• Test guidelines and planning of experiments
• Principles of GEP (Good Experimental Practice)
• Experimental design
• Preparation of application documents

Test guidelines and planning of experiments

The efficacy of plant protection products is verified in the context of the authorisation procedure according to EPPO guidelines (EPPO: European and Mediterranean Plant Protection Organization). Similarly, under current EU-legislation, the design, analysis, conduct and reporting of efficacy trials must be in accordance with the EPPO standards (cf. Section 6, efficacy data of Regulation (EU) No 284/2013). A link to the internet site of the EPPO can be found in the right-hand column.

Principles of GEP (Good Experimental Practice)

The aim of the GEP is to ensure that trials for the authorisation procedure are standardised and are conducted in line with high quality standards.

Efficacy studies which are carried out for applications for authorisation will be taken into consideration during the procedure only if they are conducted in accordance with the GEP by official or officially-recognized testing facilities. Regulation (EU) No 284/2013 provides the legal basis for this, setting out the data requirements for plant protection products. The Regulation refers to the test guideline 181 of the EPPO (Guideline for the efficacy evaluation of plant protection products), which requires efficacy evaluations according to the GEP standard.

In German legislation, the GEP-requirements are laid down in the regulation on plant protection products. Compliance with the GEP shall be mandatory for all trials which have been initiated after 1 July 1999.

The recognition of the GEP falls within the competence of the Federal Länder. The requirements concerning GEP testing facilities and the procedure for recognition in Germany are described in the GEP guideline (requirements of testing facilities in Germany and their recognition for carrying out efficacy evaluations for the authorisation of plant protection products). The guideline and the list of certified GEP testing facilities in Germany are available on the right of this page.

Experimental design

A regional distribution of the trials should ensure that the trial conditions and the conditions under which the plant protection product will be used after its authorisation are similar. The relevant EPPO standards are to be followed.

Preparation of application documents

The documents defined as “K-documents” (e.g. individual testing reports) shall be submitted separately for each annex point they are supporting. If a document covers several annex points, this document has to be submitted for each annex point. Studies which are required for several fields of application have to be allocated to all of these fields of application and consequently be submitted several times. A clear identification regarding the GEP must be marked on each study.

The title of the study must be unambiguous and the field of application must be mentioned in the form of codes used during the authorisation procedure (crop(s) and harmful organisms / intended use), if necessary, another trial detail like for example the timing of application could be mentioned in the interests of clarity. All documents submitted are to be registered in the reference list (Document LCP). Care should therefore be taken that the submitted K-documents appear 1:1 in the reference list.

Part B, section 3 of the draft Registration Reports (dRR) is a brief summary of the biological dossier (BAD) and has to be registered as one file under Document MCP, without instruction for use or individual testing reports. The BAD summarises the efficacy testing and has to be handed in separately on annex point KCP Section 6. The proposed instruction for use has to be submitted on annex point KCP 3.8, individual testing reports together with their GEP-certificates must also be submitted in the form of K-documents.

The documents must be submitted in PDF format. The reference list (document LCP), the BAD and the dRR shall be additionally submitted in Word format. Submitting the efficacy data from individual testing in PIAF format is very welcome. Documents in Word or PIAF format can be submitted as attachments on CADDY-XML.

Further information on assembling the dossier for application can be found in document 7600/VI/95 of the European Commission (see link on the right).

For each application for authorisation of a plant protection product, a description of the proper use must be provided. You can find appropriate instructions in the documents accessible on the right.