Ensuring faster registration and uptake of biological control agents

The European Parliament adopted by 590 votes to 28, with 32 abstentions, a resolution on ensuring the faster registration and uptake of biological control agents.

Parliament called on the Commission to establish, at EU level, a clear legal definition of biological control solutions, as well as a framework for the accelerated approval of biological control active substances at EU level and for the authorisation of biological control products at Member State level. Such a framework should be accompanied by clear data requirements and updated guidance documents, in order to strengthen legal certainty, foster EU innovation efforts, and promote investment in sustainable alternatives. Members further stressed that the Commission should strive to avoid market fragmentation and reduce administrative burdens.

The Commission, in the impact assessment accompanying the legislative proposal, should evaluate the suitability of current risk assessments during the approval of active substances exerting biocontrol and the authorisation of biological control products, and, if necessary, to develop tailored risk assessment protocols for each biocontrol solution.

Members called on the Commission to adapt, in the short term, the current Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market in order to cater specifically for active substances exerting biocontrol and biocontrol products.

Mutual recognition

Members encouraged Member States to use the current mutual recognition procedure in Regulation (EC) No 1107/2009 to accelerate the authorisation of biological control products in order to increase the uptake and availability of biocontrol products across the EU. The Commission is called on to: (i) work on a roadmap looking towards automatic mutual recognition of solely biocontrol products and the possibility for applicants to apply with a single dossier for a biological control product in several Member States at the same time; (ii) consider a single EU-wide authorisation zone that would ensure that the same scientific standards, efficacy criteria and safety levels are demonstrably met across the EU.

Fast-track procedures

Members recommended streamlining, optimising and accelerating the authorisation procedure as well as the re-authorisation, approval and re-approval procedures for biological control solutions, including through the establishment of fast-track procedures, in order to reduce unnecessary bureaucratic burdens. The Commission is also called on to consider allowing provisional authorisation solely for biocontrol plant protection products that fulfil the relevant safety criteria therein.

Future prospects

Parliament asked the Commission to:

- assess, in its impact assessment, the relevance of the current legislative framework and risk assessments when approving active substances for biological control and authorising biological control products, particularly with regard to data requirements, approval criteria and mutual recognition;

- establish a comprehensive biological control strategy, as well as an assessment of available tools with regard to the expected difficulties in crop protection over the next ten years. The objective is to support the development of effective alternatives, identify gaps and anticipate product withdrawals;

- examine the possibility, in the longer term, of a new stand-alone biocontrol regulation, including the conditions upon which a centralised approach may apply.

Assistance for applicants

Parliament called on Member States and the European Food Safety Authority (EFSA) to provide technical support for applications from SMEs, particularly during the application process, while implementing clear safeguards to avoid conflicts of interest. Fast, clear, and easy-to-understand administrative procedures, tailored to biological control products, should be established.

Funding

Parliament called on the Commission to allocate the necessary additional funds to train and recruit more staff at EFSA, and to ensure that EFSA's organisational structure includes dedicated and sufficient resources for biological control. Member States were also asked to ensure sufficient budget is ring-fenced for the relevant national competent authorities, which is essential to prevent undue delays in biological control authorisation procedures and to accelerate the uptake of biocontrol.

Research and Investment

The Commission and Member States are invited to foster investment in public and private research and partnerships for the development of biological and integrated pest management strategies, with a particular focus on SMEs. The resolution underlined the importance of research and development in biological control technologies over the coming decades.

Members called for more scientific research, knowledge exchange, cooperation and capacity building between all relevant actors involved in the process of developing, approving, authorising, adopting and disseminating biological control and best practices for implementing integrated pest management across the EU.

Parliament called on the Commission to regularly monitor the market uptake, availability, and affordability of biological control solutions. It also requested that efforts be made to ensure that the EU’s outermost regions can benefit from the use of biological control.