Struggling to understand EU food supplement regulations? You're not alone.
The rules are complex and can vary significantly from country to country, which can make it easy to feel lost and overwhelmed.
Missteps can lead to costly penalties, product recalls or even being barred from the market entirely. But there's good news – you don’t have to tackle this challenge by yourself.
In this guide, we’ll simplify the process for you. By the end, you’ll understand the regulations, know how to avoid common pitfalls and ensure that your products remain compliant at every step.
Understanding food supplement regulations in the EU
Food supplements in the EU are regulated to protect consumers and ensure the products on the market are safe and properly labelled. Let’s dive into what you need to know:
Definition of food supplements
Food supplements are concentrated sources of nutrients or other substances that have a nutritional or physiological benefit. They are usually available in dose forms like capsules, tablets or liquids. The goal is to supplement the normal diet.
Key regulations to know
The main regulations governing food supplements in the EU are:
Food Supplements Directive 2002/46/EC – Sets out the rules for vitamins and minerals that can be used in food supplements, including the permitted forms and purity criteria.
Regulation (EC) No 1924/2006 on nutrition and health claims – This regulation controls what health claims can be made about supplements and prevents consumers from being misled.
General Food Law Regulation (EC) No 178/2002 – Establishes the general principles and requirements of food law. It includes traceability, food safety and the responsibilities of food business operators.
Labelling requirements
Proper labelling is crucial. Product mislabelling can lead to penalties or product recalls, both of which can be very costly for your business - see our guides on the and on the . Essential information your labels need to include:
Product name – Must include the term “food supplement.”
Nutrient content – List the vitamins, minerals or other substances in the product, along with their amounts.
Recommended Daily Intake (RDI) – Indicate the recommended portion size and the nutrient content per portion.
Warnings and cautions – Include any necessary warnings, such as not exceeding the recommended dose or keeping out of reach of children.
Batch number and expiry date – This helps with traceability and ensures the product is consumed while still effective.
Ingredient Restrictions
When it comes to food supplements, the EU has strict rules about what ingredients can be used. The EU maintains a positive list of approved vitamins and minerals that are permitted in food supplements, along with specific forms of these nutrients that meet safety and efficacy standards. This means that only the vitamins and minerals on this list, in their approved forms, may be included in your products.
If you want to use an ingredient that’s not on the approved list, you’ll need to go through a rigorous approval process. This involves providing scientific evidence to demonstrate the ingredient's safety and effectiveness. Until it’s approved, such an ingredient is prohibited from being used in food supplements.
Additionally, the EU closely monitors emerging scientific data and may update the list as new information becomes available, so it’s important to stay informed about any changes.
Novel foods
If you want to use an ingredient that isn’t commonly consumed in the EU before May 1997, it might be classified as a “novel food.” These require a separate authorisation under Regulation (EU) 2015/2283.
Health claims and marketing
Marketing your food supplement requires careful consideration of the claims you make. The EU has strict rules on what you can and can’t say about your products.
Approved health claims
You can only use health claims that have been approved by the European Food Safety Authority (EFSA). These claims must be based on scientific evidence and are listed in the EU Register of Nutrition and Health Claims.
For example:
- “Vitamin C contributes to the normal function of the immune system” is an approved claim.
- “This supplement will cure your cold” is not allowed.
Non-approved claims
Avoid making any claims that suggest your product can prevent, treat or cure diseases. These are considered medicinal claims and are not permitted for food supplements.
Registration and notifications
In some EU countries, food supplements must be registered or notified to the relevant authorities before they can be sold. Here’s a quick overview:
- Notification: In countries like France and Italy, you are required to notify the relevant authorities before your product is placed on the market. This pre-market requirement is designed to ensure transparency and compliance.
- Registration: In other countries, such as Germany, you may need to go through a registration process, which can occur before or after launching the product, depending on national regulations. This process involves submitting detailed product information to ensure compliance.
Each country has its own process, so it’s important to check the specific requirements for each market that you plan to enter.
Cross-border sales
Selling food supplements across the EU involves additional considerations. Since the EU allows for the free movement of goods, your product can be sold in any EU country if it complies with the regulations of the country of origin. However, you must ensure that:
- Your product meets the labelling and ingredient requirements of the destination country.
- You are aware of any additional national restrictions or requirements.
Common pitfalls and how to avoid them
Even with the best intentions, it’s easy to make mistakes. Here are some common pitfalls and tips on how to avoid them:
Misleading claims – Stick to EFSA-approved health claims to avoid making misleading statements.
Incorrect labelling – Double-check that all required information is included on your labels and that it’s accurate.
Unapproved ingredients – Ensure all ingredients are on the approved list or have the necessary authorisations.
Regulation variations – Not every EU member state has the same national requirements, which can lead to errors, please see the following links to country specific guides.
Variations in food supplement regulations across EU countries
While the EU provides a broad regulatory framework for food supplements, individual member states often impose additional national requirements. In most cases, either notification or registration is required before you can bring your product to market. However, there are exceptions where no such process is needed.
For example, in countries like France and Italy, notification is mandatory. This means you must submit a detailed dossier to the authorities - outlining your product’s composition, labelling, and intended use - before you launch it on the market. Similarly, Germany may require a registration process for certain food supplements, which involves submitting specific documentation to ensure compliance with both national and EU regulations.
However, some countries, such as Austria, are exceptions to this rule. Since 2006, Austria no longer requires food supplements to be registered or notified before they are sold, simplifying the process of bringing products to market. However, it’s important to note that this is the exception rather than the norm.
Because a product that complies in one country may still face regulatory challenges in another, you must research the specific requirements for each market you intend to enter. Adapting your product and labelling to meet these varied standards is crucial for success. Engaging with local regulatory experts or consultants can help you navigate these complexities and mean you remain compliant with both EU-wide and national regulations.
Practical steps to ensure compliance
Regulatory compliance might seem daunting, but breaking it down into manageable steps can make the process more straightforward:
Know the regulations – Stay updated on EU and national regulations related to food supplements.
Conduct a compliance audit – Review your product's ingredients, labelling and marketing materials to ensure they meet EU standards.
Seek expert advice – If you’re unsure about any aspect of the regulations, consult with a regulatory expert or a consultancy that specialises in EU food supplement regulations. At CompareComply, we provide expert advice to help your business remain compliant.
Keep records – Maintain detailed records of your product formulations, labelling and any communications with regulatory authorities.
Monitor changes – Regulations can change, so it’s important to regularly check for updates and adjust your compliance strategy accordingly.
Key takeaways
Understanding the complex world of EU food supplement regulations can be challenging, but it’s essential for the success and safety of your business.
By understanding the key regulations, avoiding common pitfalls and taking a proactive approach to compliance, you can enjoy the peace of mind that your products meet the necessary standards.
