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Who is Responsible for Compliance Testing?

If I’m the supplier for an additive and I’ve certified that it is FDA compliant (for example §176.170), do my clients need to conduct migration...

The U.S. Food and Drug Administration (FDA) announced on October 31, 2019, that it is making available a scientifically validated method for testing 16 types of per- and polyfluoroalkyl substances (PFAS) in a variety of food groups. The validated method establishes a method detection limit (MDL) for each food group tested.

The European Food Safety Authority (EFSA) has published Guidance on the use of the Threshold of Toxicological Concern (TTC) approach in food safety assessment. This approach can be used when there is limited chemical-specific toxicity data available but where the chemical structure of the substance is known and where exposure can be estimated. EFSA’s guidance provides step-by-step instructions on how to use the TTC approach.

The European Commission (EC) asked the European Food Safety Authority (EFSA) to update its risk assessments for styrene and four other food contact materials (FCM) that are authorized in the EU’s Plastics Regulation, (EU) No 10/2011.  The EC also asked the EFSA to prioritize the need for re-evaluating the substances listed on the Plastics Regulation without a Specific Migration Limit (SML).

The five substances and their FCM numbers are:

The European Food Safety Authority (EFSA) announced that it will share more of the scientific data used for EU-wide monitoring programs and surveys, and for many of the EFSA risk assessments. The details of how EFSA will share the data are included in a report, titled  Publication of scientific data from EU-coordinated monitoring programmes and surveys.

The European Food Safety Authority (EFSA) has launched a public consultation on a draft guidance document on the use of the Threshold of Toxicological Concern (TTC) approach in food safety assessment. This draft guidance, when finalized, will update a 2012 EFSA Scientific Opinion on exploring options for providing advice about possible human health risks based on the concept of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 European Chemicals Agency (ECHA) has proposed to add 4,4'-isopropylidenediphenol (bisphenol A, BPA) and 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE) along with 16 other substances to the REACH Authorization List (Annex XIV of the REACH Regulation). BPA and DOTE are currently authorized for use as a monomer and an additive, respectively, in the manufacture of plastic food-contact materials and articles in the European Union (subject to certain restrictions).

On January 3, 2018, China’s National Center for Food Safety Risk Assessment (CFSA) issued a request for comments on the forthcoming amendment to China’s National Food Safety Standard on General Rules for Migration Testing for Food Contact Materials and Articles (GB 31604.1-2015). Comments are due by February 28, 2018.    

California Assembly Bill 906, signed into law on October 15, 2017, defines “polyethylene terephthalate” (PET) for purposes of resin code labeling as a plastic that meets certain conditions, including limits with respect to the chemical composition of the polymer and a melting peak temperature within a specified range. The ostensible purpose of the change is to exclude rigid plastic bottles and containers made from polyethylene terephthalate glycol-modified (PETG) that are sold in California from using Resin Identification Code (RIC) 1. 

Keller and Heckman attorneys and scientists will be among the speaker at the 4th International Conference on Food Contact Compliance. They will be presenting on the following topics: