Chapter 1 Food regulatory information in the Philippines

1. Eaa and Introduction

In the Philippines, the Department of Agriculture (DA) is responsible for regulating imported fresh or primary produced foods, while the Department of Health (DOH) is responsible for regulating processed foods. The Philippines Food and Drug Administration (PFDA), under the Department of Health, oversees the manufacture, import, export, distribution, sale, and transfer, promotion, advertising, sponsorship, or testing of food and food/dietary supplements. It is also responsible for conducting research on food safety, efficacy and quality, and developing standards related to food safety and quality.

2. Supervision and regulation

REPUBLIC ACT NO. 9711,2009   

Derpartment circular No.2011-0101

Republic Act No.10611,2013

Republic Act No.8976,2000

Republic Act No.7394

3. Philippine food classification

The Philippines classifies food into three categories based on risk: low risk food, medium risk food and high risk food. Vitamin and mineral or amino acid foods/dietary supplements are classified as medium risk foods, and the remaining types of foods/dietary supplements and other special foods are classified as high risk foods.

4. Entry requirement

• LTO and contact information

• Quality system certificate (GMP or ISO 22000, HACCP)

• Complete ingredient recipe, label

• Product pictures from all angles and different package sizes

• Claim supporting evidence

• Information about trademarks, manufacturers, importers, etc

• Sample, COA, stability data, safety data, etc
  

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5. Registration language 

English or Filipino, or a combination of both.

6. Philippine LTO

An LTO, or Operating license, is an authorization issued by the PFDA to a business to grant a license to conduct trade or conduct commercial activities, such as the manufacture, import, export, sale, offer for sale, distribution, or transfer of processed foods. It is a required qualification for food importers, distributors, traders and manufacturers in the Philippines. The acquisition of LTO certificate requires the verification and approval of enterprise registration compliance, personnel qualification training, quality management system and other aspects.

Chapter 2 Registration process, cycle & Government fee

1. Registration flow chart

2. Registration period and official fees

It usually takes 114 natural days to complete the registration.

If the data is rejected, a new application must be made within 57 natural days, and the process will incur additional costs.

Chapter 3 FAQ 

Q：How much does an Operating License (LTO) application cost? How long is it valid?

A：The cost of applying for the LTO varies according to the application, the general food distributor (importer, exporter, wholesaler) is 8,080.00 (valid for 2 years) for the first application, and is renewed to 20,200.00 (valid for 5 years).

Q：Which products are required to obtain a Philippine Product Registration Certificate?

A：According to RA 9711 and A.O. 2014-0029, manufacture and/or distribution (i.e., import, export and/or wholesale local distribution) of all processed foods and foodstuffs for trade and/or repackaging, including food additives, food supplements and bottled water, A certificate of product registration is required prior to sale, offer for sale or use, distribution or supply, and other marketing and promotional activities.

Q：Does Philippine Food Registration need to send product samples to PFDA?

A：Only the initial application for a food supplement is required to submit a sample consistent with the registration application.

Q：What are the requirements for registration of food supplements?

A：The same requirements as those set out in Executive Order 2014-0029 for traditional foods, but with the addition of stability studies, Certificate of Finished Product Analysis (COA), and safety data, if applicable (e.g. LD-50 toxicity test). It is suitable for food supplements containing herbs not listed in any official pharmacopoeia and substances for which safe levels have not been determined.

Q：What information should a shelf life study contain?

A：Stability data for shelf life studies should include: Conclusion parameters and method declaration Product name, batch number, production date, analysis date, physical and chemical aspects of tabular data and results as well as the names and signatures of QA analysts and QA managers. PFDA accepts the results of actual and accelerated shelf-life studies. If a shelf-life study is ongoing, test results of at least 6 months are required.

Q：What references should be used for raw material specifications for heavy metal limits?

A：If the raw material is a specific additive, reference can be made to the FAO/WHO JECFA specification on the limits of heavy metals. Also refer to the Codex Committee on Food Chemistry for raw material specifications for heavy metal limits.

Q：If the product label has changed, but there is already a Certificate of Product Registration (CPR), how do I apply for the revised label?

A：A request for modification to CPR (Change/Add label design) is required. You will need to upload a note explaining the changes made to the label and the revised label. An administrative fee of 210.00 Pesos must be paid.

Q：Can I label imported products in English when applying for CPR？

A：Agreed. Stickers are allowed, provided they are durable and not easy to tear off. The label information shall be printed on the remedial sticker of the label itself and will only be allowed to be used for 6 months from the date of approval.