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 the ASEAN Common Technical Documents into the National Requirements in April 2005 and allowed the cosmetic industry a transitory period to 31 Dec 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, its annexes and appendices.
Part 1 Regulatory Framework and Competent Authority
1 Main Cosmetic Regulations in Philippines
|Guidelines on the Unified Licensing Requirements and Procedures of the FDA
|ASEAN Cosmetic Directive
2 Competent Authority
The main competent department for the regulation of cosmetic products is the Center for Cosmetics Regulation and Research (CCRR), which 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
The definition of cosmetic product is the one contained in the Asean Cosmetics Directive: "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 Manufacturing Requirements
The requirements for manufacturing cosmetics in the respects of personnel, premises, equipment, sanitation and hygiene, and others are set by the ASEAN guidelines on Good Manufacturing Practice (GMP). Cosmetic manufacturers must ensure that their manufacturing conditions comply with the GMP.
3 License To Operate (LTO)
All cosmetic establishments shall ﬁrst secure the LTO or authorization 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.
a) Initial Application
Accomplished Application Form and Declaration and Undertaking
Proof of Business Name Registration
Site Master File (for manufacturers of drugs, devices and cosmetics)
Risk Management Plan
b) Renewal Application
Accomplished Application Form with Declaration and Undertaking
An application for LTO, whether initial, renewal, or variation, and other authorizations are deemed ﬁled upon submission of complete requirements including payment of required fees and charges.
The evaluation of all applications for LTO shall be based on the veracity of the submitted documents and compliance with appropriate standards.
In case the applicant falsiﬁed, misrepresented material facts or documents, or withheld any material data or information, the application shall be disapproved. In such cases, the applicant may be investigated, appropriate charges may be ﬁled, and penalties may be imposed.
Should there be a need for clariﬁcation on the application, a notiﬁcation, either written or through e-mail, shall he sent to the applicant.
Pre-opening inspection shall be mandatory for manufacturers. All covered establishments may be inspected at any time by FDA as part of its post-marketing surveillance activities.
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 https://ww2.fda.gov.ph. To file an application, follow the procedure below:
a) Secure a CCRR User Account by sending a request to email@example.com following with the following information:
Email address (preferably company email address)
Product classification: cosmetics
b) After securing the CCRR user account, log in at the FDA e-Portal (https://ww2.fda.gov.ph)
c) Select “New Case” and accomplish the ASEAN Notification Form.
d) Download the Order of Payment and assign the task to FDA Cashier.
e) Pay the fee at any Landbank Branch or thru online Bancnet payment and wait for the Result of Application.
h) If approved, download and print the notice of acknowledgement.
Companies with correct application documentation will be issued a Notification Certificate. For initial submissions, the notification shall be valid for a period of 1 to 3 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. The FDA lists all of its decisions on notification applications on its website.
Product Information File (PIF)
The Philippines adheres to ASEAN Cosmetic Directive (ACD). This directive requires persons or companies placing a product on the market to keep a Product Information File "readily accessible to the regulatory authority of the Member State concerned". This file can be printed or digital and should be updated every time the company decides to change any aspect of the notified product.
Cosmetic labeling in the Philippines should contain the following information:
-Product content in weight/volume
-Brand, product name and function
-Manufacturing/expiration date of the product in clear terms (month/year)
-Country of Manufacture
-Instructions/Directions for use
-List of all ingredients
-Name and address of company or person who placed the product on the market.
Part 3 Cosmetic Ingredients
In conformity with ASEAN cosmetic regulations, cosmetic ingredients in the Philippines should adhere to the standards set by ACD.
The following ASEAN documents set prohibitions to the marketing of various substances:
1. Annex II is a List of Substances Which Must Not Form Part of the Composition of Cosmetic Products
2. Annex III is a List of substances that cosmetic products must not contain except for the ones subject to restrictions and conditions laid down
3. Annex IV lists colouring agents allowed for use in cosmetic products
4. Annex VI lists the Preservatives Which Cosmetic Products May Contain
5. Annex VII is a list of UV Filters Which Cosmetic Products May Contain