How Much Capital Is Needed to Start a Corporation in the Philippines?

September 10, 2026

You’ve decided to incorporate in the Philippines, and the first number you need is the one nobody seems to agree on: how much money do you actually need in the bank? The honest answer is—it depends on who owns the company and what it does. Here’s the breakdown.

The short version: the Revised Corporation Code (Republic Act No. 11232) removed the old fixed minimum capital requirement for most corporations. Section 12 of the law states that stock corporations “shall not be required to have a minimum capital stock, except as otherwise specifically provided by special law.” That’s good news if you’re a Filipino entrepreneur starting a domestic business. It’s more complicated if you’re bringing in foreign capital or entering a regulated industry—so let’s go through the scenarios you’re most likely to be in.

Do 100% Filipino-owned corporations have a minimum capital requirement?

Generally, no. For most domestic corporations engaged in ordinary business activities, there’s no fixed peso amount you’re legally required to deposit. In practice, though, the SEC still expects your declared capital to be a reasonable, working figure—not a token amount that can’t credibly run a business—and the traditional 25%/25% rule still guides how incorporators structure their capital: at least 25% of your authorized capital stock should be subscribed, and at least 25% of that subscribed amount should be paid up at incorporation. Many small corporations still register with paid-up capital in the ₱5,000–₱10,000 range as a starting baseline, then increase it as the business grows.

What if my corporation has foreign investors?

This is where the real numbers show up. Under the Foreign Investments Act, a corporation with more than 40% foreign equity that will do business in the domestic market generally needs at least USD 200,000 in paid-up capital. That threshold drops to USD 100,000 if the company either:

Employs at least 50 direct Filipino employees, or
Uses advanced technology (as determined by the relevant government agency)

If your company is an export enterprise—meaning it sells at least 60% of its output abroad—you’re exempt from the USD 200,000 rule and can generally capitalize the business like a domestic corporation. This exemption is a major reason export-oriented startups and BPO-type businesses often prefer that structure.

Does a One Person Corporation (OPC) need more capital?

No special minimum applies just because you’re registering as an OPC. A Filipino-owned OPC follows the same general rule as any other domestic corporation—no fixed capital floor unless a special law applies to your industry. If a foreign national is the sole stockholder, the same USD 200,000 / USD 100,000 foreign investment thresholds described above still apply.

Are there industries with their own minimum capital rules?

Yes—and this is where founders get caught off guard. Some examples:

Business Type	Minimum Capital
Ordinary domestic corporation	No fixed minimum (practical baseline ~₱5,000–₱10,000)
Foreign-owned, domestic market enterprise	USD 200,000 (or USD 100,000 with 50+ employees or advanced tech)
Export enterprise (60%+ output exported)	No fixed minimum, foreign equity exemption applies
Financing/lending company	₱10,000,000
Foreign retail trade enterprise	₱25,000,000, plus ₱10,000,000 minimum investment per store
Local recruitment/manpower agency	₱500,000
Insurance company	₱1,000,000,000

Banks, financing companies, and other institutions regulated by the Bangko Sentral ng Pilipinas (BSP) have their own—much higher—capital rules set by their charters and BSP circulars, so if you’re entering a regulated sector, check with that agency before you finalize your Articles of Incorporation.

Can I register with low capital and increase it later?

Yes. Authorized capital, subscribed capital, and paid-up capital are three different things, and you’re not locked into your starting number forever. Many founders register with a modest paid-up amount and increase their authorized capital stock later through an SEC amendment once the business needs a bigger balance sheet to support financing, bidding requirements, or investor rounds. It’s a fairly routine filing, though it does take time and documentation.

Is registering with very low capital actually a good idea?

Legally, in most cases, yes. Commercially, not always. A corporation with ₱5,000 in paid-up capital signing six-figure contracts, applying for a business loan, or bidding on a government project can run into credibility issues with banks, landlords, and clients who expect to see financial substance behind the entity they’re transacting with. Undercapitalization can also raise piercing-the-corporate-veil risk if the company can’t meet its obligations. The legal minimum and the practical minimum aren’t always the same number.

When to Call in Professionals

Figuring out which capital rule applies to your specific situation—Filipino-owned versus foreign-owned, domestic market versus export enterprise, regulated versus unregulated industry—isn’t always straightforward from the outside, and getting it wrong can mean delays at the SEC or a capital structure that doesn’t serve you six months in. Dayanan Consulting helps founders determine the right capital structure before filing, not after the SEC sends back a query letter. If you’re ready to incorporate and want it done correctly the first time, our incorporation services can walk you through capital structuring, SEC filing, and post-registration compliance.

The Bottom Line

Most 100% Filipino-owned corporations can start with minimal paid-up capital under the Revised Corporation Code. Foreign-owned domestic market enterprises generally need USD 200,000 (or USD 100,000 under certain conditions), while export enterprises and several regulated industries follow their own separate rules. Before you file, confirm which category your business falls into—it’s the single biggest factor in how much capital you’ll actually need.

FAQ

Is there a universal minimum capital to start a corporation in the Philippines?
No. The Revised Corporation Code removed the general minimum for most corporations. Whether a minimum applies to you depends on ownership structure and industry.

How much capital does a foreigner need to start a business in the Philippines?
Generally USD 200,000 for a domestic market enterprise with more than 40% foreign equity, reduced to USD 100,000 if the company employs at least 50 Filipino workers or uses advanced technology.

Can I start a corporation with only ₱5,000?
Legally possible for many 100% Filipino-owned, unregulated businesses, though most founders capitalize higher for credibility with banks, landlords, and clients.

Does an OPC have a special minimum capital rule?
No. A Filipino-owned OPC follows the same general rule as other domestic corporations; a foreign-owned OPC follows the same foreign investment thresholds.

What’s the difference between authorized, subscribed, and paid-up capital?
Authorized capital is the maximum shares your corporation can issue. Subscribed capital is what shareholders commit to buy. Paid-up capital is what’s actually been paid in—the figure regulators and banks look at most closely.

Can I increase my capital after incorporating?
Yes, through an SEC amendment to your Articles of Incorporation once your business needs a larger capital base.

How Exporting Services Exempts Foreign Firms from $200k Capital Requirements

September 2, 2026

The $200,000 Capital Threshold and the Export Exemption

Under the Foreign Investments Act of 1991 (Republic Act No. 7042, as amended by RA 11647), foreign investors seeking 100% ownership of a Domestic Market Enterprise (DME) must contribute a minimum paid-in capital of US$200,000. While RA 11647 allows this requirement to be reduced to US$100,000 for companies that utilize DOST-certified advanced technology, qualify as startup enablers, or employ at least 15 direct Filipino workers, the capital threshold remains a substantial obstacle for overseas SMEs and service providers.

Foreign businesses providing services to overseas clients can bypass the US$200,000 paid-in capital requirement completely by qualifying as an Export Enterprise.

What Qualifies as an Export Service Enterprise?

Section 3 of the Foreign Investments Act defines an Export Enterprise as a company that exports at least 60% of its total output or gross sales revenue to customers located outside the Philippines.

For modern service-based industries—such as software engineering, IT consulting, digital marketing, customer support, and offshore back-office operations—qualification depends on revenue source:

Domestic Market Enterprise: Generates more than 40% of its total gross service revenue from clients located inside the Philippines.
Export Service Enterprise: Generates 60% or more of its total gross service revenue from foreign buyers located outside the country.

Because Export Enterprises draw capital into the Philippines rather than competing for domestic market revenues, the law exempts them from the US$200,000 minimum equity rule. Instead, foreign export firms are subject to general Securities and Exchange Commission (SEC) capital requirements under the Revised Corporation Code, allowing incorporation with standard operational capital.

Structural Comparison: Domestic Market vs. Export Enterprise

Operational Feature	Domestic Market Enterprise (DME)	Export Service Enterprise
Foreign Ownership Ceiling	Up to 100% (outside the Foreign Investment Negative List)	Up to 100%
Minimum Paid-In Capital	US$200,000 (or US$100,000 if qualified under RA 11647)	Exempt from US$200,000 threshold (Standard SEC capital)
Revenue Source Requirement	Serves domestic clients (> 40% local revenue)	60% or more of total revenue from foreign clients
Monitoring Agencies	Securities and Exchange Commission (SEC)	SEC and Board of Investments (BOI)
Primary Target Market	Local B2B, retail, local consultancy	IT-BPO, SaaS, KPO, offshore back-office operations

4-Step Registration Process for Foreign Export Firms

Entity Incorporation via SEC eSPARC: Register a domestic corporation with foreign equity. The primary purpose clause in the Articles of Incorporation must explicitly state that services are rendered to overseas clients.
BOI Export Compliance Registration: Under RA 11647, foreign-owned export enterprises must register with the Board of Investments (BOI) to record their export commitment and submit annual compliance reports.
BIR Tax and Invoicing Setup: Register with the Bureau of Internal Revenue (BIR). Cross-border service contracts must be properly structured to support foreign billing and qualify for 0% Value-Added Tax (VAT) zero-rating where applicable.
Local Government Licensing: Secure the local Mayor’s Permit and Barangay Clearance from the LGU where the operational or virtual office is registered.

Compliance and Risk Management

Sustaining Export Enterprise status requires ongoing operational adherence:

Annual Export Ratio Verification: Corporations must submit audited financial statements and foreign earnings documentation to the SEC and BOI annually to verify that the 60% foreign revenue threshold is met.
Consequences of Non-Compliance: If foreign export sales drop below 60%, the BOI notifies the SEC, and the firm will be ordered to cap its domestic sales at 40% of total revenue. Failure to comply or inject the required US$200,000 capital can result in administrative penalties or cancellation of SEC registration.
FIA vs. PEZA/BOI Incentive Thresholds: While a 60% export threshold waives the US$200,000 equity requirement under the Foreign Investments Act, obtaining fiscal incentives (such as PEZA or BOI Income Tax Holidays and VAT exemptions under the CREATE Act framework) requires foreign-owned locators to export at least 70% of total output.

Ready to Establish Your Export Service Enterprise in the Philippines?

Navigating foreign equity classifications, SEC eSPARC registrations, and BOI export reporting requires precise legal and operational setup. Dayanan Consulting provides end-to-end corporate formation, tax compliance, and regulatory licensing tailored specifically for foreign investors.

Book a Free Corporate Equity & Market Entry Consultation with Dayanan Consulting Today

US Companies Expanding to the Philippines: Why BIR and SEC Compliance Should Be Your First Priority

April 15, 2026

Expanding internationally is a strategic milestone for any organization. For many U.S. companies, the Philippines has become one of the most attractive destinations for growth in Southeast Asia.

With its highly skilled English-speaking workforce, competitive labor costs, and strong service sector, the Philippines offers a compelling environment for outsourcing, shared services, tech operations, and regional headquarters.

However, while market entry may look straightforward on paper, regulatory compliance in the Philippines — particularly with the Securities and Exchange Commission (SEC) and the Bureau of Internal Revenue (BIR) — is where many foreign companies face unexpected complexity.

Before hiring employees or generating revenue, your financial and regulatory foundation must be properly structured.

Why US Companies Are Expanding to the Philippines

Several factors continue to drive U.S. expansion into the Philippine market:

Access to a skilled and cost-efficient workforce
Strong BPO and IT infrastructure
Favorable time zone overlap with the United States
Growing domestic consumer market
Strategic ASEAN positioning

But expansion success depends not only on operational setup — it depends on regulatory compliance.

Understanding the Role of the Philippine SEC for Foreign Companies

The Philippine Securities and Exchange Commission (SEC) regulates corporate registration and business entities in the Philippines.

For U.S. companies expanding to the Philippines, registration with the SEC is mandatory when establishing:

A Domestic Corporation (subsidiary)
A Branch Office
A Representative Office
A Regional Headquarters

The SEC is responsible for:

Approving your Articles of Incorporation
Issuing your Certificate of Registration
Regulating corporate governance compliance
Monitoring reportorial requirements

Failure to comply with SEC reportorial requirements can result in penalties, suspension, or revocation of registration.

For foreign companies, structuring the correct entity type at the beginning is critical — as it directly affects taxation, liability, and operational flexibility.

The Bureau of Internal Revenue (BIR): Tax Compliance Starts Immediately

Once SEC registration is completed, registration with the Bureau of Internal Revenue (BIR) follows.

The BIR oversees:

Taxpayer registration
Issuance of Authority to Print official receipts
Books of accounts registration
Tax identification numbers (TIN)
Monthly, quarterly, and annual tax filings

This is where many U.S. companies underestimate the administrative requirements.

Even newly registered entities — including those not yet profitable — may have ongoing filing obligations.

Common BIR Compliance Requirements Include:

Registration of manual or computerized books of accounts
Monthly VAT or percentage tax filings
Withholding tax reporting
Annual income tax returns
Financial statement submission

Non-compliance may lead to:

Financial penalties
Accrued interest charges
Audit exposure
Business permit renewal issues

For U.S. companies unfamiliar with Philippine tax procedures, professional bookkeeping support becomes essential.

Why Outsourced Bookkeeping Is Critical for US Companies Expanding to the Philippines

When entering a new regulatory environment, financial clarity is not optional — it is infrastructure.

Outsourcing bookkeeping in the Philippines provides several strategic advantages:

1. Immediate Local Compliance Expertise

Philippine tax and accounting processes differ significantly from U.S. GAAP reporting systems.

A local outsourced bookkeeping team ensures:

Proper transaction recording aligned with BIR standards
Accurate tax calculations
Timely filing of statutory reports
Maintenance of compliant books of accounts

This prevents costly corrections later.

2. Cost-Efficient Market Entry

Hiring in-house finance staff during early expansion increases fixed overhead.

Outsourcing eliminates:

Full-time salary commitments
Employment benefits and statutory contributions
Recruitment and onboarding costs
Infrastructure setup

This allows U.S. companies to allocate capital toward revenue-generating activities instead of administrative overhead.

3. Alignment Between US Headquarters and Philippine Operations

One of the biggest challenges for multinational companies is reconciling local statutory reporting with consolidated global reporting.

Professional outsourced bookkeeping ensures:

Clean financial records
Organized documentation
Reporting that can be easily integrated into parent company financial statements

This supports transparency for leadership, investors, and auditors.

4. Reduced Regulatory Risk

BIR audits and SEC compliance checks are part of operating in the Philippines.

Proper bookkeeping ensures:

Financial records are audit-ready
Required reports are submitted on time
Tax computations are properly documented

Risk mitigation begins with accurate records.

Structuring Your Philippine Expansion Correctly from Day One

For US companies expanding to the Philippines, the correct sequence typically includes:

SEC registration of the chosen entity type
BIR registration and tax mapping
Books of accounts registration
Setup of accounting systems
Ongoing bookkeeping and compliance monitoring

Skipping steps or delaying compliance can create operational bottlenecks that slow growth.

Why Dayanan Business Solutions Supports International Companies

At Dayanan Business Solutions, we assist U.S. and international companies entering the Philippine market by providing:

SEC registration support
BIR registration guidance
Outsourced bookkeeping services
Ongoing tax and financial compliance management

We understand that foreign-owned entities require:

Regulatory clarity
Accurate financial reporting
Cost-efficient operational support
Confidence in local compliance

Our goal is to ensure your Philippine operations are compliant, structured, and financially organized from the beginning.

Frequently Asked Questions (FAQs)

1. What are the first steps for US companies expanding to the Philippines?

The first step for US companies expanding to the Philippines is choosing the appropriate legal structure (subsidiary, branch office, representative office, or regional headquarters). After selecting the entity type, registration must be completed with the Philippine Securities and Exchange Commission (SEC), followed by registration with the Bureau of Internal Revenue (BIR) for tax compliance. Proper bookkeeping systems should also be established immediately to ensure regulatory compliance from day one.

2. Do US companies need to register with both the SEC and BIR?

Yes. Foreign companies must register with the SEC to legally establish their entity in the Philippines. After SEC registration, the company must register with the BIR to obtain a Tax Identification Number (TIN), register books of accounts, and comply with tax filing requirements. Both registrations are mandatory for legal operations.

3. What is the difference between a Philippine subsidiary and a branch office?

A subsidiary is a separate domestic corporation incorporated under Philippine law, even if fully foreign-owned. A branch office, on the other hand, is an extension of the foreign parent company and is not considered a separate legal entity. The choice between the two affects taxation, liability, and capital requirements, making professional guidance essential.

4. What taxes must foreign companies file in the Philippines?

Depending on the structure and business activity, foreign companies may be required to file:

Corporate income tax
Value-added tax (VAT) or percentage tax
Withholding taxes
Annual financial statements

Filing obligations often apply even if the company has not yet generated revenue.

5. Is bookkeeping required even if the Philippine entity is not yet profitable?

Yes. Even newly registered companies without active revenue may have ongoing filing and reporting obligations with the BIR and SEC. Proper bookkeeping ensures that all transactions are recorded accurately and that compliance deadlines are met, preventing penalties.

6. Why should US companies outsource bookkeeping when expanding to the Philippines?

Outsourcing bookkeeping provides immediate access to local compliance expertise without the cost of hiring a full-time finance team. It ensures accurate financial records, timely tax filings, reduced risk of penalties, and better alignment between Philippine operations and US headquarters reporting systems.

7. How long does it take to register a foreign-owned company in the Philippines?

The timeline varies depending on the entity type and document readiness, but SEC registration typically takes several weeks. BIR registration follows thereafter. Delays can occur if documentation is incomplete or compliance requirements are misunderstood, which is why professional assistance can streamline the process.

8. Can US companies own 100% of a business in the Philippines?

In many industries, 100% foreign ownership is allowed. However, certain sectors remain restricted under Philippine foreign investment regulations. It is important to verify whether the intended business activity falls under any ownership limitations before registration.

Final Thoughts: Expansion Is Strategic. Compliance Is Foundational.

The Philippines presents tremendous opportunities for U.S. companies seeking operational efficiency and regional growth.

But expansion success depends on more than talent and market strategy.

It depends on:

Proper SEC registration
Full BIR compliance
Accurate bookkeeping systems
Ongoing regulatory alignment

If your company is planning to expand to the Philippines, ensure that your financial and regulatory foundation is established correctly from day one.

Because in international expansion, compliance is not an afterthought — it is a competitive advantage.

Dayanan Business Solutions is here to help you navigate through the Philippines Corporate Compliance landscape. Contact us.

Beyond the Sole Proprietor: 5 Surprising Truths About Starting a One Person Corporation in the Philippines

March 10, 2026March 9, 2026

One Person Corporation in the Philippines

For nearly four decades, the Philippine entrepreneurial journey was limited by a 39-year-old Corporation Code that barred the “company of one”. To gain corporate protection, solo founders had to recruit “dummy” incorporators—usually friends or relatives—just to meet the mandatory five-person threshold.

The enactment of Republic Act No. 11232, also known as the Revised Corporation Code (RCC), changed everything by democratizing corporate protection. By introducing the One Person Corporation (OPC), the law finally recognized that a single individual can build a scalable, protected business without a crowded board.

Here are five crucial truths you need to know about setting up an OPC.

1. Your Personal Assets Finally Have a Legal “Shield”

Transitioning from a sole proprietorship to an OPC is a powerful exercise in risk management.

In a sole proprietorship, you and the business are legally indistinguishable.
If the business defaults on a loan or loses a lawsuit, your personal home, car, and savings are at risk.

An OPC changes this by granting your business a Separate Juridical Personality. This creates a legal “shield” where your liability is limited to your invested capital. The law explicitly states: “An OPC is a legal entity distinct from its single stockholder. This allows the corporation to enter into contracts, acquire assets, and engage in legal actions under its corporate name.”.

By creating this legal distinction, you ensure business debts do not become personal tragedies. This status forms the foundation of a modern, “lean” risk profile.

2. You Don’t “Convert” to an OPC—You Start Over

A common trap for established business owners is thinking they can seamlessly “convert” a Department of Trade and Industry (DTI) registration into an OPC. From a legal standpoint, this is a “rebirth,” not a conversion.

Technically, a sole proprietorship cannot be directly transformed.
Strategically, you must maintain your DTI registration until the SEC process is finalized to ensure business continuity.
You must register a new entity via the SEC eSPARC system and execute a Deed of Assignment to transfer assets and liabilities.
The SEC requires the Latest Audited Financial Statements (AFS) of your sole proprietorship to allow this transfer.
Only after the OPC is fully operational should you retire the old DTI registration.

3. The “Buddy System” for Solo Founders (Nominees)

The OPC is designed for solo stockholders, but it is legally built for Perpetual Existence. To ensure the business survives beyond your lifespan, the law requires a “safety net” featuring a Nominee and an Alternate Nominee. These individuals step in to manage the business if you pass away or become incapacitated.

Furthermore, the law requires three distinct corporate roles:

President/Director: You. (Either Filipino/Foreigner)
Corporate Secretary: This cannot be you; they must be a Filipino citizen and a resident of the Philippines.
Treasurer: You can assume this role, but you must post a surety bond that scales with your Authorized Capital Stock (ACS). For instance, if your ACS is PHP 1,000,000, your surety bond coverage must be PHP 1,000,000. This bond must be renewed every two years.

4. The US$200,000 Doorway for Foreign Founders

For foreign tech founders and investors, the OPC is an excellent vehicle for 100% ownership, provided they comply with the Foreign Investments Act (FIA).

For domestic-market enterprises with more than 40% foreign equity, the FIA generally requires a US$200,000 minimum paid-in capital. However, foreign founders can look for two strategic loopholes for a leaner entry:

The Tech/Employment Carve-out: The requirement drops to US$100,000 if you use SEC-certified advanced technology or employ at least 50 direct Filipino employees.
The Export Loophole: If the OPC is an Export Enterprise (selling more than 60% of its output abroad), the US$200,000 minimum generally does not apply.

5. Professionalism is a “Subscription” to Credibility

In business, compliance is the subscription fee for credibility. While sole proprietorships are informal, an OPC is a regulated entity that builds trust with banks through a mandatory paper trail.

Fortunately, there is a “lean” advantage during setup: per Section 7 of SEC Memo 7-2019, an OPC is not required to submit and file Bylaws. The SEC eSPARC (Electronic Simplified Processing of Application for Registration of Company) system also reduces friction by allowing the digital uploading of authenticated or notarized documents.

However, you must be aware of critical restrictions:

The Professional Ban: Natural persons licensed to practice a profession (like lawyers, doctors, or CPAs) cannot organize as an OPC to practice that profession.
Sector Exclusions: Banks, insurance companies, pre-need firms, and public companies cannot adopt the OPC structure.

To maintain your standing, you must commit to annual reportorial requirements, including Audited Financial Statements (AFS), the General Information Sheet (GIS), and mandatory disclosures of “self-dealings” between you and your corporation.

The Future of the “Company of One”

The One Person Corporation is more than a registration type ; it is a tool that allows solo founders to operate with the legal gravity of a conglomerate. By leveraging the eSPARC system and the Revised Corporation Code, you can build a business with Perpetual Existence that survives long after you step away.

FAQs

Can I convert my DTI sole proprietorship to an OPC? No, a sole proprietorship cannot be directly transformed into an OPC. You must register a new entity through the SEC eSPARC system and execute a Deed of Assignment to transfer your assets.

Do I need a Corporate Secretary for an OPC? Yes. While you are the sole stockholder, the law requires you to appoint a Corporate Secretary who is a Filipino citizen and a resident of the Philippines. You cannot act as your own Corporate Secretary.

Can I be the Treasurer of my own OPC? Yes, you can act as the Treasurer of your OPC. However, if you appoint yourself, you are legally required to post a surety bond that matches your Authorized Capital Stock (ACS), which must be renewed every two years.

Can foreigners own an OPC in the Philippines? Yes, foreign nationals can own 100% of an OPC. However, for domestic-market enterprises, the Foreign Investments Act generally requires a minimum paid-in capital of US$200,000.

Do One Person Corporations need to submit Bylaws? No. According to Section 7 of SEC Memo 7-2019, an OPC is not required to submit and file Bylaws, which reduces administrative friction during setup.

Can licensed professionals form an OPC? No. Natural persons who are licensed to practice a profession, such as doctors, lawyers, or CPAs, cannot organize as an OPC for the purpose of practicing their profession.

Get Expert Guidance on Your OPC Registration

Transitioning from a sole proprietorship or starting a new One Person Corporation involves navigating specific legal hurdles—from the SEC eSPARC registration to securing the mandatory surety bond for Treasurers. Don’t let administrative friction or compliance “subscription fees” slow down your vision.

Whether you are a local entrepreneur seeking a personal asset shield or a foreign founder looking to navigate the US$200,000 entry requirement, our team is here to help you build a business designed for perpetual existence.

Connect With Our Strategy Team

Inquiry Type	Best For…
OPC Setup & SEC Filing	New founders ready to use the eSPARC system.
Asset Transfer Consultation	Business owners executing a Deed of Assignment from a DTI registration.
Foreign Investment Strategy	Foreigners navigating the FIA and capital requirements.
Compliance & Reportorials	Annual GIS, AFS, and disclosure management

The Simplified Roadmap: How Foreign Companies Register in the Philippines

October 28, 2025October 28, 2025

How to start your business in the Philippines

Why the Philippines?

The Philippines has become one of Asia’s most promising investment destinations. With its young, English-speaking workforce, competitive costs, and strategic location, it’s no wonder foreign investors are drawn here.

But here’s the truth: navigating Philippine business registration can feel like trying to read a map with missing labels. Between agency requirements, document authentication, and tax registrations, it’s easy to get lost in translation — both figuratively and literally.

This guide is your simplified roadmap to setting up your foreign company in the Philippines with clarity and confidence.

Step 1: Understand Your Options — Choose the Right Registration Type

Before diving into paperwork, decide how your business will legally operate in the country. The structure you choose will determine your obligations, tax treatment, and operational scope.

1. Branch Office

A branch office is an extension of your foreign company operating in the Philippines.
It can engage in revenue-generating activities but is not considered a separate legal entity from its parent company.
The parent company is fully liable for all obligations and debts of the branch.

This setup is ideal if your goal is to directly conduct business in the Philippines under your existing brand and management.

2. Representative Office

A representative office can promote the parent company’s products or services but cannot generate income locally.
All operating expenses must be funded by the head office.
This is perfect for market research, liaison activities, or quality control operations.

If you’re still testing the waters, this structure provides a low-risk way to establish presence and build relationships without committing to full commercial operations.

3. Regular Domestic Corporation

Why Choose a Regular Corporation?

If your goal is to establish a Philippine-registered business entity that can grow locally, attract investors, and operate independently from a parent company, this is your best option. It also offers more flexibility for ownership, capital raising, and long-term expansion.

• Ownership Structure: Composed of 2 to 15 incorporators (shareholders), who may be individuals or corporate entities.
• Liability: Each shareholder’s liability is limited to the amount of their capital investment.
• Capital Requirements: There is no general minimum capital requirement, except for certain regulated industries.
• Management: Governed by a Board of Directors, elected annually by the shareholders.
• Lifespan: Perpetual existence (unless otherwise stated in the Articles of Incorporation).

Key Features:

A regular stock corporation (also called a domestic corporation) is the most common type of business entity in the Philippines. It is a separate legal entity from its owners (called shareholders), meaning the corporation can own property, incur debts, and enter into contracts in its own name.

Step 2: Secure Name Verification and Endorsement

Your company name must be verified and reserved through the Securities and Exchange Commission (SEC). This step ensures that no other entity in the Philippines is using your chosen name.

What You’ll Need:

Verified corporate name
Proof of parent company’s existence (authenticated by the Philippine Consulate or via Apostille)
Board resolution authorizing the Philippine operations

Basic Incorporation Steps:

1. Reserve a Corporate Name – Verify and reserve your company name through the SEC Company Registration System (CRS).
2. Prepare Incorporation Documents – Articles of Incorporation, By-Laws, Treasurer’s Affidavit, Cover Sheet, and other SEC Forms.
3. File with the SEC – Submit all requirements either online or at the SEC office. Once approved, you’ll receive your Certificate of Incorporation.
4. Register with Other Agencies – Obtain your local business permits (Barangay, Mayor’s, and BIR) and register with SSS, PhilHealth, and Pag-IBIG if you’ll employ staff.

Step 3: Submit Registration Documents to the SEC

Once your name is cleared, it’s time to file your application for registration.

Required Documents:

SEC application form (Branch or Representative Office)
Certified copy of Articles of Incorporation and By-laws
Audited financial statements of the parent company
Board resolution approving the establishment of a Philippine office
Appointment of a local resident agent

Step 4: Obtain Local Business Permits and Tax Registration

Once your SEC registration is approved, you must comply with local government and tax requirements. These steps legitimize your operations and enable you to hire staff or open a local bank account.

Key Permits to Secure:

Barangay Clearance (local community permit)
Mayor’s/Business Permit (from the city or municipality)
BIR (Bureau of Internal Revenue) registration and tax identification
Registration with social agencies (SSS, PhilHealth, Pag-IBIG) if hiring employees

Why This Step Matters:

Skipping or delaying local registrations can lead to penalties or suspension of operations. Completing these early helps you establish banking relationships and ensures smooth payroll and tax compliance later on.

Step 5: Open a Corporate Bank Account and Begin Operations

After registration and permits, open a corporate bank account with an accredited Philippine bank. You’ll need your SEC Certificate of Registration, local permits, and authorized signatories’ IDs.

Once set up, you can officially conduct transactions, remit funds from abroad, and start hiring or onboarding local staff. This is where your business journey in the Philippines truly begins.

Timeline: How Long Does It Take?

For most foreign entities, the process typically takes 4 to 8 weeks, depending on document readiness and government processing times.

Name verification: 1–3 business days
Document authentication and filing: 2–3 weeks
SEC approval and post-registration: 2–4 weeks

Preparation is key — delays usually happen when documents aren’t properly authenticated or when signatories are based abroad and hard to coordinate. (Note timeline may vary and the timeline listed above only applies to a regular domestic corporation. For branch office and representative office it will take longer.)

Frequently Asked Questions

1. Can a foreign company own 100% of a Philippine business?

Yes, in most industries. However, certain sectors like retail, media, and land ownership have restrictions under the Foreign Investments Negative List.

2. What’s the minimum capital requirement?

Branch Office: Typically USD 200,000, but can be lower if exporting at least 60% of products/services.
Representative Office: USD 30,000, remitted to fund operations.
Regular Domestic Corporation: no minimum capital requirement depending on the industry.

3. Do I need a Filipino partner?

Not necessarily. Many foreign companies/foreigners can operate 100% foreign-owned businesses without a local equity partner. (With some restrictions or limitations)

4. How can Dayanan Consulting help?

Dayanan provides end-to-end assistance — from incorporation, SEC filings, to post-registration compliance, annual company maintenance, bookkeeping, payroll and HR support — ensuring your business is set up legally, efficiently, and without guesswork.

Conclusion: Start Strong with Expert Guidance

Registering a foreign company in the Philippines may seem daunting, but with the right roadmap and experienced partners, the process becomes straightforward and predictable.

At Dayanan Consulting, we’ve guided hundreds of foreign companies — from tech startups to multinational enterprises — through every stage of Philippine business registration. We know the challenges, the shortcuts, and the best practices that make your setup faster and compliant.

Ready to establish your presence in the Philippines?
Book a consultation today and start your journey with Dayanan.
Contact us

Registration of Cosmetic Products in the Philippines Made Easy

May 27, 2021

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:

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
Log in at the FDA e-portal (https://ww2.fda.gov.ph).
Click on “New Case” and accomplish the ASEAN Notification Form.
Download the “Order of Payment” and assign this task to the FDA Cashier.
Pay the fee either through any Landbank branch or by online Bancnet payment methods.
Wait for the Result of Application.
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 Directive	Regulations and Prohibitions
Annex II	Substances that are prohibited to form part of the composition of cosmetics products
Annex III	Substances that are prohibited to be contained in cosmetic products except for the ones subject to restrictions and conditions laid down
Annex IV	Coloring agents that can be used in cosmetic products
Annex VI	Preservatives 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.

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

September 8, 2020August 6, 2020

If you are interested to sell, import, and distribute FDA-approved food supplements in the Philippines, then the Food and Drug Administration (FDA) is your first stop. This article, Part 2 of this series, discusses the detailed requirements you need to prepare to get FDA approval as well as the corresponding fees and charges.

What kind of supplements need to be registered with the FDA?

All types of processed foods, including food supplements that contain no additional pharmacologically active ingredients, must receive approval first from the FDA. It must be noted that per FDA Circular 2016-014, the registration process applies to low-risk, medium-risk, and high-risk food products (refer to our previous article for a discussion on these categories).

How many kinds of FDA registrations do I need for my product?

One registration may satisfy different packaging sizes for the same product as long as they share the same brand and product names. They must also have exactly similar formulation and proportion of ingredients. When it comes to the label information, everything must also be the same except for net weight.

If you are a manufacturer, trader, or distributor (whether importer, exporter, or wholesaler), you need to get a License to Operate (LTO) before you can obtain a certificate of product registration (CPR).

To get prioritized in food registrations, you must attend and complete the Qualified Person in Industry Regulatory Affairs (QPIRA) Training organized by the Center for Food Regulation and Research (CFRR). Before availing the services of a Liaison Officer to help you transact with the FDA, check for their names in the FDA website first.

What are the requirements for FDA approval in the Philippines?

FDA-approved food supplements in the Philippines present these documents first:

Notarized and completed Integrated Application Form
Proof of payment of fees
Clear and complete loose labels or artworks of all packaging sizes
Sticker of importer for imported food supplements.
Pictures of the product from all different angles for all packaging sizes
For food supplements, a sample in actual commercial presentation needs to be submitted
Certificate of analysis to demonstrate compliance with Codex, national and other standards – Physical, Chemical and Microbiological Analysis, stability data of the finished product and Safety Data
Documentation to substantiate the use of claims in the given case
Certification to support use of logo’s (e.g. Halal, Kosher, Organic)
Certificate of analysis to determine compliance with applicable standards (e.g. Codex, Philippine National, etc.)
Relevant scientific studies to support the use of products for specific purposes
Certificate of analysis to determine compliance with FDA circular No. 2013
Quantitative analysis and computations to support nutrition facts/nutrient content claims
Scientific researches or studies published in peer-reviewed scientific journals to support declaration of health and nutrition claims
Other relevant supporting documents to substantiate claims other than health and nutrition
Additional requirements to address uncertainties on safety as deemed necessary

For more detailed information on these requirements, check out FDA Circular 2016-014 here.

How do I process my registration with FDA Philippines?

Download the Integrated Application Form [11] from the FDA website and fill-in the required details.
After filling up the document, it will generate a worksheet email which you have to send to pair@fda.gov.ph. A maximum of 10 applications with the FDA may be forwarded in a single email.
Your application will then be scheduled through a Document Tracking Log (DTL) sent to your email within two days.
After receiving the DTL, make sure to pay the fees. You can submit your application via soft copy (USB device). Note that only applications scheduled for the day will be accommodated.

What fees and charges do I need to pay for an FDA Philippines registration of my supplements?

This schedule of fees is based on FDA Administrative Order 2001-50

1) Product classification = PhP 500.00

2) Initial Registration for Food Supplements = PhP 1,000.00 (Valid for up to 2 years)

3) Renewal of Registration for Food Supplements = PhP 5,000.00 (Valid for up to 3 years)

4) Amendment of CPR = PhP 200.00

5) Re-application Fees = PhP 200.00

Please note that payment of fees cannot exceed ten applications. Manufacturing and distribution licenses require the payment of a separate fee. Such a license is initially valid for 1 year and 2 years upon renewal.

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

April 13, 2021May 25, 2020

As the threat of the COVID-19 pandemic continues to loom, the adage “health is wealth” has never been more true. People are starting to invest more seriously in the physical well-being of their families and loved ones. This is where FDA-approved food supplements in the Philippines come in.

With experts saying that a vaccine is at least a year away, maybe even more, prevention is taking center stage. Supplements help individuals increase their daily intake of recommended energy and nutrient requirements. This makes people less vulnerable to common illnesses as well as the dreaded COVID-19.

If you are thinking of selling, importing, and distributing food supplements in the Philippines, you must first obtain the approval of the Food and Drug Administration (FDA). This article provides you the basics of FDA Philippines food standards, including items such as the difference between drug-based and processed food categories for supplements, prohibited and allowed ingredients, making therapeutic claims, and what to include in a food label.

In the upcoming Part 2 article, we will discuss the detailed requirements for FDA approval and the corresponding fees and charges.

What are Food or Dietary Supplements?

As defined by Administrative Order No. 2014-0029, these are processed food products that help supplement the diet. A food supplement may contain dietary ingredients such as vitamins, minerals, herbs, amino acids, and other dietary substances made from plant, animal, natural, or artificial matter. It may take various forms, including those of liquids, capsules, pills, tablets, powders, and gels. It is not marketed as a conventional food or as replacement for drugs and medicines.

Does my dietary supplement fall under the Food or Drug category?

Based on FDA Philippines Officer Order No. 22 s. 1991, your vitamin or mineral product will be classified as drug-based if it meets the following conditions:

1) Has clinical therapeutic claim/s with regards to a specific vitamin deficiency or disease;

2) Has a concentration per dosage form of greater than 150 percent of the Philippine Dietary Reference Index (PDRI) for water-soluble vitamins and/or greater than 105 percent of the PDRI for fat-soluble vitamins;

3) Takes the form of a pharmaceutical dosage or injectable; and

4) Has additional pharmacologically-active ingredients present

On the other hand, your product will be categorized as a food supplement (more specifically a “processed food”) if:

1) Its indication is that of “Dietary or Health Supplement;

2) Its concentration per dosage form is less than 105% of the PDRI for fat- soluble vitamins and/or less than 150 percent for water-soluble vitamins;

3) It may be available in both non-pharmaceutical and pharmaceutical dosage form except parenterals;

4) It is available as either a purified or a natural product; and

5) It contains no additional pharmacologically-active ingredients.

Under FDA Philippines Administrative Order No. 2014-0029 (Annex A), food products are further classified according to microbiological risk: low, medium, and high. If your dietary supplement contains herbs and botanicals and/or products with other nutritional substances, it will be categorized as a high-risk food; if it has vitamins and minerals and/or amino acids, it will be considered as a medium-risk food. The authorization process and the inspection priorities of the FDA would depend on these subcategories.

What ingredients can be included in my health supplement?

FDA-approved food supplements in the Philippines must meet the regulatory body’s key standards. Among these is the ASEAN Negative List, which details substances that should not be used in health supplements. The prohibited items include:

1) Deadly Nightshade

2) Marijuana

3) Hemlock

4) Chaparral

5) Opium / Poppy

For its part, FDA Philippines Circular 2006-016 enumerates all authorized food additives. These are some examples of what we call additives today:

1) Artificial sweeteners

2) Emulsifiers

3) Food Colors

4) Flavor Enhancers

5) Preservatives

Any food additive and functional classes that will be adopted by the Codex Alimentarius Commission (CAC) shall be automatically included as an addendum to the circular’s Appendix for Food Additives.

What kind of claims can my food supplement make?

Food product claims are regulated under FDA Philippines Circular 2007-002. This circular adopts the CAC Guidelines for Use of Nutrition and Health Claims as its standard for evaluating nutrition and health claims made in advertisements and food labels. It must be noted that products that make unproven claims could be banned from being sold in the Philippine market.

Other relevant regulations include:

1) Administrative order 2014-0029: prohibits the use of curative and therapeutic claims under Chapter VI, Part C of the Guidelines in the Registration of Processed Food Products.

2) Administrative Order 2014-0030: precludes the declaration of misleading and prohibited claims, specifically those in the labels of prepacked foods, under Section VII.

What should be on the label of my dietary supplement?

FDA Philippines Administrative Order No. 88-B s. 1984, as amended by Administrative Order 2014-0030, regulates the labeling of prepacked food, particularly food supplements. Its main provisions are:

1) The following details must be included on the label:

Product name

Brand name and/or trademark

Full ingredient list

Net content

Note: Either a per volume or per quantity indication is allowed. For multi-packs, the total quantity as well as the number of individual portions must be indicated.

Name and address of the manufacturer and/or repacker, packer, importer, trader, and distributor

Note: For imported products, the country of origin as well as the complete name and address of the importer should be indicated.

Lot identification

Storage conditions

Expiration date

Food allergen information (to be mentioned below the ingredient list)

Note: The following allergens and its derivative products must be clearly indicated on the label:
a) Cereals containing gluten
b) Crustaceans
c) Eggs
d) Fish
e) Milk, including lactose
f) Peanuts
g) Soybean
h) Sulfites
i) Tree nut and other nuts

Instructions for use

Nutrition information

Notes:
Full nutritional declaration is required, especially if a product claims to contain certain nutrients. Only foods for special purposes, medical or otherwise, are exempted. The quantities must be displayed in a tabular form and declared according to the portion size or a specific weight or volume. Vitamins and minerals are to be expressed in mg or µg. The exceptions are Vitamin A, D, and E, which are to be expressed in IU (International Units).

The indicated recommended daily allowance must conform to the Philippine Recommended Energy and Nutrient Intakes (RENI) for male adults aged 19 to 29. Foods for specific groups may use values applicable to such age groups, which will have to be indicated in the labeling. The actual nutrient content of vitamins and minerals should at no point be lower than 80 percent of what is declared on the label. There is no upper limit of overages for micro-nutrients and fiber though.

2) Additives must be properly labeled according to CAC standards.

3) All mandatory information on labels must be in English and/or Filipino. For imported products, the use of other languages is allowed but they should also carry a corresponding English translation.

4) For FDA-approved food supplements in the Philippines, the following statement in Filipino must be included in every advertisement or promotional effort as per Administrative Order No 2010-008:

“IMPORTANT REMINDER: THIS PRODUCT IS NOT A DRUG AND SHOULD NOT BE USED FOR ANY TYPE OF ILLNESS” (non-official translation)

This message should be printed in a size of at least one-third of the size of the largest letter or logo. It must be prominently printed using capital and bold letters using either Arial or Tahoma font.

5) Qualification for other standards such as for halal (Muslim) and kosher (Jewish) may be included in the label but would require proper substantiation. The assigned registration number may also be included on the label.

Need help with registering your food or dietary supplement?

If we handle it, you are guaranteed to have your FDA-approved food supplements in the Philippines. Let us help you. Contact us here and stay tuned for our next article on the registration process, requirements, and fees.

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

April 27, 2020April 26, 2020

Certificate of Product Registration FDA Phils.

Before you can start selling food items, cosmetics, or drugs in the Philippines, you need to secure first a Certificate of Product Registration (CPR) from the Food and Drug Administration (FDA).

Obtaining a CPR for your product involves knowing if it needs one, having the proper documents and requirements, and applying for it using the FDA’s system. Take note that each product being registered will have its own CPR. This means that each variant, flavor, and dosage will have its own certificate—basically, each item must be registered individually. There is no bulk processing option for FDA CPR application on their website.

Need to know more about how to apply for a Certificate of Product Registration from the FDA? Keep reading.

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

Products with Required Certificate of Product Registration (FDA CPR)
Requirements for FDA CPR
How to Get Certificate of Product Registration from FDA
Automatic CPR Renewal
Penalty for Products with no CPR

Products with Required Certificate of Product Registration (FDA CPR)

Which products need a CPR? The following items do:

1) Food Products (canned goods, bottled beverages, infant formulae, etc.)

2) Medicines, Pharmaceuticals, and Over-the-Counter Drugs

3) Medical Devices

4) Food Supplements (vitamins, minerals, energy boosters, etc.)

5) Toys

6) Veterinary Products (pet medications, vitamins, supplements, etc.)

7) Hazardous Household Products and Urban Pesticides (cleaning supplies, disinfectant sprays, etc.)

Do cosmetics need a Certificate of Product Registration?

Cosmetic products do not have a CPR, and instead are required to have a product notification. While the FDA needs to be informed regarding such cosmetics, the procedure outlined here is for obtaining a CPR only.

Requirements for FDA Certificate of Product Registration

If your product is listed above, you are required to process a CPR for your product. The following are the requirements for doing so:

1) A valid LTO or License to Operate which can be obtained from the FDA

2) A clear, scanned, and colored copy of loose labels of all packaging sizes for the products (or equivalent, as defined by FDA), as well as pictures of the product from all angles and in different packaging sizes. This allows easy recognition of a product as the same one being registered.

For food supplements, include blister packs, Alu-Alu packs, and secondary packaging (i.e. paper box or cardboard box).

3) Other requirements for traders, wholesalers, and distributors of locally manufactured food products / for importers and distributors

4) Documents to support product claims, such as:

Technical/nutrition health studies or reports
Market research studies
Certificate of analysis, quantitative analysis, and computations
Scientific reports or studies published in peer-reviewed scientific journals
Supporting certificates to allow the use of “Sangkap Pinoy”, Halal, Organic, Kosher, and other claims in compliance with current labeling requirements

5) Certificate of Analysis stating essential details to determine product compliance to food standards and regulations for the following:

Medium to high-risk products with standards of identity such as food for infants and young children, foods intended for special medical purposes, bottled water, etc) the certificate of analysis must be uploaded. The list of low, medium, and high risks can be found here on the FDA website.
Fortified food products covered by R.A. 8176 (iodized salt) and R.A. 8976 (cooking oil, flour, and refined sugar)

6) For food supplements, additional requirements include:

A stability study of the actual food supplement
Safety data, such as toxicity tests, must be attached to address safety concerns regarding the product.

7) Actual representative product sample of food supplement (for initial application only, and is not needed during CPR renewal).

Note: This is a list of general requirements; additional requirements and procedures may be required by the FDA depending on the product being registered. Confused? You can ask us about it.

Once you have these requirements, you can opt to register these products online using the FDA e-registration system, which can be found here.

How to Get Certificate of Product Registration from FDA

The following is the basic CPR e-registration procedure (as per FDA Circular 2016-014):

1) Secure your FDA E-registration log-in details.

2) Log in to the FDA website e-portal.

3) For first-time product applications, click on “New Case.”

4) Type the details of needed information of product, such as brand name, product name, food category, list of ingredients, product specifications, and other pertinent information.

5) Upload the required documents. The documents needed vary per product and if the product is for export or not. Please check the FDA website for more details.

Note: Maximum 2MB per attachment in PDF or PNG format, and 25 MB max for all attachments per application

6) Print Order of Payment and pay corresponding fees either in person at the FDA Main Office located in Alabang, through the Bancnet online payment gateway option as per FDA Advisory 2015-021, or whatever FDSA recommends on their site.

7) You can track the application progress through the process map indicated on the FDA website.

Automatic CPR Renewal

To make CPR renewal automatic, the following conditions must be met:

1) The renewal application must be filed before the expiration date of the CPR;

2) The automatic renewal fee must be paid prior to the filing of application; and

3) There should be no condition stated at the back of the issued Certificate of Product Registration.

In case of a condition, compliance with the condition must be met and proven by including a scanned copy of the acknowledgment letter from the FDA indicating that the condition has been met.

Penalty for Products with no CPR

What if you release the product to the market without the proper certification? Not only is this illegal, but once FDA is notified, they will issue a cease and desist order. They will take your products off the market AND require you to pay fines AND process CPRs for your products that were taken off the shelves.

Going against the law can destroy the name of your business as well. The FDA issues public health warnings against products without CPRs, and this means bad publicity for your brand.

All in all, the hassles and penalties brought about by not doing things properly is just not worth the risk.

Does the application for an FDA CPR sound too tedious?

If applying for a CPR sounds like a hassle to do it yourself, then let us help! Our team of experts can help you with the whole FDA process, not just for product registration. If you have any inquiries, you may contact us here.

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

April 25, 2021January 13, 2020

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:

What is an LTO? Why would you need one?
How to Apply for FDA eLTO User Account
License to Operate Requirements
Steps for FDA LTO Application
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:

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

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 Solutions Inc.! 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.