Regulatory Compliance

The food contact legislation your product needs to comply with depends on where it is being marketed. Our experts have been helping clients show compliance since 1985 and their expertise covers the regulations that exist all around the globe. Follow the links below for specific details:

EU Regulation and Directives
European National Legislation
FDA Regulations
Global Regulations
Product Formulations
Advice on and Auditing of Compliance Systems
Training on Legislation and How to Comply

In the European Union all food contact articles and materials have to comply with The Framework Regulation No 1935/2004 and the Good Manufacturing Practice (GMP) Regulation No 2026/2006.

The Framework Regulation lays down the basic rules including requirements that articles and materials shall not transfer their components into the food in quantities that could endanger human health or bring about unacceptable change to the composition, smell or taste of the food.

The GMP Regulation lays out general requirements for the quality assurance and control systems that are needed to prove compliance, along with some more specific guidance on use of printing inks and recycled plastics.

The Framework Regulation is then implemented by specific measures for some materials:

plastics (Directive 2002/72/EC and its amendments);
regenerated cellulose films (Directive 2007/42/EC); and,
ceramics (Directive 84/500/EEC as amended by Directive 2005/31/EC).

And also for some individual substances:

vinyl chloride monomer (Directives 78/142/EEC, 80/766/EEC and 81/432/EEC);
BADGE, BFDGE and NOGE (Regulation No 1895/2005); and,
nitrosamines (Directive 93/11/EEC and BADGE, BFDGE and NOGE (Regulation No 1895/2005).

If your article or material is made from these materials, or may contain these individual substances, then you have to comply with the applicable specific measures. However, if it is made from other materials then you need to find another route to showing compliance with the Framework Regulation, most commonly by using the national legislation existing in countries like Germany, the Netherlands, France and Italy and then applying The Principle of Mutual Recognition to enable you to market in all the other member states.

In the USA there is a comprehensive body of food contact legislation contained in Chapter 21 Code of Federal Regulations (CFR) sections 170 to 199. This has been built up over the period from 1958 to the present day by incorporating food contact substances petitioned to the FDA and probably represents the most extensive system of food contact regulation. However, not everything that can be used is listed in the Regulations. In addition you have to be aware of prior sanction, substances generally recognised as safe, the basic resin doctrine, the mixture doctrine, the threshold of regulation, the housewares exemption, the no migration exemption and substances notified since October 1999 using the Food Contact notification programme.

Outside of the EU and USA there is a variety of legislation:

reasonably comprehensive regulations in Canada, Latin America, Japan, South Korea, China and Israel;
regulations covering some aspects of food contact in some countries in South East Asia and India;
little or no specific legislation, but recognition that compliance with EU or FDA Regulations is enough to show that materials or articles are safe in some other countries such as Australia and New Zealand.

Our experts understand all of the above jurisdictions, keep up to date with the changes, and are here to help you show compliance in all the markets you operate in.