Food establishments that manufacture, import, export, and sell food products are required to have a license to operate.

The food business is one of the most popular choices for entrepreneurs. Numbers from Statista show that the revenue in the food market is expected to reach $138.40 billion (approximately PHP 8.08 trillion) this year. The food service sector, in particular, is expected to grow in the next few years. The revenue of the food service sector, which was worth PHP 643 billion in 2023, is predicted to reach the one-trillion mark by 2027.

Given these figures, it is not difficult to understand why aspiring entrepreneurs gravitate towards starting a food business to kick off their entrepreneurial journey. While many opt to start with an online food business, others opt to have a brick-and-mortar store in the form of restaurants, cafes, bars, and many more. 

Setting up this kind of business needs different permits from the government. One of which is a license to operate (LTO) from the Food and Drug Administration (FDA). According to FDA, the LTO is “an authorization issued by the FDA to an establishment to grant permission to undertake a trade or carry out a business activity, such as manufacturing, importation, exportation, sale, offering for sale, distribution, or transfer of food products.”

Food establishments that wish to operate legally are required to have an LTO. But how should entrepreneurs go about applying for one? 

Documentary Requirements 

Administrative Order (AO) 2020-017, otherwise known as the Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order 2016-0003, issued by the Department of Health (DOH) requires documentary requirements for LTO applications to be uploaded using the e-Portal. 

The following documentary requirements should be submitted as part of the application process:

• Application Form (web-based form)
  • Location Plan
  • Global Positioning System (GPS) coordinates
  • Name of the Qualified Person
• Proof of Business Name Registration
  • Single proprietorship – Certificate of Business Registration issued by the Department of Trade and Industry (DTI)
  • Corporation, Partnership, and other Juridical Person – Certificate of Registration issued by the Securities and Exchange Commission (SEC) and Articles of Incorporation
  • Cooperative – Certificate of Registration issued by the Cooperative Authority and Articles of Cooperation
  • Government-owned or controlled corporation – Law creating the establishment, if with original charter, or its Certificate of Registration issued by SEC and Articles of Incorporation, if without original charter.
• Business Permit
  • Should the establishment’s address be different from the business name registration address, a copy of the Business Permit or Mayor’s Permit must be submitted.
• Proof of Capital or Income such as the latest audited Financial Statement with Balance Sheet (in PDF format) 

In addition, the following documents must be presented to the FDA inspector for review when required: 

• Risk Management Plan (required for medium and large food manufacturers, traders, and distributors
  • This includes importers, exporters, and wholesalers
• Site Master File (required for those as manufacturers of large and medium food manufacturers)

For food traders and distributors, additional requirements may be requested as needed in compliance with FDA Circular No.2021-012. These additional requirements are as follows:  

• Franchise agreement
• Contract of agreement 

Application Process for Food Manufacturing

The application varies depending on the nature of the business the applicant is applying for. For food manufacturing businesses, the applicant must request for a user account by sending an email to [email protected]. The following format must be followed:

SUBJECT: Request for eLTO User Account

BODY:

a) Email address (preferably company email address)

b) Name of the Authorized company representative (preferably permanently employed and not merely a consultant)

c) Position in the company

d) Contact Number

E) Company Name

As an attachment, a notarized Authorization letter for the eLTO User Account Application must be included. For reference, refer to ANNEX B of FDA Circular no. 2016-004. 

After a user account and password has been issued, the applicant may now proceed with the application process through the e-Portal. 

Application Process for Food Distributors and Traders

For food distributors and traders, the application process is also done through the e-Portal system. Food distributors and traders need not request for account and password creation. Instead, the applicant must declare its email address in order for the system to automatically send notifications to the provided address.

It should be noted that this email address cannot be changed. It likewise must be accessible to the company’s authorized person/s, qualified personnel and/or the actual owner of the establishment.