Labeling Threshold Formaldehyde Donors

Following a request from the European Commission (EC), the Scientific Committee on Consumer Safety (SCCS) published on May 10th, 2021, scientific advice on the threshold for the warning ‘contains formaldehyde’ in Annex V of Regulation (EC) No 1223/2009, preamble point 2 for formaldehyde-releasing substances.

SCC Conclusion and the Proposal of the European Comission

The SCCS concluded the following:

  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).

Considering these conclusions, the EC published on October 14th, 2021, a draft Commission Regulation amending the preamble of Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products. This project was open for consultation until December 14th, 2021.

In this draft, the European Commission proposed:

  1. The following modification of preamble point 2 of Annex V of the Regulation (EC) No 1223/2009: “All finished products containing substances which are listed in this Annex and which release formaldehyde shall be labelled with the warning ‘releases formaldehyde’ where the total concentration of formaldehyde released in the finished product exceeds 0,001 % (10 ppm), irrespective of whether the finished product contains one or more substances releasing formaldehyde”.

  2. Application deadlines of 24 months for placing on the market and 48 months for making available from the market. That means that every product on shelves must be compliant with the regulation 48 month after adoption of the regulation.

Cosmetic products under the scope of the draft

All cosmetic products containing formaldehyde-releasing preservatives may fall under the scope of the draft as soon as the formaldehyde threshold value of 10 ppm would be exceeded.
The formaldehyde-releasing preservatives listed in Annex V of the Regulation (EC) No 1223/2009 are the following:

SubstanceCAS numberEC number
2-BROMO-2-NITROPROPANE-1,3-DIOL 52-51-7 200-143-0
5-BROMO-5-NITRO-1,3-DIOXANE30007-47-7250-001-7
BENZYLHEMIFORMAL14548-60-8238-588-8
DIAZOLIDINYL UREA78491-02-8278-928-2
DIMETHYL OXAZOLIDINE51200-87-4257-048-2
DMDM HYDANTOIN6440-58-0229-222-8
7-ETHYLBICYCLOOXAZOLIDINE7747-35-5231-810-4
HEXETIDINE141-94-6205-513-5
IMIDAZOLIDINYL UREA39236-46-9254-372-6
METHENAMINE100-97-0202-905-8
SODIUM HYDROXYMETHYLGLYCINATE70161-44-3274-357-8

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