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EFSA Opens Public Consultation on Draft TTC Guidance

The European Food Safety Authority (EFSA) has launched a public consultation on a draft guidance document on the use of the Threshold of Toxicological Concern (TTC) approach in food safety assessment. This draft guidance, when finalized, will update a 2012 EFSA Scientific Opinion on exploring options for providing advice about possible human health risks based on the concept of TTC. 

The draft explains that the TTC approach is a methodology used to assess the safety of substances for which there is limited chemical-specific toxicity data available but where the chemical structure of the substance is known and where exposure can be estimated. However, the TTC approach should not be used when toxicity data are available to conduct a risk assessment, when EU legislation requires the submission of toxicity data or if the substance under consideration falls into one of the exclusion categories.

The draft TTC approach guidance provides step-by-step instructions on how to use the TTC approach, along with information on inclusion and exclusion criteria and an explanation of the TTC decision tree. Comments on the draft guidance are due by January 8, 2019. More information, including how to submit comments, can be found on EFSA’s website. A copy of the draft guidance can be found here.

© 2020 Keller and Heckman LLPNational Law Review, Volume VIII, Number 330


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PackagingLaw.com is the premier online resource for the global packaging industry. It provides a wide range of information on laws and regulations—both in the U.S. and other countries throughout the world—that affect packages and packaging materials. PackagingLaw.com features news articles on current issues affecting the packaging industry, in-depth features, an Ask an Attorney section, links to packaging industry and government websites, and detailed information on the U.S. Food and Drug Administration (FDA) Food Contact Notification system.