Updated Guidance Helps Food Packagers Determine Suitability Of Recycled Plastics
Product manufacturers now have another reason to take a look at recycled plastics.
The U.S. Food and Drug Administration (FDA) just published a new version of "Use of Recycled Plastics in Food Packaging: Chemistry Considerations" in August 2006 (click here to download). The updated guidance document incorporates six significant changes on how manufacturers can evaluate the suitability of recycled plastics in food-contact applications:
- Lowers the threshold to determine whether a contaminant presents no more than a negligible risk from 1 to 0.5 ppb in the diet.
- Increases the number of recommended options for surrogate contaminants that can be used in evaluating a recycling process.
- Eliminates the need for a heavy metal contaminant as a surrogate in polyethylene terephthalate (PET) challenge testing.
- Provides recommendations to address recycling of post-consumer feedstock that includes plastic packaging for non-food products such as soaps and shampoos.
- Eliminates all data requirements for tertiary recycling processes for PET and polyethylene naphthalate (PEN).
- Establishes 0.05 as the default consumption factor (CF) for any plastic recycled for food-contact use.
Why the changes?
Since the original December 1992 document was published, the FDA has developed a better understanding of plastics recycling. The new guidance reflects the FDA's current approach to evaluating process efficiency for removing chemical contaminants.
If a plastic is of a type permitted by the FDA for packaging food, FDA compliance is not affected by whether the packaging material is "virgin" or recycled.
However, recyclers are required to ensure that possible contaminants from prior use are removed sufficiently by the recycling process. And 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 "good manufacturing process"(GMP).
To accommodate the use of mixed containers, the new guidance provides a table of target minimum levels of surrogate contaminants to be incorporated in PET prior to running the challenge test. These are levels in the PET that actually must be achieved. In cases where only food-contact PET is intended to be used, specific residual levels of the contaminants are not required.
The FDA also states that "recyclers who have already had their PET recycling processes evaluated by the FDA should not assume, based on the conclusions in this guidance document, that their letters from the FDA apply to the use of non-food PET containers as feedstock."
The updated document also confirms that virgin PET can be an effective barrier to contaminants that could potentially migrate from a recycled plastic inner layer under specific conditions.
Finally, the FDA acknowledges that recycling of PET or PEN by methanolysis or glycolysis results in the production of monomers or oligomers that are sufficiently pure to produce finished polymers suitable for food-contact use.
Used with permission. Copyright FOOD & DRUG PACKAGING, September, 2006.