FDA Issues Addendum to Circular on Procedure for Use of Modified E-Registration System for Raw Materials and Prepackaged Processed Food Products
Ma. Sophia Editha Cruz-Abrenica
Senior Counsel at Villaraza & Angangco Law Offices; Recommended Individual, Leading Patent Professional in iAM 1000 The World's Top Patent Professionals 2020, 2021, 2022, 2023 and 2024 PHILIPPINES
The Philippine Food and Drug Authority issued FDA Circular No. 2020-033-B, which was an addendum to the previously-issued FDA Circular No. 2020-033.?The addendum includes process steps for correction of the Certificate of Product Registration as well as additional guidelines in accomplishing online application form.?The amendments are for compliance with the provisions of Republic Act No. 11032, the “Ease of Doing Business and Efficient Government Service Delivery Act of 2018”.
The Circular provided definitions of the following terms:
1-?????Diamond Sangkap Pinoy Seal (DSPS) - the seal of good nutrition quality awarded as incentive to FDA-registered staple manufacturers who fortify their products according to standards.
2-?????Sangkap Pinoy Seal Program (SPSP) - a strategy to encourage food manufacturers to fortify processed foods or food products with essential nutrients at levels approved by the Department of Health (DOH). ?The seal may be used as a guide by consumers in selecting nutritious foods.
3-?????Saktong Iodine Sa Asin Seal (SISA) - to strengthen and revitalize the existing DSPS used in iodized salt labelling.
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4-?????Sweetened Beverage (SB) - non-alcoholic beverages in liquid, powder, or concentrates form, containing caloric and/or non-caloric sweetener that is added by the manufacturer.?These beverages shall include but are not limited to the following [as described in the Food Category Descriptors (Codex Stan 192-1995 Rev 2017 or the latest) and adopted by the FDA]: sweetened juice drinks; sweetened tea; all carbonated beverages; flavored water; energy and sports drinks; other powdered drinks not classified as milk, juice, tea and coffee; cereal and grain beverages; and other non-alcoholic beverages that contain added sugar.
5-?????Trans-Fatty Acids (TFA) - fatty acids with at least a double bond in the trans configuration, regardless of source, including linoleic acid.
General guidelines for accomplishing electronic registration applications are provided, including information and documentary requirements that need to be provided and uploaded.?Procedural guidelines on the application for CPR renewal are amended.?All remarks in the CPR shall be complied with prior to filing renewal applications.?Procedural guidelines for correction of the CPR were also amended, as well as guidelines for CPR cancellation.
FDA Circular No. 2020-033-B further expressly repealed FDA Circular No. 2014-022 “Notification of Registered Imported Wines with New Vintage” and FDA Circular No. 2016-007 “Notification of Sources for Raw Materials, Low Risk, Medium Risk and High Risk Prepackaged Processed Food Products”, as well as other FDA issuances inconsistent therewith.
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Experienced business development professional clinical research Phase I to Phase IV.
1 年Thnanks for sharing.