EU procedures for determining whether an active substance can be ‘approved’ for use in plant protection products involve a number of stages.
However there are two main components:
- a risk assessment component where a draft assessment report DAR produced by a ‘rapporteur’ Member States is peer reviewed and a conclusion reached by the European Food Safety Authority EFSA, followed by;
- a risk management component where all Member States are involved in providing an opinion on a Commission proposal on whether the substance can be approved or not. The proposal is formulated after considering the EFSA risk assessment conclusion and taking into account risk management options.
Once a substance is approved applications for authorisation of plant protection products containing the substance can be made and such applications are now assessed on a ‘zonal’ basis. (Member states have been grouped into ‘zones’ to help share some of the work between them. CRD)'s website provides guidance here.
An outline of the steps in each of the components leading to a decision on active substance approval is as follows:
- Dossier submitted by applicant or ‘notifier’ (usually the producing company) to a ‘rapporteur’ Member State (i.e. the Member State who will conduct the evaluation and risk assessment presenting the results in the DAR);
- The rapporteur conducts a ‘completeness’ check to ensure the dossier contains the necessary data and meets other requirements;
- The rapporteur evaluates the dossier and produces the DAR which is sent to EFSA;
- The DAR is circulated by EFSA to all Member States and the applicant for comment. A version is also made available for public comment;.
- The rapporteur responds to comments. EFSA determines if there is a need for expert peer review (usually the case) and the topics (‘open points’) that need further consideration. Additional information can also be submitted and evaluated at this point if considered necessary by EFSA;
- Expert peer review involves consideration by Member State and EFSA specialists in discipline areas (depending on issues may involve all or some areas i.e. physical chemistry & methods; mammalian toxicology & operator risk; residues; environmental fate; and ecotoxicology);
- EFSA finalise the outcome of the risk assessment in their ‘EFSA conclusion’ which takes into account the outcome of the peer review but is an independent document produced by the Authority. This is provided to the Commission and published on the EFSA website.
The Commission generally seeks the views of Member States on the EFSA conclusion at a first discussion at a Standing Committee (they may or may not have an outline proposal at this stage) returning at a second meeting with a formal proposal on which the Member States provide an opinion by qualified majority vote.
There is limited opportunity for comments or lobbying in the later phases of the process. Member States are asked to vote on a decision based on the evaluation. There can be differences in opinion, for example, as to the seriousness of any data gaps, and inevitably these will be informed by the wider context within each member state.
All Member States have votes allocated for qualified majority voting. A useful summary of the EU qualified majority voting system can be found here.
If the Standing Committee cannot reach an opinion on the proposal (by qualified majority), the Commission refers it, in either its original or modified form, to an appeal committee. The committee comprises senior representatives from all Member States and is chaired by the Commission, who must look for solutions which command the widest possible support within the committee. The proposal can be amended during this procedure. There are three possible outcomes:
- a positive opinion, in which case the Commission must adopt the proposal;
- no opinion, in which case the Commission may adopt the proposal;
- a negative opinion, in which case the Commission must not adopt the proposal.
If the Commission does not, or cannot, adopt a proposal, it must put another proposal to the Standing Committee for consideration.
There is a section of CRD’s website devoted to European work that provides more detail about relevant EU legislation and processes.