Ingredient

BHT

Name / description

BHT; Butylhydroxytoluene; 2,6-Di-tert-butyl-p-cresol; in food: E 321


Function(s) of this ingredient in cosmetic products

ANTIOXIDANT

Inhibits reactions promoted by oxygen, thus avoiding oxidation and deterioration of ingredients

FRAGRANCE

Enhances the smell of a product and / or perfumes the skin

FRAGRANCE FUNCTIONAL

Functional ingredient (excipient) of perfume oils and / or flavours


Origin

synthetic


Occurrence in cosmetics

Creams, ointments, lotions, lipsticks, eye shadows


Occurrence in other products

Medicinal products and medical devices for external application; colourants, glues and plastics, rubber; foodstuffs (such as dry soups, chewing gum or processed nuts)


Background information on use in cosmetics

Use as antioxidant for the protection of the product, often together with BHA. Fragrances or mixtures of fragrances are often referred to in the cosmetics area as "perfuming agents" or "perfume oils" or "parfum oils". On the cosmetic products they are declared with the INCI name "PARFUM". These are undiluted individual substances or their mixtures which originate from natural raw materials or can be produced (semi-) synthetically. They are starting materials for the production of perfume, eau de parfum, eau de toilette, eau de cologne and other perfumed cosmetic products. The average content of fragrances amounts in perfume to 15-30 %, in eau de parfum to 10-14 %, in eau de toilette to 6-9 %, in eau de cologne to 3-5 % as well as in skin creams, shampoos, hair and deodorant sprays to approximately 0.2-1 % and approximately 1-3 in deodorant sticks. The perfume oils include essential oils, resinoids and absolutes. The sources are, amongst others, flowers, leaves and stems, fruits and fruit peels or roots of plants; woods, grasses or herbs, needles, resins and balsams. Moreover, only compounds isolated from natural products such as aldehydes, ketones, esters, alcohols etc. are used (geraniol, citronellal, citral, eugenol, menthol) as well as semi-synthetic (citronellol, geranyl acetate, jonone) and synthetic scents (eg phenylethyl alcohol and linalool) are used. Scents of animal origin such as musk and ambra are only rarely used.


Links to scientific assessments

Opinion of the SCCS (2021) on the safety as cosmetic ingredient


Why are we talking about it?

BHT is suspected of having effects on the liver, thyroid and kidneys and of being an endocrine disruptor. It is also suspected of inducing/eliciting allergies (sensitisation). The facts: Authorised as a food additive, BHT has been evaluated by several expert committees (European (1, 2), American (3, 4), OECD (5)). In 2019, the American experts (Cosmetic Ingredient Review) concluded, once again, that it is safe to use. Existing data do not confirm an endocrine disrupting potential of BHT. Effects on the liver, kidneys and thyroid have been reported, but these results are not relevant for BHT exposure via cosmetic products. In particular, these studies used peroral administration of BHT at dodes much higher than those used in cosmetic products. Moreover, percutaneous penetration of BHT is very slow and insignificant, thus resulting in negligible systemic exposure. European experts have decided to re-examine the potential endocrine activity of 28 substances suspected of being endocrine disruptors. BHT was included in this re-evaluation. According to the data, BHT cannot be considered as an endocrine disruptor and the applicable regulatory restrictions ensure a safe use for the consumer (6). With regard to allergies, available robust data do not indicate a sensitising potential. In the context of its use in cosmetic products, BHT is not considered a sensitiser. Key points to take away: The existing data on BHT allow its authorisation in cosmetic and food products. A recent re-evaluation shows that it does not meet the criteria for identification as an endocrine disruptor and its use concentrations are safe and strictly regulated. Its use is therefore considered by experts as safe in cosmetic products, including those intended for children (6). Sources: (1) French Agency for Food, Environmental and Occupational Health & Safety (ANSES/ AFSSA-AFSSE): Analysis of the most appropriate risk management option (2016): https://www.anses.fr/fr/system/files/REACH2016RE0001.pdf (2) French National Agency for the Safety of Medicines and Health Products (ANSM/ex-AFSSAPS): “Evaluation de la sécurité pour les produits pour enfants de moins de 3 ans dans le cadre de la saisine PE, 2010 (Rapport de la commission de cosmétologie du 3 décembre 2009)”/ Evaluation of the safety of products for children under 3 years of age 2010 (Report from the cosmetology commission of 3 December 2009): https://archiveansm.integra.fr/var/ansm_site/storage/original/application/9c9005c3e4124e61633455da06a64a07.pdf (3) Cosmetic Ingredient Review (CIR). Final report on the safety assessment of BHT: https://www.cir-safety.org/sites/default/files/BHT.pdf (4) United States Environmental Protection Agency (US EPA): Re-evaluation of BHA and BHT, 2005: https://www.epa.gov/sites/production/files/2015-04/documents/bhtbha.pdf (5) Organisation for Economic Cooperation and Development (OECD): Screening Information Data Sets (SIDS). UNEP Publication, 2002 (6) Opinion SCCS/1636/21 (02/12/2021): https://ec.europa.eu/health/system/files/2021-12/sccs_o_257.pdf


Further information

For the clarification of a suspicion of a contact allergy this substance can be routinely tested in the epicutaneous test at the dermatologist.


Belongs to the following substance groups


Regulating cosmetics

Cosmetics Ingredients are subject to regulation. Please note, different regulations may apply to cosmetic ingredients outside the EU.

Understanding your cosmetics

How are cosmetics kept safe in Europe?

Strict laws make sure that cosmetics and personal care products sold in the European Union are safe for people to use. Companies, national and European regulatory authorities share the responsibility of keeping cosmetic products safe.

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What should I know about endocrine disruptors?

Some ingredients used in cosmetic products have been claimed to be ‘endocrine disruptors’ because they have the potential to mimic some of the properties of our hormones. Just because something has the potential to mimic a hormone does not mean it will disrupt our endocrine system. Many substances, including natural ones, mimic hormones but very few, and these are mostly potent medicines, have ever been shown to cause disruption of the endocrine system. The rigorous product safety assessments by qualified, scientific experts that companies are legally obliged to carry out cover all potential risks, including potential endocrine disruption.

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Are cosmetics tested on animals? No!

In the European Union, testing cosmetics on animals has been fully banned since 2013. Over the last 30 years, long before a ban was in place, the cosmetics and personal care industry has invested in research and development to pioneer alternatives to animal testing tools to assess the safety of cosmetics ingredients and products.

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What about allergens in cosmetics?

Many substances, natural or man-made, have the potential to cause an allergic reaction. An allergic reaction occurs when a person’s immune system reacts to substances that are harmless to most people. A substance that causes an allergic reaction is called an allergen. Cosmetics and personal care products may contain ingredients that can be allergenic for some people. This does not mean that the product is not safe for others to use.

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Database

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