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Veljavnost dovoljenj za biocidne proizvode z opombo (3) v Sloveniji se izteka

The Chemical Office of the Republic of Slovenia has published news release affecting sale of already notified biocidal products:

"Due to the end of the SARS-CoV-2 epidemic and the relaxation of measures to prevent its spread, the placing on the market and use of biocidal products with note (3) in the Register of Biocidal Products will be permitted until October 31, 2023."

"If the license holder wishes to continue marketing these biocidal products after this date, then the license holder must submit an application to change the notification to the Chemicals Office of the Republic of Slovenia by June 30, 2023, at the latest, to which the license holder must attach appropriate effectiveness tests."

Therefore, if you still want to use or place on the market your biocidal product that currently has a note (3) in the Register of Biocidal Products - you must therefore provide the appropriate efficiency tests by June 30 and apply to change the notification.

If you do not do this, your product will be deleted from the register. However, you will still be able sell your biocidal product(s) in Slovenia until 31 October 2023.

How can you check if any of your products are among those with note (3)?

Simple. In the Register of Biocidal Products, in the fifth column entitled " Veljavnost dovoljenja” (in English Validity of the permit) you will find the number 3 written in brackets.

This number refers to a note found at the end of this document that says:

"The formulation complies with WHO/ECDC recommendations and is notified only for the prevention of the spread of COVID-19: the validity of the authorization following the notification procedure until 31/10/2023".

What's next if you've decided that you'd like to continue selling these products in Slovenia?

First of all, the decision here is whether to do this notification yourself or leave it to someone else. If you have enough time, energy, and knowledge to do it yourself, then let me help you with one more piece of information.

Products of this type with note (3) mainly contain the active substance ethanol (Product types 1 and 2 – PT1, PT2). Accordingly, they have been notified for use against the spread of the SARS-CoV-2 epidemic as “agents against enveloped viruses”.

Why is this important you say?

Because it relates to getting proper performance tests. The requirements for this demonstration of effectiveness for PT1 have been published by the Office here (sorry, just Slovene version available). The requirements for the demonstration of effectiveness for PT1 have been published by the Office here. For PT2 (also for PT1) you can find the requirements in the guidelines (again, only available in Slovene).

But if you want to save some time and spend it on other important things, then we can help.

The first step in this case is to write to me at bojan.dimic@bens-consulting.eu as soon as possible letting me know which products are the priority for you in Slovenia. Since there is quite a bit of work and time involved, my recommendation is to get started as soon as possible.

More information about what needs to be done, how much it costs and how to efficiently approach this, we will agree upon confirmation of cooperation. To get started, your e-mail with a list of products from the register of registered biocides is enough. (I see no point in burdening you with the rest of the details at this point).

What now?

First, act as soon as possible because there may be a problem later with the availability of laboratories as well as the volume of work at The Chemical Office of the Republic of Slovenia.

Second, if you decide you need our help, please send me a list of products that are important to you.

Then we can continue to guide you and help ensure that all activities are carried out on time, and you will continue to sell without worry.

We work according to the "first come, first served" principle, because that is the fairest way for everyone. One last note, which is also important and should not be ignored - we are also very busy here, so it is necessary to take this into account.

My e-mail is bojan.dimic@bens-consulting.eu.


Picture: Kelly Sikkema from Unsplash


Disclaimer:
Information on this blog is prepared with utmost care, but it is not about (chemical) consulting, and the provider does not assume any responsibility or liability for the correctness, accuracy and up-to-dateness of published content. If you need advice for a specific case, you can write to us at bojan.dimic@bens-consulting.eu
Biocides | May 10, 2023

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