Référence Agro – Gaëlle Gaudin – April 28, 2022 Risk assessment, Biocontrol solutions
Staphyt, which has been supporting crop protection companies for more than thirty years in the development and marketing of active substances and products, reviews for Référence agro the changes observed in recent years. The tightening of conventional products evaluations and the rise of biosolutions are at the heart of his work. Meeting with Amélie Grimaldi and Geoffroy Moulin, respectively in charge of regulatory affairs and coordinator of biological expertise for the company.
For thirty years, Staphyt has been involved in the development of plant protection products, risk assessment, and the preparation of registration dossiers for substances and products to be marketed throughout Europe. Staphyt has been able to observe the gradual evolution towards less chemical plant protection specialities and the evolution of dedicated regulations.
Rise of startups since 2017
“We work with a large number of players in the industry, from preliminary laboratory screening work to the marketing of the plant protection product,” says Geoffroy Moulin, biosolutions coordinator for the company. The first biocontrol product we dealt with was in 2006. But since 2017, we have seen the rise of startups in biosolutions and for the past three years, the massive arrival of conventional industrials on these alternative solutions. The sponsors of the latest editions of ABIM, the annual meetings of the biocontrol industry, are proof of this. These agrochemists are developing their product portfolio through partnerships with these startups. And vice versa: a large number of startups approach these large companies every year.”
Amélie Grimaldi, head of regulatory affairs, is supported by toxicologists, ecotoxicologists, environmental experts, chemists, residue specialists and agronomists. The division has a total of 70 employees out of Staphyt’s 240 in France. Obtaining the regulatory data required for the approval of a substance or the marketing authorization of a speciality requires all these skills,” explains the manager. But startups do not have a regulatory department, or not as complete. As for large companies, they call on us when they have to deal with peaks in workload.
Because putting together a regulatory dossier is time consuming. “We count more than a thousand hours of work to re-evaluate a single product in the three European Union zones, following the renewal of an active substance,” says Amélie Grimaldi.
The renewal of an active substance requires more work than in the past because of the increased requirements.
Reduction of the chemical load of the products
The number of conventional active substances approved at European level is falling, but chemistry is still dominant. At Staphyt, many dossiers concern reformulated conventional products. “We often have to reduce the authorized doses compared to what was accepted ten years ago,” notes Geoffroy Moulin.
Ten years ago, Staphyt set up a team of agronomists, scientists and regulatory experts to study biosolutions. Because biosolutions are on the rise and require a distinct technical and regulatory approach.
Over the past three years, the number of low-risk substances approved at the European level has doubled, the number of micro-organisms has also almost doubled and the number of natural substances has tripled.
“The share of biocontrol in our turnover has doubled in the last four years,” Geoffroy Moulin reports.
Biopesticides boosted by numerous advantages
Biopesticides are growing rapidly because of the advantages they represent,” adds Amélie Grimaldi. The cost of a dossier is lower, particularly because the number of studies is lower, as the substance is automatically eliminated if it presents a risk, apart from its irritant nature. For the approval of a biological active substance, it is necessary to count 2 M€, against sometimes 10 M€ for a conventional substance. Development and evaluation times are also shortened and approval periods are lengthened. Finally, these alternative specialties benefit from political support, both at the European and national levels.
Proving the effectiveness of a biopesticide is difficult
However, the regulatory manager is keen to temper these advantages. It’s not always easy to put together dossiers because the requirements, guidance documents and risk assessment are not all well adapted to these specialties,” she says. In addition, national regulations differ, which makes registration in Europe more complex. It is also more difficult to accurately characterize the substance of a biopesticide and prove its efficacy. Finally, while the cost of risk assessment is lower for these specialties, the cost to find the optimal positioning, as well as the cost of marketing support, are more substantial.
Conventional agrochemists work on solutions that combine conventional and biosolutions. “The trial programs for such combined solutions are gaining momentum,” says Amélie Grimaldi.