Title, commencement and extent

1.-(1) These Regulations may be cited as the Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2000 and shall come into force on 31st December 2000.

(2) These Regulations apply to England.

Amendment of Regulations

2. The Plastic Materials and Articles in Contact with Food Regulations 1998(2) ("the principal Regulations") shall be amended (in so far as they apply to England) as follows.

3. In regulation 2(1) (interpretation), in the definition of "the Directive" for the words "and 96/11/EC" there shall be substituted ", 96/11/EC and 1999/91/EC(3) (as corrected(4))".

4. For paragraph (4)(a) of regulation 3 (restriction on the use, sale or importation of plastic materials and articles) there shall be substituted-

"(a)if-

(i)it has been manufactured with a prohibited monomer as described in regulation 4(1);

(ii)it has been manufactured with a prohibited additive as described in regulation 5(1);

(iii)being a product obtained by bacterial fermentation, it does not comply with regulation 5A; or

(iv)it does not comply with regulation 4(5), 5(4) or 7,

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

5. In regulation 4 (restriction on manufacture with monomers)-

(a)in paragraph (1)(c), for the words "restrictions (if any) specified" there shall be substituted the words "restrictions and specifications (if any) set out"; and

(b)paragraph (3)(d) shall be deleted.

6. In regulation 5 (restriction on manufacture with additives)-

(a)for paragraph (1) there shall be substituted-

"(1) Subject to the following paragraphs of this regulation, no person shall use in the manufacture of plastic materials or articles any prohibited additive, that is to say an additive identified by PM/REF No., CAS No. (if any) and name respectively in columns 1, 2 and 3 of Part 1 of Schedule 2 which-

(a)is not of good technical quality, or

(b)is not used in accordance with the restrictions and specifications (if any) set out in the corresponding entry in column 4 of the relevant section of that Part of that Schedule."; and

(b)there shall be inserted at the end the following paragraphs-

"(4) Subject to paragraph (5) of this regulation, where column 4 of Part I of Schedule 2 expresses a migration limit of mg/kg in relation to any additive, no plastic material or article manufactured containing that additive shall be capable of transferring constituents of that additive to food with which that plastic material or article may come into contact in quantities exceeding the appropriate limit, and for the purposes of this paragraph the appropriate limit is-

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

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

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

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

(5) A plastic material or article manufactured containing an additive in respect of which column 4 of Part I of Schedule 2 expresses a migration limit of mg/kg shall not be considered capable of transferring constituents of that additive to food with which that plastic material or article may come into contact in quantities exceeding the appropriate limit in paragraph (4) of this regulation if the only food which that plastic material or article may come into contact with is food to which regulation 7(3) applies.".

7. After regulation 5 there shall be inserted the following regulation-

"Products obtained by bacterial fermentation

5A. A product obtained by bacterial fermentation complies with this regulation if it is-

(a)of good technical quality;

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

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

8. After regulation 7 (transfer of constituents) there shall be inserted the following regulation-

"Specifications

7A. Schedule 2B shall have effect for the purpose of giving the specifications referred to in column 4 in Schedule 1, 2 and 2A.".

9. In regulation 10 (offences) the following paragraph shall be inserted at the end-

"(15) In any proceedings for an offence under these Regulations it shall be a defence to prove that-

(a)the act was committed in relation to a plastic material or article intended to come into contact with food which was manufactured in the European Community, or imported into the European Community, before 1st January 2003, and

(b)the matters constituting the offence would not have constituted an offence under these Regulations before the amendments made by the Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2000 came into force.".

10. In Schedule 1 (monomers)-

(a)in Part I, in Section A in column 4, for the heading "Restrictions" there shall be substituted "Restrictions and specifications";

(b)the item number and letter, PM/REF No., CAS No., name, restriction and specification (if any) for each monomer identified in Part I of Schedule 1 to these Regulations shall be inserted in Section A of Part I of Schedule 1 to the principal Regulations at the place corresponding to the number and letter (if any) specified for that monomer in the column headed "item" in that Part of that Schedule to these Regulations;

(c)in Part I, in Section A, for the entries in column 4 (restrictions and specifications) opposite to and corresponding to the items listed in Part II of Schedulue 1 to these Regulations there shall be substituted the corresponding entries specified in the said Part II;

(d)in Part I, in Section A, in item 196 the entry in column 4 (restrictions and specifications) shall be deleted;

(e)in Part I, in Section B, item 67 and the entries for it shall be deleted;

(f)in Part I, in Section B, for the entries in column 4 (restrictions) opposite to and corresponding to the items listed in Part III of Schedule 1 to these Regulations there shall be substituted the corresponding entries specified in Part III of Schedule 1 to these Regulations;

(g)in Part I, in Section B, after the entries relating to item 77 there shall be inserted the item number and letter, PM/REF No., CAS No., name and restriction for the monomer identified in Part IV of Schedule 1 to these Regulations;

(h)in Part I, the items in Section B which are listed in Part V of Schedule 1 to these Regulations, and the entries for those items in that Section, shall be deleted and there shall be inserted in Section A at the place corresponding to the number and letter (if any) specified for each item in the column headed "Item No. for Section A" in Part V of Schedule 1 to these Regulations the entries relating to that item in the said Part V; and

(i)in Part II there shall be inserted at the end the following paragraph-

"4. Where an entry in column 4 in Part I of this Schedule includes a bracketed number, that entry shall be subject to the note relating to that number as follows:

(1) Warning: there is a risk that the specific migration limit could be exceeded in fatty food simulants.

(2) SML (T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 10060 and 23920.

(3) SML (T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 15760, 16990, 47680, 53650, 89440.

(4) SML (T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 19540, 19960.

(5) SML (T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 14200, 14230.

(9) SML (T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances;

(a)Badge (=2,2-�bis(4-�hydroxyphenyl)propane bis(2,3-�epoxypropyl) ether

(b)Badge.H₂O

(d)Badge.HCi

(e)Badge.2HCi

(f)Badge.H₂O.HCi

However in aqueous food simulants, the SML (T) shall also include Badge.2H2O(c) unless the material or article is labelled for use in contact only with those foods and beverages for which it has been demonstrated that the sum of the migration levels of the five above mentioned substances (a)(b)(d)(e)(f) cannot exceed 1 mg/kg.".

11. In Schedule 2 (additives)-

(a)in Part I there shall be inserted an extra column, numbered "4" and headed "Restrictions and specifications";

(b)the item number and letter, PM/REF No., CAS No., name, restriction and specification (if any) for each additive identified in Schedule 2 to these Regulations shall be inserted in Part I of Schedule 2 to the principal Regulations at the place corresponding to the number and letter specified for that additive in the column headed "Item" in Schedule 2 to these Regulations;

(c)in Part I, for the entries in column 2 (CAS No.) and column 3 (name) for item 38 there shall be substituted the following-

(d)in Part I, for the entry in column 2 (CAS No.) for item 179 there shall be substituted the entry "037244-�96-�5";

(e)in Part I, item 195 and the entries for it shall be deleted; and

(f)in Part II, there shall be inserted at the end the following paragraph-

"4. Where an entry in column 4 (restrictions and specifications) in Part I of this Schedule includes a bracketed number, that entry shall be subject to the note relating to that number as follows:

(1) Warning: there is a risk that the specific migration limit could be exceeded in fatty food simulants.

(3) SML (T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 15760, 16990, 47680, 53650, 89440.

(6) SML (T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF/Nos: 66560 and 66580.

(7) SML (T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 30080, 42320, 45195, 45200, 53610, 81760, 89200, 92030.

(8) SML (T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 85840 and 95725.

(10) Warning: there is a risk that the migration of the substance deteriorates the organoleptic characteristics of the food in contact and then that the finished product does not comply with regulation 4(2) of the Materials and Articles in Contact with Food Regulations 1987(5).".

12. After Schedule 2 there shall be inserted as Schedules 2A and 2B the contents of Schedules 3 and 4 to these Regulations.

13. In Schedule 3 (provisions applicable when testing compliance with the migration limits)-

(a)in paragraph 4(3) and (4), for "regulation 7 or Schedule 1" in each case there shall be substituted "regulation 7, Schedule 1 or Schedule 2"; and

(b)in paragraph 7(2)(c) for "M1 and M2" there shall be substituted "M2 and M3".

Regulation 10

SCHEDULE 1

PART ILIST OF MONOMERS TO BE ADDED TO SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS

PART IILIST OF MONOMERS IN SECTION A Of PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS FOR WHICH THE CONTENT OF THE COLUMN "RESTRICTIONS AND SPECIFICATIONS" IS MODIFIED

PART IIILIST OF MONOMERS IN SECTION B OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS FOR WHICH THE CONTENT OF THE COLUMN "RESTRICTIONS" IS MODIFIED

PART IVMONOMER TO BE ADDED TO SECTION B OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS

PART VLIST OF MONOMERS TRANSFERRED FROM SECTION B TO SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS

Regulation 11

SCHEDULE 2LIST OF ADDITIVES TO BE INSERTED IN PART I OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS

Regulation 12

SCHEDULE 3

Regulation 5A

"SCHEDULE 2APRODUCTS OBTAINED BY BACTERIAL FERMENTATION

Regulations 8 and 12

SCHEDULE 4

Regulation 7A

"SCHEDULE 2BSPECIFICATIONS

Item	PM/REF No.	Specifications
1	18888	3-HYDROXYBUTANOIC ACID-3-HYDROXYPENTANOIC ACID, COPOLYMER
		Definition	These 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-hydroxybutanoato-co-3-D-hydroxypentanoate).
		CAS number	80181-31-3.
		Structural formula	where n/(m+n) greater than 0 and less or equal to 0.25
		Average molecular weight	Not less than 150,000 Daltons (measured by gel permeation chromatography).
		Assay	Not less than 98% poly (3-D- hydroxybutanoato-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.
		Characteristics
		Identification tests: Solubility	Soluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically insoluble in ethanol, aliphatic alkanes and water.
		Migration	The migration of crotonic acid should not exceed 0.05 mg/kg food.
		Purity	Prior to granulation the raw material copolymer powder must contain:
		-� Nitrogen	Not more than 2,500 mg/kg 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
2	23547	POLYDIMETHYLSILOXANE (MW>6800) Minimum viscosity 100 centistokes at 25°C
3	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.
4	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)
5	76721	POLYDIMETHYLSILOXANE (Mw>6800) Minimum viscosity 100 × 10-6 m2/s (=100 centistokes) at 25°C
6	88640	SOYBEAN OIL, EPOXIDIZED Oxirane <8%, iodine number <6
7	95859	WAXES, REFINED DERIVED FROM PETROLEUM BASED OR SYNTHETIC 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 11 × 10-6 m2/s (=11 centistokes) at 100°C Average molecular weight not less than 500
8	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 × 10-6 m2/s (=8.5 centistokes) at 100°C Average molecular weight not less than 480"

Explanatory Note

(This note is not part of the Regulations)

1. These Regulations amend, for England, the Plastic Materials and Articles in Contact with Food Regulations 1998 ("the 1998 Regulations"), which apply to Great Britain. These Regulations implement Commission Directive 1999/91/EC amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs.

2. These Regulations-

(a)update the lists of monomers and additives which can be used in the manufacture of plastic materials and articles intended to come into contact with food (regulations 10 and 11 and Schedules 1 and 2);

(b)impose restrictions and specifications in respect of some of those monomers and additives (regulations 5(a), 6, 8, 10, 11 and 12 and Schedules 1, 2 and 4); in particular, a new type of restriction is introduced (maximum permitted quantity of the substance in the finished material or article expressed as mg per 6 dm² of the surface in contact with food);

(c)bring products obtained by bacterial fermentation within the scope of the 1998 Regulations and impose restrictions and specifications for such products (regulations 4, 5(b), 7 and 12 and Schedule 3);

(d)include a transitional provision (regulation 9); and

(e)make some consequential amendments (regulations 3 and 13(a)) and correct two errors in the 1998 Regulations (regulations 10(d) and 13(b)).

3. A regulatory impact assessment, which includes a compliance cost assessment of the effect which these Regulations have on business costs, has been prepared and placed in the Library of each House of Parliament. Copies may be obtained from Branch 4 of the Chemical Safety and Toxicology Division of the Food Standards Agency, Ergon House, P.O. Box 31037, Horseferry Road, London SW1P 3WG.