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[Chemlinked] Malaysia Amends Cosmetic Ingredient Use Requirements: 42 Prohibited Ingredients Added and 3 Ingredients Revised
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등록일 2023-03-09
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The main amendments include:
1) Annexe II: List of Prohibited Ingredients – 42 added
2) Annexe IV: List of Permitted Colorants – 1 revised
3) Annexe VI: List of Permitted Preservatives – 1 revised
4) Annexe VII: List of Permitted UV Filters – 1 revised
On Jan. 12, 2023, Malaysia National Pharmaceutical Regulatory Agency (NPRA) released Circular No. 1/2023 Information on the Updated Status of Ingredients in the Annexe of the Guidelines for Control of Cosmetic Products in Malaysia. 1 According to the Circular, 42 prohibited ingredients are added; 1 permitted colorant, 1 permitted preservative and 1 permitted UV filter are revised.
Detailed amendments to each annexe are as follows (the text in red indicates changes to the previous lists).
1. Adding 42 prohibited ingredients to Annexe II List of Prohibited Ingredients
Newly Included Prohibited Ingredients (Excerpt) |
|||
Ref. No. |
Substances |
CAS Number |
Transitional Period |
1388 |
Octamethylcyclotetrasiloxane; D4 |
556-67-2 |
Notified cosmetic products containing the ingredient are only allowed to be sold on the market until Nov. 21, 2024. |
1397 |
Sodium perborate [1]; Sodium peroxometaborate; sodium peroxoborate [2] |
15120-21-5 [1] 7632-04-4 [2] 10332-33-9 [2] 10486-00-7 [2] |
|
1398 |
Perboric acid (H3BO2(O2)), monosodium salt trihydrate [1]; Perboric acid, sodium salt, tetrahydrate [2]; Perboric acid (HBO(O2)), sodium salt, tetrahydrate sodium peroxoborate hexahydrate [3] |
13517-20-9 [1] 37244-98-7 [2] 10486-00-7 [3] |
|
1399 |
Perboric acid, sodium salt [1]; Perboric acid, sodium salt, monohydrate [2]; Perboric acid (HBO(O2)), sodium salt, monohydrate [3] |
11138-47-9 [1] 12040-72-1 [2] 10332-33-9 [3] |
|
*Find the full list of 42 newly included prohibited ingredients here. |
2. Adding one permitted colorant to Annexe IV List of Permitted Colorants
Colour Index Number or Denomination |
Colour |
Field of application |
Other limitations and requirements |
Transitional Period |
|||
1 |
2 |
3 |
4 |
||||
77891 1 |
White |
x |
Titanium dioxide in powder form containing 1% or more of particles with aerodynamic diameter ≤ 10 μm, to be used in compliance with Annexe III, No. [338] |
Notified cosmetic products that do not comply with the new conditions are only allowed to be sold on the market until Nov. 21, 2024. |
|||
Notes: 1. For the use of titanium dioxide as a sunscreen, please see Annexe VII. |
3. Adding one permitted preservative to Annexe VI List of Permitted Preservatives
Reference Number |
Substance |
Maximum authorized concentration |
Limitations and requirements |
Conditions of use and warnings which must be printed on the label |
Transitional Period |
3 |
Salicylic acid (69-72-7) and
its salts 1: Calcium salicylate, magnesium salicylate, MEA-salicylate, sodium salicylate, potassium salicylate, TEA-salicylate (824-35-1, 18917-89-0, 59866-70-5, 54-21-7, 578-36-9, 2174-16-5) |
0.5% (acid)
|
Salicylic acid: Not to be used in oral products. Not to be used in applications that may lead to the exposure of the end-user’s lungs by inhalation. |
Salicylic acid: |
Notified cosmetic products that do not comply with the new conditions are only allowed to be sold on the market until Nov. 21, 2024. |
Notes: |
4. Adding one permitted UV Filter to Annexe VII List of Permitted UV Filters
Reference Number |
Substance |
Maximum authorized concentration |
Limitations and requirements |
Conditions of use and warnings which must be printed on the label |
Transitional Period |
27 |
Titanium dioxide 1 |
25% (In case of combined use of titanium dioxide and titanium dioxide (nano), the sum shall not exceed 25%) |
Titanium dioxide in powder form containing 1% or more of particles with aerodynamic diameter ≤ 10 μm, to be used in compliance with Annexe III, No [338]. For the product types under letter (c) of column (c) in Annexe III, No [338], the maximum concentration in ready for use preparation provided in column (d) of this entry applies. |
/ |
Notified cosmetic products that do not comply with the new conditions are only allowed to be sold on the market until Nov. 21, 2024. |
Notes: |
Most revisions are in line with those adopted by the 36th ASEAN Cosmetic Scientific Body (ACSB) meeting. The exception is that Malaysia has not yet adopted the revision of the use requirements for "salicylic acid" included in Annexe III List of Restricted Ingredients passed by the ACSB meeting.
Further Reading
- Malaysia NPRA Adopts Six Changes to Cosmetic Ingredient Use Requirements
- Malaysia Amends Guidelines for Control of Cosmetic Products
- ASEAN Amends Cosmetic Ingredient Annexes to ACD: 42 New Ingredients Included and 10 Ingredients Revised
Reference Links
[1] Malaysia Released Circular No. 1/2023 Information on the Updated Status of Ingredients in the Annexe of the Guidelines for Control of Cosmetic Products in Malaysia
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