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PART 5 Migration Test Conditions (Times and Temperatures)

General criteria

1.  Subject to paragraphs 2, 4, 6 and 7 below 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 must 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 must 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 must be performed in a manner that 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 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 must 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 must 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 must be carried out.

8.  The Table to this Part must be read with the notes to it.

Conditions of contact in worst foreseeable use Test conditions
a

The period of time which represents the worst foreseeable conditions of contact.

b

This temperature must be used only for simulant D. For simulant A, B or C the test may be replaced by a test at 100°C or at reflux temperature for a duration of four times the time selected in accordance with paragraph 1 of this Part.

Contact time: Test time:
Less than or equal to 5 minutes a
>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
>20°C but less than or equal to 40°C 40°C
>40°C but less than or equal to 70°C 70°C
>70°C but less than or equal to100°C 100°C or reflux temperature
>100°C but less than or equal to 121°C 121°Cb
>121°C but less than or equal to 130°C 130°Cb
>130°C but less than 150°C 150°Cb
>150°C 175°C b

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.

Conventional conditions for substitute tests

Test conditions with stimulant D Test conditions with isooctane Test conditions with ethanol 95% Test conditions with MPPOa
a

MPPO = Modified polyphenylene oxide

b

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°Cb 2.5 hours at 60°C 0.5 hours at 100°C
1 hour at 100°C 1 hour at 60°Cb 3 hours at 60°Cb 1 hour at 100°C
2 hours at 100°C 1.5 hours at 60°Cb 3.5 hours at 60°Cb 2 hours at 100°C
0.5 hours at 121°C 1.5 hours at 60°Cb 3.5 hours at 60°Cb 0.5 hours at 121°C
1 hour at 121°C 2 hours at 60°Cb 4 hours at 60°Cb 1 hour at 121°C
2 hours at 121°C 2.5 hours at 60°Cb 4.5 hours at 60°Cb 2 hours at 121°C
0.5 hours at 130°C 2 hours at 60°Cb 4 hours at 60°Cb 0.5 hours at 130°C
1 hour at 130°C 2.5 hours at 60°Cb 4.5 hours at 60°Cb 1 hour at 130°C
2 hours at 150°C 3 hours at 60°Cb 5 hours at 60°Cb 2 hours at 150°C
2 hours at 175°C 4 hours at 60°Cb 6 hours at 60°Cb 2 hours at 175°C