2019 / 1009 : Legal aspects to consider
Data protection , transitional period and dualuse products are the key things to be aware of under the EU Fertilising Products Regulation , says Claudio Mereu of FieldFisher
The new Regulation ( EU ) No 2019 / 1009 on EU Fertilising Products ( FPR ) entered into full regulatory force on 16 July 2022 and repealed the previous regulatory framework applicable to fertilisers under Regulation ( EC ) No 2003 / 2003 . The FPR creates a new category known as ‘ fertilising product ’, which is more detailed but also broader than the definition of ‘ fertiliser ’ in its predecessor , the Plant Protection Products Regulation ( PPPR , 1107 / 2009 ). One of the most relevant categories is the specific category for plant biostimulants . Prior to the FPR , these were a kind of borderline product often classified between fertilisers and plant protection products that could fall within the scope of the PPPR , and could therefore , be subject to the approval and authorisation procedures laid down for plant protection products . However , this is no longer possible . Article 47 of the FPR excludes biostimulants from the scope of the PPPR by amending Article 2 ( 1 ) ( b ) as follows : ‘ influencing the life processes of plants , such as substances influencing their growth , other than as a nutrient or a plant biostimulant ’. Notwithstanding , other types of growth regulators may still be considered as plant protection products if they fall under this definition . As such , they will need to go through the regulated approval and authorisation procedure for pesticides . The FPR has introduced important changes , which have brought about a number of issues to be taken into account by manufacturers not only of biostimulants , but also of fertiliser products in general .
Biostimulants & the PPPR
Plant biostimulants or even other fertiliser products may be subject to the PPPR if , in addition to their use as a biostimulant or fertiliser , they also have one of the functions listed in the aforementioned Article 2 ( 1 ) of PPPR . These products are commonly known as ‘ dual-use ’ products . There are several cases of ‘ borderline ’ fertiliser products that are often presented as bio-alternatives to existing plant protection products . In this respect , it is important to note that those also placed on the market for intended uses and functions as a plant protection product , will be subject exclusively to the legal regime of the PPPR , instead of the FPR . The FPR ( recital 23 ) is clear in this respect . It states that “ Products with one or more functions , one of which is covered by the scope of Regulation ( EC ) No 1107 / 2009 , are plant protection products falling within the scope of that Regulation . Those products should remain under the control developed for such products and provided for by that
Regulation ”. Article 1 ( 1 )( b ) of the FPR also states that it does not apply to plant protection products covered by the scope of the PPPR . As for other fertiliser products that do not have additional functions as a plant protection product , these are not subject to the PPPR . However , they will still be subject to REACH and must comply with the legal regime set out in it . In other words , the FPR does not affect the application of REACH . In terms of registration , all substances that are incorporated into an EU fertilising product , either on their own or in a mixture , must be registered under REACH . Plant biostimulants already authorised under the PPPR will continue to be subject to it for the period foreseen in the authorisation granted . Article 47 of the FPR has included a transitional provision in Article 80 ( 8 ) of the PPPR , which refers to this matter : ‘ To a product which was granted an authorisation under Article 32 ( 1 ) based on an application submitted before 15 July 2019 , and which after that date falls under the definition in point 34 of Article 3 , this Regulation shall
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