Philippines - DOH Reinstates Requirements To Obtain License To Operate.
Legal News & Analysis - Asia Pacific - Philippines - Regulatory & Compliance
27 July, 2019
The Depart of Health (DOH) has issued Administrative Order No. 19-2019 (Order) 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 the 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 which were previously exempt from obtaining a license 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 which were previously exempt from such requirement.
FDA regulations generally define HUHS as any substance or mixture of substances intended for individual or limited purposes and which 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.
What the opinion says
The Order repealed DOH Administrative Order No. 2015-0038 issued on 8 September 2015 (Repealed Order). The Repealed Order removed the need for certain HUHS establishments to secure an LTO and comply with prior product registration and notification of the following products: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 (colored and or scented);
- glues / paste;
- polishes / waxes (metal polish, wood polish, shoe polish);
- fabric (dyes, softeners, conditioners);
- room freshener / air fresheners and deodorizer;
- disinfectant sprays;
- detergents (bar, liquid and powder);
- paints, lacquers, varnish; and
- solvent paint, lacquer thinner, mineral spirits.
Under the Repealed Order, importers, exporters, manufacturers, toll manufacturers, wholesalers, distributors, retailers, or re-packers of the foregoing products were not required to obtain an LTO or to comply with prior registration or notification requirements in connection with the importation, exportation, manufacture, sale, distribution, retail, promotion, and offer for sale of the said products.
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 directs the FDA to issue implementing rules or guidelines to clarify the provisions in the Order and facilitate its implementation. A transitory period of not more than three months will be provided to all covered establishments to comply with the Order.
The Order took effect on 12 July 2019 after its publication in two newspapers of general circulation.
Actions to consider
Affected companies should familiarize itself with the new requirements and be mindful of the guidelines which 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 which affected companies may have with regard to the new requirements.
For further information, please contact:
Alain Charles J. Veloso, Partner, Quisumbing Torres