Risks for animal and human health related to the presence of polychlorinated naphthalenes (PCNs) in feed and food.

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.

Risks for human health related to the presence of grayanotoxins in certain honey.

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.

Retrospective cumulative dietary risk assessment of craniofacial alterations by residues of pesticides.

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.

Peer review of the pesticide risk assessment of the active substance Purpureocillium lilacinum strain PL11.

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.

Modification of the existing maximum residue levels for cyantraniliprole in olives.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant FMC International Switzerland Sarl (FISSarl) submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for the active substance cyantraniliprole in table olives and olives for oil production. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the intended uses of cyantraniliprole in olives. Adequate analytical methods for enforcement are available to control the residues of cyantraniliprole in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the intake of residues resulting from the uses of cyantraniliprole according to the reported agricultural practices is unlikely to present a risk to consumer health.

Peer review of the pesticide risk assessment of the active substance Straight Chain Lepidopteran Pheromones (SCLPs).

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co-rapporteur Member State France for the pesticide active substances that are Straight Chain Lepidopteran Pheromones (SCLPs) and the considerations as regards the inclusion of the substances in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of representative uses of some SCLPs as semiochemicals used to protect grapes, pome fruits, walnuts, rice and any other crop (where Chilo suppressalis may be a pest) (all field uses). The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Modification of the existing maximum residue levels for tau-fluvalinate in tomatoes and watermelons.

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.

Peer review of the pesticide risk assessment of the active substance carbon dioxide.

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, France, and co-rapporteur Member State, Austria, for the pesticide active substance carbon dioxide 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 Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of carbon dioxide as an insecticide and acaricide on stored cereal grains, oilseeds, medicinal plants, cereal products, spices, tobacco, tea, dried fruits and other stored plant products (except semolina and oilseed meal) (all indoor uses). The reliable end points, appropriate for use in regulatory risk assessment, are presented.

Review of the existing maximum residue levels for 8-hydroxyquinoline according to Article 12 of Regulation (EC) No 396/2005.

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance 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.

Peer review of the pesticide risk assessment of the active substance Bacillus amyloliquefaciens strain IT-45.

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, France, for the pesticide active substance Bacillus amyloliquefaciens strain IT-45 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 use of Bacillus amyloliquefaciens strain IT-45 as a fungicide on citrus (field use, application to soil via drip irrigation systems). The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Review of the existing maximum residue levels for 1,4-dimethylnaphthalene according to Article 12 of Regulation (EC) No 396/2005.

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance 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.

Modification of the existing maximum residue levels for folpet in barley, oat, rye and wheat.

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.

Modification of the existing maximum residue levels for flupyradifurone and DFA in okra/lady's finger.

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.

Review of the existing maximum residue levels for valifenalate 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 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.

Modification of the existing maximum residue levels and setting of import tolerances for thiabendazole in various crops.

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.

Peer review of the pesticide risk assessment of the active substance potassium hydrogen carbonate.

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, the Netherlands and co-rapporteur Member State, Greece, for the pesticide active substance potassium hydrogen carbonate 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 Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of potassium hydrogen carbonate as a fungicide on strawberry, wine and table grapes, pome fruits, stone fruits, ornamentals and cucurbits. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are not identified.

Modification of the existing maximum residue levels for spirotetramat in leeks, spring onions and honey.

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.

Peer review of the pesticide risk assessment of the active substance Bacillus thuringiensis subsp. kurstaki strain EG2348.

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Denmark, and co-rapporteur Member State, the Netherlands, for the pesticide active substance Bacillus thuringiensis subsp. kurstaki strain EG2348 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 Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of Bacillus thuringiensis kurstaki strain EG2348 as an insecticide on pome fruits (field use), solanaceous fruiting vegetables (uses in permanent greenhouse and walk-in tunnel) and ornamentals (field, permanent greenhouse and walk-in tunnel uses). The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance Bacillus thuringiensis subsp. kurstaki strain PB 54.

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, Denmark, and co-rapporteur Member State, the Netherlands, for the pesticide active substance Bacillus thuringiensis subsp. kurstaki strain PB 54 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 Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of Bacillus thuringiensis subsp. kurstaki strain PB 54 as an insecticide on stone fruit and ornamentals (field uses) and tomato (field, permanent greenhouse and walk-in tunnel uses). The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance calcium carbonate.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Spain and co-rapporteur Member State Hungary for the pesticide active substance calcium carbonate are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of calcium carbonate as a repellent on deciduous and coniferous trees in forestry. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. No concerns were identified.