REGULATORY CONSULTANCY FOR ALL YOUR REGISTRATION NEEDS
Biopesticides
Discover how our regulatory consultancy team provides the insights you need to meet compliance and accelerate your biopesticide active substance and product registrations.
Regulatory Solutions
Regulatory consultancy
- Regulatory consulting and strategy (EU/GB, USA)
- Biopesticide active substance and product data gap analyses
- Preparation of registration dossiers (incl. IUCLID) for low-risk substances (Commission Regulation (EU) 2017/1432), microorganisms (bacteria, fungi, protozoa, viruses), botanicals (plant extracts), or semiochemicals
- Conducting human health and environmental risk assessments based on data requirements and guidelines
- Literature search and review, e.g., scientific peer-reviewed literature data is now an essential part of microbial dossiers in the EU
- Classification, labeling
- Preparation of waivers & expert statements
- Program management and study monitoring
- Submission and post-submission support
- Communication and meetings with regulatory authorities
- Training courses
Identifying and filling additional biopesticide data requirements with tailored studies
Our integrated approach and joined-up thinking helps develop studies tailored to meet the specific needs of your biopesticide active substances or products. This streamlines programs and optimizes cost effectiveness.
We can generate a range of endpoints for your biopesticide, dependent on category, including:
Testing Services
Physical chemistry
- Storage stability
- Identification and quantification of additives, relevant contaminating
- microorganisms and relevant impurities
- Physical and chemical formulation properties
- Technical active ingredient(s) characterization (5-batch)
- Certificate of Analysis (COA)
Testing Services
Human safety
- Acute toxicity and in vitro safety assessment (where applicable)
- Short-term toxicity
- Carcinogenicity and development and reproductive toxicology (DART)
- General subchronic toxicology
- Genetic toxicology
- Inhalation toxicology
- Pathogenicity (oral, dermal, pulmonary)
- Sensitization
Testing Services
Environmental safety
- Avian
- Aquatic (Daphnia, fish)
- Non-target organisms
- Earthworm
- Honeybees
- Other non-target insects
- Plant non-target organisms
Understanding the scientific and regulatory requirements for biopesticides
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Dedicated team of scientific and regulatory consultants with knowledge of biopesticide legislation in the EU, GB and US, microbiology and chemistry
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Comprehensive management of all administrative, technical and scientific aspects of biopesticide dossier preparation and submission
As the advantages of biopesticides in agriculture have become increasingly clear, the European Union (EU) has approved data requirements for microorganisms. If you need advice on your testing strategy by the new EU data requirements for microorganisms that entered into force in November 2022, contact our team of crop protection regulatory specialists to support to defend existing and obtain new approvals for active substances.
Labcorp can also support you with botanicals (plant extracts) and semiochemicals (insect pheromones) registrations both in terms of regulatory support and testing.
Labcorp also guides customers through the process of obtaining new authorizations for plant protection products and supporting existing products.
Planning a streamlined journey through biopesticide regulatory requirements
A collaborative approach and experience in regulatory science allows us to pilot your biopesticide active substance and products through all the regulatory requirements. Excellence in leveraging existing published and unpublished data ensures scientific arguments are robust and additional testing minimized.
Experience navigating a range of global biopesticide regulations and data requirements including:
Regulation (EU) 1107/2009
Regulation concerning placing of plant protection products on the market – applies to all categories of biopesticides.
Regulation (EU) 2017/1432
Amendment to Regulation (EU) 1107/2009 to recognize low-risk substances – applies to all categories of biopesticides.
Commission Regulation (EU) 2022/1439
Amending Regulation (EU) No 283/2013 as regards the information to be submitted for active substances and the specific data requirements for microorganisms.
Commission Regulation (EU) 2022/1440
Amending Regulation (EU) No 284/2013 as regards the information to be submitted for plant protection products and the specific data requirements for plant protection products containing microorganisms.Regulation (EU) 283/2013 (Data requirements for active substances) applies to botanical and semiochemicals
Regulation (EU) 284/2013
Products Data requirements for plant protection products – applies to botanical and semiochemicals
USA regulation 40 CFR Part 158 data requirements
EU Guidance documents on microbials for plant protection
Risk assessment of metabolites produced by microorganisms (SANCO/2020/12258)
The guidance provides a “step-by-step” procedure to determine whether a microorganism produces a metabolite of concern.
Approval and low-risk criteria linked to antimicrobial resistance (SANTE/2020/12260)
- Explains how to assess antimicrobial resistance of microorganisms.
- Focuses on bacteria via a stepwise approach. Viruses and fungi are not addressed extensively.
Biopesticides must still meet high quality and safety standards in order to pass EPA registration requirements, among others.
Our expert team of scientific and regulatory consultants can help navigate your biopesticide active substance through the entire registration process from research and development to product application.