In order to import and distribute nutritional supplements in Bulgaria, it is necessary to follow the legal procedure for this. The Food Act defines the procedure and the regulatory body is the Bulgarian Food Safety Agency (BFSA).
What are food supplements?
These are foods intended to supplement a normal diet. They are concentrated sources of vitamins and minerals or other substances with a nutritional or physiological effect, used alone or in combination. They are intended to be taken in small ready-to-use single doses and are placed on the market in the form of:
- capsules;
- tablets;
- pills;
- powder;
- liquid ampules;
- other similar liquid or powder forms.
How to legally trade in food supplements
If you are a producer or you are trading in food supplements planning to place them on Bulgarian market for the first time, it is necessary to submit a notification to the Regional Health Inspectorate (RHI) at the place of company registration. You can find a list of all Regional Health Inspectorate in Bulgaria HERE. The announcement must be made before placing the food supplements on the market.
A sample of the label of the food supplement should be attached to the set of documents submitted to the RHI. After completing the legal procedure, your food supplements will be registered in the Register of Food supplements. After registration you can also receive a CERTIFICATE FOR FREE TRADE. In in case of a change in the composition, name or purpose of the additive, a new notification shall be submitted.
Are there any sanctions?
In the event your food supplement creates a risk for the health of consumers, one of the following sanctions will be imposed: 1. Prohibition on placing on the market; 2. Order for suspension of placing on the market; 3. Prohibition on use; 4. Defining special conditions for placing on the market or other appropriate measures depending on the situation.
Useful information!
!!! Only the following vitamins and minerals are used in the production of food supplements: Vitamin A (µg RE), Vitamin D (µg), Vitamin E (mg a-TE), Vitamin K (µg), Vitamin B 1 (mg), Vitamin B 2 (mg), Niacin (mg NE), Pantothenic acid (mg), Vitamin B 6 (mg), Folic acid (µg) (1), Vitamin B 12 (µg), Biotin (µg), Vitamin C (mg) , Calcium (mg), Magnesium (mg), Iron (mg), Copper (µg), Iodine (µg), Zinc (mg), Manganese (mg), Sodium (mg), Potassium (mg), Selenium (µg) , Chromium (µg), Molybdenum (µg), Fluoride (mg), Chloride (mg), Phosphorus (mg), Boron (mg), Silicon (mg). The law also determines the maximum allowable amounts for daily intake of these vitamins and minerals in food supplements. It is allowed to use standardized plants, parts of plants and extracts of them with a beneficial effect on health, safe in the daily intake dose recommended by the producer.
!!! Food supplements are delivered to the consumer only pre-packaged and labeled. Labeling, presentation and advertising must not attribute to food supplements properties to prevent, treat or cure human diseases, nor refer to such properties.
!!! Food supplements are sold only in registered shops, pharmacies and drugstores.
In case you want to register a new food supplement on the Bulgarian market, you can contact us for legal advise and assistance for the entire procedure, as well as for specific situations that require legal intervention.
