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FCMs: regulations and rules for materials intended to come into contact with food

When we talk about food safety, our thoughts almost always go to the quality of ingredients, the cleanliness of facilities, proper storage or product traceability. There is, however, another less visible aspect that is just as important: everything that comes into contact with food. A cap, a bottle, a gasket, a tray, a flexible pouch, a work surface, a part of a filling machine: every material that touches a food product, directly or indirectly, can affect its safety, its quality and, in some cases, even its taste or smell.

This is where food contact materials (FCMs) come into play, meaning materials and articles intended to come into contact with food. A technical acronym, of course, but behind it there is a very concrete issue: preventing what is used to produce, package, transport or consume food from becoming a source of contamination.

What food contact materials (FCMs) really are

Food contact materials (FCMs) are not only food packaging. The definition covers a very broad set of materials and articles: containers, films, bottles, caps, tools, tableware, transport vessels, but also components of the machines used in food production and packaging. The European Commission includes food processing machinery among food contact materials, alongside packaging, containers and utensils. The point is not the material itself, but its function. If an item is intended to come into contact with food, if it is already in contact with food, or if it is reasonable to expect that it may transfer substances to food under normal conditions of use, it falls within the scope of food contact materials. This changes the way a production process is viewed. Take the case of a small company that packs a ready-made sauce in jars. The glass container, the closure cap, the inner gasket of the cap, the hose that carries the product to the filler, the dosing valve and the nozzle that enters the jar are all different elements, but they have one thing in common: they come into contact with food, or they can affect its safety. It is not enough for the jar to be suitable. The entire product path must be.

The rules cover very different materials: plastics, paper, cardboard, glass, metals, rubber, ceramics, silicones, adhesives, coatings, inks, active and intelligent materials. Some are governed by specific EU rules, others also by national provisions. For this reason, compliance cannot be assessed in a generic way: it depends on the material, the food, the temperature, the contact time, the type of processing and the intended use. A flexible pouch suitable for a cold product, for example, is not necessarily suitable for hot filling. A component that works well with an aqueous product may not be suitable for a fatty or highly acidic preparation. The wording “suitable for food contact” only makes sense if it is linked to specific conditions.

Food contact materials (FCMs): safety, inertness and good practices

The key EU reference is Regulation (EC) No 1935/2004. It sets out a simple principle: materials and articles intended to come into contact with food must be manufactured so that they do not transfer their constituents to food in quantities that could endanger human health, bring about an unacceptable change in the composition of the food, or alter its taste or smell. This principle is often summed up in one word: inertness. A suitable material must behave in a stable way. It must not release substances beyond the applicable limits, it must not change the product, it must not interfere with its characteristics. A concrete example is fatty foods. Some substances migrate more easily in the presence of fats than with other types of food. For this reason, packaging or a technical component cannot be assessed only in the abstract: it is necessary to know which product it will work with. A spreadable cream, pesto or an oily sauce create different conditions compared to a juice, a syrup or a dry product.

Alongside the framework regulation there is Regulation (EC) No 2023/2006 on good manufacturing practice, often referred to by the acronym GMP. This means that the safety of food contact materials does not depend only on the material chosen, but also on how it is designed, produced, controlled and documented. It is not enough to purchase a suitable material: it must be possible to demonstrate that this material has been handled within a controlled process. For plastics, one of the most widely used materials in packaging and technical components, the specific reference is Regulation (EU) No 10/2011. This text governs, among other things, authorised substances and migration limits. In 2025 the framework was updated by Regulation (EU) 2025/351, published in the Official Journal of the European Union on 24 February 2025 and entering into force on 16 March 2025. The update amends the plastics regulation, the regulation on recycled plastic intended to come into contact with food and the regulation on good manufacturing practice.

Regulatory evolution matters because materials change, supply chains are updated and the use of recycled or recyclable solutions increases. But sustainability does not replace safety. A lighter material, a recycled material or a solution designed to reduce environmental impact must still be assessed for contact with the specific food and under the intended conditions of use. In Italy, Legislative Decree No 29 of 10 February 2017 introduced the penalty system for breaches of EU provisions on food contact materials. The decree covers, among others, Regulation (EC) No 1935/2004, Regulation (EC) No 2023/2006 and Regulation (EU) No 10/2011. It also provides for communication obligations for economic operators that produce, process or distribute materials and articles intended to come into contact with food, subject to specific exclusions linked to direct sale to the final consumer.

Declaration of compliance and certification: they are not the same thing

One of the most frequent misunderstandings concerns the difference between a declaration of compliance and certification. The declaration of compliance is a mandatory document. It is used to state that the material or article complies with the applicable legislation. It must accompany the food contact material (FCM) through the stages of commercialisation, with the exclusion of retail sale, and it also contains indications on conditions of use and any limitations. The Italian Ministry of Health clarifies that every food contact material (FCM) placed on the market must be accompanied by a declaration of compliance issued by manufacturers, converters or importers. It is not a document to be filled in automatically. It is an assumption of responsibility. To be correct, it must be based on consistent technical documentation: material composition, migration tests where required, conditions of use, regulatory references, any restrictions, batch traceability and information received from suppliers.

Let us imagine a laboratory that purchases containers and caps to pack a hot sauce. The declaration of compliance must help to understand whether those materials are suitable for an acidic food, whether they can be used with the intended process, whether they tolerate the filling temperature and whether there are limits that must be respected. If the same container is then used for another product, fattier or filled at a different temperature, the assessment must be reconsidered. It is not said that compliance also covers the new use.

This also applies to machine components. A hose, a gasket or a valve may have correct documentation, but they must be compatible with the food and with the process. One thing is working with a cold, low-viscosity liquid, another is handling a hot, dense, oily product or one with pieces in suspension. The declaration of compliance exists precisely to avoid taking suitability for granted.

Certification, instead, is generally voluntary. It can be issued by third-party bodies under specific schemes and can be useful to strengthen process control, provide stronger evidence to the market and demonstrate the adoption of structured procedures. But it does not replace the declaration of compliance, nor does it remove the responsibility of the economic operator.

Why compliance also applies to machinery

In food packaging, the issue of food contact materials (FCMs) does not stop at choosing the jar, the bottle or the pouch. It also concerns the parts of the machine that come into contact with the product: dosing syringes, valves, hoses, nozzles, gaskets, hoppers, filling components and closing systems. Here, compliance becomes a very practical issue. Let us think of a company that packs fresh pesto in jars. The product is thick, contains oil, may have particles in suspension and requires attention during dosing. The product path must be designed to avoid stagnation, make cleaning easier and keep the quantity filled into each jar constant. The product-contact materials must be suitable, but component geometry also matters: a valve that is difficult to disassemble or a point where product builds up can become an operational problem even before a regulatory one. A different case is a sauce filled hot. In that context, temperature changes working conditions. It is not enough to know that a component is suitable for food contact: it must be verified that it is suitable for that type of product and at that temperature. The same reasoning applies to the container and the closure, because the system must work as a whole.

Cleaning is also part of the issue. If a machine runs different products during the week, for example honey, jam and cream, changeover is not only about dose adjustment. It is about the ability to quickly disassemble product-contact parts, wash them effectively and reduce the risk that residues from the previous product remain in the circuit. In some systems, built-in cleaning capability can simplify the process; in other cases, ease of disassembly remains the decisive factor. This is why, when talking about food contact materials (FCMs), the right question is not only “is this material suitable for food?”. The complete question is: “is it suitable for this food, under these conditions, within this process?”. This is where regulation becomes concrete. It does not remain on paper, but enters into the choice of the container, the configuration of the machine, cleaning, maintenance and the documentation that accompanies every production step.

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