Dental disinfection: legal requirements in Bulgaria

Which rules answer which question?

Distinguish standards, safety data sheets and authorizations. An EN standard describes testing or an assessment framework; a safety data sheet describes hazards and safe handling; a biocide authorization defines permitted uses and their conditions.

Biocide or medical-device disinfectant?

Annex V of Regulation (EU) 528/2012 defines product-type 1 for human hygiene products principally intended to disinfect skin or scalp. Product-type 2 includes specified disinfectants for surfaces, materials, equipment and other objects not intended for direct application to humans or animals. The type must match the claimed use.

Products specifically intended to disinfect or sterilize medical devices fall within Regulation (EU) 2017/745, the MDR. MDCG 2021-24 Rev.1, rule 16, explains classification by intended purpose, including the specific classification of products used to disinfect invasive devices as the final step before use. This guidance explains the regulation; it is not itself legislation.

Request documentation for the exact product and planned use. “Dental”, “medical” or “professional” on a label does not determine its legal framework. A supplier's catalogue may contain products governed by different rules.

CE marking indicates conformity with the requirements for the product’s intended purpose; it does not authorize uses outside that purpose. Conversely, a biocide-register entry does not demonstrate compatibility with a particular handpiece, impression material or internal waterline.

Checking a biocide for the Bulgarian market

Article 17 of Regulation (EU) 528/2012 links use to authorization and its conditions. Transitional national arrangements must also be considered. Approval of an active substance alone is insufficient: check the legal basis for using the particular finished product for your intended purpose.

Start with the Bulgarian Ministry of Health's biocides page, which links to registers and the European Chemicals Agency (ECHA). The Ministry also explains Union authorizations and the Bulgarian label and safety data sheet required when these products are supplied in Bulgaria.

When purchasing or changing a product:

1. Record its exact name, variant, manufacturer and supplier.
2. Locate the authorization and compare its number, product identity and permitted uses with supplier documents.
3. Check that it covers Bulgaria, the planned use and user category.
4. Read the conditions of use, restrictions and validity period, and check for any amendment or withdrawal of the authorization.
5. Compare label, instructions and documentation; resolve discrepancies before use.
6. Retain the date and result of the check in the product file.

If you cannot find the product in the national register, check whether it has a Union authorization or is supplied under another applicable legal basis. Obtain supplier documents and, when necessary, clarification from the competent authority. Online sale alone does not establish that your intended use is authorized.

Check the specific product at the time of purchase. General information about a brand is insufficient.

What changed under Ordinance Н-4/2026?

Ordinance Н-4 of 30 March 2026 governs prevention and control of healthcare-associated infections. Section 7 of its concluding provisions repeals Ordinance 2/2005 and Ordinance 3/2013. The old 2013 dental chapter must therefore no longer be cited as current law.

Article 6 refers to standard and additional precautions in annex 1 and cleaning, disinfection and sterilization monitoring in annex 2. Consult these when updating practice procedures.

Organizational duties also depend on facility type. Article 9(1) lists particular facilities, including dental centres with up to 10 beds for observation and treatment up to 48 hours. An individual outpatient practice is not equivalent to such a centre; identify the provisions applying to your registration.

For facilities outside that list, article 8(3) refers to annex 5, which specifies the infection prevention and antimicrobial resistance (AMR) programme:

• risk assessment for patients, third parties and staff;
• staff training measures;
• rules for protective equipment, asepsis and reusable-device/equipment processing;
• post-exposure actions after blood/body-fluid contact, and prevention and reporting of sharps injuries;
• disinfection policy and waste management;
• AMR policy, including antibiotic use and microbiological specimen collection and transport.

A list of products alone does not cover the whole programme. Responsibilities, procedures and responses to deviations must be clear.

Processing controls under the new ordinance

These selected requirements are located in annex 2; consult the full wording and equipment instructions.

For steam sterilization, VI.1.1 specifies daily checks before the first load using a vacuum test and Bowie-Dick test, plus Helix testing, mandatory for loads consisting mainly of lumened devices. Check how these tests are to be performed with your sterilizer, taking account of its technical capabilities and instructions. Resolve discrepancies through documented clarification with the supplier and regional health inspectorate; do not substitute one test for another on your own initiative.

These checks answer different questions. A successful steam-penetration test does not replace biological monitoring; indicator colour change does not remove the need to check parameters and packaging.

Records must show what was done

Annex 1, section I, 2.4.5 specifies the sterilization log: date and sequential number, sterilizer and programme, batch contents, parameter records, monitoring results, operator and changes in products or packaging. Include malfunction, repair and maintenance information. Record start and finish times where there is no printer. Electronic documentation is permitted.

That section does not itself state a retention period. Do not automatically present the repealed standard's ten-year period as a requirement of the new ordinance. Establish the applicable retention periods and document archival rules; a change of legal basis is not a reason to destroy existing records.

The following optional folder structure can help staff locate information; legislation governs required content, not these folder names.

Do not backdate records for work you cannot confirm. If evidence of an activity is missing, note what is missing and what action you have taken. An internal check should establish how a batch was processed, its monitoring results and who released it.

Working safely with chemicals

Ordinance 13 of 30 December 2003 requires risk assessment where hazardous chemical agents are present. The version published by the Labour Inspectorate and checked for this article includes amendments in State Gazette 33 of 3 April 2026.

Articles 3–7 cover hazard identification and risk assessment; work may begin only after the necessary protective measures have been put in place. Articles 8–10 cover prevention and control, article 12 emergency arrangements, and article 13 information, training and access to safety data sheets.

Assess actual tasks: opening concentrate, dosing, working over a bath, application, storage and spills. Choose protective measures for the substances being used and the tasks being performed. Examination gloves do not protect against every chemical: check the safety data sheet and the glove's chemical-resistance information.

The safety data sheet explains hazards, first aid, storage, exposure protection and disposal. It does not establish antimicrobial efficacy or replace use instructions. Ensure it matches the exact product and is accessible where staff need it.

Do not mix products unless the manufacturer explicitly requires mixing specified components to activate a particular product, and follow those instructions exactly. Chlorine-releasing agents mixed with acids or ammonia products are particularly dangerous. Smell cannot establish effectiveness or a safe concentration.

Working solutions and waste

Specify preparation, labelling, usable life and replacement conditions. The expiry date of an unopened concentrate does not tell you how long its diluted working solution can be used. Check product instructions and process-specific requirements together.

Ordinance 1 of 9 February 2015, including the 2018 amendment, governs healthcare-waste collection and treatment. Identify the waste type and check that the contractor is authorized to accept and treat that type of waste.

Do not assume used disinfectant may be poured into the drain. Check the safety data sheet's disposal section and applicable arrangements. Chemical residues, infectious material and sharps do not become one waste category merely because they arose during the same procedure.

Writing a processing procedure

Describe a particular surface, instrument group or equipment model. Specify its own concentration and time rather than copying the same values everywhere.

These optional fields do not replace legally required records. This is not an official regional-inspectorate form.

When to review the procedure

Review the procedure when you change a product, instrument or dental unit, receive new instructions, or carry out servicing that changes operating conditions. Also review it after unsatisfactory monitoring results or changes in legal requirements. Update affected documents and train those performing the procedure.

When asking for clarification, identify the exact legal provision, product or equipment model. Consult the Ministry for biocide requirements, the regional health inspectorate for facility organization, and occupational health services for staff exposure. This makes the response relevant to your actual practice.