Regulation should be considered from early stages to make sure the final product will fit to the legal framework according to the desired uses and geographies.
GAB Consulting is a leading company in Europe in the field of biosolutions and has submitted dossiers for a wide range of natural extracts including sources from plants, yeasts, bacterial animals, semiochemicals including single chain lepidopteran pheromones, microbes including viruses, yeast, bacteria and fungi.
GAB Consulting members are engaged in the revision of Guidance Documents for dossier preparation for biocides containing biologicals as active substances and frequently participate in the OECD Biopesticide Steering Group, EU Commission Working groups, IOBC and IBMA, EBIC, CTN – ensuring that we are always at the forefront of knowledge in regulations for Biosolutions registrations.
Biosolutions encompass all biological actives classified as Biostimulants and Biocontrol or Biopesticices, including Semiochemicals, natural extracts and microorganisms. These unconventional products require a distinct Regulatory approach. GAB delivers high quality Dossiers according to product definition and classification under the right framework:
- Biosolutions for abiotic stress and nutrition uses are regulated as biostimulants according to Regulation (EU) 2019/1009. Data requirements depend on the uses and composition of the product.
- Biosolutions for biotic stress are regulated either as plant protection products under Regulation (EC) No 1107/2009 or as biocides under Regulation (EU) 528/2012 depending on the use of the product. In both systems, the active ingredients must be registered at the EU level before product registrations can be obtained. Data requirements for plant extracts and pheromones are the same as for chemicals, whereas separate ones exist for microorganisms.
GAB Consulting is part of the SynTech Research Group. For more information visit www.syntechresearch.com