Registration of Cosmetic Products in the Philippines Made Easy

The Philippines is a growing market for cosmetics, with analytics company GlobalData forecasting the industry to be worth PhP 228.8 billion (USD 4.2 billion) by 2023. Contributing to this potential for an upswing is the country’s increasing population as well as lower unemployment rates. The archipelagic nation’s citizens appreciate beauty and social interactions, driving the demand for cosmetic products in the Philippines.

Clearly, there is an opportunity to be had here for enterprising individuals and corporations. After all, cosmetics is an umbrella term. Products such as perfumes, hair dyes, lipsticks, soaps, lotions, and other skincare items are all in high demand and will continue to be so in the short and long term.

If you are interested in importing, selling, or distributing cosmetic products in the Philippines, you need to first secure necessary permits from the Food and Drug Administration (FDA). Going through the registration process will show potential customers that you care about their health and safety.  

In this article, we give you the lowdown on how to register cosmetic products in the country.

Regulation of Cosmetic Products in the Philippines

Main Cosmetic Regulations in the Philippines

The Philippine regulatory environment for cosmetics is primarily based on the ASEAN Cosmetic Directive (ACD), an initiative to promote trade among members of the Association of Southeast Asian Nations (ASEAN)  by harmonizing technical industry requirements while maintaining safety and quality standards. 

According to this directive, cosmetic products are “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, or changing their appearance, and/or correcting body odours and/or protecting or keeping them in good condition.” 

Several other regulations have also been released by the FDA which are related to ASEAN’s streamlining initiative. Among them is Administrative Order (AO) 2016-0003 (“Guidelines on Unified Licensing Requirements and Procedures of the Food and Drug Administration”), which aims to improve the approval processes for cosmetic products and to strengthen the institution’s post-market surveillance activities by unifying and harmonizing the licensing requirements of the FDA. 

Regulating Bodies in the Philippines

The Center for Cosmetics Regulation and Research (CCRR) is the main arm of the FDA that is responsible for cosmetic product regulation. This department further branches into two divisions — (1) the Licensing and Registration Division and (2) the Product Research and Standard Development Division.

Steps in Registering Cosmetic Products in the Philippines

License to Operate (LTO)

A company is required to obtain an LTO before it can legally import, distribute, sell wholesale, and/or manufacture cosmetics.

Here at Dayanan Consulting, we help our clients by facilitating their application process with the FDA from start to finish, from LTO to labeling. They just need to provide us the necessary information and we help prepare the documents needed.

But if you choose to try doing it by yourself, here are the requirements to secure one:

• Notarized Petition form from the owner, incorporator, or authorized representative
• Joint Affidavit of Undertaking signed by the owner and an authorized individual (an allied health science professional) stating that they understand the FDA’s regulation for LTO; note that the authorized individual must also present their professional license or board certification
• Proof of your Business’ Registration
• Site Master File (this is required from manufacturers of drugs, devices, and cosmetics)
• Proof of occupancy or business address
• Floor plan and vicinity map of the business location
• Risk management plan
• Application fee

After preparing these requirements, you may now proceed to file them with the FDA. Note that if you are just renewing your LTO, submission of the first, second, and last items would suffice. You will then have to wait for the FDA evaluation results.

For manufacturers, pre-opening inspection is required as part of FDA’s post-marketing surveillance activities. The FDA may inspect all covered establishments at any time so you need to be prepared and compliant with all standards.

Notification

Before the product can be released to the market, the FDA must be notified first using the procedures outlined in the  Cosmetic E-Notification v.2.0 User Manual for Applicants. 

You need to provide the following information in your 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, and the shade name/number if a single shade is notified (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 – the category of the cosmetic product for which 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 – select whether you are applying for (1) a single product, (2) a range of variants similar in composition for the same use but differs in colors, flavors, etc., (3) palette(s) in a range of one product type, or (4) combination products in a single kit. 
• Local Company Responsible for Placing the Cosmetic Product in the Market – Indicate the local company responsible for placing the cosmetic products in the market. This company must also have a valid LTO number.  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 company representative who 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.

To apply, follow the steps below:

1. Obtain a CCRR User Account by requesting one from info@fda.gov.ph. You must provide the following information to proceed:
   1. Email address or company email address
   2. Name
   3. Position
   4. Contact No.
   5. Company Name
   6. Company Address
   7. Product Classification: Cosmetics
2. Log in at the FDA e-portal (https://ww2.fda.gov.ph).
3. Click on “New Case” and accomplish the ASEAN Notification Form.
4. Download the “Order of Payment” and assign this task to the FDA Cashier.
5. Pay the fee either through any Landbank branch or by online Bancnet payment methods.
6. Wait for the Result of Application.
7. Download and print the notice of acknowledgment once your application is approved.

Organizations that have submitted correct application documents will then be issued a Cosmetic Product Notification certificate which is valid for 1-3 years. Those with insufficient documentation will be given a Notice of Deficiencies wherein clarification or further explanation of details will be asked. Finally, anyone who declared misleading information or failed to meet FDA standards will merit a Letter of Disapproval.

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.

Note that the same process of application for cosmetic e-notification applies for revalidation. In the e-portal, 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.

In the event that the notification is desired to be cancelled, the applicant may choose to cancel the application. This option is available in the Revalidation Application Task.

Manufacturing Requirements: GMP, Ingredients, and Labelling

For manufacturers, your manufacturing processes and practices — personnel, premises, equipment, sanitation and hygiene, etc. — must be compliant with the Good Manufacturing Practices (GMP) set by the ASEAN guidelines. 

Note that a Certificate of GMP Compliance will only be issued upon the demonstration of satisfactory compliance and will be effective up to the validity of your current LTO. Thereafter, it shall be issued every time your LTO is renewed.

Aside from the procedures and processes, you also need to ensure that ingredients used in your cosmetic products adhere to ASEAN cosmetic regulations. The annexes of the ASEAN Cosmetic Directive provides prohibitions and regulations of cosmetic product ingredients as listed below:

Table 1. Annexes of ASEAN Cosmetics Directive that Provide the Regulations and Ingredient Prohibitions for Cosmetic Products in the Philippines

When it comes to labelling of cosmetic products in the Philippines, the following must be seen on your product’s packaging:

• Weight or volume of the product content
• Brand, product name, and its function
• Batch number
• Manufacturing or expiration date of the product in terms of (month/year)
• Country where the cosmetic product is manufactured
• Instructions on how the product is used
• Special precautions (if any)
• List of all the ingredients in the product
• Name and address of the company or individual who placed the product in the market

For decorative cosmetic products that are marketed in multiple color shades, all coloring agents may be listed as long as the description includes the words, “may contain” or “+/”. 

Penalties Associated with Cosmetic Products in the Philippines

Misbranding of cosmetic products, whether deliberately or accidentally, will net violators jail time of at least one (1) year or a maximum of ten (10) years. Fines can also be imposed which range from Php 15,000 to Php 500,000. Some may even have to deal with both depending on a court’s decisions.

On the other hand, for violators who are manufacturers, importers, or distributors of any cosmetic product, the minimum jail time would be five years while the amount of the fine will range from Php 500,000 to Php 5 million.

About Darwin M. Masacupan