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What does SML - Specific Migration Limit mean?

The SML (Specific Migration Limit) defines the maximum permitted migration of an individual substance from a packaging material into food.

While the OML (Overall Migration Limit) assesses the total migration of all substances, the SML focuses on specific substances or components – such as plasticisers, antioxidants, stabilisers or metal ions. SML values are defined in EU Regulation No. 10/2011, Annex I, which lists all substances authorised for food contact.

They are expressed in mg per kg of food (mg/kg food) and ensure that, even under long-term or high-temperature conditions, no harmful quantities migrate into the food.

Compliance with SML limits is verified in laboratories through migration simulations or specific chemical analyses of the test simulant. Depending on the intended use, the relevant OM test conditions (OM1–OM7) are applied.

Together, OML and SML form the basis of food-contact safety assessment for plastics. While OML covers the overall safety of the material, SML ensures control over individual substance migration. In short: SML evaluates the specific migration of single substances, whereas OML measures the overall migration of all components – both are essential for safe food packaging.

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.