Food supplements are becoming increasingly popular on the Bulgarian market. Interest in them grows exponentially with the discovery of new food products and ingredients to assist each of us on the journey to a healthier lifestyle.
The Bulgarian Food Safety Agency (“BFSA”) exerts control over the food supplements trade. They also carry out the registration procedure, which is a mandatory prerequisite for their lawful trade on the Bulgarian market. Although the procedure itself is not complicated and multi-phased, compliance with the regulatory framework is key.
Compliance of the content of the food supplement
The first step in the registration process of any food supplement is to check that the content of the food supplement complies with the current legislation at the national and EU level. Of course, such a compliance check should be carried out during the preparation and production of the product if it is a newly developed product. However, given the dynamic nature of the legal framework, monitoring by the manufacturer (or applicant) in this respect should be regular. This rule applies even more to food supplements marketed in the territory of another Member State which are yet to be distributed on the Bulgarian market.
There is a regulatory framework on the content of food supplements at both national and European level. Regulation (EC) No 1333/2008 is one of the main pieces of European legislation in this area. It contains approved food supplements listed in detail in a number of annexes. All kinds of colors, sweeteners and other additives can be found there, in what maximum permissible quantity they can be present in the composition of the product, the conditions for their use depending on the food categories.
However, the ingredients thus described are subject to change and should be monitored regularly. As an example, take the coloring agent titanium dioxide, which, although contained as an approved ingredient in the above-mentioned Regulation, was banned by the European Commission earlier last year. Such exclusion from the approved lists means not only a potential refusal of an application for registration, but also the need to withdraw products containing the substance from the market. Failure to comply with these requirements, if found following an inspection by the BFSA, would carry with it the liability of the distributing company.
At the national level, there is a so-called Food Supplements Ordinance (the ‘Ordinance’) which regulates all vitamins and minerals that may be used in the manufacture of food supplements, as well as their maximum acceptable daily intake. It is here, from the point of view of national legislation, that a divergence may occur between the requirements of two Member States. Consequently, it is possible that a food supplement may not be permissible for trade in Bulgaria but may be marketed in another Member State.
The rules on labelling are mainly regulated at European level, in particular in Regulation (EU) 1169/2011. It contains everything from the principles relating to food information (presented through labelling) to specific mandatory content on the label, depending on the type of product. For the most part, the Ordinance refers to the provisions of Regulation (EU) 1169/2011, but it also contains some additional specificities that should not be overlooked. These include: a warning not to exceed the recommended daily dose; a warning not to use the product as a substitute for a varied diet; a warning to keep the product out of the reach of children, etc.
It is of the utmost importance that the information on the label does not contain any suggestion that the food supplement prevents or cures any disease. This requirement is in place in order to distinguish this type of product from medicinal products and medical devices.
Availability of a storage facility
A prerequisite for registration with the BFDA is proof that the applicant has the necessary storage facilities for storing the food supplements. For this purpose, any documents may be submitted – title deed, lease agreements. However, a certificate that the warehouse is approved for the storage of food supplements is also required. Such a certificate is issued by the relevant regional food safety directorate.
Registration with BFSA
Once the above prerequisites have been met, an application for registration of the food supplements with the BFSA may be submitted. The application itself in the form of a template and must be accompanied by the above-mentioned documents relating to the storage facilities and details of the food supplements themselves. Depending on the product, packaging, labels, draft translation (if the product’s packaging is in a foreign language) may be attached. The application also indicates the date of placing on the market, which must be at least 14 days following the application. Within 14 days, BFSA examines the application and, depending on the compliance as per the attached documents, either enters the food supplement in its register or issues a refusal, which is sent to the applicant. Upon successful registration, each food supplement receives a unique identification number which must be present on the packaging or translation label.