On July 11, 2022, the EU announced to amend the labelling requirement for formaldehyde releasers in the preservatives list to Regulation (EC) No 1223/2009 (Cosmetics Regulation). The new amendment shall enter into force on July 31, 2022. Subject to it, the present labelling threshold of 0.05% (500 ppm) will be reduced to 0.001% (10 ppm). ¹

Formaldehyde releasers refer to certain preservatives that are gradually releasing formaldehyde to fulfil their preserving function in the final cosmetic products. Considering that the formaldehyde's presence may trigger an allergic reaction to consumers sensitized to it, the products containing formaldehyde releasers are required to be labelled with the specific warning "contains formaldehyde" where the concentration of formaldehyde in the finished product exceeds 0.05%.

However, the Scientific Committee on Consumer Safety (SCCS) concluded in its scientific advice SCCS/1632/21 that the present threshold cannot sufficiently protect consumers sensitized to formaldehyde. Instead, the SCCS proposed reducing the current threshold for the labelling requirement to 0.001% (10 ppm), which should apply to the total formaldehyde released irrespective of whether a product contains one or more formaldehyde releaser(s).

In light of the SCCS's advice, point 2 to the preamble of the preservatives list is replaced as:

2. 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.

However, all finished products containing substances referred to in the first subparagraph which comply with Regulation (EC) No 1223/2009 as applicable on 30 July 2022 may be placed on the Union market until 31 July 2024 and be made available on the Union market until 31 July 2026.

Further Reading

• EU Amends the Use Requirements for 2 UV Filters in Cosmetics Regulation
• How Are Endocrine Disruptors Regulated by EU Cosmetics Regulation?
• EU Finalizes the Updated Glossary of Common Ingredient Names

Reference Links

[1] 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

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