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PART 7 Alternative Fat Tests for Overall and Specific Migration

82.  Subject to paragraph 2 the conditions which must be fulfilled to allow the result of either test specified in paragraph 3 to be used as an alternative to the result of a migration test carried out under Part 3 are that—

(a) the result obtained in a “comparison test” shows that the values are equal to or greater than those obtained in the test with simulant D; and

(b) the migration occurring in either test specified in paragraph 3 does not, after application of the appropriate reduction factor, exceed the appropriate migration limit.

83.  The condition in sub-paragraph (a) of paragraph 1 does not have to be fulfilled if it can be shown on the basis of the result of scientific experiment that the values obtained in either of the tests specified in paragraph 3 are equal to or greater than those obtained in any of the migration tests specified in Part 3.

84.  The migration tests referred to in paragraphs 2 and 3 are —

(a) a test carried out using volatile media including isooctane, ethanol 95%, other volatile solvents or a mixture of solvents at such contact conditions as would result in values equal to or greater than those obtained in a test using simulant D;

(b) other tests using media having a very strong extraction power under very severe test conditions where, on the basis of scientific evidence, it is generally recognised that the results using these tests are equal to or higher than those obtained in a test using simulant D.

Regulation 14

SCHEDULE 4 Information to be contained in a declaration of compliance

85.  The name and address of the business operator which manufactures or imports the plastic materials or articles or the substances intended for the manufacture of those materials or articles.

86.  The identity of the materials, articles or substances intended for their manufacture.

87.  The date of the declaration.

88.  Confirmation that the plastic materials or articles meet the relevant requirements laid down in the Directive and in Regulation 1935/2004.

89.  Adequate information relating to the substances used for which restrictions or specifications are in place under the Directive to allow downstream business operators to ensure compliance with them.

90.  Adequate information relating to the substances which are subject to a restriction in food, obtained by experimental data or theoretical calculation about the level of their specific migration and, where appropriate, purity criteria in accordance with the purity Directives to enable the user of the plastic materials or articles to comply with the relevant Community provisions or, in their absence, with national provisions applicable to food.

91.  Specifications on the use of the plastic material or article, such as —

(a) the types of food intended to be in contact with it;

(b) the time and temperature of treatment and storage in contact with the food;

(c) the ratio of food contact surface area to volume used to establish the compliance of the plastic material or article.

92.  Confirmation, when a plastic functional barrier is used in a plastic multi-layer, that the plastic material or article complies with the requirements of paragraphs 2 to 4 of Article 7a of the Directive.

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations revoke the Plastic Materials and Articles in Contact with Food (No.2) Regulations (Northern Ireland) 2006, (S.R. 2006 No. 420) and re-enact those Regulations with certain 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 2007/19/EC (corrected version at OJ No. L 97, 12.4.2007, 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 —

(c) 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);

(d) 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);

(e) 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);

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

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

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

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

(j) provide for the execution and enforcement of Regulation 1895/2005 on the restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food (OJ No. L302, 19.11.2005, p.28), which contains Community provisions relating to the epoxy derivatives known as BADGE, BFDGE and NOGE (regulation 12).

(k) 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 &3);

(l) provide that prior to the retail stage plastic materials and articles must be accompanied by certain specified written information, including a declaration of legislative compliance (regulation 14 and Schedule 4).

The Regulations in Part 3 —

(m) provide that district councils shall enforce these regulations in their own districts (regulation 15);

(n) specify the offences that may be committed under these Regulations and set out the maximum penalties on conviction (regulation 16);

(o) specify a time limit for commencing a prosecution (regulation 17);

(p) provide for the prosecution of a person who causes the commission of an offence by another person, whether or not proceedings are taken against the original offender (regulation 18);

(q) provide for a defence of diligence to offences under these Regulations (regulation 19);

(r) provide for a 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 20);

(s) provide for 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 21);

(t) specify the procedure to be followed when sending a sample for analysis (regulation 22):

(u) make provision for a reference sample to be analysed by the Laboratory for the Government Chemist (regulation 23).

Part 4 of the Regulations contains provisions relating to the interim period between an application to the European Food Safety Authority for the authorisation of a new additive and the final decision by that Authority (regulation 24).

The principal Directives implemented by these Regulations are —

(v) Council Directive 82/711/EEC (OJ No. L297, 23.10.1982, 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 (OJ No. L90, 14.4.1993, p.22) and 97/48/EC (OJ No. L222, 12.8.1997, p.10);

(w) 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 (OJ No. L372, 31.12.1985, p.14), as amended by the new Commission Directive;

(x) 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, as amended by Commission Directives 2004/1/EC (OJ No. L7, 13.1.2004, p.45), 2004/19/EC (OJ No. L71, 10.3.2004, p.8) and 2005/79/EC (OJ No. L302, 19.11.2005, p.35), and the new Commission Directive.