Consumer Risk Assessment Research Articles

Trace elements risk assessment for consumption of wild mussels along South Africa coastline

The study aimed to contribute to the scarce data on concentrations in the soft tissue of wild mussels growing in coastal cities of South Africa. The intake of 26 micro and macroelements was estimated. The mass fractions of sample sets from 8 sites along the South African coast from the West (Port Nolloth) to the East (Durban) were studied by neutron activation analysis at the Joint Institute for Nuclear Research (Russia). The following elements were identified as potentially hazardous due to high consumption risks: Al, Cr, Co, Zn, As, and I at stations in the Cape Town area (Waterfront, Hout Bay) and Durban. The mean concentrations of these elements among all individuals were 208, 0.8, 0.46, 60, 2.6, and 11 ppm of wet weight, respectively. In the studied mussels, the concentrations of Cr, Zn, As, and Se (ranging between 0.2−2.8, 14–290, 1.6−4.6, and 0.31−2.4 ppm of wet weight, respectively) exceeded maximum permissible levels for fish products. The weekly consumption of more than 250 g of fresh mussels per person could increase the risk for human health by potential intake of such elements as Al, As, and I.

Mercury, Lead, and Cadmium in the Muscles of Five Fish Species from the Mechraâ-Hammadi Dam in Morocco and Health Risks for Their Consumers.

This study aims to assess the degree of metal contamination (mercury (Hg), cadmium (Cd), and lead (Pb)) in the muscles of five species of fish Esox lucius, Sander lucioperca, Micropterus salmoides, Lepomis macrochirus, and Scardinius erythrophthalmus, from the Mechraâ-Hammadi Dam between July 2017 and May 2018, and to conduct a risk assessment for human consumers. Trace metals were determined by Graphite Furnace Atomic Absorption Spectrometry for the Pb and the Cd and by Cold Vapor Atomic Absorption Spectrometry for the Hg. The results gotten from the study of the muscles of the different fish species show that the higher mean amounts of Cd and Hg were determined in E. lucius, and the maximum mean levels of Pb were detected in S. erythrophthalmus. Results suggested that demersal fishes inhabiting near the sediments and piscivorous fishes with higher trophic level were likely to accumulate higher trace metal concentrations. The general order of bioaccumulation of the trace metals measured in the muscles of the fish species is as follows: Hg > Pb > Cd. Therefore, the bioaccumulation of Hg in fish studied is more important than that of Cd and Pb. Furthermore, these concentrations are higher in summer than in winter for all trace metals. All the values of the trace metals in the muscle tissues are below the maximum limits recommended by the European Community (EC) N° 1881/2006. However, estimation of noncarcinogenic health risks by the target hazard quotient indicated no obvious noncarcinogenic risks to humans that consume those fishes (THQ < 1). Results of THQ and maximum safe consumption indicated that Hg may cause more harm to human by fish consumption especially for E. lucius and S. lucioperca. Therefore, reduced intake of carnivorous fishes should be promoted as part of a healthier diet.

Review of the existing maximum residue levels for sulfuryl fluoride according to Article 12 of Regulation (EC) No 396/2005

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sulfuryl fluoride. To assess the occurrence of sulfuryl fluoride and fluoride ion residues in plants, processed commodities and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRLs were calculated, but a consumer risk assessment could be carried out for sulfuryl fluoride only. Although no apparent risk to consumers was identified for sulfuryl fluoride, a standard consumer risk assessment to fluoride ion could not be performed, lacking information on the toxicological reference values for fluoride. Hence, an ‘overall’ consumer risk assessment could not be performed, only tentative MRLs proposal could be derived and measures for reduction of the consumer exposure should also be considered. Nevertheless, considering that fluoride ion is naturally occurring in food of plant and animal origin, EFSA performed an indicative calculation of the consumer exposure to estimate whether the uses currently authorised will contribute significantly to the overall consumer exposure to fluoride.

Review of the existing maximum residue levels for thiram according to Article 12 of Regulation (EC) No 396/2005.

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance thiram. Although this active substance is no longer authorised within the European Union, MRLs based on the use of thiram were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs) and import tolerances were reported by Member States (including the supporting residues data). Based on the assessment of the available data, EFSA assessed the existing import tolerances, and a consumer risk assessment was carried out for thiram only. Although no apparent risk to consumers was identified, the import tolerances were not fully supported by data. Hence, the consumer risk assessment is considered indicative only and further consideration by risk managers is needed.

Review of the existing maximum residue levels for quinoxyfen according to Article 12 of Regulation (EC) No 396/2005.

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance quinoxyfen. Although this active substance is no longer authorised within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs) and an import tolerance was reported by Member States (including the supporting residues data). Based on the assessment of the available data, EFSA assessed the CXLs and import tolerance requested, and a consumer risk assessment was carried out considering the toxicological reference value established for the first inclusion under Directive 91/414/EEC. All CXLs and import tolerance were found to be adequately supported by data and no risk to consumers was identified.

Evaluation of confirmatory data following the Article 12 MRL review and setting of an import tolerance for flutriafol in cucurbits (inedible peel).

The applicant Cheminova A/S submitted a request to the competent national authority in the United Kingdom to evaluate the confirmatory data for the active substance flutriafol that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005. The applicant provided residue trials on rice representative for an adjusted Good Agricultural Practice (GAP), metabolism studies in goats and storage stability data in tissues of animal origin addressing the data gaps identified in the MRL review. For the nature of residues in processed commodities, relevant to confirm the MRLs on pome fruits and wine grapes, the applicant referred to the information provided in a previous MRL application and already assessed by EFSA. The data gaps on the authorised uses on beetroots, melons and watermelons assessed in the MRL review were not addressed. At the same time, the applicant submitted a request to the United Kingdom to modify the existing maximum residue level (MRL) for flutriafol in cucurbits with inedible peel according to Article 6 of Regulation (EC) No 396/2005. The data submitted were found to be sufficient to derive an MRL proposal for these crops. EFSA concluded that the proposed use of flutriafol on the crops under assessment will not result in a consumer exposure exceeding the toxicological reference values for flutriafol and therefore is unlikely to pose a risk to consumers’ health. Regarding the triazole derivative metabolites (TDMs), the conclusions reached in a previously issued assessment for another triazole fungicide are still valid. An update of the indicative consumer risk assessment for each individual metabolite is not necessary since the residues expected in the concerned commodities are covered.

Profile and consumption risk assessment of trace elements in megamouth sharks (Megachasma pelagios) captured from the Pacific Ocean to the east of Taiwan

Focusing on 27 rare filter-feeding megamouth sharks (Megachasma pelagios) captured as a by-catch of drift gillnet fishery in the Pacific Ocean to the east of Taiwan, this study analyzes the concentrations of 24 elements in their muscle, discusses the bioaccumulation of each element and the correlation between different elements, and assesses the potential health risks of consuming megamouth shark muscle. Among the 24 elements, mean concentrations of Ga, Ag, Li, Bi, Hg, Co, and Cd were relatively low ranging from 10-3 to 10-1mg/kg, those of Pb, Ba, Mn, Ni, As, Cr, B, Sr, Cu, and Zn ranged from 10-1-101mg/kg, and those of Fe, Ca, Al, K, Mg, Ti, and Na were relatively high ranging from 101 to 103mg/kg. The toxic element content index was most significantly correlated with the concentration of Cu. Hence, this study recommends that the concentration of Cu could be used as an indicator of metal accumulation in megamouth shark muscle. The log bioconcentration factor (BCF) ranged from less than 0 to 7.85 in shark muscle. For elements with a concentration of less than 100μg/L in seawater, the log BCF was inversely proportional to their concentration in seawater. According to the correlation analysis, the accumulation of elements in muscle of megamouth sharks is primarily affected by the concentrations of dissolved elements in seawater, except that the accumulation of Hg, As, Cu, Ti, Al, and Fe appears to be mainly affected by feeding behaviors. The assessment of the health risk of consuming megamouth shark muscle showed that its total hazard index was greater than 1. This suggests that the long-term or high-frequency consumption of megamouth shark muscle may cause health hazards due to the accumulation of trace elements, particularly those with a large contribution of health risk, including As, Hg, and Cu.

Dissipation kinetics and consumer risk assessment of novaluron + lambda-cyhalothrin co-formulation in cabbage

Cabbage, one of the most popular vegetables in the world is infested by several insect-pests and diseases. Novaluron, a chitin synthesis inhibitor and lambda-cyhalothrin, a synthetic pyrethroid group insecticide are used to manage insect-pests on cabbage. The dissipation kinetics and risk assessment of combination formulation (novaluron 9.45% + lambda-cyhalothrin 1.9%) with different modes of action has not yet been investigated in cabbage. Multi–location supervised field trials were therefore, conducted in different agro-climatic regions of India for safety evaluation of the combination product. The co-formulation at the recommended (novaluron 750 g a.i. ha−1 + lambda-cyhalothrin 750 g a.i. ha−1) and double the recommended (novaluron 1500 g a.i. ha−1 + lambda-cyhalothrin 1500 g a.i. ha−1) dose was sprayed on the cabbage crop. The samples were extracted and cleaned up using a modified QuEChERS method, and the residues analyzed by GC–ECD and GC–MS. The half-life (t1/2) varied between 1.77 and 2.51 and 2.00–3.38 days for novaluron and 1.36–2.24 and 1.69–3.82 days for lambda-cyhalothrin in cabbage at respective doses. The Food Safety and Standards Authority of India (FSSAI) has set the MRL of 0.7 mg kg−1 for novaluron at PHI of 5 days, and no MRL is set for lambda-cyhalothrin in cabbage. On the basis of OECD MRL calculator, the MRLs of 0.6 and 1.5 mg kg−1 for novaluron and lambda-cyhalothrin, respectively were calculated at the respective doses at PHI of 3 days. Hazard quotient (HQ) <1, theoretical maximum daily intake (TMDI) < acceptable daily intake (ADI) and < maximum permissible intake (MPI), percent acute hazard index (% aHI) <1, and percent chronic hazard index (% cHI) <1 for both novaluron and lambda-cyhalothrin suggested that the combination formulation is safe and will not pose any dietary risk to the consumers. The study will be helpful to conduct risk assessment of other pesticides/combination pesticides on food crops on which their MRLs have not yet been fixed.

Review of the existing maximum residue levels for oxyfluorfen according to Article 12 of Regulation (EC) No 396/2005.

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance oxyfluorfen. To assess the occurrence of oxyfluorfen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and one existing European MRL still requires further consideration by risk managers.

Review of the existing maximum residue levels for quinmerac according to Article 12 of Regulation (EC) No 396/2005.

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance quinmerac. To assess the occurrence of quinmerac residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers.

Review of the existing maximum residue levels for pyroxsulam to Article 12 of Regulation (EC) No 396/2005.

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance pyroxsulam. To assess the occurrence of pyroxsulam residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the European authorisations reported by Member States. Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. All information required by the regulatory framework was present and a risk to consumers was not identified.

Review of the existing maximum residue levels for chlorantraniliprole according to Article 12 of Regulation (EC) No396/2005.

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance chlorantraniliprole. To assess the occurrence of chlorantraniliprole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the import tolerances and European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers.

Evaluation of confirmatory data following the Article 12 MRL review for chlorothalonil, including assessments for import tolerances for banana, papaya and peanuts.

The applicants Syngenta Crop Protection, UPL Europe Ltd. and Oxon Italia S.p.A. submitted requests to the competent national authority in the Netherlands to evaluate the confirmatory data for chlorothalonil that were identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available; in addition, Syngenta and UPL submitted requests for modifications of existing MRLs. Considering the recent decision on the non‐approval of chlorothalonil, the requests for amending existing MRLs to reflect intended EU uses for chlorothalonil and confirmatory data for EU uses became obsolete. EFSA focused therefore its assessment on the import tolerances and on general information on the analytical method required to enforce legal limits for chlorothalonil and its metabolite SDS‐3701 (R182281). Analytical methods for enforcement are available to control the residues of chlorothalonil and SDS‐3701 in plant matrices at the validated LOQ of 0.01 mg/kg; data on the extraction efficiency for high oil content matrices as requested in the MRL review were not provided. This data gap is relevant for the import tolerance for peanuts. The data submitted in support of import tolerances were found to be sufficient to derive MRL proposals for chlorothalonil and SDS‐3701 for bagged bananas, papayas and peanuts. Studies investigating the effect of high temperature processing on the magnitude of SDS‐3701 in processed products are not available. Based on exposure calculations for chlorothalonil, EFSA concluded that the long‐term intake of residues resulting from the use of chlorothalonil according to the reported agricultural practices is unlikely to present a risk to consumers. For papaya, an acute intake concern was noted for chlorothalonil, while for banana and peanuts, the expected short‐term intake of chlorothalonil residues was below the toxicological reference value. For the metabolite SDS‐3701, the toxicological profile is not fully elucidated, and therefore, toxicological reference values could not be derived. Hence, for this metabolite, the consumer risk assessment cannot be finalised.

Review of the existing maximum residue levels for Streptomyces lydicus strain WYEC 108 according to Article 12 of Regulation (EC) No 396/2005.

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance Streptomyces lydicus strain WYEC 108. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for Streptomyces lydicus strain WYEC 108 within the EU. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue limits) for this active substance. Therefore, residues of Streptomyces lydicus strain WYEC 108 are not expected to occur in any plant or animal commodity and therefore a consumer risk assessment is not required. Nevertheless, the available information allowed EFSA to propose a marker residue definition noting that methods for identification and quantification of Streptomyces lydicus strain WYEC 108 are available; however, a method for enforcement fully validated at a specific limit of quantification (LOQ) was not provided. An inclusion of Streptomyces lydicus strain WYEC 108 in Annex IV of (EC) No 396/2005 is not recommended.

Modification of the existing maximum residue levels for potassium phosphonates in various crops.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Tilco‐Alginure GmbH, ADAMA Agriculture BV, Lainco S.A., Exclusivas Sarabia S.A., Biovert S.L. and Landwirtschaftskammer Steiermark submitted requests to the competent national authorities in Germany, France, Greece and Austria to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in various crops. The data submitted in support of the different requests were found to be sufficient to derive MRL proposals for all crops under assessment. Adequate analytical methods for enforcement are available to control the residues of potassium phosphonates in the crops under assessment. Based on the risk assessment results, EFSA concluded that the long‐term intake of residues resulting from the use of potassium phosphonates according to the reported agricultural practices is unlikely to present a risk to consumer health. The consumer risk assessment shall be regarded as indicative and a more realistic intake assessment will be performed in the framework of the joint review of MRLs for fosetyl and phosphonates. The reliable end points, appropriate for use in regulatory risk assessment are presented.

Dissipation behavior of thiophanate-methyl in strawberry under open field condition in Egypt and consumer risk assessment.

Thiophanate methyl is a broad-spectrum benzimidazole fungicide extensively applied in pre- and post-harvest, for the control of a wide range of fruit and vegetable pathogens. In the current work, the residue behavior of thiophanate methyl after application on strawberries and an estimation of the consumer dietary exposure was performed. Supervised field trials were conducted in Egypt (Qaluobiya Governorate) as to investigate the residue dynamics and terminal residues at different PHIs of thiophanate methyl and its metabolite carbendazim in strawberries under Egyptian conditions. For the measurement of residues in fruits, a QuEChERS-based protocol coupled with LC-MS/MS was optimized and successfully validated at 0.01mgkg-1. The half-life (t1/2) of thiophanate methyl in strawberries was estimated, and a dietary risk assessment was performed employing both FAO/WHO and EFSA approaches.

Review of the existing maximum residue levels for Pseudomonas sp. strain DSMZ 13134 according to Article 12 of Regulation (EC) No 396/2005.

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance Pseudomonas sp. strain DSMZ 13134. To assess the occurrence of Pseudomonas sp. strain DSMZ 13134 residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals cannot be derived and are deemed not to be necessary. A consumer risk assessment cannot be performed quantitatively. Although no apparent risk to consumers was identified, some information required by the regulatory framework would still be desirable. The outcome of the assessment was compared to the criteria defined by the European Commission for inclusion of pesticide active substances in Annex IV of the Regulation. A proposal for inclusion of Pseudomonas sp. strain DSMZ 13134 into Annex IV of Regulation (EC) No 396/2005 is derived by EFSA based on the authorised uses of this Art. 12 review.

Review of the existing maximum residue levels for aminopyralid according to Article 12 of Regulation (EC) No 396/2005.

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance aminopyralid. To assess the occurrence of aminopyralid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. All information required by the regulatory framework was present and a risk to consumers was not identified.

Review of the existing maximum residue levels for propineb according to Article 12 of Regulation (EC) No 396/2005.

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance propineb. Although this active substance is no longer authorised within the EU, due to insufficient information in order to conclude on the consumer risk assessment for the active substance, the toxicity of the metabolite propane‐1,2‐diamine (PDA) the impact on non‐target organisms and the risk to honeybees, MRLs based on the use of propineb were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs) and are still in place. Additionally, propineb has potential endocrine‐disrupting properties related to the hazards of its major metabolite 4‐methylimidazolidine‐2‐thione (PTU). Lacking a full toxicological characterisation for the compound PDA, exposure data for metabolites propineb‐DIDT in plants and PDA in processed commodities and considering that propineb‐MRLs correlated to CXLs were based on EU uses that were withdrawn following the non‐renewal and are no longer in place, it was not possible for EFSA to perform an assessment of these MRLs and their incorporation in European legislation cannot be recommended. Nevertheless, available data allowed EFSA to propose a marker residue and a limit of quantification (LOQ) for enforcement against potential illegal uses.

Modification of the existing maximum residue level for acrinathrin in lettuce

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Cheminova A/S submitted a request to the competent national authority in Spain to modify the existing maximum residue level (MRL) for the active substance acrinathrin in lettuce. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for lettuce. Adequate analytical methods for enforcement are available to control the residues of acrinathrin on the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of acrinathrin according to the reported agricultural practice and the current approval restrictions of acrinathrin is unlikely to present a risk to consumer health. However, uncertainties remain, particularly on the toxicological profile of the different isomers. Hence, the consumer risk assessment is considered tentative.