
1998 No. 264
FOOD
Plastic Materials and Articles in Contact with Food Regulations (Northern Ireland) 1998
Made 27th July 1998
Coming into operation 14th September 1998
The Department of Health and Social Services for Northern Ireland, in exercise of the powers conferred on it by Articles 15(2), 16(1), 25(1)(a) and (3), 32 and 47(2) of the Food Safety (Northern Ireland) Order 1991 and, being a designated Department for the purposes of section 2(2) of the European Communities Act 1972 in relation to materials and articles in contact with food or drink or intended for such contact, in exercise of the powers conferred on it by the said section 2(2) and of all other powers enabling it in that behalf and after consultation in accordance with Article 47(3) of the said Order with such organisations as appear to it to be representative of interests likely to be substantially affected by these Regulations (in so far as the Regulations are made in exercise of the said Order), hereby makes the following Regulations:
Citation and commencement
1 
These Regulations may be cited as the Plastic Materials and Articles in Contact with Food Regulations (Northern Ireland) 1998 and shall come into operation on 14th September 1998.
Interpretation
2 

(1) In these Regulations—
 “additive” means a substance, other than one which directly influences the formation of polymers which is—
(a) incorporated into a plastic material or article to achieve a technical effect in the finished product and is intended to be present in the finished product; or
(b) used to provide a suitable medium in which polymerisation occurs;
 “capable” means capable as established under regulation 6;
 “Council Directive 82/711” means Council Directive 82/711/EEC laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs, as amended by Commission Directives 93/8/EEC and 97/48/EC;
 “the Directive” means Commission Directive (EEC) No. 90/128 relating to plastic materials and articles intended to come into contact with foodstuffs (as corrected) and as amended by Commission Directives 92/39/EEC, 93/9/EEC. 95/3/EC and 96/11/EC;
 “EEA Agreement” means the Agreement on the European Economic Area signed at Oporto on 2nd May 1992 as adjusted by the Protocol signed at Brussels on 17th March 1993;
 “EEA State” means a State (other than the United Kingdom) which is a contracting party to the EEA Agreement;
 “food” has the same meaning as it has in Article 15(5) of the Order;
 “good technical quality” means good technical quality as regards the purity criteria;
 “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;
 “the Order” means the Food Safety (Northern Ireland) Order 1991;
 “plastic material or article” means anything which for the purposes of the Directive is included among those plastic materials and articles and parts thereof to which the Directive applies;
 “sell” includes offer or expose for sale or have in possession for sale;
 “the 1987 Regulations” means the Materials and Articles in Contact with Food Regulations (Northern Ireland) 1987;
 “the 1993 Regulations” means the Plastic Materials and Articles in Contact with Food Regulations (Northern Ireland) 1993.
(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 expression, other than one defined in paragraph (1), used both in these Regulations and in the Directive, Council Directive 82/711, or Council Directive 85/572 EEC laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs has the same meaning as it bears in the Directive in which it appears.
(4) The Interpretation Act (Northern Ireland) 1954 shall apply to these Regulations as it applies to a Measure of the Northern Ireland Assembly.
Restriction on the use, sale or importation of plastic materials and articles
3 

(1) A plastic material or article which fails to meet the requisite standards shall not be—
(a) used by any person in the course of a business in connection with the storage, preparation, packaging, sale or serving of food for human consumption;
(b) sold by any person for the purpose of its being used in connection with the storage, preparation, packaging, sale or serving of food for human consumption; or
(c) imported by any person from any place other than an EEA State for the purpose of its being used in connection with the storage, preparation, packaging, sale or serving of food for human consumption.
(2) In any proceedings for an offence under these Regulations where it is alleged that a plastic material or article which fails to meet the requisite standards was used, sold or imported, 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 to a country, other than an EEA State, which has legislation analogous to these Regulations and that the plastic material or article complies with such legislation.
(3) In any proceedings for an offence under these Regulations where it is alleged that a plastic material or article which fails to meet the requisite standards was used, sold or imported it shall be a defence for the person charged to prove that the plastic material or article was manufactured—
(a) before 14th September 1998; and
(b) in accordance with regulation 4 of the 1993 Regulations as that regulation applied when the plastic material or article was manufactured.
(4) For the purposes of this regulation a plastic material or article fails to meet the requisite standards—
(a) if—
(i) it has been manufactured with a prohibited monomer as described in regulation 4(1) or a prohibited additive as described in regulation 5(1) or does not comply with regulation 4(5) or 7; and
(ii) no defence indicated in regulation 4(7), 5(2) or 7(5) would be available in proceedings for an offence under these Regulations relating to that manufacture or want of compliance; or
(b) if it has been manufactured outside Northern Ireland and sub-paragraph (a) would have applied to it had it been manufactured in Northern Ireland.
Restriction on manufacture with monomers
4 

(1) Subject to the following paragraphs, no plastic material or article shall be manufactured by any person with any prohibited monomer, other than a monomer which is—
(a) of good technical quality;
(b) identified by PM/REF No., CAS No., (if any) and name respectively in columns 1, 2 and 3 of the relevant section of Part 1 of Schedule 1; and
(c) used in accordance with the restrictions (if any) specified in the corresponding entry in column 4 of the relevant section of that Part of that Schedule.
(2) For the purposes of this regulation the relevant section of Part I of Schedule 1 is—
(a) in the case of a plastic material or article manufactured before 1st January 1999, Section A, B, or C;
(b) in the case of a plastic material or article manufactured after 31st December 1998 and before 1st January 2002, Section A or B; and
(c) in the case of a plastic material or article manufactured after 31st December 2001, Section A.
(3) Paragraph (1) does not apply to the use of a monomer in the manufacture of any—
(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; or
(f) printing inks.
(4) Paragraph (1) shall not be taken to prohibit the manufacture of any plastic material or article with any substance if the substance is a mixture which falls within paragraph 3(c) of Annex II to the Directive and does not contravene paragraph 4 of that Annex.
(5) Subject to paragraph (6), where column 4 of the relevant section 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) the number of milligrams expressed therein released per kilogram of food in the case of any plastic material or article other than one specified in sub-paragraph (b); and
(b) one sixth of the number of milligrams expressed therein per square decimetre of surface area of the plastic material or article 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 less than 500 millilitres or 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 surface area of that material and the quantity of food in contact with that surface area.
(6) A plastic material or article manufactured from any monomer in respect of which column 4 of the relevant section 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 (5) if the only food which that plastic material or article may come into contact with is food to which regulation 7(3) applies.
(7) In any proceedings for an offence under these Regulations where it is alleged that a plastic material or article does not comply with paragraph (1) because it was manufactured with any monomer (whether or not of good technical quality) other than one identified in the relevant section 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, which falls within paragraph 3(a) of Annex II to the Directive;
(b) each such monomer is an oligomer or a natural or synthetic macromolecular substance or a mixture thereof which falls within paragraph 3(b) of that Annex; or
(c) each such monomer falls within either sub-paragraph (a) or sub-paragraph (b)
and does not contravene paragraph 4 of that Annex
(8) Part II of Schedule 1 shall have effect to supplement this regulation and Part I of Schedule 1.
Restriction on manufacture with additives
5 

(1) Subject to the following paragraphs, no person shall use in the manufacture of plastic materials or articles any prohibited additive, that is to say an additive identified by PM/REF No., CAS No. (if any) and name respectively in columns 1, 2 and 3 of Part I of Schedule 2 which is not of good technical quality.
(2) In any proceedings for an offence under these Regulations, where it is alleged that the commission of the offence is due to the manufacture of a plastic material or article with any additive identified in Part I of Schedule 2 which is not of good technical quality, it shall be a defence for the person charged to prove that each such additive is present in the finished plastic material or article as an impurity, a reaction intermediate or a decomposition product.
(3) Part II of Schedule 2 shall have effect to supplement this regulation and Part I of Schedule 2.
Method of testing capability of transferring constituents
6 

(1) For the purposes of these Regulations, a plastic material or article 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) relates, by the verification methods specified in Schedules 3 and 4;
(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 Schedules 3 and 4, references 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.
(3) In paragraph (1)(a) analytical tolerances, as referred to in paragraph 8 of Schedule 3, shall be treated as included among verification methods.
Transfer of constituents
7 

(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.
(2) For the purposes of this regulation 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 food to which paragraph (3) applies.
(3) This paragraph applies to food which is specified in the Table to Part IV of Schedule 4 where there is no “X” placed anywhere in the group of columns headed “Simulants to be used” opposite that food.
(4) For the purposes of this regulation the appropriate limit is—
(a) an overall migration limit of 60 milligrams of constituents released per kilogram of food in the case of any plastic material or article comprising—
(i) an article which is a container or is comparable to a container or which can be filled, with a capacity of not less than 500 millilitres and not more than 10 litres;
(ii) an article which can be filled and for which it is impracticable to estimate the surface area in contact with food;
(iii) a cap, gasket, stopper or similar device for sealing, and
(b) in the case of any other plastic material or article, an overall migration limit of 10 milligrams per square decimetre of the surface area of the plastic material or article.
(5) In any proceedings for an offence under these Regulations an element of which is that a plastic material or article does not comply with this regulation the defences in paragraph 6(2) and 7(2) of Schedule 3 shall be available as specified therein.
Labelling
8 

(1) Subject to paragraph (2), at marketing stages other than the retail stage a person who is in possession of any plastic material or article which is intended to come into contact with food shall ensure that that plastic material or article is accompanied by a written declaration attesting that it complies with the legislation applicable to it.
(2) Paragraph (1) shall not apply to a person in possession of any plastic material or article which by its nature is clearly intended to come into contact with food.
Enforcement
9 
Each district council shall enforce and execute these Regulations in its own district.
Offences
10 

(1) Any person who contravenes regulation 3, 4(1), 5(1) or 8 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.
(3) Nothing in paragraph (2)(b) shall be construed as requiring any person to answer any question or give any information if to do so might incriminate him.
(4) Any person who, in purported compliance with any such requirement as is mentioned in paragraph (2)(b)—
(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.
(5) 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.
(6) In any proceedings for an offence under these Regulations it shall, subject to paragraph (10), 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.
(7) Without prejudice to the generality of paragraph (6), 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 Northern Ireland,
shall be taken to have established the defence provided by that paragraph if he satisfies the requirements of paragraph (8) or (9).
(8) 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.
(9) 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 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.
(10) If in any case the defence provided by paragraph (6) 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.
(11) 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.
(12) No prosecution for an offence under these Regulations shall be begun after the expiry of—
(a) three years from the commission of the offence; or
(b) one year from its discovery by the prosecutor,
whichever is earlier.
Presumption as to food with which a plastic material or article is to come into contact
11 
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
12 

(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 19 (evidence of analysis); and
(e) regulation 20 (analysis by Government Chemist).
(2) Article 4(d) of the Order (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 Order.
(3) Articles 29 and 30 of the Order (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 to avoid restricting the scope of paragraph 1(a), (b), (d) and (e).
Amendment
13 
In the Food Safety (Sampling and Qualifications) Regulations (Northern Ireland) 1991, in Schedule 1 (provisions to which those regulations do not apply), for the title and reference of the 1993 Regulations there shall be substituted the title and reference of these Regulations.
Revocations
14 
The 1993 Regulations, the Plastic Materials and Articles in Contact with Food (Amendment) Regulations (Northern Ireland) 1995, the Plastic Materials and Articles in Contact with Food (Amendment) Regulations (Northern Ireland) 1996 and the Plastic Materials and Articles in Contact with Food (Amendment No. 2) Regulations (Northern Ireland) 1996 are hereby revoked.
Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on
J. R. Kearney
Assistant Secretary
27th July 1998.
SCHEDULE 1
Regulation 4
Part I Authorised Monomers
SECTION A
Monomers authorised without time limit

 1 2 3 4
Item PM/REF No. CAS No. Name Restrictions
1. 10030 000514-10-3 Abietic acid
2. 10060 000075-07-0 Acetaldehyde
3. 10090 000064-19-7 Acetic acid
4. 10120 000108-05-4 Acetic acid, vinyl ester The specific migration of this substance shall not exceed 12 mg/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 of 0·01 mg/kg)
8. 10660 015214-89-8 2-Acrylamido-2-methylpropane- sulphonic acid The specific migration of this substance shall not exceed 0·05 mg/kg
9. 10690 000079-10-7 Acrylic acid
10. 10750 002495-35-4 Acrylic acid, benzyl ester
11. 10780 000141-32-2 Acrylic acid, n-butyl ester
12. 10810 002998-08-5 Acrylic acid, sec-butyl ester
13. 10840 001663-39-4 Acrylic acid, tert-butyl ester
14. 11470 000140-88-5 Acrylic acid, ethyl ester
15. As item 19 000818-61-1 Acrylic acid, hydroxyethyl ester
16. 11590 000106-63-8 Acrylic acid, isobutyl ester
17. 11680 000689-12-3 Acrylic acid, isopropyl ester
18. 11710 000096-33-3 Acrylic acid, methyl ester
19. 11830 000818-61-1 Acrylic acid, monoester with ethylene glycol
20. 11890 002499-59-4 Acrylic acid, n-octyl ester
21. 11980 000925-60-0 Acrylic acid, propyl ester
22. 12100 000104-13-1 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)
23. 12130 000124-04-9 Adipic acid
24. 12280 002035-75-8 Adipic anhydride
25. 12310 — Albumin
26. 12340 — Albumin, coagulated by formaldehyde
27. 12375 — Alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C22)
28. 12670 002855-13-2 1-Amino-3-aminomethyl-3,5,5- trimethylcyclohexane The specific migration of this substance shall not exceed 6 mg/kg
29. 12788 002432-99-7 11-Aminoundecanoic acid The specific migration of this substance shall not exceed 5 mg/kg
30. 12789 007664-41-7 Ammonia
31. 12820 000123-99-9 Azelaic acid
32. 12970 004196-95-6 Azelaic anhydride
33. 13000 001477-55-0 1,3-Benzenedimethanamine The specific migration of this substance shall not exceed 0·05 mg/kg
34. 13090 000065-85-0 Benzoic acid
35. 13150 000100-51-6 Benzyl alcohol
36. As item 79 000111-46-6 Bis(2-hydroxymethyl)ether As item 79
37. As item 217 000077-99-6 2,2-Bis(hydroxymethylbutan- 1-o1) As item 217
38. 13390 000105-08-8 1,4-Bis(hydroxymethyl)- cyclohexane
39. 13480 000080-05-7 2,2-Bis(4-hydroxyphenyl)- propane The specific migration of this substance shall not exceed 3 mg/kg
40. 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)
41. 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
42. As item 93 000110-98-5 Bis(hydroxypropyl) ether
43. As item 78 005124-30-1 Bis(4-isocyanatocyclohexyl) methane As item 78
44. 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
45. As item 39 000080-05-7 Bisphenol A As item 39
46. As item 40 001675-54-3 Bisphenol A bis(2,3- epoxypropyl) ether As item 40
47. 13614 038103-06-9 Bisphenol A bis (phthalic anhydride) As item 41
48. 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)
49. 13690 000107-88-0 Butan-1,3-diol
50. 13840 000071-36-3 Butan-1-ol
51. 13870 000106-98-9 But-1-ene
52. 13900 000107-01-7 But-2-ene
53. 14110 000123-72-8 Butyraldehyde
54. 14140 000107-92-6 Butyric acid
55. 14170 000106-31-0 Butyric anhydride
56. 14200 000105-60-2 Caprolactam The specific migration of this substance alone or together with item 57 shall not exceed a total of 15 mg/kg
57. 14230 002123-24-2 Caprolactam, sodium salt The specific migration of this substance alone or together with item 56 shall not exceed a total of 15 mg/kg (expressed as caprolactam)
58. 14320 000124-07-2 Caprylic acid
59. 14350 000630-08-0 Carbon monoxide
60. 14380 000075-44-5 Carbonyl chloride The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg
61. 14411 008001-79-4 Castor oil
62. 14500 009004-34-6 Cellulose
63. 14530 007782-50-5 Chlorine
64. As item 94 000106-89-8 1-Chloro-2,3-expoxypropane As item 94
65. 14680 000077-92-9 Citric acid
66. 14710 000108-39-4 m-Cresol
67. 14740 000095-48-7 o-Cresol
68. 14770 000106-44-5 p-Cresol
69. As item 38 000105-08-8 1,4-Cyclohexanedimethanol
70. 14950 003173-53-3 Cyclohexyl isocyanate The quantity in the finished plastic material or article of any substance within, or any combination of substances within, items 70, 78, 88, 90, 91, 92, 117, 150, 153, 211, 212 and 213 shall not exceed 1 mg/kg (expressed as isocyanate moiety)
71. 15070 001647-16-1 Dec-1,9-diene The specific migration of this substance shall not exceed 0·05 mg/kg
72. 15095 000334-48-5 Decanoic acid
73. 15100 000112-30-1 Decan-1-ol
74. 15250 000110-60-1 1,4-Diaminobutane
75. As item 97 000107-15-3 1,2-Diaminoethane As item 97
76. As item 116 000124-09-4 1,6-Diaminohexane As item 116
77. 15565 000106-46-7 1,4-Dichlorobenzene The specific migration of this substance shall not exceed 12 mg/kg
78. 15700 005124-30-1 Dicyclohexylmethane- 4,4'-diisocyanate As item 70
79. 15760 000111-46-6 Diethylene glycol The specific migration of this substance alone or together with item 98 shall not exceed a total of 30 mg/kg
80. 15790 000111-40-0 Diethylenetriamine The specific migration of this substance shall not exceed 5 mg/kg
81. 15820 000345-92-6 4,4'-Difluorobenzophenone The specific migration of this substance shall not exceed 0·05 mg/kg
82. 15880 000120-80-9 1,2-Dihydroxybenzene The specific migration of this substance shall not exceed 6 mg/kg
83. 15910 000108-46-3 1,3-Dihydroxybenzene The specific migration of this substance shall not exceed 2·4 mg/kg
84. 15940 000123-31-9 1,4-Dihydroxybenzene The specific migration of this substance shall not exceed 0·6 mg/kg
85. 15970 000611-99-4 4,4'-Dihydroxybenzophenone The specific migration of this substance shall not exceed 6 mg/kg
86. 16000 000092-88-6 4,4'-Dihydroxybiphenyl The specific migration of this substance shall not exceed 6 mg/kg
87. 16150 000108-01-0 Dimethylaminoethanol The specific migration of this substance shall not exceed 18 mg/kg
88. 16240 000091-97-4 3,3'-Dimethyl- 4,4'-diisocyanatobiphenyl As item 70
89. 16480 000126-58-9 Dipentaerythritol
90. 16570 004128-73-8 Diphenylether-4,4'-diisocyanate As item 70
91. 16600 005873-54-1 Diphenylmethane-2,4'- diisocyanate As item 70
92. 16630 000101-68-8 Diphenylmethane-4,4'- diisocyanate As item 70
93. 16660 000110-98-5 Dipropyleneglycol
94. 16750 000106-89-8 Epichlorohydrin The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg
95. 16780 000064-17-5 Ethanol
96. 16950 000074-85-1 Ethylene
97. 16960 000107-15-3 Ethylenediamine The specific migration of this substance shall not exceed 12 mg/kg
98. 16990 000107-21-1 Ethylene glycol The specific migration of this substance alone or together with item 79 shall not exceed a total of 30 mg/kg
99. 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)
100. 17020 000075-21-8 Ethylene oxide The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg
101. 17050 00104-76-7 2-Ethylhexan-1-ol The specific migration of this substance shall not exceed 30 mg/kg
102. 17160 000097-53-0 Eugenol The specific migration of this substance shall not exceed 0.01 mg/kg
103. 17170 061788-47-4 Fatty acids, coco
104. 17200 068308-53-2 Fatty acids, soya
105. 17230 061790-12-3 Fatty acids, tall oil
106. 17260 000050-00-0 Formaldehyde The specific migration of this substance shall not exceed 15 mg/kg
107. 17290 000110-17-8 Fumaric acid
108. 17530 000050-99-7 Glucose
109. 18010 000110-94-1 Glutaric acid
110. 18070 000108-55-4 Glutaric anhydride
111. 18100 000056-81-5 Glycerol
112. 18250 000115-28-6 Hexachlorendomethylene- tetrahydrophthalic 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)
113. 18280 000115-27-5 Hexachlorendomethylene- tetrahydrophthalic anhydride 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)
114. 18310 036653-82-4 Hexadecan-1-ol
115. 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)
116. 18460 000124-09-4 Hexamethylenediamine The specific migration of this substance shall not exceed 2·4 mg/kg
117. 18640 000822-06-0 Hexamethylene diisocyanate As item 70
118. 18670 000100-97-0 Hexamethylenetetramine The specific migration of this substance shall not exceed 15 mg/kg (expressed as formaldehyde)
119. As item 84 000123-31-9 Hydroquinone As item 84
120. 18880 000099-96-7 p-Hydroxybenzoic acid
121. 19000 000115-11-7 Isobutene
122. 19210 001459-93-4 Isophthalic acid, dimethyl ester The specific migration of this substance shall not exceed 0·05 mg/kg
123. 19270 000097-65-4 Itaconic acid
124. 19460 000050-21-5 Latic acid
125. 19470 000143-07-7 Lauric acid
126. 19480 002146-71-6 Lauric acid, vinyl ester
127. 19510 011132-73-3 Lignocellulose
128. 19540 000110-16-7 Maleic acid The specific migration of this substance alone or together with item 129 shall not exceed a total of 30 mg/kg
129. 19960 000108-31-6 Maleic anhydride The specific migration of this subtance alone or together with item 128 shall not exceed a total of 30 mg/kg (expressed as maleic acid)
130. As item 215 000108-78-1 Melamine As item 215
131. 20020 000079-41-4 Methacrylic acid
132. 20080 002495-37-6 Methacrylic acid, benzyl ester
133. 20110 000097-88-1 Methacrylic acid, butyl ester
134. 20140 002998-18-7 Methacrylic acid, sec-butyl ester
135. 20170 000585-07-9 Methacrylic acid, tert-butyl ester
136. 20890 000097-63-2 Methacrylic acid, ehtyl ester
137. 21010 000097-86-9 Methacrylic acid, isobutyl ester
138. 21100 004655-34-9 Methacrylic acid, isopropyl ester
139. 21130 000080-62-6 Methacrylic acid, methyl ester
140. 21190 000868-77-9 Methacrylic acid, monoester with ethyleneglycol
141. 21280 002177-70-0 Methacrylic acid, phenyl ester
142. 21340 002210-28-8 Methacrylic acid, propyl ester
143. 21460 000760-93-0 Methacrylic anhydride
144. 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)
145. 21550 000067-56-1 Methanol
146. 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)
147. 22150 000691-37-2 4-Methypent-1-ene The specific migration of this substance shall not exceed 0·02 mg/kg
148. 22350 000544-63-8 Myristic acid
149. 22390 000840-65-3 2,6-Naphthalenedicarboxylic acid, dimethyl ester The specific migration of this substance shall not exceed 0·05 mg/kg
150. 22420 003173-72-6 1,5-Naphthalene diisocyanate As item 70
151. 22450 009004-70-0 Nitrocellulose
152. 22480 000143-08-8 Nonan-1-ol
153. 22570 000112-96-9 Octadecyl isocyanate As item 70
154. 22600 000111-87-5 Octan-1-ol
155. 22660 000111-66-0 Oct-1-ene The specific migration of this substance shall not exceed 15 mg/kg
156. 22763 000112-80-1 Oleic acid
157. 22780 000057-10-3 Palmitic acid
158. 22840 000115-77-5 Pentaerythritol
159. 22870 000071-41-0 Pentan-1-ol
160. 22960 000108-95-2 Phenol
161. 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
162. As item 60 000075-44-5 Phosgene As item 60
163. 23170 007664-38-2 Phosphoric acid
164. As item 204 — Phthalic acid As item 204
165. 23200 000088-99-3 o-Phthalic acid
166. 23230 000131-17-9 Phthalic acid, diallyl ester 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)
167. 23380 000085-44-9 Phthalic anhydride
168. 23470 000080-56-8 alpha-Pinene
169. 23500 000127-91-3 beta-Pinene
170. 23590 025322-68-3 Polyethylene glycol
171. 23650 025322-69-4 Polypropylene glycol (molecular weight greater than 400)
172. 23651 025322-69-4 Polypropyleneglycol
173. 23740 000057-55-6 Propan-1,2-diol
174. 23800 000071-23-8 Propan-1-ol
175. 23830 000067-63-0 Propan-2-ol
176. 23860 000123-38-6 Propionaldehyde
177. 23890 000079-09-4 Propionic acid
178. 23950 000123-62-6 Propionic anhydride
179. 23980 000115-07-1 Propylene
180. 24010 000075-56-9 Propylene oxide The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg
181. As item 82 000120-80-9 Pyrocatechol As item 82
182. 24057 000089-32-7 Pyromellitic anhydride The specific migration of this substance shall not exceed 0·05 mg/kg (expressed as pyromellitic acid)
183. 24070 073138-82-6 Resin acids and rosin acids
184. As item 83 000108-46-3 Resorcinol As item 83
185. 24100 008050-09-7 Rosin
186. 24130 008050-09-7 Rosin gum
187. 24160 008052-10-6 Rosin tall oil
188. 24190 009014-63-5 Rosin wood
189. 24250 009006-04-6 Rubber, natural
190. 24270 000069-72-7 Salicylic acid
191. 24280 000111-20-6 Sebacic acid
192. 24430 002561-88-8 Sebacic anhydride
193. 24475 001313-82-2 Sodium sulphide
194. 24490 000050-70-4 Sorbitol
195. 24520 008001-22-7 Soybean oil
196. 24540 009005-25-8 Starch, edible The specific migration of this substance shall not exceed 0·05 mg/kg
197. 24550 000057-11-4 Stearic acid
198. 24610 000100-42-5 Styrene
199. 24820 000110-15-6 Succinic acid
200. 24850 000108-30-5 Succinic anhydride
201. 24880 000057-50-1 Sucrose
202. 24887 006362-79-4 5-Sulphoisophthalic acid, monosodium salt The specific migration of this substance shall not exceed 5 mg/kg
203. 24888 003965-55-7 5-Sulphoisophthalic acid, monosodium salt, dimethyl ester The specific migration of this substance shall not exceed 0·05 mg/kg
204. 24910 000100-21-0 Terephthalic acid The specific migration of this substance alone or together with item 205 shall not exceed a total of 7·5 mg/kg
205. 24940 000100-20-9 Terephthalic acid dichloride The specific migration of this substance alone or together with item 204 shall not exceed 7·5 mg/kg (expressed as terephthalic acid)
206. 24970 000120-61-6 Terephthalic acid, dimethyl ester
207. 25090 000112-60-7 Tetraethylene glycol
208. 25120 000116-14-3 Tetrafluoroethylene The specific migration of this substance shall not exceed 0·05 mg/kg
209. 25150 000109-99-9 Tetrahydrofuran The specific migration of this substance shall not exceed 0·6 mg/kg
210. 25180 000102-60-3 N, N, N', N'-Tetrakis (2-hydroxypropyl)- ethylenediamine
211. 25210 000584-84-9 2,4-Toluene diisocyanate As item 70
212. 25240 000091-08-7 2,6-Toluene diisocyanate As item 70
213. 25270 026747-90-0 2,4-Toluene diisocyanatedimer As item 70
214. 25360 — Trialkyl (C5-C15) acetic acid 2,3-epoxypropyl ester The specific migration of this substance shall not exceed 6 mg/kg
215. 25420 000108-78-1 2,4,6-Triamino-1,3,5,-triazine The specific migration of this substance shall not exceed 30 mg/kg
216. 25510 000112-27-6 Triethylene glycol
217. 25600 000077-99-6 1,1,1-Trimethylolpropane The specific migration of this substance shall not exceed 6 mg/kg
218. 25910 024800-44-0 Tripropylene glycol
219. 25960 000057-13-6 Urea
220. 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
221. 26110 000075-35-4 Vinylidene chloride The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg or the specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0·05 mg/kg)
222. 26140 000075-38-7 Vinylidene fluoride The specific migration of this substance shall not exceed 5 mg/kg
SECTION B
Monomers authorised up to the end of 2001

 1 2 3 4
Item PM/REF No. CAS No. Name Restrictions
1. 10599/90A 061788-89-4 Acids, fatty, unsaturated (C18), dimers, distilled
2. 10599/91 061788-89-4 Acids, fatty, unsaturated (C18), dimers, non-distilled
3. 10599/92A 068783-41-5 Acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled
4. 10599/93 068783-41-5 Acids, fatty, unsaturated (C18), dimers, hydrogenated, non-distilled
5. 11000 050976-02-8 Acrylic acid, dicyclopentadientyl ester
6. 11245 002156-97-0 Acrylic acid, dodecyl ester
7. 11500 000103-11-7 Acrylic acid, 2-ethylhexyl ester
8. 11530 000999-61-1 Acrylic acid, 2-hydroxypropyl ester
9. 12265 004074-90-2 Adipic acid, divinyl ester
10. 12910 001732-10-1 Azelaic acid, dimethyl ester
11. As item 78 000528-44-9 1,2,4-Benzenetricarboxylic acid As item 78
12. 13060 004422-95-1 1,3,5-Benzenetricarboxylic acid trichloride
13. As item 23 000091-76-9 Benzoguanamine
14. As item 28 000080-09-1 Bisphenol S
15. 13720 000110-63-4 Butan-1,4 diol
16. 13780 002425-79-8 Butan-1,4 diol, bis(2,3-epoxypropyl) ether The quantity in the finished plastic material or article of any substance within, or any combination of substances within, items 16 and 56 shall not exceed 5 mg/kg (expressed as epoxy)
17. 13810 000505-65-7 Butan-1,4 diol, formal
18. 13932 000598-32-3 But-3-en-2-ol
19. 14020 000098-54-4 4-tert-Butylphenol
20. 14260 000502-44-3 Caprolactone
21. 14800 003724-65-0 Crotonic acid
22. 15130 000872-05-9 Dec-1-ene
23. 15310 000091-76-9 2,4-Diamino-5-phenyl-1,3,5-triazine
24. 15370 003236-53-1 1,6-Diamino-2,2,4- trimethylhexane
25. 15400 003236-54-2 1,6-Diamino-2,4,4- trimethylhexane
26. 15610 000080-07-9 4,4'Dichlorodiphenyl sulphone
27. 15730 000077-73-6 Dicyclopentadiene
28. 16090 000080-09-1 4,4'-Dihydroxydiphenyl sulphone
29. 16210 006864-37-5 3,3'-Dimethyl-4,4'-diamino- dicyclohexylmethane
30. 16360 000576-26-1 2,6-Dimethylphenol
31. 16390 000126-30-7 2,2-Dimethylpropan-1,3-diol
32. 16450 000646-06-0 1,3-Dioxolane
33. 16540 000102-09-0 Diphenyl carbonate
34. 16690 001321-74-0 Divinylbenzene
35. 16697 000693-23-2 Dodecanedioic acid
36. 17110 016219-75-3 5-Ethylidenebicyclo [2.2.1]hept-2-ene
37. 18220 068564-88-5 N-Heptylaminoundecanoic acid
38. 18370 000592-45-0 Hexa-1,4-diene
39. 18441 000085-42-7 Hexahydrophthalic anhydride
40. 18700 000629-11-8 Hexan-1,6-diol
41. 18820 000592-41-6 Hex-1-ene
42. 19060 000109-53-5 Isobutyl vinyl ether
43. 19150 000121-91-5 Isophthalic acid
44. 19180 000099-63-8 Isophthalic acid dichloride
45. As item 60 000078-79-5 Isoprene
46. 19490 000947-04-6 Laurolactam
47. 19570 000999-21-3 Maleic acid, diallyl ester
48. 19600 000105-76-0 Maleic acid, dibutyl ester
49. 19990 000079-39-0 Methacrylamide
50. 20050 000096-05-9 Methacrylic acid, allyl ester
51. 20260 000101-43-9 Methacrylic acid, cyclohexyl ester
52. 20380 001189-08-8 Methacrylic acid, diester with butan-1,3-diol
53. 20410 002082-81-7 Methacrylic acid, diester with butan-1,4-diol
54. 20440 000097-90-5 Methacrylic acid, diester with ethyleneglycol
55. 20530 002867-47-2 Methacrylic acid, 2-(dimethylamino) ethyl ester
56. 20590 000106-91-2 Methacrylic acid, 2,3- epoxypropyl ester As item 16
57. 21370 010595-80-9 Methacrylic acid, 2-sulphoethyl ester
58. 21400 054276-35-6 Methacrylic acid, sulphopropyl ester
59. 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
60. 21640 000078-79-5 2-Methylbut-1,3 diene
61. 21730 000563-45-1 3-Methylbut-1-ene
62. As item 17 000505-65-7 1,4-(Methylenedioxy) butane
63. 21970 000923-02-4 N-Methylolmethacrylamide
64. 22210 000098-83-9 alpha-Methylstyrene
65. 22360 001141-38-4 2,6-Naphthalenedicarboxylic acid
66. As item 31 000126-30-7 Neopentylglycol
67. 22428 051000-52-3 Neodecanoic acid, vinyl ester
68. 22720 000140-66-9 4-tert-Octylphenol
69. 22900 000109-67-1 Pent-l-ene
70. 22937 001623-05-8 Perfluoropropyl perfluorovinyl ether
71. 23770 000504-63-2 Propan-1,3-diol
72. 23920 000105-38-4 Propionic acid, vinyl ester
73. 24370 000106-79-6 Sebacic acid, dimethyl ester
74. 24760 026914-43-2 Styrenesulphonic acid
75. 25380 — Trialkyl (C5-C15) acetic acid, vinyl ester (= vinyl versatate)
76. 25390 000101-37-1 Triallyl cyanurate
77. 25450 026896-48-0 Tricyclodecanedimethanol
78. 25540 000528-44-9 Trimellitic acid The quantity of this substance alone or together with item 79 in the finished plastic material or article shall not exceed 5 mg/kg
79. 25550 000552-30-7 Trimellitic anhydride The quantity of this substance alone or together with item 78 in the finished plastic material or article shall not exceed 5 mg/kg (expressed as trimellitic acid)
80. 25810 015625-89-5 1,1,1-Trimethylolpropane triacrylate
81. 25840 003290-92-4 1,1,1-Trimethylolpropane trimethacrylate
82. 25900 000110-88-3 Trioxane
83. 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
SECTION C
Monomers authorised up to the end of 1998

 1 2 3 4
Item PM/REF No. CAS No. Name Restrictions
1. 10160 002206-94-2 alpha-Acetoxysytrene
2. 10162 010521-96-7 beta-Acetoxystyrene
3. 10480 — Acids, aliphatic, monocarboxylic saturated (C2-C24)
4. 10510 — Acids, aliphatic, monocarboxylic unsaturated (C3-C24)
5. 10599/70 — Acids, fatty, unsaturated (C18)
6. 10930 003066-71-5 Acrylic acid, cyclohexyl ester
7. 11050 001070-70-8 Acrylic acid, diester with butan- 1,4-diol
8. 11180 017831-71-9 Acrylic acid, diester with tetraethyleneglycol
9. 11195 068901-05-3 Acrylic acid, diester with tripropyleneglycol
10. 11520 002918-23-2 Acrylic acid, 2-hydroxyisopropyl ester (= acrylic acid, 2-hydroxy- 1-methylethyl ester)
11. 11560 005888-33-5 Acrylic acid, isobornyl ester
12. 11620 001330-61-6 Acrylic acid, isodecyl ester
13. 11650 029590-42-9 Acrylic acid, isooctyl ester
14. 11695 003121-61-7 Acrylic acid, 2-methoxyethyl ester
15. 11740 010095-13-3 Acrylic acid, monoester with butan-1,3-diol
16. 11770 002478-10-6 Acrylic acid, monoester with butan-1,4-diol
17. 11800 013533-05-6 Acrylic acid, monoester with diethyleneglycol
18. 12010 040074-09-7 Acrylic acid, 2-sulphoethyl ester
19. 12040 039121-78-3 Acrylic acid, sulphopropyl ester
20. 12055 094160-26-6 Acrylic acid, triester with glycerol tris(2-hydroxypropyl) ether
21. 12062 075577-70-7 Acrylic acid, triester with 1,1,1- trimethylolpropane tris(2-hydroxy- ethyl) ether
22. 12160 002998-04-1 Adipic acid, diallyl ester
23. 12190 000105-97-5 Adipic acid, didecyl ester
24. 12220 027178-16-1 Adipic acid, diisodecyl ester
25. 12250 000123-79-5 Adipic acid, dioctyl ester
26. 12370 — Alcohols, aliphatic, monohydric, saturated, linear, secondary or tertiary (C4-C22)
27. 12610 000107-18-6 Allyl alcohol
28. 12700 000150-13-0 p-Aminobenzoic acid
29. 12790 000080-46-6 p-tert-Amylphenol
30. 12850 029602-44-6 Azelaic acid, bis(2-hydroxyethyl) ester
31. 13328 000104-38-1 Bis(2-hydroxyethyl) ether of hydroquinone
32. 13660 000584-03-2 Butan-1,2-diol
33. 13750 000513-85-9 Butan-2,3-diol
34. 13960 001852-16-0 N-(Butoxymethyl) acrylamide
35. 15020 002182-05-0 Cyclohexyl vinyl ether
36. 15280 000542-02-9 2,4-Diamino-6-methyl-1,3,5- triazine
37. 15340 000109-76-2 1,3-Diaminopropane
38. 15490 002215-89-6 4,4'-Dicarboxydiphenyl ether
39. 15580 001653-19-6 2,3-Dichlorobuta-1,3-diene
40. 16270 000526-75-0 2,3-Dimethyphenol
41. 16300 000105-67-9 2,4-Dimethyphenol
42. 16330 000095-87-4 2,5-Dimethyphenol
43. 17040 000149-57-5 2-Ethylhexanoic acid
44. 17350 000105-75-9 Fumaric acid, dibutyl ester
45. 18400 000592-42-7 Hexa-1,5-diene
46. 18905 002628-17-3 4-Hydroxystyrene
47. 18970 000078-83-1 Isobutanol
48. 19030 016669-59-3 N-(Isobutoxymethyl) acrylamide
49. 19090 000078-84-2 Isobutyraldehyde
50. 19120 025339-17-7 Isodecanol
51. 19130 026896-18-4 Isononanoic acid
52. 19936 007423-42-9 Maleic acid, mono(2-ethylhexyl) ester
53. 20470 025852-47-5 Methacrylic acid, diester with polyethyleneglycol
54. 20740 039670-09-2 Methacrylic acid, ester with ethoxytriethyleneglycol
55. 20950 000923-26-2 Methacrylic acid, 2-hydroxypropyl ester
56. 21115 000816-74-0 Methacrylic acid, methallyl ester
57. 21220 032360-05-7 Methacrylic acid, octadecyl ester
58. 21760 000694-91-7 5-Methylenebicyclo [2.2.1] hept- 2-ene
59. 21837 001116-90-1 4-Methylhexa-1,4-diene The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0·05 mg/kg)
60. 22240 000622-97-9 p-Methylstyrene
61. 22270 000107-25-5 Methyl vinyl ether
62. 22540 000104-40-5 4-Nonylphenol
63. 22585 003710-30-3 Octa-1,7-diene
64. 22932 001187-93-5 Perfluoromethyl perfluorovinyl ether
65. 23530 025190-06-1 Poly(1,4-butyleneglycol) (molecular weight greater than 1000)
66. 23650 025322-69-4 Polypropyleneglycol (molecular weight greater than 400)
67. 24560 000111-63-7 Stearic acid, vinyl ester
68. 25030 016646-44-9 Tetra(allyloxy)ethane
69. 25161 000085-43-8 1,2,3,6-Tetrahydrophthalic anhydride
70. 25300 000088-19-7 o-Toluenesulphonamide
71. 25480 000102-71-6 Triethanolamine
72. 26290 025013-15-4 Vinyltoluene
73. 26320 002768-02-7 Vinyltrimethoxysilane The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg
Part II Supplementary
1 
In regulation 4 and Part I—
(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,
(c) the name of any substance is its chemical name, and to the extent that there is any inconsistency between CAS No. and the name, the name shall take precedence over the CAS No., and
(d) references to specific migration are to be taken to mean specific migration as measured in accordance with Schedules 3 and 4.
2 
If a substance appearing in Part I 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 shall be taken to include—
(a) substances undergoing polymerisation (which shall be taken to include polycondensation, polyaddition or any other similar process) to manufacture macromolecules,
(b) natural or synthetic macromolecular substances used in the manufacture of modified macromolecules, if the monomers required to synthesise them are not so identified, and
(c) substances used to modify existing natural or synthetic macromolecular substances.
(2) If a substance identified in Part I 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.
(3) If, as indicated in paragraph 2 of Annex II to the Directive, a substance is identified in Part I 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.
SCHEDULE 2
Regulation 5
Part I Additives

 1 2 3
Item PM/REF No. CAS No. Name
1. 30000 000064-19-7 Acetic acid
2. 30045 000123-86-4 Acetic acid, butyl ester
3. 30140 000141-78-6 Acetic acid, ethyl ester
4. 30280 000108-24-7 Acetic anhydride
5. 30295 000067-64-1 Acetone
6. 30370 — Acetylacetic acid, salts
7. 30400 — Acetylated glycerides
8. 30960 — Acids, aliphatic, monocarboxylic (C6-C22), esters with polyglycerol
9. 31328 — Acids, fatty, from animal or vegetable food fats and oils
10. 31730 000124-04-9 Adipic acid
11. 33120 — Alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C24)
12. 33350 009005-32-7 Alginic acid
13. 34281 — Alkyl (C8-C22) sulphuric acids, linear, primary, with an even number of carbon atoms
14. 34475 — Aluminium calcium hydroxide phosphite, hydrate
15. 34480 — Aluminium fibres, flakes and powders
16. 34560 021645-51-2 Aluminium hydroxide
17. 34690 011097-59-9 Aluminium magnesium carbonate hydroxide
18. 34720 001344-28-1 Aluminium oxide
19. (2-hydroxyethyl) ether 35120 013560-49-1 3-Aminocrotonic acid, diester with thiobis
20. 35320 007664-41-7 Ammonia
21. 35440 012124-97-9 Ammonium bromide
22. 35600 001336-21-6 Ammonium hydroxide
23. 35840 000506-30-9 Arachidic acid
24. 35845 007771-44-0 Arachidonic acid
25. 36000 000050-81-7 Ascorbic acid
26. 36080 000137-66-6 Ascorbyl palmitate
27. 36160 010605-09-1 Ascorbyl stearate
28. 36880 008012-89-3 Beeswax
29. 36960 003061-75-4 Behenamide
30. 37040 000112-85-6 Behenic acid
31. 37280 001302-78-9 Bentonite
32. 37600 000065-85-0 Benzoic acid
33. 37680 000136-60-7 Benzoic acid, butyl ester
34. 37840 000093-89-0 Benzoic acid, ethyl ester
35. 38080 000093-58-3 Benzoic acid, methyl ester
36. 38160 002315-68-6 Benzoic acid, propyl ester
37. 38950 079072-96-1 Bis(4-ethylbenzylidene) sorbitol
38. 39890 087826-41-3 Bis(methylbenzylidene) sorbitol
  069158-41-4 Bis(methylbenzylidene) sorbitol
  054686-97-4 Bis(methylbenzylidene) sorbitol
39. 40400 010043-11-5 Boron nitride
40. 40570 000106-97-8 Butane
41. 41040 005743-36-2 Calcium butyrate
42. 41280 001305-62-0 Calcium hydroxide
43. 41520 001305-78-8 Calcium oxide
44. 41600 012004-14-7 Calcium sulphoaluminate
  037293-22-4 Calcium sulphoaluminate
45. 41760 008006-44-8 Candelilla wax
46. 41960 000124-07-2 Caprylic acid
47. 42160 000124-38-9 Carbon dioxide
48. 42500 — Carbonic acid, salts
49. 42640 009000-11-7 Carboxymethylcellulose
50. 42720 008015-86-9 Carnauba wax
51. 42800 009000-71-9 Casien
52. 42960 064147-40-6 Castor oil, dehydrated
53. 43200 — Castor oil, mono- and diglycerides
54. 43280 009004-34-6 Cellulose
55. 43300 009004-36-8 Cellulose acetate butyrate
56. 43360 068442-85-3 Cellulose, regenerated
57. 43440 008001-75-0 Ceresin
58. 44160 000077-92-9 Citric acid
59. 44640 000077-93-0 Citric acid, triethyl ester
60. 45280 — Cotton fibres
61. 45560 014464-46-1 Cristobalite
62. 45760 000108-91-8 Cyclohexylamine
63. 45920 009000-16-2 Dammar
64. 45940 000334-48-5 n-Decanoic acid
65. 46070 010016-20-3 alpha-Dextrin
66. 46080 007585-39-9 beta-Dextrin
67. 46375 061790-53-2 Diatomaceous earth
68. 46380 068855-54-9 Diatomaceous earth, soda ash flux-calcined
69. 46480 032647-67-9 Dibenzylidene sorbitol
70. 46790 004221-80-1 3,5-Di-tert-butyl-4-hydroxybenzoic acid, 2,4-di-tert-butylphenyl ester
71. 46800 067845-93-6 3,5-Di-tert-butyl-4-hydroxybenzoic acid, hexadecyl ester
72. 46870 003135-18-0 3,5-Di-tert-butyl-4-hydroxybenzylphosphonic acid, dioctadecyl ester
73. 47440 000461-58-5 Dicyanodiamide
74. 49540 000067-68-5 Dimethyl sulphoxide
75. 51200 000126-58-9 Dipentaerythritol
76. 51760 025265-71-8 Dipropyleneglycol
  000110-98-5 Dipropyleneglycol
77. 52640 016389-88-1 Dolomite
78. 52720 000112-84-5 Erucamide
79. 52730 000112-86-7 Erucic acid
80. 52800 000064-17-5 Ethanol
81. 53270 037205-99-5 Ethylcarboxymethylcellulose
82. 53280 009004-57-3 Ethylcellulose
83. 53360 000110-31-6 N,N'-Ethylenebisoleamide
84. 53440 005518-18-3 N,N'-Ethylenebispalmitamide
85. 53520 000110-30-5 N,N'-Ethylenebisstearamide
86. 53600 000060-00-4 Ethylenediaminetetracetic acid
87. 54005 005136-44-7 Ethylene-N-palmitamide-N'-stearamide
88. 54260 009004-58-4 Ethylhydroxyethylcellulose
89. 54270 — Ethylhydroxymethylcellulose
90. 54280 — Ethylhydroxypropylcellulose
91. 54450 — Fats and oils, from animal or vegetable food sources
92. 54480 — Fats and oils, hydrogenated, from animal or vegetable food sources
93. 55040 000064-18-6 Formic acid
94. 55120 000110-17-8 Fumaric acid
95. 55190 029204-02-2 Gadoleic acid
96. 55440 009000-70-8 Gelatine
97. 55520 — Glass fibres
98. 55600 — Glass microballs
99. 55680 000110-94-1 Glutaric acid
100. 55920 000056-81-5 Glycerol
101. 56020 099880-64-5 Glycerol dibehenate
102. 56360 — Glycerol, esters with acetic acid
103. 56486 — Glycerol, esters with acids, aliphatic, saturated, linear, with an even number of carbon atoms (C14-C18) and with acids, aliphatic, unsaturated linear, with an even number of carbon atoms (C16-C18)
104. 56487 — Glycerol, esters with butyric acid
105. 56490 — Glycerol, esters with erucic acid
106. 56495 — Glycerol, esters with 12-hydroxystearic acid
107. 56500 — Glycerol, esters with lauric acid
108. 56510 — Glycerol, esters with linoleic acid
109. 56520 — Glycerol, esters with myristic acid
110. 56540 — Glycerol, esters with oleic acid
111. 56550 — Glycerol, esters with palmitic acid
112. 56565 — Glycerol, esters with nonanoic acid
113. 56570 — Glycerol, esters with propionic acid
114. 56580 — Glycerol, esters with ricinoleic acid
115. 56585 — Glycerol, esters with stearic acid
116. 56610 030233-64-8 Glycerol monobehenate
117. 56720 026402-23-3 Glycerol monohexanoate
118. 56800 030899-62-8 Glycerol monolaurate diacetate
119. 56880 026402-26-6 Glycerol monooctanoate
120. 57040 — Glycerol monooleate, ester with ascorbic acid
121. 57120 — Glycerol monooleate, ester with citric acid
122. 57200 — Glycerol monopalmitate ester with ascorbic acid
123. 57280 — Glycerol monopalmitate, ester with citric acid
124. 57600 — Glycerol monostearate, ester with ascorbic acid
125. 57680 — Glycerol monostearate, ester with citric acid
126. 57920 000620-67-7 Glycerol triheptanoate
127. 58300 — Glycine, salts
128. 58320 007782-42-5 Graphite
129. 58400 009000-30-0 Guar gum
130. 58480 009000-01-5 Gum arabic
131. 58720 000111-14-8 Heptanoic acid
132. 59360 000142-62-1 Hexanoic acid
133. 59760 019569-21-2 Huntite
134. 59990 007647-01-0 Hydrochloric acid
135. 60030 012072-90-1 Hydromagnesite
136. 60080 012304-65-3 Hydrotalcite
137. 60160 000120-47-8 4-Hydroxybenzoic acid, ethyl ester
138. 60180 004191-73-5 4-Hydroxybenzoic acid, isopropyl ester
139. 60200 000099-76-3 4-Hydroxybenzoic acid, methyl ester
140. 60240 000094-13-3 4-Hydroxybenzoic acid, propyl ester
141. 60560 009004-62-0 Hydroxyethylcellulose
142. 60880 009032-42-2 Hydroxyethylmethylcellulose
143. 61120 009005-27-0 Hydroxyethyl starch
144. 61390 037353-59-6 Hydroxymethylcellulose
145. 61680 009004-64-2 Hydroxyropylcellulose
146. 61800 009049-76-7 Hydroxyropyl starch
147. 61840 000106-14-9 12-Hydroxystearic acid
148. 62140 006303-21-5 Hypophosphorous acid
149. 62240 001332-37-2 Iron oxide
150. 62450 000078-78-4 Isopentane
151. 62640 008001-39-6 Japan wax
152. 62720 001332-58-7 Kaolin
153. 62800 — Kaolin, calcined
154. 62960 000050-21-5 Lactic acid
155. 63040 000138-22-7 Latic acid, butyl ester
156. 63280 000143-07-7 Lauric acid
157. 63760 008002-43-5 Lecithin
158. 63840 000123-76-2 Levulinic acid
159. 63920 000557-59-5 Lignoceric acid
160. 64015 000060-33-3 Linoleic acid
161. 64150 028290-79-1 Linolenic acid
162. 64500 — Lysine, salts
163. 64640 001309-42-8 Magnesium hydroxide
164. 64720 001309-48-4 Magnesium oxide
165. 65020 006915-15-7 Malic acid
166. 65040 000141-82-2 Malonic acid
167. 65520 000087-78-5 Mannitol
168. 66200 037206-01-2 Methylcarboxymethylcellulose
169. 66240 009004-67-5 Methylcellulose
170. 66640 009004-59-5 Methylethylcellulose
171. 66695 — Methylhydroxymethylcellulose
172. 66700 009004-65-3 Methylhydroxypropylcellulose
173. 67120 012001-26-2 Mica
174. 67200 001317-33-5 Molybdenum disulphide
175. 67840 — Montanic acids and/or their esters with ethyleneglycol and/or with 1,3-butanediol and/or with glycerol
176. 67850 008002-53-7 Montan wax
177. 67891 000544-63-8 Myristic acid
178. 68040 003333-62-8 7-[2H-Naphtho-(1,2-D)triazol-2-yl]-3- phenylcoumarin
179. 68125 068187-64-4 Nepheline syenite
180. 68960 000301-02-0 Oleamide
181. 69040 000112-80-1 Oleic acid
182. 69760 000143-28-2 Oleyl alcohol
183. 70000 070331-94-1 2,2'-Oxamidobis[ethyl-3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate]
184. 70240 012198-93-5 Ozokerite
185. 70400 000057-10-3 Palmitic acid
186. 71020 000373-49-9 Palmitoleic acid
187. 71440 009000-69-5 Pectin
188. 71600 000115-77-5 Pentaerythritol
189. 71680 006683-19-8 Pentaerythritol tetrakis [3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate]
190. 71720 000109-66-0 Pentane
191. 72640 007664-38-2 Phosphoric acid
192. 74240 031570-04-4 Phosphorous acid, tris(2,4-di-tert-butylphenyl) ester
193. 74480 000088-99-3 o-Phthalic acid
194. 76320 000085-44-9 Phthalic anhydride
195. 76720 009016-00-6 Polydimethylsiloxane
  063148-62-9 Polydimethylsiloxane
196. 76960 025322-68-3 Polyethyleneglycol
197. 77600 061788-85-0 Polyethyleneglycol ester of hydrogenated castor oil
198. 77702 — Polyethyleneglycol esters of aliphatic monocarboxylic acids (C6-C22), and their ammonium and sodium sulphates
199. 79040 009005-64-5 Polyethyleneglycol sorbitan monolaurate
200. 79120 009005-65-6 Polyethyleneglycol sorbitan monooleate
201. 79200 009005-66-7 Polyethyleneglycol sorbitan monopalmitate
202. 79280 009005-67-8 Polyethyleneglycol sorbitan monostearate
203. 79360 009005-70-3 Polyethyleneglycol sorbitan trioleate
204. 79440 009005-71-4 Polyethyleneglycol sorbitan tristearate
205. 80240 029894-35-7 Polyglycerol ricinoleate
206. 80640 — Polyoxyalkyl (C2-C4) dimethylpolysiloxane
207. 80720 008017-16-1 Polyphosphoric acids
208. 80800 025322-69-4 Polypropyleneglycol
209. 81520 007758-02-3 Potassium bromide
210. 81600 001310-58-3 Potassium hydroxide
211. 81840 000057-55-6 1,2-Propanediol
212. 81882 000067-63-0 2-Propanol
213. 82000 000079-09-4 Propionic acid
214. 82080 009005-37-2 1,2-Propyleneglycol alginate
215. 82240 022788-19-8 1,2-Propyleneglycol dilaurate
216. 82400 000105-62-4 1,2-Propyleneglycol dioleate
217. 82560 033587-20-1 1,2-Propyleneglycol dipalmitate
218. 82720 006182-11-2 1,2-Propyleneglycol distearate
219. 82800 027194-74-7 1,2-Propyleneglycol monolaurate
220. 82960 001330-80-9 1,2-Propyleneglycol monooleate
221. 83120 029013-28-3 1,2-Propyleneglycol monopalmitate
222. 83300 001323-39-3 1,2-Propyleneglycol monostearate
223. 83320 — Propylhydroxyethylcellulose
224. 83325 — Propylhydroxymethylcellulose
225. 83330 — Propylhydroxypropylcellulose
226. 83440 002466-09-3 Pyrophosphoric acid
227. 83455 013445-56-2 Pyrophosphorous acid
228. 83460 012269-78-2 Pyrophyllite
229. 83470 014808-60-7 Quartz
230. 83610 073138-82-6 Resin acids and rosin acids
231. 83840 008050-09-7 Rosin
232. 84000 008050-31-5 Rosin, ester with glycerol
233. 84080 008050-26-8 Rosin, ester with pentaerythritol
234. 84210 065997-06-0 Rosin, hydrogenated
235. 84240 065997-13-9 Rosin, hydrogenated, ester with glycerol
236. 84320 008050-15-5 Rosin, hydrogenated, ester with methanol
237. 84400 064365-17-9 Rosin, hydrogenated, ester with pentaerythritol
238. 84560 009006-04-6 Rubber, natural
239. 84640 000069-72-7 Salicylic acid
240. 85600 — Silicates, natural
241. 85980 — Silicic acid, salts
242. 86000 — Silicic acid, silylated
243. 86160 000409-21-2 Silicon carbide
244. 86240 007631-86-9 Silicon dioxide
245. 86560 007647-15-6 Sodium bromide
246. 86720 001310-73-2 Sodium hydroxide
247. 87200 000110-44-1 Sorbic acid
248. 87280 029116-98-1 Sorbitan dioleate
249. 87520 062568-11-0 Sorbitan monobehenate
250. 87600 001338-39-2 Sorbitan monolaurate
251. 87680 001338-43-8 Sorbitan monooleate
252. 87760 026266-57-9 Sorbitan monopalmitate
253. 87840 001338-41-6 Sorbitan monostearate
254. 87920 061752-68-9 Sorbitan tetrastearate
255. 88080 026266-58-0 Sorbitan trioleate
256. 88160 054140-20-4 Sorbitan tripalmitate
257. 88240 026658-19-5 Sorbitan tristearate
258. 88320 000050-70-4 Sorbitol
259. 88600 026836-47-5 Sorbitol monostearate
260. 88800 009005-25-8 Starch, edible
261. 88880 068412-29-3 Starch, hydrolysed
262. 88960 000124-26-5 Stearamide
263. 89040 000057-11-4 Stearic acid
264. 90720 058446-52-9 Stearoylbenzoylmethane
265. 90800 005793-94-2 Stearoyl-2-lactylic acid, calcium salt
266. 90960 000110-15-6 Succinic acid
267. 91200 000126-13-6 Sucrose acetate isobutyrate
268. 91360 000126-14-7 Sucrose octaacetate
269. 91840 007704-34-9 Sulphur
270. 91920 007664-93-9 Sulphuric acid
271. 92080 014807-96-6 Talc
272. 92160 000087-69-4 Tartaric acid
273. 92195 — Taurine, salts
274. 92205 057569-40-1 Terephthalic acid, diester with 2,2'-methylenebis (4-methyl-6-tert-butylphenol)
275. 92350 000112-60-7 Tetraethyleneglycol
276. 92640 000102-60-3 N, N, N', N'-Tetrakis(2-hydroxypropyl) ethylenediamine
277. 93440 013463-67-7 Titanium dioxide
278. 93520 000059-02-9 alpha-Tocopherol
  010191-41-0 alpha-Tocopherol
279. 93680 009000-65-1 Tragacanth gum
280. 94320 000112-27-6 Triethyleneglycol
281. 95200 001709-70-2 1,3,5-Trimethyl-2,4,6-tris(3,5-di-tert-butyl-4-hydroxybenzyl) benzene
282. 95905 013983-17-0 Wollastonite
283. 95920 — Wood flour and fibres, untreated
284. 95935 011138-66-2 Xanthan gum
285. 96190 020427-58-1 Zinc hydroxide
286. 96240 001314-13-2 Zinc oxide
287. 96320 001314-98-3 Zinc sulphide
Part II Supplementry
1 
In regulation 5 and Part I—
(a) the PM/REF No. of any additive is its EEC packaging material reference number,
(b) the CAS No. of any additive is its CAS (Chemical Abstracts Service) Registry Number, and
(c) the name of any additive is its chemical name, and to the extent that there is any inconsistency between the CAS No. and the name, the name shall take precedence over the CAS No.
2 
If a substance identified in Part I 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.
3 
If, as indicated in paragraph 2 of Annex III of the Directive, a substance is identified in Part I 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.
SCHEDULE 3
Provisions Applicable when Testing Compliance with the Migration Limits
Regulations 6 and 7
A.
General provisions
1 
When the results of the migration tests specified in this Schedule and, where appropriate, Schedule 4 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 and, where appropriate, Schedule 4 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.1000where:
 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) 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) is impracticable, 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 and, where appropriate, Schedule 4.
(2) At the end of the period referred to in sub-paragraph (1), 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.
(3) Verification that migration into food complies with a migration limit specified in regulation 7 or Schedule 1 shall be carried out under the most extreme conditions of time and temperature foreseeable in actual use in accordance with the provisions of this Schedule.
(4) Verification that migration into food simulants complies with a migration limit specified in regulation 7 or Schedule 1 shall be carried out in accordance with the provisions of this Schedule and using conventional migration tests, the basic rules for which are set out in Schedule 4.
5 
Where a plastic material or article is intended to come into repeated contact with food, any migration test shall (subject to paragraph 7) be carried out three times on a single sample in accordance with the conditions laid down in this Schedule and, where appropriate, Schedule 4 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 sub-paragraph (2), 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 these Regulations where it is alleged that a plastic material or article does not comply with regulation 7 it shall be a defence for the person charged to prove that—
(a) if an aqueous simulant specified in Schedule 4 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, 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), 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 proceedings for an offence under these Regulations where it is alleged, following determination under sub-paragraph (1), that a plastic material or article does not comply with regulation 7 it shall be a defence for the person charged to prove that, if—
(a) three identical shapes of the plastic material or article had been procured;
(b) one of them had been subjected to the appropriate test according with paragraph 4 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 or three times that specified and overall migration had been determined in each case (M1 and M2 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 M2—M3 did not exceed the 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) 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 simulant 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 Schedule 4.
SCHEDULE 4
Overall and Specific Migration Testing Using Food Simulants
Regulations 6 and 7
Part I Basic Rules
1 
Subject to paragraphs 2, 3 and 4, migration tests for the determination of specific and overall migration shall be carried out using the food simulants specified in Parts II, III and, where appropriate, IV and under conventional migration test conditions as specified in Part V.
2 
Subject to paragraphs 3 and 4, substitute tests which use test media under the conventional substitute test conditions as specified in Part VI shall be carried out if the migration test using the fatty food simulants specified in Part III is not feasible for technical reasons connected with the method of analysis.
3 
Subject to paragraph 4, alternative tests as specified in Part VII may be used instead of the migration test with fatty food simulants specified in Part III but the results of such alternative tests may not be used to determine compliance with a migration limit unless the conditions specified in Part VII are fulfilled.
4 
In migration testing it is permissible to—
(a) reduce the number of tests to be carried out to that or those which, in the specific case under examination, is or are generally recognised to be the most severe on the basis of scientific evidence;
(b) omit the migration, the substitute or the alternative tests where there is conclusive proof that the migration limits cannot be exceeded in any foreseeable conditions of use of the material or article.
Part II Food Simulants to be used in Migration Testing
1 
Subject to Parts III, IV, V, VI and VII, the simulants to be used in migration testing are specified in the Table to this paragraph (referred to in this Part as “the Table”).

TABLE
Abbreviation Food Simulant
Simulant A: Distilled water or water of equivalent quality
Simulant B: 3% Acetic acid (w/v) in aqueous solution
Simulant C: 10% Ethanol (v/v) in aqueous solution save that the concentration of ethanol solution shall be adjusted to the actual alcoholic strength of the food if it exceeds 10% (v/v)
Simulant D: Rectified olive oil having the characteristics specified in paragraph 3 or, subject to paragraph 5, any of the fatty food simulants specified in paragraph 4.
2 
For the purposes of this Schedule a reference to an abbreviation in column 1 of the Table shall mean a reference to the simulant in column 1 of that Table opposite that abbreviation.
3 
The characteristics of rectified olive oil referred to in the Table are as hereinafter described—
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
4 
The fatty food simulants referred to in the Table are—
(a) corn oil with standardised specifications;
(b) sunflower oil the characteristics of which are—
Iodine value (Wijs) = 120 to 145
Refractive index at 20°C = 1,474 to 1,476
Saponification number = 188 to 193
Relative density at 20°C = 0·918 to 0·925
Unsaponifiable matter = 0·5% to 1·5%; and
(c) a synthetic mixture of triglycerides the composition of which is 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 monoglycerides (enzymatically) ≤0·2%
Content of diglycerides (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 = 1cm; 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.
5 
Where a fatty food simulant specified in paragraph 4 is used in migration testing and the result of that test shows that a plastic material or article does not comply with any migration limit specified in regulation 7 or Schedule 1 verification that the plastic material or article does not comply with the specified migration limit shall be carried out by testing that material or article using olive oil if such testing is technically feasible and if such testing is not technically feasible the plastic material or article shall be deemed not to comply with the specified migration limit.
Part III Selection of Food Simulants
A.
Testing, reduction factors and definition of food types
1 
The testing of plastic materials and articles shall be carried out under the test conditions specified in Part V using a simulant or simulants selected in accordance with this Part and taking a new test specimen of the plastic material or article for each simulant used.
2 

(1) Where a test is carried out on a plastic material or article intended to come into contact with more than one food or group of foods and a reduction factor is specified for one or more of those foods groups or groups of foods which is not equivalent to the reduction factor specified for one or more of the other foods or groups of foods with which the plastic material or article is intended to come into contact—
(a) the reduction factor specified for each food or group of foods, as appropriate, shall be applied to the test result; and
(b) the plastic material or article shall be treated as being capable of transferring its constituents to food with which it may come into contact in excess of a migration limit specified in regulation 7 or Schedule 1 if, following application of the specified reduction factors, one or more of the results show that the material or article does not comply with that specified migration limit.
(2) For the purposes of this paragraph—
(a) a reduction factor is the figure which follows an “X” and oblique stroke in the group of columns headed “Simulants to be used” in the Table to Part IV;
(b) a reduction factor is specified for a food or group of foods where, in the Table to Part IV—
(i) the food or group of foods is described in the column headed “Description of food”; and
(ii) “X” is placed in a column headed by a specified simulant opposite that food or group of foods followed by an oblique stroke and a reduction factor; and
(c) a reduction shall be applied to a test result by dividing the result by that reduction factor.
3 
Food types are defined in the Table to this paragraph (referred to in this Part as “Table 1”).

TABLE 1
Definition Meaning
Aqueous foods having a pH > 4·5 Foods in relation to which simulant A only is specified in the Table to Part IV
Acidic foods having a pH ≤ 4·5 Foods in relation to which simulant B only is specified in the Table to Part IV
Alcoholic foods Foods in relation to which simulant C only is specified in the Table to Part IV
Fatty foods Foods in relation to which simulant D only is specified in the Table to Part IV
Dry foods Foods in relation to which no simulant is specified in the Table to Part IV
B.
Selection of simulants for testing materials and articles intended for contact with all food types
4 
The simulants to be used in testing a plastic material or article which is intended for contact with all food types shall be those mentioned below which, at the test conditions specified in Part V, are considered to be the more severe:
— simulant B;
— simulant C; and
— simulant D.
C.
Selection of simulants for testing materials and articles which are already in contact with a known food
5 
The simulant or simulants to be used in testing a plastic material article which is already in contact with a known food shall be—
(a) where the known food is a specific food or is within a specific group of foods described in column 2 of the Table to Part IV and, for the purposes of Part IV, a simulant is, or simulants are, specified in relation to that specific food or specific group of foods, the simulant or simulants so specified;
(b) where the known food is neither a specific food nor within a specific group of foods described in the Table to Part IV, the simulant or simulants in column 2 of Table 2 to this Part opposite the description of food in column 1 of that Table which corresponds most closely to the known food.
D.
Selection of simulants for testing materials or articles which are accompanied by a specific indication
6 
The simulant or simulants to be used in testing a plastic material or article which, pursuant to regulation 7 or 8, as appropriate, of the 1987 Regulations, is accompanied by a specific indication stating any type or types of food described in Table 1 with which it may or may not be used shall be the simulant or simulants in column 2 of Table 2 to this Part opposite the contact food in column 1 of that Table which corresponds most closely to the type or type of food with which it may be used, as identified by the indication which accompanies the plastic material or article.
7 
The simulant or simulants to be used in testing a plastic material or article which, pursuant to regulation 7 or 8, as appropriate, of the 1987 Regulations, is accompanied by a specific indication, expressed in accordance with paragraph 8, stating any food or group of food described in the Table to Part IV with which it may or may not be used shall be—
(a) where the indication states that the plastic material or article may be used with a food or group of foods described in column 2 of the Table to Part IV, the food simulant or food simulants which, for the purposes of Part IV, is or are specified in relation to that food or group of foods;
(b) where the indication states that the plastic material or article should not be used with any food or group of foods described in column 2 of the Table to Part IV, a simulant other than the simulant or simulants which, for the purposes of Part IV, is or are specified in relation to that food or group of foods.
8 
A specific indication referred to in paragraph 7 is expressed in accordance with this paragraph if it is expressed—
(a) at a marketing stage other than retail, by using the reference number in column 1 of the Table to Part IV or the description of food in column 2 of that Table which, in either case, corresponds to the food;
(b) at the retail stage, by using an indication which refers to only a few foods or groups of foods described in the Table to Part IV.

TABLE 2
Simulants to be selected for testing food contact materials in special cases
Contact foods Simulant
Only aqueous foods Simulant A
Only acidic foods Simulant B
Only alcoholic foods Simulant C
Only fatty foods Simulant D
All aqueous and acidic foods Simulant B
All alcoholic and aqueous foods Simulant C
All alcoholic and acidic foods Simulant C and B
All fatty and aqueous foods Simulant D and A
All fatty and acidic foods Simulant D and B
All fatty, alcoholic and aqueous foods Simulant D and C
All fatty, alcoholic and acidic foods Simulant D, C and B
Part IV Simulants to be used in Relation to a Specific Food or a Specific Group of Foods
1 
For the purposes of this Part a simulant is specified in relation to a specific food or a specific group of foods where “X” is placed in the column headed by that simulant opposite that specific food or specific group of foods in the Table to this Part, and the Table shall be read in conjunction with the notes thereto and the following paragraphs of this Part.
2 
For the purposes of this Part—
(a) a reduction factor is the figure which follows an “X” and oblique stroke in the group of columns headed “Simulants to be used” in the Table to this Part;
(b) a reduction factor is specified in relation to a specific food or group of foods where, in the Table to this Part—
(i) the food or group of foods is described in the column headed “Description of food”; and
(ii) “X” is placed in a column headed by a specific simulant opposite that food or group of foods followed by an oblique stroke and a reduction factor.
3 
Where, in the Table to this Part, a reduction factor is specified in relation to a specific food or a specific group of foods, that reduction factor shall be applied to the result of any migration test using the simulant specified in relation to that food or group of foods by dividing the result of the test by that reduction factor.
4 
Where, in the Table to this Part, 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.
5 
Where a food is listed in the Table to this Part 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
Reference Number Description of food Simulants to be used
  A B C D
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, liquid chocolate, beers and other. X(a) X(a)
01.02 Alcoholic beverages of an alcohol 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 liquers  X X
01.03 Miscellaneous: undenaturated ethyl alcohol  X X
02 Cereals, cereal 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' ware, 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:
A 
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 X
04.03 Nuts (peanuts, chestnuts, almonds, hazelnuts, walnuts, pine kernels and others):
A 
Shelled, dried
 
B 
Shelled and roasted    X/5
 
C 
In paste or cream form X   X/3
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 purees 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 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
 
B 
In the form of paste X   X/3
06.02 Crustaceans and molluscs (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 
Liquid
 
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
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 Fried 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:
A 
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 X(a) X(a)  X/3
 
II. Other X(a) X(a)
08.04 Yeast 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
08.08 Sandwiches, toasted bread and the like containing any kind of foodstuff:
A 
With fatty substances on the surface    X/5
 
B 
Other
08.09 Ice creams 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 X
08.13 Cocoa:
A 
Cocoa powder    X/5
 
B 
Cocoa paste    X/3
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:
 Cinnamon, cloves, powdered mustard, pepper, vanilla, saffron and others



Part V Migration Test Conditions (Times and Temperatures)
A.
General criteria
1 
Subject to paragraphs 2, 4, 6 and 7 and to paragraph 4.4 of Chapter II of the Annex to Directive 82/711, when carrying out migration tests the time and temperature used shall be time and temperature selected from column 2 of the Table to this Part which correspond to the worst foreseeable conditions of contact specified in column 1 of that Table for the plastic material or article being tested and to any labelling information on maximum temperature for use.
2 
Where the plastic material or article being tested is intended for a food contact application covered by a combination of two or more times and temperatures specified in column 2 of the Table to this Part the migration test shall be carried out by subjecting the test specimen successively to all the applicable worst foreseeable conditions appropriate to the sample, using the same portion of food simulant.
3 
For the purposes of this Part the worst foreseeable conditions of contact are those which are recognised to be the most severe on the basis of scientific evidence.
B.
Volatile migrants
4 
When carrying out a test of the specific migration of volatile substances any test using a simulant shall be performed in a manner which recognises the loss of volatile migrants which may occur in the worst foreseeable conditions of use.
C.
Special Cases
5 
When carrying out a migration test of a plastic material or article which is intended for use in a microwave oven, if the appropriate time and temperature is selected from the Table to this Part, either a conventional oven or a microwave oven may be used.
6 
Where the carrying out of a migration test under contact conditions specified in the Table to this Part causes any physical or other change in the test specimen which does not occur under the worst foreseeable conditions of use of the plastic material or article being tested the migration test shall be carried out in the worst foreseeable conditions of use in which such physical or other change does not occur.
7 
Where, in actual use, the plastic material or article being tested is intended to be used for periods of less than 15 minutes at any temperature of not less than 70°C and not more than 100°C and such use is indicated by appropriate labelling or instructions no test other than for 2 hours at 70°C shall be carried out on the plastic material or article unless the plastic material or article is also intended to be used for storage at room temperature in which case no further test other than for 10 days test at 40°C shall be carried out.
8 
The Table to this Part shall be read with the notes to it.

TABLE
Conditions of contact in worst foreseeable use Test conditions
Contact time Test time
t ≤ 5 minutes 
5 minutes < t ≤ 0·5 hours 0·5 hours
0·5 hours < t ≤ 1 hour 1 hour
1 hour < t ≤ 2 hours 2 hours
2 hours < t ≤ 4 hours 4 hours
4 hours < t ≤ 24 hours 24 hours
t > 24 hours 10 days


Contact temperature Test temperature
T ≤ 5°C 5°C
5°C < T ≤ 20°C 20°C
20°C < T ≤ 40°C 40°C
40°C < T ≤ 70°C 70°C
70°C < T ≤ 100°C 100°C or reflux temperature
100°C < T ≤ 121°C 121°C
121°C < T ≤ 130°C 130°C
130°C < T ≤ 150°C 150°C
T > 150°C 175°C

Part VI Substitute Fat Test for Overall and Specific Migration
1 
Subject to paragraphs 2, 4 and 5, all the test media specified in the Table to this Part shall be used in the substitute fat test for overall or specific migration under the test conditions corresponding to the test conditions for simulant D.
2 
Test conditions other than those specified in the Table to this Part may be used in the substitute fat test if the assumptions underlying the test conditions specified in that Table and, where the plastic material or article being tested is a polymer, the existing experience of that type of polymer are taken into account.
3 
For each test—
(a) a new test specimen shall be used;
(b) the rules prescribed for simulant D in Part III, IV and V shall be applied for each test medium;
(c) subject to paragraph 4, compliance with a migration limit shall be determined by selecting the highest value using all the test methods.
4 
Where carrying out a migration test causes any physical or other change in the test specimen which does not occur under the worst foreseeable conditions of use of the plastic material or article the result of that test shall not be used to ascertain compliance with a migration limit.
5 
Any test conditions in the Table to this Part which are generally recognised on the basis of scientific evidence as not being appropriate for the material or article to be tested shall not be used.
6 
The Table to this Part shall be read with the notes to it.

TABLE
Conventional conditions for substitute tests
Test conditions with simulant D Test conditions with isooctane Test conditions with ethanol 95% Test conditions with MPPO
10 days at 5°C 0·5 days at 5°C 10 days at 5°C —
10 days at 20°C 1 day at 20°C 10 days at 20°C —
10 days at 40°C 2 days at 20°C 10 days at 40°C —
2 hours at 70°C 0·5 hours at 40°C 2 hours at 60°C —
0·5 hours at 100°C 0·5 hours at 60°C 2·5 hours at 60°C 0·5 hours at 100°C
1 hour at 100°C 1 hour at 60°C 3 hours at 60°C 1 hour at 100°C
2 hours at 100°C 1·5 hours at 60°C 3·5 hours at 60°C 2 hours at 100°C
0·5 hours at 121°C 1·5 hours at 60°C 3·5 hours at 60°C 0·5 hours at 121°C
1 hour at 121°C 2 hours at 60°C 4 hours at 60°C 1 hour at 121°C
2 hours at 121°C 2·5 hours at 60°C 4·5 hours at 60°C 2 hours at 121°C
0·5 hours at 130°C 2 hours at 60°C 4 hours at 60°C 0·5 hours at 130°C
1 hour at 130°C 2·5 hours at 60°C 4·5 hours at 60°C 1 hour at 130°C
2 hours at 150°C 3 hours at 60°C 5 hours at 60°C 2 hours at 150°C
2 hours at 175°C 4 hours at 60°C 6 hours at 60°C 2 hours at 175°C


Part VII Alternative Fat Tests for Overall and Specific Migration
1 
Subject to paragraph 2 the conditions which must be fulfilled to allow the result of either of the migration tests specified in paragraph 3 to be used as an alternative to the result of a migration test carried out under Part III are—
(a) the result obtained in a “comparison test” shows that the values are equal or greater than those obtained in the test with simulant D; and
(b) the migration occurring in either test specified in paragraph 3 does not, after application of the appropriate reduction factor, exceed the appropriate migration limit.
2 
The condition in sub-paragraph (a) of paragraph 1 does not have to be fulfilled if it can be shown on the basis of the result of scientific experiment that the values obtained in either of the migration tests specified in paragraph 3 are equal to or greater than those obtained in any of the migration tests specified in Part III.
3 
The migration tests referred to in paragraphs 1 and 2 are—
(a) a test carried out using volatile media including isooctane, ethanol 95%, other volatile solvents or a mixture of solvents at such contact conditions as would result in values equal or greater than those obtained in a test using simulant D;
(b) other tests using media having a very strong extraction power under very severe test conditions where, on the basis of scientific evidence, it is generally recognised that the results using these tests are equal to or higher than those obtained in a test using simulant D.