In the light of new SCCS opinions, European Commission has already prepared a draft regulation referring to the substances BHT, Acid Yellow 3, Homosalate, Resorcinol, and Bis-(Diethylaminohy d-Roxybenzoyl Benzoyl) Piperazine (HAA299).
BHT
Butylated Hydroxytoluene (BHT, CAS no 128-37-0) which is now not regulated under Regulation (EC) No 1223/2009, should be used at concentrations up to 0,001 %, 0,1 %, and 0,8 % in mouthwash, toothpaste and other leave-on and rinse-off product, respectively, based on the SCCS/1636/21 opinion.
Acid Yellow 3
The substance ‘1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts’(CAS No 8004-92-0), known as Acid Yellow 3, is currently listed under entry 82 of Annex IV to Regulation (EC) No 1223/2009 and is therefore allowed for use as a colorant in cosmetic products without any maximum concentration. However, based on the data provided by the SCCS/1631/21 opinion, Yellow 3 is safe when used in such products at on-head concentrations of up to 0,5 %.
Homosalate
The substance ‘Benzoic acid, 2-hydroxy-, 3,3,5-trimethylcyclohexyl ester’ (CAS No 118-56-9), known as Homosalate, is listed under entry 3 of Annex VI to Regulation (EC) No 1223/2009 and is therefore allowed for use as a UV filter in cosmetic products with a maximum concentration of 10 % in ready for use preparation. Based on the SCCS scientific advice (SCCS/1638/21), the use of Homosalate should be restricted to face products (non-spray and pump spray products) only up to a maximum concentration of 7,34 %.
HAA299
The substance ‘1,1'-(1,4-piperazinediyl)bis[1-[2-[4-(diethylamino)-2-hydroxybenzoyl]phenyl]-methanone’ (CAS no 919803-06-8), known as Bis- (Diethylaminohydroxybenzoyl Benzoyl) Piperazine (HAA299), is a UV-filter and is currently not regulated under Regulation (EC) No 1223/2009. In light of the SCCS/1634/21 opinion, the use of HAA299 either as non-nano or nano form is safe as a UV filter in dermally-applied cosmetic products up to a maximum concentration of 10%. The SCCS considers that the combined maximum concentration of non-nano and nanoforms of HAA299 should not exceed 10% in a cosmetic product. With regard to HAA 299 (nano), a condition should be introduced regarding its use in applications that may lead to exposure to the lungs.
Resorcinol
The substance ‘1,3-benzenediol’ (CAS No 108-46-3), known as Resorcinol, is currently listed under entry 22 of Annex III to Regulation (EC) No 1223/2009 as allowed for use in oxidative hair dye products, products intended for colouring eyelashes and hair lotions and shampoos with certain restrictions. With regard to oxidative hair dye products, the label is to contain the following warning: ‘Do not use to dye eyelashes or eyebrows. According to the definition of the term ‘hair product’ in Regulation (EC) No 1223/2009, which became applicable on 11 July 2013, a hair product means a cosmetic product that is intended to be applied to the hair of the head or face, except eyelashes. Entry 22 in Annex III to Regulation (EC) No 1223/2009 was amended by Commission Regulation (EU) No 1197/20138 to allow professional use of Resorcinol in products intended for colouring eyelashes. At that time, the warning concerning the use for eyebrows should have been deleted, since the use of Resorcinol in products intended for colouring eyebrows, considering the new definition, was allowed as included in the product type ‘oxidative hair dye products. That error should be corrected.