The European Commission, together with the European Food Safety Authority (EFSA), plays a key role in setting food law and conducting risk assessment for substances added to food supplement products. EFSA evaluates the safety and effectiveness of nutrients and other substances used in food supplements, including essential fatty acids, amino acids, and herbal extracts.
To ensure consistency across Member States, the European Parliament established harmonized rules on maximum and minimum amounts for vitamin or mineral intake. These limits consider both safety and nutritional needs of specific groups of the population, such as children, pregnant women, and the elderly.
Ingredients and Additives: Ensuring Safety and Compliance
The inclusion of nutrients in food supplement products is limited to substances that have been evaluated and listed in the annexes of Directive 2002/46/EC, particularly Annex II, which enumerates permitted vitamin and mineral substances. Only the vitamins and minerals listed—and in forms approved for human consumption—may be used in supplements.
In addition to basic nutrients, food business operators may include other substances like plant extracts or amino acids, but these must meet the criteria of nutritional or physiological effect and pass a safety assessment. Substances not previously used or with limited history in the EU may fall under the Novel Foods Regulation (Regulation (EU) 2015/2283). These must undergo pre-market authorization following a detailed risk assessment.
Some herbal extracts and botanical preparations may be regulated under the Traditional Herbal Medicinal Products Directive (Directive 2004/24/EC), especially when intended to treat or relieve symptoms of human disease. In such cases, these are classified as medicines, not food supplements, and are subject to an entirely different regulatory framework.
Food additives such as preservatives, colorants, and flavor enhancers are also tightly controlled. Only approved additives listed in the relevant EU regulations may be used, and only in permitted doses. In some cases, fortified food and supplements may overlap in their composition, but they are clearly distinguished by their dose form, intended use, and labeling.
To maintain compliance, food business operators must ensure that all ingredients are sourced responsibly and supported by full documentation. Use of supplement testing services is common to verify the content of active ingredients, including levels of vitamin C, minerals, and other essential nutrients.
Food Supplement Labels: Required Information and Prohibited Claims
Correct food supplement product labels are essential for both compliance and consumer protection. According to EU supplement regulations, the following food information must appear clearly on food supplement labels:
The names and categories of vitamins and minerals present
The dose form and amount of each nutrient per measured small unit quantity
The recommended daily intake
A warning not to exceed the stated dosage
A statement that supplements should not be used as a substitute for a varied diet
A statement that the product should be kept out of reach of children
Additionally, labels must indicate the name and address of the food business operator, country of origin (if outside the EU), and the batch number or date of manufacture. For multi-ingredient formulations, the composition of all substances must be listed in descending order by weight.
Any nutrition and health claims on labels must comply with Regulation (EC) No 1924/2006 and be approved by the European Food Safety Authority. Claims such as “supports liver function,” “contributes to normal muscle function,” or “helps reduce fatigue” are permitted only if they correspond with authorized statements from the EU Register of Nutrition and Health Claims.
False, misleading, or unsubstantiated health claims are prohibited. Products cannot imply that they prevent or treat disease, cannot guarantee specific physiological effects, and cannot suggest benefits to human health that go beyond what has been scientifically verified.
Given the diversity of Member States, specific national legislations may still vary slightly. For example, some countries may require food supplements to be notified to a national authority before being placed on the European market, while others may maintain country-specific label templates. Nevertheless, harmonization is increasing with new guidance documents issued by the European Commission.
Product Notification and Market Access in the EU
Before placing a food supplement product on the European market, companies must comply with national-level notification procedures in most Member States. This typically involves submitting:
Product label samples
Composition details
Certificate of compliance with Directive 2002/46/EC
Confirmation that vitamins or minerals used are those listed in Annex II
In some countries, the notification must be done electronically via a government portal and may include a registration fee. The goal is to facilitate efficient monitoring of products by competent authorities.
Moreover, ongoing post-market surveillance may be required. In the event of reported side effects or non-compliance, food business operators must be able to provide product documentation and conduct corrective actions. Withdrawal from the market, product recall, or public notice may be mandated depending on the severity of the risk to human health.
EU regulations encourage transparency and traceability, and brands are advised to develop a long-term regulatory strategy. This should include regular updates on relevant legislation, proactive supplement testing services, and partnerships with legal and regulatory consultants specializing in EU food law.
Future of EU Supplement Regulations: Trends and Best Practices
As demand for food supplements grows across Europe, the European Commission and European Food Safety Authority continue to review and refine EU regulations. Key developments expected in the near future include:
Updates to maximum and minimum levels for vitamins and minerals
Greater clarity on borderline products (e.g., herbal extracts vs. traditional medicinal products)
Expanded definitions and pathways for approving novel foods
Enhanced controls on nutrition and health claims
Brands entering or expanding within the European market must stay proactive. This means auditing existing products, ensuring new launches are designed with compliance in mind, and educating internal teams about evolving European legislation.
Compliance is not just a legal requirement—it’s a commitment to food safety, human health, and consumer trust. In a crowded marketplace, aligning with the regulatory framework ensures both competitive advantage and brand resilience.
By understanding and respecting Directive 2002/46/EC, navigating the roles of competent authorities, and adhering to rigorous food supplement product labels, companies can successfully bring high-quality, legally compliant supplements to European consumers.
For businesses seeking support, many European consultancy networks and supplement testing services can provide step-by-step assistance, from initial compliance reviews to final labeling approval—ensuring that your brand enters the EU with both confidence and credibility.
