Simplifying EU Food Supplement Compliance for Non-EU Businesses
Entering the EU food supplement market can be lucrative, but navigating its regulatory requirements can feel overwhelming. With varying rules across member states and strict enforcement, compliance is critical for ensuring a successful product launch. This guide breaks down the key steps and requirements, simplifying the process for your business.
Why Compliance is Crucial
The EU prioritises consumer safety and transparency, so food supplement regulations are stringent. Failure to comply can lead to product recalls, legal penalties, and reputational damage. Understanding and adhering to these rules is a legal necessity and a vital business strategy.
Key Compliance Requirements for UK Food Supplements
1. EU Food Business Operator (FBO)
Non-EU businesses are legally required to appoint an EU-based Food Business Operator. This entity will:
Ensure your products comply with EU regulations.
Serve as your regulatory point of contact.
Handle safety concerns and product recalls if needed.
Manage local registrations for your products where required by individual member states.
2. Formulation Compliance
The EU maintains strict rules on permissible ingredients and concentration limits. Key areas include:
Approved Ingredients: Substances must appear on EU-authorized lists or be assessed for safety.
Maximum Levels: Certain nutrients and additives have upper thresholds to protect consumers.
Market-Specific Approvals: Some countries may require additional approvals or notifications for specific ingredients. We can manage local registrations to ensure your products are approved for sale in each target market.
3. Labelling Compliance
Labels must adhere to EU-wide and country-specific requirements, such as:
Nutrient Reference Values (NRVs): Ensure declared daily values match EU standards
Health Claims: Claims must align with EU-approved wording and scientific substantiation
Language Requirements: Labels must be in each target country's official language(s).
4. Market-Specific Requirements
While the EU has harmonized many rules, member states may enforce additional national requirements. Countries like Germany, France, Spain, Italy, and the Netherlands often have unique rules for:
Permissible botanical ingredients.
Labelling declarations.
Notification or Registration Requirements: We can handle all local registrations, ensuring your products are legally compliant in each market.
Our Advantage
Navigating these complexities can be challenging, but Complizon specializes in providing tailored compliance solutions for non-EU businesses. Our services include:
Regulatory Formulation Audit: A detailed review of your product to ensure compliance with EU and national requirements.
Compliant Label Text Creation: Customized labels designed to meet EU and market-specific regulations.
EU Food Business Operator Service: Legal use of our address and representation for regulatory compliance.
Local Product Registration: Full management of any required registrations or notifications in individual member states, ensuring your products meet country-specific legal obligations.
How to enter the EU Supplement Market
Review Your Formulations - Submit your product specifications for an EU compliance audit. We’ll identify potential issues and manage any necessary local approvals or registrations.
Adapt Your Labels - Work with us to create labels that meet EU and national requirements, including market-specific details.
Appoint an EU Food Business Operator - Ensure compliance with this legal requirement by partnering with Complizon, who will also handle local registrations where necess
Let’s Make Compliance Easy
The EU market is within your reach, and Complizon is here to make your journey seamless. From formulation reviews to local registrations, our expertise ensures you’ll meet all regulatory requirements and have the support you need to grow your business.
Ready to get started?
Contact us today to discuss your compliance needs and take the first step toward expanding into the EU market.