FCM: compliant does not automatically mean safe
When we talk about FCM (food contact materials) – packaging, containers, utensils, etc. – the primary concern is ensuring that they do not pose a risk to consumer health.
However, confusion often arises between two concepts that, while related, are not synonymous: regulatory compliance and safety.
Compliance: adherence to written rules
An FCM is considered compliant when it passes the tests required by legislation.
For example, for plastics, Regulation (EU) No. 10/2011 sets out global and specific migration limits that must be respected. If analyses show values below the limits, the material is compliant.
Compliance, therefore, is a “legal” concept: the product meets the parameters established by law.
Safety: the actual protection of the consumer
But compliance alone is not sufficient to guarantee safety.
According to Article 3 of Regulation (EC) No. 1935/2004, an FCM is truly safe only if it does not release substances in quantities that:
- could endanger human health,
- cause a change in the composition of the food,
- alter in an unacceptable way the organoleptic characteristics of food (taste, smell or appearance).
In other words, safety is a broader concept than compliance: it concerns the actual effects that the material may have on food and, therefore, on the consumer.
Some practical examples:
- A plastic cup may show global migration values below the legal limits → compliant. However, it could release unregulated compounds that are toxicologically relevant → not safe.
- A metal container may comply with the migration limits for metals → compliant. But if it alters the taste of the food → not safe.
- A stainless-steel cutlery item that does not release hazardous substances and complies with all the analytical limits set by law → compliant and safe.
These examples show that compliance is a necessary but not sufficient condition.
Conclusions
The real protection of the consumer cannot be achieved by limiting the assessment to the analytical verification of legal limits. A more comprehensive approach is required, which includes:
- knowledge of the raw materials used and of manufacturing and processing methods,
- consideration of real conditions of use (temperature, contact time, type of food and packaging processes),
- updated toxicological and organoleptic risk assessments.
In summary:
- an FCM may be safe but not compliant if it contains non-authorized substances which, however, pose no toxicological risk;
- an FCM may be compliant but not safe if, while meeting the legal parameters, it releases undesirable substances or significantly alters the organoleptic characteristics of food.
The distinction between compliance and safety therefore lies in the difference between the formal respect of regulatory requirements and the substantive guarantee of consumer health protection (respect of art. 3 – Regulation EC 1935/2004). In this perspective, it is necessary to move from a “target” analytical approach to a risk assessment approach, integrating experimental data with expert critical evaluation and with adequate knowledge of the production chain.
Consumer protection is therefore achieved through a control system that goes beyond the verification of analytical requirements and is based on a critical analysis of data, structured dialogue with the raw material suppliers, and, where possible, with the end-users.
