How to Obtain an FDA LTO for Animal Feeds with the BAI

August 20, 2024

The Bureau of Animal Industry (BAI) is a government agency under the Department of Agriculture in the Philippines. It is responsible for regulating and promoting the livestock and poultry industry, including the safety and quality of animal feeds. The BAI plays a crucial role in ensuring that animal feeds distributed in the Philippines meet the necessary standards for quality, safety, and efficacy, essential for protecting animal health and, ultimately, public health.

One key regulatory requirement for businesses involved in the manufacture, distribution, and sale of animal feeds in the Philippines is obtaining a License to Operate (LTO) from the Food and Drug Administration (FDA). This license is essential for ensuring that all activities related to animal feeds comply with the legal standards set by the government, thereby safeguarding the quality of these products.

What is an FDA License to Operate (LTO)?

An FDA License to Operate (LTO) is an official document issued by the Philippines Food and Drug Administration. It authorizes a business entity to engage in activities such as manufacturing, importing, distributing, and selling products, including animal feeds, within the country. Obtaining an LTO is a mandatory requirement for companies in the animal feed industry, ensuring that they adhere to the safety and quality standards imposed by the FDA and BAI.

Prerequisites for Obtaining an LTO

Before applying for an LTO, businesses must meet several prerequisites, which include:

Registered Business Entity: The applicant must be a legally registered business entity in the Philippines, whether a sole proprietorship, partnership, or corporation. The business must be registered with the appropriate government agencies, such as the Department of Trade and Industry (DTI) for sole proprietorships or the Securities and Exchange Commission (SEC) for corporations and partnerships.
Compliant Facility: The manufacturing or distribution facility must comply with the FDA’s Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). This includes maintaining clean, safe, and properly equipped facilities.
Qualified Personnel: The business must have qualified personnel who are knowledgeable about the regulatory requirements and the technical aspects of animal feed production and distribution.
Documentary Requirements: Various documents are required, such as the business registration documents, proof of ownership or lease of the facility, a list of products, and a description of the manufacturing process.

Process to Apply for an LTO

The process of applying for an LTO involves several steps:

Prepare the Necessary Documents: Gather all required documents, including business registration certificates, facility layout plans, list of products, and qualifications of key personnel.
Create an Account on the FDA’s ePortal: Applications for LTOs are submitted online via the FDA’s ePortal system. Businesses need to create an account on this portal to begin the application process.
Fill Out the Application Form: Complete the online application form, providing detailed information about the business, its products, and its operations.
Submit the Application and Pay Fees: Once the application form is completed, submit it through the ePortal along with the required fees. Payment can usually be made online or through accredited banks.
Undergo Inspection: The FDA will schedule an inspection of the facility to ensure compliance with the necessary standards. This inspection is critical, as the LTO will not be granted without a satisfactory inspection report.
Await Approval: After the inspection and the submission of all required documents, the FDA will review the application. If everything is in order, the LTO will be issued.

Steps After Obtaining an LTO

Once the LTO is granted, businesses must follow additional steps to comply with regulations and commence operations fully:

Registration of Animal Feed Products

After obtaining an LTO, the next step is to register individual animal feed products. This process involves the issuance of a Certificate of Feed Product Registration by the BAI. This certificate is crucial as it authorizes the marketing, importation, distribution, selling, and use of animal feed products in the Philippines.

Application Process: The application for product registration includes submitting detailed information about the feed product, such as its composition, intended use, labeling, and safety data.
Evaluation and Testing: The BAI will evaluate the product to ensure it meets the safety and quality standards. This might involve laboratory testing to verify the claims made about the product.
Issuance of Certificate: If the product passes the evaluation, the BAI will issue a Certificate of Feed Product Registration, allowing the product to be legally sold in the market.

Issuance of Sanitary and Phytosanitary Import Clearance (SPS-IC)

Obtaining a Sanitary and Phytosanitary Import Clearance (SPS-IC) is mandatory for businesses intending to import animal feed products. This document ensures that the imported products meet the Philippines’ standards for protecting human, animal, and plant health.

Application for SPS-IC: The application must be submitted before importing any animal feed product. This application includes providing details about the product, its origin, and the conditions under which it was manufactured.
Evaluation by BAI: The BAI will evaluate the product to ensure it complies with the Philippines’ sanitary and phytosanitary standards. This may involve reviewing the production process and ensuring the product poses no health risk.
Clearance Issuance: The SPS-IC will be issued upon successful evaluation, allowing the business to import the animal feed product into the Philippines.

Is Assistance Available?

Obtaining an FDA License to Operate (LTO) in the Philippines for the Bureau of Animal Industry (BAI) involves a detailed process that ensures businesses comply with national standards for safety and quality. This process, though rigorous, is essential for maintaining the integrity of the animal feed industry and protecting public health. However, we can assist you.

For a faster and more streamlined process of obtaining your business operating license, it is highly recommended to enlist the help of professionals.

Triple i Consulting Inc. boasts over a decade of experience in navigating the complexities of the Philippine government system, managing government documentation, and securing business certificates and FDA LTOs. They specialize in a wide range of services, including accounting, business registration, incorporation, FDA licensing, and product registration. As the first ISO 9001:2008 certified company in the Philippines offering business registration services, Triple i Consulting is well-prepared to meet your business needs.

To arrange an initial consultation with one of our FDA compliance experts, please don’t hesitate to contact us using the following options: