Registration of food supplements under the bulgarian food act
Food supplements are becoming increasingly popular as they are gaining further interest among people of all ages looking to maintain good well-being. Therefore, it is important for the business involved in the food supplement manufacturing and trading to keep updated on the new regulations related to them. A key part of the legal provisions deals with the requirements for the registration of new supplements.
Pursuant to Bulgarian law the food supplements are foods intended to supplement the normal diet and which represent concentrated sources of vitamins and minerals or other substances with a nutritional or physiological effect, used alone or in combination and released to the market in dose form as capsules, tablets, pills or similar, sachets of powder, ampoules of liquids and other similar liquid or powdered supplements intended for use in small, pre-dosed quantities.
Food supplements are released to the market and sold as foodstuffs and reach end customers in prepackaged form only. The labelling, presentation, and advertising should not attribute to supplements the property of treating, curing, or preventing human disease, nor to refer to such properties.
To comply with all legal provisions, business operators is advisable to seek legal advice on the applicable requirements before registration. Below you will find basic information regarding the registration of food supplements.
Art. 4, para. 1 of the Food Supplements Ordinance, adopted with a Government Decree № 434 of 10.12.2021, promulgated in the Bulgarian Official Gazette, issue 106 of 15.12.2021, and in force since 30.12.2021, states that the release on the Bulgarian market for the first time of food supplements and the conditions and procedure for their registration fall under the scope of art. 79 and art. 80 of the Bulgarian Food Act, promulgated in the Bulgarian Official Gazette, issue 52 of 09.06.2020 in force since 09.06.2020, as amended from time to time.
Requirements for registering food supplements under art. 79 and art. 80 of the Bulgarian Food Act
When registering new food supplements to be released to the market in the Republic of Bulgaria for the first time, the business operator must submit an application to the competent authority – the executive director of the Bulgarian Food Safety Agency (BFSA). A separate application must be submitted for each food supplement.
The application is a standard form, approved by the executive director of BFSA and must include the following basic information:
- Company name, seat and registered office of the business operator, UIC under the Bulgarian Commercial Register and Register of non-profit legal entities Act (or evidence for registration in another EU Member-State);
- Address of production site, type and address of distribution centre (when different from the address of the production site);
- Description of the method used for distance selling of food supplements, including means of communication such as website, email, phone, etc. (for distance selling);
- Date of release to the market on the territory of the Republic of Bulgaria (no earlier than 14 days after submitting the application);
- Brand name, qualitative and quantitative composition and intended use of the food supplement and other information.
The following must be submitted together with the application:
- Label used for the food supplement to be released to the market on the territory of the Republic of Bulgaria;
- Original label (for food supplements manufactured outside Bulgaria);
- Declaration of compliance of the food supplement’s composition with the labelling information.
The food supplement can be released to the Bulgarian market after verification of the application and entry of the food supplement in the Register of food supplements under art. 24, para. 1 of the Food Act. The Register is available online at the BFSA website. In the event of changes of registered details, a notification regarding the changes must be submitted to the executive director of BFSA and if necessary, documents verifying the change should be enclosed.
Before registering new food supplements, business operators and distributors must familiarize themselves with the requirements under the Food Supplements Ordinance regarding:
- Nutritional substances (vitamins and minerals) that may be used for the manufacture of food supplements;
- Substances with a nutritional or physiological effect that may be used for the manufacture of food supplements;
- The purity criteria for nutritional substances intended for use in the manufacture of food supplements;
- Information that must be present on food supplement labelling;
- Plants or parts thereof that cannot be used in the manufacture of food supplements;
- Substances that cannot be used in the manufacture of food supplements.
To avoid mistakes and confusion when registering food supplements for sale in a physical or online store, we recommend to contact a reputable lawyer in the field of pharmaceutical law.
This article has been prepared for the purposes of general information only and does not constitute legal advice with respect to any particular subject or situation. For specific legal advice you should contact an attorney-at-law. Stoeva, Tchompalov & Znepolski is not responsible for any legal action undertaken on the basis of the information contained herein.