Biocidal Authorisation in Turkey: Comprehensive and Up-to-Date Guide
Biocidal products manufactured or imported to protect public health and ensure environmental safety must undergo a strict legal process before being placed on the market. In Turkey, biocidal authorisation is a highly rigorous, technical and legal process managed by the Ministry of Health.
If you manufacture or import disinfectants, pest control products or preservatives, this guide explains step by step how to obtain biocidal product authorisation in Turkey, what the legislation requires, and the key points of the process.
What is a Biocidal Product and Why Must It Be Authorised?
Biocidal products are chemical or biological formulations that, through their active substances, destroy, repel or render harmless harmful organisms (bacteria, viruses, fungi, insects, etc.).
They cover a wide range from hand sanitisers to insect repellents, wood preservatives to drinking water disinfectants. Proving that these products affect only the target organism without harming human health, animals or the environment is a legal requirement; authorisation by the Turkish Ministry of Health General Directorate of Public Health (HSGM) is mandatory.
Biocidal Legislation and Competent Authority in Turkey
Turkey's biocidal products regulation is largely aligned with the EU Biocidal Products Regulation (BPR). The sole competent authority managing the process is the Ministry of Health General Directorate of Public Health (HSGM). Biocidal products are divided into 4 main groups and 22 product types according to their use and purpose. Applying under the correct product type is the most critical step in the authorisation process.
Step-by-Step Biocidal Authorisation Process
The biocidal authorisation process requires technical preparation and administrative follow-up. It can be summarised in 5 main steps:
1. Preliminary Preparation and Product Type (PT) Determination
Clarify the purpose of your product and its label claims. Is your product Type 1 (Human hygiene) or Type 18 (Insecticide)? Incorrect product type determination can lead to rejection from the outset. The active substance in the product must also be checked against the list of approved active substances published by the Ministry of Health.
2. Formulation Declaration and Inventory Registration
The full formulation of the product, CAS numbers of active and non-active substances, and SDS (Safety Data Sheet) documents are entered into the system. Risk assessment of the product is based on this formulation.
3. Accredited Laboratory Analyses and Efficacy Tests
Laboratory analyses are the backbone of the biocidal authorisation process. Your product must be tested in laboratories authorised by the Ministry of Health or with international accreditation (e.g. TÜRKAK).
- Physical and Chemical Analyses: Stability testing (accelerated, long-term and open-container stability tests).
- Efficacy Tests: Proof of the product’s efficacy against the microorganisms it claims to target (e.g. if it claims effectiveness against Covid-19).
- Toxicological and Ecotoxicological Assessments: Reporting of potential harm to humans and the environment.
4. Technical Dossier Preparation and Application
All laboratory results, draft Turkish label, manufacturing site permits and product safety data sheets (SDS) are compiled into a complete "Technical Dossier". This dossier is submitted to the authority via the Ministry of Health’s Environmental Information System (ÇBS) or related digital platform.
5. Evaluation, Committee Decision and Authorisation
Ministry of Health experts review the dossier. If anything is missing, the company is notified and given additional time. If the dossier is complete, it goes to the Biocidal Products Advisory Committee. Upon committee approval, a Biocidal Product Authorisation is issued and the product may be placed on the market (open biocidal market, pharmacies, retail or industrial use).
Critical Points When Obtaining Biocidal Authorisation
To avoid loss of time and money during biocidal authorisation, pay attention to:
- Keeping Up with Legislation: Regulations and guidelines are updated frequently. Ensure your application dossier complies with the latest Biocidal Products Regulation.
- Correct Labelling: Claims on the label (e.g. kills 99.9% of bacteria) must match laboratory test results. Exaggerated or unsubstantiated claims are grounds for rejection.
- Expert Support: Professional advice from chemical regulatory experts and environmental/chemical engineers can shorten the process by months.
Frequently Asked Questions (FAQ – Biocidal)
How long does it take to obtain biocidal authorisation?
Provided the dossier is complete, the process typically takes between 6 and 12 months, including laboratory testing and Ministry review.
What is the cost of biocidal authorisation?
Costs vary according to product type, number of active substances and the scope of laboratory testing. Fees are updated annually by the Ministry of Health.
In short, the key to placing a quality, legal and reliable product on the market in Turkey is managing the biocidal authorisation process in full. With proper planning, reliable laboratory analyses and a solid grasp of the legislation, you can bring your products to market with confidence.