What Regulations Impact Microwaveable Pouches?
If we produce a microwavable pouch, are there any regulations in the U.S. or Europe that we need to follow?
The U.S. Food and Drug Administration (FDA) has not issued any specific regulations on food packaging for microwave use. However, the intended use of a product is an important factor in establishing FDA clearance of food contact substances under the Food Contact Notification (FCN) program. (A previous Ask an Attorney response discussed conditions of use applicable to microwave packaging).
In addition, any package used in a food contact application must be suitable for the intended use under FDA's good manufacturing practices (GMP) regulation found in Title 21 of the Code of Federal Regulations (CFR), Section 174.5 ("General provisions applicable to indirect food additives"). In the case of microwave susceptor packages, you should consider the possibility that degradation products could form since the temperatures in these packages can approach 500ºF (260ºC) during microwaving.
In the European Union (EU), most food packaging materials are not yet regulated by specific directives or regulations, other than the EU Framework Regulation, which requires, generally, that food-contact materials be safe for their intended use. The one exception is articles intended for use in contact with food made exclusively of plastics, or layers of plastics. Such articles must comply with the EU Plastics Directive (2002/72/EC), as amended.
If a pouch for holding or packaging is made only of plastic, or layers of plastic, the monomers and other starting materials (as well as any additives after December 31, 2009) used to make the pouch must be listed on the EU Plastics Directive unless a specific exemption applies. (Exemptions to the requirement for a positive listing for monomers include (among others) those monomers that are used solely in the manufacture of surface coatings, epoxy resins, adhesives and adhesion promoters, and printing inks.)
In addition to having a listing on the positive lists on the Plastics Directive, substances intended for use in food-contact plastics also must comply with any applicable limits to be considered acceptable for use in food packaging. Unlike FDA's regulations, the Plastics Directive generally does not limit the use of permitted substances according to their intended temperature conditions of use (i.e., by distinguishing whether a substance may be used for high temperature applications, such as cooking or reheating in the microwave). However, we would need to review the complete composition of the pouch under an attorney-client relationship before we could make a determination whether the product itself and its intended condition(s) of use comply with applicable EU laws, or for that matter, laws in the U.S.