We can help with:
- FDA Regulations
- EU Regulations
- EU Member States' National Legislation
- Global Regulations
- Product Formulations
- Advice on and Auditing of Compliance Systems
- Training on Legislation and How to Comply
A brief overview of Food Contact regulations for the USA, the EU, and outside of these regions is detailed below. See the dedicated pages for specific information on FDA (USA) Regulations and EU Regulations.
Food Contact Articles - USA
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 built up since 1958, 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. Additionally, you need 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 program.
Food Contact Articles - Europe
In the European Union, all Food Contact 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 healthy 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 (EU Regulation 10/2011 and its amendments)
- Regenerated Cellulose Films (Directive 2007/42/EC)
- Ceramics (Directive 84/500/EEC as amended by Directive 2005/31/EC)
And also for some individual substances:
- BADGE, BFDGE and NOGE (Regulation No 1895/2005)
- 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 show compliance with the Framework Regulation - this is most commonly achieved 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.
Outside of the USA and the EU
Globally, there is a variety of legislation:
- 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 in some other countries such as Australia and New Zealand however recognition that compliance with EU or FDA Regulations is recommended to show materials and articles are safe
Our experts understand all of the above jurisdictions, keep up to date with changes, and are here to help you show compliance in all of the markets you operate in.
For more information, please contact us.