Commission Regulation Research Articles

VinylPlus® welcomes the publication of the European Commission Regulation restricting lead in PVC

On May 4, 2023, VinylPlus®, the European PVC industry's commitment to sustainable development, welcomed the publication of the European Commission Regulation restricting lead in PVC under the EU's REACH regulation.

Statement concerning the testing strategy and timelines proposed by the applicant for the assessment of the endocrine disruption properties of acibenzolar-S-methyl in the context of the review of the approval of the active substance.

On 8 July 2021, EFSA published a Conclusion on the peer review of the pesticide risk assessment for the active substance acibenzolar-S-methyl in light of confirmatory data submitted. EFSA concluded that based on the confirmatory information submitted by the applicant, the assessment of endocrine-disrupting properties could not be finalised for humans and non-target organisms and identified further data deemed necessary to finalise the assessment. Consequently, during the decision-making stage it could not be concluded by risk managers that acibenzolar-S-methyl still meets the approval criteria laid down in Article 4 of Regulation (EC) No 1107/2009 and therefore the European Commission decided to launch a review of the existing approval in accordance with Article 21 of that Regulation and on 6 July 2022 invited the applicant to submit comments on the findings in the EFSA Conclusion including any relevant information. On 14 December 2022, the European Commission requested EFSA to consider the proposal as submitted by the applicant in light of the EFSA Conclusion and to confirm whether the proposed studies are considered sufficient to complete the assessment of the endocrine disrupting properties of the substance in line with Commission Regulation (EU) 2018/605. The current statement contains EFSA's considerations as regards the testing strategy and associated timelines for additional data generation proposed by the applicant to complete the assessment of the endocrine disrupting properties of acibenzolar-S-methyl in line with Commission Regulation (EU) 2018/605.

Heavy metals content in fresh tuna and swordfish caught from Hindian and Pacific Oceans: Health risk assessment of dietary exposure.

Yellowfin tuna and swordfish are seafood commodities commonly caught from deep oceans worldwide. Therefore, this study aimed to assess the levels of three heavy metals, namely, cadmium (Cd), lead (Pb), and mercury (Hg) in yellowfin tuna and swordfish. The results are expected to provide consumers with information on the safety of consuming or exporting these fishes caught in the Hindian and Pacific Oceans. Fresh yellowfin and swordfish were obtained from fishermen's catches in FAO Fishing Zone 57 (Indian Ocean) and 71 (Pacific Ocean) and then collected at Benoa Harbor, Bali Province. The comparative method was to evaluate the levels of heavy metals in each fish. Furthermore, heavy metal concentrations, including Pb, Cd, and Hg, were determined using atomic absorption spectroscopy analysis. These results were then used to assess the safety of these fishes by calculating the estimated daily intake (EDI) and target hazard quotients-total target hazard quotients (THQs-TTHQs). The analysis showed that none of the samples exceeded the threshold levels for the three heavy metals, which was specified by the Indonesian National Standard (SNI) and European Commission Regulation (CR) No. 1881/2006. The EDI and provisional tolerable weekly index (PTWI) obtained in this study were still in the safe range. However, the PTWI values for Pb in yellowfin tuna product from the Indian Ocean were higher (0.0038 mg/kg) compared to the recommended standard for the adult population. The THQ-TTHQ values of fish caught from these oceans were also within the acceptable range specified by the two agencies, indicating that they are safe for consumption by people with various age groups and for export purposes. The average levels of three heavy metals (Cd, Pb, and Hg) in muscle samples of yellowfin tuna and swordfish caught from the Pacific and Hindian Oceans were within the acceptable range as specified by the SNI and CR No. 1881/2006. Furthermore, the EDI and THQs values indicated that fishes caught from the Pacific and Hindian Oceans were safe for consumption. This research is still limited to assessing two capture fisheries commodities. Further research is needed on the assessment of heavy metal levels in other capture fisheries commodities in this capture zone.

Re-evaluation of sucrose esters of fatty acids (E 473) as a food additive in foods for infants below 16 weeks of age and follow-up of its previous evaluations as food additive for uses in foods for all population groups.

Sucrose esters of fatty acids (E 473) was re-evaluated in 2004 by the former EFSA Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC Panel). In addition, the former EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) issued scientific opinions on the safety of sucrose esters of fatty acids (E 473) in 2010, 2012 and 2018. As a follow-up to these assessments, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of sucrose esters of fatty acids (E 473) for its uses as food additive in food for infants below 16 weeks of age. In addition, the FAF Panel was requested to address the issues already identified by the EFSA AFC and ANS Panels when used in food for the general population. The process involved the publication of calls for data to allow the interested business operators to provide the requested information to complete the risk assessment. The Panel concluded that the technical data provided by the interested business operators support an amendment of the specifications for sucrose esters of fatty acids (E 473) laid down in Commission Regulation (EU) No 231/2012. According to the available information, E 473 is not used in food categories (FCs) 13.1.1 and 13.1.5.1, including all types of food for infants below 16 weeks of age, and in FC 13.1.5.2. As a consequence, an assessment of the safety for the uses of E473 as food additive in these FCs and age group was not performed. When the updated exposure estimates considering the provided use levels for some food categories are taken into account the estimates of exposure to sucrose esters of fatty acids (E 473) exceeded the group acceptable daily intake (ADI) of 40 mg/kg body weight (bw) per day for many population groups.

Modelling potential human exposure to the nitrification inhibitor dicyandiamide through the environment-food pathway

Dicyandiamide (DCD) is a nitrification inhibitor that effectively reduces nitrogen losses from fertiliser applied to pastures and has the potential to reduce greenhouse gas emissions. Detection of DCD in dairy products in New Zealand led to safety concerns of food products from animals grazing pastures treated with DCD at high application rates (10 kg/ha). This study explores potential risks associated with DCD's application to agricultural grasslands wherein DCD is applied with fertiliser-N at recommended rates. Probabilistic risk assessment method was employed to calculate human Estimated Daily Intake (EDI) of DCD from milk following two application methods (co-application of DCD with granular N-fertiliser and liquid N-fertiliser). The exposure assessment model consists of five separate modules covering application/soil conditions, field conditions, animal feeding, milk production and human exposure/risk to characterise risk in humans. The predicted mean DCD concentration in milk was 0.005 mg DCD/kg milk for the granular method and 0.05 mg DCD/kg milk for the liquid method, respectively. Furthermore, EDI of DCD for both the granular and liquid methods (1 × 10−5 mg and 1 × 10−4 mg DCD/kg body weight/ day, respectively) were well below the European Food Safety Authority set Tolerable Daily Intake limit of 1 mg DCD/kg body weight/ day. Back-calculation revealed that under the conditions of co-application of DCD with granular and liquid nitrogen fertilisers at maximum permissible rates, for EDI to exceed TDI of 1 mg DCD/kg body weight/ day, DCD application rate would need to exceed DCD fertiliser limit (2.25–4.5% by mass of urea nitrogen) set in Commission Regulation (EC) No 1107/2008, and the bio-transfer factor would need to be over 100%. From the sensitivity analysis, for both application types it was found that phytoaccumulation factors, milk intake and the bio-transfer factors are critical factors influencing the EDI. From the present study, the Margin Of Safety values for both application types exceed 1; indicating DCD does not present a significant risk to human health.

Short-selling threats and bank risk-taking: Evidence from the financial crisis

The focus of this paper is whether the Securities and Exchange Commission's Regulation SHO strengthens or weakens the effect of short-selling threats on banks’ risk-taking. The evidence shows that pilot banks with looser constraints on short-selling increased their risk-taking during the financial crisis of 2007–2009. The reason is that short-selling threats improved the information environment and mitigated the agency problems of banks during the pilot program that led to greater risk-taking by pilot banks. Additionally, this effect is mainly driven by pilot banks with poor corporate governance, or high information asymmetry. Overall, our paper provides novel evidence that the disciplinary role of short-sellers had a positive effect on bank risk-taking during the financial crisis.

Food safety culture in food companies: evaluation of the perception of food safety culture in three Tuscan food companies.

The Commission Regulation (EU) No. 2021/382 (European Commission, 2021), amending the Regulation (EC) No. 852/2004 (European Commission, 2004), introduced the obligation for companies to establish and maintain a food safety culture (FSC). The methodology to evaluate, implement, and enhance the level of FSC is up to the individual companies. This study aimed to investigate the perception of FSC among the employees of 3 Tuscan medium-sized enterprises in the food sector, producing cured meat (A), dairy products (B), and frozen fish products (C). The survey was conducted through the development and administration of a questionnaire based on a 5 points Likert scale, referring to different aspects of FSC, organized in 6 sections with 5-6 statements each and subjected to a percentage of employees between 76 and 85%, classified also by the length of service (≤3 and >3 years). For all the companies, the minimum median and mode value for scores obtained by the different sections was 4, and the minimum median and mode value for the single statement was 3 (A, B; except for a bimodal value 2-4) and 4 (C). The section awareness and perception of risk showed the highest mean scores in all companies. As for the length of service, senior employees gave lower scores than junior ones in all sections in B and 3 sections in C. Overall, the results of the questionnaires showed a good perception of FSC, even though it was possible to identify some partial weaknesses.

Extravasation of radiopharmaceuticals: Why report?

In this essay, I wish to discuss extravasation in the context of medical imaging and therapy with radiopharmaceuticals. Central to this discussion are two facts. First, they are easily identified, but the frequency of significant extravasations is unclear because there is no generally accepted definition of such an event. And second, there appears to be few reports of injuries from these events. The central thesis of this essay is that these events should be reported and followed so that agreement can be reached on the definition of a "significant" event which should be classified as a medical event in accordance with US Nuclear Regulatory Commission (NRC) regulations. I will also outline steps that can be taken to reduce the risk of extravasations.

Application of nano-LC – nano-ESI – Orbitrap-MS for trace determination of four priority PFAS in food products considering recently established tolerable weekly intake (TWI) limits

An analytical method was developed and validated for the analysis of four priority perfluoroalkyl substances (PFAS), namely, perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), perfluorohexanesulfonic acid (PFHxS), and perfluorooctanesulfonate (PFOS) in food products using nanoscale liquid chromatography (nano-LC) coupled with nanoscale electrospray ionization (nano-ESI) and Orbitrap mass spectrometry (Orbitrap-MS) detection. The efficiency of two different nano-LC setups for chromatographic separation of selected PFAS was evaluated. The optimal LC separation of analytes was achieved using a reversed phase C18 (RP-C18) nano bore column with an integrated emitter. The effect of matrix concentration factor on signal suppression/enhancement was evaluated for different matrices. The method validation indicated analyte recoveries in the range 83–118% and within-laboratory reproducibility from 7 to 18%, while reanalysis of the materials from proficiency tests (PTs) showed that the accuracy of the obtained concentrations ranged from 85 to 124% of the provided consensus values. The method limits of quantification (m-LOQs) were set as first validation levels ranging from 0.001 to 0.3 ng g−1 sample depending on the type of the food group. The observed method performance characteristics met the criteria stated in Commission Regulation (EU) 2022/1428, Commission Recommendation (EU) 2022/1431, as well as Guidance Document on Analytical Parameters for the Determination of Per- and Polyfluoroalkyl Substances (PFAS) in Food and Feed with regards to the compliance testing of PFAS maximum levels (MLs) and monitoring purposes. The elaborated method was applied for the analysis of selected priority PFAS in different food groups collected from the Latvian retail market.

Experts vs. Nonexperts in Online Crowdfunding Markets

The growth of crowdfunding markets that include both expert and nonexpert investors will soon accelerate due to recent changes in Securities Exchange Commission (SEC) regulations. Prior work has suggested that nonexperts (1) may benefit from experts’ participation via mimicking their trades, but (2) will also face a cost, as experts crowding nonexperts out of the best opportunities will ensure that nonexperts will suffer lower returns than experts. Traditional economic theory holds that the crowding effect means that the relative importance of nonexperts in the market will decline over time until they become unimportant. Exploiting a unique period in one crowdfunding market (Prosper.com) that allowed us to directly estimate the net cost of competing with better-informed experts, we found that the net negative effects of expert participation on nonexperts are small. We used simulations to both better understand (1) the market characteristics and crowdfunding platform choices that influence experts’ and nonexperts’ returns, their return gap, and the extent to which nonexperts are better or worse off relative to a market without expert participation, and (2) the factors that may contribute to the small expert/nonexpert Prosper return gap.

Securities and Exchange Commission Regulation and Non-GAAP Income Statements

ABSTRACTWe study firms’ decisions to provide non-GAAP income statements and the information environment consequences of Securities and Exchange Commission (SEC) comment letters directing them to stop disclosing such statements. We find firms voluntarily disclose non-GAAP income statements when firm and disclosure complexity, analyst following, and institutional ownership are higher. Using a difference-in-differences design, we find that, after firms stop disclosing full non-GAAP income statements at the direction of the SEC, the informativeness of non-GAAP earnings and overall earnings announcements decreases, information asymmetry increases, and analyst forecasts become less accurate and more disperse. We also find that firms not receiving a comment letter are more likely to stop providing non-GAAP income statements after an industry peer receives a non-GAAP income statement comment letter. Overall, our evidence suggests SEC comment letters about non-GAAP income statements appear to worsen the information environment for firms previously providing those statements.Data Availability: Data are available from the public sources cited in the text.

Use of instant controlled pressure drop technology for the preservation of edible insects' (yellow mealworm) quality: assessment of microbial inactivation.

The world population is expanding, and with it, so is the need for proteins for the food and feed sectors. Conventional livestock production is correlated with negative environmental repercussions such as global warming, land degradation, and biodiversity loss. The nutritional content of edible insects is comparable to that of conventional meat, and insect farming offers various environmental advantages over livestock production, making it a favorable sustainable protein resource. However, to be placed on the market, insects should be processed, and their microbial load should be within the accepted range of the European Commission regulation (EU) 2021/882. The purpose of this research is to investigate the use of instant controlled pressure drop (DIC) technology for the microbial inactivation of yellow mealworm larvae. This innovative decontamination treatment was compared to blanching in hot water, the conventional processing method. We also investigated the impacts on enzymatic browning. Results showed that the application of rapid (20s) DIC treatment at 0.3MPa allowed reducing the total aerobic count and the total yeast and mold count of larvae below the thresholds authorized by the commission regulation. Pressure, temperature, and number of cycle factors were found to have significant effects on the decontamination, while the treatment time had no effect for most treatments. In regard to blanching, we were able to get the authorized load at 90°C for 360s. Decimal reduction times for DIC and blanching treatments were found to be 3.8s and 67.8s for total aerobic count, and 3s and 57s for total yeast and mold count, respectively. Furthermore, DIC-treated larvae showed a significant increase in juice color brightness, which could be traced back to the oxidative enzymatic inactivation of larvae, whereas there was a slight difference between blanched and untreated larvae juice colors.

An Improved Analytical Approach Based on µ-QuEChERS Combined with LC-ESI/MS for Monitoring the Occurrence and Levels of Patulin in Commercial Apple Juices

Patulin (PAT) is a mycotoxin produced in fruits, especially in apples, by diverse fungal species that can be transferred into industrial apple juice during processing. An accurate, effective, and selective method has been validated for the quantification of PAT in different commercial apple juices by combining a modified µ-QuEChERS procedure with high-pressure liquid chromatography (LC) equipped with a triple quadrupole mass spectrometer (QqQMS). This sample extraction procedure reduced interference from the sugar-rich matrix, and the separation was performed using the C18 Atlantis T3 column within 10 min. PAT was found by MS with electrospray negative ionization (ESI−) in the mode of multiple reaction monitoring (MRM). The correlation coefficient (R2 = 0.999) satisfied the prerequisite of linearity for PAT in the concentration range of 2–50 μg/kg. The limits of detection (LOD) and quantification (LOQ) of PAT were 0.32 and 1.15 μg/kg, respectively, which were compliant with the maximum levels settled in Commission Regulation (EC) No. 1881/2006. The recoveries were within the 92–103% range, at three fortified levels of 2, 20 and 50 μg/kg, with relative standard deviations lower than 7%. Based on analytical validation, it was confirmed that the µ-QuEChERS/HPLC-MS/MS method is an enhanced, reliable, and quick approach for determination of PAT in apple juice. The current approach proposes reduced sample preparation and analysis time. In addition, it is economical, environmentally friendly, and simpler to implement in comparison to traditional approaches.

Federal Charities Law and the Taxation Power: Three Constitutional Problems

The Australian Charities and Not-for-Profits Commission Act 2012 and Australian Charities and Not-for-Profits Commission Regulation 2013 have established a comprehensive regulatory framework for the charities and not-for-profit sector at a federal level. When making the Act and Regulation the Commonwealth relied upon several heads of legislative power in section 51 of the Constitution, the most important of which is the taxation power. This article develops and assesses three arguments why the relevant provisions of the legislative scheme are not supported by the taxation power. These arguments are, firstly, that the Act and Regulations do not have a sufficient connection to the subject matter of taxation, secondly, that they are not reasonably capable of being considered appropriate and adapted to achieving a legitimate purpose or object that falls within the taxation power and, thirdly, that in combination with the Income Tax Act 1986 and Income Tax Assessment Act 1997, they impose an obligation to pay money in a manner that is so arbitrary that they cannot be characterised as laws with respect to the subject matter of taxation. It is concluded that these three lines of argument provide strong reasons why the Act and Regulations are not supported by the taxation power.

The Dispute on Determination of the General Election Commission Members: A Study of Administrative Effort Implementation

This study aims to describe the position of the Selection Team at the State Administrative Court, as well as analyze dispute resolution procedures within the scope of the General Election Commission administration. This study uses a normative juridical method. The collected legal material is analyzed using qualitative data analysis methods with a statute approach to describe the problem and answer study purposes. The results show that the position of the Selection Team is a witness in the process of dispute resolution at the State Administrative Court. Furthermore, the detrimental parties may submit an objection and appeal effort. In this case, administrative dispute resolution has been regulated in General Election Commission Regulation No. 3 of 2021. On the other hand, Judges will only adjudicate cases and resolve disputes at the State Administrative Court after the plaintiff has undergone administrative efforts. Therefore, it is recommended for the Judge to reject lawsuits from the plaintiffs if the lawsuit positions the Selection Team as the defendant. In addition, it is also recommended that the plaintiff know and understand dispute resolution procedures on the determination of members of the General Election Commission at the State Administrative Court. In contrast, if the plaintiff has undergone administrative effort while the General Election Commission rejects the effort. So to get legal certainty, the plaintiff must submit a lawsuit by positioning the Commissioner of the General Election Commission as the defendant at the State Administrative Court.

Occurrence and congener profiles of dioxins (PCDDs), furans (PCDFs) and polychlorinated biphenyls (PCBs) in ovine and caprine milk samples collected in a very polluted site in Central Italy

Concentrations of 7 polychlorinated dibenzo-p-dioxins (PCDDs), 10 polychlorinated dibenzofurans (PCDFs) and 18 polychlorinated biphenyls (PCBs), including 12 dioxin-like (DL-PCBs) and 6 non-dioxin-like PCBs (NDL-PCBs) were measured in 16 ovine and caprine milk samples collected in the territory of Bussi sul Tirino, central Italy, a Site of National Interest (SNI) due to its high and widespread environmental pollution. All the analyzed samples were compliant with the maximum levels fixed by Commission Regulation (EU) 1259/2011 for the content of PCDD/Fs and the sum of PCDD/Fs and DL-PCBs. In two cases, contamination levels of the sum of PCDD/Fs and DL-PCBs were higher than the action levels fixed by EU Recommendation 663/2014. The statistical analysis, performed by Principal Component Analysis (PCA), revealed that the differences in contamination profiles of the different milk samples were independent of the distance of the farms from the Bussi illegal landfill but likely related to local emission sources influencing the exposure to POPs of studied animals.

Re-evaluation of locust bean gum (E 410) as a food additive in foods for infants below 16 weeks of age and follow-up of its re-evaluation as a food additive for uses in foods for all population groups.

Locust bean gum (E 410) was re-evaluated in 2017 by the former EFSA Panelon Food Additives and Nutrient sources added to Food (ANS). As a follow-up to that assessment, the Panelon Food Additives and Flavourings (FAF) was requested to assess the safety of locust bean gum (E 410) for its uses as a food additive in food for infants below 16 weeks of age belonging to food category 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants). In addition, the FAF Panelwas requested to address the issues already identified during the re-evaluation of the food additive when used in food for the general population, including the safety assessment for FC 13.1.5.1 and 13.1.5.2 (Dietary foods for babies and young children for special medical purposes as defined in directive 1999/21/EC). The process involved the publication of a call for data. Based on the received data, the Panelconcluded that the technical data provided by the interested business operators support an amendment of the specifications for locust bean gum (E 410) laid down in Commission Regulation (EU) No 231/2012. The Panelidentified a reference point of 1,400mg/kg bw per day based on reduced blood zinc levels in a piglet study. It applied the margin of exposure (MoE) for the safety assessment of locust bean gum (E 410) when used as a food additive in FC 13.1.5.1 and 13.1.5.2. The Panelconcluded that a MoE above 1 would not raise a safety concern. A MoE above 1 was obtained for some of the scenarios and exposure levels for infants. For toddlers (consumers only of food for special medical purposes), the MoE was above 1 for all exposure levels.

A comparative assessment of two different methods, using devices Optiscan-TP and Optigrade-MCP, for predicting the lean meat percentage of pig carcasses in Greece in relation to the European reference method

Lean Meat Percentage (LMP) is a key index for assessing pork carcass quality as well as determining carcass classification and price. This framework offers to farmers the incentive to achieve the desired organoleptic features; therefore LMP must be measured objectively online, by means of various measuring instruments. The aim of this work was to assess two different methods for predicting the lean meat percentage of pig carcasses in Greece in comparison to the European reference method. For this reason, the same 130 pig carcasses (65 males and 65 females) were measured using 2 prediction devices (Optiscan-TP and Optigrade-MCP) and subsequently were assessed according to European reference method. A formula corresponding to each device was constructed using the ordinary least squares (OLS)method and excluding the same outliers. Calculated RMSEP for all 130 carcasses was 2.46518 for Optiscan-TP and 2.48489 for Optigrade-MCP. It can be concluded that both methods perform entirely according to EU legislation (Commission Regulation (EC) 1249/2008, European Union, 2008), and results obtained are similar regardless of different measurement points and technologies.

FOOD CONTAMINATION – CHARACTERISTICS AND LEGAL REGULATIONS. PART I – PLANT TOXINS

Food health safety is a set of conditions that must be met and actions that must be taken at all stages of production of or trade in food in order to ensure human health and life.. Food safety is guaranteed by appropriately shaped food law, and the food safety policy pursued by the European Union institutions covers all stages of the food chain, from production to consumption, and guarantees the clarity of infor mation on the origin and composition of food and its labelling. However, not all hazards can be completely eliminated from food, which is why their residues are strictly regulated by law. The key solution in this area was Commission Regulation (EC) No. 1881/2006 of 19 December 2006 setting the maximum levels of certain contaminants in foodstuffs. This legal act, which had been supplemented and amended many times, was replaced by Commission Regulation (EU) 2023/915 of 25 April 2023 on the maximum levels of certain contaminants in food and repealing Regulation (EC) No. 1881/2006. The aim of the work was to characterize plant toxins as contaminants in food, the highest permissible levels of which were introduced by amendments to Regulation EC 1881/2006 and included in the current EU Regulation 915/2023. Results and conclusions: Numerous amendments to Regulation 1881/2006, and consequently Regula tion 2023/915, introduced the highest permissible levels for the following plant toxins: erucic acid, tropane and pyrrolizidine alkaloids and opium alkaloids, hydrogen cyanide and cyanogenic glycosides, and delta 9-tetrahydrocannabinol equivalents. Due to the potential threat of these substances, their highest residues in individual foodstuffs must be regulated and monitored as part of official food control activities, while when obtaining raw materials that may contain this type of substances, it is necessary to follow appropri ate recommendations and good practices.

Review of the existing maximum residue levels for dithianon 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 dithianon. To assess the occurrence of dithianon 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 MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States and the UK, including the supporting residues data. Given that a data gap as regards the magnitude of residues of the metabolites 1,4-naphthoquinone and phthalic acid was identified in the peer review for dithianon in light of confirmatory data, the toxicological profile of these metabolites was also assessed in the framework of the Article 12 MRL review. 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. In particular, it is highlighted that the toxicological reference values derived for the metabolite 1,4-naphthoquinone are provisional only, pending a conclusion on the mutagenicity potential. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers.