Codex Maximum Residue Limits Research Articles

Updated reasoned opinion on the toxicological properties and maximum residue levels (MRLs) for the benzimidazole substances carbendazim and thiophanate-methyl.

In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received from the European Commission in 2020 a mandate to provide its reasoned opinion on the toxicological properties and maximum residue levels (MRLs) for the benzimidazole substances carbendazim and thiophanate-methyl. Specifically, EFSA was asked to assess whether thiophanate-methyl or carbendazim has clastogenic potential and, in case clastogenic potential can be excluded, to derive toxicological reference values necessary for consumer risk assessment and assessment of maximum residue levels (MRLs). Although these active substances are no longer authorised within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs), and import tolerances are in place. Based on the assessment of the available data, toxicological reference values and MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was found to be missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment was considered indicative only and all MRL proposals derived by EFSA still require further consideration by risk managers. In October 2022, to ensure that MRLs derived by EFSA in its assessment of 2021 are safe for consumers also in view of endocrine-disrupting properties, EFSA was requested to carry out a follow-up assessment taking into account the scientific criteria for identifying endocrine disruptors (ED). Based on the outcome of the assessment, the experts agreed that the reference values are also covering the concern related to the identified hazards indicative of endocrine disruption for thiophanate-methyl. No further considerations on the impact of the ED assessment on the current reference values were needed for carbendazim since the ED criteria are not met for this substance. Therefore, the risk assessment and the MRL recommendations derived in 2021 are confirmed.

Targeted review of maximum residue levels (MRLs) for profenofos.

In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the non-approved active substance profenofos in view of the possible lowering of the MRL. EFSA investigated the origin of the current EU MRLs. Existing EU MRLs are based on Codex Maximum Residue Limits still in place or reflect temporary MRLs set from monitoring data. EFSA performed an indicative chronic and acute dietary risk assessment for the list of MRLs to allow risk managers to take the appropriate decisions. For some commodities, further risk management discussions are required to decide which of the risk management options proposed by EFSA should be implemented in the EU MRL legislation.

Monitoring of imidacloprid residues in fresh fruits and vegetables from the central parts of Jordan

Imidacloprid pesticide is widely utilized in agriculture due to its effectiveness in controlling a broad spectrum of insect pests. However, its usage has raised concerns about potential environmental impacts, and requires careful monitoring and responsible application to ensure sustainable agricultural practices. Thus, Gas chromatography-mass spectrometry (GC-MS) was utilized to analyze imidacloprid in 300 vegetable and fruit samples obtained from 15 major wholesalers in four regions of Amman, Jordan's capital city. Among the examined samples, 39.7 % were found to be contaminated with imidacloprid residues. Imidacloprid levels in different edible fruits and vegetables ranged from less than the Limit of Quantification (LOQ) to 0.40 mg kg−1. Significantly, eggplant and apples exhibited the highest average values (0.40 and 0.25 mg kg−1, respectively). Lower levels were detected in bananas (0.04 mg kg−1), potatoes (0.05 mg kg−1), grapes (0.07 mg kg−1), and cabbage (0.07 mg kg−1). Imidacloprid was below the method detection limit (BD) in samples of okra, peaches, apricots, and carrots. Overall, 25 samples (8.3 %) exceeded the Codex maximum residue limit (MRL) for imidacloprid. Moreover, 8 out of the 300 samples (2.7 %) exceeded the MRL established by the Pest Management Regulatory Agency (PMRA). Notably, the fruits of eggplant and apple contained the highest residual levels (1.30 and 0.83 mg kg−1, respectively), markedly exceeding the CODEX and PMRA MRLs. Additionally, the maximum detected imidacloprid residue concentration in bananas (0.25 mg kg−1) was 500 % higher than the CODEX MRLs. The estimated average daily intake (EDI) of the Amman population varied from 0.00 to 0.144 μg kg−1 body weight day−1 across various products. The hazard index (HI) for imidacloprid ranged from 0.00 to 0.24, all of which were below unity in all samples (<1). In conclusion, this investigation reveals low HI levels of imidacloprid residues in commonly consumed fruits and vegetables. However, the significant presence of imidacloprid residues in some samples highlights the urgent need for comprehensive measures to limit potential health hazards to consumers.

Targeted review of maximum residue levels (MRLs) for dicofol.

In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the non-approved active substance dicofol in view of the possible lowering of the MRL. EFSA investigated the origin of the current EU MRLs. All existing EU MRLs reflect previously authorised uses in the EU or are based on obsolete Codex Maximum Residue Limits. Furthermore, in view of the limitations of the toxicological dataset and related uncertainties, the existing toxicological reference values derived at the EU level cannot be confirmed for dicofol. EFSA therefore proposed lowering all existing EU MRLs for dicofol to the limit of quantification.

Role of Farmers’ Training on Improving Pesticide Management and Food Safety in Conventional Cabbage and Eggplant Production

Pesticides pose a serious risk to the environment and public health when used in crop production in an unsafe and indiscriminate manner. Moreover, there is a preconceived notion that conventionally grown crops are not as safe as organic crops due to the presence of pesticide residues. To address this, an intervention that focused on farmers’ training on proper pesticide management was conducted. Two farmer clusters were organized separately, and pesticide usage and practices were monitored and evaluated. The results of the evaluation indicated a significant decline in the usage of pesticides not registered for cabbage and eggplant production. Residue analysis for major insecticide groups (organochlorines, organophosphates, and pyrethroids) of the harvested crops showed that 100% of the eggplant samples (n = 20) and 80% of the cabbage samples (n = 20) had non-detectable pesticide residues (&lt; 0.01 mg/kg). The cabbage samples with detectable residues are found to be compliant with the currently established CODEX and ASEAN maximum residue limits for the indicated pesticides. Overall, this suggests that training and monitoring activities conducted to strengthen the knowledge and adherence to pesticide safety practices resulted in safe conventional vegetable production. It is recommended that farmers’ training and other extension activities be conducted periodically to promote the judicious use of pesticides for food safety.

Targeted risk assessment for prochloraz.

In accordance with Article 43 of Regulation (EC) No 396/2005, the European Commission requested EFSA to prepare a statement with a targeted risk assessment for prochloraz. Based on the data available, EFSA performed an acute exposure assessment for EU consumers for the existing EU maximum residue levels (MRLs) based on codex maximum residue limits (CXLs) and identified possible risk for consumers for the CXLs on granate apples and papaya.

Targeted review of maximum residue levels (MRLs) for endosulfan.

In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the non-approved active substance endosulfan in view of the possible lowering of the MRLs. EFSA investigated the origin of the current EU MRLs. For existing EU MRLs that reflect previously authorised uses in the EU, or that are based on obsolete Codex maximum residue limits, or import tolerances that are not required any longer, EFSA proposed the lowering to the limit of quantification or to an alternative MRL. EFSA performed an indicative chronic and acute dietary risk assessment for the revised list of MRLs to allow risk managers to take the appropriate decisions. For all commodities, further risk management discussions are required to decide which of the risk management options proposed by EFSA should be implemented in the EU MRL legislation.

Targeted review of maximum residue levels (MRLs) for fenarimol.

In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the non-approved active substance fenarimol in view of the possible lowering of the MRLs. EFSA investigated the origin of the current EU MRLs. For existing EU MRLs that reflect previously authorised uses in the EU, or that are based on obsolete Codex maximum residue limits, or import tolerances that are not required any longer, EFSA proposed the lowering to the limit of quantification. EFSA performed a chronic and acute dietary risk assessment for the revised list of MRLs to allow risk managers to take the appropriate decisions. For some commodities, further risk management discussions are required to decide which of the risk management options proposed by EFSA should be implemented in the EU MRL legislation.

Targeted review of maximum residue levels (MRLs) for fenpropathrin.

In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the non-approved active substance fenpropathrin in view of the possible lowering of the MRLs. EFSA investigated the origin of the current EU MRLs. For existing EU MRLs that reflect previously authorised uses in the EU, or that are based on obsolete Codex Maximum Residue Limits, or import tolerances that are not required any longer, EFSA proposed the lowering to the limit of quantification or to an alternative MRL. EFSA performed an indicative chronic and acute dietary risk assessment for the revised list of MRLs to allow risk managers to take the appropriate decisions.

Targeted review of maximum residue levels (MRLs) for azocyclotin and cyhexatin.

In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the non-approved active substances azocyclotin and cyhexatin in view of the possible lowering of these MRLs. EFSA investigated the origin of the current EU MRLs. For existing EU MRLs that reflect previously authorised uses in the EU, or that are based on obsolete Codex Maximum Residue Limits, or import tolerances that are not required any longer, EFSA proposed the lowering to the limit of quantification. EFSA performed an indicative chronic and acute dietary risk assessment for the revised list of MRLs to allow risk managers to take the appropriate decisions. For some commodities under assessment, further risk management discussions are required to decide which of the risk management options proposed by EFSA should be implemented in the EU MRL legislation.

Behavior of trifloxystrobin and propineb as combi-product in tomato (Solanum lycopersicum) and their risk assessment for human health.

Fungicides have their own unique characteristics and modes of action; a combination formulation of trifloxystrobin and propineb was applied to tomatoes for their dissipation kinetics and to ensure consumer safety. The combi-product was applied at a 10-day interval with standard (61.25 + 1072.75 g a.i. ha-1 ) and double (122.5 + 2145.50 g a.i. ha-1 ) doses. The efficient analytical method was established using the QuEChERS approach followed by liquid chromatography-mass spectrometry. The maximum residue levels of 0.15 and 0.35 mg kg-1 of trifloxystrobin were detected in tomato fruits immediately after application at standard and double doses, respectively. The corresponding levels of propineb as carbon disulfide were 0.47 and 0.90 mg kg-1 , respectively. Considering trifloxystrobin (0.7 mg kg-1 ) codex MRL and propineb as dithiocarbamate (3.0 mg kg-1 ) EU-MRL in tomato, a PHI of 1 day can be proposed. The anticipated residue contributions of both fungicides were far less than the acceptable daily intake. The targeted hazard quotient and hazard index were also less than one for both fungicides. Furthermore, the theoretical maximum residue contribution was less than its maximum permissible intake, which indicates that the consumption of tomatoes containing the measured value of each fungicide residue could not pose any health risks.

Simultaneous monitoring and dietary risk assessment of 386 pesticides in market samples of black tea

Black tea samples (390) collected from local markets situated in different locations of India were monitored for the residues of 386 pesticides using QuEChERS (Quick, Easy, Cheap, Effective, Rugged, and Safe) based extraction and analysis by gas and liquid chromatography tandem mass spectrometry (GC–MS/MS and LC–MS/MS). Residues of seventeen pesticides were detected, of which propargite, cypermethrin, and novaluron showed the highest % positive detections. A comparison of the concentrations of the detected pesticide residues with the available national and international maximum residue limits (MRLs) showed that seven samples exceeded the Indian MRLs while no sample was found to exceed the CODEX MRLs. The risk due to the detected pesticide levels evaluated in terms of hazard quotient (HQ) and hazard index (HI) was found to be very low (<1), suggesting that the pesticide residues in the tea were safe for consumption by Indian adults and children.

Modification of the existing maximum residue levels for imazalil in courgettes, cucumbers and gherkins.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Certis Europe B.V. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance imazalil in cucumbers, courgettes and gherkins. The data submitted in support of the request were found to be sufficient to derive an MRL proposal of 0.08 mg/kg for the whole group of cucurbits with edible peel. It is noted that the derived MRL is proposed to replace the existing tentative MRL of 0.1 mg/kg for courgettes, thus also addressing the data gap identified in the context of the MRL review. As regards to cucumbers and gherkins, it is noted that the MRL proposal derived in the current application is covered by the MRL of 0.5 mg/kg currently in place for these commodities. Nevertheless, it is also noted that the aforementioned MRLs are based on Codex maximum residue limits (CXLs) which were revoked in 2019 following the JMPR proposal. Should this proposal be implemented in the EU regulation in the future, the proposed MRL of 0.08 mg/kg as derived in the current application would be considered an appropriate fall-back option for the whole group of cucurbits with edible peel. Further risk management considerations are therefore required. Adequate analytical methods for enforcement are available to control the residues of imazalil on the commodities under consideration at the validated limit of quantification (LOQ) of 0.005 mg/kg (QuEChERS method based on LC-MS/MS) and 0.01 mg/kg (HPLC-MS/MS method). Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of imazalil according to the reported agricultural practices is unlikely to present a risk to consumer health. However, it should be noted that a high degree of uncertainty on the overall long-term exposure calculation remains due to the data gaps identified in the context of the MRL review on full toxicological assessment of the metabolite R014821, which is expected to occur following post-harvest uses of imazalil, and animal metabolites FK-772 and FK-284.

Setting of import tolerances for fipronil in potatoes, sugar canes and commodities of animal origin.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Austria to set an import tolerance for the active substance fipronil in potatoes, maize, rice, sugar canes and to modify the existing EU MRLs (maximum residue levels) for fipronil in commodities of animal origin. During the assessment, the applicant withdrew the import tolerance requests on maize and rice. The data submitted in support of the present assessment were found to be sufficient to derive MRL proposal for sugar canes. For potatoes, data gaps were identified which precluded the derivation of MRL proposal. The livestock exposure to fipronil residues from the intake of sugar canes molasses required the setting of MRL in fat of bovine, sheep and goat. Adequate analytical methods for enforcement are available to control the total residues of fipronil in plant and animal matrices at the validated limit of quantification (LOQ) 0.005 mg/kg. Based on the risk assessment results, EFSA concluded that consumer intake concerns are not associated with fipronil residues in food commodities under consideration: sugar canes and fat of bovine, sheep and goat. There are no EU authorisations of fipronil as well as no Codex maximum residue limits (CXLs) or import tolerances are set for fipronil in the EU MRL legislation; therefore, other plant and animal commodities were not considered in the consumer exposure assessment.

Targeted risk assessment for famoxadone.

In accordance with Article 43 of Regulation (EC) No 396/2005, the European Commission requested EFSA to assess whether existing Codex Maximum Residue Limits (CXLs) for famoxadone are safe for consumers in light of the lowered toxicological reference values established following the non-renewal of approval of the active substance famoxadone. Based on the targeted assessment EFSA identified a potential acute concern for the CXL on table grapes. For the other CXLs consumers intake concern was not identified.

Statement on the short-term (acute) dietary risk assessment and evaluation of confirmatory data for certain maximum residue levels (MRLs) for thiacloprid.

In accordance with Article 43 of Regulation (EC) No 396/2005, the European Commission requested EFSA to assess whether existing maximum residue levels (MRLs) based on codex maximum residue limits (CXLs) and import tolerances for thiacloprid are safe for consumers in light of the lowered toxicological acute reference value established following the non-renewal of approval of the active substance thiacloprid. Based on the assessment, EFSA identified a potential acute concern for the CXL on peaches and sweet peppers. EFSA did not identify a consumer health risk for all the other remaining commodities of plant and animal origin.

Review of the existing maximum residue levels for cypermethrins 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 group of pesticide active substances cypermethrins. To assess the occurrence of cypermethrin, alpha-cypermethrin, zeta-cypermethrin, beta-cypermethrin residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Regulation (EC) No 1107/2009, the MRLs established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs) for cypermethrin, alpha-cypermethrin and zeta-cypermethrin as well as the European authorisations and import tolerances reported by Member States and the UK (including the supporting residues data) for cypermethrin and zeta-cypermethrin. The toxicological profile of zeta-cypermethrin was also assessed. Based on the assessment of the available data, MRL proposals were derived, and a consumer risk assessment was carried out. Some information required by the regulatory framework was missing and a possible chronic/acute risk to consumer was identified. Hence, the consumer risk assessment is considered indicative only, all MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.

Targeted review of maximum residue levels (MRLs) for bifenthrin.

In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the non-approved active substance bifenthrin in view of the possible lowering of the MRLs. EFSA investigated the origin of the current EU MRLs. For existing EU MRLs that reflect previously authorised uses in the EU, or that are based on obsolete Codex maximum residue limits, or import tolerances that are not required any longer, EFSA proposed the lowering to the limit of quantification or to an alternative MRL. EFSA performed an indicative chronic and acute dietary risk assessment for the revised list of MRLs to allow risk managers to take the appropriate decisions. For some commodities, further risk management discussions are required to decide which of the risk management options proposed by EFSA should be implemented in the EU MRL legislation.

Risk assessment supporting the establishment of a maximum residue limit for ractopamine in beef liver, applicable in the Arab Republic of Egypt.

In 2012, the Codex Alimentarius Commission adopted maximum residue limits (MRLs) for ractopamine in pig and cattle tissues. Egypt, a country that records a high consumption of beef liver, conducted a health risk assessment to estimate the risks associated with the adoption of Codex MRLs and the possible adoption of alternative values that may offer higher protection. Ractopamine was characterized based on previous assessments performed by international regulatory agencies, and an acceptable daily intake was set at 1µg/kg bw for both chronic and acute ractopamine exposure. Beef liver consumption data for the Egyptian population were collected through a field survey (529 households, 1929 individuals). The standard body weight of 60kg was used, as well as 70kg, as a potentially more representative weight for the Egyptian population. Simulations showed that when the MRL for ractopamine in beef liver is set to 40µg/kg (Codex MRL) or 20µg/kg, the health-based guidance value of 1µg/kg bw was not exceeded, as a result of chronic or acute exposure. An MRL of 20µg/kg of ractopamine in beef liver was shown to provide optimum protection of Egyptian consumers, considering other potential sources of ractopamine intake and abnormally high consumption patterns, and was therefore recommended for adoption in Egypt. This study presents the inputs, model, and results of the probabilistic risk assessment that supported such recommendation. PRACTICAL APPLICATION: Residues of veterinary drugs, such as ractopamine, accumulate in animal tissues and may pose a risk to consumers. Establishing maximum residue limits (MRLs) will help importers by giving them the necessary visibility for commercial trade. It will also benefit Egyptian consumers, large consumers of beef liver, who will be better protected with a lower MRL than the internationally recommended one.

Targeted review of maximum residues levels (MRLs) for haloxyfop-P.

In compliance with Article 43 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) received a mandate from the European Commission to perform a targeted review of the existing maximum residues levels (MRLs) for the active substance haloxyfop-P to check whether the existing EU MRL in onions, sunflower seeds and soya beans (covering codex maximum residue limits (CXLs) or import tolerances) and the proposed import tolerance MRLs in linseeds, rapeseeds/canola seeds are safe for consumers and can eventually be maintained in the MRL Regulation after the expiry of the approval of the active substance. EFSA screened these MRLs considering the toxicological reference values established during the EU peer review process for the renewal of the approval of haloxyfop-P and identified chronic consumer intake concerns for two diets when for the remaining plant and animal commodities, the input values were at the LOQ. Fall-back MRLs could not be proposed, but the additional information provided by EURLs allowed to resolve the chronic intake concerns using lower validated LOQs for a range of plant commodities and milk. EFSA concludes that the existing EU MRLs in soya beans and onions, the CXL in sunflower seeds and the proposed import tolerances in linseed and rapeseed/canola seeds are not expected to pose a risk to consumers. However, to guarantee consumer's safety regarding the chronic exposure to haloxyfop-P residues, the enforcement LOQs in several plant commodities and milks would have to be lowered to the levels reported by the EURLs.