Biorationals – an Overview
What is a biorational?
Biorationals, characterised by their low environmental impact, are a huge and very diverse group of substances or products such as biopesticides, biostimulants or plant aids. Typically they are of biological origin or, if synthetic, structurally and functionally similar to their natural occurring analogue.
The Impact of the EU Green Deal
The European Green Deal, including the Farm to Fork and Biodiversity Strategies, significantly influences the use and perception of biorationals. This is especially true for the compatibility with Integrated Production IP including Integrated Pest Management (IPM) as well as Organic, Precision and Digital farming and their impact on product use, performance or risk assessments. Detailed knowledge of agricultural, regulatory, technical and scientific requirements and innovations, are key factors for efficient and successful product development, registration and sales under the new political frameworks. SCC can help you to survey your portolio for products with IPM, organic and precision farming potential and advice you on regulatory and scientific aspects of sustainable integrated crop management.
Since entry into force of Regulation 1107/2009 concerning the placing of plant protection products on the EU market, several specific issues regarding the data requirements for the very inhomogeneous group of biopesticides have been amended and updated. Special considerations were made, for example regarding the data requirements for micro-organisms or botanicals. However, due to the diversity of 'biopesticide' active substances, such as fungi, bacteria, plant extracts and microbial metabolites, the registration of 'biopesticides' remains complex, requiring particular knowledge of the latest scientific research and regulatory procedures. This is especially true since, according to European legislation, 'biopesticides' are not a regulatory defined group of active substances and products. Instead, Europe distinguishes between conventional, basic and low risk active substances, for which different data requirements and regulations apply.
As mixtures or preparations added to crop protection products, adjuvants are subject to authorisation in Europe, falling under the scope of the plant protection products Regulation 1107/2009. With this, their registration procedures including data requirements have still not been harmonised across the EU.
Learn more about adjuvants and how our experts can help you with your regulatory obligations.
Alongside fertilisers, biostimulants and an a number of other products of the so-called Product Function Categories (PFC) are regulated by the European Fertiliser Regulation 2019/1009. These products can be placed on the EU market only if they are proven to be sufficiently effective. In parallel to the EU harmonised procedure, national registrations remain possible.
Follow the link to find out more on the regulatory aspects of biostimlants and fertilisers in the EU.
SCC supports you with the registration of biorationals
In the complex world of regulatory affairs, customized project strategies (tailored to the authorities, CROs, academia and research institutes) are of great importance to achieve your goals efficiently and effectively. Companies interested in registering a biorational must consider aspects that do not apply to conventional chemicals and vice versa.
To provide our customers the best regulatory and scientific support for their needs, SCC has established a team of experts to deal explicitly with the registration of biorationals and the scientific support related to this. As a privately owned, independent and neutral organisation, without any ties to contract research organisations, but with vast experience in R&D and registration of biorationals and fertilisers, SCC can provide independent support and advice you need regardless whether you are a small, medium-sized, or large multinational business.