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)
3.9 Product Recall
3.10 Reporting Of Adverse Event

 

 

3.1 Product Particulars

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

 

 

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 for Guideline for Safety Assessment of Cosmetic Product.

 

 

3.3 Cosmetic Ingredients

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

  • Substances listed in Poisons List (unless exempted); Poison Act 1952.
  • Substances listed in Annex II, Part 1.
  • Substances listed in Annex III, Part 1 which are used beyond the specified limits and outside the conditions laid down.
  • Colouring agents other than those listed in Annex IV, Part 1 with the exception of cosmetic products containing colouring agents intended solely for hair colouring.
  • Colouring agents listed in Annex IV, Part 1 which are used outside the conditions laid down, with the exception of cosmetic products containing colouring agents intended solely to for hair colouring.
  • Preservatives other than those listed in Annex VI, part 1.
  • Preservatives listed in Annex VI, part 1 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.
  • UV filters other than those listed in Annex VII, part 1.
  • UV filters listed in Annex VII, part 1 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.

iii) 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.

 

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.

 

 

 

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: 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.

 

 

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 9: 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 10: Guideline for Cosmetic Good Manufacturing Practice and Annex I, part 11: 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.

 

 

3.8 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 12 - Guideline for Product Information File (PIF) for information required in a PIF and the recommended format.

 

 

3.9 Product Recall

The decision for recall of a product shall be made when there is or may cause potential risk to the user of the products. Recalls may be done voluntarily by the CNH or as directed by the DPS.

The CNH is responsible for conducting recalls of defective or unsafe products. No recall should take place without first consulting/informing the NPRA.

Please refer to Guidelines on Good Distribution Practice, Chapter 10 which is available at NPRA’s website.

 

 

3.10 Reporting Of Adverse Event

CNH shall report any serious adverse events or high incidences of adverse events occurred, regardless of the source of the report (e.g. consumer and healthcare professional). Please refer to Annex I, part 13: Guide Manual for Adverse Event Reporting for more information.

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
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