On Friday, 10 January 2025, the Government of the Republic of Slovenia published the aforementioned regulation in the Official Gazette.
The regulation will enter into force on the fifteenth day after its publication in the Official Gazette of the Republic of Slovenia – i.e. 25 January 2025.
If you're selling biocides in Slovenia then you need to be aware of the upcoming changes. Let's dive in and take a look at the main changes compared to the existing regulation.
The first question is certainly – What are the fees for biocidal registration procedures compared to the current ones?
The fees will generally increase.
This is also a consequence of the fact that the Chemicals Office of the Republic of Slovenia (hereinafter "the Office") needs to cooperate with external collaborators who are experts in individual fields in certain procedures for assessing applications for biocidal product authorisations.
For example, the current fee for the biocidal product authorisation procedure in Slovenia (national authorisation), when the Office acts as the evaluating competent authority, is €23,400. With the new regulation, this fee will amount to €33,000. For a Union permit, the assessment fee is currently €32,760, with the new regulation it will be €53,000.
You can see the fees for other procedures regarding the authorization of a biocidal product in the regulation itself.
The fee for the more frequent registration procedure - notification of a biocidal product will amount to €350 (currently €210). A change in product notification will now be €150 (currently €90).
Higher fees are not the only thing brought by the regulation.
Another important fact - when notifying biocidal products, the exception "When the biocidal product referred to in the first paragraph of this article is used in its entirety to manufacture a new biocidal product, only the final product shall be notified" is no longer provided.
This means that you will now also have to notify the biocidal product that you use to manufacture a new biocidal product.
The Regulation now also introduces a distinction between “professional user” and “qualified professional user” of biocidal products. In addition to the requirements for professional users, qualified professional users will also have to meet additional specific conditions set by the Office when issuing a biocidal product authorisation.
It is also worth highlighting the requirements for products placed on the market and intended for professional use by professional and qualified professional users – this will also apply to online stores:
-it is necessary to provide a separate place for their sale and
-at this point of sale, information on the intended use of biocidal products must be published with the warning: “Biocidal products for professional use. Safe use only when strictly following the instructions for use and using the prescribed protective equipment.” (please note this is a translation from the Slovenian language, the relevant text should be in Slovenian).
Another important new requirement is that the Office must be notified of the case number when an application for authorisation has been submitted for a notified product, within 150 days of submitting the application to the R4BP information system.
Until now, this was not prescribed, but it was still necessary to inform the office that the notified biocidal product could remain registered in the BP register.
This usually allows the notifier to continue to place this biocidal product on the market during the processing of the application.
The amounts of the prescribed fines for non-compliance with the legislation remain the same for the time being and you can also view them in detail in the new regulation.
If you also have any questions in the field of biocides or how the new regulation will affect your smooth business with biocides in Slovenia, you can write to us at info@bens-consulting.eu.
Author of original photograph: Giorgio Trovato on Unsplash