On December 22, 2020, the FAQs and decision matrix (for determining whether a product is subject to Household/Urban Hazardous Substances (HUHS) regulations) regarding Food and Drug Administration (FDA) Circular No. 2020-025, Implementing Guidelines for Department of Health Administrative Order No. 2019-0019, which regulates HUHS Products, were released in the Philippines. HUHS covers a variety of household products including detergents, air fresheners, adhesives, button batteries, and paints, and requirements such as licensing, product registration, and GHS labeling are imposed on them. The FAQ released this time contains a total of 24 questions and answers regarding the HUHS regulations, mostly regarding the License to Operate (LTO).
The original text of the FAQs can be viewed at the following URL.
The decision matrix for determining whether a product is subject to HUHS regulations can be viewed at the following URL.
The following are examples of specific questions and answers.
Q: Do suppliers of chemical raw material used for the manufacture of HUHS product need to secure the LTO?
A: No. The licensing and registration requirements provided in FDA Circular No. 2020-025 shall not apply to the following establishments and products.
- Manufacturers, importers, or distributors of raw materials used in the production of HUHS products, and their products
- Retailers of HUHS products
- HUHS products which are:
- for donation, in which Administrative Order No. 2020-001 shall apply
- imported for personal use, in which DOH-FDA-BOC Joint Circular No. 1 shall apply
- intended to be used for exhibits
- intended for exclusive use in agricultural setting
- intended for other health-related/medical-related use
- intended to be used for research and development and analysis of HUHS product
Q: How do I apply for the LTO?
A: Application for the LTO shall be submitted through the FDA e-Portal System V.2. To do so, an applicant should start with creating a user account in accordance with Annex B and B.1 of FDA Circular No. 2020-025.
Q: How long is the validity of the LTO?
A: The license issued for the first time shall be valid for three years, and the renewed license shall be valid for five years.