The Danish EPA’s engagement in evaluation of active substances
The Danish Environmental Protection Agency (EPA) is part of the joint European collaboration on evaluation of active substances for plant protection products. The assessment work includes both new active substances and renewal of already approved active substances. According to the EU Regulation (EC) No 1107/2009 active substances needs to be reassessed within a specific interval of time stipulated with the approval or renewal of the active substance (often every 10th or 15th year).
Before active substances can be used in plant protection products, they must be approved in the EU and included in the EU's positive list. For the reassessment of active substances, Denmark prioritises to be included in the assessment work for substances used in plant protection products that are already approved in Denmark. This is in line with the principle followed by the Commission in defining work programs for reassessment. This priority has been chosen in order to ensure the efficient utilization of the member states' resources, as the assessment work is very time-consuming and resource-intensive. The prioritisation of these active substances is also based on the Danish EPA’s ambition to retain a high professional competence within the active substances that can affect the environment and health in Denmark.
The EU Commission does not coordinate the assessment work of new active substances, as this is only the case for already approved active substances. It is therefore the responsibility of the industry to find a member state that will take on the role as Rapporteur Member State (RMS) and co-RMS.
Priority considerations for new active substances
When the Danish EPA decides to take on the role of RMS or co-RMS for the assessment of new active substances, it is based on a number of prioritization principles in the following order:
- Denmark/applicant has knowledge of /experience with assessment of similar substances.
- The active substance has a positive environmental and health / low risk to the environment and health.
- The active substance has new modes of action that can break or limit the development of resistance.
- The active substance can be used for new applications or solve special challenges regarding pests and / or crops.
- The active substance can assessed based on existing data requirements and guidelines.
- The active substance can be used for crops that are of great commercial importance in Denmark.
- Active substances with modes of action that is already on the market.
The Danish EPA will base its decision to act as RMS or co-RMS on the abovementioned priority considerations. It is not a necessity that all of the above must meet, but emphasis will be given to active substances that fulfill multiple requirements. Finally, the Danish EPA assesses the inquiries based on the available resources, as there must be sufficient capacity to engage the task.