The Plastic Materials and Articles in Contact with Food (Scotland) Regulations 2008

Explanatory Note

(This note is not part of the Regulations)

These Regulations revoke the Plastic Materials and Articles in Contact with Food (Scotland) (No. 2) Regulations 2006 and re enact those Regulations with changes.

The main changes are–

(a) implementation of the further amendments made to Commission Directive 2002/72/EC and to Council Directive 85/572/EEC by Commission Directive 2007/19/EC (corrected version at O.J. No. L 97, 12.4.07, p.50) (“the new Commission Directive”), which introduces new specifications and restrictions relating to plastic multi – layer materials and articles and to substances used in the manufacture of plastic materials and articles in contact with food in general, and amends certain specifications relating to migration testing in fatty foods; and

(b) provision that a reference in these Regulations to an Annex to Commission Directive 2002/72/EC is to be construed as a reference to that Annex as it may be amended from time to time.

The regulations in Part 2–

(a) prohibit specified activities in relation to any plastic material or article (as defined in regulation 2) which fails to meet the appropriate required standards set out in the Regulations (regulation 3);

(b) prohibit the use of monomers and additives in the manufacture of plastic materials and articles other than in accordance with specified conditions (regulation 4 and Schedule 1 in the case of monomers and regulation 5 and Schedule 1 in the case of additives);

(c) specify the required standards relating to the capability of a monomer or an additive to confer its constituents to food (regulation 6 for monomers and regulation 7 for additives);

(d) specify the required standard for products obtained by bacterial fermentation (regulation 8);

(e) specify the required standard relating to overall migration limits from plastic materials or articles to food (regulation 9);

(f) specify the required standards relating to the migration of primary aromatic amines from plastic materials or articles to food (regulation 10);

(g) specify the required standard relating to plastic multi layer materials and articles (regulation 11);

(h) provide for the execution and enforcement of Regulation 1895/2005 (O.J. No. L 302, 19.11.05, p.28), which contains Community provisions relating to the epoxy derivatives known as BADGE, BFDGE and NOGE (regulation 12);

(i) specify the methods for determining the capability of a plastic material or article to transfer its constituents to food, and for detecting the presence of any such constituents in food (regulation 13 and Schedules 2 and 3);

(j) provide for a written declaration in accordance with article 16(1) of Regulation 1935/2004 (regulation 14 and Schedule 4).

The regulations in Part 3–

(a) provide for enforcement (regulation 15);

(b) specify offences and penalties (regulation 16);

(c) provide for defences to offences under regulation 16 (regulation 17);

(d) provide a transitional defence relating to the sale of glass jars that contain certain foods for infants and young children and that have been sealed with a PVC gasket containing epoxidised soybean oil (regulation 18);

(e) provide for other transitional defences in relation to certain plastic materials or articles that have already been manufactured or put into circulation in advance of a change in the law that would otherwise have made their manufacture or circulation unlawful (regulation 19);

(f) specify the procedure to be followed when sending a sample for analysis (regulation 20);

(g) make provision for a reference sample to be analysed by the Government Chemist (regulation 20).

The regulations in Part 4 set out the procedure to be followed in relation to applications to the European Food Safety Authority for the authorisation of a new additive made before 1st January 2007 (regulation 22).

The regulations in Part 5–

(a) apply sections of the Food Safety Act 1990 (regulation 23); and

(b) make consequential amendments and revocations (regulations 24, 25 and 26).

The principal Directives implemented by these Regulations are–

(a) Council Directive 82/711/EEC (O.J. No. L 297, 23.10.82, p.26) laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs, as amended by Commission Directives 93/8/EEC (O.J. No. L 90, 14.4.93, p.22) and 97/48/EC (O.J. No. L 222, 12.8.97, p.10);

(b) Council Directive 85/572/EEC laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs (O.J. No. L 372, 31.12.85, p.14);

(c) Commission Directive 2002/72/EC (O.J. No. L 220, 15.8.02, p.18) relating to plastic materials and articles intended to come into contact with foodstuffs, as amended by Commission Directives 2004/1/EC (O.J. No. L 7, 13.1.04, p.45), 2004/19/EC (O.J. No. L 71, 10.3.04, p.8), 2005/79/EC (O.J. No. L 302, 19.11.05, p.35) and 2007/19/EC (O.J. No. L 91, 31.3.2007, p.17).

A full regulatory impact assessment of the effect that this instrument will have on business costs has been prepared and placed in the Scottish Parliament Information Centre. Copies may be obtained from the Foods Standards Agency, 6th Floor, St Magnus House, 25 Guild Street, Aberdeen AB11 6NJ.