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

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"Directive 82/711" ("Cyfarwyddeb 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" ("Cyfarwyddeb 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" ("Cyfarwyddeb 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" ("Cyfarwyddeb 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" ("y Gyfarwyddeb") 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] and Commission Directive 2005/79/EC[11];

"EEA State" ("Gwladwriaeth AEE") means a member State (other than the United Kingdom), Norway, Iceland and Liechtenstein;

"EFSA" ("EFSA") means the European Food Safety Authority;

"enforcement authority" ("awdurdod gorfodi") means an authority having responsibility under regulation 14 for executing and enforcing these Regulations;

"food" (" bwyd") is to be construed in accordance with section 16(5) of the Act;

"good technical quality" ("ansawdd technegol da") means good technical quality as regards the purity criteria;

"handling of food" ("trin bwyd") means use in connection with the storage, preparation, packaging, sale or serving of food;

"import" ("mewnforio") means import in the course of a business;

"material or article" ("deunydd neu eitem") means a material or article falling within the definition of materials and articles in Article 1(2) of Regulation 1895/2005;

"monomer" ("monomer") means any substance that is included for the purposes of the Directive among monomers and other starting substances;

"NOGE" ("NOGE") has the meaning given in Article 1(1)(c) of Regulation 1895/2005;

"the 1998 Regulations" ("Rheoliadau 1998") means the Plastic Materials and Articles in Contact with Food Regulations 1998[12];

"the 2005 Regulations" ("Rheoliadau 2005") means the Materials and Articles in Contact with Food (Wales) Regulations 2005[13];

"plastic material or article" (" deunydd neu eitem plastig") 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" (" y Cyfarwyddebau Purdeb") means Commission Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs[14], Commission Directive 95/45/EC laying down purity criteria concerning colours for use in foodstuffs[15] and Commission Directive 96/77/EC laying down specific purity criteria for food additives other than colours or sweeteners[16];

"Regulation 1895/2005" ("Rheoliad 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[17];

"sell" ("gwerthu") includes offer or expose for sale or have in possession for sale, and "sale" ("gwerthiant") is construed accordingly;

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

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

    (4) Except in Part 5 of Schedule 3, any reference to a numbered Annex is a reference to that Annex to the Directive.

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 Sections A or B of Annex II; and

(c) used in accordance with any restrictions and specifications for that monomer set out or referred to in column 4 of those sections.

    (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) must 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 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 is a defence for the person accused to prove that each such monomer —

(a) 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, or

(b) 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) Schedule 1 has effect to supplement this regulation.

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 Section A or B of Annex III 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 Section A or B of that Annex; 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 Annex III, 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 Section A or B of Annex III which is not of good technical quality, it is 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) Schedule 1 has effect to supplement this regulation.

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 Section A or B of Annex II 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 Section A or B of Annex II 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 Section A or B of Annex III 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 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 Annex IV; and

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

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 3; 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 2 are 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 the Directive, to food with which that plastic material or article may come into contact.

    (2) Part B of Annex V has effect for the purpose of prescribing, for certain items listed in Section A or B of Annex II, Section A or B of Annex III, or Annex IV, the specifications for those items that are referred to in column 4 of the Annex or Section of the Annex 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 is 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 2 (including the analytical tolerances referred to in paragraph 8 of that Schedule) and Schedule 3;

(b) in any case where the extent to which vinyl chloride, as identified in Section A of Annex II, 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 2 and 3, 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 is where applicable to be determined in the manner specified in the relevant sub-paragraph of paragraph 8 of Annex II.

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

Labelling
     12. —(1) At marketing stages other than the retail stage a person 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[18]; 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 1 January 2007), no person may 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 may without reasonable excuse fail to comply with a request made under Article 6(4) (requirement to disclose date of filling to competent authority).

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 17(3) 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 or her.

    (4) Where an offence under these Regulations which has been committed by a body corporate or a Scottish partnership is proved to have been committed with the consent or connivance of or to be attributable to any neglect on the part of —

(a) any director, manager, secretary or other similar officer of the body corporate or any partner of the Scottish partnership, or

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

that person as well as the body corporate or, as the case may be, the Scottish partnership, is 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 is to 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 is also 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 is, subject to paragraph (5), a defence for the person accused to prove that he or she took all reasonable precautions and exercised all due diligence to avoid the commission of the offence by him or herself or by a person under his or her 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,

is taken to have established the defence provided by paragraph (1) if he or she satisfies the requirements of paragraphs (3) and (4).

    (3) A person satisfies the requirements of this paragraph if he or she proves —

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

(b) that either —


(i) he or she 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 or her to rely on checks carried out by the person who supplied him or her with the plastic material or article or the material or article in question; and



(c) that he or she did not know and had no reason to suspect at the time the offence was committed that his or her 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 or she proves —

(a) that the commission of the offence was due to the act or default of some other person who was not under his or her 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 or her name or mark; and

(c) that he or she did not know and could not reasonably have been expected to know at the time the offence was committed that his or her 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 is not without leave of the court entitled to rely on that defence unless —

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

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

he or she 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 or her possession.

Transitional defence relating to PVC gaskets containing epoxidised soybean oil
     17. —(1) In any proceedings for an offence under regulation 3 concerning the sale of a glass jar—

(a) which contains


(i) infant formula or follow-on formula as defined by Commission Directive 91/321/EC[19], or

(ii) processed cereal-based foods or baby foods for infants and young children as defined by Commission Directive 96/5/EC[20], and



(b) the lid of which is sealed by means of a PVC gasket containing epoxidised soybean oil having PM/Ref No.88640 in Section A of Annex III,

it is a defence to prove the matters set out in paragraph (2)

    (2) The matters to be proved are that —

(a) the glass jar was filled and sealed before 19th November 2006;

(b) the date of filling or a coded indication of that date was present on the jar or its lid at the time of sale; and

(c) the labelling or marking with the particulars mentioned in sub-paragraph (b) at the time of sale complied with the requirements relating to durability in Article 2.1(a) of Directive 2000/13/EC of the European Parliament and of the Council[21].

    (3) No person may without reasonable excuse fail to comply with a request made by the enforcement authority to disclose the date signified by the coded indication mentioned in paragraph (2)(b).

Other transitional defences and savings
     18. —(1) Notwithstanding the revocations made in regulation 25, in relation to any plastic material or article —

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

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

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

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

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

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

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

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

    (2) In any proceedings for an offence under these Regulations other than an offence mentioned in regulation 17(1), it is a defence to prove —

(a) that the act constituting the alleged offence was committed in relation to a plastic material or article which was manufactured or imported into the European Community before 19 November 2007; and

(b) that the matter constituting the alleged offence would not otherwise have constituted an offence under these Regulations if the amendments to the Directive made by Commission Directive 2005/79/EC had not been implemented in Wales at the time the matter occurred.

Procedure where a sample is to be analysed
     19. —(1) An authorised officer who has procured a sample under section 29 of the Act and who considers it should be analysed must 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 must divide the sample into parts by putting the containers into three lots, and each lot is treated as being a part.

    (3) The authorised officer must—

(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 or her 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 20.

Secondary analysis by the Government Chemist
     20. —(1) Where a sample has been retained under regulation 19 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 or her own volition;

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

(c) must if the court so orders; or

(d) must (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 must analyse the part sent to him or her 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 is signed by or on behalf of him or her , but the testing may be carried out by any person under the direction of the person who signs the certificate.

    (5) The authorised officer must 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.

Amendment of the Food Safety (Sampling and Qualifications) Regulations 1990
     23. In the Food Safety (Sampling and Qualifications) Regulations 1990[22], 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 (Wales) Regulations 2005
     24. —(1) The 2005 Regulations are amended in accordance with paragraphs (2) to (4).

    (2) In regulation 2(1) —

(b) [a] In the appropriate place in alphabetical order insert the following definition—

" "Directive 2002/72/EC" ("Cyfarwyddeb 2002/72/EC") means Commission Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs[23], as last amended by Commission Directive 2005/79/EC[24]";

(b) [b]In the appropriate place in alphabetical order insert the following definition—

" "the 2006 Regulations" ("Rheoliadau 2006") means the Plastic Materials and Articles in Contact with Food (Wales) Regulations 2006[25]."

    (3) In regulation 8 —

(a) at the beginning of paragraph (2) add the expression "Except in paragraph (4),":

(b) for paragraph (4) substitute the following paragraph —

    " (4) No person may manufacture any coating to be applied to film referred to in paragraph (3)(b) using any substance or group of substances except those listed in Annexes II, III or IV to Directive 2002/72/EC and other than in accordance with the appropriate requirements, restrictions and specifications contained in those Annexes and in the 2006 Regulations.".

    (4) In regulation 9 —

(a) in paragraph (3), for the expression "in Part I of Schedule 1 to the 1998 Regulations" substitute "in Section A or B of Annex II to Directive 2002/72/EC";

(b) in sub-paragraph (b) of paragraph (3), for the expression "that Part as read with Part II of that Schedule." substitute "those Sections as read with the general introduction to that Annex.";

(c) in paragraph (5), for the expression "Schedules 3 and 4" substitute "Schedules 2 and 3".

Revocations
     25. The following Regulations or parts thereof are revoked —

(a) the 1998 Regulations in so far as they apply in relation to Wales;

(b) the Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2001[26];

(c) the Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2002[27];

(d) the Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2003[28];

(e) the Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2005[29];

(f) the Plastic Materials and Articles in Contact with Food (Amendment) (No.2) (Wales) Regulations 2005[30];

(g) regulation 15 of the 2005 Regulations.

Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998[31].


D. Elis-Thomas
The Presiding Officer of the National Assembly

14 November 2006

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[32] ("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 must 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 are—

(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

(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 is 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 is used in the migration test, that is to say —

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

(b) if the pH value of the foodstuff is 4.5 or less, simulant B must 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
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

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

⁽²⁾This test must 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 must not be used.

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

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

(a) a new test specimen must be used;

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

(c) subject to paragraph 4, compliance with a migration limit must 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 must 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 must not be used.

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


Conventional conditions for substitute tests

Test conditions simulant D	Test conditions with isooctane	Test conditions with ethanol 95%	Test conditions with with MPPO(1)
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

⁽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.

(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 1 and 2 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.

[2] Functions of the Secretary of State under the Food Safety Act 1990, so far as exercisable in relation to Wales, were transferred to the National Assembly for Wales by the National Assembly for Wales (Transfer of Functions) Order 1999 (S.I. 1999/672).back

[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).back

[4] OJ No. L297, 23.10.1982, p.26.back

[5] OJ No. L222, 12.8.1997, p.10.back

[6] OJ No. L372, 31.12.1985, p.14.back

[7] OJ No. L184, 15.7.1988, p.61.back

[8] OJ No. L40, 11.2.1989, p.27.back

[9] OJ No. L220, 15.8.2002, p.18.back

[10] OJ No. L71, 10.3.2004, p.8.back

[11] OJ No. L302, 19.11.2005. p.35.back

[12] S.I. 1998/1376, as amended in relation to Wales by S.I. 2001/1236 (W.70), S.I. 2002/2834 (W.272) S.I. 2003/302 (W.44), S.I. 2005/182 (W.15) and S.I. 2005/1649 (W.130).back

[13] S.I. 2005/1647 (W.128).back

[14] OJ No. L178, 28.7.97, p.1, as last amended by Commission Directive 2004/46, OJ No. L114, 21.4.2004, p.15.back

[15] OJ No. L226, 22.9.95, p.1, as last amended by Commission Directive 2004/47, OJ No. L113, 20.4.2004, p.24.back

[16] OJ No. L339, 30.12.96, p.1, as last amended by Commission Directive 2003/95, OJ No. L283, 31.10.2003, p.71.back

[17] OJ No. L302, 19.11.2005, p.28.back

[18] 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).back

[19] OJ No.L175, 4.7.1991, p.35, as last amended by Directive 2003/14/EC (OJ No. L41, 14.2.2003, p.37)back

[20] OJ No.L49, 28.2.1996, p.17, as last amended by Directive 2003/13/EC (OJ No. L41, 14.2.2003, p.33)back

[21] OJ No. L109, 6.5.2000, p.29, as last amended by Directive 2003/89/EC (OJ No.L308, 25.11.2003, p.15).back

[22] S.I. 1990/2463.back

[23] OJ No. L220, 15.8.2002, p.18. This Directive has been previously 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).back

[24] OJ No. L302, 19.11.2005, p.35,back

[25] S.I. 2006/2932 (w.273)[c].back

[26] S.I. 2001/1263 (W.70).back

[27] S.I. 2002/2834 (W.272).back

[28] S.I. 2003/302 (W.44).back

[29] S.I. 2005/182 (W.15).back

[30] S.I. 2005/1649 (W.130).back

[31] 1998 c.38.back

[32] OJ No. L338, 13.11.2004, p.4..back

[a] Amended by Correction Slip. Page 22, English language version, regulation 24(2), line two: immediately before the sentence beginning, "In the appropriate place…", insert sub-paragraph reference, "(a)

Tudalen 22, fersiwn Saesneg, rheoliad 24(2), ail linell: yn union cyn y frawddeg sy’n dechrau â, "In the appropriate place…", mewnosoder cyfeirnod isbaragraff, "(a)" back

[b] Amended by Correction Slip. Page 22, English language version, regulation 24(2)(b), line one: the sentence beginning, "after the definition of…", should be deleted. Regulation 24(2)(b) should start with the sentence beginning, "In the appropriate place…"

Tudalen 22, fersiwn Saesneg, rheoliad 24(2)(b), llinell gyntaf: dylai’r frawddeg sydd yn dechrau â "after the definition of…", gael ei dileu. Dylai rheoliad 24(2)(b) dechrau â’r frawddeg, "In the appropriate place&hellipl" back

[c] Amended by Correction Slip. Page 22, English language version, footnote (4): should read, "S.I. 2006/2982 (W.273)."

Page 22, fersiwn Gymraeg, troednodyn (4): dylai darllen fel "O.S. 2006/2982 (W.273)." back