Micro-organisms
Date: 14 May 2020
In general, for the registration of micro-organisms – living, inactivated or their metabolites – different regulatory frameworks may apply in the EU. The present overview focusses on their use in plant protection products, bi-ostimulants or fertilisers and does not consider uses in e.g. biocidal products, food, feed, human or veterinary medicine although such uses and the respective regulatory frameworks may influence registration possibilities under plant protection or fertiliser laws.
There are two primary criteria which determine the regulatory framework applicable for the specific micro-organism or its metabolite(s) – plant protection or fertiliser.
In regards to the first criterion, claims, definitions and restrictions given by the respective framework regulations, the amendment to the Plant Protection Products Regulation 1107/2009 of 5 June 2019, induced by Regulation 2019/1009 laying down rules on the making available on the market of EU fertilising products, are of special importance. Accordingly, if a product is used for “protecting plants or plant products against all harmful organisms or preventing the action of such organisms, unless the main purpose of these products is considered to be for reasons of hygiene rather than for the protection of plants or plant products” or if the product is used for “influencing the life processes of plants, such as substances influencing their growth, other than as a nutrient or a plant biostimulant”, the product falls under the plant protection product regulatory framework. Regulation 2019/1009 further defines “plant biostimulant” as “a product stimulating 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 or (d) availability of confined nutrients in soil or rhizosphere”. Currently, the new EU fertiliser/Biostimulant Regulation, which entered into force in June 2019 and will be applicable from July 2022 onwards, considers microbial-based biostimulants to be products containing “micro-organisms, including dead or empty-cell micro-organisms and non-harmful residual elements of the media on which they were produced, which (a) have undergone no other processing than drying or freeze-drying and (b) belong to the following genera or groups: Azotobacter spp., Mycorrhizal fungi, Rhizobium spp. or Azospirillum spp”. It remains to be seen if and/or which other micro-organisms will be included in the positive and negative lists of Regulation 2019/1009.
The second major criterion is the existing regulatory background, i.e. existing approvals and authorisations and the respective substance claims and Mode of Actions for similar microbial strains or related species, genera or functional groups. Differentiation in this regard may be especially difficult due to biological/physiological simi-larities between strains to be registered. Modes of Action known for one strain/species may be transferred to other strains/species based on their biology and thus assignment to a regulatory framework may be predestined by previous/existing registrations. Scientific evidence, e.g. based on whole genome analysis, and scientific ar-gumentation are then required to be able to register under a different regulatory framework. As already stated above, respective strain/species characteristics may also be due to registrations in regulatory frameworks not considered in this article e.g. use as biocide. This applies not only for the micro-organism itself but also to func-tional groups of metabolites.
Lars Huber