Implementation of the Plant Protection Programme Regulation (EC) No 1107/2009

The European Parliament adopted by 529 votes to 34, with 63 abstentions, a resolution on the implementation of Regulation (EC) No 1107/2009 on plant protection products (PPP).

Members noted that the objectives and instruments of Regulation (EC) No 1107/2009, as well as its implementation, are not always sufficiently in line with European policies in the fields of agriculture, health, animal welfare, food safety, water quality, climate change, sustainable use of pesticides and maximum residue levels for pesticides in food and feed. Improvements could be made to achieve the objectives of the Regulation.

Main conclusions: while considering that the European Union is the appropriate level to pursue the regulatory strategy in the field of pesticides, Members expressed concern at the fact that the Regulation has not been effectively implemented and that, as a result, its objectives as regards agricultural production and innovation are not being achieved in practice. They highlighted the fact that, partly owing to the low degree of innovation, the number of pesticide active substances is decreasing.

While recalling the precautionary principle, Members also considered it unacceptable that the approval requirements for safeners and synergists have not yet been applied and that the negative list of co-formulants has still not been adopted, especially after the ban on POE-tallowamines in combination with glyphosate, which has highlighted the adverse effects that certain co-formulants can have.

Members are also concerned about:

• the steadily increasing use and identified cases of misuse of emergency authorisations granted under Article 53 in some Member States;
• the incomplete harmonisation of data and testing requirements in some scientific fields;
• the limited public availability of information on the evaluation and authorisation procedure, as well as the limited access to information.

Highlighting that the credibility of the PPP authorisation system strongly depends on public trust in European agencies, Parliament urged the Commission to propose improvements to further enhance the transparency of the regulatory process, including on access to the data in safety studies submitted by producers as part of their applications for market authorisation of PPPs in the EU. Members recognise the need to review the procedure in order to improve evaluations, increase the independence of the authorities tasked with carrying out studies, avoid conflicts of interest and make the procedure more transparent.

According to Parliament, the system for the scientific evaluation of plant protection products should be scientifically robust, objective and based on peer-reviewed evidence, derived from an open, independent and multidisciplinary scientific approach in authorising any active substance, in line with the EU’s risk analysis principles and the precautionary principle.

Low-risk pesticides: the resolution stressed that the authorisation and promotion of low-risk and non-chemical pesticides is an essential measure to support integrated pest management with low pesticide inputs. It recognised the need for more research on these products and underlined the importance of creating an innovation-friendly regulatory framework which will allow the replacement of older chemistry by new and better crop protection products.

Recommendations: the Commission and the Member States are called on to:

• ensure effective implementation of the Regulation as regards their specific roles in the approval and authorisation procedures;
• acknowledge that the protection of human and animal health and the environment are key objectives of the legislation, while improving agricultural production and safeguarding  the competitiveness of the agricultural sector;
• ensure full and uniform application of the hazard cut-off criteria, following the existing harmonised guidance, and to make sure that substances are assessed for their risk only if there is evidence that they do not present hazardous (cut-off) properties, as required by the Regulation;
• implement the provisions on co-formulants, safeners and synergists, to establish a list of unacceptable co-formulants and rules so that safeners and synergists are tested at EU level;
• finalise methods to determine when certain derogations should be applied, in particular as regards ‘negligible exposure’ or ‘serious danger to plant health’;
• incentivise research initiatives concerning active substances, including biological low-risk substances, and PPPs within Horizon Europe and the Multiannual Financial Framework 2021-2027;
• increase the overall transparency of the procedures in particular by explaining and justifying the decisions of the Standing Committee on Plants, Animals, Food and Feed.

Member States are called upon to:

• improve the serious and chronic understaffing of the national competent authorities, which leads to delays at the stage of hazard identification and initial risk assessment performed by Member States;
• better implement the authorisation procedures at national level, in order to limit the derogations and extensions granted under Article 53 of the Regulation to actual emergency situations;
• ensure effective enforcement of the Regulation, especially as regards controls on the PPPs marketed in the EU and regardless of whether they have been produced in the EU or imported from third countries.

Industry is called on to provide all data and scientific studies in a uniform electronic and machine-readable format to the rapporteur Member States and the EU agencies.