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The Plastic Materials and Articles in Contact with Food Regulations 1998

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Statutory Instruments

1998 No. 1376

FOOD

The Plastic Materials and Articles in Contact with Food Regulations 1998

Made

1st June 1998

Laid before Parliament

4th June 1998

Coming into force

1st July 1998

The Minister of Agriculture, Fisheries and Food, the Secretary of State for Health and the Secretary of State for Wales, acting jointly in relation to England and Wales, and the Secretary of State for Scotland in relation to Scotland, in exercise of the powers conferred on them by sections 6(4), 16(2), 17(1), 26(1)(a) and (3), 31 and 48(1) of the Food Safety Act 1990(1), after consultation in accordance with section 48(4) with such organisations as appear to them to be representative of interests likely to be substantially affected by the Regulations; the Minister of Agriculture, Fisheries and Food and the Secretary of State, being Ministers designated(2) for the purposes of section 2(2) of the European Communities Act 1972(3) in relation to materials and articles in contact with food or drink or intended for such contact, acting jointly, in exercise of the powers conferred on them by the said section 2(2) in so far as these Regulations could not have been made under the powers hereinbefore mentioned; and in exercise of all other powers enabling the said Minister and aforesaid Secretaries of State in that behalf hereby make the following Regulations:

Title, commencement and extent

1.—(1) These Regulations may be cited as the Plastic Materials and Articles in Contact with Food Regulations 1998 and shall come into force on 1st July 1998.

(2) These Regulations apply in Great Britain.

Interpretation

2.—(1) In these Regulations, unless the context otherwise requires—

the Act” means the Food Safety Act 1990;

“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;

“business” has the same meaning as it has in the Act;

“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(4), as amended by Commission Directives 93/8/EEC(5) and 97/48/EC(6);

the Directive” means Commission Directive (EEC) No. 90/128 relating to plastics materials and articles intended to come into contact with foodstuffs(7) (as corrected) and as amended by Commission Directives 92/39/EEC, 93/9/EEC, 95/3/EC and 96/11/EC(8);

EEA Agreement” means the Agreement on the European Economic Area(9) signed at Oporto on 2nd May 1992 as adjusted by the Protocol(10) 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 section 16(5) of the Act;

“good technical quality” means good technical quality as regards the purity criteria;

“human consumption” has the same meaning as it has in the Act;

“import” means import in the course of a business;

“monomer” means anything which is included for the purposes of the Directive among monomers and other starting substances;

“the 1987 Regulations” means the Materials and Articles in Contact with Food Regulations 1987(11);

“the 1992 Regulations” means the Plastic Materials and Articles in Contact with Food Regulations 1992(12);

“person charged” includes, in Scotland, the accused;

“plastic material or article” means anything which for the purposes of the Directive is included among those plastics materials and articles and parts thereof to which the Directive applies;

“preparation” has the same meaning as it has in the Act; and

“sell” includes offer or expose for sale or have in possession for sale, and “sale” shall be construed accordingly.

(2) For the purposes of these Regulations the supply of any plastic material or article, otherwise than on sale, in the course of a business shall be deemed to be a sale of the plastic material or article.

(3) Any expression, other than one defined in paragraph (1) of this regulation, 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(13) has, in so far as the context admits, the same meaning as it bears in the Directive in which it appears.

(4) Any reference in these Regulations to a numbered regulation or Schedule shall unless the context otherwise requires be construed as a reference to the regulation or Schedule bearing that number in these Regulations.

Restriction on 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 1st July 1998; and

(b)in accordance with regulation 5 of the 1992 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 Great Britain and sub-paragraph (a) above would have applied to it had it been manufactured in Great Britain.

Restriction on manufacture with monomers

4.—(1) Subject to the following paragraphs of this regulation, no plastic material or article shall be manufactured by any person with any prohibited monomer, that is to say any monomer other than a monomer which is—

(a)of good technical quality;

(b)identifed 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) of this regulation does not apply to the use of a monomer in the manufacture of any—

(a)surface coatings obtained from resinous or polymerised 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) of this regulation 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) of this regulation, 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) below; 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 the 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) of this regulation 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) of this regulation 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) above,

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 of this regulation, 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) below 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) above 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) below 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) of this regulation, 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) of this regulation 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.—(1) Each authority which is the enforcement authority for the 1987 Regulations shall enforce and execute in its area the provisions of these Regulations.

(2) Nothing in this regulation shall be taken as authorising in Scotland an enforcement authority to institute proceedings for an offence against these Regulations.

Offences

10.—(1) Any person who contravenes or fails to comply with 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) of this regulation 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) of this regulation—

(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 an offence under these Regulations which has been committed by a body corporate is proved to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of—

(a)any director, manager, secretary or other similar officer of the body corporate, and in Scotland, any partner of a partnership, or

(b)any person who was purporting to act in any such capacity,

he as well as the body corporate shall be deemed to be guilty of that offence and shall be liable to be proceeded against and punished accordingly.

(6) For the purposes of paragraph (5) of this regulation “body corporate” shall in Scotland include a partnership.

(7) 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.

(8) In any proceedings for an offence under these Regulations it shall, subject to paragraph (12) below, be a defence for the person charged to prove that he took all reasonable precautions and exercised all due diligence to avoid the commission of the offence by himself or by a person under his control.

(9) Without prejudice to the generality of paragraph (8) of this regulation, a person charged with an offence under these Regulations who neither—

(a)prepared the plastic material or article in respect of which the offence is alleged to have been committed, nor

(b)imported it into Great Britain,

shall be taken to have established the defence provided by that paragraph if he satisfies the requirements of paragraph (10) or (11) of this regulation.

(10) 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.

(11) A person satisfies the requirements of this paragraph if the offence is one of sale and he proves—

(a)that the commission of the offence was due to an act or default of another person who was not under his control, or to reliance on information supplied by such a person;

(b)that the sale of which the alleged offence consisted was not a sale under his name or mark; and

(c)that he did not know, and could not reasonably have been expected to know, at the time of the commission of the alleged offence that his act or omission would amount to an offence under these Regulations.

(12) If in any case the defence provided by paragraph (8) of this regulation 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.

(13) 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.

(14) 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 the 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 17 (authorised officer acting in good faith);

(e)regulation 20 (evidence of analysis); and

(f)regulation 21 (analysis by Government chemist).

(2) Section 3(4) of the Act (relating to the presumption of intention for human consumption) shall apply for the purposes of these Regulations as it applies for the purposes of the Act.

(3) Sections 29 and 30 of the Act (which deal with procurement and analysis of samples) shall, in so far as they relate to plastic materials or articles, be modified to the extent necessary to avoid restricting the scope of paragraph (1)(a), (b), (e) and (f) above.

Amendment of existing Regulations

13.  In the Food Safety (Sampling and Qualifications) Regulations 1990(14) in Schedule 1 (provisions to which those Regulations do not apply) for the title and reference of the 1992 Regulations there shall be substituted the title and reference of these Regulations.

Revocation of existing Regulations

14.  The 1992 Regulations, the Plastic Materials and Articles in Contact with Food (Amendment) Regulations 1995(15), the Plastic Materials and Articles in Contact with Food (Amendment) Regulations 1996(16) and the Plastic Materials and Articles in Contact with Food (Amendment) (No. 2) Regulations 1996(17) are hereby revoked.

Jeff Rooker

Minister of State, Ministry of Agriculture, Fisheries and Food

28th May 1998

Signed by authority of the Secretary of State for Health

Tessa Jowell

Minister of State for Public Health,

Department of Health

1st June 1998

Signed by the authority of the Secretary of State for Wales

Win Griffiths

Parliamentary Under Secretary of State, Welsh Office

28th May 1998

Sam Galbraith

Parliamentary Under Secretary of State, Scottish Office

29th May 1998

Regulation 4

SCHEDULE 1

PART IAuthorised Monomers

SECTION AMonomers authorised without time limit

1234
ItemPM/REF No.CAS No.NameRestrictions
1.10030000514-10-3Abietic acid
2.10060000075-07-0Acetaldehyde
3.10090000064-19-7Acetic acid
4.10120000108-05-4Acetic acid, vinyl esterThe specific migration of this substance shall not exceed 12 mg/kg
5.10150000108-24-7Acetic anhydride
6.10210000074-86-2Acetylene
7.10630000079-06-1AcrylamideThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg)
8.10660015214-89-82-Acrylamido-2-methylpropane sulphonic acidThe specific migration of this substance shall not exceed 0.05 mg/kg
9.10690000079-10-7Acrylic acid
10.10750002495-35-4Acrylic acid, benzyl ester
11.10780000141-32-2Acrylic acid, n-butyl ester
12.10810002998-08-5Acrylic acid, sec-butyl ester
13.10840001663-39-4Acrylic acid, tert-butyl ester
14.11470000140-88-5Acrylic acid, ethyl ester
15.As item 19000818-61-1Acrylic acid, hydroxyethyl ester
16.11590000106-63-8Acrylic acid, isobutyl ester
17.11680000689-12-3Acrylic acid, isopropyl ester
18.11710000096-33-3Acrylic acid, methyl ester
19.11830000818-61-1Acrylic acid, monoester with ethylene glycol
20.11890002499-59-4Acrylic acid, n-octyl ester
21.11980000925-60-0Acrylic acid, propyl ester
22.12100000104-13-1AcrylonitrileThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included)
23.12130000124-04-9Adipic acid
24.12280002035-75-8Adipic anhydride
25.12310Albumin
26.12340Albumin, coagulated by formaldehyde
27.12375Alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C22)
28.12670002855-13-21-Amino-3-aminomethyl-3,5,5-trimethylcyclohexaneThe specific migration of this substance shall not exceed 6 mg/kg
29.12788002432-99-711-Aminoundecanoic acidThe specific migration of this substance shall not exceed 5 mg/kg
30.12789007664-41-7Ammonia
31.12820000123-99-9Azelaic acid
32.12970004196-95-6Azelaic anhydride
33.13000001477-55-01,3-BenzenedimethanamineThe specific migration of this substance shall not exceed 0.05 mg/kg
34.13090000065-85-0Benzoic acid
35.13150000100-51-6Benzyl alcohol
36.As item 79000111-46-6Bis(2-hydroxyethyl) etherAs item 79
37.As item 217000077-99-62,2-Bis(hydroxymethylbutan-1-ol)As item 217
38.13390000105-08-81,4-Bis(hydroxymethyl)-cyclohexane
39.13480000080-05-72,2-Bis(4-hydroxyphenyl)-propaneThe specific migration of this substance shall not exceed 3 mg/kg
40.13510001675-54-32,2-Bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) etherThe quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg or the specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included)
41.13530038103-06-92,2-Bis(4-hydroxyphenyl)propane bis(phthalic anhydride)The specific migration of this substance shall not exceed 0.05 mg/kg
42.As item 93000110-98-5Bis(hydroxypropyl) ether
43.As item 78005124-30-1Bis(4-isocyanatocyclohexyl)methaneAs item 78
44.13600047465-97-43,3-Bis(3-methyl-4-hydroxyphenyl)-indolin-2-oneThe specific migration of this substance shall not exceed 1.8 mg/kg
45.As item 39000080-05-7Bisphenol AAs item 39
46.As item 40001675-54-3Bisphenol A bis(2,3-epoxypropyl) etherAs item 40
47.13614038103-06-9Bisphenol A bis(phthalic anhydride)As item 41
48.13630000106-99-0ButadieneThe quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg or the specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included)
49.13690000107-88-0Butan-1,3-diol
50.13840000071-36-3Butan-1-ol
51.13870000106-98-9But-1-ene
52.13900000107-01-7But-2-ene
53.14110000123-72-8Butyraldehyde
54.14140000107-92-6Butyric acid
55.14170000106-31-0Butyric anhydride
56.14200000105-60-2CaprolactamThe specific migration of this substance alone or together with item 57 shall not exceed a total of 15 mg/kg
57.14230002123-24-2Caprolactam, sodium saltThe specific migration of this substance alone or together with item 56 shall not exceed a total of 15 mg/kg (expressed as caprolactam)
58.14320000124-07-2Caprylic acid
59.14350000630-08-0Carbon monoxide
60.14380000075-44-5Carbonyl chlorideThe quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg
61.14411008001-79-4Castor oil
62.14500009004-34-6Cellulose
63.14530007782-50-5Chlorine
64.As item 94000106-89-81-Chloro-2,3-epoxypropaneAs item 94
65.14680000077-92-9Citric acid
66.14710000108-39-4m-Cresol
67.14740000095-48-7o-Cresol
68.14770000106-44-5p-Cresol
69.As item 38000105-08-81,4-Cyclohexanedimethanol
70.14950003173-53-3Cyclohexyl isocyanateThe 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 and shall not exceed 1 mg/kg (expressed as isocyanate moiety)
71.15070001647-16-1Dec-1,9-dieneThe specific migration of this substance shall not exceed 0.05 mg/kg
72.15095000334-48-5Decanoic acid
73.15100000112-30-1Decan-1-ol
74.15250000110-60-11,4-Diaminobutane
75.As item 97000107-15-31,2-DiaminoethaneAs item 97
76.As item 116000124-09-41,6-DiaminohexaneAs item 116
77.15565000106-46-71,4-DichlorobenzeneThe specific migration of this substance shall not exceed 12 mg/kg
78.15700005124-30-1Dicyclohexylmethane-4,4'-diisocyanateAs item 70
79.15760000111-46-6Diethylene glycolThe specific migration of this substance alone or together with item 98 shall not exceed a total of 30 mg/kg
80.15790000111-40-0DiethylenetriamineThe specific migration of this substance shall not exceed 5 mg/kg
81.15820000345-92-64,4'-DifluorobenzophenoneThe specific migration of this substance shall not exceed 0.05 mg/kg
82.15880000120-80-91,2-DihydroxybenzeneThe specific migration of this substance shall not exceed 6 mg/kg
83.15910000108-46-31,3-DihydroxybenzeneThe specific migration of this substance shall not exceed 2.4 mg/kg
84.15940000123-31-91,4-DihydroxybenzeneThe specific migration of this substance shall not exceed 0.6 mg/kg
85.15970000611-99-44,4'-DihydroxybenzophenoneThe specific migration of this substance shall not exceed 6 mg/kg
86.16000000092-88-64,4'-DihydroxybiphenylThe specific migration of this substance shall not exceed 6 mg/kg
87.16150000108-01-0DimethylaminoethanolThe specific migration of this substance shall not exceed 18 mg/kg
88.16240000091-97-43,3'-Dimethyl-4,4'-diisocyanatobiphenylAs item 70
89.16480000126-58-9Dipentaerythritol
90.16570004128-73-8Diphenylether-4,4'-diisocyanateAs item 70
91.16600005873-54-1Diphenylmethane-2,4'-diisocyanateAs item 70
92.16630000101-68-8Diphenylmethane-4,4'-diisocyanateAs item 70
93.16660000110-98-5Dipropyleneglycol
94.16750000106-89-8EpichlorohydrinThe quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg
95.16780000064-17-5Ethanol
96.16950000074-85-1Ethylene
97.16960000107-15-3EthylenediamineThe specific migration of this substance shall not exceed 12 mg/kg
98.16990000107-21-1Ethylene glycolThe specific migration of this substance alone or together with item 79 shall not exceed a total of 30 mg/kg
99.17005000151-56-4EthyleneimineThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg)
100.17020000075-21-8Ethylene oxideThe quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg
101.1705000104-76-72-Ethylhexan-1-olThe specific migration of this substance shall not exceed 30 mg/kg
102.17160000097-53-0EugenolThe specific migration of this substance shall not exceed 0.01 mg/kg
103.17170061788-47-4Fatty acids, coco
104.17200068308-53-2Fatty acids, soya
105.17230061790-12-3Fatty acids, tall oil
106.17260000050-00-0FormaldehydeThe specific migration of this substance shall not exceed 15 mg/kg
107.17290000110-17-8Fumaric acid
108.17530000050-99-7Glucose
109.18010000110-94-1Glutaric acid
110.18070000108-55-4Glutaric anhydride
111.18100000056-81-5Glycerol
112.18250000115-28-6Hexachloroendomethylene-tetrahydrophthalic acidThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg)
113.18280000115-27-5Hexachloroendomethylene-tetrahydrophthalic anhydrideThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg)
114.18310036653-82-4Hexadecan-l-ol
115.18430000116-15-4HexafluoropropyleneThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg)
116.18460000124-09-4HexamethylenediamineThe specific migration of this substance shall not exceed 2.4 mg/kg
117.18640000822-06-0Hexamethylene diisocyanateAs item 70
118.18670000100-97-0HexamethylenetetramineThe specific migration of this substance shall not exceed 15 mg/kg (expressed as formaldehyde)
119.As item 84000123-31-9HydroquinoneAs item 84
120.18880000099-96-7p-Hydroxybenzoic acid
121.19000000115-11-7Isobutene
122.19210001459-93-4Isophthalic acid, dimethyl esterThe specific migration of this substance shall not exceed 0.05 mg/kg
123.19270000097-65-4Itaconic acid
124.19460000050-21-5Lactic acid
125.19470000143-07-7Lauric acid
126.19480002146-71-6Lauric acid, vinyl ester
127.19510011132-73-3Lignocellulose
128.19540000110-16-7Maleic acidThe specific migration of this substance alone or together with item 129 shall not exceed a total of 30 mg/kg
129.19960000108-31-6Maleic anhydrideThe specific migration of this substance alone or together with item 128 shall not exceed a total of 30 mg/kg (expressed as maleic acid)
130.As item 215000108-78-1MelamineAs item 215
131.20020000079-41-4Methacrylic acid
132.20080002495-37-6Methacrylic acid, benzyl ester
133.20110000097-88-1Methacrylic acid, butyl ester
134.20140002998-18-7Methacrylic acid, sec-butyl ester
135.20170000585-07-9Methacrylic acid, tert-butyl ester
136.20890000097-63-2Methacrylic acid, ethyl ester
137.21010000097-86-9Methacrylic acid, isobutyl ester
138.21100004655-34-9Methacrylic acid, isopropyl ester
139.21130000080-62-6Methacrylic acid, methyl ester
140.21190000868-77-9Methacrylic acid, monoester with ethyleneglycol
141.21280002177-70-0Methacrylic acid, phenyl ester
142.21340002210-28-8Methacrylic acid, propyl ester
143.21460000760-93-0Methacrylic anhydride
144.21490000126-98-7MethacrylonitrileThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included)
145.21550000067-56-1Methanol
146.21940000924-42-5N-MethylolacrylamideThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg)
147.22150000691-37-24-Methylpent-1-eneThe specific migration of this substance shall not exceed 0.02 mg/kg
148.22350000544-63-8Myristic acid
149.22390000840-65-32,6-Naphthalenedicarboxylic acid, dimethyl esterThe specific migration of this substance shall not exceed 0.05 mg/kg
150.22420003173-72-61,5-Naphthalene diisocyanateAs item 70
151.22450009004-70-0Nitrocellulose
152.22480000143-08-8Nonan-1-ol
153.22570000112-96-9Octadecyl isocyanateAs item 70
154.22600000111-87-5Octan-1-ol
155.22660000111-66-0Oct-l-eneThe specific migration of this substance shall not exceed 15 mg/kg
156.22763000112-80-1Oleic acid
157.22780000057-10-3Palmitic acid
158.22840000115-77-5Pentaerythritol
159.22870000071-41-0Pentan-1-ol
160.22960000108-95-2Phenol
161.23050000108-45-21,3-PhenylenediamineThe quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg
162.As item 60000075-44-5PhosgeneAs item 60
163.23170007664-38-2Phosphoric acid
164.As item 204Phthalic acidAs item 204
165.23200000088-99-3o-Phthalic acid
166.23230000131-17-9Phthalic acid, diallyl esterThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg)
167.23380000085-44-9Phthalic anhydride
168.23470000080-56-8alpha-Pinene
169.23500000127-91-3beta-Pinene
170.23590025322-68-3Polyethylene glycol
171.23650025322-69-4Polypropylene glycol (molecular weight greater than 400)
172.23651025322-69-4Polypropyleneglycol
173.23740000057-55-6Propan-1,2-diol
174.23800000071-23-8Propan-1-ol
175.23830000067-63-0Propan-2-ol
176.23860000123-38-6Propionaldehyde
177.23890000079-09-4Propionic acid
178.23950000123-62-6Propionic anhydride
179.23980000115-07-1Propylene
180.24010000075-56-9Propylene oxideThe quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg
181.As item 82000120-80-9PyrocatecholAs item 82
182.24057000089-32-7Pyromellitic anhydrideThe specific migration of this substance shall not exceed 0.05 mg/kg (expressed as pyromellitic acid)
183.24070073138-82-6Resin acids and rosin acids
184.As item 83000108-46-3ResorcinolAs item 83
185.24100008050-09-7Rosin
186.24130008050-09-7Rosin gum
187.24160008052-10-6Rosin tall oil
188.24190009014-63-5Rosin wood
189.24250009006-04-6Rubber, natural
190.24270000069-72-7Salicylic acid
191.24280000111-20-6Sebacic acid
192.24430002561-88-8Sebacic anhydride
193.24475001313-82-2Sodium sulphide
194.24490000050-70-4Sorbitol
195.24520008001-22-7Soybean oil
196.24540009005-25-8Starch, edibleThe specific migration of this substance shall not exceed 0.05 mg/kg
197.24550000057-11-4Stearic acid
198.24610000100-42-5Styrene
199.24820000110-15-6Succinic acid
200.24850000108-30-5Succinic anhydride
201.24880000057-50-1Sucrose
202.24887006362-79-45-Sulphoisophthalic acid, monosodium saltThe specific migration of this substance shall not exceed 5 mg/kg
203.24888003965-55-75-Sulphoisophthalic acid, monosodium salt, dimethyl esterThe specific migration of this substance shall not exceed 0.05 mg/kg
204.24910000100-21-0Terephthalic acidThe specific migration of this substance alone or together with item 205 shall not exceed a total of 7.5 mg/kg
205.24940000100-20-9Terephthalic acid dichlorideThe specific migration of this substance alone or together with item 204 shall not exceed 7.5 mg/kg (expressed as terephthalic acid)
206.24970000120-61-6Terephthalic acid, dimethyl ester
207.25090000112-60-7Tetraethylene glycol
208.25120000116-14-3TetrafluoroethyleneThe specific migration of this substance shall not exceed 0.05 mg/kg
209.25150000109-99-9TetrahydrofuranThe specific migration of this substance shall not exceed 0.6 mg/kg
210.25180000102-60-3N,N,N',N'-Tetrakis(2-hydroxypropyl)-ethylenediamine
211.25210000584-84-92,4-Toluene diisocyanateAs item 70
212.25240000091-08-72,6-Toluene diisocyanateAs item 70
213.25270026747-90-02,4-Toluene diisocyanate dimerAs item 70
214.25360Trialkyl(C5-C15)acetic acid, 2,3-epoxypropyl esterThe specific migration of this substance shall not exceed 6 mg/kg
215.25420000108-78-12,4,6-Triamino-1,3,5-triazineThe specific migration of this substance shall not exceed 30 mg/kg
216.25510000112-27-6Triethylene glycol
217.25600000077-99-61,1,1-TrimethylolpropaneThe specific migration of this substance shall not exceed 6 mg/kg
218.25910024800-44-0Tripropylene glycol
219.25960000057-13-6Urea
220.26050000075-01-4Vinyl chlorideThe restrictions are those in regulation 5(1)(a) and (b) of the 1987 Regulations when analysed by the method referred to in regulation 14 of those Regulations
221.26110000075-35-4Vinylidene chlorideThe 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)
222.26140000075-38-7Vinylidene fluorideThe specific migration of this substance shall not exceed 5 mg/kg

SECTION BMonomers authorised up to the end of 2001

1234
Item PM/REF No. CAS No. Name Restrictions
1.10599/90A061788-89-4Acids, fatty, unsaturated (C18), dimers, distilled
2.10599/91061788-89-4Acids, fatty, unsaturated (C18), dimers, non-distilled
3.10599/92A068783-41-5Acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled
4.10599/93068783-41-5Acids, fatty, unsaturated (C18), dimers, hydrogenated, non-distilled
5.11000050976-02-8Acrylic acid, dicyclopentadienyl ester
6.11245002156-97-0Acrylic acid, dodecyl ester
7.11500000103-11-7Acrylic acid, 2-ethylhexyl ester
8.11530000999-61-1Acrylic acid, 2-hydroxypropyl ester
9.12265004074-90-2Adipic acid, divinyl ester
10.12910001732-10-1Azelaic acid, dimethyl ester
11.As item 78000528-44-91,2,4-Benzenetricarboxylic acidAs item 78
12.13060004422-95-11,3,5-Benzenetricarboxylic acid trichloride
13.As item 23000091-76-9Benzoguanamine
14.As item 28000080-09-1Bisphenol S
15.13720000110-63-4Butan-1,4-diol
16.13780002425-79-8Butan-1,4-diol, bis(2,3-epoxypropyl) etherThe 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)
17.13810000505-65-7Butan-1,4-diol formal
18.13932000598-32-3But-3-en-2-ol
19.14020000098-54-44-tert-Butylphenol
20.14260000502-44-3Caprolactone
21.14800003724-65-0Crotonic acid
22.15130000872-05-9Dec-1-ene
23.15310000091-76-92,4-Diamino-5-phenyl-1,3,5-triazine
24.15370003236-53-11,6-Diamino-2,2,4-trimethylhexane
25.15400003236-54-21,6-Diamino-2,4,4-trimethylhexane
26.15610000080-07-94,4'-Dichlorodiphenyl sulphone
27.15730000077-73-6Dicyclopentadiene
28.16090000080-09-14,4'-Dihydroxydiphenyl sulphone
29.16210006864-37-53,3'-Dimethyl-4,4'-diamino-dicyclohexylmethane
30.16360000576-26-12,6-Dimethylphenol
31.16390000126-30-72,2-Dimethylpropan-1,3-diol
32.16450000646-06-01,3-Dioxolane
33.16540000102-09-0Diphenyl carbonate
34.16690001321-74-0Divinylbenzene
35.16697000693-23-2Dodecanedioic acid
36.17110016219-75-35-Ethylidenebicyclo[2.2.1] hept-2-ene
37.18220068564-88-5N-Heptylaminoundecanoic acid
38.18370000592-45-0Hexa-1,4-diene
39.18441000085-42-7Hexahydrophthalic anhydride
40.18700000629-11-8Hexan-1,6-diol
41.18820000592-41-6Hex-1-ene
42.19060000109-53-5Isobutyl vinyl ether
43.19150000121-91-5Isophthalic acid
44.19180000099-63-8Isophthalic acid dichloride
45.As item 60000078-79-5Isoprene
46.19490000947-04-6Laurolactam
47.19570000999-21-3Maleic acid, diallyl ester
48.19600000105-76-0Maleic acid, dibutyl ester
49.19990000079-39-0Methacrylamide
50.20050000096-05-9Methacrylic acid, allyl ester
51.20260000101-43-9Methacrylic acid, cyclohexyl ester
52.20380001189-08-8Methacrylic acid, diester with butan-1,3-diol
53.20410002082-81-7Methacrylic acid, diester with butan-1,4-diol
54.20440000097-90-5Methacrylic acid, diester with ethyleneglycol
55.20530002867-47-2Methacrylic acid, 2-(dimethylamino)ethyl ester
56.20590000106-91-2Methacrylic acid, 2,3-epoxypropyl esterAs item 16
57.21370010595-80-9Methacrylic acid, 2-sulphoethyl ester
58.21400054276-35-6Methacrylic acid, sulphopropyl ester
59.21520001561-92-8Methallylsulphonic acid, sodium saltThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg
60.21640000078-79-52-Methylbut-1,3-diene
61.21730000563-45-13-Methylbut-1-ene
62.As item 17000505-65-71,4-(Methylenedioxy)butane
63.21970000923-02-4N-Methylolmethacrylamide
64.22210000098-83-9alpha-Methylstyrene
65.22360001141-38-42,6-Naphthalenedicarboxylic acid
66.As item 31000126-30-7Neopentylglycol
67.22428051000-52-3Neodecanoic acid, vinyl ester
68.22720000140-66-94-tert-Octylphenol
69.22900000109-67-1Pent-1-ene
70.22937001623-05-8Perfluoropropyl perfluorovinyl ether
71.23770000504-63-2Propan-1,3-diol
72.23920000105-38-4Propionic acid, vinyl ester
73.24370000106-79-6Sebacic acid, dimethyl ester
74.24760026914-43-2Styrenesulphonic acid
75.25380Trialkyl(C5-C15)acetic acid, vinyl ester (=vinyl versatate)
76.25390000101-37-1Triallyl cyanurate
77.25450026896-48-0Tricyclodecanedimethanol
78.25540000528-44-9Trimellitic acidThe quantity of this substance alone or together with item 79 in the finished plastic material or article shall not exceed 5 mg/kg
79.25550000552-30-7Trimellitic anhydrideThe 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)
80.25810015625-89-51,1,1-Trimethylolpropane triacrylate
81.25840003290-92-41,1,1-Trimethylolpropane trimethacrylate
82.25900000110-88-3Trioxane
83.26170003195-78-6N-Vinyl-N-methylacetamideThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg

SECTION CMonomers authorised up to the end of 1998

ItemPM/REF No.CAS No.NameRestrictions
1234
1.10160002206-94-2alpha-Acetoxystyrene
2.10162010521-96-7beta-Acetoxystyrene
3.10480Acids, aliphatic, monocarboxylic, saturated (C2-C24)
4.10510Acids, aliphatic, monocarboxylic, unsaturated (C3-C24)
5.10599/70Acids, fatty, unsaturated (C18)
6.10930003066-71-5Acrylic acid, cyclohexyl ester
7.11050001070-70-8Acrylic acid, diester with butan-1,4-diol
8.11180017831-71-9Acrylic acid, diester with tetraethyleneglycol
9.11195068901-05-3Acrylic acid, diester with tripropyleneglycol
10.11520002918-23-2 Acrylic acid, 2-hydroxyisopropyl ester (= acrylic acid, 2-hydroxy-1-methylethyl ester)
11.11560005888-33-5Acrylic acid, isobornyl ester
12.11620001330-61-6Acrylic acid, isodecyl ester
13.11650029590-42-9Acrylic acid, isooctyl ester
14.11695003121-61-7Acrylic acid, 2-methoxyethyl ester
15.11740010095-13-3Acrylic acid, monoester with butan-1,3-diol
16.11770002478-10-6Acrylic acid, monoester with butan-1,4-diol
17.11800013533-05-6Acrylic acid, monoester with diethyleneglycol
18.12010040074-09-7Acrylic acid, 2-sulphoethyl ester
19.12040039121-78-3Acrylic acid, sulphopropyl ester
20.12055094160-26-6Acrylic acid, triester with glycerol tris(2-hydroxypropyl) ether
21.12062075577-70-7Acrylic acid, triester with 1,1,1-trimethylolpropane tris(2-hydroxyethyl) ether
22.12160002998-04-1Adipic acid, diallyl ester
23.12190000105-97-5Adipic acid, didecyl ester
24.12220027178-16-1Adipic acid, diisodecyl ester
25.12250000123-79-5Adipic acid, dioctyl ester
26.12370Alcohols, aliphatic, monohydric, saturated, linear, secondary or tertiary (C4-C22)
27.12610000107-18-6Allyl alcohol
28.12700000150-13-0p-Aminobenzoic acid
29.12790000080-46-6p-tert-Amylphenol
30.12850029602-44-6Azelaic acid,bis(2-hydroxyethyl) ester
31.13328000104-38-1Bis(2-hydroxyethyl) ether of hydroquinone
32.13660000584-03-2Butan-1,2-diol
33.13750000513-85-9Butan-2,3-diol
34.13960001852-16-0N-(Butoxymethyl)acrylamide
35.15020002182-05-0Cyclohexyl vinyl ether
36.15280000542-02-92,4-Diamino-6-methyl-1,3,5-triazine
37.15340000109-76-21,3-Diaminopropane
38.15490002215-89-64,4'-Dicarboxydiphenyl ether
39.15580001653-19-62,3-Dichlorobuta-1,3-diene
40.16270000526-75-02,3-Dimethylphenol
41.16300000105-67-92,4-Dimethylphenol
42.16330000095-87-42,5-Dimethylphenol
43.17040000149-57-52-Ethylhexanoic acid
44.17350000105-75-9Fumaric acid, dibutyl ester
45.18400000592-42-7Hexa-1,5-diene
46.18905002628-17-34-Hydroxystyrene
47.18970000078-83-1Isobutanol
48.19030016669-59-3N-(Isobutoxymethyl)acrylamide
49.19090000078-84-2Isobutyraldehyde
50.19120025339-17-7Isodecanol
51.19130026896-18-4Isononanoic acid
52.19936007423-42-9Maleic acid, mono(2-ethylhexyl) ester
53.20470025852-47-5Methacrylic acid, diester with polyethyleneglycol
54.20740039670-09-2Methacrylic acid, ester with ethoxytriethyleneglycol
55.20950000923-26-2Methacrylic acid,2-hydroxypropyl ester
56.21115000816-74-0Methacrylic acid, methallyl ester
57.21220032360-05-7Methacrylic acid, octadecyl ester
58.21760000694-91-75-Methylenebicyclo[2.2.1]hept-2-ene
59.21837001116-90-14-Methylhexa-1,4-dieneThe specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.05 mg/kg)
60.22240000622-97-9p-Methylstryrene
61.22270000107-25-5Methyl vinyl ether
62.22540000104-40-54-Nonylphenol
63.22585003710-30-3Octa-1, 7-diene
64.22932001187-93-5Perfluoromethyl perfluorovinyl ether
65.23530025190-06-1Poly(1,4-butyleneglycol) (molecular weight greater than 1,000)
66.23650025322-69-4Polypropleneglycol (molecular weight greater than 400)
67.24560000111-63-7Stearic acid, vinyl ester
68.25030016646-44-9Tetra(allyloxy)ethane
69.25161000085-43-81,2,3,6-Tetrahydrophthalic anhydride
70.25300000088-19-7o-Toluenesulphonamide
71.25480000102-71-6Triethanolamine
72.26290025013-15-4Vinyltoluene
73.26320002768-02-7VinyltrimethoxysilaneThe quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg

PART IISupplementary

1.  In regulation 4 and Part I of this Schedule—

(a)the PM/REF No. of any substance is its EEC packaging material reference number,

(b)the CAS No. of any substance is its CAS (Chemical Abstracts Service) Registry Number,

(c)the name of any substance is its chemical name, and to the extent that there is any inconsistency between the CAS No. and the name, the name shall take precedence over the CAS No., 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 of this Schedule as an individual compound also falls within a generic term which appears therein, the restriction (if any) applying to that substance shall be that indicated for the individual compound and the entry applying to the generic term shall be treated as varied to such extent (if any) as is necessary therefor.

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

(3)  If, as indicated in paragraph 2 of Annex II to the Directive, a substance is identified in Part I of this Schedule as an “ ... ... ... ... acid, salt” and has salts of one or more of the following names (that is to say salts of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium or zinc), then the free acid corresponding to that substance is not treated as included in the specification of that substance.

Regulation 5

SCHEDULE 2

PART IAdditives

ItemPM/REF No.CAS No.Name
123
1.30000000064-19-7Acetic acid
2.30045000123-86-4Acetic acid, butyl ester
3.30140000141-78-6Acetic acid, ethyl ester
4.30280000108-24-7Acetic anhydride
5.30295000067-64-1Acetone
6.30370Acetylacetic acid, salts
7.30400Acetylated glycerides
8.30960Acids, aliphatic, monocarboxylic (C6-C22), esters with polyglycerol
9.31328Acids, fatty, from animal or vegetable food fats and oils
10.31730000124-04-9Adipic acid
11.33120Alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C24)
12.33350009005-32-7Alginic acid
13.34281Alkyl(C8-C22) sulphuric acids, linear, primary, with an even number of carbon atoms
14.34475Aluminium calcium hydroxide phosphite, hydrate
15.34480Aluminium fibres, flakes and powders
16.34560021645-51-2Aluminium hydroxide
17.34690011097-59-9Aluminium magnesium carbonate hydroxide
18.34720001344-28-1Aluminium oxide
19.35120013560-49-13-Aminocrotonic acid, diester with thiobis(2-hydroxyethyl) ether
20.35320007664-41-7Ammonia
21.35440012124-97-9Ammonium bromide
22.35600001336-21-6Ammonium hydroxide
23.35840000506-30-9Arachidic acid
24.35845007771-44-0Arachidonic acid
25.36000000050-81-7Ascorbic acid
26.36080000137-66-6Ascorbyl palmitate
27.36160010605-09-1Ascorbyl stearate
28.36880008012-89-3Beeswax
29.36960003061-75-4Behenamide
30.37040000112-85-6Behenic acid
31.37280001302-78-9Bentonite
32.37600000065-85-0Benzoic acid
33.37680000136-60-7Benzoic acid, butyl ester
34.37840000093-89-0Benzoic acid, ethyl ester
35.38080000093-58-3Benzoic acid, methyl ester
36.38160002315-68-6Benzoic acid, propyl ester
37.38950079072-96-1Bis(4-ethylbenzylidene) sorbitol
38.39890087826-41-3Bis(methylbenzylidene) sorbitol
069158-41-4 ” ” ” ” ”
054686-97-4 ” ” ” ” ”
39.40400010043-11-5Boron nitride
40.40570000106-97-8Butane
41.41040005743-36-2Calcium butyrate
42.41280001305-62-0Calcium hydroxide
43.41520001305-78-8Calcium oxide
44.41600012004-14-7Calcium sulphoaluminate
037293-22-4 ” ” ” ” ”
45.41760008006-44-8Candelilla wax
46.41960000124-07-2Caprylic acid
47.42160000124-38-9Carbon dioxide
48.42500Carbonic acid, salts
49.42640009000-11-7Carboxymethylcellulose
50.42720008015-86-9Carnauba wax
51.42800009000-71-9Casein
52.42960064147-40-6Castor oil, dehydrated
53.43200Castor oil, mono- and diglycerides
54.43280009004-34-6Cellulose
55.43300009004-36-8Cellulose acetate butyrate
56.43360068442-85-3Cellulose, regenerated
57.43440008001-75-0Ceresin
58.44160000077-92-9Citric acid
59.44640000077-93-0Citric acid, triethyl ester
60.45280Cotton fibres
61.45560014464-46-1Cristobalite
62.45760000108-91-8Cyclohexylamine
63.45920009000-16-2Dammar
64.45940000334-48-5n-Decanoic acid
65.46070010016-20-3alpha-Dextrin
66.46080007585-39-9beta-Dextrin
67.46375061790-53-2Diatomaceous earth
68.46380068855-54-9Diatomaceous earth, soda ash flux-calcined
69.46480032647-67-9Dibenzylidene sorbitol
70.46790004221-80-13,5-Di-tert-butyl-4-hydroxybenzoic acid, 2,4-di-tert-butylphenyl ester
71.46800067845-93-63,5-Di-tert-butyl-4-hydroxybenzoic acid, hexadecyl ester
72.46870003135-18-03,5-Di-tert-butyl-4-hydroxybenzylphosphonic acid, dioctadecyl ester
73.47440000461-58-5Dicyanodiamide
74.49540000067-68-5Dimethyl sulphoxide
75.51200000126-58-9Dipentaerythritol
76.51760025265-71-8Dipropyleneglycol
000110-98-5 ” ”
77.52640016389-88-1Dolomite
78.52720000112-84-5Erucamide
79.52730000112-86-7Erucic acid
80.52800000064-17-5Ethanol
81.53270037205-99-5Ethylcarboxymethylcellulose
82.53280009004-57-3Ethylcellulose
83.53360000110-31-6N,N'-Ethylenebisoleamide
84.53440005518-18-3N,N'-Ethylenebispalmitamide
85.53520000110-30-5N,N'-Ethylenebisstearamide
86.53600000060-00-4Ethylenediaminetetraacetic acid
87.54005005136-44-7Ethylene-N-palmitamide-N'-stearamide
88.54260009004-58-4Ethylhydroxyethylcellulose
89.54270Ethylhydroxymethylcellulose
90.54280Ethylhydroxypropylcellulose
91.54450Fats and oils, from animal or vegetable food sources
92.54480Fats and oils, hydrogenated, from animal or vegetable food sources
93.55040000064-18-6Formic acid
94.55120000110-17-8Fumaric acid
95.55190029204-02-2Gadoleic acid
96.55440009000-70-8Gelatine
97.55520Glass fibres
98.55600Glass microballs
99.55680000110-94-1Glutaric acid
100.55920000056-81-5Glycerol
101.56020099880-64-5Glycerol dibehenate
102.56360Glycerol, esters with acetic acid
103.56486Glycerol, 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)
104.56487Glycerol, esters with butyric acid
105.56490Glycerol, esters with erucic acid
106.56495Glycerol, esters with 12-hydroxystearic acid
107.56500Glycerol, esters with lauric acid
108.56510Glycerol, esters with linoleic acid
109.56520Glycerol, esters with myristic acid
110.56540Glycerol, esters with oleic acid
111.56550Glycerol, esters with palmitic acid
112.56565Glycerol, esters with nonanoic acid
113.56570Glycerol, esters with propionic acid
114.56580Glycerol, esters with ricinoleic acid
115.56585Glycerol, esters with stearic acid
116.56610030233-64-8Glycerol monobehenate
117.56720026402-23-3Glycerol monohexanoate
118.56800030899-62-8Glycerol monolaurate diacetate
119.56880026402-26-6Glycerol monooctanoate
120.57040Glycerol monooleate, ester with ascorbic acid
121.57120Glycerol monooleate, ester with citric acid
122.57200Glycerol monopalmitate, ester with ascorbic acid
123.57280Glycerol monopalmitate, ester with citric acid
124.57600Glycerol monostearate, ester with ascorbic acid
125.57680Glycerol monostearate, ester with citric acid
126.57920000620-67-7Glycerol triheptanoate
127.58300Glycine, salts
128.58320007782-42-5Graphite
129.58400009000-30-0Guar gum
130.58480009000-01-5Gum arabic
131.58720000111-14-8Heptanoic acid
132.59360000142-62-1Hexanoic acid
133.59760019569-21-2Huntite
134.59990007647-01-0Hydrochloric acid
135.60030012072-90-1Hydromagnesite
136.60080012304-65-3Hydrotalcite
137.60160000120-47-84-Hydroxybenzoic acid, ethyl ester
138.60180004191-73-54-Hydroxybenzoic acid, isopropyl ester
139.60200000099-76-34-Hydroxybenzoic acid, methyl ester
140.60240000094-13-34-Hydroxybenzoic acid, propyl ester
141.60560009004-62-0Hydroxyethylcellulose
142.60880009032-42-2Hydroxyethylmethylcellulose
143.61120009005-27-0Hydroxyethyl starch
144.61390037353-59-6Hydroxymethylcellulose
145.61680009004-64-2Hydroxypropylcellulose
146.61800009049-76-7Hydroxypropyl starch
147.61840000106-14-912-Hydroxystearic acid
148.62140006303-21-5Hypophosphorous acid
149.62240001332-37-2Iron oxide
150.62450000078-78-4Isopentane
151.62640008001-39-6Japan wax
152.62720001332-58-7Kaolin
153.62800Kaolin, calcined
154.62960000050-21-5Lactic acid
155.63040000138-22-7Lactic acid, butyl ester
156.63280000143-07-7Lauric acid
157.63760008002-43-5Lecithin
158.63840000123-76-2Levulinic acid
159.63920000557-59-5Lignoceric acid
160.64015000060-33-3Linoleic acid
161.64150028290-79-1Linolenic acid
162.64500Lysine, salts
163.64640001309-42-8Magnesium hydroxide
164.64720001309-48-4Magnesium oxide
165.65020006915-15-7Malic acid
166.65040000141-82-2Malonic acid
167.65520000087-78-5Mannitol
168.66200037206-01-2Methylcarboxymethylcellulose
169.66240009004-67-5Methylcellulose
170.66640009004-59-5Methylethylcellulose
171.66695Methylhydroxymethylcellulose
172.66700009004-65-3Methylhydroxypropylcellulose
173.67120012001-26-2Mica
174.67200001317-33-5Molybdenum disulphide
175.67840Montanic acids and/or their esters with ethyleneglycol and/or with 1,3-butanediol and/or with glycerol
176.67850008002-53-7Montan wax
177.67891000544-63-8Myristic acid
178.68040003333-62-87-[2H-Naphtho-(1,2-D)triazol-2-yl]-3-phenylcoumarin
179.68125068187-64-4Nepheline syenite
180.68960000301-02-0Oleamide
181.69040000112-80-1Oleic acid
182.69760000143-28-2Oleyl alcohol
183.70000070331-94-12,2'-Oxamidobis[ethyl-3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
184.70240012198-93-5Ozokerite
185.70400000057-10-3Palmitic acid
186.71020000373-49-9Palmitoleic acid
187.71440009000-69-5Pectin
188.71600000115-77-5Pentaerythritol
189.71680006683-19-8Pentaerythritol tetrakis [3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
190.71720000109-66-0Pentane
191.72640007664-38-2Phosphoric acid
192.74240031570-04-4Phosphorous acid, tris(2,4-di-tert-butylphenyl) ester
193.74480000088-99-3o-Phthalic acid
194.76320000085-44-9Phthalic anhydride
195.76720009016-00-6Polydimethylsiloxane
063148-62-9” ” ”
196.76960025322-68-3Polyethyleneglycol
197.77600061788-85-0Polyethyleneglycol ester of hydrogenated castor oil
198.77702Polyethyleneglycol esters of aliphatic moncarboxylic acids (C6-C22), and their ammonium and sodium sulphates
199.79040009005-64-5Polyethleneglycol sorbitan monolaurate
200.79120009005-65-6Polyethyleneglycol sorbitan monooleate
201.79200009005-66-7Polyethyleneglycol sorbitan monopalmitate
202.79280009005-67-8Polyethyleneglycol sorbitan monostearate
203.79360009005-70-3Polyethyleneglycol sorbitan trioleate
204.79440009005-71-4Polyethyleneglycol sorbitan tristearate
205.80240029894-35-7Polyglycertol ricinoleate
206.80640Polyoxyalkl(C2-C4)dimethylpolysiloxane
207.80720008017-16-1Polyphosphoric acids
208.80800025322-69-4Polypropyleneglycol
209.81520007758-02-3Potassium bromide
210.81600001310-58-3Potassium hydroxide
211.81840000057-55-61,2-Propanediol
212.81882000067-63-02-Propanol
213.82000000079-09-4Propionic acid
214.82080009005-37-21,2-Propyleneglycol alginate
215.82240022788-19-81,2-Propyleneglycol dilaurate
216.82400000105-62-41,2-Propyleneglycol dioleate
217.82560033587-20-11,2-Propyleneglycol dipalmitate
218.82720006182-11-21,2-Propyleneglycol distearate
219.82800027194-74-71,2-Propyleneglycol monolaurate
220.82960001330-80-91,2-Propyleneglycol monooleate
221.83120029013-28-31,2-Propyleneglycol monopalmitate
222.83300001323-39-31,2-Propyleneglycol monostearate
223.83320Propylhydroxyethylcellulose
224.83325Propylhydroxymethylcellulose
225.83330Propylhydroxypropylcellulose
226.83440002466-09-3Pyrophosphoric acid
227.83455013445-56-2Pyrophosphorous acid
228.83460012269-78-2Pyrophyllite
229.83470014808-60-7Quartz
230.83610073138-82-6Resin acids and rosin acids
231.83840008050-09-7Rosin
232.84000008050-31-5Rosin, ester with glycerol
233.84080008050-26-8Rosin, ester with pentaerythritol
234.84210065997-06-0Rosin, hydrogenated
235.84240065997-13-9Rosin, hydrogenated, ester with glycerol
236.84320008050-15-5Rosin, hydrogenated, ester with methanol
237.84400064365-17-9Rosin, hydrogenated, ester with pentaerythritol
238.84560009006-04-6Rubber, natural
239.84640000069-72-7Salicylic acid
240.85600Silicates, natural
241.85980Silicic acid, salts
242.86000Silicic acid, silylated
243.86160000409-21-2Silicon carbide
244.86240007631-86-9Silicon dioxide
245.86560007647-15-6Sodium bromide
246.86720001310-73-2Sodium hydroxide
247.87200000110-44-1Sorbic acid
248.87280029116-98-1Sorbitan dioleate
249.87520062568-11-0Sorbitan monobehenate
250.87600001338-39-2Sorbitan monolaurate
251.87680001338-43-8Sorbitan monooleate
252.87760026266-57-9Sorbitan monopalmitate
253.87840001338-41-6Sorbitan monostearate
254.87920061752-68-9Sorbitan tetrastearate
255.88080026266-58-0Sorbitan trioleate
256.88160054140-20-4Sorbitan tripalmitate
257.88240026658-19-5Sorbitan tristearate
258.88320000050-70-4Sorbitol
259.88600026836-47-5Sorbitol monostearate
260.88800009005-25-8Starch, edible
261.88880068412-29-3Starch, hydrolysed
262.88960000124-26-5Stearamide
263.89040000057-11-4Stearic acid
264.90720058446-52-9Stearoylbenzoylmethane
265.90800005793-94-2Stearoyl-2-lactylic acid, calcium salt
266.90960000110-15-6Succinic acid
267.91200000126-13-6Sucrose acetate isobutyrate
268.91360000126-14-7Sucrose octaacetate
269.91840007704-34-9Sulphur
270.91920007664-93-9Sulphuric acid
271.92080014807-96-6Talc
272.92160000087-69-4Tartaric acid
273.92195Taurine, salts
274.92205057569-40-1Terephthalic acid, diester with 2,2'-methylenebis(4-methyl-6-tert-butylphenol)
275.92350000112-60-7Tetraethyleneglycol
276.92640000102-60-3N,N,N',N'-Tetrakis(2-hydroxypropyl)ethylenediamine
277.93440013463-67-7Titanium dioxide
278.93520000059-02-9alpha-Tocopherol
010191-41-0 ” ”
279.93680009000-65-1Tragacanth gum
280.94320000112-27-6Triethyleneglycol
281.95200001709-70-21,3,5-Trimethyl-2,4,6-tris(3,5-di-tert-butyl-4-hydroxybenzyl)benzene
282.95905013983-17-0Wollastonite
283.95920Wood flour and fibres, untreated
284.95935011138-66-2Xanthan gum
285.96190020427-58-1Zinc hydroxide
286.96240001314-13-2Zinc oxide
287.96320001314-98-3Zinc sulphide

PART IISUPPLEMENTARY

1.  In regulation 5 and Part I of this Schedule—

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

3.  If, as indicated in paragraph 2 of Annex III to the Directive, a substance is identified in Part I of this Schedule as an “. . . acid, salt” and has salts of one or more of the following names (that is to say, salts of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium or zinc), then the free acid corresponding to that substance is not treated as included in the specification of that substance.

Regulations 6 and 7

SCHEDULE 3PROVISIONS APPLICABLE WHEN TESTING COMPLIANCE WITH THE MIGRATION LIMITS

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:

Where:

  • M is the migration in mg/kg;

  • m is the mass in mg of substance released by the sample as determined by the migration test;

  • a1 is the surface area in square decimetres of the sample in contact with the food or simulant during the migration test;

  • a2 is the surface area in square decimetres of the plastic material or article in actual conditions of use;

  • q is the quantity in grams of food in contact with the plastic material or article in actual conditions of use.

3.—(1) Subject to sub-paragraph (2) below, any testing of migration from any plastic material or article shall be carried out on that plastic material or article.

(2) In any case where determination in accordance with sub-paragraph (1) above is 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) above, analytical determination of the total quantity of substances (overall migration), each specific quantity of a substance (specific migration) or, as the case may be, both that total and that specific quantity released by the sample shall be carried out on the simulant or food, as the case may be.

(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 below) 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) below, 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 above, the test shall be so modified as to enable the level of migration occurring during the third such test to be determined and, subject to sub-paragraph (2) below, such a determination may be used to prove excess of an overall migration limit in relation to a plastic material or article.

(2) In any proceedings for an offence under these Regulations where it is alleged, following determination under sub-paragraph (1) above, 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 samples of the plastic material or article had been procured,

(b)one of them had been subjected to the appropriate test according with paragraph 4 above and the overall migration determined (M1),

(c)the second and third samples had been subjected to the same conditions of temperature but the period of contact had been two and three times that specified and overall migration had been determined in each case (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 that overall migration limit,

the plastic material or article would not have been deemed to exceed that limit.

8.—(1) Any plastic material or article which exceeds its overall migration limit by an amount not exceeding the analytical tolerance specified in sub-paragraph (2) below shall be deemed for the purposes of these Regulations not to exceed its overall migration limit.

(2) The following analytical tolerances shall be applied for limits of overall migration—

(a)20 mg/kg or, as the case may be, 3 milligrams per square decimetre in migration tests using as a 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.

Regulations 6 and 7

SCHEDULE 4OVERALL AND SPECIFIC MIGRATION TESTING USING FOOD SIMULANTS

PART IBasic Rules

1.  Subject to paragraphs 2, 3 and 4 of this Part of this Schedule, 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 of this Schedule and under conventional migration test conditions as specified in Part V of this Schedule.

2.  Subject to paragraphs 3 and 4 of this Part of this Schedule, substitute tests which use test media under the conventional substitute test conditions as specified in Part VI of this Schedule shall be carried out if the migration test using the fatty food simulants specified in Part III of this Schedule is not feasible for technical reasons connected with the method of analysis.

3.  Subject to paragraph 4 of this Part of this Schedule, alternative tests as specified in Part VII of this Schedule may be used instead of the migration test with fatty food simulants specified in Part III of this Schedule 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 of this Schedule 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 IIFood Simulants to be used in Migration Testing

1.  Subject to Parts III, IV, V, VI and VII of this Schedule, the simulants to be used in migration testing are specified in the Table to this paragraph (referred to in this Part of this Schedule as “the Table”).

TABLE

AbbreviationFood 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 of this Part of this Schedule or, subject to paragraph 5 of this Part of this Schedule, any of the fatty food simulants specified in paragraph 4 of this Part of this Schedule

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 residue681012141618others
GLC area (%)∼16–98–1145–5212–158–108–12<=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 point28 ± 2°C

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

Wavelength (nm)290310330350370390430470510
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 of this Part of this Schedule 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 IIISelection 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 of this Schedule using a simulant or simulants selected in accordance with this Part of this Schedule 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 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 of this Schedule;

(b)a reduction factor is specified for a food or group of foods where, in the Table to Part IV of this Schedule—

(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 factor 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 of this Schedule as “Table 1”).

TABLE 1
DefinitionMeaning
Aqueous foods having a pH> 4.5Foods in relation to which simulant A only is specified in the Table to Part IV of this Schedule
Acidic foods having a pH<= 4.5Foods in relation to which simulant B only is specified in the Table to Part IV of this Schedule
Alcoholic foodsFoods in relation to which simulant C only is specified in the Table to Part IV of this Schedule
Fatty foodsFoods in relation to which simulant D only is specified in the Table to Part IV of this Schedule
Dry foodsFoods in relation to which no simulant is specified in the Table to Part IV of this Schedule

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 of this Schedule, 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 or 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 of this Schedule and, for the purposes of Part IV of this Schedule, 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 of this Schedule, the simulant or simulants in column 2 of Table 2 to this Part of this Schedule 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 and 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 of this Schedule opposite the contact food in column 1 of that Table which corresponds most closely to the type or types 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 of this Part of this Schedule, stating any food or group of foods described in the Table to Part IV of this Schedule 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 of this Schedule, 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 of this Schedule, a simulant other than the simulant or simulants which, for the purposes of Part IV of this Schedule, is or are specified in relation to that food or group of foods.

8.  A specific indication referred to in paragraph 7 of this Part of this Schedule 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 of these Regulations or the decription 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 of this Schedule.

TABLE 2
Simulants to be selected for testing food contact materials in special cases
Contact foodsSimulant
Only aqueous foodsSimulant A
Only acidic foodsSimulant B
Only alcoholic foodsSimulant C
Only fatty foodsSimulant D
All aqueous and acidic foodsSimulant B
All alcoholic and aqueous foodsSimulant C
All alcoholic and acidic foodsSimulants C and B
All fatty and aqueous foodsSimulants D and A
All fatty and acidic foodsSimulants D and B
All fatty, alcoholic and aqueous foodsSimulants D and C
All fatty, alcoholic and acidic foodsSimulants D, C and B

PART IVSimulants to be used in relation to a specific food or a specific group of foods

1.  For the purposes of this Part of this Schedule 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 of this Schedule, and the Table shall be read in conjunction with the notes thereto and the following paragraphs of this Part of this Schedule.

2.  For the purposes of this Part of this Schedule—

(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 of this Schedule;

(b)a reduction factor is specified in relation to a specific food or group of foods where, in the Table to this Part of this Schedule—

(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 allowed by an oblique stroke and a reduction factor.

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

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

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

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

Table

Simulants to be used
Reference NumberDescription of foodABCD

NOTES:

(*)

Simulant B shall not be used where the pH is more than 4.5.

(**)

This test shall be carried out in the case of liquids or beverages of an alcoholic strength exceeding 10% vol. with aqueous solutions of ethanol of a similar strength.

(***)

If it can be demonstrated under regulation 11 or proved by means of an appropriate test that there is to be no fatty contact with the plastic material or article, simulant D shall not be used.

01Beverages
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 alcoholic strength equal to or exceeding 5% vol.:

  • Beverages shown under heading 01.01 but with an alcoholic strength equal to or exceeding 5% vol.:

    • Wines, spirits and liqueurs

X(*)X(**)
01.03Miscellaneous: undenatured ethyl alcoholX(*)X(**)
02Cereals, cereal products, pastry, biscuits, cakes and other bakers' wares
02.01Starches
02.02Cereals, unprocessed, puffed, in flakes (including popcorn, cornflakes and the like)
02.03Cereal flour and meal
02.04Macaroni, spaghetti and similar products
02.05Pastry, biscuits, cakes and other bakers' wares, dry:
A. With fatty substances on the surfaceX/5
B. Other
02.06Pastry, cakes and other bakers' wares, fresh:
A. With fatty substances on the surfaceX/5
B. OtherX
03Chocolate, sugar and products thereof Confectionery products
03.01Chocolate, chocolate-coated products, substitutes and products coated with substitutesX/5
03.02Confectionery products:
A. In solid form:
I. With fatty substances on the surfaceX/5
II. Other
B. In paste form
I. With fatty substances on the surfaceX/3
II. MoistX
03.03Sugar and sugar products
A. In solid form
B. Honey and the likeX
C. Molasses and sugar syrupsX
04Fruit, vegetables and products thereof
04.01Whole fruit, fresh or chilled
04.02Processed fruit:
A. Dried or dehydrated fruit, whole or in the form of flour or powder
B. Fruit in the form of chunks, puree or pasteX(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 mediumX(a)X(a)
II. In an oily mediumX(a)X(a)X
III. In an alcoholic medium (>=5% vol.)X(*)X
04.03Nuts (peanuts, chestnuts, almonds, hazelnuts, walnuts, pine kernels and others)
A. Shelled, dried
B. Shelled and roastedX/5(***)
C. In paste or cream formXX/3(***)
04.04Whole vegetables, fresh or chilled
04.05Processed vegetables:
A. Dried or dehydrated vegetables whole or in the form of flour or powder
B. Vegetables, cut, in the form of puréesX(a)X(a)
C. Preserved vegetables:
I. In an aqueous mediumX(a)X(a)
II. In an oily mediumX(a)X(a)X
III. In an alcoholic medium (>=5% vol.)X(*)X
05Fats and oils
05.01Animal and vegetable fats and oils, whether natural or treated (including cocoa butter, lard, resolidified butter)X
05.02Margarine, butter and other fats and oils made from water emulsions in oilX/2
06Animal products and eggs
06.01Fish:
A. Fresh, chilled, salted, smokedXX/3(***)
B. In the form of pasteXX/3(***)
06.02Crustaceans and molluscs (including oysters, mussels, snails) not naturally protected by their shellsX
06.03Meat of all zoological species (including poultry and game):
A. Fresh, chilled, salted, smokedXX/4
B. In the form of paste, creamsXX/4
06.04Processed meat products (ham, salami, bacon and other)XX/4
06.05Preserved and part-preserved meat and fish:
A. In an aqueous mediumX(a)X(a)
B. In an oily mediumX(a)X(a)X
06.06Eggs not in shell:
A. Liquid
B. OtherX
06.07Egg yolks:
A. LiquidX
B. Powdered or frozen
06.08Dried white of egg
07Milk products
07.01Milk:
A. WholeX
B. Partly driedX
C. Skimmed or partly skimmedX
D. Dried
07.02Fermented milk such as yoghurt, buttermilk and such products in association with fruit and fruit productsX
07.03Cream and sour creamX(a)X(a)
07.04Cheeses:
A. Whole, with rind
B. Processed cheesesX(a)X(a)
C. All othersX(a)X(a)X/3(***)
07.05Rennet:
A. In liquid or viscous formX(a)X(a)
B. Powdered or dried
08Miscellaneous products
08.01VinegarX
08.02Fried or roasted foods:
A. Fried potatoes, fritters and the likeX/5
B. Of animal originX/4
08.03Preparations 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 surfaceX/5
II. Other
B. Liquid or paste:
I. With fatty substances on the surfaceX(a)X(a)X/3
II. OtherX(a)X(a)
08.04Yeasts and raising agents
A. In paste formX(a)X(a)
B. Dried
08.05Salt
08.06Sauces:
A. Without fatty substances on the surfaceX(a)X(a)
B. Mayonnaise, sauces derived from mayonnaise, salad creams and other oil in water emulsionsX(a)X(a)X/3
C. Sauce containing oil and water forming two distinct layersX(a)X(a)X
08.07Mustard (except powdered mustard under heading 08.17)X(a)X(a)X/3(***)
08.08Sandwiches, toasted bread and the like containing any kind of foodstuff:
A. With fatty substances on the surfaceX/5
B. Other
08.09Ice-creamsX
08.10Dried foods:
A. With fatty substances on the surfaceX/5
B. Other
08.11Frozen or deep-fozen foods
08.12Concentrated extracts of an alcoholic strength equal to or exceeding 5% vol.X(*)X
08.13Cocoa:
A. Cocoa powderX/5(***)
B. Cocoa pasteX/3(***)
08.14Coffee, whether or not roasted, decaffeinated or soluble, coffee substitutes, granulated or powdered
08.15Liquid coffee extractsX
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 other

PART VMigration Test Conditions (Times and Temperatures)

A. General criteria

1.  Subject to paragraphs 2, 4, 6 and 7 below 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 the time and temperature selected from column 2 of the Table to this Part of this Schedule 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 of this Schedule 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 of this Schedule 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 of this Schedule, 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 of this Schedule causes any physical or other change in the test specimen which does not occur under the worst forseeable 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 test other than for 10 days test at 40°C shall be carried out.

8.  The Table to this Part of this Schedule shall be read with the notes to it.

TABLE
Conditions of contact in worst foreseeable useTest conditions
Contact timeTest time
t<=5 minutes(*)
5 minutes<t<=0.5 hours0.5 hours
0.5 hours<t<=0.5 hours1 hour
1 hour<t<=2 hours2 hours
2 hours<t<=4 hours4 hours
4 hours<t<=24 hours24 hours
t>24 hours10 days
contact temperatureTest temperature

NOTES:

(1)

The period of time which represents the worst foreseeable conditions of contact.

(2)

This temperature shall be used only for simulant D. For simulant A, B or C the test may be replaced by a test at 100°C or at reflux temperature for a duration of four times the time selected in accordance with paragraph 1 of this Part of this Schedule.

T<=5°C5°C
5°C<T<=20°C20°C
20°C<T<=40°C40°C
40°C<T<=70°C70°C
70°C<T<=100°C100°C or reflux temperature
100°C<T<=121°C121°C(2)
121°C<T<=130°C130°C(2)
130°C<T<=150°C150°C(2)
T>150°C175°C(2)

PART VISubstitute Fat Test for Overall and Specific Migration

1.  Subject to paragraphs 2, 4 and 5 below, all the test media specified in the Table to this Part of this Schedule 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 of this Schedule 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 of this Schedule shall be applied for each test medium;

(c)subject to paragraph 4 below, 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 of this Schedule 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 of this Schedule shall be read with the notes to it.

TABLE

Conventional conditions for substitute tests

Test conditions with simulant DTest conditions with isooctaneTest conditions with ethanol 95%Test conditions with MPPO(1)

NOTES:

(1)

MPPO = Modified polyphenylene oxide

(2)

The volatile test media are used up to a maximum temperature of 60°C. A precondition of using these tests is that the material or article will withstand the test conditions that would otherwise be used with simulant D. Immerse a test specimen in olive oil under the appropriate conditions. If the physical properties are changed (e.g. melting, deformation) then the material is considered unsuitable for use at that temperature. If the physical properties are not changed then proceed with the substitute tests using new specimens.

10 days at 5°C0.5 days at 5°C10 days at 5°C
10 days at 20°C1 day at 20°C10 days at 20°C
10 days at 40°C2 days at 20°C10 days at 40°C
2 hours at 70°C0.5 hours at 40°C2 hours at 60°C
0.5 hours at 100°C0.5 hours at 60°C (2)2.5 hours at 60°C0.5 hours at 100°C
1 hour at 100°C1 hour at 60°C (2)3 hours at 60°C (2)1 hour at 100°C
2 hours at 100°C1.5 hours at 60°C (2)3.5 hours at 60°C (2)2 hours at 100°C
0.5 hours at 121°C1.5 hours at 60°C (2)3.5 hours at 60°C (2)0.5 hours at 121°C
1 hour at 121°C2 hours at 60°C (2)4 hours at 60°C (2)1 hour at 121°C
2 hours at 121°C2.5 hours at 60°C (2)4.5 hours at 60°C (2)2 hours at 121°C
0.5 hours at 130°C2 hours at 60°C (2)4 hours at 60°C (2)0.5 hours at 130°C
1 hour at 130°C2.5 hours at 60°C (2)4.5 hours at 60°C (2)1 hour at 130°C
2 hours at 150°C3 hours at 60°C (2)5 hours at 60°C (2)2 hours at 150°C
2 hours at 175°C4 hours at 60°C (2)6 hours at 60°C (2)2 hours at 175°C

PART VIIAlternative Fat Tests for Overall and Specific Migration

1.  Subject to paragraph 2 of this Part of this Schedule the conditions which must be fulfilled to allow the result of either test specified in paragraph 3 of this Part of this Schedule to be used as an alternative to the result of a migration test carried out under Part III of this Schedule are that—

(a)the result obtained in a “comparison test” shows that the values are equal to or greater than those obtained in the test with simulant D; and

(b)the migration occurring in either test specified in paragraph 3 of this Part of this Schedule does not, after application of the appropriate reduction factor, exceed the appropriate migration limit.

2.  The condition in sub-paragraph (a) of paragraph 1 of this Part of this Schedule 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 tests specified in paragraph 3 of this Part of this Schedule are equal to or greater than those obtained in any of the migration tests specified in Part III of this Schedule.

3.  The migration tests referred to in paragraphs 2 and 3 of this Part of this Schedule 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 to 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.

Explanatory Note

(This note is not part of the Regulations)

These Regulations, which apply to Great Britain, come into force on 1st July 1998.

These Regulations implement—

(a)Council Directive (EEC) 82/711 (OJ No. L297, 23.10.82, p.26), as amended by Commission Directives 93/8/EEC (OJ No. L90, 14.4.93, p.22) and 97/48/EC (OJ No. L222, 12.8.97, p.10), laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs;

(b)Council Directive (EEC) 85/572 (OJ No. L372, 31.12.85, p.14) 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; and

(c)Commission Directive (EEC) 90/128 (OJ No. L75, 21.3.90, p.19, to be read with the corrigendum in OJ No. L349, 13.12.90, p.26), as amended by Commission Directives (EEC) 92/39 (OJ No. L168, 23.6.92, p.21), 93/9 (OJ No. L90, 14.4.93, p.26), 95/3/EEC (OJ No. L41, 23.2.95, p.44) and 96/11/EC (OJ No. L61, 12.3.96, p.26), relating to plastic materials and articles intended to come into contact with foodstuffs.

These Regulations—

(a)prohibit the use, sale or importation of plastic materials and articles which do not meet specified standards and provide a defence in relation to plastic materials and articles intended for export (regulation 3(1), (2) and (4));

(b)prohibit the manufacture of plastic materials and articles with any monomer other than one which meets specified requirements and provide a defence in relation to plastic materials and articles manufactured before 1st July 1998 and in accordance with regulation 5 of the Plastic Materials and Articles in Contact with Food Regulations 1992 (regulations 3(3) and 4);

(c)prohibit the use in the manufacture of plastic materials or articles of any specified additive which is not of good technical quality (regulation 5);

(d)provide the methods for testing the capability of plastic materials or articles of transferring constituents to food (regulation 6);

(e)stipulate the overall migration limit for plastic materials and articles (regulation 7);

(f)require, at marketing stages other than retail, persons in possession of any plastic material or article intended to come into contact with food to ensure such material or article is accompanied by a specified declaration (regulation 8);

(g)identify the enforcement authorities (regulation 9);

(h)provide offences and defences and specify penalties (regulation 10);

(i)provide that specified presumptions shall arise from particulars shown in relation to a plastic material or article in accordance with the Materials and Articles in Contact with Food Regulations 1987 (“the 1987 Regulations”) (regulation 11);

(j)apply provisions of the 1987 Regulations and of the Food Safety Act 1990 (regulation 12); and

(k)amend and revoke other legislation (regulations 13 and 14).

The materials and articles to which these Regulations relate are also subject to the 1987 Regulations.

These Regulations are made under specified provisions of the Food Safety Act 1990 and—insofar as they cannot be made under those provisions—section 2(2) of the European Communities Act 1972. The provisions included under the 1972 Act are those which key into provisions of the 1987 Regulations (save where covered by section 48(1)(a) of the 1990 Act) and revocations of regulations made under section 2(2) of the 1972 Act.

A regulatory appraisal, which includes a compliance cost assessment, has been placed in the library of each House of Parliament and copies can be obtained from the Additives and Novel Foods Division of the Ministry of Agriculture, Fisheries and Food, Ergon House, 17 Smith Square, London SW1P 3JR.

(1)

1990 c. 16; “the Ministers” is defined in section 4(1) of the Act; section 6(4)(a) was amended by paragraph 6 of Schedule 9 to the Deregulation and Contracting Out Act 1994 (c. 40).

(4)

OJ No. L297, 23.10.82, p.26.

(5)

OJ No. L90, 14.4.93, p.22.

(6)

OJ No. L222, 12.8.97, p.10.

(7)

OJ No. L75, 21.3.90, p.19.

(8)

Corrigendum in OJ No. L349, 13.12.90, p.26; amending Directives in OJ No. L168, 23.6.92, p.21, OJ No. L90, 14.3.93, p.26, OJ No. L41, 23.2.95, p.44 and OJ No. L61, 12.3.96, p.26.

(9)

OJ No. L1, 3.1.94, p.1.

(10)

OJ No. L1, 3.1.94, p.571.

(11)

S.I. 1987/1523; relevant amending instruments are S.I. 1990/2487 and 1994/979.

(13)

OJ No. L372, 30.12.85, p.14.

(14)

S.I. 1990/2463; relevant amending instruments is S.I. 1995/360.

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