SCHEDULE continued
1. Subject to paragraphs 2, 4, 6 and 7 and to paragraph 4.4 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 to this Part 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.
4. When carrying out a test of the specific migration of volatile substances any test using a simulant shall be performed in a manner that recognises the loss of volatile migrants which may occur in the worst foreseeable conditions of use.
5. When carrying out a migration test of a plastic material or article that 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 that 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 for 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.
(1)
The period of time which represents the worst foreseeable conditions of contact. |
|
(2)
This temperature shall be used only for simulant D. For simulant A, B or C the test may be replaced by a test at 100oC or at reflux temperature for a duration of four times the time selected in accordance with paragraph 1. |
|
| Conditions of contact in worst foreseeable use | Test conditions |
|---|---|
| Contact time: | Test time: |
| less than or equal to 5 minutes | (1) |
| >5 minutes but less than or equal to 0.5 hours | 0.5 hours |
| >0.5 hours but less than or equal to 1 hour | 1 hour |
| >1 hour but less than or equal to 2 hours | 2 hours |
| >2 hours but less than or equal to 4 hours | 4 hours |
| >4 hours but less than or equal to 24 hours | 24 hours |
| >24 hours | 10 days |
| Contact temperature: | Test temperature: |
| less than or equal to 5°C | 5°C |
>5°C but less than or equal to 20°C >20°C but less than or equal to 40°C >40°C but less than or equal to 70°C >70°C but less than or equal to 100°C >100°C but less than or equal to 121°C >121°C but less than or equal to 130°C >130°C but less than 150°C >150°C |
20°C 40°C 70°C 100°C or reflux temperature 121°C (2) 130°C (2) 150°C (2) 175°C (2) |
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 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 shall be used;
(b) the rules prescribed for simulant D in Parts 3, 4 and 5 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.
(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. |
|||
| Test conditions with simulant D | Test conditions with isooctane | Test conditions with ethanol 95% | Test conditions with MPPO(1) |
|---|---|---|---|
| 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(2) | 2.5 hours at 60°C | 0.5 hours at 100°C |
| 1 hour at 100°C | 1 hour at 60°C(2) | 3 hours at 60°C(2) | 1 hour at 100°C |
| 2 hours at 100°C | 1.5 hours at 60°C(2) | 3.5 hours at 60°C(2) | 2 hours at 100°C |
| 0.5 hours at 121°C | 1.5 hours at 60°C(2) | 3.5 hours at 60°C(2) | 0.5 hours at 121°C |
| 1 hour at 121°C | 2 hours at 60°C(2) | 4 hours at 60°C(2) | 1 hour at 121°C |
| 2 hours at 121°C | 2.5 hours at 60°C(2) | 4.5 hours at 60°C(2) | 2 hours at 121°C |
| 0.5 hours at 130°C | 2 hours at 60°C(2) | 4 hours at 60°C(2) | 0.5 hours at 130°C |
| 1 hour at 130°C | 2.5 hours at 60°C(2) | 4.5 hours at 60°C(2) | 1 hour at 130°C |
| 2 hours at 150°C | 3 hours at 60°C(2) | 5 hours at 60°C(2) | 2 hours at 150°C |
| 2 hours at 175°C | 4 hours at 60°C(2) | 6 hours at 60°C(2) | 2 hours at 175°C |
1. 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.
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 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
1. 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.
2. The identity of the materials, articles or substances intended for their manufacture.
3. The date of the declaration.
4. Confirmation that the plastic materials or articles meet the relevant requirements laid down in the Directive and in Regulation 1935/2004.
5. 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.
6. 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.
7. 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.
8. 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.”