Recently announced changes to cosmetic regulation in the EU will mean some big changes for skincare companies using Retinol, Arbutin and Kojic acid in Europe.
Under the rules Retinol will be restricted to a maximum concentration of 0.3%, Alpha-Arbutin to 2%, Arbutin to 7% and Kojic acid to 1%.
The changes will mean that from 2025 new products with levels of the ingredients above the limits won’t be approved and that existing products will no longer be approved for sale from 2025 for Kojic acid and Arbutin and 2027 for Retinol.
What this means for your clinic.
Time for a skincare audit. The changes are a great opportunity to review whether you stock products using approved ingredients like Retinal and 4-n-butylresorcinol or those that will be subject to restrictions like Retinol, Arbutin and Kojic acid.
Don’t panic.
Right now, the changes will only affect the EU market. Since Brexit, the UK system has mostly mirrored the EU but the UK has not announced whether it plans to continue this pattern or chart its own course. The rules in the US and Australia are not changing. and while the EU regulatory body does influence other non EU regulatory bodies, there are no rumours of any USA or Australian changes on the horizon.
So the likely impact outside of the EU will be
- For brands who manufacture mostly for EU markets (and also export some products to the EU), they may choose to discontinue products that would fall foul of the EU rules
- Public perception changes: For Retinol, the changes in rules relate to concerns about Vitamin A use in pregnancy. While the concentration limits on Arbutin and Kojic acid still allow its use in the EU at levels similar to those being used by many brands, the concerns relate to endocrine disruption and in the case of Arbutin, conversion into Hydroquinone. The changes for those ingredients will likely start a bigger conversation about their safety.
I’ve examined the proposed legislation and I don’t think that the new rules will have a direct impact on users outside the EU. But I do believe that there are some risks for brands using Retinol and even more so for those using Arbutin and Kojic acid.
The ESK philosophy has always been: If there are rational safety concerns around ingredients, rather than using them and hoping that things would be OK, we would rather avoid them completely. We’re happy this approach means that we won’t have to justify to our customers, why we are making products that the EU regulator thinks are not safe.