Food Supplements

Ensure vitamins and minerals are from the EU's permitted positive list (Directive 2002/46/EC).

Verify if other ingredients (e.g., botanicals, amino acids) are authorized.

Assess whether any ingredient qualifies as a "novel food" under Regulation (EU) 2015/2283 (if yes, apply for novel food authorization).

Confirm that the product is safe at the intended dosages.

Review toxicological data and potential contaminants.

Check if maximum levels or specific warnings are required (especially for vitamins, minerals, and botanicals).

Notify the competent authority in countries where notification is mandatory (e.g., France, Italy, Spain, Belgium).

Submit required documentation (composition, label samples, and safety data if needed).

Pay applicable notification fees where necessary.

Follow Regulation (EU) 1169/2011 on food information to consumers.

Include mandatory information: ingredient list, nutritional information, recommended daily intake, warnings, and safety statements (e.g., "not a substitute for a varied diet").

Apply specific rules for food supplements under Directive 2002/46/EC.

Use only approved health claims listed in the EU Register of Nutrition and Health Claims (Regulation (EC) 1924/2006).

Avoid disease prevention, treatment, or cure claims (which would reclassify the product as a medicinal product).

Ensure production follows general food hygiene rules under Regulation (EC) 852/2004.

Implement HACCP (Hazard Analysis and Critical Control Points) systems.

Maintain traceability and adhere to Good Manufacturing Practices (GMPs).

Monitor the safety of the supplement once it is on the market.

Report any serious adverse effects to national authorities.

Be prepared to act in case of issues (e.g., product recalls, notifications via RASFF).