MEMORANDUM CIRCULAR No.2 0 1 5 - 0 SUBJECT Chemical Importation Advisory - Requirements for importa

We have been receiving reports from locator enterprises that imported goods, considered as household urban hazardous substance (HUHS), are being put on-hold at the port pending presentation of appropriate Food and Drug Administration (FDA) permits to port officials. We wish to inform that as a result of the issuance last 10 Apri12015, of the Customs Memorandum Order (CMO) 9-2015 (Annex 1) with the subject "On the strict enforcement of rules concerning regulated imports", importation requirements for goods considered as HUHS are now being stringently implemented at all ports. How to ensure compliance to FDA regulation on importation of HUHS? 1. Check the Material Safety Data Sheet of the chemical or materials to be imported and compare with the list of HUHS (Annex 2). [Reference: Section II. Scope and Coverage FDA MC 2013-045] The complete list of regulated materials considered as HUHS may also be downloaded from the Bureau of Customs website at this link: http://customs.gov.ph/wpcontent/up I oads/20 15/04/Reg u lated-I m ports-20 1 5-04-06-Vers ion-2 -So rted-byCategorv.xlsx. Use the filter in the first column entitled "Category" of the excel file and select "Household Urban Hazardous Substance" to view the complete list. Screenshots of the BoC website link and the MS Excel file of regulated materials are provided in Annex 3. 2. Lodge the PEZA electronic import permit (e-IP) application and allow the supplier to ship the chemical or materials only after: a. Goods are cleared by the PEZA Zone Office as unregulated; OR, b. Regulated goods are accompanied by appropriate permits and PEZA Zone Office has given clearance to lodge e-IP application. What are the requirements for importation of materials considered as HUHS? 3. Importers are required to secure the FDA License to Operate (L TO) and Certificate of Product Notification (PN), these shall be presented to the port of entry for every shipment of HUHS. [Reference for LTO: FDA MC 2014-003; Reference for PN: F Roxas Boulevard corner San Luis Street, Pasay City. Melro Manila. Philippines Telephones: (632) 5513451 5513438· Facsimile (632) 5513442 E-mail mfo@pcza.gov.ph·Website www.peza.gov.ph What if the HUHS are already at the port and the appropriate permits have yet to be secured? 4. The Center for Cosmetics Regulation and Research (CCRR) of the FDA has advised PEZA that a Bureau of Customs (BoC) Clearance may be issued by the CCRR to importers if the HUHS is intended solely for the company's own consumption and will not be for cornmercial or wholesale distribution. 5. The BoC Clearance may be issued by the CCRR in lieu of the L TO and PN per shipment to establishments that import HUHS products subject to submission of the following requirements to the FDA: a. Letter of intent / cover letter addressed to Secretary of Health and Acting FDA Director General Janette P. Loreto - Garin, MD, MBA-H. b. Notarized affidavit of undertaking stating that the imported product/s does not contain any banned ingredient/s and is intended solely for own consumption and not for marketing nor for commercial or wholesale distribution. c. Copy of bill of lading, invoice and packing list. d. Proof of payment of Php 510.00. Kindly submit documents during office hours from Monday - Friday at the FDA office in Alabang, Room 106, Annex Bldg., Filinvest Corporate City. Application shall be processed by the FDA within five (5) working days. Once application is lodged, the FDA will issue a Document Tracking Number and applicants will be able to check the status of their application through the FDA website. [Reference: FDA MC 2015-006] Can we apply for a BoC Clearance from the FDA annually instead of a per shipment basis? 6. PEZA is working with the FDA to streamline the requirements for registered enterprises especially those who frequently import HUHS. The FDA be issuing guidelines to enable this. To ensure that said guidelines will be responsive to the needs of the stakeholders, we will need your support to back up your claims. Thus, please write a letter to PEZA requesting for an expanded BoC Clearance for the release of HUHS with the following information: a. Material Safety Data Sheet of the HUHS; b. Frequency and volume of importation per month of HUHS; and, c. Brief description of how the HUHS is used in the PEZA-registered activity with a declaration that the HUHS does not contain any banned ingredient/s and is intended solely for own consumption and not for marketing nor for commercial or wholesale distribution. You may visit the PEZA Zone Office or email esg@peza.gov.ph for assistance. For information and compliance.