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Registration of Food Supplement in Bulgaria

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Registration of Food Supplement in Bulgaria

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 Bulgaria for the first time, the company 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 every food supplement.

The following basic information must be included in the application, which is a standard form that has been authorized by the BFSA executive director:

  1. Name of the company, registered office and seat of the company operator, UIC under the Bulgarian Commercial Register and Register of non-profit legal entities Act (or evidence for registration in another EU Member-State);
  2. Type, location, and address of the distribution center (if distinct from the manufacturing site address).
  3. explaination of the process used for distance selling of food supplements, including means of communication such as website, email, phone, etc. (for distance selling).
  4. Date of market release within the territory of the Republic of Bulgaria (no sooner than 14 days after submitting the application).
  5. 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:

  1. Label that will be used for the food supplement to be released to the market on the territory of the Republic of Bulgaria;
  2. Original label (for food supplements manufactured outside Bulgaria);
  3. Declaration of compliance of the food supplement’s composition with the labelling information.
  • The food supplement can be available to the Bulgarian market after verification of the application and entry of the food supplement in the Register of food supplements under article 24, para. 1 of the Food Act.
  • The Register is available online at the BFSA website
  • If there are any changes of registered details, a notification regarding the changes must be submitted to the executive director of BFSA and if required, documents verifying the change should be enclosed.

Before registering new food supplements, companies' operators and distributors must be aware with the requirements under the Food Supplements Ordinance regarding:

  • Nutritional substances such as vitamins and minerals, that may be used for food supplements.
  • Substances with a physiological or nutritional effectthat may be used for the manufacture of food supplements;
  • The purity criteria for nutritional substances used by the manufacturer in the formulation of food supplements;
  • Information that must be present on food supplement labelling;
  • Plants or parts of plants that cannot be used in the manufacture of food supplements;
  • Substances that cannot be used in the manufacture of food supplements.

New procedure for registration of food supplements in Bulgaria:

  • The application should include the following:
  1. the manufacturer ‘s/distributor’s identification data;
  2. details of the manufacturing/distribution site of the product;
  3. the date of the expected placing on the market (this may take place at least 14 days after the application was submitted);
  4. the name of the product;
  5. the quantitative and qualitative content of the product;
  6. the intended use of the product;

 

  • The following attachments should be added to the application:
  1. The label, which the product will be placed on the market on the territory of the Republic of Bulgaria with.
  2. the original label (in case the product is not produced in Bulgaria);
  • The application will be processed by the BFSA within 10 days of its submission.
  • The applicant will be notified by the authorities of any irregularities and given a deadline of no less than 10 working days for their removal.
  • The competent authority may require the company owner to provide scientific research or data to demonstrate the compliance of the product with the requirements for its content, characteristics and intended use and other necessary information.
  • 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, and other institutions and organizations may also be asked by the competent authority to provide an opinion on whether the product’s content, amount, and kind of ingredients comply with legal requirements.
  • The director of the BFSA issues an order within seven days of the procedure’s completion directing him to either put the product in a special national public register or decline to do so.
  • Fundamentally, the denial is a single administrative act that can be challenged within 14 days of its notification in accordance with the Bulgarian Administrative Procedural Code.
  • Following its registration in the national public register, the food supplement or food for intense muscular exertion may be sold on the market within the borders of the Republic of Bulgaria.