For manufacturers, distributors, and retailers, this deadline is more than a simple labelling update. It represents the final step in a regulatory process that began in 2022, following new scientific assessments of consumer exposure to formaldehyde. For consumers, it is another example of how cosmetic regulations evolve to improve transparency and safety.
Why Is Formaldehyde a Concern?
Formaldehyde is classified in the European Union as a carcinogenic substance and a skin sensitiser. As a result, its intentional use in cosmetic products is prohibited under the EU Cosmetics Regulation.
However, the situation is more complex than it may appear. Some preservatives permitted in cosmetics do not contain formaldehyde as an ingredient but can gradually release small amounts of it over time. These substances are commonly known as formaldehyde releasers.
Examples include preservatives such as DMDM Hydantoin, Imidazolidinyl Urea, and Diazolidinyl Urea, which have historically been used to protect cosmetic formulations from microbial contamination.
What Changed in the Regulation?
The regulatory change originated from an opinion issued by the Scientific Committee on Consumer Safety (SCCS). The committee concluded that the existing warning threshold did not adequately protect consumers already sensitised to formaldehyde.
Previously, cosmetic products only required a specific warning when the concentration of released formaldehyde exceeded 0.05% (500 ppm). The SCCS determined that allergic reactions could occur at much lower levels and recommended a substantially lower threshold.
As a result, Commission Regulation (EU) 2022/1181 amended the preamble of Annex V of the Cosmetics Regulation and reduced the threshold to 0.001% (10 ppm) in the finished product.
Under the revised rule, any finished cosmetic product containing formaldehyde-releasing substances must carry the warning:
“Releases formaldehyde” whenever the total amount of formaldehyde released exceeds 0.001%, regardless of whether one or several formaldehyde-releasing preservatives are present.
Understanding the Two Deadlines
The regulation introduced a four-year transition period to allow companies sufficient time to adapt formulations, generate data, revise artwork, and manage existing stock.
The first deadline was 31 July 2024. From that date, newly placed products had to comply with the updated labelling requirements.
The second and final deadline is 31 July 2026. After this date, products that were previously allowed to remain on shelves under transitional provisions can no longer be made available on the EU market if they do not meet the new requirements.
In practical terms, the sell-through period ends on 31 July 2026.
What Does This Mean for Manufacturers?
For manufacturers and brand owners, the deadline highlights the importance of understanding not only the ingredients listed in a formula but also their potential degradation products and release mechanisms.
Companies should ensure that they have reliable data demonstrating whether formaldehyde release exceeds the 10 ppm threshold. Where required, product labels must include the mandatory warning statement.
For businesses still holding legacy stock, the deadline serves as a final reminder that non-compliant products must be removed from commercial circulation after 31 July 2026.
This regulatory change also illustrates a broader trend in cosmetic legislation: increasing emphasis on protecting sensitised consumers and providing clearer information at the point of purchase.
What Does It Mean for Consumers?
For consumers, the impact will mostly be visible on product packaging.
The new warning does not necessarily indicate that a product is unsafe. Instead, it provides additional information for individuals who are already sensitised to formaldehyde and may experience allergic reactions even at very low exposure levels.
By lowering the warning threshold from 500 ppm to 10 ppm, regulators aim to help these consumers make more informed choices and reduce the risk of unintended exposure.
