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?

The European Union has set up rules for the sustainable use of pesticides with regards to human and environmental safety, the Sustainable Use Directive (Directive 2009/128/EC). In this context, European countries define their national objectives and timetables in their National Action Plans (NAPs). Therefore, the use of techniques such as non-chemical methods and integrated pest management (IPM) included in the NAPs are scheduled by the European Commission to be reviewed at least every 5 years. The US, Asia and other regions of the world also share the compromise to facilitate the use of biopesticides.

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 Europe, they can be regulated as agrochemicals under Regulation EC 1107/2009/EC, or as biocides under Regulation 528/2012/EC. 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. In Thailand, botanicals fall under Category 1 or 2, depending on the solvent used, and in other Asian countries, biopesticides are included in the category of special pesticides as “biochemical pesticides.” 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 customised project management worldwide
  • Strategic consultancy
  • Support on consultation with Member State authorities for submission of minimum data requirements, pre-submission meetings
  • Definition of the active substance for risk assessment: identification, analysis of contaminants, secondary metabolites (microbials), among others
  • Technical equivalence evaluation
  • Efficacy assessment: evaluation data (different approach compared to conventional chemicals)
  • Data package evaluation and cost analysis (phys-chem, toxicology, ecotox, environmental fate ) including 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
Ángeles Rico Rico Managing Director
+34 91 112 60 80 +34 91 112 60 75 send mail

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