| INFORMATION IN THE CONTENT | ||
| First Edition, First Revision | Second Edition | |
| Glossary | Manufacturer The manufacturing process includes all operations of purchase of starting materials, bulk intermediates and products, formulation and production (such as grinding, mixing,encapsulation and/or packaging), quality control, release, storage and distribution of cosmetic products and the related controls. | Amended: Manufacturer The manufacturing process includes the complete set of activities to produce a product, comprising of production and quality control, from acquisition of all raw materials through processing and subsequent packaging and release for distribution of the finished product. |
| Section 3: Regulatory Requirements for Cosmetics | 3.3 Cosmetic Ingredients 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. - - 3.7 Good Manufacturing Practice (GMP) 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. 3.9 Product Recall (Moved to Section 5.3) 3.10 Reporting of Adverse Event (Moved to Section 4.4) | 3.3 Cosmetic Ingredients (Deleted content in 3.3 (iii))3.4 Labelling Requirement (Moved ‘Halal’ from section 9)3.5 Cosmetic Claims Inserted: For specific guidance regarding sunscreen products/claims, please refer to Annex 1 part 9 (i) Guideline for Sunscreen Product. For specific guidance regarding hand sanitizers,please refer to Annex 1 part 9 (ii) Guideline for Hand Sanitizer Product. For specific guidance regarding antibacterial hygiene wash products/claims, please refer to Annex 1 part 9 (iii) Guideline for Antibacterial Hygiene Wash Products. 3.7 Good Manufacturing Practice (GMP) Amended: 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. |
| Section 4: Post Market Surveillance | 4.3 Product Complaint (Inserted new requirement for Product Complaint)4.4 Reporting of Adverse Event (Moved from Section 3.10)4.5 Notification of Product Quality Issues (Inserted new requirement for Notification of Product Quality Issues) | |
| Section 5: Notification Exemption | 5.3 Product Recall (Moved from Section 3.9) (Inserted Application Process) | |
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INFORMATION IN THE ANNEXES |
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| Annex I, Part 7 | Cosmetic Labelling Requirements | Cosmetic Labelling Requirements Added information under Objective: - They are required to be labelled in accordance with the Regulations before they can be sold or supplied in Malaysia and to make claims that will not mislead the consumer about the product’s contents,quality or safety. Added requirement under 3.1i): - Definition of “Professional use” and“Professional” - Products packaged in vial or ampoule must be labelled ‘for external use only’ (Deleted 3.1j) Valid contact number of the CNH) Added list under Appendix A: 4. Any other approved standard references. 5. Botanicals and extract of botanicals should be identified by its genus and species. |
