2-METHYL-5-HYDROXYETHYLAMINOPHENOL

US FDA substance register · UNII T872B9E83J · registered name 5-(2-HYDROXYETHYLAMINO)-2-METHYLPHENOL · single chemical substance

Source: US FDA Unique Ingredient Identifier (UNII)

Banned

South Korea

Restricted or banned

South Korea · Taiwan

Restricted

Taiwan · United Kingdom

Source: MFDS (Korea) cosmetic regulatory information · ASEAN Cosmetic Directive · EU Cosmetics Regulation · Taiwan FDA cosmetic ingredients · Taiwan FDA cosmetic regulations · UK cosmetics regulations (OPSS)

ASEAN

• Field of application and/or use : Hair dye substance in oxidative hair dye products. Use for dyeing eyelashes and eyebrows is not permitted.
• Other limitations and requirements : After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1.5 % • Do not use with nitrosating systems • Maximum nitrosamine content: 50 μg/kg • Keep in nitrite-free containers The direction for use “wear suitable gloves” must be included in label or leaflet text.
• Conditions of use and warning which must be printed on the labels : The mixing ratio must be printed on the label. Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary “black henna” tattoos may increase your risk of allergy. Do not colour your hair if: • you have a rash on your face or sensitive, irritated and damaged scalp, • you have ever experienced any reaction after colouring your hair, • you have experienced a reaction to a temporary “black henna” tattoo in the past Do not use to dye eyelashes or eyebrows

China

• Maximum concentration : 1%

European Union

• Product Type, body parts : (a) Hair dye substance in oxidatie hair dye products. (b) Products intended for colouring eyelashes
• Other : For (a) and (b): After mixing under oxidative conditions the maximum concentration applied to hair or eyelashes must not exceed 1,5% - Do not use with nitrosating agents - Maximum nitrosamine content: 50 microgram/Kg - Keep in nitrite-free containers
• Wording of conditions of use and warnings : (a) To be printed on the label: The mixing ratio. “ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.” (b) To be printed on the label: The mixing ratio. “For professional use only. This product can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase the risk of allergy. Eyelashes shall not be coloured if the consumer: — has a rash on the face or sensitive, irritated and damaged scalp, — has experienced any reaction after colouring hair or eyelashes, — has experienced a reaction to a temporary ‘black henna’ tattoo in the past. Rinse eyes immediately if product comes into contact with them.” ’

EU Cosmetics Regulation, Annex III (restricted substances), entry 229 · applies to (a) Hair dye substance in oxidatie hair dye products. (b) Products intended for colouring eyelashes

Source: EU restricted substances (Annex III)

Restriction III/229

Source: EU CosIng ingredient list

Reviewed by CIR: Annual Review of Cosmetic Ingredient Safety Assessments: 2005/2006

Source: US Cosmetic Ingredient Review (CIR)

Reviewed by CIR: Final Report on the Safety Assessment of 2-Methyl-5-Hydroxyethylaminophenol

Source: US Cosmetic Ingredient Review (CIR)