Commission Regulation (EU) No 10/2011Show full title

CHAPTER 3 Testing for overall migration

Overall migration testing shall be performed under the standardised testing conditions set out in this chapter.

3.1. Standardised testing conditions

The overall migration test for materials and articles intended for the food contact conditions described in column 3 of Table 3 shall be performed for the time specified and at the temperature specified in column 2. For test OM5 the test can be performed either for 2 hours at 100 °C (food simulant D2) or at reflux (food simulant A, B, C, D1) or for 1 hour at 121 °C. The food simulant shall be chosen in accordance with Annex III.

If it is found that carrying out the tests under the contact conditions specified in Table 3 causes physical or other changes in the test specimen which do not occur under worst foreseeable conditions of use of the material or article under examination, the migration tests shall be carried out under the worst foreseeable conditions of use in which these physical or other changes do not take place.

Table 3

Standardised testing conditions

Column 1	Column 2	Column 3
Test number	Contact time in days [d] or hours [h] at Contact temperature in [°C]	Intended food contact conditions
OM1	10 d at 20 °C	Any food contact at frozen and refrigerated conditions.
OM2	10 d at 40 °C	Any long term storage at room temperature or below, including heating up to 70 °C for up to 2 hours, or heating up to 100 °C for up to 15 minutes.
OM3	2 h at 70 °C	Any contact conditions that include heating up to 70 °C for up to 2 hours, or up to 100 °C for up to 15 minutes, which are not followed by long term room or refrigerated temperature storage.
OM4	1 h at 100 °C	High temperature applications for all food simulants at temperature up to 100 °C.
OM5	2 h at 100 °C or at reflux or alternatively 1 h at 121 °C	High temperature applications up to 121 °C.
OM6	4 h at 100 °C or at reflux	Any food contact conditions with food simulants A, B or C, at temperature exceeding 40 °C.
OM7	2 h at 175 °C	High temperature applications with fatty foods exceeding the conditions of OM5.

Test OM 7 covers also food contact conditions described for OM1, OM2, OM3, OM4, OM5. It represents the worst case conditions for fatty food simulants in contact with non-polyolefins. In case it is technically not feasible to perform OM 7 with food simulant D2 the test can be replaced as set out in paragraph 3.2.

Test OM 6 covers also food contact conditions described for OM1, OM2, OM3, OM4 and OM5. It represents worst case conditions for food simulants A, B and C in contact with non-polyolefins.

Test OM 5 covers also food contact conditions described for OM1, OM2, OM3, OM4. It represents the worst case conditions for all food simulants in contact with polyolefins.

Test OM 2 covers also food contact conditions described for OM1 and OM3.

3.2. Substitute test for OM7 with food simulant D2

In case it is technically NOT feasible to perform OM7 with food simulant D2 the test can be replaced by test OM 8 or OM9. Both test conditions described under the respective test shall be performed with a new test sample.

Test number	Test conditions	Intended food contact conditions	Covers the intended food contact conditions described in
OM 8	Food simulant E for 2 hours at 175 °C and food simulant D2 for 2 hours at 100 °C	High temperature applications only	OM1, OM3, OM4, OM5, and OM6
OM 9	Food simulant E for 2 hours at 175 °C and food simulant D2 for 10 days at 40 °C	High temperature applications including long term storage at room temperature	OM1, OM2, OM3, OM4, OM5 and OM6

3.3. Repeated use articles

Where a material or article is intended to come into repeated contact with foods, the migration test shall be carried out three times on a single sample using another sample of the food simulant on each occasion.

Its compliance shall be checked on the basis of the level of the migration found in the third test. However, if there is conclusive proof that the level of the migration does not increase in the second and third tests and if the overall migration limit is not exceeded on the first test, no further test is necessary.

3.4. Screening approaches

To screen if a material or article complies with the migration limits any of the following approaches can be applied which are considered more severe than the verification method described in sections 3.1. and 3.2.

3.4.1. Residual content

To screen for overall migration the migration potential can be calculated based on the residual content of migratable substances determined in a complete extraction of the material or article.

3.4.2. Food simulant substitutes

To screen for overall migration food simulants can be replaced if based on scientific evidence the substitute food simulants overestimate migration compared to the regulated food simulants.