Share this Post!

The Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research
(CCHUHSRR) is soliciting comments on the proposed policy, provisionally entitled “Updated
Guidelines on Product Information File (PIF) for Cosmetic Products Repealing FDA Circular
No. 2018-001 ‘Reiterating the Mandatory Implementation of Article 8 of the ASEAN Cosmetic
Directive, Product Information’”.

The proposed issuance aims to improve the regulatory compliance to PIF requirements as set
forth by the ACD and establish an updated PIF guidelines in the context of evolving digital
technology and pandemic resiliency. Specifically, the proposed policy aims to incorporate the
alternative PIF audit arrangements that will be conducted by the FDA and outline the
responsibilities of the Market Authorization Holders in line with this; and, for the purposes of
transparency, clarity and efficiency, introduce the classification of deficiencies for non-
conformances found during PIF Audits and the corresponding resolutions.

All concerned stakeholders, including Cosmetic Manufacturers, Distributors and Traders, and
other related establishments, are requested to submit their comments in MSWord Format via
email to [email protected] on or before 11 August 2022 using the “Template for
Comments” attached below.

Thank you very much.