Philippines Cosmetic Regulation

In the Philippines, the Food and Drug Administration (FDA) (formerly the Bureau of Food and Drugs) created under the Department of Health, is responsible for regulating cosmetic products and ensuring the safety, purity, and quality of cosmetics in Philippines market. Being a prominent member of ASEAN, Philippines formally adopted the ASEAN Harmonized Regulatory Scheme and ASEAN common technical documents into national requirements in April 2005, and allowed the cosmetic industry a transitory period to December 31, 2007. Since then, a notification scheme has been implemented in Philippines.

All cosmetic companies shall obtain a License to Operate (LTO) prior to engaging in manufacturing, importation, distribution and sale of cosmetics. The LTO is also an essential requirement to be able to notify cosmetic products. All companies are asked to ensure that their notified products meet the requirements of the ASEAN Cosmetic Directive (ACD), its annexes and appendices.

Part 1 Regulatory Framework and Competent Authority

1.1 Main Cosmetic Regulations in Philippines

The main competent department for the regulation of cosmetic products is the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR). It belongs to the Philippines FDA and has 2 sub-branches, the Licensing and Registration Division and the Product Research and Standard Development Division.

Part 2 Cosmetic Products

2.1 Definition

The definition of cosmetic product is the one contained in ACD: "Any substance or preparation intended to be placed in contact with the external parts of the human body... or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly for cleaning them, perfuming them, changing their appearance , and/or correcting body odours and/or protecting or keeping them in good condition".

2.2 Manufacturing Requirements

The requirements for manufacturing cosmetics in terms of personnel, premises, equipment, sanitation and hygiene, and others are set by the ASEAN Guidelines on Good Manufacturing Practice (GMP). Cosmetic manufacturers shall ensure that their manufacturing conditions comply with the GMP.

2.3 License to Operate (LTO)

All cosmetic establishments shall first secure the LTO from FDA prior to engaging in the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertisement and for sponsorship of any activity that involves cosmetics. They must continuously comply with the existing requirements, regulations and standards and under the supervision of a qualified person as required by the regulations. The responsibility of ensuring the safety, quality, and when applicable, the efficacy and/or purity of health products, shall rest upon all the establishments or persons involved in the production, sale, handling, packing, transport, distribution, trading and storage thereof.

All licensed manufacturers are granted an Initial LTO based on the minimum requirements set by FDA in order to operate a manufacturing plant. A Certificate of GMP Compliance shall only be issued upon demonstration of satisfactory compliance to GMP and effective up to the validity of the current LTO. Thereafter, the Certificate of GMP Compliance shall be issued each time the LTO is renewed.

For further details regarding the fundamental requirements for and steps of LTO application, as well as the most recent updates, please refer to this article. 

2.4 Notification

The company or person responsible for placing the cosmetic products in the market shall notify the FDA before the product is placed in the market. Submission of the notification application shall be done using the FDA e-Portal, accessible through FDA official website. To file an application, follow the procedures listed below:

1. Access the e-Portal with the user account;

2. Select "New Case" and accomplish the application form;

3. Download the payment order, and assign the task to FDA Cashier;

4. Pay the fee through options outlined in FDA Advisory No.2015-021 and FDA Memorandum Circular No. 2013-01, and wait for the result of application;

5. If approved, download and print the notice of acknowledgement.

Companies with complete application documentation will be issued a Notification Certificate. For initial submissions, the notification shall be valid for a period of one to three years maximum at the option of the applicant. Those with insufficient documentation will receive a Notice of Deficiencies, asking for clarification or further explanation of some details. Any company declaring false or misleading information will get a Denial Letter. 

2.5 Product Information File (PIF)

PIF is a document storing the evidence to review the cosmetic product's safety, quality and claimed efficacies. As per ACD, the local responsible company in the Philippines should create and maintain a PIF for each product, readily available for FDA consultation. This file can be printed or digital, and should be updated every time the company decides to change any aspect of the notified product.

Consistent with the ASEAN Guidelines for Product Information File, the PIF should be organized into four parts as shown in the table:

2.6 Labeling

Following the ASEAN cosmetic labeling requirements, the Philippines requires cosmetic labels bear nine items, including:

1. Name and function of the cosmetic

2. Instruction for use

3. Full ingredient listing

4. Country of manufacture

5. Name and address of the company or person responsible for placing the product on the market

6. Contents (weight/volume)

7. Batch number

8. Manufacturing/expiry date

9. Special precautions

Where it's impossible to label all the required information because of the size, shape or nature of product's container or package, information including the cosmetic's name and batch number shall appear on the immediate packaging at least.  For other information, they could be labelled in the leaflets, pamphlets, hang tags, display panel or shrink wrap. 

Part 3 Cosmetic Ingredients

As part of adopting the ASEAN harmonized cosmetic regulatory scheme, the Philippines incorporated the technical documents of ACD into the national requirements, which include five ingredient annexes and any subsequent amendments thereof. These ingredient annexes are:

1. Annex II: List of Substances Prohibited in Cosmetic Products

2. Annex III: List of Substances Which Cosmetic Products Must Not Contain Except Subject to the Restrictions Laid Down

3. Annex IV: List of Colouring Agents Allowed in Cosmetic Products

4. Annex V: List of Preservatives Which Cosmetic Products May Contain

5. Annex VI: List of Permitted UV Filters Which Cosmetic Products May Contain