Existing Maximum Residue Levels Research Articles

Modification of the existing maximum residue levels for aminopyralid in certain cereals.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences Denmark submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance aminopyralid in cereals. The data submitted in support of the request were found to be sufficient to derive MRL proposals for barley, rye, sorghum, millet and oats. A modification of the existing MRL of aminopyralid in wheat has been considered unnecessary. Adequate analytical methods for enforcement are available to control the residues of aminopyralid and its conjugates in plant matrices and on the commodities under assessment 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 aminopyralid according to the intended agricultural practices is unlikely to present a risk to consumer health.

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

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences submitted a request to the competent national authority in Ireland to modify the existing maximum residue levels (MRLs) for the active substance sulfoxaflor in various crops, including limes imported from Australia. The data submitted in support of the request were found to be sufficient to derive MRL proposals for limes, cauliflowers, Brussels sprouts, kales, spinaches and similar leaves, herbs and edible flowers, beans without pods, peas with pods, oat, rye and triticale (wheat). Adequate analytical methods for enforcement are available to control the residues of sulfoxaflor on the commodities under consideration. Based on the risk assessment results, EFSA concluded that the use of sulfoxaflor according to the intended good agricultural practices is unlikely to present a risk to consumers’ health.

Modification of the existing maximum residue levels for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Isagro S.p.A submitted a request to the competent national authority in Italy to modify the existing maximum residue levels (MRLs) for the active substance tetraconazole in various crops and animal commodities. The data submitted in support of the request were found to be sufficient to derive MRL proposals for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds. Adequate analytical methods for enforcement are available to control MRL compliance for parent compound tetraconazole on the commodities under consideration and in animal products. The proposed use of tetraconazole on crops under assessment will not result in a dietary exposure to residues of parent tetraconazole exceeding the toxicological reference values for tetraconazole. For triazole derivative metabolites (TDMs), only an indicative exposure assessment was performed considering only the crops under assessment; the results showed that the expected exposure to TDMs in the three assessed commodities is well below the toxicological reference values derived for the TDMs. The proposed use of tetraconazole on crops under assessment is therefore unlikely to pose a risk to consumers’ health. TDMs may be generated by several pesticides belonging to the group of triazole fungicides, a comprehensive risk assessment has thus to be performed that covers all existing EU uses and import tolerances for all pesticides belonging to the class of triazole fungicides. EFSA recommended to elaborate together with risk managers a strategy to ensure that the required data are made available to finalise the overall risk assessment for triazole fungicides.

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Landesanstalt für Landwirtschaft und Gartenbau Sachsen‐Anhalt (LSA) and Dienstleistungszentrum Ländlicher Raum Rheinpfalz (DLR), respectively, submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRL) for the active substance aclonifen in chives, parsley, celery leaves/dill leaves, thyme/savoury and in celeriacs/turnip‐rooted celery. 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 aclonifen in high water 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 exposure to residues resulting from the use of aclonifen according to the reported agricultural practices is unlikely to present a risk to consumer health.

Review of the existing maximum residue levels for hexythiazox 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 hexythiazox. To assess the occurrence of hexythiazox 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 import tolerances and 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 metam 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 metam. To assess the occurrence of metam residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008C 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 sedaxane 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 sedaxane. To assess the occurrence of sedaxane 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 (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.

Review of the existing maximum residue levels for spiromesifen 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 spiromesifen. To assess the occurrence of spiromesifen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Regulation (EC) No 1107/2009, the MRLs established by the Codex Alimentarius Commission, as well as the import tolerances and 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 imidacloprid 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 imidacloprid. To assess the occurrence of imidacloprid 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 import tolerances and/or 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/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 dazomet 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 dazomet. To assess the occurrence of dazomet 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 chromafenozide according to Article 12 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 chromafenozide. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for chromafenozide within the EU. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue limits) for this active substance. Therefore, residues of chromafenozide are not expected to occur in any plant or animal commodity and therefore a consumer risk assessment is not required. Nevertheless, the available information allowed EFSA to propose a marker residue definition and a limit of quantification (LOQ) for enforcement against potential illegal uses.

Review of the existing maximum residue levels for fluometuron 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 fluometuron. To assess the occurrence of fluometuron 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, an MRL proposal was derived and a consumer risk assessment was carried out. All information required by the regulatory framework was present and a risk to consumers was not identified. In addition, EFSA identified some data gaps which are not expected to impact on the validity of the MRL derived but which might have an impact on national authorisations.

Review of the existing maximum residue levels for triazoxide 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 triazoxide. To assess the occurrence of triazoxide 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. Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. All information required by the regulatory framework was present and a risk to consumers was not identified.

Modification of the existing maximum residue level for trifloxystrobin in broccoli.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance trifloxystrobin in broccoli. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for broccoli. Adequate analytical methods for enforcement are available to control the residues of trifloxystrobin on the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. EFSA performed a tentative risk assessment in which the calculated exposure to residues of trifloxystrobin and one of its metabolites CGA 321113 did not exceed the toxicological reference values derived for trifloxystrobin. The risk assessment is tentative since the toxicological properties of certain metabolites identified in some metabolism studies are not fully elucidated and data on the occurrence of metabolites CGA 357262, CGA 357261, CGA 331409 in crops for which MRLs were established in the past are not available.

Modification of the existing maximum residue level for captan in cranberries.

In accordance with Article 6 of Regulation (EC) No 396/2005, the Belgian Federal Public Service (FPS) for Health, Food chain safety and Environment, submitted an application as the competent national authority in Belgium to modify the existing maximum residue level (MRL) for the active substance captan in cranberries. The data submitted in support of the request were found to be sufficient to derive MRL proposal for cranberries. Adequate analytical methods for enforcement are available to control the residues of captan in plant matrices at the validated limit of quantification (LOQ) of 0.01 mg/kg for each analyte in the crops assessed. Based on the exposure calculation, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of captan according to the reported agricultural practice will not result in a consumer exposure exceeding the existing toxicological reference values.

Review of the existing maximum residue levels for pencycuron 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 pencycuron. To assess the occurrence of pencycuron 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. Some information required by the regulatory framework was missing and a possible risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only and no MRL proposals were derived by EFSA. Further consideration by risk managers are needed and measures for reduction of the consumer exposure should also be considered.

Modification of the existing maximum residue level for captan in hops.

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 the Netherlands to modify the existing maximum residue level for the active substance captan in hops. The data submitted in support of the request were found to be insufficient to conclude whether the existing residue definitions are appropriate for hops. Although the number of residue trials is sufficient to derive a tentative maximum residue level (MRL) for hops according to the residue definitions derived for fruits and fruiting vegetables, EFSA did not recommend this MRL for being implemented in the MRL legislation because due to the lack of a reliable residue definition for risk assessment. Adequate analytical methods for enforcement are available to control the residues of captan in hops.

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

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted two requests to the competent national authority in Germany. The first one, to modify the existing maximum residue levels (MRL) for the active substance pyraclostrobin in various crops and to set import tolerances for sugar canes and American persimmons; the second one to set import tolerances for pineapples and passion fruits/maracujas. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for mandarins, grapefruits, lemons, limes, passion fruits/maracujas, pineapples, flowering brassica, head cabbages, lamb's lettuce, cresses and other sprouts, land cresses, rucola, red mustards, baby leaf crops, globe artichokes and leeks. For oranges, American persimmons, spinaches and similar leaves and sugar canes, data gaps were identified which precluded the derivation of MRL proposals. The data submitted did not provide evidence that the existing MRLs for crops belonging to the group of lettuces and maize have to be modified to accommodate for the intended uses. For escaroles, no MRL was proposed as the intended use was found to lead to residues for which a potential consumer health risk cannot be excluded. EFSA concluded that the short‐term intake of residues resulting from the uses of pyraclostrobin according to the reported agricultural practices assessed is unlikely to present a risk to consumer health, except for escaroles, where the expected intake was found to exceed the toxicological reference value. Taking into account the existing and the proposed new MRLs, a long‐term intake concern for consumers was not identified.

Review of the existing maximum residue levels for tau-fluvalinate 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 tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate 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. An MRL application for modification of MRLs in products of animal origin was also considered in this review. 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 pyraclostrobin in soyabean.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for the active substance pyraclostrobin in soyabean. The data submitted in support of the request were found to be sufficient to derive MRL proposals for soyabean. The applicant provided a new validated analytical method to control residues of pyraclostrobin on the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg, which is a value lower than the one currently in use. Adequate analytical methods for enforcement in animal matrices at the validated LOQ of 0.01 mg/kg are available. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of pyraclostrobin according to the reported agricultural practice is unlikely to present a risk to consumer health.