FOOD SAFETY
restrictions or dual-use additives), as well as the identification number that links the declaration to specific batches. The document also refers to the relevant legislation, indicates the intended conditions of use( for example, the type of food, contact times and temperatures), and bears the date, name and signature of the person responsible.
GMP for materials
In 2006, alongside the framework Regulation( EC) No. 1935 / 2004, Regulation( EC) No. 2023 / 2006 was introduced. This regulation lays down the rules on good manufacturing practice( GMP) for materials and articles intended to come into contact with food, as required by Article 3. GMP refers to those aspects of quality assurance which guarantee that materials and articles are consistently produced and controlled so as to comply with the applicable rules and meet the quality standards appropriate to their intended use, without endangering human health or causing unacceptable changes in the composition or sensory characteristics of food. While the framework regulation envisages the adoption of specific safety rules for each material class( as implied in Article 3), to date, only some categories benefit from harmonised EU measures. For others, national legislation or industry standards continue to fill the gap, often resulting in a fragmented and non-uniform regulatory environment across Member States.
Regulation( EC) No. 2023 / 2006 lays down the rules on good manufacturing practice for materials and articles intended to come into contact with food.
For example, plastic materials are regulated by Regulation( EU) No. 10 / 2011, which sets specific requirements for the manufacture and marketing of plastic materials and articles intended to come into contact with food or which can reasonably be expected to do so. This regulation outlines the requirements on the composition of plastic materials and articles and establishes the contents of the Union list of authorised substances. It also details the procedures for migration testing and defines the limits within which compliance must be assessed, thereby ensuring the suitability of the material for food contact.
Rubber materials
The case of rubber materials is considerably more complex, since no EU regulation currently exists and national regulations remain the main reference. Each country applies its own approval schemes, safety requirements and testing protocols, often leading to significant differences, with notable examples including:
• BfR Recommendation XXI“ Commodities based on natural and synthetic rubber”, BfR Recommendation XXI / 1“ Commodities based on natural and synthetic rubber in contact with food” and BfR Recommendation XXI / 2“ Special consumer goods made of natural and synthetic rubber and of lattices made of natural and synthetic rubber( formerly special category)” for Germany.
• Arrêté of August 5th, 2020 for France.
• D. M. 21 / 03 / 1973 for Italy.
• Royal Decree 847 / 2011 for Spain.
Advancing food safety
Although the points discussed here represent only a fraction of the complex regulatory framework governing food contact materials, it is clear that EU legislation has undoubtedly advanced food safety by establishing clear principles and introducing specific rules for certain material classes. Regulation( EC) No. 1935 / 2004, together with its related measures, has provided a solid foundation for ensuring consumer protection, while instruments such as Regulation( EU) No. 10 / 2011 for plastics demonstrate how harmonised legislation can foster both safety and market consistency. However, the lack of a fully harmonised approach for all material categories, particularly for elastomers, creates significant challenges for manufacturers and end users. The coexistence of national legislations, often divergent in scope and testing requirements, increases complexity, raises compliance costs, and sometimes generates uncertainty in crossborder trade. A common European framework covering all materials would not only enhance consumer safety but also streamline regulatory compliance for industry operators, promoting innovation and ensuring fair competition. Until such harmonisation is achieved, companies must continue to navigate a fragmented landscape, relying on a combination of EU regulations, national provisions and recognised industry standards.
References
• EC 1935 / 2004
• EC 2023 / 2006
• EU 10 / 2011
• Explanatory views on Regulation( EU) No. 10 / 2011 on plastic materials and articles intended to come into contact with food – Plastic Europe
• Position paper Rubber materials in contact with food and drinking water – ETRma
22 Valve World December 2025 www. valve-world. net