Registration of Cosmetic Products in the Philippines Made Easy

registration of cosmetic products in the philippines

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

ASEAN Cosmetics DirectiveRegulations and Prohibitions
Annex IISubstances that are prohibited to form part of the composition of cosmetics products
Annex IIISubstances that are prohibited to be contained in cosmetic products except for the ones subject to restrictions and conditions laid down
Annex IVColoring agents that can be used in cosmetic products
Annex VIPreservatives that can be contained in cosmetic products

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.

How to Apply for FDA LTO (License to Operate) in the Philippines

Interested in FDA LTO application (License to Operate from the Philippine Food and Drug Administration) but don’t know where to start?

This new guide gives you a complete step-by-step process on how to apply for an FDA LTO in 2020.

While there are quite a few articles online on FDA LTO application, they are mostly outdated.

One major change to the process is that it is now done online via https://eportal.fda.gov.ph (the integrated application form may be found here).

Once processed and approved, the LTO will be mailed to you; no need to pick it up from regional FDA centers.

Click the links below to go directly to that part of this article:

  1. What is an LTO? Why would you need one?
  2. How to Apply for FDA eLTO User Account
  3. License to Operate Requirements
  4. Steps for FDA LTO Application
  5. Tips to make application easier and faster

What is an LTO or License to Operate? Why would you need one?

An LTO allows you to legally import, distribute, sell wholesale, and/or manufacture food, drugs, cosmetics, and medical devices. It is also a requirement before you can obtain a Certificate of Product Registration (CPR), a seal of approval which indicates that your product complies with health, safety, and technical standards set by the FDA in the Philippines.

Operating without a license can spell disaster for your business. If caught, your LTO may be suspended, revoked, canceled, or disapproved upon renewal. Likewise, existing licenses that were not renewed after one-hundred twenty (120) days from the date of expiration will be automatically canceled by the FDA. Not only that, but the company will automatically be delisted from the FDA’s list of licensed establishments, so be sure to renew on time.

Important Reminder:
Only companies incorporated in the Philippines may apply for LTO.

All guidelines and penalties may be found on the FDA website: http://www.fda.gov.ph

 

How to Apply for FDA eLTO User Account

Per FDA Circular 2016-004 (Procedures on the Use of the New Application Form for License to Operate through the FDA Electronic Portal), the application process has been moved online. With the goal of increasing transparency, accessibility, and efficiency of the process, this decision has been especially beneficial for businesses based outside Metro Manila.

Before you can access the E-portal, you must first create a User Account, the application for which is not as straightforward as what you may be used to. Instead of a simple sign-up button, it instead involves sending a few emails. Here’s how to create a new User Account for the FDA E-Portal System:

Creating eLTO User Account
  • First, accomplish an authorization letter for the eLTO User Account Application. This will designate a specific individual as eLTO account holder.
  • Next, send an email to request for a User Account to the FDA’s Public Assistance, Information and Receiving (PAIR) unit via pair@fda.gov.ph with the following format:

SUBJECT: Request for eLTO User Account

BODY:

a. E-mail address (preferably company email address)
b. Name of the authorized company representative (preferably permanently employed and not merely a consultant)
c. Position in the company
d. Contact Number
e. Company Name

  • Don’t forget to attach a scanned Authorization Letter in PDF format. Be sure that it is completed (signed and notarized) and virus-free.

Below is a sample email provided by the FDA:

From: https://ww2.fda.gov.ph/attachments/article/330042/FDA%20Circular%20No.%202016-004.pdf
About the eLTO User Account

Please take note that the User Account details will be sent to the company email address provided in the body of the email, not to the original sender’s email address. User Accounts are usually issued within two (2) days upon receipt of the completed request by the FDA in the Philippines. Requests received after 5:00 pm on regular working days, holidays, Saturdays, and Sundays shall be processed on the next working day.

Each User Account is unique to one company and is valid for one (1) year. Requests for replacing the authorized company representative as well as account reactivation must be sent to pair@fda.gov.ph at least three (3) months before the expiration of the User Account.

Once you have a valid User Account in hand, the E-Portal can now be accessed. Filling up the forms and uploading the documents can now be done via the portal. The E-Portal accepts new, renewal, and variation applications.

The accomplishment of the eLTO may be done via http://www.fda.gov.ph.

License to Operate Requirements

The following are the License to Operate requirements for initial and renewal applications. Ensure that all documents are secured before applying to avoid processing delays.

Requirements for FDA LTO - Initial and Renewal Application

FDA LTO Initial Requirements:

  • Completed Application Form with Declaration and Undertaking
  • Proof of Business Name Registration
  • Risk Management Plan
  • Site Master File (for manufacturers of drugs, devices and cosmetics)
  • Fees payment

FDA LTO Renewal Requirements:

  • Completed Application Form with Declaration and Undertaking
  • Payment of fees

Now that you have all the requirements, the application for the actual license can now follow.

Steps for FDA LTO Application

Applying for an initial FDA LTO consists of the following steps: filing, evaluation, and inspection. An application is considered filed only if all necessary requirements are met, including payment of fees. After filing, the FDA will evaluate all LTO applications to determine whether to grant the license or not. Lastly, a pre-opening inspection shall be conducted for manufacturers. In addition, all establishments covered under the FDA may be inspected anytime by the agency to ensure proper compliance with its set rules and regulations.

  • Log-in to the e-Portal using the User Account provided by FDA at http://www.fda.gov.ph.
  • Click “New Case” on the upper left-hand side and select “License to Operate v2.0” which can be found under Electronic Licensing.
  • Make sure you’ve read and fully understood the “Declaration and Undertaking” and click the “I Agree” button before proceeding.
  • Under the General Information tab, select the appropriate Product Type, Primary Activity, and Type of Application from their respective drop-down menus.
  • (Each primary activity has its applicable sub-options. Accomplish the General Information appropriately).
  • Under Establishment Information, provide the complete establishment name, TIN, address, and contact details. Use the Show Map Tool and move the arrow to the exact address of the establishment and click the “Submit” button.
  • Provide needed information under “Details of the Authorized Officer” and “Details of the Applicant.”Upload the required documents (depending on LTO type). Make sure documents are in PDF format.
  • Double-check the total amount to be paid by looking at the Order of Payment section, which can be downloaded if needed.
  • Payment can be made using existing FDA mechanisms.
  • Please note: Under the “Assign Task” section, please click the “Continue” button in order for the application to be processed by the FDA.

Here are some tips to make application easier and faster:

Tips for Faster and Easier FDA LTO Application

Tip 1: Follow documentary requirements listed in Administrative Order (AO) 2016-0003 (“Guidelines on Unified Licensing Requirements and Procedures of the Food and Drug Administration”):

  • Submit files in PDF format and ensure that there are no bugs, viruses, or anything that can jeopardize the system of the FDA.
  • All documents must be scanned and compiled with 100-150 dots-per-inch (dpi).
  • All document file names must be less than 40 characters, should not contain the following characters: \ ? / : * ” > <

Tip 2: Make sure to submit all forms completely. Do not forget to attach files to emails before sending them.

Tip 3: Get assistance from DAYANAN Business Consultancy! With our FDA Consulting services, you would no longer have to stress and fret over the LTO application process.

After you’re done applying, expect your FDA License to Operate (LTO) in the mail! We hope these tips answer your queries on how to apply for an FDA LTO. If you would like to avail of our FDA consulting services, you may contact us here.

FDA Consulting Philippines

FDA Consulting

The Food and Drug Administration (FDA) is the Philippine government agency charged with ensuring the quality and safety of the following products:

  • Processed food and drinks
  • Drugs and other pharmaceutical products
  • Dietary/herbal supplements
  • Medical devices
  • Cosmetics
  • Toys and child care articles
  • Household pesticides/cleaning agents
  • Veterinary products
  • Animal Feeds

In line with its mandate under the Department of Health (DOH), the FDA regulates the production, importation, and distribution of these products in the country.

A company that wishes to engage in such business activities must first obtain a License To Operate (LTO) from the FDA either as an importer or a manufacturer. Once done, the company must then apply for a Certificate of Product Registration (CPR) to ensure that its products comply with FDA technical standards.

DAYANAN can serve as primary liaison between your company and the FDA. Our familiarity with the regulatory framework and proactive approach will help ensure faster turnaround on your application. We will also link your company to laboratories recognized by the FDA to perform various required analytical tests on your products.

FDA Resources

How to Apply for FDA LTO (License to Operate) in the Philippines

FDA-Approved Food Supplements in the Philippines: A Quick Guide (Part 1)

Fees and Requirements for FDA-Approved Food Supplements in the Philippines (Part 2)

FDA CPR Certificate of Product Registration Requirements and Application Process in the Philippines

Registration of Cosmetic Products in the Philippines Made Easy

HR Consulting

A company’s most important resource is its people. To fully harness their productivity and avoid labor issues, your human resources system must be up to par. DAYANAN can help strengthen your existing HR infrastructure or even set it up from scratch.

We offer the most comprehensive HR Templates Pack optimized to Philippine labor conditions and regulations. The package includes the following:

  • Employee Handbook
  • Compensation Details
  • Proprietary Information and Confidentiality
  • Application for Employment
  • Probationary Employment Contract
  • Probationary Evaluation Form
  • Notice of Termination of Probationary Employment
  • Regularization Letter
  • Release Waiver and Quitclaim
  • Trainee Contract
  • Equipment Release Form
  • Certificate of Employment
  • Certificate of Employment and Compensation
  • SL-VL form
  • Employee Clearance
  • DOLE-Required Policies:
    • Alcohol-free Workplace
    • Drug-free Workplace
    • Hepatitis B
    • HIV / AIDS
    • Sexual Harassment
    • Smoke-free Workplace
    • TB

These documents come with our guarantee of iron-clad provisions that uphold employee rights while protecting businesses from legal liabilities. We can further customize these documents according to your company’s needs.

DAYANAN also provides ongoing HR support such as guidance on relevant laws, resolution of employee issues, and implementation of company-wide policies. Contact us today and get started on your way to HR success.

The Apostille: Simpler Authentication for Documents To Be Used Abroad

HCCH

Bringing documents from one state to another and having their validity recognized has always been difficult. A foreign corporation that wants to establish a Philippine subsidiary has to go through several steps just to authenticate its articles of incorporation from abroad. But with the Philippines recently joining the Apostille Convention, things are bound to get easier.

The Convention

The Apostille Convention (formally known as the Hague Convention Abolishing the Requirement of Legalisation for Foreign Public Documents) provides for the use of a security certificate called the “Apostille.” This simplifies the authentication process for public documents used across signatory countries. The Philippines officially became a member last September 12, 2018.

Drafted by the Hague Conference on Private International Law (HCCH), the international treaty will take effect between the Philippines and other states party to it on May 14, 2019. This is pending changes to be made by the Supreme Court to the Rules of Court with regards to foreign public documents. The Office of Consular Affairs under the Department of Foreign Affairs (DFA) will be responsible for implementing the treaty.

The Apostille

Previously, a public document must be authenticated both by the foreign ministry of its originating country and the foreign ministry of the country where it is to be used. This process is usually handled by embassies and consulates of the concerned states. In the Philippines, the certification issued by the DFA is popularly called the “red ribbon.”

Once the Convention becomes effective, public documents would no longer need to be consularized. An apostillized public document will immediately have legal effect in a foreign country where it is presented. Of course, the affixing of a red ribbon is still needed for states which are not members of the Convention.

The apostille is a standard form that can be placed or attached to the original document. It testifies that a document bears the signature of an authorized person, the capacity of the signatory, and an official stamp or seal. It does not, however, certify the content or purpose for which the document was issued.

Covered Documents

Public documents that can be apostillized according to the Convention are the following:

a) documents emanating from an authority or an official connected with the courts or tribunals of the State, including those emanating from a public prosecutor, a clerk of a court, or a process-server (“huissier de justice“)

b) administrative documents

c) notarial acts
       Note: This may include seemingly “private” documents such as contracts and wills

d) official certificates which are placed on documents signed by persons in their private capacity, such as official certificates recording the registration of a document or the fact that it was in existence on a certain date and official and notarial authentications of signatures.

Those that are not valid for apostillization include:

a) documents executed by diplomatic or consular agents;

b) administrative documents dealing directly with commercial or customs operations.

 

The apostille, once it is fully implemented in the Philippines, can boost trade and investment while making personal transactions easier. It will be useful for the millions of Filipinos working abroad as well as the large number of expatriates who have made (or are planning to make) the Philippines their second home.

Business Consultant Philippines

Success in the Philippines depends on choosing the right business consultant to assist you in studying the Philippines market and developing the correct market entry strategy.

Starting and doing business in the Philippines requires information and knowledge.

DBC specializes in helping foreign companies acquire the specific facts they need to establish their office and find clients and partners. Introduce you to the necessary government agencies to obtain business permits and apply for tax incentives.

Business Plan Consultancy

Whether you are a local or international company DBC’s team of professional consultants has the required expertise to prepare comprehensive Feasibility Studies, Business Planning, Market Entry Strategy Reports, Market Research and Real Estate Development Market Studies.

Business Registration Consultant

DBC has assisted many local and foreign businesses, who wish to start doing business in the Philippines in completing their company registration requirements. Organizing all that is needed to have your Philippines business registration accomplished smoothly and rapidly with the required government agencies. Most companies will need to apply or register with the SEC, DTI, BIR, SSS, Pag-IBIG, and PhilHealth. DBC will explain the different company structures available in the Philippines and advise you on the advantages of each one.


Let DBC be your business consultant in the Philippines