Exporting Cosmetics to Malaysia: NPRA Notification, Labels and Halal
Every cosmetic made, imported or sold in Malaysia must first be notified to the National Pharmaceutical Regulatory Agency (NPRA), under regulation 18A of the Control of Drugs and Cosmetics Regulations 1984. A Malaysian company registered with SSM files it online in QUEST3+ on your behalf, for RM 50 per product; the notification is valid for 2 years. Halal certification is voluntary, and NPRA issues no separate import permit.
Checked against official sources: 2026-09
At a glance
Who notifies: the Cosmetic Notification Holder
Regulation 18A bans the manufacture, sale, supply, import or possession of a cosmetic that is not notified. The notification is filed by the Cosmetic Notification Holder (CNH), the company responsible for placing the product on the market. The CNH must be a locally incorporated company or legal entity in the field of cosmetics, with a permanent address, registered with the Companies Commission of Malaysia (SSM). A foreign brand therefore appoints a Malaysian importer, distributor or subsidiary.
The product owner issues a Letter of Authorisation (LOA) that lists the products or brands and authorises the CNH to notify them and handle all notification matters. If the CNH owns the brand, it gives a Letter of Declaration instead; contract-manufactured products also need the appointment and acceptance letters between owner and manufacturer.
The notification belongs to the CNH. Under Annex I Part 5, a change of company because distribution rights change needs a new notification, while a change of importer or distributor listed in the file is only an amendment. Agree in the distribution contract what happens to the notifications if you part ways.
Filing in QUEST3+: fee, timing and renewal
The CNH first registers as a QUEST3+ member. Access uses a digital certificate on a USB token; Annex I Part 3 (August 2022) lists RM 260 for one year or RM 290 for two years for a main user, so confirm the current charge. Since 8 July 2026 members can also log in with MyTrustID in Chrome, Firefox or Edge, and the older Java login remains available.
Each product and each variant is filed separately, with product particulars, manufacturer and assembler, importer, formula and label. The processing fee is RM 50 per product or variant and is not refundable. Once NPRA confirms payment, the CNH can print the Notification Note from QUEST3+ straight away if all requirements are met. NPRA checks compliance after launch, through sampling and testing, GMP audits and PIF audits.
The number reads NOTyymmxxxxxK (year, month, serial number). A notification is valid for 2 years; renew no later than 1 month before expiry, for another RM 50, to keep the same number. A product not renewed in time gets a new number. A new brand name, product name, formula, manufacturer, product type or intended use also needs a new notification.
What the brand owner supplies
Send the CNH the LOA, the full ingredient list by INCI name, label artwork and evidence of GMP. The QUEST3+ manual makes percentages mandatory for substances listed in Annexes III to VII (restricted substances, colourants, preservatives and UV filters), and makes it mandatory to attach a GMP certificate or equivalent for a foreign manufacturer or primary assembler. The guideline says GMP evidence must be issued or endorsed by an authorised body in the country of manufacture.
The CNH must also hold a Product Information File (PIF) in four parts: administrative documents and product summary, quality data of raw materials, quality data of the finished product, and safety and efficacy data, including a safety assessment. Most of this comes from you or your manufacturer, so prepare it before filing.
The guideline and the QUEST3+ manual do not list a Certificate of Free Sale for notification. Some importers still ask for one or for notarised copies, so confirm their list before you order documents.
Ingredients: ASEAN annexes and 2025–2026 updates
Malaysia adopts the ASEAN Cosmetic Directive annexes and announces each update by NPRA circular. The current NPRA files for Annexes II, III, IV and VI are dated 10 June 2026 and Annex VII 12 December 2025. Heavy metals must not exceed mercury 1 ppm, lead 20 ppm, arsenic 5 ppm and cadmium 5 ppm (Annex I Part 14).
Recent circulars with deadlines: Circular 3/2024 (December 2024) added substances such as benzophenone to the prohibited list and set BHT limits, with compliance due by 19 November 2026. Circular 1/2025 (July 2025) prohibited 2-ethylhexanoic acid and trimethylolpropane triacrylate and restricted salicylic acid.
Circular 1/2026 (January 2026) prohibited miconazole at once and 4-methylbenzylidene camphor (4-MBC), with products to comply by 17 November 2028. Circular 2/2026 (6 July 2026), after the 43rd ASEAN Cosmetic Committee meeting, added 16 prohibited substances, including several antifungals, set limits for kojic acid and changed colourant and preservative entries. Check its transition dates in the circular itself. A reformulated product needs a new notification.
- Annex II: prohibited substances
- Annex III: restricted substances, with limits and conditions
- Annex IV: permitted colourants
- Annex VI: permitted preservatives
- Annex VII: permitted UV filters
- Annex I Part 8: claims guideline (no medicinal claims)
Labels in Bahasa Malaysia or English
Label information must be in Bahasa Malaysia and/or English, easily legible and indelible (Annex I Part 7). The outer pack, or the container if there is no outer pack, shows the items below. Ingredients go in descending order of weight; those under 1% may follow in any order, and botanicals are named by genus and species.
On a container too small for everything, only the product name and batch number are required; the rest can go on the outer pack, a leaflet or a tag. Part 7 does not list the notification number as a label item; buyers can check a product's status in NPRA's QUEST3+ product search. A halal logo may be used only on a product certified by JAKIM or an Islamic body recognised by JAKIM.
- Product name and function
- Directions for use, unless clear from the name
- Full ingredient list
- Country of manufacture
- Name and address of the CNH
- Contents by weight or volume (metric)
- Batch number
- Manufacturing or expiry date; expiry date required if durability is under 30 months
- Special precautions, if any
Import, halal and duties after launch
NPRA does not issue a separate import licence or per-shipment permit for notified cosmetics: under the guideline the CNH may import once it has the Notification Note. Ship only after that, and keep product names identical on the notification, commercial invoice and packing list; Triplicate's free invoice and packing list generator and HS code lookup can help. Customs duty and sales tax are assessed at import on the HS code.
Halal certification is not required for cosmetics. If you want a halal logo, use a certificate from JAKIM or a foreign halal certification body on JAKIM's recognised list (last updated 21 August 2026), because only certified goods may be described as halal.
After launch the CNH keeps the PIF at the address on the label; NPRA recommends keeping it for at least 3 years after the product was last on the market, and asks for the technical parts within 15 to 60 calendar days, or sooner if urgent. It reports serious adverse events within 7 calendar days if fatal or life-threatening and within 15 days otherwise, keeps distribution records, and informs NPRA at least 24, 48 or 72 hours before starting a recall, depending on its degree. NPRA can cancel a notification; its 2025–2026 cancellations were for mercury, hydroquinone, tretinoin or betamethasone 17-valerate.
Step by step
- Appoint a Malaysian company registered with SSM as your Cosmetic Notification Holder, and agree in writing what happens to the notifications if you change partners.
- Have the CNH register as a QUEST3+ member and get its digital certificate and USB token.
- Check each formula against NPRA's current Annexes II to VII, the circular deadlines and the heavy metal limits, and each claim against the claims guideline.
- Send the CNH your Letter of Authorisation, the full INCI ingredient list with percentages for Annex III to VII substances, label artwork and a GMP certificate or equivalent.
- Have the CNH file each product and variant in QUEST3+, pay RM 50 each and print the Notification Note.
- Finalise the label in Bahasa Malaysia and/or English with the CNH's name and address.
- Build the four-part PIF and make sure the CNH can produce it on request.
- Ship after the Notification Note is issued, with an invoice and packing list whose product names match the notification.
- After launch, report serious adverse events, keep distribution records, watch NPRA circulars and renew each notification at least 1 month before its 2-year expiry.
Documents you usually need
- NPRA Notification Note for each product and variant, held by the Malaysian CNH
- Letter of Authorisation from the product owner listing the products or brands
- Full ingredient list (INCI) with percentages for Annex III to VII substances
- GMP certificate or equivalent for the foreign manufacturer, issued or endorsed by an authorised body
- Label artwork in Bahasa Malaysia and/or English
- Product Information File (PIF) in four parts, with the safety assessment
- Halal certificate from JAKIM or a JAKIM-recognised body, only if you use a halal logo
- Commercial invoice, packing list, bill of lading or air waybill, and certificate of origin if claiming an ATIGA, RCEP or other FTA rate
Common problems and how to avoid them
What to do: Only a company registered with SSM in Malaysia can be the CNH. Appoint an importer, distributor or subsidiary and give it an LOA.
What to do: Importing an unnotified cosmetic breaches regulation 18A. Ship only after the CNH has printed the Notification Note.
What to do: Reformulate before the deadline and file a new notification; a formula change cannot be made by amendment.
What to do: Attach a GMP certificate or equivalent endorsed in the country of manufacture, and give percentages for every Annex III to VII substance.
What to do: The new CNH must file new notifications. Set out in the contract how notifications end, and issue a new LOA.
What to do: Renew at least 1 month before expiry; a late product gets a new notification and a new number.
Sources
- Guidelines for Control of Cosmetic Products in Malaysia, Second Edition (effective 1 August 2022) National Pharmaceutical Regulatory Agency (NPRA), Malaysia
- Control of Drugs and Cosmetics Regulations 1984 (regulation 18A) Pharmaceutical Services Programme, Ministry of Health Malaysia
- Cosmetics Guideline (Annex I to VII), including ingredient annexes released 10 June 2026 National Pharmaceutical Regulatory Agency (NPRA), Malaysia
- Annex I Part 4: Manual for QUEST3+ online submission for cosmetic notification National Pharmaceutical Regulatory Agency (NPRA), Malaysia
- Annex I Part 7: Cosmetic labelling requirements National Pharmaceutical Regulatory Agency (NPRA), Malaysia
- Annex I Part 13: Guideline for the Product Information File (PIF) National Pharmaceutical Regulatory Agency (NPRA), Malaysia
- Annex I Part 15: Guide manual for adverse event reporting National Pharmaceutical Regulatory Agency (NPRA), Malaysia
- Directives: cosmetic products (ingredient circulars 1/2025, 1/2026 and 2/2026) National Pharmaceutical Regulatory Agency (NPRA), Malaysia
- Recognised foreign halal certification bodies Department of Islamic Development Malaysia (JAKIM)
- ASEAN Cosmetic Directive and annexes Health Sciences Authority, Singapore
Rules change often. This note is practical guidance based on the sources above, not legal advice. Confirm current requirements with the authority, your importer or a licensed customs broker before you ship.
Trade notes
Common questions
Can a foreign brand hold the Malaysian notification itself?
No. The CNH must be a locally incorporated company or legal entity with a permanent address, registered with SSM. A foreign company appoints a local company as holder.
Is halal certification required for cosmetics in Malaysia?
No, it is voluntary. A halal logo may be used only if the product is certified by JAKIM or by a foreign body on JAKIM's recognised list. This differs from Indonesia, where halal becomes mandatory for cosmetics from 18 October 2026.
Can I send samples before the product is notified?
Yes, but not for sale. The guideline exempts market sampling (a one-time entry for test marketing) and in-house evaluation; the CNH applies in QUEST3+ and needs written approval from the Director of Pharmaceutical Services.
How much does a notification cost and how long is it valid?
RM 50 per product and per variant, not refundable, plus the CNH's QUEST3+ membership. It is valid for 2 years; renewal costs RM 50 and should be done at least 1 month before expiry.
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