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[Chemlinked] Malaysia Amends Guidelines for Control of Cosmetic Products
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등록일 2022-07-27
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The main amendments are
1) Adding product examples classified as cosmetics and not classified as cosmetics, requirements for product complaints, as well as 3 guidance for hand sanitizers, antibacterial hygiene products, and product reporting and recall;
2) Revising and clarifying requirements for cosmetic notification, GMP inspection, GMP certificate, as well as cosmetic naming, labeling, claiming, and advertising.
Organizations and Terms: National Pharmaceutical Regulatory Agency (NPRA): Cosmetic competent authority in Malaysia, which is in charge of cosmetic notification and post-market surveillance. Cosmetic Notification Holder (CNH): CNH refers to a company that is responsible for placing the cosmetic product in the Malaysian market. Guidelines for Control of Cosmetic Products in Malaysia: The Guidelines serves as a reference for the notification process including quality control, inspection, and post-market surveillance of cosmetics. NPRA Quest Online System: All submissions for cosmetic notification shall be made online through the NPRA Quest system via NPRA’s website at npra.gov.my. Quest Membership: Before submitting the cosmetic notification, a CNH must register for a Quest membership in NPRA Quest Online System. |
On July 18, 2022, Malaysia NPRA released the updated Guidelines for Control of Cosmetic Products in Malaysia (Guidelines). 1 The Guidelines will replace the previous 2017 version and take effect on Aug. 1, 2022. After the date, CNH shall comply with all provisions in the Guidelines.
The main amendments are summarized as follows.
1. Adding 3 examples classified as cosmetics and 12 examples not classified as cosmetics
The Guidelines adds 3 examples of products classified as cosmetics and 12 examples of products not classified as cosmetics.
Added examples of products classified as cosmetics |
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Added examples of products not classified as cosmetics |
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2. Revising the requirements for cosmetics notification
1) For a notified product, the application requirement for the change of company name or address (without a shift in distribution rights) is amended. The new requirement is to contact the Center of Regulatory Coordination & Strategic Planning for the change;
2) Amending the fees for Quest Membership registration in the NPRA Quest Online System (new or updated fees are underlined):
Description |
1 Year |
2 Year |
Main User – New, Replacement, or Change Authorized Person (Certificate + USB Token) |
RM 260.00 |
RM 290.00 |
Supplementary User – New, Replacement, or Change Authorized Person (Certificate + USB Token) |
RM 245.00 |
RM 275.00 |
Change Authorized Person (Certificate Only) |
RM 48.00 |
RM 95.00 |
Renewal (Digital Certificate only – using existing MSC USB Token) |
RM 48.00 |
RM 95.00 |
Postage (Peninsular Malaysia) |
RM 10.00 |
|
Postage (Sabah/Sarawak) |
RM 20.00 |
|
*Token Price/Package (excluding 6% GST) |
3) Clarifying the methods and required documents for applying for notification exemption.
Products Applying for Notification Exemption |
Application Methods |
Required Documents |
|
Online submission in NPRA Quest Online System |
/ |
|
Manual hardcopy and e-mail submission |
1. Official cover letter stating the purpose of the notification exemption application 2. Complete product list
3. Ingredients list (for FEO products only)
|
3. Revising the requirements for GMP inspection and clarifying the requirements for the GMP certificate
1) For local manufacturers, a new requirement is added. A new local manufacturer/new production line shall be inspected by NPRA prior to cosmetics notification;
2) For foreign manufacturers, the requirement for GMP certificates is clarified. Document/declaration of compliance to cosmetic GMP must be issued/endorsed by an authorized body or agency in the country of the manufacturer.
4. Revising the naming/labeling/claiming/advertising requirements for cosmetics
1) Clarifying that prohibited ingredient names cannot be used as part of product names, and adding examples of words and expressions that are not allowed to be used as part of product names;
Added Examples of Prohibited Product Name (Excerpt) |
Cannabis, Hemp, Oestrogens, Progesterone, Collagen Cream for the product not containing collagen, Mouth Gargle, Psoriasis, Atopic Dermatitis, Seborrheic Dermatitis |
2) Adding a labeling requirement and deleting a labeling requirement;
Added labeling requirement |
Products packaged in vial or ampoule must be labeled "for external use only." |
Deleted labeling requirement |
Labeling the valid contact number of the CNH. |
3) Updating the list of examples of permitted and prohibited claims for cosmetics. Click here to see the full list;
Permitted and Prohibited Claims (Excerpt) |
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Permitted Claims |
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Prohibited Claims |
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4) Clarifying requirements for safety and quantitative claims;
Safety Claims |
|
Quantitative Claims |
Numerical claims of product performance/effectiveness, such as 99.9%, in 3 days, 10 times, etc., are permitted if substantiated by relevant evidence. |
5) Adding an optional requirement for advertisement with a testimonial. Advertisement with a testimonial is suggested to include this statement: "The effects of the product may vary among individuals."
5. Adding requirements for product complaints
The CNH shall investigate all complaints related to quality and safety problems pertaining to their notified cosmetics, and be aware and responsible for determining appropriate corrective and preventive action.
6. Adding 3 guidance for hand sanitizers, antibacterial hygiene products, and product reporting and recall
Guidance for hand sanitizer products |
The guidance applies to those hand sanitizers classified as cosmetics and clarifies the hand sanitizers’ classification, permitted active ingredients, as well as permitted and prohibited claims. |
Guidance for antibacterial hygiene products |
The guidance applies to antibacterial wash, wipes, deodorant, and talc, and clarifies common antibacterial ingredients and requirements for products containing new antibacterial ingredients. |
Guidance for product reporting and recall |
The guidance clarifies the definition, type, degree, level, and process of product recall. |
For all updates in the new Guidelines, please refer to this list.
Further Reading
- Malaysia NPRA Adopts Six Changes to Cosmetic Ingredient Use Requirements
- ASEAN Introduces Amendments to the Ingredient Lists of ACD: 3 New Ingredients Included and 13 Ingredients Revised
- Malaysia Releases Guidelines for Application for Inspections of GMP and GDP
- Malaysia NPRA Clarifies Regulatory Requirements for Hand Sanitizers
Reference Links
[1] Circular No. 2 /2022 Publication Notice of the Latest Edition of Cosmetic Guidelines
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