Plant protection products and local residents

Through 2013: risk for local residents assessed using indirect methods

Until the beginning of 2014, during the authorisation procedure for plant protection products, the Ctgb did not use a separate exposure model to assess the risk for local residents and bystanders. This risk was assessed indirectly by calculating the exposure for bystanders who were present during the spraying in a professional capacity. This indirect method usually leads to an overestimation of the risks for local residents and bystanders; as a result, the authorised products are also safe for these groups.

2014: reassessment

Beginning in 2014, however, the Ctgb begin conducting an explicit risk assessment for local residents. For this purpose we used the British and German methods referred to in the advisory report of the Health Council. In October 2014, the Ctgb began the reassessment with the aim of determining whether local residents and bystanders (including children) are exposed to a health risk when the products are used according to the legal conditions for use.

The new EFSA model used for the reassessment

At the start of the reassessment in October 2014, the new EU exposure model was published by the European Food Safety Authority (EFSA). Since this EFSA model would become the standard for Europe, the Board decided to use the model for the reassessment. This model is part of the new Guidance  on calculating the exposure of operators, workers, local residents and bystanders.

The European Commission approved the definitive EFSA model at the end of May 2015. After 1 January 2016, the model will be used by the Member States during the assessment of new applications for substances and products.

Model-based risk assessment

The basic principle of every model-based risk assessment is that the model is initially used in a worst-case scenario. All products that are 'safe' under those conditions are authorised without further investigation. Products that cause excessive exposure in this worst-case scenario undergo additional investigation. For these remaining products, the model is refined: the parameters are changed in steps to a more realistic exposure scenario based on supplementary, scientifically supported information about the substance and the conditions of use.

For the EFSA model in the module for local residents and bystanders, this refinement has not yet been completed. For the time being, the European Commission therefore decided to leave it up to Member States to decide how they want to use this model to assess applications for product authorisation. Since the new EFSA model contributes to a harmonised European approach, the Ctgb decided to start using this model from 1 January 2016. If refinement steps are required, these will be based on supplementary data, other models (the British and German models) or expert judgement.

Selection of products: 116 products reassessed

At present, more than 850 Plant protection products are authorised. Not every authorisation is relevant with respect to calculating the exposure of local residents and bystanders. Therefore, a selection was made based on the method of use and whether the products are used intensively. The selection focused on products that must be sprayed upwards (applications in fruit growing: increased exposure due to drift of the product) and products that are sprayed downwards with high frequency (products used for the production of bulbs and flowers from bulbs). In total, the model was used to reassess 116 products: 88 products that are sprayed upwards and 28 products that are used in flower bulb production.

This selection of products is compatible with the selection of substances and products from the national study on pesticides and local residents conducted by RIVM. This is important because in the long term this will enable a comparison to be made between the exposure calculated in the models and the actual exposure of people who live near agricultural parcels or who stay there for shorter periods.

Outcome of the risk assessment: no identified risk

The reassessment, based on the EFSA model, showed that all authorised products are safe: 109 products complied with the standard without further refinement; additional refinement of the model calculations was required for 7 products. Important for the interpretation of these outcomes is the explanation given above: this concerns a risk assessment based on a worst-case scenario. For these 7 products, the assessment was refined to a more realistic exposure scenario in well-substantiated steps. For this purpose, the above-mentioned British and German methods were used. This refinement of the model showed that these 7 products are also safe for local residents and bystanders when used as intended.

Conclusion of the Board:  there is no necessity to intervene in the authorisations

Based on the reassessment with the new model, the Board concluded that the currently authorised products are safe. Considering these results, the Board sees no necessity to intervene in the conditions of authorisation for these products.

Use of models from 1 January 2016

After 1 January 2016, the effective date of the new European directives, the EFSA model has become the basis of risk assessment for local residents and bystanders. Where required, the models will be refined as described above based on additional data, other models (the British and German models) or expert judgement.