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.
Standardised conditions for testing the overall migration
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| Test number | Contact time in days [d] or hours [h] at Contact temperature in [°C] for testing | Intended food contact conditions |
| OM0 | 30 min at 40 °C | Any food contact at cold or ambient temperatures and for a short duration (≤ 30 minutes). |
| 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 when packaged under hot-fill conditions, and/or heating up to a temperature T where 70 °C ≤ T ≤ 100 °C for a maximum of t = 120/2^((T-70)/10) minutes. |
| OM3 | 2 h at 70 °C | Any food contact conditions that include hot-fill and/or heating up to a temperature T where 70 °C ≤ T ≤ 100 °C for maximum of t = 120/2^((T-70)/10) minutes, which are not followed by long-term room temperature or refrigerated storage. |
| OM4 | 1 h at 100 °C or at reflux | High temperature applications for all types of food 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 at a temperature exceeding 40 °C, and with foods for which point 4 of Annex III assigns simulants A, B, C or D1. |
| OM7 | 2 h at 175 °C | High temperature applications with fatty foods exceeding the conditions of OM5. |
Textual Amendments
Test OM 7 covers also food contact conditions described for OM0, 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 OM0, 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 OM0, 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 OM0, OM1 and OM3.]