What to Do When the Composition of a Biocidal Product Changes?

A biocidal product is a substance or mixture composed of active substances intended for the destruction, deterrence, or neutralization of harmful organisms or to prevent their action.

Biocidal products differ from regular chemicals in that their marketing is regulated by the Regulation No. 528/2012 concerning the making available on the market and use of biocidal products - BPR.

All biocidal products on the market must be registered. This means that before selling, a registration process must be completed, ensuring that the biocidal product is listed in the register of biocidal products maintained by the Chemicals Office of the Republic of Slovenia.

But what should you do if you want to change the composition of an already registered biocidal product?

First, you need to update the accompanying documentation in line with the composition change. The change can affect the safety data sheet, UFI and PCN notification, product label, and related application. In the case of a significant change in the concentration of active substances, new efficacy studies must also be prepared.

After preparing the new documentation, the license holder or notifier is obliged to inform the Chemicals Office of the Republic of Slovenia about this change. The procedure varies significantly depending on the type of registration. For registration during the transitional period – notification, the process is simpler, requiring an application and a 90 € administrative fee. For authorized biocidal products, according to the BPR regulation, it is a more prolonged process, precisely defined in the Regulation No. 354/2013 on changes to biocidal products. The duration, cost, and execution can vary significantly from case to case, and it is not possible to provide a general answer.

After submitting the application for change, you need to wait for the change to be approved. Only after the approval of the change can you start selling the appropriately labeled biocidal product with the changed composition.

If you need assistance with changing the composition of a biocidal product or have any other questions related to biocidal products, safety data sheets, or PCN notifications, feel free to contact me at tim.bencik@bens-consulting.eu.