REPUBLIC OF THE PHILIPPINES. DEPARTMENT OF HEALTH BUREAU OF FOOD AND DRUGS ‘Cie Deve, Fiinvaet Ceeparate Cy ‘Aiebang. Mortons Coy, DOH-BFAD Advisory No. 2008 -Q03 Subject: icts, as well as, Licenses to fies. Manufact Raw Materials. As a necessary consequence of the Supreme Court decision dated 08 February 2007 holding that the Fertilizer and Pesticides Authority (FPA) has jutisdiction only over agricultural pesticides and not to pesticides used in household, business establishments, and offices in urban areas (“Household Pesticides” for brevity), registration of such products, as well as, licensing of entities engaged in the manufacture or importation/distribution of the products or raw materials shall now be referred to the Department of Health, through the Bureau of Food and Drugs (BFAD), which is vested by law with the power to regulate household hazardous substances, considering that the above pesticides are inherently hazardous. Accordingly, until the new rules and regulations for the purpose is issued and so as not to impede the supply of household pesticides in the market, the following directives are hereby imposed and made effective immediately: I, Household pesticides shall be categorized under Household Hazardous Substances, I. Renewal of the registration of products and licensing of establishments shall be in accord with the following: A. For Renewal istration of Household Pesticides: 1, The Fertilizer and Pest les Authority (FPA) is requested to process, evaluate and renew registration of household pesticides which were submitted with the FPA prior to 2. vember 2007.UL 2, All holders of existing certificates of product registration duly issued by the FPA which expired beginning 23 November_2007 and those expiring one (1 nth or less of the approved validi eric are directed to submit their renewal applications together with the documents required at the Product Services vision of BFAD following the existing renewal procedures, and payment of appropriate fees. For this purpose, the original certificate of product registration must also be surrendered otherwise the renewal application shall be denied outright. 1. The FPA is requested to process, evaluate and renew icenses of establishments manufacturing, importing, exporting or distributing household pesticides, as wall a, licenses of establishments importing raw materials used or intended for use as a component in the manufacture of household pesticides, which were submitted with the FPA prior te 23 November 2007. Il holders of existing licenses to operate (which includes licenses to import raw materials) duly issued by the FPA which expired beginning 23 November 007 and those expi e approved validity period are directed to submit their renewal applications together with the documents required at the respective divisions of BFAD identified below following the existing renewal procedures, and Payment of appropriate fees. For this purpose, the original license to operate issued by FPA must also be surrendered otherwise the renewal application sha de denied outright. a. For manufacturers — Regulation Division II b. For istributors/importers/exporters — Regulation Division I The FPA is requested to process, evaluate and submit its final recommendations to BFAD all initial applications for registration of household pesticides (excluding raw materials) and license establishments (excluding _pest_contro! Operators) which were su with the FPA prior to 23 November 2007, The BFAD |, accordingly, issue the appropriate certificate of product registration or license,VL VIL. I applications (product registration or license of establishments) after 23 November 2007 shall be submitted with BFAD together with the required documents for the purnose through the respective divisions of BFAD identified below. a. For manufacturers — Regulation Division II b. For distributors/importers/exporters — Regulation Division I c. For Product Registration — Product Services Division Imported raw materials used or intended for use as a component in the manufacture of househol her require registration nor is an import permit required prior to entry into the country. However, the license to operate of the importer must be Presented with the Bureau of Customs for the release of the raw materials imported, BFAD shail not, as a matter of procedure, issue any import/export permit for household pesticides being imported or offered for import or export provided the s registered and has an istration issued by the FPA or BFAD exporter (consignor) thereof Is_a erate as such. For the above purpose, those products the registration of which, and importers or exporters whose license, have expired beginning 23 November 2007 shall be deemed valid and existing subject to the directive in item II. Finally, BFAD shall not accept applications for license to operate, whether renewal or initial, of pest control operators provided! the household pesticides they use or about to use are registered with the FPA or BFAD, as the case may be. As such, for purposes of dings or other legal transactions where a license of the pest control operator is required, a certified true copy of the certificate of product registration of the household pesticide used or to be Used may be presented in lieu of such license. Neither seminars required of, nor certifications be issued to, pest control operators. For the guidance of all concerned. Prof. LETICIA-BARBARA B. GUP{ERREZ, M.S. ector IV