Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nufarm España S.A. submitted an application to the competent national authority in Spain to modify the existing maximum residue levels (MRL) for the active substance dichlorprop-P in citrus fruits (except oranges). 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 dichlorprop-P in citrus fruits. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of dichlorprop-P according to the reported agricultural practices is unlikely to present a risk to consumer health.

-Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, Nufarm España S.A. submitted an application to the competent national authority in Spain (evaluating Member State, EMS) to modify the existing maximum residue levels (MRLs) for the active substance dichlorprop-P in citrus fruits (except oranges). The EMS drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 23 January 2017. To accommodate for the intended uses of dichlorprop-P in the southern Europe (SEU), the EMS proposed to raise the existing MRLs in all citrus fruits, except oranges, from the limit of quantification (LOQ) to 0.3 mg/kg.

EFSA bases its assessment on the evaluation report submitted by the EMS, the draft assessment report (DAR) (and its addenda) prepared under Directive 91/414/EEC, the Commission review report on dichlorprop-P, the conclusion on the peer review of the pesticide risk assessment of the active substance dichlorprop-P as well as the conclusions from previous EFSA opinions on dichlorprop-P, including the opinion on the MRL review according to Article 12 of Regulation (EC) No 396/2005 (hereafter MRL review).

The metabolism of dichlorprop-P following foliar application was investigated in fruit (oranges) and cereals/grasses (wheat) crop groups. Studies investigating the effect of processing on the nature of dichlorprop-P (hydrolysis studies) have not been performed and are not required as the overall chronic exposure amounts to less than 10% of the acceptable daily intake (ADI).

As the proposed use of dichlorprop-P is on permanent crops, investigations of residues in rotational crops are not required.

Based on the metabolic pattern identified in metabolism studies and the toxicological significance of metabolites, the residue definitions for fruit crop group and cereals/grasses crop group were proposed under the MRL review as the ‘sum of dichlorprop (including dichlorprop-P), its salts, esters and conjugates, expressed as dichlorprop’ for enforcement and risk assessment.

EFSA concludes that for citrus fruits assessed in this application, metabolism of dichlorprop-P in primary crops has been sufficiently addressed and that the previously derived residue definitions are applicable.

A sufficiently validated analytical method based on gas chromatography with mass spectrometry (GC–MS) is available to quantify residues in citrus fruits according to the enforcement residue definition. The method enables quantification of total residues at or above 0.02 mg/kg (LOQ).

The available residue data are sufficient to propose a MRL of 0.3 mg/kg for grapefruits, lemons, limes and mandarins, derived from a combined residue data set on oranges and mandarins.

New processing studies to investigate the magnitude of dichlorprop-P residues in processed citrus commodities have not been submitted in the framework of the current application.

Dried citrus pulp may be used for feed purposes, and therefore, a potential carry-over of dichlorprop-P residue into food of animal origin has to be assessed. The MRL review assessed livestock exposure to dichlorprop-P residues from the existing uses and derived tentative MRL proposals for animal commodities based on high intake of residues in cereals and grass. It is noted that approval restrictions of dichlorprop-P according to Regulation (EU) No 1166/2013, which entered into force after the publication of MRL review opinion, envisage a withdrawal of authorisations on grasslands and a modification of use pattern on cereals (lower application rate) by Member States by 9 June 2014. Thus, the dietary burden calculated under MRL review does not anymore reflect the actual livestock exposure to dichlorprop-P residues.

In order to see the potential contribution of residues in citrus dried pulp to the livestock exposure calculated under the MRL review, EFSA recalculated the dietary burden according to OECD guidance including the new residue data on citrus fruits and excluding the contribution of grass from livestock diet. For cereals, considering that fall-back good agricultural practices (GAPs) and residue data compliant with the approval restrictions are not available to EFSA, the same input values as derived during the MRL review were considered as a worst-case scenario. The results of the dietary burden calculation demonstrated that the exposure of all livestock species to dichlorprop-P residues exceeds the trigger values and is driven by residues in cereal by-products. Overall, the livestock exposure has significantly decreased for all livestock species, except for poultry where it now exceeds the trigger value. Therefore, for all animal commodities (except poultry), existing EU MRLs are considered sufficient to account for additional residues that could occur in animal matrices from the intake of dried citrus pulp. For poultry, further investigation on the metabolism and the magnitude of residues in tissues and in eggs is in principle required. Nevertheless, since poultry are not fed with citrus by-products, this is not considered relevant in the framework of the current application. EFSA acknowledges that the existing MRLs for animal commodities should be reconsidered in the view of approval restrictions. Lacking residue information in cereals according to fall-back GAPs, EFSA is not in the position to derive proper MRLs. This issue will be reconsidered in the framework of the renewal of the active substance approval which is in progress.

The toxicological profile of dichlorprop-P was assessed in the framework of the EU pesticides peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI of 0.06 mg/kg body weight (b)w per day and an acute reference dose (ARfD) of 0.5 mg/kg bw.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). The estimated long-term dietary intake was 2% of the ADI. The short-term exposure did not exceed the ARfD for any crops assessed in this application.

EFSA concludes that the proposed use of dichlorprop-P on citrus fruits will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumer health.

EFSA proposes to amend the existing MRLs as reported in the summary table below.

-Background

Regulation (EC) No 396/20051 (hereinafter referred to as ‘the MRL regulation’) establishes the rules governing the setting of pesticide maximum residue levels (MRLs) at European Union (EU) level. Article 6 of the MRL regulation lays down that any party having a legitimate interest or requesting an authorisation for the use of a plant protection product in accordance with Council Directive 91/414/EEC2, repealed by Regulation (EC) No 1107/20093, shall submit an application to a Member State to modify a MRL in accordance with the provisions of Article 7 of the MRL regulation.

The applicant Nufarm España S.A.4 submitted an application to the competent national authority in Spain, hereafter referred to as the evaluating Member State (EMS), to modify the existing MRLs for the active substance dichlorprop-P in citrus fruit (except oranges). This application was notified to the European Commission and the European Food Safety Authority (EFSA) and was subsequently evaluated by the EMS in accordance with Article 8 of the MRL regulation.

The EMS summarised the data provided by the applicant in an evaluation report which was submitted to the European Commission and forwarded to EFSA on 23 January 2017. The application was included in the EFSA Register of Questions with the reference number EFSA-Q-2017-00058 and the following subject:

Dichlorprop-P: Application to modify MRLs in various commodities

Spain proposed to raise the existing MRLs of dichlorprop-P in grapefruit, lemon, lime and mandarin from the limit of quantification (LOQ) (0.02 mg/kg) to 0.3 mg/kg.

EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation.

-Terms of Reference

In accordance with Article 10 of Regulation (EC) No 396/2005, EFSA shall assess the application and the evaluation report and give a reasoned opinion on the risks to the consumer and where relevant to animals associated with the setting of the requested MRLs. The opinion shall include:
•an assessment of whether the analytical method for routine monitoring proposed in the application is appropriate for the intended control purposes;
•the anticipated LOQ for the pesticide/product combination;
•an assessment of the risks of the acceptable daily intake and acute reference dose being exceeded as a result of the modification of the MRL;
•the contribution to the intake due to the residues in the product for which the MRLs was requested;
•any other element relevant to the risk assessment.

In accordance with Article 11 of the MRL regulation, EFSA shall give its reasoned opinion as soon as possible and at the latest within 3 months from the date of receipt of the application.

The evaluation report submitted by the EMS (Spain, 2016) and the exposure calculations using the EFSA Pesticide Residues Intake Model (PRIMo) are considered as supporting documents to this reasoned opinion and, thus, are made publicly available as background documents to this reasoned opinion. Furthermore, a screenshot of the Report sheet of the PRIMo is presented in Appendix C.

-The active substance and its use pattern

The detailed description of the intended southern Europe (SEU) use of dichlorprop-P in citrus fruits, which is the basis for the current MRL application, is reported in Appendix A.

Dichlorprop-P is the ISO common name for (R)-2-(2,4-dichlorophenoxy) propionic acid (IUPAC). The chemical structures of the active substance and its main metabolites are reported in Appendix E.

Dichlorprop-P was evaluated in the framework of Directive 91/414/EEC with Denmark designated as the rapporteur Member State (RMS) for the representative use as a foliar treatment on cereals/grass crop group. The draft assessment report (DAR) prepared by the RMS has been peer reviewed by EFSA (EFSA, 2006).

Following the peer review a decision on inclusion of the active substance in Annex I to Directive 91/414/EEC was published by means of Commission Directive 2006/74/EC5, which entered into force on 1 June 2007. According to Regulation (EU) No 540/20116, dichlorprop-P is deemed to have been approved under Regulation (EC) No 1107/2009. This approval was restricted to uses as herbicide only and included a requirement for the notifier to provide further confirmatory information on livestock metabolism and risk assessment for birds and herbivorous mammals. Confirmatory data were submitted, evaluated by the RMS and a peer review was carried out by EFSA (2012). Considering that a high acute risk for birds and mammals could not be excluded by EFSA, further restrictions to the approval have been established by means of Commission Implementing Regulation (EU) No 1166/2013.7 These restrictions stipulate that the use on grasslands shall no longer be authorised and that, as regards cereals, only applications in spring shall be authorised at application rates not exceeding 0.8 kg a.s./ha per application. Member States shall amend or withdraw authorisations in line with these restrictions by 9 June 2014 and any period of grace granted by Member States for disposal of stocks shall expire by 9 June 2015 at the latest.

The EU MRLs for dichlorprop-P are established in Annex II of Regulation (EC) No 396/2005. The review of existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (MRL review) has been performed (EFSA, 2014) and the proposed modifications have been implemented in the MRL legislation.8 It is noted that at the time of the MRL review the approval restrictions were still not in place. Therefore, the review included authorised uses on grasslands and uses on cereals at dose rates higher than 0.8 kg/ha.

After completion of the MRL review, EFSA has not issued any reasoned opinion on the modification of MRLs for dichlorprop-P.

-Assessment

EFSA has based its assessment on the evaluation report submitted by the EMS (Spain, 2016), the DAR (and its addenda) prepared under Directive 91/414/EEC (Denmark, 2005a,b, 2011), the Commission review report on dichlorprop-P (European Commission, 2013), the conclusion on the peer review of the pesticide risk assessment of the active substance dichlorprop-P (EFSA, 2006, 2012), as well as the conclusions from previous EFSA opinions on dichlorprop-P (EFSA, 2011, 2014).

For this application, the data requirements established in Regulation (EU) No 544/20119 and the guidance documents applicable at the date of submission of the application to the EMS are applicable (European Commission, 1997a, b, c, d, e, f, g, 2000, 2010a, b, 2016; OECD, 2011, 2013). The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation and the Authorisation of Plant Protection Products adopted by Commission Regulation (EU) No 546/2011.10

As the EU pesticides peer review for the renewal of the active substance approval in accordance with Regulation (EC) No 844/2012 is not yet finalised, the conclusions reported in this reasoned opinion should be taken as provisional and might need to be reconsidered in the light of the outcome of the peer review.

A selected list of end points of the studies assessed by EFSA in the framework of the MRL review, including the end points of studies submitted in support of the current MRL application, are presented in Appendix B.

more information

http://www.efsa.europa.eu/en/efsajournal/pub/4834