What Is the Proposed CLH Classification of Padimate O and What Could It Mean for Cosmetics?
Padimate O is an authorised EU cosmetic UV filter with a maximum concentration of 8%. Spain has proposed a Repr. 1B classification for reproductive toxicity, which could affect its future use in cosmetics. The proposal is still under assessment and does not currently constitute a ban.
What Is Padimate O’s Current Status Under EU Cosmetics Regulations?
Padimate O (2-ethylhexyl 4-(dimethylamino)benzoate; CAS 21245-02-3; EC 244-289-3), also known as Ethylhexyl Dimethyl PABA, is listed in Annex VI of Regulation (EC) No. 1223/2009 as an authorised UV filter, with a maximum concentration of 8% in finished cosmetic products.
Why Has Padimate O Been Proposed for CMR 1B Classification?
The situation could change following the proposal for harmonised classification and labelling (CLH) submitted by Spain under the CLP Regulation.
The proposal concerns Padimate O together with other derivatives of dimethylaminobenzoic acid and proposes classifying Padimate O as Repr. 1B (toxic to reproduction), with the hazard statement H360F: “May damage fertility”.
How Could a CMR 1B Classification Affect Padimate O in Cosmetics?
The proposal is particularly relevant for the cosmetics sector because a harmonised classification such as CMR 1B would have consequences that go beyond the simple modification of the CLP classification.
Pursuant to Article 15 of Regulation (EC) No. 1223/2009, in fact, substances classified as carcinogenic, mutagenic or toxic for reproduction in categories 1A or 1B are, in general, prohibited in cosmetic products, except where a specific derogation is granted under the conditions set out in the cosmetics legislation, following a Scientific Committee on Consumer Safety (SCCS) assessment.
What Is the Current Regulatory Status of Padimate O in the EU?
It is important to note that the classification is not yet harmonised and legally applicable. In September 2026, ECHA opened the CLH consultation on the Spanish proposal; the process will have to continue through the assessment of the Committee for Risk Assessment (RAC) and the subsequent legislative steps.
What Should Cosmetic Brands Do About the Proposed Padimate O Classification?
For cosmetic operators, it is not yet an immediate ban on Padimate O. However, considering the Repr. 1B/H360F proposal, it is advisable to carefully monitor the CLH process and assess in advance the possible need for reformulation of products that use this UV filter.
Key Takeaways on Padimate O’s Proposed CMR 1B Classification
- Padimate O is an authorised EU cosmetic UV filter, permitted at concentrations of up to 8%.
- Spain has proposed a harmonised Repr. 1B classification for reproductive toxicity, with the hazard statement H360F.
- If adopted, the classification could lead to a ban on its use in cosmetics unless a specific derogation is granted.
- The proposal is still under assessment, so brands should monitor developments and consider potential reformulation needs.
