Agrochemicals
Supporting companies in the registration of plant protection products through GLP-compliant analytical studies, residue testing and expert guidance in defining the required regulatory strategy.
Renolab has developed solid expertise through many years of experience working with products for agriculture. The laboratory provides technical support to identify, on a case-by-case basis, the most appropriate procedures and studies required for regulatory approval.
Our strong experience in conducting regulatory studies, combined with continuous feedback from international authorities, allows us to support companies in the successful registration of agrochemical products.
Chemical and Physical Characterisation of formulated products
Renolab performs chemical and physical characterisation studies of formulated products and 5-batch analysis of technical active substances in accordance with GLP principles.
The laboratory carries out the analyses required by current directives for the pre- and post-registration of technical active substance and formulated products. Chemical and physical characteristics are determined according to recognised methods and 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.
- Commission Regulation (EU) no. 283/2013 of 1 March 2013, setting out the data requirements for active substances, in accordance with Regulation (EC) no. 1107/2009.
- Commission Regulation (EU) no. 284/2013 of 1 March 2013, setting out the data requirements for plant protection products, in accordance with Regulation (EC) no. 1107/2009.
- FAO Guideline, Manual on Development and Use of FAO Specifications for plant protection products.
- 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 284/2013.
Residue Studies
The Residue Studies section evaluates residues of active substances and their metabolites in crops, animal matrices, processed products, soil, water, and air.
To support the preparation of product registration dossiers, Renolab can act as Study Director in collaboration with external field trial centers, and/ or as Principal Investigator for ecotoxicology and environmental fate studies, ensuring full compliance with current guidelines and regulatory requirements.
The laboratory also performs studies on adjuvants to assess their influence on the residue levels of different active substances, including insecticides, fungicides, and herbicide.
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 types of agrochemical products does Renolab support?
Renolab provides analytical studies and regulatory support for agrochemical products used in agriculture, including insecticides, fungicides and herbicides. The laboratory supports companies in identifying the most appropriate studies and analytical procedures required for product registration.
What regulatory studies can Renolab perform for agrochemical products?
Renolab performs studies related to the chemical and physical characterisation of formulated products and the analysis of technical active substances. The laboratory also conducts residue studies to evaluate residues of active substances and their metabolites in different environmental and agricultural matrices.
Does Renolab perform studies in compliance with GLP principles?
Yes. Renolab performs its analytical and regulatory studies in accordance with GLP (Good Laboratory Practices) principles, ensuring that studies are conducted following recognised quality standards and internationally accepted procedures.
Which matrices are analysed in residue studies?
Renolab evaluates residues of active substances and their metabolites in a range of matrices, including crops, animal matrices, processed products, soil, water and air.
Can Renolab support the preparation of registration dossiers?
Yes. To support the preparation of product registration dossiers, Renolab can act as Study Director in collaboration with external field trial centers and/or as Principal Investigator for ecotoxicology and environmental fate studies, in compliance with current guidelines and regulatory requirements.
Which regulatory guidelines and methods are followed in agrochemical studies?
Analyses are performed according to recognised international methods and guidelines, including EC Methods, CIPAC Handbook Series, OECD Guidelines and OPPTS Series, and in accordance with the regulatory framework governing plant protection products, such as Regulation (EC) No. 1107/2009 and related data.