The European Commission is to clarify and extend the scope of active ingredients that may be considered as “low-risk” substances, in a bid to boost approvals of biological and naturally occurring pesticides. Micro-organisms, baculoviruses and semiochemicals will be considered as low risk, unless specific concerns are identified, while naturally occurring substances will be exempted from certain hazard-based criteria. The proposed amendments will be made to the identification criteria for low-risk pesticides in the EU agrochemical registration Regulation (1107/2009).
They have been voted through by EU member states and will come into effect following publication in the EU Official Journal. The Commission has been under pressure over the last year from the European Parliament, which passed several resolutions calling for faster biopesticide approvals.
Regulation 1107/2009 introduced the “low-risk” category, under which ais could benefit from a longer 15-year approval period. The existing identification criteria are largely based on a long list of hazard characteristics that must not be present. For the sake of clarity, more details should be provided, says the Commission. It notes that hazard criteria on persistence and bioconcentration could prevent approval of certain naturally occurring substances, such as botanicals and minerals, even though they present “considerably less” of a risk than other ais.
The changes stipulate that a half-life in soil of more than 60 days or a bioconcentration factor higher than 100 would normally exclude an ai, other than a micro-organism, from being considered low-risk. However, a naturally occurring substance that exceeds these levels may still be considered low-risk, provided that it does not trigger any other hazard criteria.
Micro-organisms will be assessed at strain level for compliance with low-risk criteria. They will be considered low-risk unless the strain has demonstrated multiple resistance to antimicrobials used in human or veterinary medicine. Baculoviruses will be considered low-risk, unless a strain has demonstrated adverse effects on non-target insects. Semiochemicals, which include pheromones, will be considered low-risk, unless they trigger any hazard criteria.
A further amendment stipulates that ais that have been defined as priority substances under rules on preventing water pollution will not be considered as low-risk ais.
The changes are limited to identification criteria, and there are no amendments reflecting the MEPs’ call for a separate “fast-track” approval process for biopesticides. In previous debates with MEPs, the Commission pointed out that low-risk pesticides are to be given priority in the next round of renewing existing EU approvals. EU Health and Food Safety Commissioner Vytenis Andriukaitis also noted that the effectiveness of incentives, such as longer approval periods, is to be assessed during the review of agrochemical legislation under the REFIT “fitness check” programme.