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Pharma Newsletters >> Eurofins BioPharma Services Newsletter 18 - November 2017 >> Biopesticides

Biopesticides: Eurofins supports analytical regulatory registration in EU and US-EPA

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Michele Cavalleri, Eurofins BioPharma Product Testing Italy, MicheleCavalleri@eurofins.com

The increase in the numbers and types of microbial pesticides and their uses as plant protection and biocidal products has come about as a result of innovation in the industry and of the need to produce more targeted and sustainable products.

Microbial pesticides specifically include any microbiological entity, including lower fungi and viruses, cellular or non-cellular, capable of replication or of transferring genetic material (in accordance with the definition used in the EU Regulation (EC) No 1107/2009).

The properties of living microbial pesticides differ from the properties of chemical pesticides, not least because microorganisms have the capability of propagation. Based on these differences, the type and level of regulatory requirements for microbial pesticides can be challenging.

In particular, the characterisation of microbial pesticides involve many different types of expertise. Genotyping to identify the active ingredient at strain level is normally required as well as a sound experience in classical microbiology and microbial method validation to quantify the active ingredient content and the microbial pathogenic impurities in the formulation itself and different matrices (for instance, drinking water).

Furthermore, OECD in vivo technical guidelines for chemicals should be evaluated, and proposals for adaptation to microorganisms should be made in different ways, including parameters such as growth temperature, O2 and CO2 concentration and so on.

Alternative methods and their results should also be taken into account, such as US EPA 885 technical guidelines, specifically validated for microbial pests.

With comprehensive Biopest expertise, Eurofins BioPharma Product Testing has responded to the growing market needs and established global laboratory teams specifically dedicated to the study of microbial pests to support manufacturers with their successful submissions of their innovative and beneficial products to the EU and US highly regulated markets.

For more information, visit: www.eurofins.com/biopharma