Evaluation of scientific publications

Wherever possible, we take into account studies published in the scientific literature by (independent) research institutes, even if this is not always obvious. On the one hand, this process is carried out on a structural basis. Independent scientific publications on the concerned product or active substance have to be taken into account in the evaluation of an application file. This is re-evaluated during the regular reviews of the evaluation of the active substance. On the other hand, alarming publications are examined immediately after publication.

It is not possible for the administration to evaluate all new publications on an ongoing basis. This is why scientific publications are evaluated when an application is made to renew the approval of the active substance. If unacceptable effects are demonstrated, action will be taken, such as the adaptation or withdrawal of the authorisation. If doubt persists, the authorisation holder may be requested to provide further information or to carry out an appropriate study. Monitoring studies (i.e. regular analyses of soil, air, water,…) will be carried out to verify whether or not the concentrations observed are harmful, and authorisations will be adapted or withdrawn if necessary. The trend of contamination is, as it were, tracked in time.

Scientific studies are often carried out using different, innovative methods, making them less relevant for a comparison between methods or a review of compliance with standards. These new methods are valuable, but the results are difficult to compare to studies using different methodologies. Using new methods, it is absolutely possible to demonstrate certain effects for one particular product or substance, but this new information can be difficult to interpret and compare because other products or substances have not yet been studied in a similar manner. Additionally, before a specific type of study becomes legally obligated, it needs to be tested, harmonised and described in order to be reliable and reproduceable.

These new methods may be able to demonstrate effects for which no standard has been set, because the study of these effects has not (yet) been ordered. If relevant effects are found, the legislation will of course be adapted, but until this happens, it will not be possible to take a (legally binding) position on knowing whether the effect is acceptable.

Occasionally, a study is published which finds harmful effects under circumstances which are not relevant, for example after application of a dose significantly higher than the authorised dose.  Based on this result, it is not possible to rule on the effect of the plant protection product when used at the authorised (lower) dose. Whether or not a substance is dangerous, depends entirely on the dose (“the dose makes the poison”). Indeed, if the dose is high enough, everything becomes harmful. For example, if a study shows severely harmful effects from drinking 10 pints of beer, then it does not automatically show severely harmful effects from drinking 1 pint a day. The same goes for the effects of plant protection products. In order to be relevant, the circumstances in the study need to be consistent with the circumstances under which a substance is actually applied.

Finally, when a scientific study shows a specific effect of a substance or product, then this result needs to be evaluated against the available and detailed application file. This file ultimately confirms that the product complies with legal standards. The studies contained in the file are robust, of high quality and show acceptable effects, since these are needed to authorise the product, possibly with the obligation of restrictions on use and risk-mitigating measures.