Is FDA Review of Recycling Processes Required?
Is it necessary to submit information to FDA on the effectiveness of a recycling process to produce material that is safe for food contact applications? Or, can a re-processer certify the safety of its recycled product based on a review of extraction test results by a independent lab and/or Keller and Heckman without a formal review by FDA?
The U.S. Food and Drug Administration's (FDA) food additive regulations do not mandate special regulatory review or additional clearance of recycled food-contact material. FDA generally regulates food-contact materials based on their composition, and not on the specific process by which they are manufactured or the source of the raw materials. Accordingly, recycled food-contact material must meet the safety requirements of the Food, Drug and Cosmetic Act (the Act). They also must comply with the good manufacturing practices (GMP) requirements applicable to food-contact materials (found in Title 21, Section 174.5 of the Code of Federal Regulations), which require all indirect food additives to be of a purity suitable for their intended use. This means that the finished food-contact article must not contain any materials that will adulterate the food by making it harmful or deleterious to human health.
In addition, one can establish an acceptable regulatory status for a food-contact material (again, either virgin or recycled) by demonstrating through appropriately conducted extraction studies or calculations that it is not reasonably expected to become a component of food and, therefore, is not a food additive under the Act when used as intended.
FDA has provided guidance on the use of recycled plastics in its August 2006 document, "Guidance for Industry: Use of Recycled Plastics in Food Packaging: Chemistry Considerations." In the guidance, FDA discusses some specific issues that manufacturers should address in establishing the safety and regulatory compliance of recycled polymers for food packaging, including the requirement that recyclers ensure that possible contaminants from prior use are removed sufficiently by the recycling process. Although, a company may determine on its own if a recycling process produces material sufficiently free of contaminants so that the finished article will be suitably pure for its intended use in accordance with GMP requirements.
Therefore, in response to your question, since recycled food-contact materials that comply with the existing regulations do not require additional FDA regulation, a company that can establish to its own satisfaction, using scientifically sound methods, that a recycled material complies with the existing regulations and is suitably pure for the intended use is not required to consult with FDA for further clearance. However, companies that produce recycled food-contact materials can request a "no objection letter" from the Agency as a way of providing assurance to their customers as to the regulatory compliance and safety of their packages.