Malaysia NPRA Updates Cosmetic Ingredient Use Requirements

Malaysia adopted 8 changes to cosmetic ingredient use requirements: ·Adding three prohibited ingredients; ·Adding two restricted ingredients; ·Correcting the errors of two colorants’ use requirements; ·Amending the preamble of List of Permitted Preservatives.

On Sep. 29, 2021, Malaysia National Pharmaceutical Regulatory Agency (NPRA) released Circular No. 2/2021 Information on the Updated Status of Ingredients in Annex in 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, three prohibited ingredients, two restricted ingredients, two permitted colorants, and the preamble of the List of Permitted Preservatives are subject to revisions.

1. Add three prohibited ingredients

Annex II List of Prohibited Substances
Ref. No.	Substances	CAS Number	Implementation Date
1642	1,2,4-Trihydroxybenzene when used as a substance in hair and eyelash dye products	533-73-3	Notified cosmetic products containing the ingredient are only allowed to be on the market until May 28, 2022.
1643	4-Amino-3-hydroxytoluene when used as a substance in hair and eyelash dye products	2835-98-5
1644	2-[(4-Amino-2-nitrophenyl)-amino]-benzoic acid when used as a substance in hair and eyelash dye products	117907-43-4

2. Add two restricted ingredients

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	Implementation date
		Field of application and/or use	Maximum authorised concentration in the ready for use preparation	Other limitations and requirements
328 (313)	2-Hydroxyethyl Methacrylate (HEMA) 868-77-9	Nail products	/	Professional use only	For professional use only Can cause an allergic reaction	Notified cosmetic products that do not comply with the new conditions are only allowed to be sold on the market until Nov. 28, 2022.
329 (314)	11, 14-Dioxa-2, 9-d iazaheptadec-16-enoic Acid, 4,4,6, 16-tetramethyl-10, 15- dioxo, 2-[(2-methyl-1-oxo-2-propenyl) oxy]ethyl ester (DI-HEMA TRIMETHYLHEXYL DICARBAMATE) 41137-60-4/72869-86-4	Nail products	/	Professional use only	For professional use only Can cause an allergic reaction

3. Correct the errors of two colorants' use requirements

Annex IV List of Coloring Agents
Colour Index Number or Denomonation	Colour	Field of Application				Other Limitations and Requirements	Implementation Date
		1	2	3	4
77266	Black	×				Purity > 97%, with the following impurity profile: Ash content ≤ 0.15%, total sulphur ≤ 0.65%, total PAH ≤ 500 ppb and benzo(a)pyrene ≤ 5 ppb, dibenz(a,h)anthracene ≤ 5 ppb, total As ≤ 3 ppm, total Pb ≤ 10 ppm, total Hg ≤ 1 ppm.	Effective immediately
77266 (nano)	Black	×				10%. 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 > 97%, with the following impurity profile: Ash content ≤ 0.15%, total sulphur ≤ 0.65%, total PAH ≤ 500 ppb, and benzo(a)pyrene ≤ 5 ppb, dibenz(a,h)anthracene ≤ 5 ppb, total As ≤ 3 ppm, total Pb ≤ 10 ppm, total Hg ≤ 1 ppm; Primary particle size ≥ 20 nm.
*Note:* Errors in the use requirements of the above two colorants were corrected from "total Hg≤10 ppm" to "total Hg≤1 ppm".

4. Amend the preamble of List of Preservatives

Preamble of Annex VI List of Preservatives

All finished products containing formaldehyde or substances in this Annex and which release formaldehyde (Entries 20,21,27,30,31,33,46,49,51,55) must be labelled with the warning "contains formaldehyde" where the concentration of formaldehyde in the finished product exceeds 0.05%.

Malaysia NPRA Updates Cosmetic Ingredient Use Requirements

1. Add three prohibited ingredients

2. Add two restricted ingredients

3. Correct the errors of two colorants' use requirements

4. Amend the preamble of List of Preservatives

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