EU Food Supplement Compliance: Navigating the Regulatory Landscape

The European Union (EU) represents a significant market for food supplements, but navigating its regulatory landscape can be challenging. In this blog post, we’ll explore the critical elements of EU food supplement compliance, focusing on labelling guidelines, the necessity of an EU Food Business Operator (FBO) address, and the intricacies of pre-market notification paperwork.

Stringent Labelling Guidelines: A Cornerstone of Compliance Labelling of food supplements in the EU is governed by precise and comprehensive guidelines. Key aspects of these guidelines include:

• Nutrient Reference Values (NRVs): Unlike the Daily Values (DVs) used in some regions, EU regulations mandate the use of NRVs. These values provide guidance on the recommended amounts of vitamins, minerals, and other nutrients and must be clearly stated on the label.

• Local Language Translations: Labels must be translated into the language or languages of the Member State where the product is sold. This requirement ensures that all information is accessible and understandable to consumers in their local language.

• Mandatory Statements: Labels must include specific mandatory statements such as "Food Supplement", a caution to not exceed the recommended daily dose, a reminder that supplements should not replace a varied diet, and an advisory to keep the product out of reach of young children.

• Nutritional Information: The term 'Nutritional Information' is preferred over 'Supplement Facts'. This section should detail the nutrient content of the supplement, including the percentage of NRVs.

• Health and Nutrition Claims: Any health or nutrition claims must comply with EU Regulation (EC) No 1924/2006. These claims must be authorised and substantiate.

EU Food Business Operator (FBO) Address: A Must for Market Access For a food supplement to be legally marketed in the EU, it must be linked to an EU-based Food Business Operator. The FBO's address must be present on the product label. This requirement ensures a contact point within the EU for regulatory authorities and consumers, enhancing the traceability and accountability of the product.

Pre-Market Notification: The Preliminary Step Before introducing a food supplement to the EU market, companies are required to complete pre-market notification procedures. This process involves:

• Notification to National Authorities: Companies must notify the appropriate national authorities in the EU Member State where the product will first be marketed. This notification typically includes product information, labelling details, and a sample of the product.

• Safety Documentation: For certain ingredients, especially those not on the EU's list of approved vitamins and minerals, additional safety documentation and approval may be required.

• Novel Food Regulation Compliance: If a food supplement contains 'novel' ingredients (i.e., those not widely consumed in the EU before May 1997), it must comply with the Novel Food Regulation (EU) 2015/2283, which may require a separate authorisation process.

Complizon: Your Partner in EU Food Supplement Compliance Navigating the complexities of EU food supplement regulations can be daunting. Complizon.com is here to assist. We specialise in ensuring that your food supplements are compliant with EU regulations. Our services include:

• Expert Guidance: We provide tailored advice on EU food supplement regulations, helping you understand and implement the necessary compliance measures.

• Local Language Translation Assistance: Our team can assist with the translation of labels and documentation into the required EU Member State languages, ensuring that your product meets local language requirements.

• Pre-Market Notification Paperwork: We can facilitate the process of obtaining and submitting the necessary pre-market notification paperwork, streamlining your market entry.

• Compliance Check: Our experts can review your product labels and formulations to ensure they meet all EU requirements, reducing the risk of non-compliance.

Conclusion: Ensuring Compliance with Confidence With the right partner, ensuring compliance with EU food supplement regulations can be a smooth and efficient process. Complizon.com is dedicated to providing comprehensive support, from understanding labelling guidelines to navigating pre-market notifications. Contact us today to ensure your food supplements are compliant and ready for the EU market.