The evaluation of active substances of plant protection products is carried out in an EU Community mechanism, in which Member States together with the European Commission and the European Food Safety Authority (EFSA) assess active substances of plant protection products in particular regarding fate and behaviour in the environment, toxicological properties and residue behaviour.
In contrast, the assessment and review of plant protection products is carried out on a national/zonal level; in Austria this is done by experts from the Austrian Agency for Health and Food Safety (AGES). The final authorisation of plant protection products is granted by the Federal Office for Food Safety, however.
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC constitutes the legal basis in the EU for the review of plant protection products and their active substances, safeners, synergists and co-formulants, as well as the authorisation, placing on the market, the use and control of plant protection products.
There is also a provision for this regulation to include a list of active substances (approved as candidates for substitution) that need to be withdrawn if that assessment identifies alternative plant protection products which are significantly safer and have neither an immediate or delayed harmful effect on human or animal health nor an unacceptable effect on the environment.
According to Regulation (EC) No 1107/2009, the European Union is divided into three zones, wherein the plant protection products assessment by a zonal Rapporteur Member State (zRMS) forms the basis for the following specific evaluation and authorisation by the individual Member States.
For each active substance, a Rapporteur Member State ("RMS") is appointed rapporteur to initially assess the application dossier (complete data package). If the active substance dossier is compliant with the agreed evaluation procedures and requirements of the Regulation, the RMS prepares a detailed Draft Assessment Report (DAR). In an extensive peer review process, the RMS then reports their findings to the applicant, other Member States, the European Food Safety Authority (EFSA) and the European Commission.
Questions and issues that sometimes arise in the course of the evaluation are discussed in additional meetings of experts organised by EFSA as well as during conference calls with the Member States; a uniform approach is being developed.
The decision whether a safe use of the assessed active substance is given, considering appropriate risk-minimising measures, and whether it is in accordance with Regulation (EC) No 1107/2009, is subject to a vote by Member States at the Standing Committee on the Food Chain and Animal Health (SCFCAH), which assists the European Commission in the development of food safety measures.
In the case of a decision on non-approval of an active substance because, on the basis of a comprehensive scientific risk assessment, it does not to meet the necessary standards required by that legislation, all existing authorisations for plant protection products containing that substance are to be withdrawn from the EU market within a given period.
First- approved active substances must be re-evaluated and adapted to the current scientific knowledge and technology after ten years the latest. A renewal of approval of active substances can be granted for a maximum of 15 years; candidates for substitution, however, can only be approved for a maximum of five years.
For the Department of Environmental Behaviour (eFate), specific national criteria such as climate conditions, soil conditions, agricultural structures and much more are taken into account within the framework of the national assessment, which have a major influence, in particular, on the degradation and distribution behaviour of plant protection products.
On this basis, the Federal Office for Food Safety issues corresponding requirements or risk-minimising measures as part of the approval process.
The following document contains basic information on how to carry out the national environmental exposure calculation:
For ecotoxicology, the national assessment is based on the legal basis valid in the EU, the legally prescribed data requirements, and the currently agreed guidance documents.
Corresponding background information on risk assessment, data requirements and possible risk-mitigation measures are summarised in the following documents for all organism groups relevant to assessment:
The risk assessment for honey bees is carried out by AGES based on the EFSA guidance document (EFSA Journal 2013;11(7):3295). For the assessment, all relevant exposure routes according to "Tier 1" have been considered so far, including exposure via pollen and nectar and exposure via drinking water intake. After several years of experience with the EFSA guidance document (2013), it became apparent that the assumptions made in the document regarding the exposure routes (1) drinking water and (2) pollen and nectar in succeeding crops were chosen in a particularly conservative way, due to the lack of data available at that time.
With the revised EFSA guidance document (EFSA Journal 2023;21(5):7989) new data and information have now been taken into account, allowing a more realistic description of the above exposure scenarios (1 and 2). It was therefore decided that until the newly revised EFSA guidance document (2023) enters into force in Austria, a transitional rule will be adopted at national level with effect from the beginning of July 2023 for the two scenarios (1) drinking water and (2) pollen and nectar in succeeding crops on the basis of the EFSA guidance document (2023) in order to avoid an overly conservative risk assessment. This means for all national assessments:
- A drinking water risk assessment (guttation water, water in puddles and surface water) does not need to be performed.
- Before an assessment of the exposure scenario "succeeding crop" is performed, the relevance of the exposure scenario for the applied crop shall be verified. The guidance in the EFSA guidance document of 2023 (section 4.3.4) shall be followed; i.e. based on the properties (DT50 in soil, Koc) and toxicity of the active substance as well as the application rate, the relevance of the exposure scenario shall be decided. If the exposure scenario is considered relevant, an assessment shall be performed according to the EFSA Guidance Document (2013).
For all other exposure scenarios (i.e. treated crop, weeds in the field, field margins, adjacent crops), the EFSA guidance document (2013) shall continue to be applied. It should also be noted that at zonal level (AT acts as zRMS) as well as at EU level (evaluation of active substances) the EFSA guidance document (2013) continues to be applied in its entirety.
For the application of product procedures, the use of the following forms is recommended for the assessment of ecotoxicology:
Form 1 should be used if Austria is zonal Rapporteur Member State (zRMS).
Form 2 should be used if a national assessment part (national addendum) is necessary for Austria as concerned Member State (cMS).
For an equivalence check to active substance batches according to the technical report “Outcome of the Pesticides Peer Review Meeting on general recurring issues in ecotoxicology" and the EFSA Supporting publication 2019:EN-1673, Appendix D ”How to present the assessment for the equivalence of batches” the following form is recommended:
For the assessment of "Mixture Toxicity" according to the Aquatic Guidance Document EFSA Journal 2013; 11(7):3290 the Mixtox tool is available.