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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

 

Lynxee consulting’s team is at your disposal to answer your questions.

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EUROPE – EFSA: Update of the Pesticide Residue Intake Model 3 (PRIMo rev. 3.1)

EFSA has released the revision 3.1 of the Pesticide Residue Intake Model. The following modifications were introduced:

  • A new spreadsheet was added to facilitate the conversion of MRLs derived from the European Commission database in a format compatible with PRIMo;
  • Correction of a number of large portion consumption data;
  • Correction of unit weight data;
  • Correction of TMDI calculation;
  • Correction of the calculation of the threshold residue in processed products (IESTI case 2a and 2b);
  • Editorial modifications.

A comparison of old and new versions indicates that the revisions impact the acute risk assessment, for several commodities, but not the chronic risk assessment.

To download:

Pesticide Residue Intake Model – EFSA PRIMo revision 3.1 (update of EFSA PRIMo revision 3), EFSA Supporting publication 2019:EN-1605

EFSA PRIMo revision 3.1 (spreadsheet)

See also our previous articles:

EUROPE: New version of the Pesticide Residue Intake Model (PRIMo rev. 3)

Lynxee consulting’s team is at your disposal to answer your questions.
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EUROPE – EFSA: Technical report on the proportionality approach for residues

In order to enhance the harmonisation of the risk assessment of active substances in the area of residues, EFSA and Member States held discussions that lead to the publication of this technical report on the proportionality approach.

The discussions were based on:

– the  recommendations  on the proportionality  concept as defined at Codex  level and adopted at EU level at the Standing Committee on the Food Chain and Animal Health Meeting in September 2015.

– the   OECD guidance   document on crop   field trials published in September   2016 (ENV/JM/MONO(2011)50/REV1).

The conclusions and recommendations regard specific cases that were not fully covered by  the general principles of the proportionality concept described in the OECD guidance  document or that lead to different interpretation among experts.

Cases where scaling is appropropriate or on the contrary not necessary/not appropriate are illustrated.

Different case studies where the proportionality concept was used are also presented in Appendix.

 

To download: EFSA Technical Report: Recommendations on the use of the proportionality approach in the framework of risk assessment for pesticide residues (06.11.2018)

 

Lynxee consulting’s team is at your disposal to answer your questions.

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EUROPE – EFSA: Database on processing techniques and factors

EFSA is conducting pan-European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA’s comprehensive food consumption database and pesticide-specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and worldwide.

EFSA therefore launched the project “Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2”. The main overall objective of the project is to develop a database of processing types and processing factors compatible with the EFSA food classification and description system FoodEx 2.

On 26 November 2018, EFSA published a series of 3 external scientific reports as part of this project. Each report corresponds to one of the three objectives:

– Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

– Objective 2: Linking the processing techniques investigated in regulatory studies with the EFSA food classification and description system FoodEx2

– Objective 3: European database of processing factors for pesticides in food

The coding system (objective 2) and the  database (objective 3) are also provided as Excel spreadsheets.

 

To download:

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx2 related to pesticide residues Objective 2: Linking the processing techniques investigated in regulatory studies with the EFSA food classification and description system FoodEx2

Appendix A -FoodEx 2 Coding system

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 3: European database of processing factors for pesticides in food

EU processing factors database

 

Lynxee consulting’s team is at your disposal to answer your questions.

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EUROPE: New version of the Pesticide Residue Intake Model (PRIMo rev. 3)

EFSA has released a new version of PRIMO model.

Since 2007, the EFSA PRIMo model, an Excel-based calculation spreadsheet, is the standard tool used to perform the dietary risk assessment for pesticide residues at EU level.

The model was now updated with regard to food consumption data derived from some recent dietary food surveys. In addition, new functionalities were included in the calculation spreadsheet to make the tool more user-friendly and to allow automatic integration of the EFSA PRIMo in the workflows where dietary risk assessments are performed.

PRIMo revision 3 should be used for new applications as from 1 February 2018.

 

To download:

Guidance document on the use of the EFSA Pesticide Residue Intake Model (EFSA PRIMo revision 3). EFSA Journal 2018;16(1):5147

EFSA calculation model Pesticide Residue Intake Model “PRIMo” revision 3

 

Lynxee consulting’s team is at your disposal to answer your questions.

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EUROPE: A new database with genotoxicity endpoints

The overall objective from this EFSA project is the compilation of a database specific for pesticide active substances and their metabolites, which is comprising the different genotoxicity endpoints i.e. point mutations, structural and numerical chromosome aberrations. The database represents a practical tool to complement the in-silico tools i.e. QSAR, grouping and read across for prediction and indication of the genotoxicity hazard.

The availability of a database specific for pesticides active substances and their metabolites is expected to increase the specificity and sensitivity of the in-silico tools and to enlarge the chemical domains for their applicability. The database includes information on the endpoints evaluated, the test system used, activity following metabolic activation and the underlying mechanism of genotoxicity.

This information is necessary to derive the residue definition for the dietary risk assessment, a key step in the evaluation of the dietary risk for consumers of food commodities containing pesticides residues.

One of the key recommendations for further work includes the creation of a web portal to improve the accessibility of the data.

 

To download:  Compilation of a database, specific for the pesticide active substance and their metabolites, comprising the main genotoxicity endpoints

 

Lynxee consulting’s team is at your disposal to answer your questions.

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Europe: guidance on the establishment of the residue definition for dietary assessment

The EFSA Panel on Plant Protection Products and their Residues (PPR Panel) has published a guidance on the establishment of the residue definition for dietary assessment. The residue definition for risk assessment is used by risk assessors to evaluate the potential risk of dietary intake of residues resulting from the application of a pesticide.

The guidance describes a stepwise approach starting with the compilation of an inventory of identified metabolites and the assessment of their genotoxicity endpoints (Module 1), followed by the assessment of other regulatory endpoints of toxicity (termed ‘general toxicity’; Module 2). The assessment is based on factual information (derived from toxicological data, metabolism data) and non-testing methods and tools ((quantitative) structure–activity relationship ((Q)SAR), read-across, threshold of toxicological concern (TTC)). For every single metabolite, this screening generates an inventory of toxicity complemented with dietary exposure information for consumers and livestock. All together the toxicity and exposure information forms the basis to estimate the contribution of each metabolite to the toxicological burden for consumers and to derive the final proposal of the residue definition for dietary risk assessment (Module 3). The scenario-specific information has to be completed by a list of identified uncertainties deemed relevant for decision making by risk managers.

The guidance document is complemented with three practical case studies that are intended to demonstrate the applicability of the proposed decision scheme.

Although the guidance document and the case studies describe EFSA’s current thinking on this topic, this has to be viewed as recommendation only. However, it is expected that scientifically justified evidence is given when deviating from the decision scheme described in this guidance document.

To download:

Guidance on the establishment of the residue definition for dietary risk assessment (EFSA Journal 2016;14(12):4549)

Lynxee consulting’s team is at your disposal to answer your questions.

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