Cumulative assessment of plant protection products: BfR concept to become part of authorisation process
As of 1 March 2017, the result of the cumulative risk assessments conducted by the German Federal Institute for Risk Assessment (BfR) will be part of the zonal authorisation process for plant protection products (ppp). This means that in the human health assessment of ppp, the acute cumulative acute risk resulting from multiple residues for consumers and the medium-term cumulative risk for users will also be better assessed. In 2014, the BfR developed and presented the underlying assessment concept. It was then tested and discussed in numerous expert committees across Europe. This concept is now to be used at the European level. "The BfR has been working on scientific concepts for several years in order to take greater account of the health assessment of multiple residues in the authorisation process", says BfR President Professor Dr. Dr. Andreas Hensel. "The new testing method for authorisation applications will significantly strengthen consumer and user protection at the European level."
Modern active ingredients of plant protection products (ppp) are characterised by their specific effect on certain pests. Substances of earlier generations typically had a broader effect and thus more side effects. The alternating use of active substances with different modes of action is necessary to prevent resistance in harmful organisms, as otherwise they cannot be controlled in the long run. The use of so-called broad-spectrum active ingredients has therefore seen a significant decrease in recent years, whereas pesticides targeting specific organisms are now more widely used. This trend means that, depending on the level of infestation, many different ppp are used, from which residues can remain in the crops. As a result of appropriate and needs-oriented ppp applications, multiple residues can occur.
The BfR has developed a concept for integrating the cumulative risk assessment in the various zonal authorisation procedures. The concept builds on the previous work of the European Food Safety Authority (EFSA), the European Chemicals Agency (ECHA, for biocides) and the Joint Research Centre (JRC) of the European Commission. It takes into account current international developments, which are also collated and discussed within the framework of a European research project. It applies to the assessment areas of application and consumer safety. As part of the active substance approval and product authorisation procedures, the cumulative effects of different substances are to be considered. The concept is suitable for cumulatively assessing the user exposure or the acute consumer exposure, since the active ingredients contained in a ppp or a requested tank mix are considered conjointly.
The aspect of cumulative effects is also taken into account during the evaluation at the EU level. If Germany is the assessing member state, the other member states will have the opportunity to provide critical comments on the conducted cumulative assessment. As a participating member state, Germany will also have the opportunity to comment on the cumulative risk assessment, thereby ensuring professional exchange between member states.
About the BfR
The German Federal Institute for Risk Assessment (BfR) is a scientifically independent institution within the portfolio of the Federal Ministry of Food and Agriculture (BMEL) in Germany. It advises the Federal Government and Federal Laender on questions of food, chemical and product safety. The BfR conducts its own research on topics that are closely linked to its assessment tasks.
The BfR is celebrating its 15th anniversary this year. To mark the occasion, the institute has published a jubilee brochure which can be downloaded or ordered free of charge at http://www.bfr.bund.de/de/publikation/broschueren-660.html.
This text version is a translation of the original German text which is the only legally binding version.
Human health risk assessment from combined exposure in the framework of plant protection products and biocidal products