The new Bulgarian Ordinance on Food Supplements was published just before the Christmas holidays on 15 December 2021 in an extraordinary issue of the Bulgarian State Gazette. It entered into force by the end of the year, leaving very little time to reflect on its content.
Ordinances are secondary legislative acts in Bulgaria. They are usually voted by the competent ministry or by the government. This type of legislation is often used to implement the requirements adopted by directives in Community law.
The adoption of the new Ordinance on Food Supplements (the "Ordinance") is an echo of the radical change in the Bulgarian food law imposed after the adoption of the new Foodstuff Act in June 2020. After the long period of political crisis, the inability of three consecutive parliaments to form a government and the Covid pandemic, the government's choice to put food legislation first is interesting, but logical given the politically stated support for the development of the life sciences in Bulgaria.
This article aims to briefly summarise some new facts about the Ordinance and should not be regarded as a detailed analysis of applicable Bulgarian law.
Food supplements that were placed on the market before the entry into force of the Ordinance on 30 December 2021 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 24 months from the Ordinance's entry into force. The draft Ordinance was notified to the European Commission under Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and rules on information society services.
According to the new Foodstuff Act (adopted in June 2021) and the Ordinance, the placing of food supplements on the Bulgarian market must be preceded by the registration of the relevant product in the public register kept by the Bulgarian Food Safety Agency ("BFSA"). The conditions and the procedure for the registration of a food supplement, as well as the deletion from the register, must comply with art. 79 and 80 of the Foodstuff Act. The BFSA has already developed a rapid registration procedure and publishes a list of registered food supplements on its website that is updated weekly.
The ordinance prohibits a single registration application being used for more than one product. This means that if more than one food supplement is placed on the market simultaneously, the responsible food business operator must prepare and submit a separate application for each of the products subject to registration.
According to the Ordinance, a food supplement that is legally 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.
The Ordinance stipulates that when the content, production, specifications, presentation or labelling of a food supplement meets the legal requirements, the control authorities have no right to prohibit or restrict its distribution. The BFSA may temporarily prohibit or restrict the placement on the market of a food supplement only if, as a result of new information or the reassessment of existing information, it is established that despite complying with the requirements of the Ordinance, the food supplement endangers consumers' health. In these cases, BFSA is obliged to immediately notify the Ministry of Agriculture, Food and Forestry and the national Risk Assessment Centre. The Ministry of Agriculture, Food and Forestry is obliged to take action to inform the other Member States and the European Commission of the measures taken.
Food supplements can be offered to final consumers only in food distribution facilities/premises registered under the Foodstuff Act, as well as in pharmacies and drugstores. The Foodstuff Act provides for mandatory registration for both the enterprises selling food through means of distance communication and their platforms used for business. The Bulgarian government has adopted a special Ordinance regulating the e-commerce of food.
Annex 2 of the Ordinance lists the forms of vitamins and minerals that can be used in the production of food supplements intended for the Bulgarian market. These must comply with the safety criteria set out in the European Union law. If there are no defined EU safety criteria for certain forms of vitamins and minerals listed in Annex 2, producers must comply with the stricter rules generally accepted by the competent international organisations or by the Bulgarian national legislation.
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.
The new Ordinance, unlike the previous Ordinance 47, does not contain a negative list of plants, but prohibits the use in food supplements of substances from plants:
- listed in Annex III, Part A of Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the intake of vitamins and minerals and of certain other substances in foodstuffs (special Bulgarian edition, Chapter 13, Volume 59); and/or
- listed in Annex 5 of Ordinance 5 of 2004 on the requirements to be met by the herb procurement points and warehouses for herbs (published in the State Gazette, issue 85 of 2004); and/or
- classified as narcotic according to the Ordinance on the Procedure for Classification of Plants and Substances as Narcotic.
There are no major surprises in the requirements on the provision of information on food supplements through labelling, presentation and advertising. According to the Ordinance, this information must comply with the requirements of Regulation (EU) 1169/2011. In addition to the mandatory information under this Regulation, the food supplement label must also contain the following information:
- name of the categories of nutrients or substances characterising the product or indication of their nature;
- recommended daily dose;
- warning not to exceed the recommended daily dose;
- warning not to use the product as a substitute for a varied diet;
- warning to keep the product out of the reach of small children; and
- number and date of entry of the food supplement in the register kept by the BFSA in accordance with the Bulgarian Foodstuff Act.