Request a Demo
On January 19, 2024, Malaysia National Pharmaceutical Regulatory Agency (NPRA) released Circular No. 1/2024 Information on the Updated Status of Ingredients in the Annex of the Guidelines for Control of Cosmetic Products in Malaysia. 1 According to the Circular, the amendments are:
1) Annex II: List of Prohibited Ingredients - 15 added and 4 revised
2) Annex III: List of Restricted Ingredients - 5 revised
3) Annex IV: List of Permitted Colorants – 1 revised
4) Annex VI: List of Permitted Preservatives - 1 deleted
5) Annex VII: List of Permitted UV Filters – 2 added and 1 revised
Detailed amendments to each Annex are as follows (the text in red indicates changes to the previous lists).
1. Adding 15 prohibited ingredients and amending the names of 4 prohibited ingredients in Annex II List of Prohibited Ingredients
1) Adding 15 prohibited ingredients
Newly Included Prohibited Ingredients (Excerpt) | |||
Ref. No. | Substances | CAS No. | Effective date |
A1144 | N,N-diethyl-m-toluamide/Diethyltoluamide (DEET) | 134-62-3, 26545-51-7 | Notified cosmetic products containing the ingredient are only allowed to be sold on the market until January 19, 2024. |
1681 | Tetrafluoroethylene | 116-14-3 | Notified cosmetic products containing the ingredient are only allowed to be sold on the market until November 15, 2024. |
1682 | 6 ,6'-di-tert-butyl-2, 2'-methylenedi-p-cresol; [DBMC] | 119-47-1 | |
1683 | (5-chloro-2-methoxy-4-methyl-3-pyridyl)(4,5,6-trimethoxy-o-tolyl)methanone; pyriofenone | 688046-61-9 | |
*Find the full list of 15 newly included prohibited ingredients here. | |||
2) Amending the names of 4 prohibited ingredients
Ref. No. | Substances | CAS No. | Effective date |
221 | Mercury and its compounds except those special cases included in Annex VI | 7439-97-6, 54-64-8, 62-38-4, 94-43-9, 102-98-7, 1192-89-8, 100-56-1 | Notified cosmetic products containing the ingredient are only allowed to be sold on the market until January 19, 2024. |
1605 | N,N'-Methylenedimorpholine; N,N'-methylenebismorpholine; [formaldehyde released from N,N'-Methylenebismorpholine]; [MBM] if the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is ≥ 0.1 % w/w | 5625-90-1 | |
1606 | Reaction products of paraformaldehyde with 2-hydroxypropylamine (3:2); [formaldehyde released from 3,3'-methylenebis[5–methyloxazolidine]; [formaldehyde released from oxazolidin]; [MBO] if the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is ≥ 0.1 % w/w | / | |
1607 | Reaction products of paraformaldehyde with 2-hydroxypropylamine (1:1)); [formaldehyde released from a,a,atrimethyl-1,3,5-triazine-1,3,5(2H,4H,6H)-triethanol]; [HPT] if the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is ≥ 0.1 % w/w | / |
2. Amending the use requirements of 5 restricted ingredients in Annex III List of Restricted Ingredients
The revision of restricted ingredients mainly involves changes to ingredient names and notes. Notified cosmetic products that do not comply with the new conditions are only allowed to be sold on the market until January 19, 2024.
Ref No. ACD # (EU #) | Substance/CAS No. | Restrictions | Conditions of use and warning which must be printed on the labels | ||
Field of application and/or use | Maximum authorized concentration in the ready for use preparation | Other limitations and requirements | |||
A | B | C | D | E | F |
12 | Hydrogen peroxide, and other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxide, with the exception of the following substances in Annex II: No. 1397, 1398, 1399
CAS No. 7722-84-1 | (a) Hair products (b) Skin products (c) Nail hardening products (d) Oral hygiene products, including mouth rinse, toothpaste. (e) Tooth whitening or bleaching products (i) For general consumer use (ii) For use by the consumer under the supervision of a qualified dental practitioner (iii) For application by a qualified dental practitioner only | (a) 12% of H2O2 (40 volumes), present or released (b) 4% of H2O2, present or released (c) 2% of H2O2, present or released (d) 0.1% of H2O2, present or released (e) (i) 0.1% H2O2 present or released (ii) >0.1% to < 6% H2O2 present or released (iii) >6% to 35% H2O2 present or released | (e) (ii) For supply only through a qualified dental practitioner. Not for direct sale to the general public. (iii) Only to be used by a qualified dental practitioner. Not for direct sale to the general public. | For (a) Wear suitable gloves
For (a) (b) (c) and (e): Contains hydrogen peroxide. Avoid contact with eyes. Rinse immediately if product comes into contact with them.
(e) (ii) and (iii) To be printed on the label Not to be used on a person under 18 years of age. Percentage of Hydrogen Peroxide to be declared. (ii) Not for direct sale to the public. For supply only through qualified dental practitioner. Read & follow the instructions and use the product accordingly. Do not use the product within two weeks prior to, or immediately after dental restoration. Not for use by pregnant women or habitual tobacco and/or alcohol users. Stop using immediately if you experience any tooth sensitivity, gum irritation, toothache, defective restorations, gingivitis, nausea etc. Store out of reach of children.
(iii) Not for direct sale to the public. Only to be used by a qualified dental practitioner. Do not use the product within two weeks prior to, or immediately after dental restoration. Not for use by pregnant women or habitual tobacco and/or alcohol users. Stop using immediately in cases of tooth sensitivity, gum irritation, toothache, defective restorations, gingivitis, nausea etc. |
324 (308) | Tagetes minuta flower extract (22) CAS No. 91770-75-1
Tagetes minuta flower oil (22) CAS No. 91770-75-1/8016-84-0 | a) Leave-on products b) Rinse-off products | a) 0.01% b) 0.1% | For (a) and (b). Alpha terthienyl (terthiophen) content in the extract/oil ≤ 0.35%.
For (a): Not to be used in sunscreen products and products marketed for exposure to natural/artificial UV light. (22)
For (a) and (b): In case of combined use with Tagetes patula (entry 325) or Tagetes erecta (entry 327), the total combined content of Tagetes in ready for use preparation shall not exceed the maximum concentration limits set out in column (d) | / |
325 (309) | Tagetes patula flower extract (22) CAS No. 91722-29-1
Tagetes patula flower oil (22) CAS No. 91722-29-1/8016-84-0 | a) Leave-on products b) Rinse-off products | a) 0.01% b) 0.1% | For (a) and (b). Alpha terthienyl (terthiophen) content in the extract/oil ≤ 0.35%.
For (a): Not to be used in sunscreen products and products marketed for exposure to natural/artificial UV light. (22)
For (a) and (b): In case of combined use with Tagetes minuta (entry 324) or Tagetes erecta (entry 327), the total combined content of Tagetes in ready for use preparation shall not exceed the maximum concentration limits set out in column (d) | / |
327 (1383 Annex II) | Tagetes erecta flower extract (22) CAS No. 90131-43-4
Tagetes erecta flower oil (22) CAS No. 90131-43-4 | a) Leave-on products b) Rinse-off products | a) 0.01% b) 0.1% | For (a) and (b). Alpha terthienyl (terthiophen) content in the extract/oil ≤ 0.35%.
For (a): Not to be used in sunscreen products and products marketed for exposure to natural/artificial UV light. (22)
For (a) and (b): In case of combined use with Tagetes minuta (entry 324) or Tagetes patula (entry 325), the total combined content of Tagetes in ready for use preparation shall not exceed the maximum concentration limits set out in column (d) | / |
339 (323) | Methyl-N-methylanthranilate (22) CAS No. 85-91-6 | (a) Leave-on products (b) Rinse-off products | (a) 0.1% (b) 0.2% | For (a): Not to be used in sunscreen products and products marketed for exposure to natural or artificial UV light. (22)
For (a) and (b): — Do not use with nitrosating agents — Maximum nitrosamine content: 50 μg/kg — Keep in nitrite-free containers | / |
Note No.22: 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. | |||||
3. Amending the use requirements of 1 permitted colorant in Annex IV List of Permitted Colorant
Colour Index Number or Denomination | Colour | Field of application | Other limitations and requirements | |||
1 | 2 | 3 | 4 | |||
45430 (2) | Red | X | Not more than 1% 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid and 3% 2-(iodo-6-hydroxy-3-oxo3H-xanthen-9-yl)benzoic acid | |||
Note No.2: The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will be determined by the procedure laid down in Article 9. | ||||||
4. Deleting 1 permitted preservative and amending the preamble to Annex VI List of Permitted Preservatives
1) Deleting 1 permitted preservative
Ref No. | Substance | Maximum authorized concentration | Limitations and requirements | Conditions of use and warnings which must be printed on the label |
31 | Methenamine 3-chloroallylochloride (INN) | 0.2% | / | / |
2) Amending the preamble to Annex VI List of Permitted Preservatives
1. Preservatives are substances which may be added to cosmetic products for the primary purpose of inhibiting the development of microorganisms in such products.
2. The substances marked with the symbol (+) may also be added to cosmetic products in concentration other than those laid down in this Annex for other purposes apparent from the presentation of the products, e.g. as deodorants in soaps or as anti-dandruff agents in shampoos.
3. Other substances used in the formulation of cosmetic products may also have anti-microbial properties and thus help in the preservation of the products, as, for instance, many essential oils and some alcohols. These substances are not included in the ANNEX.
4. For the purposes of this list - “Salts” is taken to mean: salts of the cations sodium, potassium, calcium, magnesium, ammonium, and ethanolamines; salts of the anions chloride, bromide, sulphate, acetate. - “Esters” is taken to mean: esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl, phenyl.
5. 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%. |
5. Adding 2 permitted UV filters and amending the use requirements of 1 permitted UV filter in Annex VII List of Permitted UV Filters
1) Adding 2 permitted UV filters
Ref No. | Substance | Maximum authorized concentration | Other limitations and requirements | Conditions of use and warnings which must be printed on the label | Effective date |
32 | 1,1'-(1 ,4-piperazinediyl)bis[1-[2-[4-(diethylamino)-2-hydroxybenzoyl]phenyl]-methanone
Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine
CAS No. 919803-06-8 | 10% (7) | / | / | Effective immediately |
33 | 1,1'-(1,4-piperazinediyl)bis[1-[2-[4-(diethylamino)-2-hydroxybenzoyl]phenyl]-methanone
Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine (nano) CAS No. 919803-06-8 | 10% (7) | Only nanomaterials having the following characteristics are allowed: - Purity ≥ 97% - Median particle size D50 (50% of the number below this diameter): ≥50 nm of number size distribution.
Not to be used in applications that may lead to exposure of the end user’s lungs by inhalation. | / | |
Note No.7: In case of combined use of Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine and Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine (nano), the sum shall not exceed 10%. | |||||
2) Amending the use requirements of 1 permitted UV filter
Ref No. | Substance | Maximum authorized concentration | Other limitations and requirements | Conditions of use and warnings which must be printed on the label | Effective date |
4 | 2-Hydroxy-4-methoxy-benzophenone/Oxybenzone (6)
Benzophenone-3 CAS No. 131-57-7 | a) 6% b) 2.2% c) 0.5% | For a) and b) Not more than 0.5% to protect product formulation
a) Face products, hand products, and lip products, excluding propellant and pump spray products
If used at 0.5% to protect product formulation, the levels used as UV filter must not exceed 5.5%
b) Body products, including propellant and pump spray products
If used at 0.5% to protect product formulation, the levels used as UV filter must not exceed 1.7%
c) Other products | For a) and b): Contains Benzophenone-3 (1) | Notified cosmetic products that do not comply with the new conditions are only allowed to be sold on the market until November 15, 2026. |
Note No.1: Not required if concentration is 0.5% or less and when it is used only for product protection purposes; Note No.6: Benzophenone as an impurity and/or degradation product of Octocrylene shall be kept at trace level. | |||||
We provide full-scale global cosmetic market entry services (including cosmetic registering & filing, regulatory consultation, customized training, market research, branding strategy). Please contact us to discuss how we can help you by 
