The Plastic Materials and Articles in Contact with Food (Scotland) Regulations 2006

Made: 7th June 2006

Laid before the Scottish Parliament: 7th June 2006

Coming into force: 30th June 2006

The Scottish Ministers, in exercise of the powers conferred by sections 6(4), 16(2), 17(1) and (2), 26(1)(a) and (3), 31(2) and 48(1) of the Food Safety Act 1990[^f00001], and of all other powers enabling them in that behalf, having had regard in accordance with section 48(4A)[^f00002]of that Act to relevant advice given by the Food Standards Agency and after consultation as required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety[^f00003], hereby make the following Regulations:

PART 1 — Preliminary

Citation, commencement and extent

1

• (1) These Regulations may be cited as the Plastic Materials and Articles in Contact with Food (Scotland) Regulations 2006, and come into force on 30th June 2006.

• (2) These Regulations extend to Scotland only.

Interpretation

2

• (1) In these Regulations–

• “the Act” means the Food Safety Act 1990;

• “BADGE” has the meaning it bears in Article 1.1(a) of Regulation 1895/2005;

• “BFDGE” has the meaning it bears in Article 1.1(b) of Regulation 1895/2005;

• “business” has the meaning it bears in the Act;

• “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 Directive 93/8/EEC[^f00005]and Commission Directive 97/48/EC[^f00006];

• “Directive 85/572” means 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[^f00007];

• “Directive 88/388” means Council Directive 88/388/EEC on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production[^f00008]as corrected by a corrigendum dated 15th July 1988[^f00009];

• “Directive 89/107” means Council Directive 89/107/EEC on the approximation of the laws of the Member States concerning food additives authorised in foodstuffs intended for human consumption[^f00010]as amended by European Parliament and Council Directive 94/34[^f00011];

• “the Directive” means Commission Directive 2002/72/EC[^f00012]relating to plastic materials and articles intended to come into contact with foodstuffs, as amended by Commission Directive 2004/1/EC[^f00013]and Commission Directive 2004/19/EC[^f00014];

• “EEA State” means a member State (other than the United Kingdom), Norway, Iceland and Liechtenstein;

• “EFSA” means the European Food Safety Authority;

• “food” is to be construed in accordance with section 16(5) of the Act;

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

• “handling of food” means use in connection with the storage, preparation, packaging, sale or serving of food;

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

• “material or article” means a material or article falling within the definition of materials and articles in Article 1.2 of Regulation 1895/2005;

• “monomer” means any substance that is included for the purposes of the Directive among monomers and other starting substances;

• “NOGE” has the meaning it bears in Article 1.1(c) of Regulation 1895/2005;

• “the 1998 Regulations” means the Plastic Materials and Articles in Contact with Food Regulations 1998[^f00015];

• “the 2005 Regulations” means the Materials and Articles in Contact with Food (Scotland) Regulations 2005[^f00016];

• “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;

• “the Purity Directives” means Commission Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs[^f00017]as amended by Commission Directive 98/66/EC[^f00018], Commission Directive 2000/51/EC[^f00019], Commission Directive 2001/52/EC[^f00020]and Commission Directive 2004/46/EC[^f00021]; Commission Directive 95/45/EC laying down purity criteria concerning colours for use in foodstuffs[^f00022]as amended by Commission Directive 1999/75/EC[^f00023], Commission Directive 2001/50/EC[^f00024]and Commission Directive 2004/47/EC[^f00025]; and Commission Directive 96/77/EC laying down specific purity criteria for food additives other than colours or sweeteners[^f00026]as amended by Commission Directive 98/86/EC[^f00027], Commission Directive 2000/63/EC[^f00028], Commission Directive 2001/30/EC[^f00029], Commission Directive 2002/82/EC[^f00030], Commission Directive 2003/95/EC[^f00031]and Commission Directive 2004/45/EC[^f00032];

• “Regulation 1895/2005” means Commission Regulation (EC) No. 1895/2005 on the restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food[^f00033];

• “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 otherwise than on sale, in the course of a business, of any material or article is deemed to be a sale.

• (3) Any other expression used in these Regulations and in the Directive, Directive 82/711, Directive 85/572 or Regulation 1895/2005 bears the same meaning in these Regulations as it bears in that Directive or Regulation.

• (4) Except in Part 5 of Schedule 6, any reference to a numbered Annex is a reference to that Annex in the Directive.

PART 2 — Requirements for Plastic Materials and Articles

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

3

• (1) No person shall–

• (a) use for the handling of food in the course of a business; or

• (b) for the purpose of handling food–

• (i) sell; or

• (ii) import from anywhere other than an EEA State,

a plastic material or article which fails to meet the required standard.

• (2) For the purposes of this regulation a plastic material or article fails to meet the required standard if–

• (a) it has been manufactured with a prohibited monomer as described in regulation 4(2) or a prohibited additive as described in regulation 5(2);

• (b) it does not meet the required standards set out in regulation 6, 7, 8, 9 or 10.

Restriction on the use of monomers in the manufacture of plastic materials and articles

4

• (1) Subject to paragraphs (3), (4) and (5), no person shall use any prohibited monomer in the manufacture of any plastic material or article.

• (2) A prohibited monomer is any monomer which is not–

• (a) of good technical quality;

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

• (c) used in accordance with any restrictions and specifications for that monomer set out or referred to in column 4 of Part I of Schedule 1 of the corresponding entry.

• (3) Paragraph (1) 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) epoxy resins;

• (c) adhesives and adhesion promoters; or

• (d) printing inks.

• (4) Paragraph (1) shall not be taken to prohibit the manufacture of any plastic material or article with any substance which falls within paragraph (3)(c) (relating to mixtures of authorised substances) of Annex II and is of good technical quality.

• (5) 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 mentioned in paragraph (2)(b) it shall a be defence for the accused to prove that each monomer is present in the finished plastic material as%

• (a) an impurity, a reaction intermediate or a decomposition product which falls within paragraph 3(a) of Annex II and is of good technical quality; or

• (b) an oligomer or a natural or synthetic macromolecular substance or a mixture thereof which falls within paragraph 3(b) of that Annex.

• (6) Part 2 of Schedule 1 has effect to supplement this regulation and Part 1 of Schedule 1.

Restriction on the use of additives in the manufacture of plastic materials and articles

5

• (1) Subject to paragraph (3) no person shall use any prohibited additive in the manufacture of any plastic material or article.

• (2) A prohibited additive is–

• (a) any additive identified by PM/REF No., CAS No. (if any) and name in columns 1, 2 and 3 respectively of Part 1 or Part 2 of Schedule 2 which is not–

• (i) of good technical quality; and

• (ii) used in accordance with any restrictions and specifications for that additive set out in the corresponding entry in column 4 of Part 1 or Part 2 of that Schedule; or

• (b) any food additive authorised by Directive 89/107 or any flavouring authorised by Directive 88/388 that migrates into food–

• (i) in a quantity that has a technological function in the final food product; or

• (ii) where the food is of a type for which the use of any such food additive or flavouring is so authorised, in quantities exceeding the limits provided for in Directive 89/107 or Directive 88/388 as appropriate, or in Schedule 2, whichever is the lower.

• (3) 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 1 or Part 2 of Schedule 2 which is not of good technical quality, it shall be a defence for the accused 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.

• (4) Part 3 of Schedule 2 has effect to supplement this regulation and Parts 1 and 2 of that Schedule.

Required standard for non-migration of constituents of monomers

6

• (1) Subject to paragraph (2), where a migration limit expressed in mg/kg is indicated in column 4 of Part 1 of Schedule 1 in relation to any monomer, a plastic material or article manufactured from that monomer meets the required standard under this regulation if it is not capable of transferring constituents of that monomer to food with which it 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 in column 4 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 in column 4 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 can be filled, having a capacity of less than 500 millilitres or more than 10 litres; or

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

• (2) A plastic material or article manufactured from any monomer for which a migration limit in mg/kg is expressed in column 4 of the relevant section of Part 1 of Schedule 1 is not to be considered capable of transferring constituents of that monomer to food with which it may come into contact in quantities exceeding the appropriate limit in paragraph (1) if the only food with which that plastic material or article may come into contact is food to which regulation 9(3) applies.

Required standard for non-migration of constituents of additives

7

• (1) Subject to paragraph (2), where a migration limit expressed in mg/kg is indicated in column 4 of Part 1 or 2 of Schedule 2 in relation to any additive, a plastic material or article manufactured containing that additive meets the required standard under this regulation if it is not capable of transferring constituents of that additive to food with which it 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 indicated in column 4 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 in column 4 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 can be filled, having a capacity of less than 500 millilitres or more than 10 litres; or

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

• (2) A plastic material or article manufactured containing an additive for which a migration limit in mg/kg is expressed in column 4 of Part 1 or Part 2 of Schedule 2 is not to be considered capable of transferring constituents of that additive to food with which the plastic material or article may come into contact in quantities exceeding the appropriate limit in paragraph (1) if the only food with which that plastic material or article may come into contact is food to which regulation 9(3) applies.

Required standard for products obtained by bacterial fermentation

8

A product obtained by bacterial fermentation meets the required standard under this regulation if it is–

• (a) of good technical quality;

• (b) identified by PM/REF No., CAS No. and name in column 1, 2 and 3 respectively of Schedule 3; and

• (c) in compliance with the restrictions and specifications set out in column 4 of that Schedule.

Required standards relating to overall migration limits

9

• (1) Subject to paragraph (3), a plastic material or article meets the required standard under this regulation if it is not capable of transferring its constituents to food with which it may come into contact in quantities exceeding the appropriate limit specified in paragraph (2).

• (2)

• (a) In the case of any plastic material or article comprising–

• (i) an article which is a container or comparable to a container or 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; or

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

the appropriate limit is an overall migration limit of 60 milligrams of constituents released per kilogram of food.

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

• (3) For the purposes of this regulation a plastic material or article is not deemed to have failed to meet the required standard under paragraph (1) if the only food with which it may come into contact is food–

• (a) which is specified in the table to Part 4 of Schedule 6; and

• (b) where there is no “X” placed anywhere in the group of columns headed “Simulants to be used” in the entry for that food.

• (4) In any proceedings for an offence under this regulation, the defences available in paragraph 6(2) and 7(2) of Schedule 5 shall be available as specified in those paragraphs.

Required standard for non-migration of primary aromatic amines

10

• (1) Subject to paragraph (3), a plastic material or article manufactured using isocyanates or colourants prepared by diazo-coupling meets the required standard under this regulation if it is not capable of transferring in a detectable quantity primary aromatic amines (expressed as aniline), not being primary aromatic amines listed in these Regulations, to food with which it may come into contact.

• (2) Schedule 4 has effect to prescribe specifications for certain of the substances listed in Part 1 of Schedule 1, Part 1 or 2 of Schedule 2 or Schedule 3.

• (3) For the purposes of paragraph (1) a detectable quantity means a quantity of at least 0.02 milligrams per kilogram of food or food simulant (including analytical tolerance).

Method of testing the capability of plastic materials or articles to transfer constituents, and methods of analysis

11

• (1) A plastic material or article shall be treated as capable of transferring constituents to food with which it may come into contact to the extent that such capability is established–

• (a) in any case other than one to which sub-paragraph (b) applies, and subject to Article 8.4 of the Directive (which may be applied in accordance with the conditions stated therein), by the verification methods specified in Schedule 5 (including the analytical tolerances referred to in paragraph 8 of that Schedule) and Schedule 6;

• (b) in any case where the extent to which vinyl chloride, as identified in Part 1 of Schedule 1, is capable of such transfer falls to be established, by the method referred to in regulation 7(2) of the 2005 Regulations.

• (2) In Schedules 5 and 6, references to migration or release of a substance are to be construed as references to the transfer of constituents to the simulant representing the food with which it is in or may come into contact.

• (3) The specific migration of a constituent from a plastic material or article shall where applicable be determined in the manner specified in the relevant sub-paragraph of paragraph 8 of Annex II to the Directive.

• (4) The quantity of a constituent in a plastic material or article shall where applicable be determined in the manner specified in the sub-paragraph of paragraph 8 of Annex II relating to the term “QM(T)”, “QMA” or “QMA(T)” as the case may be.

Labelling

12

• (1) At marketing stages other than the retail stage a person in possession of any plastic material or article shall ensure that it is accompanied by a written declaration which–

• (a) accords with Article 16.1 of Regulation (EC) No. 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food and repealing Directives 80/950/EEC and 89/109/EEC[^f00034];

• (b) provides, in respect of substances that are subject to a restriction on quantities migrating into food, information obtained from experimental data or theoretical calculation concerning–

• (i) the levels of migration specific to those substances; and

• (ii) where appropriate, purity criteria in accordance with the purity Directives

sufficient to enable the user to comply with food law.

• (2) In establishing which descriptions of food a material or article may come into contact with, it is to be assumed until the contrary is proved that, for the purposes of these Regulations, the particulars shown in relation to it in accordance with paragraph (1)(a) are accurate and that unless the particulars so indicate, there are no restrictions on the intended conditions of contact.

Provisions relating to the use of certain epoxy derivatives (BADGE, BFDGE and NOGE)

13

• (1) In this regulation–

• (a) any reference to a numbered Article is a reference to that Article in Regulation 1895/2005;

• (b) paragraphs (2) to (5) are subject to Article 1.3 (exception relating to certain storage containers and pipelines);

• (c) for the purpose of Article 6.4 the competent authority is a food authority.

• (2) Subject to Articles 6.1, 6.2 (transitional provisions) and 6.4. (labelling requirements), no person shall–

• (a) manufacture;

• (b) use for the handling of food in the course of a business; or

• (c) for the purpose of the handling of food–

• (i) sell; or

• (ii) import,

any material or article in contravention of Article 3 or Article 4 (prohibitions relating to BFDGE and NOGE respectively).

• (3) No person shall manufacture any material or article in such a way as to contravene the requirements of Article 2 (controls on the migration of BADGE from materials and articles).

• (4) Subject to Article 6.1, no person shall–

• (a) use for the handling of food in the course of a business; or

• (b) for the purpose of the handling of food–

• (i) sell; or

• (ii) import,

any material or article that has been manufactured in such a way as to contravene the requirements of Article 2.

• (5) Subject to Article 6.3 (transitional provisions relating to materials and articles brought into contact with food before 1st January 2007), no person shall contravene or fail to comply with the requirements of Article 5 (obligations regarding the provision of a written statement when marketing materials or articles containing BADGE or its derivatives).

• (6) No person shall without reasonable excuse fail to comply with a request made under Article 6.4 (requirement to disclose date of filling to competent authority).

PART 3 — Execution and Enforcement

Enforcement

14

Each food authority shall execute and enforce–

• (a) the provisions of Regulation 1895/2005 mentioned in regulation 13; and

• (b) these Regulations,

in its area.

Offences and Penalties

15

• (1) Any person who–

• (a) contravenes or fails to comply with regulation 3(1), 4(1), 5(1), 12(1) or 13(2) to (5);

• (b) intentionally obstructs any person acting in the execution of Regulation 1895/2005 or these Regulations;

• (c) without reasonable excuse fails–

• (i) to comply with regulation 13(6); or

• (ii) to give to any person acting in the execution of Regulation 1895/2005 or these Regulations any assistance or information which that person may reasonably require; or

• (d) in purported compliance with any requirement mentioned in sub-paragraph (c), knowingly or recklessly supplies information that is false or misleading in any material particular,

is guilty of an offence.

• (2) Any person convicted of an offence under these Regulations is liable–

• (a) in the case of an offence under paragraph (1)(a)–

• (i) on conviction on indictment to a term of imprisonment not exceeding two years or to a fine or both;

• (ii) on summary conviction to a term of imprisonment not exceeding six months or to a fine not exceeding the statutory maximum or both;

• (b) in the case of any other offence under these Regulations, on summary conviction to a term of imprisonment not exceeding three months or to a fine not exceeding level five on the standard scale or to both.

• (3) Nothing in paragraph (1)(c) is to be construed as requiring any person to answer any question or give any information if to do so might incriminate that person.

• (4) Where an offence under these Regulations which has been committed by a body corporate or a Scottish partnership 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 or any partner of the Scottish partnership; or

• (b) any person purporting to act in such a capacity,

that person as well as the body corporate or, as the case may be, the Scottish partnership is to be deemed to be guilty of that offence and liable to be proceeded against and punished accordingly.

• (5) No prosecution for an offence under these Regulations shall be begun after the expiry of 3 years from the commission of the offence or 1 year from the date on which evidence sufficient in the opinion of the prosecutor to warrant proceedings came to the knowledge of the prosecutor, whichever is the earlier.

• (6) For the purposes of this regulation, a certificate signed by or on behalf of the prosecutor and stating the date on which evidence sufficient in the prosecutor’s opinion to warrant the proceedings came to the knowledge of the prosecutor, shall be conclusive evidence of that fact.

• (7) A certificate stating that matter and purporting to be so signed shall be deemed to be so signed unless the contrary is proved.

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

General defences

16

• (1) In any proceedings for an offence under these Regulations it shall, subject to paragraph (5), be a defence to prove that the accused took all reasonable precautions and exercised all due diligence to avoid the commission of the offence by the accused or by a person under the accused’s control.

• (2) Without prejudice to the generality of paragraph (1), a person accused of an offence under these Regulations who did not–

• (a) prepare the plastic material or article or, as the case may be, the material or article in respect of which the offence is alleged to have been committed; nor

• (b) import it,

shall be taken to have established the defence provided by paragraph (1) if the requirements of paragraphs (3) and (4) are satisfied.

• (3) The requirements of this paragraph are satisfied if it is proved that–

• (a) the commission of the offence was due to the act or default of some other person who was not under the control of the accused, or to reliance on information supplied by such a person;

• (b) either–

• (i) the accused carried out all such checks of the plastic material or article or material or article in question as were reasonable in all the circumstances; or

• (ii) it was reasonable in all the circumstances for the accused to rely on checks carried out by the person who supplied the accused with the plastic material or article or the material or article in question; and

• (c) the accused did not know and had no reason to suspect at the time the offence was committed that the accused’s act or omission would amount to an offence under these Regulations.

• (4) The requirements of this paragraph are satisfied if the offence is one of sale and it is proved that–

• (a) the commission of the offence was due to the act or default of some other person who was not under the control of the accused, or to reasonable reliance on information supplied by such a person;

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

• (c) the accused did not know and could not reasonably have been expected to know at the time the offence was committed that the accused’s act or omission would amount to an offence under these Regulations.

• (5) If in any case the defence provided by this regulation involves the allegation that the commission of the offence was due to the act or default of another person, or to reliance on information supplied by another person, the accused shall not without leave of the court be entitled to rely on that defence unless at the earlier of–

• (a) a date 7 days before the trial diet (not being a notional trial diet); or

• (b) a date 28 days after the first appearance of the accused before a court in connection with the alleged offence,

the accused 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 the possession of the accused.

Transitional defences and savings

17

Not withstanding the revocations made by regulation 24, in relation to any plastic material or article–

• (a) manufactured before the 1st July 1998, the defence in regulation 3(3) of the 1998 Regulations;

• (b) manufactured or imported into the European Community before 1st January 2003, the defence in regulation 10(15) of the 1998 Regulations;

• (c) put into free circulation in the European Community before 30th November 2002, the defence in regulation 10(16) of the 1998 Regulations;

• (d) manufactured or imported into the European Community before 1st March 2004, the defence in regulation 10(21)(a) of the 1998 Regulations;

• (e) manufactured or imported into the European Community before 1st March 2003, the defence in regulation 10(21)(b) of the 1998 Regulations;

• (f) containing azodicarbonamide and brought into contact with food before 2nd August 2005, the defence in regulation 10(23) of the 1998 Regulations; or

• (g) manufactured or imported into the European Community before 1st March 2006, the defence in regulation 10(25) of the 1998 Regulations,

shall apply in relation to offences under these Regulations as it applied to offences under the equivalent provisions in those Regulations.

Procedure where a sample is to be analysed

18

• (1) An authorised officer who has procured a sample under section 29 of the Act and who considers it should be analysed shall divide the sample into three parts.

• (2) If the sample consists of sealed containers and opening them would, in the opinion of the authorised officer, impede a proper analysis, the authorised officer shall divide the sample into parts by putting the containers into three lots, and each lot shall be treated as being a part.

• (3) The authorised officer shall–

• (a) if necessary place each part in a suitable container and seal it;

• (b) mark each part or container;

• (c) as soon as reasonably practicable, give one part to the owner and notify the owner in writing that the sample will be analysed;

• (d) submit one part for analysis in accordance with section 30 of the Act; and

• (e) retain one part for future submission under regulation 19.

Secondary analysis by the Government Chemist

19

• (1) Where a sample has been retained under regulation 18 and–

• (a) a decision has been made to send a report to the procurator fiscal or proceedings have been commenced against a person for an offence under these Regulations; and

• (b) the result of the analysis carried out in accordance with regulation 18(3)(d) is to be adduced as evidence,

paragraphs (2) to (6) apply.

• (2) The authorised officer–

• (a) may of the officer’s own volition prior to a report being sent to the procurator fiscal; and

• (b) shall—

• (i) if requested by the prosecutor;

• (ii) if the court so orders on the application of the prosecutor or the accused; or

• (iii) if requested by the accused (subject to paragraph (5)),

send the retained part of the sample to the Government Chemist for analysis.

• (3) The Government Chemist shall analyse the part sent under paragraph (2) and where the analysis is carried out–

• (a) under paragraph (2)(a) or (b)(i) or (iii), provide the authorised officer; or

• (b) under paragraph (2)(ii), provide the prosecutor and the accused,

with a certificate of analysis.

• (4) The authorised officer shall immediately on receipt under paragraph 3(a) supply the prosecutor and the accused with a copy of the Government Chemist’s certificate of analysis.

• (5) Where a request is made under paragraph (2)(b)(iii) the authorised officer may give notice in writing to the accused requesting payment of a fee specified in the notice in respect of the functions mentioned in paragraph (3), and in the absence of agreement by the accused to pay the fee the authorised officer may refuse to comply with the request.

• (6) Any certificate of the results of testing transmitted by the Government Chemist under this regulation may be signed by or on behalf of the Government Chemist, and the testing may be carried out by any person under the direction of the person who signs the certificate.

• (7) Any certificate transmitted by the Government Chemist in accordance with paragraph (6) shall be taken as sufficient evidence of the facts stated therein unless any part to the proceedings requests that the person by whom the certificate is signed be called as a witness.

• (8) In this regulation “accused” includes a person who is intended by the authorised officer to be the subject of a report to the procurator fiscal.

PART 4 — Application for Authorisation

Applications for inclusion of an additive in the Community list of authorised additives

20

• (1) This regulation applies where a person wishes to make an application for the inclusion of an eligible additive in the Community list referred to in Article 4 of the Directive.

• (2) The application mentioned in paragraph (1), including supporting data, must be made to EFSA before 1st January 2007.

• (3) If during examination of the data referred to in paragraph (2), EFSA calls for supplementary information, the eligible additive may, if permitted to be used under Scots law, continue to be so used until EFSA has issued an opinion, provided the supplementary opinion is submitted within the time limits specified by EFSA.

• (4) For the purposes of this regulation, an eligible additive is one whose use is permitted in one or more Member States before 1st January 2007.

PART 5 — General and Supplementary

Application of provisions of the Act

21

The following provisions of the Act shall apply for the purposes of these Regulations as they apply for the purposes of the Act–

• (a) section 3 (presumptions that food intended for human consumption);

• (b) section 30(8) (relating to documentary evidence);

• (c) section 44 (protection of officers acting in good faith).

Amendment to the Food Safety (Sampling and Qualifications) Regulations 1990

22

In the Food Safety (Sampling and Qualifications) Regulations 1990[^f00035], in Schedule 1 (provisions to which those Regulations do not apply)–

• (a) for the title and reference of the 1998 Regulations substitute the title and reference of these Regulations; and

• (b) for the title and reference to the Materials and Articles in Contact with Food Regulations 1987[^f00036]substitute the title and reference to the Materials and Articles in Contact with Food (Scotland) Regulations 2005[^f00037].

Amendments to the Materials and Articles in Contact with Food (Scotland) Regulations 2005

23

• (1) The 2005 Regulations are amended in accordance with paragraphs (2) to (6).

• (2) In regulation 2(1)–

• (a) omit the definition of “the 1998 Regulations”; and

• (b) after the definition of “sell” insert–

• “the 2006 Regulations” means the Plastic Materials and Articles in Contact with Food (Scotland) Regulations 2006[^f00038].

• (3) In regulation 8(4) for “Schedules 1, 2 or 2A to the 1998 Regulations” substitute “Schedules 1, 2 or 3 to the 2006 Regulations”.

• (4) In regulation 9(3)–

• (a) for “Part I of Schedule 1 to the 1998 Regulations” substitute “Part 1 of Schedule 1 to the 2006 Regulations”; and

• (b) in subparagraph (b) for “Part II” substitute “Part 2”.

• (5) In regulation 9(5) for “Schedules 3 and 4 of the 1998 Regulations as read with regulation 6 of those Regulations” substitute “Schedules 5 and 6 to the 2006 Regulations as read with regulation 11 of those Regulations”.

Revocations

24

The following Regulations are revoked–

• (a) the 1998 Regulations in so far as they extend to Scotland;

• (b) the Plastic Materials and Articles in Contact with Food (Amendment) (Scotland) Regulations 2000[^f00039];

• (c) the Plastic Materials and Articles in Contact with Food (Amendment) (Scotland) Regulations 2002[^f00040];

• (d) the Plastic Materials and Articles in Contact with Food (Amendment) (Scotland) Regulations 2003[^f00041];

• (e) the Plastic Materials and Articles in Contact with Food Amendment (Scotland) Regulations 2004[^f00042];

• (f) the Plastic Materials and Articles in Contact with Food Amendment (Scotland) Regulations 2005[^f00043]; and

• (g) regulation 15 of the 2005 Regulations.

SCHEDULE 1 — Authorised Monomers

PART 1 — List of Monomers with Restrictions and Specifications

	1	2	3	4
	PM/REF No	CAS No	Name	Restrictions and specifications
1	10030	000514-10-3	Abietic acid
2	10060	000075-07-0	Acetaldehyde	SML(T) = 6mg/kg (2)
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 12mg/kg
5	10150	000108-24-7	Acetic anhydride
6	10210	000074-86-2	Acetylene
6A	10599/90A	061788-89-4	Acids, fatty, unsaturated (C₁₈), dimers, distilled	QMA(T) = 0.05 mg/6 dm² (²⁷)
6B	10599/91	061788-89-4	Acids, fatty, unsaturated (C₁₈), dimers, non distilled	QMA(T) = 0.05 Mg/6 dm² (27)
6C	10599/92A	068783-41-5	Acids, fatty, unsaturated (C₁₈), dimers, hydrogenated, distilled	QMA(T) = 0.05 Mg/6 dm² (27)
6D	10599/93	068783-41-5	Acids, fatty, unsaturated (C₁₈), dimers, hydrogenated, distilled	QMA(T) = 0.05 mg/6 dm² (27)
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
13A	11000	050976-02-8	Acrylic acid, discyclopentaidien-yl ester	The quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 m²
13B	11245	002156-97-0	Acrylic acid, dodecyl ester	The specific migration of this substance shall not exceed 0.05 mg/kg (1)
14	11470	000140-88-5	Acrylic acid, ethyl ester
15	As item 19	000818-61-1	Acrylic acid, hydroxyethyl ester
15A	11530	00999-61-1	Acrylic acid, 2-hydroxypropyl ester	QMA = 0.05 mg/6 dm² for the sum of acrylic acid, 2-hydroxypropoyl ester and acrylic acid, 2-hydroxyisopropyl ester and in compliance with the specifications laid down in Schedule 4
16	11590	000106-63-8	Acrylic acid, asobutyl 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
23A	12265	004074-90-2	Adipic acid, divinyl ester	The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg. For use only as comonomer
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
28A	12761	000693-57-2	12-Aminododecanoic acid	The specific migration of this substance shall not exceed 0.05 mg/kg
28B	12763	000141-43-5	2-Aminoethanol	SML = 0.05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC and for indirect food contact only, behind the PET layer
28C	12765	844354-12-8	N-(2-aminoethyl)-beta-alanine, sodium salt	SML – 0.05 mg/kg
29	12788	002432-99-7	11-Aminoundecanoic acid	The specific migration of this substance shall not exceed 5mg/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-Benzenedi-methanamine	The specific migration of this substance shall not exceed 0.05 mg/kg
33A	13060	004422-95-1	1,3,5-Benzenetricarboxylic acid trichloride	The quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 m² (measured as 1,3,5- benzenetricarboxylic acid)
33B	13075	00091-76-9	Benzoguanamine	(see “2,4-Diamino-6-Phenyl-1,3,5-Triazine”)
34	13090	000065-85-0	Benzoic acid
35	13150	000100-51-6	Benzyl alcohol
35A	13180	000498-66-8	Bicyclo [2.2.1] hept-2-ene (= Norbornene)	The specific migration of this substance shall not exceed 0.05 mg/kg
35B	13210	001761-71-3	Bis (4-aminocyclohexyl) methane	The specific migration of this substance shall not exceed 0.05 mg/kg
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
37A	13323	000102-40-9	1,3-Bis (2-hydroxyethoxy) benzene	SML = 0.05 mg/kg
38	13390	000105-08-8	1,4-Bis (hydroxymethyl)-cyclohexane
38A	13395	04767-03-7	2,2-Bis (hydroxymethyl) propionic acid	QMA = 0.05 mg/6 dm²
39	13480	000080-05-7	2,2-Bis (4-hydroxyphenyl) propane	SML(T) = 0.6 mg/kg (28)
40	13510	001675-54-3	2,2-Bis (4-hydroxyphenyl) propane bis (2,3-epoxypropyl) ether	Use must be in accordance with Regulation 1895/2005
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	13560	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
47A	13617	000080-09-1	Bisphenol S	As item 86A
47B	13620	010043-35-3	Boric acid	SML(T) – 6 mg/kg (22) (expressed as boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption
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 not be detectable (when measured by a method with a limit of detection of 0.02mg/kg, analytical tolerance included)
49	13690	000107-88-0	1,3-Butanediol
49A	13720	00110-63-4	1,4-Butanediol	SML(T) = 0.05 mg/kg (23)
49B	13780	002425-79-8	1,4-Butanediol (bis 2,3-epoxypropyl) ether	The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg (expressed as epoxy group, molecular weight equal to 43)
49C	13810	000505-65-7	1,4-Butanediol formal	QMA = 0.05 mg/6 dm²
50	13840	000071-36-3	Butan-1-ol
51	13870	000106-98-9	But-1-ene
52	13900	000107-01-7	But-2-ene
52A	13932	000598-32-3	3-Buten-2-ol	QMA = ND (DL = 0.02 mg/6 dm²). To be used only as a co-monomer for the preparation of polymeric additive
52B	14020	000098-54-4	4-tert-Butylphenol	The specific migration of this substance shall not exceed 0.05 mg/kg
53	14110	000123-72-8	Butyraldehyde
54	14140	000107-92-6	Butyric acid
55	14170	000106-31-0	Butyric acid anhydride
56	14200	000105-60-2	Caprolactam	SML(T) = 15 mg/kg (5)
57	14230	002123-24-2	Caprolactam, sodium salt	SML(T) = 15 mg/kg (5) (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	Caster oil
62	14500	009004-34-6	Cellulose
63	14530	007782-50-5	Chlorine
63A	14650	000079-38-9	Chlorotrifluorethylene	QMA = 0.5 mg/6 dm²
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
68MA	14800	003724-65-0	Crotonic acid	QMA(T) = 0.05 mg/6 dm² (33)
68A	14841	000599-64-4	4-Cumylphenol	The specific migration of this substance shall not exceed 0.05 mg/kg
69	As item 38	000105-08-8	1,4-Cyclohexanedimethanol
70	14950	003173-53-3	Cyclohexyl isocyanate	QM(T) = 1mg/kg in FP (expressed as NCO) (26)
70A	15030	00931-88-4	Cyclooctene	SML = (0.05 mg/kg. For use only in polymers contacting foods for which simulant A is laid down in Council Directive 85/572/EEC
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
73A	15130	000872-05-9	1-Decene	The specific migration of this substance shall not exceed 0.05 mg/kg
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
76A	15310	00091-76-9	2,4-Diamino-6-phenyl-1,3,5-triazine	QMA = 5 mg/6 dm²
77	15565	000106-46-7	1,4-Dichlorobenzene	The specific migration of this substance shall not exceed 12 mg/kg
77A	15610	00080-07-9	4,4'-Dichlorodiphenyl sulphone	SML = 0.05 mg/kg
78	15700	005124-30-1	Dicyclohexylmethane-4,4'-diisocyanate	QM(T) = 1mg/kg (expressed as NCO (25)
79	15760	000111-46-6	Diethylene glycol	SML(T) = 30 mg/kg (3)
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 shall not exceed 2.4 mg/kg
84	15940	000123-31-9	1,4-Dihydroxybenzene	The specific migration of this shall not exceed 0.6 mg/kg
85	15970	000611-99-4	4,4'-Dihydroxybenzophenone	SML(T) = 6 mg/kg (14)
86	16000	000092-88-6	4,4'-Dihydroxybiphenyl	The specific migration of this substance shall not exceed 6 mg/kg
86A	16090	00080-09-01	4,4'-Dihydroxydiphenyl sulphone	SML = 0.05 mg/kg
87	16150	000108-01-0	Dimethylaminoethanol	The specific migration of this substance shall not exceed 18 mg/kg
87A	16210	006864-37-5	3,3'-Dimethyl-4,4'-diaminodicyclohexyl methane	SML = 0.05 mg/kg (32). To be used only in polyamides
88	16240	000091-97-4	3,3'-Dimethyl-4,4'-diisocyanatobiphenyl	QM(T) = 1 mg/kg (expressed as NCO) (25)
88A	16360	000576-26-1	2,6-Dimethylphenol	The specific migration of this substance shall not exceed 0.05 mg/kg
88B	16390	000126-30-7	2,2'-Dimethyl-1,3-propanediol	SML = 0.05 mg/kg
88C	16450	000646-06-0	1,3-Dioxolane	The specific migration of this substance shall not exceed 0.05 mg/kg
89	16480	000126-58-9	Dipentaerythritol
89A	16540	000102-09-0	Diphenyl carbonate	SML = 0.05 mg/kg
90	16570	004128-73-8	Diphenylether-4,4'-diisocyanate	QM(T) = 1mg/kg (expressed as NCO) (25)
91	16600	005873-54-1	Diphenylmethane-2,4'-diisocyanate	QM(T) = 1 mg/kg (expressed as NCO) (25)
92	16630	000101-68-8	Diphenylmethane-4,4'-diisocyanate	QM(T) – 1 mg/kg (expressed as NCO) (25)
92A	16650	000127-63-9	Diphenyl sulphone	SML(T) = 3 mg/kg (24)
93	16660	000110-98-5	Dipropyleneglycol
93A	16690	001321-74-0	Divinylbenzene	QMA = 0.01 mg/6 dm2 or SML = ND (DL = 0.02 mg/kg, analytical tolerance included) for the sum of divinylbenzene and ethylvinylbenzene and in compliance with the specifications laid down in Schedule 4
93B	16694	013811-50-2	N,N'-Divinyl-2-imidazolidinone	The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg
93C	16697	000693-23-2	n-Dodecanedioic Acid
93D	16704	000112-41-4	1-Dodecene	The specific migration of this substance shall not exceed 0.05 mg/kg
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	SML(T) = 30 mg/kg (3)
99	17005	000151-56-4	Ethyleneneamine	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	000104-76-7	2-Ethylhexan-1-ol	The specific migration of this substance shall not exceed 30 mg/kg
101A	17110	016219-75-3	5-Ethylidenebicyclo[2,2,1] hept-2-ene	QMA = 0.05 mg/6 dm². The ratio surface/quantity of food shall be lower than 2 dm²/kg
102	17160	000097-53-0	Eugenol	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)
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	SML(T) = 15mg/kg (21)
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
111A	18220	068564-88-5	N-Heptylaminoundecanoic acid	The specific migration of this substance shall not exceed 0.05 mg/kg
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 not be 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	QM(T) = 1 mg/kg (expressed as NCO) (25)
118	18670	000100-97-0	Hexamethylenetetramine	SML(T) = 15 mg/kg (expressed as formaldehyde) (21)
118MA	18700	000629-11-8	1,6-Hexanediol	SML = 0.05 mg/kg
118A	18820	000592-41-6	1-Hexene	The specific migration of this substance shall not exceed 3 mg/kg
119	As item 84	000123-31-9	Hydroquinone	As item 84
120	18880	000099-96-7	p-Hydroxybenzoic acid
120ZA	18896	001679-51-2	4-(Hydroxymethyl)-1-cyclohexene	SML = 0.05 mg/kg
120A	18897	16712-64-4	6-Hydroxy-2-naphthalenecarboxylic acid	SML = 0.05 mg/kg
120B	18898	000103-90-2	N-(4-Hydroxyphenyl) acetamide	SML = 0.05 mg/kg
121	19000	000115-11-7	Isobutene
121A	19060	000109-53-5	Isobutyl vinyl ether	The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg
121B	19110	04098-71-9	1-Isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane	QM(T) = 1 mg/kg (expressed as NCO (25)
121C	19150	000121-91-5	Isophthalic acid	The specific migration of this substance shall not exceed 5 mg/kg
122	19210	001459-93-4	Isophthalic acid, dimethyl ester	The specific migration of this substance shall not exceed 0.05 mg/kg
122A	19243	000780-79-5	Isoprene	As item 145A
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
126A	19490	000947-04-6	Laurolactam	SML = 5 mg/kg
127	19510	011132-73-3	Lignocellulose
128	19540	000110-16-7	Maleic acid	SML(T) = 30 mg/kg (4)
129	19960	000108-31-6	Maleic anhydride	SML(T) = 30 mg/kg (4) (expressed as maleic acid)
130	As item 215	000108-78-1	Melamine	As item 215
130A	19990	000079-39-0	Methacrylamide	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)
131	20020	000079-41-4	Methacrylic acid
131A	20050	000096-05-9	Methacrylic acid, allyl ester	The specific migration of this substance shall not exceed 0.05 mg/kg
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
135A	20260	000101-43-9	Methacrylic acid, cyclohexyl ester	SML = 0.05 mg.kg
135B	20410	002082-81-7	Methacrylic acid, diester with 1,4-butanediol	SML = 0.05 mg/kg
135BM	20440	000097-90-5	Methacrylic acid, diester with ethyleneglycol	SML = 0.05 mg/kg
135C	20530	002867-47-2	Methacrylic acid, 2-(dimethylamino) ethyl ester	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)
135D	20590	00106-91-2	Methacrylic acid, 2,3-epoxypropyl ester	QMA = 0.02 mg/6 dm²
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
142A	21400	054276-35-6	Methacrylic acid, sulphopropyl ester	QMA = 0.05 mg/6 dm²
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)
144A	21520	01561-92-8	Methallylsulphonic acid, sodium salt	SML = 5 mg/kg
145	21550	000067-56-1	Methanol
145A	21640	00078-79-5	2-Methyl-1,3-butadiene	QM = 1 mg/kg in FP or SML = ND (DL = 0.02 mg/kg, analytical tolerance included)
145B	21730	000563-45-1	3-Methyl-1-butene	The quantity of this substance in the finished plastic material or article shall not exceed 0.006 mg/ 6 dm². For use only in polypropylene
145C	21765	106246-33-7	4,4'-Methylenebis (3-chloro-2,6-diethylaniline)	QMA = 0.05 mg/6 dm²
145D	21821	00505-65-7	1,4-(Methylenedioxy) butane	As item 49C
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-Methyl-1-pentene	SML = 0.05 mg/kg
147A	22331	025513-64-8	Mixture of (35–45% w/w) 1,6-diamino-2,2,4-trimethylhexane and (55–65% w/w) 1,6-diamino-2,4,4-trimethylhexane	QMA = 5 mg/6 dm²
147B	22332	–	Mixture of (40% w/w) 2,2,4-trimethylhexane-1, 6-diisocyanate and (60% w/w) 2,4,4-trimethylhexane-1,6-diisocyanate	QM(T) = 1 mg/kg (expressed as NCO (26)
148	22350	000544-63-8	Myristic acid
148A	22360	01141-38-4	2,6- Naphthalenedicarboxylic acid	SML = 5 mg/kg
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	QM(T) = 1 mg/kg (expressed as NCO) (25)
150A	22437	00126-30-7	Neopentylglycol	As item 88B
151	22450	009004-70-0	Nitrocellulose
152	22480	000143-08-8	Nonan-1-ol
152A	22550	000498-66-8	Norbornene	The specific migration of this substance shall not exceed 0.05 mg/kg
153	22570	000112-96-9	Octadecyl isocyanate	QM(T) = 1mg/kg (expressed as NCO) (25)
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
156XA	22775	000144-62-7	Oxalic acid	SML(T) = 6 mg/kg (29)
156A	22778	07456-68-0	4,4'-Oxybis (benzenesulphonyl azide	QMA = 0.05 mg/6 dm²
157	22780	000057-10-3	Palmitic acid
158	22840	000115-77-5	Pentaerythritol
159	22870	000071-41-0	Pentan-1-ol
159A	22900	00109-67-1	1-Pentene	SML = 5 mg/kg
159B	22937	001623-05-8	Perfluoropropyl perfluorovinyl ether	The specific migration of this substance shall not exceed 0.05 mg/kg
160	22960	000108-95-2	Phenol
161	23050	000108-45-2	1,3-Phenylenediamine	SML = ND (DL = 0.02 mg/kg. Analytical tolerance included)
161A	23070	000102-39-6	(1,3-Phenylenedioxy) diacetic acid	QMA = 0.05 mg/6 dm²
162	As item 60	000075-44-5	Phosgene	As item 60
163	23170	007665-38-2	Phosphoric acid
163A	23175	000122-52-1	Phosphorous acid, triethyl ester	The quantity of this substance in the finished plastic material or article shall be not detectable (when measured by a method with a detection limit of 1 mg/kg
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
169A	23547	009016-00-6	Polydimethylsiloxane (Mw >6800)	In compliance with the specifications laid down in Schedule 4
		063148-62-9
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
173A	23770	000504-63-2	1,3-Propanediol	The specific migration of this substance shall not exceed 0.05 mg/kg
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
177A	23920	000105-38-4	Propionic acid, vinyl ester	SML(T) = 6 mg/kg (2) (expressed as acetaldehyde)
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	000128-80-9	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
184A	24073	000101-90-6	Resorcinol diglycidyl ether	QMA = 0.005 mg/6 dm². Not for use in polymers contacting foods for which simulant D is laid down in Council Directive 85/572/EEC and for indirect food contact only, behind the PET layer
185	24100	008050-09-7	Rosin
186	24130	008050-09-7	Rosin gum
187	24160	008052-10-6	Rosin tall oil
188	24190	065997-05-9	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
197	24550	000057-11-4	Stearic acid
198	24610	000100-42-5	Styrene
198A	24760	026914-43-2	Styrenesulphonic acid	The specific migration of this substance shall not exceed 0.05 mg/kg
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 along 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
206A	25080	001120-36-1	1-Tetradecene	The specific migration of this substance shall not exceed 0.05 mg/kg
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	QM(T) = 1 mg/kg (expressed as NCO) (25)
212	25240	000091-08-7	2,6-Toluene diisocyanate	QM(T) = 1 mg/kg (expressed as NCO) (25)
213	25270	026747-90-0	2,4-Toluene diisocyanate dimer	QM(T) = 1 mg/kg (expressed as NCO) (25)
214	25360		Trialkyl (C5-C15) acetic acid, 2,3-epoxypropyl ester	The quantity of this substance in the finished plastic material or article shall not exceed 1 mg/kg (expressed as epoxy group, molecular weight = 43)
214A	25380		Trialkyl acetic acid (C7 – C17), vinyl esters (= vinyl versatate)	QMA = 0.05 mg/6 dm²
214B	25385	000102-70-5	Triallylamine	In compliance with the specifications laid down in Schedule 4
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
215A	25450	026896-48-0	Tricyclodecanedime-thanol	SML = 0.05 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
217A	25840	03290-92-4	1,1,1-trimethylolpropane trimethacrylate	SML = 0.05 mg/kg
217B	25900	00110-88-3	Trioxane	SML = 0.05 mg/kg
218	25910	024800-44-0	Tripropylene glycol
218A	25927	027955-94-8	1,1,1-Tris (4-hydroxyphenol) ethane	The quantity of this substance in the finished plastic material or article shall not exceed 0.5 mg/kg. For use only in polycarbonates
219	25960	000057-13-6	Urea
220	26050	000075-01-4	Vinyl chloride	The restrictions are those in regulation 6 (1) of the 2005 Regulations when analysed by the method referred to in regulation 7 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
223	26155	001072-63-5	1-Vinylimidazole	The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg
224	26170	003195-78-6	N-Vinyl-N- methylacetamide	The quantity of this substance in the finished plastic material or article shall not exceed 2 mg/kg
225	26320	002768-02-7	Vinyltrimethoxysilane	The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg
226	26360	007732-18-5	Water	In compliance with Directive 98/83/EC on the quality of water intended for human consumption

PART 2 — Supplementary

1

In regulation 4 and Part 1 of this Schedule–

• (a) the PM/REF number. of any substance is its EEC packaging material reference number;

• (b) the CAS number 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 number and the name, the name shall take precedence over the CAS number; and

• (d) references to specific migration are to be taken to mean specific migration as measured in accordance with Schedules 5 and 6.

2

If a substance appearing in Part 1 of this Schedule as an individual compound also falls within a generic term which appears therein, any restriction 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 as is necessary.

3

• (1) The items identified in Part 1 of this Schedule shall be taken to include–

• (a) substances undergoing polymerisation (including 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 1 of this Schedule is an acid, a phenol or an alcohol and has salts (including double salts) of one or more of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium or zinc then any such salts shall be treated as included in the specification of that substance.