Food Contact Materials (FCM) - how the European Union regulates packaging safety

Risks associated with product contamination

Packaging intended for contact with food products is classified as a product with more stringent hygiene requirements. We can divide the risks and hazards associated with packaging into several groups. The first are contaminants of a biological nature; these are mainly micro-organisms present on the surface of the packaging. Another group is chemical agents, for example residues of cleaning agents. The risk classification also includes contaminants of a physical nature, such as foreign bodies from raw materials, packaging fragments or machine components.

Packaging legislation

The key piece of legislation governing packaging in the European Union markets is Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food. It regulates the manufacture, sale and processing of materials and articles intended to come into contact with food. It defines Food Contact Materials (FCMs), materials in contact with food and those which are reasonably likely to be brought into contact with food or to transfer their constituents to food under natural or foreseeable conditions of use.

The regulation regulates the types of substances and materials used in the manufacture of FCMs. It classifies, together with specific provisions, monomers, additives, excipients, barrier layers, as well as macromolecules formed during the process. The regulation introduces a key principle - inertness, or overall safety. According to Article 3(1), a material or article shall not cause the migration of constituents into food in quantities that endanger human health, bring about an unacceptable change in the composition of the food or bring about a deterioration in the organoleptic characteristics. The principle is fundamental in terms of migration testing, declaration of conformity (DoC), requirements for suppliers and quality control.

Pictogram: Approved for contact with food

The pictogram, with the symbol of a glass and fork, is a widely recognised label in EU countries. Its origin was based on the need for a mark to indicate the intended use of materials in contact with foodstuffs. Introduced by Regulation (EC) No 1935/2004, today it has a full identification function. In a legal context, the symbol indicates the food contact use of a material and is used for products made of plastics, metals, ceramics or paper when their food contact use is not obvious. Its characteristic design is strictly defined by regulation and is not subject to any modification. The symbol of a glass with a fork is used for easy identification also outside the EU. It can be found in the United States and some Asian countries, where its use is not explicitly regulated by legislation, but is applied in accordance with market practice.

Traceability or full traceability

Regulation 178/2002 introduced the principle of one step back - one step forward, thus establishing the obligation of full traceability of food, feed and materials and articles that may come into contact with food. The traceability principle was applied in Regulation 1935/2004, which imposed it on Food Contact Materials in the production, processing and distribution sector.

The key functions of the traceability principle are to protect public health, to enable effective and targeted batch recalls and, in addition, to assign responsibility to the operator. In the case of FCM, this is particularly relevant in incidents of migration, raw material contamination or Good Manufacturing Practice (GMP) errors. Traceability makes it possible to identify which entity in the supply chain has introduced a non-compliant substance, used a defective material or violated GMP requirements. This makes it possible to enforce accountability, conduct audit investigations and meet the requirements of IFS, BRC, ISO 22000 or HACCP audits. At each stage, identification of batches of materials is required in such a way that they can be traced. Documentation is to reflect the relationship of raw materials to the finished product. A prerequisite for the legal marketing of FCMs is the availability of traceability documentation to control authorities.

The first pillar of traceability, one-step traceability, means that the operator must have knowledge of the origin of materials, products, raw materials and any substances used in production. In practice, this means the need to document the suppliers, the individual delivery dates, the batches of materials involved in production. The second pillar is one-step traceability, thus the entity must have documentation of the B2B customer (this is not required for retail sales). The third pillar of traceability is the systemic linking of data into a coherent whole. This is important as it allows the traceability of a batch along the supply chain. It also makes it possible to establish the relationship between raw materials, intermediate products, the finished product and the customer. As a result, traceability makes it possible to immediately recall specific batches from the market, thus making it a viable safety tool.

Food contact plastics regulation

On 21 February 2025, Commission Regulation (EU) 2025/351 came into force, amending the FCM plastics regulations. It introduced the requirement of a high degree of purity (high purity) for substances used in the production of food contact plastics. This means that all substances must be uniquely identified and have a defined chemical identity. The regulation updates the regulations for recycled plastics and introduces clear rules for their authorisation for food contact, with an emphasis on purification and testing processes. It regulates the quality and purity requirements of raw materials, minimising the risk of migration of harmful substances. It extends the basic principles of material safety to the recycled raw material segment, which is of particular importance for reusable packaging and sustainable materials.

The regulation was introduced to update and clarify the EU regulatory framework for plastics in the context of food safety. They aim to raise the safety standards of FCM materials. It acts as an adaptation of existing legislation to technological change and increased use of recyclates. It is a strategic extension of existing legislation (in particular Regulations (EU) 10/2011 and 2022/1616) to enhance food safety, market transparency and support the integration of recycling in FCMs.