Existing Maximum Residue Levels Research Articles

Modification of the existing maximum residue levels for sulfoxaflor in grape leaves and similar species, and globe artichokes.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences Ltd submitted two separate requests to the competent national authority in France to modify the existing maximum residue levels (MRLs) for the active substance sulfoxaflor in grape leaves and globe artichokes. The data submitted in support of the requests were found to be sufficient to derive MRLs proposals of 2 mg/kg in grape leaves and similar species and of 0.06 mg/kg in globe artichokes. Adequate analytical methods for enforcement are available to control the residues of sulfoxaflor 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 uses of sulfoxaflor on grape leaves and similar species and globe artichokes according to the reported agricultural practices is unlikely to present a risk to consumers’ health.

Pesticide active substances that do not require a review of the existing maximum residue levels under Article 12 of Regulation (EC) No396/2005.

According to Article 5(1) of Regulation (EC) No 396/2005, active substances of plant protection products evaluated under Directive 91/414/EEC for which no maximum residue levels (MRLs) are required shall be defined and listed in Annex IV to this Regulation. Among the active substances that need to be reviewed under Article 12 of Regulation (EC) No 396/2005, EFSA identified nine active substances that were already included in Annex IV of Regulation (EC) No 396/2005 by risk managers, without identifying any need for further assessment. EFSA prepared a statement explaining that for those nine active substances a review of MRLs is no longer necessary. The relevant question numbers are considered addressed by this statement.

Setting of maximum residue levels for cyantraniliprole in raspberries and blackberries.

In accordance with Article 53 of Regulation (EC) 1107/2009, the United Kingdom granted a 120‐day emergency authorisation for the use of cyantraniliprole in raspberries and blackberries. In order to accommodate for the new uses, the Agriculture & Horticulture Development Board submitted an application to raise the existing maximum residue level (MRL) for the crops concerned. The United Kingdom, as evaluating Member State, summarised the data provided by the applicant in an evaluation report which was submitted to the European Commission and forwarded to EFSA. Sufficient residue trials are available to derive an MRL proposal of 0.9 mg/kg for raspberries and blackberries grown under indoor/greenhouse conditions. For the NEU outdoor use on raspberries/blackberries, the available information was insufficient to derive an MRL proposal. Adequate analytical methods for enforcement are available to control the residues of cyantraniliprole in the commodities under consideration. Based on the risk assessment results, EFSA concluded that intake of residues resulting from the use of cyantraniliprole according to the reported agricultural practices (indoor/greenhouse use) is unlikely to present a risk to consumer health.

Review of the existing maximum residue levels for pyridaben according to Article 12 of Regulation (EC) No396/2005.

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 pyridaben. To assess the occurrence of pyridaben residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC and under 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 some MRL proposals derived by EFSA still require further consideration by risk managers.

Modification of the existing maximum residue levels for folpet in apples and pears.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Belchim Crop Protection NV/SA submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRL) for the active substance folpet in apples and pears. The data submitted in support of the request were found to be sufficient to derive MRL proposals for these two crops. Appropriate analytical methods allowing monitoring the proposed MRLs are available. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intakes of residues resulting from the intended uses of folpet according to the reported agricultural practice are unlikely to present a risk to consumers’ health.

Modification of the existing maximum residue level for tefluthrin in carrots.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta France S.A.S. submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for the active substance tefluthrin in carrots. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for carrots. Adequate analytical methods for enforcement are available to control the residues of tefluthrin in carrots 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 tefluthrin according to the reported agricultural practices is unlikely to present a risk to consumer health. The reliable end points, appropriate for use in regulatory risk assessment are presented.

Modification of the existing maximum residue level for abamectin in bananas.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Cheminova Agro Italia Srl submitted a request to the competent national authority in Italy to modify the existing maximum residue level (MRL) for the active substance abamectin in bananas. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under consideration. Adequate analytical methods for enforcement are available to control the residues of abamectin in the plant matrix under consideration. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of abamectin according to the reported agricultural practice is unlikely to present a risk to consumer health.

Review of the existing maximum residue levels for carboxin according to Article 12 of Regulation (EC) No396/2005.

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 carboxin. To assess the occurrence of carboxin residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC 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. Some information required by the regulatory framework was missing and a risk to consumers cannot be excluded for the existing EU MRLs. Hence, the consumer risk assessment is considered indicative only and all MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.

Modification of the existing maximum residue levels for fluxapyroxad in various crops.

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member States (EMS), the Netherlands and the United Kingdom, received an application from BASF SE to modify the existing maximum residue levels (MRLs) for the active substance fluxapyroxad in several crops in order to accommodate for proposed new uses in Europe and for the import of crops. According to EFSA, the data are sufficient to derive MRL proposals for all the crops assessed, except for citrus fruits other than oranges and grapefruits. Adequate analytical enforcement methods are available to control the residues of fluxapyroxad on the commodities under consideration, but additional validation data on herbal infusion and spices would be desirable. Based on the risk assessment results, EFSA concluded that the proposed uses on various crops of fluxapyroxad and the use authorised in Brazil on oranges and grapefruits for which import of crops has been requested, will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a consumer health risk.

Modification of the existing maximum residue level for acibenzolar-S-methyl in kiwi fruits.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta France SAS submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for the active substance in kiwi fruits. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for the crop under consideration. Adequate analytical methods for enforcement are available to control the residues of acibenzolar‐S‐methyl in the plant matrix under consideration. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of acibenzolar‐S‐methyl according to the reported agricultural practice is unlikely to present a risk to consumer health.

Modification of the existing maximum residue level for fluopyram in purslanes.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue level (MRL) for the active substance fluopyram in purslanes. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for purslanes. Adequate analytical methods for enforcement are available to control the residues of fluopyram in plant matrices/on the commodity under consideration. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of fluopyram according to the reported agricultural practice is unlikely to present a risk to consumer health.

Review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No396/2005.

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 imazalil. To assess the occurrence of imazalil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC and under Regulation (EC) No 1107/2009, 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, MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was missing and a possible chronic and acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.

Review of the existing maximum residue levels for bromuconazole according to Article 12 of Regulation (EC)No396/2005.

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 bromuconazole. To assess the occurrence of bromuconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the 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.

Modification of the existing maximum residue level for bifenazate in soya bean.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta LifeScience Great Britain Ltd submitted a request to the competent national authority in Italy to set new maximum residue level (MRL) for the active substance bifenazate in soya beans. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for soya beans. Adequate analytical methods for enforcement are available to control the residues of bifenazate and its metabolite in the commodity under consideration. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of bifenazate according to the reported agricultural practice is unlikely to present a risk to consumer health.

Review of the existing maximum residue levels for paclobutrazol according to Article 12 of Regulation (EC) No396/2005.

According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance paclobutrazol. To assess the occurrence of paclobutrazol residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC 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 some MRL proposals derived by EFSA still require further consideration by risk managers.

Review of the existing maximum residue levels for etofenprox according to Article 12 of Regulation (EC) No396/2005.

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 etofenprox. To assess the occurrence of etofenprox residues in plants, processed commodities, rotational crops 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, 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.

Focussed review of the existing maximum residue levels for lambda-cyhalothrin in light of the unspecific residue definition and the existing good agricultural practices for the substance gamma-cyhalothrin.

In compliance with Article 43 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) received from the European Commission a mandate to provide its reasoned opinion on the existing maximum residue levels (MRLs) for lambda‐cyhalothrin which might lead to consumers intake concerns on the basis of the new toxicological reference values for gamma‐cyhalothrin and of the data currently available to EFSA for lambda‐cyhalothrin. In order to identify the MRLs of potential concern that require a more detailed assessment, EFSA performed a conservative risk assessment screening taking into account the crops for which MRLs were proposed in the framework of the Article 12 and the Article 43 of Regulation (EC) No 396/2005 reflecting the use of lambda‐cyhalothrin and the new toxicological reference values for gamma‐cyhalothrin.

Modification of the existing maximum residue levels for difenoconazole in various crops.

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member States (EMS), Greece and Austria, received applications from Syngenta and Adama, respectively, to modify the existing maximum residue levels (MRLs) for the active substance difenoconazole in various crops and barley, respectively. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for all crops under consideration. Adequate analytical methods for enforcement are available to control the residues of difenoconazole on the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed uses of difenoconazole on the commodities under consideration will not result in a consumer exposure exceeding the toxicological reference values for the active substance and therefore are unlikely to pose a consumer health risk, except for the indoor use on scaroles. An acute consumer risk cannot be excluded for this use and a lower MRL is proposed based on the outdoor uses only.

Modification of the existing maximum residue levels for fluazifop-P in various products of plant and animal origin.

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 Portugal to modify the existing maximum residue levels (MRL) for the active substance fluazifop‐P in tomato, carrot and courgette. The data submitted in support of the request were found to be sufficient to derive MRL proposals for carrot and courgette. For tomato, data gaps were identified which precluded the derivation of MRL proposal. Adequate analytical methods for enforcement are available to control the residues of fluazifop‐P in plant matrices under consideration. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of fluazifop‐P on carrots and courgettes according to the reported agricultural practices and the products of animal origin under consideration is unlikely to present a risk to consumer health.

Modification of the existing maximum residue levels for fluazinam in onions, shallots and garlic.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Adama Makhteshim submitted a request to the competent national authority in the Netherlands to set maximum residue levels (MRL) for the active substance fluazinam in onions, shallots and garlic. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under consideration. An adequate analytical method for enforcement is available to control the residues of fluazinam in plant matrices. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of fluazinam according to the intended agricultural practices is unlikely to present a risk to consumer health.