ASEAN Updates the Annexes of ASEAN Cosmetic Directive

Takehome: Entries of cosmetic prohibited ingredients and permitted UV filter in ASEAN Cosmetic Directive (ACD) have been updated at the 29th ACSB Meeting.

The 29th ASEAN Cosmetic Scientific Body (ACSB) Meeting was held in Singapore in October 2018, during which it decided to amend and append cosmetic ingredients listed in the annexes of ACD. The implementation date of the amendments has not been determined and the industry is welcome to provide feedback until the 30th of November 2018.

Details of the updates are as follows:

1. Amendments to three entries in Annex II: List of substances which must not form part of the composition of cosmetic products

Substance (before modifications)	CAS Number	Ref. No	Substance (after modifications )
4,4'-Carbonimidoylbis[N,N-dimethylaniline]	492-80-8	1067	4,4'-Carbonimidoylbis[N,N-dimethylaniline] and its salts
Salts of 4,4’-carbonimidoylbis[N,N-dimethylaniline]	/	1129	Moved or Deleted (See Ref. No. 1067)
1,2,3,4,5,6-Hexachlorohexanes with the exception of those specified elsewhere in this annex	/	1130	Moved or Deleted (See Ref. No. 195)

2. Addition of a new entry in Annex VII: List of permitted UV filters which cosmetic products may contain.

The Annex VII was appended to include the nano form of 2,2'-Methylene-bis(6-(2H-benzotriazol-2-yl)-4-(tetramethyl-butyl)-1,1,3,3-phenol); 2,2’-Methylenebis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol) (also known as Methylene Bis BenzotriazolylTetramethylbutylphenol or MBBT) and the footnote 5.

Ref. No	Substance	Maximum authorised concentration	Other limitations and requirements	Conditions of use and warnings which must be printed on the label
a	b	c	d	e
23a	2,2’-Methylenebis(6-(2Hbenzotriazol-2-yl)- 4-(tetramethylbutyl)-1,1,3,3- phenol);2,2’- Methylenebis(6- (2H-benzotriazol2-yl)-4-(1,1,3,3- tetramethylbutyl) phenol) (Methylene BisBenzotriazolyl Tetramethylbutyl Phenol (nano)/MBBT (nano)) CAS 103597-45-1	10%(⁵)	Not to be used in applications that may lead to exposure of the end user's lungs by inhalation. Only nanomaterials having the following characteristics are allowed: Purity ≥ 98.5 %, with 2,2’-methylene-bis-(6(2H-benzotriazol-2-yl)-4-(isooctyl)phenol) isomer fraction not exceeding 1.5 %; Solubility < 5 ng/L in water at 25 °C; Partition coefficient (Log Pow): 12.7 at 25 °C; Uncoated; Median particle size D50 (50% of number below this diameter): ≥120 nm of mass distribution and/or ≥ 60 nm of number size distribution.
5. In case of combined use of Methylene Bis-Benzotriazolyl Tetramethylbutylphenol and Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (nano), the sum shall not exceed the limit given in column g.