On January 21, 2022, Philippine’s Food and Drug Administration (FDA) issued the Circular No. 2021-011-A: Extension of Transitory Period and Provision of Interim Guidelines for Product Registration, including the Labeling Requirements, for Household/Urban Hazardous Substances (hereinafter referred to as “the Circular”). The Circular, for some product categories, re-extends the implementation date of FDA Circular No. 2020-025 that sets out detailed rules to regulate Household/Urban Hazardous Substances products (HUHS products). Specifically, the Circular provides an additional two-year extension to the transitory period for the Categories III and IV products from the original due date of December 31, 2021. This means, for such products, the registration and labeling requirements under FDA Circular No. 2020-025 will be exempt until December 31, 2023.
The Circular can be viewed at the following URL:
https://www.fda.gov.ph/wp-content/uploads/2022/01/FDA-Circular-No.2021-011-A.pdf
FDA Circular No. 2020-025 can be viewed at the following URL:
https://www.fda.gov.ph/wp-content/uploads/2020/08/FDA-Circular-No.2020-025.pdf
Products and establishments applicable to the transitory period extension
The Circular applies to Categories III and IV HUHS products as stipulated by the FDA Circular No. 2020-025, and the establishments engaged in manufacture, importation, exportation, distribution, sale, offer for sale, transfer, promotion, advertising and/or sponsorship thereof. However, only products that are intended for consumer or institutional use are covered by the Circular while those intended for industrial use are not eligible for such extension.
The HUHS products classified as Categories III and IV are shown in the table below:
Category | Item |
Category III Cleaners, Air Fresheners and Deodorizers |
|
Category IV Do-It-Yourself and Hobby Items |
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The extended transitory period runs two years from January 1, 2022 to December 31, 2023. You can refer to other key points of the Circular below.
License to Operate (LTO)
FDA Circular No. 2020-025 requires HUHS establishments to obtain a License of Operate (LTO). The transitory period extension does not apply to LTO licensing so all regulated establishments under FDA Circular No. 2020-025 need to have obtained an LTO before January 1, 2022.
Certificate of Product Registration (CPR)
FDA Circular No. 2020-025 requires for HUHS establishments to obtain a Certificate of Product Registration (CPR) for their HUHS products. Since the transitory period extension under the Circular applies is given to registration of HUHS products, HUHS establishments may continue to distribute their products without a CPR until December 31, 2023. During the extended transitory period, HUHS products that are not compliant with the labeling requirements stipulated in Annex J of FDA Circular No. 2020-025 are also allowed to be distributed.
On and after January 1, 2024, when the transitory period ends, CPR shall be mandatory for all HUHS products distributed in the market and the labeling requirements stipulated in Annex J of FDA Circular No. 2020-025 (including GHS labelling requirements) shall be fully complied with.
Sales and Promo Permit
To obtain Sales and Promo Permit for the products covered by the Circular is not mandatory during the two-year transitory period extension, but after the end of the transitory period it shall be mandatory for all companies conducting promotional activities.