FDA Certification

I. Cosmetics Notification with the Philippine FDA

In the Philippines, the safety and quality regulation of cosmetics fall under the purview of the Food and Drug Administration (FDA). According to the 2009 Food and Drug Administration Act (Republic Act No. 9711) and its corresponding regulations, all cosmetics marketed in the Philippines—including both locally manufactured and imported products—must be registered with the FDA to ensure compliance with safety, quality, and labeling standards.

The Philippine FDA defines cosmetics as “substances intended to be applied to the external parts of the human body (such as the skin, hair, nails, lips, or teeth) for the purposes of cleansing, beautifying, enhancing attractiveness, or altering appearance,” excluding those intended to treat or prevent diseases. Therefore, while cosmetic registration differs from drug registration, it must still comply with stringent safety and labeling requirements.

Explanatory Notes on the Nature of Philippine FDA Cosmetic Certification

Certification Attributes	FDA Registration (Mandatory)
Registration Authority	Philippine Food and Drug Administration
Testing Authority	FDA-Accredited Testing Laboratory (if required)
Product Scope	Cosmetic Products
Testing Content	Safety & Performance
Mandatory/Voluntary	Mandatory
Factory Inspection	Not Required
Local Representative	Required
Certificate Validity Period	3 Years
Certification Mark	—
Certification Cycle	1 Month
Consultation Hotlines	+63 956 274 9266

II. FDA Certification Process for Cosmetics in the Philippines

1. Determine the Product Category
   • Cosmetics in the Philippines are classified into two types:
     Regular Cosmetics: Such as skin care products, color cosmetics, shampoo, etc.
     Special Cosmetics: Products containing sunscreen ingredients (SPF), whitening ingredients or anti-dandruff ingredients, which require additional efficacy certification.
2. Apply for Company Registration (LTO)
   • For importers or local manufacturers, it is necessary to first apply for a License to Operate (LTO) from the Philippine FDA. This certificate is a prerequisite for the legal operation of the enterprise. (Microchip Testing can provide local representative services.)
3. Submit Cosmetic Product Notification (CPN)
   • The Philippines implements a “Notification System” rather than a strict approval system for cosmetics. Enterprises are required to submit a Cosmetic Product Notification (CPN) along with relevant technical documents.
4. Document Review and Payment
   • The Philippine FDA will review the submitted documents, which usually takes 5-15 working days. After the review is approved, the corresponding fee must be paid, and then wait for the FDA to issue the Certificate of Product Notification (CPN).
5. Obtain Certification and Launch for Sale
   • Once the CPN certificate is obtained, the product can be legally sold in the Philippine market. The certificate is valid for 1/2/3 years, and a renewal application must be submitted before expiration.

III. Documents Required for FDA (Cosmetics) Certification Application

No.	Document Content
1	Company Business License (if applicable)
2	Philippine LTO (License to Operate) Certificate
3	Power of Attorney (if applying through an authorized agent)
4	Product Formula (complete list of ingredients and their concentrations)
5	Product Label (in English or Filipino, complying with FDA labeling requirements)
6	Product Safety Assessment Report (e.g., toxicological testing, stability testing)
7	GMP Certificate (Good Manufacturing Practices Certificate)
8	Product Liability Declaration
9	Special Requirements: Sunscreen products: SPF test report required; Whitening products: Efficacy certification and safety data required; Anti-dandruff shampoos: Antifungal activity test report required.

IV. Key Notes for FDA Certification Application

1. Label Compliance
   • The Philippine FDA imposes strict requirements on cosmetic labels, which must include the following information:a) Product Nameb) Ingredient List (listed in descending order of content)c) Net Contentd) Batch Number / Expiry Datee) Manufacturer / Importer Informationf) Usage Instructions and Precautions
2. Prohibited Ingredients
   • The Philippine FDA prohibits or restricts the use of certain ingredients in cosmetics, such as mercury, high-concentration hydroquinone, and specific preservatives. Enterprises must ensure their products adhere to Philippine regulations on cosmetic ingredients.
3. Agent Application Requirements
   • If the enterprise is not located in the Philippines, it must entrust a local agent or registered importer to submit the application and provide authorization documents.
4. Market Supervision and Compliance
   • The Philippine FDA conducts random market inspections. In case of unregistered or non-compliant products found, measures such as product withdrawal, fines, or even criminal penalties may be imposed.
5. Certification Validity and Renewal
   • The CPN certificate is valid for 1, 2, or 3 years. Enterprises must submit a renewal application 3 months prior to the expiration date and provide the latest product information.

V. Philippine FDA Certificate Templates

VI. What is the Application Fee? What is the Processing Time?

1. Application fees vary significantly by product type.
2. Certification Processing Time: 1 month.
3. Specific certification fees depend on the standards applicable to the product; please confirm with the engineer for details.

VII. Why Choose Microchip Testing? What Are Our Advantages?

1. Years of experience in Philippine FDA certification, helping enterprises fully understand the requirements for Philippine FDA cosmetic certification.
2. Joint-venture local subsidiary in the Philippines, providing local representative services.
3. Provision of a complete set of template materials to simplify the document preparation process.
4. Full-process communication available in Chinese and English, enabling seamless connection between manufacturers and the Philippine FDA certification authority.