Biopesticides Regulation Services

Biopesticides Regulation Services

Biopesticides are widely used to manage pests, weeds and diseases, and they are usually used in conjunction with synthetic crop protection products. Biopesticide products include biochemical pesticides, microbial pesticides, and plant-integrated protectants. In general, biochemicals can be classified into different functional categories based on their mode of action, which include semiochemicals (pheromones), natural insect growth regulators and natural plant growth regulators. Biopesticides have been used commercially for more than 60 years, and their evaluation, registration and regulated use vary depending on the laws and policies of different countries and regions. The submission process for biopesticide products is lengthy and the registration is often costly. Biopesticide products require pre-approval from the relevant authorities before they can be marketed, and are evaluated for their chemical, toxicological and product performance according to prescribed guidelines. In addition, different biopesticide products may need to comply with different data requirements based on the microorganism, proposed use pattern and nature of the genetic modification. BOC Sciences can help keep your biopesticide approval on track by addressing the evolving regulatory framework for biopesticides.

Why Choose BOC Sciences?

  • A collaborative approach and regulatory science expertise allows us to guide your biopesticide products through all regulatory requirements.
  • Using existing regulatory data on biopesticides, we are able to ensure the reliability of scientific evidence and minimize additional testing.

Overview-of-the-EU-regulatory-process-based-on-a-new-active-ingredientFigure 1. Overview of the EU regulatory process based on a new active ingredient. (Hauxwell, C.; et al. 2010)

Our Capabilities

Extensive experience in a wide range of global biopesticide regulations

  • Regulations for placing plant protection products on the market
  • Data requirements for active substances
  • Data requirements for plant protection products

A diversity of endpoints for your biopesticide

  • Identification and characterization
  • Human health effects: acute toxicity/pathogenicity, allergenicity, genotoxicity
  • Fate and behavior in the environment
  • Ecotoxicology

Our comprehensive workflow

  • Prepare and submit registration applications
  • Develop product registration strategy
  • Prepare and submit biochemical classification
  • Prepare and submit inert applications for biopesticides
  • Conduct compliance audits
  • Develop and review labels
  • Review product claims for compliance
  • Process registration reviews and renewals

The-process-for-registration-of-a-new-microbial-pesticide-in-AustraliaFigure 2. The process for registration of a new microbial pesticide. (Hauxwell, C.; et al. 2010)

BOC Sciences Advantages

  • Highly specialized technical and analytical services for the worldwide registration and regulatory compliance of agrochemicals
  • Robust analytical testing programs that span from research and product development through the production process to final product
  • Relies on broad industrial experience, ensuring that all of our work meets the high standards expected by our clients
  • Our regulatory experts, toxicology consultants, scientists and inspectors will ensure that you receive maximum levels of guidance, testing and inspection you need.

Reference

  • Hauxwell, C.; et al. The use and regulation of microbial pesticides in Australia. THE USE AND REGULATION OF MICROBIAL PESTICIDES IN REPRESENTATIVE JURISDICTIONS WORLDWIDE. 2010. 80-88.
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