Updated on 02 09 2023
Application form to register a biostimulant in Czech Republic
This application form is set up in line with Section 4 of Law no. 156/1998 on fertilisers, biostimulants, growth substrates, as well as agrochemical testing of agricultural land.
You will be requred to complete the following information:
- type of product
- trade name
- information about your company
- contact person for CISTA
It is mentioned also that it is not permitted to add any term such as "ecological", or "biological" (also not in form of abreviations to any product trade name.
The form comes wiht some annexes and without these annexes the application for registration will not be deemed complete.
Annexes comprise: technical product documentation, laboratory reports with all relevant parameters, information on the product's conditioning, the label (with, for instance, instructions on storage), manufacturing process description. There are potentially other annexes to be provided but these will be communicated to you by CISTA.
You will also have to pay an administrative fee for your application to be received and a semple has to be provvided to the National Reference Laboratory.
Last but not least, the original form in czech language must be completed in Czech to be received by the authorities.
Form to notify a biostimulant in Czech (to be used for submission)
Form translated in English for comprehension purposes (machine translation/illustrative only)
Annexes to be submitted include:
- Label - instructions for use containing, in particular, the range and way of its use and the conditions for its storage, including the other obligations laid down in Section 7 of Act No. 156/1998 Coll. Label to be edited in Word (ie .doc, .docx formats) to the email address of the CISTA fertilizer department responsible for fertilizer (supplementary substance) notification
- Safety data sheet for a substance classified as dangerous according to Regulation (EC) No. 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemicals, establishing a European Chemicals Agency.
- Confirmation of authorized body that a product is not an explosive substance in accordance with Law No. 61/1988 Coll. 21, if a fertiliser contains nitrogen in the form of ammonium nitrate more than 27%.
Biostimulants fall under the Czech Fertiliser law dated June 12, 1998 (Zákon č. 156/1998 Sb.
Zákon o hnojivech, pomocných půdních látkách, rostlinných biostimulantech a substrátech a o agrochemickém zkoušení zemědělských půd (zákon o hnojivech).
The law on fertilisers, soil amendments, biostimulants and growth substrates also covers testing on agricultural soils.
This act lays down the conditions for placing on the market and the use of fertilisers and all products mentioned above. It does not apply to fertiliser mixtures though.
It contains details about the registration of fertiliser products, which has to be requested by an importer or manufacturer, such as what an application should contain.
Depending on the product/application, the Central Agricultural Inspection and Testing Institute will decide if the application will require biological testing (field or greenhouse).
Update 21 12 2022
Czech Republic has a very good website explaining how things work in terms of the placing on the market of biostimulants.
In a nutshell: biostimulants must be authorised before they can be placed on the Czech market, unless they are placed on the market under Mutual Recognition. The application is submitted with a form to be completed. The evaluation is done by CISTA. In case an application is submitted and no reponse received within 30 days, the authorisation can be considered to be granted (no response is positive response). In any case, CISTA (Central Institute for Supervising and Testing in Agriculture) carries out controls (label, composition, etc.).
Details on the authorisation procedure can be found on the CISTA website.
The national fertiliser legislation is currently being updated. The related draft can be found here.
The national fertiliser registry can be found here.