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[Chemlinked] Malaysia Amends Cosmetic Ingredient Use Requirements: 19 Prohibited Ingredients Added and 5 Ingredients Revised
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등록일 2023-07-06
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The main amendments include:
1) Annexe II: List of Prohibited Ingredients – 19 added
2) Annexe III: List of Restricted Ingredients – 2 added and 1 revised
3) Annexe VI: List of Permitted Preservatives – 1 revised
4) Annexe VII: List of Permitted UV Filters – 1 revised
On July 4, 2023, Malaysia National Pharmaceutical Regulatory Agency (NPRA) released Circular No. 2/2023 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, 19 prohibited ingredients and 2 restricted ingredients are added; 1 restricted ingredient, 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 19 prohibited ingredients and 2 restricted ingredients
1) Adding 19 prohibited ingredients to Annexe II List of Prohibited Ingredients
|
Newly Included Prohibited Ingredients (Excerpt) |
|||
|
Ref. No. |
Substances |
CAS Number |
Transitional period |
|
1386 |
Cis-1-(3-chlorallyl)-3,5, 7-triaza-1-azoniaadamantane chloride (cis-CTAC), quaternium-15 |
51229-78-8 |
Notified cosmetic products containing the ingredient are only allowed to be sold on the market until May 8, 2025. |
|
1387 |
2-Chloracetamide |
79-07-2 |
|
|
1391 |
Acetaldehyde; ethanol |
75-07-0 |
|
|
1393 |
N-Methyl-2-pyrrolidone; 1-methyl-2-pyrrolidone |
872-50-4 |
|
|
1457 |
Nickel diarsenide [1]; Nickel arsenide [2] |
12068-61-0 [1]; 27016-75-7 [2] |
|
|
*Find the full list of 19 newly included prohibited ingredients here. |
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2) Adding 2 restricted ingredients to Annexe III List of Restricted Ingredients
|
Ref. No. ACD # (EU #) |
Substance / CAS No. |
Maximum authorized concentration |
Limitations and requirements |
Conditions of use and warnings which must be printed on the label |
Transitional period |
|
339 (323) |
Methyl-N-methylanthranilate* CAS No. 85-91-6 |
(a) Leave-on products (b) Rinse-off products |
(a) 0.1% (b) 0.2% |
/ |
Notified cosmetic products that do not comply with the new conditions are only allowed to be sold on the market until May 8, 2025. |
|
340 (x) |
Ammonium silver zinc aluminum silicate CAS No. 130328-20-0 |
(a) Foundation (b) Deodorant (Spray type, Non Spray type) |
(a) 1% (b) 1% |
/ |
|
|
*This restriction does not apply to products with secondary UV protection claims, such as moisturizing and skin lightening products as described in the preamble of ASEAN Sunscreen Labeling Guidelines. |
|||||
2. Amending the use requirements of 1 restricted ingredient, 1 permitted preservative and 1 permitted UV filter
1) Amending the use requirements of 1 restricted ingredient in Annexe III List of Restricted Ingredients
|
Ref. No. ACD # (EU #) |
Substance/CAS No. |
Maximum authorized concentration |
Limitations and requirements |
Conditions of use and warnings which must be printed on the label |
Transitional period |
|
98 |
Benzoic acid, 2-hydroxy- Salicylic acid CAS No. 69-72-7 |
(a) Rinse-off hair products (b) Other products except body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant (c) Body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant |
(a) 3.0% (b) 2.0% (c) 0.5% |
(a) (b) (c)
For purposes other than inhibiting the development of microorganisms in the product. This purpose has to be apparent from the presentation of the product. These levels are inclusive of any use of salicylic acid. As a preservative, see Annex VI, Part 1, No.3 |
Notified cosmetic products that do not comply with the new conditions are only allowed to be sold on the market until November 21, 2024. |
2) Amending the use requirements of 1 permitted preservative in Annexe VI List of Permitted Preservatives
|
Ref. No. ACD # |
Substance |
Maximum authorized concentration |
Limitations and requirements |
Conditions of use and warnings which must be printed on the label |
Transitional period |
|
51 |
Sodium hydroxymethylamino acetate (Sodium hydroxymethylglycinate) |
0.5% |
Not to be used unless the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, can be less than 0.1% w/w in the mixture as placed on the market. |
/ |
Notified cosmetic products that do not comply with the new conditions are only allowed to be sold on the market until May 8, 2025. |
3) Amending the use requirements of 1 permitted UV filter in Annexe VII List of Permitted UV Filters
|
Ref. No. ACD # |
Substance |
Maximum authorized concentration |
Other limitations and requirements |
Conditions of use and warnings which must be printed on the label |
Transitional period |
|
10 |
2-Cyano-3,3-diphenyl acrylic acid, 2-ethylhexyl ester/Octocrylene
Octocrylene
CAS No. 6197-30-4 |
a) 9% b) 10% |
a) Propellant spray products b) Other products |
/ |
Notified cosmetic products that do not comply with the new conditions are only allowed to be sold on the market until May 8, 2025. |
Further Reading
- Malaysia Amends Cosmetic Ingredient Use Requirements: 42 Prohibited Ingredients Added and 3 Ingredients Revised
- Malaysia Amends Guidelines for Control of Cosmetic Products
- Malaysia NPRA Adopts Six Changes to Cosmetic Ingredient Use Requirements
Reference Links
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