FCM Compliance: Is There an Official Certification?

wfbadmin — Fri, 22 Aug 2025 19:34:54 +0000

The short answer is: no, there is no single, official “FCM certification” issued by a European or Italian regulatory body.

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.

L'articolo FCM Compliance: Is There an Official Certification? proviene da Carmen Sorice Regulatory Affairs.

Introduction to EC Framework Reg. 1935/2004: What Companies Need to Know

wfbadmin — Tue, 07 Nov 2023 06:56:58 +0000

For Companies operating in the food industry, understanding the EC Framework Regulation 1935/2004 is crucial. This Regulation lays down the basic principles for all materials and articles intended to come into contact with foodstuffs.

What the Rules of Procedure

The Reg. EC 1935/2004 lays the foundations for ensuring a high level of protection of human health and consumer interests. It establishes that materials in contact with food must not release substances in quantities likely to endanger human health or resulting in an unacceptable change in the composition of foods or a deterioration in their organoleptic characteristics.

Obligations for Companies

Companies must ensure that materials in contact with food comply not only with the framework regulation but also with all the specific measures that may apply.
Systems and procedures must be implemented to ensure that:

The materials used are suitable for their intended use and meet safety requirements.
It is maintained a complete and updated documentation that can track the compliance of each product.
Regular checks and tests are carried out to ensure that there is no migration of dangerous substances.
The traceability of products is ensured at all stages to facilitate the control, recall of defective products, information to consumers and the attribution of liability.
There should be adequate labelling of the materials so that they can be used properly.

Good Manufacturing Practices (GMP)

The regulation underlines the importance of Good Manufacturing Practices (GMP). Companies must adopt GMP to ensure that FCM production takes place under hygienic and controlled conditions, preventing contamination and ensuring product safety and compliance.

Adherence to EC Reg. 1935/2004 is a legal obligation and an ethical responsibility for Companies in the sector. Understanding and applying the provisions of the Regulation is essential to protect consumers and maintain confidence in the food market.