LegalizeThe Plastic Materials and Articles in Contact with Food (Wales) Regulations 2006
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 must be used in the substitute fat test for overall or specific migration under the test conditions corresponding to the test conditions for simulant 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 that 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 must be used;
- (b) the rules prescribed for simulant D in Parts 3, 4 and 5 of this Schedule must be applied for each test medium;
- (c) subject to paragraph 4, compliance with a migration limit must 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 must 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 must not be used.
6
The Table to this Part must be read with the notes to it.
| Test conditions simulant D | Test conditions with isooctane | Test conditions with ethanol 95% | Test conditions with with MPPO[^f01005] |
|---|---|---|---|
| (1) MPPO = Modified polyphenylene oxide | (1) MPPO = Modified polyphenylene oxide | (1) MPPO = Modified polyphenylene oxide | (1) MPPO = Modified polyphenylene oxide |
| (2) The volatile test media are used up to a maximum temperature of 60°C. A precondition of using these tests is that the material or article will withstand the test conditions that would otherwise be used with simulant D. Immerse a test specimen in olive oil under the appropriate conditions. If the physical properties are changed (eg melting, deformation) then the material is considered unsuitable for use at that temperature. If the physical properties are not changed then proceed with the substitute tests using new specimens. | (2) The volatile test media are used up to a maximum temperature of 60°C. A precondition of using these tests is that the material or article will withstand the test conditions that would otherwise be used with simulant D. Immerse a test specimen in olive oil under the appropriate conditions. If the physical properties are changed (eg melting, deformation) then the material is considered unsuitable for use at that temperature. If the physical properties are not changed then proceed with the substitute tests using new specimens. | (2) The volatile test media are used up to a maximum temperature of 60°C. A precondition of using these tests is that the material or article will withstand the test conditions that would otherwise be used with simulant D. Immerse a test specimen in olive oil under the appropriate conditions. If the physical properties are changed (eg melting, deformation) then the material is considered unsuitable for use at that temperature. If the physical properties are not changed then proceed with the substitute tests using new specimens. | (2) The volatile test media are used up to a maximum temperature of 60°C. A precondition of using these tests is that the material or article will withstand the test conditions that would otherwise be used with simulant D. Immerse a test specimen in olive oil under the appropriate conditions. If the physical properties are changed (eg melting, deformation) then the material is considered unsuitable for use at that temperature. If the physical properties are not changed then proceed with the substitute tests using new specimens. |
| 10 days at 5°C | 0.5 days at 5°C | 10 days at 5°C | |
| 10 days at 20°C | 1 day at 20°C | 10 days at 20°C | |
| 10 days at 40°C | 2 days at 20°C | 10 days at 40°C | |
| 2 hours at 70°C | 0.5 hours at 40°C | 2 hours at 60°C | |
| 0.5 hours at 100°C | 0.5 hours at 60°C[^f01006] | 2.5 hours at 60°C | 0.5 hours at 100°C |
| 1 hour at 100°C | 1 hour at 60°C[^f01006] | 3 hours at 60°C[^f01006] | 1 hour at 100°C |
| 2 hours at 100°C | 1.5 hours at 60°C[^f01006] | 3.5 hours at 60°C[^f01006] | 2 hours at 100°C |
| 0.5 hours at 121°C | 1.5 hours at 60°C[^f01006] | 3.5 hours at 60°C[^f01006] | 0.5 hours at 121°C |
| 1 hour at 121°C | 2 hours at 60°C[^f01006] | 4 hours at 60°C[^f01006] | 1 hour at 121°C |
| 2 hours at 121°C | 2.5 hours at 60°C[^f01006] | 4.5 hours at 60°C[^f01006] | 2 hours at 121°C |
| 0.5 hours at 130°C | 2 hours at 60°C[^f01006] | 4 hours at 60°C[^f01006] | 0.5 hours at 130°C |
| 1 hour at 130°C | 2.5 hours at 60°C[^f01006] | 4.5 hours at 60°C[^f01006] | 1 hour at 130°C |
| 2 hours at 150°C | 3 hours at 60°C[^f01006] | 5 hours at 60°C[^f01006] | 2 hours at 150°C |
| 2 hours at 175°C | 4 hours at 60°C[^f01006] | 6 hours at 60°C[^f01006] | 2 hours at 175°C |
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 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.
2
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.
3
The migration tests referred to in paragraphs 1 and 2 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.
Signed
Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998[^f00031].
D. Elis-Thomas — The Presiding Officer of the National Assembly — 14 November 2006
Explanatory note
(This note is not part of the Regulations)
1 These Regulations, which apply in relation to Wales, revoke the Plastic Materials and Articles in Contact with Food Regulations 1998 as amended (“the 1998 Regulations”) in so far as they apply in relation to Wales, and re-enact or re-enact with changes certain provisions contained in those Regulations. The principal Directives that continue to be implemented by these Regulations are listed in paragraph 5 below. These Regulations also provide for the execution and enforcement of Commission Regulation (EC) No 1895/2005 on the restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food (“Regulation 1895/2005”).
2 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 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 11 and Schedules 2 and 3); h 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 12); i provide for the 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 13).
3 The Regulations in Part 3 — a designate food authorities and port health authorities as the enforcement authorities in their respective areas or districts (regulation 14); b specify the offences that may be committed under these Regulations and set out the maximum penalties on conviction (regulation 15); c provide for defences of a general nature, such as exercise of due diligence etc, to offences under regulation 15 (regulation 16); d provide for a transitional defence relating to the sale of jars in foods for infants and young children sealed PVC gaskets containing epoxidised soybean oil; (regulation 17); e 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 18); f specify the procedure to be followed when sending a sample for analysis (regulation 19); g make provision for a reference sample to be analysed by the Laboratory for the Government Chemist (regulation 20);
4 Part 4 of the Regulations contains provisions relating to the procedure to be followed and the time limit to be observed where a person wishes apply to the European Food Safety Authority for the authorisation of a new additive (regulation 21).
5 The principal Directives implemented by the 1998 Regulations which these Regulations continue to implement are — a 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); 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 (OJ No. L372, 31.12.1985, p.14); c 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) and 2004/19/EC (OJ No. L71, 10.3.2004, p.8).
6 A full regulatory appraisal has been prepared for these Regulations and has been placed in the Library of the National Assembly for Wales along with a copy of the transposition note relating to these Regulations. Copies are also available from the Food Standards Agency, 11th Floor, Southgate House, Cardiff CF10 1EW.
Footnotes
[^f00001]: 1990 c. 16.
[^f00002]: Functions of the Secretary of State under the Food Safety Act 1990, so far as exercisable in relation to Wales, were transferred to the National Assembly for Wales by the National Assembly for Wales (Transfer of Functions) Order 1999 (S.I. 1999/672).
[^f00003]: OJ No. L31, 1.2.2002, p.1. That Regulation was last amended by Regulation (EC) No. 1642/2003 of the European Parliament and of the Council (OJ No. L245, 29.9.2003, p.4).
[^f00004]: OJ No. L297, 23.10.1982, p.26.
[^f00005]: OJ No. L222, 12.8.1997, p.10.
[^f00006]: OJ No. L372, 31.12.1985, p.14.
[^f00007]: OJ No. L184, 15.7.1988, p.61.
[^f00008]: OJ No. L40, 11.2.1989, p.27.
[^f00009]: OJ No. L220, 15.8.2002, p.18.
[^f00010]: OJ No. L71, 10.3.2004, p.8.
[^f00011]: OJ No. L302, 19.11.2005. p.35.
[^f00012]: S.I. 1998/1376, as amended in relation to Wales by S.I. 2001/1236 (W.70), S.I. 2002/2834 (W.272) S.I. 2003/302 (W.44), S.I. 2005/182 (W.15) and S.I. 2005/1649 (W.130).
[^f00013]: S.I. 2005/1647 (W.128).
[^f00014]: OJ No. L178, 28.7.97, p.1, as last amended by Commission Directive 2004/46, OJ No. L114, 21.4.2004, p.15.
[^f00015]: OJ No. L226, 22.9.95, p.1, as last amended by Commission Directive 2004/47, OJ No. L113, 20.4.2004, p.24.
[^f00016]: OJ No. L339, 30.12.96, p.1, as last amended by Commission Directive 2003/95, OJ No. L283, 31.10.2003, p.71.
[^f00017]: OJ No. L302, 19.11.2005, p.28.
[^f00018]: Regulation (EC) No 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ No. L338, 13.11.2004, p.4).
[^f00019]: OJ No.L175, 4.7.1991, p.35, as last amended by Directive 2003/14/EC (OJ No. L41, 14.2.2003, p.37)
[^f00020]: OJ No.L49, 28.2.1996, p.17, as last amended by Directive 2003/13/EC (OJ No. L41, 14.2.2003, p.33)
[^f00021]: OJ No. L109, 6.5.2000, p.29, as last amended by Directive 2003/89/EC (OJ No.L308, 25.11.2003, p.15).
[^f00022]: S.I. 1990/2463.
[^f00023]: OJ No. L220, 15.8.2002, p.18. This Directive has been previously amended by Commission Directives 2004/1/EC (OJ No. L7, 13.1.2004, p.45) and 2004/19/EC (OJ No. L71, 10.3.2004, p.8).
[^f00024]: OJ No. L302, 19.11.2005, p.35,
[^f00025]: type=start slip=2019-04-24 time=1311862474626S.I. 2006/2982 (W.273).type=end slip=2019-04-24 time=1311862474626
[^f00026]: S.I. 2001/1263 (W.70).
[^f00027]: S.I. 2002/2834 (W.272).
[^f00028]: S.I. 2003/302 (W.44).
[^f00029]: S.I. 2005/182 (W.15).
[^f00030]: S.I. 2005/1649 (W.130).
[^f00031]: 1998 c. 38.
[^f00032]: OJ No. L338, 13.11.2004, p.4..
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