How to Obtain a Biocidal Product License?

Biocidal Product Licensing Process

Biocidal Products Regulation was published in 2009 in Türkiye. The Turkish BPR was prepared in accordance with 98/8/EC EU Biocidal Products Directive. In later years, "Consolidated Regulation on Biocidal Products No.28939” was published in 2013 in parallel with the Directive 98/8/EC of the European Union and Regulation 528/2012/EU.

To place a biocidal product into the Turkish market, authorization shall be granted by the competent authorities under the "Biocidal Products Regulation" dated 31 December 2009 and numbered 27449 (4). And the active substances contained in that biocidal product must be previously approved.

There are two main Active Substance Lists in Türkiye; List A and List 1. List A includes the active substances whose status is “Under Review” and List 1 includes the active substances whose status is “Approved” within the scope of EU BPR.

List A and List 1 undergo regular updates in accordance with ECHA. Active substances in biocidal products that will be sold in Türkiye must fall within the categories of "Under Review" or "Approved". If an active substance is rejected for EU BPR, it will also be removed from the Biocidal Products Active Substance Lists.

The Biocidal Product Licensing Process can be summarized in 3 key steps.

Registration Process to Get the Biocidal Product License

1. STEP: Necessary analyses of the biocidal product

•         The Biocidal Product License dossier should include the below analysis results of the biocidal products:
  
  

• Physicochemical tests,

• Long-term and short-term (accelerated) stability tests,

• Stability test of the opened package of the product according to product type,

• Efficacy tests.

•         If these tests are not available, they must be carried out in authorized laboratories in Türkiye.
•         The Ministry of Health can accept the results of tests conducted abroad for applications of imported product registration, provided that these tests meet certain conditions laid out in the Regulation.

 

2. STEP: Dossier study of biocidal product

•         Searching laboratory in Türkiye to perform the analysis requested by the Ministry (if tests are not available, upon company request)
•         Preparation and controlling studies of the documents received
•         Preparation of the Safety Data Sheet (SDS) of the Biocidal Product
•         Preparation of Biocidal Product Label under Annex-XII
•         Preparation of the Formulation and Specification documents of the Biocidal Product
•         Preparation of Biocidal Products Dossier in accordance with Annex-IIB
•         Preparation of Active Substance Dossier in accordance with Annex-IIA
•         Preparation of toxicological and ecotoxicological Risk Assessment Report of the product under Annex-VI

 

3. STEP: Submission of the Biocidal Product License File and awaiting Ministry evaluation

•         Submission of the hard copies of the Biocidal Product License File to the Ministry of Health
•         Following up the application regularly
•         Providing the additional information or documents requested by the Ministry timely and correctly
•         Evaluation of the authority and licensing of Biocidal Product
  
  

The licensing process for biocidal products is a thorough procedure that necessitates expertise. Depending on the requirements of our customers, we offer a comprehensive range of services under the Biocidal Products Regulation.

Click here to reach our services regarding Biocidal Products Regulation.