Review of the existing maximum residue levels (MRLs) for 2,4-D according to Article 12 of Regulation (EC) No 396/2005 1

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1 EFSA Journal 2011;9(11):2431 REASONED OPINION Review of the existing maximum residue levels (MRLs) for 2,4-D according to Article 12 of Regulation (EC) No 396/ European Food Safety Authority 2, 3 European Food Safety Authority (EFSA), Parma, Italy SUMMARY 2,4-D was included in Annex I to Directive 91/414/EEC on 01 October 2002, which is before the entry into force of Regulation (EC) No 396/2005 on 02 September EFSA is therefore required to provide a reasoned opinion on the review of the existing MRLs for that active substance in compliance with Article 12(2) of afore mentioned regulation. In order to collect the relevant pesticide residues data, EFSA asked Greece, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile). The requested information was submitted to EFSA on 19 November 2008 and, after having considered several comments made by EFSA, the RMS provided on 26 March 2010 a revised PROFile. Based on the conclusions derived under the supervision of the European Commission in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission and the additional information provided by the RMS, EFSA issued on 19 April 2011 a draft reasoned opinion that was circulated to Member State experts for consultation. Comments received by 24 June 2011 were considered for finalisation of this reasoned opinion. The following conclusions are derived. The toxicological profile of 2,4-D was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI of 0.05 mg/kg bw/d which was established for 2,4-D acid. An ARfD was not required. Primary crop metabolism of 2,4-D was investigated following foliar applications on wheat and potato and following soil treatment in apples, hereby covering 3 different crop groups. Metabolism of 2,4-D was also investigated for local treatments by injection in plants or cell cultures of soybean and maize. Metabolic patterns in the different studies were shown to be similar and the relevant residue for both enforcement and risk assessment in all plant commodities could be defined as the sum of 2,4-D, its salts, esters and conjugates, expressed as 2,4-D. Validated analytical methods for enforcement of the residue definition in foods of plant origin are available with an LOQ of at least 0.05 mg/kg in high 1 On request from EFSA, Question No EFSA-Q , issued on 27 October Correspondence: pesticides.mrl@efsa.europa.eu 3 Acknowledgement: EFSA wishes to thank the rapporteur Member State Greece for the preparatory work on this scientific output. Suggested citation: European Food Safety Authority; Review of the existing maximum residue levels (MRLs) for 2,4-D according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2011;9(11):2431. [52 pp.] doi: /j.efsa Available online: European Food Safety Authority, 2011

2 water content, dry and acid commodities. An analytical method for the enforcement of 2,4-D, its salts, its esters and conjugates in high oil content commodities is also available but its ILV is still required. Regarding the magnitude of residues, the available residues data are considered sufficient to derive adequate MRL proposals as well as risk assessment values for most of the commodities under assessment, except in almonds and hazelnuts where only a tentative MRL could be derived in the absence of an ILV of the analytical method; tentative MRLs were also derived for grass and cereal straws in view of the future need to set MRLs in feed items. For oranges, buckwheat, alfalfa and clover, the number of residues trials was too limited for deriving MRL proposals and risk assessment values. As quantifiable residues of 2,4-D are not expected in edible part of crops and total chronic exposure represents less than 10% of the ADI, there is no need to investigate the effect of industrial and/or household processing. Specific processing factors for enforcement of processed commodities are therefore not proposed. 2,4-D was demonstrated to decline rapidly in soil. Further investigation of residues in rotational crops is therefore not required and relevant residues in these crops are not expected. Based on the uses reported by the RMS, significant intakes were calculated for dairy ruminant, meat ruminants and pigs. Metabolism in lactating ruminants and poultry was sufficiently investigated and findings can be extrapolated to pigs as well. The relevant residue definition for enforcement and risk assessment was defined as the sum of 2,4-D, its salts, esters and conjugates, expressed as 2,4-D. A validated analytical method for enforcement of the residue definition is also available with an LOQ of 0.01 mg/kg in milk and eggs, and an LOQ of 0.05 mg/kg in meat, liver, kidney and fat. Based on the available livestock feeding study in ruminants, significant residues in edible matrices of ruminants and pigs are not expected, except in ruminant fat and kidney as well as pig kidney. It is therefore concluded that MRLs for these commodities can be established at the LOQ, except for ruminant fat, ruminant kidney and pig kidney where higher MRLs are proposed. For poultry, no MRLs are proposed as a significant intake was not identified for this type of livestock. Chronic consumer exposure resulting from the MRL proposed in the framework of this review was calculated using revision 2 of the EFSA PRIMo and no exceedance of the ADI was identified; the highest chronic exposure was calculated for German children, representing 8.8 % of the ADI. Acute exposure calculations were not carried out because an ARfD was not deemed necessary for this active substance. Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs have also been established for 2,4-D. Additional calculations of the consumer exposure, including these CXLs, were therefore performed and no exceedance of the ADI was identified. In this case, the highest chronic exposure was calculated for Dutch children, representing 12.1 % of the ADI. Based on the above assessment, EFSA does not recommend inclusion of this active substance in Annex IV to Regulation (EC) No 396/2005. MRL recommendations were derived in compliance with the decision tree reported in Appendix D (see table below for a summary). All MRL values listed as Recommended in the table are sufficiently supported by data and therefore proposed for inclusion in Annex II to the Regulation. The remaining MRL values listed in the table are not recommended for inclusion in Annex II because they require further consideration by risk managers (see table footnotes for details). In particular, certain existing EU MRLs still need to be confirmed by the following data: an ILV for enforcement of residues in high oil content commodities; 4 residues trials complying with the northern GAP on buckwheat. EFSA Journal 2011;9(11):2431 2

3 It is highlighted, however, that some of the Recommended MRLs result from a CXL or from a GAP in one climatic zone only, while other GAPs reported by the RMS were not fully supported by data. EFSA therefore identified the following data gaps which are not expected to impact on the validity of the recommended MRLs but which might have an impact on national authorisations: 8 residues trials complying with the Spanish GAP on oranges and further clarification about this GAP; 6 residues trials complying with the southern GAP and 6 additional residues trials complying with the northern GAP on maize forage; 4 residue trials complying with the southern GAP and 4 residue trials complying with the northern GAP on alfalfa; 4 residue trials complying with the southern GAP and 4 residue trials complying with the northern GAP on clover. If the above reported data gaps are not addressed in the future, Member States are recommended to withdraw or modify the relevant authorisations at national level. A minor deficiency was also identified in the assessment but this deficiency is not expected to impact either on the validity of the Recommended MRLs or on the national authorisations. A validation of the hydrolysis step for the analysis of esters and conjugates of 2,4-D in plant and animals (data gap resulting from the new guidance document) is therefore considered desirable but not essential. Code Commodity Existing Existing Outcome of the review number EU MRL CXL MRL Comment Enforcement residue definition: Sum of 2,4-D, its salts, esters and conjugates expressed as 2,4-D Grapefruits 1 1 (**) 1 Recommended (a) Oranges 1 1 (**) 1 Recommended (b) Lemons 1 1 (**) 1 Recommended (a) Limes 1 1 (**) 1 Recommended (a) Mandarins 1 1 (**) 1 Recommended (a) Almonds 0.05* Further consideration needed (c) Brazil nuts 0.05* Further consideration needed (d) Cashew nuts 0.05* Further consideration needed (d) Chestnuts 0.05* Recommended (a) Coconuts 0.05* Further consideration needed (d) Hazelnuts 0.05* Further consideration needed (c) Macadamia 0.05* Further consideration needed (d) Pecans 0.05* Further consideration needed (d) Pine nuts 0.05* Further consideration needed (d) Pistachios 0.05* Further consideration needed (d) EFSA Journal 2011;9(11):2431 3

4 Code number Commodity Existing EU MRL Existing CXL MRL Outcome of the review Comment Walnuts 0.05* Further consideration needed (d) Pome fruit 0.05* 0.01* 0.05* Recommended (e) Stone fruit 0.05* 0.05* 0.05* Recommended (e) Table and wine grapes 0.05* Recommended (a) Strawberries 0.05* Recommended (f) Cane fruit 0.05* Recommended (a) Other small fruit & berries 0.05* Recommended (a) Potatoes 0.05* Recommended (a) Sweet corn 0.05* 0.05* 0.05* Recommended (a) Asparagus 0.05* * Recommended (g) Soya bean 0.1* 0.01* 0.01* Further consideration needed (d) Barley grain 0.05* * Recommended (g) Buckwheat grain 0.05* * Further consideration needed (h) Maize grain 0.05* * Recommended (e) Millet grain 0.05* * Recommended (g) Oats Grain 0.05* * Recommended (g) Rice grain 0.05* Recommended (a) Rye grain 0.05* 2 2 Recommended (f) Sorghum grain 0.05* 0.01* 0.05* Recommended (e) Wheat grain 0.05* 2 2 Recommended (f) Sugar cane 0.05* * Recommended (e) Swine meat 0.05* Recommended (f) Swine fat (free or lean meat) 0.05* Recommended (f) Swine liver 0.05* 5 5 Recommended (f) Swine kidney Recommended (f) Bovine meat 0.05* Recommended (f) Bovine fat 0.05* Recommended (f) Bovine liver 0.05* 5 5 Recommended (f) Bovine kidney Recommended (f) Sheep meat 0.05* Recommended (f) Sheep fat 0.05* Recommended (f) Sheep liver 0.05* 5 5 Recommended (f) Sheep kidney Recommended (f) Goat meat 0.05* Recommended (f) Goat fat 0.05* Recommended (f) EFSA Journal 2011;9(11):2431 4

5 Code number Commodity Existing EU MRL Existing CXL MRL Outcome of the review Comment Goat liver 0.05* 5 5 Recommended (f) Goat kidney Recommended (f) Poultry meat 0.05* 0.05* 0.05* Recommended (a) Poultry fat 0.05* 0.05* 0.05* Recommended (a) Poultry liver 0.05* 0.05* 0.05* Recommended (a) Ruminant milk 0.01* * Recommended (e) Birds eggs 0.01* 0.01* 0.01* Recommended (a) - Other products of plant and animal origin See App. C Further consideration needed (i) (*): Indicates that the MRL is set at the limit of analytical quantification. (**): All citrus uses registered in Codex are post-harvest. (a): MRL is derived from the existing CXL, which is supported by data and for which no risk to consumers is identified; there are no relevant authorisations or import tolerances reported at EU level (combination A-VII in Appendix D). (b): MRL is derived from the existing CXL, which is supported by data and for which no risk to consumers is identified; GAP evaluated at EU level is not supported by data but the existing EU MRL is not higher than the existing CXL (combination C-VII in Appendix D). (c): MRL is derived from the existing CXL, which is not sufficiently supported by data (in the absence of a fully validated analytical method for high oil content commodities) but for which no risk to consumers is identified; GAP evaluated at EU level, which is also not fully supported by data, would lead to a lower tentative MRL (combination E-V in Appendix D). (d): MRL is derived from the existing CXL, which is not sufficiently supported by data (in the absence of a fully validated analytical method for high oil content commodities) but for which no risk to consumers is identified; there are no relevant authorisations or import tolerances reported at EU level (combination A-V in Appendix D). (e): MRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to consumers is identified; existing CXL is covered by the recommended MRL (combination G-III in Appendix D). (f): MRL is derived from the existing CXL, which is supported by data and for which no risk to consumers is identified; GAP evaluated at EU level, which is also fully supported by data, leads to a lower MRL (combination G-VII in Appendix D). (g): MRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to consumers is identified; no CXL is available (combination G-I in Appendix D). (h): GAP evaluated at EU level is not supported by data but no risk to consumers could be identified for the existing EU MRL; no CXL is available (combination C-I in Appendix D). (i): There are no relevant authorisations or import tolerances reported at EU level; no CXL is available. Either the specific LOQ or the default MRL of 0.01 mg/kg may be considered (combination A-I in Appendix D). KEY WORDS 2,4-D, MRL review, Regulation (EC) No 396/2005, consumer risk assessment, phenoxy acetic, herbicide. EFSA Journal 2011;9(11):2431 5

6 TABLE OF CONTENTS Summary... 1 Table of contents... 6 Background... 7 Terms of reference... 8 The active substance and its use pattern... 8 Assessment Methods of analysis Methods for enforcement of residues in food of plant origin Methods for enforcement of residues in food of animal origin Mammalian toxicology Residues Nature and magnitude of residues in plant Primary crops Rotational crops Nature and magnitude of residues in livestock Dietary burden of livestock Nature of residues Magnitude of residues Consumer risk assessment Consumer risk assessment without consideration of the existing CXLs Consumer risk assessment with consideration of the existing CXLs Conclusions and recommendations Documentation provided to EFSA References Appendix A Good Agricultural Practices (GAPs) Appendix B Pesticide Residues Intake Model (PRIMo) Appendix C Existing EU maximum residue limits (MRLs) and Codex Limits (CXLs) Appendix D Decision tree for deriving MRL recommendations Appendix E List of metabolites and related structural formula Abbreviations EFSA Journal 2011;9(11):2431 6

7 BACKGROUND Regulation (EC) No 396/ establishes the rules governing the setting as well as the review of pesticide MRLs at European level. Article 12(2) of that regulation lays down that EFSA shall provide by 01 September 2009 a reasoned opinion on the review of the existing MRLs for all active substances included in Annex I to Directive 91/414/EEC 5 before 02 September As 2,4-D was included in Annex I to the above mentioned directive on 01 October 2002, EFSA initiated the review of all existing MRLs for that active substance and a task with the reference number EFSA-Q was included in the EFSA Register of Questions. According to the legal provisions, EFSA shall base its reasoned opinion in particular on the relevant assessment report prepared under Directive 91/414/EEC. It should be noted, however, that in the framework of Directive 91/414/EEC only a few representative uses are evaluated while MRLs set out in Regulation (EC) No 396/2005 should accommodate for all uses authorised within the EU as well as uses authorised in third countries having a significant impact on international trade. The information included in the assessment report prepared under Directive 91/414/EEC is therefore insufficient for the assessment of all existing MRLs for a given active substance. In order to have an overview on the pesticide residues data that have been considered for the setting of the existing MRLs, EFSA developed the Pesticide Residue Overview File (PROFile). The PROFile is an electronic inventory of all pesticide residues data relevant to the risk assessment as well as the MRL setting for a given active substance. This includes data on: the nature and magnitude of residues in primary crops; the nature and magnitude of residues in processed commodities; the nature and magnitude of residues in rotational crops; the nature and magnitude of residues in livestock commodities and; the analytical methods for enforcement of the proposed MRLs. Greece, the designated rapporteur Member State (RMS) in the framework of Directive 91/414/EEC, was asked to complete the PROFile for 2,4-D. The requested information was submitted to EFSA on 19 November 2008 and subsequently checked for completeness. On 26 March 2010, after having clarified some issues with EFSA, the RMS provided a revised PROFile. A draft reasoned opinion was issued by EFSA on 19 April 2011 and submitted to Member States (MS) for commenting. All MS comments received by 24 June 2011 were considered by EFSA for finalization of the reasoned opinion. 4 Commission Regulation (EC) No 396/2005 of 23 February OJ L 70, , p Council Directive 91/414/EEC of 15 July 1991, OJ L 230, , p EFSA Journal 2011;9(11):2431 7

8 TERMS OF REFERENCE According to Article 12 of Regulation (EC) No 396/2005, EFSA shall provide a reasoned opinion on: the inclusion of the active substance in Annex IV to the Regulation, when appropriate; the necessity of setting new MRLs for the active substance or deleting/modifying existing MRLs set out in Annex II or III of the Regulation; the inclusion of the recommended MRLs in Annex II or III to the Regulation; the setting of specific processing factors as referred to in Article 20(2) of the Regulation. THE ACTIVE SUBSTANCE AND ITS USE PATTERN 2,4-D is the ISO common name for (2,4-dichlorophenoxy) acetic acid (IUPAC). 2,4-D may be manufactured as different variants such as salts (e.g. dimethylamine salt) and esters (e.g. 2-ethylexyl ester), but 2,4-D (acid compound) is considered as the active component. 2,4-D, its salts and its esters belong to the group of phenoxy acetic compounds. 2,4-D acid is a selective, systemic herbicide readily absorbed by leaves and roots, with a growth regulating activity at lower application rates. 2,4-D is used for post-emergence control of broad leaved weeds in agriculture and horticulture. It induces uncontrolled cell division in the plant tissues which causes such a disproportion between assimilation performed and water balance on the one hand, and the normal vegetative growth process on the other hand, that eventually the plant dies. Esters and salts of 2,4-D are rapidly converted in its acid form resulting in the same activity as 2,4-D. 2,4-D was evaluated in the framework of Directive 91/414/EEC with Greece being the designated rapporteur Member State (RMS). The representative uses supported for the peer review process were outdoor treatments of winter cereals (wheat, barley and rye) at a rate of 0.9 kg a.s./ha, spring cereals (wheat and barley) at a rate of 0.42 kg a.s./ha, pasture and seed grasses at a rate of 1.5 kg a.s./ha and fallow lands at a rate of 3 kg a.s./ha. These uses were supported both in northern and southern Europe. Following the peer review, which was carried out under the supervision of the European Commission, a decision on inclusion of the active substance in Annex I to Directive 91/414/EEC was published by means of Commission Directive 2001/103/EC 6, entering into force on 01 October According to Regulation (EU) No 540/2011 7, 2,4-D is deemed to have been approved under regulation (EC) No 1107/ as well. This approval is restricted to uses as a herbicide only. EU MRLs for 2,4-D in products of plant and animal origin have been set for the first time in 2002 by means of Directive 2002/97/EC 9. These MRLs were based on the uses authorised within the EC at that time and have been transferred to Annex II of Regulation (EC) No 396/2005 without further 6 Commission Directive 2001/103/EC of 28 November 2001, OJ L 313, 30/11/2001, p Regulation (EU) No 540/2011 of 25 May 2011, OJ L 153, , p Regulation (EC) No 1107/2009 of 21 October 2009, OJ 309, , p Commission Directive 2002/97/EC of 16 December 2002, OJ L343, 18/12/2002, p EFSA Journal 2011;9(11):2431 8

9 amendments. Additional MRLs for commodities that were not covered by the former European MRL legislation are established in Annex III B of the Regulation. These temporary MRLs were derived from the MRLs that have been set at national level before the Regulation entered into force. All existing EU MRLs, which are established for the sum of 2,4-D and its esters expressed as 2,4-D, are summarized in Appendix C.1 to this document. CXLs for 2,4-D were also established by the Codex Alimentarius Commission and are reported in Appendix C.2 to this reasoned opinion. These CXLs refer to parent compound only. For the purpose of this MRL review, the critical uses of 2,4-D currently authorized within the EU have been collected by the RMS and reported in the PROFile (see Appendix A). They include soil and foliar applications on a wide range of crops in outdoor conditions. Local treatment on citrus fruits is also reported but it is not clear to EFSA what kind of application it refers to. The RMS did not report any use authorised in third countries that might have a significant impact on international trade. ASSESSMENT EFSA bases its assessment on the PROFile submitted by Greece, the Draft Assessment Report (DAR) and its addenda prepared under Council Directive 91/414/EEC (Greece, 1996, 1997, 2000, 2001), the Review Report on 2,4-D (EC, 2001), the JMPR Evaluation reports (FAO, 1998, 2001) and the French evaluation report submitted during the Member State consultation (France, 2011a, 2011b). The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation of the Authorization of Plant Protection Products adopted by Commission Regulation (EU) No 546/ and the currently applicable guidance documents relevant for the consumer risk assessment of pesticide residues (EC, 1996, 1997a, 1997b, 1997c, 1997d, 1997e, 1997f, 1997g, 2000, 2004, 2010a, 2010b, 2011). 1. Methods of analysis 1.1. Methods for enforcement of residues in food of plant origin During the peer review under Directive 91/414/EEC, an analytical method using GC-ECD and its ILV were evaluated and validated in plant matrices for the determination of 2,4-D and its salts, with an LOQ of 0.05 mg/kg for the sum of the compounds in dry commodities (wheat). However, as this method is using diazomethane in its derivatization step, it cannot be reported as enforcement method. In addition, an analytical method using GC-ECD was evaluated and validated in plant matrices for the determination of 2,4-D and its salts, with an LOQ of 0.01 mg/kg for the sum of the compounds in dry (wheat, rice, sorghum, corn) and high water content (sugar cane, grass rangeland) and high oil (soybean) commodities (Greece, 1996). Nevertheless, no ILV was available for this method. During the Member State Consultation, France provided an additional analytical method using GC- MS which does not require diazomethane for the derivatization step. This method was evaluated and validated in plant matrices for the determination of 2,4-D and its salts, with an LOQ of 0.05 mg/kg for the sum of the compounds in dry (wheat), high water commodities (grass) and straw. An ILV was also available (France, 2011b). Moreover, it must be mentioned that a validated method using GC-MS is also available in the JMPR report for the determination of 2,4-D and its salts in acidic commodities (raw citrus fruit) with an LOQ of 0.05 mg/kg (FAO, 2001). 10 Regulation (EU) No546/2011 of 10 June 2011, OJ L 155, , p EFSA Journal 2011;9(11):2431 9

10 All the methods cited above include a hydrolysis step and has therefore always been considered adequate for the analysis of esters and conjugates as well. Nevertheless, the hydrolysis step was never formally validated. In order to be in compliance with the current guidance documents (EC, 2010b) and considering that all available methods were assessed before this new guidance document came into force, further validation of this hydrolysis step is considered desirable. For information, the multi-residue QuEChERS method in combination with HPLC-MS/MS is also available to dose parent 2,4-D with an LOQ of 0.01 mg/kg for high water content, acidic and dry commodities (EURL, 2011). A detailed description of the QuEChERS method is reported by CEN (2008) but this method does not include hydrolysis step of esters and conjugates; it is therefore not suitable for enforcement of this substance according to its complete residue definition. Table 1-1: Recovery data for the analysis o.f 2,4-D in different crop groups using the QuEChERS method in combination with LC-MS/MS (EURL, 2011) Commodity group Spiking levels Recoveries No of labs Min. Max. Mean (%) RSD (%) n Acidic Watery Dry (cereals, pulses) Hence it is concluded, according to overall availability of methods, that the sum of 2,4-D, its salts, its esters and conjugates (only the conjugates obtained by alkaline hydrolysis step), expressed as 2, 4-D can be enforced in food of plant origin with an LOQ of at least 0.05 mg/kg in high water, dry and acidic commodities. However, independent laboratory validation of this LOQ in high oil content commodities is still required and a validation of the hydrolysis step for the analysis of esters and conjugates of 2,4-D is also desirable Methods for enforcement of residues in food of animal origin During the peer review under Directive 91/414/EEC, two analytical methods using GC-ECD confirmed by GC-MS were evaluated and validated in food of animal origin for the determination of 2,4-D and its salts, with an LOQ of 0.05 mg/kg for poultry and beef muscle, fat, liver and kidney and an LOQ of 0.01 mg/kg for milk and eggs. No ILV for both methods have been submitted and should therefore be provided (Greece, 2000). The method includes a hydrolysis step and has therefore always been considered adequate for the analysis of esters and conjugates as well. Nevertheless, the hydrolysis step was never formally validated. In order to be in compliance with the current guidance documents (EC, 2010b) and considering that this method was assessed before this new guidance document came into force, further validation of this hydrolysis step is considered desirable. Hence it is concluded that the sum of 2,4-D, its salts, its esters and conjugates, expressed as 2,4-D can be enforced in food of animal origin with an LOQ of 0.05 mg/kg for poultry and beef muscle, fat, liver and kidney and an LOQ of 0.01 mg/kg for milk and eggs. Nevertheless, a validation of the hydrolysis step for the analysis of esters and conjugates of 2,4-D is still desirable. EFSA Journal 2011;9(11):

11 2. Mammalian toxicology The toxicological assessment of 2,4-D was peer reviewed under Directive 91/414/EEC and toxicological reference values were established by the European Commission from studies carried out with 2,4-D ester and 2,4-D acid (2001). These toxicological reference values, expressed as 2,4-D acid, are summarized in Table 2-1. Table 2-1: Overview of the toxicological reference values Source Year Value Study relied upon Safety factor 2,4-D (acid) ADI EC mg/kg bw/d Long term studies on rats and mice ARfD EC 2001 Not required Residues 3.1. Nature and magnitude of residues in plant Primary crops Nature of residues Metabolism of 2,4-D was investigated for foliar applications on cereals (wheat) and root and tuber vegetables (potato) and for soil treatment in fruits and fruiting vegetables (apple). Metabolism of 2,4- D was also investigated for local treatments by injection in plants or cell cultures of pulses and oilseeds (soybean), and cereals (maize) (Greece, 1996). Data are summarized in table 3-1. In apples and potatoes, residues were too low for identification (0.009 mg 2,4 D eq./kg and mg 2,4 D eq./kg respectively). In wheat grain, almost half of the TRR was associated with natural products (protein, starch and cellulose fractions). The remaining residue consisted primarily of polar unknowns and unextractable compounds. Parent 2,4-D accounted for 6 % of the TRR and was the only identified component. In wheat forage and straw, parent 2,4-D was the major component of the total residue, since 72 to 77% of the TRR are identified as free or conjugated parent compound. The remaining residue comprised a large number of distinct metabolites, out of which 4-OH-2,5-D 11 was the major metabolite of 2,4-D. This metabolite results from the shift of one chlorine atom of the phenyl ring of 2,4-D and its replacement by a hydroxy group; it accounted for 8 % of the TRR. Other metabolites were defined as hydroxylated derivatives of 2,4-D and unknowns, none of them exceeding 2.5 % of the TRR. Following injection of 2,4-D into the stem or into the callus, it was shown that metabolic pathways in soybean and maize plants were quite similar to the one observed in wheat straw and forage, i.e. conjugation of 2,4-D, and, to a lesser extent, hydroxylation of the phenyl ring. Based on these studies, it is concluded that metabolic pathway is similar in all categories of crop. Consequently, as 2,4-D is commercialised under a wide variety of salts and esters and metabolism studies demonstrated that the final residue in plants comprises both esters and 2,4-D in its acid form, 11 4-OH-2,5-D: 4-hydroxy-2,5-dichlorophenoxyacetic acid. See Appendix E. EFSA Journal 2011;9(11):

12 the residue for both enforcement and risk assessment in all plant commodities is defined as the sum of 2,4-D, its salts, esters and conjugates, expressed as 2,4-D. According to the RMS, validated analytical methods for enforcement of the proposed residue definition are available, except in high oil content commodities where an ILV is still missing (see also section 1.1). Considering that the use of 2,4-D is also supported in almonds and hazelnuts, this ILV is required. It is noted that the JMPR proposed to define the residue for both enforcement and risk assessment as 2,4-D (parent compound) only. Nevertheless, the difference in residue definitions proposed by JMPR and EFSA is not expected to impact the outcome of the risk assessment because, although not explicitly mentioned in the residue definitions of the JMPR, CXLs for 2,4-D also include all salts, esters and conjugates. Indeed, analytical methods reported by JMPR hydrolyse esters, conjugates and salts of 2,4-D into the acid form. Table 3-1: Summary of available metabolism studies in plants Group Crop Label position Fruits and fruiting vegetables Root and tuber vegetables Pulses and oilseeds Apple U- 14 C- phenyl labelled Potato U- 14 C- phenyl labelled Potato U- 14 C- phenyl labelled Soybean 1-14 C-2,4- D Cereals Wheat U- 14 C- phenyl labelled Application and sampling details Method, Rate No Sampling F or G (a) (DAT) Application around the trunk Remarks 2.13 kg /ha Foliar 0.07 kg/ha Foliar Injection, G 0.14 kg/ha 0.28 kg/ha 21 µg/plant or callus Plants: 14 Callus: 7 Foliar 1.68 kg/ha 1 0, 10, 28, 49 Wheat Unlabelled Foliar, F 0.50 kg/ha 1 1, 2, 3, 5, 9, 19, 35 Maize 1-14 C-2,4- D Injection, G 21 µg/plant or callus (a): Outdoor/field application (F) or glasshouse/protected/indoor application (G) 1 Plants: 14 Callus: Magnitude of residues According to the RMS, the active substance 2,4-D is authorised for soil and foliar applications in a large number of crops (see Appendix A). 2,4-D is also authorised for local treatment in oranges. To assess the magnitude of 2,4-D residues resulting from these GAPs, EFSA considered all residues trials reported in the PROFile by the RMS, including residues trials evaluated in the framework of the peer review (Greece, 1997, 2000, 2001), and additional data submitted during the Member State consultation (France, 2011a). All available residues trials that, according to the RMS, comply with the authorised GAPs, are summarized in Table 3-2. EFSA Journal 2011;9(11):

13 Table 3-2: Overview of the available residues trials data Commodity Region (a) Outdoor /Indoor Individual trial results Enforcement (sum of 2,4-D, its salts, esters and conjugates expressed as 2,4-D) Risk assessment (sum of 2,4-D, its salts, esters and conjugates expressed as 2,4-D) Median residue (b) Highest residue (c) MRL proposal Median CF (d) Oranges SEU Outdoor Almonds Hazelnuts Pome fruit Stone fruit NEU Outdoor 3 x < x < * (tentative) SEU Outdoor 3 x < x < * (tentative) Comments 1.00 Extrapolation from combined data sets on pome fruits and stone fruits (see below; France, 2011a). In the absence of validated 1.00 analytical method for enforcement in high oil content commodities, only a tentative MRL can be derived (see also body text and section 1.1). NEU Outdoor 3 x < x < * 1.00 Trials carried out with an application rate of 0.96 kg as/ha. Combined data set on apple, pears and plums (France, 2011a). SEU Outdoor 3 x < x < * 1.00 Trials carried out with an application rate of 0.96 kg as/ha. Combined data set on apples, peaches, and plums (France, 2011a). Not authorised on quinces, medlar and loquat in SEU. EFSA Journal 2011;9(11):

14 Commodity Region (a) Outdoor /Indoor Individual trial results Enforcement (sum of 2,4-D, its salts, esters and conjugates expressed as 2,4-D) Risk assessment (sum of 2,4-D, its salts, esters and conjugates expressed as 2,4-D) Median residue (b) Highest residue (c) MRL proposal Median CF (d) Comments Strawberries NEU Outdoor * 1.00 Considering that the application is made on plants after the fruits were harvested and that no residues are expected in rotational crops, residues exceeding the enforcement LOQ are not expected. Asparagus Barley grain Oats grain Rye grain Wheat grain Buckwheat grain SEU/ NEU Outdoor * 1.00 Considering that the application is made after harvest and that no residues are expected in rotational crops, residues exceeding the enforcement LOQ are not expected. SEU Outdoor 8 x < x < * 1.00 Trials on barley (3) and wheat (5) compliant with GAP (France, 2011a). NEU Outdoor 11 x < x < * 1.00 Trials on barley (7) and wheat (4) compliant with the GAP (France, 2011a). NEU Outdoor EFSA Journal 2011;9(11):

15 Commodity Maize grain Millet grain Sorghum grain Region (a) Outdoor /Indoor Individual trial results Enforcement (sum of 2,4-D, its salts, esters and conjugates expressed as 2,4-D) Risk assessment (sum of 2,4-D, its salts, esters and conjugates expressed as 2,4-D) Median residue (b) Highest residue (c) MRL proposal Median CF (d) Comments SEU NEU Outdoor Outdoor 2 x < x < x < x < * 0.05* Residue trials on maize performed with an application rate of 1.2 kg a.s./ha (compliant with GAP on maize and sorghum). Considering that residues are below the LOQ, extrapolation to less critical GAP on millet is also acceptable (France, 2011a). Sugar cane SEU Outdoor 9 x <0.01; x <0.01; * 1.00 Trials compliant with GAP (France, 2011a). R max = 0.02 R ber = 0.02 Alfalfa Clover SEU/ NEU SEU/ NEU Outdoor Outdoor EFSA Journal 2011;9(11):

16 Commodity Region (a) Outdoor /Indoor Individual trial results Enforcement (sum of 2,4-D, its salts, esters and conjugates expressed as 2,4-D) Grass SEU Outdoor 1; 3; 3.8; 7.2; 18; 19.8; 22; 26 Barley straw Oats straw Rye straw Wheat straw NEU Outdoor 2.4; 4.8; 7.2; 9.4; 9.4; 11.4; 16.4; 17.2 SEU Outdoor 2 x <0.05; 0.06; 2 x 0.08; 0.44; 0.96; 1.23 NEU Outdoor 7 x <0.05; 0.06; 0.69; 0.83; 1.88 Risk assessment (sum of 2,4-D, its salts, esters and conjugates expressed as 2,4-D) 1; 3; 3.8; 7.2; 18; 19.8; 22; ; 4.8; 7.2; 9.4; 9.4; 11.4; 16.4; x <0.05; 0.06; 2 x 0.08; 0.44; 0.96; x <0.05; 0.06; 0.69; 0.83; 1.88 Median residue (b) Highest residue (c) MRL proposal (tentative) (tentative) (tentative) (tentative) Median CF (d) Comments 1.00 Trials compliant with the GAP. Results on dry weight basis were recalculated to fresh weight assuming a dry matter content of 20% for grass. R max =44.07 R ber = Trials compliant with the GAP. Results on dry weight basis were recalculated to fresh weight assuming a dry matter content of 20% for grass. R max =26.28 R ber = Trials on barley (3) and wheat (5) compliant with the GAP (France, 2011a). Rber: 1.66 Rmax: Trials on barley (7) and wheat (4) compliant with the GAP (France, 2011a). Rber: 1.38 Rmax: 1.99 EFSA Journal 2011;9(11):

17 Commodity Region (a) Outdoor /Indoor Individual trial results Enforcement (sum of 2,4-D, its salts, esters and conjugates expressed as 2,4-D) Risk assessment (sum of 2,4-D, its salts, esters and conjugates expressed as 2,4-D) Median residue (b) Highest residue (c) MRL proposal Maize forage SEU Outdoor <0.05; 0.06 <0.05; (tentative) NEU Outdoor 2 x < x < * (tentative) Median CF (d) (*): Indicates that the MRL is set at the limit of analytical quantification. (a): NEU, SEU, EU or Import (country code). In the case of indoor uses there is no necessity to differentiate between NEU and SEU. (b): Median value of the individual trial results according to the enforcement residue definition. (c): Highest value of the individual trial results according to the enforcement residue definition. (d): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual conversion factors for each residues trial. Comments 1.00 Trials on immature maize compliant with the GAP (France, 2011a). Rber: 0.09 Rmax: Trials on immature maize compliant with the GAP (France, 2011a). EFSA Journal 2011;9(11):

18 The number of residues trials and extrapolations were evaluated in view of the European guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs (EC, 2011). The following considerations were made by EFSA: Oranges: no residue trials are available to support the Spanish GAP. Therefore 8 residue trials complying with the southern GAP are required. Furthermore, further clarifications are needed for this GAP (application rate, PHI, intended use as herbicide or growth regulator). No MRL or risk assessment values are derived. Orchard trees (including tree nuts, pome fruits and stone fruits): Only 3 northern and 3 southern outdoor residues trials have been provided. Considering that the residue levels of the trials remain below the LOQ and the very low level of residues in the metabolism studies, no additional data are required. Appropriate risk assessment values can be derived for all these commodities and an MRL of 0.05* mg/kg can be derived on pome fruits and stone fruits. However, in the absence of validated analytical method for high oil content commodities (see also section 1.1), only a tentative MRL can be derived on almonds and hazelnuts. Strawberries: no residue trials are available to support the northern GAP. Nevertheless, considering that the application is made on plants after the fruits were harvested and that no residues are expected in rotational crops, residues exceeding the enforcement LOQ of 0.05 mg/kg are not expected. Consequently, a waiver for residue trials can be accepted. Asparagus: no residue trials are available to support the northern and southern GAPs. Nevertheless, considering that the application is made on plants after the asparagi are harvested and that no residues are expected in rotational crops, residues exceeding the enforcement LOQ of 0.01 mg/kg are not expected. Consequently, a waiver for residue trials can be accepted. Buckwheat: no residue trials are available to support the northern outdoor GAP. 4 residue trials are required. No MRL or risk assessment values are derived. Maize, millet and sorghum grain: only 2 northern and 2 southern outdoor residues trials are available. However, as they remain below the LOQ, no additional trial is considered necessary. Maize forage: only 2 northern and 2 southern outdoor residues trials are available. Considering that residues above the LOQ were quantified and that maize is a major crop in both northern and southern zones, 6 northern and 6 southern additional residues trials complying GAP are requested. In the absence of these trials, only tentative MRLs and risk assessment can be derived. Sugar cane: 10 US residue trials were provided. They were considered acceptable by the French authorities as they were performed under climatic conditions comparable to those of the French regions where sugar cane is grown (oversea departments). Application rates were significantly higher than the critical GAP: 2 applications instead of 1 and dose rates of 2240 g/ha or 4480 g/ha instead of 1140 g/ha. Residue levels in the sugarcane were <0.01 mg/kg in all trials except in one (0.015 mg/kg). It can therefore be concluded that all residue levels are below the enforcement LOQ of 0.05 mg/kg. Alfalfa: no residue trials are available to support the northern and the southern GAP. 4 residue trials complying with the GAPs are required for each area. No MRL or risk assessment values are derived. EFSA Journal 2011;9(11):

19 Clover: no residue trials are available to support the northern and the southern GAPs. 4 residue trials complying with the GAPs are required for each area. No MRL or risk assessment values are derived. The number of supervised residues trials requested above may be reduced if residue levels are demonstrated to be below the LOQ. The potential degradation of residues during storage of the residue trials samples was also assessed. In the framework of the peer review, storage stability of 2,4-D was demonstrated for a period of 12 months under frozen conditions in high water content (sugar cane, wheat and maize forage), dry (wheat, sorghum and maize grain) and high oil content commodities (soybean seeds) (Greece, 2000). According to the RMS, all residue trials samples reported in the PROFile were stored in compliance with the above reported storage conditions, except for grass. It is highlighted however that, if residues trials on citrus fruits are provided in the future, a study investigating storage stability of 2,4-D in high acid content commodities might be required depending on the storage conditions of the residues trials samples. Consequently, the available residues data are considered sufficient to derive adequate MRL proposals as well as risk assessment values for most of the commodities under assessment, except in almonds and hazelnuts where only a tentative MRL could be derived in the absence of an ILV of the analytical method; tentative MRLs were also derived for grass and cereal straws in view of the future need to set MRLs in feed items. For oranges, buckwheat, alfalfa and clover, the number of residues trials was too limited for deriving MRL proposals and risk assessment values Effect of industrial processing and/or household preparation As quantifiable residues of 2,4-D are not expected in edible part of crops based on available residue data and total chronic exposure was found to represent less than 10 % of the ADI, there is no need to investigate the effect of industrial and/or household processing Rotational crops All crops under consideration, except permanent crops (orchard trees and grass), may be grown in rotation but, according to the soil degradation studies evaluated in the framework of the peer review, the DT 90 value calculated of 2,4-D, was 67.7 days which is below the trigger value of 100 days. Relevant soil metabolites were also not identified (Greece, 1997). According to the European guidelines on rotational crops (EC, 1997b), further investigation of residues in rotational crops is not required and relevant residues in these crops are not expected Nature and magnitude of residues in livestock Dietary burden of livestock 2,4-D is authorised for use on several crops that might be fed to livestock. The median and maximum dietary burdens were therefore calculated for different groups of livestock using the agreed European methodology (EC, 1996). The input values for all relevant commodities have been selected according to the recommendations of JMPR (FAO, 2009) and are summarized in Table 3-3. For grass hay and cereal bran, default processing factors of 4 and 8 respectively have been included in the calculation in order to consider potential concentration of residues in these commodities. For grass and maize silage, the default processing factor is in any case 1 while for apple pomace, no default processing factor was applied because esfenvalerate is applied early in the growing season (soil treatment) and residues are expected to be below the LOQ. For oranges, alfalfa, clover and all processed commodities thereof, no EFSA Journal 2011;9(11):

20 values have been selected because no residue trials data are available for these crops. Nevertheless, it should be noted that the lack of residues trials in these crops are not expected to impact significantly the livestock dietary burden which is already driven by grass consumption mainly. Table 3-3: Input values for the dietary burden calculation Commodity Median dietary burden Maximum dietary burden Input value Comment Input value Comment Risk assessment residue definition: sum of 2,4-D, its salts, esters and conjugates expressed as 2,4-D Grass (fresh & silage) Median residue Highest residue Maize silage Median residue 0.06 Highest residue Apple pomace 0.01 Median residue 0.01 Highest residue Grass (hay) Median residue x Highest residue x 4 Cereal grain 0.05 Median residue 0.05 Median residue Maize grain 0.05 Median residue 0.05 Median residue Cereal bran 0.40 Median residue x Median residue x 8 Cereal straw 0.05 Median residue 1.88 Highest residue The results of the calculations are reported in Table 3-4. The calculated dietary burdens for dairy ruminants, meat ruminants and pigs were found to exceed the trigger value of 0.1 mg/kg DM. Further investigation of residues is therefore only required in these groups of livestock. Table 3-4: Results of the dietary burden calculation Maximum dietary burden (mg/kg bw/d) Median dietary burden (mg/kg bw/d) Highest contributing commodity Max dietary burden (mg/kg DM) Risk assessment residue definition: sum of 2,4-D, its salts, esters and conjugates expressed as 2,4-D Trigger exceeded (Y/N) Dairy ruminants Grass (fresh) Yes Meat ruminants Grass (fresh) Yes Poultry Wheat (bran) 0.07 No Pigs Grass silage Yes Nature of residues The nature of 2,4-D residues in commodities of animal origin was investigated in the framework of Directive 91/414/EEC. Reported metabolism studies include one study in lactating goats and one in laying hens using 14 C-phenyl ring labelled 2,4-D (Greece, 1997). EFSA Journal 2011;9(11):

21 Table 3-5: Summary of available metabolism studies in livestock Group Species Label position Lactating ruminants Laying poultry Goat U- 14 C- phenyl labelled Hens U- 14 C- phenyl labelled No of animal Application details Rate (mg/kg bw/d) Duration (days) Sample details Commodity Time Milk Daily Urine and faeces Tissues Daily After sacrifice Eggs Daily Excreta Tissues Daily After sacrifice A single lactating goat was dosed at 24 mg/kg bw/d for 3 consecutive days, corresponding to the 4N exposure of meat ruminants. For poultry there is in principle no necessity to establish a residue definition because the calculated dietary burden of poultry to 2,4-D residues amounted to less than 0.1 mg/kg DM based on the available residue data. Nevertheless, a metabolism study with laying hens is reported in the DAR. 15 laying hens were dosed at 1.4 mg/kg bw/d for 7 days (Greece, 1997). When fed to livestock, 2,4-D is extensively excreted in urine (90 % or more of the TRR). Degradation into dichlorophenol and into dichloroanisole is observed but it affects a relatively small portion of the administered compound, which is primarily recovered as unchanged or conjugated forms of 2,4-D. Less than 0.1 % of the administrated radioactivity was recovered in milk, eggs and tissues. Parent 2,4- D was the major compound (38 % of the TRR in milk, 23 % of the TRR in eggs, 25 % of the TRR in chicken fat, 18 % of the TRR in chicken liver and 76 % of the TRR in chicken kidney). The low concentration of residues in most edible fractions impeded their identification. However, in others fractions some metabolites were identified, among them 4-chlorophenoxyacetic acid 12 (6.9 % of the TRR in milk) and 2,4-dichlorophenol 13 (5 % of the TRR in milk; 7.3 % of the TRR in eggs and 4 % of the TRR in chicken liver). Residues levels in kidney were higher than in other tissues with concentrations of 1.44 and 0.71 mg 2,4-D eq./kg in goat and hen respectively. The metabolic patterns identified for goats and hens were consistent with the rat metabolism and therefore considered applicable to pigs as well. However, metabolism studies in livestock were performed with 2,4-D under its acid form and it is therefore not clear whether esters will be completely hydrolysed in livestock commodities. Considering that livestock will be exposed to different salts and esters of 2,4-D, it is therefore desirable, according to EFSA, to use the same residue definition as for plant commodities for both enforcement and risk assessment: sum of 2,4-D, its salts, esters and conjugates, expressed as 2,4-D. Validated analytical methods for enforcement of the proposed residue definition are available (see also section 1.2). There is some evidence that salts and esters of 2,4-D might be extensively hydrolysed through the livestock metabolism. However, this was not properly demonstrated in the available studies. Besides, the available analytical methods will anyhow determine 2,4-D, its salts and esters all together. Therefore, a modification of the residue definition is not relevant CPA : 4-chlorophenoxyacetic acid. See Appendix E. 13 2,4-DCP : 2,4-dichlorophenol. See Appendix E. EFSA Journal 2011;9(11):

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