Requirements for Cosmetics Registration with the FDA in the 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). Here is an overview of cosmetic registration requirements and tips for streamlining the process in the Philippines.

Cosmetic Product Registration 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.

What Cosmetic Products Need to be Registered in the Philippines?

The term “cosmetic” encompasses a wide range of products:

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

All finished consumer products must be registered, even free samples. Registration isn’t necessary for raw ingredients or components.

Cosmetic product registration process in the Philippines

1. Obtain a Licence to Operate (LTO) for the company
2. Prepare the necessary documents, like manufacturing licences and certificates of quality
3. Submit the application and fees to the FDA
4. Undergo a factory inspection once approved
5. Secure a Certificate of Registration (CPR) before selling products

The registration process usually takes 6-8 weeks if documents are in order. Manufacturers must also update their registration every 3-5 years.

Key aspects 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 need to be followed 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 Food Products Getting Rejected in the Philippies

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 agains 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. Using false and misleading claims is not prohibited. 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.

ASEAN Cosmetic Product Labelling Guidelines for Importation

The Philippines follows the cosmetic product labelling standards set by ASEAN. 

Below is an example with required specifications from the skincare registration bottle key elements that should be present on the cosmetic product labels:

Front Label

• Product Content: Mention the volume or weight of the product.
• Brand & Product Name: State both – the brand and product name. Also, mention its intended use or function.
• Batch Number: This is essential for tracking and referencing, especially during feedback or any issues related to the product.
• Manufacturing & Expiry Date: Present the dates clearly, enabling consumers to identify fresh products and avoid those past their best usage date.
• Country of Manufacture: This provides transparency about where the product was made or produced.

Back Label

• Instructions for Use: This is a guide on how to use the product.
• Ingredient List: Detailed breakdown of all ingredients, essential for those with allergies or specific ingredient preferences.
• Special Precautions: Any precautions related to storage options and vital information on how to react to adverse reactions caused by the use of the product.

Image source

Sample make-up registration submission with the Philippines FDA

Brand Name	Chenelo
Product Name	Lipshack
Product Variants	RosaEvery variation of your product must be registered. Variations can be:Formulation (shade, ingredient, etc.)PackagingIntended use
Product Types	Product used on the face and bodySee the examples below.
Intended Use	For application to the lips.See the examples below.
Product Presentations	Choose correctly, i.e: Single use: LipstickPalettesKits
Local Company Responsible for Placing the cosmetics products in the market	Your company that holds the valid LTO
Establishment Information	Your company that holds the valid LTO
Person Representing the Local Company	Either a Pharmacist or someone who registered as Allied Health Science Profession, representing your company.
Product Ingredient List	The functions and percentages of ingredients must be declared up to 100%.

ASEAN cosmetics Directive Food Products in the Philippines

In 2013, ASEAN countries adopted the ASEAN Cosmetic Directive to harmonise regulations. As the Philippines works to align its policies, requirements may evolve. Companies should monitor FDA announcements for the latest updates.

With mandatory registration and close monitoring, the FDA registration facilitates responsible, safe innovation in the Filipino cosmetics sector. Although securing registration involves time and resources, it enables manufacturers to conduct business legally and ethically. 

Our team provides personalised consultations to help business owners understand the FDA’s requirements and ensure their products comply with all regulations. If you require assistance to streamline your FDA registration process, we invite you to contact us for a consultation.