Requirements for Cosmetics Registration with the FDA Philippines

The cosmetics industry in the Philippines has seen rapid growth in recent years, with local brands gaining popularity and global players entering the market.

However, before marketing and selling cosmetics in the country, manufacturers must register their products with the Food and Drug Administration (FDA). This involves obtaining a License to Operate (LTO) for your company and then a Certificate of Product Notification (CPN) for each product.

This article provides an overview of cosmetic registration requirements and tips for streamlining the process in the Philippines.

Understanding FDA Regulations for Cosmetics in the Philippines

Under the FDA Act of 2009, all cosmetic products manufactured or imported for sale in the Philippines must be registered. Unregistered goods can be confiscated, and the responsible parties fined or imprisoned. Besides being mandatory, registration also lends credibility to products in the eyes of consumers.

Cosmetic Products Requiring FDA Registration in the Philippines

The term “cosmetic” in the Philippines encompasses a wide range of products which include:

• Skin creams, lotions 
• Perfumes  
• Lipsticks, makeup 
• Shampoos 
• Hair dyes, relaxers, etc. 

It is important to note that all finished consumer products must be registered, even free cosmetic samples. FDA Registration isn’t necessary for raw ingredients or components of cosmetic products.

How to Get FDA Approval for Your Cosmetics in the Philippines

The FDA registration process for cosmetic has two main stages. The first stage is licensing your company by securing license to operate (LTO). Then you need to apply for registration of your cosmetic products.

For cosmetic products in the Philippines and across ASEAN, the official process for “registration” is called notification. Therefore, upon successful completion, the FDA issues a Certificate of Product Notification (CPN), which is your product’s official market authorization. The entire process can take up to 3 months.

Here’s the step by step process to secure FDA registration for cosmetic products:

1: Secure Your Company’s License to Operate (LTO)

Before you can register any product, your company must first secure a valid License to Operate (LTO) from the FDA. The LTO is the foundational license that certifies your company has the permission to engage in the business of cosmetics (whether as a manufacturer, importer, or distributor).

Recommended Reading: How to secure FDA License to Operate (LTO) in the Philippines

2: Prepare Required Documents for Cosmetic Product Notification (CPN)

Here are the key documents you must compile for your cosmetic registration application:

• A copy of your company’s valid License to Operate (LTO).
• A comprehensive Product Information File (PIF), which contains technical details such as:
  • Artwork of the product labeling.
  • Detailed Instructions for Use.
  • An explanation of the product’s mechanism of action.
  • Certificate of Origin for the ingredients.
  • A Safety Data Sheet (SDS).
  • A Certificate of Analysis (COA).
• A Good Manufacturing Practice (GMP) Certificate from the product’s manufacturer.

3: Application Submission via the FDA Online Portal

The application is submitted electronically through the FDA’s official online portal. Your company’s qualified person handles the submission of the PIF and all other required documents.

Emerhub manages this entire process on your behalf, from preparing and reviewing documents to handling the online submission, ensuring accuracy and compliance.

4: Evaluation of Documents by the FDA

The FDA follows a thorough evaluation process which has 3 stages:

1. Pre-Assessment: The FDA first checks your submission for completeness. Incomplete applications will not proceed.
2. Payment of Fees: Once documents are verified as complete, a payment order is issued. The formal evaluation begins only after payment is confirmed.
3. Evaluation: FDA assessors review the documents for compliance with regulations and ASEAN Cosmetic Directive (ACD) guidelines.

5: Issuance of Cosmetic Product Notification

If the evaluation is successful, FDA issues a digital Certificate of Product Notification (CPN) via the e-portal. If there are deficiencies, a notice for correction is sent, which our team will address promptly.

Guidelines to Follow When Preparing Cosmetics Products for FDA Registration

Based on Emerhub’s experience in registering cosmetics products with the Philippines FDA, there are several principles that you must follow for a successful registration:

• Verify that your product’s claims align with the standards set by the FDA.
• Ensure that your brand names and labelling adhere to the required ASEAN specifications.
• Include FDA reference numbers prominently on your product packaging.
• Submit all necessary documentation well in advance to prevent any processing delays.
• Keep all your documentation well-organised for easy reference and compliance tracking.

How to Avoid Cosmetics Products Rejections in the Philippines

In the Philippines, when seeking FDA certification for makeup products, there are claims that are not permissible. These typically include any claims that suggest:

• Medical or therapeutic benefits. It is against the FDA rules to claim the foundation, for example, cures acne, redness or other skin conditions. Products with such claims are almost automatically taken down from the market unless you have a scientific study to prove the claims.
• Altering the physiological functions of the skin. You can’t use false and misleading claims. These might include exaggerated statements like “guaranteed to remove all wrinkles” or “instantly erases all blemishes,” which are unrealistic and misleading.
• Other unsubstantiated health benefits. Claims such as “100% effective for all skin types” or “clinically proven” without actual clinical evidence or studies to back up these statements. 

The FDA ensures that makeup products are marketed accurately and does not allow misleading or medically oriented claims that could be misconstrued as drug benefits. It’s crucial to avoid making such claims to comply with FDA regulations and ensure consumer safety.

Cosmetic Labeling Requirements FDA Philippines

The Philippines follows the cosmetic product labelling standards set by ASEAN. Below are the required specifications from the skincare registration bottle key elements that should be present on the cosmetic product labels:

Why FDA Registration Matters for Cosmetics

Here’s why FDA registration matters under Philippine FDA requirements for cosmetics:

• Regulatory Compliance: Securing your License to Operate (LTO) and Certificate of Product Notification (CPN) allows you to legally sell cosmetic products in the Philippines. Operating without FDA clearance may lead to fines or legal action.
• Consumer Safety Assurance: FDA registration verifies that your cosmetic products are free from prohibited substances like mercury, hydroquinone, and unapproved dyes ensuring public safety and product integrity.
• Retail and E-commerce Access: Many online platforms and retail stores require FDA-registered products. With proper documentation, your cosmetics can reach more customers and meet vendor requirements.
• ASEAN Market Entry: The FDA’s alignment with the ASEAN Cosmetic Directive (ACD) opens opportunities for regional export. A valid CPN can support smoother registration across ASEAN member states.
• Risk Reduction: Unregistered products are vulnerable to recall, seizure, or bans. Product recalls can cost millions, proper FDA compliance minimizes such risks from the outset.
• Brand and Market Advantage: FDA-registered cosmetics are more appealing to distributors and partners who seek compliant, trustworthy products.

Secure your FDA Cosmetic Product Registration with Emerhub

From securing your initial LTO to managing individual product notifications, Emerhub provides end-to-end support throughout the FDA registration process. Our team provides personalized consultations to help business owners understand the FDA’s requirements and ensure their products comply with all regulations.

Ready to bring your cosmetic products to the Philippine market? Contact our experts for a consultation today.