Approvals / notifications for trial purposes

Approval and notification procedures at the BVL

Plant protection products must be approved before they are imported, placed on the market and used for research and development purposes. The legal basis for this is Article 54 in conjunction with Article 28 of Regulation (EC) No 1107/2009 and § 20 (1) of the German Plant Protection Act (PflSchG).

Subsequently, the following must be approved:

imports of plant protection products, which are not authorised, from third countries or other EU Member States for trial purposes
the placing on the market of plant protection products, which are not authorised, for trial purposes (placing on the market also includes manufacturers distributing products to third parties, for example to testing facilities)
the use of plant protection products, which are not authorised, if the products are used on field areas or are released into the environment
the use of authorised plant protection products for uses which are not permitted if the products are used on field areas or are released into the environment

The Federal Office of Consumer Protection and Food Safety (BVL) issues approvals on application. Please use the forms provided:

a) Application for placing a product on the market
This form applies when a plant protection product is only intended to be placed on the market for trial purposes without being used on field areas or released into the environment. With a single form several plant protection products can be requested to be placed on the market. A table may be attached if necessary.

b) Application for use / placing a product on the market
This form is for applying for approval for using a plant protection product for trial purposes and - if relevant - for subsequently placing it on the market. Appendix A is part of this application. One application is sufficient for a trial series consisting of several trials with the same plant protection product or up to 20 different plant protection products for the same trial purpose, also over a period of several years. Please see also the note on guiding values for the number of sites and size of areas.

c) Notification of use / application for placing a product on the market
If trials are carried out by the manufacturer or on behalf of the manufacturer, the manufacturer or contractor is exempt from compulsory approval according to § 20 (3) PflSchG but must notify the BVL of the trial taking place at the latest one month before it begins. The form for notification is provided here. The form also includes the application for placing the product on the market should this be required. Appendix A must be submitted in addition to this form. The contractor also requires written authorization from the manufacturer. One application is sufficient for a trial series consisting of several trials with the same plant protection product or up to 20 different plant protection products for the same trial purpose, also over a period of several years. Please see also the note on guiding values for the number of sites and size of areas.

Appendix A of the application / notification form also asks for the chemical name and the structural formula of the active substance, and the content of the active substance (g/kg or g/L) in the product. Annex A is not required if the active substance has already been approved in the EU or if the information has already been submitted to the BVL. The information about an active substance which is in the process of development may be subject to special protection. In order to guarantee confidentiality these data can be sent separately addressed to the Head of the Department for Plant Protection Products at the BVL (labelled confidential). The active substance must be clearly coded in the application/notification form so that it can be allocated correctly.

Safety data sheets must always be enclosed, regardless of the type of process a) to d), even if Appendix A is not required. These should be submitted in the current version, in English or German, not older than five years.

Both the approval procedure and the notification procedure involve costs.

Information on approval and notification requirements

If the application does not take place on field areas and the product is not released into the environment - e.g. greenhouse applications and trials for seed treatment without sowing on field areas - no approval is required to carry out the tests. However, an approval for import or placing on the market may be necessary in order to enable the trial applicant to get the product.

The experiments for research and development purposes, in accordance with Article 54 of Regulation (EC) No 1107/2009 and § 20 PflSchG, comprise trials where the plant protection product is the experimental object and thus has the objective of obtaining information on the plant protection product. The tests are usually used to prepare applications for the authorization of this plant protection product. In contrast, a different case is where the plant protection product in question is not the experimental object. Thus, if e.g. a herbicide X is to be used in an experiment in which the insecticide Y is actually tested or in a seed varietal test, then herbicide X must be an authorized product for the corresponding application; a trial permit for herbicide X is not possible in such cases.

Experiments for marketing purposes before introducing a new plant protection product on the market which is still in the approval process are also not permissible since such tests are not necessary for the authorization of the product.

Notification to the federal state ("Länder") authorities of the commencement of a trial

According to Article 20 (1) sentence 5 PflSchG (German Plant Protection Act) the competent authority in the respective state must be notified before a trial is carried out. To submit your notification to the Länder authorities, please use their form "Anzeige von Versuchen nach § 20 bei den Länderbehörden" (form for notifying the Länder authorities of trials according to Article 20).

To be able to clearly identify a trial area, the field block or piece of land and the plot must be stated. If this information is not available, the latitude and longitude (Gauss-Krüger coordinates) can be entered temporarily.

The addresses for the appropriate Länder authorities can be found in the list of competent Länder authorities according to Article 20. The notification can be submitted to the authority by post or e-mail.

The Federal Office of Consumer Protection and Food Safety provides the Länder authorities with notifications and approval certificates so that this documentation is not required when notifying of the commencement of a trial.

The form and address list can be found below.