Czech Republic

Summary

Biostimulants need to be registered in Czech Republic, for them to be placed on the market. For this registration, a dossier must be submitted, which contains the following documents:

- Label including use instructions in an editable format (word, Txt.) together with the application to the data mailbox

- MSDS if it is a substance classified as dangerous according to Regulation of the EP and Council No. 1907/2006

- Analysis with the required range of parameters or a sample of the product (for analysis in the ÚKZÚZ, it is necessary to attach an analysis order - form and instructions here )

- Description of the production process including a list of raw materials in percentages used for production

There are potentially other annexes to be provided and these will be communicated by the authorities themselves.

Also, the form (in Czech) must be completed and all requested documents attached must be sent to the authorities. Keep in mind that the the original form in Czech language must be completed in Czech to be received by the authorities.

What you should also keep in mind is that it is not permitted to add any term such as "ecological", or "biological" (also not in form of abbreviations to any product trade name.

The application fee is about 500 euros and the evaluation time around 6 months. The registration is valid for 5 years.

The underlying legislative framework for fertiliser and biostimulants in Czech Republic is

Decree 392/2021 amending Decree 377/2013 Coll. on the storage and method of using fertilisers, and Decree 474/2000 Coll., on setting requirements for fertilisers.

The Decree was issued on October 22, 2021 and introduced, i.a., new terms, such as auxiliary soil substances, plant biostimulants and substrates. The importance of proper application methods and timing is outlined for these types of product.

Decree 474/2000 provided requirements for fertilisers, soil amendments and plant preparations and set limit values for hazardous substances in these products, including the list of fertiliser types, labelling requirements and packaging requirements. It also provides details on allowable deviations in terms of chemical and physical product properties.

Act N° 156/1998 on fertilisers regulates the circulation, storage and use of fertilisers, soil amendments, plant biostimulants and substrates. Its key provisions are about conditions to sell in Czech Republic.