The Philippines Department of Health (DOH) has issued Administrative Order No. 19-2019, which reinstates the requirements for establishments engaged in the manufacture, importation, distribution, repacking and other activities involving certain household/urban hazardous substances (HUHS) in the Philippines.
On 15 February 2019, the Securities and Exchange Commission (SEC) released Memorandum Circular No. 4, Series of 2019 on the Sustainability Reporting Guidelines for Publicly Listed Companies (PLCs). The memorandum circular took effect on 8 March 2019, and will apply to the 2019 annual reports that are to be submitted in 2020.
Implications for HUHS establishments
The order provides that certain HUHS establishments that were previously exempt from obtaining a licence to operate (LTO) from the Food and Drug Administration (FDA) will now need to obtain an LTO before engaging in the manufacture, importation, distribution, repacking, and other activities involving certain HUHS products. Prior registration or notification requirements are also now required for the HUHS products that were previously exempt.
FDA regulations generally define HUHS as any substance or mixture of substances intended for individual or limited purposes and that is toxic, corrosive, an irritant, a strong sensitizer, is flammable or combustible, or generates pressure through decomposition, heat or other means, if such substance or mixture of substances may cause substantial injury or substantial illness during or as a proximate result of any customary or reasonably foreseeable ingestion by children.
The order repealed DOH Administrative Order No. 2015-0038 issued on 8 September 2015.
The Repealed Order removed the need for certain HUHS establishments to secure an LTO and comply with prior product registration and notification of the following products: Educational set and miscellaneous chemistry set; dishwashing (liquid and paste); stationeries/art paper (coloured and or scented); glues / paste; polishes/waxes (metal polish, wood polish, shoe polish); fabric (dyes, softeners, conditioners); bleaches; adhesives; cleaners; room freshener/air fresheners and deodorizers; disinfectant sprays; detergents (bar, liquid and powder); paints, lacquers, varnish; and solvent paint, lacquer thinner, and mineral spirits.
The order revoked the foregoing exemption. Accordingly, HUHS establishments dealing with the foregoing products are now required to comply with the licensing, registration and notification requirements (as the case may be) of the FDA.
The order took effect on 12 July 2019. Affected companies should familiarize themselves with the new requirements and be mindful of the guidelines that the FDA will issue to ensure compliance. Affected companies may also participate in discussions with the FDA to allow the government agency to consider any concerns they may have with regard to the new requirements.
Business Law Digest is compiled with the assistance of Baker McKenzie. Readers should not act on this information without seeking professional legal advice. You can contact Baker McKenzie by emailing Danian Zhang at firstname.lastname@example.org.