The Plastic Materials and Articles in Contact with Food Regulations 1998

Link to law: http://www.legislation.gov.uk/uksi/1998/1376/made/data.htm?wrap=true
Published: 1998-06-01

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

1
2
3
4

Item
PM/REF No.
CAS No.
Name
Restrictions

1.
10030
000514-10-3
Abietic acid

2.
10060
000075-07-0
Acetaldehyde

3.
10090
000064-19-7
Acetic acid

4.
10120
000108-05-4
Acetic acid, vinyl ester
The specific migration of this substance shall not exceed 12 mg/kg

5.
10150
000108-24-7
Acetic anhydride

6.
10210
000074-86-2
Acetylene

7.
10630
000079-06-1
Acrylamide
The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg)

8.
10660
015214-89-8
2-Acrylamido-2-methylpropane sulphonic acid
The specific migration of this substance shall not exceed 0.05 mg/kg

9.
10690
000079-10-7
Acrylic acid

10.
10750
002495-35-4
Acrylic acid, benzyl ester

11.
10780
000141-32-2
Acrylic acid, n-butyl ester

12.
10810
002998-08-5
Acrylic acid, sec-butyl ester

13.
10840
001663-39-4
Acrylic acid, tert-butyl ester

14.
11470
000140-88-5
Acrylic acid, ethyl ester

15.
As item 19
000818-61-1
Acrylic acid, hydroxyethyl ester

16.
11590
000106-63-8
Acrylic acid, isobutyl ester

17.
11680
000689-12-3
Acrylic acid, isopropyl ester

18.
11710
000096-33-3
Acrylic acid, methyl ester

19.
11830
000818-61-1
Acrylic acid, monoester with ethylene glycol

20.
11890
002499-59-4
Acrylic acid, n-octyl ester

21.
11980
000925-60-0
Acrylic acid, propyl ester

22.
12100
000104-13-1
Acrylonitrile
The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included)

23.
12130
000124-04-9
Adipic acid

24.
12280
002035-75-8
Adipic anhydride

25.
12310

Albumin

26.
12340

Albumin, coagulated by formaldehyde

27.
12375

Alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C22)

28.
12670
002855-13-2
1-Amino-3-aminomethyl-3,5,5-trimethylcyclohexane
The specific migration of this substance shall not exceed 6 mg/kg

29.
12788
002432-99-7
11-Aminoundecanoic acid
The specific migration of this substance shall not exceed 5 mg/kg

30.
12789
007664-41-7
Ammonia

31.
12820
000123-99-9
Azelaic acid

32.
12970
004196-95-6
Azelaic anhydride

33.
13000
001477-55-0
1,3-Benzenedimethanamine
The specific migration of this substance shall not exceed 0.05 mg/kg

34.
13090
000065-85-0
Benzoic acid

35.
13150
000100-51-6
Benzyl alcohol

36.
As item 79
000111-46-6
Bis(2-hydroxyethyl) ether
As item 79

37.
As item 217
000077-99-6
2,2-Bis(hydroxymethylbutan-1-ol)
As item 217

38.
13390
000105-08-8
1,4-Bis(hydroxymethyl)-cyclohexane

39.
13480
000080-05-7
2,2-Bis(4-hydroxyphenyl)-propane
The specific migration of this substance shall not exceed 3 mg/kg

40.
13510
001675-54-3
2,2-Bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether
The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg or the specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included)

41.
13530
038103-06-9
2,2-Bis(4-hydroxyphenyl)propane bis(phthalic anhydride)
The specific migration of this substance shall not exceed 0.05 mg/kg

42.
As item 93
000110-98-5
Bis(hydroxypropyl) ether

43.
As item 78
005124-30-1
Bis(4-isocyanatocyclohexyl)methane
As item 78

44.
13600
047465-97-4
3,3-Bis(3-methyl-4-hydroxyphenyl)-indolin-2-one
The specific migration of this substance shall not exceed 1.8 mg/kg

45.
As item 39
000080-05-7
Bisphenol A
As item 39

46.
As item 40
001675-54-3
Bisphenol A bis(2,3-epoxypropyl) ether
As item 40

47.
13614
038103-06-9
Bisphenol A bis(phthalic anhydride)
As item 41

48.
13630
000106-99-0
Butadiene
The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg or the specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included)

49.
13690
000107-88-0
Butan-1,3-diol

50.
13840
000071-36-3
Butan-1-ol

51.
13870
000106-98-9
But-1-ene

52.
13900
000107-01-7
But-2-ene

53.
14110
000123-72-8
Butyraldehyde

54.
14140
000107-92-6
Butyric acid

55.
14170
000106-31-0
Butyric anhydride

56.
14200
000105-60-2
Caprolactam
The specific migration of this substance alone or together with item 57 shall not exceed a total of 15 mg/kg

57.
14230
002123-24-2
Caprolactam, sodium salt
The specific migration of this substance alone or together with item 56 shall not exceed a total of 15 mg/kg (expressed as caprolactam)

58.
14320
000124-07-2
Caprylic acid

59.
14350
000630-08-0
Carbon monoxide

60.
14380
000075-44-5
Carbonyl chloride
The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg

61.
14411
008001-79-4
Castor oil

62.
14500
009004-34-6
Cellulose

63.
14530
007782-50-5
Chlorine

64.
As item 94
000106-89-8
1-Chloro-2,3-epoxypropane
As item 94

65.
14680
000077-92-9
Citric acid

66.
14710
000108-39-4

m-Cresol

67.
14740
000095-48-7

o-Cresol

68.
14770
000106-44-5

p-Cresol

69.
As item 38
000105-08-8
1,4-Cyclohexanedimethanol

70.
14950
003173-53-3
Cyclohexyl isocyanate
The quantity in the finished plastic material or article of any substance within, or any combination of substances within, items 70, 78, 88, 90, 91, 92, 117, 150, 153, 211, 212 and 213 and shall not exceed 1 mg/kg (expressed as isocyanate moiety)

71.
15070
001647-16-1
Dec-1,9-diene
The specific migration of this substance shall not exceed 0.05 mg/kg

72.
15095
000334-48-5
Decanoic acid

73.
15100
000112-30-1
Decan-1-ol

74.
15250
000110-60-1
1,4-Diaminobutane

75.
As item 97
000107-15-3
1,2-Diaminoethane
As item 97

76.
As item 116
000124-09-4
1,6-Diaminohexane
As item 116

77.
15565
000106-46-7
1,4-Dichlorobenzene
The specific migration of this substance shall not exceed 12 mg/kg

78.
15700
005124-30-1
Dicyclohexylmethane-4,4'-diisocyanate
As item 70

79.
15760
000111-46-6
Diethylene glycol
The specific migration of this substance alone or together with item 98 shall not exceed a total of 30 mg/kg

80.
15790
000111-40-0
Diethylenetriamine
The specific migration of this substance shall not exceed 5 mg/kg

81.
15820
000345-92-6
4,4'-Difluorobenzophenone
The specific migration of this substance shall not exceed 0.05 mg/kg

82.
15880
000120-80-9
1,2-Dihydroxybenzene
The specific migration of this substance shall not exceed 6 mg/kg

83.
15910
000108-46-3
1,3-Dihydroxybenzene
The specific migration of this substance shall not exceed 2.4 mg/kg

84.
15940
000123-31-9
1,4-Dihydroxybenzene
The specific migration of this substance shall not exceed 0.6 mg/kg

85.
15970
000611-99-4
4,4'-Dihydroxybenzophenone
The specific migration of this substance shall not exceed 6 mg/kg

86.
16000
000092-88-6
4,4'-Dihydroxybiphenyl
The specific migration of this substance shall not exceed 6 mg/kg

87.
16150
000108-01-0
Dimethylaminoethanol
The specific migration of this substance shall not exceed 18 mg/kg

88.
16240
000091-97-4
3,3'-Dimethyl-4,4'-diisocyanatobiphenyl
As item 70

89.
16480
000126-58-9
Dipentaerythritol

90.
16570
004128-73-8
Diphenylether-4,4'-diisocyanate
As item 70

91.
16600
005873-54-1
Diphenylmethane-2,4'-diisocyanate
As item 70

92.
16630
000101-68-8
Diphenylmethane-4,4'-diisocyanate
As item 70

93.
16660
000110-98-5
Dipropyleneglycol

94.
16750
000106-89-8
Epichlorohydrin
The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg

95.
16780
000064-17-5
Ethanol

96.
16950
000074-85-1
Ethylene

97.
16960
000107-15-3
Ethylenediamine
The specific migration of this substance shall not exceed 12 mg/kg

98.
16990
000107-21-1
Ethylene glycol
The specific migration of this substance alone or together with item 79 shall not exceed a total of 30 mg/kg

99.
17005
000151-56-4
Ethyleneimine
The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg)

100.
17020
000075-21-8
Ethylene oxide
The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg

101.
17050
00104-76-7
2-Ethylhexan-1-ol
The specific migration of this substance shall not exceed 30 mg/kg

102.
17160
000097-53-0
Eugenol
The specific migration of this substance shall not exceed 0.01 mg/kg

103.
17170
061788-47-4
Fatty acids, coco

104.
17200
068308-53-2
Fatty acids, soya

105.
17230
061790-12-3
Fatty acids, tall oil

106.
17260
000050-00-0
Formaldehyde
The specific migration of this substance shall not exceed 15 mg/kg

107.
17290
000110-17-8
Fumaric acid

108.
17530
000050-99-7
Glucose

109.
18010
000110-94-1
Glutaric acid

110.
18070
000108-55-4
Glutaric anhydride

111.
18100
000056-81-5
Glycerol

112.
18250
000115-28-6
Hexachloroendomethylene-tetrahydrophthalic acid
The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg)

113.
18280
000115-27-5
Hexachloroendomethylene-tetrahydrophthalic anhydride
The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg)

114.
18310
036653-82-4
Hexadecan-l-ol

115.
18430
000116-15-4
Hexafluoropropylene
The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg)

116.
18460
000124-09-4
Hexamethylenediamine
The specific migration of this substance shall not exceed 2.4 mg/kg

117.
18640
000822-06-0
Hexamethylene diisocyanate
As item 70

118.
18670
000100-97-0
Hexamethylenetetramine
The specific migration of this substance shall not exceed 15 mg/kg (expressed as formaldehyde)

119.
As item 84
000123-31-9
Hydroquinone
As item 84

120.
18880
000099-96-7

p-Hydroxybenzoic acid

121.
19000
000115-11-7
Isobutene

122.
19210
001459-93-4
Isophthalic acid, dimethyl ester
The specific migration of this substance shall not exceed 0.05 mg/kg

123.
19270
000097-65-4
Itaconic acid

124.
19460
000050-21-5
Lactic acid

125.
19470
000143-07-7
Lauric acid

126.
19480
002146-71-6
Lauric acid, vinyl ester

127.
19510
011132-73-3
Lignocellulose

128.
19540
000110-16-7
Maleic acid
The specific migration of this substance alone or together with item 129 shall not exceed a total of 30 mg/kg

129.
19960
000108-31-6
Maleic anhydride
The specific migration of this substance alone or together with item 128 shall not exceed a total of 30 mg/kg (expressed as maleic acid)

130.
As item 215
000108-78-1
Melamine
As item 215

131.
20020
000079-41-4
Methacrylic acid

132.
20080
002495-37-6
Methacrylic acid, benzyl ester

133.
20110
000097-88-1
Methacrylic acid, butyl ester

134.
20140
002998-18-7
Methacrylic acid, sec-butyl ester

135.
20170
000585-07-9
Methacrylic acid, tert-butyl ester

136.
20890
000097-63-2
Methacrylic acid, ethyl ester

137.
21010
000097-86-9
Methacrylic acid, isobutyl ester

138.
21100
004655-34-9
Methacrylic acid, isopropyl ester

139.
21130
000080-62-6
Methacrylic acid, methyl ester

140.
21190
000868-77-9
Methacrylic acid, monoester with ethyleneglycol

141.
21280
002177-70-0
Methacrylic acid, phenyl ester

142.
21340
002210-28-8
Methacrylic acid, propyl ester

143.
21460
000760-93-0
Methacrylic anhydride

144.
21490
000126-98-7
Methacrylonitrile
The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included)

145.
21550
000067-56-1
Methanol

146.
21940
000924-42-5

N-Methylolacrylamide
The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg)

147.
22150
000691-37-2
4-Methylpent-1-ene
The specific migration of this substance shall not exceed 0.02 mg/kg

148.
22350
000544-63-8
Myristic acid

149.
22390
000840-65-3
2,6-Naphthalenedicarboxylic acid, dimethyl ester
The specific migration of this substance shall not exceed 0.05 mg/kg

150.
22420
003173-72-6
1,5-Naphthalene diisocyanate
As item 70

151.
22450
009004-70-0
Nitrocellulose

152.
22480
000143-08-8
Nonan-1-ol

153.
22570
000112-96-9
Octadecyl isocyanate
As item 70

154.
22600
000111-87-5
Octan-1-ol

155.
22660
000111-66-0
Oct-l-ene
The specific migration of this substance shall not exceed 15 mg/kg

156.
22763
000112-80-1
Oleic acid

157.
22780
000057-10-3
Palmitic acid

158.
22840
000115-77-5
Pentaerythritol

159.
22870
000071-41-0
Pentan-1-ol

160.
22960
000108-95-2
Phenol

161.
23050
000108-45-2
1,3-Phenylenediamine
The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg

162.
As item 60
000075-44-5
Phosgene
As item 60

163.
23170
007664-38-2
Phosphoric acid

164.
As item 204

Phthalic acid
As item 204

165.
23200
000088-99-3

o-Phthalic acid

166.
23230
000131-17-9
Phthalic acid, diallyl ester
The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01 mg/kg)

167.
23380
000085-44-9
Phthalic anhydride

168.
23470
000080-56-8

alpha-Pinene

169.
23500
000127-91-3

beta-Pinene

170.
23590
025322-68-3
Polyethylene glycol

171.
23650
025322-69-4
Polypropylene glycol (molecular weight greater than 400)

172.
23651
025322-69-4
Polypropyleneglycol

173.
23740
000057-55-6
Propan-1,2-diol

174.
23800
000071-23-8
Propan-1-ol

175.
23830
000067-63-0
Propan-2-ol

176.
23860
000123-38-6
Propionaldehyde

177.
23890
000079-09-4
Propionic acid

178.
23950
000123-62-6
Propionic anhydride

179.
23980
000115-07-1
Propylene

180.
24010
000075-56-9
Propylene oxide
The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg

181.
As item 82
000120-80-9
Pyrocatechol
As item 82

182.
24057
000089-32-7
Pyromellitic anhydride
The specific migration of this substance shall not exceed 0.05 mg/kg (expressed as pyromellitic acid)

183.
24070
073138-82-6
Resin acids and rosin acids

184.
As item 83
000108-46-3
Resorcinol
As item 83

185.
24100
008050-09-7
Rosin

186.
24130
008050-09-7
Rosin gum

187.
24160
008052-10-6
Rosin tall oil

188.
24190
009014-63-5
Rosin wood

189.
24250
009006-04-6
Rubber, natural

190.
24270
000069-72-7
Salicylic acid

191.
24280
000111-20-6
Sebacic acid

192.
24430
002561-88-8
Sebacic anhydride

193.
24475
001313-82-2
Sodium sulphide

194.
24490
000050-70-4
Sorbitol

195.
24520
008001-22-7
Soybean oil

196.
24540
009005-25-8
Starch, edible
The specific migration of this substance shall not exceed 0.05 mg/kg

197.
24550
000057-11-4
Stearic acid

198.
24610
000100-42-5
Styrene

199.
24820
000110-15-6
Succinic acid

200.
24850
000108-30-5
Succinic anhydride

201.
24880
000057-50-1
Sucrose

202.
24887
006362-79-4
5-Sulphoisophthalic acid, monosodium salt
The specific migration of this substance shall not exceed 5 mg/kg

203.
24888
003965-55-7
5-Sulphoisophthalic acid, monosodium salt, dimethyl ester
The specific migration of this substance shall not exceed 0.05 mg/kg

204.
24910
000100-21-0
Terephthalic acid
The specific migration of this substance alone or together with item 205 shall not exceed a total of 7.5 mg/kg

205.
24940
000100-20-9
Terephthalic acid dichloride
The specific migration of this substance alone or together with item 204 shall not exceed 7.5 mg/kg (expressed as terephthalic acid)

206.
24970
000120-61-6
Terephthalic acid, dimethyl ester

207.
25090
000112-60-7
Tetraethylene glycol

208.
25120
000116-14-3
Tetrafluoroethylene
The specific migration of this substance shall not exceed 0.05 mg/kg

209.
25150
000109-99-9
Tetrahydrofuran
The specific migration of this substance shall not exceed 0.6 mg/kg

210.
25180
000102-60-3

N,N,N',N'-Tetrakis(2-hydroxypropyl)-ethylenediamine

211.
25210
000584-84-9
2,4-Toluene diisocyanate
As item 70

212.
25240
000091-08-7
2,6-Toluene diisocyanate
As item 70

213.
25270
026747-90-0
2,4-Toluene diisocyanate dimer
As item 70

214.
25360

Trialkyl(C5-C15)acetic acid, 2,3-epoxypropyl ester
The specific migration of this substance shall not exceed 6 mg/kg

215.
25420
000108-78-1
2,4,6-Triamino-1,3,5-triazine
The specific migration of this substance shall not exceed 30 mg/kg

216.
25510
000112-27-6
Triethylene glycol

217.
25600
000077-99-6
1,1,1-Trimethylolpropane
The specific migration of this substance shall not exceed 6 mg/kg

218.
25910
024800-44-0
Tripropylene glycol

219.
25960
000057-13-6
Urea

220.
26050
000075-01-4
Vinyl chloride
The restrictions are those in regulation 5(1)(a) and (b) of the 1987 Regulations when analysed by the method referred to in regulation 14 of those Regulations

221.
26110
000075-35-4
Vinylidene chloride
The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg or the specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.05 mg/kg)

222.
26140
000075-38-7
Vinylidene fluoride
The specific migration of this substance shall not exceed 5 mg/kg

SECTION BMonomers authorised up to the end of 2001

1
2
3
4

Item
PM/REF No.
CAS No.
Name
Restrictions

1.
10599/90A
061788-89-4
Acids, fatty, unsaturated (C18), dimers, distilled

2.
10599/91
061788-89-4
Acids, fatty, unsaturated (C18), dimers, non-distilled

3.
10599/92A
068783-41-5
Acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled

4.
10599/93
068783-41-5
Acids, fatty, unsaturated (C18), dimers, hydrogenated, non-distilled

5.
11000
050976-02-8
Acrylic acid, dicyclopentadienyl ester

6.
11245
002156-97-0
Acrylic acid, dodecyl ester

7.
11500
000103-11-7
Acrylic acid, 2-ethylhexyl ester

8.
11530
000999-61-1
Acrylic acid, 2-hydroxypropyl ester

9.
12265
004074-90-2
Adipic acid, divinyl ester

10.
12910
001732-10-1
Azelaic acid, dimethyl ester

11.
As item 78
000528-44-9
1,2,4-Benzenetricarboxylic acid
As item 78

12.
13060
004422-95-1
1,3,5-Benzenetricarboxylic acid trichloride

13.
As item 23
000091-76-9
Benzoguanamine

14.
As item 28
000080-09-1
Bisphenol S

15.
13720
000110-63-4
Butan-1,4-diol

16.
13780
002425-79-8
Butan-1,4-diol, bis(2,3-epoxypropyl) ether
The quantity in the finished plastic material or article of any substance within, or any combination of substances within, items 16 and 56 shall not exceed 5 mg/kg (expressed as epoxy)

17.
13810
000505-65-7
Butan-1,4-diol formal

18.
13932
000598-32-3
But-3-en-2-ol

19.
14020
000098-54-4
4-tert-Butylphenol

20.
14260
000502-44-3
Caprolactone

21.
14800
003724-65-0
Crotonic acid

22.
15130
000872-05-9
Dec-1-ene

23.
15310
000091-76-9
2,4-Diamino-5-phenyl-1,3,5-triazine

24.
15370
003236-53-1
1,6-Diamino-2,2,4-trimethylhexane

25.
15400
003236-54-2
1,6-Diamino-2,4,4-trimethylhexane

26.
15610
000080-07-9
4,4'-Dichlorodiphenyl sulphone

27.
15730
000077-73-6
Dicyclopentadiene

28.
16090
000080-09-1
4,4'-Dihydroxydiphenyl sulphone

29.
16210
006864-37-5
3,3'-Dimethyl-4,4'-diamino-dicyclohexylmethane

30.
16360
000576-26-1
2,6-Dimethylphenol

31.
16390
000126-30-7
2,2-Dimethylpropan-1,3-diol

32.
16450
000646-06-0
1,3-Dioxolane

33.
16540
000102-09-0
Diphenyl carbonate

34.
16690
001321-74-0
Divinylbenzene

35.
16697
000693-23-2
Dodecanedioic acid

36.
17110
016219-75-3
5-Ethylidenebicyclo[2.2.1] hept-2-ene

37.
18220
068564-88-5

N-Heptylaminoundecanoic acid

38.
18370
000592-45-0
Hexa-1,4-diene

39.
18441
000085-42-7
Hexahydrophthalic anhydride

40.
18700
000629-11-8
Hexan-1,6-diol

41.
18820
000592-41-6
Hex-1-ene

42.
19060
000109-53-5
Isobutyl vinyl ether

43.
19150
000121-91-5
Isophthalic acid

44.
19180
000099-63-8
Isophthalic acid dichloride

45.
As item 60
000078-79-5
Isoprene

46.
19490
000947-04-6
Laurolactam

47.
19570
000999-21-3
Maleic acid, diallyl ester

48.
19600
000105-76-0
Maleic acid, dibutyl ester

49.
19990
000079-39-0
Methacrylamide

50.
20050
000096-05-9
Methacrylic acid, allyl ester

51.
20260
000101-43-9
Methacrylic acid, cyclohexyl ester

52.
20380
001189-08-8
Methacrylic acid, diester with butan-1,3-diol

53.
20410
002082-81-7
Methacrylic acid, diester with butan-1,4-diol

54.
20440
000097-90-5
Methacrylic acid, diester with ethyleneglycol

55.
20530
002867-47-2
Methacrylic acid, 2-(dimethylamino)ethyl ester

56.
20590
000106-91-2
Methacrylic acid, 2,3-epoxypropyl ester
As item 16

57.
21370
010595-80-9
Methacrylic acid, 2-sulphoethyl ester

58.
21400
054276-35-6
Methacrylic acid, sulphopropyl ester

59.
21520
001561-92-8
Methallylsulphonic acid, sodium salt
The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg

60.
21640
000078-79-5
2-Methylbut-1,3-diene

61.
21730
000563-45-1
3-Methylbut-1-ene

62.
As item 17
000505-65-7
1,4-(Methylenedioxy)butane

63.
21970
000923-02-4

N-Methylolmethacrylamide

64.
22210
000098-83-9

alpha-Methylstyrene

65.
22360
001141-38-4
2,6-Naphthalenedicarboxylic acid

66.
As item 31
000126-30-7
Neopentylglycol

67.
22428
051000-52-3
Neodecanoic acid, vinyl ester

68.
22720
000140-66-9
4-tert-Octylphenol

69.
22900
000109-67-1
Pent-1-ene

70.
22937
001623-05-8
Perfluoropropyl perfluorovinyl ether

71.
23770
000504-63-2
Propan-1,3-diol

72.
23920
000105-38-4
Propionic acid, vinyl ester

73.
24370
000106-79-6
Sebacic acid, dimethyl ester

74.
24760
026914-43-2
Styrenesulphonic acid

75.
25380

Trialkyl(C5-C15)acetic acid, vinyl ester (=vinyl versatate)

76.
25390
000101-37-1
Triallyl cyanurate

77.
25450
026896-48-0
Tricyclodecanedimethanol

78.
25540
000528-44-9
Trimellitic acid
The quantity of this substance alone or together with item 79 in the finished plastic material or article shall not exceed 5 mg/kg

79.
25550
000552-30-7
Trimellitic anhydride
The quantity of this substance alone or together with item 78 in the finished plastic material or article shall not exceed 5 mg/kg (expressed as trimellitic acid)

80.
25810
015625-89-5
1,1,1-Trimethylolpropane triacrylate

81.
25840
003290-92-4
1,1,1-Trimethylolpropane trimethacrylate

82.
25900
000110-88-3
Trioxane

83.
26170
003195-78-6

N-Vinyl-N-methylacetamide
The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg

SECTION CMonomers authorised up to the end of 1998

Item
PM/REF No.
CAS No.
Name
Restrictions

1
2
3
4

1.
10160
002206-94-2

alpha-Acetoxystyrene

2.
10162
010521-96-7

beta-Acetoxystyrene

3.
10480

Acids, aliphatic, monocarboxylic, saturated (C2-C24)

4.
10510

Acids, aliphatic, monocarboxylic, unsaturated (C3-C24)

5.
10599/70

Acids, fatty, unsaturated (C18)

6.
10930
003066-71-5
Acrylic acid, cyclohexyl ester

7.
11050
001070-70-8
Acrylic acid, diester with butan-1,4-diol

8.
11180
017831-71-9
Acrylic acid, diester with tetraethyleneglycol

9.
11195
068901-05-3
Acrylic acid, diester with tripropyleneglycol

10.
11520
002918-23-2
Acrylic acid, 2-hydroxyisopropyl ester (= acrylic acid, 2-hydroxy-1-methylethyl ester)

11.
11560
005888-33-5
Acrylic acid, isobornyl ester

12.
11620
001330-61-6
Acrylic acid, isodecyl ester

13.
11650
029590-42-9
Acrylic acid, isooctyl ester

14.
11695
003121-61-7
Acrylic acid, 2-methoxyethyl ester

15.
11740
010095-13-3
Acrylic acid, monoester with butan-1,3-diol

16.
11770
002478-10-6
Acrylic acid, monoester with butan-1,4-diol

17.
11800
013533-05-6
Acrylic acid, monoester with diethyleneglycol

18.
12010
040074-09-7
Acrylic acid, 2-sulphoethyl ester

19.
12040
039121-78-3
Acrylic acid, sulphopropyl ester

20.
12055
094160-26-6
Acrylic acid, triester with glycerol tris(2-hydroxypropyl) ether

21.
12062
075577-70-7
Acrylic acid, triester with 1,1,1-trimethylolpropane tris(2-hydroxyethyl) ether

22.
12160
002998-04-1
Adipic acid, diallyl ester

23.
12190
000105-97-5
Adipic acid, didecyl ester

24.
12220
027178-16-1
Adipic acid, diisodecyl ester

25.
12250
000123-79-5
Adipic acid, dioctyl ester

26.
12370

Alcohols, aliphatic, monohydric, saturated, linear, secondary or tertiary (C4-C22)

27.
12610
000107-18-6
Allyl alcohol

28.
12700
000150-13-0

p-Aminobenzoic acid

29.
12790
000080-46-6

p-tert-Amylphenol

30.
12850
029602-44-6
Azelaic acid,bis(2-hydroxyethyl) ester

31.
13328
000104-38-1
Bis(2-hydroxyethyl) ether of hydroquinone

32.
13660
000584-03-2
Butan-1,2-diol

33.
13750
000513-85-9
Butan-2,3-diol

34.
13960
001852-16-0

N-(Butoxymethyl)acrylamide

35.
15020
002182-05-0
Cyclohexyl vinyl ether

36.
15280
000542-02-9
2,4-Diamino-6-methyl-1,3,5-triazine

37.
15340
000109-76-2
1,3-Diaminopropane

38.
15490
002215-89-6
4,4'-Dicarboxydiphenyl ether

39.
15580
001653-19-6
2,3-Dichlorobuta-1,3-diene

40.
16270
000526-75-0
2,3-Dimethylphenol

41.
16300
000105-67-9
2,4-Dimethylphenol

42.
16330
000095-87-4
2,5-Dimethylphenol

43.
17040
000149-57-5
2-Ethylhexanoic acid

44.
17350
000105-75-9
Fumaric acid, dibutyl ester

45.
18400
000592-42-7
Hexa-1,5-diene

46.
18905
002628-17-3
4-Hydroxystyrene

47.
18970
000078-83-1
Isobutanol

48.
19030
016669-59-3

N-(Isobutoxymethyl)acrylamide

49.
19090
000078-84-2
Isobutyraldehyde

50.
19120
025339-17-7
Isodecanol

51.
19130
026896-18-4
Isononanoic acid

52.
19936
007423-42-9
Maleic acid, mono(2-ethylhexyl) ester

53.
20470
025852-47-5
Methacrylic acid, diester with polyethyleneglycol

54.
20740
039670-09-2
Methacrylic acid, ester with ethoxytriethyleneglycol

55.
20950
000923-26-2
Methacrylic acid,2-hydroxypropyl ester

56.
21115
000816-74-0
Methacrylic acid, methallyl ester

57.
21220
032360-05-7
Methacrylic acid, octadecyl ester

58.
21760
000694-91-7
5-Methylenebicyclo[2.2.1]hept-2-ene

59.
21837
001116-90-1
4-Methylhexa-1,4-diene
The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.05 mg/kg)

60.
22240
000622-97-9

p-Methylstryrene

61.
22270
000107-25-5
Methyl vinyl ether

62.
22540
000104-40-5
4-Nonylphenol

63.
22585
003710-30-3
Octa-1, 7-diene

64.
22932
001187-93-5
Perfluoromethyl perfluorovinyl ether

65.
23530
025190-06-1
Poly(1,4-butyleneglycol) (molecular weight greater than 1,000)

66.
23650
025322-69-4
Polypropleneglycol (molecular weight greater than 400)

67.
24560
000111-63-7
Stearic acid, vinyl ester

68.
25030
016646-44-9
Tetra(allyloxy)ethane

69.
25161
000085-43-8
1,2,3,6-Tetrahydrophthalic anhydride

70.
25300
000088-19-7

o-Toluenesulphonamide

71.
25480
000102-71-6
Triethanolamine

72.
26290
025013-15-4
Vinyltoluene

73.
26320
002768-02-7
Vinyltrimethoxysilane
The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg

PART 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

Item
PM/REF No.
CAS No.
Name

1
2
3

1.
30000
000064-19-7
Acetic acid

2.
30045
000123-86-4
Acetic acid, butyl ester

3.
30140
000141-78-6
Acetic acid, ethyl ester

4.
30280
000108-24-7
Acetic anhydride

5.
30295
000067-64-1
Acetone

6.
30370

Acetylacetic acid, salts

7.
30400

Acetylated glycerides

8.
30960

Acids, aliphatic, monocarboxylic (C6-C22), esters with polyglycerol

9.
31328

Acids, fatty, from animal or vegetable food fats and oils

10.
31730
000124-04-9
Adipic acid

11.
33120

Alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C24)

12.
33350
009005-32-7
Alginic acid

13.
34281

Alkyl(C8-C22) sulphuric acids, linear, primary, with an even number of carbon atoms

14.
34475

Aluminium calcium hydroxide phosphite, hydrate

15.
34480

Aluminium fibres, flakes and powders

16.
34560
021645-51-2
Aluminium hydroxide

17.
34690
011097-59-9
Aluminium magnesium carbonate hydroxide

18.
34720
001344-28-1
Aluminium oxide

19.
35120
013560-49-1
3-Aminocrotonic acid, diester with thiobis(2-hydroxyethyl) ether

20.
35320
007664-41-7
Ammonia

21.
35440
012124-97-9
Ammonium bromide

22.
35600
001336-21-6
Ammonium hydroxide

23.
35840
000506-30-9
Arachidic acid

24.
35845
007771-44-0
Arachidonic acid

25.
36000
000050-81-7
Ascorbic acid

26.
36080
000137-66-6
Ascorbyl palmitate

27.
36160
010605-09-1
Ascorbyl stearate

28.
36880
008012-89-3
Beeswax

29.
36960
003061-75-4
Behenamide

30.
37040
000112-85-6
Behenic acid

31.
37280
001302-78-9
Bentonite

32.
37600
000065-85-0
Benzoic acid

33.
37680
000136-60-7
Benzoic acid, butyl ester

34.
37840
000093-89-0
Benzoic acid, ethyl ester

35.
38080
000093-58-3
Benzoic acid, methyl ester

36.
38160
002315-68-6
Benzoic acid, propyl ester

37.
38950
079072-96-1
Bis(4-ethylbenzylidene) sorbitol

38.
39890
087826-41-3
Bis(methylbenzylidene) sorbitol

069158-41-4
” ” ” ” ”

054686-97-4
” ” ” ” ”

39.
40400
010043-11-5
Boron nitride

40.
40570
000106-97-8
Butane

41.
41040
005743-36-2
Calcium butyrate

42.
41280
001305-62-0
Calcium hydroxide

43.
41520
001305-78-8
Calcium oxide

44.
41600
012004-14-7
Calcium sulphoaluminate

037293-22-4
” ” ” ” ”

45.
41760
008006-44-8
Candelilla wax

46.
41960
000124-07-2
Caprylic acid

47.
42160
000124-38-9
Carbon dioxide

48.
42500

Carbonic acid, salts

49.
42640
009000-11-7
Carboxymethylcellulose

50.
42720
008015-86-9
Carnauba wax

51.
42800
009000-71-9
Casein

52.
42960
064147-40-6
Castor oil, dehydrated

53.
43200

Castor oil, mono- and diglycerides

54.
43280
009004-34-6
Cellulose

55.
43300
009004-36-8
Cellulose acetate butyrate

56.
43360
068442-85-3
Cellulose, regenerated

57.
43440
008001-75-0
Ceresin

58.
44160
000077-92-9
Citric acid

59.
44640
000077-93-0
Citric acid, triethyl ester

60.
45280

Cotton fibres

61.
45560
014464-46-1
Cristobalite

62.
45760
000108-91-8
Cyclohexylamine

63.
45920
009000-16-2
Dammar

64.
45940
000334-48-5

n-Decanoic acid

65.
46070
010016-20-3

alpha-Dextrin

66.
46080
007585-39-9

beta-Dextrin

67.
46375
061790-53-2
Diatomaceous earth

68.
46380
068855-54-9
Diatomaceous earth, soda ash flux-calcined

69.
46480
032647-67-9
Dibenzylidene sorbitol

70.
46790
004221-80-1
3,5-Di-tert-butyl-4-hydroxybenzoic acid, 2,4-di-tert-butylphenyl ester

71.
46800
067845-93-6
3,5-Di-tert-butyl-4-hydroxybenzoic acid, hexadecyl ester

72.
46870
003135-18-0
3,5-Di-tert-butyl-4-hydroxybenzylphosphonic acid, dioctadecyl ester

73.
47440
000461-58-5
Dicyanodiamide

74.
49540
000067-68-5
Dimethyl sulphoxide

75.
51200
000126-58-9
Dipentaerythritol

76.
51760
025265-71-8
Dipropyleneglycol

000110-98-5
” ”

77.
52640
016389-88-1
Dolomite

78.
52720
000112-84-5
Erucamide

79.
52730
000112-86-7
Erucic acid

80.
52800
000064-17-5
Ethanol

81.
53270
037205-99-5
Ethylcarboxymethylcellulose

82.
53280
009004-57-3
Ethylcellulose

83.
53360
000110-31-6

N,N'-Ethylenebisoleamide

84.
53440
005518-18-3

N,N'-Ethylenebispalmitamide

85.
53520
000110-30-5

N,N'-Ethylenebisstearamide

86.
53600
000060-00-4
Ethylenediaminetetraacetic acid

87.
54005
005136-44-7
Ethylene-N-palmitamide-N'-stearamide

88.
54260
009004-58-4
Ethylhydroxyethylcellulose

89.
54270

Ethylhydroxymethylcellulose

90.
54280

Ethylhydroxypropylcellulose

91.
54450

Fats and oils, from animal or vegetable food sources

92.
54480

Fats and oils, hydrogenated, from animal or vegetable food sources

93.
55040
000064-18-6
Formic acid

94.
55120
000110-17-8
Fumaric acid

95.
55190
029204-02-2
Gadoleic acid

96.
55440
009000-70-8
Gelatine

97.
55520

Glass fibres

98.
55600

Glass microballs

99.
55680
000110-94-1
Glutaric acid

100.
55920
000056-81-5
Glycerol

101.
56020
099880-64-5
Glycerol dibehenate

102.
56360

Glycerol, esters with acetic acid

103.
56486

Glycerol, esters with acids, aliphatic, saturated, linear, with an even number of carbon atoms (C14-C18) and with acids, aliphatic, unsaturated, linear, with an even number of carbon atoms (C16-C18)

104.
56487

Glycerol, esters with butyric acid

105.
56490

Glycerol, esters with erucic acid

106.
56495

Glycerol, esters with 12-hydroxystearic acid

107.
56500

Glycerol, esters with lauric acid

108.
56510

Glycerol, esters with linoleic acid

109.
56520

Glycerol, esters with myristic acid

110.
56540

Glycerol, esters with oleic acid

111.
56550

Glycerol, esters with palmitic acid

112.
56565

Glycerol, esters with nonanoic acid

113.
56570

Glycerol, esters with propionic acid

114.
56580

Glycerol, esters with ricinoleic acid

115.
56585

Glycerol, esters with stearic acid

116.
56610
030233-64-8
Glycerol monobehenate

117.
56720
026402-23-3
Glycerol monohexanoate

118.
56800
030899-62-8
Glycerol monolaurate diacetate

119.
56880
026402-26-6
Glycerol monooctanoate

120.
57040

Glycerol monooleate, ester with ascorbic acid

121.
57120

Glycerol monooleate, ester with citric acid

122.
57200

Glycerol monopalmitate, ester with ascorbic acid

123.
57280

Glycerol monopalmitate, ester with citric acid

124.
57600

Glycerol monostearate, ester with ascorbic acid

125.
57680

Glycerol monostearate, ester with citric acid

126.
57920
000620-67-7
Glycerol triheptanoate

127.
58300

Glycine, salts

128.
58320
007782-42-5
Graphite

129.
58400
009000-30-0
Guar gum

130.
58480
009000-01-5
Gum arabic

131.
58720
000111-14-8
Heptanoic acid

132.
59360
000142-62-1
Hexanoic acid

133.
59760
019569-21-2
Huntite

134.
59990
007647-01-0
Hydrochloric acid

135.
60030
012072-90-1
Hydromagnesite

136.
60080
012304-65-3
Hydrotalcite

137.
60160
000120-47-8
4-Hydroxybenzoic acid, ethyl ester

138.
60180
004191-73-5
4-Hydroxybenzoic acid, isopropyl ester

139.
60200
000099-76-3
4-Hydroxybenzoic acid, methyl ester

140.
60240
000094-13-3
4-Hydroxybenzoic acid, propyl ester

141.
60560
009004-62-0
Hydroxyethylcellulose

142.
60880
009032-42-2
Hydroxyethylmethylcellulose

143.
61120
009005-27-0
Hydroxyethyl starch

144.
61390
037353-59-6
Hydroxymethylcellulose

145.
61680
009004-64-2
Hydroxypropylcellulose

146.
61800
009049-76-7
Hydroxypropyl starch

147.
61840
000106-14-9
12-Hydroxystearic acid

148.
62140
006303-21-5
Hypophosphorous acid

149.
62240
001332-37-2
Iron oxide

150.
62450
000078-78-4
Isopentane

151.
62640
008001-39-6
Japan wax

152.
62720
001332-58-7
Kaolin

153.
62800

Kaolin, calcined

154.
62960
000050-21-5
Lactic acid

155.
63040
000138-22-7
Lactic acid, butyl ester

156.
63280
000143-07-7
Lauric acid

157.
63760
008002-43-5
Lecithin

158.
63840
000123-76-2
Levulinic acid

159.
63920
000557-59-5
Lignoceric acid

160.
64015
000060-33-3
Linoleic acid

161.
64150
028290-79-1
Linolenic acid

162.
64500

Lysine, salts

163.
64640
001309-42-8
Magnesium hydroxide

164.
64720
001309-48-4
Magnesium oxide

165.
65020
006915-15-7
Malic acid

166.
65040
000141-82-2
Malonic acid

167.
65520
000087-78-5
Mannitol

168.
66200
037206-01-2
Methylcarboxymethylcellulose

169.
66240
009004-67-5
Methylcellulose

170.
66640
009004-59-5
Methylethylcellulose

171.
66695

Methylhydroxymethylcellulose

172.
66700
009004-65-3
Methylhydroxypropylcellulose

173.
67120
012001-26-2
Mica

174.
67200
001317-33-5
Molybdenum disulphide

175.
67840

Montanic acids and/or their esters with ethyleneglycol and/or with 1,3-butanediol and/or with glycerol

176.
67850
008002-53-7
Montan wax

177.
67891
000544-63-8
Myristic acid

178.
68040
003333-62-8
7-[2H-Naphtho-(1,2-D)triazol-2-yl]-3-phenylcoumarin

179.
68125
068187-64-4
Nepheline syenite

180.
68960
000301-02-0
Oleamide

181.
69040
000112-80-1
Oleic acid

182.
69760
000143-28-2
Oleyl alcohol

183.
70000
070331-94-1
2,2'-Oxamidobis[ethyl-3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]

184.
70240
012198-93-5
Ozokerite

185.
70400
000057-10-3
Palmitic acid

186.
71020
000373-49-9
Palmitoleic acid

187.
71440
009000-69-5
Pectin

188.
71600
000115-77-5
Pentaerythritol

189.
71680
006683-19-8
Pentaerythritol tetrakis [3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]

190.
71720
000109-66-0
Pentane

191.
72640
007664-38-2
Phosphoric acid

192.
74240
031570-04-4
Phosphorous acid, tris(2,4-di-tert-butylphenyl) ester

193.
74480
000088-99-3

o-Phthalic acid

194.
76320
000085-44-9
Phthalic anhydride

195.
76720
009016-00-6
Polydimethylsiloxane

063148-62-9
” ” ”

196.
76960
025322-68-3
Polyethyleneglycol

197.
77600
061788-85-0
Polyethyleneglycol ester of hydrogenated castor oil

198.
77702

Polyethyleneglycol esters of aliphatic moncarboxylic acids (C6-C22), and their ammonium and sodium sulphates

199.
79040
009005-64-5
Polyethleneglycol sorbitan monolaurate

200.
79120
009005-65-6
Polyethyleneglycol sorbitan monooleate

201.
79200
009005-66-7
Polyethyleneglycol sorbitan monopalmitate

202.
79280
009005-67-8
Polyethyleneglycol sorbitan monostearate

203.
79360
009005-70-3
Polyethyleneglycol sorbitan trioleate

204.
79440
009005-71-4
Polyethyleneglycol sorbitan tristearate

205.
80240
029894-35-7
Polyglycertol ricinoleate

206.
80640

Polyoxyalkl(C2-C4)dimethylpolysiloxane

207.
80720
008017-16-1
Polyphosphoric acids

208.
80800
025322-69-4
Polypropyleneglycol

209.
81520
007758-02-3
Potassium bromide

210.
81600
001310-58-3
Potassium hydroxide

211.
81840
000057-55-6
1,2-Propanediol

212.
81882
000067-63-0
2-Propanol

213.
82000
000079-09-4
Propionic acid

214.
82080
009005-37-2
1,2-Propyleneglycol alginate

215.
82240
022788-19-8
1,2-Propyleneglycol dilaurate

216.
82400
000105-62-4
1,2-Propyleneglycol dioleate

217.
82560
033587-20-1
1,2-Propyleneglycol dipalmitate

218.
82720
006182-11-2
1,2-Propyleneglycol distearate

219.
82800
027194-74-7
1,2-Propyleneglycol monolaurate

220.
82960
001330-80-9
1,2-Propyleneglycol monooleate

221.
83120
029013-28-3
1,2-Propyleneglycol monopalmitate

222.
83300
001323-39-3
1,2-Propyleneglycol monostearate

223.
83320

Propylhydroxyethylcellulose

224.
83325

Propylhydroxymethylcellulose

225.
83330

Propylhydroxypropylcellulose

226.
83440
002466-09-3
Pyrophosphoric acid

227.
83455
013445-56-2
Pyrophosphorous acid

228.
83460
012269-78-2
Pyrophyllite

229.
83470
014808-60-7
Quartz

230.
83610
073138-82-6
Resin acids and rosin acids

231.
83840
008050-09-7
Rosin

232.
84000
008050-31-5
Rosin, ester with glycerol

233.
84080
008050-26-8
Rosin, ester with pentaerythritol

234.
84210
065997-06-0
Rosin, hydrogenated

235.
84240
065997-13-9
Rosin, hydrogenated, ester with glycerol

236.
84320
008050-15-5
Rosin, hydrogenated, ester with methanol

237.
84400
064365-17-9
Rosin, hydrogenated, ester with pentaerythritol

238.
84560
009006-04-6
Rubber, natural

239.
84640
000069-72-7
Salicylic acid

240.
85600

Silicates, natural

241.
85980

Silicic acid, salts

242.
86000

Silicic acid, silylated

243.
86160
000409-21-2
Silicon carbide

244.
86240
007631-86-9
Silicon dioxide

245.
86560
007647-15-6
Sodium bromide

246.
86720
001310-73-2
Sodium hydroxide

247.
87200
000110-44-1
Sorbic acid

248.
87280
029116-98-1
Sorbitan dioleate

249.
87520
062568-11-0
Sorbitan monobehenate

250.
87600
001338-39-2
Sorbitan monolaurate

251.
87680
001338-43-8
Sorbitan monooleate

252.
87760
026266-57-9
Sorbitan monopalmitate

253.
87840
001338-41-6
Sorbitan monostearate

254.
87920
061752-68-9
Sorbitan tetrastearate

255.
88080
026266-58-0
Sorbitan trioleate

256.
88160
054140-20-4
Sorbitan tripalmitate

257.
88240
026658-19-5
Sorbitan tristearate

258.
88320
000050-70-4
Sorbitol

259.
88600
026836-47-5
Sorbitol monostearate

260.
88800
009005-25-8
Starch, edible

261.
88880
068412-29-3
Starch, hydrolysed

262.
88960
000124-26-5
Stearamide

263.
89040
000057-11-4
Stearic acid

264.
90720
058446-52-9
Stearoylbenzoylmethane

265.
90800
005793-94-2
Stearoyl-2-lactylic acid, calcium salt

266.
90960
000110-15-6
Succinic acid

267.
91200
000126-13-6
Sucrose acetate isobutyrate

268.
91360
000126-14-7
Sucrose octaacetate

269.
91840
007704-34-9
Sulphur

270.
91920
007664-93-9
Sulphuric acid

271.
92080
014807-96-6
Talc

272.
92160
000087-69-4
Tartaric acid

273.
92195

Taurine, salts

274.
92205
057569-40-1
Terephthalic acid, diester with 2,2'-methylenebis(4-methyl-6-tert-butylphenol)

275.
92350
000112-60-7
Tetraethyleneglycol

276.
92640
000102-60-3

N,N,N',N'-Tetrakis(2-hydroxypropyl)ethylenediamine

277.
93440
013463-67-7
Titanium dioxide

278.
93520
000059-02-9

alpha-Tocopherol

010191-41-0
” ”

279.
93680
009000-65-1
Tragacanth gum

280.
94320
000112-27-6
Triethyleneglycol

281.
95200
001709-70-2
1,3,5-Trimethyl-2,4,6-tris(3,5-di-tert-butyl-4-hydroxybenzyl)benzene

282.
95905
013983-17-0
Wollastonite

283.
95920

Wood flour and fibres, untreated

284.
95935
011138-66-2
Xanthan gum

285.
96190
020427-58-1
Zinc hydroxide

286.
96240
001314-13-2
Zinc oxide

287.
96320
001314-98-3
Zinc sulphide

PART 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

Abbreviation
Food Simulant

Simulant A:
Distilled water or water of equivalent quality

Simulant B:
3% Acetic acid (w/v) in aqueous solution

Simulant C:
10% Ethanol (v/v) in aqueous solution save that the concentration of ethanol solution shall be adjusted to the actual alcoholic strength of the food if it exceeds 10% (v/v)

Simulant D:
Rectified olive oil having the characteristics specified in paragraph 3 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 residue
6
8
10
12
14
16
18
others

GLC area (%)

∼1
6–9
8–11
45–52
12–15
8–10
8–12
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