Legal Framework — Food Act and EU Regulations
- Food Act (Zakon za hranite, ZH) — State Gazette No. 52/2020, in force since 9 June 2020, last amended by State Gazette No. 55/2026. Food production, processing and distribution take place after registration or approval (Art. 23(1)). Registration is governed by Art. 26 and approval by Art. 31.
- Regulation (EC) No 852/2004 on the hygiene of foodstuffs — requires every operator to notify the competent authority of each establishment under its control (Art. 6(2)) and to apply procedures based on the HACCP principles (Art. 5).
- Regulation (EC) No 853/2004 — specific hygiene rules for food of animal origin and the requirement for approval of establishments handling it (Art. 4(2)).
- BFSA Fee Tariff — adopted by Council of Ministers Decree No. 240 of 11 November 2025 (State Gazette No. 97/2025), amended by Decree No. 266 of 27 November 2025; the euro fees apply from 1 January 2026.
The competent authority for registration is the director of the RDFS where the establishment is located. For establishments bottling natural mineral, spring and table waters it is the director of the Regional Health Inspectorate (Art. 23(2) ZH).
Registration or Approval: Which Regime Applies
Before filing, determine the regime — it decides the procedure and the document you receive.
Registration under Art. 26 ZH
This is the regime for most establishments. BFSA’s public register lists them separately:
- retail establishments — grocery and specialised food shops;
- catering establishments — restaurants, cafés, bars, bistros;
- establishments producing, processing and distributing food of non-animal origin, including warehouses;
- mobile, temporary, movable or open-air establishments and vending machines;
- operators trading from rented storage space or only transporting food (with a simplified application under Art. 26(4)–(5)).
Approval under Art. 31 ZH
Establishments that produce, process or store food of animal origin — meat, milk, fish, eggs and products thereof — for supply to other establishments are, as a rule, subject to approval under Regulation (EC) No 853/2004. That Regulation does not apply to retail unless expressly stated otherwise (Art. 1(5)). An approved establishment receives an approval certificate with a veterinary approval number.
Separate registrations
- Distance (online) selling of food — entered in the register as a separate activity under Arts. 60–61 ZH, in the same application or later (see below).
- Food supplements — entered in BFSA’s register before they are first placed on the Bulgarian market; the competent authority is BFSA’s executive director (Art. 79 ZH).
The application states the operator’s company ID (Art. 26(2)(1) ZH), so the business is registered before the establishment. If you have no company yet, see company registration in Bulgaria.
Registration Procedure — Step by Step
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Preparation
The premises must be lawful under the Spatial Planning Act, meet the hygiene requirements, and you need a draft food safety management (own-check) system. The fee is paid before filing.
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Filing the application on form KH No. 1
File with the RDFS where the establishment is located — at the counter, by post, by e-mail or electronically via egov.bg (administrative service No. 769). The application states a start date at least 14 days after filing (Art. 26(2)(11) ZH).
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Document check — up to 5 working days
If there are deficiencies, the RDFS sets a deadline of 10 working days to 6 months to remedy them; meanwhile the 14-day period until the start date stops running (Art. 26(6) ZH).
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Entry in the register — up to 5 working days
Within 5 working days of filing, or of remedying the deficiencies, the establishment is registered for the declared activities; registration has no expiry (Art. 26(7)(2) ZH). A refusal is issued only if deficiencies are not remedied in time; it can be appealed under the Administrative Procedure Code, but the appeal does not suspend it (Art. 26(7)–(8)).
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Start of operations
After registration and not before the date stated in the application. No separate act or certificate is issued for registration — the result is the entry in BFSA’s public register.
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On-site inspection
An RDFS commission inspects the establishment within 30 days of registration for food production and processing, and within 60 days for distribution establishments, including trade (Art. 26(9)). Non-compliance leads to an instruction with a deadline of 10 working days to 3 months or, in case of an immediate and serious risk to health, suspension of the activity (Art. 26(11)). No on-site inspection applies to transport-only operators or to trade from rented storage space (Art. 26(10)).
VAT registration is a separate procedure with the National Revenue Agency — see VAT registration.
Required Documents
The application under Art. 26(1) ZH is accompanied by:
- Application on form KH No. 1, approved by BFSA’s executive director, with Annex 1 “List of food groups” and, where needed, Annex 2 (mobile and temporary establishments, vending machines) and Annex 3 (distance selling contracts).
- Spatial Planning Act document — a copy of the certificate of commissioning (Art. 177(3) ZUT), of the building permit for ancillary buildings (Art. 41(1) ZUT), of the placement permit for movable structures (Art. 56(2) ZUT), or a document showing that the premises are not subject to commissioning. Where there is a use permit, its number and date are stated in the application.
- Proof of ownership, lease or right of use of the premises.
- For vehicles — a copy of the registration certificate and proof of the right of use, where applicable.
- Proof of payment of the fee under the BFSA Tariff.
The application itself (Art. 26(2) ZH) states the type and address of the establishment, the activities, the food groups and sub-groups, water supply and wastewater disposal, capacity, vehicles and the start date. You declare compliance with Regulation (EC) No 852/2004 and that a draft food safety management system has been prepared. Transport-only operators, traders from rented storage space and distance sellers need only a traceability plan.
HACCP and Own-Check System
Every food business operator, except primary producers and the pharmacies and drugstores under Art. 30 ZH, puts in place and maintains a permanent procedure or procedures based on the HACCP principles (Art. 5 of Regulation (EC) No 852/2004; Art. 10 ZH). The seven principles are:
- identifying hazards that must be prevented, eliminated or reduced to acceptable levels;
- identifying the critical control points;
- establishing critical limits;
- monitoring procedures at the critical control points;
- corrective actions when a point is not under control;
- regular verification that the measures work;
- documents and records commensurate with the nature and size of the business.
The last point matters for small businesses: the system is proportionate to the type and size of the activity and may rely on good practices and approved sector guides (Art. 26(2)(15) ZH). At registration you declare that a draft system exists; its actual application is checked during the on-site inspection and later controls.
Hygiene Requirements for Premises and Staff
The general hygiene requirements are in Annex II to Regulation (EC) No 852/2004. They include:
- an adequate number of flush lavatories connected to effective drainage, and washbasins with hot and cold water and materials for cleaning and drying hands (Chapter I);
- suitable natural or mechanical ventilation, lighting and drainage (Chapter I);
- an adequate supply of potable water (Chapter VII);
- adequate pest-control procedures (Chapter IX) — in practice often through a contract with a specialised provider;
- training of staff in food hygiene and, for those responsible for HACCP procedures, in the HACCP principles (Chapter XII).
National staff requirements are in the Food Act: people working in the establishment undergo preliminary and periodic medical examinations (Art. 12), and a food production establishment must employ at least one person on an employment contract with education or qualifications in food technology or veterinary medicine and, for certain categories such as food supplements, in medicine or pharmacy. No hire is needed if the operator itself meets the condition (Art. 13).
State Fees (2026)
The fees are set in Art. 51(1) of the BFSA Fee Tariff. The registration fee is fixed and does not depend on floor area:
| Service | Fee |
|---|---|
| Registration or approval of a food production, storage and trade establishment | EUR 17.38 (BGN 34) |
| Registration of a temporary or mobile establishment | EUR 10.72 |
| Registration of a food transport vehicle | EUR 10.72 |
| Change of name, address, owner or other registered circumstance | EUR 10.72 |
| Establishment that only stores and donates food (charity) | no fee |
Registration for distance selling is requested under the same administrative service No. 769, for which the Administrative Register lists a fixed fee of EUR 17.38. Fees can be paid at the counter in cash or by card, by bank transfer or electronically. Budget separately for food safety documentation, service contracts and any refitting of the premises.
Online Food Sales — a Separate Registration
Distance selling of food takes place after registration (Art. 60(2) ZH). Registering the warehouse or kitchen does not replace it, but you can request both together on the same KH No 1 application form (a separate tick-box and annex for distance selling) — or add online selling later on its own.
- Who registers — the operator with a registered or approved establishment, or the service provider operating the means of distance communication, such as a platform (Art. 60(1)).
- Where — with the RDFS where the establishment, or the head office of the means of communication, is located (Art. 60(3)).
- When — at least 14 days before starting; the application is checked within 5 working days (Art. 61(2)–(4)).
- Content — website, phone and other means of communication, the operators you have contracts with and their registration numbers, vehicles, and a declaration of a traceability plan (Art. 61(1)).
Mandatory information on prepacked food — including allergens — must be available before the purchase is concluded, except the date of minimum durability or use-by date (Art. 14 of Regulation (EU) No 1169/2011). Foods for special medical purposes may not be sold at a distance (Art. 63(1) ZH). The right of withdrawal does not apply to goods liable to deteriorate rapidly or with a short shelf life, nor to sealed goods unsealed after delivery that cannot be returned for hygiene reasons (Art. 57, items 4 and 5 of the Consumer Protection Act) — address this in the shop’s terms and conditions.
Food supplements also require separate registration of the product itself with BFSA before it is first placed on the Bulgarian market (Art. 79 ZH).
How to Check a BFSA Registration by Company ID
BFSA keeps a public national register of food business operators and establishments (Art. 24(1) ZH). On the agency’s website bfsa.egov.bg choose “Регистри” (Registers), then the National Register of establishments for the production and distribution of food and food contact materials, and open the list for your type of establishment — retail, catering, mobile and temporary establishments, distance selling, food supplements or approved establishments.
You can search by company ID (EIK) or personal ID, operator name, registration number (approval number for approved establishments), RDFS, establishment status and food groups. Since no certificate is issued for registration, the entry and the establishment’s registration number serve as proof towards business partners and inspectors.
Post-Registration Obligations
- Changes in circumstances — operator details, food groups, mobile establishments, vehicles, means of distance selling: notify the RDFS within 3 working days; the change is entered within 7 days (Art. 26(14)–(15) ZH).
- New registration — on a change of address or type of activity, and on succession with an interruption of activity (Art. 26(16)).
- Suspension of activity — notify within 7 days, stating the period (Art. 29). Registration is deleted if activity is not resumed after that period or if the establishment has been closed for more than a month without notice (Art. 27(1)(7)–(8)).
- Own checks and traceability — maintaining the HACCP procedures and traceability under Art. 18 of Regulation (EC) No 178/2002 (“one step back, one step forward”).
- Staff — medical examinations and hygiene training (Art. 12 ZH; Chapter XII of Annex II to Regulation (EC) No 852/2004).
- Official controls — granting access and providing documents during inspections; failure is also sanctioned (Art. 132 ZH).
Penalties for Operating without Registration
| Violation (Food Act) | Food business operator | Other person |
|---|---|---|
| Activity without entry in the register, or an activity that is not registered (Art. 128(1)(3)–(4) and (2)) | BGN 4,000 – 6,000 (EUR 2,045.17 – 3,067.75) |
BGN 2,000 – 4,000 (EUR 1,022.58 – 2,045.17) |
| Distance selling in breach of Arts. 61–65 (Art. 131(1)(9) and (2)) | BGN 4,000 – 6,000 (EUR 2,045.17 – 3,067.75) |
BGN 2,000 – 4,000 (EUR 1,022.58 – 2,045.17) |
The Act states the amounts in leva; the euro equivalents use the fixed rate of 1.95583 (Art. 11(2) of the Euro Introduction Act). A repeat violation of the same kind within three years of a final penalty decision triples the penalty (Art. 135); systematic violations carry five times the highest penalty imposed (Art. 136). If the fine or penalty is paid within 7 days of the penalty decision, 70% is due (Art. 137).
Gross or systematic violations lead to deletion of the registration (Art. 27(1)(4)), and the operator cannot obtain a new one (Art. 36).
Frequently Asked Questions
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