A Comprehensive Guide to Starting a Food Supplement Business in the European Union

The first step in starting a food supplement business is registering your company in an EU member state. To legally sell nutritional supplements within the EU, the business must be established as a legal entity. It’s important to choose a country that offers favorable conditions for your business, considering factors such as tax incentives, streamlined administrative processes, and access to key markets.
After registering your company, obtaining Food Operator status is essential. This is a mandatory requirement for all businesses involved in the production, storage, packaging, or sale of food products, including supplements. To become a registered food operator, you must complete the following steps:

• Establish an Agreement with a Certified Warehouse:

Nutritional supplements often require specific storage conditions, particularly in terms of temperature control. You will need to enter into an agreement with a certified warehouse that meets the requirements set by the food and veterinary authorities of the country where your business is registered. The warehouse must be officially approved for storing nutritional supplements to ensure compliance with regulatory standards.

• Establish Your Own Warehouse:

Alternatively, you can set up your own warehouse for storing products. This warehouse must be certified by the relevant food and veterinary authorities to ensure it complies with all required safety and hygiene standards.

• Obtain a Food Operator Registration Number:

After fulfilling one of the above requirements, you will be issued a Food Operator Registration Number. This number authorizes you to legally trade food supplements within the EU.

Once your company is registered and you have obtained Food Operator status, the next step is to define the product you plan to sell. It's crucial to carefully evaluate the following aspects:

Product Format
Food supplements can be available in various forms, including:

• Capsules (gelatin or vegan)
• Pills
• Powders
• Liquids (syrups, solutions)
• Chewable lozenges or candies
• Sachets (containing powdered additives for dilution in water)

The choice of supplement form depends on the target audience, production capabilities, and market trends. For instance, capsules are often favored by those who prioritize convenience, while powders may be more suitable for sports nutrition.

Product Strategy
At this stage, you need to choose one of three main strategies:
1) Development of Your Own Product – Private Label:
This approach involves creating a unique supplement formula in collaboration with professional technologists and nutritionists. Developing your own product allows for greater control over quality and brand positioning. However, the product development, certification, and registration processes are complex and require a significant investment of time and financial resources.


2) Work According to the White Label System:
The White Label approach enables you to market products under your own brand while utilizing existing formulas and production facilities from third-party companies. This method can facilitate a faster time to market, though it offers less control over product formulation.


3) Distribution of Finished Products:
At the initial stage, becoming a distributor of existing products is the easiest and fastest option. This approach allows you to study the market, minimize risks, and gain experience in working with nutritional supplements. Distributing finished products does not involve a complex development and certification process; however, it may limit your opportunities for building your own brand.

One of the key steps in entering the market is the registration of dietary supplements. It is important to note that registration requirements and maximum dosage limits for dietary supplements can vary by EU member state.

General EU Regulations
In the EU, there are several general regulations governing food supplements, which pertain to:

• Composition
• Product safety
• Packaging information (labeling)
• Health claims

EU regulations establish the fundamental rules that all food supplements sold within the Union must adhere to. However, each member state may have its own domestic requirements, which can create challenges when distributing products.

The Principle of Free Movement of Products in the EU
If a product is registered and meets the requirements of one EU member state, it can be freely sold and distributed in other countries within the Union. This applies to both physical stores and online sales. However, if a product is stored and distributed in a different country, it must comply with that country’s domestic regulations.

To register a new product in an EU member state, you must submit an application to the food veterinary service or the relevant authority in that country. During the registration process, it is important to:
1) Prepare Technical Documentation:

• Product formulation
• Description of ingredients and their sources
• Safety testing protocols

2) Check Dosage Compliance:
I.It is essential to ensure that the dosages of active ingredients meet the regulatory requirements of the country where the product will be sold. For instance, maximum dosage limits for vitamins and minerals can vary between EU member states.
3) Obtain a Conclusion from the Certification Body:
After submitting your application and all necessary documents, the certification authorities will review your product and issue a conclusion regarding its eligibility for market distribution.

One of the strictest aspects of dietary supplement regulation pertains to health claims, which you can use for advertising and labeling your product. All claims must be substantiated by scientific evidence and comply with EU Regulation (No. 1924/2006).

False or exaggerated claims regarding the health benefits of a product are prohibited. For instance, claims that a supplement “treats” or “prevents” a disease may be forbidden unless they are backed by appropriate scientific research and approved at the EU level.

Additionally, some countries may require separate registration of a product name or trademark to ensure compliance with legal and ethical standards.

Establishing a nutritional supplement business in the European Union involves navigating numerous legal, technical, and marketing requirements. It is crucial to carefully consider all stages—from company registration and product selection to the process of registering dietary supplements in EU member states and ensuring compliance with labeling requirements.

Furthermore, some countries may necessitate separate registration of a product name or trademark to avoid violating legal or ethical standards. By following these steps, you can ensure that your business operates legally and successfully, while minimizing the risks associated with entering the dietary supplement market.