ASEAN Explains Revision of Cosmetic Directive

Apart from amendments of ingredients requirements on 26th ACSB (see news on CL), ASEAN Cosmetic Committee also discussed further revision of the ASEAN Cosmetic Directive during a recent meeting. Methylisothiazonlinone (M1 or MIT) in Rinse-off product, Limits of Contaminants in Cosmetics and ASEAN Cosmetic Method (ACM) will be revised...

Takehome:

Apart from amendments of ingredients requirements on 26th ACSB (see news on CL), ASEAN Cosmetic Committee also discussed further revision of the ASEAN Cosmetic Directive during a recent meeting.
Methylisothiazonlinone (M1 or MIT) in Rinse-off product, Limits of Contaminants in Cosmetics and ASEAN Cosmetic Method (ACM) will be revised.

1. Methylisothiazonlinone (M1 or MIT) in Rinse-off product.

ASEAN follow the standard of 0.01% as maximum concentration of MIT in rinse-off products, but during the meeting of the Scientific Committee on Consumer Safety it was stated that 0.01% concentration of MIT may cause contact allergy and 0.0015% is considered safe. ASEAN is proposing to adopt a maximum concentration of 0.0015%. ASEAN still encourage the cosmetic industry to look into reformulating rinse-off cosmetic products to comply with the anticipated restriction on MIT.

2. Limits of Contaminants in Cosmetics

The current limitations of microbial and heavy metal contaminants are issued as below, but the limits may change as needed according to the latest compendium or safety information.

ASEAN Microbiological Limits

	Products for children under 3 years, eye area and mucous membranes	Other products
Total Aerobic Mesophilic Microorganisms (Bacteria, Yeast & Molds)	=< 500 cfu/g or cfu/ml	=< 1000 cfu/g or cfu/ml
P. aeruginosa	Absent in 0.1g or 0.1ml test sample	Absent in 0.1g or 0.1ml test sample
S. aureus	Absent in 0.1g or 0.1ml test sample	Absent in 0.1g or 0.1ml test sample
C. albicans	Absent in per 0.1g or 0.1ml test sample	Absent in 0.1g or 0.1ml test sample

The list is not necessarily exhaustive. It may be necessary to test for other micro-organisms* depending on the nature of the starting materials and the manufacturing process.

Thailand will continue to perform an additional test for Clostridia spp. on products containing crude herbal extracts. The requirement is that such products test negative for Clostridium spp. (botulinum, perfringens etc.)

ASEAN Maximum Limits of Heavy Metals

Heavy Metals	Limits
Mercury (Hg)	NMT 1 mg/kg or 1 mg/L (1 ppm) when tested by ASEAN Cosmetic Method
Lead (Pb)	NMT 20mg/kg or 20 mg/L (20 ppm) when tested by ASEAN Cosmetic Method
Arsenic (As)	NMT 5mg/kg or 5 mg/L (5 ppm) when tested by ASEAN Cosmetic Method
Cadmium (Cd)	NMT 5 mg/kg or 5 mg/L (5 ppm)** when tested by ASEAN Cosmetic Method

Note: Due to special circumstances such as national regulatory requirements, the limit of cadmium in the Thailand is 3 mg/kg or 3 mg/L (3 ppm).

3. Update List of ASEAN Cosmetic Method (ACM) Harmonized Standards

There are totally 8 ACMs in ASEAN, and two of them, ACM3 (Identification and Determination of Hydroquinone in Cosmetic Products by TLC and HPLC) and ACM04 (Identification and Determination of 2-Phenoxyethanol, Methyl, Ethyl, Propyl, and Butyl 4-Hydroxybenzoate in Cosmetic Products by HPLC) are under final revision. Once they are completed, the total ACMs documents will be posted.