As is well known, there are two ways to classify and position a new fertilizer on the market according to the FPR:
- Following the harmonized regulatory framework defined by EU Regulation 2019/1009
- Applying the concept of mutual recognition according to EU Regulation 2019/515
From 2026, there will also be the possibility of obtaining a “Clone” certification!
What does this mean?
If a company has an existing and valid registration for a biostimulants according to the FPR,
It can enter into an agreement with another company to market a clone of the same product through a much more streamlined procedure than the standard one.
It is necessary to draft and agree on a LoA (Letter of Access) involving the Notified Body that issued the original CE marking certification.
The Notified Body will review the documentation and approve the label and the LoA.
It is not necessary to demonstrate efficacy tests or technical data beyond the documentation (the dossier) covered by the LoA.
The new company may use new packaging and a new name, but the product content must be the same as the original product from the company granting the LoA.
Similarly, a biostimulants already registered as PFC6 can be added to PFC1 by following Module A (internal production control) without the intervention of a Notified Body!
For more information, contact the AGRO division of TEAMmastery!