2 December, 2025

How to sell food supplements in the European Union from outside Europe

The European market is one of the most attractive in the world for food supplement companies. Its size, stability, diversity of countries and high level of consumption make it a priority destination for manufacturers from the United States, China, Mexico, Latin America and other countries outside the European Economic Area. But it is also one of the most regulated and demanding markets.

At LegaleGo Regulatory Affairs, we also help international companies overcome these barriers to entry and market their products quickly, safely and in full compliance with the regulations applicable in each European Union country.

The European Union

The European Union (EU) continues to consolidate its position as one of the world’s most important, extensive and economically robust markets. At the beginning of 2025, the population of the EU is estimated to be approximately 450.4 million people.

This bloc not only represents a very significant population, but also a large economy. The EU brings together a diverse set of national economies with different income levels, but with a common market that allows the free movement of goods, including food supplements.

Within this context, the food supplement market is experiencing strong growth. The most recent estimates suggest that the European food supplement market will be worth around £25 billion by 2025. This growth is driven by several factors: increased interest in preventive health, an ageing population, higher standards of living, and growing awareness of wellbeing, nutrition and healthy lifestyles. As a result, in many EU countries, a substantial proportion of the population already consumes food supplements on a regular basis.

This scenario makes the EU one of the most attractive destinations for companies outside the bloc that wish to internationalise their products. For manufacturers in the United States, China, Latin America or other regions outside Europe, the EU offers a major channel of access to dozens of national markets, all connected by a common regulatory framework, legal stability and high standards of safety and quality.

From this perspective, joining the EU represents not only a market opportunity, but also a strategic commitment to international expansion with enormous potential for growth and return.

Are you a non-EU company wishing to sell food supplements in Europe? Here is what you need to know.

To sell food supplements within the European Union, it is not enough to have a product that is ‘healthy, safe or high quality’. European food legislation requires that there be a responsible company located within the EU itself.

This forms part of the general framework defined by regulations such as Regulation (EC) 178/2002, which establishes the responsibility of food business operators in the EU, and by the information requirements set out in Regulation (EU) 1169/2011.

If your company is located in China, the USA, Mexico, Argentina, Japan, the United Kingdom or another country outside the European Union, you can only market food supplements in the EU by following one of these three legal routes:

1. Working with a European distributor

This is the most common and simplest option. A distributor within the EU assumes the role of Food Business Operator (FBO) — that is, the company responsible for the product in European territory.

This means that:

• • The distributor is listed on the label.

  • He is legally responsible for the product.

  • Manage mandatory notifications in each country

  • Report to the authorities in the event of incidents.

It is a valid option, but it also means relinquishing control of the product and, in some cases, the market.

2. Hire an independent FBO (Food Business Operator)

An FBO is an authorised food operator within the European Union that can assume legal responsibility for your products.

When a company outside the EU works with an FBO:

• • The FBO appears on the label.

  • Acts as the person responsible for placing the product on the market.

  • Manage national notifications

  • Ensures regulatory compliance of the product

Many international manufacturers choose this option because it allows them to sell throughout the European Union without relinquishing distribution, maintaining complete control over their sales, strategy, and channels (Amazon, Temu, TikTok Shop, own e-commerce, retailers, local distributors, etc.).

3. Setting up your own company within the EU

This is the slowest and most expensive option. It involves higher:

• • Bureaucratic procedures

  • Incorporation costs

  • Tax obligations

  • Audits and controls

  • Need for local staff

It remains a perfectly valid option, but is only recommended for companies that want to establish long-term operations within Europe.

At LegaleGo Regulatory Affairs, we assist you regardless of the option you choose.

Companies around the world value three things when they want to sell in Europe:

• Speed

• Security

• And be able to operate smoothly in marketplaces and digital channels

That’s why our team takes care of absolutely everything related to regulatory compliance, so that your company only has to do one thing: sell.

Our services include:

1. Complete label review: We adapt and correct labels in accordance with European regulations and the internal regulations of the country where you wish to market your product (Spain, France, Italy, Germany, etc.).

2. Ingredient verification: We check that your ingredients are permitted in the EU and analyse restrictions by country. This is particularly important because many ingredients that are permitted in countries such as the United States, China or Mexico are prohibited or restricted in the EU.

3. Mandatory notification in each country: Some countries require prior notification before selling food supplements. We will help you manage the preparation, submission, and follow-up of the notification.

4. Regulatory compliance for selling on Amazon, Temu, TikTok Shop, and European marketplaces: Amazon and other marketplaces may block products that do not comply with food supplement regulations. As an official Amazon partner, LegaleGo guarantees that your product will pass legal reviews without delay.

5. Review of claims: We only allow claims authorised by the specific union regulations. Helping you avoid penalties and blocks for unauthorised statements.

6. Full support until market launch: From initial reformulation to final launch, we work with you every step of the way.

In which countries do we offer our services?

We provide regulatory compliance for food supplements in most European Union countries, including:

🇪🇸 Spain
🇫🇷 France
🇮🇹 Italy
🇩🇪 Germany
🇵🇹 Portugal
🇮🇪 Ireland
🇧🇪 Belgium
🇵🇱 Poland
🇸🇪 Sweden
🇫🇮 Finland
🇱🇺 Luxembourg
🇧🇬 Bulgary
🇨🇿 Czech Republic
🇸🇰 Slovakia
🇭🇺 Hungary
🇳🇱 The Netherland
🇦🇹 Austria
🇷🇴 Romania
🇬🇧 United Kingdom
🇺🇸 USA
🇪🇪 Estonia
🇨🇭 Switzerland
🇦🇩 Andorra
… and more.

If you still don’t know how to sell food supplements in the European Union, get help from experts.

You can always count on the assistance of LegaleGo Regulatory Affairs, as we specialise in more than just food supplements. Our portfolio of services also includes cosmetics and complementary pet food.

In addition, you will have access to Spain’s first official Amazon partner food consultancy, allowing us to offer speed, security and a direct route to compliance in European marketplaces.

Grow your brand in Europe without any risks. Thousands of companies from outside the EU already sell their food supplements in Europe thanks to our support.

Start selling in the European Union today with the help of a specialised, fast and reliable partner. Contact us!