3.0 Regulatory Requirements For Cosmetics

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CNH must ensure compliance to the following requirements prior to notification submission.

 

3.1 Product Particulars
3.2 Safety Requirements
3.3 Cosmetic Ingredients
3.4 Labelling Requirements
3.5 Cosmetic Claims
3.6 Cosmetic Advertisement
3.7 Good Manufacturing Practice (GMP)
3.8 Product Information File (PIF)

 

 

3.1 Product Particulars

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

  3.1.1 Particulars of product including product name, product type, intended use and product presentation
  3.1.2 Name and address of the manufacturer(s) and assembler(s), if any
  3.1.3 Name, address and valid contact number (and e-mail address) of the CNH
  3.1.4 Particulars of person representing the company of CNH including valid contact number
  3.1.5 Name and address of the importer(s), if any
  3.1.6 Full product ingredient list (the content i.e. percentage (%) of the restricted ingredients must be declared)
  3.1.7 Letter of Authorisation/Letter of Declaration/Letter of Contract Manufacturing, where applicable
  3.1.8 Label(s) of the product

 

 

 

3.2 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. Please refer to Annex I, Part 6: Guidelines for Safety Assessment of Cosmetic Product

 

 

3.3 Cosmetic Ingredients

i) Marketing of cosmetic product(s) containing the following ingredients is prohibited:

   3.3.1 Substances listed in Poisons List (unless exempted); Poison Act 1952.
   3.3.2 Substances listed in Annex II
   3.3.3 Substances listed in Annex III which are used beyond the specified limits and outside the conditions laid down.
   3.3.4 Colouring agents other than those listed in Annex IV with the exception of cosmetic products containing colouring agents intended solely for hair colouring.
   3.3.5 Colouring agents listed in Annex IV which are used outside the conditions laid down, with the exception of cosmetic products containing colouring agents                            intended solely to for hair colouring.
   3.3.6 Preservatives other than those listed in Annex VI
   3.3.7 Preservatives listed in Annex VI which are used beyond the specified limits and outside the stated conditions laid down therein, unless other concentrations                       are used for specific purposes apparent from the presentation of the product.
   3.3.8 UV filters other than those listed in Annex VII
   3.3.9 UV filters listed in Annex VII which are used beyond the limits and stated outside the conditions laid down therein.

 

ii) 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.

 

 

 

 

3.4 Labelling Requirements

CNH shall ensure that the label of cosmetic product complies with the labelling requirements as defined in Annex I, part 7: Cosmetic Labelling Requirements. The information on the label shall be in Bahasa Malaysia and/or English.

Halal logo may be used voluntarily on a notified cosmetic product, for both the local and export markets, provided that the product has been certified and approved Halal by the Malaysia Department of Islamic Development (Jabatan Kemajuan Islam Malaysia, JAKIM) or any Islamic Body recognised by JAKIM.

 

 

  

3.5 Cosmetic Claims

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 Annex I, part 8 : Guideline for Cosmetic Claims.

For specific guidance regarding sunscreen products/claims, please refer to Annex I, part 9(i) : Guideline for Sunscreen Product.

For specific guidance regarding hand sanitizers, please refer to Annex I, part 9(ii) : Guideline for Hand Sanitizer Product

For specific guidance regarding antibacterial hygiene wash products/claims, please refer to Annex I, part 9(iii) : Guideline for Antibacterial Hygiene Wash Product

It is prudent for CNH to seek legal or expert advice to ensure that the proposed claims do not breach existing Acts or Regulations

 

 

 

 

3.6 Cosmetic Advertisement

CNH shall ensure that the advertisement of cosmetic product complies with the Guideline for Cosmetic Advertisement. For further details, please refer to Annex I, part 10 : Guideline for Cosmetic Advertisement.

 

3.7 Good Manufacturing Practice (GMP)

All cosmetic products must be manufactured in accordance to the Guidelines for Cosmetic Good Manufacturing Practice or its equivalent. For details, please refer to Annex I, part 11: Guideline for Cosmetic Good Manufacturing Practice (GMP) and Annex I, part 12: List of Equivalent Cosmetic GMP Guidelines.

A new local manufacturer/ new production line shall be inspected by NPRA prior to cosmetics notification. The manufacturer needs to ensure that the layout of the manufacturing facility is designed and planned according to GMP principles. Please refer to the Frequently Asked Questions (FAQs) related to GMP inspection, which is available in NPRA website.

Following from that, all local manufacturers are subjected to periodical regulatory GMP inspection to ensure continuous compliance.

For foreign manufacturers, documentation to prove GMP compliance is to be made available upon request by the NPRA. Document/declaration of compliance to cosmetic GMP (or equivalent) must be issued/endorsed by authorised body/agency at country of manufacturer.

 

 

 

 

3.8 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.

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.

 

Please refer to Annex I, part 13 : Guideline for Product Information File (PIF) for information required in a PIF and the recommended format.

 

 

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

 

 

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