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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)

 

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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

 

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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

 

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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

 

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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)

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