Cosmetics Regulatory Databases

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NamesDescriptionsPublished DateStatusDownloads
Agreement on the ASEAN Harmonized Cosmetic Regulatory SchemeDocuments includes:
Schedule A : ASEAN Mutual Recognition Arrangement of Product Registration Approvals for Cosmetics
Schedule B: ASEAN Cosmetics Directive
2008In force
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ASEAN COSMETIC DIRECTIVE (ACD)The general cosmetic regulation of ASEAN2008In force
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ASEAN Cosmetic Claims GuidelinesASEAN Cosmetic Documents
Appendix III

This document provides guidance in relation to cosmetic/drug interface in respect of product claims.
2008In force
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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.2008In force
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Asean Cosmetic Labelling RequirementsASEAN 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.
2008In force
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Asean Cosmetic Product Registration RequirementsASEAN Cosmetic Documents
Appendix IV – ASEAN Cosmetic Product Registration Requirements
2008In force
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Asean Guidelines for Cosmetic Good Manufacturing PracticeASEAN Cosmetic Documents
Appendix V – ASEAN Guidelines for Cosmetic Good Manufacturing Practice
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ASEAN Heavy Metal LimitThe Meeting agreed on the following limits for heavy metals to be used by
regulators for post-market surveillance:
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ASEAN Illustrative List by Category of Cosmetic ProductsASEAN Cosmetic Documents
Appendix I – Ilustrative List by Category of Cosmetic Poducts
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ASEAN Sunscreen Labeling GuidelineThis 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.
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Attachment A - A Guide Manual for the Industry - Adverse Event Reporting of Cosmetic Productsa) The development of standard definitions and terminology for key aspects of
adverse event reporting, and
b) The appropriate mechanism for handling adverse event reporting
2005In force
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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.
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Guidelines for the Safety Assessment of a Cosmetic ProductThe 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”.
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ANNEX III – PART 1 LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS AND CONDITIONS LAID DOWN
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ASEAN Guidelines on Microbiological Limit in Cosmetic Products
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Updates and Amendments of the ASEAN Cosmetic Directive
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Annex II Part 1 List of substances which must not form part of the composition of cosmetic productsASEAN Cosmetic Requirements for Ingredient Listings
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Annex III Part 2 List of substances provisionally allowedASEAN Cosmetic Requirements for Ingredient Listings
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Annex IV Part 1 List of colouring agents allowed for use in cosmetic productsASEAN Cosmetic Requirements for Ingredient Listings
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Annex IV Part 2 List of colouring agents provisionally allowed for use in cosmetic productsASEAN Cosmetic Requirements for Ingredient Listings
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Annex V List of excluded from the scope of the DirectiveASEAN Cosmetic Requirements for Ingredient Listings
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Annex VI List of preservatives which cosmetic products may containASEAN Cosmetic Requirements for Ingredient Listings
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Annex VII List of UV filters which cosmetic products may containASEAN Cosmetic Requirements for Ingredient Listings
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Annex VIII Asean Handbook of Cosmetic IngredientsASEAN Cosmetic Requirements for Ingredient Listings
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