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Malaysia to Amend Cosmetic Ingredient Use Requirements: 223 Newly Prohibited Ingredients and 10 Newly Permitted Ingredients

On Dec. 13, 2021, Malaysia National Pharmaceutical Regulatory Agency (NPRA) released Circular No. 3/2021 "Information on the Updated Status of Ingredients in Annex in the Guidelines for Control of Cosmetic Products in Malaysia". According to the Circular, 223 prohibited ingredients, 8 restricted ingredients, 1 permitted preservative, and 1 permitted UV filter are added.

1. Add 223 prohibited ingredients

Notified cosmetic products containing these ingredients are only allowed to be sold on the market until October 6, 2022.

Annex II List of Prohibited Substances

Ref. No.

Substances

CAS Number

No. A1143

Silver Nitrate

7761-88-8

No. 1385-1394, No. 1401-1574, No. 1580-1641

Add 222 ingredients to be in line with EU 2019/1966 and 2019/831.

 

Find the 222 prohibited ingredients here.

/

2. Add 8 restricted ingredients

Notified cosmetic products that do not comply with the new conditions are only allowed to be sold on the market until April 6, 2023.

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

Field of Application and/or Use

Maximum Authorised Concentration in the Ready-for-use Preparation

Other Limitations and Requirements

330

(315)

4-(3-aminopyrazolo[1,5-A] pyridin-2-yl)-1, 1- dimethylpiperazin-1-ium chloride hydrochloride

 

Dimethylpiperazinium Aminopyrazolopyridine HCI

 

1256553-33-9

Hair dye substance in oxidative hair dye products

/

After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2 % (calculated as free base)

To be printed on the label: The mixing ratio.

 

6E0AAEE1-9032-4617-B5B9-D3032EE342FC.pngHair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary “black henna” tattoos may increase your risk of allergy.

 

Do not colour your hair if:

— you have a rash on your face or sensitive, irritated and damaged scalp,

— you have ever experienced any reaction after colouring your hair,

— you have experienced a reaction to a temporary “black henna” tattoo in the past.’

331

(316)

1-(3-((4-Aminopheny\)   amino)propyl)-3-methyl-1 H-imidazol-3-ium chloride hydrochloride

 

Methylimidazoliumpropyl p-phenylenediamine HCI

 

220158-86-1

Hair dye substance in oxidative hair dye products

/

After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2 % (calculated as free base)

To be printed on the label: The mixing ratio.

 

'6E0AAEE1-9032-4617-B5B9-D3032EE342FC.pngHair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary “black henna” tattoos may increase your risk of allergy.

 

Do not colour your hair if:

— you have a rash on your face or sensitive, irritated and damaged scalp,

— you have ever experienced any reaction after colouring your hair,

— you have experienced a reaction to a temporary “black henna” tattoo in the past.’

332

(317)

Di-[2-[(E)-2-[4-[bis(2- hydroxyethyl)am   inophenyl]vinyl] pyridin-1-ium]-ethyl]disulphide dimethanesulfonate

 

HC Orange No. 6

 

1449653- 83-1

Hair dye substance in non-oxidative hair dye products

0.5%

Methanesulfonates impurities, in particular ethyl methanesulfonate shall not be present.

/

333

(318)

Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzene sulfonate

 

Acid Orange 7

 

633-96-5

Hair dye substance in non-oxidative hair dye products

0.5%

/

/

334

(319)

Phenol, 4,4'-(4,5,6,7-tetrabromo-1,1-dioxido-3H-2,1-benzoxathiol-3- ylidene)bis [2,6-dibromo

 

Tetrabromophenol Blue

 

4430-25-5

(a) Hair dye substance in oxidative hair dye products

 

(b) Hair dye substance in non-oxidative hair dye products

0.2%

After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0.2% (calculated as free base)

To be printed on the label: The mixing ratio.

 

'6E0AAEE1-9032-4617-B5B9-D3032EE342FC.pngHair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary “black henna” tattoos may increase your risk of allergy.

 

Do not colour your hair if:

— you have a rash on your face or sensitive, irritated and damaged scalp,

— you have ever experienced any reaction after colouring your hair,

— you have experienced a reaction to a temporary “black henna” tattoo in the past.’

335

(320)

Indigofera tinctoria, dried and pulverised leaves of Indigofera tinctoria L

 

Indigofera tinctoria leaf

Indigofera tinctoria leaf powder

Indigofera tinctoria leaf extract

Indigofera tinctoria extract

 

84775-63-3

Hair dye substance in non-oxidative hair dye products

25%

/

/

336

(311)

Diphenyl(2,4,6- trimethylbenzoyl) phosphine oxide

 

Trimethylbenzoyl diphenylphosphine oxide

 

75980-60-8

Artificial nail systems

5.0 %

Professional use

For professional use only

 

Avoid skin contact

 

Read directions for use carefully

337

(312)

2-Furaldehyde

 

Furfural

 

98-01-1

/

0.001%

/

/

3. Add 1 permitted preservative

Notified cosmetic products that do not comply with the new conditions are only allowed to be sold on the market until April 6, 2023.

Annex VI List of Preservatives Which Cosmetic Products May Contain

Ref. No.

Substance

Maximum Authorized Concentration

Limitations and Requirements

Conditions of Use and Warnings Which Must be Printed on the Label

28

Poly(1-hexamethylenebiguanide hydrochloride) Polyaminopropyl biguanide

 

CAS No. 32289-58-0, 27083-27-8, 28757-47-3, 133029-32-0

0.1%

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

/

4. Add 1 permitted UV filter

Annex VII List of UV Filters Which Cosmetic Products May Contain

Ref. No.

Substance

Maximum   Authorized Concentration

Limitations and Requirements

Conditions of Use and Warnings Which Must be Printed on the Label

Implementation Date

31

2-ethoxyethyl (2Z)-2-cyano- 2-[3-(3-methoxypropylamino) cyclohex-2-en-1-ylidene]acetate

 

Methoxypropylamino Cyclohexenylidene   Ethoxyethylcyanoacetate

 

CAS No. 1419401-88-9

3%

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

 

- Do not use with nitrosating agents

 

- Maximum nitrosamine content: 50µg/kg

 

- Keep in nitrite-free containers

/

Effective immediately

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