ADMINISTRATIVE ORDER NO. 2015-0038

SUBJECT : REMOVING THE REQUIREMENTS OF LICENSING AS IMPORTERS, EXPORTERS, MANUFACTURERS, TOLL MANUFACTURERS, WHOLESALERS, DISTRIBUTORS, RETAILERS, OR RE-PACKERS OF THOSE ENGAGE IN CERTAIN HOUSEHOLD/URBAN HAZARDOUS SUBSTANCES, AND FROM THE REQUIREMENT OF PRIOR REGISTRATION AND/OR NOTIFICATION OF SAID PRODUCTS

I. BACKGROUND AND RATIONALE

Administrative Order No. 312 (s. 1977) declared certain items as hazardous pursuant to Section 2, par. 1 of Presidential Decree No. (PD) 881 (s. 1976), in relation to Section 2, par. 2 thereof, and in light of existing pieces of evidence then. FDA Memorandum Circular No. 2013-045 (s. 2013) added certain items on the list of hazardous substances.

In view of the minimal risk and hazard posed to the health and safety of the people and based on standards being practiced and followed by foreign regulatory institutions on household hazardous items falling within the jurisdiction of their local FDA, the requirements of license to operate and product registration or notification shall not be imposed on the importation, exportation, manufacture, sale, distribution, retail and related activities on certain household/urban hazardous substances. However, importers, exporters, manufacturers, toll manufacturers, wholesalers, distributors, retailers, or re-packers are not exempted from certain regulatory actions of the FDA, particularly on post-marketing surveillance, monitoring and compliance.



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