Cosmetic Compliance
Intelligence & Solutions
Malaysia Cosmetic Regulation
Feb 01, 2021
Angelita Hu
Tags : MalaysiaGMP
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CONTENTS

From year 2002 to the end of year 2007, the control of cosmetic products was conducted through pre-market registration; where the company which is responsible for placing the product in the local market submit product details and relevant certificates for review and registration before the product can be manufactured, imported or sold in the country.

As a member state of ASEAN Malaysia agreed to replace the system with a notification procedure starting from 1 January 2008 in conformance with the harmonization of cosmetic regulations in the ASEAN region. Instead of registration, companies are now required to only notify/declare their compliance status to the Director of Pharmaceutical Services (known as DPS) through National Pharmaceutical Regulatory Agency (NPRA). Regulatory action will be taken in the event of false declaration and/or product found to be non- compliant to the stipulated regulations and guidelines.

Part 1 Regulatory Framework and Competent Authority

1 Existing Main Cosmetic Regulations in Malaysia

Regulations

Remark

Control of Drugs and Cosmetics Regulations 1984

Overarching regulation

Guidelines for Control of Cosmetic Products in Malaysia(2017)Reference for notification process including quality control, inspection and post-market surveillance activities of cosmetics

Guideline for Product Information File (PIF)

Guidence how to organize and compile the PIF based on a recommended PIF format

Guidelines for Safety Assessment of Cosmetic Product

Help the Cosmetic Industry in assessing the safety of the product as well as the Regulators in auditing the data contained in the Product Information File (PIF)

Guideline for Cosmetic Advertisement

Guidance to the cosmetic industry in developing advertising message in ethical manner and to ensure responsible advertising by the advertiser

Cosmetic Labeling Requirements

Guidance for the labelling requirements of cosmetic products

Cosmetic Claims Guidelines

Provides a simple 5-step decision-making process that helps to identify products and claims which can be considered to be cosmetics

Guideline for Cosmetic Good Manufacturing Practice

Offer assistance to the cosmetic industry in compliance with the requirements for Cosmetic GMP

2 Competent Authority

Director of Pharmaceutical Services (DPS) is the authority responsible for the regulation of cosmetics products.

National Pharmaceutical Regulatory Agency (NPRA) acts as a secretariat to the DPS which is in charge of the cosmetic notification process and the post-market surveillance.

Part 2 Cosmetic Products

1 Definition

The definition of cosmetics is based on the ACD. A cosmetic product shall mean “any substance or preparation intended to be placed in contact with various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition”. (click here to see the illustrative list of cosmetic product by categories).

2 Manufacturing Requirements

All cosmetic products must be manufactured in accordance to the Guidelines for Cosmetic Good Manufacturing Practice or its equivalent. For details, please refer to Guideline for Cosmetic Good Manufacturing Practice and List of Equivalent Cosmetic GMP Guidelines. Local manufacturer is subjected to periodical inspection by GMP auditors from the NPRA to ensure continuous compliance. For foreign manufacturer, documentation to prove GMP compliance is to be made available upon request by the NPRA.

3 Notification

malaysia cosmetic regulationsThe Cosmetic Notification Holder (CNH) is responsible to notify the DPS prior to manufacture, sell, supply, import or possess any cosmetic product. The CNH refers to a company who is responsible for placing the cosmetic product in the market. The CNH must be a locally incorporated company or legal entity in the field of cosmetics, with permanent address and registered with Companies Commission of Malaysia (with the scope of business related to the health/cosmetic product as it appears in the `Memorandum and Article of Association' of the company). The CNH may or may not be the product owner.

All submission for notification shall be done online through NPRA Quest system via NPRA’s website at http://npra.moh.gov.my. Before the submission for notification, a CNH must first register for a Quest membership. A detailed guide for Quest membership registration is available on NPRA's website. CNH may also refer to Frequently Asked Questions (FAQ) section on Quest System at NPRA's website for more information. For online submission of notification of cosmetic product, CNH must complete the notification form on the Quest system for each cosmetic product and variant, if any and proceed with the payment to the NPRA.

The processing fee for notification of a cosmetic product is RM50.00 for each product (and variant, if any). The processing fee for renewal of notification of a cosmetic product is also RM50.00 for each product (and variant, if any). Any payment made shall not be refundable once the application has been submitted and payment is confirmed.

The notification of a cosmetic product shall be valid for 2 years. The renewal should be done no later than 1 month prior to notification expiry.

CNH may manufacture or import the cosmetic product upon receipt of authorization given in the Notification Note from the DPS. CNH may generate the Notification Note immediately from the Quest system after confirmation of payment by NPRA subject to meeting all notification requirements.

3.1 Dossiers Required

CNH is required to submit the following information during the notification process:

  • Particulars of product including product name, product type, intended use and product presentation

  • Name and address of the manufacturer(s) and assembler(s), if any

  • Name, address and valid contact number (and e-mail address) of the CNH

  • Particulars of person representing the company of CNH including valid contact number

  • Name and address of the importer(s), if any

  • Full product ingredient list (the content i.e. percentage (%) of the restricted ingredients must be declared)

  • Letter of Authorisation/Letter of Declaration/Letter of Contract Manufacturing, where applicable

  • Label(s) of the product

Any document and material submitted to NPRA must be in Bahasa Malaysia or English. Translated version from other languages must be endorsed or authorized.

3.2 Product Information File (PIF)

CNH shall be responsible for providing all information, certificates/documents and data requested by the NPRA. The PIF can be either in the form of a “dossier” (i.e. an extensive collection of paper records stored in a specific location) or in electronic format (i.e. soft copy). It should be readily available and accessible upon request by the NPRA.

Information required in the PIF are:

a) The qualitative and quantitative composition of the product, in case of perfume compositions, the name and code number of the composition and the identity of the supplier

b) Specifications of the raw materials and finished product

c) The method of manufacture complying with the good manufacturing practice as laid down in the Guideline for Cosmetic Good Manufacturing Practice

d) Assessment of the safety for human health of the finished product, its ingredients, their chemical structure and level of exposure

e) Existing data on undesirable effects on human health resulting from use of the cosmetic product

f) Supporting data for claimed benefits of cosmetic products should be made available; to justify the nature of its effect

The CNH is also required to provide information on the method of analysis to the regulatory authority:

a) The available methods used by the manufacturer to check the ingredients of cosmetic products corresponding with the Certificate of Analysis

b) The criteria used for microbiological control of cosmetic products and chemical purity of ingredients of cosmetic products and/or methods for checking compliance with those criteria.

Please refer to Guideline for Product Information File (PIF) for specific information required in a PIF and the recommended format.

The PIF shall be in Bahasa Malaysia or English.

The PIF shall be kept updated for all changes made to the notified product such as new ingredients, manufacturers, raw material suppliers and production process. Date of document revision, where appropriate shall be stated for verification.

3.3 Safety Requirements

 A cosmetic product placed on the market must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use. The CNH shall ensure that safety assessment has been conducted for each product. 

4 Post Market Surveillance

The NPRA shall monitor compliance of cosmetic products through Post Market Surveillance (PMS) programme. The PMS activities for cosmetics consist of:
  • Screening of product formulation and information to ensure that cosmetics do not contain any prohibited or harmful substances and all restricted ingredients are used within the allowable limits and conditions of use. Screening criteria also includes product name and its claimed benefits

  • Sample collection and testing

  • Monitoring of label compliance

  • Audit of premises for compliance to the Cosmetic GMP

  • Handling of product complaints

  • Monitoring of advertisements

  • Monitoring of adverse reactions

  • Audit on the PIF

  • Risk communication

  • Information sharing through ASEAN Post Marketing Alert System (PMAS)

5 Labeling & Claims

CNH shall ensure that the label of cosmetic product complies with the labelling requirements as defined in Cosmetic Labelling Requirements. The information on the label shall be in Bahasa Malaysia and/or English.

As a general rule, claimed benefits of a cosmetic product shall be justified by substantial evidence and/or by the cosmetic formulation or preparation itself. The CNH shall provide scientifically accepted protocols or study designs in generating the technical or clinical data with justification. A cosmetic product should not use a name and claims that are regarded as medicinal in nature or beyond the cosmetic scope. A guidance document on cosmetic claim including some examples of non-permissible claims is available in Cosmetic Claims Guideline. It is prudent for CNH to seek legal or expert advice to ensure that the proposed claims do not breach existing Acts or Regulations.

6 Advertising

CNH shall ensure that the advertisement of cosmetic product complies with the Guideline for Cosmetic Advertisement.

Part 3 Cosmetic Ingredients

In conformance with the harmonization of cosmetic regulations in the ASEAN region, cosmetic ingredients shall comply with the standards set in the technical documents of ACD.

According to the technical documents, marketing of cosmetic products containing the following ingredients is prohibited

  1. substances listed in Poisons List ( unless exempted )

  2. substances listed in Annex II

  3. substances listed in the first part of Annex III, beyond the limits and outside the conditions laid down

  4. colouring agents other than those listed in Annex IV, Part 1 with the exception of cosmetic products containing colouring agents intended solely to colour hair

  5. colouring agents listed in Annex IV, Part 1 used outside the conditions laid down, with the exception of cosmetic products containing colouring agents intended solely to colour hair · preservatives other than those listed in Annex VI, Part 1

  6. preservatives listed in Annex VI, Part 1 beyond the limits and outside the conditions laid down therein, unless other concentrations are used for specific purposes apparent from the presentation of the product

  7. UV filters other than those listed in Annex VII, Part 1

  8. UV filters listed in Annex VII, Part 1 beyond the limits and outside the conditions laid down therein

The presence of traces of substances listed in Annex II shall be allowed provided that such presence is technically unavoidable in good manufacturing practice and that it conforms to safety requirements.

Marketing of cosmetic product(s) containing the following shall be allowed:

  • Substances and other ingredients listed in Annex III, Part 2 which are used within the limits and stated the conditions laid down and conforms to the dates as stated in column (g) of Annex III, Part 2.

  • Colouring agents listed in Annex IV, Part 2 which are used within the limits and under the conditions laid down, until the admission dates given in that Annex.

  • Preservatives listed in Annex VI, part 2 used within the limits and under the conditions laid down, until the dates given in column (f) of that Annex. However, some of these substances may be used in other concentrations for specific purposes apparent from the presentation of the product.

  • UV filters listed in Annex VII, part 2 used within the limits and under the conditions laid down, until the dates given in column (f) of that Annex.

For more ingredient lists, please click here.

Tags : MalaysiaGMP