BHA is commonly used as an antioxidant in cosmetic formulations. Its primary role is to protect products from oxidation, helping to maintain stability, quality, and shelf life. The ingredient is used across a variety of cosmetic categories, including both leave-on and rinse-off products.
The SCCS evaluation was requested in light of available scientific evidence, recent literature, advances in toxicological assessment methods, and ongoing discussions regarding substances with potential endocrine activity.
The Main Conclusion
After reviewing the available evidence and conducting a risk assessment, the SCCS concluded that BHA is safe for use in cosmetic products applied to the skin at concentrations up to 0.07%.
This conclusion applies to both leave-on and rinse-off cosmetic products. Importantly, the committee considered aggregate dermal exposure, meaning that the assessment takes into account the possibility that consumers may use multiple cosmetic products containing BHA.
For manufacturers, this conclusion provides a clear scientific benchmark. According to the SCCS, the available data support the safe use of BHA in dermally applied cosmetic products provided that concentrations do not exceed 0.07%.
Why Was BHA Reassessed?
The reassessment forms part of a broader European effort to review cosmetic ingredients that have been identified as potential endocrine disruptors.
An endocrine disruptor is a substance that may interfere with the body’s hormonal system. Over recent years, the European Commission has prioritised the evaluation of several cosmetic ingredients for possible endocrine-related effects, requesting scientific assessments and advice from the SCCS.
In the case of BHA, the committee reviewed toxicological studies, scientific publications, exposure data, and information generated through modern assessment approaches, including in silico tools. The objective was not only to determine whether BHA exhibits endocrine-related activity, but also whether such properties would result in a risk to consumers under realistic cosmetic use conditions.
The SCCS ultimately based its conclusion on a risk assessment approach, considering both hazard and exposure. As is often the case in cosmetic safety evaluation, the presence of a potential hazard alone does not automatically translate into a consumer risk if exposure levels remain sufficiently low.
Understanding the Scope of the Scientific Advice
One important aspect of the SCCS Scientific Advice is its scope.
The committee explicitly states that the assessment covers only dermal exposure from cosmetic products applied to the skin. The conclusion therefore applies to leave-on and rinse-off cosmetic products used on the skin, but it does not extend to oral care products or products that may result in inhalation exposure.
This distinction is particularly relevant for manufacturers developing products such as toothpastes, mouthwashes, powders, sprays, or aerosol formulations. The SCCS did not assess these exposure routes within this Scientific Advice, meaning that the safety conclusion cannot be directly extrapolated to such applications.
What Does This Mean for the Cosmetic Industry?
From a regulatory perspective, the Scientific Advice provides valuable clarity regarding the current scientific assessment of BHA’s safety in cosmetics.
For formulators and manufacturers, the SCCS conclusion confirms that BHA can continue to be considered a viable antioxidant for dermally applied cosmetic products, provided that its concentration remains within the assessed safe level of 0.07%.
This Scientific Advice also illustrates the increasing emphasis placed by European regulators on evaluating ingredients that may have endocrine-related properties. Companies should expect similar assessments for other substances as the European Commission continues its programme of scientific reviews.
More broadly, the BHA assessment demonstrates how modern cosmetic safety evaluation is evolving. Regulatory decisions are increasingly informed by comprehensive reviews that combine traditional toxicological data, exposure modelling, scientific literature, and newer predictive methodologies.
What Happens Next?
The publication of a Scientific Advice does not, in itself, create new legal requirements. Like SCCS Opinions, it serves as scientific input for European regulatory decision-making and helps inform future discussions on the safety and use of cosmetic ingredients.
In this case, the key outcome is the SCCS conclusion that BHA is safe for use in leave-on and rinse-off cosmetic products applied to the skin at concentrations up to 0.07%.
For industry stakeholders, this Scientific Advice provides an important scientific reference for formulation decisions, product safety assessments, and regulatory compliance activities. It also highlights the increasing focus of European regulators on the evaluation of substances with potential endocrine-related effects and demonstrates how cosmetic ingredient safety continues to be reviewed in light of evolving scientific knowledge.
