Regulatory Services for Chemical Products & Mixtures in the Philippines

Overview

Here are a few key facts for you!

  • Household/Urban Hazardous Substances (HUHS) products are divided into five (05) categories, and Surface disinfectants/Detergents-cleaners fall under Category III.
  • The products in Category III can be classified as ready-to-use products and professional-use (highly concentrated) products.
  • HUHS products cover a large variety of products range (mentioned in Annex A of the FDA circular 2020-025) except pharma, cosmetics, and medical devices.

General Requirements for HUHS Products (Surface Disinfectant/Detergent-Cleaners)

  • Shall be classified into the relevant category
  • Shall not contain CMR ingredient or banned ingredient
  • Shall not bear unsubstantiated claims or misleading information
  • HUHS manufacturers should follow good manufacturing practice
  • Product Information File (PIF) shall be maintained and kept ready post-registration for inspection purposes

“In case you are a foreign company who is exporting HUHS product (Surface disinfectant/ detergent-cleaners) to Philippine, make sure your distributor-importer hold valid License to operate (LTO) in order to apply for company product registration and to clear customs”

License To Operate (LTO) for HUHS Establishments – The Philippines

License to Operate (LTO) for HUHS establishment is a crucial document to hold in the Philippines by local establishments like distributor-importer before getting engaged in any activity related to HUHS products like marketing/distribution/importation/export/sale and offer for sale/promotion, etc. & to apply for HUHS product registration through FDA. Further, LTO & CPR are equally important and required by the Bureau of Customs (BOC) to clear customs.

Applicants can apply for LTO to FDA through FDA e-portal system V.2. which takes 20 – 30 days of time to process the application, where major data requirements would be

  • Declaration and Oath of undertaking and accomplished application form
  • Proof of Business name registration
  • Proof of Income
  • Fee payment

Initial validity of Philippine LTO is for 3yrs where after renewal, the validity is for 5 yrs unless revoked.

Under the transitory period (Jan 01, 2022, to Dec 31, 2023), extension is not applied to the License To Operate (LTO), hence, from Jan 01, 2022, LTO as HUHS establishments shall be mandatory for all establishments engaged or intending to engage in HUHS-related activities.

Expertise

Freyr Expertise

  • Company Product Registration (CPR) services
    • Product classification
    • Building data requirements matrix
    • Data collection and data gaps validation
    • Preparation of declaration statements & application form
    • Application submission via FDA e-portal
    • Post-submission support - Quick responses to authority raised queries before the assigned deadlines
    • Follow up till approval and approval validation
  • License To Operate (LTO) application submission
  • LTO - legal representative & authorized holder services
  • Regulatory intelligence support
Freyr Advantages
Advantages

Freyr Advantages

  • End-to-end chemical Regulatory services
  • Expert advice on the Regulatory strategy
  • Easily navigate complexities of Regulatory authorities
  • Support for region-specific Regulatory complexities
  • A structured and cost-effective approach to ensure regulatory compliance
  • Robust partner network in the Philippines
  • Focused chemical Regulatory compliance solution
  • Quick turnarounds and faster time-to-market