On September 3rd, 2020, the Food and Drug Administration (FDA) of Philippines issued Advisory No. 2020-1599 [1], announcing the Implementation of FDA Circular No. 2020-0025 [2], namely the Implementing Guideline for Administrative Order No. 2019-0019 [3] Reinstatement of Requirements of Licensing as Importers, Exporters, Manufacturers, Toll Manufacturers, Wholesalers, Distributors, Retailers, or Re-Packers of Those Engaged in Certain Household/Urban Hazardous Substances, and from the Requirement of Prior Registration and/or Notification of Said Products. The reinstatement of licensing requirement as well as the Implementing Guidelines shall enter into effect 15 days after their publication in two national newspapers.
FDA Administrative Order No. 2019-0019 was issued on June 25th, 2019, to repeal the Administrative Order 2015-0038, which removed the licensing requirements for household/urban hazardous substances (HUHS), and bring the licensing requirements back. However, the establishments were not impacted until the issuance of Implementing Guidelines, which was approved by virtue of FDA Circular No. 2020-0025 issued on August 19th, 2020.
The business operators, including manufacturers, importers, exporters, packers, traders, wholesalers, etc. of the following five categories of HUHS products shall comply with the reinstated licensing requirements. The full lists of the five categories of products are detailed in Annex A of the Implementing Guidelines.
Category Ⅰ: Novel HUHS Products (Vapor Products), including electronic nicotine/non-nicotine delivery systems, and heated tobacco products;
Category Ⅱ: Yard and Home Products, including household/urban pesticides;
Category Ⅲ: Cleaners, Fresheners and Deodorizers, including bleaches, polishes, pool chemicals, etc.;
Category Ⅳ: Do-It-Yourself and Hobby Items, including adhesives, button batteries, paint stripper, etc.;
Category Ⅴ: TCCA Products, namely the toys and children article products under FDA Jurisdiction.
As for the licensing requirements, HUHS establishments shall abide by the applicable provisions of Administrative Order No. 2020-0017 [4] Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003. It shall be noted that at last according to relevant provisions in Administrative Order No. 2019-0019, a transitory period of three moths will be given to the obligators.
