All concerned stakeholders may submit comments in MSWord Format via email to [email protected] with copy furnished to [email protected] on or before 30 April 2022 using the format below:
I. RATIONALE
Administrative Order (AO) No. 2014-0029 was issued on 08 September 2014 to effectively strengthen the food control system and implement risk-based food control strategies by setting the rules and regulations for the issuance of License to Operate (LTO) and Certificate of Product Registration (CPR) to food establishments.
Consistent with the objective of Republic Act (RA) No. 8792 or the Electronic Commerce Act of 2000 in promoting the universal use of electronic transactions in the government, the electronic registration (e-registration) is now being adopted to streamline the application and evaluation process for registration of processed food products.
In view of the passing of Republic Act (RA) No. 11032, otherwise known as the Ease of Doing Business and Efficient Government Service Delivery Act of 2018 has led to the issuance of FDA Circular (FC) No. 2021-012 to support the implementation of the eServices Portal System for LTO application of Food Establishments and FC No. 2020-033 which provided a more user-friendly E-Registration System attuned with the requirements of the RA No. 11032.
II. OBJECTIVES
This Order aims to:
- Amend certain provisions of AO 2014-0029 in the licensing of food establishments and registration of food products to adopt the new system of application aligned with existing national laws, programs, policies and consistent with adopted international standards and best practices.
- Comply with the objectives of RA No. 8792 or the “Electronic Commerce Act of 2000” and any other relevant laws.
- To align with the requirements of ASEAN Sectoral Mutual Recognition Arrangement (MRA) for Inspection and Certification Systems on Food Hygiene for Prepared Foodstuff Products.
III. SPHERE OF APPLICATION
This Administrative Order shall not cover fresh or raw food derived from plant, animal, fisheries and aquaculture products or foods in the primary production and post-harvest stages of the supply chain which are under the regulatory jurisdiction of the Department of Agriculture. However, consistent with the ASEAN Harmonized Tariff Nomenclature, products which undergo pre-treatment process after post-harvest, i.e. brining, smoking, including physical preparation such as cutting and trimming (reduction of extraneous materials such as peels, stems, fins & scales, or other non-edible parts) which may significantly alter the original nature of the food product after harvest and post-harvest treatment, shall be under the jurisdiction of the FDA. This shall not cover imported and locally produced foods in the primary production and post-harvest stages of food supply chain including minimal transformation of plant and animal foods after primary production such as removal of field heat for fruits, slaughter of animals, sorting, grading and cutting of fresh plant and animal foods, icing and freezing, and milling and storage of grain which are under the jurisdiction of Department of Agriculture.
This Administrative Order shall cover imported and locally produced processed and prepackaged foods under the jurisdiction of the FDA as defined in the RA 10611 or the Food Safety Act of 2013.
This shall also not cover Food businesses such as, but not limited to, activities in slaughter-houses, poultry dressing plants, fish ports, wet markets, supermarkets, school canteens, restaurants without manufacturing activity of prepacked foods, catering establishments, water refilling stations, street food sale, including ambulant vending, food kiosk of prepared foods, which are under the purview of the Local Government Unit (LGU).
IV. DEFINITION OF TERMS
The Definition of Terms is specified in Annex A of this Issuance.
V. GUIDELINES
A. Guidelines for Licensing of Food Establishments
- General Principles
a. Classification of establishments based on activities shall be defined by the current issuance from the Food and Drug Administration. The FDA shall issue authorization to food business operators based on compliance with current guidelines on food hygiene and risk classification of food products. Risk classification of food products (Annex B) shall be updated by FDA subject to prior consultation with stakeholders.
b. All FDA-covered food business operators shall:
i. secure a License to Operate (LTO) before engaging in food manufacturing, importation, exportation, sale, offer for sale, distribution, transfer and where applicable the use, testing, promotion, advertisement, and/or sponsorship of food products.
ii. comply with the general principles of food hygiene including general requirements on sanitation, and as appropriate for the food business operator, comply with the relevant standards and requirements of the Code of Good Manufacturing Practice (GMP), HACCP, Good Storage Practice (GSP), Good Distribution Practice (GDP), or the Sanitary Standard Operating Procedures (SSOP) to ensure safety and quality of products.
iii. comply with relevant laws that address the nutritional quality of food and food products, such as the RA 8172 (ASIN Law) and RA 8976 (Food Fortification Act).
iv. comply with the provisions of RA 9711, RA 10611, RA 3720 as amended by E.O. 175 (Foods, Drugs and Devices, and Cosmetics Act), RA 7394 (Consumer Act of the Philippines), and Presidential Decree No.856 (Code on Sanitation of the Philippines) to ensure food quality and safety.
v. comply with the regulatory requirements of the importing country before engaging in food export; and
vi. allow inspection of their premises to verify compliance based on existing requirements.
c. The activities allowed under a single license are summarized in Table 4 under Annex C.
d. All applications for a License to Operate shall be accepted by the FDA only when all the requirements including payment of prescribed fees have been completed.
e. An entity, natural or juridical person, applying for LTO as a food manufacturer, distributor, importer, exporter, wholesaler, trader or repacker shall be issued the LTO per establishment, regardless of the ownership, only when they have complied with all the necessary requirements and if consistency in manufacture and/or distribution of safe and quality products are demonstrated.
f. Food business operators shall first apply for an initial LTO following the existing licensing requirements and prescribed fees as per current FDA regulations.
g. Application for initial CPR shall be filed once the FDA-LTO is approved.
h. The LTO and CPR shall be a requirement before a food establishment can join food trade and exhibitions, market research or testing of unregistered processed food products. For foreign exhibitors may join local food expositions or exhibit prior issuance of an LTO to their consignees. Note, however, that the sample of the products imported for the exhibition shall be secured with BOC Clearance by complying with the requirements listed in Annex F of this order.
i. Applicants must prove their capability and capacity to assure food safety and quality through compliance with GMP, GDP, GSP, HACCP, and/or other food industry best practices recognized by the Food and Agriculture Organization of the World Health Organization, as appropriate.
j. All FDA-licensed food establishments shall be primarily responsible for determining the regulatory requirements of the importing country before engaging in food export.
k. Only one licensed establishment shall operate at a given address or facility. Establishments engaged in the same activity are not allowed to share the same address or facility, regardless of ownership.
l. The inclusion of virtual offices shall be allowed only when coupled with a physical address.
m. For affiliated companies with different activities, sharing of facilities may be allowed provided that each establishment shall secure a license accordingly.
n. Valid LTO shall be displayed in a conspicuous place in the establishment or business office or premises. Failure to display the valid LTO shall be grounds for revocation of the LTO.
o. Changes of Business Information of the establishment, such as but not limited to: location, business name and owner, additional or reduction in the product lines, inclusion or deletion of any activities/products shall prior notification to FDA by filing an application for LTO variation.
p. For assignment and transfer of pending applications, existing licenses, if there is a change in ownership while the application is in process, the application shall be considered terminated. The new owner or the new regulatory officer shall file for initial application.
q. For licensed establishments with revoked/ cancelled/ suspended LTO resulting from violations as stated in this Order and/or in RA 9711 and/or other relevant food regulations, after due process, shall not be allowed to re-apply for a new LTO using the same company/owner/business name for a period of three (3) years.
2. Specific Guidelines for Manufacturers including Traders
a. A single LTO shall be issued to manufacturing plants in different locations within the same municipality/city producing a single product at different processing stages indicating their respective addresses. In this instance, the principal office address shall be reflected at the front page of the LTO while the other address/es at the back page thereof or secondary page appended thereto.
b. A food manufacturer producing different products at different locations within the same municipality/city shall be issued separate licenses for each location.
c. Imported and locally-sourced raw materials covered by RA 8976 and its IRR, and RA 8172 for own use of manufacturers shall comply with the requirements such as results of analysis and other documents as deemed necessary.
d. A licensed salt manufacturer or repacker may engage in manufacturing or repacking of other food products within the same address under a single license. Similarly, a licensed food manufacturer or repacker may engage in manufacturing or repacking of iodized salt and distribute it accordingly, subject to compliance of technical requirements and subsequent monitoring.
e. Manufacturers may engage in any activity it is able to satisfy the requirements for, including processing;
f. Packer or Repacker may engage in any activity it is able to satisfy the requirements for, except processing.
g. For bottled drinking water, the standards and GMP requirements as stated in Administrative Order No.18-A s.1993 or its amendment shall be followed.
h. A food business operator without a food manufacturing facility and contracts the services of a licensed food manufacturer to toll-manufacture its products shall secure an LTO as Trader.
i. A trader may engage in any activity it is able to satisfy the requirements for, except processing or packaging.
3. Specific Guidelines for Distributor (Importer/Exporter/Wholesaler)
a. Food distributors (importer, exporter, and/or wholesaler) utilizing or sharing one office with another establishment shall not be allowed regardless of ownership. For establishments using the same location, further distinction as to room/unit/level/ or building number shall be specified in the address.
b. For distributors, all warehouses and depots shall be declared in the LTO.
c. Importers shall comply with the applicable law, rules and regulations. Importers of raw materials covered by RA 8976 and its IRR, and RA 8172 shall comply with the requirements prior to importation.
d. A distributor (importer, exporter or wholesaler) may engage in manufacturing or repacking provided that an LTO as manufacturer or repacker is secured.
e. Exporters should satisfy the requirements of the importing country prior to export.
f. Distributors (importer, exporter, wholesaler) engaged in online distribution using internet-based platform shall secure applicable LTO prior to engaging in importation, exportation, sale, offer for sale, distribution, transfer, and where applicable, using, testing, promoting, advertising, and/or sponsorship of food product/s.
g. A consolidator/indenter/middleman engaging in any distributor activity except limited to representation shall likewise secure an LTO as distributor.
h. Distributors with a license for a specific activity may engage in other distributor activities it is able to satisfy the requirements for.
i. Distributors activities may be applied for by a manufacturer or distributor, at the same time as the license or later added as an amendment after licensing
4. Inspection and Certificate of Compliance
a. The FDA-Regional Field Office (RFO) will verify documentary requirements based on current licensing requirements submitted during the filing of application and technical documents based on guidelines on food hygiene during inspection prior to issuance of a License to Operate as a Food Manufacturer.
b. Manufacturers shall be subjected to pre-licensing inspection following the FDA quality manual. All other establishments shall be inspected at any time within the validity of its LTO.
c. A certificate of compliance (COC) shall be issued following a risk-based approach or HACCP depending on the level of risks and complexity of production, among others.
d. Recommendation letter (RL) may be issued to establishments instead under the following conditions:
i. The establishment is applying for renewal provided that the criteria stated in RA 9711, Book II, Art. I Sec.3. A. (2) are duly satisfied.
ii. The establishment is applying for variations that does not require inspection.
If the licensed establishment is not inspected or fails to conform with existing rules and regulation upon inspection within the validity of its LTO, the establishment is not qualified for its automatic renewal. In addition, a GMP Certificate, requiring at least one year of operation in good standing, is likewise disqualified.
e. The FDA reserves the right to conduct inspection of food establishments for any of the following purposes: routine; spot check; post-market surveillance of products; or action on any report of food-borne illness or complaints received by FDA. Upon validation of non-compliance to FDA safety and quality standards, the FDA CFRR Director shall revoke the LTO and CPR immediately, following due process.
f. For warehouse/s in location/s other than the address covered by the issued LTO, the concerned RFO shall coordinate with respective regions to forward a copy of the inspection report per warehouse address/es. Addition of warehouse and/or cold storage shall be filed as a LTO variation and is subject to inspection depending on the risk of the products.
g. The FDA may conduct inspections in collaboration with the LGUs and any agency or office under the DOH, DA and DILG.
5. Requirements
The requirements for issuance of LTO and its amendments are specified in Administrative Order No. 2020-0017 “Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003” or its latest amendment.
6. Validity of the LTO
a. Unless revoked, the LTO shall have the following validity period:
i. An initial license issued shall be valid for two (2) years; and
ii. A renewal license shall be valid for five (5) years.
7. Process of Application
The process of application is as prescribed by current FDA regulations and shall be guided by the following:
a. A Certificate of Compliance (COC) per post-inspection, or Recommendation Letter (RL) if post-licensing inspection applies, shall be issued by the FDA inspectorate in the respective regions. Should a site inspection or pre-licensing inspection be required, the inspection shall be scheduled with the applicant before the COC is issued.
b. However, in the course of RFO evaluation, monitoring, inspection and spot checking, upon finding of any violation in the compliance and other requirements by the FDA and its implemented laws, such as the FDA Act of 2009 and other relevant laws, the RFO shall submit a report of violation to serve as basis for the motu propio action of the Director of the Regional Field Office;” as per Book 1 Article VIII of the IRR of RA 9711 under Section 7 (g). Hence, the RFO upon verification/inspection that the food establishment has not complied with the requirement has the power to recommend for disapproval and sign the proper action by the Director of the RFO.
c. Approval or disapproval of applications with COCs shall be signed by the Director of the Center for Food Regulation and Research under the authority of the FDA Director General.
d. The notice of disapproval of applications for license shall clearly state the reason for disapproval.
B. Guidelines in the Registration of Processed Food Products
- General Principles
a. All processed food products including food additives, food supplements (FS) and bottled water, shall first be registered with the FDA before these are distributed, supplied, sold or offered for sale or use and advertised, among other marketing or promotional activities.
b. Only one (1) Certificate of Product Registration CPR shall be issued to a product that has multiple packaging sizes provided that it meets all of the following conditions:
i. The same brand name;
ii. The same product name/ variant;
iii. The same product formulation/ same ingredients in the same order of proportion; and
iv. The same label information, except net weight.
c. Likewise, regardless of the packaging sizes, only one (1) CPR shall be issued to a product that has labels with multiple models and/or multiple suggested recipes on the pack provided that it meets all of the following conditions:
i. The same brand name;
ii. The same product name/ variant;
iii. The same product formulation/same ingredients in the same order of proportion; and
iv. The same label information except net weight.
d. The company should secure permission from the FDA through amendment applications (i.e. additional packaging design) for any additional label design or other label changes prior to use in advertisement, promotion, and commercial distribution.
e. Should a product fail to meet the requirements for product registration, applicable product standards, and labeling regulations, a Letter of Denial shall be sent electronically through the e-registration system and through registered email. A maximum of six (6) months shall be given to comply and file for re-application. Beyond this date, it shall be treated as INITIAL and the prescribed fee shall be paid.
f. All product applications shall undergo pre-assessment to determine completeness of the submitted documentary requirements based on the issued guidelines for pre-assessment or its amendment thereof.
g. Food establishments with License to Operate (LTO) activity as Importer/Distributor, Trader, and Manufacturer shall be regarded as the Market Authorization Holder (MAH). The MAH shall be primarily responsible for the filing of CPR applications using its own account, ensuring quality and safety and continued compliance of the product with applicable rules and regulations of the FDA.
h. CPR shall be secured by the respective distributor, trader, exporter, repacker or manufacturer for each imported and locally manufactured raw materials, ingredients and food additives which are intended to be sold, offered for sale or use or for distributed to other food establishments and food business operators for further processing and/or for institutional use.
Food manufacturers or traders who directly import raw materials, ingredients, and food additives to be used for the production of their own products or by their toll-manufacturers need not secure a CPR provided that their LTO has an approved activity as an importer of raw materials for their own use. The finished products that use these imported raw materials shall be registered with the FDA.
i. Should the FDA-licensed food manufacturer/importer use or source out local ingredients and food additives, it shall be purchased from FDA-licensed establishments.
j. The registration requirements for food establishments intending to export products are the same. However, food establishments with the intention to export shall comply with all the regulatory standards and requirements of the importing country, including the labelling requirements.
k. A previously registered product initially for local distribution shall be allowed to be exported using the same CPR as long as the following conditions are met and labelling and standards of the importing country are likewise met:
i. The same brand name;
ii. The same product name/ variant;
iii. The same product formulation/ same ingredients in the same order of proportion; and
iv. The same label information except net weight.
Filing of amendment applications (i.e. additional packaging design) to FDA shall be made and labels in the language of the importing country shall likewise be submitted.
l. Only food additives listed in the latest Codex Stan 192-1995 known as the General Standards for Food Additives (GSFA) and/or the latest FDA Listing of Food Additives and/or approved pharmaceutical excipients list intended for processed foods products including FS in pharmaceutical dosage form such as tablet, soft gel capsule and capsule shall be issued a CPR.
m. Validity of CPR will be 2 years minimum to 5 years’ maximum for initial and 5 years for renewal; provided that upon renewal, its MAH conforms with the pertinent standards and requirements including labeling regulations.
n. The FDA may require additional documents on products that are considered high risk food provided that the reason for the additional requirements is to address uncertainties on safety as deemed necessary to ensure quality and safety.
i. For medium and high risk food products including for “institutional use only” with standard of identity (e.g. Infant Formula, Milk Supplement, Foods for Infants and Young Children, Foods for Special Medical Purposes, Foods for Special Dietary Uses, FS, bottled water, etc.), the corresponding Certificates of Analysis for assessment of compliance to such standards must be uploaded. In addition, these products should conform to the chemical and microbiological parameters and nutritional requirements based on existing Codex standards, national and FDA regulations.
o. In case there is a health issue other than the growth of pathogenic microorganisms or other food safety related incidents (e.g. chemical contamination or adulteration), FDA has the option to impose other requirements through regulatory issuances.
p. In addition to the requirements in the proceeding sections, the FDA may conduct inspection of the manufacturing or processing plant or verification of documents submitted or may require additional documents or evidence to ascertain the safety and/or quality of the product.
q. If the company has several plants in one or different cities/towns/provinces manufacturing the same product, each plant shall apply for separate registration of the product.
2. Quality and Safety Standard
a. Food products shall be evaluated based on the technical documents submitted for safety and quality. Only those food establishments with products that have complied with the requirements and meet the standards for food safety, quality, and labeling, including relevant standards set by the FDA/Codex for specific food categories, as applicable, will be issued a CPR.
b. All processed and prepackaged food products shall comply with the relevant appropriate/ applicable quality and safety standards, if any.
c. Imported food products must come from countries with an equivalent food safety regulatory system with the FDA. Hence, the following are hereby recognized as equivalent:
i. Certificate of Registration with GMP Compliance or its equivalent
ii. Valid Sanitary Phyto-Sanitary Certificate or Health Certificate
iii. ISO 22000 Certificate or FSSC Certificate
iv. HACCP Certificate
v. Certificate of Free Sale
d. All certificates of analysis submitted must be issued within twelve (12) months from the date of filing of the application or the date of payment.
e. For FS, the physical, chemical, and microbiological analysis, Stability Data of the finished product and Safety Data (e.g. LD50 or toxicity tests as applicable to products with herbs and botanical ingredients not included in Official Pharmacopoeias and Generally Recognized as Safe (GRAS) list or other applicable test procedures or reports to assess potential toxicity) must be attached to establish safety and/or address uncertainties on safety of the product.
f. For food products covered by Republic Act No. 8172 otherwise known as “An Act for Salt Iodization Nationwide (ASIN)” and Republic Act No. 8976 or the “Philippine Food Fortification Act of 2000”, the Certificate of Analysis attesting its conformity to prescribed fortification levels must be uploaded. Levels of iodine must conform to the latest acceptable level of fortification based on FDA Circular 2013-007 or its amendment.
3. Product Claims and Labeling
a. Except for FS, no food samples shall be submitted to the FDA provided that the labels of primary and secondary packaging (if any) are clear and bear the complete label information.
b. Food supplements shall not have curative claims or therapeutic claims. Other claims shall be reviewed in accordance with existing and relevant labeling guidelines.
c. Advertising and promotional materials of food establishments and food business operators shall not make curative or therapeutic claims.
d. Nutrition and Health Claims declared on the product labels must be supported by relevant documents (e.g. scientific research, etc.) following Bureau Circular 2007-002 (Guidelines in the Use of Nutrition and Health Claims in Food).
e. Label Exhaustion (e.g. Labels of products covered by Milk Code reflecting the old FR Number) can be requested provided that there is a letter of justification and the inventory with the target date for consumption is clearly stated. Approval of such a request shall be subject to review. Request for label exhaustion shall not be considered for food products with an issued Report of Violation by the FDA.
f. In cases of exhaustion of existing labels permitted by the FDA, the use of a provisional sticker label shall only be allowed for a maximum period of 6 months. All information should be accurate and legible. The sticker must be durable, i.e. cannot be easily removed from the label or packaging.
4. Requirements
The requirements for issuance of Certificate of Product Registration and its amendments are specified in Annex E of this Issuance.
5. Validity of the Registration
Unless revoked within the validity period, the CPR shall be valid for 2 years minimum to 5 years maximum for initial (except for FS) and 5 years for renewal. Maximum years of validity for initial registration of FS shall be based on A.O. 50 s. 2001 or the latest.
6. Registration Process
The procedure for CPR application shall follow the Electronic Registration System as prescribed in FDA Circular 2020-033 “Procedure for the Use of Electronic Registration System for Prepackaged Processed Food Products” or its latest amendment thereof.
7. Grounds for Disapproval of Applications
The following shall be grounds for disapproval of an application:
a. Failure to submit complete documentary requirements.
b. Failure to meet the appropriate standards, existing rules and regulations, guidelines or requirement documents or inspection of the food establishment’s offices and premises.
c. Failure to respond to notice of deficiency or to submit documents within prescribed timeline.
d. Misrepresentations, false entries, or withholding any relevant data contrary to the provisions of the law, these Rules and Regulations or appropriate standards.
e. Such other analogous grounds or causes as determined by the FDA.
D. Fees and Other Charges
Initial and renewal application fees and other charges shall be collected as may be allowed by the existing rules on fees and charges or surcharges.
E. Post-Market Surveillance and Product Monitoring
Post-Market Surveillance and product monitoring shall be conducted by the FDA based on the risks presented by food products. Samples of products shall be collected for testing, and routine or spot checking of food establishments shall be conducted on a regular basis. Food-borne illnesses and epidemiological data shall be studied as a basis for planning or instituting measures to reduce food-borne outbreaks. Risk communication in collaboration with other stakeholders shall be heightened to reduce the risk of food borne illnesses brought about by food products. Risk management plan or food safety plan as well as attendance to food safety seminars or training shall be required food business operators to ensure continuous compliance with food safety standards.
VI. PENALTY CLAUSE
Any establishment or processed prepackaged food product found to be in violation of any provision of this issuance shall be a ground for disapproval of application, suspension, revocation or cancellation of LTO, CPR or any authorization pursuant to Section 4, Article 1, Book II of the Implementing Rules and Regulations (IRR) of RA No. 9711.
Notwithstanding the preceding paragraph, nothing in this section shall restrict the FDA in imposing the penalty and sanctions as prescribed under RA No. 10611 and its IRR.
VII. SEPARABILITY CLAUSE
If any part or provision of this Order is rendered invalid by any court of law or competent authority, the remaining parts or provisions not affected shall remain valid and effective.
VIII. REPEALING CLAUSE
Administrative Order No. 2014-0029 or the “Rules and Regulations on the Licensing of Food Establishments and Registration of Processed Food, and Other Food Products, and for Other Purposes” and other related issuances inconsistent or contrary to the provisions of this Administrative Order are hereby repealed, amended, or modified accordingly.
IX. EFFECTIVITY
This Order shall take effect fifteen (15) days from the date of its publication in the Official Gazette or in any national newspaper of general circulation, with three (3) certified copies to be filed with the Office of the National Administrative Register (ONAR) of the UP Law Center.