Biocidal products (disinfectant, preservative, pest control products, etc.) are licensed under the Biocidal Products Regulation in Turkey. The process varies depending on the product type and active ingredient.
Basic steps: determination of product type; control of active ingredient-product compatibility; compilation of efficacy and safety data; Preparation of product information file and registration application. Labeling and SDS obligations are also included in the process.
Active substance suitability and efficacy data are the most critical components of the registration. ONAY Mühendislik offers conformity analysis, dossier preparation and registration process management for biocidal products.
Prerequisite for License Application
In order for a biocidal product to be licensed, the active substance it contains must be on the approved list for the relevant product type. If the active substance is still in the evaluation phase, transitional period provisions apply. Therefore, before licensing planning, it is essential to check the current status of the active substance on a product type basis.
Components of the Application File
Product file; It includes full formulation information, physical-chemical properties, analytical methods, efficacy data, packaging and label draft, instructions for use, shelf life and stability data and risk assessment for human health and the environment. In order to reference the active substance dossier, the right of access must be documented.
Compliance of Event Data with Declaration of Use
Supporting data must be provided for each effect declared on the label. Different potency claims, such as bactericide, fungicide and virucidal, require separate tests. Tests must be performed under the concentration, contact time and application surface conditions specified on the label. This incompatibility is the heading for which deficiency requests are most frequently received in applications.
Label and Packaging Evaluation
The biocidal product label must carry both the hazard information within the scope of the SEA Regulation and the license number, active substance name and rate, instructions for use and expiration date information required by the biocidal legislation. The child safety requirements of the packaging are also evaluated according to the product classification.
Time Management and Common Mistakes
The evaluation process can take months, and deficiency requests extend the time period. The most common mistakes; The effectiveness test does not coincide with the label declaration, the formulation information is incomplete and the right to access the active substance file is not documented. Checking these three headings before applying will shorten the process by at least one round of deficiency.
Label Draft for Biocidal Product License Application
In the Biocidal Product Registration application, the label draft must be exactly compatible with the effectiveness data. The concentration, contact time and application surface declared on the label must match the conditions under which the tests were performed. The most frequently received deficiency claim in Biocidal Product License applications arises from this very incompatibility.
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Official full text of the regulation: KKDIK Regulation - Official Gazette.