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What does OML - Overall Migration Limit mean?

The Overall Migration Limit (OML) defines the maximum total amount of substances that may migrate from a plastic material into food.

It is one of the key parameters defined in EU Regulation No. 10/2011 governing all plastics intended for food contact. Migration is determined through standardized tests under defined time and temperature conditions – the so-called OM test conditions (OM1 to OM7).

These tests simulate realistic scenarios such as long-term storage at room temperature, heating in a water bath, or sterilization in an autoclave. The OML ensures that, even under worst-case conditions, the packaging does not release unacceptable levels of substances into the food.

For plastics in food contact, the legal limit is 10 mg/dm² (or 60 mg/kg of food if the surface-to-volume ratio is unknown). Additionally, specific components may be subject to SML limits (Specific Migration Limits), which restrict the migration of individual substances more strictly.

In short: The OML controls the overall migration of all components, while SML values regulate the migration of specific substances – together ensuring the safety of food packaging materials.

Test Conditions OM1 – OM7 (Overall Migration)
according to EU Regulation No. 10/2011, Annex V.
Note for OM2 / OM3: Short-term heating can be calculated using t = 120 / 2^((T − 70)/10) (t in minutes, T in °C).

Designation Conditions (temperature · time) Description / typical application
OM110 d at 20 °CFood contact under frozen / chilled conditions and long-term storage at room temperature without heating.
OM210 d at 40 °C
+ short heating to T (70–100 °C) for at most t		Long-term storage up to room temperature; hot filling and/or heating to T with t = 120 / 2^((T − 70)/10) min.
OM32 h at 70 °C
or heating to T (70–100 °C) for at most t		Hot filling / heating without subsequent long-term storage. t = 120 / 2^((T − 70)/10) min.
OM41 h at 100 °C or under refluxHigh-temperature uses up to 100 °C (e.g. pasteurisation, water bath).
OM52 h at 100 °C or under refluxMore intensive high-temperature uses up to 100 °C (longer duration / harsher conditions).
OM64 h at 100 °C or under reflux
or alternatively 1 h at 121 °C		Very demanding applications (e.g. autoclaving / sterilisation).
OM72 h at 175 °CHigh-temperature conditions with fatty foods; strictest “worst-case” condition.

Notes

  • The selection of the OM condition depends on real temperature, contact time and food type (aqueous / fatty / alcoholic / acidic).
  • OM2 / OM3: Short-term heating in the range 70–100 °C is represented by t = 120 / 2^((T − 70)/10).
  • OM7 is typically used for fatty foods and represents the strictest condition.
  • Please check carefully under which test conditions (e.g. OM2 or OM3) the product has been tested.

Comparison OML vs. SML – EU 10/2011
Overall migration vs. specific migration – key parameters for assessing packaging safety.

Criterion OML (Overall Migration Limit) SML (Specific Migration Limit)
Definition Total amount of all substances that can migrate from the material into the food. Maximum permitted amount of an individual substance that may migrate into the food.
Unit 10 mg/dm² or 60 mg/kg food mg/kg food (substance-specific)
Legal basis EU 10/2011, Annex II EU 10/2011, Annex I (“Positive list”)
Test procedure Simulated migration tests under OM1–OM7 conditions. Targeted analysis of individual substances (e.g. GC, LC, ICP-MS, etc.).
Evaluation Total chemical load on the food from all substances. Toxicologically assessed limits for specific substances.
Purpose Assessment of general material compatibility with food. Control of targeted risks from additives, monomers or residuals.

Notes

  • Both OML and SML limits must be complied with for a material to be considered suitable for food contact.
  • For SML-relevant substances, individual migration reports are required.
  • Testing and confirmation of compliance are carried out by accredited laboratories in accordance with EU standards.