The Plastic Materials and Articles in Contact with Food (Scotland) Regulations 2009

Made: 3rd February 2009

Laid before the Scottish Parliament: 4th February 2009

Coming into force: 7th March 2009

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 1 — PRELIMINARY

Citation, commencement and extent

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Interpretation

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 2 — REQUIREMENTS FOR PLASTIC MATERIALS AND ARTICLES

Restriction on the use, sale or import of plastic materials and articles

3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Restriction on the use of monomers in the manufacture of plastic materials and articles

4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Restriction on the use of additives in the manufacture of plastic materials and articles

5

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Required standard for non migration of constituents of monomers

6

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Required standard for non migration of constituents of additives

7

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Required standard for products obtained by bacterial fermentation

8

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Required standards relating to overall migration limits

9

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Required standard for non migration of primary aromatic amines

10

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Required standard relating to plastic multi-layer materials and articles

11

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Provisions relating to the use of certain epoxy derivatives (BADGE, BFDGE and NOGE)

12

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Method of testing the capability of plastic materials or articles to transfer constituents and methods of analysis

13

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Labelling and documentation

14

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 3 — EXECUTION AND ENFORCEMENT

Enforcement

15

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Offences and penalties

16

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

General defences

17

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Transitional defence relating to PVC gaskets containing epoxidised soybean oil

18

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Procedure where a sample is to be analysed

19

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Secondary analysis by the Government Chemist

20

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 4 — GENERAL AND SUPPLEMENTARY

Application of provisions of the Act

21

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment to the Food Safety (Sampling and Qualifications) Regulations 1990

22

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendments to the Materials and Articles in Contact with Food (Scotland) Regulations 2007

23

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Revocations

24

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 1 — SUPPLEMENTARY PROVISIONS RELATING TO ANNEXES II AND III

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 2 — PROVISIONS APPLICABLE WHEN TESTING COMPLIANCE WITH THE MIGRATION LIMITS

General Provisions

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Special provisions relating to the fat reduction factor

6

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Special provisions relating to the correction of specific migration in simulant D

9

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Special provisions relating to overall migration

10

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

12

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Special provisions relating to caps, lids, gaskets, stoppers and similar sealing articles

13

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 3 — OVERALL AND SPECIFIC MIGRATION TESTING USING FOOD SIMULANTS

PART 1 — BASIC RULES

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 2 — FOOD SIMULANTS TO BE USED IN MIGRATION TESTING

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 3 — SELECTION OF FOOD SIMULANTS

Testing, reduction factors and definition of food types

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Selection of simulants for testing materials and articles intended for contact with all food types

4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Selection of simulants for testing materials and articles which are already in contact with a known food

5

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Selection of simulants for testing materials and articles which are accompanied by a specific indication

6

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 4 — SIMULANTS TO BE USED IN RELATION TO A SPECIFIC FOOD OR GROUP OF FOODS

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 5 — MIGRATION TEST CONDITIONS (TIMES AND TEMPERATURES)

General criteria

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Volatile migrants

4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Special cases

5

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 6 — SUBSTITUTE FAT TEST FOR OVERALL AND SPECIFIC MIGRATION

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 7 — ALTERNATIVE FAT TESTS FOR OVERALL AND SPECIFIC MIGRATION

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 4 — INFORMATION TO BE CONTAINED IN A DECLARATION OF COMPLIANCE

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 5 — TRANSITIONAL ARRANGEMENTS

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Signed

SHONA ROBISON — Authorised to sign by the Scottish Ministers — 2009-02-03

Explanatory note

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Footnotes

[^f00001]: 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 the Food Standards Act 1999 (c. 28) (“the 1999 Act”), Schedule 5, paragraph 8; section 17(1) and (2) was amended by the 1999 Act, Schedule 5, paragraphs 8 and 12; section 26(3) was amended by the 1999 Act, Schedule 6 and is to be read with section 45 of the Criminal Proceedings etc. (Reform) (Scotland) Act 2007 (asp 6); section 48(4) is disapplied in respect of these Regulations by virtue of section 48(4C) which was inserted by S.I. 2004/2990; amendments made by Schedule 5 to the 1999 Act 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, in so far as within devolved competence, were transferred to the Scottish Ministers by virtue of section 53 of the 1998 Act. In so far as not so transferred, and insofar as relating to food (including drink) including the primary production of food those functions were transferred to the Scottish Ministers by the Scotland Act 1998 (Transfer of Functions to the Scottish Ministers etc.) Order 2005 (S.I. 2005/849).

[^f00002]: 1972 c. 68; paragraph 1A was inserted by the Legislative and Regulatory Reform Act 2006 (c. 51), section 28.

[^f00003]: Section 48(4A) was inserted by paragraph 21 of Schedule 5 to the 1999 Act.

[^f00004]: O.J. No. L 31, 1.2.02, p.1, as amended by Regulation (EC) No. 1642/2003 of the European Parliament and of the Council (O.J. No. L 245, 29.9.03, p.4), Commission Regulation (EC) No. 575/2006 (O.J. No. L 100, 7.4.06, p.3) and Commission Regulation (EC) No. 202/2008 (O.J. No. L 60, 5.3.08, p.17).

[^f00005]: O.J. No. L 297, 23.10.82, p.26; as amended by Commission Directive 93/8/EEC (O.J. No. L 90, 14.4.93, p.22) and Commission Directive 97/48/EC (O.J. No. L 222, 12.8.97, p.10).

[^f00006]: O.J. No. L 372, 31.12.85, p.14.

[^f00007]: O.J. No. L 345, 14.12.88, p.29; as corrected by a corrigendum dated 15th July 1988 (O.J. No. L 184, 15.7.88, p.61).

[^f00008]: O.J. No. L 40, 11.2.89, p.27; as amended by European Parliament and Council Directive 94/34 (O.J. No. L 237, 10.9.94, p.1).

[^f00009]: O.J. No. L 220, 15.8.02, p.18; as amended by Commission Directive 2004/1/EC (O.J. No. L 7, 13.1.04, p.45), Commission Directive 2004/19/EC (O.J. No. L 71, 10.3.04, p.8), Commission Directive 2005/79/EC (O.J. No. L 302, 19.11.05, p.35), Commission Directive 2007/19/EC (O.J. No. L 97, 12.4.07, p.50) and Commission Directive 2008/39/EC (O.J. No. L 63, 7.3.08, p.6).

[^f00010]: O.J. No. L 158, 18.6.08, p.17.

[^f00011]: O.J. No. L 6, 10.1.09, p.20.

[^f00012]: O.J. No. L 253, 20.9.08, p.1.

[^f00013]: O.J. No. L 338, 13.11.04, p.4.

[^f00014]: O.J. No. L 302, 19.11.05, p.28.

[^f00015]: S.I. 1998/1376 as amended by S.S.I. 2000/431, 2002/498, 2003/9, 2004/524 and 2005/92. It was revoked by S.S.I. 2006/314.

[^f00017]: S.S.I. 2008/127; as amended by S.S.I. 2008/261.

[^f00018]: O.J. No. L 196, 16.8.67, p.1 as last amended by Directive 2006/121/EC of the European Parliament and of the Council (O.J. No. L 396, 30.12.06, p.850).

[^f00019]: O.J. No. L 175, 4.7.1991, p.35; as amended by Commission Directive 96/4/EC (O.J. No. L 49, 28.2.96, p.12), Commission Directive 1999/50/EC (O.J. No. L 139, 2.6.1999, p.29) Commission Directive 2003/14/EC (O.J. No. L 41, 14.2.03, p.37) and Commission Directive 2006/82/EC (O.J. No. L 362, 20.12.06, p.94). Commission Directive 91/32/EC was repealed by Commission Directive 2006/141/EC (O.J. No. L 401, 30.12.06, p.1). The definitions of infant formulae and follow-on formulae remain the same (see pages 4 and 5 of Directive 2006/141).

[^f00020]: O.J. No. L 41, 14.2.03, p.37; as amended by Commission Directive 98/36/EC (O.J. No. L 167, 12.2.98, p.23), Commission Directive 1999/39/EC (O.J. No. L 124, 18.5.99, p.8) and Commission Directive 2003/13/EC (O.J. No. L 41, 14.2.03, p.33). Commission Directive 96/5/EC was repealed by Commission Directive 2006/125 (O.J. No. L 339, 6.12.06, p.16). The definitions of processed cereal-based foods or baby foods remain the same (see page 18 of Directive 2006/125).

[^f00021]: S.S.I 2006/314; revoked by S.S.I. 2006/517.