Please be informed that the initial draft was first posted for comments on 07 April 2022. However, there are updates that were included after series of meetings with several concerned FDA offices and government offices. Thus, the CFRR requested the reposting of the attached draft Administrative Order entitled “New Rules and Regulations on the Authorizations Covering Food Business Operators and Processed Food, and Other Food Products Repealing Administrative Order 2014-0029”. All concerned stakeholders may submit comments in MSWord format via email to [email protected] on or before 05 May 2023.
I. RATIONALE
Administrative Order (AO) No. 2014-0029 was issued on 08 September 2014 consistent with Republic Act No. 10611 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 likewise 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.
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 this law.
Further, the signing of Mutual Recognition Arrangement for Inspection and Certification Systems on Food Hygiene for Prepared Foodstuff Products (MRA on PF) on 27 April 2018 enabled the mutual recognition of inspection and certification systems on food hygiene with regard to the production, import and export of prepared foodstuff products in order to facilitate trade in ASEAN and protect the health of consumers. Thus, updating the rules and regulations on the licensing of establishments and registration of food products are promulgated under this Order.
II. OBJECTIVES
This Order aims to Repeal AO 2014-0029 and other related issuances in the licensing of food establishments and registration of food products to address emerging concerns and to be abreast with internationally acceptable standards.
III. SCOPE OF APPLICATION
This Administrative Order shall cover all Food Business Operators (FBOs), and imported and locally produced processed and prepackaged foods under the jurisdiction of the FDA as aligned with RA No. 10611 and its IRR.
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, retailers, school canteens and restaurants without manufacturing/repacking activity of prepacked foods, catering establishments, water refilling station businesses, 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
1. 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 license on food business operators based on compliance with current guidelines on food hygiene and risk classification of food products.
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), Hazard Analysis Critical Control Point (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 the applicable provisions of RA No. 9711, RA No. 10611, RA No. 3720 as amended by E.O. No. 175, RA No. 7394, and Presidential Decree No.856 to ensure food quality and safety. Those that are engaged in manufacturing, importing, distributing or wholesaling of covered food products that are required to address nutritional needs shall, in addition to the foregoing laws, comply with specific law, such as RA No. 8172 (ASIN Law) and RA No. 8976 (Food Fortification Act), among others including any rules issued pursuant thereto.
iv. comply with the regulatory requirements of the importing country before engaging in food export; and
v. 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. If the establishment is importing processed food products that will be packed/repacked locally, the establishment shall secure an LTO as a Repacker/Importer of Raw Materials for Own Use.
f. Product bundling activity without re-labelling and repacking of imported and local food products, for promotion purposes may be allowed provided that they secure an LTO as Repacker. Manufacturers doing bundling activity need not apply for a separate license as Repacker provided that they declared the bundling activity during inspection.
Products that are allowed for bundling are those products with at least a 6-month expiration period except those with short shelflife (i.e. breads, softdrinks, etc.).
g. Stickering for additional information such as name & address of importer and language translation on labels is likewise an allowed activity for the licensed food distributor.
h. Food business operators shall first apply for an initial LTO following the existing licensing requirements and prescribed fees as per current FDA regulations. Once the FDA-LTO is secured, the initial CPR application shall be filed.
i. 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.
j. Food business operators shall first apply for an initial LTO following the existing licensing requirements and prescribed fees as per current FDA regulations.
k. Application for initial Certificate of Product Registration (CPR) shall be filed once the FDA-LTO is approved.
l. LTO is a requirement before a food establishment can join food trade and exhibitions, conduct market research or testing of unregistered processed food products.
m. Imported food products intended for market research or testing may be allowed provided that they secure an Import Permit for Samples and comply with the requirements thereof as cited in Annex F of this issuance.
n. Foreign exhibitors may join local food expositions or exhibit prior issuance of an LTO to their consignees provided that there will be no selling or commercial distribution. Note, however, that the sample of the products imported for exhibition purposes shall secure BOC Clearance by complying with the requirements listed in Annex G of this issuance.
o. CPR shall be required if the imported product is offered for sale or for “free tasting” during the food trade and exhibitions.
p. 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.
For affiliated companies (i.e. subsidiaries) as justified with supporting documents such as with different activities, sharing of facilities may be allowed provided that each establishment shall secure a license accordingly.
q. The inclusion of virtual offices shall be allowed only when coupled with a physical address.
r. For affiliated companies with different activities, sharing of facilities may be allowed provided that each establishment shall secure a license accordingly.
s. Valid LTO shall be displayed in a conspicuous place in the establishment or business office or premises.
t. For changes of Business Information, no change in the previously approved circumstances of the application 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 be effected unless with prior notification to, and approval by FDA through amendment.
u. For licensed establishments with revoked or cancelled 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.
v. The processing timeline for LTO shall follow the FDA Citizen’s Charter 2022 and its latest revision.
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 amended version 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 a 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. Any establishment applying for a license to the FDA as a Food Distributor (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 the address should have a distinction as to room/unit/level/ or building number shall be specified.
b. For offices of distributors, all warehouses and depots shall be declared. Sharing of offices by different distributors shall not be allowed.
c. A distributor (importer, exporter or wholesaler) may engage in manufacturing or repacking provided that an LTO as manufacturer or repacker is secured.
d. 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.
i. A consolidator/indentor engaging in any distributor activity likewise shall secure an LTO as importer or distributor and CPR for processed food products, except for brokers and/or shipping firms that act as a representative only for or on behalf of the company.
ii. A processed food intended for export shall at all times comply with national regulations and regulations of the importing country and shall not be deemed to be adulterated or misbranded if it (1) conforms with the specifications of the foreign purchaser, (2) is not conflict with laws of the country to which it is intended for export, and (3) is labelled on the outside of the shipping package to show that it is intended for export.
iii. But if such processed food is sold or offered for sale in domestic commerce it shall comply with the provisions of this Order.
e. Distributors with a license for a specific activity may engage in other distributor activities it is able to satisfy the requirements for.
f. Distributor activities may be applied for by a manufacturer or distributor (e.g. Importer of raw materials), at the time of the license application or later added as an amendment after licensing issuance of LTO.
1. Inspection and Certificate of Compliance
a. The FDA-Regional Field Office (RFO) will verify compliance of documentary requirements based on current licensing requirements submitted during filing of application and determine conformity to technical requirements based on guidelines on food hygiene during inspection prior to issuance of a License to Operate.
b. Pre-licensing inspection and a Certificate of Compliance (COC) shall be issued, following a risk-based approach or HACCP/GMP requirements depending on the level of risks and complexity of production, among others. The conduct of inspection shall be covered by the Quality Manual.
c. Recommendation letter (RL) shall be issued to establishments applying for automatic renewal provided that the criteria stated in RA 9711, Book II, Article I Sec.3. A. (2) are duly satisfied.
d. Food establishments classified as high risk shall be the priority for 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 (needs rationale)
e. For warehouse/s located other than the premises covered by an issued LTO, 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.
f. The FDA may conduct inspections in collaboration with the LGUs and any agency or office under the DOH, DA and DILG.
2. Requirements
The requirements for issuance of LTO and its amendments are specified in the Annex D of this Circular.
3. 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.
4. Process of Application
The process for LTO application shall follow the currently implemented Electronic System as prescribed by FDA regulations.
B. Guidelines in the Registration of Processed Food Products
1. 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/complete list of ingredients in the same order of proportion; and
iv. The same label information, except net weight.
v. The same manufacturer and manufacturing site
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.
v. The same manufacturer and manufacturing site
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/or labeling regulations, a Letter of Denial shall be sent electronically through the e-portal 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 FDA Circular No.2020-033-A Addendum to FDA Circular 2020-033, “Procedure for the Use of the Modified Electronic Registration System for Raw Materials and Prepackaged Processed Food Products Repealing FDA Circular No. 2016-014 “Procedure for the Use of Electronic Registration System for Prepackaged Processed Food Products” to include Guidelines for Pre-assessment and Reiteration of Pre-Assessment Procedures in Applying for Certificate of Product Registration for Food” or its latest revision.
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 electronic portal 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 used 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. Exportation of previously registered product initially for local distribution) 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. The FDA may require additional documents on products that are considered high risk food provided that the reason for the additional requirements based on the citizen’s charter is to address uncertainties on safety 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 shall be uploaded in the e-portal. In addition, these products should conform to the chemical and microbiological parameters and nutritional requirements based on existing Codex standards, national and FDA regulations.
n. In case there is an existing health issue such as but not limited to the growth of pathogenic microorganisms or other food safety related incidents (e.g. chemical contamination or adulteration), may be grounds for disapproval of application specified in the Section V (b) No. 7
In addition to the requirements in the preceding sections, the FDA may conduct inspection of the manufacturing or processing plant and/or verification of documents submitted or may require additional documents or evidence to ascertain the safety and/or quality of the product.
o. 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.
p. The processing timeline for CPR shall follow the FDA Citizen’s Charter 2022 and its latest revision.
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.
i. Standards shall be established on the basis of science, risk analysis, scientific advice from expert body/bodies, standards of other countries, existing Philippine National Standards (PNS) and the standards of the Codex Alimentarius Commission (Codex), where these exist and are applicable;
ii. Codex standards shall be adopted except when these are in conflict with what is necessary to protect consumers and scientific justification exists for the action taken;
b. All certificates of analysis submitted shall be issued within twenty-four (24) months from the date of filing of the application or the date of payment.
c. For FS, the physical, chemical (i.e. quantitative assay of vitamins and minerals), 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) shall be uploaded in the e-portal to establish safety and/or address uncertainties on safety of the product.
d. 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 shall be uploaded in the currently implemented FDA Electronic System. Levels of iodine shall conform to the latest acceptable level of fortification based on FDA Circular 2013-007 or its amendment.
3. Product Claims and Labeling
a. No claims, therapeutic, scientific or otherwise shall be made on the label that has not been supported by scientific evidence and duly approved by the FDA.
b. Food supplements shall not have curative claims or therapeutic claims. Other claims shall be used only upon review and approval of the FDA 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 and shall comply with the applicable rules on advertisements and promotions.
d. Nutrition and Health Claims declared on the product labels shall 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).
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 5 years for initial and renewal; provided that upon renewal, its MAH conforms with the pertinent standards and requirements including labeling regulations.
6. Registration Process
Consistent with the policy to implement a web-based software enabled registration system all registration applications shall be coursed through the currently implemented Electronic System as prescribed by FDA regulations.
7. Grounds for Disapproval of Applications
The following shall be grounds for disapproval of an application:
a. License to Operate
i. The application requirements submitted show that the establishment does not meet the required technical requirements or appropriate standards;
ii. The applicant made misrepresentations, false entries, or withheld any relevant data contrary to the provisions of the law, these Rules and Regulations or appropriate standards;
iii. The owner has violated any of the terms and conditions of its license;
iv. Such other analogous grounds or causes as determined by the FDA.
b. Authorization/Certificate of Product Registration.
i. The application requirements submitted show that the establishment does not meet the required technical requirements or appropriate standards;
ii. The applicant made misrepresentations, false entries, or withheld any relevant data contrary to the provisions of the law or these Rules and Regulations or appropriate standards;
iii. The holder or owner has violated any of the terms and conditions of its authorization or registration;
iv. The label of the health product is false and misleading or does not conform with current labeling requirements;
v. The holder or owner of the CPR/authorization, without legitimate reason fails to sell the health product or fails to cause it to be marketed during an uninterrupted period of at least three (3) years from date of issuance or renewal of the registration or the last date of operation or marketing;
vi. Such other analogous grounds or causes as determined by the FDA.
C. Fees and Other Charges
Initial and renewal application fees and other charges shall be collected based on the existing rules on fees and charges or surcharges.
D. Post-Market Surveillance and Product Monitoring
Post-Market Surveillance and product monitoring shall be based on the risks presented by food products. Samples of products may be collected for testing and verification.
Food-borne illnesses and epidemiological data shall be studied as a basis for planning or instituting measures to reduce and prevent food-borne outbreaks.
All components of Risk analysis which includes risk assessment, risk management and risk communication shall be conducted to be able to properly identify and choose appropriate preventive measures in controlling risk, and involving the stakeholders during risk communication.
Mandatory training on safe food handling and similar courses shall be implemented for food handlers of food businesses
VI. PENALTY CLAUSE
If within the 5-year validity, a violation on the product and label was monitored, there will be corresponding sanctions as indicated in Section XI of RA 9711 and CPR will be revoked/ cancelled if not complied within the period of 6 months. Food establishments will file for an initial application.
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”; FDA Circular No. 2016-007 “Notification of Sources for Raw Materials, Low Risk, Medium Risk and High Risk Prepackaged Processed Food Products”; and other related issuances inconsistent or contrary to the provisions of this Administrative Order are hereby repealed.
IX. EFFECTIVITY
This Order shall take effect after fifteen (15) days following its publication in a newspaper of general circulation and upon filing to the University of the Philippines Law Center.