Maximum Residue Levels Of Pesticides Research Articles

Pesticide active substances that do not require a review of the existing maximum residue levels under Article 12 of Regulation (EC) No 396/2005.

Regulation (EC) No 396/2005 establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. According to Article 12(1) of Regulation (EC) No 396/2005, EFSA shall provide within 12 months from the date of the inclusion or non-inclusion of an active substance in Annex I to Directive 91/414/EEC a reasoned opinion on the review of the existing MRLs for that active substance. Among the active substances that need to be reviewed under Article 12(1), EFSA identified two active substances for which a review of MRLs is no longer considered necessary. EFSA prepared a statement explaining the reasons why a review of MRLs for these substances became obsolete. The relevant question numbers are considered addressed by this statement.

Pesticide active substances that do not require a review of the existing maximum residue levels under Article 12 of Regulation (EC) No 396/2005.

Regulation (EC) No 396/2005 establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. According to Article 12(1) of Regulation (EC) No 396/2005, EFSA shall provide within 12months from the date of the inclusion or non-inclusion of an active substance in Annex I to Directive 91/414/EEC a reasoned opinion on the review of the existing MRLs for that active substance. Among the substances that need to be reviewed under Article 12(1) of Regulation (EC) No 396/2005, EFSA identified six active substances for which a review of MRLs is no longer considered necessary. EFSA prepared a statement explaining the reasons why a review of MRLs for these substances became obsolete. The relevant question numbers are considered addressed by this statement.

Framework for defining pesticide maximum residue levels in feed: applications to cattle and sheep.

Pesticide residues in animal feed can endanger animal health and compromise the safety of livestock products for human consumption. Even though policymakers such as the European Union and the World Health Organization have established maximum residue levels (MRLs) for pesticides in both human food and animal feed, there is no systematic management of pesticides in animal feed that considers the entire supply chain. In response, we propose a framework for defining consistent MRLs for pesticides in animal feed that assesses the impact of defined MRLs on upstream (e.g., MRLs in feed crops) and downstream (e.g., MRLs in livestock products) sectors of the livestock-product supply chain. The MRLs determined for the selected pesticides in the feed of cattle and sheep as case study animals indicate that lipophilic pesticides tend to have lower MRLs than hydrophilic pesticides, primarily due to the relatively high toxicity and biotransfer factors of lipophilic pesticides. In addition, we observe that, primarily for lipophilic pesticides, upstream and downstream regulations are not aligned in terms of defining MRLs in feed using current MRLs in crops with relevance to feed and foods of animal origin. Some of the current pesticide regulations in the livestock-product supply chain need to be re-evaluated to ensure that MRLs in the upstream sector (i.e., crops) do not result in unacceptable residues in the downstream sector (i.e., MRLs in livestock products affecting animal and human health). Finally, we provide recommendations for optimizing the derivation of MRLs in feed, including the evaluation of residue fate during feed and food manufacturing processes. © 2022 The Authors. Pest Management Science published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.

Evaluation of specific import provisions for food products from third countries based on an analysis of RASFF notifications on pesticide residues

Maximum residue levels for pesticides in food and feed are an important part of the European pesticide policy. The Annual Reports summarising the results of official controls on pesticide residues in food indicate low rates of non-compliance and a correspondingly high level of food safety in the European Union (EU). However, products from third countries have received particular attention in recent years due to more frequent exceedances of maximum limits. To ensure high levels of consumer protection in the EU, Regulation (EC) No 396/2005 on pesticide residues in food and feed enables emergency measures for products from third countries in accordance with General Food Law. Consequently, specific import provisions for certain products from third countries were first introduced by Commission Regulation (EC) No 669/2009 and later repealed by Commission Implementing Regulation (EU) 2019/1793. Based on legal references to the European Rapid Alert System for Food and Feed (RASFF), an influence of the emergency measures on the notifications submitted in the RASFF has been expected. To investigate the effectiveness of the risk management measures and to identify potential need for improvement, 5211 notifications on pesticide residues in food submitted in the RASFF between 2002 and 2020 were analysed in the context of the specific import provisions. The analysis reveals clear correlations between the notifications in the RASFF and the emergency measures, which are particularly evident in the large proportion of and the trend in border rejection notifications as well as in frequently concerned products and frequently involved countries of origin. The risk management measures appear to be effective for several products from third countries; however, a need for improvement was identified for sweet peppers/bell peppers and granate apples/pomegranates from Turkey as well as for teas from China. Furthermore, the adoption of risk management measures for rice from India should be considered. Overall, the analysis highlights past achievements of the specific import provisions, provides an outlook on future trends and illustrates the contribution of import controls and border rejections of non-compliant products to food safety in the EU. • RASFF notifications and emergency measures for imported food products were analysed. • The analysis shows correlations between notifications and risk management measures. • Concerned products and countries were often subject to special import conditions. • Special import provisions are effective for several products from third countries. • Need for improvement was identified for products from Turkey, China and India.

The Effect of Soil Submersion and Conditioner Materials on Residual Organophosphate Pesticides in Soil and Shallot Bulbs

Soil health decreases and residual pesticides increase due to the application of inorganic fertilizers and pesticides continuously during the cultivation of crops. The effect of 12 hours or 24 hours soil submersion and chicken litters or zeolite application before planting on residual pesticides in soil and bulbs of shallots (Allium ascalonicum L.) are studied. Samples of soils and bulbs have proceeded after shallot cultivation conducted in Brebes, Indonesia. Then organophosphate residues in the samples are analyzed using gas chromatography in the Laboratory of the Indonesian Agricultural Environment Research Institute, Bogor. The data are compared to the standard of maximum residue levels (MRL) of pesticides in agricultural products. Results show that residual pesticides in treated soils are below the detection limit of the GC equipment, except malathion is detected with values ranging from 0.039-0.050 ppm. However, residual organophosphate pesticides in the bulbs are mainly below the maximum residue levels. The only exception is chlorpyrifos which has a value above the maximum residue levels of pesticides (0.076 ppm). Farmers should be educated in integrated pest management and applying synthetic pesticides as the last option for controlling pests and diseases.

Pesticide active substances that do not require a review of the existing maximum residue levels under Article 12 of Regulation (EC) No 396/2005

Regulation (EC) No 396/2005 establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. According to Article 12(1) of Regulation (EC) No 396/2005, EFSA shall provide within 12 months from the date of the inclusion or non‐inclusion of an active substance in Annex I to Directive 91/414/EEC a reasoned opinion on the review of the existing MRLs for that active substance. Article 12(2) of that Regulation stipulates that EFSA shall provide by 1 September 2009 a reasoned opinion on the review of the existing MRLs for all active substances included in Annex I to Directive 91/414/EEC before 2 September 2008. Among the active substances that need to be reviewed under Article 12(1) or Article 12(2) of Regulation (EC) No 396/2005, EFSA identified 6 active substances for which a review of MRLs is no longer considered necessary. EFSA prepared a statement explaining the reasons why a review of MRLs for these substances became obsolete. The relevant question numbers are considered addressed by this statement.

Аналіз міжнародних підходів до нормування пестицидів у продуктах переробки сільськогосподарської сировини (огляд літератури)

Object . Analysis of pesticide regulations documents and scientific works regarding processed agricultural products. Results. The principles to establish maximum residue levels (MRLs) for active ingredients of pesticides in raw agricultural commodities (RACs) and processed products are currently available in the European Union and Ukraine and are provided by the WHO Commission “Codex Alimentarius” and the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) were reviewed. The European Food Safety Authority (EFSA) project with the overall objective is to develop a database of validated processing factors based on the residue definitions for enforcement, which is compatible with the EFSA food classification and description system was outlined. The European Association of Plant Producers of the EU Vegetable Oil and Proteinmeal Industry (FEDIOL) position on pesticide MRLs in vegetable oils and fats were described. This concept has identified two main elements allowing to give an indication of the fat solubility of an substances. In particular, variants of interpretation of the octanol/water partition coefficient (log Pow) were analyzed. It can be used to predict whether the substance is fat - or water-soluble and to provides an estimate of the tendency of a active ingredients of pesticides to bioaccumulate in fat. In the case of vegetable oils, MRLs can be approximated based on the physico/chemical properties of the pesticides and on the oil content of the raw agricultural commodities (theoretical processing factors from oilseeds seed to oil). Conclusions. The review determines the necessity of improve Ukrainian pesticides regulation procedure and the development of a risk-oriented approach to the selection of priority indicators for the set of MRLs of pesticides in agricultural processed products. Key Words: pesticides, residues, processed products, oilseeds.

Analysis of Multi-Pesticide Residues and Dietary Risk Assessment in Fresh Tomatoes (Lycopersicum esculentum) from Local Supermarkets of the Metropolitan Region, Chile.

In recent years, the official authorities in Chile have reported transgressions in the maximum residue levels of pesticides in fresh vegetables. There is no official information about traceability, pesticide levels, and potential health risks. The aim of this study was to analyse pesticide residues and their corresponding dietary risk assessments in tomatoes from supermarkets in the Metropolitan Region. Pesticides were extracted using the Quick, Easy, Cheap, Effective, Rugged and Safe, QuEChERS method, and their concentrations were determined by using chromatography with HPLC-FL/UV and GC-MS/ECD/NPD, following the Analytical Quality Control and Method Validation Procedures for Pesticides Residues Analysis in Food and Feed, SANTE guide and ISO 17025:2017 standard. In addition, a dietary risk assessment was carried out by comparing Chilean data to international references. The results reported that 9% of the samples had pesticide residue levels above the maximum residue levels permitted in Chile. All the scenarios evaluated revealed the highest estimated daily intake and hazard quotients for methamidophos and chlorpyrifos. Both the active substances used were acetylcholinesterase inhibitors and were neurotoxic under chronic risk assessment. The results showed the highest chronic hazard index in the Chilean scenario for all age groups and genders. The evidence obtained revealed that methamidophos, methomyl, and chlorpyrifos should be restricted for their use in Chilean agriculture.

Monitoring of Paraquat in soya products intended for animal feed

Even though paraquat is considered to be one of the most toxic herbicides, it is one of the most used ones. Paraquat-based preparations are heavily used across many important agricultural countries and for a lot of types of crops such as soya. As soya is used in large quantities in the feed production, paraquat residues in soya products are a potential threat to livestock. The aim of this study was to investigate whether soya products intended for animal feed contain residues of paraquat. Therefore, an optimized Quick Polar Pesticides (QuPPe) Method was developed. In total, 174 samples were analyzed via LC-MS/MS using zwitterionic hydrophilic interaction liquid chromatography (ZIC-HILIC). The results showed that paraquat was detected in 66 % of the samples above 0.008 mg/kg. Residues were mainly present in soya bean meals that were imported from Brazil or the USA and cultivated using genetically modified soya. Around 5 % of the samples were not compliant with the European regulation on maximum residue levels of pesticides in or on food and feed. The results of this study support the view that paraquat residues play a significant role in soya products intended for animal feed and, thus, need to be controlled on a regular basis. However, for enforcement actions reliable processing factors for paraquat in soya products or maximum residue levels for processed soya products are urgently required.

A lognormal model for evaluating maximum residue levels of pesticides in crops.

To evaluate pesticide regulatory standards in agricultural crops, we introduced a regulatory modeling framework that can flexibly evaluate a population's aggregate exposure risk via maximum residue levels (MRLs) under good agricultural practice (GAP). Based on the structure of the aggregate exposure model and the nature of variable distributions, we optimized the framework to achieve a simplified mathematical expression based on lognormal variables including the lognormal sum approximation and lognormal product theorem. The proposed model was validated using Monte Carlo simulation, which demonstrates a good match for both head and tail ends of the distribution (e.g., the maximum error=2.01% at the 99th percentile). In comparison with the point estimate approach (i.e., theoretical maximum daily intake, TMDI), the proposed model produced higher simulated daily intake (SDI) values based on empirical and precautionary assumptions. For example, the values at the 75th percentile of the SDI distributions simulated from the European Union (EU) MRLs of 13 common pesticides in 12 common crops were equal to the estimated TMDI values, and the SDI values at the 99th percentile were over 1.6-times the corresponding TMDI values. Furthermore, the model was refined by incorporating the lognormal distributions of biometric variables (i.e., food intake rate, processing factor, and body weight) and varying the unit-to-unit variability factor (VF) of the pesticide residues in crops. This ensures that our proposed model is flexible across a broad spectrum of pesticide residues. Overall, our results show that the SDI is significantly reduced, which may better reflect reality. In addition, using a point estimate or lognormal PF distribution is effective as risk assessments typically focus on the upper end of the distribution.

Pesticide active substances that do not require a review of the existing maximum residue levels under Article 12 of Regulation (EC) No396/2005.

Regulation (EC) No 396/2005 establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. According to Article 12(1) of Regulation (EC) No 396/2005, EFSA shall provide within 12 months from the date of the inclusion or non‐inclusion of an active substance in Annex I to Directive 91/414/EEC a reasoned opinion on the review of the existing MRLs for that active substance. Article 12(2) of that Regulation stipulates that EFSA shall provide by 1 September 2009 a reasoned opinion on the review of the existing MRLs for all active substances included in Annex I to Directive 91/414/EEC before 2 September 2008. Among the active substances that need to be reviewed under Article 12(1) or Article 12(2) of Regulation (EC) No 396/2005, EFSA identified 12 active substances for which a review of MRLs is no longer considered necessary, including five active substances that were already included temporarily in Annex IV of Regulation (EC) No 396/2005 by risk managers pending finalisation of their evaluation under Directive 91/414/EEC or Regulation (EC) No 1107/2009 and pending submission of EFSA's reasoned opinion in accordance with Article 12 of Regulation (EC) No 396/2005. EFSA prepared a statement explaining the reasons why a review of MRLs for these substances became obsolete. The relevant question numbers are considered addressed by this statement.

Identification of a pesticide exposure based market basket suitable for cumulative dietary risk assessments and food monitoring programmes

ABSTRACT Consideration of cumulative dietary risks is a requirement in the European legislation for setting maximum residue levels for pesticides. Current cumulative exposure assessment methodologies strongly rely on representative occurrence data from food monitoring programmes. This study provides a sensitivity analysis, utilising (i) European consumption data expressed as raw agricultural commodity (RAC) equivalents from 23 different countries as published by the European Food Safety Authority and (ii) all maximum residue levels established for pesticides under European Regulation (EC) No 396/2005. Based on two different degrees of conservatism, market baskets consisting of 16 or 41 RACs, respectively, were identified, covering the majority of the total chronic and acute daily exposure. The coverage of the exposure by these market baskets was tested by comparison of cumulative probabilistic exposure assessments for the German population using all food commodities and those using the reduced sets. It was demonstrated that ≥85% of the total chronic exposure is already covered by 16 RACs, while 41 RACs are required to reach a similarly satisfying coverage of the total acute exposure. Results from this study support resource efficient modelling of complex cumulative assessment scenarios and may help to improve the design of food monitoring programmes with respect to a more efficient assessment of potential consumer risks.

Modified QuEChERS Extraction and HPLC-MS/MS for Simultaneous Determination of 155 Pesticide Residues in Rice (Oryza sativa L.).

Rice (Oryza sativa L.) is the staple food of more than half of the world’s population. The main factors affecting the quality of rice include grain length, texture, stickiness, flavor, and aroma. Pesticides are intended for the protection of plant products from weeds, fungi, or insects. However, pesticides also result in negative effects such as environment disturbances, pest resistance and toxicity to both users and food consumers. The aim of this study was to conduct validation experiments of a method for the determination of multi-pesticides in rice, a model food of other cereals. A quick, easy, cheap, effective, rugged, and safe (QuEChERS) method was used for the extraction of pesticide residues from rice followed by high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) with a triple quadrupole instrument using electrospray ionization. The analytical method has chromatography-tandem according to SANTE/11813/2017. The limit of quantification was 5 μg/kg. Recoveries for the 155 analyzed pesticides ranged between 77.1% for pirimiphos-ethyl and 111.5% for flutriafol and they were determined at 3 spiking levels. The proposed method was demonstrated to be quick, simple, precise, and accurate and allowed for evaluating the compliance of cereals samples with legislated maximum residue levels of pesticides in the European Union.

Pesticide active substances that do not require a review of the existing maximum residue levels under Article 12 of Regulation (EC) No396/2005.

Regulation (EC) No 396/2005 establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. According to Article 12(1) of Regulation (EC) No 396/2005, EFSA shall provide within 12 months from the date of the inclusion or non‐inclusion of an active substance in Annex I to Directive 91/414/EEC a reasoned opinion on the review of the existing MRLs for that active substance. Article 12(2) of that Regulation stipulates that the EFSA shall provide by 1 September 2009 a reasoned opinion on the review of the existing MRLs for all active substances included in Annex I to Directive 91/414/EEC before 2 September 2008. Among the active substances that need to be reviewed under Article 12(1) or Article 12(2) of Regulation (EC) No 396/2005, EFSA identified 11 active substances for which a review of MRLs is no longer considered necessary, including 7 active substances that were already included temporarily in Annex IV of Regulation (EC) No 396/2005 by risk managers pending finalisation of their evaluation under Directive 91/414/EEC or Regulation (EC) No 1107/2009 and pending submission of EFSA's reasoned opinion in accordance with Article 12 of Regulation (EC) No 396/2005. EFSA prepared a statement explaining the reasons why a review of MRLs for these substances became obsolete. The relevant question numbers are considered addressed by this statement.

Reporting data on pesticide residues in food and feed according to Regulation (EC) No396/2005 (2018 data collection).

According to Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed, Member States have to monitor pesticide residue levels in food samples and submit the monitoring results to EFSA and the European Commission. The Standard Sample Description (SSD, version 1) is the data model used for reporting the data on analytical measurements of chemical substances occurring in food, feed and water to EFSA. This document is a consolidated version of the past four years’ guidance defining the appropriate SSD codes to describe the samples and the analytical results and it gives directions for the reporting of the pesticide residues monitoring data starting with the data generated in 2018 onwards. These provisions take into account the experience of both the previous reporting seasons and the new legislation applicable in 2018. This EFSA Guidance will not be applicable for the 2019 data collection provided to EFSA in 2020. In 2020, all data on annual monitoring will be transmitted in SSD2 format only.

Recommendations on the use of the proportionality approach in the framework of risk assessment for pesticide residues

The technical report reflects the outcome of the discussions and agreements that were reached in the pesticides peer review meeting on residues and maximum residue levels regarding the principles and guidance for application of the proportionality concept in the risk assessment methodologies used at European level for the estimation of the maximum residue levels for pesticides. In addition, practical experiences on the use of the proportionality approach gained by EFSA have been included in this document. Specific cases that are not fully covered by the general principles of the proportionality concept outlined in the OECD guidance document and further recommendations are reported. This output does not preclude the production of other technical reports on this topic to clarify further aspects of the proportionality concept used in the context of the assessment of pesticide residues in food.

Reporting data on pesticide residues in food and feed according to Regulation (EC) No396/2005 (2017 data collection).

According to Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed, Member States have to monitor pesticide residue levels in food samples and submit the monitoring results to EFSA and the European Commission. The Standard Sample Description (SSD, version 1) is the data model used for reporting the data on analytical measurements of chemical substances occurring in food, feed and water to EFSA. This document is a consolidated version of the past 3 years’ guidance defining the appropriate SSD codes to describe the samples and the analytical results and it gives directions for the reporting of the pesticide residues monitoring data starting with the data generated in 2017 onwards. These provisions take into account the experience of both the previous reporting seasons and the new legislation applicable in 2017.

Monitoring data on pesticide residues in food: results on organic versus conventionally produced food

According to Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed, European Union Member States, Iceland and Norway monitor pesticide residue levels in food samples and submit the monitoring results to EFSA. This report provides the results of an ad-hoc data extraction and comparison of the monitoring results on organic and conventionally produced food samples. The data extraction focussed on samples taken in the framework of the EU-coordinated control programmes in the reference period 2013, 2014 and 2015 (for a total of 28,912 conventional and 1,940 organic food samples). Overall, 44% of the conventional produced food samples contained one or more quantifiable residues, while in organic food the frequency of samples with measurable pesticide residues was lower (6.5% of the organic samples). The MRL exceedance rate for conventional and organic food amounted to 1.2% and 0.2% of the samples tested, respectively. The calculated average number of pesticides analysed per food sample in organic and conventional food products was considered to be comparable.

Use of EFSA Pesticide Residue Intake Model (EFSA PRIMo revision 3).

Since 2007, the EFSA PRIMo (Pesticide Residue Intake Model), an Excel‐based calculation spreadsheet, is the standard tool used at EU level to perform the dietary risk assessment for pesticide residues in the framework of setting and reviewing of maximum residue levels for pesticides under Regulation (EC) No 396/2005 and in the peer review of pesticides under Regulation (EU) No 1107/2009. 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 spread sheet 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.

Pilot study on uncertainty analysis in EFSA Reasoned Opinions on the modification of pesticide maximum residue levels.

Applicability of the EFSA Scientific Committee revised draft Guidance on uncertainty in EFSA scientific assessment is tested in the context of an EFSA Reasoned Opinion on the modification of pesticide maximum residue levels (MRLs). EFSA purchased services for the preparation of a non‐regulatory Evaluation Report with example non‐standard uncertainties related to a fictitious application for the modification of MRLs. The Evaluation Report was assessed by EFSA in the format of a Reasoned Opinion and case‐specific examples of non‐standard uncertainty in the acute and chronic dietary risk assessments were analysed. Methods were selected from the general framework outlined in the Scientific Committee draft Guidance in order to apply a relatively simple strategy that could be considered for use in a regulatory context. The individual non‐standard uncertainties were assessed by sensitivity analysis with iterative back‐calculation of the parameter values that would lead to exceedance of the toxicological reference value (exceedance limit calculation), and quantified by subjective probability estimation. Non‐standard uncertainties affecting the chronic risk assessment were quantified by subjective upper bound probability percentile estimation and the combined estimated non‐standard uncertainty calculated by probability bounds analysis. Probability bounds analysis provides a relatively simple approach for calculating the probability related to a combination of uncertainties. The draft Guidance was found to provide a comprehensive range of methods for uncertainty analysis. However, process‐specific guidelines and practical procedures may need to be developed in order to implement the uncertainty assessment framework in routine pesticide risk assessments. The uncertainty assessment is intended to provide additional information on how certain the conclusions of the risk assessment are and thereby support the risk‐based decision‐making process by enabling risk managers to take account of uncertainty. The outcome of the pilot study will inform the EFSA Scientific Committee Working Group on how to further tailor the draft Guidance on uncertainty for the needs of the EFSA panels and units.