There is an emphasis throughout the United States on increasing the uses of post-consumer recycled (PCR) materials, including plastic. FDA is involved when industry collects used polymeric materials (usually food containers) and proposes to recycle these materials to make new food containers. FDA's main safety concerns with the use of PCR plastic materials in food-contact articles are: 1) that contaminants from the PCR material may appear in the final food-contact product made from the recycled material, 2) that PCR material may not be regulated for food-contact use may be incorporated into food-contact article, and 3) that adjuvants in the PCR plastic may not comply with the regulations for food-contact use. To address these concerns, FDA considers each proposed use of recycled plastic on a case-by-case basis and issues informal advice as to whether the recycling process is expected to produce PCR plastic of suitable purity for food-contact applications. FDA has prepared a document entitled Guidance for Industry - Use of Recycled Plastics in Food Packaging: Chemistry Considerations that will assist manufacturers of food packaging in evaluating processes for PCR plastic into food packaging.
If a manufacturer would like FDA to consider the use of recycled plastic for a food-contact application, the following information should be submitted:
- A complete description of the recycling process, including a description of the source of the PCR plastic and a description of any source controls in place intended to ensure that only plastic that initially complied with the applicable regulations is recycled. Also, a description of any steps that are taken to ensure that the recyclable plastic is not contaminated at some point, either before collection for recycling, or during the recycling process.
- The results of any tests performed to show that the recycling process removes possible incidental contaminants. For use of the recycled material as a substitute for plastic made from virgin materials, it would be necessary to either show that there has been no possibility of contamination with substances other than food, such as strict source control on the input material, or to demonstrate the cleaning efficiency of the recycling process through surrogate contaminant testing. If appropriate, additional migration testing or migration modeling may be conducted to show that the recycling process successfully removes possible incidental contaminants to a level that does not allow each contaminant to migrate from recycled plastic to food that would result in a dietary concentration (DC) exceeding 0.5 ppb, which FDA equates to a negligible exposure level for the use of recycled plastics for food packaging. However, surrogate contaminant testing is no longer considered necessary to demonstrate that PCR polyethylene terephthalate (PET) or polyethylene naphthalate (PEN) produced by a tertiary recycling process is suitable for food-contact use. Because FDA has determined that tertiary recycling processes produce PCR-PET or PCR-PEN of suitable purity for food-contact use, the Agency no longer evaluates tertiary recycling processes for PCR-PET or PCR-PEN or issues individual opinion letters for those processes.
- A description of the proposed conditions of use of the plastic (e.g., information on intended temperature of use, type of food with which the plastic will come into contact, the duration of the contact, and whether the food-contact plastic will be for repeated or single-use applications.)
Questions pertaining to the use of recycled plastics in food packaging should be directed to the Office of Food Additive Safety (firstname.lastname@example.org).
Click the launch button below to access a list of submissions for which FDA issued a favorable opinion on the suitability of a specific process for producing post-consumer recycled (PCR) plastic to be used in the manufacturing of food-contact articles.