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Statutory Instruments of the Scottish Parliament


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SCOTTISH STATUTORY INSTRUMENTS


2005 No.92

FOOD

The Plastic Materials and Articles in Contact with Food Amendment (Scotland) Regulations 2005

  Made 1st March 2005 
  Laid before the Scottish Parliament 1st March 2005 
  Coming into force 24th March 2005 

The Scottish Ministers 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 of all other powers enabling them in that behalf, having had regard, in accordance with section 48(4A)[2] of that Act, to relevant advice given by the Food Standards Agency, hereby make the following Regulations:

Citation, commencement and extent
     1.  - (1) These Regulations may be cited as the Plastic Materials and Articles in Contact with Food Amendment (Scotland) Regulations 2005 and come into force on 24th March 2005.

    (2) These Regulations extend to Scotland only.

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[3] ("the principal Regulations") are amended in accordance with regulations 3 to 16 of these Regulations.

     3. In regulation 2 (interpretation) paragraph (1)-

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

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

     6. After regulation 5A insert-

     7. For regulation 8 (labelling) substitute-

     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 being additives 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)-

     15. For Schedule 2B (specifications) substitute the contents of 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-


RHONA BRANKIN
Authorised to sign by the Scottish Ministers

St Andrew's House, Edinburgh
1st March 2005



SCHEDULE 1
Regulation 9(a)(ii)


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


     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 (26)
6B 10599/91 061788-89-4 Acids, fatty, unsaturated (C18), dimers, non distilled QMA(T) = 0.05 mg/6 dm2 (26)
6C 10599/92A 068783-41-5 Acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled QMA(T) = 0.05 mg/6 dm2 (26)
6D 10599/93 068783-41-5 Acids, fatty, unsaturated (C18), dimers, hydrogenated, non distilled QMA(T) = 0.05 mg/6 dm2 (26)
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 (32)
87A 16210 006864-37-5 3,3'-Dimethyl-4,4'-diaminodicyclohexylmethane SML = 0.05 mg/kg (31). 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-cyclohexeneSML; = 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(28)
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 TO THE PRINCIPAL REGULATIONS)





SCHEDULE 3
Regulation 11(a)


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


     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 (27)
51A 42880 008001-79-4 Castor oil     
61A 45600 003724-65-0 Crotonic acid QMA(T) = 0.05 mg/6 dm2 (32)
61B 45640 005232-99-5 2-Cyano-3,3-dipheneylacrylic acid, ethyl ester SML = 0.05 mg/kg
69A 46700  -  5,7-di-tert-Butyl-3-(3,4-and 2,3-di-methylphenyl)-3H-benzofuran-2-one containing:

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

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

SML = 5 mg/kg
69B 46720 004130-42-1 2,6-Di-tert-butyl-4-ethylphenol QMA = 4.8 mg/6 dm2
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 (28)
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 ENTRIES IN PART I OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS)





SCHEDULE 5
Regulation 12(a)


(ENTRIES TO BE INSERTED IN PART II OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS





SCHEDULE 6
Regulation 15


(SUBSTITUTE FOR SCHEDULE 2B TO THE PRINCIPAL REGULATIONS)








EXPLANATORY NOTE

(This note is not part of the Regulations)


These Regulations, which extend to Scotland only, further amend the Plastic Materials and Articles in Contact with Food Regulations 1998 (S.I. 1998/1376), ("the 1998 Regulations"), which extend to the whole of Great Britain. These Regulations implement, in Scotland, Commission Directive 2004/19/EC (O.J. No. L 71, 10.3.04, p.8) amending Commission Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs (O.J. No. L 220, 15.8.02, p.18), ("the Directive").

The Regulations amend the 1998 Regulations by-

They also amend the Schedules to the 1998 Regulations by-

A Regulatory Impact Assessment, which includes a compliance cost assessment of the effect which these Regulations are likely to have on business costs, has been prepared and has been placed in the Scottish Parliament Information Centre. Copies may be obtained from the Food Standards Agency, 6th Floor, St Magnus House, 25 Guild Street, Aberdeen AB11 6NJ.


Notes:

[1] 1990 c.16; section 1(1) and (2) (definition of "food") was substituted by S.I. 2004/2990; sections 16(2) and 48(1) were amended by paragraph 8 of Schedule 5 to the Food Standards Act 1999 ("the 1999 Act"); section 17(1) was amended by paragraphs 8 and 12 of Schedule 5 to the 1999 Act; section 26(3) was amended by Schedule 6 to the 1999 Act; section 48(4) is disapplied in respect of these Regulations by virtue of section 48(4C), inserted by S.I. 2004/2990; amendments made by Schedule 5 to the 1999 Act which extend to Scotland shall be taken as pre-commencement enactments for the purposes of the Scotland Act 1998 (c.46) ("the 1998 Act") by virtue of section 40(2) of the 1999 Act. The functions of the Secretary of State were transferred to the Scottish Ministers by virtue of section 53 of the 1998 Act.back

[2] Section 48(4A) was inserted by the 1999 Act, Schedule 5, paragraph 21.back

[3] S.I. 1998/1376, relevantly amended by S.S.I. 2000/431, S.S.I. 2002/498, S.S.I. 2003/9 and S.S.I. 2004/524.back

[4] O.J. No. L 184, 15.7.88, p.61.back

[5] O.J. No. L 345, 14.12.88, p.29.back

[6] O.J. No. L 42, 15.2.91, p.25.back

[7] O.J. No. L 140, 11.2.89, p.27.back

[8] O.J. No. L 237, 10.9.94, p.1.back

[9] O.J. No. L 71, 10.3.04, p.8.back

[10] O.J. No. L 178, 28.7.95, p.1.back

[11] O.J. No. L257, 19.9.98, p. 35.back

[12] O.J. No. L 198, 4.8.00, p.41.back

[13] O.J. No. L 190, 12.7.01, p.18.back

[14] O.J. No. L 114, 21.4.04, p.15.back

[15] O.J. No. L 226, 22.9.95, p.1.back

[16] O.J. No. L 206, 5.8.99, p.19.back

[17] O.J. No. L 190, 12.7.01, p.14.back

[18] O.J. No. L 113, 20.4.04, p.24.back

[19] O.J. No. L 339, 30.12.96, p.1.back

[20] O.J. No. L 334, 9.12.98, p.1.back

[21] O.J. No. L 277, 30.10.00, p.1.back

[22] O.J. No. L 146, 31.5.01, p.1.back

[23] O.J. No. L 292, 28.10.02, p.1.back

[24] O.J. No. L 283, 31.10.03, p.71.back



ISBN 0 11 069446 5


  © Crown copyright 2005

Prepared 7 March 2005


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