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What FDA Food-Contact Regulations Apply to “Green” Solvents?

December 4, 2015
Question 

Some solvents, such as PCBTF (CAS# 98-56-6) are being touted as "green" solvents because they are VOC exempt.  How do these solvents fall under any FDA regulations that pertain to food contact packaging?

Answer 

FDA typically does not regulate solvents in food-contact packaging because, due to their generally volatile nature, they are not expected to be present in the finished product at “significant” levels. However, it is necessary to establish that the use of a solvent (or any other food-contact material or component) complies with FDA's good manufacturing practice (GMP) requirements. In particular, Section 174.5 ("General provisions applicable to indirect food additives") states that "[a]ny substance used as a component of articles that contact food shall be of a purity suitable for its intended use."

In many cases, since the solvent will volatilize during processing and not be present in the finished material, there is no concern raised. In some cases, though, there is the potential for low residual levels of the solvent to be present. If this is the case, it is important to ensure these that the potential dietary exposure, based on publicly available information on the solvent's toxicity, is sufficiently low to be considered safe.