A guide to EC1935/2004 food contact materials regulations

Prior to 2004, requirements for FCMs in Europe varied significantly from country to country, with each government having its own local rules and regulations. The European Commission recognised that a new single piece of legislation was required to standardise the regulation of FCMs and in 2004, EC1935/2004 regulation was established. The regulation is commonly referred to as the ‘Framework Regulation’. It was implemented in 2012 and it has been in effect since 2016. 

There are two main requirements for FCM and articles as laid down in Article 3 of Regulation (EC) No 1935/2004.

First, all FCM and articles should be manufactured in compliance with good manufacturing practice, so that, under normal and foreseeable conditions of use 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 (e.g. taste or odour)
• bring about a deterioration of its organoleptic (acting on, or involving the use of, the sense organs) characteristics.

Second, the labelling, advertising and presentation of a FCM or article should not mislead the consumers.

Good manufacturing practice (GMP) is further defined in Regulation (EC) No 2023/2006, which applies to all materials and articles intended to come into contact with food. Under the GMP regulation, business operators are obliged to establish, implement and adhere to ‘quality assurance’ and ‘quality control’ systems. 

It is worth noting that the term FCM includes direct or indirect contact and does not cover fixed public or private water supply equipment.

Each material needs to have appropriate certification to comply with the regulation and the certificate needs to include specific information. Every certificate should include data as shown in figure 1, including material and traceability data, Declaration of Compliance (DOC) statement and Food and Drugs Administration (FDA) statement. Migration test results and stickers must also be present on the certificate for it to be valid. What’s more, certificates must be obtained before any component is placed on the market.

The regulations apply to each specific component material and part that comes into direct contact with food. For example, every O-ring in a machine will need a certificate for the different material compounds. And each time an O-ring is replaced by one made from a different material batch, you need a new certificate according to its batch. Don’t underestimate the amount of components that require a certificate, even the bearing lubricants have to be food safe.

Additionally, the necessity for certification depends on the final location of the machine, rather than the origin of the equipment. And, the responsibility for adhering to legislation not only lies with those manufacturing food, but also those manufacturing equipment for use in food processing

Figure 1 – Information that must be included on a certificate to comply with EC1935/2004

The manufacturer provides the conditions of operation, for example, type of food, temperature, contact time, number of contacts and contact surface, and tests must be carried out as per EN 1186 standard at an ISO17025 laboratory.

One material group that is not controlled by EU 10/2011 is rubber and silicon. There is no EU harmonization for these materials and instead they must comply with applicable law in the EU Member State in which they are operating. Alternatively, they are also in compliance if it meets the requirements as set out by article 3 of the EC1935/2004. 

Figure 3 – Example of migration values based on test. 

This article states that:

• Food contact materials should be manufactured according to the GMP, so that they do not transfer their constituents in quantities that could:
• Endanger human health, or;
• Bring about an unacceptable change in the composition of the food, or;
• Bring deterioration in the organoleptic characteristics of the food.
• Labelling, advertising, and presentation of material or article cannot mislead consumers.
   

Other international standards to be aware of when working with food and supplying equipment to the industry are those set by the U.S. FDA and the NHFPC China Food Safety Law, who govern food safety standards in other major markets. 

It is worth bearing in mind, that even though you may be conforming to FDA standards, it does not mean you are necessarily adhering to EC1935/2004. Indeed, you need to pay special attention to this European regulation.