The Special Committee on the Union’s authorisation procedure for pesticides adopted the joint report by Norbert LINS (EPP, DE) and Bart STAES (Greens/EFA, BE) on the Union’s authorisation procedure for pesticides.
The EU authorisation procedure for plant protection products is one of the most stringent in the world. In the light of the concerns raised by several stakeholders about the assessment of glyphosate, the Special Committee on the Union’s authorisation procedure for pesticides (PEST) was set up to identify areas that can be further improved with regard to the Union authorisation procedure for plant protection products, by providing recommendations that it considers to be necessary in order to ensure the achievement of a high level of protection of both human and animal health and the environment.
General remarks
Members stressed the importance of ensuring independent, objective and transparent scientific assessment of active substances and plant protection products.
They called on the Commission and the Member States to:
- allocate sufficient resources and appropriate expertise to the assessment of active substances and plant protection products and to ensure independent, objective and transparent assessment in light of current scientific and technical knowledge;
- ensure full and uniform application of the hazard-based cut-off criteria for active substances that are mutagenic, carcinogenic or toxic for reproduction, or that have endocrine-disrupting properties;
- duly apply the precautionary principle when the possibility of harmful effects on health is identified but scientific uncertainty persists, by adopting provisional risk management measures necessary to ensure a high level of protection of human health;
- no longer allow the use of plant protection products in areas used by the general public or by vulnerable groups.
- ensure effective controls of the agricultural products imported from third countries with a view to ensuring a high level of protection and a level playing field for European food production;
- engage in increased efforts to stop the trade of illegal plant protection products, as these products undermine the objectives of Union legislation in this area.
The report also called for the creation of an effective post-market vigilance system to systematically monitor the real-life impacts of the use of plant protection products on human and animal health and on the environment as a whole, including in the long term.
The Commission was called urged to:
- ensure that sales statistics concerning pesticides are publicly available per active substance and per Member State, and that pesticide use statistics are further improved so as to provide full information for the environmental risk assessment as well as the comparative assessment under the Regulation;
- develop a standardised EU-wide IT platform or database to support the sharing of post-market monitoring data, and considers that post-market monitoring data and other available monitoring data should be used in the authorisation process;
- accelerate the implementation of the pilot project ‘Environmental monitoring of pesticide use through honey bees’, which will, inter alia, allow the implementation of EU legislation in terms of pesticide application and authorisation to be evaluated.
Application for approval of active substances
The committee called on the Commission to propose amending the Regulation so as to empower it to adopt a work programme with regard to the designation of the rapporteur Member State (RMS) for applications for approvals, on the basis of criteria for an independent, objective and transparent assessment: expertise, resources, absence of conflict of interest, relevance for the product, technical capacity and ability to achieve scientifically robust and reliable outcomes within the given timeframe, together with a comprehensive peer review process and a stakeholder consultation, on lines similar to the system for re-approval of active substances.
Members considered it important that applicants should be required to register all regulatory studies that will be performed in a public register, and allow a comment period during which stakeholders are able to provide existing data to ensure all relevant information is taken into account.
Draft assessment by the RMS
The committee stressed that the assessment should include a thorough evaluation of the raw data, as well as data related to final product formulations as available at that stage of the evaluation.
Member States should ensure that they are properly represented in the European Food Safety Authority (EFSA) by independent national experts. EFSA and the European Chemicals Agency (ECHA) should also be allocated sufficient funds in order to carry out their tasks in an independent, objective and transparent manner, so as to ensure a high level of protection of human and animal health and the environment, and also in view of the additional workload anticipated for those agencies.
Authorisation of plant protection products by Member States
Members called on the Commission to undertake an in-depth assessment of the zonal system, with a view to assessing how best to ensure the proper harmonised scientific assessment of plant protection products while safeguarding the responsibilities of Member States for the authorisation, restriction or refusal thereof, and to revise the limitations for refusal of authorisation.
Harmonised guidelines for the assessment of plant protection products should be established by EFSA.
Members proposed that the Commission submit a detailed report to Parliament within 2 years on the national practices of risk assessment and risk management of plant protection products.
Alternative methods
The Commission and the Member States are called on to promote the development and use of sustainable and ecological alternatives to plant protection products, integrated pest management measures and low-risk pesticides, as an important measure for reducing the adverse impacts of pest management.