On October 1st, the Franchise Expo opened in Milan, with brands from 11 countries and a significant fact: in 2025 Italian franchising generated revenue. 39 billion euros With 62,449 outlets, according to Assofranchising. Two weeks later, on October 16, Captain D’s, an American chain of fish fast food restaurants with about 540 locations, announced that it was in talks with potential partners in Italy. In the summer, Wendy’s had announced the first opening in Milan, as part of a plan to have 170 restaurants by 2035. USA franchising Look at Italy, and he does so with determination.
The road goes in both directions. American brands are looking for Italian partners capable of opening and managing a network. And more and more Italian entrepreneurs are evaluating the United States based on a proven model, with public figures and a method to follow, rather than starting from a blank sheet of paper.
The difficult part is choosing. There are about 4,000 brands in franchising in the USA, each with its own characteristics. FDD, The information document that federal law requires to be provided to candidates. Every two weeks we read part of it, cross-check growth data and industry news, and choose the most solid models for a European investor. Here is the selection from late October, divided into three different paths.
In short: the three paths of this selection
1. Moving in and managing in person: Metal Supermarkets, PuroClean
2. Invest in and rely on a manager: Express Employment Professionals, BODYBAR Pilates
3. Bringing an American brand to Italy: Visiting Angels, Duck Donuts
1. Moving to the USA and managing it in person
What it means. They are franchises for those who move and run the business every day. The franchisors also work with foreign investors, which we verify on a case-by-case basis. Depending on the type of activity and the volume of investment, they may qualify for Visa E-2, If the project is built well.
Metal Supermarkets
Sector: sale of custom-cut metals · Investment: 357.000 € – 602.000 €
It sells small quantities of custom-cut metals to artisans, workshops and small businesses. The franchisor declares average sales of 2.1 million dollars In 2025, with a gross margin of over 50%. The limit: the investment exceeds €600,000 and the warehouse ties the accounts to the price trend of metals. A commercial mindset is required, because the customers are companies.
PuroClean
Sector: restoration of damage caused by water, fire and mold · Investment: 217.000 € – 249.000 €
It is based in Tamarac, a few kilometers from Miami, and has over 500 locations. On October 7th it announced that owners with dedicated sales teams generate an average of 1.4 million dollars. Here we would be cautious on one point: it is a B2B job related to insurance and experts, with different licenses from state to state. It is not for those who dream of having a shop on the street.
2. Invest and entrust the management to a manager
What it means. The investor remains the owner but does not work in the retail outlet. They are semi-absentee models with a local manager, designed for those who stay in Europe or want a role as an investor.
The owner does not make the selection in person. He leads a team of sales and selection managers, and offices with more than two years of activity average about 5.4 million euros. Attention, however: in temporary work, turnover is high and margins are tight. In the early years, commercial development requires a presence.
Bodybar Pilates
Sector: study of Pilates reformer · Investment: 350.000 € – 682.000 €
It provides for management in writing with a management study formed before opening. It is among the few to publish the profit: in 2024 the median net profit of the 21 studies opened throughout the year was approximately 185.000 €. The limit is the network, which is still small, and a cost that exceeds our budget.
Do you already have a franchise in mind? We help you verify the numbers before signing: Let's talk about it
3. Bringing an American brand to Italy
What it means. You become the Italian partner of a US brand with a master franchise: The rights for the country, a pilot store, then the development of the network. This is the most challenging path and must be set up in accordance with Law 129/2004.
Visiting Angels
Sector: home care for the elderly · Status: not yet in Italy
It offers non-health care at home, has about 800 affiliates worldwide and over 60 in the United Kingdom, from where it has announced a European plan. In a country that is aging like ours the need is evident. The limit: the competition from informal work and regional rules to be studied carefully.
Duck Donuts
Sector: warm donuts made on the spot · Status: not yet in Italy
The donuts are prepared and decorated in front of the customer. The brand has about 150 stores in the USA and its first European headquarters is in Belfast. It operates in shopping centers and tourist cities, but here donuts and pastry shops are everywhere and they cost little. The format must sell the experience, not just the product.
The 6 models compared
Franchise
Street
Sector
Indicative investment
Metal Supermarkets
In person
B2B trade
357.000 € – 602.000 €
PuroClean
In person
B2B services
217.000 € – 249.000 €
Express Employment Professionals
With a manager
Work
118.000 € – 258.000 €
Bodybar Pilates
With a manager
Fitness
350.000 € – 682.000 €
Visiting Angels
Master Italia
Support
US unit: €113,000 – €154,000
Duck Donuts
Master Italia
Catering
US unit: €417,000 – €583,000
The figures are indicative, converted from the dollar at the exchange rate of October 28, 2026 (1 € = 1.1133 USD). They should be verified on the updated FDD of the franchisor and with a specialized lawyer. For master franchises, the fee for Italy is negotiated with the franchisor.
How can we help you?
Choosing a franchise in the United States is not a decision to be made alone, nor based on brochures. Numbers, territories, and questions must be verified before signing.
Our team in Miami assists you in three stages:
1. Research. We identify the models that suit your budget and your goals.
2. Selection. We compare the most promising ones and tell you where we would be cautious.
3. Data verification. We read the FDD with you and prepare the questions to ask the franchisor.
Are you interested in one of these franchises, or are you thinking of creating another one? Click the button below and fill out the short questionnaire: we will contact you for a first assessment. We will contact you again to schedule a first assessment of the project…
Author: Link2America | USA Market Consultants Updated: June 2026 Reading time: 12 minutes Category: Practical Guide · US Corporate Structures · International Taxation
In short: The LLC is the most used structure, but it is not automatically the right choice for an Italian company. The correct answer depends on three variables: what you want to do in the USA, where you are a tax resident, and what your growth plans are over the next three years. This guide helps you understand which structure is right for you — before investing time and money.
1) Why the choice of structure is critical for Italian SMEs
Opening a company in the USA has become technically simple. You can form a Delaware LLC in a few days, spending less than 200 dollars. The problem is not opening it — it is opening the right one for your specific situation.
For an American entrepreneur, the LLC is almost always the obvious choice: simple, flexible, tax-efficient. For an Italian entrepreneur, the same reasoning can lead to a costly mistake. The reason is simple: The Italian and American tax systems overlap, and the structure you choose determines how your profits are taxed in not one, but two countries.
An error in judgment at this stage typically translates to:
unplanned double taxation of profits (in the US and Italy)
tax filing obligations in Italy on income you thought you had “kept” in the USA
inability to raise capital from American investors at a later stage
corporate restructuring costs ranging between $10,000 and $30,000 when changing structure after launch
The right structure is chosen only once, at the beginning. Changing it later is possible, but costly.
2) The three structures compared: LLC, C-Corp, S-Corp
In the US there are different legal forms for a business, but for an Italian SME wanting to enter the American market, the relevant options are essentially three. Here is a quick initial overview.
LLC (Limited Liability Company) It is the most common business structure in the U.S.: more than 70% of new American businesses are incorporated as LLCs. It combines the protection from personal liability typical of corporations with the tax flexibility of partnerships. Its main advantage is the so-called pass-through taxationthe company does not pay its own federal taxes, the profits “pass through” directly to the partners who report them on their personal income.
C-Corporation (C-Corp) It is the American equivalent of a joint-stock company. A C-Corp is a separate taxable entity: it pays federal corporate tax at a rate of 21% on its profits. Only when it distributes dividends to shareholders are those dividends taxed a second time. This mechanism is called double taxation and it is the main disadvantage of the C-Corp for simple structures. However, it is the only form accepted by American institutional investors (venture capital, private equity) and the preferred structure for companies intended to raise capital.
S-Corporation (S-Corp) It is an American corporation that has opted for pass-through taxation, similar to an LLC. It has higher management costs than an LLC and stricter constraints. The most significant limitation for Italian SMEs: An S-Corp cannot have foreign shareholders. An Italian citizen who is not a U.S. resident cannot be a shareholder of an S-Corp. This effectively excludes it from 90% of the situations faced by Italian SMEs entering the U.S. market.
3) LLC: the most used, but not always the most suitable
How does the tax system work
The LLC is by default a pass-through entity: its profits are attributed directly to the shareholders and taxed on their personal tax return. In the USA this works very well: an American entrepreneur in Florida or Texas (states without a state income tax) only pays federal tax on personal income.
For an Italian entrepreneur, the picture is more complex. The Italian Revenue Agency considers the LLC to be a fiscally transparent entity, which means that LLC profits are included in the personal income of the Italian partner even if they are not distributed. This phenomenon is called phantom income: If you generate a profit of 100,000 euros and decide to reinvest the entire amount in the U.S. company, you won’t receive a single euro—but you must still report those 100,000 euros in Italy and pay IRPEF taxes on them (maximum rate 43%).
Italian tax obligations for an LLC member
An Italian member of a US LLC is required to:
declare participation in RW Board of the Italian tax return (tax monitoring of foreign assets)
I will present the FBAR (FinCEN Form 114) if you have US bank accounts with a balance of more than 10,000 dollars at any time during the year
discuss with your accountant the risk of foreign investment — or the requalification of the LLC as an Italian company if actual management takes place from Italy
US tax obligations for an LLC with Italian members
On the American side, an LLC with foreign members is required to file the Form 5472 (Information Return for a 25% Foreign-Owned U.S. Corporation) along with Form 1120, even if there is no U.S. taxable income. Failure to file results in a penalty of $25,000 for each violation.
When the LLC is the right choice for an Italian
The LLC remains a valid structure for Italian SMEs in these cases:
the entrepreneur has already transferred their tax residence to the USA (or is in the process of doing so)
the company serves exclusively as a commercial vehicle for the US market, with minimal profits and limited activity
A simple and economical structure is desired as a first exploratory step, with full awareness of the Italian tax implications
4) C-Corporation: when is the right choice
How does the tax system work
The C-Corp pays the 21% of federal corporate tax on its profits (flat rate following the 2017 Tax Cuts and Jobs Act). In addition to this is the state income tax, which varies from state to state: Florida has a rate of 5.5%, Delaware 8.7%, and Nevada 0%.
When a C-Corp distributes dividends to an Italian shareholder, the applicable Conventional deduction of 15% as provided for in the Italy-U.S. Tax Treaty (signed in 1984, ratified in 1985). The withholding tax rate is reduced to 5% if the Italian shareholder has held more than 25% of the capital for over 12 months. In Italy, dividends received from foreign companies are subject to a 26% substitute tax, with credit recognized for taxes already paid in the U.S.
The advantage of the C-Corp over the LLC for Italian partners
Paradoxically, the C-Corp — which has a reputation for being an “expensive” structure due to double taxation — can be more efficient than the LLC for an Italian partner who is a non-US resident. The reason is control over profit distribution: with the C-Corp, the Italian partner pays Italian taxes only on the profits they actually receive as dividends, not on those that the company reinvests. It eliminates the phantom income problem.
When to choose a C-Corp
The C-Corporation is the recommended choice in these scenarios:
It is planned to reinvest the profits in the USA for several years without distributing them
we want to attract American investors (venture capital, angel investors, family offices)
a future listing or exit to American buyers is expected
You have an American partner who requires a traditional corporate structure
The US business volume is significant and there is a desire to clearly separate American taxation from Italian taxation.
5) S-Corporation: the limit that almost nobody knows
What it is and how it works
The S-Corp is an American corporation that filed the Form 2553 to the IRS to be taxed transparently, similar to an LLC. It avoids the double taxation of a C-Corp while maintaining the more formal corporate structure of a corporation.
The constraint that excludes it for the majority of Italian SMEs
To be eligible to elect S-Corp status, the company must meet specific requirements. The most relevant one for Italian SMEs is this: All partners must be US citizens or permanent residents of the US (Green Card or visa allowing permanent residence). An Italian citizen who is not a US resident cannot be a shareholder of an S-Corp.
This requirement automatically excludes the S-Corp from most situations in which Italian businesses find themselves when entering the US market.
When an S-Corp can be relevant
The S-Corp becomes an option only if the Italian entrepreneur has already obtained US permanent residency (Green Card) or US citizenship. In this case, it can be an efficient structure to manage the compensation of the shareholder-director in a tax-optimized manner.
6) The three most common scenarios for Italian SMEs
7) Scenario 1: solo export, nessuna presenza fisica negli USA
Profile: Italian company looking to sell products or services in the USA without opening a physical office, without American employees, and without relocating.
Objective: having an American company to open US bank accounts, issue invoices in dollars, and contract with American partners and distributors credibly.
Recommended structure: LLC
In this scenario, the LLC is appropriate, but with a few caveats:
The LLC's profits will be declared in Italy as the partner's personal income (pass-through).
if profits are low or are immediately reinvested in US assets, the Italian tax impact is manageable
It is essential to agree with the Italian accountant on the correct filling out of Section RW and the assessment of the foreign-subjection risk.
Recommended state for incorporation: Wyoming (low costs, strong member privacy, no state income tax) or Delaware (if future growth with investors is anticipated).
8) Scenario 2: US office, American employees, on-site presence
Profile: Italian company opening an operational headquarters in the USA, hiring American personnel, and managing local operations. The entrepreneur spends significant periods in the USA but maintains tax residency in Italy.
Objective: solid structure for significant US operations, with a clear separation between Italian and American taxation.
Recommended structure: C-Corporation
In this scenario, the C-Corp offers concrete advantages:
clear separation between US corporate income and Italian personal income
no phantom income: the Italian partner pays Italian taxes only on dividends actually received
credible structure for US corporate clients and potential partnerships with US companies
ability to reinvest US profits into business development without immediate tax impact in Italy
Watch out for the additional costs of a C-Corp compared to an LLC:
more formal and expensive accounting (typically $3,000–$8,000/year)
obligation to hold board meetings and minutes of shareholders' meetings
double taxation on distributed profits (manageable with tax planning)
9) Scenario 3: US partner or fundraising from US investors
Profile: Italian company looking to enter the US market with a local American partner, or to raise capital from American investors (angels, VCs, corporate venture).
Objective: structure that allows the participation of American partners and is compatible with the typical investment mechanisms of the US market.
Recommended structure: Delaware C-Corporation
This is the case where the C-Corp is not just recommended — it is practically the only option:
American investors, particularly venture capitalists, invest almost exclusively in Delaware C-Corps
The C-Corp allows the issuance of different classes of stock (common, preferred) necessary to structure investment rounds.
The Delaware legal structure is the best known and most appreciated in the American startup and corporate ecosystems.
Standard investment contracts (SAFE, convertible note) are designed for C-Corps, not LLCs
An alternative structure for the non-investor US partner: If the American partner is an operational partner (not a financial investor), the LLC with a well-structured operating agreement can work. In this case, it is essential to draft a detailed Operating Agreement that regulates the rights, duties, and exit mechanisms of each partner.
10) Summary comparative table
Feature
LLC
C-Corp
S-Corp
Foreign members admitted
✅ Yes
✅ Yes
❌ No
Double taxation
❌ No (pass-through)
✅ Yes (manageable)
❌ No (pass-through)
Phantom income for Italians
⚠️ High risk
✅ No risk
⚠️ High risk
Attractiveness for US investors
⚠️ Limited
✅ High
❌ No
Annual management costs
💲 Bassi
💲💲 Medi-alti
💲💲 Medi
Administrative complexity
🟢 Bassa
🔴 High
🟡 Media
Export only suitability
✅ Good
✅ Great
❌ Not applicable
US physical presence eligibility
🟡 With caution
✅ Great
❌ Not applicable
Capital raising eligibility
Limited
✅ Ideal
❌ Not applicable
Mandatory Form 5472
✅ Yes (foreign partners)
✅ Yes
N/A
RW Section in Italy
✅ Mandatory
✅ Mandatory
N/A
11) The 5 most common mistakes when choosing the structure
1. Choosing the LLC because “everyone uses it” The popularity of the LLC in the USA is real, but it is based on an assumption that does not apply to Italians: the members are US residents. Copying this choice without considering the Italian tax implications is the most common mistake.
2. Do not consider phantom income Many Italian entrepreneurs are surprised when their Italian accountant asks them to declare income they have never seen in their bank account. The LLC taxes profits on a pass-through basis—even those you left in the American company.
3. Choosing the structure thinking only about today The right structure for those exporting today might not be the right one for someone opening an office in two years or looking for an American investor in three. Changing structures is possible but costly. It is worth thinking about it beforehand.
4. Ignoring reporting obligations in Italy FBAR, Quadro RW, Form 5472: these are mandatory requirements. The penalties for omission are disproportionately high compared to the cost of handling them properly with an expert in US-Italian taxation.
5. Relying on an accountant who knows only the Italian or only the American system A US corporate structure with Italian partners requires expertise in both tax systems simultaneously. An Italian accountant who doesn't know US taxation, or a US attorney who doesn't know the Italian implications, will give you a partial—and potentially wrong—answer.
12) Frequently Asked Questions (Q&A)
What is the main difference between an LLC and a C-Corp for an Italian?
The main difference lies in how profits are taxed. An LLC is a pass-through entity: profits are attributed directly to the Italian shareholder and taxed in Italy as personal income, even if they are not distributed (phantom income). A C-Corp is a separate taxable entity: it pays 21% in corporate tax in the U.S., and the Italian shareholder pays Italian taxes only on the dividends they actually receive. For those planning to reinvest profits back into the U.S. business, the C-Corp eliminates the issue of phantom income.
Can an Italian open an S-Corp in the USA?
No. The S-Corporation requires that all shareholders be US citizens or permanent residents in the US (Green Card holders). A non-resident Italian citizen cannot be a shareholder of an S-Corp. For the vast majority of Italian SMEs entering the US market, the S-Corp is not a viable option.
How much does it cost to form an LLC in the USA?
Setting up an LLC has very low direct costs: state fees range from 50 dollars (Kentucky) to 500 dollars (Massachusetts). Delaware and Wyoming, the two states most used by foreigners, cost about 90 and 100 dollars respectively. To these must be added the costs of the registered agent (100-300 dollars/year), any legal expenses for drafting the Operating Agreement (500-2,000 dollars one-off), and the costs of annual tax compliance (Italian-American CPA: 1,500-4,000 euros/year).
Is it better to incorporate in Delaware or another state?
It depends on how you plan to use it. Delaware is the preferred choice for C-Corps aiming to raise capital from US investors: Delaware's legal system is the most established and recognized in the US corporate ecosystem. Wyoming is the optimal choice for non-resident LLCs wanting simplicity, privacy, and low costs. Florida is recommended if you have actual physical operations in the state (you still need a registered agent in the state where you actually operate).
If I live in Italy and open an LLC in the USA, do I have to declare anything to the Italian Revenue Agency?
Yes, with specific obligations. You must report your participation in the LLC in Section RW of the Italian tax return (monitoring of foreign assets). If you have US bank accounts with a balance exceeding $10,000 at any time during the year, you must file the FBAR (FinCEN Form 114) by April 15. LLC profits are included in your Italian taxable income even if they are not distributed. Failure to declare entails significant penalties.
What is Form 5472 and who must file it?
Form 5472 is an informational form required by the IRS for LLCs with foreign members who own 25% or more of the company. It must be filed annually along with Form 1120, even if there is no U.S. taxable income. It reports all transactions between the LLC and its foreign members: capital contributions, loans, distributions, and services rendered. Failure to file results in an automatic penalty of $25,000 for each violation.
Can I convert an LLC to a C-Corp at a later time?
Yes, it is technically possible to convert an LLC into a C-Corp (or vice versa) at a later time. However, the process is not free: it involves legal and tax costs typically ranging between 10,000 and 30,000 dollars, and it can have immediate tax implications in both the US and Italy. For this reason, it is strongly recommended to choose the right structure from the beginning, considering not only current needs but also those of the next 3-5 years.
Is the Italian LLC the same as the American LLC?
No. The American LLC does not have a direct equivalent in Italian law. It is often compared to an SRL, but the correspondence is only partial. The most significant tax difference is that the American LLC is a pass-through entity (transparent) by default, whereas the Italian SRL is an autonomous tax entity that pays IRES. This difference has concrete consequences for the management of taxation for Italian shareholders.
Does an E-2 or L-1 visa change the recommended corporate structure?
Not directly, but indirectly yes. If you obtain a visa that allows you to work in the USA and you transfer your tax residency to the USA, the problem of phantom income and Form RW ceases to be relevant from an Italian perspective. In that case, the LLC becomes a simple and efficient option once again, exactly as it is for an American entrepreneur. The visa changes your tax residency, not the legal structure of the company.
Which structure is best if I want to sell on Amazon USA?
It depends on the volume and the strategy. For a first exploratory approach with limited volumes, the LLC is sufficient and cheaper to manage. If you anticipate significant revenue and want to optimize US profit taxation while avoiding phantom income, the C-Corp is more suitable. In either case, you will need an EIN (Employer Identification Number), a US business bank account, and a US physical address to register as a seller on Amazon.
13) How can we help you
Choosing the right corporate structure is one of the most important decisions you will make in your internationalization journey to the USA. It is not a decision that can be delegated entirely to an Italian accountant without American experience, nor to an American attorney without knowledge of the Italian tax system.
At Link2America, we work with Italian entrepreneurs and SMEs looking to enter the US market from a solid position—with the proper legal structure, a planned tax strategy, and a clear vision of real costs and obligations.
Our approach: Before recommending a structure, let's understand where you are today and where you want to be in three years. Let's analyze your business model, your current tax scenario in Italy, and your goals in the US market. Only then will we propose the most suitable structure.
The first step is free: We have prepared a preliminary questionnaire that allows us to arrive at the first call already focused on your specific case. No time wasted by either party.
👉 Fill out the questionnaire below to be contacted within 48 hours.
This guide is updated to June 2026 and is for informational purposes only. It does not constitute tax or legal advice. For specific decisions regarding your situation, we recommend consulting an experienced Italian-American tax professional.
In recent years, the United States has strengthened policies to attract foreign investment, offering concrete tools for foreign companies—including Italian ones—that intend to relocate production to American soil. Among these opportunities, the program stands out SBA 7(a), a government-backed subsidized loan from the US federal government, designed to support the expansion of business ventures in the United States.
What is the SBA 7(a) program?
He 7(a) Loan Program it is the main financing instrument of Small Business Administration (SBA), the US government agency dedicated to supporting small and medium-sized enterprises. Allows you to get up to 5 million dollars for investments in machinery, real estate, working capital, operational expansion, or even for the acquisition of existing companies.
Even though it is an American initiative, Italian companies can also access it that they have already established a active subsidiary in the USA, like an LLC or C-Corp, with an actual operational headquarters (e.g., warehouse, offices, personnel, etc.).
What is an SBA loan for?
The funding can be used for:
Transfer or start the made directly in the USA
Buy machinery, equipment, systems
Acquire commercial properties or industrial warehouses
Cover start-up expenses and working capital
Acquiring an established American company (an excellent entry strategy)
The main conditions
Maximum financiable amount: up to 5 million dollars
Duration: up to 25 years for real estate, 10 years for machinery or working capital
Average interest rate: between 11% and 12.5% per year (variable, linked to the Prime Rate)
Warranty: The SBA covers up to 75-85% of the loan with a federal guarantee
It is not a non-repayable grant, but a subsidized loan with facilitated access thanks to the state guarantee.
Minimum requirements
To access SBA 7(a) financing, you must:
To have a legally incorporated company in the United States, also controlled by an Italian holding company
Demonstrate the’live operations on American soil (an active subsidiary in a state like Florida, Texas, Georgia, etc.)
I will present a structured business plan, with realistic financial projections
Demonstrate the ability to repay the loan
In some cases, the presence of at least one US resident partner is required (not mandatory, but advantageous)
Why it is advantageous to move production to the USA
Moving part or all of production to the United States allows to:
Reduce customs and logistics costs on exports
Easier access to major American clients Hey public tenders
Position one's brand as made in USA product
To make use of others local incentives (state and regional)
Build a stable presence in the largest market in the world
Link2America: the operational partner to get your SBA Loan
Accessing an SBA loan requires experience, expertise, and relationships with the right financial partners. Link2America it supports you at every stage of the journey:
Preliminary analysis of your industrial project
Establishment or optimization of your US corporate structure
Drafting a business plan compliant with SBA criteria
Selection of the most suitable lender
Support in the preparation and submission of the application
We work alongside Italian SMEs, industrial groups, investors, and artisans who want to grow in the United States with a solid and financially sustainable structure.
Would you like to know more?
Contact us today for a free evaluation of your project and find out how we can help you get an SBA 7(a) loan and bring your production directly to the USA.
Lombardy Region: “Towards New Markets” Call for Applications – Applications starting June 3, 2025
The Lombardy Region has launched the “Toward New Markets” call for proposals to support the internationalization of micro, small, and medium-sized enterprises in Lombardy. The call offers financial support of up to 85% of eligible expenses, broken down as follows:
20% as a non-repayable grant
65% as a subsidized loan (fixed rate of 1.5%, term of 3 to 6 years)
📅 Application submission dates
Opening June 3, 2025, at 10:30 AM
Closing: September 9, 2025, 12:00 PM
Applications must be submitted through the Bandi e Servizi platform of the Lombardy Region.
🔍 Eligible expenses
Consulting services for the definition of the internationalization plan
Marketing and communication in foreign markets
Certifications for products destined abroad
Adaptation of products/services to foreign markets
Temporary and virtual showrooms
Specific training of company personnel
Project staff (20% flat rate)
Indirect costs (7% flat rate)
💡 How can we help you
Link2America is by your side for:
Assess the feasibility of your project in advance
To support you in preparing the necessary documentation
Assist you in submitting the application
Provide support during project implementation and reporting
To speed up our responses and quickly obtain a preliminary evaluation, please fill out the form available at the following link:
Do not miss this opportunity to expand your business internationally with the support of the Lombardy Region.
Or contact us for further clarification click here
# Lombardy Region Call for Proposals # Internationalization # PMI Lombardy # Italian Exports # Toward New Markets # Subsidized Loans # Made in Italy # Business Support#Link to America #Foreign Markets #International Expansion #Lombardy Businesses
He Modernization of Cosmetics Regulation Act (MoCRA) represents one of the most significant regulatory reforms in the US cosmetic sector. With new provisions regarding registration, labeling, adverse event reporting and inspections, the MoCRA imposes stricter compliance standards for companies operating in the US market. This guide offers a detailed in-depth look at the main requirements and their respective deadlines.
📅 Key Dates and Main Obligations
July 1, 2024Deadline for registration of cosmetic facilities and product listing with the FDA.
December 29, 2024Requirement to update labels with contact information for reporting adverse events.
December 29, 2025FDA publication of the safety report on PFAS in cosmetics.
🏭 Facility Registration and Product Listing
Companies that manufacture or process cosmetics destined for the United States must:
Get a Facility Establishment Identifier (FEI) from the FDA.
Register the plant every two years.
Submit an updated list of marketed cosmetic products to the FDA, specifying the ingredients contained.
⚠️ Adverse Events and FDA Reporting
Starting December 29, 2023, companies must report to the FDA any serious adverse event within 15 working days using the form MedWatch 3500. The definition of “serious adverse event” includes:
Death, life-threatening danger, or hospital admission.
Persistent disability or congenital anomalies.
Severe persistent skin rashes and significant hair loss.
🏷️ New Labeling Requirements
From December 29, 2024, cosmetic labels must include:
Electronic contact information (URL or QR code) for reporting adverse events.
Declaration of identity of the product and net quantity of the contents.
List of ingredients in descending order of weight (INCI names and colorants without CI code).
Warnings and instructions for safe use.
Specific wording for professional use products.
🏛️ New FDA Authorities
MoCRA has expanded the FDA's authority, which can now:
Conduct inspections on the facilities and access company records.
Mandatory recalls of non-conforming products.
Issue Warning Letters and Import Alerts, blocking the distribution and importation of unregulated products.
🌍 Role of the US Agent for Non-US Companies
Foreign companies exporting cosmetics to the United States must appoint a US Agent, which will act as an intermediary with the FDA for communications and inspections.
🏢 Small Business Exemptions
Companies with a turnover of less than $1 million annually they can benefit from certain exemptions, but they must still ensure the safety and compliance of the products.
📖 Frequently Asked Questions (FAQ)
🔹 Which companies must register with the FDA? All companies that manufacture, package, or distribute cosmetics intended for the US market.
🔹 How is the registration of a cosmetic facility carried out? Companies must obtain an FEI Number and complete registration on the FDA platform.
🔹 What is the difference between an adverse event and a serious adverse event? A serious adverse event includes permanent damage, hospitalization, or life-threatening conditions, while a minor adverse event might be temporary irritation.
🔹 What information must be included on the label of a cosmetic product? Product name, net quantity, ingredient list, manufacturer, warnings and claims.
🔹 Can cosmetic products contain pharmaceutical ingredients? No, if a product contains active ingredients that modify the biological function of the skin, it could be classified as an OTC drug.
🔹 What happens if a product does not comply with MoCRA? It may be subject to recalls, customs holds, and FDA penalties.
🔹 Is there a transition period to comply with MoCRA? Companies must comply by the established dates, without grace periods.
📚 Glossary of Terms (in alphabetical order)
AdulterationContamination or presence of unsafe ingredients in a product.
ClaimClaim about a cosmetic product property.
Facility Establishment Identifier (FEI)Unique facility identifier assigned by the FDA.
FDA (Food and Drug Administration)US regulatory agency for drugs, cosmetics, and other products.
Good Manufacturing Practices (GMP)Good manufacturing practices to ensure the quality of cosmetics.
Import AlertFDA notification blocking the import of non-compliant products.
INCI (International Nomenclature of Cosmetic Ingredients)Cosmetic ingredient naming system.
Labeling ComplianceCompliance of labels with FDA regulations.
From January 1, 2024, the Financial Crimes Enforcement Network (FinCEN), an agency of the US Department of the Treasury, has introduced new transparency requirements for many US and foreign companies operating in the US. With the entry into force of the Corporate Transparency Act, corporate entities are required to report details on their beneficial owners through the Beneficial Ownership Information Report (BOIR).
What is FinCEN Compliance and the BOIR?
The new legislation was created with the objective of improving transparency in the US financial sector, combating money laundering and fraud. The FinCEN now requires specific business entities, both US and foreign, to report their beneficial owners, namely the individuals who own or control a significant share of a company.
Who needs to file the BOIR?
He DRINK must be filed by all companies identified as “reporting companies,” unless they fall under a specific list of exemptions (available at the Chapter 1 of the Small Entity Compliance Guide (by FinCEN). For example, publicly traded companies and certain regulated entities are exempt.
What needs to be reported?
The BOIR report must include information about:
Full legal name of the company and any trade names.
Address complete in the U.S.
Articles of incorporation or initial registration for foreign companies.
TIN (Taxpayer Identification Number) and other tax identifiers.
For each beneficial owner and corporate applicant, the following must also be reported:
Name, date of birth, and address.
Valid identification document (such as a passport or driver's license).
Submission Deadlines
FinCEN accepts BOIRs from January 1, 2024. Companies in existence as of the effective date of the regulation must submit their initial report by January 1, 2025. New companies registered after January 1, 2024, on the other hand, have 90 days from the time of registration to submit their BOIR. Any changes to the information provided must be updated by 30 days.
Where and How to Submit the BOIR
The BOIR can be submitted exclusively online through the dedicated portal: https://boiefiling.fincen.gov. Link2America customers can also count on us to handle the entire process, ensuring compliance with FinCEN regulations in a simple and secure way.
Risks and Penalties for Non-Compliance
Companies that fail to comply with these requirements by the established deadlines risk incurring severe penalties from the US Tax Office, with further legal implications.
How Link2America Can Help You
Link2America offers comprehensive support in managing the FinCEN compliance process, ensuring a simple and seamless transition to the new regulations. For more information or to request assistance, please contact us here: info@link2america.us
Please don't hesitate to contact us for further details or clarification—we're here to simplify the process and ensure your peace of mind and security!
