Maximum Residue Levels Research Articles

Development of an HPLC-PDA Method for the Simultaneous Estimation of Three Antibiotics in Pharmaceutical Formulations and Bovine Milk and Health Risk Assessment

A simple new, rapid, sensitive, and cost-effective HPLC–PDA method was developed and validated for the determination of tetracycline (TC), oxytetracycline (OTC), and ciprofloxacin (CIP) simultaneously. Chromatographic separations were carried out using a reversed-phase Shim-pack GIS C18 column (4.60 × 250.00 mm; 5.00 µm) at 30°C. Oxalic acid (0.05 M), acetonitrile, and methanol were used as mobile phase under gradient elution conditions at the flow rate of 1.50 mL min−1. Detection wavelength was set at 330 nm. An aliquot of 20.00 µL solution was injected, and three drugs were eluted within 7.39 ± 0.05 min. As per ICH guidelines linearity, recovery, accuracy, precision, selectivity, specificity, sensitivity, stability, column efficiency, system suitability, and robustness were determined for the validation of the proposed method. Calibration curves were linear over a studied concentration range of 8.00 µg mL−1 with a correlation coefficient (r) of 0.999 for all drugs. Relative standard deviation (RSD) for intra− and interday precision was found less than 2.87% and 3.22%, respectively, indicating the method to be reproducible. The proposed method has been suitably applied for the estimation of TC, OTC, and CIP in pharmaceutical formulation and milk samples collected from local market in Bangladesh. Among 15 milk samples analyzed, most of the cases (more than 50%) TC, OTC, and CIP were detected above maximum residue levels (MRLs) though no significant toxicological effect on the health of consumers in the study area was identified.

Modification of the existing maximum residue levels for fluxapyroxad in kaki/Japanese persimmons and cultivated mushrooms.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted two requests to the competent national authority in Spain and Ireland to modify the existing maximum residue levels (MRLs) for the active substance fluxapyroxad in kaki/Japanese persimmons and in cultivated fungi, respectively. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for kaki/Japanese persimmons and cultivated fungi. Adequate analytical methods for enforcement are available to control the residues of fluxapyroxad on the commodities under consideration at the validated 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 fluxapyroxad, according to the reported agricultural practices, is unlikely to present a risk to consumer health. The long-term consumer risk assessment is indicative, pending the submission of the confirmatory data requested under the MRL review.

The 2022 European Union report on pesticide residues in food.

Under European Union legislation (Article 32, Regulation (EC) No 396/2005), the European Food Safety Authority provides an annual report assessing the pesticide residue levels in foods on the European market. In 2022, 96.3% of the overall 110,829 samples analysed fell below the maximum residue level (MRL), 3.7% exceeded this level, of which 2.2% were non-compliant, i.e. results in a given sample exceeded the MRL after taking into account the measurement uncertainty. For the EU-coordinated multiannual control programme subset, 11,727 samples were analysed of which 0.9% were non-compliant. To assess acute and chronic risk to consumer health, dietary exposure to pesticide residues was estimated and compared with available health-based guidance values (HBGV). Continuation of the probabilistic assessment methodology was consolidated to all pesticides listed in the 2022 EU Regulation providing the probability of a consumer being exposed to an exceedance of the HBGV. Overall, the assessed risk to EU consumer's health is low. Recommendations to risk managers are given to increase the effectiveness of European control systems and to ensure a high level of consumer protection throughout the EU.

Targeted review of the maximum residue levels (MRLs) for ethephon.

Targeted review of the maximum residue levels (MRLs) for ethephon.

Evaluation of Brazilian pesticide residue reported by monitoring programs considering foods offered to childrens

The consumption of fruits and vegetables, which are the basis of infant nutrition, carries a high risk of pesticide residue contamination. With higher food intake and lower body weight, infants can be considered more sensitive to contamination than adults, which justifies the growing concern about the diet of this population in recent decades. In 2006 in the European Union (EU), processed baby foods were regulated and should not contain individual pesticide residues at levels higher than 0.01 mg/kg, to protect children from ingesting harmful substances. Considering the reference pesticide residues for infant food in the EU and the pesticide residue monitoring programs in Brazil (from the National Health Surveillance Agency and the Ministry of Agriculture, Livestock and Supply), this study compared the results of pesticide residues in some vegetables and fruits with the maximum residue level (MRL) for infant foods established by the EU. 10,174 vegetable samples were analyzed by the monitoring programs, and 80.3% were in accordance with their respective MRLs. Some foods, such as rice, potatoes, and chayote, have average pesticide residue levels equal to or lower than the EU-baby-MRL. However, only 44.0% of the analyzed foods presented residues with results lower than 0.01 mg/kg of food. It can be concluded that most fruits and vegetables contain pesticide residues above the EU recommendations for infant food.

Generic methodology to prevent food contamination by soil born legacy POPs in free range livestock

Government monitoring commonly includes regulating POPs in animal feed and products of animal origin, with many countries setting Maximum Residue Levels (MRLs) to ensure safe tolerable concentrations. However, these MRLs do not address the presence of most POP families in soil, where concentrations can be much higher due to the contaminants' strong affinity and persistence in comparison to other environmental matrices. Extensive damage to food and production systems during a pollution incident causing soil contamination by POPs lead to severe economic and social consequences for the affected area. To mitigate these effects, it is crucial to implement necessary measures for consumer protection while also focusing on rehabilitating conditions for food production, tailored to both commercial farms and private holders. In this context, the present work aims to develop and test a methodology for assessing the tolerable concentration of the most cancerogenic legacy POPs in soil for various livestock animals in diverse rearing systems ensuring the safety of food of animal origin. Therefore, we summarize existing knowledge about the risk of POP transfer in different livestock breeding systems via soil exposure, and modeling via a backward calculation from the MRLs the corresponding tolerable quantity of POPs that may be ingested by animals in the considered rearing system. Results of these simulations showed that soil ingestion is a predominant contamination pathway, which is a central factor in the risk assessment of POP exposure on livestock farms, especially in free-range systems. In field conditions of POP exposure, low productive animals may be more susceptible to uptake through soil than high-yielding animals, even if the feed respected MRLs. Results show that PCDD/Fs revealed the lowest security ratio for low productive dairy cows (1.5) compared to high productive ones (52). Laying hens with a productivity of 45% show also as a high sensitivity to POPs exposure via soil ingestion. Indeed, their security ratio for PCDD/Fs, lindane and DDT were 3, 2 and 1, respectively. In perspective, proposed methodology can be adapted for assessing the risk of industrial POPs newly listed in the Stockholm Convention. In practice, it could be useful for food producers to apprehend their own risk of chemical contamination.

Optimization of an HPLC-MS/MS method to analyze chlordecone in bovine serum and correlations with levels in liver, muscle and fat

Chlordecone is an organochlorine pesticide used from 1972 to 1993 in the French West Indies. Its extensive use and high persistence in soils induced massive contamination of the environment and of the food chain, especially in cattle through contaminated soil ingestion. To ensure suitability for consumption of bovine meat, monitoring plans are set up based on perirenal fat concentrations after slaughtering. In the present study, we have investigated an in-vivo monitoring approach by measuring chlordecone levels in serum samples. For this purpose, a sensitive high-performance liquid-chromatography-tandem mass spectrometry (HPLC-MS/MS) method following a QuEChERS extraction method was successfully optimized and validated, reaching a limit of quantification of 0.05 ng g−1 fresh weight. This method was applied to 121 serum samples collected from bovines originating from contaminated areas of Martinique and Guadeloupe. Chlordecone was detected in 88% of the samples, and quantified in 77% of the samples, with concentrations ranging from 0.05 to 22 ng g−1. Perirenal fat, liver, and muscle were also sampled on the same animals and the measured concentrations of chlordecone were statistically correlated to the levels determined in serum. Mean concentration ratios of 6.5 for fat/serum, 27.5 for liver/serum, and 3.3 for muscle/serum were calculated, meaning that chlordecone was not only distribute in fat (as expected), muscle and liver, but also in serum. Good correlations were found to allow prediction of chlordecone concentrations in muscle based on concentrations measured in serum. This study opens the door to possible pre-control of bovines before slaughter. In cases of probable non-compliance with maximum residue levels (MRLs), farm management could proceed to allow for depuration under controlled conditions. This would have a strong impact on both economic and food safety management measures.

Determination of Pesticide Residues in Vine Leaves Using the QuEChERS Method and Liquid Chromatography-Tandem Mass Spectrometry.

Commercial viticulture necessitates regular pesticide applications to manage diseases and pests, raising significant concerns regarding pesticide residues among stakeholders. Due to health risks associated with these residues in Turkish vine leaves, the European Commission has increased the frequency of official control from 20% to 50%. Thus, the aim of this study was to determine multi-class pesticide residues in brined vine leaves from Turkey. A total of 766 samples of vine leaves were collected between May 2022 and June 2023. More than 500 residues were analyzed using the quick, easy, cheap, effective, rugged, and safe (QuEChERS) method, followed by liquid chromatography-tandem mass spectrometry. In-house validation data demonstrated that the analytical method exhibits fit-for-purpose performance in terms of linearity, accuracy, precision, and measurement uncertainty. Out of 766 samples analyzed, 180 samples (23.5%) contained one (131, 17.1%) or multiple (49, 6.4%) pesticides. Both the frequencies of occurrence and the rate of maximum residue level (MRL) exceedance increased in 2023 compared to 2022, with the MRL exceedance rate rising from 9.5% to 25.2%. Forty-three different residues were found in quantifiable concentrations and eight of them were non-approved. Among the residues, the non-systemic pyrethroid insecticides, lambda-cyhalothrin (8.0%) and cypermethrin (7.2%), were the two most frequently detected, with concentrations ranging from 0.010 to 0.248 mg kg-1 and from 0.011 to 0.533 mg kg-1, respectively. Turkey is a major exporter of vine leaves and these results provide crucial information regarding pesticide occurrence and quality assessment of vine leaves. The significant increase in both pesticide occurrence and MRL exceedance rates between 2022 and 2023 underscores the urgency for regulatory bodies to reassess current pesticide usage and monitoring practices. The findings emphasize the importance of implementing more stringent rules and improving enforcement methods in order to reduce the spread of unapproved pesticides and ensure adherence to global food safety standards.

Occurrence and health risk of pesticide residues in Chinese herbal medicines from Shandong Province, China.

Pesticide residue was one of the stress factors affecting quality and safety of Chinese herbal medicines (CHMs). The present study was designed to investigate the occurrence and dietary exposure of 70 pesticide residues in 307 samples of CHMs, including 104 American ginseng, 100 Ganoderma lucidum (G. lucidum), and 103 Dendrobium officinale (D. officinale) in Shandong Province, China. The study revealed that a total of 29 pesticides were detected in the majority (92.5%) of samples, and the pesticide residues of 85 (27.7%) samples exceeded the maximum residue levels (MRLs). Particularly, the maximum concentration of chlorpyrifos was 23.8mgkg-1, almost 50 times of the MRLs in food in GB 2763-2021, while there's no standard restrictions specified in CHMs in China. The chronic, acute, and cumulative risk assessment results indicated that risk exposure of the three types of CHMs were unlikely to pose a health risk to consumers. However, more attention should be paid to the multiple residues with the presence of four or more pesticides in one sample and high over-standard rate of pesticides. The pesticide users and the government should pay more attention to the pesticides used in CHMs and regularly monitor the presence of these compounds. The study recommended the MRLs of these pesticides in CHMs should be established and perfected by the relevant departments in China.

Heart-Cutting Bidimensional Liquid Chromatography for the Simultaneous Analysis of Veterinary Drugs Residues and Nucleotide Monophosphates in Sheep's Milk.

Sheep's milk is a significant source of nucleotide monophosphates (NMPs) but can also contain undesirable residues from veterinary drugs, posing a potential human health risk. This study introduces a novel application of two-dimensional liquid chromatography (2D-LC), in heart-cutting mode, for the simultaneous determination of nucleotides and veterinary drug residues in sheep's milk. 2D-LC allows for the separation of these compounds in a single chromatographic run despite their differing physicochemical properties. The proposed method separates six veterinary drug residues and five NMPs in a single injection. The compounds were separated using a C18 reversed-phase column in the first dimension and a Primesep SB analytical column in the second dimension. The method performance was evaluated in terms of linearity range, detection and quantification limits, matrix effects, precision, and accuracy. The results demonstrated good linearity and sensitivity, with quantification limits allowing for the quantification of veterinary drugs at the maximum residue level and nucleotides at typical levels found in milk samples. The method has been successfully applied to the analysis of sheep's milk samples acquired from local supermarkets, with recoveries within a range of 70-119% and 82-117% for veterinary residues and NMPs, respectively.

A Novel Approach for Single Step Analyte Fractionation of Raw Milk Prior to Antbiotica Residue Trace Analysis as an Alternative to QuEchERS Based Extraction.

Antibiotic residues in milk are a well-known hazard in the dairy food chain. Detection methods for these residues, such as non-specific microbiological inhibitor tests or group-specific receptor tests, respectively, are relatively inexpensive, easy to use and widely applied to ensure food safety. In contrast, specific detection by liquid chromatography tandem mass spectrometry (LC-MS/MS) - although a critical, complimentary method to confirm the results of non-specific testing-is relatively costly, time consuming and laborious. Furthermore, sample processing before LC-MS/MS analysis requires unique preparation procedures for different groups of antibiotic compounds. To simplify and speed up specific antibiotic residue detection, a low-cost, passive and single-step method to fractionate analytes in raw milk was developed. Untreated raw milk was fractionated into its water and fat/protein phases using a FraMiTrACR® AB fractionation unit. The water fraction was then analyzed by LC-MS/MS. The analyte fractionation method was evaluated against a QuEChERS based method for sample preparation. Our method allows qualitative and quantitative detection of substances from the Penicillin, Cephalosporin, Macrolide, Lincosamide, Sulfonamide, Tetracycline and Fluoroquinolone groups of antibiotics. Detection limits are below the legally prescribed maximum residue levels, allowing reliable, specific and rapid validation of a positive result in non-specific microbiological inhibitor tests. Analyte fractionation by FraMiTrACR® AB is a faster alternative to QuEChERS based sample preparation for the detection of antibiotic substances in milk. This method describes a low-cost, environmentally friendly, passive and single-step milk analyte fractionation. As an alternative to QuEChERS based preparation, this fractionation method simplifies and speeds up the process for specific antibiotic residue detection.

Updated peer review of the pesticide risk assessment of the active substance dichlorprop-P and variant dichlorprop-P-2-ethylhexyl.

The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Ireland, and co-rapporteur Member State, Poland, for the pesticide active substance dichlorprop-P and the variant dichlorprop-P-2-ethylhexyl and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of dichlorprop-P as a herbicide on cereals, grassland and grass seed crops and of the variant dichlorprop-P-2-ethylhexyl as a plant growth regulator on citrus. MRLs were assessed in mandarin and lemon. The conclusions from 2018 were updated in 2024 following the request from the European Commission with regard to the endocrine-disrupting properties. The reliable end points, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.

Safety and efficacy of a feed additive consisting of monensin sodium (Coxidin®) for chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding (Huvepharma N.V.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of monensin sodium (Coxidin®) as a coccidiostat for chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. The additive currently on the market complies with the existing conditions of authorisation. The FEEDAP Panel concluded that Coxidin® remains safe for turkeys for fattening (up to 16 weeks) and extends this conclusion to turkeys reared for breeding (up to 16 weeks). The Panel was not in the position to confirm that the current maximum authorised level of 125 mg monensin sodium/kg complete feed remains safe for chickens for fattening and chickens reared for laying. The use of monensin sodium from Coxidin® at the corresponding maximum authorised/proposed use levels in the target species is safe for the consumer. The existing maximum residue levels (MRLs) for poultry tissues ensure consumer safety. No withdrawal time is necessary. Both formulations of Coxidin® pose a risk by inhalation. The formulation with wheat bran as a carrier was neither irritant to the skin nor a skin sensitiser but it was irritant to the eyes. In the absence of data, no conclusions could be made on the potential of the formulation containing calcium carbonate to be irritant to skin and eyes and to be a skin sensitiser. The use of monensin sodium from Coxidin® in complete feed for the target species poses no risk for the terrestrial compartments and for sediment. No risk for groundwater is expected. For chickens for fattening the risk for aquatic compartment cannot be excluded, but no risks are expected for the other animal categories. There is no risk of secondary poisoning. Coxidin® is efficacious in controlling coccidiosis at a level of 100 mg/kg complete feed for chickens for fattening and at 60 mg/kg complete feed for turkeys for fattening. These conclusions are extended to chickens reared for laying and turkeys reared for breeding. The Panel noted that there are signs of development of resistance of Eimeria spp. to monensin sodium.

Pharmacokinetics ofpraziquantel and its metabolites ingrass carp (Ctenopharyngodon idella) following the oral administration ofasingle bolus.

The study aimed toevaluate and compare the routes and rates ofthe depletion ofthe antiparasitic praziquantel (PZQ), aderivative ofpyrazinoisoquinoline, following its oral administration ingrass carp (Ctenopharyngodon idella). Wefocused onthe depletion ofPZQ and its major metabolites - cis-hydroxy praziquantel (CPZQ) and trans-hydroxy praziquantel (TPZQ), inwater, the plasma, hepatopancreas, kidney, muscle, and skin, following asingle oral administration ofPZQ inaconcentration of50mg/kg. Fish were sampled before the drug administration and then eight times inthe course ofthe 30-day-long experiment. Our results indicate the rapid absorption and elimination ofPZQ and its metabolites inall the analysed matrices. The most PZQ-burdened tissue was the hepatopancreas, the gill and the skin. Inall the samples, the concentration ofthe drug and its metabolites consistently declined over time. The residue ofthe parent compound was detected for the longest time inall thetissues. During the study, asignificant (P<0.01) correlation was found within the concentration ofPZQ, CPZQ, and TPZQ inthe water and all the biological matrices. Itwas also found that the PZQ residue was not detected below the maximum residue levels (i.e., 20μg/kg) until 16 days after exposure inthe muscle and skin.

BİTKİSEL KÖKENLİ GIDALARDA YÜKSEK POLARİTELİ PESTİSİTLERİN SIVI KROMATOGRAFİ/KÜTLE SPEKTROMETRİSİ YÖNTEMİYLE ANALİZİ

Pesticides in foods of plant origin are becoming a major issue due to their intensive use in agriculture. Since pesticides are potentially harmful to the environment and consequently to human health through the consumption of pesticide contaminated foods. The European Community and also the Ministry of Agriculture and Forestry in Turkish Republic established maximum residue levels (MRLs), based on the assumption that good agricultural practice is applied at the use of pesticides in farming, for pesticide residues in food of plant origin. As a consequence food commodities have to be controlled to assure the non-violation of the MRLs. Thus an appropriate control of their residues in samples has to be operated. &#x0D; In this study, we inferred the analytical methods for highly polar pesticides in foods of plant origin via LC-MS/MS after extraction with acidified methanol according to QuPPe (Quick Polar Pesticides) method. Optimization of 13 highly polar pesticides was carried out with LC-MS/MS Q-Trap. After the optimization process has been completed, the samples to be taken according to the SANTE (Guidance document on analytical quality control and method validation procedures for pesticide residues and analysis in food and feed) guidelines have been carefully selected, including high water, high acid/high water, high sugar/low water, high oil/low water and high starch/low water content and difficult or unique commodities. Six samples carefully selected according to the SANTE guideline were carried out at two different concentrations, one of at the detection limit which is 10 µg/L. At the end of the studies, it was found that the RSD criteria for repeatabilitiy was below 20 % for all substances. In addition, the recovery value for all substances was in the range of 70 – 120 %. As a result, 13 different polar pesticides can be analyzed in product groups of plant origin via LC-MS/MS method developed by using hypercarb column.

High Prevalence of Mycotoxigenic Fungi and Aflatoxin B1 Contamination in Corn and Wheat Grains Grown to Albania: Implications for Food Safety

Background: Today, mycotoxins are considered critical contaminants in foodstuffs produced by fungi, highlighting the importance of food safety to human health. The toxigenic fungi invasion and mycotoxin production are highly variable and depend on climate, plant, and agronomic practices. Among these, Aflatoxins (AFs) are considered the most potent toxins. This study investigated the fungi presence and AFB1 contamination in corn and wheat grown in Albania during the 2022 harvesting year.&#x0D; Methods: Wheat samples were collected during the summer, while corn during the autumn, and further analyzed. Mycological contamination assessment applied the Verband Deutscher Landëirtschaftlicher Untersuchungs ̶ und Forschungsanstalten (VDLUFA) procedures. The AFB1 levels were measured using the Enzyme-Linked Immunosorbent Assay (ELISA) method. The MATLAB R2016b software was applied to perform statistical analysis. The Estimated Daily Intake on AFB1 was calculated to evaluate human exposure.&#x0D; Results: The genera Alternaria, Aspergillus, Cladosporium, Fusarium, and Penicillium were isolated, with higher rates of contamination in corn and the highest frequency Penicillium genus (77.89%). The Korça region presented a higher fungal load, 104 Colony Forming Unit (CFU)/g in corn. The AFB1 incidence (88.23%) in corn, was significantly higher than in wheat (4.91%). Additionally, the maximum level in corn was found 69.120 μg/kg, while in wheat, only 0.402 μg/kg. None of the wheat samples, in contrast to the 41.18% of corn samples, exceeded the threshold when referring to the respective Maximum Residue Levels.&#x0D; Conclusions: Our observation indicates a higher rate of AFB1 contamination in corn than in wheat. The high concentration levels and contamination incidence in corn require targeted interventions to reduce the AFB1 amounts. Strengthened regulation based on scientific evidence can reduce contamination outbreaks, economic implications, and potential benefits, such as increased consumer trust. Our study indicates that the exposure to AFB1 originates from corn consumption among the adult population

A systemic study of cyenopyrafen in strawberry cultivation system: Efficacy, residue behavior, and impact on honeybees (Apis mellifera L.)

The pesticide application method is one of the important factors affecting its effectiveness and residues, and the risk of pesticides to non-target organisms. To elucidate the effect of application methods on the efficacy and residue of cyenopyrafen, and the toxic effects on pollinators honeybees in strawberry cultivation, the efficacy and residual behavior of cyenopyrafen were investigated using foliar spray and backward leaf spray in field trials. The results showed that the initial deposition of cyenopyrafen using backward leaf spray on target leaves reached 5.06–9.81 mg/kg at the dose of 67.5–101.25 g a.i./ha, which was higher than that using foliar spray (2.62–3.71 mg/kg). The half-lives of cyenopyrafen in leaves for foliar and backward leaf spray was 2.3–3.3 and 5.3–5.9 d, respectively. The residues (10 d) of cyenopyrafen in leaves after backward leaf spray was 1.41–3.02 mg/kg, which was higher than that after foliar spraying (0.25–0.37 mg/kg). It is the main reason for the better efficacy after backward leaf spray. However, the residues (10 d) in strawberry after backward leaf spray and foliar spray was 0.04–0.10 and < 0.01 mg/kg, which were well below the established maximum residue levels of cyenopyrafen in Japan and South Korea for food safety. To further investigate the effects of cyenopyrafen residues after backward leaf spray application on pollinator honeybees, sublethal effects of cyenopyrafen on honeybees were studied. The results indicated a significant inhibition in the detoxification metabolic enzymes of honeybees under continuous exposure of cyenopyrafen (0.54 and 5.4 mg/L) over 8 d. The cyenopyrafen exposure also alters the composition of honeybee gut microbiota, such as increasing the relative abundance of Rhizobiales and decreasing the relative abundance of Acetobacterales. The comprehensive data on cyenopyrafen provide basic theoretical for environmental and ecological risk assessment, while backward leaf spray proved to be effective and safe for strawberry cultivation.

Stress analysis of a large diameter aspheric plastic lens in the variable temperature assisted injection molding process.

The technology known as precision injection molding (PIM) has shown great promise in the large-scale manufacturing of optical plastic lenses. The primary challenge with the PIM process is accurately predicting and reducing residual stress in optical plastic lenses. In this work, the finite element method (FEM) was used to analyze the residual stress distribution in plastic lenses. A three-dimensional model was created using COMSOL software to investigate how residual stress and temperature varied in optical plastic lenses during the packing and cooling stages. Based on the results, variable temperature assisted injection molding experiments were conducted. The results show that the average residual stress in the optical plastic lenses has decreased by 56%, while the minimum and maximum residual stress levels have decreased by 60% and 61%, respectively. Since this method does not require the extra heat treatment of the optical lenses, it offers considerable cost and efficiency benefits.

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.

Evaluation of confirmatory data following the Article 12 MRL review for quizalofop-P-ethyl, quizalofop-P-tefuryl and propaquizafop and modification of the existing maximum residue levels for quizalofop-P-tefuryl.

The applicant Arysta Life Science Great Britain Limited submitted a request to the competent national authority in Croatia to evaluate the confirmatory data that were identified for quizalofop-P-tefuryl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. Since Article 12 data gaps were also set for the two other quizalofop-P variants sharing the same residue definitions for risk assessment and monitoring, EFSA included in the present assessment all quizalofop-P variants: quizalofop-P-ethyl, quizalofop-P-tefuryl and propaquizafop. Moreover, in the application submitted to Croatia, the applicant also included a request to modify the existing MRLs for quizalofop-P-tefuryl in grapes, sunflower seeds and soyabeans in accordance with Article 6 of Regulation (EC) No 396/2005. To address the data gaps, new data on hydrolysis efficiency of quizalofop-P-tefuryl, quizalofop acid, quizalofop-pentanoic acid and quizalofop-P-glycerate in different matrices of animal origin in accordance with the guidance document SANTE/2020/12830 Rev.1 were submitted, along with a validated analytical method for animal commodities. EFSA concluded that the data gap on validation of the efficiency of the extraction and hydrolysis included in the enforcement method of residues in livestock animal commodities was only fully addressed for muscle, poultry liver and eggs. Regarding plant commodities, the remaining data gaps were not addressed. EFSA also considered data gaps for quizalofop-p-ethyl in caraway as sufficiently addressed in the context of a previous MRL application. In general, the new information provided required a revision of the existing MRLs for several commodities of plant and animal origin. Further risk management considerations are required. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of quizalofop-P-tefuryl according to the reported agricultural practices is unlikely to present a risk to consumer health.