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

• (2) Where the letter “b” is shown in brackets after the “X”, the indicated text shall be carried out with ethanol 50% (v/v).

5

Where a food is listed in the Table under both a specific and a general heading, the simulant relating to the specific heading is the simulant which falls to be used for the migration test.

PART 5 — Migration Test Conditions (Times and Temperatures)

General criteria

1

Subject to paragraphs 2, 4, 6 and 7 and to paragraph 4.4 to this Part of Chapter II of the Annex to Directive 82/711, when carrying out migration tests the time and temperature used shall be the time and temperature selected from column 2 of the Table which correspond to the worst foreseeable conditions of contact specified in column 1 of that Table for the plastic material or article being tested and to any labelling information on maximum temperature for use.

2

Where the plastic material or article being tested is intended for a food contact application covered by a combination of two or more times and temperatures specified in column 2 of the Table to this Part, the migration test shall be carried out by subjecting the test specimen successively to all the applicable worst foreseeable conditions appropriate to the sample, using the same portion of food simulant.

3

For the purposes of this Part the worst foreseeable conditions of contact are those which are recognised to be the most severe on the basis of scientific evidence.

Volatile migrants

4

When carrying out a test of the specific migration of volatile substances any test using a simulant shall be performed in a manner which recognises the loss of volatile migrants which may occur in the worst foreseeable conditions of use.

Special cases

5

When carrying out a migration test of a plastic material or article which is intended for use in a microwave oven, if the appropriate time and temperature is selected from the table to this Part, either a conventional oven or a microwave oven may be used.

6

Where the carrying out of a migration test under contact conditions specified in the Table to this Part causes any physical or other change in the test specimen which does not occur under the worst foreseeable conditions of use of the plastic material or article being tested, the migration test shall be carried out in the worst foreseeable conditions of use in which such physical or other change does not occur.

7

Where, in actual use, the plastic material or article being tested is intended to be used for periods of less than 15 minutes at any temperature of not less than 70°C and not more than 100°C and such use is indicated by appropriate labelling or instructions no test other than for 2 hours at 70°C shall be carried out on the plastic material or article unless the plastic material or article is also intended to be used or storage at room temperature in which case no test other than for 10 days test at 40°C shall be carried out.

8

The Table to this part shall be read with the notes to it.

PART 6 — Substitute Fat Test for Overall and Specific Migration

1

Subject to paragraphs 2, 4 and 5, all the test media specified in the Table to this Part shall be used in the substitute fat test for overall or specific migration under the test conditions corresponding to the test conditions for stimulant D.

2

Test conditions other than those specified in the Table to this Part may be used in the substitute fat test if the assumptions underlying the test conditions specified in the Table and, where the plastic material or article being tested is a polymer, the existing experience of that type of polymer are taken into account.

3

For each test–

• (a) a new test specimen shall be used;

• (b) the rules prescribed for simulant D in Parts 3, 4 and 5 of this Schedule shall be applied for each test medium;

• (c) subject to paragraph 4, compliance with a migration limit shall be determined by selecting the highest value using all the test methods.

4

Where carrying out a migration test causes any physical or other change in the test specimen which does not occur under the worst foreseeable conditions of use of the plastic material or article the result of that test shall not be used to ascertain compliance with a migration limit.

5

Any test conditions in the Table to this Part which are generally recognised on the basis of scientific evidence as not being appropriate for the material or article to be tested shall not be used.

6

The Table to this part shall be read with the notes to it.

PART 7 — Alternative Fat Tests for Overall and Specific Migration

1

Subject to paragraph 2 of this Part 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 stimulant 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.

2

The condition in paragraph 1(a) 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.

3

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 stimulant 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.

SCHEDULE 4 — Information to be contained in a declaration of compliance

1

The identity and address of the business operator which manufactures or imports the plastic materials or articles or the substances intended for the manufacturing of those materials or articles.

2

The identity of the materials, the articles or the substances intended for the manufacturing of those materials and articles.

3

The date of the declaration.

4

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

5

Adequate information relative to the substances used for which restrictions and/or specifications are in place under this Directive to allow the downstream business operators to ensure compliance with those restrictions.

6

Adequate information relative to the substances which are subject to a restriction in food, obtained by experimental type=start time=1223980944252datatype=end time=1223980944252 or theoretical calculation about the level of their specific migration and, where appropriate, the purity criteria to enable the user of these materials or articles to comply with the relevant Community provisions or, in their absence, with national provisions applicable to food.

7

Specifications on the use of the material or article, such as–

• (a) type or types of food with which it is intended to be put in contact;

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

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

8

Confirmation that, when a plastic functional barrier is used in a plastic multi layer material or article, the material or article complies with the requirements of Article 7a(2), (3) and (4) of the Directive.

Signed

S ROBISON — Authorised to sign by the Scottish Ministers — 19th March 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 type=start time=1223988734867ortype=end time=1223988734867 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.

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 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) (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) and Commission Regulation (EC) No. 575/2006 (O.J. No. L 100, 7.4.06, p.3).

[^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), and Commission Directive 2007/19/EC (O.J. No. L 97, 12.4.2007, p.50).

[^f00010]: O.J. No. L 178, 28.7.95, p.1; as amended by Commission Directive 98/66/EC (O.J. No. L 257, 19.9.98, p.35), Commission Directive 2000/51/EC (O.J. No. L 198, 4.8.00, p.41), Commission Directive 2001/52/EC (O.J. No. L 190, 12.7.01, p.18) and Commission Directive 2004/46/EC (O.J. No. L 114, 21.4.04, p.15).

[^f00011]: O.J. No. L 226, 22.9.95, p.1; as amended by Commission Directive 1999/75/EC (O.J. L 206, 5.8.99, p.19), Commission Directive 2001/50/EC (O.J. No. L 190, 12.7.01, p.14) and Commission Directive 2004/47/EC (O.J. L 113, 20.4.04, p.24).

[^f00012]: O.J. No. L 339, 30.12.96, p.1; as amended by Commission Directive 2001/30/EC (O.J. No. L 146, 31.5.01, p.1), Commission Directive 2002/82/EC (O.J. No. L 292, 28.10.02, p.1), Commission Directive 2003/95/EC (O.J. No. L 283, 31.10.03, p.71) and Commission Directive 2004/45/EC (O.J. No. L 113, 20.4.04, p.19).

[^f00013]: O.J. No. L 338, 13.11.2004, 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.

[^f00016]: S.S.I. 2006/517.

[^f00017]: S.S.I. 2007/471.

[^f00018]: O.J. No. L 196, 16.8.1967, p.1 as last amended by Directive 2006/121/EC of the European Parliament and of the Council (O.J. No. L 396, 30.12.2006, 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, 28.2.1996, 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, 14.2.2003, p.37) and Commission Directive 2006/82/EC (O.J. No. L 362, 20.12.2006). Commission Directive 91/32/EC was repealed by Commission Directive 2006/141/EC (O.J. No. L 401, 30.12.2006). The definitions of infant formulae and follow-on formulae remain the same.

[^f00020]: O.J. No. L 41, 14.2.03, p.37; as amended by Commission Directive 98/36/EC (O.J. No. L 167, 12.2.1998, p.23), Commission Directive 1999/39/EC (O.J. No. L 124, 18.5.1999, p.8) and Commission Directive 2003/13/EC (O.J. No. L 41, 14.2.2003, p.33). Commission Directive 96/5/EC was repealed by Commission Directive 2006/125 (O.J. No. L 339, 6.12.2006). The definitions of processed cereal-based foods or baby foods remain the same.

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

[^f00022]: O.J. No. L 109, 6.5.00, p.29; as corrected by a Corrigendum published on 25th May 2000 (O.J. No. L 124, 25.5.00, p.66), and as amended by Commission Directive 2001/101/EC (O.J. No. L 310, 28.11.01, p.19), (which was itself amended by Commission Directive 2002/86/EC (O.J. No. L 305, 7.11.02, p.19), the Act concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded (O.J. No. L 236, 23.9.03, p.33) and Directive 2003/89/EC (O.J. No. L 308, 25.11.03, p.15).

[^f00023]: O.J. No. L 92, 3.4.2007, p.9.

[^f00024]: S.I. 1990/2463as relevantly amended by S.S.I. 2006/517.

[^f00025]: S.S.I. 2008/127

[^f00026]: S.S.I. 2007/433.

[^f00027]: Section 36A was inserted by secion 40 of, and Schedule 5 to the Food Standards Act 1999 (c.28).