Cosmetic product registration in the Philippines

Whether you plan to produce, trade, or distribute cosmetic products in the Philippines, you’ll need to go through the following steps:

1. Register a company in the Philippines
2. Get a license to operate (LTO)
3. Register your products with the FDA
4. Follow ASEAN Cosmetic Labeling Guidelines for Importation

In this article, we’ll cover the last three steps of cosmetic product registration in the Philippines. You can learn more about company registration in the Philippines here.

1. Obtaining the license to operate (LTO) as a cosmetics establishment

In the Philippines, the Food and Drugs Administration (FDA) regulates the following establishments before they can sell cosmetic products to end users:

• Cosmetics Manufacturer: Produces cosmetic products and must adhere to FDA’s Good Manufacturing Practice (GMP) guidelines. Each product must be registered with the FDA.
• Cosmetics Trader: Buys and sells cosmetic products without altering them. Must ensure products are FDA-registered, properly labeled, and correctly stored.
• Cosmetics Importer: Brings cosmetic products into the Philippines. Imported products must comply with FDA regulations and be registered with the FDA before sale.
• Cosmetics Distributors: Distributes cosmetic products to retailers or other distributors. Like traders, distributors must ensure products are FDA-registered, properly labeled, and correctly stored.

General Requirements to obtain LTO in the Philippines

• Authorized Person: Appoint an Authorized Person who must be either a registered Pharmacist or someone from the Allied Health Science Profession.
• Business Registration Proof:
  • A valid SEC Registration
  • Articles of Incorporation
• Proof of office occupancy, which can be a valid contract of Lease/Sublease, floor plan, and photo of the office with visible signage.

Technical Requirements for LTO

• Product List: Provide a list of products distributed in a matrix format. The list must indicate the name of raw materials, manufacturer, supplier, and country of origin for each product.
• Foreign Agency Agreement: Obtain a valid Foreign Agency Agreement from each supplier, authenticated by the Philippine Consulate/Embassy in the country of origin.
• Good Manufacturing Practice (GMP) Certificate: Present a valid GMP certificate issued by an accredited business association in the country of origin or a self-declaration of compliance to GMP, or Certificate Free of Sales.
• Distribution Agreement: Provide a notarized and valid distribution agreement.
• Warehouse Proof of Occupancy: Show proof of occupancy for your warehouse.

Ensuring that all these requirements are met is key to a successful application for an LTO, helping to facilitate your entry into the cosmetic products market in the Philippines.

In the Philippines, the License to Operate (LTO) for cosmetics establishments is usually granted for a period of one to three years, depending on the specific regulations and requirements of the Food and Drug Administration (FDA) of the Philippines. It is important to check the specific duration of your LTO and renew it at least three months before expiration.

2. E-Notification for Cosmetics with the FDA

After obtaining the LTO, the next significant phase for cosmetic product registration in the Philippines is the E-Notification process with the FDA. Here’s what you need to know:

• Time Frame: Anticipate a processing time of about 14 calendar days post-payment confirmation to the FDA.
• Ingredient Declaration: Provide a thorough Ingredient List. All ingredients should align 100% with the ASEAN Cosmetics Labeling Requirements’ standard reference.
• Notification Guidelines:
  • Each distinct product, identifiable by manufacturer or SKU, necessitates its own notification.
  • Kits or sets should be notified separately, especially if a unique component within them needs a specific declaration.
• Duration of E-Notification: Companies have the flexibility to select a notification validity of 1, 2, or 3 years.

Sample product submission with the Philippines FDA

Brand Name	Pretty Lady
Product Name	Lipshack
Product Variants	Rosa If there are different shades, the shade name/number for each shade shall be declared.
Product Types	Product used on the face and body Must follow ASEAN Directive
Intended Use	For application to the lips
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 Cosmetic Labeling Guidelines for Importation

The Philippines follows the cosmetic product labeling standards set by the ASEAN. Below are the key elements that should be present on the cosmetic product labels:

Front Label

• Product Content: Clearly mention the volume or weight of the product.
• Brand & Product Name: State both the brand and the specific name of the product. 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: Dates should be presented 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 should provide guidance on how to apply the product and specify the frequency of use.
• Full Ingredient List: Detailed breakdown of all ingredients, essential for those with allergies or specific ingredient preferences.
• Special Precautions: Any precautions related to storage, or any vital information on how to handle adverse reactions related to the use of the product should be mentioned.
• Company Information: Clearly state the name and address of the company or person responsible for placing the product in the market. This is vital for any inquiries or clarifications consumers may have about the product.

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Getting started with cosmetic product registration in the Philippines

Emerhub has been registering companies and products in the Philippines since 2017. Reach out to us to discuss the best way for your company to start selling or manufacturing cosmetic products in the Philippines.