SCCS Preliminary Opinion on the inhalation toxicity of Acetylated Vetiver Oil in sprayable cosmetic products

Ingredients: ACETYLATED VEVITER OIL

Date of publication: 28/02/2024

On February 28 2024, the Scientific Committee on Consumer Safety (SCCS) published a preliminary Opinion on the inhalation toxicity of the fragrance ingredient Acetylated Vetiver Oil (AVO, CAS No 84082-84-8, EC No 282-031-1) in sprayable cosmetic products. The deadline for comments is set to May 3, 2024.

BACKGROUND

Vetiver oil is obtained from the distillation of fresh or dried roots of Vetiveria (Chrysopogon) zizanioides sourced from various geographical regions, primarily for the fragrance industry. Further processing originates Acetylated Vetiver oil – AVO (CAS No 84082-84-8, EC No 282-031-1).

In June 2019, the Scientific Committee on Consumer Safety (SCCS) issued a corrigendum to its opinion on Acetylated Vetiver Oil – AVO (SCCS/1599/18). The SCCS considered the use of Acetylated Vetiver Oil with 1% alpha-tocopherol as a fragrance ingredient in cosmetic leave-on and rinse-off products as safe, based on concentrations set by the International Fragrance Association (IFRA). However, the SCCS highlighted that the inhalation toxicity of AVO was not evaluated due to lack of data and that safety assessment for sprayable products was needed.

On March 31 2023 the industry submitted a new safety dossier, focusing on the inhalation toxicity of AVO in sprayable cosmetic products to address SCCS concerns. Typical cosmetic applications include fine fragrance pump sprays, deodorant sprays, hairsprays, and body lotion sprays, with intended maximum concentrations (IMCs) of AVO ranging 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. The European Commission requested the SCCS to conduct a safety assessment of AVO in sprayable cosmetic products in light of the new information regarding inhalation toxicity.

WHAT’S NEW?

In light of the information provided and taking into account the aggregate exposure and an in vitro study, the SCCS concluded that Acetylated Vetiver Oil (AVO) (with 1% alpha tocopherol) is safe when used at the intended maximum concentrations (IMCs) of:

0.9% (w/w) in fragrance pump sprays
0.05% (w/w) in deodorant sprays
0.1% (w/w) in hairsprays and body lotion sprays

These conclusions are aligned with the SCCS’s previous preliminary opinion in June 2019.

This preliminary opinion is open for comments until May 3, 2024.

References:

Scientific Committee on Consumer Safety (SCCS) – Opinion on the inhalation toxicity of the fragrance ingredient Acetylated Vetiver Oil – AVO (CAS No 84082-84-8, EC No 282-031-1) in sprayable cosmetic products – Submission IV, SCCS/1663/24, preliminary version of 28 February 2024.

other REGULATORY UPDATES

French labelling requirement for leave-on products containing Phenoxyethanol repealed

Ingredients: PHENOXYETHANOL

The EU Court of Justice repealed the French requirement for the labelling of the precautionary measurement “Not to be used on the nappy-skin area of children under 3 years of age” on leave-on cosmetic products containing Phenoxyethanol. Therefore, the labelling restriction related to Phenoxyethanol is officially not mandatory for products imported into France.

Regulation (EU) 2022/1531 – OMNIBUS ACT V – applicable as of 17 December 2022

Ingredients: METHYL SALICYLATE, SODIUM HYDROXYMETHYLGLYCINATE, DBMC, MIBK

Date of publication: 15/09/2022

Date of application: 17/12/2022

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

SCCS Revision of the Scientific Opinion on Vitamin A

Ingredients: RETINOL, RETINYL PALMITATE, RETINYL ACETATE, RETINYL LINOLEATE, RETINAL

Date of publication: 25/10/2022

The Scientific Committee on Consumer Safety has issued a final version of the Scientific Opinion on Vitamin A, concluding that exposure to Vitamin A derived from cosmetics can be a concern for higher exposure consumers, and since cosmetics alone do not exceed the upper limit the SCCS cannot suggest maximum concentration limits that take into account contributions from other sources.

Italy and France – Environmental Labelling of Cosmetic Products

PACKAGING WASTE MANAGEMENT

Date of application:01/01/2023

Although the European Cosmetics Regulation is applicable to every cosmetic product made available in the European Union market, some national legislations may also apply. Environmental regulations in Italy and France specify mandatory labelling requirements applicable to packaged products marketed in these countries.

SCCS consultation on opinion about Salicylic Acid

Ingredients: SALICYLIC ACID

Date of publication: 15/12/2022

On December 15, 2022, the EU Scientific Committee on Consumer Safety (SCCS) released the preliminary opinion on Salicylic Acid (CAS No. 69-72-7). This opinion is open for comments until February 17, 2023.

SCCS Preliminary Opinion on Sodium Bromothymol Blue (C186) as hair dyeing

Ingredients: SODIUM BROMOTHYMOL BLUE (C186)

Date of publication: 28/10/2022

Following the request from the EU Commission for a scientific opinion on the hair dye Sodium Bromothymol Blue (C186), on October 2022 the Scientific Committee on Consumer Safety (SCCS) issued a preliminary opinion. In light of the data provided, when used in non-oxidative hair colouring products up to a maximum on-head concentration of 0.5%, the SCCS is of the opinion that the complete safety of Sodium Bromothymol Blue could not be assessed.