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.

Regulatory framework

• FCMs (Food contact materials) are regulated at the European level by Regulation (EC) No. 1935/2004, also called the FCM Framework Regulation, which sets out the general principles.
• For certain categories of materials (e.g., plastics under Reg. (EU) 10/2011), there are specific harmonized regulations that establish migration limits and other technical requirements.
• In Italy, some decrees supplement these provisions for various types of non-harmonized materials: paper, glass, rubber, stainless steel, aluminium, etc.

What is mandatory

Every business operator must ensure that their FCMs comply with the legislation.
The main obligation is to draft and make available a Declaration of Compliance (DoC), based on adequate supporting documentation:

• traceability and proper documentation of raw materials,
• test results demonstrating compliance with specific rules,
• toxicological and organoleptic evaluations,
• adherence to GMP (Good Manufacturing Practices, Reg. (EC) 2023/2006) with controlled production procedures to ensure material safety.

“FCM Certification”: why are we talking about it?

• Some certification bodies issue voluntary certificates or attestations, primarily based on audits and laboratory tests, demonstrating compliance with regulatory requirements.
• These are not mandatory certifications nor unique at the EU level: they have commercial value and serve as guarantees for customers, not as legal proof.
• Sometimes the term “FCM certification” is used incorrectly; in reality, these are compliance attestations or voluntary certifications related to management systems (e.g., ISO 22000, BRC Packaging, etc.) that include FCMs.

Conclusions

To ensure FCM safety and regulatory compliance:

• There is no official and mandatory “FCM certification”. Compliance with regulatory requirements is demonstrated through a mandatory document, the Declaration of Compliance.
• For FCM manufacturers and distributors, the concrete obligations are to ensure material safety through:
  • drafting and making available the Declaration of Compliance (DoC),
  • conducting specific tests and toxicological evaluations,
  • ensuring traceability of raw materials,
  • adopting GMP throughout the production process.
• Voluntary certifications exist and can, in some cases, enhance reliability toward customers and markets.

Operators in the FCM sector should focus on regulatory compliance, safety and traceability, while any voluntary certifications serve as additional guarantees.

EFSA has recently carried out a new assessment of the public health risks of styrene, a substance used in plastic FCM, currently regulated in Regulation (EU) 10/2011 on plastics without a specific migration limit (SML) or other use restrictions.
In 2019, the International Agency for Research on Cancer (IARC) published a monograph classifying styrene and its main metabolite, styrene-7,8-oxide (SO), as “probably carcinogenic to humans”. As this classification could influence the inclusion of styrene in the Plastics Regulation, the European Commission asked EFSA to assess whether the evidence presented by IARC could impact the safety of using styrene in food contact materials.

In September 2020 EFSA, with a first assessment, concluded that concerns about the genotoxicity of styrene following oral exposure could not be excluded and that further data were needed to accurately assess its safety in FCM.
Considering the uncertainty about genotoxicity, the absence of an SML and the high potential for styrene to migrate into food from FCM, the European Commission proposed a draft measure setting an SML for styrene of 40 ppb, based on the tolerable daily intake (TDI) suggested by the World Health Organization (WHO) for styrene in drinking water.
The European Commission subsequently requested EFSA to review the potential genotoxicity of styrene following oral exposure and its safety for use in plastic FCM with an SML of 40 ppb.
As the WHO TDI predates the new scientific information emerging from the 2019 IARC classification and EFSA opinion in 2020, EFSA conducted a new assessment to determine whether the 40 ppb limit for styrene in food was adequate to ensure safety, evaluating, among others, the studies reported in the 2019 IARC monograph.

EFSA concluded that the reviewed studies did not show evidence of genotoxic effects of styrene following physiological exposures, including oral exposure.
For substances for which no genotoxic effects have been found, EFSA’s Note for Guidance for FCM states that an SML of up to 50 µg/kg food would not pose a health risk. Therefore, the use of styrene in the production of FCM with a migration limit set at 40 µg/kg food does not pose a health risk to consumers.

EFSA invited interested parties to submit comments on the draft opinion by 28 January 2025.