The ASEAN Cosmetic Directive (ACD) requires persons or companies placing a product on the market to keep a product information file “readily accessible to the regulatory authority of the Member State concerned at the address specified on the label in accordance with article 6 of this Directive”.

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.

Table of Content

1. Introduction and Objective

2. PIF Organization

2.1 Product Information Required under ACD

2.2 Recommended PIF format

• Part I: Administrative Documents and Product Summary

• Part II: Quality Data of Raw Materials

• Part III: Quality Data of Finished Product

• Part IV: Safety and Efficacy Data

3. Who is responsible to keep the PIF

4. PIF Audits

4.1 Types of audits

4.2 Documents to be made readily available

4.3 Documents to be made accessible to Authorities within reasonable time

4.4 Background or supplementary documents

4.5 Document media

*This is not a legal document and as such, compliance is not a mandatory requirement.