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Statutory Instruments made by the National Assembly for Wales


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STATUTORY INSTRUMENTS


2005 No. 1649 (W.130)

FOOD, WALES

The Plastic Materials and Articles in Contact with Food (Amendment) (No. 2) (Wales) Regulations 2005

  Made 21 June 2005 
  Coming into force 24 June 2005 

The National Assembly for Wales, in exercise of the powers conferred by sections 16(2), 17(1), 26(1)(a) and (3) and 48(1) of the Food Safety Act 1990[1] and now vested in it[2], having had regard, in accordance with section 48(4A) of that Act, to relevant advice given by the Food Standards Agency, and after consultation as required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety[3], makes the following Regulations:

Title, application and commencement
     1. The title of these Regulations is the Plastic Materials and Articles in Contact with Food (Amendment) (No. 2) (Wales) Regulations 2005 which apply in relation to Wales and come into force on 24 June 2005.

Amendments to the Plastic Materials and Articles in Contact with Food Regulations 1998
    
2. The Plastic Materials and Articles in Contact with Food Regulations 1998[4] are amended, in so far as they apply in relation to Wales, in accordance with regulations 3 to 16 of these Regulations.

     3. In regulation 2 (interpretation) —

     4. In regulation 4 (restriction on the use of monomers in the manufacture of plastic materials and articles)—

     5. In regulation 5 (restriction on the use of additives in the manufacture of plastic materials and articles)—

     6. After regulation 5A insert the following regulation—

     7. For regulation 8 (labelling) substitute the following —

     8. In regulation 10 (offences) —

     9. In Schedule 1, Part I—

     10. In Schedule 1, Part II (supplementary) paragraph 4—

     11. In Schedule 2, Part I (incomplete list of additives used in the manufacture of plastic materials and articles) —

     12. In Schedule 2, Part II (incomplete list of additives used in the manufacture of plastic materials and articles to which paragraph 5 of Part III of Schedule 2 applies) —

     13. In Schedule 2, Part III (supplementary) —

     14. In Schedule 2A (products obtained by bacterial fermentation) for the entry in the column headed "restrictions and specifications" substitute the following —

     15. For Schedule 2B (specifications) substitute the table set out in Schedule 6 to these Regulations.

    
16. For paragraph 4(b) of Part I (basic rules) of Schedule 4 (overall and specific migration testing using food simulants) substitute —



Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998[
10]


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

21 June 2005



SCHEDULE 1
Regulation 9(a)(i)


(ENTRIES TO BE INSERTED IN SECTION A OF PART I OF SCHEDULE 1)


           1 2 3 4
Item PM/REF No. CAS No. Name Restrictions and specifications
6A 10599/90A 061788-89-4 Acids, fatty, unsaturated (C18), dimers, distilled QMA(T) = 0.05 mg/6 dm2 (27)
6B 10599/91 061788-89-4 Acids, fatty, unsaturated (C18), dimers, non distilled QMA(T) = 0.05 mg/6 dm2 (27)
6C 10599/92A 068783-41-5 Acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled QMA(T) = 0.05 mg/6 dm2 (27)
6D 10599/93 068783-41-5 Acids, fatty, unsaturated (C18), dimers, hydrogenated, non distilled QMA(T) = 0.05 mg/6 dm2 (27)
37A 13323 000102-40-9 1,3-Bis(2-hydroxyethoxy) benzene SML = 0.05 mg/kg
68MA 14800 003724-65-0 Crotonic acid QMA(T) = 0.05 mg/6 dm2 (33)
87A 16210 006864-37-5 3,3'-Dimethyl-4,4'-diaminodicyclohexylmethane SML = 0.05 mg/kg (32). To be used only in polyamides.
89A 16540 000102-09-0 Diphenyl carbonate SML = 0.05 mg/kg
101A 17110 016219-75-3 5-Ethylidenebicyclo [2,2,1]hept-2-ene QMA = 0.05 mg/6 dm2. The ratio surface / quantity of food shall be lower than 2 dm2/kg
118MA 18700 000629-11-8 1,6-Hexanediol SML = 0.05 mg/kg
120ZA 18896 001679-51-2 4-(Hydroxymethyl)-1-cyclohexene SML = 0.05 mg/kg
135BM 20440 000097-90-5 Methacrylic acid, diester with ethyleneglycol SML = 0.05 mg/kg
142A 21400 054276-35-6 Methacrylic acid, sulphopropyl ester QMA = 0.05 mg/6 dm2
156XA 22775 000144-62-7 Oxalic acid SML(T) = 6 mg/kg(29)
161A 23070 000102-39-6 (1,3-Phenylenedioxy) diacetic acid QMA = 0.05 mg/6 dm2



SCHEDULE 2
Regulation 9(a)(ii)


(ENTRIES TO BE SUBSTITUTED FOR ENTRIES IN SECTION A OF PART I OF SCHEDULE 1)


           1 2 3 4
Item PM/REF No. CAS No. Name Restrictions and specifications
15A 11530 00999-61-1 Acrylic acid, 2-hydroxypropyl ester QMA = mg/6 dm2 for the sum of acrylic acid, 2-hydroxypropyl ester and acrylic acid, 2-hydroxyisopropyl ester and in compliance with the specifications laid down in Schedule 2B
39 13480 000080-05-7 2,2-Bis (4-hydroxyphenyl) propane SML(T) = 0.6 mg/kg (28)
70 14950 003173-53-3 Cyclohexyl isocyanate QMT(T) = 1 mg/kg in FP (expressed as NCO) (26)
120B 18898 000103-90-2 N-(4-Hydroxyphenyl) acetamide SML = 0.05 mg/kg
147 22150 000691-37-2 4-Methyl-1-pentene SML = 0.05 mg/kg
147A 22331 025513-64-8 Mixture of (35-45% w/w) 1,6-diamino-2,2, 4-trimethylhexane and (55—65% w/w) 1,6-diamino-2,4,4-trimethylhexane QMA = 5 mg/6 dm2
147B 22332 Mixture of (40% w/w) 2,2, 4-trimethylhexane-1,6-diisocyanate and (60% w/w) 2,4,4-trimethylhexane-1,6-diisocyanate QM(T) — 1 mg/kg (expressed as NCO) (26)
188 24190 065997-05-9 Rosin Wood           



SCHEDULE 3
Regulation 11(a)


(ENTRIES TO BE INSERTED IN PART I OF SCHEDULE 2)


           1 2 3 4
Item PM/REF No. CAS No. Name Restrictions and specifications
18A 34850 143925-92-2 Amines, bis(hydrogenated tallow alkyl) oxidised QM = For use only:

    (a) in polyolefines at 0.1% (w/w) but not in LDPE when it is in contact with foods for which the Directive 85/572/EEC establishes a reduction factor less than 3;

    (b) in PET at 0.25% (w/w) in contact with foods other of those for which the simulant D is laid down in Directive 85/572/EEC

18B 34895 000088-68-6 2-Aminobenzamide SML = 0.05 mg/kg. To be used only for PET for water and beverages
37AA 39680 000080-05-7 2,2-Bis(4-hydroxyphenyl) propane SML(T) = 0.6 mg/kg (28)
51A 42880 008001-79-4 Castor oil           
61A 45600 003724-65-0 Crotonic acid QMA(T) = 0.05 mg/6 dm2 (33)
61B 45640 005232-99-5 2-Cyano-3,3-diphenylacrylic acid, ethyl ester SML = 0.05 mg/kg`
69A 46700 15,7-di-tert-Butyl-3-(3,4- and 2,3-di-methylphenyl)-3H-benzofuran-2-one containing: 3(a)5,7-di-tert-butyl-3-(3,4-dimethylphenyl)-3H-benzofuran-2-one (80-100% w/w); and 3(b)5,7-di-tert-butyl-3-(2,3-dimethylphenyl)-3H-benzofuran-2-one (0-20% w/w) SML = 5 mg/kg
69B 46720 004130-42-1 2,6-Di-tert-butyl-4-ethylphenol QMA = 4.8 mg/6 dm2
109A 56535 Glycerol, esters with nonanoic acid           
131A 59280 000100-97-0 Hexamethylenetetramine SML(T) = 15 mg/kg (21) (expressed as Formaldehyde)
178A 68078 027253-31-2 Neodecanoic acid, cobalt salt SML(T) = 0.05 mg/kg (expressed as Neodecanoic acid) and SML(T) = 0.05 mg/kg (13) (expressed as Cobalt). Not for use in polymers contacting foods for which simulant D is laid down in Directive 85/572/EEC
182A 69920 000144-62-7 Oxalic acid SML(T) = 6 mg/kg (29)
195D 76866 Polyesters of 1,2-propanediol and/or 1,3- and/or 1,4-butanediol and/or polypropyleneglycol with adipic acid, which may be end-capped with acetic acid or fatty acids C12-C18 or n-octanol and / or n-decanol SML = 30 mg/kg
240ZA 85601 Silicates, natural (with the exception of asbestos)           
280B 95000 028931-67-1 Trimethylolpropane trimethacrylatemethyl methacrylate copolymer           



SCHEDULE 4
Regulation 11(b)


(ENTRIES TO BE SUBSTITUTED FOR THE ENTRIES IN PART I OF SCHEDULE 2)


           1 2 3 4
Item PM/REF No. CAS No. Name Restrictions and specifications
60A 45450 068610-51-5 p-Cresol-dicyclopentadiene-isobutylene, copolymer SML = 5 mg/kg
198A 77895 068439-49-6 Polyethyleneglycol (EO = 2-6) monoalkyl (C16—C18) ether SML = 0.05 mg/kg and in compliance with the specifications laid down in Schedule 2B



SCHEDULE 5
Regulation 12(a)


(ENTRIES TO BE INSERTED IN PART II OF SCHEDULE 2)


           1 2 3 4
Item PM/REF No. CAS No. Name Restrictions and specifications
4A 34650 151841-65-5 Aluminium hydroxybis [2,2'-methylenebis (4,6-di-tert-butylphenyl) phosphate] SML = 5 mg/kg
7A 38000 000553-54-8 Benzoic acid, lithium salt SML(T) = 0.6 mg/kg (8) (expressed as Lithium)
18A 40720 025013-16-5 tert-Butyl-4-hydroxyanisole (= BHA) SML = 30 mg/kg
27B 46640 000128-37-0 2,6-Di-tert-butyl-p-cresol (= BHT) SML = 3.0 mg/kg
54A 54880 000050-00-0 Formaldehyde SML(T) = 15 mg/kg (21)
54B 55200 001166-52-5 Gallic acid, dodecyl ester SML(T) = 30 mg/kg (34)
54C 55280 001034-01-1 Gallic acid, octyl ester SML(T) = 30 mg/kg (34)
54D 55360 000121-79-9 Gallic acid, propyl ester SML(T) = 30 mg/kg (34)
79A 67896 020336-96-3 Myristic acid, lithium salt SML(T) = 0.6 mg/kg (8) (expressed as Lithium)
83A 71935 007601-89-0 Perchloric acid, sodium salt monohydrate SML = 0.05 mg/kg (31)
88A 76680 068132-00-3 Polycyclopentadiene, hydrogenated SML = 5 mg/kg (1)
101A 86480 007631-90-5 Sodium bisulphite SML(T) = 10 mg/kg (30) (expressed as S02)
102A 86920 007632-00-0 Sodium nitrite SML = 0.6 mg/kg
102B 86960 007757-83-7 Sodium sulphite SML(T) = 10 mg/kg (30) (expressed as S02)
102C 87120 007772-98-7 Sodium thiosulphate SML(T) = 10 mg/kg (30) (expressed as S02)
110A 94400 036443-68-2 Triethyleneglycol bis[3-(3-tert-butyl-4-hydroxy-5-methylphenyl) propionate] SML = 9 mg/kg



SCHEDULE 6
Regulation 15


(TABLE TO BE SUBSTITUTED FOR TABLE IN SCHEDULE 2B)


Item PM/REF No. Specifications
1 11530 Acrylic acid, 2-hydroxypropyl ester.

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

2 16690 Divinylbenzene

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

3 18888 3-Hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer
                      Definition The copolymers are produced by the controlled fermentation of Alcaligenes eutrophus using mixtures of glucose and propanoic acid as carbon sources. The organism used has not been genetically engineered and has been derived from a single wild-type organism Alcaligenes eutrophus strain H16 NCIMB 10422. Master stocks of the organism are stored as freeze-dried ampoules. A submaster / working stock is prepared from the master stock and stored in liquid nitrogen and used to prepare inocula for the fermenter. Fermenter samples will be examined daily both microscopically and for any changes in colonial morphology on a variety of agars at different temperatures. The copolymers are isolated from heat treatment bacteria by controlled digestion of the other cellular components, washing and drying. These copolymers are normally offered as formulated, melt formed granules containing additives such as nucleating agents, plasticisers, fillers, stabilisers and pigments which all conform to the general and individual specifications.
                      Chemical name Poly(3-D-hydroxybutanoate-co-3-D-hydroxypentanoate)
                      CAS number 080181-31-3
                      Structural formula                       CH3           
                                 CH3 O CH2 O
                                 | || | ||
                                 (-O-CH-CH2-C-)m-(O-CH-CH2-C-)n
                                 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-hydroxybutanoate-co-3-D-hydroxypentanoate) analysed after hydrolysis as a mixture of 3-D-hydroxybutanoic and 3-D-hydroxypentanoic acids
                      Description White to off-white powder after isolation
                      Characteristics
                      Identification tests:
                      Solubility Soluble in chlorinated hydrocarbons such as a chloroform or dichloromethane but practically insoluble in ethanol, aliphatic alkanes and water
                      Restriction QMA for crotonic acid is 0.05 mg/6 dm2
                      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
4 23547 Polydimethylsiloxane (MW > 6800)

Minimum viscosity 100 centistokes at 25°C

5 25385 Triallylamine

40 mg/kg hydrogel at a ratio of 1 kg food to a maximum of 1.5 grams of hydrogel.

For use only in hydrogels intended for non-direct food contact use.

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

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

7 43680 Chlorodifluoromethane Content of chlorofluoromethane less than 1 substance
8 47210 Dibutylthiostannoic acid polymer

Molecular unit = (C8H18S3Sn2)n (n = 1,5-2)

9 76721 Polydimethylsiloxane (Mw > 6800)

Minimum viscosity 100 × 10-6 m2/s (= 100 centistokes) at 25°C

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

The composition of this mixture is as follows:

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

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

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

11 83595 Reaction product of di-tert-butylphosphonite with biphenyl, obtained by condensation of 2,4-di-tert-butylphenol with friedel craft reaction product of phosphorus trichloride and biphenyl
                      Composition

— 4,4'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 38613-77-3) (36-46% w/w (1))

— 4,3'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 118421-00-4) (17-23% w/w)

— 3,3'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 118421-01-5) (1-5% w/w)

— 4-Biphenylene-0,0-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 91362-37-7) (11-19% w/w)

— Tris (2,4-di-tert-butylphenyl) phosphite (CAS No. 31570-04-4) (9-18% w/w)

— 4,4'-Biphenylene-0,0-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonate-0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 112949-970) (5% w/w )

Other specifications

— Phosphor content of minimum 5.4% to 5.9%

— Acid value of maximum 10 mg KOH per gram

— Melt range of 85—110°C

12 88640 Soyabean oil, epoxidized

Oxirane < 8% , iodine number < 6

13 95859 Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks

The product has 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

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

The product has the following specifications:

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

— Viscosity note 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, which apply in relation to Wales, further amend the Plastic Materials and Articles in Contact with Food Regulations 1998 (S.I. 1998/1376, "the 1998 Regulations"), which apply to the whole of Great Britain. These Regulations implement in Wales Commission Directive 2004/19/EC ("the Directive") OJ No. L71, 10.3.2004, p.8.) amending Commission Directive 2002/72/EC (OJ No. L220, 15.8.2002, p.18) (relating to plastic materials and articles intended to come into contact with foodstuffs.

     2. The Regulations amend the 1998 Regulations by —

     3. They also amend the Schedules to the 1998 Regulations by —

     4. A regulatory appraisal pursuant to section 65 of the Government of Wales Act 1998 has been prepared for these regulations and placed in the library of the National Assembly for Wales together with a Transposition Note setting out how the main elements of Commission Directive 2004/19/EC are transposed in these Regulations. Copies may be obtained from the Food Standards Agency, 11th Floor, Southgate House, Wood Street, Cardiff CF10 1EW.


Notes:

[1] 1990 c. 16.back

[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] S.I. 1998/1376, amended in relation to Wales by S.I. 2001/1263 (W.70), S.I. 2002/2834 (W.272), S.I. 2003/302 (W.44) and S.I. 2005/182 (W.15).back

[5] OJ No. L184, 15.7.88, p.61. This Directive was last amended by Regulation (EC) No. 1882/2003 of the European Parliament and of the Council (OJ No. L284, 31.10.2003, p.1).back

[6] OJ No. L40, 11.2.89, p.27. This Directive was last amended by Regulation (EC) No 1882/2003.back

[7] OJ No. L178, 28.7.95, p.1. This Directive was last amended by Commission Directive 2004/46 (OJ No. L114, 21.4.2004, p.15).back

[8] OJ No. L226, 22.9.95, p.1. This Directive was last amended by Commission Directive 2004/47 (OJ No.L113, 20.4.2004, p.24).back

[9] OJ No. L339, 30.12.96, p.1. This Directive was last amended by Commission Directive 2003/95 (OJ No. L283, 31.10.2003, p.71).back

[10] 1998 c.38.back



Cymraeg (Welsh)



ISBN 0 11 091157 1


 © Crown copyright 2005

Prepared 29 June 2005


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