What to do when the composition of a biocidal product changes?

A biocidal product is substance or mixture, consisting of active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of any harmful organism.

The biocidal product differs from ordinary chemicals in that the marketing of the biocidal product is conditioned by the Regulation no. 528/2012 on market availability and use of biocidal products – BPR.

All biocidal products on the market must be registered. This means that before placing on the market, it is necessary to complete the registration process and ensure that the biocidal product is registered on that market.

And what should be done if you want to change the composition of an already registered biocidal product?

First of all, it is necessary to update the accompanying documentation in accordance with the change in composition. A change in composition may affect the safety data sheet, UFI and PCN notification, product label and associated application form. In the case of a significant change in the concentration of active substances, it is also necessary to prepare new efficacy studies.

After the new documentation has been prepared, the registration holder is obliged to inform the Competent Authorities about this change. The process differs significantly depending on the type of registration. If the product is registered in the transition period – usually a notification has to be done. This procedure is much more simple and less time and money consuming. In the case of authorized biocidal products in accordance with the BPR regulation, a more complex process applies, which is precisely defined in Regulation No. 354/2013 on changes of biocidal products. The duration, cost and implementation can vary significantly from case to case and it is not possible to give a general answer.

After submitting an application for a change, it is necessary to wait for the change to be accepted. Only after the change has been approved, it is possible to start selling a properly labeled biocidal product with a changed composition.

If you need help with changing the composition of a biocidal product or if you have any other question related to biocidal products, safety data sheets or PCN submissions, you can contact me at tim.bencik@bens-consulting.eu.