The new Food Act, effective as of June 9, 2020, seeks to reinforce consumer protection as regards food products, as well as to ensure systematization of the national legal framework and its harmonization with the European Union legislation in this area. And while the new Act addressеs matters which lacked and required regulation, the novelties introduced by the Act raise certain issues which remain to be further defined and clarified in by-laws and practice.
Business operators and establishments for food production, processing and/or distribution
The Act introduces some new concepts consistent with the European legislation and defining the range of objects and subjects falling within the scope of the Food Act.
Business operators are natural or legal persons responsible for ensuring that food legislation is observed in the food establishments under their control. An establishment, on the other hand, is any unit where entrepreneurial activity is carried out for profit or for nonprofit purposes and which is related to the production, processing and/or distribution of food products, and includes: land with or with no buildings, enterprise, vehicle (including boat, ship, plane, railway carriage or other); mobile, temporary, movable or open facility.
It is exactly the food production, processing and/or distribution activities performed within such wide range of establishments which are subject to mandatory registration or approval, where the respective establishment – either before the Regional Food Safety Directorates or before the Regional Health Inspectorates - for registration of production of natural mineral, spring and table water.
Public registers of business operators and food establishments shall be kept on the websites of the Bulgarian Food Safety Agency (BFSA) and the Ministry of Health.
It should be noted that the certificates for registration of establishments for the production and sale of food products issued in accordance with the repealed Food Act remain valid for the period for which they have been issued, i.e. there is no need to re-register such establishments under the new Act. Their operators, however, should consider taking measures in respect of the activities for which registration regimes have been newly introduced, such as online sales and transportation of certain food groups.
Distance food selling can only be performed after completing the registration procedure under the new Act. An application form as approved by the BFSA is to be submitted no later than 14 days prior to the commencement of the activity by a business operator of a registered or approved establishment or a service provider operating by means of distance communication. In this regard, the new provisions apply to all distance food traders – both those using a physical establishment for processing and storage (restaurants, bars, online stores), and online trading platforms.
The Act prohibits distance selling of infant formulae and food for young children (up to the age of three), as well as food for special medical purposes.
The Minister of Agriculture is expected to issue an ordinance laying down the specific requirements regarding distance selling of food.
Given the fact that there was no special registration regime regarding the distance selling of food prior to the adoption of the new Act, traders performing such activities are provided with a three-month period (until September 9, 2020) so as to bring their activities in line with the new requirements.
Food of animal origin, flour, bread, bakery products and confectionery may be transported only by using vehicles registered under a special procedure laid down by the new Food Act, which is certified by a sticker.
Registration of food supplements and certain types of food
- Food supplements and food products intended for use during intense muscular effort
Any business operator is obliged to register at BFSA a food supplement or a food product intended for use during intense muscular effort prior to placing it on the market for the first time. The application form is to be approved and published on the BFSA website within a two-month period as of the entry into force of the Food Act (i.e. by July 9, 2020). The competent authority may request the business operator to present a research or data confirming compliance with the requirements for composition, characteristics and purpose, as well as any other relevant information; such authorities may also request from specialised agencies (such as the Risk Assessment Center on Food Chain), the National Center for Public Health and Analyses, the Anti-Doping Center, etc.) to provide an opinion on compliance with the regulatory requirements. The food supplements or the food products intended for use during intensive muscular effort shall be included in the public register kept on the BFSA website.
Under the previous regime, food supplements were subject to notification to the relevant regional directorate for food safety prior to placing them on the Bulgarian market for the first time. It is not explicitly provided whether the notification regarding food supplements under the previous regime will be ex officio recognised and entered into the BFSA public register, and therefore such supplements will not be subject to the new registration procedure. An argument to support the position that already marketed supplements do not need to be registered is the fact that the Food Act provides for submitting application under the new regime for placing on the market in Bulgaria for the first time. Nevertheless, manufactures and traders of such products are advised to follow the practice of implementing the new Act. In any case, if there is change of circumstances subject to entry into the public register (such as composition, name or purpose of the food supplement, business operator data, production or distribution establishment, etc.), the business operator shall immediately submit a notification to the BFSA, accompanied by information or documents certifying the change.
- Infant formulae, food products for special medical purposes and foods with added vitamins and minerals
Business operators are obliged to submit a notification to the Ministry of Health prior to placing such foods on the market in Bulgaria. This requirement applies to infant formulae, certain follow-on formulae, foods for special medical purposes, as well as foods with added vitamins, minerals and certain other substances whose use in foods is restricted or controlled.
“Product from Bulgaria”/ “Obtained in Bulgaria”
The above indications shall be affixed to primary products obtained on the territory of Bulgaria. Primary products are products of primary production, including products of the soil, of stock farming, of hunting and fishing. The Act sets no additional requirements with regard to using the “Obtained in Bulgaria” indication. There are, however, certain requirements regarding the “Product from Bulgaria” indication under which the primary ingredient is to be obtained in Bulgaria and all stages of the production process need to be carried out in the country. As the Food Act provides no definition of a ‘primary product’, the European legislator’s concept shall apply, namely an ingredient(s) representing more than 50 % of the food or usually associated with the name of the food by the consumer and for which in most cases a quantitative indication is required. The indication “Product from Bulgaria” may be accompanied by a geographical map or another symbol containing information that the food has been produced on the territory of Bulgaria.
Prohibition on children’ participation in advertising
The restriction applies to advertisements or other forms of commercial communication of the following groups of foods: genetically modified foods and foods subject to regulatory restrictions on use by children, as well as foods containing nutrients and substances with nutritional or physiological effects that do not meet the requirements for healthy nutrition in accordance with the regulations. Involving children as performers in any form of commercial communication of these groups of foods is prohibited.
Penalties for carrying out activities without entry into the registers under the Food Act where such entry is required, as well as for other violations, for example, with regard to labeling or advertising, may reach up to BGN 6,000. In case of systemic violations (three or more), the envisaged penalty is five times the highest penalty under an effective penal decree issued to the respective person or entity. The penalties regarding production and sale of genetically modified foods in violation of the legal requirements remain the highest ones and may reach up to BGN 110,000.