Relevant legal aspects to consider: data protection, transitional period and dual-use products
The new Regulation (EU) No 2019/1009 on EU Fertilising Products (hereinafter, the "FPR") entered into full regulatory force on 16 July 2022 and repealed the previous regulatory framework applicable to fertilisers under Regulation (EC) No 2003/2003.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" of its predecessor. One of the most relevant categories is the specific category for plant biostimulants. Prior to the FPR, biostimulants were a kind of "borderline" product often classified between fertilisers and plant protection products. In the past, biostimulants could fall within the scope of Regulation (EC) No 1107/2009 on plant protection products (hereinafter, "PPPR") and 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 Fertilisers Regulation excludes biostimulants from the scope of Regulation (EC) No 1107/2009 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 this amendment, other types of growth regulators may still be considered as plant protection products if they fall under the definition of the above mentioned Article 2(1)(b) and, as such, they will need to go through the regulated approval/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.
Will biostimulants or other fertilising products be subject to the PPPR in any specific case?
Plant biostimulant 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 fertiliser products, also placed on the market for intended uses and functions as a plant protection product, will be subject to the legal regime of the PPPR.
The FPR (recital 23) is clear in this respect: "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. [...]". This is also stated in Article 1(1)(b) of the new Fertilisers Regulation: "[...] This Regulation does not apply to: (b) plant protection products covered by the scope of Regulation (EC) No 1107/2009".
As for other fertiliser products that do not have additional functions as a plant protection product, these fertilisers are not subject to the PPPR. However, they will still be subject to Regulation (EC) 1907/2006, also known as REACH, and must comply with the legal regime for registration, evaluation, authorisation and restriction of chemicals set out therein. 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.
Will plant biostimulants and substances contained already approved and authorised under PPPR still be subject to the PPPR?
Plant biostimulants already authorised under PPPR will continue to be subject to this regulation 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 continue to apply for the duration provided in the authorisation".
Therefore, plant biostimulants 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 said Regulation and REACH.
What happens with ongoing procedures for approval/renewal of substances and product authorisations under PPPR, which are not finished yet?
There is a controversial position on whether these ongoing procedures and the products or substances concerned should continue to be considered as subject to the PPPR. On the 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 the above understanding is not shared by all companies and competent authorities 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.
In 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.
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