EU SCCS Released Preliminary Opinion on Benzyl Salicylate in Cosmetic Products
On 13 June 2023, EU Scientific Committee on Consumer Safety (SCCS) released a preliminary opinion on Benzyl Salicylate in cosmetic products, which is open for comments until 24 August 2023.
Benzyl Salicylate is produced naturally in a variety of plants and plant 26 extracts where it can be extracted. In cosmetics, Benzyl Salicylate is used for its fragrance/perfuming function. Under the current EU regulation, it is considered as an established contact allergen in humans.
Based on the data provided and assessed and taking under consideration the concerns related to potential endocrine disrupting properties, the SCCS released its preliminary opinion, which considers Benzyl Salicylate safe when used up to the maximum concentrations provided in Table 1 of this Opinion.
Table 1: Maximum Use Concentration of Benzyl Salicylate in Cosmetic Products
Type of cosmetic product exposure | Maximum % concentration used |
Hydroalcoholic-based fragrances (spray and non-spray) | 4 |
Rinse-off skin & hair products (except rinse off body products) | 0.5 |
Rinse off body products | 1.3 |
Leave on skin & hair products (non-spray/non-aerosol)(except body lotion) | 0.5 |
Leave on hair products (spray/aerosol) | 0.5 |
Leave on body products (non-spray/spray/aerosol) | 0.7 |
Face make-up products and make-up remover | 0.2 |
Oral care | 0.004 |
Deodorant products (spray/aerosol) | 0.91 |
EU SCCS Issues Final Opinion on Salicylic Acid in Cosmetic Products
Salicylic acid is used in cosmetic products with reported functions as a denaturant, hair and skin conditioning agent, exfoliant/keratolytic, anti-sebum agent, anti-dandruff/antiseborrheic agent and a product preservative. Salicylic acid has been subject to a safety evaluation.
In December 2022, the EU Scientific Committee on Consumer Safety (SCCS) launched a public consultation period of two months to gather comments on the preliminary opinion regarding the use of Salicylic Acid in cosmetic products. After carefully considering the data received, the SCCS released the final opinion on June 9, 2023.
This final opinion provides updated guidelines and recommendations for the use of Salicylic Acid in cosmetics, and it is important for manufacturers and consumers to be aware of these changes.
1.the SCCS is of the opinion that salicylic acid (CAS 69-72-7) is safe when used as
preservative at a concentration of 0.5 % in cosmetic products, considering its current restrictions in place. The provided information shows that salicylic acid is an eye irritant with the potential to cause serious damage to the eye.
2.this Opinion is not applicable to any sprayable product (including mouth spray) that may lead to exposure of end-user’s lungs by inhalation.
3.The use of salicylic acid as a restricted ingredient for purposes other than inhibiting
the development of micro-organisms is safe at a concentration:
- up to 3.0 % for the cosmetic rinse-off hair products,
- up to 2.0 % for other products, except body lotion, eye shadow, mascara, eyeliner,
lipstick, non-spray deodorant, and
- up to 0.5% for body lotion, eye shadow, mascara, eyeliner, lipstick, oral products and non-spray deodorant.
4.This Opinion is not applicable to any sprayable product (including mouth spray) that may lead to exposure of end-user’s lungs by inhalation.
5.In the absence of exposure data of Salicylic acid in cosmetic products for children, safety concerns have been noted for the younger age groups (between 3-10 years). Since the Cosmetic Regulation does not allow the use of salicylic acid in products for children under 3 years of age, this age category has not been considered in this Opinion.
EU SCCS Request for a Scientific Opinion on the Fragrance Ingredient Acetylated Vetiver Oil
Vetiver oil is produced for the fragrance industry by distillation of fresh or dried roots of Vetiveria (Chrysopogon) zizanioides originating from different geographical areas. The Vetiver oil is subject to further processing to obtain Acetylated Vetiver oil(AVO).
The SCCS considered the use of Acetylated Vetiver Oil with 1% alpha-tocopherol as a fragrance ingredient in cosmetic leave-on and rinse-off type products as safe. However, the SCCS noted that ‘Inhalation toxicity of Acetylated Vetiver Oil (AVO) was not assessed in this Opinion because no data were provided.’
According to industry, typical cosmetic applications of AVO that may lead to inhalation exposure include fine fragrance pump sprays, deodorant sprays, hairsprays, and body lotion sprays with Intended Maximum Concentrations (IMCs) of AVO being up to 0.9% (w/w) in fine fragrance sprays, 0.05% (w/w) in deodorant sprays and 0.1% (w/w) in hairsprays and body lotion sprays.
Stakeholders have 9 months to submit scientific opinion on the above use of AVO.
EU SCCS Released Preliminary Opinion on Methylparaben in Cosmetic Products
On 8 June 2023, EU Scientific Committee on Consumer Safety (SCCS) released a preliminary opinion on Methylparaben in cosmetic products, which is open for comments until 21 August 2023.
On the basis of the safety assessment of Methylparaben, and considering the concerns related to potential endocrine activity, the SCCS has concluded that Methylparaben is safe when used as a preservative in cosmetic products up to a maximum concentration of 0.4% (as acid) when used on its own and up to 0.8% (as acid) for mixtures of esters as indicated in entry 12 of Annex V to the Cosmetics Regulation.
EU SCCS Released Preliminary Opinion on Butylparaben in Cosmetic Products
On 8 June 2023, the EU Scientific Committee on Consumer Safety (SCCS) has recently published a preliminary opinion on the use of Butylparaben in cosmetic products. The public is invited to provide their comments on this opinion until 21 August 2023.
On the basis of safety assessment considering all available data and the concerns related to endocrine activity, the SCCS is of the opinion that the use of Butylparaben as a preservative in cosmetic products at concentrations of up to 0.14% (expressed as acid) is safe.
This is an important opportunity for stakeholders to voice their opinions and concerns regarding the use of Methylparaben in cosmetics.
US FDA Published Cosmetics Guidance Documents
On 12 June, US FDA Published Cosmetics Guidance Documents for the cosmetic industry, which covers insanity conditions, recommended maximum level for lead, cosmetics good manufacturing practice, nanomaterial safety, and labeling requirements.
Guidance documents represent FDA's current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. Manufacturers can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.
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