Cosmetic Regulatory Databases
| Names | Descriptions | Published Date | Status | Downloads |
|---|---|---|---|---|
| Agreement on the ASEAN Harmonized Cosmetic Regulatory Scheme | Documents includes: Schedule A : ASEAN Mutual Recognition Arrangement of Product Registration Approvals for Cosmetics Schedule B: ASEAN Cosmetics Directive | 2008 | In force | |
| ASEAN COSMETIC DIRECTIVE (ACD) | The general cosmetic regulation of ASEAN | 2008 | In force | |
| ASEAN Cosmetic Claims Guidelines | ASEAN Cosmetic Documents Appendix III This document provides guidance in relation to cosmetic/drug interface in respect of product claims. | 2008 | In force | |
| COMMON REQUIREMENTS FOR IMPORT/EXPORT OF COSMETIC PRODUCTS | Only regulatory requirements imposed by health authorities are considered in this document. The requirements are applicable to Phase I of the harmonised scheme only. | 2008 | In force | |
| Asean Cosmetic Labelling Requirements | ASEAN Cosmetic Documents Appendix II This document provides guidance for labelling requirements of cosmetic products to which Article 5 of the ASEAN Cosmetic Directive 05/01/ACCSQPWG apply. | 2008 | In force | |
| Asean Cosmetic Product Registration Requirements | ASEAN Cosmetic Documents Appendix IV – ASEAN Cosmetic Product Registration Requirements | 2008 | In force | |
| Asean Guidelines for Cosmetic Good Manufacturing Practice | ASEAN Cosmetic Documents Appendix V – ASEAN Guidelines for Cosmetic Good Manufacturing Practice | |||
| ASEAN Heavy Metal Limit | The Meeting agreed on the following limits for heavy metals to be used by regulators for post-market surveillance: | |||
| ASEAN Illustrative List by Category of Cosmetic Products | ASEAN Cosmetic Documents Appendix I – Ilustrative List by Category of Cosmetic Poducts | |||
| ASEAN Sunscreen Labeling Guideline | This guideline applies only to sunscreen products i.e. those product whose primary function is UV protection as indicated by relative order, size, content and extent of claim material. It does not apply to products which make secondary UV protection claims, such as moisturising and skin lightening products. | |||
| Attachment A - A Guide Manual for the Industry - Adverse Event Reporting of Cosmetic Products | a) The development of standard definitions and terminology for key aspects of adverse event reporting, and b) The appropriate mechanism for handling adverse event reporting | 2005 | In force | |
| Guidelines for Product Information File (PIF) | The main objective of this ASEAN Product Information File (PIF) Guideline* is to provide companies placing a cosmetic product in the market recommendations on how to organize and compile the PIF based on a recommended PIF format. This document also provides guidance on who is responsible to keep the PIF and some guiding points for PIF audits. | |||
| Guidelines for the Safety Assessment of a Cosmetic Product | The purpose of this Guideline is to 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). This guideline serves to highlight some of the important considerations in the safety assessment of cosmetic product in line with Article 8 d of the ASEAN Cosmetics Directive 1 which requires an “assessment of the safety for human health of the finished product, its ingredients, its chemical structure and its level of exposure”. | |||
| ANNEX III – PART 1 LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS AND CONDITIONS LAID DOWN | ||||
| ASEAN Guidelines on Microbiological Limit in Cosmetic Products | ||||
| Updates and Amendments of the ASEAN Cosmetic Directive | ||||
| Annex II Part 1 List of substances which must not form part of the composition of cosmetic products | ASEAN Cosmetic Requirements for Ingredient Listings | |||
| Annex III Part 2 List of substances provisionally allowed | ASEAN Cosmetic Requirements for Ingredient Listings | |||
| Annex IV Part 1 List of colouring agents allowed for use in cosmetic products | ASEAN Cosmetic Requirements for Ingredient Listings | |||
| Annex IV Part 2 List of colouring agents provisionally allowed for use in cosmetic products | ASEAN Cosmetic Requirements for Ingredient Listings | |||
| Annex V List of excluded from the scope of the Directive | ASEAN Cosmetic Requirements for Ingredient Listings | |||
| Annex VI List of preservatives which cosmetic products may contain | ASEAN Cosmetic Requirements for Ingredient Listings | |||
| Annex VII List of UV filters which cosmetic products may contain | ASEAN Cosmetic Requirements for Ingredient Listings | |||
| Annex VIII Asean Handbook of Cosmetic Ingredients | ASEAN Cosmetic Requirements for Ingredient Listings |
