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[Chemlinked] Malaysia NPRA Adopts Six Changes to Cosmetic Ingredient Use Requirements
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등록일 2022-07-08
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Malaysia adopted six changes to cosmetic ingredient use requirements, including:
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.
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 c) 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 |
|
60 |
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% |
/ |
|
|
|
Note: The added requirements are marked in red, and the deleted requirements are marked with a |
||||||
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 |
|
32 |
1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3- dimethylbutan-2-one) 15 Climbazole CAS 38083-17-9 |
(a) 0.2% (b) 0.2% (c) 0.5% (d) 0.5% |
(a) Hair lotions (b) Face cleaners (c) Rinse-off shampoo (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. |
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Further Reading
- Malaysia to Amend Cosmetic Ingredient Use Requirements: 223 Newly Prohibited Ingredients and 10 Newly Permitted Ingredients
- Malaysia NPRA Updates Cosmetic Ingredient Use Requirements
- Webinar | Malaysia Cosmetic Regulatory Compliance and Importation Requirements
Reference Links
출처 : Chemlinked
