Scientific Advice on the threshold for the warning ‘contains formaldehyde’ in Annex V, preamble point 2 for formaldehyde-releasing substances

SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
SCCS external expert: A. Koutsodimou, W. Uter (Rapporteur), N. Von Goetz
Contact: SANTE-C2-SCCSec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1632/21
Adopted on: 7 May 2021

Conclusion 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/1632/21

Opinion 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.