BIOCIDAL PRODUCT CONSULTANCY
Biocidal products can be placed on the market only after meeting the requirements set forth by the Biocidal Products Regulation issued by the Ministry of Health on 31 December 2009 (Official Gazette No. 27449, 4th Repetition).
According to the current legislation:
- The process initiated by the Biocidal Products Regulation dated 31 December 2009 and numbered 27449 (4th Repetition),
- Has been revised with the Regulation Amending the Biocidal Products Regulation published on 30 December 2021 (Official Gazette No. 31705).
Prepare your biocidal products for both market entry and potential inspections
Chemleg manages all processes on your behalf, including the preparation of the biocidal product license, submission documents, and obtaining the product authorization in compliance with current regulations.
Our biocidal product service includes:
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
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