EAR expert statement on the updated EPPO Evaluation Manual, Chapter 8 Efficacy
Senior Efficacy Regulatory Expert, Eduardo Vidal Izquierdo, comments on the Dutch Board for the Authorisation of Plant Protection Products and Biocides (Ctgb) up-date: Chapter 8 Efficacy, EPPO Evaluation Manual
The submission to the authorities of a Plant Protection Product dossier requires a considerable amount of data to demonstrate the efficacy and the safety of the product.
A full package according to EPPO Standard PP 1/226 (3) “Number of efficacy trials” is required for a major pest in a major crop, while the EPPO Standard PP 1/224 (2) “Principles of efficacy evaluation for minor uses” is used in the case of minor uses. Finally, the EPPO Standard PP 1/257 (2) “Efficacy and crop safety extrapolations for minor uses” reports the possible extrapolations between crops and also, between biological agents as insects, diseases and weeds which can affect to the plants.
For clarification, minor uses are those uses of plant protection products (defined in relation to crops and pests) in which the crop is either considered to be of low economic importance at a national level (minor crop), or the pest is of limited importance on a major crop (minor pest). It should be noted that a minor use in one country may be a major use in another country, and it is for each country to define what its minor uses are (EPPO PP 1/224 (2), EPPO PP 1/257(2)).
Most European countries have classified the crops and pests present in their territory as major or minor. With this information, the uses can be classified as major or minor. For instance, the general rule in the Netherlands is, a minor crop is defined as a crop with a cultivation area less than 5000 ha for field crops, and less than 1000 ha for greenhouse crops, thus all uses in minor crops are being classified as minor use. All the information available regarding major and minor crops and minor uses in each European country is detailed in the European Union Minor Uses Database (EUMUDA) (www.eumuda.eu).
Some countries have specified extrapolation tables for important type of crops.
In this regard, the Netherlands has issued a working document titled “Possibilities for extrapolation of efficacy and phytotoxicity of Plant Protection Products for ornamentals crops” (CTGB, 2023); the last update (1.3) was issued on 17th April 2023.
This extrapolation document is based on the scientific and practical knowledge of efficacy and crop safety research in ornamental crops carried out in the Netherlands for many decades. The document follows the same structure and procedure conducted in the extrapolation tables for minor uses issued by EPPO. The chronology of this document would be:
- In version 1.0, specific pests and diseases, or groups of pests and diseases, for one of the underlying crop groups (such as fire blight in flower bulbs) were not included in the extrapolation document for ornamentals.
- These have been added in version 1.1.
- In version 1.2 the document was updated so that crop names are now based on version 2.2 of the DTG list (June 2019).
- In version 1.3 this English version is compared to the Dutch version 1.3 and discrepancies are adapted (CTGB, 2023).
This extrapolation document is very useful for any company which wants to register a plant protection product whose target is ornamental crops in the Netherlands, the most important market in ornamentals crops in all the EU (Eurostat, 2021).
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Bibliography
- EPPO Standard PP 1/224 (2) “Principles of efficacy evaluation for minor uses”
- EPPO Standard PP 1/226 (3) “Number of efficacy trials”
- EPPO Standard PP 1/257 (2) “Efficacy and crop safety extrapolations for minor uses”
- EUROSTAT. 2021 (https://ec.europa.eu/eurostat/, last visit 16th May 2023)
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