The European Chemicals Agency (ECHA) has recommended classifying the musk fragrance ingredient galaxolide as toxic to reproduction. If this classification becomes legally binding, the substance will be banned in cosmetics. Here’s what that means for your fragrances—and why you should start planning the transition now.
Key Points at a Glance
- The ECHA RAC recommends the classification Repr. 1B, H360D for Galaxolide (INCI: Hexamethylindanopyran, HHCB).
- Upon inclusion in Annex VI of the CLP Regulation, the CMR ban under Article 15 of the EU Cosmetics Regulation takes effect—without a minimum quantity requirement.
- Galaxolide is still fully permitted today. We do not expect a ban before 2028.
- Experience has shown that switching to a new fragrance takes significantly longer than a year.
Galaxolides: one of the most commonly used musk fragrances
Galaxolide (INCI: hexamethylindanopyran, also known as HHCB) is found in a wide variety of fragrance oils. This fragrance ingredient adds richness and longevity to formulations and is found in eau de parfum as well as in shower gels, creams, and body sprays. Consequently, the potential impact on existing product portfolios is significant.
What happened?
In December 2025, ECHA’s Committee for Risk Assessment (RAC) recommended classifying Galaxolide as a Category 1B reproductive toxicant. This is accompanied by the hazard statement H360D: May harm the unborn child. The committee did not recommend a classification regarding fertility. The proposal was submitted by the French agency ANSES.
What the Classification Means for Cosmetic Products
The classification becomes legally binding only once the European Commission includes it in Annex VI of the CLP Regulation. At that point, Article 15 of the EU Cosmetics Regulation (Regulation (EC) No. 1223/2009) applies:
Substances classified as CMR substances in Category 1A or 1B are prohibited in cosmetic products.
Exceptions are possible only under very strict conditions—including a positive assessment by the Scientific Committee on Consumer Safety (SCCS). There is no minimum quantity: the regulation applies to any product to which Galaxolide is added.
Timeline: When can we expect a ban?
| December 2025 | RAC recommends classification Repr. 1B |
| Today | Unrestricted; no maximum quantity |
| Next Step | Inclusion in Annex VI of the CLP Regulation |
| Not before 2028 | Ban on Cosmetic Products Expected |
Why It Pays to Act Early
2028 sounds like a long time from now. But reformulating a fragrance involves much more than simply replacing a raw material:
- New perfume oil and samples
- Stability and compatibility tests
- Updated Safety Assessment
- New CPNP notification
- Customized packaging text
Experience has shown that this process takes significantly longer than a year. Those who start early can manage the transition in a planned and organized manner—rather than under time pressure.
Our Recommendation for Brand Owners
1. New Developments Without Galaxolides
Contact the perfume manufacturer now to inquire about new and reformulated fragrances that do not contain galaxolides.
2. Check inventory
For perfume oils that do not list their full ingredients, request a statement regarding their galaxolide content. Many oils only list the allergens required by law—galaxolide does not appear on that list.
3. Plan the transition
Be sure to factor in your perfume oil and finished goods inventory from the very beginning to avoid ending up with excess inventory.
Here's How Cosmetic Service Supports You
Portfolio Review and Support Through to Mass Production
We’ll review your portfolio based on the formulation data you’ve provided us, show you which products are affected, and support you through the transition—from sample production to mass production. Please contact your project management representative or our Regulatory Affairs team.
Request a Portfolio Review →Source: European Chemicals Agency (ECHA), Committee for Risk Assessment (RAC), Opinion on the Harmonized Classification of Galaxolide, December 2025. This article is intended for general informational purposes only and does not replace a legal assessment of individual cases.
