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The topic ″Borderline Substances in Europe: Plant Protection Products or Fertilising Products?″ was elaborated by Dr. Sean McCarthy, Head of Division - Regulatory Affairs Crop Protection, Nutrition & Biologicals at Knoell Consulting Group, at the Novonesis • 5th Biopesticides, Biostimulants and Biofertilizers Summit (BioEx 2024), held in Shanghai on March 7-8, 2024.
The increasing demand for sustainable farming practices has driven a rise in the use of biological or natural or novel fertilising products in agriculture. However, placing such products on the market does not come without challenges as their mode of action can often blur the line between the definition of a fertilising product and a plant protection product. The determination as to whether a product may or may not fall within the scope of an applicable regulation is not always straightforward.
Products that straddle the legislative line between being a fertilising product and a plant protection product can be described as borderline products. In general terms, the two groups of products can be defined as follows:
A fertilising product is any product aimed at providing the plants or mushrooms with nutrients or improving their nutrition efficiency.
A plant protection product is any product aimed at protecting plants or plant products against harmful organisms, influencing the life processes of plants, preserving plant products, or destroying undesired plants or parts of plants.
Under the available legislative categories of fertilising products allowed under the Fertilising Products Regulation (EU) 2019/1009 (hereinafter referred to as the FPR), the plant biostimulants Product Function Category (PFC) 6 is probably one of the most diverse as it can contain a wide range of components e.g., microorganisms, amino acids, polysaccharides, humic acids, fulvic acids, minerals, seaweed extracts and plant extracts.
In addition, the FPR provides a common definition of plant biostimulants and offers access to the European Single Market. The FPR defines plant biostimulant as EU fertilising products whose function is to stimulate plant nutrition processes independently of 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
(d) availability of confined nutrients in the soil or rhizosphere
Plant biostimulants are further sub-categorised into two categories: microbial plant biostimulants (PFC 6 (A)) and non-microbial plant biostimulants (PFC 6 (B)). Currently the microorganisms allowed in microbial plant biostimulants can only be based on the following: Azospirillum spp., Azotobacter spp., Mycorrhizal spp., and Rhizobium spp. Nevertheless, the EU has appointed the Austrian Institute of Technology as contractor to assess other microorganisms that could be considered as biostimulants in the future. The source of non-microbial plant biostimulants as previously mentioned can be varied. By their nature, plant biostimulants are more closely aligned with fertilising products, but sometimes their effects can be like those of plant growth regulators, which are regulated under the Plant Protection Products Regulation (EC) 1107/2009 (hereinafter referred to as the PPPR).
Prior to the entry into force of FPR plant biostimulants have been commonly regulated under national laws (where they exist), thereby generating non-uniform requirements at a national level. In Italy, for instance, most plant biostimulants are regulated under the Legislative Decree 75/2010 on fertilising products. Likewise in Spain, many plant biostimulants may be considered as falling within the scope of Royal Decree 506/2013 on fertilisers, although the legislation does not specifically mention the term ″biostimulant″. Alternatively, dependent on the claims associated with a plant biostimulant it could be registered as plant growth regulators under the PPPR.
Plant biostimulants meeting the above FPR definition are consequently now out of the scope of the PPPR. Nevertheless, products that were authorised as plant protection products before 15 July 2019 will be considered as such until their authorisations expire. After expiration, products that fall under the new definition of plant biostimulants will have to follow processes under the FPR (Article 47 of the FPR including a transitional provision in Article 80(8) of the PPPR). Though those products that are influencing the life processes of plants, other than as a nutrient or a plant biostimulant, are still considered within the scope of PPPR.
To navigate the intricate landscape of borderline products, the European Commission developed a working document ″Regulation (EC) no. 1107/2009 - Scope and borderline issues″ (SANCO 6621-99 rev 75 January 2024) containing summaries of the conclusions taken by the Standing Committee on Plants, Animals, Food and Feed on products or active substance in relation to the PPPR and other sectorial product legislation. SANCO 6621-99 rev 75 is a useful reference document to assist in determining whether a product falls within the scope of PPPR or not as the case may be. Additionally, it outlines the procedure for presenting new requests for interpretation in cases not explicitly listed.
Products that have a dual or multiple functions, one of which is covered by the scope of the PPPR are automatically excluded from the scope of the FPR and would require registration under the PPPR. The possibility of declaring any additional biostimulant or fertilising function to a plant protection product is to be assessed under the PPPR and the relevant national rules for fertilising products.
However, this does not completely exclude substances or microorganisms with a known pesticidal, or other plant protection use from being employed in a fertilising product. If a fertilising product containing such a component complies with all requirements set out in the FPR and the fertilising product does not have a pesticidal or other plant protection function within the meaning of the PPPR, then it can be potentially considered under the FPR. This would typically mean that plant protection substances or microorganisms could be used in a different way to elicit a fertilising or biostimulant effect [1].
Hence, the same component may fulfil different functions and be part of either a plant biostimulant, a plant protection product, or both (Figure 1) depending on:
Relative concentration of components and their exact combination;
The application rate(s), and application method;
The crop(s) and the growth stage of the application;
Mode of action;
Claimed effects.
Figure 1. Categorisation of substances or microorganisms according to their function. Actives A and B display only primary function, active C display a dual function.
Accordingly, substances or microorganisms with a dual function require dual authorisation and must undergo the relevant procedure applicable to plant biostimulants (either at EU or national level) and plant protection products.
To demonstrate plant biostimulant claims and prove compliance with the requirements of the FPR, the European Committee for Standardisation (CEN) is developing a series of harmonised standards. These standards establish clear definitions and categorisations of plant biostimulants, specifies the procedures for the determination and calculation of different parameters and describe the principles to generate and analyse experimental data to demonstrate claimed effects with the goal of ensuring consistency, quality, and safety.
A very important consideration with plant biostimulants, like any other fertilising product (i.e. final formulated product), is that their components may be subject to registration under Regulation (EC) 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) for the purpose of the FPR. This obligation is mandatory unless the substances incorporated in the EU fertilising product are covered by one of the registration exemptions stated in the FPR. Likewise, plant biostimulant components may be subject to Commission Delegated Regulation 2022/973 laying down criteria on agronomic efficiency and safety for the use of by-products in EU fertilising products.
In conclusion, although current legislation provides more clarity to the definitions of fertilisers, biostimulants, and plant protection products, borderline cases will continue to require in-depth analysis to ensure that all the legislative requirements are respected.
For additional information and advice contact us on cropnutrition@knoell.com
References
[1] Regulation (EU) 2019/1009 – the Fertilising Products Regulation Frequently Asked Questions of 15 July 2022.
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