Arbutin (alpha + beta): What the SCCS Concluded About Safety in Cosmetics
Arbutin (alpha + beta) safety summary from SCCS/1642/22: SCCS conclusion, NOAEL, maximum concentration or conditions, and source-linked context.
Arbutin (alpha + beta) is covered by SCCS/1642/22, an SCCS-family cosmetic safety opinion dated 2023-01-31. The opinion conclusion for this opinion is direct enough for a substance-specific summary: The SCCS is of the opinion that alpha-arbutin used in face creams up to a maximum concentration of 2% and in body lotions up to a concentration of 0.5% is safe, also when used together.
Core Opinion Facts
- Opinion: SCCS/1642/22
- Opinion date: 2023-01-31
- Primary substance: Arbutin (alpha + beta)
NOAEL Values Cited in the Opinion
The no-observed-adverse-effect data below is shown only from the SCCS source fields for this opinion. It is not a calculated margin-of-safety output.
| Endpoint | Value | Unit | Study context |
|---|---|---|---|
| repeated_dose_oral_toxicity | 1000 | mg/kg bw/day | rat, 28-day oral |
| repeated_dose_dermal_toxicity | 618 | mg/kg bw/day | rat, 90-day dermal |
| reproductive_toxicity | 100 | mg/kg bw/day | reproduction toxicity (subcutaneous administration) |
Maximum Concentration or Conditions
| Use condition | Value | Unit |
|---|---|---|
| face cream | 2 | % |
| body lotion | 0.5 | % |
| face cream | 7 | % |
Conditions from the Opinion
The SCCS is of the opinion that alpha-arbutin used in face creams up to a maximum concentration of 2% and in body lotions up to a concentration of 0.5% is safe, also when used together.; The SCCS is of the opinion that alpha-arbutin used in face creams up to a maximum concentration of 2% and in body lotions up to a concentration of 0.5% is safe, also when used together.; The SCCS is of the opinion that beta-arbutin.
How to Read This Safety Conclusion
The key point for formulators is the match between the named ingredient, the cited NOAEL, and the SCCS conclusion. A NOAEL is a study point of departure, not a standalone permission to use Arbutin (alpha + beta) at any level. The SCCS conclusion and any concentration or product-type conditions remain the controlling context for cosmetic use.
The source also matters because SCCS opinions can be ingredient-specific. The internal ingredient page for Arbutin (alpha + beta) should be treated as the substance hub, while SCCS/1642/22 is the opinion-level page for the committee record.
Practical Formulation Takeaway
For a formula review, start with the identity check: confirm the INCI name, CAS number, and opinion reference align with the material in the formula. Then compare the intended product type against the SCCS concentration or condition language above. If the formulation uses a different exposure route, product category, or concentration basis, the SCCS conclusion should not be stretched beyond what SCCS/1642/22 actually assessed.
Source
- SCCS opinion: SCCS/1642/22
- Source file: sccs_o_264.pdf
- Extraction JSON: SCCS Scientific Opinions