The household/urban hazardous substances (HUHS) industry is reminded that it has only until the end of the year to comply with the new licensing and registration requirements of the Food and Drug Administration (FDA) as the transitory period for compliance ends on December 31, 2021.
This comes as the Bureau of Customs (BOC) issued last October 15 Customs Memorandum Circular (CMC) No. 218-2021 directing all concerned customs officials to take note of the end of the transitory period to implement FDA Circular No. 2020-025 next month.
FDA Circular 2020-025 executes Administrative Order No. 2019-0019, which reinstates the requirements of licensing and registration for importers, exporters, manufacturers, toll manufacturers, wholesalers, distributors, retailers, or re-packers of those engaged in certain HUHS substances.
FDA Circular 2021-011, meanwhile, extends the transitory period until December 31 2021 for HUHS industry and stakeholders to fully comply with the newly implemented licensing and registration requirements under FDA Circular 2020-025. The extension was made due to the challenges brought about by the COVID-19 pandemic.
The transitory period “allows the said industry and stakeholders to engage in the manufacture, importation, exportation, sale, offer for sale, distribution, transfer, promotion, advertising, and/or sponsorship of HUHS products without the requisite License to Operate (LTO) as HUHS establishment and Certificate of Product Registration (CPR) while they are in the process of completing the documentary requirements as well as the lodging of their LTO/CPR applications with FDA,” said the BOC CMC.
Further, a moratorium period has been in effect throughout the transitory period “where no government agencies shall require FDA authorizations (LTO, CPR and other certifications or clearances) while the HUHS industry [is] in the process of complying with the new regulations,” it continued.
The BOC memo was issued after FDA early last month sought help to disseminate the information that the licensing and regulation requirements for the HUHS sector have been reinstated.
The HUHS industry covered under FDA Circular 2020-025 and the transitory period are establishments engaged in the manufacture, importation, sale, offer for sale, distribution, transfer, promotion, advertising, and/or sponsorship of Categories III and IV HUHS products, the FDA said.
Category III covers cleaners, fresheners and deodorizers, dishwashing and laundry detergents/soaps, disinfectants, fabric conditioners/softeners and ironing aids, fresheners and aromatic diffusers, moisture-absorbing agents, polishes, and pool chemicals.
Covered under Category IV, meanwhile, are adhesives, glues and sealants; automotive, furniture and jewelry care and restoring products; button batteries; coloring materials; fabric dyes and tattoo dyes; paints, varnishes and thinners; paint stripper; and rut remover/degreasers.
On the other hand, FDA said not covered by the reinstated licensing and registration requirements are the following:
Establishments engaged in raw materials used in the production of HUHS products
Retailers of HUHS products
HUHS products which are donated, imported for personal use, intended for exhibits, intended for exclusive use in agricultural setting; intended for other health-related/medical-related use, and intended for research and development and laboratory analysis
FDA Circular 2020-025 provides the implementing guidelines for Administrative Order (AO) No. 2019-0019, which reinstates the requirements of licensing for the HUHS sector.
Specifically, this circular establishes the guidelines for the licensing and inspection of HUHS establishments; establishes the guidelines for registration and other relevant authorizations for HUHS products; and updates the categorization of HUHS products.
It also seeks to institutionalize the Globally Harmonized System of Classification and Labeling of Chemicals as the new hazard category for labeling of HUHS products.
It likewise sets out to ensure compliance by HUHS establishments to FDA regulatory standards, such Good Manufacturing Practice, Good Distribution Practice, Good Storage Practice, and Good Labeling Practice.