Our Services within the Scope of Biocidal Products Regulation
Biocidal products can be placed on the market after the requirements of the Ministry of Health's "Biocidal Products Regulation" dated 31 December 2009 and numbered 27449 (4th Repeated) Biocidal Products Regulation (BPR) are fulfilled.
With the Regulation Amending the Regulation on Biocidal Products published in the Official Gazette dated 30/12/2021 and numbered 31705, amendments were made to the Regulation on Biocidal Products, which determines the procedures and principles regarding the operations and processes related to biocidal products in Turkey.
Accordingly, the provisional application and sealed sampling process, which caused difficulties and confusion in licensing procedures, has been abolished. The companies shall provide their samples to the laboratories that meet the conditions specified in the relevant procedures and principles.
Furthermore, for products other than pest control products, the provision of conducting analyses in authorised laboratories for licence purposes has been abolished and it is stated that the results of biocidal product analyses (physicochemical tests, long-term stability and short-term stability tests and efficacy tests) conducted abroad for imported product licence applications may be accepted by the Ministry of Health if they meet certain conditions.
1. Preparation of Application Documents
- Preparation of Biocidal Product Licence Dossier in accordance with Annex-IIB format
- Preparation of Biocidal Product Label in accordance with Annex-XII format
- Preparation of Biocidal Product Active Substance Dossier in accordance with Annex-IIA format
- Preparation of the Safety Data Sheet (SDS/MSDS) of the Biocidal Product in accordance with the provisions of the KKDIK Annex II Regulation dated 23.06.2017 and numbered 30105
- Preparation of Biocidal Product Formulation and Specification documents
- Preparation of the Biocidal Product Risk Assessment Report in accordance with the Annex-VI format within the scope of BPR
- Performing ecotoxicological and toxicological risk assessment calculations within the scope of the Risk Assessment Report
- Carrying out the necessary literature searches from all scientific sources, especially ECHA (European Chemicals Agency)
- Technical translation of required documents (analysis report, technical data sheet, certificate of analysis, etc.)
- Examination of biocidal product analysis reports and control of compliance
- Carrying out testing processes with the relevant laboratories in case the tests of the biocidal product are not available:
- Contacting with accredited laboratories
- Requesting quotations from laboratories
- Ensuring the organisation of sample delivery
- Following-up of the test process
- Controlling of test reports
2. Submission of the Application Dossier to the Ministry of Health
- Preparation of the application dossier according to the ‘Biocidal Product Licence Application Checklist’
- Submission of the application dossier to the Ministry of Health
3. Follow-up of the Application Process
- Meeting the additional information/document requests by the Ministry of Health after the application
- Regular tracking of the application process
- Obtaining biocidal product licence
You can get support from our team and ask for help with the service details.
