EU SCCS Issues Safety Assessment Opinions on Multiple Chemical Raw Materials Used in Cosmetics

In November 2023, the European Union's Scientific Committee on Consumer Safety (SCCS) issued a number of final safety opinions and preliminary opinions on cosmetic raw materials, which are summarized as follows.

Fullerenes, hydroxylated fullerenes and hydrated forms of hydroxylated fullerenes (nano)

On November 3, 2023, the EU Scientific Committee on Consumer Safety (SCCS) issued the final safety opinion (SCCS/1649/23) on Fullerenes, Hydroxylated Fullerenes and hydrated forms of Hydroxylated Fullerenes (nano). The core content is summarized as follows:

Due to the lack of sufficient and reliable data on physicochemical, toxicokinetic and toxicological aspects, the SCCS is unable to draw conclusions on the safety of fullerenes and (hydrated) hydroxylated fullerenes, especially with regard to genotoxicity.

Based on the available information, the SCCS considers the hydrated form of hydroxylated fullerene to be potentially genotoxic and has raised concerns about the genotoxicity of hydroxylated fullerene.

The SCCS stated that no conclusions can be made about the genotoxicity of fullerenes (C60 and C70) at this time.

Related points: Judging from the data displayed in the SCCS assessment report, there are multiple genotoxicity reports and literature studies on fullerene, and many reports also show negative results. However, SCCS believes that considering the particularity of nanomaterials, the existing negative data have deficiencies in test methods, characterization of test substances and interpretation of test results. For example, SCCS proposed in Guidance on Nanomaterials (SCCS/1611/19) that the Ames test is not suitable for mutagenicity evaluation of nanomaterials, therefore the Ames test results for fullerenes were not accepted.

In addition, there are also reports of positive results on the genotoxicity of fullerenes and derivatives in some literatures. Based on the weight of evidence, SCCS believes that the existing research evidence is insufficient to assess the genotoxic safety of fullerenes.

After the release of SCCS’s assessment opinions, there are also some different opinions in the industry, such as relevant statements issued by major raw material manufacturers. The main controversial points are whether fullerene should be considered a nano raw material and whether the existing test data is sufficient.

Regarding the definition of nanomaterials, in June 2022, the European Commission revised the general definition of nanomaterials (Commission recommendation (EU) 10.6.2022). This new modification to the definition of nanomaterials has not yet been included in the EU cosmetics regulations. (EC NO. 1223/2009).

Water soluble zinc salt

On November 6, 2023, the European Union's Scientific Committee on Consumer Safety (SCCS) released its final safety opinion (SCCS/1657/23) on water-soluble zinc salts used in oral hygiene products.

(1) For children over 1 year old, it is safe to use 1% water-soluble zinc salt in toothpaste; For children 6 months to 1 year old, the recommended safe concentration of soluble zinc salts in toothpaste is 0.72%.

(2) Adding 0.1% water-soluble zinc salt to mouthwash is safe for users over 6 years old.

Benzyl salicylate

On November 6, 2023, the European Union's Scientific Committee on Consumer Safety (SCCS) released the final safety opinion on Benzyl Salicylate (SCCS/1656/23), adding a new maximum concentration of benzyl salicylate in various cosmetics.

The SCCS considers benzyl salicylate safe for use at the following maximum concentrations: hydroalcoholic fragrances (4%), rinse-off skin and hair products (0.5%), rinse-off body products (1.3%), leave-on skin and hair products and hair products (0.5%), leave-on body products (0.7%), facial cosmetics (0.2%), oral care products (0.004%), deodorant products (0.91%).

Butylparaben

On November 6, 2023, the European Union's Scientific Committee on Consumer Safety (SCCS) released its final safety opinion (SCCS/1651/23) on Butylparaben, CAS No. 94-26-8.

The SCCS believes that butylparaben at a concentration of 0.14% (based on acid) is safe for use as a preservative in cosmetics, but this opinion does not involve an environmental safety assessment. At the same time, SCCS pointed out that due to the lack of relevant exposure data, potential safety concerns about butylparaben on children cannot be ruled out.

Hydroxypropyl p-phenylenediamine and its dihydrochloride

On November 6, 2023, the European Union's Scientific Committee on Consumer Safety (SCCS) issued a preliminary opinion on Hydroxypropyl p-phenylenediamine and its dihydrochloride salt (SCCS/1659/23). Comments are open until January 8, 2024.

In the draft for comments, SCCS believes that the use of hydroxypropyl p-phenylenediamine and hydroxypropyl p-phenylenediamine dihydrochloride in oxidative hair dye products is safe at a maximum concentration of 2%. Hydroxypropyl p-phenylenediamine and its dihydrochloride have the potential for eye irritation and moderate skin sensitization.

Hexyl salicylate

On November 9, 2023, the European Union's Scientific Committee on Consumer Safety (SCCS) issued a preliminary opinion on Hexyl salicylate (SCCS/1658/23) and publicly solicited opinions. Comments are open until January 12, 2024.

The SCCS considers hexyl salicylate to be safe for use at the following maximum concentrations: hydroalcoholic fragrances (2%), all rinse-off products (0.5%), all leave-on products (0.3%), toothpastes and mouthwashes (0.001%). This assessment does not address environmental safety.

Sodium myristoyl sarcosinate

On November 20, 2023, the European Commission requested the European Scientific Committee on Consumer Safety (SCCS) to conduct safety assessments on Sodium Myristoyl Sarcosinate, CAS No. 30364-51-3 / EC No. 250-151-3 as a coating for titanium dioxide (nano), the substance can be used in sunscreens.

Hydroxyapatite (nano)

On November 20, 2023, the European Commission requested the European Scientific Committee on Consumer Safety (SCCS) to conduct a safety assessment of Hydroxyapatite (nano), CAS No. 1306-06-5, EC No. 215-145-7.

Silver

On November 23, 2023, the European Commission requested the European Scientific Committee on Consumer Safety (SCCS) to conduct a safety assessment on the use of silver, CAS/EC No. 7440-22-4/231-131-3 in cosmetics.