In Turkey, the market surveillance and inspection of treated articles are conducted under Law No. 4703 and the Regulation on the Procedures and Principles of Market Surveillance and Inspection by the Ministry of Health.
During these inspections, the labels, inspection forms, and technical dossiers of treated articles containing biocidal products are checked. In case of non-compliance, companies are either granted time to make corrections or subjected to legal sanctions.
Chemleg helps you prepare technical dossiers in compliance with Turkish legislation for your treated articles containing biocidal products, ensuring you avoid such negative outcomes.
Technical Dossier Requirements
According to the Communiqué on Treated Articles with Biocidal Products, technical dossiers for treated articles to be placed on the market must be prepared in Turkish and include the following content:
- A sample label of the biocidal product contained in the treated article, along with its authorization certificate and/or permit
- Safety data sheets of the biocidal active substances or biocidal products used, to be obtained from biocidal active substance or biocidal product suppliers,
- Updated label samples of the treated article
- Safety Data Sheet of the treated article, if applicable
- A detailed explanation of the design and manufacturing process, including a list of components and materials used in the treated article
- Addresses of manufacturing and storage facilities
- Analysis reports as specified in Article 11 of the Communique Regarding the Treated Articles
These requirements are also summarized in the following table:
| Document / Information Type | Mandatory | Description |
| Sample label of the biocidal product | Yes | Must be submitted together with the authorization or permit document. |
| SDS for the active substance | Yes | Must be obtained from the supplier. |
| Label samples of the product | Yes | Must include current versions. |
| Safety Data Sheet (SDS) | Depends | Mandatory only if applicable. |
| Component/material list and manufacturing details | Yes | Must include technical and production details. |
| Analysis reports | Depends | Must be provided when required as per Article 11. |
During market surveillance and inspection activities conducted by the Ministry, companies must present their technical dossiers to the Ministry or inspector upon request.
Prepare Your Technical Dossier with Chemleg
Technical dossiers for treated articles containing biocidal products must comply with the requirements of the Communiqué on Treated Articles with Biocidal Products. These dossiers should be prepared by experts who are well-versed in regulatory provisions.
With its experience in the sector and a team of chemical assessment specialists, Chemleg prepares your technical dossiers and ensures the process runs smoothly for your company.
Frequently Asked Questions
Who must prepare a technical dossier for treated articles?
Manufacturers and importers based in Turkey, or foreign manufacturers and importers represented by an Only Representative, are obligated to prepare a technical dossier if placing treated articles on the Turkish market.
What if the biocidal active substance used in the treated article is not authorized in Turkey?
Treated articles containing unauthorized biocidal active substances cannot be placed on the market. If the active substance is not listed in List 1 or List 1A, the technical dossier is unacceptable, and importation or manufacturing is prohibited.
Is an analysis report mandatory in the technical dossier?
An analysis report from a laboratory authorized by the Ministry of Health may be requested during inspections. Manufacturers or importers must comply with this request.
In what language must the documents in the technical dossier be?
Technical dossiers for treated articles to be placed on the Turkish market must be in Turkish. Documents in other languages must be translated by an official or sworn translator.
How long must the technical dossier be retained?
Technical dossiers must be kept accessible for at least 10 years after the product is placed on the market.
Can importation be done without a technical dossier?
Importation cannot take place without a prepared technical dossier. The dossier must be ready before importation and available for submission in case of customs checks.
Is it mandatory to obtain a biological efficacy test from an authorized laboratory?
The claims of the treated article must be tested and reported by authorized laboratories to support the efficacy claim.
