When it comes to requirements for materials and articles intended to come into contact with food (FCM), understanding key concepts is of fundamental importance. Consumer safety depends on accurate risk assessment, which requires distinguishing between terms that are often confused. In this article, we will explain the difference between overall and specific migration, as defined in Regulation (EU) No 10/2011, and show why this distinction is so important for ensuring food safety.
Overall migration: An indicator of stability, not safety!
It is often believed that overall migration testing is sufficient to assess the safety of FCMs. Nothing could be further from the truth! Overall migration, in the context of Regulation (EU) No 10/2011, is primarily used to assess the inertness of a material, i.e. its overall ‘neutrality’ towards food. This test allows us to determine whether the material releases excessive amounts of non-volatile substances in a specific food simulant and under specified conditions, in accordance with Article 12 of the Regulation.
This is undoubtedly a basic compliance test that must be carried out for all plastics intended to come into contact with food. It acts as a kind of ‘filter’ that allows materials with high overall migration to be rejected. However, a positive result in the overall migration test is by no means equivalent to a full FCM safety assessment. Why? Because overall migration does not provide information on which specific substances are migrating or whether they are toxic.
In summary, overall migration is a test of material inertia, essential for assessing compliance with Article 12 of Regulation (EU) No 10/2011, but insufficient for assessing safety. It is only the sum of non-volatile substances migrating from material.
So what should be done to achieve full compliance with the requirements?
Specific migration: The key to health risk assessment
A true safety assessment of a food contact material is based on specific migration. It allows the migration of individual substances to be identified and measured, both intentionally added substances (IAS) and non-intentionally added substances (NIAS).
This brings us to the heart of the matter, which is particularly emphasised by the latest amendment to Regulation (EU) No 10/2011, the so-called ‘Quality Amendment’. It reinforces the need to identify and assess NIAS that may appear in FCM as a result of manufacturing processes, material degradation or contamination. Ultimately, it is specific migration that allows us to answer the key question: can migrating substances pose a risk to human health?
This fits perfectly with the fundamental principle contained in Article 3 of Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food, which states that:
“Materials and articles (..) shall be manufactured in compliance with good manufacturing practice so that (..) they do not transfer their constituents to food in quantities which could:
- pose a risk to human health;
- cause unacceptable changes in the composition of food;
- cause deterioration in the organoleptic properties of food. “
Only by testing specific migration can the first and most important point be verified – whether the migrating substances pose a risk to human health. Overall migration, although necessary, does not provide this critical information.
Summary
Overall migration is a test of material inertia, essential for assessing compliance with Article 12 of Regulation (EU) No 10/2011, but insufficient for assessing safety. It is only the sum of non-volatile substances.
Specific migration is key to assessing the safety of FCMs, allowing the identification and assessment of risks associated with the migration of both intentionally added substances (IAS) and unintentionally added substances (NIAS).
Full FCM safety can only be ensured through a comprehensive analysis that takes into account both overall migration requirements and a detailed assessment of migrating substances (specific migration) in accordance with the latest guidelines and Good Manufacturing Practice (GMP).
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