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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

Sunscreen products
Hand sanitizers
Essential oil for skin/hair/nail

Added examples of products not classified as cosmetics

Products for injection/micro needling
Products for oral ingestion
Products for the treatment of diseases
Pain relief products
Sleep aid products
Surface disinfectants
Body disinfectants/sanitizers
Insect repellents
Products for animal/pet care
Massage oils for therapeutic purposes
Essential oil for therapeutic purpose only
Essential oil for diffuser use only
Products for systemic detoxification

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

Products for market sampling
Products for in-house evaluation

Online submission in NPRA Quest Online System

Products manufactured for export only (FEO) or imported for re-exporting
Products in transmit
Products to be sold or supplied in the free-trade zone or international carriage entering or leaving Malaysia

Manual hardcopy and e-mail submission

1. Official cover letter stating the purpose of the notification exemption application

2. Complete product list

product code
product name
pack size (volume or weight)
quantity
product category

3. Ingredients list (for FEO products only)

ingredients (INCI name)
ingredient function
CAS number
percentage

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)
Permitted Claims	control/reduce/prevent dandruff anti-hair loss/hair fall or treatment/control of hair loss/hair fall nourish/rejuvenate/regenerate cells whiten teeth/bleaching prevent/eliminate body odor
Prohibited Claims	permanently eliminate/stop dandruff hair loss can be arrested or reversed reference to production of collagen and elastin, inhibition of melanin synthesis, DNA repair, skin metabolism treatment or prevention of dental abscess completely prevent or stop sweating/perspiration

4) Clarifying requirements for safety and quantitative claims;

Safety Claims	Claims pertaining to product safety should not imply that the product is not associated with or free from any side effects. Phrases such as "No side effects," "No harmful effects," "No toxic or adverse effects" are not allowed; Products containing natural ingredients should not mislead consumers to assume that the product is safe due to the fact that it contains natural ingredients.
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

Reference Links

[1] Circular No. 2 /2022 Publication Notice of the Latest Edition of Cosmetic Guidelines

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