Is the 0,05% threshold for the warning “contains formaldehyde — Update from 13/07/2022 – New warning for cosmetic preservatives that release formaldehyde

Formaldehyde is an ingredient usually used in nail hardeners that can potentially cause allergic skin reactions, and that has also been listed as a Carcinogen substance by the European Commission (EC).

Timeline of events

Initially, in November 2014, the Scientific Committee on Consumer Safety (SCCS) released the opinion that formaldehyde could have been used for nail strengtheners under the condition of a maximum concentration of 2,2%. However, after the discussions of the EC Working Groups, it was analyzed that there could be other appropriate replacements for this substance, to avoid side effects. Therefore, formaldehyde (classified as 1 CMR by REACH) was banned and moved from Annex V (preservatives) to Annex II (substances prohibited in cosmetic products).

However, there is one exception that concerns the preserving function for products that release this ingredient. According to Annex V, other substances that contain a concentration of maximum 0,05% of formaldehyde in the finished product can be placed on the market, under the condition that they need to have a warning label explicitly mentioning that the product “contains formaldehyde”.

What will happen now?

Recent studies have reported more data on the consequences and risks associated with the use of this ingredient on the skin. Nevertheless, as there are still substances that release formaldehyde, the European Commission and SMEs requested SCCS to look into the safety restrictions to be applied. The SCCS has a timeframe of 5 months to respond with its scientific opinion, starting from February, 12 2021.

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

In May 2021, the SCCS published a scientific advice concluding that the present threshold (i.e. 0.05%) does not sufficiently protect consumers sensitised to formaldehyde. Furthermore, the Scientific Committee suggested that in order to protect the majority of consumers sensitised to formaldehyde the present threshold should be reduced to 0.001% (10 ppm). This threshold applies to the total free formaldehyde irrespective of whether a product contains one or more formaldehyde releaser(s).

Further restrictions will highly likely be adopted following this opinion.

Update from 13/07/2022 – New warning for cosmetic preservatives that release formaldehyde

The European Commission fully implemented the SCCS Scientific Advice to protect consumers sensitised to formaldehyde; therefore, on July 8, 2022, it adopted Regulation (EU) 2022/1181. The new law amends the preamble of Annex V to the EU Cosmetics Regulation regarding the mandatory warning for finished products containing preservatives that release formaldehyde. Hence, when a cosmetic product contains substances releasing more than 0,001% (10 ppm) of formaldehyde*, it must bear the warning “releases formaldehyde”.

Regulation (EU) 2022/1181 provides an adequate period for the industry to adapt to the new requirements (24-48 months). Thus, the following deadlines apply:

  • July 31, 2024, for placing on the market cosmetic products that comply with the previous threshold (50 ppm);
  • July 31, 2026, for making those available on the market. All non-compliant cosmetic products must be off shelves as of that date.

You can find additional information about formaldehyde releasers in the Watch-out Database — Check it here.

* The total formaldehyde released no matter the fact if a product contains one or more formaldehyde releasers.


Carla Pintor – Regulatory Affairs Department

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  • European Commission. (2021). Request for a scientific advice on the threshold for the warning ‘contains formaldehyde’ in Annex V, preamble point 2 for formaldehyde-releasing substances. Retrieved on 26.05.2021 from
  • European Commission. (2014). Opinion on the safety of the use of formaldehyde in nail hardeners. Retrieved on 26.05.2021 from
  • Obelis Group. Formaldehyde in Cosmetics – What You Should Know. Retrieved on 26.05.2021 from
  • European Commission. (2022). Commission Regulation (EU) 2022/1181 of 8 July 2022 amending the preamble of Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products. Retrieved on 13/07/2022 from

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