To provide further guidance and as a follow-through to its commitment made during the Kapihan at Talakayan activity held for its household/urban hazardous substances (HUHS) stakeholders, the Food and Drug Administration (FDA), through the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) is pleased to issue the Guide Manual for the HUHS Industry – Initial Product Registration.
The Guide Manual provides general guidance and detailed information on securing an initial Certificate of Product Registration (CPR) for Category III and IV HUHS products for consumer and institutional use under the scope of FDA Circular No. 2020-025. The Guide Manual includes the following topics:
- Information on Technical Requirements (e.g Product Formulation, Globally Harmonized System of Classification and Labeling of Chemicals, Certificate of Analysis, Claim Substantiation, HUHS Product Labeling and Packaging)
- Introduction and navigating the FDA Electronic Portal V2.0 System
- Application form and registration process for the Initial HUHS Product Registration in the FDA Electronic Portal V2.0 System
- Self-Assessment Checklist for Initial HUHS Product Registration
The aim of the Guide Manual is to serve as a guidance document supplementary to the regulations provided under FDA Circular No. 2020-025, in order to assist HUHS stakeholders in complying with the instituted regulatory requirements to secure initial Certificates of Product Registration for HUHS products. Users of the Guide Manual are advised that the information contained therein is up-to-date as of the date of its publication. Updates to the Guide Manual will be issued as future revisions for ease in reference. To be updated with any new information relevant to HUHS regulations, stakeholders are advised to regularly check the FDA website at www.fda.gov.ph.
Should you have any inquiries, please send an e-mail to [email protected], or call the CCHUHSRR hotline at (02) 8857-1900 loc. 8113 or 8107.
Dissemination of this advisory to all concerned is hereby requested.