Exporters seek exemption from ruling on chemicals

MANILA, Philippines — The Philippine Exporters Confederation Inc. (Philexport) wants exporters to be exempt from a Food and Drug Administration (FDA) order reinstating the licensing and registration requirements for the use of household or urban hazardous substances (HUHS).

In a letter to FDA director general Rolando Enrique Domingo, Philexport president Sergio Ortiz-Luis Jr. said that while the group supports the aim to promote health and efficient regulation through FDA Circular 2020-025, which provides guidelines for the licensing of establishments using HUHS and the registration of such products, it is concerned about the order’s impact on exporters and micro, small and medium enterprises.

He said the circular “complicates and makes doing business in the country more expensive.”

As such, the group is pushing for the exemption of all establishments, especially exporters in and out of the economic zones, that use HUHS products exclusively for industrial purposes from the 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,” Ortiz-Luis said.

FDA Circular 2020-025, approved last month, provides the implementing guidelines for Administrative Order 2019-0019 issued last year to reinstate the licensing and registration requirements for certain HUHS.

It covers importers, exporters, manufacturers, toll manufacturers, wholesalers, distributors, retailers and those repacking certain HUHS products.

Under the circular, a license to operate  must be secured before engaging in the manufacture, import, export, sale, distribution, transfer, promotion, advertising, and/or sponsorship of HUHS products.

A certificate of product registration must also be secured for HUHS products intended to be manufactured, imported, exported, distributed, sold and or promoted, and only FDA-licensed establishments would be allowed to apply for such.

“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,” Ortiz-Luis said.

He also said Philexport wants the FDA to clarify the basis for the categories of HUHS products subject to the regulation as the regulated items do not appear in any international agreements.

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

Philexport is also urging the  FDA to immediately coordinate with the Bureau of Customs (BOC) to update 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,” Ortiz-Luis said.

He said  the FDA should likewise conduct a regulatory impact assessment to rationalize the circular.