Biocidal Licensing

Biocidal product licensing & biocidal raw material licensing process, the purpose of pre-market licensing of biocidal products is to assess the risks of the products to human health, animal health, and the environment.

One of the most frequently asked questions is, can I market the product I claim is biocidal while it is in the licensing phase?
Products for which the term of the biocidal license has not been completed cannot be placed on the market. This is clearly stated in the corresponding regulation.

What to do in the term of the biocidal license;

• Completion of SDS label classification MSDS documents of the biocidal product
• To provide a literature review and technical data collection for the biocidal product
• To offer relevant accredited laboratories
• Test fee information, notification of license fees
• The biocidal product risk analysis
• Preparation of biocidal toxicological reports
• Submitting a biocidal common basic dataset
• The biocidal common basic dataset
• Biocidal and toxicological risk assessment report
• Submitting the necessary documentation of the biocidal product to the ministry

What are the documents required in the term of the biocidal product license?

• Biocidal license petition
• Label from Biocidal Product (in accordance with the Biocides Regulation)
• Responsible Manager Agreement (If Production)
• Product Safety Data Sheet (GBF (Turk SDS)/SDS/MSDS) (SDS prepared by a certified specialist)
• Contract Manufacturing Contract If the production is subcontracted
• Responsible Management Certificate (If Production)
  Biocidal Annex -2B File
• Literature information of biocidal product and substance
• Specifications of the Biocidal Product or Substance
• Biocidal Product Analysis results
• Biocidal Product Workflow Chart
• Non-Sanitary Enterprise License (For the activity, at least one of the terms disinfectant, biocidal must be included).
• Responsible Manager Diploma (If Production)
• Company’s Circular of Signature
• Full formulation of the Biocidal Product

Please call us for biocidal substance and product consultation, biocidal registration in Turkey, biocidal permits, biocidal license consultation, biocidal production permit, biocidal product risk analysis, biocidal product fundamental dataset.

“For all questions and service requests to Biocidal Licensing, you can write to us via the contact form. “