Philippines Cosmetics Regulation
As a member of the ASEAN, the Philippines Cosmetics Regulation is under the ASEAN Harmonized regulatory Scheme and is required to implement the cosmetic notification and Product information files preparation under the supervision of the Philippine Food and Drug Administration (FDA).
It is important to know that businesses involved in the importation, exportation, trading, and distribution of food, drinks, drugs, pharmaceuticals, cosmetics, or medical devices in the Philippines need to obtain a license to operate (LTO) and a certificate of product registration (CPR) from the Food and Drug Administration (FDA).
What is an LTO?
An LTO allows you to legally import, distribute, sell and manufacture food, drugs, cosmetics, and medical devices. It is also a requirement before you can obtain a Certificate of Product Registration (CPR) that indicates the products complies with the health, safety, and technical standards of the Philippines FDA.
Operating without a license or violate the principle of LTO, the business will be suspended and the LTO license may be canceled, or disapproved upon renewal. Existing licenses that were not renewed after 120 days from the date of expiration will be automatically canceled by the Philippines FDA.
Consider the company with LTO is like EU responsible person that required a certificate from FDA to operate cosmetic importing and distribution business. It could be your distributor or subsidiary in the Philippines. Therefore, it is necessary to check the qualification of your distributor before making the decision to appointing any legal entity to represent your brands locally if you don’t have a subsidiary locally.
Cosmetics Notification and Registration
Exporting cosmetic products to the Philippines shall complete the online notification procedure first according to Philipines FDA before the products are placed in the market.
Submission of the cosmetics notification application shall be done using the FDA E-Portal, accessible through FDA official website https://ww2.fda.gov.ph. The process is necessary to be done by the LTO holders and to be ensured that the notified products meet the requirements of the ASEAN Cosmetic Directive, its annexes, and appendices.
Product Information File (PIF)
As mentioned above, the Philippines cosmetics regulation follows the ASEAN Cosmetic Directive (ACD) that requires the LTO to keep a Product Information File for the Philippines FDA inspection after the successful notification. The PIF can be recorded as a printed or digital version and necessary to be updated if any change of the notified product.
Please read the article of “ASEAN Cosmetics Directive Overview” to understand further of ASEAN Harmonized Regulatory Scheme that Philippine follows.
The following information should be listed on the labels of the products:
- Product content in weight/volume
- Brand and product name along with the function
- Batch number
- Manufacturing/expiry date of the product in clear terms like month/year
- Country of Manufacture
- Instructions/Directions for use
- List of all ingredients
- Special precautions
- Name and address of company or person who placed the product on the market
The cosmetics ingredients safety requirements of the Philippines are complete follows ASEAN cosmetic regulations. Please check the following links to download the ingredients lists requirements.
- APPLICATION GUIDELINES FOR LICENSE TO OPERATE (LTO) FOR ENDS/ENNDS PRODUCTS
- Philippines Food and Drug Administration
- How to Apply for FDA LTO (License to Operate) in the Philippines