Latest news about the Akademie Fresenius

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High authorisation costs and long evaluation periods often put a stop to the advancement of biopesticides

The market for biopesticides, biofertilisers and biostimulants is continually growing. However, a multitude of questions on authorisation and risk assessment are still waiting to be answered. At the international "Biocontrol Conference", hosted by Akademie Fresenius in Mainz/Germany on 5 and 6 June 2018, researchers, politicians and representatives from the regulatory bodies discussed how the risk assessment, authorisation and regulatory practise  of biopesticides could be improved.

Currently, the share of biopesticides on the world pesticide market amounts to just a few percent. Compared to conventional pesticides, the production costs are extremely high. At the same time, despite being more environmentally friendly, the effects are often less radical. This makes unbureaucratic and low-cost registration procedures all the more important to manufacturers. 

ECHA Ad hoc working group on biocidal agents has commenced work

Outi Priha of the European Chemicals Agency ECHA (Helsinki) described where efforts to expand the scope of the Biocidal Products Regulation (BPR) to cover biocides currently stood. Last year, the agency started up an ad hoc working group to examine microbiological agents. This working group is intended to support the Biocidal Products Committee with a view to improving the processes for authorising and enhancing biocidal agents.

Biostimulants: Authorisation costs and procedures vary from country to country

One main section at the conference was devoted to the future of biostimulants. Biostimulants are substances or microorganisms stimulating plant nutrition processes with the aim of improving nutrient use efficiency, tolerance to abiotic stress or crop quality. Marta López of the Belgian Redebel Regulatory Affairs consulting company took a look at the European regulatory situation. This situation is far from being homogeneous. Not only do the procedures, requirements, dossier compilation and deadlines vary from country to country - so do the costs. That is why manufacturers require a detailed market entry strategy - one that is not only aligned to the customers and sales opportunities but also takes the respective national regulatory procedures and authorisation costs into account. Currently, Europe is a long way from achieving homogeneous legislation. Marta López is hoping for improvement and unbureaucratic solutions: “The protection of humans and nature should be the primary objective. Nevertheless, the data requirements for the biostimulant product group should be pragmatically and justly determined.”

Market for biostimulants in the USA still not homogeneous

Keith Pitts from the Marrone Bio Innovations company in California, which produces biopesticides and biostimulants, reported on biopesticide market trends and the approval procedure for biostimulants in the USA. Manufacturers are also finding themselves facing challenges here, too, as so far no standardised regulations have been introduced - neither at Federal nor Federal State level - that define and allow the use of the term “biostimulant”. The major manufacturers have now joined forces to obtain a standardised definition from the legislator and to define clear criteria that describe biostimulants and establish a path to commercialisation.

Baculovirus products: Niche market with high entry costs

Philip Kessler of the Andermatt Biocontrol pesticide manufacturing company (Switzerland) gave a report on the production and authorisation of viruses – using baculoviruses as an example. Baculovirus products belong to the most successful biological insecticides in the world. Their implementation is considered to be safe and efficient. Nonetheless, manufacturers see themselves facing high investment costs and considerable uncertainty, as Philip Kessler went on to report. He criticised, for example, the high and, above all, unpredictable costs for compiling data packages, the lack of experience in handling biopesticides on the part of the authorities. All this led to delays and uncertainty. He would like to see the authorisation fees for products that are suitable for a niche market adjusted and the OECD dossier formats standardised. 

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Phone  +49 231 75896-50
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