In a feature article published on September 9, 2019, by Chemical Watch, reporter Lisa Martine Jenkins discusses the regulatory complications being caused by data gaps describing breakdown products of fluorotelomers. Fluorotelomers are compounds within the umbrella of per- and polyfluoroalkyl substances (PFAS), but not all of their carbon-hydrogen bonds have been replaced by carbon-fluorine bonds. Jenkins writes that while PFAS have previously been in the spotlight for their persistence in the environment, there has been an increase in concern about their presence in food contact materials (FCMs). This has prompted further investigations into resulting human exposure and health effects, including calls to ban PFAS entirely from food packaging (FPF reported) and a promise from Denmark to do so by 2020 (FPF reported).

Fluorotelomers such as 6:2 fluorotelomer alcohol (CAS 647-42-7) break down into, among other compounds, perfluorohexanoic acid (PFHxA; CAS 307-24-4). Studies into PFHxA’s toxicity are ongoing, with the industry association FluoroCouncil reported to have described its risk to humans as “negligible” and the German environmental agency rather proposing that it be classified as a substance of very high concern (SVHC). Discussions are also ongoing among researchers and regulatory agencies regarding which biomarker should be used to assess human exposure to breakdown products. The article goes on to discuss the challenge faced by governments to regulate these substances in the midst of such large data gaps. A number of short chain PFASs, including fluorotelomers, have already been approved for use in food packaging in the U.S. through the U.S. Food and Drug Administration’s (FDA) Food Contact Notification (FCN) program. Bioaccumulation is described as being a key concern for stakeholders and a property that should significantly impact any regulatory exposure limits.

Ned Sharpless from the FDA said that the agency “does not have any indication that these substances are a human health concern … at the levels found in this limited sampling.” However, he went on to comment that “while the science surrounding the potential health effects of PFAS is developing, current evidence suggests that the bioaccumulation of certain PFAS may cause serious health conditions.” Non-governmental organization Environmental Defense Fund has challenged these FDA findings and also called for revoking the existing food contact notifications for PFAS (FPF reported).

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Lisa Martine Jenkins (September 9, 2019). “Feature: Fluorotelomer data gaps create new PFAS regulatory challenge.” Chemical Watch