Although seemingly similar to food supplements at first glance, foods for special medical needs are subject to a separate registration regime. Both types of products are consumed as a supplement to the daily diet. However, foods for special medical needs have a composition and purpose that require their intake be supervised by a medical specialist.
The definition of food for special medical needs is found in Regulation (EU) No 609/2013 (the “Regulation”). In short, this type of food is used for dietary therapy in patients with limited, reduced, or impaired ability to consume or metabolize regular foods and their ingredients. In other words, they are intended for individuals with health issues that cannot be addressed by changing a regular diet.
Unlike dietary supplements, foods for special medical needs are not registered with the Bulgarian Food Safety Agency (BFSA) but with the Ministry of Health (MH). Nevertheless, there are significant similarities in the administrative procedures.
A notification must be submitted to the MH, which should include:
- Identification details of the distributor/importer;
- Address of the production facility of the product;
- Date of market release in Bulgaria, which cannot be earlier than 14 days after the notification is submitted;
- The purpose of the product.
The applicant must also attach the label under which the food for special medical needs will be marketed. If the product is imported and its packaging is in a foreign language, a draft label in Bulgarian must be prepared. It should match the content of the original label and comply with the requirements of the Bulgarian Food Act (FA).
After submission, the notification is forwarded to the Health Control Directorate. If necessary, the National Center for Public Health and Analyses may be consulted for a scientific opinion on the product’s composition and effects. Additional information may also be requested from the applicant company.
The procedure concludes with a letter from the MH to the applicant stating that the product complies with the requirements of the Regulation and the FA. The approval is also communicated to the BFSA.
