Regulatory Issuance Governing Cosmetic Product Notification
From manual application process, the application for cosmetic product notification in the Philippines can now be done online.
Aiming to streamline the process by updating the submission of application requirements from the previously manual form to online submissions, the Food and Drug Administration (FDA) allowed online application process. This modernization was kickstarted in March 2013 through FDA Memorandum Circular No. 2013-011.
In August 2015, to further enhance the efficiency of the application process and transparency of information, the cosmetic product notification scheme was updated and incorporated in the FDA’s website https://www.fda.gov.ph.
But despite the changes in the application process, the requirement of the FDA remain, in terms of regulatory compliance and submission of documents for a person applying for a cosmetic product notification in the Philippines.
What Information should be Declared in the Product Notification?
The following information shall be declared in the Cosmetic Product Notification:
- Brand Name/Product Name/Product Variants – The complete name of the product should be given, in the following sequence: brand name, line name (if applicable), product name, if a single shade is notified, the shade name/number (e.g. BRAND ABC PRODUCT XYZ EYSHADOW SHADE 1). If there are different shades, the shade name/number for each shade shall be declared.
- Product Types, or the type/s of the cosmetic product that you are applying for notification.
- Particulars of the Product – The validity of the notification may either be 1, 2, or 3 years at the option of the applicant.
- Intended Use – This refers to the function or use of the product and not the directions for use e.g. to moisturize the face, hand, etc.
- Product Presentations – A Single Product exists in a single presentation form. A range of variants similar in composition for the same use but differs in colors, flavors, etc. is a range of cosmetic products, which are similar in composition and produced by the same manufacturer, and are intended for the same use but are available in different shades of color (e.g. lipsticks, eye shadows or nail polish but not composite packs of different types). Palette(s) in a Range of One Product Type refers to a range of colors as defined above, which may be presented in a series of palettes. Combination Products in a Single Kit refer to similar and/ or different product types packed and sold in a single kit. They cannot be sold separately (e.g. a make-up kit of eye and lip colors; a set of skin-care products sold in a single kit). Please note that components of such kits must be notified separately.
- Local Company Responsible for Placing the Cosmetic Product in the Market – It refers to the local company responsible for placing the cosmetic products in the market, which may be a local manufacturer or an agent appointed by a manufacturer to market the product or the company that is responsible for bringing in the product for sale in the country, etc. The applicant for notification must have a valid License to Operate (LTO) and must state in the notification application the LTO number of the company responsible for placing the cosmetic product in the market. If the company responsible for placing the cosmetic product in the market is a distributor, then the applicant must also declare the details of the direct supplier or manufacturer of the cosmetic product, namely Country of Manufacture, Address, and others.
- Establishment Information – It refers to the particulars of the manufacturer and/or supplier of the notified cosmetic product.
- Person Representing the Local Company – It refers to the person representing the local company responsible. The representative of the Company, and his or her details must be stated in the application. This person may be contacted by the FDA in case there are questions on the cosmetic product, or if additional documents are needed to substantiate the application.
- Product Ingredient List – All the ingredients in the product must be specified by using the nomenclature from the latest edition of standard references (International Cosmetic Ingredient Dictionary, British Pharmacopoeia, United States Pharmacopoeia, Chemical Abstract Services). Botanicals and extract of botanicals should be identified by its genus and species. The genus may be abbreviated. The functions and percentages of ingredients must be declared if they are substances with restrictions for use as specified in the annexes of the ASEAN Cosmetic Directive.
What are the Procedures in the Application for Cosmetic Product Notification in the Philippines?
The application process has four (4) main parts: Submission, Payment, Download Result, and Revalidation.
The First Step is the Submission. This is now done through the FDA’s portal at https://www.fda.gov.ph. Once you have filled up the necessary details of the cosmetic product to be notified, you can submit the application with the FDA through their portal.
The Second Step is Payment. Of course, the application for notification has a filing fee, depending on the number of years applied for, or the number of years that you want the registration with the FDA to be valid. The best option for payment is always paying at the Cashier’s office of the FDA. However, to facilitate applications, the FDA provided alternative payment options, without need to going physically to the FDA’s offices.
The Final Step is to await the results of the FDA’s evaluation. The time frame depends largely on the circumstances, and the submission of complete information with the FDA. There are instances when the FDA will send an email requiring additional documents or information concerning the application. Compliance with the email by submitting the required documents or supplying the needed information is a requisite to the FDAs approval of the notification. On the other hand, the failure to comply with the additional documents or information required will lead to the rejection of the application for notification.
Acknowledged cosmetic notifications may be revalidated for a new validity date, where the new validity date will be based on the date of submission of the revalidation application.
The same process of application for cosmetic notification applies for revalidation. Using the previous application and information, the previously acknowledged case must be selected to continue with the task for Revalidation Application. There must be no modifications from the information provided during the previous application to avail of revalidation. Hence, any changes to the information will constitute a new notification application.
About Nicolas and De Vega Law Offices
If you need assistance in registration with the Food and Drug Administration, applications for Licenses to Operate, drug, cosmetic, medical device or food registration, registration of cosmetics, food supplements, licenses to operate or other applications with the Food and Drug Registration, or have issues in corporate law, commercial law, corporate or commercial litigation, or civil or other criminal law-related issues, we can help you. Nicolas and de Vega Law Offices is a full-service law firm in the Philippines. You may visit us at the 16th Flr., Suite 1607 AIC Burgundy Empire Tower, ADB Ave., Ortigas Center, 1605 Pasig City, Metro Manila, Philippines. You may also call us at +632 84706126, +632 84706130, +632 84016392 or e-mail us at [email protected]. Visit our website https://ndvlaw.com.