- Welsh Statutory Instrument 2001 No. 1263 (W.70)
The Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2001
© Crown Copyright 2001
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FOOD, WALES
The Plastic Materials and Articles in Contact with Food (Amendment) (Wales) Regulations 2001
| Made | 20th March 2001 | ||
| Coming into force | 1st April 2001 |
In exercise of the powers conferred by sections 16(2), 17(1), 26(1)(a) and 48(1) of the Food Safety Act 1990[1] and now vested in the National Assembly for Wales[2], the National Assembly for Wales, having had regard in accordance with section 48(4A) of that Act to relevant advice given by the Food Standards Agency and after consultation in accordance with section 48(4) and (4B) of that Act, makes the following Regulations:
Title, commencement and application
1. - (1) These Regulations may be cited as
the Plastic Materials and Articles in Contact with Food (Amendment) (Wales)
Regulations 2001 and shall come into force on 1st April 2001.
(2) These Regulations apply to Wales only.
Amendment of Regulations
2. The Plastic Materials and Articles in Contact
with Food Regulations 1998[3] ("the principal Regulations")
shall be amended (in so far as they apply to Wales) as follows.
3. In regulation 2 (interpretation), in the definition of "the Directive" for the words "and 96/11/EC[4]" there shall be substituted ", 96/11/EC and 1999/91/EC[5] as corrected [6]".
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,
- (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.
- (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 I 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
- " (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.
- " 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.".
- " Specifications
7A. Schedule 2B shall have effect for the purpose of giving the specifications referred to in column 4 in Schedules 1, 2 and 2A.".
- " (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) (Wales) Regulations
2001 came into force.".
- (a) in Part I, in section A in column 4, for the heading "Restrictions"
there shall be substituted "Restrictions and/or 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 Schedule 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
- (a) in Part I there shall be added 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 -
| 087826- 41-3 | Bis(methylbenzylidene) sorbitol |
| 069158- 41-1 | Bis(methylbenzylidene) sorbitol |
| 054686- 97-4 | Bis(methylbenzylidene) sorbitol |
| 081541- 12-0 | Bis(methylbenzylidene) sorbitol |
(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
[7].".
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".
Signed on behalf of the National Assembly for Wales under section
66(1) of the Government of Wales Act 1998[8]
D.Elis Thomas
The Presiding Officer of the National Assembly
20th March 2001
PART I
LIST OF MONOMERS TO BE ADDED TO SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS
PART II
LIST 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
| ITEM | PM/REF No. | CAS No. | Name | Restrictions and specifications |
| 2 | 10060 | 000075-07-0 | Acetaldehyde | SML (T) = 6 mg/kg (2) |
| 40 | 13510 | 001675-54-3 | 2,2-Bis(4- hydroxyphenyl)propane bis(2,3-epoxypropyl) ether (=BADGE) | SML (T) = 1 mg/kg (9). Authorised only until 1 January 2005 |
| 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) |
| 79 | 15760 | 000111-46-6 | Diethyleneglycol | SML (T) = 30 mg/kg (3) |
| 98 | 16990 | 000107-21-1 | Ethyleneglycol | SML (T) = 30 mg/kg (3) |
| 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) |
| 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) |
| 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) |
PART III
LIST 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
| ITEM | PM/REF No | CAS/No. | Name | Restrictions |
| 34 | 16690 | 001321-74-0 | Divinylbenzene | The quantity of this material in the finished plastic material or article shall not exceed 1 mg/kg or the specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.02 mg/kg, analytical tolerance included) |
| 56 | 20590 | 000106-91-2 | Methacrylic acid, 2,3-epoxypropyl ester | The quantity of this material in the finished plastic material or article shall not exceed 5 mg/kg (expressed as epoxy group, molecular weight = 43) |
| 68 | 22720 | 000140-66-9 | 4-tert-Octylphenol | The specific migration of this substance shall be not detectable (when measured by a method with a limit of detection of 0.01mg/kg, analytical tolerance included) |
PART IV
MONOMER TO BE ADDED TO SECTION B OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS
| Items | PM/REF No. | CAS No. | Name | Restrictions |
| 77A | 25185 | 000140-66-9 | 4-(1,1,3,3-Tetramethylbutyl) phenol (=4-tert-octylphenol) | As item 68 |
PART V
LIST OF MONOMERS TRANSFERRED FROM SECTION B TO SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS
| Item No. in Section B | Item No. For Section A | PM/REF No. | CAS No. | NAME | Restrictions and specifications |
| 5 | 13A | 11000 | 05976-02-8 | Acrylic acid, dicyclopentadienyl ester | The quantity of this substance in the finished plastic material or article shall not exceed 0.05 mg/6 dm2 |
| 6 | 13B | 11245 | 002156-97-0 | Acrylic acid, dodecyl ester | The specific migration of this substance shall not exceed 0.05 mg/kg (1) |
| 9 | 23A | 12265 | 004074-90-2 | Adipic acid, divinyl dodecyl ester | The quantity of this substance in the finished plastic material or article shall not exceed 5 mg/kg. For use only as a comonomer. |
| 12 | 33A | 13060 | 004422-95-1 | 1,3,5 - Benzenetricarboxylic acid trichloride | The quantity of this substance in the finished plastic material or artical shall not exceed 0.05 mg/6dm2 (measured as 1,3,5 - benzenetricarboxylic |
| 16 | 49A | 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) |
| 19 | 52A | 14020 | 000098-54-4 | 4-tert-Butylphenol | The specific migration of this substance shall not exceed 0.05 mg/kg |
| 22 | 73A | 15130 | 000872-05-9 | 1-Decene | The specific migration of this substance shall not exceed 0.05 mg/kg |
| 30 | 88A | 16360 | 000576-26-1 | 2,6-Dimethylphenol | The specific migration of this substance shall not exceed 0.05 mg/kg |
| 32 | 88B | 16450 | 000646-06-0 | 1,3-Dioxolane | The specific migration of this substance shall not exceed 0.05 mg/kg |
| 37 | 111A | 18220 | 068564-88-5 | N-Heptylaminoundeca noic acid | The specific migration of this substance shall not exceed 0.05 mg/kg (1) |
| 41 | 118A | 18820 | 000592-41-6 | 1-Hexene | The specific migration of this substance shall not exceed 3 mg/kg |
| 42 | 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 |
| 43 | 121B | 19150 | 000121-91-5 | Isophthalic acid | The specific migration of this substance shall not exceed 5 mg/kg |
| 49 | 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) |
| 50 | 131A | 20050 | 000096-05-9 | Methacrylic acid, allyl ester | The specific migration of this substance shall not exceed 0.05 mg/kg |
| 55 | 135A | 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) |
| 61 | 145A | 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 |
| 70 | 159A | 22937 | 001623-05-8 | Perfluoropropyl perfluorovinyl ether | The specific migration of this substance shall not exceed 0.05 mg/kg |
| 71 | 173A | 23770 | 000504-63-2 | 1,3-Propanediol | The specific migration of this substance shall not exceed 0.05 mg/kg |
| 72 | 177A | 23920 | 000105-38-4 | Propionic acid, vinyl ester | SML (T) = 6 mg/kg (2) (expressed as acetaldehyde) |
| 74 | 198A | 24760 | 026914-43-2 | Styrenesulphonic acid | The specific migration of this substance shall not exceed 0.05 mg/kg |
| 83 | 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 |
LIST OF ADDITIVES TO BE INSERTED IN PART I OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS
PRODUCTS OBTAINED BY BACTERIAL FERMENTATION
| ITEM | PM/REF No. | CAS No. | NAME | Restrictions and specifications |
| 1 | 18888 | 80181-31-3 | 3-hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer | The specific migration of this substance shall not exceed 0.05 mg/kg for croton acid (as impurity) and in compliance with the specifications laid down in Schedule 2B" |
SPECIFICATIONS
| ITEM | PM REF No | OTHER 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 x 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 should have the following specifications:
- Viscosity not less than 11 x 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 should have the following specifications:
- Viscosity not less than 8.5 x 10-6 m2/ s (=8.5 centistokes) at 100°C - Average molecular weight not less than 480 " |
|
(This note does not form part of the Regulations)
1. These Regulations amend, in relation to Wales, 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 list 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 milligrammes per 6 square decimetres of the surface in contact with the 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)).
Notes:
[2] The National Assembly for Wales (Transfer of Functions) Order 1999 (SI 1999/672)back
[4] OJ No. L161, 12.3.96, p.26.back
[5] OJ No. L310, 4.12.99, p.41.(f) OJ No. L249, 4.10.2000, p.26.back
[6] OJ No. L249, 4.10.2000, p.26.back
[7] SI 1987/1523, to which there are amendments not relevant to these Regulations.back
[9] OJ No. L330, 5.12.1998, p.32.back
[10] OJ No. L372, 31.12.85, p.14.back
[11] OJ No. L330, 5.12.1998, p.32.back
ISBN 0-11-090239-4