Registration of soil enzymes and biostimulant products
Question
We are applying for registration of our 3 soil enzyme fertilizer products and 2 biostimulant products in BE by way of their derogation pathway. Once we have registration of our products in BE are we able to directly market them in Slovakia also under 2019/515?
If so, do we need to make any notifications to any government bodies?
If we are not allowed to market under 2019/515, could you please tell me what the procedure would be to market our products in Slovakia, without the need for registration under the FPR 2019/1009.
I have one other question regarding the use of GMO. Our enzymes are derived from GMM, although the products themselves do not contain any active or live microorganisms. Does Slovakia allow such products?
Answer
Please, find below the reply of the Ministry of Environment of the Slovak Republic to the question regarding the use of GMO:
In the case of enzymes that are derived from GMMs and the final enzyme product does not contain any live (active) GMMs, no marketing authorization is required under the GMO legislation. According to the GMO legislation, the applicant would need a permit for the preparation (production) of such enzymes if he decided to produce them in the Slovak Republic. This activity would be classified as the contained use of GMMs and the competent authority would be the Ministry of the Environment of the Slovak Republic, Department of Environmental Hazards and Biosafety. In order to be able to apply the principle of mutual recognition according to Regulation (EU) 2019/515 of the European Parliament and of the Council, the goods must be placed on the market in another member state in accordance with legal regulations. If your products are registered in Belgium, then this registration can be mutually recognized in Slovakia as well. For mutual recognition and inclusion of the product in the list of mutually recognized fertilizers in Slovakia, it is necessary to submit an application (1 application = 1 product) to our institute (the recipient’s address is given in the application). Applications are processed within 30 days of registration and this action is charged according to the current price list of the ÚKSÚP, currently €50/1 product.
In the attachment, I am sending you the application form for mutual recognition together with the necessary attachments and also the requirements of the ÚKSÚP for the content of the text part of the label. As for the question about GMOs, this issue falls under the Ministry of the Environment of the Slovak Republic, it is not within my competence and, unfortunately, I cannot answer it.