.23050000108-45-21,3-PhenylenediamineThe quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg.
144.As item 56000075-44-5PhosgeneAs item 56.
145.23170007644-38-2Phosphoric acid
146.As item 181Phthalic acidAs item 181.
147.232500000088-99-3o-Phthalic Acid
148.23230000131-17-9Phthalic acid diallyl esterThe specific migration of this sustance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg).
149.23380000085-44-9Phthalic anhydride
150.23470000080-56-8alpha-Pinene
151.23500000127-91-3beta-Pinene
152.23590025322-68-3Polyethylene glycol
153.23650025322-69-4Polypropylene glycol (molecular weight greater than 400)
154.23740000057-55-6Propan-1,2-diol
155.23800000071-23-8Propan-1-ol
156.23830000067-63-0Propan-2-ol
157.23860000123-38-6Propionaldehyde
158.23890000079-09-4Propionic acid
159.23950000123-62-6Propionic anhydride
160.23980000115-07-1Propylene
161.24010000075-56-9Propylene oxideThe quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg.
162.As item 73000120-80-9PyrocatecholAs item 73.
163.24070073138-82-6Resin acids and rosin acids
164.As item 74000108-46-3ResorcinolAs item 74.
165.24100008050-09-7Rosin
166.24130008050-09-7Rosin gum
167.24160008052-10-6Rosin tall oil
168.24190009014-63-5Rosin wood
169.24250009006-04-6Rubber, natural
170.24270000069-72-7Salicyclic acid
171.24280000111-20-6Sebacic acid
172.24430002561-88-8Sebacic anhydride
173.24490000050-70-4Sorbitol
174.24520008001-22-7Soybean oil
175.24550000057-11-4Stearic acid
176.24610000100-42-5Styrene
177.24820000110-15-6Succinic acid
178.24850000108-30-5Succinic anhydride
179.24880000057-50-1Sucrose
180.24887006326-79-45-Sulphoisophthalic acid, monosodium saleThe specific migration of this substance shall not exceed 0.05 mg/kg.
181.24910000100-21-0Terephthalic acidThe specific migration of this substance shall not exceed 7.5 mg/kg.
182.24970000120-61-6Terephthalic acid, dimethyl ester
183.25090000112-60-7Tetraethylene glycol
184.25150000109-99-9TetrahydrofuranThe specific migration of this substance shall not exceed 0.6 mg/kg.
185.25180000102-60-3N,N,N',N'-Tetrakis(2-hydroxypropyl)ethylenediamine
186.25210000584-84-92,4-Toluene diisocyanateAs item 66.
187.25240000091-08-72,6-Toluene diisocyanateAs item 66.
188.25270026747-90-02,4-Toluene diisocyanate dimerAs item 66.
189.25360Trialdyl(C5-C15)acitic acid, 2,3-epoxypropyl esterThe specific migration of this substance shall not exceed 0.6 mg/kg.
190.25420000108-78-12,4,6-Triamino-1,3,5-triazineThe specific migration of this substance shall not exceed 30 mg/kg.
191.25510000112-27-6Triethylene glycol
192.25600000077-99-61,1,1-TrimethylolpropaneThe specific migration of this substance shall not exceed 6 mg/kg.
193.25910024800-44-0Tripropylene glycol
194.25960000057-13-6Urea
195.26050000075-01-4Vinyl chlorideThe 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.
196.26110000075-35-4Vinylidene chlorideThe 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

1234
ItemPM/REF No.CAS No.NameRestrictions
1.As item 9200542-02-9Acetoguanamine
2.10160002206-94-2alpha-Acetoxystyrene
3.10162010521-96-7beta-Acetoxystyrene
4.10480Acids, aliphatic, monocarboxylic, saturated (C2-C24)
5.10510Acids, aliphatic, monocarboxylic, unsaturated (C3-C24)
6.10599/70Acids, fatty, unsaturated (C18)
7.10599/70061788-89-4Acids, fatty, unsaturated (C18), dimers
8.10599/92068783-41-5Acids, fatty, unsaturated (C18), dimers, hydrogenated
9.10600Acids, linear, with an even number of carbon atoms (C8-C22), and the dimers and trimers of the unsaturated acids
10.10660015214-89-8Acrylamidomethylpropanesulphonic acid
11.10720000999-55-3Acrylic acid, allyl ester
12.10750002495-35-4Acrylic acid, benzyl ester
13.10775084100-23-2Acrylic acid, 4-tert.-butylcyclohexyl ester
14.10930003066-71-5Acrylic acid, cyclohyxyl ester
15.10990002156-96-9Acrylic acid, decyl ester
16.11000050967-02-8Acrylic acid, dicyclopentadienyl ester
17.11005012542-30-2Acrylic acid, dicyclopentenyl ester
18.11010024447-78-7Acrylic acid, diester with 2,2-bis(4-hydroxyphenyl)-propane bis(2-hydroxyethyl) ether
19.11020019485-03-1Acrylic acid, diester with butan-1,3-diol
20.11050001070-70-8Acrylic acid, diester with butan-1,4-diol
21.11080004074-88-8Acrylic acid, diester with diethyleneglycol
22.11110002274-11-5Acrylic acid, diester with ethyleneglycol
23.11140013048-33-4Acrylic acid, diester with hexan-1,6-diol
24.11170026570-48-9Acrylic acid, diester with polyethyleneglycol
25.11180017831-71-9acrylic acid, diester with tetraethyleneglycol
26.11195068901-05-3Acrylic acid, diester with tripropyleneglycol
27.11200002426-54-2Acrylic acid, 2-(diethylamino)ethyl ester
28.11230002439-35-2Acrylic acid, 2-(dimethylamino)ethyl ester
29.11245002156-97-0Acryhlic acid, dodecyl ester
30.11260000106-90-1Acrylic acid, 2,3-epoxypropyl esterThe 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).
31.11500000103-11-7Acrylic acid, 2-ethylhexyl ester
32.11520002918-23-2Acrylic acid, 2-hydroxyisopropyl ester(=acrylic acid, 2-hydroxy-1-methylethyl ester)
33.11530000999-61-1Acrylic acid, 2-hydroxypropyl ester
34.11532002761-08-2Acrylic acid, 3-hydroxypropyl ester
35.11560005888-33-5Acrylic acid, isobornyl ester
36.11620001330-61-6Acrylic acid, isodecyl ester
37.11695003121-61-7Acrylic acid, 2-methoxyethyl ester
38.11650029590-42-9Acrylic acid, isooctyl ester
39.11740010095-13-3Acrylic acid, monoester with butan-1,3-diol
40.11770002478-10-6Acrylic acid, monoester with butan-1,4-diol
41.11800013533-05-6Acrylic acid, monoester with diethyleneglycol
42.11860Acrylic acid, monoester with propyleneglycol
43.11875004813-57-4Acrylic acid, octadecyl ester
44.11890002499-59-4Acrylic acid, octadecyl esterAcrylic acid, n-octyl ester
45.12010040074-09-7Acrylic acid, 2-sulphoethyl ester
46.12040039121-78-3Acrylic acid, sulphopropyl ester
47.12055094160-26-6Acrylic acid, triester with glycerol tris(2-hydroxypropyl) ether
48.12062075577-70-7Acrylic acid, triester with 1,1,1-trimethylolpropane tris(2-hydroxyethyl) ether
49.12160002998-04-1Adipic acid, diallyl ester
50.12190000105-97-5Adipic acid, didecyl ester
51.12220027178-16-1Adipic acid, diisodecyl ester
52.12250000123-79-5Adipic acid, dioctyl ester
53.12265004074-90-2Adipic acid, divinyl ester
54.12370Alcohols, aliphatic, monohydric, saturated, linear, secondary or tertiary (C4-C22)
55.12610000107-18-6Allyl alcohol
56.12640000106-92-3Allyl 2,3-epoxypropyl etherAs item 30.
57.12700000150-13-0p-Aminobenzoic acid
58.12790000080-46-6p-tert.-Amylphenol
59.12850029602-44-6Azelaic acid, bis(2-hydroxyethyl) ester
60.12910001732-10-1Azelaic acid, dimethyl ester
61.As item 255000528-44-91,2,4-Benzenetricarboxylic acidAs item 255.
62.13060004422-95-11,3,5-Benzenetricarboxylic acid trichloride
63.As item 94000091-76-9Benzoguanamine
64.13210001761-71-3Bis(4-aminocyclohexyl)-methane
65.13328000104-38-1Bis(2-hydroxyethyl) ether of hydroquinone
66.As item 103000080-09-1Bisphenol S
67.13660000584-03-2Butan-1,2-diol
68.13720000110-63-4Butan-1,4-diol
69.13750000513-85-9Butan-2,3-diol
70.13780002425-79-8Butan-1,4-diol bis(2,3-epoxypropyl) etherAs item 30.
71.13810000505-65-7Butan-1,4-diol formal
72.13932000598-32-3Butan-3-en-2-ol
73.13960001852-16-0N-(Butoxymethyl)-acrylamide
74.14008000098-52-24-tert.-Butylcyclohexanol
75.14020000098-54-44-tert.-Butylphenol
76.14035001746-23-24-tert.-Butylstyrene
77.14260000502-44-3Caprolactone
78.As item 101, Section A000115-28-6Chlorendic acidAs item 101, Section A.
79.14560000126-99-82-Chlorobutan-1,3-diene
80.14650000079-38-9ChlorotrifluoroethyleneThe quantity of this substance in the finished platic material or article shall not exceed 5 mg/kg.
81.14800003724-65-0Crotonic acid
82.14833000623-43-8Crotonic acid, methyl ester
83.14980001631-25-0N-CyclohexylmaleimideThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg.
84.15020002182-05-0Cyclohexyl vinyl ether
85.15030000931-88-4Cyclooctene
86.15060000142-29-0Cyclopentene
87.15070001647-16-1Dec-1,9-diene
88.15095000334-48-5Decanoic acid
89.15120000872-05-9Dec-1-ene
90.15260000646-25-31,10-Diaminodecane
91.15270002783-17-71,12-Diaminododecane
92.15280000542-02-92,4-Diamino-6-methyl-1,3,5-triazine
93.15295000373-44-41,8-Diaminooctane
94.15310000091-76-92,4-Diamino-6-phenyl-1,3,5,-triazine
95.15340000109-76-21,3-Diaminopropane
96.15370003236-53-11,6-Diamino-2,2,4-trimethylhexane
97.15400003236-54-21,6-Diamino-2,4,4-trimethylhexane
98.15490002215-89-64,4'-Dicarboxydiphenyl ether
99.15580001653-19-62,3-Dichlorobuta-1,3-diene
100.15610000080-07-94,4'-Dichlorodiphenyl sulphone
101.15730000077-73-6Dicyclopentadiene
102.15790000111-40-0Diethylenetriamine
103.16090000080-09-14,4'-Dihydroxydiphenyl sulpone
104.16120000110-97-4Diisopropanolamine
105.16180005205-93-6N-(Dimethylaminopropyl)methacrylamide
106.16210006864-37-53,3'-Dimethyl-4,4'-diaminodicyclohexylmethane
107.16252000110-03-22,5-Dimethylhexane-2,5-diol
108.16270000526-75-02,3-Dimethylphenol
109.16300000105-67-92,4-Dimethylphenol
110.16330000095-87-42,5-Dimethylphenol
111.16360000576-26-12,6-Dimethylphenol
112.16390000126-30-72,2-Dimethylpropan-1,3-diol
113.16450000646-06-01,3-Dioxolane
114.16510000138-86-3Dipentene
115.16540000102-09-0Diphenyl carbonate
116.16690001321-74-0Divinylbenzene
117.16697000693-23-2Dodecanedioic acid
118.16719003813-52-3Endomethylenetetrahydrophthalic acid
119.16900013036-41-4N-(Ethoxymethyl)-acryhlamide
120.17040000149-57-52-Ethylhexanoic acid
121.17050000104-76-72-Ethylhexan-1-ol
122.17110016219-75-35-Ethylidenebicyclo-[2.2.1]hept-2-ene
123.17116005877-42-94-Ethyloct-1-yn-3-ol
124.17150000078-27-31-Ethynylcyclohexanol
125.17305000141-02-6Fumeric acid, bis(2-ethylhexyl ester)
126.17320002807-54-7Fumaric acid, diallyl ester
127.17350000105-75-9Fumaric acid, dibutyl ester
128.17380000623-91-6Fumaric acid, diethyl ester
129.17398007283-68-3Fumaric acid, dioctadecyl ester
130.17800Glucosides obtained from glucose and pentaerythritol
131.17830Glucosides obtained from glucose and polyethyleneglycol (molecular weight greater than 200)
132.17860Glucosides obtained from glucose and polypropyleneglycol (molecular weight greater than 400)
133.18220068564-88-5N-Heptylaminoundecanoid acid
134.18370000592-45-0Hexa-1,4-diene
135.18400000592-42-7Hexa-1,5-diene
136.18436001687-30-5Hexadydrophthalic acid
137.18441000085-42-7Hexahydrophthalic anhydride
138.18490015511-81-6Hexamethylenediamine adipate
139.18610006422-99-7Hexamethylenediamine sebacate
140.18700000629-11-8Hexan-1,6-diol
141.18820000592-41-6Hex-1-ene
142.18850000107-41-5Hexyleneglycol
143.18865003031-66-1Hex-3-yn-2,5-diol
144.18905002628-17-34-Hydroxystyrene
145.18970000078-83-1Isobutanol
146.19030016669-59-3N-(Isobutoxymethyl)-acrylamide
147.19060000109-53-5Isobutyl vinyl ether
148.19090000079-84-2Isobutyraldehyde
149.19120025339-17-7Isodecanol
150.19130026896-18-4Isononanoic acid
151.19140026952-21-6Isooctanol
152.19150000121-91-5Isophthalic acid
153.19180000099-63-8Isophthalic acid dichloride
154.19210001459-93-4Isophthalic acid, dimethyl ester
155.As item 200000078-79-5Isoprene
156.19270000097-65-4Itaconic acid
157.19480002146-71-6Lauric acid, vinyl ester
158.19490000947-04-6Laurolactam
159.19570000999-21-3Maleic acid, diallyl ester
160.19600000105-76-0Maleic acid, dibutyl ester
161.19660000141-05-9Maleic acid, diethyl ester
162.19690014234-82-3Maleic acid, diisobutyl ester
163.19720001330-76-3Maleic acid, diisooctyl ester
164.19750000624-48-6Maleic acid, dimethyl ester
165.19915000925-21-3Maleic acid, monobutyl ester
166.19936007423-42-9Maleic acid, mono(2-ethylhexyl) ester
167.19990000079-39-0Methacrylamide
168.20050000096-05-9Methacrylic acid, allyl ester
169.20080002495-37-6Methacrylic acid, benzyl ester
170.20095046729-07-1Methacrylic acid, 4-tert.-butylcyclohexyl ester
171.20200001888-94-4Methacrylic acid, 2-chloroethyl ester
172.20260000101-43-9Methacrylic acid, cyclohexyl ester
173.20320003179-47-3Methacrylic acid, decyl ester
174.20380001189-08-8Methacrylic acid, diester with butan-1,3-diol
175.20410002028-81-7Methacrylic acid, diester with butan-1,4-diol
176.20440000097-90Methacryl5ic acid, diester with ethyleneglycol
177.20455006606-59-3Methacrylic acid, diester with hexan-1,6-diol
178.20470025852-47-5Methacrylic acid, diester with polyethyleneglycol
179.20530002867-47-2Methacrylic acid, 2-(dimethylamino)-ethyl ester
180.20560000142-90-5Methacrylic acid, dodecyl ester
181.20590000106-91-2Methacrylic acid, 2,3-epoxypropyl esterAs item 30.
182.20740039670-09-2Methacrylic acid, ester with ethoxytriethyleneglycol
183.20830Methacrylic acid, esters with propan-1,2-diol
184.20920000688-84-6Methacrylic acid, 2-ethylhexyl ester
185.20945004664-49-7Methacrylic acid, 2-hydroxyisopropyl ester (=methacrylic acid, 2-hydroxy-1-methylethyl ester)
186.20950000923-26-2Methacrylic acid, 2-hydroxypropyl ester
187.20965002761-09-3Methacrylic acid, 3-hydroxypropyl ester
188.20980007534-94-3Methacrylic acid, isobornyl ester
189.21040029964-84-9Methacrylic acid, isodecyl ester
190.21070028675-80-1Methacrylic acid, isooctyl ester
191.21115000816-74-0Methacrylic acid, methallyl ester
192.21170000997-46-6Methacrylic acid, monoester with butan-1,4-diol
193.21220032360-05-7Methacrylic acid, octadecyl ester
194.21250002157-01-9Methacrylic acid, n-octyl ester
195.21280002177-70-0Methacrylic acid, phenyl ester
196.21370010595-80-9Methacrylic acid, 2-sulphoethyl ester
197.21400054276-35-6Methacrylic acid, sulphopropyl ester
198.21430004245-37-8Methacrylic acid, vinyl ester
199.21520001561-92-8Methallylsulphonic acid, sodium saltThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg.
200.21640000078-79-52-Methylbut-1,3-diene
201.21670000563-46-22-Methylbut-1-ene
202.21730000563-45-13-Methylbut-1-ene
203.21733000115-19-52-Methylbut-3-yn-2-ol
204.21736002549-61-3alpha-Methyl-epsilon-caprolactone
205.21739002549-60-2beta-Methyl-epsilon-caprolactone
206.21742002549-58-8delta-Methyl-epsilon-caprolactone
207.21745002549-59-9epsilon-Methyl-epsilon-caprolactone
208.21748002549-42-0gamma-Methyl-epsilon-caprolactone
209.21760000694-91-75-Methylenebicyclo-[2.2.2]hept-2-ene
210.As item 71000506-65-71,4-(Methylenedioxy)butane
211.21867001116-90-14-methylhex-1,4-dieneThe specific migration pof this substance shall be not detectable (when measured by a method with a limit of detection of 0.05 mg/kg).
212.21850000095-71-6Methylhydroquinone
213.21880000717-27-1Methylhydroquinone diacetate
214.21970000923-02-4N-Methylolmethacrylamide
215.22210000098-86-9alpha-Methylstyrene
216.22240000622-97-9p-Methylstyrene
217.22270000107-25-5Methyl vinyl ether
218.22360001141-38-42,6-Naphthalenedicarboxylic acid
219.As item 112000126-30-7Neopentylglycol
220.22428051000-52-3Neodecanoic acid, vinyl ester
221.22465000112-05-0Nonanoic acid
222.22540000104-40-54-Nonylphenol
223.13180 (also used for bicyclo[2.2.2]hept-2-ene)000498-66-8NorborneneAs item 39 on Part I Section C.
224.22585003710-30-3Octa-1,7-diene
225.22690001806-26-44-Octylphenol
226.22720000140-66-94-tert.-Octylphenol
227.22811000591-93-5Pent-1,4-diene
228.22842002590-16-1Pentaerythritol diallyl ether
229.22858005343-92-0Pentan-1,2-diol
230.22861000111-29-5Pentan-1,5-diol
231.22900000109-67-1Pent-1-ene
232.22901000109-68-2Pent-2-ene
233.22932001187-93-5Perfluoromethyl perfluorovinyl ether
234.22935003823-94-7Perfluoromethyl vinyl ether
235.22937001623-05-8Perfluoropropyl perfluorovinyl ether
236.22940006996-01-06Perfluoropropyl vinyl ether
237.23140000092-69-34-Phenylphenol
239.23530025190-06-1Poly(1,4-butyleneglycol) (molecular weight greater than 1000)
240.23770000504-63-2Propan-1,3-diol
241.23920000105-38-4Propionic acid, vinyl ester
242.24370000106-79-6Sebacic acid, dimethyl ester
243.24560000111-63-7Stearic acid, vinyl ester
244.24760026914-43-2Styrenesulphonic acid
245.24940000100-20-9Terephthalic acid dichloride
246.25030016646-44-9Tetra(allyloxy)ethane
247.25120000116-14-3Tetrafluoroethylene
248.25158000088-98-21,2,3,6-Tetrahydrophthalic acid
249.25161000085-43-81,2,3,6-Tetrahydrophthalic anhydride
250.25300000088-19-7o-Toluenesulphonamide
251.25380Trialkyl(C5-C15) acetic acid vinyl ester (=vinyl versatate)
252.25390000101-37-1Triallyl cyanurate
253.25450026896-48-0Tricyclodecadedimethanol
254.25480000102-71-6Triethanolamine
255.25540000528-44-9Trimellitic acidThe quantity of this substance alone or together with item 256 in the finished plastic material or article shall not exceed 5 mg/kg.
256.25550000552-30-7Trimellitic anhydrideThe 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).
257.25630037275-47-11,1,1-Trimethylolpropane diacrylate
258.25645000682-09-71,1,1-Trimethylolpropane diallyl ether
259.25780025723-16-41,1,1-Trimethylolpropane propoxylated
260.25810015625-89-51,1,1-Trimethyololpropane triacrylate
261.25840003290-92-41,1,1-Trimethylolpropane trimethacrylate
262.25900000110-88-3Trioxane
263.As item 254000102-71-6Tris(2-hydroxyethyl)amine
264.25930001067-53-4Tris(2-methoxyethoxy)-vinylsilaneThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg.
265.26140000075-38-7Vinylidene fluorideThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.05 mg/kg).
266.26170003195-78-6N-Vinyl-N-methylacetamideThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg.
267.26200002867-48-3N-Vinyl-N-methylformamide
268.26230000088-12-0Vinylpyrrolidone
269.26260001184-84-5Vinylsulphonic acid
270.26290025013-15-4Vinyhltoluene
271.As item 216000622-97-9p-Vinyltoluene
272.26320002768-02-7VinyltrimethoxysilaneThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg.
273.As item 109000105-67-9m-Xylenol
274.As item 108000526-75-0o-Xylenol
275.As item 110000095-87-4p-Xylenol

SECTION CMonomers authorised until 1st April 1995

1234
ItemPM/REF No.CAS No.NameRestrictions
1.10180000556-08-1p-(Acetylamino)benzoic acid
2.10240Acids, aliphatic, dicarboxylic, esters with alcohols, aliphatic, monohydric
3.10270Acids, aliphatic, dicarboxylic (C3-C12), esters with alcohols, unsaturated (C3-C18)
4.10300Acids, aliphatic, dicarboxylic, saturated (C4-C18)
5.10330Acids, aliphatic, dicarboxylic, unsaturated (C4-C12)
6.10360Acids, aliphatic, dicarboxylic, unsaturated, esters with polyethyleneglycol
7.10390Acids, aliphatic, dicarboxylic, unsaturated, esters with polypropyleneglycol
8.10420Acids, aliphatic, mono- and dicarboxylic (C2-C20), vinyl esters
9.10450Acids, aliphatic, monocarboxylic (C3-C12), esters with alcohols, unsaturated (C3-C18)
10.10540Acids, aliphatic, monocarboxylic, unsaturated (C3-C8), esters with alcohols, aliphatic, monohydric, saturated (C2-C12)
11.10570Acids, aliphatic, monocarboxylic, unsaturated, esters with polypropyleneglycol
12.10630000079-06-1Acrylamide
13.10870002206-89-5Acrylic acid, 2-chloroethyl ester
14.10900Acrylic acid, cyclohexylaminoethyl ester
15.10960016868-13-6Acrylic acid, cyclopentyl ester
16.11290Acrylic acid, esters with alcohols, aliphatic, monohydric, saturated (C1-C21)
17.11320Acrylic acid, esters with alcohols, aliphatic, monohydric, unsaturated (C4-C18)
18.11350Acrylic acid, esters with alcohols, aliphatic, polyhydric (C2-C21)
19.11380Acrylic acid, esters with etheralcohols
20.11410Acrylic acid, esters with glycolethers obtained from mono- and/or diglycols with alcohols, aliphatic, monohydric (C1-C18)
21.11440044992-01-0Acrylic acid, ester with trimethylethanolammonium chloride
22.11920005048-82-8Acrylic acid, phenylaminoethyl ester
23.11950000937-41-7Acrylic acid, phenyl ester
24.12070002177-18-6Acrylic acid, vinyl ester
25.12400Alcohols, aliphatic, monohydric, unsaturated (up to C18)
26.12430Alcohols, aliphatic, polyhydric (up to C18)
27.12460Alcohols, cycloaliphatic, mono- and/or polyhydric, substituted (up to C18)
28.12490Aldehydes (C4)
29.12520Alkadienes
30.12550n-Alkenes (up to C16)
31.12580p-Alkyl (C4-C9) phenols
32.12670002855-13-21-Amino-3-aminomethyl-3,5,5-trimethylcyclohexane
33.12730000060-32-26-Aminocaproic acid
34.12670omega-Aminocarboxylic acids, aliphatic, linear (C6-C12)
35.12880000123-98-8Azelaic acid dichloride
36.12940004080-88-0Azelaic acid, diphenyl ester
37.13030000539-48-01,4-Benzenedimethanamine
38.13120000769-78-8Benzoic acid, vinyl ester
39.13180000498-66-8Bicyclo[2.2.1]hept-2-ene
40.13240003377-24-02,2-Bis(4-aminocyclohexyl)propane
41.13300038050-97-41,4-Bis(4',4'-dihydroxytriphenylmethyl)benzene
42.13330Bis(2-hydroxyethyl) ether of hydroquinone and its condensation products with propylene oxide
43.13360001620-68-42,6-Bis(2-hydrowy-5-methylbenzyl)-4-methylphenol
44.13420000843-55-01,1-Bis(4-hydroxyphenyl)cyclohexane
45.13450000125-13-33,3-Bis(4-hydroxyphenyl)-2-indolinone
46.13570000141-07-11,3-Bis(methoxymethyl)urea
47.13930006117-91-5But-2-en-1-ol
48.13990005153-77-5N-(Butoxymethyl)methacrylamide
49.14050000111-34-2Butyl vinyl ether
50.14080000926-02-3tert.-Butyl vinyl ether
51.14290Caprolactone, substituted
52.14440064147-40-6Castor oil, dehydrated
53.14470008001-78-3Castor oil, hydrogenated
54.14590000615-67-8Chlorohydroquinone
55.14620057981-99-4Chlorohydroquinone diacetate
56.14830Crotonic acid, esters with alcohols, mono- and polyhydric
57.14860Cycloalkenes
58.14920002842-38-82-(Cyclohexylamino)ethanol
59.15010001131-60-8p-Cyclohexylphenol
60.15040000542-92-7Cyclopenta-1,3-diene
61.15160000765-05-9Decyl vinyl ether
62.15190Diamines, aliphatic, linear (C2-C12)
63.15430003749-77-74,4'-Dicarboxydiphenoxybutane
64.15460003753-05-74,4'-Dicarboxydiphenoxyethane
65.15520004919-48-64,4'-Dicarboxydiphenyl sulphide
66.15550002449-35-64,4'-Dicarboxydiphenyl sulphone
67.15640000156-59-2cis-1,2-Dichloroethylene
68.15670000156-60-5trans-1,2-Dichloroethylene
69.16030001965-09-94,4'-Dihydroxydiphenyl ether
70.16060002664-63-34,4'-Dihydroxydiphenyl sulphide
71.16420000123-91-1Dioxane
72.16720000826-62-0Endomethylenetetrahydrophthalic anhydride
73.16810Ether alcohols
74.16840Ethers of N-methylolacrylamide
75.16870Ethers of N-methylolmethacrylamide
76.16930000075-00-3Ethyl chloride
77.17080000103-44-62-Ethylhexyl vinyl ether
78.17140000109-92-2Ethyl vinyl ether
79.17410Fumaric acid, esters with alcohols, aliphatic, monohydric, saturated (C1-C18)
80.17440Fumaric acid, esters with alcohols, aliphatic, monohydric, unsaturated (C1-C18)
81.17470Fumaric acid, esters with alcohols, polyhydric
82.17500000098-01-0Furfural
83.17560Glucosides obtained from glucose and butan-1,3-diol
84.17590Glucosides obtained from glucose and butan-1,4-diol
85.17620Glucosides obtained from glucose and diethyleneglycol
86.17650Glucosides obtained from glucose and 2,2-dimethylpropan-1,3-diol
87.17680Glucosides obtained from glucose and ethyleneglycol
88.17710Glucosides obtained from glucose and glycerol
89.17740Glucosides obtained from glucose and hexan-1,6-diol
90.17770Glucosides obtained from glucose and hexan-1,2,6-triol
91.17890Glucosides obtained from glucose and propanediol
92.17920Glucosides obtained from glucose and sorbitol
93.17950Glucosides obtained from glucose and sucrose
94.17980Glucosides obtained from glucose and 1,1,1-trimethylolpropane
95.18040029733-18-4Glutaric acid, diisodecyl ester
96.18130004371-64-61,1-Heptadecanedicarboxylic acid
97.18160025339-56-4Heptene
98.18190000592-76-7Hept-1-ene
99.18250000115-28-6Hexachloroendomethylenetetrahydrophthalic acidThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg.
100.18280000115-27-5Hexachloroendomethylenetetrahydrophthalic anhydride
101.18340000822-28-6Hexadecyhl vinyl ether
102.18430000116-15-4Hexafluoropropylene
103.18520038775-37-0Hexamethylenediamine azelate
104.18550Hexamethylenediamine dodecanedicarboxylate
105.18580Hexamethylenediamine heptadecanedicarboxylate
106.18670000100-97-0Hexamethylenetetramine
107.18730002935-44-6Hexan-2,5-diol
108.18760000106-69-4Hexan-1,2,6-triol
109.18790025264-93-1Hexene
110.18910000288-32-4Imidazole
111.18940000095-13-6Indene
112.19240000744-45-6Isophthalic acid, diphenyl ester
113.19300002155-60-4Itaconic acid, dibutyl ester
114.19330007748-43-8Itaconic acid, 2,3-eposypropyl diesterThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg.
115.19360Itaconic acid, 2,3-epoxypropyl monoesterThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg.
116.19390Itaconic acid, esters with alcohols, aliphatic, monohydric, saturated (C1-C18)
117.19420Itaconic acid, esters with alcohols, polyhydric
118.19450Latcams of omega-aminocarboxylic acids, aliphatic, linear (C7-C12)
119.19630071550-61-3Maleic acid, diester with propan-1,2-diol
120.19780002915-53-9Maleic acid, dioctyl ester
121.19810Maleic acid, esters with alcohols, aliphatic, saturated (C1-C18)
122.19840Maleic acid, esters with alcohols, polyhydric
123.19870Maleic acid, ester with butan-1,3-diol
124.19900002424-58-0Maleic acid, monoallyl ester
125.19930Maleic acid, monoesters with alcohols, aliphatic, monohydric, unsaturated (C3-C18)
126.20230Methacrylic acid, cyclohexylaminoethyl ester
127.20290016868-14-7Methacrylic acid, cyclopentyl ester
128.20350Methacrylic acid, (di-tert.-butylamino)ethyl ester
129.20500000105-16-8Methacrylic acid, 2-(diethylamino)ethyl ester
130.20620Methacrylic acid, esters with alcohols, aliphatic, monohydric, saturated (C1-C21)
131.20650Methacrylic acid, esters with alcohols, aliphatic, monohydric, unsaturated (C4-C18)
132.20680Methacrylic acid, esters with alcohols, polyhydric (C2-C21)
133.20710Methacrylic acid, esters with etheralcohols
134.20770Methacrylic acid, esters with glycolethers obtained from mono- and/or diglycols with alcohols, aliphatic, monohydric (C1-C18)
135.20800024493-59-2Methacrylic acid, ester with methoxytriethyleneglycol
136.20860Methacrylic acid, ester with trimethylethanolammonium chloride
137.21160Methacrylic acid, monoester with butan-1,3-diol
138.21310003683-12-3Methacrylic acid, phenylethyl ester
139.21580003644-11-9N-(Methoxymethyl)-acrylamide
140.21610003644-12-0N-(Methoxymethyl)-metharcylamide
141.21700000513-35-92-Methylbut-2-ene
142.21790000110-26-9Methylenebisacrylamide
143.21820013093-19-1Methylenebiscaprolactam
144.21910000814-78-8Methyl isopropenyl ketone
145.21940000924-42-5N-Methylolacrylamide
146.22000001118-58-72-Methylpent-1,3-diene
147.22030001115-08-83-Methylpent-1,4-diene
148.22060000926-56-74-Methylpent-1,3-diene
149.22090000763-29-12-Methylpent-1-ene
150.22120000760-20-33-Methylpent-1-ene
151.22150000691-37-24-Methylpent-1-ene
152.22180004461-48-74-Methylpent-2-ene
153.22300000078-94-4Methyl vinyl ketoneThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg.
154.22330001822-74-8Methyl vinyl thioether
155.22510027215-95-8Nonene
156.22580000930-02-9Octadecyl vinyl ether
157.22630025377-83-7Octene (except oct-1-ene)
158.22750000929-62-4Octyl vinyl ether
159.22810000504-60-9Pent-1,3-diene
160.22930Perfluoroalkyl(C1-C3)vinyl ethers
161.22990Phenols, mono- and dihydric, alkoxylated or hydrogenated
162.23020028994-41-4alpha-Penyl-o-cresol
163.23080001079-21-6Phenylhydroquinone
164.23110058244-28-3Phenylhydroquinone diacetate
165.23230000131-17-9Phthalic acid, diallyl ester
166.23260000088-95-9o-Phthalic acid dichloride
167.23290Phthalic acids, halogenated derivatives
168.23320Phthalic acids, hydrogenated
169.23350Phthalic acids, hydrogenated, substituted, endosubstituted, and their halogenated derivatives
170.23410Phthalic anhydride, hydrogenated
171.23440000111-16-0Pimelic acid
172.23560Polyethers based on ethylene oxide, propylene oxide and/or tetrahydrofuran, containing free hydroxyl groups
173.23620Polyols derived from phenols and bisphenols hydrogenated and/or condensed with epoxyalkanes and/or arylepoxyalkanes possibly halogenated, alkoxylated, aryloxylated
174.23680009002-89-5Polyvinylalcohols
175.23710063148-65-2Polyvinylbutyrals
176.24040000764-47-6Propyl vinyl ether
177.24220009006-03-5Rubber, chlorinated
178.24310000111-19-3Sebacic acid, dichloride
179.24340002432-89-5Sebacic acid, didecyl ester
180.24400002918-18-5Sebacic acid, diphenyl ester
181.24640Styrene, substituted by alkyl groups (alpha)
182.24670Styrene, substituted in the benzene ring
183.24700Styrene, substituted by halogens (alpha or beta)
184.24730Styrene, substituted in the vinyl group
185.24790000505-48-6Suberic acid
186.25000001539-04-4Terephthalic acid, diphenyl ester
187.25060000632-58-6Tetrachlorophthalic acid
188.25330000070-55-3p-Toluenesulphonamide
189.25570000067-48-1Trimethylethanolammonium chloride
190.25660019727-16-31,1,1-Trimethylolpropane dimethacrylate
191.256901,1,1-Trimethylolpropane maleates
192.25720007024-08-01,1,1-Trimethylolpropane monoacrylate
193.25750007024-09-11,1,1-Trimethylolpropane monomethacrylate
194.25870000107-39-12,4,4-Trimethylpent-1-ene
195.25990000689-97-4VinylacetyleneThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg.
196.26020001484-13-5N-VinylcarbazoleThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg.
197.26080Vinyl ethers of alcohols, aliphatic, monohydric, saturated (C2-C18)
198.26140000075-38-7Vinylidene fluoride

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

1A. 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.

2A. 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.

3A. 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.

4A. 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.

5A. 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.

6B. 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.

7B. 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.

8B. 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.

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).