One of the basic steps in the registration of biocidal products is that the active substance used in the product is approved and suitable for the relevant product type.
Process; It includes evaluation of the active substance by product type (PT), efficacy and safety data, and compliance with approved active substance lists. Products containing unapproved active ingredients cannot be licensed.
ONAY Mühendislik analyzes active ingredient-product compatibility and manages the biocidal licensing process.
Why is active substance approval a separate process?
There are two layers to a biocidal product: the presence of the active substance on the approved list and the registration of the product. If the active ingredient is not approved, product registration is not possible; That's why the project always starts with active ingredient control.
Product type determination
Active ingredient approval is based on product type. The same active ingredient may be approved in one product type but not in another. Therefore, the product's usage area and claim should be clarified before active ingredient control.
Data requirement
Active substance file; It includes identity, physico-chemical properties, efficacy, toxicology and ecotoxicology data. This data set is expensive and is usually supported by the active ingredient manufacturer; The right of access becomes critical for the product registration applicant.
Calendar
If the active ingredient is approved, product approval is measured in months. If it is not approved, the process takes years. This distinction should be made at the very beginning of the product development decision.
Scope of Active Substance Dossier
The application for biocidal active substance approval begins with the identity of the substance, production method and impurity profile. This is followed by physical-chemical properties, analytical methods, efficacy data, toxicological and ecotoxicological studies and environmental fate data. The file must be prepared based on product type; The same active substance requires separate exposure assessment for different product types.
Determinism of Event Data
The most frequently received feedback during the approval process is activity data. Laboratory studies must be designed so that the target organism, contact time and use concentration exactly match the conditions declared on the label. Tests not performed under simulated use conditions are not considered sufficient for the declared use, even if successful in the laboratory.
Post-Approval Product License Stage
Approval of the active substance does not mean that the product can be placed on the market. After being included in the approved active substance list, a separate license application is made for each biocidal product containing that substance. At this stage, the product's formulation, packaging, label text and instructions for use are evaluated. Companies that do not plan the period between active ingredient approval and product registration experience disruption in the market.
Period between Biocidal Active Substance Approval and License
After Biocidal Active Substance approval is obtained, a product license is also required before the product can be placed on the market, and there may be a gap lasting for months between these two processes. Following the evaluation schedule of the Biocidal Active Substance dossier and starting the preparation of the product license application simultaneously is the only method that prevents any interruption in the market.
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Official full text of the regulation: KKDIK Regulation - Official Gazette.