On 19 August 2020, the Philippines Food and Drug Administration (FDA) published FDA Circular No. 2025-025 on its website, which finalized updated labeling, licensing, and registration requirements for household/urban hazardous substance products (HUHS).
The Circular, which will become effective in August 2023, implements Guidelines of Administrative Order No. 2019-0019, “Reinstatement of Licensing as Importers, Exporters, 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.”
GHS label requirements
The Guideline incorporates the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) into the regulatory requirements for HUHS distributed in the Philippines. By 2023, hazardous products sold to consumers will need to be classified and labeled according to GHS criteria.
Registration and Authorization
The Guideline also updates the categorization of HUHS products, establishes requirements for registration and authorization of HUHS, reinstates provisions for licensing and inspection, and aims to assure compliance of HUHS establishments with FDA regulatory standards.
HUHS establishments must obtain a License to Operate (LTO) before engaging in the manufacture, importation, exportation, sale, and distribution of HUHS products. HUHS organizations must also secure a Certificate of Product Registration (CPR) for their products, with only FDA-licensed HUHS establishments permitted to apply for a CPR.
Some companies have expressed concern that the reinstatement of licensing and registration requirements for HUHS products will make doing business in the Philippines much more expensive. Importers, exporters, manufacturers, toll manufacturers, wholesalers, distributors, retailers, and repackers of certain HUHS products must comply with FDA licensing and registration requirements to be able to handle these substances. These hurdles can be costly, especially at such a delicate time when many smaller enterprises are struggling to stay afloat due to challenges of the COVID-19 pandemic. The new requirement could potentially result in supply chain disruptions due to the new regulatory obligations being implemented.
We will watch out for updates to these new requirements and be sure to keep you posted. For SDS and label compliance for the Philippines and around the world, contact Nexreg today!