EC 1935/2004

Regulation (EC) No 1935/2004 of the European Parliament and of the Council is the central legal basis for materials that come into contact with food. It is an essential standard for the rubber industry, especially for food seals, rubber profiles, O-rings and moulded parts, to ensure safety and conformity.

What is Regulation (EC) No 1935/2004 about?

The regulation stipulates that all materials that come into contact, or may come into contact, with food must be manufactured so that they:

• do not, under normal or foreseeable conditions of use, release constituents in quantities that could endanger health
• do not cause an unacceptable change in the composition of the food
• do not impermissibly alter the odour or taste of the food

What does EC 1935/2004 mean for rubber products?

The regulation applies to all rubber materials in contact with food as a seal, hose, profile or moulded part. Common applications include:

• food processing (machines, agitators, plant components)
• filling and packaging technology
• beverage and dairy technology
• household appliance industry (e.g. coffee machines, water filters, blenders)

Which materials can be manufactured in compliance?

• Silicone (VMQ): outstanding temperature resistance, taste-neutral, flexible, frequently EC 1935/2004 compliant
• EPDM: suitable for aqueous foods, good resistance to steam and cleaning agents
• FKM (Viton): for fatty or oily foods in particularly demanding applications (on request)
• NBR: oil-resistant, food-compliant to a limited extent depending on compound and formulation

How do we prove conformity?

For materials that come into contact with food, a declaration of conformity in accordance with Art. 16 of the regulation is issued on request. This declaration includes:

• information on composition and material identity
• applicable migration limits (SML / OML)
• conditions of use (temperature, medium, duration)
• test results from accredited laboratories where applicable

Additional regulations and harmonisation

Since rubber is not a harmonised material within the meaning of the regulation, testing is often based on national regulations such as:

• Recommendation XXI of the BfR (German Federal Institute for Risk Assessment, formerly BgVV)
• FDA 21 CFR §177.2600 (USA)
• Standards such as ISO 10993, USP Class and Sanitary in the medical sector

In many cases, additional tests for specific migration are carried out.

Our services for food-compliant rubber parts

• Material advice and selection of EC 1935/2004 compliant materials
• Manufacture of seals, profiles, O-rings and moulded parts for food contact
• Provision of declarations of conformity and laboratory tests
• FDA, BfR or USP compliant on request