RESUMEN
EFSA was asked for a scientific opinion on the risks for animal and human health related to the presence of polychlorinated naphthalenes (PCNs) in feed and food. The assessment focused on hexaCNs due to very limited data on other PCN congeners. For hexaCNs in feed, 217 analytical results were used to estimate dietary exposures for food-producing and non-food-producing animals; however, a risk characterisation could not be performed because none of the toxicological studies allowed identification of reference points. The oral repeated dose toxicity studies performed in rats with a hexaCN mixture containing all 10 hexaCNs indicated that the critical target was the haematological system. A BMDL20 of 0.05 mg/kg body weight (bw) per day was identified for a considerable decrease in the platelet count. For hexaCNs in food, 2317 analytical results were used to estimate dietary exposures across dietary surveys and age groups. The highest exposure ranged from 0.91 to 29.8 pg/kg bw per day in general population and from 220 to 559 pg/kg bw per day for breast-fed infants with the highest consumption of breast milk. Applying a margin of exposure (MOE) approach, the estimated MOEs for the high dietary exposures ranged from 1,700,000 to 55,000,000 for the general population and from 90,000 to 230,000 for breast-fed infants with the highest consumption of breast milk. These MOEs are far above the minimum MOE of 2000 that does not raise a health concern. Taking account of the uncertainties affecting the assessment, the Panel concluded with at least 99% certainty that dietary exposure to hexaCNs does not raise a health concern for any of the population groups considered. Due to major limitations in the available data, no assessment was possible for genotoxic effects or for health risks of PCNs other than hexaCNs.
RESUMEN
The European Commission asked EFSA for a scientific opinion on the risks for human health of the presence of grayanotoxins (GTXs) in 'certain honey' from Ericaceae plants. The risk assessment included all structurally related grayananes occurring with GTXs in 'certain' honey. Oral exposure is associated with acute intoxication in humans. Acute symptoms affect the muscles, nervous and cardiovascular systems. These may lead to complete atrioventricular block, convulsions, mental confusion, agitation, syncope and respiratory depression. For acute effects, the CONTAM Panel derived a reference point (RP) of 15.3 µg/kg body weight for the sum of GTX I and III based on a BMDL10 for reduced heart rate in rats. A similar relative potency was considered for GTX I. Without chronic toxicity studies, an RP for long-term effects could not be derived. There is evidence for genotoxicity in mice exposed to GTX III or honey containing GTX I and III, showing increased levels of chromosomal damage. The mechanism of genotoxicity is unknown. Without representative occurrence data for the sum of GTX I and III and consumption data from Ericaceae honey, acute dietary exposure was estimated based on selected concentrations for GTX I and III reflecting concentrations measured in 'certain' honeys. Applying a margin of exposure (MOE) approach, the estimated MOEs raised health concerns for acute toxicity. The Panel calculated the highest concentrations for GTX I and III below which no acute effects would be expected following 'certain honey' consumption. The Panel is 75% or more certain that the calculated highest concentration of 0.05 mg for the sum of GTX I and III per kg honey is protective for all age groups regarding acute intoxications. This value does not consider other grayananes in 'certain honey' and does not cover the identified genotoxicity.
RESUMEN
EFSA established cumulative assessment groups and conducted retrospective cumulative risk assessments for two types of craniofacial alterations (alterations due to abnormal skeletal development, head soft tissue alterations and brain neural tube defects) for 14 European populations of women in childbearing age. Cumulative acute exposure calculations were performed by probabilistic modelling using monitoring data collected by Member States in 2017, 2018 and 2019. A rigorous uncertainty analysis was performed using expert knowledge elicitation. Considering all sources of uncertainty, their dependencies and differences between populations, it was concluded with varying degrees of certainty that the MOET resulting from cumulative exposure is above 100 for the two types of craniofacial alterations. The threshold for regulatory consideration established by risk managers is therefore not exceeded. Considering the severity of the effects under consideration, it was also assessed whether the MOET is above 500. This was the case with varying levels of certainty for the head soft tissue alterations and brain neural tube defects. However, for the alterations due to abnormal skeletal development, it was found about as likely as not that the MOET is above 500 in most populations. For two populations, it was even found more likely that the MOET is below 500. These results were discussed in the light of the conservatism of the methodological approach.
RESUMEN
The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, the United Kingdom, for the pesticide active substance Purpureocillium lilacinum strain PL11 and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of Purpureocillium lilacinum strain PL11 as nematicide on tomato, pepper, aubergine, cucumber, courgette, melon, watermelon, pumpkin (field and greenhouse applications). The reliable endpoints appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed.
RESUMEN
A retrospective cumulative risk assessment of dietary exposure to pesticide residues was conducted for chronic inhibition of acetylcholinesterase. The pesticides considered in this assessment were identified and characterised in a previous scientific report on the establishment of cumulative assessment groups of pesticides for their effects on the nervous system. The exposure assessments used monitoring data collected by Member States under their official pesticide monitoring programmes in 2016, 2017 and 2018, and individual food consumption data from 10 populations of consumers from different countries and from different age groups. Exposure estimates were obtained by means of a two-dimensional probabilistic model, which was implemented in SAS ® software. The characterisation of cumulative risk was supported by an uncertainty analysis based on expert knowledge elicitation. For each of the 10 populations, it is concluded with varying degrees of certainty that cumulative exposure to pesticides contributing to the chronic inhibition of acetylcholinesterase does not exceed the threshold for regulatory consideration established by risk managers.
RESUMEN
According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance 1,4-dimethylnaphthalene. To assess the occurrence of 1,4-dimethylnaphthalene residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, as well as the European authorisations reported by Member States and the UK (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and all MRL proposals derived by EFSA still require further consideration by risk managers.
RESUMEN
According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance 8-hydroxyquinoline. To assess the occurrence of 8-hydroxyquinoline residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and all MRL proposals derived by EFSA still require further consideration by risk managers.
RESUMEN
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta España S.A. submitted a request to the competent national authority in Spain to modify the existing maximum residue levels (MRLs) in citrus fruits, bananas and witloofs. Additionally, Syngenta Crop Protection AG submitted two applications to Spain to set import tolerances in mangoes and in sweet potatoes. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for the commodities under evaluation and for commodities of animal origin. Adequate analytical methods for enforcement are available to control the residues of thiabendazole in the commodities under consideration and in animal matrices at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of thiabendazole according to the reported agricultural practices is unlikely to present a risk to consumer health.
RESUMEN
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Adama Agriculture B.V on behalf of Adama Makhteshim Ltd submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRL) for the active substance folpet in barley, oat, rye and wheat. The data submitted in support of the request were found to be sufficient to derive MRL proposals for these commodities. Adequate analytical methods for enforcement are available to control the residues of folpet and phthalimide in dry commodities at the validated limit of quantification (LOQ) of 0.01 mg/kg per analyte. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of folpet according to the reported agricultural practices is unlikely to present a risk to consumer health.
RESUMEN
In accordance with Article 6 of Regulation (EC) No 396/2005, FPS Public Health, Food Chain Safety and Environment on behalf of Belgium (evaluating Member State, EMS) submitted an application to modify the existing maximum residue levels (MRLs) for the active substance flupyradifurone and its metabolite difluoroacetic acid (DFA) in okra/lady's finger. The data submitted in support of the request were found sufficient to derive MRL proposals for the crop under consideration. The potential contribution of DFA residues in okra/lady's finger from the soil uptake was also estimated. Adequate analytical methods for enforcement are available to control the relevant residues in the crop under consideration. Based on the risk assessment results, EFSA concluded that the long-term intake of residues of flupyradifurone and of its soil metabolite DFA resulting from the use of flupyradifurone is unlikely to present a risk to consumer health. Due to the lack of proper consumption data of okra/lady's finger, the acute exposure assessment could not be reliably undertaken but due to this crop being a minor commodity it is unlikely that acute consumer intake concerns will be associated with this crop.
RESUMEN
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 valifenalate. To assess the occurrence of valifenalate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, as well as European authorisations reported by Member States and the UK (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and one MRL proposal derived by EFSA still requires further consideration by risk managers.
RESUMEN
According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance pinoxaden. To assess the occurrence of pinoxaden residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States and the UK (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers.
RESUMEN
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ADAMA Agriculture BV on behalf of ADAMA Makhteshim Ltd submitted a request to the competent national authority in Denmark to modify the existing maximum residue levels (MRL) for the active substance tau-fluvalinate in tomatoes and watermelons. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for tomatoes. For watermelons, a change of the MRL recently set in the EU legislation is not required. Adequate analytical methods for enforcement are available to control the residues of tau-fluvalinate in the commodities under consideration. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the intended uses of tau-fluvalinate according to the reported agricultural practices is unlikely to present a risk to consumer health. The risk assessment shall be regarded as indicative.
RESUMEN
According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sulfuryl fluoride. To assess the occurrence of sulfuryl fluoride and fluoride ion residues in plants, processed commodities and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRLs were calculated, but a consumer risk assessment could be carried out for sulfuryl fluoride only. Although no apparent risk to consumers was identified for sulfuryl fluoride, a standard consumer risk assessment to fluoride ion could not be performed, lacking information on the toxicological reference values for fluoride. Hence, an 'overall' consumer risk assessment could not be performed, only tentative MRLs proposal could be derived and measures for reduction of the consumer exposure should also be considered. Nevertheless, considering that fluoride ion is naturally occurring in food of plant and animal origin, EFSA performed an indicative calculation of the consumer exposure to estimate whether the uses currently authorised will contribute significantly to the overall consumer exposure to fluoride.
RESUMEN
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for bentazone in beans and peas with and without pods. The data submitted in support of the request were found to be sufficient to derive MRL proposals for peas with pods. Results from the residue trials indicated that there is no need to modify the existing MRLs for beans with pods, beans without pods and peas without pods. Adequate analytical methods for enforcement are available to control the residues of bentazone and its metabolites in the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. EFSA concluded that the proposed use of bentazone on peas with pods will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers' health for parent bentazone. The risk assessment however is indicative and affected by additional, non-standard uncertainties resulting from the insufficient information related to the toxicological properties for 6-hydroxy-bentazone in the wheat metabolism study.
RESUMEN
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Italia Srl submitted a request to the competent national authority in Italy to set import tolerances for the active substance metiram in passion fruits/maracujas, bananas, pineapples and to modify the existing maximum residue level (MRL) in celeriacs on the basis of intended northern Europe (NEU) use. The data submitted in support of the request were found sufficient to derive MRL proposals for pineapples and passion fruits/maracujas; according to the data provided, the existing EU MRL in bananas did not require modification and the data were not sufficient to derive an MRL proposal for celeriacs. A consumer exposure calculation, which considered only metiram uses, indicated no long-term consumer intake concerns, but is affected by several uncertainties related to the lack of residue data reflecting the existing uses of metiram. A second exposure scenario in which the lack of information was overcome by conservative assumptions indicated potential chronic exposure concerns for a number of diets. The contribution of residues in the crops under consideration to the long-term consumer exposure is low. The consumer exposure to ethylenethiourea (ETU) residues from the existing and intended metiram uses indicated no consumer intake concerns. However, the risk assessment is affected by a number of uncertainties that could not be addressed with the currently available data. EFSA therefore proposed that a comprehensive consumer exposure to ETU residues is performed in the framework of Article 12 MRL review, considering the existing uses of dithiocarbamates that are known to degrade to ETU in processed products. Considering the inconclusive results and overall uncertainties in the risk assessment, EFSA is of the opinion that further risk management discussions are required whether a modification of existing dithiocarbamate MRLs is justified prior to the finalisation of the MRL review on metiram and other dithiocarbamates.
RESUMEN
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance difenoconazole in commodities belonging to the group of leafy brassica. The data submitted in support of the request were found to be sufficient to derive MRL proposals for leafy brassica. Adequate analytical methods for enforcement are available to control the residues of difenoconazole in plant matrices under consideration at the validated LOQ of 0.01 mg/kg and for difenoconazole and metabolite CGA205375 in animal matrices at the validated LOQ of 0.01 mg/kg for meat muscle, fat, liver, kidney and eggs and at the validated LOQ of 0.005 mg/kg for milk. Based on the risk assessment results, EFSA concluded that for the crops assessed in this application the short-term intake of residues resulting from the use of difenoconazole according to the reported agricultural practices is unlikely to present a risk to consumer health. Long-term consumer intake concerns cannot be excluded for the intended and existing difenoconazole uses as they are affected by uncertainties associated with the toxicity of metabolite CGA205375 and the lack of information on all existing difenoconazole uses in the EU. Overall, this risk assessment is considered provisional, pending the submission of confirmatory data on possible preferential metabolism/degradation of the four stereo isomers of difenoconazole in plants and has to be re-considered when the missing data become available. Additionally, this assessment does not take into consideration triazole derivative metabolites (TDMs) which may be generated by several pesticides belonging to the group of triazole fungicides as this application was submitted before September 2019 which is the date of application of the new strategy endorsed by the risk managers for the assessment of TDMs.
RESUMEN
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Exponent International Ltd. (on behalf of the U.S. Highbush Blueberry Council (USHBC)) submitted a request to the competent national authority in France to set an import tolerance for the active substance potassium phosphonates in blueberries. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for blueberries. Adequate analytical methods for enforcement are available to control the residues of phosphonic acid on the commodity under consideration at the validated limit of quantification (LOQ) of 0.1 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 potassium phosphonates according to the reported agricultural practice is unlikely to present a risk to consumer health. The consumer risk assessment shall be regarded as indicative and a refined intake assessment will be performed in the framework of the joint review of MRLs for fosetyl and phosphonates.
RESUMEN
In compliance with Article 43 of Regulation (EC) No 396/2005, the EFSA received from the European Commission a mandate to provide its reasoned opinion on the existing maximum residue levels (MRLs) for spinosad which might lead to consumers intake concerns on the basis of a new toxicological reference value established during the peer review and of the data currently available to EFSA. In order to identify the MRLs of potential concern that require a more detailed assessment, EFSA screened the existing MRLs for spinosad considering the new toxicological reference values and an acute risk could not be excluded for six commodities. Fall-back MRLs for all six commodities were proposed on the basis of the data received under the present assessment.
RESUMEN
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer S.A.S. - Crop Science division submitted a request to the competent national authority in Austria to modify the existing maximum residue levels (MRLs) for the active substance spirotetramat in leeks, spring onions and in honey. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all these crops and honey. Adequate analytical methods for enforcement are available to control the residues of spirotetramat and its metabolites in plant matrices on the commodities under consideration and in honey at the validated limit of quantification (LOQ) of 0.01 mg/kg for each analyte. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of spirotetramat according to the reported agricultural practices is unlikely to present a risk to consumer health.