#125 Composition of MPCP
Objective of the study
The composition of the MPCP, in contrast with chemical-based plant protection products, typically include unclassified (no hazard) substances that are often inert also. The stability of the active substance should be reasonably shown to be within a range which is effective in the field over its recommended storage length and conditions.
Circumstances under which the study is recommended to be required
Information on the composition of the MPCP is always required, though the information given is considered confidential when it concerns formulations.
Principles about reasoned cases for non-provision of studies
Composition, quality control and production summary data, and a discussion of possibility of unintentional ingredients should always be required.
Test organism or substrate
The entire MPCP.
Typical information to be provided by the applicant
Information typically includes:
- Amount of MPCA in the MPCP.
- Composition and amount of each ingredient in MPCP.
- Quality criteria for the production and storage of MPCP.
- Quality control data for 3-5 production batches (if pilot-scale production, then 3 batches may be sufficient and later when the product is on the market, they provide information on additional batches).
- Formation, presence and/or impact of unintentional ingredients.
- Recommendations regarding handling, storage, and fire.
Ref: 1: The amount of the MPCA within the MPCP is measured in terms of g/kg or g/L of the MPCP and is described in terms of CFU or other valid biopotency indicator. The scientific name, strain designation, and developmental stage of the microbial should be indicated.
Ref. 2: Confidential information includes the composition of the MPCP in g/kg, g/L or %w/w of each ingredient, including technical grade, additives, microbial and non-microbial requirements.
Ref. 3: MPCP indicate specific storage and shelf-life requirements and these should be specified and match the storage stability study provided.
Ref. 4: A “5-batch analysis”, which should include 3 to 5 batches, dependent upon production levels, indicates the strength and variability levels of production. It is common for MPCP to have what may seem to be a wide range in potency; the range and reasoning can be described.
Ref. 5: Within the batch analysis, production process, and composition statement, it would be useful to discuss any possibility of unintentional ingredients. Microbial pest control products often have inert ingredients for formulation, and risk of interactions during storage is low.
Typical endpoints of the study
There are no endpoints.
Testing guidelines
There is no single guideline adapted for microorganisms which should be used for this data requirement, however it is useful for the applicant to use the following guidelines alone or in combination, as well as including good quality literature and studies from reputable sources.
- USA EPA Microbial Pesticide Test Guidelines: OPPTS 885.1300 Discussion of formation of unintentional ingredients.
- OECD (2023) Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products. 2nd edition. Series on Pesticides and Biocides, No. 65.
- SANCO/10054/2013-rev. 3 (2013), Guidance document on data requirements on efficacy for the dossier to be submitted for the approval of new active substances contained in plant protection products.
- Evaluation Manual for the Authorisation of Biopesticides according to Reg. (EC) No 1107/2009. Part I: Micro-organisms. Version 2.2, October 2023, Board for the Authorisation of Plant Protection Products and Biocides (CTGB), Netherlands
- Evaluation Manual for the Authorisation of Microbial pesticides according to Regulation (EC) No 1107/2009. Version 2, January 2023, Denmark.