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Regulations 9 and 13
1. Subject to paragraphs 2, 3 and 4 of this Part, migration tests for the determination of specific and overall migration must be carried out using the food simulants specified in Parts 2, 3 and, where appropriate 4, and under conventional migration test conditions as specified in Part 5.
2. Subject to paragraphs 3 and 4 of this Part, substitute tests which use test media under the conventional substitute test conditions as specified in Part 6 must be carried out if the migration test using the fatty food simulants specified in Part 3 is not feasible for technical reasons connected with the method of analysis.
3. Subject to paragraph 4 of this Part, alternative tests as specified in Part 7 may be used instead of the migration test with fatty food simulants specified in Part 3 but the results of such alternative tests may not be used to determine compliance with a migration limit unless the conditions specified in Part 7 are fulfilled.
4. In migration testing it is permissible to—
(a) reduce the number of tests to be carried out to that or those which, in the specific case under examination, is or are generally recognised to be the most severe on the basis of scientific evidence;
(b) omit the migration, the substitute or the alternative tests where —
(i) there is conclusive proof that the migration limits cannot be exceeded in any foreseeable conditions of use of the material or article, or
(ii) the conditions for non-compulsory testing set out in Article 8(2) or 8(3) of the Directive are met.
1. Subject to Parts 3, 4, 5 and 7, the simulants to be used in migration testing are specified in the Table to this paragraph (referred to in this Part as “the Table”).
| 1 | 2 |
|---|---|
| Abbreviation | Food Simulant |
| Simulant A: | Distilled water or water of equivalent quality |
| Simulant B: | 3% Acetic acid (w/v) in aqueous solution |
| Simulant C: | 10% Ethanol (v/v) in aqueous solution except that the concentration of ethanol solution must be adjusted to the actual alcoholic strength of the food if it exceeds 10% (v/v) |
| Simulant D: | Rectified olive oil having the characteristics specified in paragraph 3 or, subject to paragraph 5, any of the fatty food simulants specified in paragraph 4 |
2. For the purposes of this Schedule a reference to an abbreviation in column 1 of the Table means a reference to the simulant in column 1 of that Table opposite that abbreviation.
3. The characteristics of rectified olive oil referred to in the Table are —
(a) Iodine value (Wijs) = 80 to 88;
(b) Refractive index at 25°C = 1.4665 to 1.4679;
(c) Acidity (expressed as % of oleic acid) = 0.5% maximum;
(d) Peroxide number (expressed as oxygen milli-equivalents per kg of oil) = 10 maximum.
4. The fatty food simulants referred to in the Table are —
(a) corn oil with standardised specifications;
(b) sunflower oil, the characteristics of which are —
(i) Iodine value (Wijs) = 120 to 145;
(ii) Refractive index at 20°C = 1.474 to 1.476;
(iii) Saponification number = 188 to 193;
(iv) Relative density at 20°C = 0.918 to 0.925;
(v) Unsaponifiable matter = 0.5% to 1.5%;
(c) a synthetic mixture of triglycerides the composition of which is as set out in the following tables:
| No. of C-atoms in fatty acid residue | 6 | 8 | 10 | 12 | 14 | 16 | 18 | others |
| GLC area (%) | 1 | 6—9 | 8—11 | 45—52 | 12—15 | 8—10 | 8—12 | 1 |
| Content of monoglycerides (enzymatically) | <0.2% |
| Content of diglycerides (enzymatically) | <2.0% |
| Unsaponifiable matter | <0.2% |
| Iodine value(Wijs) | <0.1% |
| Acid value | <0.1% |
| Water content (K Fischer) | <0.1% |
| Melting point | 28 ± 2°C |
| Wavelength (nm) | 290 | 310 | 330 | 350 | 370 | 390 | 430 | 470 | 510 |
| Transmittance (%) | 2 | 15 | 37 | 64 | 80 | 88 | 95 | 97 | 98 |
| At least 10% light transmittance at 310 nm | |||||||||
5. Where a fatty food simulant specified in paragraph 4 is used in migration testing and the result of that test shows that a plastic material or article does not comply with any migration limit specified in regulation 9 or the Annexes, verification that the plastic material or article does not comply with the specified migration must be carried out by testing that material or article using olive oil if such testing is technically feasible, and if such testing is not technically feasible the plastic material or article is to be deemed not to comply with the specified migration limit.
The Plastic Materials and Articles in Contact With Food (Wales) (No.2) Regulations 2008