Under Commission Regulation (EU) 2022/1181 published by the European Commission, significant changes have been introduced to the labelling requirements for formaldehyde-releasing preservatives.
Scope of the Regulation
Although the direct use of formaldehyde in cosmetic products is prohibited, certain preservatives may gradually release formaldehyde within the product over time.
Under the new regulation:
- If the total amount of formaldehyde released in the finished cosmetic product exceeds the threshold of 0.001% (10 ppm),
- The following warning statement must appear on the product label:
“releases formaldehyde”
This change was introduced because the previous threshold of 0.05% was considered insufficient from a consumer safety perspective.
Critical Deadline
Within the scope of the regulation:
- The deadline for making products compliant with the previous rules available on the market has been set as 31 July 2026.
- After this date, products that do not comply with the new requirements will no longer be allowed on the EU market.
Impact on the Industry
This regulation requires a comprehensive assessment, particularly in the following areas:
- Formulations containing formaldehyde-releasing preservatives
- Label compliance
- Product Information File (PIF) and safety assessments
Recommended Actions
Revising technical files in line with the new threshold value
Reviewing the product portfolio in terms of formaldehyde release
Updating labels where necessary