Source: https://www.global-regulation.com/law/united-kingdom/134773/the-plastic-materials-and-articles-in-contact-with-food-%2528england%2529-regulations-2006.html
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Document Index: 291869157

Matched Legal Cases: ['art 1', 'art 2', 'art 1', 'art 1', 'art 2', 'art 1', 'art 2', 'art 1', 'art 2', 'art 3', 'arts 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 2', 'art 4', 'art 1', 'art 1', 'art 1', 'art 1', 'art 2', 'ART 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'ART 1', 'art 3', 'ART 2', 'art 3', 'arts 1', 'arts 1', 'arts 1', 'art 1', 'art 2', 'art 2', 'art 4', 'art 4', 'art 4', 'art 4', 'art 4', 'art 4', 'art 3', 'art 2', 'art 3', 'art 4']

The Plastic Materials and Articles in Contact with Food (England) Regulations 2006 (United Kingdom)
The Plastic Materials and Articles in Contact with Food (England) Regulations 2006
2006 No. 1401
The Secretary of State makes the following Regulations in exercise of the powers conferred by sections 16(2), 17(1) and (2), 26(1)(a) and (3), 31 and 48(1) of the Food Safety Act 1990(1), and now vested in her(2).
In accordance with section 48(4A) of that Act she has had regard to relevant advice given by the Food Standards Agency.
1. These Regulations may be cited as the Plastic Materials and Articles in Contact with Food (England) Regulations 2006, apply in relation to England only and come into force on 30th June 2006.
“capable” means capable as established under regulation 11;
“Directive 82/711” means Council Directive 82/711/EEC(4) laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs, as last amended by Commission Directive 97/48/EC(5);
“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(6);
“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(7);
“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(8);
“the Directive” means Commission Directive 2002/72/EC(9) relating to plastic materials and articles intended to come into contact with foodstuffs, as last amended by Commission Directive 2004/19/EC(10);
“enforcement authority” means an authority having responsibility under regulation 14 for executing and enforcing these Regulations;
“the 1998 Regulations” means the Plastic Materials and Articles in Contact with Food Regulations 1998(11);
“the 2005 Regulations” means the Materials and Articles in Contact with Food (England) Regulations 2005(12);
“the Purity Directives” means Commission Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs(13), Commission Directive 95/45/EC laying down purity criteria concerning colours for use in foodstuffs(14) and Commission Directive 96/77/EC laying down specific purity criteria for food additives other than colours or sweeteners(15);
(b)it does not meet the required standards set out in regulation 6, 7, 8, 9 or 10.
4.—(1) Subject to paragraphs (3), (4) and (5), no person may use any prohibited monomer in the manufacture of any plastic material or article.
(b)identified by PM/REF No, CAS No (if any) and name in columns 1, 2 and 3 respectively of the relevant section of Part 1 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 that section.
(4) Paragraph (1) shall not be taken to prohibit the manufacture of any plastic material or article with any substance if the substance in question is a mixture which falls within paragraph 3(c) (relating to mixtures of authorised substances) of Annex II to the Directive 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 be a defence for the person accused to prove that —
(a)each 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, or
(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,
(6) Part 2 of Schedule 1 has effect to supplement this regulation and Part 1 of that Schedule.
5.—(1) Subject to paragraph (3) no person may use in the manufacture of any plastic material or article any prohibited additive.
(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 —
(ii)is not 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
(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 person 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.
6.—(1) Subject to paragraph (2), where a migration limit expressed in mg/kg is indicated in column 4 of the relevant section 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 the 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 —
(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 deemed to be capable of transferring constituents of that monomer 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.
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 the 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 —
(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 deemed to be 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.
(b)identified by PM/REF No, CAS No and name in columns 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.
(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
(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 the surface area of the plastic material or article.
(3) For the purposes of this regulation a plastic material or article is not deemed to fail to meet the required standard under paragraph (1) if the only food with which that material or article may come into contact is food —
(a)which is specified in the table to Part 4 of Schedule 6; and
(4) In any proceedings for an offence under these Regulations where it is alleged that a plastic material or article does not comply with this regulation, the defences available in paragraph 6(2) and 7(2) of Schedule 5 shall be available as specified in those paragraphs.
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 that plastic material or article may come into contact.
(2) Schedule 4 has effect for the purpose of prescribing, for certain items listed in Part 1 of Schedule 1, Part 1 or 2 of Schedule 2, or Schedule 3, the specifications for those items that are referred to in column 4 of the Part or Schedule concerned.
(3) In paragraph (1) a detectable quantity means a quantity which can be determined with an analytical method capable of achieving a detection limit of at least 0.02 milligrams per kilogram of food or food simulant (including analytical tolerance).
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 on compliance 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 or, as the case may be, food with which it 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 to the Directive relating to the term “QM(T)”, “QMA” or “QMA(T)” as the case may be.
12.—(1) At marketing stages other than the retail stage a person who is in possession of any plastic material or article must ensure that the plastic material or article is accompanied by a written declaration which —
(a)accords with the requirements of Article 16(1) of Regulation (EC) No. 1935/2004 of the European Parliament and of the Council(17); and
(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 —
(ii)where appropriate, purity criteria in accordance with the purity Directives.
(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, if particulars are shown in relation to that material or article in accordance with paragraph (1)(a), those particulars are accurate and that unless the particulars so indicate, there are no restrictions on the intended conditions of contact.
13.—(1) In this regulation —
(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 the authority identified in regulation 14.
(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).
14. Each food authority in its area and each port health authority in its district shall execute and enforce —
(a)the provisions of Regulation 1895/2005 mentioned in regulation 13, and
(a)contravenes or fails to comply with regulation 3(1), 4(1), 5(1), 12(1) or 13(2) to (5);
(c)contravenes regulation 13(6) or, without reasonable excuse, otherwise fails 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
(2) Anyone convicted of an offence under these Regulations is liable —
(a)in the case of an offence under paragraph (1)(a) —
(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
he as well as the body corporate or, as the case may be, the Scottish partnership shall 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 three years from the commission of the offence or one year from its discovery by the prosecutor, whichever is the earlier.
(6) 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 also be guilty of the offence; and a person may be charged with and convicted of the offence whether or not proceedings are taken against the first mentioned person.
16.—(1) In any proceedings for an offence under these Regulations it shall, subject to paragraph (5), be a defence for the person accused 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.
shall be taken to have established the defence provided by paragraph (1) if he satisfies the requirements of paragraphs (3) and (4).
(3) A person satisfies the requirements of this paragraph if he proves —
(a)that the commission of the offence was due to the act or default of some other person who was not under his control, or to reliance on information supplied by such a person;
(b)that either —
(i)he 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 him to rely on checks carried out by the person who supplied him with the plastic material or article or the material or article in question; and
(c)that he did not know and had no reason to suspect at the time the offence was committed that his act or omission would amount to an offence under these Regulations.
(4) 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 the act or default of some other person who was not under his control, or to reasonable reliance on information supplied by such a person;
(c)that he did not know and could not reasonably have been expected to know at the time the offence was committed that his 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 person accused shall not without leave of the court be entitled to rely on that defence unless —
(b)where he has previously appeared before the court in connection with the alleged offence, within one month of his first such appearance,
he has served on the prosecutor a written notice giving such information identifying or assisting in the identification of that other person as was then in his possession.
Transitional defences and savings
17. Not withstanding the revocations made in 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;
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.
(c)as soon as reasonably practicable, give one part to the owner and notify him in writing that the sample will be analysed;
(e)retain one part for future submission under regulation 19.
19.—(1) Where a sample has been retained under regulation 18 and —
(4) Any certificate of the results of testing transmitted by the Government Chemist under this regulation shall be signed by or on behalf of him, but the testing may be carried out by any person under the direction of the person who signs the certificate.
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.
(3) If during examination of the data referred to in paragraph (2), EFSA calls for supplementary information, the eligible additive may, if otherwise permitted to be used under English 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.
21. The following provisions of the Act shall apply for the purposes of these Regulations as they apply for the purposes of the Act —
(c)section 36 (offences by bodies corporate);
(d)section 36A (offences by Scottish partnerships);
(e)section 44 (protection of officers acting in good faith).
22. In the Food Safety (Sampling and Qualifications) Regulations 1990(18), in Schedule 1 (provisions to which those Regulations do not apply) for the title and reference of the 1998 Regulations substitute the title and reference of these Regulations.
Amendments to the Materials and Articles in Contact with Food (England) Regulations 2005
23.—(1) The 2005 Regulations are amended in accordance with paragraphs (2) to (6).
(a)omit the definition of “the 1998 Regulations”;
(b)after the definition of “sell” add the following definition —
“”the 2006 Regulations” means the Plastic Materials and Articles in Contact with Food (England) Regulations 2006(19).”
(3) In regulation 8(4), for the expression “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 the expression “Part I of Schedule 1 to the 1998 Regulations” substitute “Part 1 of Schedule 1 to the 2006 Regulations”; and
(b)in sub-paragraph (b) for “Part II” substitute “Part 2”.
(5) In regulation 9(5), for the expression “Schedules 3 and 4 of the 1998 Regulations as read with regulation 6 of those Regulations” substitute “Schedules 5 and 6 of the 2006 Regulations as read with regulation 11 of those Regulations”.
(6) In regulation 10(2), for the expression “proceedings for an offence under regulation” substitute “proceedings for an offence of contravening regulation”.
24. The following Regulations or parts thereof are revoked —
(a)the 1998 Regulations in so far as they apply in relation to England;
(b)the Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2000(20);
(c)the Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2002(21);
(d)the Plastic Materials and Articles in Contact with Food (Amendment) (England) (No.2) Regulations 2002(22);
(e)the Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2004(23);
(f)the Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005(24);
(g)regulation 15 of the 2005 Regulations.
SCHEDULE 1Authorised Monomers
PART 1List of Monomers with Restrictions and Specifications
SML(T) = 6mg/kg (2)
The specific migration of this substance shall not exceed 12mg/kg
QMA(T) = 0.05 mg/6 dm2 (27)
QMA(T) = 0.05
mg/6 dm2 (27)
Acrylic acid, dicyclopentaidien-yl ester
The quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 m2
The specific migration of this substance shall not exceed 0.05 mg/kg (1)
QMA = 0.05 mg/6 dm2for 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
Acrylic acid, asobutyl ester
The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg. For use only as comonomer
1-Amino-3-aminomethyl-3, 5, 5-trimethylcyclohexane
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
844354-12-8
SML – 0.05 mg/kg
The specific migration of this substance shall not exceed 5mg/kg
1,3-Benzenedi-methanamine
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)
(see “2,4-Diamino-6- Phenyl-1,3,5-Triazine”)
2,2-Bis (hydroxymethylbutan-1-ol)
1,3-Bis (2-hydroxyethoxy) benzene
1,4-Bis (hydroxymethyl) – cyclohexane
QMA = 0.05 mg/6 dm2
SML(T) = 0.6 mg/kg (28)
2,2-Bis (4-hydroxyphenyl) propane bis (2,3-epoxypropyl) ether
Use must be in accordance with Regulation 1895/2005
2,2-Bis (4-hydroxyphenyl) propane bis (phthalic anhydride)
3,3-Bis (3-methyl-4-hydroxyphenyl) – indolin-2-one
Bisphenol A bis (2,3-epoxypropyl) ether
As item 86A
SML(T) – 6 mg/kg (22) (expressed as boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption
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)
SML(T) = 0.05 mg/kg (23)
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)
QMA = ND (DL = 0.02 mg/6 dm2). To be used only as a co-monomer for the preparation of polymeric additive
SML(T) = 15 mg/kg (5)
SML(T) = 15 mg/kg (5) (expressed as caprolactam)
QMA = 0.5 mg/6 dm2
QMA(T) = 0.05 mg/6 dm2 (33)
QM(T) = 1mg/kg in FP (expressed as NCO) (26)
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
Dec-1, 9-diene
Dicyclohexylmethane-4,4' – diisocyanate
QM(T) = 1mg/kg (expressed as NCO (25)
SML(T) = 30 mg/kg (3)
The specific migration of this shall not exceed 2.4 mg/kg
The specific migration of this shall not exceed 0.6 mg/kg
SML(T) = 6 mg/kg (14)
000080-09-01
SML = 0.05 mg/kg (32). To be used only in polyamides
QM(T) = 1 mg/kg (expressed as NCO) (25)
QM(T) = 1mg/kg (expressed as NCO) (25)
QM(T) – 1 mg/kg (expressed as NCO) (25)
SML(T) = 3 mg/kg (24)
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
N,N'-Divinly-2-imidazolidinone
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
SML(T) = 15mg/kg (21)
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)
SML(T) = 15 mg/kg (expressed as formaldehyde) (21)
120ZA
000780-79-5
As item 145A
SML(T) = 30 mg/kg (4) (expressed as maleic acid)
SML = 0.05 mg./kg
135BM
QMA = 0.02 mg/6 dm2
QM = 1 mg/kg in FP or SML = ND
(DL = 0.02 mg/kg, analytical tolerance included)
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
4,4'-Methylenebis (3-chloro-2,6-diethylaniline)
As item 49C
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
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)
2,6- Naphthalenedicarboxylic acid
As item 88B
156XA
SML(T) = 6 mg/kg (29)
4,4'-Oxybis (benzenesulphonyl azide
SML = ND (DL = 0.02 mg/kg. Analytical tolerance included)
(1,3-Phenylenedioxy) diacetic acid
007665-38-2
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)
Polydimethylsiloxane (Mw >6800)
In compliance with the specifications laid down in Schedule 4
SML(T) = 6 mg/kg (2) (expressed as acetaldehyde)
000128-80-9
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
The specific migration of this substance along or together with item 204 shall not exceed 7.5 mg/kg (expressed as terephthalic acid)
N,N,N'N'-Tetrakis (2-hydroxypropyl)- ethylenediamine
QM(T) = 1 mg/kg
(expressed as NCO) (25)
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)
Trialkyl acetic acid (C7 – C17), vinyl esters (= vinyl versatate)
Tricyclodecanedime-thanol
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
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
N-Vinyl-N- methylacetamide
The quantity of this substance in the finished plastic material or article shall not exceed 2 mg/kg
In compliance with Directive 98/83/EC on the quality of water intended for human consumption
1. In regulation 4 and Part 1 of this Schedule—
(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—
(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 the following names (that is to say salts 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.
(3) If, as indicated in paragraph 2 of Annex II to the Directive, a substance is identified in Part 1 of this Schedule as an “… acid, salt” and has salts of one or more of the following names (that is to say salts of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium or zinc), then the free acid corresponding to that substance is not treated as included in the specification of that substance.
4. Where an entry in column 4 of Part 1 of this Schedule (restrictions and specifications) includes a bracketed number, that entry shall be subject to a note relating to that number as follows, the following bracketed numbers corresponding with those appearing in that Part —
(1): Warning: there is a risk that the specific migration limit could be exceeded in fatty food simulants.
(2): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 10060 and 23920.
(3): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 15760, 16990, 47680, 53650 and 89440.
(4): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 19540, 19960 and 64800.
(5): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 14200, 14230 and 41840.
(14): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances of the substances having PM/REF Nos. 15970, 48640, 48720, 48880, 61280, 61360 and 61600.
(21): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 17260, 18670, 54880 and 59280.
(22): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF/Nos. 13620, 36840, 40320 and 87040.
(23): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF/Nos. 13720 and 40580.
(24): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF/Nos. 16650 and 51570.
(25): QM(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the substances having PM/REF/Nos. 14950, 15700, 16240, 16570, 16600, 16630, 18640, 19110, 22332, 22420, 22570, 25210, 25240 and 25270.
(27): QMA(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 10599/90A, 10599/91, 10599/92A and 10599/93.
(28): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 13480 and 39680.
(29): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 22775 and 69920.
(32): Compliance testing when there is a fat contact should be performed using isooctane as substitute of simulant D (unstable).
(33): QMA(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 14800 and 45600.
SCHEDULE 2Authorised Additives
PART 1Incomplete List of Additives Used in the Manufacture of Plastic Materials and Articles (not being Additives to which Paragraph 5 of Part 3 of this Schedule Applies)
Acids C2-C24 aliphatic, linear monocarboxylic, from natural oils and fats and their mono-, di- and triglycerol esters (branched fatty acids at naturally occurring levels are included)
Acids C2-C24 aliphatic linear, monocarboxylic, synthetic and their mono-, di- and triglycerol esters
Acids, fatty, from animal or vegetable foods fats and oils
Acrylic acid, 2,4-di-tert-pentyl-6[1(3,5-di-tert-pentyl-2- hydroxyphenyl) ethyl] phenyl ester
Alcohol's, aliphatic, monohydric, saturated, linear, primary (C4-C24)
n-Alkyl (C10-C13) benzenesulphonic acid
Amines, bis (hydrogenated tallow alkyl) oxidised
in polyolefines at 0.1% (w/w) not in LDPE when it is in contact with foods for which Directive 85/572/EEC establishes a reduction factor less than 3;
in PET at 0.25% (w/w) in contact with foods other than those for which the simulant D is laid down in Directive 85/572/EEC SML = 0.05 mg/kg
SML = 0.05 mg/kg. To be used only for PET for water and beverages
3-Aminocronic acid, diester with thiobis (2-hydroxyethyl) ether
000141-53-5
SML(T) = 1 mg/kg expressed as barium (11) and SML(T) = 6 mg/kg (22) (expressed as boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption
005242-49-9
4-(2-benzoxazolyl)-4'- (5-methyl-2-benzoxazolyl) stilbene
1,2-Bis(3-aminopropyl) ethylenediamine, polymer with N-butyl-2,2,6,6-tetramethyl-4-piperidinamine and 2,4,6-trichloro-1,3,5-triazine
Bis(2,6-di-tert-butyl-4-methylphenyl) pentaerythritol diphosphite
The specific migration of this substance shall not exceed 5 mg/kg (sum of phosphite and phosphate)
Bis(2,4-dicumylphenyl) pentaerythritoldiphosphite
SML = 5 mg/kg (as sum of the substance itself, its oxidised form bis (2,4-dicumylphenyl) pen-taerythritol-phosphate and its hydrolysis product (2,4-dicumylphenol)
Bis (2-hydroxyethyl)-2-hydroxypropyl-3-(dodecyloxy) methylammonium chloride
9,9-Bis(methoxymethyl) fluorene
The quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 dm2
3,3-Bis (methoxymethyl)- 2,5-dimethyl hexane
SML(T) = 6 mg/kg (22) (expressed as boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption
1,4,-Butanediol
The quantity of this substance in the finished plastic material or article shall not exceed 0.9 mg/ 6 dm2
SML(T) = 30 mg/kg (7) (expressed as copper) and the specific migration of this substance shall not exceed 1 mg/kg (10) (expressed as iodine)
p-Cresol-dicyclopentadiene- isobutylene, copolymer
QMA(T) = 0.05 mg/ 6 dm2(33)
2-Cyano-3,
3-dipheneylacrylic acid, ethyl ester
Diatomaceous earth. Soda ash flux-calcined
5,7-di-tert-Butyl-3- (3,4- and 2,3 –dimethylphenyl)-3H-benzofuran-2-one containing:
5,7-di-tert-butyl-3-(3,4-dimethylphenyl)-3H-benzofuran-2-one (80-100% w/w); and
5,7-di-tert-butyl-3-(2,3-dimethylphenyl)-3H-benzofuran-2-one (0-20% w/w)
QMA = 4.8 mg/ 6 dm2
3,5-Di-tert-butyl-4-hydroxybenzyl phosphonic acid, monoethyl ester, calcium salt
Dibutylthiostannoic acid polymer [= thiobis(butyl-tin sulphide), polymer]
In compliance with this specifications laid down in Schedule 4
4,4'Dihydroxybenzophenone
The specific migration of this substance shall not exceed 1 mg/kg
2-(4,6-Diphenyl-1,3,5-triazin-2-yl)-5- (hexyloxy) phenol
Ethylenediaminetetraacetic acid, copper salt
SML(T) = 30 mg/kg (7) (expressed as copper) (3)
Ethylene-N-palmitamide-N'- stearamide
2,2'-Ethylidenebis (4,6-di-tert-butylphenyl) fluorophosphonite
Formaldehyde-1-naphthol, copolymer [ = Poly (1-hydroxynaphthyl-methane)]
Glycerol, esters with acids, aliphatic, saturated, linear, with an even number of carbon atoms C14-C18) and with acids, aliphatic, unsaturated, linear, with even number of carbon atoms (C16-C18)
SML(T) = 15 mg/kg (21) (expressed as Formaldehyde)
2-(2-Hydroxy-3,5,-di-tert-butylphenyl)-5- chlorobenzotriazole
SML(T) = 30 mg/kg (18)
SML(T) = 30 mg/kg(4)
N-methacryloyloxyethyl-N,N-dimethyl-N- carboxymethyl-ammonium chloride, sodium salt-octadecyl methacrylate- ethyl methacrylate –cyclohexyl methacrylate-N-vinyl-2-pyrrolidone, copolymers
2,2'-Methylenebis (4-methyl-6-cyclohexylphenol)
SML(T) = 3 mg/kg (6)
2,2'-Methylenebis (4-methyl-6-(1-methylcyclo-hexyl) phenol)
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
Mixture of (50% w/w) phthalic acid n-decyl n-octyl ester, (25% w/w) phthalic acid di-n-decyl ester, and (25% w/w) phthalic acid di-n-octyl ester
The specific migration of this substance shall not exceed 5 mg/kg (1)
7-(2H-Naphtho-(1,2-D) triazol-2-yl)-3-phenylcoumarin
SML(T) = 0.05 mg/kg (expressed as Neodecanoic acid) and SML(T) = 0.05 mg/kg (13) (expressed as Cobalt). Not for use in polymers contacting foods for which simulant D is laid down in Directive 85/572/EEC
2,2',2”-Nitrilo(triethyl tris (3,3',5,5'- tetra-tert-butyl-1-1'-bi-phenyl-2-2-diyl) phosphite)
2,2'-Oxamidobis(ethyl-3-(3,5-di-tert-butyl-4- hydroxyphenyl) propionate)
The specific migration of this substance shall not exceed 0.05 mg/kg. Not for use with foods for which simulant D is laid down in Directive 85/572/EEC
Pentaerythritol tetrakis [3-(3,5-di-tert-butyl-4- hydroxyphenyl) -propionate]
Phosphorous acid, bis (2,4-di-tert-butyl-6- methylphenyl) ethyl ester
The specific migration of this substance shall not exceed 5 mg/kg (covering the sum of phosphite and phosphate)
Phosphorous acid, tris (2,4-di-tert-butylphenyl) ester
Polyesters of 1,
2-propanediol and/or 1,3- and/or 1,4-butanediol and/or polypropyleneglycol with adipic acid, which may be end-capped with acetic or fatty acids C12-C18 or n-octanol and/or n-decanol
Polyethyleneglycol ester of hydrogenated caster oil
SML = 0.05 mg/kg and in compliance with the specifications laid down in Schedule 4
Poly-[[6-[N-(2,2,6,6- tetramethyl-4-piperidinyl)-n-butylamino]- 1,3,5-triazine-2,4-diyl][2,2,6,6-tetramethyl-4-piperidinyl)imino]-1,6-hexanedyl[2,2,6,6- tetramethyl-4-piperidinyl) imino]] – alpha- [N,N,N',N'''-tetrabutyl-N – (2,2,6,6-tetramethyl-4- piperidinyl)-N''-[6,(2,2,6,6-tetramethyl-4-piperidinylamino)-hexyl][1,3,5-triazine-2,4,6-triamine]-omega- N,N,N',N'-tetrabutyl-1,3,5-triazine-2,4-diamine
SML(T) = 30 mg/kg (7) (expressed as copper); the specific migration of this substance shall not exceed 48 mg/kg (expressed as iron)
SML(T) = 0.18 mg/kg (15) (expressed as tin)
008050-09-6
240ZA
Silicates, natural, (with the exception of asbestos)
SML(T) = 0.6 mg/kg (8) (expressed as lithium)
N,N,N',N'- Tetrakis (2-hydroxypropyl) ethylenediamine
2,2,4,4- Tetramethyl-20-(2,3- epoxypropyl)- 7-oxa-3,20-diazadispiro-[5.1.11.2]-heneicosan-21-one, polymer
Thiodiethanolbis (5-methoxycarbonyl-2,6-dimethyl-1,4-dihydropridine-3-carboxylate)
1,3,5-Trimethyl-2,4,6-tris (3,5-di-tert-butyl-4- hydroxybenzyl) benzene
2,4,6-Tris(tert-butyl) phenyl 2-butyl-2-ethyl-1,3-propanediol phosphite
SML = 2 mg/kg (as sum of phosphite, phosphate and the hydrolysis product = TTBP)
Vermiculite, reaction product with citric acid, lithium salt
In compliance with Directive 98/83/EC
PART 2Incomplete List of Additives Used in the Manufacture of Plastic Materials and Articles (Being Additives to which Paragraph 5 of Part 3 of this Schedule Applies)
PM/REFNo.
SML(T) = 0.6 mg/kg (9) (expressed as manganese)
Acrylic acid, 2-tert-butyl- 6-(3-tert- butyl- 2-hydroxy-5-methylbenzyl)-4-methylphenyl ester
Alkyl (C8-C22) sulphonic acids
Aluminium hydroxybis [2,2'-methylenebis (4,6-di-tert-butylphenyl)] phospate
SML = 0.02 mg/kg (expressed as anti-monium and analytical tolerance included)
SML(T) = 1 mg/kg (11) (expressed as barium)
Bis (2-carbobutoxyethyl) tin- bis (isooctyl mercaptoacetate)
N,N'-Bis (3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionyl) hydrazide
Bis (2,4-di-tert-butylphenyl) pentaery-thritol diphosphite
1,1-Bis (2-hydroxy-3, 5-di-tert-butylphenyl) ethane
N,N-bis (2-hydroxyethyl) alkyl (C8-C18) amine
SML(T) = 1.2 mg/kg (12)
N,N-bis (2-hydroxyethyl)-alkyl (C8-C18) amine hydrochlorides
SML(T) = 1.2 mg/kg (12) expressed as tertiary amine (expressed excluding HCI)
2,4-Bis (octylmercapto) – 6- (4-hydroxy- 3,5,di-tert-butylanilino) - 1,3,5-triazine
2,4-Bis (octylthiomethyl) – 6- methylphenol
N,N'-bis (2,2,6,6-tetramethyl-4- piperidyl) hexamethy-lenediamine- 1,2- dibromoethane, copolymer
Tert-butyl- 4-hydroxyanisole (= BHA)
4,4' – butylidene-bis (6-tert-butyl-3-methylphenyl-ditridecyl phosphite)
(2-carbobutoxyethyl) tin-tris (isooctyl mercaptoacetate)
1- (3- Chloroallyl) – 3,5,7 – triaza-1-azoniaadamantane chloride
SML = 6 mg/kg and in compliance with the specifications laid down in Schedule 4
SML(T) = 0.05 mg/kg (13) (expressed as cobalt)
SML = 3.0 mg/kg
Di-n-dodecyltin bis (isooctyl mercaptoacetate)
2,2'Dihydroxy-4-methoxybenzophenone
Dimethyltin bis (isooctyl mercaptoaecetate)
SMT(T) 0.18 mg/kg (15) (expressed as tin)
SMT = 3 mg/kg
Di-n-octyltin bis(n-alkyl (C10-C16) mercaptoacetate)
SML(T) = 0.04 mg/kg (16) (expressed as tin)
Di-n-octyltin bis (2-ethylhexyl maleate)
Di-n-octyltin bis (2-ethylhexyl mercaptoaectate)
Di-n-octyltin bis (ethyl maleate)
Di-n-octyltin bis (isooctyl maleate)
Di-n-octyltin bis (isooctyl mercaptoacetate)
Di-n-octyltin 1,4-butanediol bis (mercaptoacetate)
Di-n-octyltin ethyleneglycol bis (mercaptoacetate)
Di-n-octyltin thiobenzoate 2-ethyl-hexyl mercaptoacetate
2-(4-Dodecylphenyl) indole
SML = 3.6 mg/kg
SML(T) = 15 mg/kg (21)
SML(T) = 30 mg/kg (34)
1,6-Hexamethylene-bis (3- (3,5-di-tert-butyl-4-hydroxyphenyl) propionamide)
1,6- Hexamethylene-bis (3- (3,5-di-tert-butyl-4-hydroxyphenyl) propionate
2- (2'-Hydroxy-3'-tert-butyl- 5'-methylphenyl) –5-chlorobenzotriazole
SML(T) = 30 mg./kg (18)
1-(2- Hydroxyethyl) –4-hydroxy- 2,2, 6,6-tetramethyl, piperidine-succinic acid, dimethyl ester, copolymer
SML(T) = 1 mg/kg (10) (expressed as iodium) and SML(T) = 0.6 mg/kg (8) (expressed as lithium)
SML(T) = 0.6 mg/kg (9) (expressed as manganese
2-2'-Methylene bis (4,6-di-tert-butylphenyl) sodium phosphate
2-2'-Methylene bis (4-ethyl-6-tert-butylphenol)
SML(T) = 1.5 mg/kg (19)
2-2'-Methylene bis (4-methyl-6-tert-butylphenol)
Mono-n-dodecyltin tris (isooctyl mercaptoacetate)
SML = 24 mg/kg
Monomethyltin tris (isooctyl mercaptoacetate)
Mono-n-octyltin tris (alkyl (C10-C16) - mercaptoacetate
SML(T) = 1.2 mg/kg (17) (expressed as tin)
Mono-n-octyltin tris (2-ethylhexyl mercaptoacetate
Mono-n-octyltin tris (isooctyl mercaptoacetate)
Octadecyl 3- (3,5-di-tert-butyl-4- hydroxylphenyl) propionate
SML = 0.05 mg/kg (31)
Phosphorous acid, tris (nonyl- and/or dinonylphenyl) ester
068132-00-3
Polyethyleneglycol ester of caster oil
SML – 42 mg/kg
Poly [6- [1,1,3,3- tetramethylbutyl) – amino]- 1,3,5-triazine-2,4-diyl]- [(2,2,6,6-tetramethyl- 4-piperidyl)-imino] hexamethylene- [2,2,6,6-tetramethyl-4-piperidyl) imino]
SML(T) = 1 mg/kg (10) (expressed as iodium)
SML = 18 mg/kg and in compliance with the specifications in Schedule 4
Silicic acid, lithium aluminium salt (2:1:1)
SML(T) = 10 mg/kg (30) (expressed as SO2)
Sodium monoalkyl dialkylphenoxybenzenedi-sulphonate
Tetradecyl-polyethyleneglycol (EO = 3-8) ether of glycolic acid
Tetrakis (2,4- di-tert-butyl-phenyl) – 4-4' –biphenylylene diphosphonite
4,4'-Thiobis (6-tert-butyl- 3-methylphenol)
SML = 0.48 mg/kg
Thiodiethanol bis (3-(3-5-di-tert- butyl-4-hydroxyphenyl) propionate)
SML(T) = 5 mg/kg (20)
Triethyleneglycol bis[ 3-(3-tert-butyl- 4-hydroxy- 5-methylphenyl) propionate]
1,3,5- Tris (4-tert-butyl-3-hydroxy –2,6- dimethylbenzyl)- 1,3,5-triazine-2,4,6 (1H, 3H,5H)- trione
1,3,5 – Tris (3,5-di-tert-butyl-4 hydroxybenzyl)- 1,3,5-triazine –2,4,6 (1H, 3H, 5H) - trione
1,1,3- Tris (2-methyl-4-hydroxy-5-tert-butylphenyl) butane
1. In regulations 5 and 7 and Parts 1 and 2 of this Schedule—
(a)the PM/REF No of any additive is its EEC packaging material reference number,
(b)the CAS No. of any additive is its CAS (Chemical Abstracts Service) Registry Number; and
2. If a substance identified in Parts 1 or 2 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 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.
3. If, as indicated in paragraph 2 of Annex III to the Directive, a substance is identified in Parts 1 or 2 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.
4. Where an entry in column 4 of Part 1 or Part 2 includes a bracketed number, that entry shall be subject to a note relating to that number as follows, the following bracketed numbers corresponding with those appearing in those Parts —
(1): Warning: there is a risk that the SML could be exceeded in fatty food simulants.
(6): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 66560 and 66580.
(7): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 30080, 42320, 45195, 45200, 53610, 81760, 89200 and 92030.
(8): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 38000, 42400, 64320, 67896, 73040, 85760, 85840, 85920 and 95725.
(9): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 30180, 40980, 63200, 65120, 65200, 65280, 65360, 65440 and 73120.
(10): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels (expressed as iodine) of the substances having PM/REF Nos. 45200, 64320, 81680 and 86800.
(11): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 36720, 36800, 36840 and 92000.
(12): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 39090 and 39120.
(13): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 44960, 68078, 82020 and 89170.
(14): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 15970, 48640, 48720, 48880, 61280, 61360 and 61600.
(15): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 49600, 67520 and 83599.
(16): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 50160, 50240, 50320, 50360, 50400, 50480, 50560, 50640, 50720, 50800, 50880, 50960, 51040 and 51120.
(17): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PR/REF Nos. 67600, 67680 and 67760.
(18): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 60400, 60480 and 61440.
(19): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 66400 and 66480.
(20): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 93120 and 93280.
(21): SML(T) in this cases means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 17260, 18670, 54880 and 59280.
(24): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 16650 and 51570.
(26): QMA(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 14950, 15700, 16240, 16570, 16600, 16630, 18640, 19110, 22332, 22420, 22570, 25210, 25240 and 25270.
(29) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 22775 and 69920.
(30): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 86480, 86960 and 87120.
(31): Compliance testing when there is a fat contact should be performed using saturated fatty food simulants as simulant D.
(34): SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 55200, 55280 and 55360.
5. In the case of the substances listed in Part 2, the specific migration limits specified in column 4 of that Part (restrictions and specifications) shall have effect with effect from 1st July 2006 where the verification of compliance is carried out in simulant D or in test media of substitute tests as prescribed in Council Directive 82/711/EEC and Council Directive 85/572/EEC.
SCHEDULE 3Products Obtained by Bacterial Fermentation
3-hydroxybutanoic acid-
3-hydroxypentanoic acid, copolymer
In compliance with specifications included in Schedule 4
Schedules 1,2 & 3
SCHEDULE 4Specifications
Quantity of substance used/quantity of formulation
3-Hydroxybutanoic acid – 3-hydroxypentanoic acid, copolymer
The copolymers are produced by the controlled fermentation of Alcaligenes eutrophus using mixtures of glucose and propanoic acid as carbon sources. The organism used has not been genetically engineered and has been derived from a single wild-type organism Alcaligenes eutrophus strain H16 NCIMB 10442.
Master stocks of the organism are stored as freeze-dried ampoules. A submaster/working stock is prepared from the master stock and stored in liquid nitrogen and used to prepare inocula for the fermenter. Fermenter samples will be examined daily both microscopically and for any changes in colonial morphology on a variety of agars at different temperatures. The copolymers are isolated from heat treatment bacteria by controlled digestion of the other cellular components, washing and drying. These copolymers are normally offered as formulated, melt formed granules containing additives such as nucleating agents, plasticisers, fillers, stabilisers and pigments which all conform to the general and individual specifications.
As set out in Part B of Annex V to the Directive
Not less than 150 000 Daltons (measured by gel permeation chromatography)
Not less than 98% poly (3-D-hydroxybutanoate
-co-3-D-hydroxypentanoate) analysed after hydrolysis as a mixture of 3-D-hydroxybutanoic and 3-D-hydroxypentanoic acids
White to off-white powder after isolation
Soluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically insoluable in ethanol, aliphatic alkanes and water
QMA for crotonic acid is 0.05 mg/6 dm2
Prior to granulation of the raw material copolymer powder must contain:
Not more than 2,500 mg/g of plastic
Not more than 100 mg/kg of plastic
Not more than 5 mg/kg of plastic
Not more than 2 mg/kg of plastic
Minimum viscosity 100 x 10 -m2/s (= 100 centistokes) at 25° C
Molecular unit = (C8H18S3Sn2) n (n = 1.5-2)
Minimum viscosity 100 x 10 -;m2/s (= 100 centistokes) at 25° C
-polyethyleneglycol (EO = 2-6) monoalkyl (C16-C18) ether approximately 28%)
-fatty alcohols (C16-C18) (approximately 48%)
-ethyleneglycol monoalkyl (C16-C18) ether (approximately 24%)
Reaction product of di-tert-butylphosphonite with biphenyl, obtained by condensation of 2,4-di-tert-butylphenol with Friedel Craft reaction product of phosphorus trichloride and bipheny(1)
-4,4'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 38613-77-3) (36-46% w/w)(1)
-4,3'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 118421-00-4) (17-23% w/w)(1)
-3-3'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] CAS No. 118421-01-5) (1-5% w/w )(1)
-4-Biphenylene-0,0-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 91362 – 37-7 (11-19% w/w)(1)
-Tris (2,4-di-tert-butylphenyl) phosphite (CAS No. 31570-04-4) (9-18% w/w)(1)
-4,4'-Biphenylene-0,0-bis (2,4-di-tert-butylphenyl) phosphonate-0,0-bis (2,4-di-tert-butylphenyl) phosphonite (CAS No. 112949–97-0) (< 5% w/w)(1)
-Phosphor content of minimum 5.4% to maximum 5.9%
-Acid value of maximum 10 mg KOH per gram
-Melt range of 85-110°C
Oxirane less than 8%, iodine number < 6
Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks. The product should have the following specifications:
-Content of mineral hydrocarbons with carbon number less than 25: not more than 5% (w/w)
-Viscosity not less than 11 x 10 -m2/s (= 11 centistokes) at 100°C
-Average molecular weight not less than 500
-Viscosity not less than 8.5 x 10-m2/s (= 8.5 centistokes) at 100°C
-Average molecular weight not less than 480
SCHEDULE 5Applicable Provisions when Testing Compliance with the Migration Limits
1. When the results of the migration tests specified in this Schedule and, where appropriate Schedule 6, are analytically determined, the specific gravity of any simulants used shall be assumed to be 1, so that milligrams of any substance released per litre of simulant will correspond numerically to milligrams of that substance released per kilogram of that simulant.
2. Where any migration test specified in this Schedule and, where appropriate, Schedule 6 is carried out on any sample taken from any plastic material or article and the quantities of food or simulant placed in contact with the sample differ from those employed in the actual conditions under which the plastic material or article is used or is to be used, the results obtained should be corrected by applying the formula M = (( m.a2/a1.q).1000) where —
3.—(1) Subject to sub-paragraph (2), any testing of migration from any plastic material or article shall be carried out on that plastic material or article.
4.—(1) Any sample of plastic material or article shall be placed in contact with the appropriate simulant or the food for a period and at a temperature which are chosen by reference to the contact conditions in actual use in accordance with the provisions of this Schedule and, where appropriate, Schedule 6.
(3) Verification that migration into food complies with a migration limit specified in regulation 9, Schedule 1 or Schedule 2 shall be carried out under the most extreme conditions of time and temperature foreseeable in actual use in accordance with the provisions of this Schedule.
(4) Verification that migration into food simulants complies with a migration limit specified in regulation 9, Schedule 1 or Schedule 2 shall be carried out in accordance with the provisions of this Schedule and using conventional migration tests, the basic rules for which are set out in Schedule 6.
5. Where a plastic material or article is intended to come into repeated contact with food, any migration test shall (subject to paragraph 7 below) be carried out three times on a single sample in accordance with the conditions laid down in this Schedule and, where appropriate, Schedule 6 using separate samples of the simulant or, as the case may be food, on each occasion, and the level of the migration found in the third test shall be treated as the level relevant to that test.
(a)if an aqueous simulant specified in Schedule 6 had been used, and the analytical determination of the total quantity of substances released by a sample of the plastic material or article tested had been carried out by evaporation of the simulant and weighing of the residue; or
(2) In any proceedings for an offence under these Regulations where it is alleged, following determination under sub-paragraph (1) above, that a plastic material or article does not comply with regulation 9 it shall be a defence for the person charged to prove that, if—
(a)three identical samples of the plastic material or article had been procured;
(b)one of them had been subjected to the appropriate test according with paragraph 4 above and the overall migration determined (M1);
(c)the second and third samples had been subjected to the same conditions of temperature but the period of contact had been two and three times that specified and overall migration had been determined in each case (M2 and M3 respectively); and
(d)the plastic material or article had been deemed to comply with the overall migration limit relevant to it provided that either M1 or M3– M2 did not exceed that overall migration limit,
(b)12mg/kg or, as the case may be, 2 milligrams per square decimetre in migration tests using other simulants referred to in Schedule 6.
SCHEDULE 6Overall and Specific Migration Testing Using Food Simulants
(a)reduce the number of tests to be carried out to that or those which, in the specific ase under examination, is or are generally recognised to be the most severe on the basis of scientific evidence;
(ii)the conditions for non-compulsory testing set out in Article 8.2 or 8.3 of the Directive are met.
(d)Peroxide number (expressed as oxygen milli-equivalents per kg of oil) = 10 maximum
(i)Iodine value (Wijs) = 120 to 145
(ii)Refractive index at 20°C = 1.474 to 1.476
(iii)Saponification number = 188 to 193
(iv)Relative density at 20°C = 0.918 to 0.925
(v)Unsaponifiable matter = 0.5% to 1.5%.
Foods in relation to which simulant A only is specified in the Table to Part 4
Acidic foods having a pH ≤ 4.5
Foods in relation to which simulant B only is specified in Table to Part 4
Foods in relation to which simulant C only is specified in the Table to Part 4
Foods in relation to which simulant D only is specified in the Table to Part 4
Foods in relation to which no simulant is specified in the Table to Part 4
5. The simulant or simulants to be used in testing a plastic material or article which is already in contact with a known food shall be —
6. The simulant or simulants to be used in testing a plastic material or article which, pursuant to Regulation (EC) No 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food(25) (“Regulation 1935/2004”), is accompanied by a specific indication stating any type or types of food described in Table 1 with which it may or may not be used shall be the simulant or simulants in column 2 of Table 2 opposite the contact food in column 1 of that Table which corresponds most closely to the type or types of food with which it may be used, as identified by the indication which accompanies the plastic material or article.
7. The simulant or simulants to be used in testing a plastic material or article which, pursuant to Regulation 1935/2004, is accompanied by a specific indication, expressed in accordance with paragraph 8, stating any food or group of foods described in the Table to Part 4 with which it may or may not be used shall be—
Simulants D and A
Simulants D and B
Simulants D and C
Simulants D, C and B
4. Where the letter “a” is shown in brackets after the “X”, only one of the two simulants specified shall be used in the migration test, that is to say —
Miscellaneous: undenatured ethyl alcohol
A With fatty substances on the surface
Pastry, biscuits, cakes and other bakers' wares, fresh
— with fatty substances on the surface
B Honey and the like
C Molasses and sugar syrups
Fruit, vegetable and products thereof
B Fruit in the form of chunks, puree or paste
— i) In an aqueous medium
— ii) In an oily medium
— iii) In an alcoholic medium > 5% vol
Nuts (peanuts, chestnuts, almonds, hazelnuts, walnuts, pine kernels and others)
B Shelled and roasted
C In paste or cream form
B Vegetables, cut, in the form of purees
— iii) In an alcoholic medium (> 5% vol)
Animal and vegetable fats and oils, whether natural or treated (including cocoa butter, lard, re-solidified butter)
A Fresh, chilled, salted, smoked
B In the form of paste
B In the form of paste, creams
A In an aqueous medium
B In an oily medium
B Partly dried
C Skimmed or partly skimmed
B Processed cheeses
A In liquid or viscous form
A Fried potatoes, fritters and the like
B Of animal origin
— i) With fatty substances on the surface
A In paste form
A Without fatty substances on the surface
B Mayonnaise, sauces derived from mayonnaise, salad creams and other oil in water emulsions
C Sauce containing oil and water forming two distinct layers
A Cocoa powder
B Cocoa paste
1. Subject to paragraphs 2, 4, 6 and 7 below and to paragraph 4.4 of Chapter II of the Annex to Directive 82/711, when carrying out migration tests the time and temperature used shall be the time and temperature selected from column 2 of the Table to this Part which correspond to the worst foreseeable conditions of contact specified in column 1 of that Table for the plastic material or article being tested and to any labelling information on maximum temperature for use.
2. Where the plastic material or article being tested is intended for a food contact application covered by a combination of two or more times and temperatures specified in column 2 of the Table to this Part, the migration test shall be carried out by subjecting the test specimen successively to all the applicable worst foreseeable conditions appropriate to the sample, using the same portion of food simulant.
Conditions of contact in worse foreseeable use
>5 minutes but less than or equal to 0.5 hours
>0.5 hours but less than or equal to 1 hour
>1 hour but less than or equal to 2 hours
>2 hours but less than or equal to 4 hours
>4 hours but less than or equal to 24 hours
less than or equal to 5°C
>70°C but less than or equal to100°C
0.5 days at 5°C
0.5 hours at 40°C
0.5 hours at 100°C
0.5 hours at 60°C(2)
2.5 hours at 60°C
1.5 hours at 60°C(2)
3.5 hours at 60°C(2)
0.5 hours at 121°C
2.5 hours at 60°C(2)
4.5 hours at 60°C(2)
0.5 hours at 130°C
1. Subject to paragraph 2 of this Part the conditions which must be fulfilled to allow the result of either test specified in paragraph 3 to be used as an alternative to the result of a migration test carried out under Part 3 are that—
1. These Regulations, which apply in relation to England only, revoke the Plastic Materials and Articles in Contact with Food Regulations 1998 as amended (“the 1998 Regulations”) in so far as they apply in relation to England, and re-enact or re-enact with changes certain provisions contained in those Regulations. The principal Directives that continue to be implemented by these Regulations are listed in paragraph 5 below. These Regulations also provide for the execution and enforcement of 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 (“Regulation 1895/2005”).
2. The Regulations in Part 2 —
(a)prohibit specified activities in relation to any plastic material or article (as defined in regulation 2) which fails to meet the appropriate required standards set out in the Regulations (regulation 3);
(b)prohibit the use of monomers and additives in the manufacture of plastic materials and articles other than in accordance with specified conditions (regulation 4 and Schedule 1 in the case of monomers and regulation 5 and Schedule 2 in the case of additives);
(c)specify the required standards relating to the capability of a monomer or an additive to confer its constituents to food (regulation 6 for monomers and regulation 7 for additives);
(d)specify the required standard for products obtained by bacterial fermentation (regulation 8 and Schedule 3);
(e)specify the required standard relating to overall migration limits from plastic materials or articles to food (regulation 9);
(f)specify the required standards relating to the migration of primary aromatic amines from plastic materials or articles to food (regulation 10);
(g)specify the methods for determining the capability of a plastic material or article to transfer its constituents to food, and for detecting the presence of any such constituents in food (regulation 11 and Schedules 5 & 6);
(h)provide that prior to the retail stage plastic materials and articles must be accompanied by certain specified written information, including a declaration of legislative compliance (regulation 12);
(i)provide for the enforcement of Regulation 1895/2005, which contains Community provisions relating to the epoxy derivatives known as BADGE, BFDGE and NOGE (regulation 13).
3. The Regulations in Part 3 —
(a)designate food authorities and port health authorities as the enforcement authorities in their respective areas or districts (regulation 14);
(b)specify the offences that may be committed under these Regulations and set out the maximum penalties on conviction (regulation 15);
(c)provide for defences of a general nature, such as exercise of due diligence etc, to offences under regulation 15 (regulation 16);
(d)provide for transitional defences in relation to certain plastic materials or articles that have already been manufactured or put into circulation in advance of a change in the law that would otherwise have made their manufacture or circulation unlawful (regulation 17);
(e)specify the procedure to be followed when sending a sample for analysis (regulation 18);
(f)make provision for a reference sample to be analysed by the Laboratory for the Government Chemist (regulation 19);
4. Part 4 of the Regulations contains provisions relating to the procedure to be followed and the time limit to be observed where a person wishes apply to the European Food Safety Authority for the authorisation of a new additive (regulation 20).
5. The principal Directives implemented by the 1998 Regulations which these Regulations continue to implement are —
(a)Council Directive 82/711/EEC (OJ No. L297, 23,10,1982, p.26) laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs, as amended by Commission Directives 93//8/EEC (OJ No. L90, 14.4.1993, p.22) and 97/48/EC (OJ No. L222, 12.8.1997, p.10);
(b)Council Directive 85/572/EEC laying down the list of stimulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs (OJ No. L372, 31.12.1985, p.14);
(c)Commission Directive 2002/72/EC (OJ No. L220, 15.8.2002, p.18) relating to plastic materials and articles intended to come into contact with foodstuffs, as amended by Commission Directives 2004/1/EC (OJ No. L7, 13.1.2004, p.45) and 2004/19/EC (OJ No. L71, 10.3.2004, p.8).
6. A full regulatory impact assessment of the effect that this instrument will have on the costs of business has been prepared and placed in the library of each House of Parliament. Copies may be obtained from the Chemical Safety Division of the Food Standards Agency, Aviation House, 125 Kingsway, London WC2B 6NH.
Functions formerly exercisable by “the Ministers” (being, in relation to England and Wales and acting jointly, the Minister of Agriculture, Fisheries and Food and the Secretaries of State respectively concerned with health in England and food and health in Wales and, in relation to Scotland, the Secretary of State) are now exercisable in relation to England by the Secretary of State pursuant to paragraph 8 of Schedule 5 to the Food Standards Act 1999 (1999 c. 28). Those functions, so far as exercisable in relation to Wales, were transferred to the National Assembly for Wales by S.I. 1999/672 as read with section 40(3) of the 1999 Act. Those functions, so far as exercisable in relation to Scotland, were transferred to the Scottish Ministers by section 53 of the Scotland Act 1998 (1998 c. 46) as read with section 40(2) of the 1999 Act. Section 17(1) was amended by paragraph 12(a), section 17(2) by paragraph 12(b) and section 48 by paragraph 21, of Schedule 5 to the 1999 Act.
OJ No. L297, 23.10.1982, p.26.
OJ No. L222, 12.8.1997, p.10.
OJ No. L372, 31.12.1985, p.14.
S.I. 1998/1376, as amended in relation to England by S.I. 2000/3162, S.I. 2002/2364, S.I. 2002/3008, S.I. 2004/3113 and S.I. 2005/325.
S.I.2005/898.
OJ No. L178, 28.7.97, p.1, as last amended by Commission Directive 2004/46, OJ No. L114, 21.4.2004, p.15.
OJ No. L226, 22.9.95, p.1, as last amended by Commission Directive 2004/47, OJ No. L113, 20.4.2004, p.24.
OJ No. L339, 30.12.96, p.1, as last amended by Commission Directive 2003/95, OJ No. L283, 31.10.2003, p.71.
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 80/590/EEC and 89/109/EEC (OJ No. L338, 13.11.2004, p.4).
S.I. 1990/2463
S.I. 2006/1401
S.I. 2000/3162
S.I. 2002/2364
S.I. 2002/3008
S.I. 2004/3113
S.I. 2005/325
1998 Plastic Materials and Articles in Contact with Food Regulations (Northern Ireland) 1998
1998 The Plastic Materials and Articles in Contact with Food Regulations 1998
2002 The Plastic Materials and Articles in Contact with Food (Amendment) (Scotland) Regulations 2002
2001 The Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2001
2000 The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2000
2000 Plastic Materials and Articles in Contact with Food (Amendment) Regulations (Northern Ireland) 2000