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. The overall objective of this project is to develop a database of validated processing factors, which is compatible with the EFSA food classification and description system FoodEx 2.
In the first part of the project, a compendium of representative processing techniques was elaborated which serves as a standard description of all relevant processes and as a basis for validation of processing studies. In the second part of the project all relevant processes and raw and processed commodities were coded according to FoodEx2. In the third and last part of the project all processing studies used by EFSA in their Conclusions and Reasoned Opinions issued until 30/06/2016 were re‐evaluated according to uniform quality criteria and reported in a database. The database is provided as a flat Excel spreadsheet. Information on processing conditions, on analytical methods, storage stability and GLP was collected from the studies and was used to judge the acceptability of each processing study. The representativeness of the processing conditions applied in the studies was judged by comparing them to the compendium of representative processing techniques. Processing factors (PF) were derived from the studies according to comprehensible calculation rules and based on the residue definitions for monitoring. The individual PF were judged for their acceptability. For each commodity/process/active substance combination a median PF was calculated from the individual ones, based on the trials from one or more studies. The database is a ready‐to‐use inventory of PF for pesticides in a variety of processed food items.
In a pilot project a second database was set up with processing factors based on the residue definition for dietary risk assessment. Extension of this database is recommended.
Suggested citation: Vv.Aa.; Toxicological data analysis to support grouping of pesticide active substances for cumulative risk assessment of effects on liver, on the nervous system and on reproduction and development. Supporting Publications
In the framework of the project ‘Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx2’ a compendium of representative processing techniques was prepared as a result of Objective 1. In Objective 2 the food / feed items and processes as described in the compendium of Objective 1 were coded using the FoodEx2 coding system. The coding covers the raw agricultural commodities and the food / feed items obtained after processing. Additionally a key facet was added in order to be able to link food and feed items to the EFSA RAC (Raw Agricultural Commodity)‐model. The RAC‐model links the food items as coded in the consumption data to raw agricultural commodities. Food items in this model are also coded using the FoodEx2 coding system. The sources used to code the foods, feeds and processes are described, as well as the coding decisions.
Proposals to update the methodology for the international estimated short-term intake (IESTI) equations were made during an international workshop held in Geneva in 2015. Changes to several parameters of the current four IESTI equations (cases 1, 2a, 2b, and 3) were proposed. In this study, the overall impact of these proposed changes on estimates of short-term exposure was studied using the large portion data available in the European Food Safety Authority PRIMo model and the residue data submitted in the framework of the European Maximum Residue Levels (MRL) review under Article 12 of Regulation (EC) No 396/2005. Evaluation of consumer exposure using the current and proposed equations resulted in substantial differences in the exposure estimates; however, there were no significant changes regarding the number of accepted MRLs. For the different IESTI cases, the median ratio of the new versus the current equation is 1.1 for case 1, 1.4 for case 2a, 0.75 for case 2b, and 1 for case 3. The impact, expressed as a shift in the IESTI distribution profile, indicated that the 95th percentile IESTI shifted from 50% of the acute reference dose (ARfD) with the current equations to 65% of the ARfD with the proposed equations. This IESTI increase resulted in the loss of 1.2% of the MRLs (37 out of 3110) tested within this study. At the same time, the proposed equations would have allowed 0.4% of the MRLs (14 out of 3110) that were rejected with the current equations to be accepted. The commodity groups that were most impacted by these modifications are solanacea (e.g., potato, eggplant), lettuces, pulses (dry), leafy brassica (e.g., kale, Chinese cabbage), and pome fruits. The active substances that were most affected were fluazifop-p-butyl, deltamethrin, and lambda-cyhalothrin.
In 2015 a scientific workshop was held in Geneva, where updating the four equations for estimating the short-term dietary exposure (International Estimated Short Term Intake, IESTI) to pesticides was suggested. The impact of these proposed changes on the exposure was studied by using residue data and large portion consumption data from Codex and Australia. For the Codex data, the exposure increased by a median factor of 2.5 per commodity when changing to the proposed IESTI equations. The increase in exposure was highest for bulked and blended food commodities (case 3 equations), followed by medium-sized food commodities (case 2a equations) and small- and large-sized food commodities (case 1 and case 2b equations). For the Australian data, out of 184 maximum residue limit (MRL) large portion combinations showing acute exposures below the acute reference dose (ARfD) with the current IESTI equations, 23 exceeded the ARfD with the proposed IESTI equations (12%). The percentage exceeding the ARfD was higher for the Australian MRL large portion combinations (12% of 184) than for those of Codex (1.3% of 8,366). However, the percentage MRL loss in the Australian dataset may not be representative of all pesticide MRLs since it concerns six pesticides only, specifically selected to elucidate the potential effects of the use of the proposed IESTI equations. For the Codex data, the increase in exposure using the proposed equations resulted in a small increased loss of 2.6% of the 1,110 MRLs estimated by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR): 1.4% of the MRLs were already not acceptable with the current equations, 4.0% of the MRLs were not acceptable with the newly proposed equations. Our study revealed that case 3 commodities may be impacted more by the proposed changes than other commodities. This substantiates one of the conclusions of the Geneva workshop to gather information on bulking and blending practices in order to refine MRL setting and dietary risk assessment for case 3 commodities where possible.
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