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


Published: 2006-05-23

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Statutory Instruments
2006 No. 1401

FOOD, ENGLAND
The Plastic Materials and Articles in Contact with Food (England) Regulations 2006

Made
23rd May 2006

Laid before Parliament
2nd June 2006

Coming into force
30th June 2006

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.

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(3), there has been open and transparent public consultation during the preparation and evaluation of these Regulations.

PART 1Preliminary

Title, application and commencement

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.

Interpretation

2.—(1) In these Regulations —

“the Act” means the Food Safety Act 1990;

“authorised officer” means any person, whether or not an officer of the enforcement authority, who is authorised by it in writing to act in matters arising under these Regulations;

“BADGE” has the meaning given in Article 1(1)(a) of Regulation 1895/2005;

“BFDGE” has the meaning given in Article 1(1)(b) of Regulation 1895/2005;

“business” is to be construed in accordance with section 1(3) of the Act;

“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);

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

“EFSA” means the European Food Safety Authority;

“enforcement authority” means an authority having responsibility under regulation 14 for executing and enforcing these Regulations;

“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 given in Article 1(1)(c) of Regulation 1895/2005;

“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);

“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(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);

“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(16);

“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.

PART 2Requirements for Materials and Articles

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

3.—(1) No person may —

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

(b)sell for the purpose of handling of food; or

(c)import from anywhere other than an EEA State for the purpose of handling of food,

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); or

(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 may 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 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.

(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 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,

and is of good technical quality.

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

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

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

(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 —

(i)is not of good technical quality, or

(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

(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 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.

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 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 —

(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 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.

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 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 —

(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 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.

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 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.

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 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

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

(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.

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 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).

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 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.

Labelling

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 —

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

(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.

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 Regulation1895/2005;

(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 the authority identified in regulation 14.

(2) Subject to Article 6(1), (2) (transitional provisions) and (4) (labelling requirements), no person may —

(a)manufacture,

(b)use for the handling of food in the course of a business,

(c)sell for the purpose of the handling of food, or

(d)import for the purpose of the handling of food

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

(3) No person may 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 may —

(a)use for the handling of food in the course of a business,

(b)sell for the purpose of the handling of food, or

(c)import for the purpose of the handling of food

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 3Execution and Enforcement

Enforcement

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

(b)these Regulations.

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)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

(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) Anyone 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 to a term of imprisonment not exceeding three months or to a fine not exceeding level five on the standard scale or 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 him.

(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,

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.

General defences

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.

(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 into the United Kingdom,

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;

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

(c)that he did not know and could not reasonably have been expected to know at the time 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 —

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

(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;

(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 in like manner 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 him 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)proceedings are intended to be or have been commenced against a person for an offence under these Regulations; and

(b)the prosecution intends to adduce as evidence the result of the analysis mentioned above,

paragraphs (2) to (7) apply.

(2) The authorised officer —

(a)may of his own volition;

(b)shall if requested by the prosecutor (if a person other than the authorised officer);

(c)shall if the court so orders; or

(d)shall (subject to paragraph (6)) if requested by the defendant,

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

(3) The Government Chemist shall analyse the part sent to him under paragraph (2) and send to the authorised officer a certificate of analysis.

(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.

(5) The authorised officer shall immediately on receipt supply the prosecutor (if a person other than the authorised officer) and the defendant with a copy of the Government Chemist’s certificate of analysis.

(6) Where a request is made under paragraph (2)(d) the authorised officer may give notice in writing to the defendant requesting payment of a fee specified in the notice to defray some or all of the Government Chemist’s charges for performing the functions under paragraph (3), and in the absence of agreement by the defendant to pay the fee specified in the notice the authorised officer may refuse to comply with the request.

(7) In this regulation “defendant” includes a prospective defendant.

PART 4Application 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 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.

(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 5General 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 (presumption that food is intended for human consumption);

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

(c)section 36 (offences by bodies corporate);

(d)section 36A (offences by Scottish partnerships);

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

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

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).

(2) In regulation 2(1) —

(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”.

Revocations

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.

Signed by authority of the Secretary of State for Health

Caroline Flint
Minister of State,
Department of Health
23rd May 2006

Regulations 4 and 6

SCHEDULE 1Authorised Monomers

PART 1List of Monomers with Restrictions and Specifications

1

PM/REF No

2

CAS No

3

Name

4

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, dicyclopentaidien-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
000999-61-1
Acrylic acid, 2-hydroxypropyl ester
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

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
000091-76-9
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
004767-03-7
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
000110-63-4
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
000931-88-4
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
000091-76-9
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
000080-07-9
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
000080-09-01
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'-Divinly-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
Ethyleneamine
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
016712-64-4
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
004098-71-9
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
000106-91-2
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
001561-92-8
Methallylsulphonic acid, sodium salt
SML = 5 mg/kg

145
21550
000067-56-1
Methanol

145A
21640
000078-79-5
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
000505-65-7
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
001141-38-4
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
000126-30-7
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
007456-68-0
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
000109-67-1
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

063148-62-9

Polydimethylsiloxane (Mw >6800)
In compliance with the specifications laid down in Schedule 4

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
003290-92-4
1,1,1-trimethylolpropane trimethacrylate
SML = 0.05 mg/kg

217B
25900
000110-88-3
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 2Supplementary

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 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.

Regulations 5 and 7

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)

Item

1

PM/REF No.

2

CAS No.

3

Name

4

Restrictions and specifications

1
30000
000064-19-7
Acetic acid

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

2A
30080
004180-12-5
Acetic acid, copper salt
SML(T) = 30 mg/kg (7) (expressed as copper)

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

4
30280
000108-24-7
Acetic anhydride

5
30295
000067-64-1
Acetone

6
30370
-
Acetylacetic acid, salts

7
30400
-
Acetylated glycerides

7A
30610
-
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)

7B
30612
-
Acids C2-C24 aliphatic linear, monocarboxylic, synthetic and their mono-, di- and triglycerol esters

8
30960
-
Acids, aliphatic, monocarboxylic (C6-C22), esters with polyglycerol

9
31328
-
Acids, fatty, from animal or vegetable foods fats and oils

9A
31530
123968-25-2
Acrylic acid, 2,4-di-tert-pentyl-6[1(3,5-di-tert-pentyl-2- hydroxyphenyl) ethyl] phenyl ester
The specific migration of this substance shall not exceed 5 mg/kg

10
31730
000124-04-9
Adipic acid

11
33120
-
Alcohol's, aliphatic, monohydric, saturated, linear, primary (C4-C24)

12
33350
009005-32-7
Alginic acid

12A
33801
-
n-Alkyl (C10-C13) benzenesulphonic acid
The specific migration of this substance shall not exceed 30 mg/kg

13
34281
-
Alkyl (C8-C22) sulphuric acids, linear, primary, with an even number of carbon atoms

14
34475
-
Aluminium calcium hydroxide phosphite, hydrate

15
34480
-
Aluminium fibres, flakes and powders

16
34560
021645-51-2
Aluminium hydroxide

17
34690
011097-59-9
Aluminium magnesium carbonate hydroxide

18
34720
001344-28-1
Aluminium oxide

18A
34850
143925-92-2
Amines, bis (hydrogenated tallow alkyl) oxidised

QM = For use only:

(a)
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;

(b)
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

18B
34895
000088-68-6
2-Aminobenzamide
SML = 0.05 mg/kg. To be used only for PET for water and beverages

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

19A
35160
006642-31-5
6-Amino-1,3-dimethyluracil
SML = 5 mg/kg

19B
35170
000141-53-5
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

19C
35284
000111-41-1
N-(2-aminoethyl) ethanolamine
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

20
35320
007664-41-7
Ammonia

21
35440
001214-97-9
Ammonium bromide

22
35600
001336-21-6
Ammonium hydroxide

23
35840
000506-30-9
Arachidic acid

24
35845
007771-44-0
Arachidonic acid

25
36000
000050-81-7
Ascorbic acid

26
36080
000137-66-6
Ascorbyl palmitate

27
36160
010605-09-1
Ascorbyl stearate

27B
36840
012007-55-5
Barium tetraborate
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

28
36880
008012-89-3
Beeswax

29
36960
003061-75-4
Behenamide

30
37040
000112-85-6
Behenic acid

31
37280
001302-78-9
Bentonite

31A
37360
000100-52-7
Benzaldehyde
(10)

32
37600
000065-85-0
Benzoic acid

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

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

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

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

36A
38320
005242-49-9
4-(2-benzoxazolyl)-4'- (5-methyl-2-benzoxazolyl) stilbene
In compliance with the specifications laid down in Schedule 4

36B
38510
136504-96-6
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
The specific migration of this substance shall not exceed 5 mg/kg

36C
38515
001533-45-5
4,4'-Bis(2-benzoxazolyl) stilbene
The specific migration of this substance shall not exceed 0.05 mg/kg (1)

36D
38810
080693-00-1
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)

36E
38840
154862-43-8
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)

36F
38879
135861-56-2
Bis (3,4-dimethylbenzylidene) sorbitol

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

37A
39200
006200-40-4
Bis (2-hydroxyethyl)-2-hydroxypropyl-3-(dodecyloxy) methylammonium chloride
The specific migration of this substance shall not exceed 1.8 mg/kg

37AA
39680
000080-05-7
2,2-Bis(4-hydroxyphenyl) propane
SML(T) = 0.6 mg/kg (28)

37B
39815
182121-12-6
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

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

069158-41-4
Ditto

054686-97-4
Ditto

081541-12-0
Ditto

38A
39925
129228-21-3
3,3-Bis (methoxymethyl)- 2,5-dimethyl hexane
SML = 0.05 mg./kg

38B
40120
068951-50-8
Bis(polyethyleneglycol) hydroxymethylphosphonate
SML = 0.6 mg/kg

38C
40320
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

39
40400
010043-11-5
Boron nitride

40
40570
000106-97-8
Butane

40A
40580
000110-63-4
1,4,-Butanediol
SML(T) = 0.05 mg/kg (23)

41
41040
005743-36-2
Calcium butyrate

41A
41120
010043-52-4
Calcium chloride

42
41280
001305-62-0
Calcium hydroxide

43
41520
001305-78-8
Calcium oxide

44
41600
012004-14-7
Calcium sulphoaluminate

037293-22-4
Ditto

44A
41680
000076-22-2
Camphor
(10)

45
41760
008006-44-8
Candelilla wax

45A
41840
000105-60-2
Caprolactam
SML(T) = 15 mg/kg (5)

46
41960
000124-07-2
Caprylic acid

47
42160
000124-38-9
Carbon dioxide

47A
42320
007492-68-4
Carbonic acid, copper salt
SML(T) = 30 mg/kg (7) (expressed as copper)

48
42500
-
Carbonic acid, salts

49
42640
009000-11-7
Carboxymethylcellulose

50
42720
008015-86-9
Carnauba wax

51
42800
009000-71-9
Casein

51A
42880
008001-79-4
Castor oil

52
42960
064147-40-6
Castor oil, dehydrated

53
43200
-
Castor oil, mono- and diglycerides

54
43280
009004-34-6
Cellulose

55
43300
009004-36-8
Cellulose acetate butyrate

56
43360
068442-85-3
Cellulose, regenerated

57
43440
008001-75-0
Ceresin

57A
43515
-
Chlorides of choline esters of coconut oil fatty acids
The quantity of this substance in the finished plastic material or article shall not exceed 0.9 mg/ 6 dm2

58
44160
000077-92-9
Citric acid

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

59A
45195
007787-70-4
Copper bromide
SML(T) = 30 mg/kg (7) (expressed as copper)

59B
45200
001335-23-5
Copper iodide
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)

60
45280
-
Cotton fibres

60A
45450
068610-51-5
p-Cresol-dicyclopentadiene- isobutylene, copolymer
SML = 5 mg/kg

61
45560
014464-46-1
Cristobalite

61A
45600
003724-65-0
Crotonic acid
QMA(T) = 0.05 mg/ 6 dm2(33)

61B
45640
005232-99-5

2-Cyano-3,

3-dipheneylacrylic acid, ethyl ester

SML = 0.05 mg/kg

62
45760
000108-91-8
Cyclohexylamine

63
45920
009000-16-2
Dammar

64
45940
000334-48-5
n-Decanoic acid

65
46070
010016-20-3
Alpha-Dextrin

66
46080
007585-39-9
Beta-Dextrin

67
46375
061790-53-2
Diatomaceous earth

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

69
46480
032647-67-9
Dibenzylidene sorbitol

69A
46700
-

5,7-di-tert-Butyl-3- (3,4- and 2,3 –dimethylphenyl)-3H-benzofuran-2-one containing:

(a)
5,7-di-tert-butyl-3-(3,4-dimethylphenyl)-3H-benzofuran-2-one (80-100% w/w); and

(b)
5,7-di-tert-butyl-3-(2,3-dimethylphenyl)-3H-benzofuran-2-one (0-20% w/w)

SML = 5 mg/kg

69B
46720
004130-42-1
2,6-Di-tert-butyl-4-ethylphenol
QMA = 4.8 mg/ 6 dm2

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

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

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

72A
46880
065140-91-2
3,5-Di-tert-butyl-4-hydroxybenzyl phosphonic acid, monoethyl ester, calcium salt
The specific migration of this substance shall not exceed 6 mg/kg

72B
47210
026427-07-6
Dibutylthiostannoic acid polymer [= thiobis(butyl-tin sulphide), polymer]
In compliance with this specifications laid down in Schedule 4

73
47440
000461-58-5
Dicyanodiamide

73A
47540
027458-90-8
Di-tert-dodecyl disulfide
SML – 0.05 mg/kg

73B
47680
000111-46-6
Diethyleneglycol
SML(T) = 30 mg/kg (3)

73C
48460
000075-37-6
1,1-Difluoroethane

73D
48620
000123-31-9
1,4-Dihydroxybenzene
SML = 0.6 mg/kg

73E
48720
000611-99-4
4,4'Dihydroxybenzophenone
SML(T) = 6 mg/kg (14)

73F
49485
134701-20-5
2,4-Dimethyl-6-(1-methylpentadecyl) phenol
The specific migration of this substance shall not exceed 1 mg/kg

74
49540
000067-68-5
Dimethyl sulphoxide

75
51200
000126-58-9
Dipentaerythritol

75A
51700
147315-50-2
2-(4,6-Diphenyl-1,3,5-triazin-2-yl)-5- (hexyloxy) phenol
The specific migration of this substance shall not exceed 0.05 mg/kg

76
51760
025265-71-8
Dipropyleneglycol

000110-98-5
Ditto

77
52640
016389-88-1
Dolomite

77A
52645
010436-08-5
Cis-11-eicosenamide

78
52720
000112-84-5
Erucamide

79
52730
000112-86-7
Erucic acid

80
52800
000064-17-5
Ethanol

81
53270
037205-99-5
Ethylcarboxymethylcellulose

82
53280
009004-57-3
Ethylcellulose

83
53360
000110-31-6
N,N'-Ethylenebisoleamide

84
53440
005518-18-3
N,N'-Ethylenebispalmitamide

85
53520
000110-30-5
N,N'-Ethylenebisstearamide

86
53600
000060-00-4
Ethylenediaminetetraacetic acid

86A
53610
054453-03-1
Ethylenediaminetetraacetic acid, copper salt
SML(T) = 30 mg/kg (7) (expressed as copper) (3)

86B
53650
000107-21-1
Ethyleneglycol
SML(T) = 30 mg/kg

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

88
54260
009004-58-4
Ethylhydroxyethylcellulose

89
54270
-
Ethylhydroxymethylcellulose

90
54280
-
Ethylhydroxypropylcellulose

90A
54300
118337-09-0
2,2'-Ethylidenebis (4,6-di-tert-butylphenyl) fluorophosphonite
The specific migration of this substance shall not exceed 6 mg/kg

91
54450
-
Fats and oils, from animal or vegetable food sources

92
54480
-
Fats and oils, hydrogenated, from animal or vegetable food sources

92A
54930
025359-91-5
Formaldehyde-1-naphthol, copolymer [ = Poly (1-hydroxynaphthyl-methane)]
The specific migration of this substance shall not exceed 0.05 mg/kg

93
55040
000064-18-6
Formic acid

94
55120
000110-17-8
Fumaric acid

95
55190
029204-02-2
Gadoleic acid

96
55440
009000-70-8
Gelatine

97
55520
-
Glass fibres

98
55600
-
Glass microballs

99
55680
000110-94-1
Glutaric acid

100
55920
000056-81-5
Glycerol

101
56020
099880-64-5
Glycerol dibehenate

102
56360
-
Glycerol, esters with acetic acid

103
56486
-
Glycerol, esters with acids, aliphatic, saturated, linear, with an even number of carbon atoms C14-C18) and with acids, aliphatic, unsaturated, linear, with even number of carbon atoms (C16-C18)

104
56487
-
Glycerol, esters with butyric acid

105
56490
-
Glycerol, esters with erucic acid

106
56495
-
Glycerol, esters with 12-hydroxystearic acid

107
56500
-
Glycerol, esters with lauric acid

108
56510
-
Glycerol, esters with linoleic acid

109
56520
-
Glycerol, esters with myristic acid

109A
56535
-
Glycerol, esters with nonanoic acid

110
56540
-
Glycerol, esters with oleic acid

111
56550
-
Glycerol, esters with palmitic acid

113
56570
-
Glycerol, esters with propionic acid

114
56580
-
Glycerol, esters with ricinoleic acid

115
56585
-
Glycerol, esters with stearic acid

116
56610
030233-64-8
Glycerol monobehenate

117
56720
026402-23-3
Glycerol monohexanoate

118
56800
030899-62-8
Glycerol monolaurate diacetate

119
56880
026402-26-6
Glycerol monooctanoate

120
57040
-
Glycerol monooleate, ester with ascorbic acid

121
57120
-
Glycerol monooleate, ester with citric acid

122
57200
-
Glycerol monopalmitate, ester with ascorbic acid

123
52780
-
Glycerol monopalmitate, ester with citric acid

124
57600
-
Glycerol monostearate, ester with ascorbic acid

125
57680
-
Glycerol monostearate, ester with citric acid

125A
57800
018641-57-1
Glycerol tribehenate

126
57920
000620-67-7
Glycerol triheptanoate

127
58300
-
Glycine, salts

128
58320
007782-42-5
Graphite

129
58400
009000-30-0
Guar gum

130
58480
009000-01-5
Gum arabic

131
58720
000111-14-8
Heptanoic acid

131A
59280
000100-97-0
Hexamethylenetetramine
SML(T) = 15 mg/kg (21) (expressed as Formaldehyde)

132
59360
000142-62-1
Hexanoic acid

133
59760
019569-21-2
Huntite

134
59990
007647-01-0
Hydrochloric acid

135
60030
012072-90-1
Hydromagnesite

136
60080
012304-65-3
Hydrotalcite

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

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

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

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

140A
60480
003864-99-1
2-(2-Hydroxy-3,5,-di-tert-butylphenyl)-5- chlorobenzotriazole
SML(T) = 30 mg/kg (18)

141
60560
009004-62-0
Hydroxyethylcellulose

142
60880
009032-42-2
Hydroxyethylmethylcellulose

143
61120
009005-27-0
Hydroxyethyl starch

144
61390
037353-59-6
Hydroxymethylcellulose

145
61680
009004-64-2
Hydroxypropylcellulose

146
61800
009049-76-7
Hydroxypropyl starch

146
61840
000106-14-9
12-Hydroxystearic acid

148
62140
006303-21-5
Hypophosphorous acid

149
62240
001332-37-2
Iron oxide

150
62450
000078-78-4
Isopentane

151
62640
008001-39-6
Japan wax

152
62720
001332-58-7
Kaolin

153
62800
-
Kaolin, calcined

154
62960
000050-21-5
Lactic acid

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

156
63280
000143-07-7
Lauric acid

157
63760
008002-43-5
Lecithin

158
63840
000123-76-2
Levulinic acid

159
63920
000557-59-5
Lignoceric acid

160
64015
000060-33-3
Linoleic acid

161
64150
028290-79-1
Linolenic acid

162
64500
-
Lysine, salts

163
64640
001309-42-8
Magnesium hydroxide

164
64720
001309-48-4
Magnesium oxide

164A
64800
000110-16-7
Maleic acid
SML(T) = 30 mg/kg(4)

165
65020
006915-15-7
Malic acid

166
65040
000141-82-2
Malonic acid

167
65520
000087-78-5
Mannitol

167A
65920
066822-60-4
N-methacryloyloxyethyl-N,N-dimethyl-N- carboxymethyl-ammonium chloride, sodium salt-octadecyl methacrylate- ethyl methacrylate –cyclohexyl methacrylate-N-vinyl-2-pyrrolidone, copolymers

168
66200
037206-01-2
Methylcarboxymethylcellulose

169
66240
009004-67-5
Methylcellulose

169A
66560
004066-02-8
2,2'-Methylenebis (4-methyl-6-cyclohexylphenol)
SML(T) = 3 mg/kg (6)

169B
66580
000077-62-3
2,2'-Methylenebis (4-methyl-6-(1-methylcyclo-hexyl) phenol)
SML(T) = 3 mg/kg (6)

170
66640
009004-59-5
Methylethylcellulose

171
66695
-
Methylhydroxymethylcellulose

172
66700
009004-65-3
Methylhydroxypropylcellulose

172A
66755
002682-20-4
2-Methyl-4-isothiazolin-3-one
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

173
67120
012001-26-2
Mica

173B
67180
-
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)

174
67200
001317-33-5
Molybdenum disulphide

175
67840
-
Montanic acids and/or their esters with ethyleneglycol and/or with 1,3-butanediol and/or with glycerol

176
67850
008002-53-7
Montan wax

177
67891
000544-63-8
Myristic acid

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

178A
68078
027253-31-2
Neodecanoic acid, cobalt salt
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

179
68125
037244-96-5
Nepheline syenite

179A
68145
080410-33-9
2,2',2”-Nitrilo(triethyl tris (3,3',5,5'- tetra-tert-butyl-1-1'-bi-phenyl-2-2-diyl) phosphite)
The specific migration of this substance shall not exceed 5 mg/kg (sum of phosphite and phosphate)

180
68960
000301-02-0
Oleamide

181
69040
000112-80-1
Oleic acid

182
69760
000143-28-2
Oleyl alcohol

182A
69920
000144-62-7
Oxalic acid
SML(T) = 6 mg/kg (29)

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

184
70240
012198-93-5
Ozokerite

185
70400
000057-10-3
Palmitic acid

186
71020
000373-49-9
Palmitoleic acid

187
71440
009000-69-5
Pectin

188
71600
000115-77-5
Pentaerythritol

188A
71635
025151-96-6
Pentaerythritol dioleate
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

188B
71670
178671-58-4
Pentaerythritol tetrakis (2-cyano-3,3-diphenylacrylate)
SML = 0.05 mg/kg

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

190
71720
000109-66-0
Pentane

191
72640
007664-38-2
Phosphoric acid

191A
73160

Phosphoric acid, mono- and di-n-alkyl (C16 and C18) esters
SML = 0.05 mg/kg

191B
73720
000115-96-8
Phosphoric acid, trichloroethyl 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

191C
74010
145650-60-8
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)

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

193
74480
000088-99-3
o-Phthalic acid

194
76320
000085-44-9
Phthalic anhydride

195A
76721

009016-00-6

063148-62-9

Polydimethylsiloxane (Mw > 6800)
In compliance with the specifications laid down in Schedule 4

195B
76730

Polydimethylsiloxane, gamma-hydroxypropylated
SML = 6 mg/kg

195D
76865
-

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

SML = 30 mg/kg

196
76960
025322-68-3
Polyethyleneglycol

197
77600
061788-85-0
Polyethyleneglycol ester of hydrogenated caster oil

198
77702
-
Polyethyleneglycol esters of aliphatic monocarboxylic acids (C6-C22), and their ammonium and sodium sulphates

198A
77895
068439-49-6
Polyethyleneglycol (EO = 2-6) monoalkyl (C16-C18) ether
SML = 0.05 mg/kg and in compliance with the specifications laid down in Schedule 4

199
79040
009005-64-5
Polyethyleneglycol sorbitan monolaurate

200
79120
009005-65-6
Polyethyleneglycol sorbitan monooleate

201
79200
009005-66-7
Polyethyleneglycol sorbitan monopalmitate

202
79280
009005-67-8
Polyethyleneglycol sorbitan monostearate

203
79360
009005-70-3
Polyethyleneglycol sorbitan trioleate

204
79440
009005-71-4
Polyethyleneglycol sorbitan tristearate

205
80240
029894-35-7
Polyglycerol ricinoleate

206
80640
-
Polyoxyalkyl (C2-C4) dimethylpolysiloxane

207
80720
008017-16-1
Polyphosphoric acids

208
80800
025322-69-4
Polypropyleneglycol

208A
81220
192268-64-7
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 = 5 mg/kg

208B
81515
087189-25-1
Poly(zinc glycerolate)

209
81520
007758-02-3
Potassium bromide

210
81660
001310-58-3
Potassium hydroxide

210A
81760
-
Powders, flakes and fibres of brass, bronze, copper, stainless steel, tin and alloys of copper, tin and iron
SML(T) = 30 mg/kg (7) (expressed as copper); the specific migration of this substance shall not exceed 48 mg/kg (expressed as iron)

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

212
81882
000067-63-0
2-Propanol

213
82000
000079-09-4
Propionic acid

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

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

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

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

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

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

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

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

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

223
83320
-
Propylhydroxyethylcellulose

224
83325
-
Propylhydroxymethylcellulose

225
83330
-
Propylhydroxypropylcellulose

226
83440
002466-09-3
Pyrophosphoric acid

227
83455
013445-56-2
Pyrophosphorous acid

228
83460
012269-78-2
Pyrophyllite

229
83470
014808-60-7
Quartz

229A
83599
068442-12-6
Reaction products of oleic acid, 2-mercaptoethyl ester, with dichlorodimethyltin, sodium sulphide and trichloromethyltin
SML(T) = 0.18 mg/kg (15) (expressed as tin)

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

231
83840
008050-09-6
Rosin

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

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

234
84210
065997-06-0
Rosin, hydrogenated

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

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

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

238
84560
009006-04-6
Rubber, natural

239
84640
000069-72-7
Salicylic acid

239A
85360
000109-43-3
Sebacic acid, dibutyl ester

240A
85610
-
Silicates, natural, silanated (with the exception of asbestos)

240ZA
85601
-
Silicates, natural, (with the exception of asbestos)

240B
85680
001343-98-2
Silicic acid

240C
85840
053320-86-8
Silicic acid, lithium magnesium sodium salt
SML(T) = 0.6 mg/kg (8) (expressed as lithium)

242
86000
-
Silicic acid, silylated

243
86160
000409-21-2
Silicon carbide

244
86240
007631-86-9
Silicon dioxide

244A
86285
-
Silicon dioxide, silanated

245
86560
007647-15-6
Sodium bromide

246
86720
001310-73-2
Sodium hydroxide

246A
87040
001330-43-4
Sodium tetraborate
SML(T) = 6 mg/kg (22) (expressed as boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption

247
87200
000110-44-1
Sorbic acid

248
87280
029116-98-1
Sorbitan dioleate

249
87520
062568-11-0
Sorbitan monobehenate

250
87600
001338-39-2
Sorbitan monolaurate

251
87680
001338-43-8
Sorbitan monooleate

252
87760
026266-57-9
Sorbitan monopalmitate

253
87840
001338-41-6
Sorbitan monostearate

254
87920
061752-68-9
Sorbitan tetrastearate

255
88080
026266-58-0
Sorbitan trioleate

256
88160
054140-20-4
Sorbitan tripalmitate

257
88240
026658-19-5
Sorbitan tristearate

258
88320
000050-70-4
Sorbitol

259
88600
026836-47-5
Sorbitol monostearate

259A
88640
008013-07-8
Soybean oil, epoxidized
In compliance with the specifications laid down in Schedule 4

260
88800
009005-25-8
Starch, edible

261
88880
068412-29-3
Starch, hydrolysed

262
88960
000124-26-5
Stearamide

263
89040
000057-11-4
Stearic acid

263A
89200
007617-31-4
Stearic acid, copper salt
SML(T) = 30 mg/kg (7) (expressed as copper)

263B
89440
-
Stearic acid, esters with ethyleneglycol
SML(T) = 30 mg/kg (3)

264
90720
058446-52-9
Stearoylbenzoylmethane

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

266
90960
000110-15-6
Succinic acid

267
91200
000126-13-6
Sucrose acetate isobutyrate

268
91360
000126-14-7
Sucrose octaacetate

269
91840
007704-34-9
Sulphur

270
91920
007664-93-9
Sulphuric acid

270A
92030
010124-44-4
Sulphuric acid, copper salt
SML(T) = 30 mg/kg (7) (expressed as copper)

271
92080
014807-96-6
Talc

271A
92150
001401-55-4
Tannic acids

According to the JECFA specifications

272
92160
000087-69-4
Tartaric acid

273
92195
-
Taurine, salts

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

275
92350
000112-60-7
Tetraethyleneglycol

276
92640
000102-60-3
N,N,N',N'- Tetrakis (2-hydroxypropyl) ethylenediamine

276A
92700
078301-43-6
2,2,4,4- Tetramethyl-20-(2,3- epoxypropyl)- 7-oxa-3,20-diazadispiro-[5.1.11.2]-heneicosan-21-one, polymer
The specific migration of this substance shall not exceed 5 mg/kg

276B
92930
120218-34-0
Thiodiethanolbis (5-methoxycarbonyl-2,6-dimethyl-1,4-dihydropridine-3-carboxylate)
The specific migration of this substance shall not exceed 6 mg/kg

277
93440
013463-67-7
Titanium dioxide

278
93520

000059-02-9

010191-41-0

alpha-Tocopherol

Ditto

279
93680
009000-65-1
Tragacanth gum

279A
93720
000108-78-1
2,4,6-Triamino-1,3,5-triazine
SML = 30 mg/kg

280
94320
000112-27-6
Triethyleneglycol

280A
94960
000077-99-6
1,1,1-Trimethylolpropane
The specific migration of this substance shall not exceed 6 mg/kg

280B
95000
028931-67-1
Trimethylolpropane trimethacrylatemethyl methacrylate copolymer

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

281A
95270
161717-32-4
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)

281B
95725
110638-71-6
Vermiculite, reaction product with citric acid, lithium salt
SML(T) = 0.6 mg/kg (8) (expressed as lithium)

281C
95855
007732-18-5
Water
In compliance with Directive 98/83/EC

281D
95859
-
Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks
In compliance with the specifications laid down in Schedule 4

281E
95883
-
White mineral oils, paraffinic, derived from petroleum based hydrocarbon feedstocks
In compliance with the specifications laid down in Schedule 4

282
95905
013983-17-0
Wollastonite

283
95920
-
Wood flour and fibres, untreated

284
95935
011138-66-2
Xanthan gum

285
91690
020427-58-1
Zinc hydroxide

286
96240
001314-13-2
Zinc oxide

287
96320
001314-98-3
Zinc sulphide

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)

Item

1

PM/REFNo.

2

CAS No

3

Name

4

Restrictions and specifications

1
30180
002180-18-9
Acetic acid, manganese salt
SML(T) = 0.6 mg/kg (9) (expressed as manganese)

2
31520
061167-58-6
Acrylic acid, 2-tert-butyl- 6-(3-tert- butyl- 2-hydroxy-5-methylbenzyl)-4-methylphenyl ester
SML = 6 mg/kg

3
31920
000103-23-1
Adipic acid, bis (2-ethylhexyl) ester
SML = 18 mg/kg (1)

4
34230

Alkyl (C8-C22) sulphonic acids
SML = 6 mg/kg

4A
34650
151841-65-5
Aluminium hydroxybis [2,2'-methylenebis (4,6-di-tert-butylphenyl)] phospate
SML = 5 mg/kg

5
35760
001309-64-4
Antimony trioxide
SML = 0.02 mg/kg (expressed as anti-monium and analytical tolerance included)

6
36720
017194-00-2
Barium hydroxide
SML(T) = 1 mg/kg (11) (expressed as barium)

7
36800
010022-31-8
Barium nitrate
SML(T) = 1 mg/kg (11) (expressed as barium)

7A
38000
000553-54-8
Benzoic acid, lithium salt
SML(T) = 0.6 mg/kg (8) (expressed as lithium)

8
38240
000119-61-9
Benzophenone
SML = 0.6 mg/kg

9
38560
007128-64-5
2,5-Bis (5-tert-butyl-2-benzoxazolyl) thiophene
SML = 0.6 mg/kg

10
38700
063397-60-4
Bis (2-carbobutoxyethyl) tin- bis (isooctyl mercaptoacetate)
SML = 18 mg/kg

11
38800
032687-78-8
N,N'-Bis (3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionyl) hydrazide
SML = 15 mg/kg

12
38820
026741-53-7
Bis (2,4-di-tert-butylphenyl) pentaery-thritol diphosphite
SML = 0.6 mg/kg

13
39060
035958-30-6
1,1-Bis (2-hydroxy-3, 5-di-tert-butylphenyl) ethane
SML = 5 mg/kg

14
39090

N,N-bis (2-hydroxyethyl) alkyl (C8-C18) amine
SML(T) = 1.2 mg/kg (12)

15
39120

N,N-bis (2-hydroxyethyl)-alkyl (C8-C18) amine hydrochlorides
SML(T) = 1.2 mg/kg (12) expressed as tertiary amine (expressed excluding HCI)

16
40000
000991-84-4
2,4-Bis (octylmercapto) – 6- (4-hydroxy- 3,5,di-tert-butylanilino) - 1,3,5-triazine
SML = 30 mg/kg

17
40020
110553-27-0
2,4-Bis (octylthiomethyl) – 6- methylphenol
SML = 6 mg/kg

18
40160
061269-61-2
N,N'-bis (2,2,6,6-tetramethyl-4- piperidyl) hexamethy-lenediamine- 1,2- dibromoethane, copolymer
SML = 2.4 mg/kg

18A
40720
025013-16-5
Tert-butyl- 4-hydroxyanisole (= BHA)
SML = 30 mg/kg

19
40800
013003-12-8
4,4' – butylidene-bis (6-tert-butyl-3-methylphenyl-ditridecyl phosphite)
SML = 6 mg/kg

20
409080
019664-95-0
Butyric acid, manganese salt
SML(T) = 0.6 mg/kg (9) (expressed as manganese)

21
42000
063438-80-2
(2-carbobutoxyethyl) tin-tris (isooctyl mercaptoacetate)
SML = 30 mg/kg

22
42400
010377-37-4
Carbonic acid, lithium salt
SML(T) = 0.6 mg/kg (8) (expressed as lithium)

23
42480
000584-09-8
Carbonic acid, rubidium salt
SML = 12 mg/kg

24
43600
004080-31-3
1- (3- Chloroallyl) – 3,5,7 – triaza-1-azoniaadamantane chloride
SML = 0.3 mg/kg

25
43680
000075-45-6
Chlorodifluoromethane
SML = 6 mg/kg and in compliance with the specifications laid down in Schedule 4

26
44960
011104-61-3
Cobalt oxide
SML(T) = 0.05 mg/kg (13) (expressed as cobalt)

27
45440
-
Cresols, butylated, styrenated
SML = 12 mg/kg

27A
45650
006197-30-4
2-Cyano-3,3-diphenylacrylic acid, 2-ethylhexyl ester
SML = 0.05 mg/kg

27B
46640
000128-37-0
2,6-di-tert-butyl-p-cresol (= BHT)
SML = 3.0 mg/kg

29
47600
084030-61-5
Di-n-dodecyltin bis (isooctyl mercaptoacetate)
SML = 12 mg/kg

30
48640
000131-56-6
2,4-Dihydroxybenzophenone
SML(T) = 6 mg/kg (14)

31
48800
000097-23-4
2,2'-Dihydroxy-5,5'-dichlorodiphenylmethane
SML = 12 mg/kg

32
48880
000131-53-3
2,2'Dihydroxy-4-methoxybenzophenone
SML(T) = 6 mg/kg (14)

33
49600
026636-01-1
Dimethyltin bis (isooctyl mercaptoaecetate)
SMT(T) 0.18 mg/kg (15) (expressed as tin)

34
49840
002500-88-1
Dioctadecyl disulphide
SMT = 3 mg/kg

35
50160

Di-n-octyltin bis(n-alkyl (C10-C16) mercaptoacetate)
SML(T) = 0.04 mg/kg (16) (expressed as tin)

36
50240
010039-33-5
Di-n-octyltin bis (2-ethylhexyl maleate)
SML(T) = 0.04 mg/kg (16) (expressed as tin)

37
50320
015571-58-1
Di-n-octyltin bis (2-ethylhexyl mercaptoaectate)
SML(T) = 0.04 mg/kg (16) (expressed as tin)

38
50360

Di-n-octyltin bis (ethyl maleate)
SML(T) = 0.04 mg/kg (16) (expressed as tin)

39
50400
033568-99-9
Di-n-octyltin bis (isooctyl maleate)
SML(T) = 0.04 mg/kg (16) (expressed as tin)

40
50480
026401-97-8
Di-n-octyltin bis (isooctyl mercaptoacetate)
SML(T) = 0.04 mg/kg (16) (expressed as tin)

41
50560

Di-n-octyltin 1,4-butanediol bis (mercaptoacetate)
SML(T) = 0.04 mg/kg (16) (expressed as tin)

42
50640
003648-18-8
Di-n-octyltin dilaurate
SML(T) = 0.04 mg/kg (16) (expressed as tin)

43
50720
015571-60-5
Di-n-octyltin dimaleate
SML(T) = 0.04 mg/kg (16) (expressed as tin)

44
50800
-
Di-n-octyltin dimaleate, esterified
SML(T) = 0.04 mg/kg (16) (expressed as tin)

45
50880
-
Di-n-octyltin dimaleate, polymers (n = 2-4)
SML(T) = 0.04 mg/kg (16) (expressed as tin)

46
50960
069226-44-4
Di-n-octyltin ethyleneglycol bis (mercaptoacetate)
SML(T) = 0.04 mg/kg (16) (expressed as tin)

47
51040
015535-79-2
Di-n-octyltin mercaptoacetate
SML(T) = 0.04 mg/kg (16) (expressed as tin)

48
51120

Di-n-octyltin thiobenzoate 2-ethyl-hexyl mercaptoacetate
SML(T) = 0.04 mg/kg (16) (expressed as tin)

49
51570
000127-63-9
Diphenyl sulphone
SML(T) = 3 mg/kg (24)

50
51680
000102-08-9
N,N'-diphenylthiourea
SML = 3 mg/kg

51
52000
027176-87-0
Dodecylbenzenesulphonic acid
SML = 30 mg/kg

52
52320
052047-59-3
2-(4-Dodecylphenyl) indole
SML = 0.06 mg/kg

53
52880
023676-09-7
4-Ethoxybenzoic acid, ethyl ester
SML = 3.6 mg/kg

54
53200
023949-66-8
2-Ethoxy-2'-ethyloxanilide
SML = 30 mg/kg

54A
54880
000050-00-0
Formaldehyde
SML(T) = 15 mg/kg (21)

54B
55200
001166-52-5
Gallic acid, dodecyl ester
SML(T) = 30 mg/kg (34)

54C
55280
001034-01-1
Gallic acid, octyl ester
SML(T) = 30 mg/kg (34)

54D
55360
000121-79-9
Gallic acid, propyl ester
SML(T) = 30 mg/kg (34)

55
58960
000057-09-0
Hexadecyltrimethylammonium bromide
SML = 6 mg/kg

56
59120
023128-74-7
1,6-Hexamethylene-bis (3- (3,5-di-tert-butyl-4-hydroxyphenyl) propionamide)
SML = 45 mg/kg

57
59200
035074-77-2
1,6- Hexamethylene-bis (3- (3,5-di-tert-butyl-4-hydroxyphenyl) propionate
SML = 6 mg/kg

58
60320
070321-86-7
2- (2-Hydroxy-3,5-bis (1,1-dimethylbenzyl) phenyl) benzotriazole
SML = 1.5 mg/kg

59
60400
003896-11-5
2- (2'-Hydroxy-3'-tert-butyl- 5'-methylphenyl) –5-chlorobenzotriazole
SML(T) = 30 mg./kg (18)

60
60800
065447-77-0
1-(2- Hydroxyethyl) –4-hydroxy- 2,2, 6,6-tetramethyl, piperidine-succinic acid, dimethyl ester, copolymer
SML = 30 mg/kg

61
61280
003293-97-8
2-Hydroxy-4-n-hexyloxybenzophenone
SML(T) = 6 mg/kg (14)

62
61360
000131-57-7
2-Hydroxy-4-methoxybenzophenone
SML(T) = 6 mg/kg (14)

63
61440
002440-22-4
2-(2-Hydroxy-5-methylphenyl) benzotriazole
SML(T) = 30 mg/kg (18)

64
61600
001843-05-6
2-Hydroxy-4-n-octyloxybenzophenone
SML(T) = 6 mg/kg (14)

65
63200
051877-53-3
Lactic acid, manganese salt
SML(T) = 0.6 mg/kg (9) (expressed as manganese)

66
64320
010377-51-2
Lithium iodide
SML(T) = 1 mg/kg (10) (expressed as iodium) and SML(T) = 0.6 mg/kg (8) (expressed as lithium)

67
65120
007773-01-5
Manganese chloride
SML(T) = 0.6 mg/kg (9) (expressed as manganese)

68
65200
012626-88-9
Manganese hydroxide
SML(T) = 0.6 mg/kg (9) (expressed as manganese

69
65280
010043-84-2
Manganese hypophosphite
SML(T) = 0.6 mg/kg (9) (expressed as manganese

70
65360
011129-60-5
Manganese oxide
SML(T) = 0.6 mg/kg (9) (expressed as manganese

71
65440

Manganese pyrophosphite
SML(T) = 0.6 mg/kg (9) (expressed as manganese

72
66360
085209-91-2
2-2'-Methylene bis (4,6-di-tert-butylphenyl) sodium phosphate
SML = 5 mg/kg

73
66400
000088-24-4
2-2'-Methylene bis (4-ethyl-6-tert-butylphenol)
SML(T) = 1.5 mg/kg (19)

74
66480
000119-47-1
2-2'-Methylene bis (4-methyl-6-tert-butylphenol)
SML(T) = 1.5 mg/kg (19)

75
67360
067649-65-4
Mono-n-dodecyltin tris (isooctyl mercaptoacetate)
SML = 24 mg/kg

76
67520
054849-38-6
Monomethyltin tris (isooctyl mercaptoacetate)
SML(T) = 0.18 mg/kg (15) (expressed as tin)

77
67600

Mono-n-octyltin tris (alkyl (C10-C16) - mercaptoacetate
SML(T) = 1.2 mg/kg (17) (expressed as tin)

78
67680
027107-89-7
Mono-n-octyltin tris (2-ethylhexyl mercaptoacetate
SML(T) = 1.2 mg/kg (17) (expressed as tin)

79
67760
026401-86-5
Mono-n-octyltin tris (isooctyl mercaptoacetate)
SML(T) = 1.2 mg/kg (17) (expressed as tin)

79A
67896
020336-96-3
Myristic acid, lithium salt
SML(T) = 0.6 mg/kg (8) (expressed as lithium)

81
68320
002082-79-3
Octadecyl 3- (3,5-di-tert-butyl-4- hydroxylphenyl) propionate
SML = 6 mg/kg

82
68400
010094-45-8
Octadecylerucamide
SML = 5 mg/kg

82A
68860
004724-48-5
n-Octylphosphonic acid
SML = 0.05 mg/kg

83
69840
016260-09-6
Oleylpalmitamide
SML = 5 mg/kg

83A
71935
007601-89-0
Perchloric acid, sodium salt monohydrate
SML = 0.05 mg/kg (31)

84
72160
000948-65-2
2-Phenylindole
SML = 15 mg/kg

85
72800
001241-94-7
Phosphoric acid, diphenyl 2-ethylhexyl ester
SML = 2.4 mg/kg

86
73040
013763-32-1
Phosphoric acid, lithium salts
SML(T) = 0.6 mg/kg (8) (expressed as lithium)

87
73120
010124-54-6
Phosphoric acid, manganese salt
SML(T) = 0.6 mg/kg (9) (expressed as manganese)

88
74400

Phosphorous acid, tris (nonyl- and/or dinonylphenyl) ester
SML = 30 mg/kg

88A
76680
068132-00-3
Polycyclopentadiene, hydrogenated
SML = 5 mg/kg (1)

89
77440

Polyethyleneglycol diricinoleate
SML = 42 mg/kg

90
77520
061791-12-6
Polyethyleneglycol ester of caster oil
SML = 42 mg/kg

91
78320
009004-97-1
Polyethyleneglycol monoricinoleate
SML – 42 mg/kg

92
81200
071878-19-8
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 = 3 mg/kg

93
81680
007681-11-0
Potassium iodide
SML(T) = 1 mg/kg (10) (expressed as iodium)

94
82020
019019-51-3
Propionic acid, cobalt salt
SML(T) = 0.05 mg/kg (13) (expressed as cobalt)

95
83595
119345-01-6
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 biphenyl
SML = 18 mg/kg and in compliance with the specifications in Schedule 4

96
83700
000141-22-0
Ricinoleic acid
SML = 42 mg/kg

97
84800
000087-18-3
Salicylic acid, 4-tert-butylphenyl ester
SML = 12 mg/kg

98
84880
000119-36-8
Salicylic acid, methyl ester
SML = 30 mg/kg

99
85760
012068-40-5
Silicic acid, lithium aluminium salt (2:1:1)
SML(T) = 0.6 mg/kg (8) (expressed as lithium)

100
85920
012627-14-4
Silicic acid, lithium salt
SML(T) = 0.6 mg/kg (8) (expressed as lithium)

100A
86480
007631-90-5
Sodium bisulphite
SML(T) = 10 mg/kg (30) (expressed as SO2)

101
86800
007681-82-5
Sodium iodide
SML(T) = 1 mg/kg (10) (expressed as iodium)

102
86880

Sodium monoalkyl dialkylphenoxybenzenedi-sulphonate
SML = 9 mg/kg

102A
86920
007632-00-0
Sodium nitrite
SML = 0.6 mg/kg

102B
86960
007757-83-7
Sodium sulphite
SML(T) = 10 mg/kg (30) (expressed as SO2)

102C
87120
007772-98-7
Sodium thiosulphate
SML(T) = 10 mg/kg (30) (expressed as SO2)

103
89170
013586-84-0
Stearic acid, cobalt salt
SML(T) = 0.05 mg/kg (13) (expressed as cobalt)

104
92000
007727-43-7
Sulphuric acid, barium salt
SML(T) = 1 mg/kg (11) (expressed as barium)

105
92320

Tetradecyl-polyethyleneglycol (EO = 3-8) ether of glycolic acid
SML = 15 mg/kg

106
92560
038613-77-3
Tetrakis (2,4- di-tert-butyl-phenyl) – 4-4' –biphenylylene diphosphonite
SML = 18 mg/kg

107
92800
000096-69-5
4,4'-Thiobis (6-tert-butyl- 3-methylphenol)
SML = 0.48 mg/kg

108
92880
041484-35-9
Thiodiethanol bis (3-(3-5-di-tert- butyl-4-hydroxyphenyl) propionate)
SML = 2.4 mg/kg

109
93120
000123-28-4
Thiodipropionic acid, didodecyl ester
SML(T) = 5 mg/kg (20)

110
93280
000693-36-7
Thiodipropionic acid, dioctadecyl ester
SML(T) = 5 mg/kg (20)

110A
94400
036443-68-2
Triethyleneglycol bis[ 3-(3-tert-butyl- 4-hydroxy- 5-methylphenyl) propionate]
SML = 9 mg/kg

111
94560
000122-20-3
Triisopropanolamine
SML = 5 mg/kg

112
95280
040601-76-1
1,3,5- Tris (4-tert-butyl-3-hydroxy –2,6- dimethylbenzyl)- 1,3,5-triazine-2,4,6 (1H, 3H,5H)- trione
SML = 6 mg/kg

113
95360
027676-62-6
1,3,5 – Tris (3,5-di-tert-butyl-4 hydroxybenzyl)- 1,3,5-triazine –2,4,6 (1H, 3H, 5H) - trione
SML = 5 mg/kg

114
95600
001843-03-4
1,1,3- Tris (2-methyl-4-hydroxy-5-tert-butylphenyl) butane
SML = 5 mg/kg

PART 3Supplementary

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

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

2.  If a substance identified in 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.

(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.

(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.

(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.

(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.

(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.

(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.

(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.

(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.

Regulation 8

SCHEDULE 3Products Obtained by Bacterial Fermentation

Item

1

PM/REF No

2

CAS No

3

Name

4

Restrictions and specifications

1
18888
080181-31-3

3-hydroxybutanoic acid-

3-hydroxypentanoic acid, copolymer

In compliance with specifications included in Schedule 4

Schedules 1,2 & 3

SCHEDULE 4Specifications

Item

1

PM/REF No

2

Specifications

(1)
Quantity of substance used/quantity of formulation

1
11530
Acrylic acid, 2-hydroxypropyl ester

It may contain up to 25% (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No. 002918-23-2)

2
16690
Divinylbenzene

It may contain up to 45% (m/m) of Ethylvinylbenzene

3
18888
3-Hydroxybutanoic acid – 3-hydroxypentanoic acid, copolymer

Definition

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.

Chemical name
Poly(3-D-hydroxybutanoate-co-3-D-hydroxypentanoate)

CAS number
080181-31-3

Structural formula
As set out in Part B of Annex V to the Directive

Average molecular weight
Not less than 150 000 Daltons (measured by gel permeation chromatography)

Assay

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

Description
White to off-white powder after isolation

Solubility
Soluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically insoluable in ethanol, aliphatic alkanes and water

Restriction
QMA for crotonic acid is 0.05 mg/6 dm2

Purity
Prior to granulation of the raw material copolymer powder must contain:

- nitrogen
Not more than 2,500 mg/g of plastic

- zinc
Not more than 100 mg/kg of plastic

- copper
Not more than 5 mg/kg of plastic

- lead
Not more than 2 mg/kg of plastic

- arsenic
Not more than 1 mg/kg of plastic

- chromium
Not more than 1 mg/kg of plastic

4
23547
Polydimethylsiloxane (Mw > 6800)

Minimum viscosity 100 x 10 -m2/s (= 100 centistokes) at 25° C

5
25385
Triallylamine

40 mg/kg hydrogel at a ratio of 1 kg food to a maximum of 1.5 grams of hydrogel. For use only in hydrogels intended for non-direct food contact use.

6
38320
4-(2-Benzoxazolyl)-4'- (5-methyl-2-benzoxazolyl) stilbene

Not more than 0.05% w/w (quantity of substance used / quantity of the formulation)

7
43680
Chlorodifluoromethane

Content of chlorofluoromethane less than 1 mg/kg of the substance

8
47210
Dibutylthiostannoic acid polymer

Molecular unit = (C8H18S3Sn2) n (n = 1.5-2)

9
76721
Polydimethylsiloxane (Mw > 6800)

Minimum viscosity 100 x 10 -;m2/s (= 100 centistokes) at 25° C

10
77895
Polyethyleneglycol (EO = 2-6) monoalkyl (C16-C18) ether

The composition of this mixture is as follows:

-polyethyleneglycol (EO = 2-6) monoalkyl (C16-C18) ether approximately 28%)

-fatty alcohols (C16-C18) (approximately 48%)

-ethyleneglycol monoalkyl (C16-C18) ether (approximately 24%)

11
83595
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)

Composition

-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)

Other specifications

-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

12
88640
Soybean oil, epoxidized

Oxirane less than 8%, iodine number < 6

13
95859
Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks. The product should have the following specifications:

-Phosphor content of minimum 5.4% to maximum 5.9%

-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

14
95883
White mineral oils, paraffinic, derived from petroleum based hydrocarbon feedstocks

The product shall have the following specifications:

-Content of mineral hydrocarbons with carbon number less than 25: not more than 5% (w/w)

-Viscosity not less than 8.5 x 10-m2/s (= 8.5 centistokes) at 100°C

-Average molecular weight not less than 480

Regulations 9 and 11

SCHEDULE 5Applicable Provisions when Testing Compliance with the Migration Limits

General Provisions

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 —

(a)M is the migration in mg/kg:

(b)m is the mass in the mg of substance released by the sample as determined by the migration test;

(c)a1 is the surface area in square decimetres of the sample in contact with the food or simulant during the migration test;

(d)a2 is the surface area in square decimetres of the plastic material or article in actual conditions of use; and

(e)q is the quantity in grams of food in contact with the plastic material or article in actual conditions of use.

3.—(1) Subject to sub-paragraph (2), any testing of migration from any plastic material or article shall be carried out on that plastic material or article.

(2) In any case where determination in accordance with sub-paragraph (1) above is impracticable, such testing shall be carried out, using either specimens taken from that plastic material or article, or where appropriate, specimens representative of that plastic material or article.

(3) Any sample used for such testing shall be placed in contact with the simulant or food, as the case may be, in a manner representing the contact conditions in actual use, and for this purpose the testing shall be carried out in such a way that only those parts of the sample intended to come into contact with food in actual use will be in contact with the simulant or food.

(4) Any migration testing of caps, gaskets, stoppers or similar devices for sealing shall be carried out on these articles by applying them to the containers for which they are intended in a manner which corresponds to the conditions of closing in normal or foreseeable use.

4.—(1) Any sample of 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.

(2) At the end of the period referred to in sub-paragraph (1), analytical determination of the total quantity of substances (overall migration), each specific quantity of a substance (specific migration) or, as the case may be, both that total and that specific quantity released by the sample shall be carried out on the simulant or food, as the case may be.

(3) Verification that migration into food complies with a migration limit specified in regulation 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.

Special provisions relating to overall migration

6.—(1) Subject to sub-paragraph (2), any method of analytical determination may be used to prove excess of an overall migration limit in relation to a plastic material or article.

(2) In any proceedings for an offence under these Regulations where it is alleged that a plastic material or article does not comply with regulation 9 it shall be a defence for the person charged to prove that—

(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

(b)if rectified olive oil or any of its substitutes had been used as a simulant and—

(i)a sample of the plastic material or article had been weighed before and after contact with the simulant;

(ii)the simulant absorbed by the sample had been extracted and determined quantitatively;

(iii)the quantity of simulant so found had been subtracted from the weight of the sample measured after contact with the simulant; and

(iv)the difference between the initial and corrected final weights had been determined to represent the overall migration of the sample examined,

there would have been no such excess so determined.

7.—(1) Where a plastic material or article is intended to come into repeated contact with food and it is technically impossible to carry out the test described in paragraph 5, the test shall be so modified as to enable the level of migration occurring during the third such test to be determined and, subject to sub-paragraph (2), such a determination may be used to prove excess of an overall migration limit in relation to a plastic material or article.

(2) In any proceedings for an offence under these Regulations where it is alleged, following determination under sub-paragraph (1) above, that a plastic material or article does not comply with regulation 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,

the plastic material or article would not have been deemed to exceed that limit.

8.—(1) Any plastic material or article which exceeds its overall migration limit by an amount not exceeding the analytical tolerance specified in sub-paragraph (2) shall be deemed for the purposes of these Regulations not to exceed its overall migration limit.

(2) The following analytical tolerances shall be applied for limits of overall migration—

(a)20 mg/kg or, as the case may be, 3 milligrams per square decimetre in migration tests using as a simulant rectified olive oil or substitutes;

(b)12mg/kg or, as the case may be, 2 milligrams per square decimetre in migration tests using other simulants referred to in Schedule 6.

Regulations 9 and 11

SCHEDULE 6Overall and Specific Migration Testing Using Food Simulants

PART 1Basic Rules

1.  Subject to paragraphs 2, 3 and 4 of this Part, migration tests for the determination of specific and overall migration shall be carried out using the food simulants specified in Parts 2, 3 and, where appropriate 4, and under conventional migration test conditions as specified in Part 5.

2.  Subject to paragraphs 3 and 4 of this Part, substitute tests which use test media under the conventional substitute test conditions as specified in Part 6 shall be carried out if the migration test using the fatty food simulants specified in Part 3 is not feasible for technical reasons connected with the method of analysis.

3.  Subject to paragraph 4 of this Part, alternative tests as specified in Part 7 may be used instead of the migration test with fatty food simulants specified in Part 3 but the results of such alternative tests may not be used to determine compliance with a migration limit unless the conditions specified in Part 7 are fulfilled.

4.  In migration testing it is permissible to—

(a)reduce the number of tests to be carried out to that or those which, in the specific ase under examination, is or are generally recognised to be the most severe on the basis of scientific evidence;

(b)omit the migration, the substitute or the alternative tests where —

(i)there is conclusive proof that the migration limits cannot be exceeded in any foreseeable conditions of use of the material or article, or

(ii)the conditions for non-compulsory testing set out in Article 8.2 or 8.3 of the Directive are met.

PART 2Food Simulants to be used in Migration Testing

1.  Subject to Parts 3, 4, 5 and 7, the simulants to be used in migration testing are specified in the Table to this paragraph (referred to in this Part as “the Table”).

1

Abbreviation

2

Food Simulant

Simulant A:
Distilled water or water of equivalent quality

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

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

Simulant D:
Rectified olive oil having the characteristics specified in paragraph 3 of this Part of this Schedule or, subject to paragraph 5 of this Part of this Schedule, any of the fatty food simulants specified in paragraph 4 of this Part of this Schedule

2.  For the purposes of this Schedule a reference to an abbreviation in column 1 of the Table shall mean a reference to the simulant in column 1 of that Table opposite that abbreviation.

3.  The characteristics of rectified olive oil referred to in the Table are —

(a)Iodine value (Wijs) = 80 to 88

(b)Refractive index at 25°C = 1.4665 to 1.4679

(c)Acidity (expressed as % of oleic acid) = 0.5% maximum

(d)Peroxide number (expressed as oxygen milli-equivalents per kg of oil) = 10 maximum

4.  The fatty food simulants referred to in the Table are —

(a)corn oil with standardised specifications;

(b)sunflower oil, the characteristics of which are —

(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%.

(c)a synthetic mixture of triglycerides the composition of which is as set out in the following tables:

Fatty acid distribution

No of C-atoms in fatty acid residue
6
8
10
12
14
16
18
Others

GLC area (%)

~1
6-9
8-11
45-52
12-15
8-10
8-12
1

Purity

Content of monoglycerides (enzymatically)
≤0.2%

Content of diglycerides (enzymatically)
≤2.0%

Unsaponifiable matter
≤0.2%

Iodine value

(Wijs)

≤0.1%

Acid value
4.5
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

Alcoholic foods
Foods in relation to which simulant C only is specified in the Table to Part 4

Fatty foods
Foods in relation to which simulant D only is specified in the Table to Part 4

Dry Foods
Foods in relation to which no simulant is specified in the Table to Part 4

Selection of simulants for testing materials and articles intended for contact with all food types

4.  The simulants to be used in testing a plastic material or article which is intended for contact with all food types are simulant B, simulant C and simulant D which, at the test conditions specified in Part 5, are considered to be more severe.

Selection of simulants for testing materials and articles which are already in contact with a known food

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 —

(a)where —

(i)the known food is a specific food or is within a specific group of foods described in column 2 of the Table to Part 4 and,

(ii)for the purposes of that Part, a simulant is, or simulants are, specified in relation to that specific food or specific group of foods,

the simulant or simulants so specified;

(b)where —

(i)the known food is neither a specific food, nor

(ii)within a specific group of foods described in the Table to Part 4 of this Schedule,

the simulant or simulants in column 2 of Table 2 opposite the description of food in column 1 of that Table which corresponds most closely to the known food.

Selection of simulants for testing materials and articles which are accompanied by a specific indication

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—

(a)where the indication states that the plastic material or article may be used with a food or group of foods described in column 2 of the Table to Part 4, the food simulant or food simulants which, for the purposes of Part 4, is or are specified in relation to that food or group of foods;

(b)where the indication states that the plastic material or article should not be used with any food or group of foods described in column 2 of Table to Part 4, a simulant other than the simulant or simulants which, for the purposes of Part 4, is or are specified in relation to that food or group of foods.

8.  A specific indication referred to in paragraph 7 is expressed in accordance with this paragraph if it is expressed—

(a)at a marketing stage other than retail, by using the reference number in column 1 of the Table to Part 4 of these Regulations or the description of food in column 2 of that Table which, in either case, corresponds to the food;

(b)at the retail stage, by using an indication which refers to only a few foods or groups of foods described in the Table to Part 4.

Table 2: Simulants to be selected for testing food contact materials in special cases

Contact foods
Simulant

Only aqueous foods
Simulant A

Only acidic foods
Simulant B

Only alcoholic foods
Simulant C

Only fatty foods
Simulant D

All aqueous and acidic foods
Simulant B

All alcoholic and aqueous foods
Simulant C

All alcoholic and acidic foods
Simulant C and B

All fatty and aqueous foods
Simulants D and A

All fatty and acidic foods
Simulants D and B

All fatty, alcoholic and aqueous foods
Simulants D and C

All fatty, alcoholic and acidic foods
Simulants D, C and B

PART 4Simulants to be used in relation to a Specific Food or Group of Foods

1.  For the purposes of this Schedule a simulant is specified in relation to a specific food or a specific group of foods where “X” is placed in the column headed by that simulant opposite that specific food or specific group of foods in the Table to this Part, and the Table shall be read in conjunction with the notes to it and with paragraphs 2 to 5.

2.  For the purposes of this Part —

(a)a reduction factor is the figure which follows an “X” and oblique stroke in the group of columns headed “Simulants to be used” in the Table to this Part;

(b)a reduction factor is specified in relation to a specific food or group of foods where, in the Table —

(i)the food or group of foods is described in the column headed “Description of food”; and

(ii)“X” is placed in a column headed by a specified simulant opposite that food or group of foods allowed by an oblique stroke and a reduction factor.

3.  Where a reduction factor is specified in the Table in relation to a specific food or a specific group of foods, that reduction factor shall be applied to the result of any migration test using the simulant specified in relation to that food or group of foods by dividing the result of the test by the reduction factor.

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 —

(a)if the pH value of the food is higher than 4.5, simulant A shall be used;

(b)if the pH value of the foodstuff is 4.5 or less, simulant B shall be used.

5.  Where a food is listed in the Table under both a specific and a general heading, the simulant relating to the specific heading is the simulant which falls to be used for the migration test.

Reference Number
Description of food
Simulants to be used

A
B
C
D

(1)
Simulant B shall not be used where the pH is more than 4.5.

(2)
This test shall be carried out in the case of liquids or beverages of an alcoholic strength exceeding 10% vol with aqueous solutions of ethanol of a similar strength.

(3)
If it can be demonstrated under regulation 12(2) or proved by means of an appropriate test that there is to be no fatty contact with the plastic material or article, simulant D shall not be used.

01
Beverages

01.01

Non-alcoholic beverages or alcoholic beverages of an alcoholic strength lower than 5% vol:

Waters, ciders, fruit or vegetable juices of normal strength or concentrated, musts, fruit nectars, lemonades and mineral waters, syrups, bitters, infusions, coffee, tea, liquid chocolate, beers and other

X(a)
X(a)

01.02

Alcoholic beverages of an alcoholic strength equal to or exceeding 5% vol.

Beverages shown under heading 01.01 but with an alcoholic strength equal to or exceeding 5% vol.

Wines, spirits and liqueurs

X(1)

X(2)

01.03
Miscellaneous: undenatured ethyl alcohol

X(1)

X(1)

02
Cereals, cereal products, pastry, biscuits, cakes and other bakers' wares

02.01
Starches

02.02
Cereals, unprocessed, puffed, in flakes (including popcorn, cornflakes and the like)

02.03
Cereal flour and meal

02.04
Macaroni, spaghetti and similar products

02.05
Pastry, biscuits, cakes and other bakers' wares, dry:

A With fatty substances on the surface

X/5

B Other

02.06
Pastry, biscuits, cakes and other bakers' wares, fresh

A With fatty substances on the surface

X/5

B Other
X

03
Chocolate, sugar and products thereof Confectionery products

03.01
Chocolate, chocolate-coated products, substitutes and products coated with substitutes

X/5

03.02
Confectionery products:

A in solid form

— with fatty substances on the surface

X/5

— Other

B in paste form:

— with fatty substances on the surface

X/3

— moist
X

03.03
Sugar and sugar products

A In solid form

B Honey and the like
X

C Molasses and sugar syrups
X

04
Fruit, vegetable and products thereof

04.01
Whole fruit, fresh or chilled

04.02
Processed fruit:

A Dried or dehydrated fruit, whole or in the form of flour or powder

B Fruit in the form of chunks, puree or paste
X(a)
X(a)

C Fruit preserves (jams and similar products

– whole fruit or chunks or in the form of flour or powder, preserved in a liquid medium):

— i) In an aqueous medium
X(a)
X(a)

— ii) In an oily medium
X(a)
X(a)

X

— iii) In an alcoholic medium > 5% vol

X(1)

X

04.03
Nuts (peanuts, chestnuts, almonds, hazelnuts, walnuts, pine kernels and others)

A Shelled, dried

B Shelled and roasted

X/5(3)

C In paste or cream form
X

X/3(3)

04.04
Whole vegetables, fresh or chilled

04.05
Processed vegetables:

A Dried or dehydrated vegetables whole or in the form of flour or powder

B Vegetables, cut, in the form of purees
X(a)
X(a)

C Preserved vegetables:

— i) In an aqueous medium
X(a)
X(a)

— ii) In an oily medium
X(a)
X(a)

X

— iii) In an alcoholic medium (> 5% vol)

X(1)

X

05
Fats and oils

05.01
Animal and vegetable fats and oils, whether natural or treated (including cocoa butter, lard, re-solidified butter)

X

05.02
Margarine, butter and other fats and oils made from water emulsions in oil

X/2

06
Animal products and eggs

06.01
Fish:

A Fresh, chilled, salted, smoked
X

X/3(3)

B In the form of paste
X

X/3(3)

06.02
Crustaceans and molluscs (including oysters, mussels, snails) not naturally protected by their shells
X

06.03
Meat of all zoological species (including poultry and game):

A Fresh, chilled, salted, smoked
X

X/4

B In the form of paste, creams
X

X/4

06.04
Processed meat products (ham, salami, bacon and other)
X

X/4

06.05
Preserved and part-preserved meat and fish:

A In an aqueous medium
X(a)
X(a)

B In an oily medium
X(a)
X(a)

X

06.06
Eggs not in shell:

A Powdered or dried

B Other
X

06.07
Egg yolks:

A Liquid
X

B Powdered or frozen

06.08
Dried white of egg

07
Milk products

07.01
Milk:

A Whole
X

B Partly dried
X

C Skimmed or partly skimmed
X

D Dried

Fermented milk such as yoghurt, buttermilk and such products in association with fruit and fruit products

X

07.03
Cream and sour cream
X(a)
X(a)

07:04
Cheeses:

A Whole, with rind

B Processed cheeses
X(a)
X(a)

C All others
X(a)
X(a)

X/3(3)

07:05
Rennet:

A In liquid or viscous form
X(a)
X(a)

B Powdered or dried

08
Miscellaneous products

08.01
Vinegar

X

08.02
Fried or roasted foods:

A Fried potatoes, fritters and the like

X/5

B Of animal origin

X/4

08.03
Preparations for soups, broths in liquid, solid or powder form (extracts, concentrates); homogenized composite food preparations, prepared dishes:

A Powdered or dried

— i) With fatty substances on the surface

X/5

— ii) Other

B Liquid or paste:

— i) With fatty substances on the surface
X(a)
X(a)

X/3

— ii) Other
X(a)
X(a)

08.04
Yeasts and raising agents:

A In paste form
X(a)
X(a)

B Dried

08.05
Salt

08.06
Sauces:

A Without fatty substances on the surface
X(a)
X(a)

B Mayonnaise, sauces derived from mayonnaise, salad creams and other oil in water emulsions
X(a)
X(a)

X/3

C Sauce containing oil and water forming two distinct layers
X(a)
X(a)

X

08.07
Mustard (except powdered mustard under heading 08.17)
X(a)
X(a)

X/3(3)

08.08
Sandwiches, toasted bread and the like containing any kind of foodstuff:

A With fatty substances on the surface

X/5

B Other

08.09
Ice-creams
X

08.10
Dried foods:

A With fatty substances on the surface

X/5

B Other

08.11
Frozen or deep-frozen foods

08.12
Concentrated extracts of an alcoholic strength equal to or exceeding 5% vol

X(1)

X

08.13
Cocoa:

A Cocoa powder

X/5(3)

B Cocoa paste

X/3(3)

08.14
Coffee, whether or not roasted, decaffeinated or soluble, coffee substitutes, granulated or powdered

08.15
Liquid coffee extracts
X

08.16
Aromatic herbs and other herbs:

Camomile, mallow, mint, tea, lime blossom and others

08.17
Spices and seasonings in the natural state:

Cinnamon, cloves, powdered mustard, pepper, vanilla, saffron and other

PART 5Migration Test Conditions (Times and Temperatures)

General criteria

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.

3.  For the purposes of this Part the worst foreseeable conditions of contact are those which are recognised to be the most severe on the basis of scientific evidence.

Volatile migrants

4.  When carrying out a test of the specific migration of volatile substances any test using a simulant shall be performed in a manner which recognises the loss of volatile migrants which may occur in the worst foreseeable conditions of use.

Special cases

5.  When carrying out a migration test of a plastic material or article which is intended for use in a microwave oven, if the appropriate time and temperature is selected from the table to this Part, either a conventional oven or a microwave oven may be used.

6.  Where the carrying out of a migration test under contact conditions specified in the Table to this Part causes any physical or other change in the test specimen which does not occur under the worst foreseeable conditions of use of the plastic material or article being tested the migration test shall be carried out in the worst foreseeable conditions of use in which such physical or other change does not occur.

7.  Where, in actual use, the plastic material or article being tested is intended to be used for periods of less than 15 minutes at any temperature of not less than 70°C and not more than 100°C and such use is indicated by appropriate labelling or instructions no test other than for 2 hours at 70°C shall be carried out on the plastic material or article unless the plastic material or article is also intended to be used for storage at room temperature in which case no test other than for 10 days test at 40°C shall be carried out.

8.  The Table to this Part shall be read with the notes to it.

Conditions of contact in worse foreseeable use
Test conditions

(1)
The period of time which represents the worst foreseeable conditions of contact.

(2)
This temperature shall be used only for simulant D. For simulant A, B or C the test may be replaced by a test at 100°C or at reflux temperature for a duration of four times the time selected in accordance with paragraph 1 of this Part.

Contact time:
Test time:

less than or equal to 5 minutes
(1)

>5 minutes but less than or equal to 0.5 hours
0.5 hours

>0.5 hours but less than or equal to 1 hour
1 hour

>1 hour but less than or equal to 2 hours
2 hours

>2 hours but less than or equal to 4 hours
4 hours

>4 hours but less than or equal to 24 hours
24 hours

>24 hours
10 days

Contact temperature:
Test temperature:

less than or equal to 5°C
5°C

>5°C but less than or equal to 20°C

>20°C but less than or equal to 40°C

>40°C but less than or equal to 70°C

>70°C but less than or equal to100°C

>100°C but less than or equal to 121°C

>121°C but less than or equal to 130°C

>130°C but less than 150°C

>150°C

20°C

40°C

70°C

100°C or reflux temperature

121°C (2)

130°C (2)

150°C (2)

175°C (2)

PART 6Substitute Fat Test for Overall and Specific Migration

1.  Subject to paragraphs 2, 4 and 5, all the test media specified in the Table to this Part shall be used in the substitute fat test for overall or specific migration under the test conditions corresponding to the test conditions for simulant D.

2.  Test conditions other than those specified in the Table to this Part may be used in the substitute fat test if the assumptions underlying the test conditions specified in that Table and, where the plastic material or article being tested is a polymer, the existing experience of that type of polymer are taken into account.

3.  For each test—

(a)a new test specimen shall be used;

(b)the rules prescribed for simulant D in Parts 3, 4 and 5 of this Schedule shall be applied for each test medium;

(c)subject to paragraph 4, compliance with a migration limit shall be determined by selecting the highest value using all the test methods.

4.  Where carrying out a migration test causes any physical or other change in the test specimen which does not occur under the worst foreseeable conditions of use of the plastic material or article the result of that test shall not be used to ascertain compliance with a migration limit.

5.  Any test conditions in the Table to this Part which are generally recognised on the basis of scientific evidence as not being appropriate for the material or article to be tested shall not be used.

6.  The Table to this Part shall be read with the notes to it.

Conventional conditions for substitute tests

Test conditions with simulant D
Test conditions with isooctane
Test conditions with ethanol 95%

Test conditions with MPPO(1)

(1)
MPPO = Modified polyphenylene oxide

(2)
The volatile test media are used up to a maximum temperature of 60°C. A precondition of using these tests is that the material or article will withstand the test conditions that would otherwise be used with simulant D. Immerse a test specimen in olive oil under the appropriate conditions. If the physical properties are changed (eg melting, deformation) then the material is considered unsuitable for use at that temperature. If the physical properties are not changed then proceed with the substitute tests using new specimens.

10 days at 5°C
0.5 days at 5°C
10 days at 5°C

10 days at 20°C
1 day at 20°C
10 days at 20°C

10 days at 40°C
2 days at 20°C
10 days at 40°C

2 hours at 70°C
0.5 hours at 40°C
2 hours at 60°C

0.5 hours at 100°C
0.5 hours at 60°C(2)

2.5 hours at 60°C
0.5 hours at 100°C

1 hour at 100°C
1 hour at 60°C(2)

3 hours at 60°C(2)

1 hour at 100°C

2 hours at 100°C
1.5 hours at 60°C(2)

3.5 hours at 60°C(2)

2 hours at 100°C

0.5 hours at 121°C
1.5 hours at 60°C(2)

3.5 hours at 60°C(2)

0.5 hours at 121°C

1 hour at 121°C
2 hours at 60°C(2)

4 hours at 60°C(2)

1 hour at 121°C

2 hours at 121°C
2.5 hours at 60°C(2)

4.5 hours at 60°C(2)

2 hours at 121°C

0.5 hours at 130°C
2 hours at 60°C(2)

4 hours at 60°C(2)

0.5 hours at 130°C

1 hour at 130°C
2.5 hours at 60°C(2)

4.5 hours at 60°C(2)

1 hour at 130°C

2 hours at 150°C
3 hours at 60°C(2)

5 hours at 60°C(2)

2 hours at 150°C

2 hours at 175°C
4 hours at 60°C(2)

6 hours at 60°C(2)

2 hours at 175°C

PART 7Alternative Fat Tests for Overall and Specific Migration

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—

(a)the result obtained in a “comparison test” shows that the values are equal to or greater than those obtained in the test with simulant D; and

(b)the migration occurring in either test specified in paragraph 3 does not, after application of the appropriate reduction factor, exceed the appropriate migration limit.

2.  The condition in sub-paragraph (a) of paragraph 1 does not have to be fulfilled if it can be shown on the basis of the result of scientific experiment that the values obtained in either of the tests specified in paragraph 3 are equal to or greater than those obtained in any of the migration tests specified in Part 3.

3.  The migration tests referred to in paragraphs 2 and 3 are —

(a)a test carried out using volatile media including isooctane, ethanol 95%, other volatile solvents or a mixture of solvents at such contact conditions as would result in values equal to or greater than those obtained in a test using simulant D;

(b)other tests using media having a very strong extraction power under very severe test conditions where, on the basis of scientific evidence, it is generally recognised that the results using these tests are equal to or higher than those obtained in a test using simulant D.

Explanatory Note

(This note is not part of the Regulations)

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.

(1)
1990 c. 16.

(2)
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.

(3)
OJ No. L31, 1.2.2002, p.1. That Regulation was last amended by Regulation (EC) No. 1642/2003 of the European Parliament and of the Council (OJ No. L245, 29.9.2003, p.4).

(4)
OJ No. L297, 23.10.1982, p.26.

(5)
OJ No. L222, 12.8.1997, p.10.

(6)
OJ No. L372, 31.12.1985, p.14.

(7)
OJ No. L184, 15.7.1988, p.61.

(8)
OJ No. L40, 11.2.1989, p. 27.

(9)
OJ No. L220, 15.8.2002, p.18.

(10)
OJ No. L71, 10.3.2004, p.8.

(11)
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.

(12)
S.I.2005/898.

(13)
OJ No. L178, 28.7.97, p.1, as last amended by Commission Directive 2004/46, OJ No. L114, 21.4.2004, p.15.

(14)
OJ No. L226, 22.9.95, p.1, as last amended by Commission Directive 2004/47, OJ No. L113, 20.4.2004, p.24.

(15)
OJ No. L339, 30.12.96, p.1, as last amended by Commission Directive 2003/95, OJ No. L283, 31.10.2003, p.71.

(16)
OJ No. L302, 19.11.2005, p.28.

(17)
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).

(18)
S.I. 1990/2463

(19)
S.I. 2006/1401

(20)
S.I. 2000/3162

(21)
S.I. 2002/2364

(22)
S.I. 2002/3008

(23)
S.I. 2004/3113

(24)
S.I. 2005/325

(25)
OJ No. L338, 13.11.2004, p.4.

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