European Commission sets new regulatory standards for BHT, Acid Yellow and Homosalate

22 Nov 2022 --- The European Commission (EC) has amended the regulations for using Butylated Hydroxytoluene (BHT), Acid Yellow 3, Homosalate and HAA299 in cosmetic products. In addition, the commission has corrected the regulation for the use of Resorcinol in cosmetic products.

Regulation 2022/2195, published in the Official Journal of the European Union, provides new conditions for their use and the authorization of a new UV filter.

In light of the SCCS opinion, it can be concluded that there is a potential risk to human health arising from the use of BHT in mouthwash, toothpaste and other leave-on and rinse-off products when the concentration of that substance exceeds certain levels.

BHT is the more controversial compound of the group with potential endocrine-disrupting properties, which prompted the EC to launch a public call for data in 2019. Industry representatives were required to submit scientific evidence demonstrating the safety of BHT. The commission requested the Scientific Committee for Consumer Safety (SCCS) to conduct a safety assessment of BHT in view of the information provided.

Safe for dental use
BHT is a synthetic antioxidant that helps maintain the properties and performance of products when exposed to air and is widely used in cosmetics.

The SCCS concluded in its opinion of December 2021 that BHT is safe as an ingredient up to a maximum concentration of 0.001% in mouthwash, 0.1% in toothpaste and 0.8% in other leave-on and rinse-off products when those product categories are used individually or together.The SCCS has conducted safety assessments on these compounds in view of scientific evidence presented by the cosmetic industry.

The use of BHT in these products should be restricted to the maximum concentrations stipulated.

Headed for lower concentrations
Substance 1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated sodium salts known as Acid Yellow 3 have previously been allowed for use as a colorant in cosmetic products without any maximum concentration.

The SCCS concluded in its opinion of July 2021 that it is safe when used in products at on-head concentrations of up to 0.5%, indicating that there is a potential risk to human health arising from its use in non-oxidative hair coloring products when the concentration of that substance exceeds a certain level. Therefore, Acid Yellow 3 should be restricted to a maximum concentration of 0.5%.

Curbing potential endocrine disruptors
In light of concerns related to the potential endocrine-disrupting properties of Homosalate, known scientifically as Benzoic acid, 2-hydroxy-, 3,3,5-trimethylcyclohexyl ester, the commission launched a public call for data in 2019.

Homosalate is listed as a UV filter in cosmetic products with a maximum concentration of 10% in ready-for-use preparation.

The industry submitted scientific evidence to demonstrate the safety of Homosalate when used in cosmetic products. The commission requested the SCCS to conduct a safety assessment of Homosalate in view of the information provided.

The SCCS concluded that Homosalate is not safe when used as a UV filter in cosmetic products at concentrations of up to 10%. They found that it is safe for the consumer only up to a maximum concentration of 0.5 % in the final product.

The SCCS concluded that Homosalate is safe as a UV filter at concentrations up to 7.34% in face products in the form of cream and pump spray. The combined use of Homosalate up to 0.5% in all cosmetic products and up to 7.34% in face products are not considered safe by the SCCS since the margin of safety of such combined use is below 100.UV filters, Homosalate and HAA299 have come under scrutiny and regulations concerning them have been amended.

Nano vs. non-nano effects of UV filters
HAA299 is another UV filter under scrutiny. In 2009, the commission received a dossier from the industry to support the safe use of HAA299 (micronized and non-micronized) in cosmetic products, which was further substantiated in 2012. In 2014, the SCCS concluded that the use of HAA299 in non-nano form at a concentration of up to 10% did not pose a risk of systemic toxicity in humans.

In view of that opinion on the non-nano form of HAA299, the industry submitted additional data and requested an assessment of the safety of a UV filter up to a maximum concentration of 10% in September 2020.

In 2021, SCCS concluded that HAA299 in a nano form, as covered within the provided characteristics (minimum purity equal to or above 97%, median particle size in terms of particle number equal to or above 50 nm), is safe when used as a UV-filter in dermally applied cosmetic products up to a maximum concentration of 10%.

Considering the inflammatory effects on the lung after acute inhalation exposure to products containing HAA299 (nano), the SCCS did not recommend using HAA299 (nano) in applications that could lead to exposure of the consumer’s lungs via inhalation.

Coloring cosmetic products
Resorcinol is used in products for coloring eyelashes, hair lotions and shampoos with certain restrictions.

With regard to oxidative hair dye products, the label should contain the following warning: “do not use to dye eyelashes or eyebrows.”

The definition of “hair product” from 2013 is a cosmetic product intended to be applied to the hair of the head and face except for eyelashes. The exclusion of eyelashes was motivated by the fact that the level of risk is different when cosmetic products are applied on the hair of the head than on eyelashes.

The commission amended the entry to allow the professional use of Resorcinol in products intended for coloring eyelashes.

Industry developments
In other industry news, the commission consulted the public about changing the current list of potentially carcinogenic, mutagenic and reprotoxic chemicals under the Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation 1907/2006. The list covers a broad range of chemicals that are hazardous and not to be used in cosmetic and personal care formulations.

It also seeks the SCCS’s opinion on the safe use of the hair dye Hydroxypropyl p-phenylenediamine and its dihydrochloride salt. This is the second submitted request on the compound, with the first adopted in 2019.

Edited by Inga de Jong

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