BHT Became Non-Compliant January 1, 2024 - Did Your Products?

Key Dates (Already Passed)

November 10, 2022: Regulation published
July 1, 2023: New products must comply (market placement deadline)
January 1, 2024: All products must comply (market availability deadline)

If you're still selling or using products with BHT concentrations exceeding the new limits, they're non-compliant in the EU. Here's what changed and what you need to do about it.

What Changed?

BHT (Butylated Hydroxytoluene, INCI: BHT, CAS: 128-37-0) was previously unrestricted in EU cosmetics. It was used freely as an antioxidant to prevent product oxidation, typically at 0.01-0.5% in formulations.

Following SCCS Opinion SCCS/1636/21, the EU determined that while BHT has an acceptable Margin of Safety (MoS of 1,445 for aggregate exposure), restrictions were warranted due to:

Weak anti-estrogenic and anti-androgenic properties
Cumulative exposure across multiple products
Precautionary approach to endocrine-active substances

The New Concentration Limits

Product Type	Maximum BHT Concentration
Mouthwash products	0.001%
Toothpaste	0.1%
All other cosmetic products	0.8%

The 0.8% limit for general cosmetics won't affect most products - typical use levels are well below this. But the mouthwash limit of 0.001% is extremely restrictive and caught many oral care formulators off guard.

EU vs. US: Different Rules

This is where international brands face complications:

Jurisdiction	BHT Status
European Union	Annex III restricted (0.001-0.8% depending on product)
United States	GRAS since 1958, no cosmetic restrictions
FDA food use	0.02% in fats/oils (21 CFR 172.115)

The same SCCS opinion exists. The US simply didn't act on it. This creates compliance challenges for brands selling in both markets.

What About BHA?

BHT's cousin, BHA (Butylated Hydroxyanisole), is undergoing similar scrutiny. In October 2025, the SCCS issued preliminary opinion SCCS/1682/25 recommending:

Maximum concentration: 0.07%
Comment period until January 19, 2026
Final opinion expected Q1 2026

If you use both BHT and BHA in formulations, expect BHA restrictions to follow a similar regulatory timeline.

Compliance Checklist

                    For Formulators & Brands
                    Audit your current formulations - Identify all products containing BHT
Check concentrations against new limits - Especially oral care products
Update Product Information Files (PIFs) - Document compliance
Reformulate if necessary - Consider alternative antioxidants
Update Safety Assessments - Ensure Margin of Safety calculations reflect current use

                

Alternative Antioxidants

If you need to reduce or eliminate BHT, consider these alternatives:

Alternative	Notes
Tocopherol (Vitamin E)	Natural, widely accepted, effective at 0.05-0.5%
Rosemary Extract	Natural, COSMOS-approved, good for oils
Ascorbyl Palmitate	Oil-soluble Vitamin C, synergistic with tocopherol
TBHQ	Synthetic, effective but also facing scrutiny

The Regulatory Takeaway

The BHT restriction demonstrates how EU cosmetic regulations continue to tighten based on emerging safety data - particularly around endocrine disruption. The pattern is clear:

SCCS issues opinion
Commission proposes restrictions
Industry gets ~18 month transition period
Enforcement begins

With BHA restrictions likely coming in 2026-2027, now is the time to review your antioxidant strategy across all formulations.

Non-Compliance Consequences

Products exceeding BHT limits cannot legally be sold in the EU. Consequences include product recalls, fines, and notification to the EU Cosmetic Products Notification Portal (CPNP). Responsible Persons face liability.

References

Commission Regulation (EU) 2022/2195 of November 10, 2022
SCCS/1636/21 - Opinion on BHT
EU Cosmetics Regulation 1223/2009, Annex III
21 CFR 172.115 - FDA BHT regulations