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
