The current data requirements for active substances are described in Regulation (EU) No 283/2013, and in the case of residue behaviour, also for plant protection products. The respective test methods and guidance documents are a result of Commission Communication 2013/C 95/01. On the website of the European Commission there are available the guidance documents which have been used in the past and which are still valid for a transitional period. However, of these documents only two are referred to in the above mentioned Commission Communication:

• EU guidance document "Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs" (SANCO 7525/VI/95 rev. 9, March 2011).
• EU guidance document "Calculation of Maximum Residue Levels and Safety Intervals e.g. Pre-harvest Intervals" (SANCO 7039/VI/95, 22/7/1997

Further documents have been approved after the above mentioned Commission Communiciation:

Honey:
Technical guidelines for determining the magnitude of pesticide residues in honey and setting Maximum Residue Levels in honey (SANTE/11956/2016 rev. 9)

Fish:
It should be noted that Regulation (EU) No. 283/2013 (OJ L 93 of 3.4.2013, p. 1) provides for tests to be carried out on the nature and level of residues in fish under certain conditions. As far as it was necessary, the above-mentioned prerequisites have been further specified in the working documents. The German authorities expect that these test results will be presented if the requirements are met.

The results are not yet used in the EU to set maximum residue levels. However, various member states, including Germany, possess information on consumption data for fish products, so that an exposure estimate can be made in humans.

These are working documents and not guidelines. This is justified by the fact that this test area is still new and the knowledge is not yet consolidated. By this means changes should be possible more quickly. In the case of a working document, it is also easier to justify deviations or to use alternative test designs from other countries.

• nature of residues in fish (SANTE / 10254/2021 23 February 2021)
  This document is a revised version of the original document from 2013 (SANCO/11187/2013, 31 January 2013 rev. 3). It describes the test procedure to determine how an active substance that is ingested with the feed is broken down in the fish. The calculation of the residues ingested with the feed contained in the previous document has been deleted here and transferred to a new document (see below)
• level of residues in fish (SANTE / 10252/2021 23 February 2021)
  This document is new. It describes the test procedure to determine the level of residues in fish products after feeding on feed contaminated with pesticide residues.
• Calculation of the residues ingested with the feed (SANTE / 10250/2021 23 February 2021)
  This document is new. It contains the previously published calculation of the residues ingested by fish with the feed. The information contained therein has been checked and supplemented and now relates to three relevant fish species.
  In addition, a calculation tool was developed with which the result is calculated after entering the corresponding residues in feed. The tool is provided by the Institute for Molecular Biology and Applied Ecology of the Fraunhofer Society.

The working documents and the link to the calculation model can be found on the website of the European Commission (see Appendix J).

Predicting residue intake and risk assessment

The models for assessing potential risks for consumers caused by plant protection products are developed and discussed internationally. Pertinent WHO guidelines are available (Document WHO/FSF/FOS/97.7). Moreover, the comments of the European Commission's "Scientific Committee on Plants" are taken into consideration, particularly its expert assessments and recommendations for the protection of consumers from plant produce treated with pesticides (SCP/RESI/021; SCP/RESI/024).

All consumption data which have been sampled by the Member States are integrated in a calculation model of EFSA, the PRIMo (Pesticide Residue Intake Model). The current Revision 2 will be updated by EFSA as the need arises. The model is based on the above mentioned WHO guidelines.

For ongoing developments of WHO guidelines please refer in particular to the publications of the "Joint Meeting on Pesticide Residues" (JMPR).