NGOs Criticise EFSA’s FCM Safety Assessment Review

« NIAS and support for TTC, among weaknesses, says ChemTrust- “NGOs say non-intentionally added substances (NIAS) are not addressed sufficiently in the European Food Safety Authority’s (EFSA) draft opinion on recent developments in the safety assessment of chemicals in food.

The draft opinion will inform a regulatory discussion on how substances in food contact materials should be assessed for safety. A consultation closed on 7 October.

The document says that “in principle” the toxicological assessment of Nias could follow the same approach as that used for authorised substances, since the same degree of safety should be warranted for all migrating substances.
Efsa suggests the use of read-across, the margin-of-exposure, and the threshold of toxicological concern (TTC) methods to assess them. TTC, it says, could be used when assessing low-exposure situations, where the substance is only partly identified.

In its consultation response, NGO ChemTrust says the text contradicts Efsa’s opinion on the use of TTC from 2012, in which it states that the approach “is applicable to substances for which the chemical structure is known. It is vitally important that no-one who reads this document gets the impression that TTC is some sort of magic method that can be used to claim that an unknown chemical is safe.”

Research non-profit organisation, the Food Packaging Forum (FPF), pointed to the same contradiction.
Additionally, its response says the complications, involved in evaluating Nias, highlight that chemical risk assessment of FCMs should be carried out in the finished article, rather than by substance.

According to the FPF, Efsa should discuss whether lists of authorised finished plastics that have been assessed for their overall migration, including all migrating Nias, could be introduced alongside the existing positive lists for plastic FCMs.
Both NGOs say that the draft opinion fails to address substances of very high concern (SVHCs), and cumulative effects from combined exposures. A risk assessment approach for the latter, in particular, needs to be “an important part of this scientific opinion”, says ChemTrust.

Further, they criticise the tiered approach to toxicity testing, which Efsa describes in the opinion as lacking “convincing scientific evidence”. According to the FPF, the first threshold, in particular, is “too arbitrarily chosen” and should be re-evaluated using more recent data. »

ChemTrust response :
FPF response :

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