Dietary Supplement Registration Assistance and Services

This directive sets the framework for the harmonization of rules related to the sale of food supplements in the EU. It establishes the specific requirements for vitamins and minerals used in dietary supplements, including their forms and purity criteria. Additionally, the directive mandates that all food supplements must be safe for consumption and properly labeled to provide consumers with adequate information about the product, such as ingredients, nutritional values, and recommended daily doses.

This regulation focuses on ensuring that consumers have access to comprehensive and accurate information about the food products they purchase, including dietary supplements. It requires clear labeling of ingredients, nutritional information, allergen warnings, and other relevant details. The regulation also emphasizes the importance of transparency and prohibits misleading claims about the health benefits or nutritional properties of supplements.

This regulation governs the use of nutrition and health claims made on food products, including dietary supplements. It requires that any claims regarding the health benefits of a supplement (e.g., "supports immune function" or "reduces tiredness and fatigue") must be substantiated by scientific evidence and approved by the European Food Safety Authority (EFSA). Claims that are not on the approved list are prohibited, and misleading or unverified claims are not allowed.

This is a foundational regulation that provides the overarching framework for food safety in the EU. It sets out the general principles and requirements of food law, including the responsibilities of food business operators and the role of the EFSA in providing scientific advice and risk assessments. For dietary supplements, this regulation emphasizes the importance of ensuring that all products placed on the market are safe and do not pose any risk to human health.

This regulation governs the use of additives in food products, including dietary supplements. It establishes a positive list of permitted additives, such as sweeteners, colorants, and preservatives, along with their conditions of use. Only additives that have been evaluated and deemed safe by the EFSA are allowed in dietary supplements, and their use must comply with the specific requirements outlined in the regulation.

This regulation addresses the authorization and marketing of novel foods, which include ingredients not commonly consumed in the EU before May 1997. If a dietary supplement contains a novel food ingredient, it must undergo a safety assessment and receive approval from the European Commission before it can be marketed in the EU.