Biostimulants and biopesticides regulatory landscape in light of Regulation (EU) No 2019/1009

Date:04-07-2021

This piece is originally released on Fieldfisher >>

On the 25 June 2019, the EU adopted Regulation (EU) No 2019/1009, i.e., the new EU Fertilising Products Regulation. The current legal framework applicable to fertilising products is Regulation (EC) No 2003/2003. The new Fertilising Products Regulation comes into full regulatory force on 16 July 2022, almost twenty years after its predecessor's premiere. 

Unlike Regulation (EC) No 2003/2003, the new Fertilising Products Regulation ("FPR") creates a category for plant biostimulants. As borderline products, plant biostimulants were often classified between fertilisers and plant protection products. FPR brings clarity to the categorisation of plant biostimulant products, removing them from the purview of Regulation (EC) 1107/2009, i.e., the Plant Protection Products Regulation ("PPPR"), and differentiating plant biostimulants from fertilisers. On the other hand, biopesticides remain under the scope of PPPR. Therefore, plant biostimulants and biopesticides are subject to different regulatory regimes in the European Union. However, both biostimulants and biopesticides remain within the scope of Regulation (EC) 1907/2006, otherwise known as REACH (short for the Registration, Evaluation, Authorisation and Restriction of Chemicals).

FPR does not affect the application of REACH. Insofar as registration goes, all substances incorporated into an EU fertilising product, whether stand alone or in a mixture, must be registered under REACH with a dossier containing both the information provided for by Annexes VI, VII and VIII to REACH, and a Chemistry Safety Report ("CSR") pursuant to Article 14 of REACH covering the product's use as a fertilising product. This obligation is mandatory unless the substances incorporated in an EU fertilizing product is covered by one of the registration obligation exemptions provided for by Annex IV, or by points 6, 7, 8, or 9 of Annex V, to REACH.

FPR creates a new category known as a 'fertilising product' whereas its predecessor simply referred to 'fertilisers.' FPR defines a 'fertilising product' as a "substance, mixture, micro-organism or any other material, applied or intended to be applied on plants or their rhizosphere or on mushrooms or their mycoshpere, or intended to constitute the rhizosphere or mycoshpere, either on its own or mixed with another material, for the purpose of providing the plants or mushrooms with nutrient or improving their nutrition efficiency." The new regulation also introduces seven Product Function Categories ("PFC") of EU fertilising products: (i) fertilisers; (ii) liming material; (iii) soil improvers; (iv) growing mediums; (v) inhibitors; (vi) plant bio-stimulants; and (vii) fertilising product blends. In particular, the regulation defines plant biostimulants as a fertilising product that functions to stimulate plant nutrition processes independent from the product's nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere: (a) nutrient use efficiency, (b) tolerance to abiotic stress, (c) quality traits, or (d) availability of confined nutrients in soil or rhizosphere.  

Whereas there was no specific regulation on plant biostimulants in the EU before, FPR defines plant biostimulants and amends PPPR, carving out an exception for plant biostimulants. In other words, the amendment excludes plant biostimulants from the scope of Regulation (EC) No 1107/2009, thus securing them under the scope of the new Fertilising Products Regulation. While the creation of 'fertilising product' as a regulatory classification is aimed at expanding the scope of the regulation's application, FPR states that products with one or more functions, one of which is covered by PPPR, is a plant protection product. In the case of such dual use, the approval and authorization procedures under PPPR apply, thus excluding the plant protection product from the fertilising products' regulatory regime.  

Under FPR, plant biostimulants are organized into two subcategories: microbial plant biostimulants and non-microbial plant biostimulants. Microbial plant bio-stimulants are biostimulants consisting of a micro-organism or a consortium of micro-organisms, i.e., azotobacter spp., mycorrhizal fungi, rhizobium spp., and azospirillum spp.  Non-microbial plant biostimulants are plant biostimulants other than microbial plant biostimulants. If a plant biostimulant product is composed of micro-organisms not listed in FPR, the European Commission may adopt delegated acts to add new micro-organisms or strains of micro-organisms, or additional processing methods to the component material category. However, depending on the employment of the product, companies may find it easier to categorise their product under a different PFC (e.g., as a 'fertiliser') if the process of adding new micro-organisms or strains of micro-organisms to the regulation is too burdensome.

Finally, products that were authorised as plant protection products before 15 July 2019 will be considered as such until their authorisations expire. After authorisation expiration, products that fall under the new definition of plant biostimulants will have to follow processes under FPR. Thus, it is possible that national biostimulants are manufactured and placed on the market of a Member State as long as they comply with national legislation – at least until FPR becomes the applicable legal framework for fertilising products on 16 July 2022. Products must respect the basic principles of the TFEU, including the principle of free movement of goods. Accordingly, a biostimulant legally authorised in one Member State would likely be permitted to circulate in other Member States, according to the principle of mutual recognition.

Insofar as data protection goes, there is no data protection mechanism at both substance and product level under FPR. Unlike REACH, there is no establishment of a centralized EU system of notification and registration of biostimulants. It may be suggested that manufacturers explore the possibility of data protection models under REACH, PPPR or BPR (short for Biocidal Products Regulation, Regulation (EC) 528/2012. REACH requires EU level authorisation, overseen by the ECHA. The ECHA employs a "one substance, one registration" method for substances. Data used for registration purposes under REACH is protected for 12 years. (REACH, Article 25.3). REACH obliges manufacturers to fulfil the fundamental obligation of data sharing. (REACH, Title III). Under PPPR, the active substance is authorised at the EU level while the product is authorised at the national level (i.e., Member States). Data for both the active substance and the product formulation is protected at the Member State level for a period of 10 year. PPPR only requires data sharing in regards to vertebrate animal studies. Similar to PPPR, BPR also has a two-tiered authorisation process. Under BPR, the active substance is authorized at the EU level and each biocidal product is authorised at the national level. Data protection for active substances varies depending on whether the active substances is new, existing, or in the process of renewal. Overall, data protection for active substances under the BPR can last 5 to 15 years. Data sharing for biocidal products is required for tests on vertebrates, and may be required for non-vertebrate tests. 

As there is no authorisation scheme for biostimulants, it seems that data protection is unwarranted. However, data protection is relevant as data could be obtained by other applicant for their product certification, or data may be used for another purpose. Companies should consider the above when contemplating how to register their product.