BHA Gets October 2025 SCCS Verdict: Maximum 0.07%
The preliminary SCCS opinion on BHA (Butylated Hydroxyanisole) is out. Despite endocrine disruption concerns, the committee found it safe at significantly reduced concentrations. Here's what you need to know.
Key Dates
- October 2025: SCCS/1682/25 preliminary opinion published
- January 19, 2026: Comment period deadline
- Q1-Q2 2026: Final opinion expected
- Late 2026-2027: Potential Annex III amendment (if finalized)
The Headline Numbers
| Parameter | SCCS Finding |
|---|---|
| Recommended Maximum | 0.07% |
| Margin of Safety (MoS) | 610-17,251 (depending on product type) |
| Current Typical Use | 0.01-0.5% |
| Endocrine Disruption | Weak anti-estrogenic/anti-androgenic activity noted |
The proposed 0.07% limit is significantly lower than current typical use levels. Many existing formulations will need reformulation if this becomes regulation.
What Is BHA?
BHA (Butylated Hydroxyanisole) is a synthetic antioxidant used to prevent oxidation in cosmetics. Basic facts:
- INCI: BHA or Butylated Hydroxyanisole
- CAS: 25013-16-5
- Function: Antioxidant (prevents rancidity in oils/fats)
- Current EU Status: Permitted (no restrictions)
- Common Use Levels: 0.01-0.5%
Why the Scrutiny?
BHA has been flagged for potential endocrine disrupting properties. The SCCS assessment examined:
- In vitro studies: Weak estrogenic activity in some cell assays
- In vivo studies: Anti-androgenic effects in rodent models
- Human relevance: Uncertain - the evidence was insufficient for point-of-departure derivation
Despite the uncertainty, the SCCS took a precautionary approach - recommending restrictions even though the calculated Margin of Safety exceeded 100.
The Safety Assessment
The SCCS calculated Margins of Safety ranging from 610 to 17,251 depending on product type and exposure scenario. These are well above the minimum acceptable MoS of 100.
So why the restrictions? Two factors:
- Aggregate exposure: BHA is used across multiple product categories - cumulative exposure was considered
- Endocrine activity: Even weak endocrine effects warrant caution under current EU regulatory philosophy
SCCS Conclusion
"BHA is considered safe when used as an antioxidant in cosmetic products at a maximum concentration of 0.07%."
What This Means for Formulators
If the Opinion Becomes Regulation:
- Lip products: Often contain 0.1-0.5% BHA - will need reformulation
- Moisturizers: Typical 0.01-0.02% levels may be fine
- Sunscreens: BHA used to stabilize UV filters - may need alternatives
- Color cosmetics: Often higher BHA levels - significant reformulation needed
Timeline Expectations
Based on the BHT precedent:
- Final SCCS opinion: Q1-Q2 2026
- Commission proposal: Q3-Q4 2026
- Regulation published: Early 2027
- Market placement deadline: ~6 months after publication
- Market availability deadline: ~18 months after publication
Practical deadline: Likely late 2028 for full compliance.
Alternatives to Consider
| Alternative | Pros | Cons |
|---|---|---|
| Tocopherol (Vitamin E) | Natural, well-established, consumer-friendly | Less potent, may affect color |
| Rosemary Extract | Natural, COSMOS-approved | Characteristic odor, variable potency |
| Ascorbyl Palmitate | Oil-soluble, multifunctional | Stability challenges |
| BHT | Similar efficacy | Already restricted in EU (0.8% max) |
| Propyl Gallate | Effective, permitted | May discolor in presence of iron |
US vs. EU Divergence Continues
Like BHT, BHA demonstrates the growing regulatory divergence between the EU and US:
| Jurisdiction | BHA Status |
|---|---|
| EU (proposed) | 0.07% maximum |
| US FDA | No cosmetic restrictions |
| US FDA (food) | GRAS, 0.02% in fats |
Brands selling globally will need dual formulations or reformulate to the stricter EU standard.
How to Comment
The comment period for SCCS/1682/25 is open until January 19, 2026. Industry stakeholders can submit:
- Additional safety data
- Use concentration surveys
- Exposure refinements
- Technical feasibility concerns
Comments should be submitted through the European Commission's consultation portal.
What to Do Now
Recommended Actions
- Audit your portfolio - Identify all products containing BHA
- Check concentrations - Flag anything above 0.07%
- Start alternative testing - Tocopherol, rosemary extract in stability studies
- Plan reformulation timeline - Assume 2028 compliance deadline
- Monitor the final opinion - The 0.07% may change based on comments
The Bigger Picture
The BHA opinion continues a clear EU regulatory trend: increased scrutiny of endocrine-active substances, even when traditional toxicological endpoints show adequate safety margins.
Formulators should expect similar assessments for other ingredients flagged as potential endocrine disruptors. The precautionary principle is being applied more broadly.
The era of unrestricted synthetic antioxidant use in EU cosmetics is ending. Natural alternatives and lower use levels are the future.
References
- SCCS/1682/25 - Preliminary Opinion on Butylated Hydroxyanisole (BHA)
- EU Cosmetics Regulation 1223/2009
- Commission Regulation (EU) 2022/2195 (BHT restrictions - precedent)