How to Get FDA Approval for Food in the Philippines

If you are planning to manufacture, import, or distribute food products in the Philippines, it is mandatory to obtain approval from Philippines Food and Drug Authority (FDA).

Without the FDA approval, you cannot legally sell or distribute your food products in the country.

In this article, we’ll walk you through the steps to secure FDA approval for your food products in the Philippines.

What Food Products Require FDA Approval in the Philippines

In the Philippines, FDA approval is required for a wide range of food products to ensure safety and quality standards, including:

• Processed foods such as canned goods, snack foods, frozen meals etc.
• General food products
• Food additives
• Food supplements
• Bottled water

The Food and Drug Administration (FDA) in the Philippines issues various types of certificates depending on the product category. For food products, the FDA approval certificate is known as the Certificate of Product Registration (CPR).

It is important to note that each individual food product, including different variants, flavors, or packaging sizes, requires its own CPR.

However, if you plan on importing fresh or frozen unprocessed foods such as fresh fruits, frozen meat, fresh fish, you need to obtain approval from the Department of Agriculture of the Philippines instead of FDA.

FDA Requirements for Food in the Philippines

Following are the key FDA requirements to secure approval for food products in the Philippines:

• A valid License to Operate (LTO) as a manufacturer, importer, or distributor
• Complete CPR application form
• Clear and complete product labels
• Product photos in all packaging sizes and from all angels
• Documents to support claims on the label such as Nutritional Health Claims Halal Certification, Organic Certification, etc.
• Product sample in actual commercial presentation (for food supplements)
• Certificate of Analysis (COA) for medium and high risk products

Moreover, for high risk products such as infant formulas, dietetic foods, bottled water, etc, you might be required to provide additional documents as per FDA’s request.

Steps to Secure FDA Approval for Food in the Philippines

1. Obtain a Licence to Operate (LTO)

Before you can register your food products with FDA, you’ll need to secure a License to Operate. This license is essential for any business involved in manufacturing, importing, exporting, or distributing food products in the Philippines.

If you already have the FDA LTO as a manufacturer, importer, or distributor, you can submit the CPR application right away.

Refer to FDA License to Operate for more details.

2. Application Submission to FDA

Once you have your LTO, the next step is to submit an application for Certificate of Product Registration for each food product you want to sell.

You’ll need to compile all mandatory documents related to your product, including its composition, manufacturing process, packaging details, and more as mentioned above.

3. Pre-assessment of CPR Application

After submission, your application undergoes a pre-assessment phase. During this stage, FDA officials will review your submission to ensure all required documents are present and properly filled out.

If any document is missing or incorrect, FDA will issue a notice of deficiency and your application will be closed, potentially setting you back weeks. Based on the results of pre-assessment, companies are required to submit a new application that includes all the missing documents.

Emerhub’s local experts will gather all mandatory documents on your behalf and submit the application to ensure accuracy and avoid delays.

Once your application passes pre-assessment, FDA will issue an invoice for payment.

4. Evaluation and Issuance of CPR for Food Products

After making the payment, FDA will start a detailed evaluation of your documents. The standard time for CPR evaluation phase is 20 working days.

If your product meets all FDA requirements, you’ll receive your Certificate of Product Registration (CPR). The CPR is the official authorization to sell your food product in the Philippines.

A CPR is initially valid for 2-5 years and can be renewed for 5 years.

However, if you make any modifications to the product in terms of formulation, packaging, or the intended use, you must obtain a new certificate of registration from FDA.

Simplify Your FDA Approval Process in the Philippines with Emerhub

Want to secure FDA approval for food products in the Philippines? Emerhub will help you with that.

Our experienced local experts are well versed in FDA regulations and will handle the entire approval process on your behalf. We will gather all the required documents and apply for Certificate of Product Registration, making it easier for you to manufacture, import, export, and/or sell your products.

Fill out the form below to discuss your needs and plans with our experts.