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International audience; SCCS SCIENTIFIC ADVICE ON on the threshold for the warning ‘contains formaldehyde’ in Annex V, preamble point 2 for formaldehyde-releasing substances - SCCS/1632/21– Scientific adviceU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, N. von Götz, S. Wijnhoven, A. Koutsodimou, W. UterThe SCCS adopted this document by written procedure on 7 May 2021 (12 Pages)Mise en ligne 10 Mai 2021 https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_254.pdfOn request from: European CommissionSCCS Number: SCCS/1632/21Adopted on: 7 May 2021Conclusion of the opinion:1. In light of the data provided and taking under consideration the available scientific literature, does the SCCS consider the 0.05% threshold for labelling formaldehyde releasing substances adequate to protect consumers?The SCCS considers that the present threshold does not sufficiently protect consumers sensitised to formaldehyde from exposure to free formaldehyde from formaldehyde releasers.2. Does the SCCS consider necessary to change the 0.05% threshold and at which level?Reducing the present threshold by a factor of 50, that is, to 0.001% (10 ppm), will protect the vast majority of consumers sensitised to formaldehyde. This threshold applies to the total free formaldehyde irrespective of whether a product contains one or more formaldehyde releaser(s).Keywords:SCCS, scientific advice, formaldehyde, Regulation 1223/2009, CAS No. 50-00-0, EC No. 200-001-8, SCCS/1632/21Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Scientific advice on the threshold for the warning ‘contains formaldehyde’ in Annex V, preamble point 2 for formaldehyde-releasing substances, final version of 7 May 2021, SCCS/1632/21.

The estimated dietary exposure to residual formaldehyde in alginates and carrageenan, based on data from the USA on the consumption of ice cream and ready to eat dairy dessert cream, examined by the Panel, is between 400 and 70 times lower than the Tolerable Daily Intake (TDI) value of 150 µg/kg bw set by the World Health Organisation (WHO) for drinking water. No information was available to the Panel on residual formaldehyde in other gelling additives or on their actual use levels. However, the Panel considered an extreme worst case exposure scenario which assumes that an adult could eat 1 kg of food per day containing 2 % of any gelling agent containing 50 mg formaldehyde/kg. This exposure scenario would also include the uses of alginate and carrageenan outlined above. Under these conditions formaldehyde exposure levels would be 1 mg per person per day or for a 60 kg individual approximately 17 µg/kg bw/day, assuming an exposure to 1 kg of food per day containing gelling additives. Formaldehyde in food additives The EFSA Journal (2006) 415, 2 of 10 The estimated dietary exposure levels arising from this worst case exposure scenario would still be approximately 9 times lower than the TDI value of 150 µg/kg b.w. set by the WHO. The Panel examined recent and previous evaluations of formaldehyde and concluded that there is no evidence indicating that formaldehyde is carcinogenic by the oral route. Considering that the potential dietary exposures estimates remain low compared to the toxicological reference values outlined above and that no systemic exposure to formaldehyde is to be expected at the estimated residual levels, the Panel estimates that exposure to gelling additives containing residual formaldehyde at the levels of 50 mg/kg of additive would be of no safety concern.