Upcoming EU cosmetic ingredient bans and restrictions

Azadirachta Indica Seed Oil

Trimethylolpropane triacrylate

Pentetic acid

Pentasodium pentetate

(CMR Omnibus VI)

Expected December 1, 2023

Expected December 1, 2023

·         Restricted to 0.2% in rinse-off products

·         For leave-on products:

o   Not to be used in sunscreen products and products marketed for exposure to natural or artificial UV light.

·         For leave on and rinse-off products:

o   Do not use with nitrosating agents.

o   Maximum nitrosamine content: 50 μg/kg.

o   Keep in nitrite-free containers

·         safe when used according to the following concentrations:

·         Not to be used in preparations for children under 6 years of age

·         Restricted to the following concentrations:

a)       Leave-on skin products (except face makeup, spray/aerosol body lotion, spray/aerosol deodorant and hydroalcoholic based fragrances) and leave on hair products (except spray/aerosol products): 0.06%

b)      Face makeup (except lip products, eye makeup and makeup remover): 0.05%

c)       Eye makeup and makeup remover: 0.002%

d)      Leave-on hair products (spray/aerosol): 0.009%

e)      Deodorant spray/aerosol: 0.003%

f)        Body lotion spray/aerosol: 0.04%

g)       Rinse-off skin products (except hand wash) and rinse -off hair products: 0.06%

h)      Hand wash: 0.6%

i)        Hydroalcoholic-alcoholic fragrances: 0.6%

j)        Lip products: 0.03%

k)       Toothpaste: 2.52%

l)        Mouthwash intended for children aged 6–10 years: 0.1%

m)    Mouthwash intended for children above 10 years of age and adults: 0.6%

n)      Mouth spray: 0.65%

(UV filter)

·         Other products: max 10%

·         Benzophenone as an impurity and/or degradation product of Octocrylene shall be kept at trace level.

(UV filter)

o   max 6%

o   Not more than 0,5 % to protect product formulation

o   If used at 0,5 % to protect product formulation, the levels used as UV filter must not exceed 5,5 %.

o   Warning required: Contains Benzophenone-3 (Not required if concentration is 0,5 % or less and when it is used only for product protection purposes.)

·         Body products, including propellant and pump spray products:

o   max 2.2%

o   Not more than 0,5 % to protect product formulation

o   If used at 0,5 % to protect product formulation, the levels used as UV filter must not exceed 1.7 %.

o   Warning required: Contains Benzophenone-3 (Not required if concentration is 0,5 % or less and when it is used only for product protection purposes.)

·         Other products: max 0.5%

·         (entry 82 of Annex IV still applies if the ingredient is used as a colorant)

·         Toothpastes: 0.1%

·         Other leave-on and rinse-off products: 0.8%

Triclosan

o   As a preservative: max 0.2%

o   Rinse-off products when used individually or in combination: 1.5%

·         Triclosan:

o   Shower gel and hand soap: 0.3%

o   Mouthwash: 2%

o   Toothpaste, deodorant stick, face powder and blemish concealer, when used individually or in combination: 3%

o   Body lotion: 0.03% (when used individually or combined with the above-mentioned products)

(UV filter)

 “Do not use to dye eyelashes.”

o   A Working Document and draft Annex III entry to the EU Cosmetics Regulation have been drafted by the Commission.  The intention is to require the on-pack labelling of the additional fragrance allergens if they exceed the relevant thresholds.

o   The last draft proposed transition periods of three years for placing on the market and five years for withdrawing non-compliant products from the market.