Plastic Materials and Articles in Contact with Food Regulations (Northern Ireland) 1998

Made: 27th July 1998

Coming into operation: 14th September 1998

The Department of Health and Social Services for Northern Ireland, in exercise of the powers conferred on it by Articles 15(2), 16(1), 25(1)(a) and (3), 32 and 47(2) of the Food Safety (Northern Ireland) Order 1991[^f00001] and, being a designated Department[^f00002] for the purposes of section 2(2) of the European Communities Act 1972[^f00003] in relation to materials and articles in contact with food or drink or intended for such contact, in exercise of the powers conferred on it by the said section 2(2) and of all other powers enabling it in that behalf and after consultation in accordance with Article 47(3) of the said Order with such organisations as appear to it to be representative of interests likely to be substantially affected by these Regulations (in so far as the Regulations are made in exercise of the said Order), hereby makes the following Regulations:

Citation and commencement

1

These Regulations may be cited as the Plastic Materials and Articles in Contact with Food Regulations (Northern Ireland) 1998 and shall come into operation on 14th September 1998.

Interpretation

2

• (1) In these Regulations—

• “additive” means a substance, other than one which directly influences the formation of polymers which is— 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 used to provide a suitable medium in which polymerisation occurs;

• “capable” means capable as established under regulation 6;

• “Council Directive 82/711” means Council Directive 82/711/EEC laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs[^f00004], as amended by Commission Directives 93/8/EEC[^f00005] and 97/48/EC[^f00006];

• “the Directive” means Commission Directive (EEC) No. 90/128 relating to plastic materials and articles intended to come into contact with foodstuffs[^f00007] (as corrected) and as amended by Commission Directives 92/39/EEC, 93/9/EEC. 95/3/EC and 96/11/EC[^f00008];

• “EEA Agreement” means the Agreement on the European Economic Area[^f00009] signed at Oporto on 2nd May 1992 as adjusted by the Protocol[^f00010] signed at Brussels on 17th March 1993;

• “EEA State” means a State (other than the United Kingdom) which is a contracting party to the EEA Agreement;

• “food” has the same meaning as it has in Article 15(5) of the Order;

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

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

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

• “the Order” means the Food Safety (Northern Ireland) Order 1991;

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

• “sell” includes offer or expose for sale or have in possession for sale;

• “the 1987 Regulations” means the Materials and Articles in Contact with Food Regulations (Northern Ireland) 1987[^f00011];

• “the 1993 Regulations” means the Plastic Materials and Articles in Contact with Food Regulations (Northern Ireland) 1993[^f00012].

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

• (3) Any expression, other than one defined in paragraph (1), used both in these Regulations and in the Directive, Council Directive 82/711, or Council Directive 85/572 EEC laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs[^f00013] has the same meaning as it bears in the Directive in which it appears.

• (4) The Interpretation Act (Northern Ireland) 1954[^f00014] shall apply to these Regulations as it applies to a Measure of the Northern Ireland Assembly.

Restriction on the use, sale or importation of plastic materials and articles

3

• (1) A plastic material or article which fails to meet the requisite standards shall not be—

• (a) used by any person in the course of a business in connection with the storage, preparation, packaging, sale or serving of food for human consumption;

• (b) sold by any person for the purpose of its being used in connection with the storage, preparation, packaging, sale or serving of food for human consumption; or

• (c) imported by any person from any place other than an EEA State for the purpose of its being used in connection with the storage, preparation, packaging, sale or serving of food for human consumption.

• (2) In any proceedings for an offence under these Regulations where it is alleged that a plastic material or article which fails to meet the requisite standards was used, sold or imported, it shall be a defence for the person charged to prove that the plastic material or article in respect of which the offence is alleged to have been committed was intended for export to a country, other than an EEA State, which has legislation analogous to these Regulations and that the plastic material or article complies with such legislation.

• (3) In any proceedings for an offence under these Regulations where it is alleged that a plastic material or article which fails to meet the requisite standards was used, sold or imported it shall be a defence for the person charged to prove that the plastic material or article was manufactured—

• (a) before 14th September 1998; and

• (b) in accordance with regulation 4 of the 1993 Regulations as that regulation applied when the plastic material or article was manufactured.

• (4) For the purposes of this regulation a plastic material or article fails to meet the requisite standards—

• (a) if—

• (i) it has been manufactured with a prohibited monomer as described in regulation 4(1) or a prohibited additive as described in regulation 5(1) or does not comply with regulation 4(5) or 7; and

• (ii) no defence indicated in regulation 4(7), 5(2) or 7(5) would be available in proceedings for an offence under these Regulations relating to that manufacture or want of compliance; or

• (b) if it has been manufactured outside Northern Ireland and sub-paragraph (a) would have applied to it had it been manufactured in Northern Ireland.

Restriction on manufacture with monomers

4

• (1) Subject to the following paragraphs, no plastic material or article shall be manufactured by any person with any prohibited monomer, other than a monomer which is—

• (a) of good technical quality;

• (b) identified by PM/REF No., CAS No., (if any) and name respectively in columns 1, 2 and 3 of the relevant section of Part 1 of Schedule 1; and

• (c) used in accordance with the restrictions (if any) specified in the corresponding entry in column 4 of the relevant section of that Part of that Schedule.

• (2) For the purposes of this regulation the relevant section of Part I of Schedule 1 is—

• (a) in the case of a plastic material or article manufactured before 1st January 1999, Section A, B, or C;

• (b) in the case of a plastic material or article manufactured after 31st December 1998 and before 1st January 2002, Section A or B; and

• (c) in the case of a plastic material or article manufactured after 31st December 2001, Section A.

• (3) Paragraph (1) does not apply to the use of a monomer in the manufacture of any—

• (a) surface coatings obtained from resinous or polymerized products in liquid, powder or dispersion form, including, but not limited to, varnishes, lacquers and paints;

• (b) silicones;

• (c) epoxy resins;

• (d) products obtained by means of bacterial fermentation;

• (e) adhesives and adhesion promoters; or

• (f) printing inks.

• (4) Paragraph (1) shall not be taken to prohibit the manufacture of any plastic material or article with any substance if the substance is a mixture which falls within paragraph 3(c) of Annex II to the Directive and does not contravene paragraph 4 of that Annex.

• (5) Subject to paragraph (6), where column 4 of the relevant section of Part I of Schedule 1 expresses a migration limit of mg/kg in relation to any monomer, no plastic material or article manufactured from that monomer shall be capable of transferring constituents of that monomer to food with which that plastic material or article may come into contact in quantities exceeding the appropriate limit, and for the purposes of this paragraph the appropriate limit is—

• (a) the number of milligrams expressed therein released per kilogram of food in the case of any plastic material or article other than one specified in sub-paragraph (b); and

• (b) one sixth of the number of milligrams expressed therein per square decimetre of surface area of the plastic material or article if the plastic material or article comprises—

• (i) an article which is a container or is comparable to a container or which can be filled, with a capacity of less than 500 millilitres or more than 10 litres, or

• (ii) sheet, film or other material which cannot be filled or for which it is impracticable to estimate the relationship between surface area of that material and the quantity of food in contact with that surface area.

• (6) A plastic material or article manufactured from any monomer in respect of which column 4 of the relevant section of Part I of Schedule 1 expresses a migration limit of mg/kg shall not be considered capable of transferring constituents of that monomer to food with which that plastic material or article may come into contact in quantities exceeding the appropriate limit in paragraph (5) if the only food which that plastic material or article may come into contact with is food to which regulation 7(3) applies.

• (7) In any proceedings for an offence under these Regulations where it is alleged that a plastic material or article does not comply with paragraph (1) because it was manufactured with any monomer (whether or not of good technical quality) other than one identified in the relevant section of Part I of Schedule 1, it shall be a defence for the person charged to prove that—

• (a) each such monomer is present in the finished plastic material as an impurity, a reaction intermediate or a decomposition product, which falls within paragraph 3(a) of Annex II to the Directive;

• (b) each such monomer is an oligomer or a natural or synthetic macromolecular substance or a mixture thereof which falls within paragraph 3(b) of that Annex; or

• (c) each such monomer falls within either sub-paragraph (a) or sub-paragraph (b)

and does not contravene paragraph 4 of that Annex

• (8) Part II of Schedule 1 shall have effect to supplement this regulation and Part I of Schedule 1.

Restriction on manufacture with additives

5

• (1) Subject to the following paragraphs, no person shall use in the manufacture of plastic materials or articles any prohibited additive, that is to say an additive identified by PM/REF No., CAS No. (if any) and name respectively in columns 1, 2 and 3 of Part I of Schedule 2 which is not of good technical quality.

• (2) In any proceedings for an offence under these Regulations, where it is alleged that the commission of the offence is due to the manufacture of a plastic material or article with any additive identified in Part I of Schedule 2 which is not of good technical quality, it shall be a defence for the person charged to prove that each such additive is present in the finished plastic material or article as an impurity, a reaction intermediate or a decomposition product.

• (3) Part II of Schedule 2 shall have effect to supplement this regulation and Part I of Schedule 2.

Method of testing capability of transferring constituents

6

• (1) For the purposes of these Regulations, a plastic material or article shall be treated as being capable of transferring constituents to food with which it may come into contact to the extent that it is established for those purposes—

• (a) in any case other than one to which sub-paragraph (b) relates, by the verification methods specified in Schedules 3 and 4;

• (b) in any case where the extent to which vinyl chloride, as identified in Section A of Part I of Schedule 1, is capable of such transfer falls to be established, by the method referred to in regulation 14(2) of the 1987 Regulations.

• (2) In Schedules 3 and 4, references to migration or release of a substance shall be construed as references to the transfer of constituents to the simulant representing the food or, as the case may be, food with which it may come into contact.

• (3) In paragraph (1)(a) analytical tolerances, as referred to in paragraph 8 of Schedule 3, shall be treated as included among verification methods.

Transfer of constituents

7

• (1) No plastic material or article shall be capable of transferring its constituents to food with which it may come into contact in quantities exceeding the appropriate limit.

• (2) For the purposes of this regulation a plastic material or article shall not be considered capable of transferring its constituents to food with which it may come into contact, in quantities exceeding the appropriate limit, if the only food which that plastic material or article may come into contact with is food to which paragraph (3) applies.

• (3) This paragraph applies to food which is specified in the Table to Part IV of Schedule 4 where there is no “X” placed anywhere in the group of columns headed “Simulants to be used” opposite that food.

• (4) For the purposes of this regulation the appropriate limit is—

• (a) an overall migration limit of 60 milligrams of constituents released per kilogram of food in the case of any plastic material or article comprising—

• (i) an article which is a container or is comparable to a container or which can be filled, with a capacity of not less than 500 millilitres and not more than 10 litres;

• (ii) an article which can be filled and for which it is impracticable to estimate the surface area in contact with food;

• (iii) a cap, gasket, stopper or similar device for sealing, and

• (b) in the case of any other plastic material or article, an overall migration limit of 10 milligrams per square decimetre of the surface area of the plastic material or article.

• (5) In any proceedings for an offence under these Regulations an element of which is that a plastic material or article does not comply with this regulation the defences in paragraph 6(2) and 7(2) of Schedule 3 shall be available as specified therein.

Labelling

8

• (1) Subject to paragraph (2), at marketing stages other than the retail stage a person who is in possession of any plastic material or article which is intended to come into contact with food shall ensure that that plastic material or article is accompanied by a written declaration attesting that it complies with the legislation applicable to it.

• (2) Paragraph (1) shall not apply to a person in possession of any plastic material or article which by its nature is clearly intended to come into contact with food.

Enforcement

9

Each district council shall enforce and execute these Regulations in its own district.

Offences

10

• (1) Any person who contravenes regulation 3, 4(1), 5(1) or 8 shall be guilty of an offence.

• (2) Any person who—

• (a) intentionally obstructs any person acting in the execution of these Regulations, or

• (b) without reasonable cause, fails to give to any person acting in the execution of these Regulations any assistance or information which that person may reasonably require of him for the performance of his functions under these Regulations,

shall be guilty of an offence.

• (3) Nothing in paragraph (2)(b) shall be construed as requiring any person to answer any question or give any information if to do so might incriminate him.

• (4) Any person who, in purported compliance with any such requirement as is mentioned in paragraph (2)(b)—

• (a) furnishes information which he knows to be false or misleading in a material particular, or

• (b) recklessly furnishes information which is false or misleading in a material particular,

shall be guilty of an offence.

• (5) Where the commission by any person of an offence under these Regulations is due to an act or default of some other person, that other person shall be guilty of the offence; and a person may be charged with and convicted of the offence by virtue of this paragraph whether or not proceedings are taken against the first mentioned person.

• (6) In any proceedings for an offence under these Regulations it shall, subject to paragraph (10), be a defence for the person charged to prove that he took all reasonable precautions and exercised all due diligence to avoid the commission of the offence by himself or by a person under his control.

• (7) Without prejudice to the generality of paragraph (6), a person charged with an offence under these Regulations who neither—

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

• (b) imported it into Northern Ireland,

shall be taken to have established the defence provided by that paragraph if he satisfies the requirements of paragraph (8) or (9).

• (8) A person satisfies the requirements of this paragraph if he proves—

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

• (b) that he carried out all such checks of the plastic material or article in question as were reasonable in all the circumstances, or that it was reasonable in all the circumstances for him to rely on checks carried out by the person who supplied the plastic material or article to him; and

• (c) that he did not know and had no reason to suspect at the time of the commission of the alleged offence that his act or omission would amount to an offence under these Regulations.

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

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

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

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

• (10) If in any case the defence provided by paragraph (6) involves the allegation that the commission of the offence was due to an act or default of another person, or to reliance on information supplied by another person, the person charged shall not, without leave of the court, be entitled to rely on that defence unless—

• (a) at least seven clear days before the hearing, and

• (b) where he has previously appeared before a court in connection with the alleged offence, within one month of his first such appearance,

he has served on the prosecutor a notice in writing giving such information identifying or assisting in the identification of that other person as was then in his possession, and in this paragraph any reference to appearing before a court shall be construed as including a reference to being brought before a court.

• (11) Any person guilty of an offence under these Regulations shall be liable on summary conviction to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding three months or to both and on conviction on indictment to a fine or to imprisonment for a term not exceeding two years or both.

• (12) No prosecution for an offence under these Regulations shall be begun after the expiry of—

• (a) three years from the commission of the offence; or

• (b) one year from its discovery by the prosecutor,

whichever is earlier.

Presumption as to food with which a plastic material or article is to come into contact

11

In establishing which descriptions of food a plastic material or article may come into contact with it shall be assumed for the purposes of these Regulations, until the contrary is proved, that, if particulars are shown in relation to that plastic material or article in accordance with the 1987 Regulations, those particulars are accurate and that, unless the particulars so indicate, there are no restrictions on the intended conditions of contact.

Application of other provisions

12

• (1) The following provisions of the 1987 Regulations shall apply in relation to plastic materials or articles as they apply to materials and articles for the purposes of those Regulations, as if those provisions formed part of these Regulations—

• (a) regulation 12 (powers of authorised officers);

• (b) regulation 13 (analysis, examination and testing);

• (c) regulation 16 (confidentiality);

• (d) regulation 19 (evidence of analysis); and

• (e) regulation 20 (analysis by Government Chemist).

• (2) Article 4(d) of the Order (relating to the presumption of intention for human consumption) shall apply for the purposes of these Regulations as it applies for the purposes of the Order.

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

Amendment

13

In the Food Safety (Sampling and Qualifications) Regulations (Northern Ireland) 1991[^f00015], in Schedule 1 (provisions to which those regulations do not apply), for the title and reference of the 1993 Regulations there shall be substituted the title and reference of these Regulations.

Revocations

14

The 1993 Regulations, the Plastic Materials and Articles in Contact with Food (Amendment) Regulations (Northern Ireland) 1995[^f00016], the Plastic Materials and Articles in Contact with Food (Amendment) Regulations (Northern Ireland) 1996[^f00017] and the Plastic Materials and Articles in Contact with Food (Amendment No. 2) Regulations (Northern Ireland) 1996[^f00018] are hereby revoked.

SCHEDULE 1

Part I — Authorised Monomers

SECTION A — Monomers authorised without time limit

	1	2	3	4
Item	PM/REF No.	CAS No.	Name	Restrictions
1.	10030	000514-10-3	Abietic acid
2.	10060	000075-07-0	Acetaldehyde
3.	10090	000064-19-7	Acetic acid
4.	10120	000108-05-4	Acetic acid, vinyl ester	The specific migration of this substance shall not exceed 12 mg/kg
5.	10150	000108-24-7	Acetic anhydride
6.	10210	000074-86-2	Acetylene
7.	10630	000079-06-1	Acrylamide	The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0·01 mg/kg)
8.	10660	015214-89-8	2-Acrylamido-2-methylpropane- sulphonic acid	The specific migration of this substance shall not exceed 0·05 mg/kg
9.	10690	000079-10-7	Acrylic acid
10.	10750	002495-35-4	Acrylic acid, benzyl ester
11.	10780	000141-32-2	Acrylic acid, n-butyl ester
12.	10810	002998-08-5	Acrylic acid, sec-butyl ester
13.	10840	001663-39-4	Acrylic acid, tert-butyl ester
14.	11470	000140-88-5	Acrylic acid, ethyl ester
15.	As item 19	000818-61-1	Acrylic acid, hydroxyethyl ester
16.	11590	000106-63-8	Acrylic acid, isobutyl ester
17.	11680	000689-12-3	Acrylic acid, isopropyl ester
18.	11710	000096-33-3	Acrylic acid, methyl ester
19.	11830	000818-61-1	Acrylic acid, monoester with ethylene glycol
20.	11890	002499-59-4	Acrylic acid, n-octyl ester
21.	11980	000925-60-0	Acrylic acid, propyl ester
22.	12100	000104-13-1	Acrylonitrile	The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0·02 mg/kg analytical tolerance included)
23.	12130	000124-04-9	Adipic acid
24.	12280	002035-75-8	Adipic anhydride
25.	12310	—	Albumin
26.	12340	—	Albumin, coagulated by formaldehyde
27.	12375	—	Alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C22)
28.	12670	002855-13-2	1-Amino-3-aminomethyl-3,5,5- trimethylcyclohexane	The specific migration of this substance shall not exceed 6 mg/kg
29.	12788	002432-99-7	11-Aminoundecanoic acid	The specific migration of this substance shall not exceed 5 mg/kg
30.	12789	007664-41-7	Ammonia
31.	12820	000123-99-9	Azelaic acid
32.	12970	004196-95-6	Azelaic anhydride
33.	13000	001477-55-0	1,3-Benzenedimethanamine	The specific migration of this substance shall not exceed 0·05 mg/kg
34.	13090	000065-85-0	Benzoic acid
35.	13150	000100-51-6	Benzyl alcohol
36.	As item 79	000111-46-6	Bis(2-hydroxymethyl)ether	As item 79
37.	As item 217	000077-99-6	2,2-Bis(hydroxymethylbutan- 1-o1)	As item 217
38.	13390	000105-08-8	1,4-Bis(hydroxymethyl)- cyclohexane
39.	13480	000080-05-7	2,2-Bis(4-hydroxyphenyl)- propane	The specific migration of this substance shall not exceed 3 mg/kg
40.	13510	001675-54-3	2,2-Bis(4-hydroxyphenyl)- propane bis(2,3-epoxypropyl) ether	The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg or the specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0·02 mg/kg, analytical tolerance included)
41.	13530	038103-06-9	2,2-Bis(4-hydroxyphenyl) propane bis(phthalic anhydride)	The specific migration of this substance shall not exceed 0·05 mg/kg
42.	As item 93	000110-98-5	Bis(hydroxypropyl) ether
43.	As item 78	005124-30-1	Bis(4-isocyanatocyclohexyl) methane	As item 78
44.	13600	047465-97-4	3,3-Bis(3-methyl-4- hydroxyphenyl-indolin-2-one	The specific migration of this substance shall not exceed 1·8 mg/kg
45.	As item 39	000080-05-7	Bisphenol A	As item 39
46.	As item 40	001675-54-3	Bisphenol A bis(2,3- epoxypropyl) ether	As item 40
47.	13614	038103-06-9	Bisphenol A bis (phthalic anhydride)	As item 41
48.	13630	000106-99-0	Butadiene	The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg or the specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0·02 mg/kg, analytical tolerance included)
49.	13690	000107-88-0	Butan-1,3-diol
50.	13840	000071-36-3	Butan-1-ol
51.	13870	000106-98-9	But-1-ene
52.	13900	000107-01-7	But-2-ene
53.	14110	000123-72-8	Butyraldehyde
54.	14140	000107-92-6	Butyric acid
55.	14170	000106-31-0	Butyric anhydride
56.	14200	000105-60-2	Caprolactam	The specific migration of this substance alone or together with item 57 shall not exceed a total of 15 mg/kg
57.	14230	002123-24-2	Caprolactam, sodium salt	The specific migration of this substance alone or together with item 56 shall not exceed a total of 15 mg/kg (expressed as caprolactam)
58.	14320	000124-07-2	Caprylic acid
59.	14350	000630-08-0	Carbon monoxide
60.	14380	000075-44-5	Carbonyl chloride	The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg
61.	14411	008001-79-4	Castor oil
62.	14500	009004-34-6	Cellulose
63.	14530	007782-50-5	Chlorine
64.	As item 94	000106-89-8	1-Chloro-2,3-expoxypropane	As item 94
65.	14680	000077-92-9	Citric acid
66.	14710	000108-39-4	m-Cresol
67.	14740	000095-48-7	o-Cresol
68.	14770	000106-44-5	p-Cresol
69.	As item 38	000105-08-8	1,4-Cyclohexanedimethanol
70.	14950	003173-53-3	Cyclohexyl isocyanate	The quantity in the finished plastic material or article of any substance within, or any combination of substances within, items 70, 78, 88, 90, 91, 92, 117, 150, 153, 211, 212 and 213 shall not exceed 1 mg/kg (expressed as isocyanate moiety)
71.	15070	001647-16-1	Dec-1,9-diene	The specific migration of this substance shall not exceed 0·05 mg/kg
72.	15095	000334-48-5	Decanoic acid
73.	15100	000112-30-1	Decan-1-ol
74.	15250	000110-60-1	1,4-Diaminobutane
75.	As item 97	000107-15-3	1,2-Diaminoethane	As item 97
76.	As item 116	000124-09-4	1,6-Diaminohexane	As item 116
77.	15565	000106-46-7	1,4-Dichlorobenzene	The specific migration of this substance shall not exceed 12 mg/kg
78.	15700	005124-30-1	Dicyclohexylmethane- 4,4'-diisocyanate	As item 70
79.	15760	000111-46-6	Diethylene glycol	The specific migration of this substance alone or together with item 98 shall not exceed a total of 30 mg/kg
80.	15790	000111-40-0	Diethylenetriamine	The specific migration of this substance shall not exceed 5 mg/kg
81.	15820	000345-92-6	4,4'-Difluorobenzophenone	The specific migration of this substance shall not exceed 0·05 mg/kg
82.	15880	000120-80-9	1,2-Dihydroxybenzene	The specific migration of this substance shall not exceed 6 mg/kg
83.	15910	000108-46-3	1,3-Dihydroxybenzene	The specific migration of this substance shall not exceed 2·4 mg/kg
84.	15940	000123-31-9	1,4-Dihydroxybenzene	The specific migration of this substance shall not exceed 0·6 mg/kg
85.	15970	000611-99-4	4,4'-Dihydroxybenzophenone	The specific migration of this substance shall not exceed 6 mg/kg
86.	16000	000092-88-6	4,4'-Dihydroxybiphenyl	The specific migration of this substance shall not exceed 6 mg/kg
87.	16150	000108-01-0	Dimethylaminoethanol	The specific migration of this substance shall not exceed 18 mg/kg
88.	16240	000091-97-4	3,3'-Dimethyl- 4,4'-diisocyanatobiphenyl	As item 70
89.	16480	000126-58-9	Dipentaerythritol
90.	16570	004128-73-8	Diphenylether-4,4'-diisocyanate	As item 70
91.	16600	005873-54-1	Diphenylmethane-2,4'- diisocyanate	As item 70
92.	16630	000101-68-8	Diphenylmethane-4,4'- diisocyanate	As item 70
93.	16660	000110-98-5	Dipropyleneglycol
94.	16750	000106-89-8	Epichlorohydrin	The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg
95.	16780	000064-17-5	Ethanol
96.	16950	000074-85-1	Ethylene
97.	16960	000107-15-3	Ethylenediamine	The specific migration of this substance shall not exceed 12 mg/kg
98.	16990	000107-21-1	Ethylene glycol	The specific migration of this substance alone or together with item 79 shall not exceed a total of 30 mg/kg
99.	17005	000151-56-4	Ethyleneimine	The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0·01 mg/kg)
100.	17020	000075-21-8	Ethylene oxide	The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg
101.	17050	00104-76-7	2-Ethylhexan-1-ol	The specific migration of this substance shall not exceed 30 mg/kg
102.	17160	000097-53-0	Eugenol	The specific migration of this substance shall not exceed 0.01 mg/kg
103.	17170	061788-47-4	Fatty acids, coco
104.	17200	068308-53-2	Fatty acids, soya
105.	17230	061790-12-3	Fatty acids, tall oil
106.	17260	000050-00-0	Formaldehyde	The specific migration of this substance shall not exceed 15 mg/kg
107.	17290	000110-17-8	Fumaric acid
108.	17530	000050-99-7	Glucose
109.	18010	000110-94-1	Glutaric acid
110.	18070	000108-55-4	Glutaric anhydride
111.	18100	000056-81-5	Glycerol
112.	18250	000115-28-6	Hexachlorendomethylene- tetrahydrophthalic acid	The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0·01 mg/kg)
113.	18280	000115-27-5	Hexachlorendomethylene- tetrahydrophthalic anhydride	The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0·01 mg/kg)
114.	18310	036653-82-4	Hexadecan-1-ol
115.	18430	000116-15-4	Hexafluoropropylene	The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0·01 mg/kg)
116.	18460	000124-09-4	Hexamethylenediamine	The specific migration of this substance shall not exceed 2·4 mg/kg
117.	18640	000822-06-0	Hexamethylene diisocyanate	As item 70
118.	18670	000100-97-0	Hexamethylenetetramine	The specific migration of this substance shall not exceed 15 mg/kg (expressed as formaldehyde)
119.	As item 84	000123-31-9	Hydroquinone	As item 84
120.	18880	000099-96-7	p-Hydroxybenzoic acid
121.	19000	000115-11-7	Isobutene
122.	19210	001459-93-4	Isophthalic acid, dimethyl ester	The specific migration of this substance shall not exceed 0·05 mg/kg
123.	19270	000097-65-4	Itaconic acid
124.	19460	000050-21-5	Latic acid
125.	19470	000143-07-7	Lauric acid
126.	19480	002146-71-6	Lauric acid, vinyl ester
127.	19510	011132-73-3	Lignocellulose
128.	19540	000110-16-7	Maleic acid	The specific migration of this substance alone or together with item 129 shall not exceed a total of 30 mg/kg
129.	19960	000108-31-6	Maleic anhydride	The specific migration of this subtance alone or together with item 128 shall not exceed a total of 30 mg/kg (expressed as maleic acid)
130.	As item 215	000108-78-1	Melamine	As item 215
131.	20020	000079-41-4	Methacrylic acid
132.	20080	002495-37-6	Methacrylic acid, benzyl ester
133.	20110	000097-88-1	Methacrylic acid, butyl ester
134.	20140	002998-18-7	Methacrylic acid, sec-butyl ester
135.	20170	000585-07-9	Methacrylic acid, tert-butyl ester
136.	20890	000097-63-2	Methacrylic acid, ehtyl ester
137.	21010	000097-86-9	Methacrylic acid, isobutyl ester
138.	21100	004655-34-9	Methacrylic acid, isopropyl ester
139.	21130	000080-62-6	Methacrylic acid, methyl ester
140.	21190	000868-77-9	Methacrylic acid, monoester with ethyleneglycol
141.	21280	002177-70-0	Methacrylic acid, phenyl ester
142.	21340	002210-28-8	Methacrylic acid, propyl ester
143.	21460	000760-93-0	Methacrylic anhydride
144.	21490	000126-98-7	Methacrylonitrile	The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0·02 mg/kg, analytical tolerance included)
145.	21550	000067-56-1	Methanol
146.	21940	000924-42-5	N-Methylolacrylamide	The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0·01 mg/kg)
147.	22150	000691-37-2	4-Methypent-1-ene	The specific migration of this substance shall not exceed 0·02 mg/kg
148.	22350	000544-63-8	Myristic acid
149.	22390	000840-65-3	2,6-Naphthalenedicarboxylic acid, dimethyl ester	The specific migration of this substance shall not exceed 0·05 mg/kg
150.	22420	003173-72-6	1,5-Naphthalene diisocyanate	As item 70
151.	22450	009004-70-0	Nitrocellulose
152.	22480	000143-08-8	Nonan-1-ol
153.	22570	000112-96-9	Octadecyl isocyanate	As item 70
154.	22600	000111-87-5	Octan-1-ol
155.	22660	000111-66-0	Oct-1-ene	The specific migration of this substance shall not exceed 15 mg/kg
156.	22763	000112-80-1	Oleic acid
157.	22780	000057-10-3	Palmitic acid
158.	22840	000115-77-5	Pentaerythritol
159.	22870	000071-41-0	Pentan-1-ol
160.	22960	000108-95-2	Phenol
161.	23050	000108-45-2	1,3-Phenylenediamine	The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg
162.	As item 60	000075-44-5	Phosgene	As item 60
163.	23170	007664-38-2	Phosphoric acid
164.	As item 204	—	Phthalic acid	As item 204
165.	23200	000088-99-3	o-Phthalic acid
166.	23230	000131-17-9	Phthalic acid, diallyl ester	The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0·01 mg/kg)
167.	23380	000085-44-9	Phthalic anhydride
168.	23470	000080-56-8	alpha-Pinene
169.	23500	000127-91-3	beta-Pinene
170.	23590	025322-68-3	Polyethylene glycol
171.	23650	025322-69-4	Polypropylene glycol (molecular weight greater than 400)
172.	23651	025322-69-4	Polypropyleneglycol
173.	23740	000057-55-6	Propan-1,2-diol
174.	23800	000071-23-8	Propan-1-ol
175.	23830	000067-63-0	Propan-2-ol
176.	23860	000123-38-6	Propionaldehyde
177.	23890	000079-09-4	Propionic acid
178.	23950	000123-62-6	Propionic anhydride
179.	23980	000115-07-1	Propylene
180.	24010	000075-56-9	Propylene oxide	The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg
181.	As item 82	000120-80-9	Pyrocatechol	As item 82
182.	24057	000089-32-7	Pyromellitic anhydride	The specific migration of this substance shall not exceed 0·05 mg/kg (expressed as pyromellitic acid)
183.	24070	073138-82-6	Resin acids and rosin acids
184.	As item 83	000108-46-3	Resorcinol	As item 83
185.	24100	008050-09-7	Rosin
186.	24130	008050-09-7	Rosin gum
187.	24160	008052-10-6	Rosin tall oil
188.	24190	009014-63-5	Rosin wood
189.	24250	009006-04-6	Rubber, natural
190.	24270	000069-72-7	Salicylic acid
191.	24280	000111-20-6	Sebacic acid
192.	24430	002561-88-8	Sebacic anhydride
193.	24475	001313-82-2	Sodium sulphide
194.	24490	000050-70-4	Sorbitol
195.	24520	008001-22-7	Soybean oil
196.	24540	009005-25-8	Starch, edible	The specific migration of this substance shall not exceed 0·05 mg/kg
197.	24550	000057-11-4	Stearic acid
198.	24610	000100-42-5	Styrene
199.	24820	000110-15-6	Succinic acid
200.	24850	000108-30-5	Succinic anhydride
201.	24880	000057-50-1	Sucrose
202.	24887	006362-79-4	5-Sulphoisophthalic acid, monosodium salt	The specific migration of this substance shall not exceed 5 mg/kg
203.	24888	003965-55-7	5-Sulphoisophthalic acid, monosodium salt, dimethyl ester	The specific migration of this substance shall not exceed 0·05 mg/kg
204.	24910	000100-21-0	Terephthalic acid	The specific migration of this substance alone or together with item 205 shall not exceed a total of 7·5 mg/kg
205.	24940	000100-20-9	Terephthalic acid dichloride	The specific migration of this substance alone or together with item 204 shall not exceed 7·5 mg/kg (expressed as terephthalic acid)
206.	24970	000120-61-6	Terephthalic acid, dimethyl ester
207.	25090	000112-60-7	Tetraethylene glycol
208.	25120	000116-14-3	Tetrafluoroethylene	The specific migration of this substance shall not exceed 0·05 mg/kg
209.	25150	000109-99-9	Tetrahydrofuran	The specific migration of this substance shall not exceed 0·6 mg/kg
210.	25180	000102-60-3	N, N, N', N'-Tetrakis (2-hydroxypropyl)- ethylenediamine
211.	25210	000584-84-9	2,4-Toluene diisocyanate	As item 70
212.	25240	000091-08-7	2,6-Toluene diisocyanate	As item 70
213.	25270	026747-90-0	2,4-Toluene diisocyanatedimer	As item 70
214.	25360	—	Trialkyl (C5-C15) acetic acid 2,3-epoxypropyl ester	The specific migration of this substance shall not exceed 6 mg/kg
215.	25420	000108-78-1	2,4,6-Triamino-1,3,5,-triazine	The specific migration of this substance shall not exceed 30 mg/kg
216.	25510	000112-27-6	Triethylene glycol
217.	25600	000077-99-6	1,1,1-Trimethylolpropane	The specific migration of this substance shall not exceed 6 mg/kg
218.	25910	024800-44-0	Tripropylene glycol
219.	25960	000057-13-6	Urea
220.	26050	000075-01-4	Vinyl chloride	The restrictions are those in regulation 5(1)(a) and (b) of the 1987 Regulations when analysed by the method referred to in regulation 14 of those Regulations
221.	26110	000075-35-4	Vinylidene chloride	The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg or the specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0·05 mg/kg)
222.	26140	000075-38-7	Vinylidene fluoride	The specific migration of this substance shall not exceed 5 mg/kg

SECTION B — Monomers authorised up to the end of 2001

	1	2	3	4
Item	PM/REF No.	CAS No.	Name	Restrictions
1.	10599/90A	061788-89-4	Acids, fatty, unsaturated (C18), dimers, distilled
2.	10599/91	061788-89-4	Acids, fatty, unsaturated (C18), dimers, non-distilled
3.	10599/92A	068783-41-5	Acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled
4.	10599/93	068783-41-5	Acids, fatty, unsaturated (C18), dimers, hydrogenated, non-distilled
5.	11000	050976-02-8	Acrylic acid, dicyclopentadientyl ester
6.	11245	002156-97-0	Acrylic acid, dodecyl ester
7.	11500	000103-11-7	Acrylic acid, 2-ethylhexyl ester
8.	11530	000999-61-1	Acrylic acid, 2-hydroxypropyl ester
9.	12265	004074-90-2	Adipic acid, divinyl ester
10.	12910	001732-10-1	Azelaic acid, dimethyl ester
11.	As item 78	000528-44-9	1,2,4-Benzenetricarboxylic acid	As item 78
12.	13060	004422-95-1	1,3,5-Benzenetricarboxylic acid trichloride
13.	As item 23	000091-76-9	Benzoguanamine
14.	As item 28	000080-09-1	Bisphenol S
15.	13720	000110-63-4	Butan-1,4 diol
16.	13780	002425-79-8	Butan-1,4 diol, bis(2,3-epoxypropyl) ether	The quantity in the finished plastic material or article of any substance within, or any combination of substances within, items 16 and 56 shall not exceed 5 mg/kg (expressed as epoxy)
17.	13810	000505-65-7	Butan-1,4 diol, formal
18.	13932	000598-32-3	But-3-en-2-ol
19.	14020	000098-54-4	4-tert-Butylphenol
20.	14260	000502-44-3	Caprolactone
21.	14800	003724-65-0	Crotonic acid
22.	15130	000872-05-9	Dec-1-ene
23.	15310	000091-76-9	2,4-Diamino-5-phenyl-1,3,5-triazine
24.	15370	003236-53-1	1,6-Diamino-2,2,4- trimethylhexane
25.	15400	003236-54-2	1,6-Diamino-2,4,4- trimethylhexane
26.	15610	000080-07-9	4,4'Dichlorodiphenyl sulphone
27.	15730	000077-73-6	Dicyclopentadiene
28.	16090	000080-09-1	4,4'-Dihydroxydiphenyl sulphone
29.	16210	006864-37-5	3,3'-Dimethyl-4,4'-diamino- dicyclohexylmethane
30.	16360	000576-26-1	2,6-Dimethylphenol
31.	16390	000126-30-7	2,2-Dimethylpropan-1,3-diol
32.	16450	000646-06-0	1,3-Dioxolane
33.	16540	000102-09-0	Diphenyl carbonate
34.	16690	001321-74-0	Divinylbenzene
35.	16697	000693-23-2	Dodecanedioic acid
36.	17110	016219-75-3	5-Ethylidenebicyclo [2.2.1]hept-2-ene
37.	18220	068564-88-5	N-Heptylaminoundecanoic acid
38.	18370	000592-45-0	Hexa-1,4-diene
39.	18441	000085-42-7	Hexahydrophthalic anhydride
40.	18700	000629-11-8	Hexan-1,6-diol
41.	18820	000592-41-6	Hex-1-ene
42.	19060	000109-53-5	Isobutyl vinyl ether
43.	19150	000121-91-5	Isophthalic acid
44.	19180	000099-63-8	Isophthalic acid dichloride
45.	As item 60	000078-79-5	Isoprene
46.	19490	000947-04-6	Laurolactam
47.	19570	000999-21-3	Maleic acid, diallyl ester
48.	19600	000105-76-0	Maleic acid, dibutyl ester
49.	19990	000079-39-0	Methacrylamide
50.	20050	000096-05-9	Methacrylic acid, allyl ester
51.	20260	000101-43-9	Methacrylic acid, cyclohexyl ester
52.	20380	001189-08-8	Methacrylic acid, diester with butan-1,3-diol
53.	20410	002082-81-7	Methacrylic acid, diester with butan-1,4-diol
54.	20440	000097-90-5	Methacrylic acid, diester with ethyleneglycol
55.	20530	002867-47-2	Methacrylic acid, 2-(dimethylamino) ethyl ester
56.	20590	000106-91-2	Methacrylic acid, 2,3- epoxypropyl ester	As item 16
57.	21370	010595-80-9	Methacrylic acid, 2-sulphoethyl ester
58.	21400	054276-35-6	Methacrylic acid, sulphopropyl ester
59.	21520	001561-92-8	Methallylsulphonic acid, sodium salt	The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg
60.	21640	000078-79-5	2-Methylbut-1,3 diene
61.	21730	000563-45-1	3-Methylbut-1-ene
62.	As item 17	000505-65-7	1,4-(Methylenedioxy) butane
63.	21970	000923-02-4	N-Methylolmethacrylamide
64.	22210	000098-83-9	alpha-Methylstyrene
65.	22360	001141-38-4	2,6-Naphthalenedicarboxylic acid
66.	As item 31	000126-30-7	Neopentylglycol
67.	22428	051000-52-3	Neodecanoic acid, vinyl ester
68.	22720	000140-66-9	4-tert-Octylphenol
69.	22900	000109-67-1	Pent-l-ene
70.	22937	001623-05-8	Perfluoropropyl perfluorovinyl ether
71.	23770	000504-63-2	Propan-1,3-diol
72.	23920	000105-38-4	Propionic acid, vinyl ester
73.	24370	000106-79-6	Sebacic acid, dimethyl ester
74.	24760	026914-43-2	Styrenesulphonic acid
75.	25380	—	Trialkyl (C5-C15) acetic acid, vinyl ester (= vinyl versatate)
76.	25390	000101-37-1	Triallyl cyanurate
77.	25450	026896-48-0	Tricyclodecanedimethanol
78.	25540	000528-44-9	Trimellitic acid	The quantity of this substance alone or together with item 79 in the finished plastic material or article shall not exceed 5 mg/kg
79.	25550	000552-30-7	Trimellitic anhydride	The quantity of this substance alone or together with item 78 in the finished plastic material or article shall not exceed 5 mg/kg (expressed as trimellitic acid)
80.	25810	015625-89-5	1,1,1-Trimethylolpropane triacrylate
81.	25840	003290-92-4	1,1,1-Trimethylolpropane trimethacrylate
82.	25900	000110-88-3	Trioxane
83.	26170	003195-78-6	N-Vinyl-N-methylacetamide	The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg

SECTION C — Monomers authorised up to the end of 1998

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

Part II — Supplementary

1

In regulation 4 and Part I—

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

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

• (c) the name of any substance is its chemical name, and to the extent that there is any inconsistency between CAS No. and the name, the name shall take precedence over the CAS No., and

• (d) references to specific migration are to be taken to mean specific migration as measured in accordance with Schedules 3 and 4.

2

If a substance appearing in Part I as an individual compound also falls within a generic term which appears therein, the restriction (if any) applying to that substance shall be that indicated for the individual compound and the entry applying to the generic term shall be treated as varied to such extent (if any) as is necessary therefor.

3

• (1) The items identified in Part I shall be taken to include—

• (a) substances undergoing polymerisation (which shall be taken to include polycondensation, polyaddition or any other similar process) to manufacture macromolecules,

• (b) natural or synthetic macromolecular substances used in the manufacture of modified macromolecules, if the monomers required to synthesise them are not so identified, and

• (c) substances used to modify existing natural or synthetic macromolecular substances.

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

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

SCHEDULE 2

Part I — Additives