How are plant protection products authorised?

The assessment of active substances in the European Union (EU) in accordance with Regulation (EC) No 1107/2009 is carried out jointly by all Member States, the European Food Safety Authority (EFSAshort forEuropean Food Safety Authority) and the European Commission. Applications for the approval of a new active substance or the review of an existing active substance approval are processed by the competent authority of a Member State. This country, called Rapporteur Member State (RMS), carries out the risk assessment and prepares a comprehensive assessment report. The other Member States, EFSAshort forEuropean Food Safety Authority and the public review and comment on this assessment report, which is then finalised by the RMS. If necessary, expert meetings on specific issues are held at EU level, coordinated by EFSAshort forEuropean Food Safety Authority. Based on the RMS assessment report, EFSAshort forEuropean Food Safety Authority prepares a summary report (known as the EFSAshort forEuropean Food Safety Authority Conclusion), which forms the basis for the European Commission's decision on whether to approve or not approve an active substance. 

Once an active substance has been (re)approved by the European Commission, the conditions are in place for plant protection products containing this active substance to be authorised in the EU. However, an important distinction must be made: The active substance is not synonymous with the plant protection product. The latter is the ready-to-market product that is to be used in practice. It contains one or more active substances approved in the EU as well as other adjuvants (known as co-formulants). This intended "mixture" undergoes a separate authorisation procedure at Member State level.

Unlike the approval of active substances, authorisations for plant protection products are granted nationally in the country where they are to be marketed or used. 

For the evaluation of plant protection products within the authorisation procedure, the EU has been divided into three zones: South, Central and North. Germany belongs to the central zone. Authorisations can be applied simultaneously for several Member States within these zones, together with all the relevant documentation. A Member State acting as the so-called zonal Rapporteur Member State (zRMS) is responsible for carrying out the evaluations and prepares a comprehensive evaluation report (draft Registration Report; dRR). The dRR is submitted to the other Member States concerned (cMS) for comment. They review the zRMS's evaluation and submit any points they consider to be outstanding, which should be taken into account or amended in the evaluation. The zRMS finalises the Registration Report (RRshort forrelative risk), taking into account the comments received. The finalised RRshort forrelative risk then forms the basis for authorisation in the cMS.

If a plant protection product is already legally authorised in a Member State, the transfer of this authorisation can also be applied for at a later date in a country in the zone and take place as mutual recognition.

The procedure is based on the results of the active substance assessment by the European Commission and includes a health risk assessment of the specific plant protection product, including all co-formulants.

In Germany, plant protection products must be authorised for their intended use by the German Federal Office of Consumer Protection and Food Safety (BVLshort forGerman Federal Office of Consumer Protection and Food Safety). The BfRshort forGerman Federal Institute for Risk Assessment, the Julius Kühn Institute (JKIshort forJulius Kühn Institute) and the German Federal Environment Agency (UBAshort forGerman Environment Agency) are involved in the procedure and carry out partial assessments within the scope of their responsibilities.

In the event of an exceptional situation, the national authorisation authorities (in Germany, this is the BVLshort forGerman Federal Office of Consumer Protection and Food Safety) can grant emergency approval for a crop/plant protection product combination upon request. Emergency authorisation is provided on for a limited time period. We have compiled FAQs on this topic at External Link:https://www.bfr.bund.de/en/service/frequently-asked-questions/topic/emergency-authorisations-of-plant-protection-products/.

The BfRshort forGerman Federal Institute for Risk Assessment assesses plant protection products in terms of the health risks to humans and animals, the prevention of health damage caused by soil contamination, and the methods used to analyse residues. All potentially affected groups of people are taken into account:

• Consumers as well as domestic animals and livestock that may ingest plant protection product residues through their food or feed;
• Users of plant protection products;
• Workers who, for example, carry out follow-up work on a previously treated field or in a greenhouse;
• People living near fields, agricultural land or greenhouses treated with plant protection products;
• So-called "bystanders" (e.g. people going for walks who may be exposed during treatment with plant protection products).

The health risk assessment is intended to ensure that plant protection products do not have any harmful effects on the health of the aforementioned groups of people, domestic animals or livestock. The German Federal Environment Agency is responsible for assessing the effects of plant protection products on the health of wild animals.

Companies submitting an application must provide extensive data packages for the approval or authorisation of both the active substance and the plant protection products, which are then reviewed by the regulatory authorities. The authorities' overall assessment takes into account the studies required by law from applicants in accordance with OECD guidelines, which regulate the correct procedure for such studies, as well as the results of independent scientific studies reported in the public literature.

With regard to the health risk assessment, toxicological health-based guidance values are first determined for each active substance, which specify the amount up to which the intake of an active substance does not cause any detectable harmful effect in the human body. For the authorisation process for plant protection products, the scientists at the BfRshort forGerman Federal Institute for Risk Assessment then evaluate the proposed uses of a plant protection product with regard to exposureClose dialogexposureExposureTo glossary to the active substance. In doing so, they also evaluate possible interactions of the active substance with other formulation components of the product. A plant protection product is only considered safe if, when used as intended, the amount of its active substances absorbed by consumers, users or uninvolved third parties is below the toxicological limits. To ensure safe use, it may be necessary to prescribe the use of personal protective equipment in order to comply with the limits.

Further information on this can be found in our FAQ: External Link:https://www.bfr.bund.de/en/service/frequently-asked-questions/topic/questions-and-answers-on-residues-of-plant-protection-products-in-food/. Information on risk mitigation measures to reduce the exposure of persons who handle plant protection products professionally can be found on the BVLshort forGerman Federal Office of Consumer Protection and Food Safety website –External Link: www.bvl.bund.de/PSA .