Biopesticides
GLP analytical studies and regulatory expertise dedicated to biopesticides, supporting the development and registration of products based on microorganisms, natural substances and other biological active agents.
The diversity of biological active substances requires tailored analytical approaches and specific regulatory considerations, particularly in relation to data requirements, study design and method selection.
Renolab supports companies in addressing these challenges through GLP-compliant studies and technical expertise aligned with the specific characteristics of biopesticides.
Our team provides case-by-case guidance to define the most appropriate analytical procedures and generate the data required for plant protection product registration.
Chemical and Physical Characterisation of formulated products
5-Batch Analysis of Technical Active Substance
In accordance with GLP principles, the laboratory’s Chemical and Physical Characterisation section is able to perform all the analyses required by current directives for the pre- and post-registration of technical active substance and formulated products.
All chemical and physical characteristics are determined according to recognised analytical methods and international guidelines, including:
- EC Methods
- CIPAC Handbook Series
- OECD Guidelines
- OPPTS Series
Regulatory framework
- Regulation (EC) no. 1107/2009 of the European Parliament and of the Council of 21 October 2009, concerning the placing of plant protection products on the market;
- Regulation (EU) 2022/1439 – amends Regulation (EU) No 283/2013 as regards the information to be submitted for active substances and the specific data requirements concerning microorganisms.
- Regulation (EU) 2022/1440 – amends 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
- CropLife, Technical Monograph no. 17, Guidance for Specifying the Shelf life of plant protection products;
- SANCO/3030/99 rev. 5 : Technical Active Substance and Plant protection products: Guidance for generating and reporting methods of analysis in support of pre- and post-registration data requirements for Annex (Section 4) of Regulation (EU) No 283/2013 and Annex (Section 5) of Regulation (EU) No 284/SANCO/12116/2012 rev. 0 or OECD no. 65: OECD Issue Paper on Microbial Contaminant Limits for Microbial Pest Control Products.
Residue Studies
Renolab’s Residue Studies section measures residues of active substances and their metabolites in:
- materials of plant origin
- animal matrices
- processed products
- soil
- water
- air
To support the preparation of product registration dossiers, Renolab can act as Study Director in collaboration with external field trial centres and/or as Principal Investigator for ecotoxicity and environmental impact studies, in accordance with current guidelines and regulatory requirements.
The laboratory also performs studies on adjuvants to evaluate their influence on the residue levels of different active substances.
Regulatory framework
- Regulation (EC) no. 1107/2009; Concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC;
- EC working document, 1607/VI/97, rev. 2;
- Guidelines for the generation of data concerning residues;
- OECD 509 – Guideline for the testing of chemicals: crop field trial;
- OECD 506 – Guideline for the testing of chemical: stability of pesticide residues in stored commodities;
- Guidance Document on Pesticide Analytical Methods for Risk Assessment and Post-approval Control and Monitoring Purposes SANTE/2020/12830, Rev.2;
- OECD Series on Testing and Assessment No. 9 “Guidance document on the conduct of studies of occupational exposure to pesticides during agricultural application”, Paris 1997. OCDE/GD(97)148;
- EPA Series 875.2100 Occupational and Residential Exposure Test Guidelines. Foliar Dislodgeable Residue Dissipation.
- Recommendations for DFR studies in the EFSA (2021) Guidance on the assessment of exposure of operators, workers, residents, and bystanders in risk assessment of plant protection products. EFSA Journal 2022; 20(1); 7032, 134 pp.
FAQ
What are biopesticides?
Biopesticides are plant protection products derived from natural sources such as microorganisms, plant extracts or biological organisms. They may include microbial agents such as fungi, bacteria, viruses, protozoa or algae, as well as insects and nematodes used for pest control.
What analytical studies are required for biopesticide registration?
The registration of biopesticides may require chemical and physical characterisation of the formulated product and technical active substance, as well as residue studies to evaluate the presence of active substances and their metabolites in different environmental and agricultural matrices.
Does Renolab perform GLP studies for biopesticides?
Yes. Renolab performs analytical studies according to GLP (Good Laboratory Practices) principles to support the generation of data required for regulatory submissions.
Which matrices are analysed in biopesticide residue studies?
Residue studies evaluate residues of active substances and their metabolites in plant materials, animal matrices, processed products, soil, water and air.
Which regulations apply to biopesticides in the EU?
Biopesticides are regulated under the European framework for plant protection products, particularly Regulation (EC) No. 1107/2009, together with specific data requirements for microorganisms introduced by Regulations (EU) 2022/1439 and (EU) 2022/1440.
Can Renolab support the preparation of registration dossiers for biopesticides?
Renolab provides technical support for identifying the analytical procedures and studies required to prepare registration dossiers and can act as Study Director or Principal Investigator in collaboration with external field trial centres.