Malaysia NPRA Adopts Six Changes to Cosmetic Ingredient Use Requirements

On July 6, 2022, Malaysia National Pharmaceutical Regulatory Agency (NPRA) released Circular No. 1/2022 Information on the Updated Status of Ingredients in Annex of the Guidelines for Control of Cosmetic Products in Malaysia. ¹ NPRA conducted periodic reviews on the Guidelines, and amended the Guidelines' contents to make it in line with the amendments made to the ASEAN Cosmetic Directive (ACD).

According to the Circular, one prohibited ingredient, three restricted ingredients, and two permitted preservatives are revised.

1. Adding one prohibited ingredient, one restricted ingredient and one permitted preservative

1. Adding one prohibited ingredient to Annex II List of Prohibited Substances

Ref. No.	Substances	CAS Number	Transitional Period
1657	4-[(tetrahydro-2H-pyran-2-yl)oxy]phenol (Deoxyarbutin, Tetrahydropyranyloxy Phenol)	53936-56-4	Notified cosmetic products containing the ingredient are only allowed to be sold on the market until May 11, 2023.

2. Adding one restricted ingredient to Annex III List of Restricted Substances

Ref. No.

ACD #

(EU #)

Substances / CAS No.

Restrictions

Conditions of use and warning which must be printed on the labels

Transitional Period

Field of application and/or use

Maximum authorized concentration in the ready for use preparation

Other limitations and requirements

338

(x)

Titanium dioxide in powder form containing 1% or more of particles with aerodynamic diameter < 10 µm

Titanium Dioxide

13463-67-7 / 1317-70-0 / 1317-80-2

a) Face products in loose powder form

b) Hair aerosol spray products

c) Other products

a) 25%

b) 1.4% for general consumers, and 1.1% for professional use

a) b)

Only in the pigmentary form

Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation.

Notified cosmetic products that do not comply with the new conditions are only allowed to be sold on the market until May 11, 2024.

3. Add one permitted preservative to Annex VI List of Preservatives

Ref. No.

Substance

Maximum authorized concentration

Limitations and requirements

Conditions of use and warnings which must be printed on the label

Implementation Date

4-(3-ethoxy-4-hydroxyphenyl)butan-2-one

Hydroxyethoxyphenyl Butanone

CAS 569646-79-3

0.7%

Effective immediately

2. Amending the use requirements of two restricted ingredients and one permitted preservative

1. Amending the use requirements of two restricted ingredients in Annex III List of Restricted Substances

Ref. No. ACD # (EU #)	Substances/CAS No.	Restrictions			Conditions of use and warnings which must be printed on the label	Transitional Period
		Field of application and/or use	Maximum authorized concentration in the ready for use preparation	Other limitations and requirements
326 (310)	1-(4-Chlorophenoxy)-1 (imidazole-1-yl)-3,3-dimethylbutan-2-one (22) Climbazole 38083-17-9	a) Rinse-off Anti-dandruff Shampoo b) Rinse-off Anti-dandruff Conditioners	a) 2.0% b) 0.5%	For a) and b) : for purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product.	/	Notified cosmetic products that do not comply with the new conditions are only allowed to be sold on the market until November 11, 2023.
A8	1,3-Dihydroxy-2-propanone Dihydroxyacetone 96-26-4	a) Hair dye substance in non-oxidative hair dye products b) Self-tanning products Use for dyeing eyelashes and eyebrows is not permitted.	a) 6.5% b) 10%	/	This product does not contain a sunscreen and does not protect against sunburn
Note: The added requirements are marked in red, and the deleted requirements are marked with a strikethrough.

2. Amending the use requirements of one permitted preservative in Annex VI List of Permitted Preservatives

Ref. No.

Substance

Maximum authorized concentration

Limitations and requirements

Conditions of use and warnings which must be printed on the label

Transitional Period

1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-

dimethylbutan-2-one) 15

Climbazole

CAS 38083-17-9

(a) 0.2%

(b) 0.2%

(d) 0.5%

(a) Hair lotions

(b) Face creams

(d) Rinse-off hair conditioner

Notified cosmetic products containing the ingredient are only allowed to be sold on the market until November 11, 2023.

Note: The amended requirements are marked in red.

Malaysia NPRA Adopts Six Changes to Cosmetic Ingredient Use Requirements

1. Adding one prohibited ingredient, one restricted ingredient and one permitted preservative

2. Amending the use requirements of two restricted ingredients and one permitted preservative

Further Reading