Biopesticides are pesticides derived from natural materials. They can be used as insecticides, fungicides, herbicides, nematicides, plant or animal growth regulators, plant strengtheners, bioestimulants, biofertilizers and more.

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Biopesticides can be “microbials” based on living organisms such as bacteria, fungi, viruses and viroids or “macrobials” based on macroorganisms, or “botanicals“ based on plant extracts, or “biochemicals,” which may contain pheromones and other semiochemicals, as well as other natural products such as  hormones, minerals and enzymes.

Why Biopesticides?

Biopesticides have seen rapid growth in Asia and is attracting interest as one of the leading options in crop protection programs. However, the primary obstacle to these products is the regulatory process for biopesticide products in different Asian countries. The main legislations for biopesticide registration in ASEAN countries are usually similar to the chemical pesticide legislations. But the requirements on data and local trials are different in each country.

Regulation of Biopesticides

Biopesticides are also known as biologicals, biological pesticides, natural pesticides, biocontrol agents or biochemical pesticides. Although biopesticides are used globally, the regulations and authorities involved in the registration processes vary at a regional or national level worldwide. In Thailand, botanicals fall under Category 1 or 2 of the chemical regulation, depending on the solvent used, and in other Asian countries, biopesticides are included in the category of special pesticides as “biochemical pesticides.” In Europe, they can be regulated as agrochemicals under Regulation EC 1107/2009, or as biocides under Regulation 528/2012. In the United States, the EPA is the authority involved. NAFTA and Canada are also regulated separately. In South America, the Andean Community and Mercosur are the two blocks dividing the continent. These are some examples of diversity and complexity in the area of the global registration of biopesticides. 

Regulatory hurdles?

Is your biopesticide in a defined category according to the regulations of where you intend to register? Is your active substance defined for registration procedures? Which regulations apply to your substance/product? Is your biopesticide a low-risk substance? Do you need to perform a risk assessment for my product? Is the cost of a biopesticide registration the same as for a conventional chemical product? What is the minimum data requirement? Do you need to register your product? Is there any special fast track procedure in the country you intend to register your product?

knoell is a member of the Biostimulant Industry Council (EBIC) and is therefore at the forefront of your needs in the registration process.

Our services with regard to biopesticides

  • Registration services and customized project management in the ASEAN countries and worldwide
  • Strategic consultancy
  • Definition of the active substance for risk assessment: identification, analysis of contaminants, secondary metabolites (microbials), among others
  • Technical equivalence evaluation
  • Data evaluation for efficacy assessment
  • Data package evaluation and cost analysis (phys-chem, toxicology, ecotox, environmental fate) incl. preliminary risk assessment customized to biopesticides - Check of Completeness
  • Management and monitoring of key studies with Contract Research Institutes
  • Preparation of Expert Statements and Literature Research
  • Preparation and compilation of registration dossiers
  • Dossier compilation or stand-alone risk assessment for human health and environment
  • Dossier submission and follow up with authorities
  • Preparation of submission documents to authorities
Pamornwan Kahl Managing Director
+66 52 080451 +66 52 080452 send mail

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