Mr. M. Myslicki, Syngenta Poland

In February 2013, Karate Zeon 050 CS, a plant protection product produced by Syngenta Crop Protection AG, was re-registered in Poland on the basis of a Site Similarity Certificate (SSC) provided by Spatial Business Integration, Germany.

SSC for KARATE ZEON®

The Biological Assessment Dossier was based on trials conducted in Poland and the Czech Republic. However, in order to provide a thorough basis to underpin efficacy trial data for Poland, a Site Similarity Certificate was attached. The SSC proved the similarity between a Czech and a Polish site, thereby successfully substantiating the transferability of the Czech trial results to Poland. The Polish Registration Authority accepted the conclusions on site similarity drawn in the SBI’s SSC, and KARATE ZEON® 050 CS was successfully re-registered in February 2013.

In recent years, Syngenta Crop Protection AG has been a regular customer for SSCs. Several European subsidiaries ordered SSCs to facilitate the process of providing the registration authorities with appropriate data and data analyses. They have recognized the benefits of the technology which enables a comparison of trial sites on the basis of satellite image information linked with other parameters. By processing and analyzing satellite image series, SBI compares the dynamics and intensity of crop biomass growth between two growing regions, together with other relevant key factors required by the registration authorities.

If the site characteristics are similar, SBI elaborates a SCC. The assumption is that trials conducted in one region would lead to similar results in the other region, which implies that the trial results are transferable from the one specific region to the other.

Mr. Marian Myslicki, Regulatory Manager Insecticides & Seed Care at Syngenta Polska Sp. z o.o (photo, left) explained: “The SSC provided us with a sound source of data and scientifically based analyses which supplemented and secured our own results. It made our work easier and increased the acceptance of our BAD at the registration authority.”

“Thanks to the SSC, we not only saved doing additional trials while securing our BAD but were also able to submit it earlier”, concluded Mr. Myslicki.

Today, SBI not only successfully applies satellite image technology for site similarity analyses, but also provides support for many plant protection products companies right at the early planning stage of their field trial programs. SBI assesses the optimal locations for trials by providing pest pressure maps, analyzing the site-specific crop biomass growth derived from satellite images, computing the weather conditions favoring pest development and spatially analyzing the risks of pest outbreaks in each country of interest. Fewer trials are therefore necessary in the context of zonal registration projects, since the sites selected offer a greater probability that the trials will succeed. Thanks to this technology, the registration authorities are able to verify that the trials conducted on those sites cover the full range of conditions in terms of, for instance, crop growth habit, weather, soil and other parameters. The registration authorities therefore have confirmation that all relevant conditions were encountered in the trials as the site selection is scientifically traceable and documented by SBI. Once the trials are planted on the field, SBI uses satellite remote sensing for monitoring and assessing crop characteristics and yield expectation.

KARATE ZEON® is a synthetic insecticide which is highly effective on most damaging chewing and sucking insects at all stages of development, even under difficult weather conditions. It can be applied to a wide range of crops, such as cotton, maize, cereals and vegetables. First launched in 1985, the product is registered today for more than 140 crops in over 100 countries worldwide.

KARATE ZEON® 050 CS had already been registered in Poland until January 2011. In March 2010, documents were submitted to the Polish Ministry of Agriculture and Rural Development for re-registration. They were compiled according to the OECD Guidance for Industry Data Submissions on Plant Protection Products and their Active Substance, Revision 1, March 2001.

About Syngenta Crop Protection AG

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