SCCS Preliminary Opinion on Butylated Hydroxytoluene (BHT)
Following the mandate from the European Commission, the Scientific Committee on Consumer Safety (SCCS) has published a preliminary opinion on Butylated Hydroxytoluene (BHT). This preliminary opinion is open for comments and the deadline was set for 23 november 2021.
Marta Pinto

Marta Pinto

Regulatory Affairs Associate

BUTYLATED HYDROXYTOLUENE (BHT)

The European Commission adopted the review of Regulation (EC) No 1223/2009 on cosmetic products regarding substances with endocrine disrupting properties in 2018. Although the Commission does not have specific provision on endocrine disruptors, it provides a regulatory framework with the aim to ensure a high level of protection of human health.

In early 2019, a priority list of 28 potential endocrine disruptors (not already covered by the bans of cosmetic regulation) was established by the Commission. From these 28 substances, 14 were considered as higher priority (Group A) and the other 14 were included in the low priority group (Group B). The public call for data for the considered higher priority substances was carried out in 2019. Butylated Hydroxytoluene was included in Group A.

BHT is a substituted toluene that is used in cosmetics and personal care products as an antioxidant and fragrance. This ingredient is also used in other sectors, including food additives, pharmaceuticals, plastics/rubbers and other petroleum products.

Neither the in silico nor the in vitro data give indication of endocrine disrupting properties of BHT. In vivo studies showed that the liver is the main target of BHT via the oral route, increasing liver weight and the activity of liver enzymes.

On the basis of a safety assessment, and considering the concerns related to potential endocrine disrupting properties of this ingredient, the SCCS concluded that BHT is safe as an ingredient up to a maximum concentration of 0.001% in mouthwash, 0.1% in toothpaste, 0.8% in other leave-on and rinse-off products. The SCCS also considers BHT safe for a combined use of mouthwash at a concentration of 0.001%, toothpaste of 0.1% and other leave-on and rinse-off products at the concentration of 0.8%.

If you wish to get more information these ingredients and their use in cosmetic products, feel free to contact us at info@criticalcatalyst.com.

References:

  1. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
  2. Scientific Committee on Consumer Safety (SCCS). Opinion on Butylated Hydroxytoluene (BHT). (SCCS/1636/21). Preliminary version. 2021

further
reading

cosmetic products

New Amendments to the European Cosmetics Regulation – CMR Substances

The European Commission published the Commission Regulation (EU) 2022/1531, which amends Regulation (EC) No 1223/2009 in regards to the use in cosmetic products of certain substances classified as CMR. This amendment introduces new entries to Annex II and Annex III and revises an entry to Annex V to Regulation (EC) No 1223/2009.

Read More »
medical devices

EUDAMED – harmonized practices and alternative solutions for IVDR until the database is fully functional

EUDAMED is one of the key aspects of the new rules on in vitro diagnostic medical devices – Regulation (EU) 2017/746. However, it is only expected to achieve full functionality by the second quarter of 2024. Until then, how is the information submitted and/or exchanged between manufacturers, notified bodies and competent authorities?

Read More »
medical devices

EUDAMED – update on timelines

EUDAMED is one of the key aspects of the new rules on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746), and it is expected to achieve full functionality by the second quarter of 2024.

Read More »
cosmetic products

UK OPSS call for data on six cosmetic ingredients

On 14 July 2022, the Office for Product Safety and Standards (OPSS – the UK regulator for cosmetic products) issued a call for data on the safety of the following six cosmetic ingredients to investigate any suspected endocrine disrupting properties. 

Read More »
cosmetic products

European Commission Recommendation on the Definition of Nanomaterial

Nanomaterials are increasingly used in cosmetics and personal care products. They are similar to other chemicals/substances, but with specific risks associated to their use. The European Commission has published a new Recommendation to clarify the definition of ‘nanomaterial’. This definition may serve different policy, legislative and research purposes when addressing materials or issues concerning products of nanotechnologies.

Read More »
cosmetic products

Expected Restriction on the Use of Methyl Salicylate

The European Commission has notified the World Trade Organization (WTO) of a draft amendment to the Regulation (EC) No. 1223/2009 on cosmetic products. Annex III to Regulation will be amended, and the use of Methyl Salicylate in cosmetic products will be restricted.

Read More »