EUROPE – EFSA: Public consultation on cumulative risk assessment (CRA) of pesticides in food

EFSA is carrying out a public consultation on its pilot assessments of the risks posed to humans by residues of multiple pesticides in food.

Interested parties have until 15 November 2019 to submit comments on two assessments: one considers chronic effects on the thyroid system and the other looks at acute effects on the nervous system.

These pilot assessments were conducted as a sequential process:

 

The first step was the establishment of cumulative assessment groups (CAGs) of pesticides for their effects on the nervous system and the thyroid. The methodology rests on the assumption that pesticides causing the same specific effects can produce cumulative toxicity.

Establishment of cumulative assessment groups of pesticides for their effects on the nervous system

All effects of pesticides on the nervous system were reviewed and five were found to meet the criteria established by the PPR Panel and to be specific for consideration in CRA. 

Two CAGs (for brain and/or erythrocyte AChE inhibition and for functional alterations of the motor division) were considered sufficient to cover the cumulative risks associated to all five specific effects.

Establishment of cumulative assessment groups of pesticides for their effects on the thyroid

All effects of pesticides on the thyroid were reviewed and two were found to meet the criteria established by the PPR Panel and to be specific for consideration in CRA (hypothyroidism and C-cell hypertrophy, hyperplasia and neoplasia).

 

For the second step, cumulative exposure assessments were conducted using probabilistic modelling with two different software tools (MCRA and SAS®). The two tools produced nearly identical results and any observed differences are mainly attributed to the random effect of probabilistic modelling. These minor differences do not impact on the outcome of the exposure assessment.

Monte Carlo Risk Assessment (MCRA) software:

Cumulative dietary exposure assessment of pesticides that have chronic effects on the thyroid using MCRA software

Cumulative dietary exposure assessment of pesticides that have acute effects on the nervous system using MCRA software

SAS® software:

Cumulative dietary exposure assessment of pesticides that have chronic effects on the thyroid using SAS® software

Cumulative dietary exposure assessment of pesticides that have acute effects on the nervous system using SAS® software

 

The third step was a cumulative risk characterisation which was based on the outcome of the first two steps and included an uncertainty analysis.

The draft assessments are the culmination of a multi-year collaboration between EFSA and the National Institute for Public Health and the Environment for the Netherlands (RIVM):

EFSA Scientific report – DRAFT Cumulative dietary risk characterisation of pesticides that have acute effects on the nervous system

Overall, taking account of the available data and the uncertainties involved, it is concluded that cumulative exposure to pesticides that have acute effects on the nervous system does not exceed the threshold for regulatory consideration established by risk managers.

EFSA Scientific report – DRAFT Cumulative dietary risk characterisation of pesticides that have chronic effects on the thyroid

Overall, taking account of the available data and the uncertainties involved, it is concluded that cumulative exposure to pesticides that have chronic effects on the thyroid does not exceed the threshold for regulatory consideration established by risk managers.

 

The overall draft conclusion for both assessments is that consumer risk from dietary cumulative exposure is below the threshold that triggers regulatory action for all the population groups covered.

The EU regulation on maximum levels of pesticides in food (MRLs) stipulates that decisions on MRLs should take into account cumulative effects of pesticides as and when the methods to assess such effects become available. In addition, the regulation covering the placing of pesticides on the market stipulates that pesticides should have no harmful effects – including cumulative effects – on humans.

 

For more information: 

Public consultation on the draft EFSA scientific reports on a cumulative dietary risk characterisation of pesticides that have acute effects on the nervous system and chronic effects on the thyroid

 

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