On August 19, 2020, Food and Drug Administration (FDA) Circular No. 2020-025: Implementing Guidelines for Administrative Order No. 2019-0019, “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” (hereinafter referred to as this Circular) was issued in the Philippines. This Circular serves as the implementation rules for regulating “household/urban hazardous substances products (HUHS products)”, stipulating the items including obligations of establishments, target products, registration of HUHS products, and labeling of HUHS products.
The purposes of this Circular are as follows.
- To establish the guidelines for the licensing and inspection of HUHS establishments.
- To establish the guidelines for registration and other relevant authorizations for HUHS products.
- To update the categorization of HUHS products.
- To institutionalize the GHS as the hazard category for the labeling of HUHS products.
- To ensure that HUHS establishments comply with the FDA regulatory standards.
This Circular shall take effect 15 days following the completion of its publication in two newspapers of general circulation and submission of a copy thereof to the Office of the National Administrative Register in the University of the Philippines Law Center. A transitory period of three months from the issuance of this Circular shall be provided for covered establishments to comply with the new licensing and product registration guidelines. Furthermore, a transitory period of three years shall be provided to comply with the GHS labeling requirements.
The original text of this Circular can be downloaded from the following URL.
The scope of the HUHS products
The HUHS products are classified into five major categories as follows, and specific items are listed in each category. However, the scope of the products to be covered is not limited to the following and will be revised according to the decision of FDA.
Novel HUHS Products
Yard and Home Products
Cleaners, Air Fresheners and Deodorizers
Do-It-Yourself and Hobby Items
Toys and Childcare Article (TCCA) Products
HUHS products including above shall not contain any carcinogenic, mutagenic, reprotoxic (CMR) ingredient, or other banned substances.
Requirements for HUHS Products
This Circular imposes the following requirements on HUHS products.
- A Product Information File (PIF) following the format as specified in Annex I shall be prepared and kept by the Marketing Authorization Holder (MAH).
- HUHS products that have been banned or withdrawn in the country of origin/source or manufacture shall not be allowed to enter the Philippine market. HUHS products that are already in the market shall be immediately recalled if it is banned or withdrawn in the country of origin/source or manufacture.
- Any product that is determined by the FDA to be hazardous or dangerous shall be recalled immediately.
- The HUHS products shall comply with the labeling and packaging requirements specified in this Circular. The main requirements are as follows.
Labeling requirements to display the information as specified in Annex J of this circular, and appropriate packaging requirements shall be met.
The methods based on the UN GHS shall be used to determine the hazards of HUHS products.
The labels on the HUHS products shall follow the GHS labeling requirements (pictograms, signal words and hazard statements). The labeling requirements shall take effect after three years from the issuance of this Circular.
The labels on the HUHS products shall not bear the words “safe,” “non-toxic,” “non-hazardous,” or other equivalent words.
On December 22, 2020, Philippines FDA published FAQs on HUHS regulations.
Philippines releases FAQs on HUHS products regulations
On January 21, 2022, FDA re-extends the implementation date of FDA Circular No. 2020-025.
Philippines re-extends transitory period for regulations on household hazardous products