Import & Trade of Food Supplements in Bulgaria (2026)

Legal Framework

The trade of food supplements in Bulgaria is regulated by a combination of European and national legislation:

• Директива 2002/46/ЕО — the main European act governing food supplements, including definitions, permitted vitamins and minerals and labelling rules.
• Регламент (ЕС) 1169/2011 — regulates the provision of food information to consumers, including general labelling rules applicable to food supplements.
• Регламент (ЕС) 2019/515 — on mutual recognition of goods lawfully marketed in another Member State. This regulation is relevant for importers of supplements registered in another EU country.
• Food Act (2020) — the main national law governing the production, processing and trade of food, including food supplements. Defines the competent authorities and sanctions.
• Ordinance No. 47 of 28.12.2004 и Ordinance No. 434 of 30.12.2021 — specify the requirements for registration, composition and labelling of food supplements offered on the Bulgarian market.

Registration with the BFSA

Every food supplement offered on the Bulgarian market is subject to mandatory registration with the Bulgarian Food Safety Agency (BFSA). Registration is carried out for each individual product — different flavours, dosages or forms of the same product require separate applications.

Application Documents

To register a food supplement, an application is filed with the BFSA, accompanied by the following documents:

• Manufacturer data — name, address, country of registration.
• Production facility data of production or packaging — address and registration number (if applicable).
• Date of market placement — the product must be submitted for registration at least 14 days before its placement on the Bulgarian market.
• Product name — trade name and name under Directive 2002/46/EC.
• Quantitative and qualitative composition — full list of ingredients with exact quantities per daily dose.
• Intended purpose — description of the target group and the intended purpose of the supplement.
• Label in Bulgarian — draft label translated into Bulgarian, complying with all regulatory requirements.
• Original label — a copy of the label in the language of the country of origin.
• Declaration — a declaration signed by the applicant regarding the accuracy of the information provided. It should be noted that submitting false data may lead to criminal liability under Art. 313 of the Criminal Code (false declaration).

Procedure Timelines

The food supplement registration procedure involves the following stages with specific deadlines:

1. Filing the application

   The application is filed with the BFSA (Central Office or Regional Directorate).

2. BFSA Review — 10 days

   The BFSA reviews the documents and the product's compliance with regulatory requirements within 10 business days.

3. Rectification of irregularities

   Where irregularities are found (incomplete documentation, non-compliant label, etc.), the applicant receives instructions and has at least 10 business days for correction and resubmission.

4. Decision — 7 days

   Following a positive review, the BFSA issues a decision for entry in the register within 7 business days.

5. Appeal — 14 days

   In case of refusal, the applicant has the right to appeal the decision before the administrative court within 14 days under the Administrative Procedure Code.

6. Entry in the public register

   Approved food supplements are entered in the BFSA's public register, accessible online. The registration number and date of entry are mandatory label elements.

Labelling Requirements

Labelling of food supplements in Bulgaria must comply with Regulation (EU) 1169/2011 and national provisions. Key requirements include:

• Designation "food supplement" — the product category must be clearly stated.
• Recommended daily dose — precise indication of the quantity to be taken daily.
• Warning — text "Do not exceed the recommended daily dose".
• Substitute — text "A food supplement is not a substitute for a varied diet".
• Children — text "Keep out of reach of children".
• BFSA registration number and date — the number and date of the BFSA decision for register entry must be stated on the label.
• In Bulgarian — all label information must be in Bulgarian. Additional languages are permitted, but Bulgarian is mandatory.

Prohibitions

It is strictly prohibited to attribute medicinal or therapeutic properties to food supplements. Food supplements are not medicines and cannot be advertised as means of treating, preventing or diagnosing diseases. Violation of this prohibition leads to severe sanctions from the BFSA and potentially from the Consumer Protection Commission.

Vitamins, Minerals and Prohibited Ingredients

The composition of food supplements is strictly regulated with respect to permitted ingredients and their quantities:

• Minimum 15 % of reference values — for an ingredient (vitamin or mineral) to be listed on the label, it must be present in an amount of at least 15 % of the recommended daily intake per daily dose.
• Permitted forms — vitamins and minerals must be in the chemical forms permitted under Annex 2 of Directive 2002/46/EC.
• Prohibited substances — Regulation (EC) 1925/2006, Annex III, defines substances whose use in food (including food supplements) is prohibited or restricted. Additionally, Ordinance No. 5/2004, Annex 5 contains a list of prohibited plants and substances specific to the Bulgarian market.
• Narcotic substances — food supplements may not contain substances classified as narcotics under the Narcotic Substances and Precursors Control Act.

Distribution Channels

Food supplements may be sold through the following channels:

• Registered food establishments — grocery stores, specialised health food shops, online stores (subject to food establishment registration requirements under the Food Act).
• Pharmacies — food supplements may be sold in pharmacies but are not subject to the pharmaceutical regime (no prescription required).
• Drugstores — specialised retail outlets licensed to sell cosmetic products, food supplements and medical devices.

It should be noted that the seller (natural or legal person) must have a duly registered food establishment under the Food Act. Online sales do not exempt from this requirement.

Mutual Recognition

Regulation (EU) 2019/515 on mutual recognition of goods provides an opportunity for operators whose food supplements are lawfully marketed in another EU Member State to invoke the principle of mutual recognition when placing products on the Bulgarian market.

• Evidence — the operator must present evidence (certificate, registration or other official document) that the product is lawfully marketed in another EU Member State.
• Declaration за взаимно признаване — the operator may submit a declaration under Regulation 2019/515, which the BFSA is obliged to examine.
• Bulgarian registration is still required — regardless of the mutual recognition principle, registration with the BFSA remains mandatory. Mutual recognition may facilitate the process and serve as grounds in the event of a refusal, but does not exempt from the national procedure.

Penalties for Violations

Violation of the regulatory requirements for food supplements may lead to serious consequences:

• Sale without registration — offering a food supplement without BFSA registration is an administrative violation punishable by a fine for natural persons and a pecuniary sanction for legal persons under the Food Act.
• False declaration — submitting false data in the registration application constitutes a criminal offence under Art. 313 of the Criminal Code (false declaration before a public authority), punishable by up to 3 years of imprisonment or a fine.
• BFSA inspections — the Agency conducts regular inspections of food establishments and may issue orders for rectification of violations.
• Market withdrawal — in case of serious violations (dangerous product, prohibited ingredients, misleading labelling), the BFSA may order immediate withdrawal of the product from the market and destruction of available quantities.

7 Practical Steps for Import and Trade

1. Register a company in Bulgaria

   If you do not have a Bulgarian legal entity, the first step is to register a company (EOOD or OOD). Alternatively, you may act through an already registered Bulgarian partner.

2. Register a food establishment

   The establishment (including a warehouse or online store) from which trade will be conducted must be registered under the Food Act with the relevant BFSA regional directorate.

3. Prepare the label in Bulgarian

   Translate and adapt the label in accordance with Regulation 1169/2011 and national requirements. Include all mandatory elements (category, daily dose, warnings, composition).

4. File a registration application with the BFSA

   Compile the full set of documents and file the application at least 14 days before the planned market placement.

5. Await the BFSA decision

   Expect a decision within 10 + 7 business days. If irregularities are found — rectify them within the specified period.

6. Place the registration number on the label

   After approval, add the number and date of the BFSA decision to the label. The product may not be sold without this information.

7. Commence trading

   Place the product on the market through registered food establishments, pharmacies, drugstores or online stores (with a registered food establishment).

Frequently asked questions