REGULATION & COMPLIANCE continue to apply for the duration provided in the authorisation ’. Therefore , plant biostimulants that were authorised and approved based on an application submitted before 15 July 2019 will still be subject to the PPPR until their granted approval and authorisation expires . After expiry of the granted authorisation , products and substances falling under the definition of plant biostimulant in the FPR will have to follow processes under this regulation and REACH .
Unfinished business
There is a controversial position on whether ongoing procedures for the approval or renewal of substances , product authorisations under PPPR that are not finished yet and whether the products or substances concerned should continue to be considered as subject to the PPPR . On one hand , it could be understood that these ongoing procedures are still subject to the PPPR and therefore the procedure should be completed and the final approval or authorisation decision should be issued . This is because the aforementioned Article 80 ( 8 ) only sets as a condition that applications must be submitted by 15
July 2019 . In other words , it does not set a deadline by which these ongoing approvals or authorisations should be finalised or decided . However , it is possible that not all companies and competent authorities share this understanding , and this may be creating problems at present that will need to be addressed in the short term . In any case , given that these are applications submitted before the date of application of the FPR ( or even before its publication ), any decision taken in this respect must be in accordance with the legal principles of non-retroactivity , legal certainty and legitimate expectations .
Conclusion
The new FPR may offer further advantages to manufacturers of plant biostimulants by removing the regulatory complexities of the authorisation procedure for plant protection products and simplifying the procedure for registering fertilisers in the EU . However , some plant biostimulants or even other categories of fertiliser products may still be subject to the PPPR if they are also placed on the market for one of the intended uses or functions listed in Article 2 ( 1 ) of PPPR ( so-called ‘ dual-use products ’). In these cases , the fertiliser product and the substance contained will have to undergo the whole process of approval at EU level and subsequent authorisation at national level in order to be placed on the market . As mentioned above , there are several cases of ‘ borderline ’ fertiliser products that are often presented as bio-alternatives to existing plant protection products . These products could be considered as dual-use products and would therefore be specifically subject to the PPPR and the respective authorisation process for pesticides . Therefore , manufacturers and distributors of fertilisers should carefully assess this aspect before placing their products on the market . •
Claudio Mereu
JOINT MANAGING PARTNER
FIELDFISHER k + 32 2 742 70 60 J claudio . mereu @ fieldfisher . com j www . fieldfisher . com
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