FDA licensing requirement for certain hazardous substances to hurt businesses, warns Ortiz-Luis

The head of the umbrella organization of Philippine exporters has expressed concern over the possible impact on exporters and businesses of the order reinstating licensing and registration requirements for certain household/urban hazardous substances.

In a recent letter to the Food and Drug Administration (FDA), Sergio R. Ortiz-Luis Jr., president of the Philippine Exporters Confederation Inc. (PHILEXPORT), said the group supports FDA Circular No. 2020-025’s aim to protect people’s health and implement an efficient regulatory system.

“However, we have serious concerns about the adverse impacts of the proposed FDA Circular on our competitiveness, noting that it complicates and makes doing business in the country more expensive,” said Ortiz-Luis.

He added that this comes at a critical time when businesses, particularly exporters and micro, small and medium enterprises (MSMEs), are fighting for survival amid the fallout from the COVID-19 pandemic and community quarantines.

FDA Circular No. 2020-025, approved last month, provides the implementing guidelines for Administrative Order No. 2019-0019, which was issued June last year and reinstates the licensing and registration requirements for certain household/urban hazardous substances (HUHS).

The newly approved circular covers importers, exporters, manufacturers, toll manufacturers, wholesalers, distributors, retailers and repackers of certain HUHS products, who are required to comply with FDA licensing and registration requirements to be able to handle these substances.

Under the circular, HUHS establishments must secure a License to Operate (LTO) before engaging in the manufacture, importation, exportation, sale, offer for sale, distribution, transfer, promotion, advertising, and/or sponsorship of HUHS products.

HUH establishments must also secure a Certificate of Product Registration (CPR) for said products, with only FDA-licensed HUHS establishments allowed to apply for a CPR.

Ortiz-Luis in his letter suggested that all establishments, especially exporters in and out of the economic zones, that use HUHS products exclusively for industrial purposes be exempted from this regulation.

“These manufacturers and their products do not directly pose potential harm to the general public and they are already subjected to more stringent regulations imposed by the importing country,” he explained.

The organization is also asking that FDA clarify the basis for subjecting categories of HUHS products to this regulation, noting that the regulated HUHS products “do not appear in any international agreements.”

Ortiz-Luis continued: “We are talking of products such as crayons, adhesives, household cleaning agents that are being required license from FDA for the commercial use, importation, exportation, or distribution.”

Moreover, he said, the supply chain could experience “significant disruptions” if these products are regulated without validation. This is because the lists include necessary export inputs such as paints, paint primers, dyes and paints, adhesives, polishes, bleaches, corrosion or rust inhibitors/lubricants for equipment, and machineries and automotive.

The group also recommended that FDA immediately coordinate with the Bureau of Customs (BOC) on updating the Regulated Import List (RIL). “Currently, BOC has only one RIL and it does not specify any exemptions. Therefore, it is possible that shipments of exempted firms may still be put on hold,” said Ortiz-Luis.

He also urged the FDA to conduct a Regulatory Impact Assessment to rationalize this circular.

“We noted that since the implementation of AO 2019-009, there had been no reports of major incidents arising from the fears that this AO is trying to address. Hence, we recommend instead that the FDA continue conducting post-market surveillance, monitoring and compliance instead of implementing such unreasonable regulatory procedures of licensing, registration, and notification,” he concluded.

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