CIR Panel Meeting #163: Hair Dye Basic Yellow 87, Fatty Ethers & Ginger

The 163rd Expert Panel Meeting was published on December 8th, 2022 by CIR (Cosmetic Ingredient Review). The meeting agenda and announcements state that there have been two final safety assessment reports, one for fatty ethers, which includes eight components that are safe for use, and the other for ginger, which has nine compounds, eight of which are suitable for use and one of which has inadequate data. Four tentative safety assessment reports and four announcements of insufficient data are also been listed.

Reports can be downloaded directly at the bottom of the articles.

Within the tentative safety assessments report, It is worth noticing that Basic Yellow 87 is reported the function as a semi-permanent and oxidative hair dye in hair coloring products.  Due to its sluggish skin absorption, lack of genotoxicity, and low reported amounts of usage, the panel evaluation from CIR determined that it is safe for use in hair color products.

However, it has been discovered in multiple instances that Basic Yellow 87 has been utilized in 4 non-coloring cosmetic products (non-coloring hair conditioner, shampoo, and other hair preparations).

Under the Federal Food, Drug, and Cosmetics Act, color additives must be approved by the US Food and Drug Administration (FDA) for their intended use before they can be used. As Basic Yellow 87 is an unauthorized color addition in cosmetics, such usage are prohibited.

Basic Yellow 87, on the other hand, reportedly also appears in an aerosol hair color spray. Data on the toxicity of this chemical when inhaled were not available. However, CIR believes that due to the minimal actual exposure in the breathing zone and the low concentrations at which the component is utilized, unintentional inhalation would not be a substantial route of exposure that can cause local respiratory or systemic effects.

The summary findings from CIR 163 conference are shown in the table below:

IngredientsDerivesFindings
Final Safety Assessments
Fatty EthersCetyl Dimethylbutyl Ether
Dicaprylyl Ether
Dicetyl Ether*
Didecyl Ether*
Diisononyl Ether*
Dilauryl Ether*
Dimyristyl Ether*
Distearyl Ether
safe as used in the present practices of use
GingerZingiber Officinale (Ginger) Extract
Zingiber Officinale (Ginger) Rhizome Extract
Zingiber Officinale (Ginger) Root
Zingiber Officinale (Ginger) Root Extract
Zingiber Officinale (Ginger) Root Juice
Zingiber Officinale (Ginger) Root Oil

Zingiber Officinale (Ginger) Root Powder
Zingiber Officinale (Ginger) Water

8 Non-sensitizing ginger-derived compounds are safe of use, insufficient data to issue a conclusion of safety for Zingiber Officinale (Ginger) Leaf Cell Extract. .
Tentative Safety Assessments
Basic Yellow 87Basic Yellow 87Safe as a hair dye ingredient, can not be used as colorant in general cosmetics
MallowMalva Sylvestris (Mallow) Extract

Malva Sylvestris (Mallow) Flower Malva Sylvestris (Mallow) Flower Extract Malva Sylvestris (Mallow) Flower/Leaf Extract Malva Sylvestris (Mallow) Flower/Leaf/Stem Extract Malva Sylvestris (Mallow) Leaf Extract Malva Sylvestris (Mallow) Leaf Powder Malva Sylvestris (Mallow) Oil

8 Non-sensitizing malva sylvestris (mallow)-derived components are safe of use.

 

Final product formulations may contain multiple botanicals, each possibly containing the same

constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers.

Octyldodecyl Stearoyl Stearate Formulators should be aware of this potential and ensure that products containing this ingredient should be formulated to be non-irritating. 
Phytosteryl GlutamatesPhytosteryl/Behenyl/Octyldodecyl Lauroyl Glutamate
Phytosteryl/Behenyl/ Octyldodecyl/Isostearyl
Lauroyl Glutamate Phytosteryl/Octyldodecyl Lauroyl Glutamate
Available data are insufficient to make a determination of safety 

Insufficient Data Announcement

6-Amino-m-Cresol Additional data needed to determine safety for this hair dye ingredient.
6-Amino-o-Cresol Additional data needed to determine safety for this hair dye ingredient.
OliveHydrolyzed Olive Fruit Hydrolyzed Olive Fruit Extract
Hydrolyzed Olive Leaf Extract
Olea Europaea (Olive) Bark Extract
Olea Europaea (Olive) Branch Extract
Olea Europaea (Olive) Bud Extract
Olea Europaea (Olive) Flower Extract
Olea Europaea (Olive) Flower Water
Olea Europaea (Olive) Fruit Olea Europaea (Olive) Fruit Extract
Olea Europaea (Olive) Fruit Juice
Olea Europaea (Olive) Fruit Juice Extract
Olea Europaea (Olive) Fruit Unsaponifiables
Olea Europaea (Olive) Fruit Water
Olea Europaea (Olive) Husk Powder
Olea Europaea (Olive) Leaf Olea Europaea (Olive) Leaf Extract
Olea Europaea (Olive) Leaf Powder
Olea Europaea (Olive) Leaf Water
Olea Europaea (Olive) Sap Extract
Olea Europaea (Olive) Seed Olea Europaea (Olive) Seed Powder
Olea Europaea (Olive) Wood Extract
Additional data needed to determine safety for this hair dye ingredient.
Zanthoxylum piperitumZanthoxylum Piperitum Fruit Extract

Zanthoxylum Piperitum OilZanthoxylum Piperitum Peel ExtractZanthoxylum Piperitum Peel Water

Additional data needed to determine safety for this hair dye ingredient.

Downloads: 

Post Meeting Announcement

TENTATIVE DOCUMENTS

 

FINAL DOCUMENTS

Featured Articles

READ MORE

Latest US Regulatory Updates on Cosmetics (January 2025)

Overview The Modernization of Cosmetics Regulation Act (MoCRA), enacted in December 2022, has strengthened federal oversight of cosmetics. However, it does not regulate cosmetic ingredients,...

China Eases Trade Controls on Low-Concentration Triethanolamine Products Starting January 2025

On January 25, 2024, China declared that starting February 1, 2024, products containing low concentrations of triethanolamine—such as non-medical disinfectants, synthetic detergents, cosmetics, and...

Analysis of Indonesia’s New Cosmetic Notification Regulation (Draft)

I. Background The Indonesian National Agency of Drug and Food Control (BPOM) has recently released a draft regulation on "Procedures for Submitting Cosmetic Notifications" (Tata...

Indonesia BPOM Drafts New Regulation on Cosmetic Notification Procedures

The Indonesian Food and Drug Authority (BPOM) has released a draft regulation concerning the procedures for submitting cosmetic notifications, aimed at enhancing public safety...

Find a Consultant >>