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What does SML - Specific Migration Limit mean?

An SML (Specific Migration Limit) limits the amount of a specific substance that may migrate from a plastic material into food or, during testing, into a food simulant.

While the OML (Overall Migration Limit) limits the total amount of substances migrating from the plastic material, an SML applies to a specific substance. Regulation (EU) No 10/2011 establishes different Specific Migration Limits for various regulated substances.

SML values are generally expressed in mg/kg of food. They are established taking toxicological assessments into account and are intended to ensure that the migration of a specific substance does not exceed the respective permitted level.

Depending on the substance, material and intended application, compliance with an SML may be assessed using migration testing, analytical testing, calculations, modelling or other appropriate verification methods. The actual or foreseeable conditions of contact between the packaging and the food must be taken into account.

Important: An SML is not a general limit for a packaging product but a substance-specific migration limit. Several different SML requirements may therefore be relevant for a single plastic material. Compliance with the applicable Specific Migration Limits is an important part of the conformity assessment of plastic materials intended for food contact.

SML Fact Sheet – specific migration at a glance

Specific Migration Limits are substance-specific. Several different SML requirements may therefore be relevant for a single plastic material.

Question Answer
What is an SML? An SML (Specific Migration Limit) limits the migration of a specific substance from a plastic material into food or a food simulant.
In which unit is an SML expressed? SML values are generally expressed in mg/kg of food.
Does a packaging product have one single SML? No. An SML applies to a specific substance. Several different Specific Migration Limits may therefore be relevant for a single plastic material.
Are all SML values the same? No. SML values are substance-specific and may differ depending on the substance concerned.
What influences migration? Migration can be influenced by factors including the type of food or food simulant, contact time, temperature and the intended conditions of use.
How is compliance with an SML assessed? Depending on the substance, material and application, compliance may be assessed using appropriate migration tests, analytical testing, calculations, modelling or other suitable verification methods.
Where are SML values regulated? Specific Migration Limits for plastic materials intended for food contact are established in particular in Regulation (EU) No 10/2011.
Where can I find product-specific information? Information on the requirements relevant to a particular product can be found in the available compliance documentation and technical information for the respective product.

Important information

An SML is not a general limit for a packaging product. It applies to a specific substance. Several different SML requirements may therefore be relevant for a single plastic material.

Which Specific Migration Limits and verification requirements are relevant for a particular application depends, among other factors, on the material used, the substances involved, the food and the intended contact conditions.