The trade with food supplements and foods, which are intended for intensive muscular effort, and in particular the online trade, has experienced a significant increase in Bulgaria in recent years. This has given the Bulgarian legislator the opportunity to regulate this trade anew by adopting the new Food Act, published on 09.06.2020 in the State Gazette (SG).
The previous legal requirements demanded only a notification procedure, whereby producers and/or distributors of food supplements had to submit a notification in a form to the Director of the competent District Department of the Bulgarian Food Safety Agency (BFSA). With the adoption of the new Food Act, control has been tightened up by requiring trade in these products to undergo a special registration procedure, which is again the remit of the BFSA.
In accordance with the legal definition under § 1, p. 21 of the Supplementary Provisions to the Bulgarian Food Act, food supplements are “foods, intended to supplement the general diet and which are concentrated sources of vitamins and minerals or other substances with a nutritional or physiological effect, used alone or in combination. They are placed on the market in dosage forms such as capsules, tablets, pills and other similar forms of presentation, in powder, liquid ampoules and the like, or in a powder form, which are intended for use in previously measured small quantities.” Under p. 20 of the Supplementary Provisions, foods for intensive muscular effort are defined as "foods intended to satisfy the specific nutritional requirements of the body during an intensive muscular activity, which are consumed in accordance with the instructions for use, prescribed by the manufacturer".
Through an explicit Order № RD 11-1696/24.07.2020 of the Executive Director of the BFSA was adopted a new sample of the Application for placing on the market a food supplement and / or a food for intensive muscular effort.
Upon placing a food supplement or food for intensive muscular effort on the market for the first time on the territory of the Republic of Bulgaria the respective producer/distributor shall to submit an application to the Executive Director of BFSA. The application shall include the following:
- the manufacturer‘s/distributor’s identification data;
- details of the manufacturing/distribution site of the product;
- the date of the expected placing on the market (this may take place at least 14 days after the application was submitted);
- the name of the product;
- the quantitative and qualitative content of the product;
- the intended use of the product;
The following attachments must be added to the application:
- the label, which the product will be placed on the market on the territory of the Republic of Bulgaria with;
- the original label (in case the product is not produced in Bulgaria);
Last but not least, the application declares that the product’s content complies with the one being described in the label, which includes the absence in its content of substances, determined in the respective regulations under Art. 81 of the Food Act. Applicant, who declares false information, bears criminal liability in accordance with Art. 313 of the Bulgarian Criminal Code.
The application will be processed by the BFSA within 10 days of its submission. Upon finding irregularities, the authority shall notify the applicant and sent him/her a deadline for their removal, which may not be shorter than 10 working days. The competent authority may require the business operator to provide scientific research or data to establish the compliance of the product with the requirements for its content, characteristics and intended use, as well as other necessary information. The competent authority may also request the Ministry of Health, the Center for Risk Assessment on Food Chain, the National Center for Public Health and Analysis, the Anti-Doping Center, the Bulgarian Drug Agency or other institutions and organizations to provide an opinion on the compliance of the content, quantity and type of ingredients, which are used in the product, with the regulatory requirements.
Within 7 days after the completion of the procedure, the director of the BFSA issues an order, by which he either enters the product in a special national public register, or refuses to enter it. The refusal in its essence is an individual administrative act, which is subject to appeal under the Bulgarian Administrative Procedural Code within 14 days of its announcement. The food supplement or food for intensive muscular effort shall be offered on the market on the territory of the Republic of Bulgaria after its entry within the national public register.
There is no explicit legal regulation, whether the products that are offered at the market within the old notification procedure are subject to mandatory registration under the new regime. However, from the systematic interpretation of the texts of the new Act should be concluded that the same products are not subject to mandatory registration, insofar as the Food Act provides a condition for the submission of an application under the new procedure –this is to be filled when a product is placed on the market for the first time in Bulgaria.
Food supplements and foods for intensive muscular effort are "foods" within the meaning of the legal definitions given in the Supplementary Provisions of the Food Act, and as such, the objects for their production, processing and distribution are also subject to registration / approval. An application for the same shall be submitted in a form to the Director of the respective regional directorate of the BFSA.