On 20 Jun 2013, the Philippines Food and Drug Administration (FDA) issued FDA Circular No 2013-015 announcing that bulk industrial chemicals used as raw materials in cosmetic and household/urban hazardous substance (HUHS) products (except Household/Urban Pesticides) are exempt from FDA authorization obligations upon issuance of the Circular.
Philippines FDA defines cosmetic products as those intended to be placed in contact with the various external parts of the human body or with the teeth and the mucous membranes of the oral cavity. The HUHS products are those products with substance or mixture of substances intended for individual or limited purposed and is toxic, corrosive, an irritant, a strong sensitizer, is flammable or combustible, or generates pressure through decomposition, heat or other means.
The dealers (i.e. importer, exporter, manufacturer, trader, distributor etc.) of the raw and bulked industrial chemicals used in producing cosmetic and HUHS products (except HUHS used in pesticides) are no longer obligated to obtain or renew their authorizations (e.g. License to Operate (LTO) and Certificate of Product Registrations (CPR)) from the FDA. However, enterprises using HUHS in pesticides, as well as packing and labeling industrial chemicals in consumer products are continuously subject to proper FDA approvals.
The FDA withdrawing its surveillance over the above-mentioned industrial chemicals with the intention to relieve enterprises from repetitive obligations as several other government agencies already regulate the dealers of industrial chemicals. The Environmental Management Bureau under the Department of Environment and Natural Resources (DENR) controls toxic substance and hazardous waste materials; Department of Labor and Employment (DOLE) regulates the occupational health and workplace safety aspects of industrial chemicals. Industrial chemicals involved in firearms and ammunition and their related instruments are managed by the Philippine National Police (PNP). The Philippines Drug Enforcement Agency (PDEA) is responsible for industrial chemicals correlated with dangerous drugs, controlled precursors and essential substances.
The change in supervision scope shows the Philippines FDA’s initiative to shift its chemical management approach from a substance-oriented to a more product-oriented way.
