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By this call, EFSA intends to develop approaches to consider special substance properties or uses, for example reduced data collection for substances used as food or feed. In this context, EFSA put specific focus on semiochemicals, botanical active substances, other biological materials (like fermentation products of micro-organisms) and inorganic materials (such as minerals), although this list is non-comprehensive.
The proposals should help to identify circumstances where, from scientific point of view, only reduced data packages are required due to the nature of the active substance and its proposed uses. A further objective is to develop a fit-for-purpose Environmental Risk Assessment (ERA) accounting for the specificities of these types of substances. In addition, EFSA has formulated a list of seven sub-objectives (e.g., development of science-based criteria for justifying the non-submission of guideline studies), as well as tasks and timelines related to the sub-objectives.
The complete duration of this project is scheduled for 18 months after the kick-off. Competent organisations can send their proposals to EFSA until 15 September 2023.
Certain problems in the risk assessments or data requirements for potential low-risk substances, particularly those of biological origin, are already being discussed diversely on various levels. Inappropriate data requirements and risk assessments for such substances can reduce the economic interest of bringing low risk plant protection products to the market which would be a huge setback in reducing the use of chemical plant protection products under the EU Green Deal and the Farm to Fork strategy. Moreover, this can significantly reduce the farmers’ toolbox. The call for proposals by EFSA, therefore, is an important step to let the Commission adjust the regulations for these low-risk substances.
For more information on related topics such as low risk crop health active substances and products, please contact us.
