The manufacture and commercial use of fluorinated chemistries, like most polymers and chemicals, are subject to review by regulatory bodies around the world. For food packaging and food contact applications, many governments require additional data. Following is a brief overview of some of the regulatory agencies around the world that have reviewed fluorinated chemistries. This list is not exhaustive, but highlights many of the major relevant regulatory agencies.
The U.S. Environmental Protection Agency (EPA) regulates existing and new chemicals in commerce, including chemicals imported to the U.S. Reviewing New Chemicals under the Toxic Substances Control Act (TSCA)
The U.S. Food and Drug Administration (FDA) assesses the safety of food contact applications (“food contact substances”), including substances used in packaging materials and repeat-use food contact applications such as components of dispensers and food processing equipment. Packaging & Food Contact Substances (FCS)
Environment and Climate Change Canada
Under Canada’s New Substances Notification Regulations, new substances (chemicals and polymers) are assessed for potential risks to human health and the environment and, if required, control measures are put in place before they are introduced into the Canadian marketplace. New Substances Notification Regulations (Chemicals and Polymers) .
In the European Union, chemicals are regulated under REACH (registration, evaluation, authorization and restriction of chemicals). Understanding REACH
The European Food Safety Authority (EFSA) evaluates the safety of substances used in food contact materials (FCM) in Europe. European Food Safety Authority
In Australia, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) assesses the risks of industrial chemicals and provides information to promote their safe use. NICNAS
China’s Ministry of Environmental Protection (MEP) Provisions on Environmental Administration of New Chemical Substances (China REACH) requires companies to submit a new chemical substance notification for new chemicals. The notification also applies to new substances used in cosmetics and as food additives. MEP
Under the Japan Chemical Substance Control Law, the Ministry of Economy, Trade, and Industry subjects new chemicals coming on the market to a strict pre-manufacturing evaluation. Additionally, manufacturers and importers are required to report existing substances if the volume of those substances exceeds a certain amount. Chemical Management (METI)
Manufacture and import of new and existing chemical substances in Korea are subject to potential registration requirements with the Ministry of Environment under the Act on the Registration and Evaluation of Chemicals (known as K-REACH). Ministry of Environment