New Regulation on Food Supplements in Bulgaria

New Ordinance on Food Supplements is effective in Bulgaria from 30 December 2021. The secondary legislative act implements the requirements of Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements and of Directive 2006/37/EC of 30 March 2006 amending Annex II to Directive 2002/46/EC of the European Parliament and of the Council as regards the inclusion of certain substances.

The Ordinance regulates the forms of vitamins and minerals that can be used in the production of food supplements intended for the Bulgarian market and the substances that cannot be used therein. The minimum amounts of vitamins and minerals in the recommended daily dose of food supplements must not be less than 15 % of the reference values stated in Annex XIII, Part A, point 1 of Regulation (EU) No 1169/2011.

Regarding the provision of information on food supplements through labeling, presentation and advertising the Ordinance refers to the requirements of the Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers. The Ordinance prohibits the labeling, presentation, and advertising to attribute qualities to the food supplements for safeguarding or treatment of diseases.

The Foodstuff Act, effective from June 2021, set forth the rules for the registration of food supplements before placing them on the Bulgarian market. The register is kept by the Bulgarian Food Safety Agency. Food supplement which is lawfully marketed in another Member State, in a country that is a party to the Agreement on the European Economic Area, or in Turkey can be placed on the Bulgarian market based on the requirements of Regulation (EU) 2019/515 of the European Parliament and of the Council of 19 March 2019 on the mutual recognition of goods lawfully placed on the market in another Member State.

A peculiarity introduced by the Ordinance, that should be noted, is that the business operators cannot use one single application for more than one food supplement.

Food supplements that were placed on the market before the entry into force of the Ordinance and that do not meet its requirements regarding the maximum permissible amounts of vitamins and minerals can be marketed until the available quantities are exhausted, but not longer than 31 December 2023.