EFSA Journal 2015;13(1):3972 REASONED OPINION Reasoned opinion on the review of the existing maximum residue levels (MRLs) for according to Article 12 of Regulation (EC) No 396/2005 1 European Food Safety Authority 2, 3 European Food Safety Authority (EFSA), Parma, Italy ABSTRACT 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. In order to assess the occurrence of 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. Some information required by the regulatory framework was found to be missing and a possible chronic risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, 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. European Food Safety Authority, 2015 KEY WORDS, MRL review, Regulation (EC) No 396/2005, consumer risk assessment, quaternary ammonium, herbicide 1 On request from EFSA, Question No EFSA-Q-2008-531, approved on 15 December 2014. 2 Correspondence: pesticides.mrl@efsa.europa.eu 3 Acknowledgement: EFSA wishes to thank the rapporteur Member State, the United Kingdom, for the preparatory work on this scientific output. Suggested citation: EFSA (European Food Safety Authority), 2015. Reasoned opinion on the review of the existing maximum residue levels (MRLs) for according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2015;13(1):3972, 69 pp. doi:10.2903/j.efsa.2015.3972 Available online: www.efsa.europa.eu/efsajournal European Food Safety Authority, 2015
Review of the existing MRLs for SUMMARY Diquat was included in Annex I to Directive 91/414/EEC on 01 January 2002, which is before the entry into force of Regulation (EC) No 396/2005 on 2 September 2008. 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 the aforementioned regulation. In order to collect the relevant pesticide residues data, EFSA asked United Kingdom, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile). The requested information was submitted to EFSA on 30 March 2011 and, after having considered several comments made by EFSA, the RMS provided on 02 April 2013 a revised PROFile. Based on the conclusions derived 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 May 2014 a draft reasoned opinion that was circulated to Member States experts for consultation. Comments received by 25 July 2014 were considered in the finalisation of this reasoned opinion. The following conclusions are derived. The toxicological profile of was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI being established at 0.002 mg/kg bw per day. An ARfD was not deemed necessary. The metabolism of in primary crops was investigated in fruit crops (tomatoes), root and tuber vegetables (potatoes), pulses and oilseeds (rape seed) and in cereals (wheat, barley) following foliar spray application representative of the pre-harvest use of as a desiccant. Following soil application as a herbicide for weed control, it is agreed that the submitted confined rotational crop studies on leafy crops, root and tuber vegetables and cereals following a bare soil application of may also cover the use of as an herbicide for weed control in primary crops. The residue definition for enforcement is proposed as and its salts expressed as only. For risk assessment, the residue definition is proposed as the sum of, its salts and TOPPS expressed as on a tentative basis and, based on the metabolism study in cereals, EFSA derived a tentative conversion factor of 1.5 for enforcement to risk assessment that applies to all crops groups when is applied as a crop desiccant. Where is applied to the soil as a herbicide, a no residue situation is expected and a conversion factor for risk assessment is not considered necessary. Furthermore, in view of the deficiencies identified in the metabolism studies regarding the limited characterization and identification of the radioactive residues in fruit crops, pulses and oilseeds and root and tuber vegetables, metabolism data covering 2 additional categories of crops are required in order to fully address the metabolism of as a crop desiccant in plants. A validated analytical method for enforcement of the residue definition is available but a confirmatory method and an ILV are still required. The analytical method was also not sufficiently validated in hops. Regarding the magnitude of the residues in primary crops, the available residues data are considered sufficient to derive MRL proposals as well as risk assessment values for table and wine grapes, strawberries, asparagus, pulses dry, linseed, poppy seed, sesame seed, sunflower seed, rape seed, mustard seed, borage, hempseed,, barley and oats and hops (dried). For all other uses reported in the framework of this review, data were insufficient to derive MRLs. Moreover, considering the data gaps that were identified regarding plant metabolism, residues trials data and validation of the analytical methods, all the MRL proposals should be considered on a tentative basis only. A processing study to address the nature of and TOPPS residues under the standard hydrolysis conditions is not available and is therefore required. Meanwhile, it is proposed, on a tentative basis, to apply the same residue definition for enforcement and risk assessment as for primary crops. Studies investigating the magnitude of residues in processed commodities of cereals and oilseeds were also reported. Tentative processing factors for enforcement and risk assessment were derived for barley, wheat and oilseeds processed commodities. EFSA Journal 2015;13(1):3972 2
Review of the existing MRLs for A specific residue definition for rotational crops is not deemed necessary and it was concluded that significant residues in rotational crops are not expected provided that is applied in compliance with the authorized uses reported in Appendix A. Based on the uses reported by the RMS, significant dietary intakes were calculated for dairy and meat ruminants, poultry and pigs. However, at the calculated dietary burden, the total residues are not expected to exceed the LOQ of the method in ruminant or poultry matrices. The residue definition for enforcement and risk assessment in livestock matrices is therefore proposed as the sum of and its salts, expressed as only. Although not fully validated, analytical methods for enforcement of the proposed residue definition in animal commodities are available. Feeding studies were not triggered because the residue levels in ruminants and poultry commodities are expected to remain below the enforcement LOQ of 0.01 mg/kg in milk and eggs and below the LOQ of 0.05 mg/kg in muscle, fat, liver and kidney. Chronic consumer exposure resulting from the authorised uses reported in the framework of this review was calculated using revision 2 of the EFSA PRIMo. For those commodities where data were insufficient to derive an MRL, EFSA considered the existing EU MRL for an indicative calculation. The highest chronic exposure was calculated for the Irish adult, representing 383 % of the ADI (IE adult), maize and barley being the main contributors to the chronic dietary intake. Furthermore, EFSA identified that the current LOQ of 0.05 mg/kg might not be sufficiently protective to consumers, in particular for high water content, acidic and dry commodities where it is expected that lower LOQs can be achieved in routine enforcement. Further calculations were therefore carried out excluding authorisations on maize and barley and including the lower LOQs of 0.01 mg/kg for high water content and acidic commodities and 0.02 mg/kg for dry commodities. According to the results of this calculation, the highest chronic exposure declined to 61 % of the ADI (UK infant). However, although authorisations of in the relevant commodities are likely to result in a no-residue situation, an exceedance of the lowered LOQs cannot be excluded in the absence of appropriate residues trials supporting those authorisations. Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs have also been established for. Additional calculations of the consumer exposure, considering these CXLs, were therefore carried out and the highest chronic exposure was calculated for WHO cluster diet B, representing 1433 % of the ADI, wheat and barley being the major contributors to the dietary intake. A second exposure calculation was therefore performed, excluding the CXLs on these two crops. According to the results of this second calculation, the highest chronic exposure declined to 82 % of the ADI for Dutch children. Acute exposure calculations were not carried out considering that an ARfD was not deemed necessary for this active substance. 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 of the reasoned opinion (see summary table). None of the MRL values listed in the table are recommended for inclusion in Annex II to the Regulation as they are not sufficiently supported by data. In particular, all tentative MRLs or existing EU MRLs need to be confirmed by the following data: a confirmatory method and an ILV for enforcement of in commodities of plant and animal origin; a fully validated analytical method for enforcement of in hops (dried); representative studies investigating the metabolism of in 2 additional crop groups different from cereals; EFSA Journal 2015;13(1):3972 3
Review of the existing MRLs for toxicological data on the major plant metabolite TOPPS; additional residues trials supporting authorisations and/or further clarifications on authorisations in tree nuts and olives for oil production (conducted with appropriate LOQs); where is applied as a crop desiccant, residue trials analysing the residues in compliance with the proposed risk assessment residue definition; a processing study simulating representative hydrolytic conditions for pasteurisation (20 minutes at 90 C, ph 4), boiling/brewing/baking (60 minutes at 100 C, ph 5) and sterilisation (20 minutes at 120 C, ph 6) addressing the nature of and TOPPS residues in processed commodities. It is highlighted, however, that some of the MRLs derived result 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 MRLs derived but which might have an impact on national authorisations: additional residues trials supporting the authorizations on strawberries, asparagus, dry pulses, poppy seed, sesame seed, sunflower seed, rape seed, mustard seed, borage and oats (conducted with appropriate LOQs). 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. Member States are in any case recommended to withdraw or modify their authorized uses on maize and barley in view of the identified chronic intake concern. Furthermore, although a no-residue situation is likely for the remaining commodities listed in the summary table and no major chronic concern is expected for these crops, the enforcement LOQ of 0.05 mg/kg currently established in legislation might not be sufficiently protective and a reduction of those LOQs to 0.01 mg/kg in high water content and acidic commodities, and 0.02 mg/kg in dry commodities is advisable. However, an exceedance of these lowered LOQs cannot be completely excluded and further confirmation is required by means of the following data: additional residue trials supporting authorisations and/or further clarifications on authorisations in citrus fruits, pome fruits, stone fruits, blackberries, raspberries, currants, gooseberries, persimmon, passion fruit, bananas, mangoes, papaya, cherimoya, potatoes, sweet potatoes, other root and tuber vegetables, garlic, onions, tomatoes, peppers, cucurbits with edible peel, cucurbits with inedible peel, brassica vegetables, lettuces and salad plants, spinaches and similar leaves, herbs and edible flowers, legume vegetables, celery, cardoon, fennel, rhubarb, globe artichokes, leek, sugar beets and wheat (conducted with appropriate LOQs). For these commodities risk managers will need to decide whether authorisations need to be withdrawn or whether the higher LOQ for enforcement can be maintained pending availability of the missing data. A minor deficiency was also identified in the assessment but this deficiency is not expected to impact either on the validity of the MRLs derived or on the national authorisations. The following data are therefore considered desirable but not essential: a confirmation that the maximum storage time interval of the samples of the residue trials on apples, strawberries, asparagus, pulses (dry), linseed, barley and oats grain and straw and maize did not exceed 24 months. EFSA Journal 2015;13(1):3972 4
Review of the existing MRLs for SUMMARY TABLE Code number Commodity Existing EU MRL Existing CXL MRL Outcome of the review Enforcement residue definition (existing): Enforcement residue definition (proposed): sum of and its salts, expressed as Comment 0110000 Citrus fruit 0.05* 0.02* 0.02 Further consideration is needed (a) 0120000 Tree nuts 0.05* 0.02* 0.05* Further consideration is needed (b) 0130000 Pome fruit 0.05* 0.02* 0.02 Further consideration is needed (a) 0140000 Stone fruit 0.05* 0.02* 0.02 Further consideration is needed (a) 0151000 Table and wine grapes 0.05* - 0.01* Further consideration is needed (c) 0152000 Strawberries 0.05* 0.05* 0.05 Further consideration is needed (d) 0153010 Blackberries 0.05* - - Further consideration is needed (e) 0153030 Raspberries 0.05* - - Further consideration is needed (e) 0154030 Currants (red, black and white) 0.05* - - Further consideration is needed (e) 0154040 Gooseberries 0.05* - - Further consideration is needed (e) 0161040 Kumquats 0.05* 0.02* 0.02 Further consideration is needed (f) 0161060 Persimmon 0.05* - - Further consideration is needed (e) 0162030 Passion fruit 0.05* - - Further consideration is needed (e) 0163020 Bananas 0.05* 0.02* 0.02 Further consideration is needed (a) 0163030 Mangoes 0.05* - - Further consideration is needed (e) 0163040 Papaya 0.05* - - Further consideration is needed (e) 0163060 Cherimoya 0.05* - - Further consideration is needed (e) 0211000 Potatoes 0.05* 0.1 0.1 Further consideration is needed (a) 0212020 Sweet potatoes 0.05* - - Further consideration is needed (e) 0213000 Other root and tuber vegetables 0.05* - - Further consideration is needed (e) 0220010 Garlic 0.05* - - Further consideration is needed (e) 0220020 Onions 0.05* - - Further consideration is needed (e) 0231010 Tomatoes 0.05* 0.01* 0.01* Further consideration is needed (a) 0231020 Peppers 0.05* 0.01* 0.01* Further consideration is needed (a) 0231030 Aubergines 0.05* 0.01* 0.01* Further consideration is needed (f) 0231040 Okra (lady s finger) 0.05* 0.01* 0.01* Further consideration is needed (f) 0232000 Cucurbits with edible peel 0233000 Cucurbits with inedible peel 0.05* - - Further consideration is needed (e) 0.05* - - Further consideration is needed (e) 0241000 Flowering brassica 0.05* - - Further consideration is needed (e) 0242000 Head brassica 0.05* - - Further consideration is needed (e) 0243000 Leafy brassica 0.05* - - Further consideration is needed (e) EFSA Journal 2015;13(1):3972 5
Review of the existing MRLs for Code number Commodity Existing EU MRL Existing CXL MRL Outcome of the review Comment 0244000 Kohlrabi 0.05* - - Further consideration is needed (e) 0251000 Lettuces and salad plants 0.05* - - Further consideration is needed (e) 0252000 Spinaches and similar leaves 0.05* - - Further consideration is needed (e) 0256000 Herbs and edible flowers 0.05* - - Further consideration is needed (e) 0260000 Legume vegetables 0.05* - - Further consideration is needed (e) 0270010 Asparagus 0.05* - 0.01* Further consideration is needed (c) 0270020 Cardoon 0.05* - - Further consideration is needed (e) 0270030 Celery 0.05* - - Further consideration is needed (e) 0270040 Fennel 0.05* - - Further consideration is needed (e) 0270050 Globe artichokes 0.05* - - Further consideration is needed (e) 0270060 Leek 0.05* - - Further consideration is needed (e) 0270070 Rhubarb 0.05* - - Further consideration is needed (e) 0300010 Beans (dry) 0.2 0.2 0.2 Further consideration is needed (g) 0300020 Lentils (dry) 0.2 0.2 0.2 Further consideration is needed (g) 0300030 Peas (dry) 0.2 0.3 0.3 Further consideration is needed (d) 0300040 Lupins (dry) 0.2-0.2 Further consideration is needed (c) 0401010 Linseed 5-10 Further consideration is needed (c) 0401030 Poppy seed 0.1* - 0.8 Further consideration is needed (c) 0401040 Sesame seed 0.1* - 0.8 Further consideration is needed (c) 0401050 Sunflower seed 1 0.9 0.9 Further consideration is needed (d) 0401060 Rape seed 2 1.5 1.5 Further consideration is needed (d) 0401070 Soya bean 0.2 0.3 0.3 Further consideration is needed (f) 0401080 Mustard seed 0.5-0.8 Further consideration is needed (c) 0401120 Borage 0.1* - 0.8 Further consideration is needed (c) 0401140 Hempseed 0.5-0.9 Further consideration is needed (c) 0402010 Olives for oil production 0.05* - 0.05* Further consideration is needed (h) 0500010 Barley 10 5 - Further consideration is needed (i) 0500030 Maize 1 - - Further consideration is needed (j) 0500050 Oats 2 2 8 Further consideration is needed (g) 0500090 Wheat 0.05* 2 - Further consideration is needed (k) 620000 Coffee beans 0.1* 0.02* 0.02* Further consideration is needed (f) 0700000 Hops (dried) 0.1* - 0.01* Further consideration is needed (c) 0900010 Sugar beet root 0.05* - - Further consideration is needed (e) 1011010 Swine muscle 0.05* 0.05* 0.05* Further consideration is needed (g) 1011020 Swine fat 0.05* - 0.05* Further consideration is needed (c) EFSA Journal 2015;13(1):3972 6
Review of the existing MRLs for Code number Commodity Existing EU MRL Existing CXL MRL Outcome of the review Comment 1011030 Swine liver 0.05* 0.05* 0.05* Further consideration is needed (g) 1011040 Swine kidney 0.05* 0.05* 0.05* Further consideration is needed (g) 1012010 Bovine muscle 0.05* 0.05* 0.05* Further consideration is needed (g) 1012020 Bovine fat 0.05* - 0.05* Further consideration is needed (c) 1012030 Bovine liver 0.05* 0.05* 0.05* Further consideration is needed (g) 1012040 Bovine kidney 0.05* 0.05* 0.05* Further consideration is needed (g) 1013010 Sheep muscle 0.05* 0.05* 0.05* Further consideration is needed (g) 1013020 Sheep fat 0.05* - 0.05* Further consideration is needed (c) 1013030 Sheep liver 0.05* 0.05* 0.05* Further consideration is needed (g) 1013040 Sheep kidney 0.05* 0.05* 0.05* Further consideration is needed (g) 1014010 Goat muscle 0.05* 0.05* 0.05* Further consideration is needed (g) 1014020 Goat fat 0.05* - 0.05* Further consideration is needed (c) 1014030 Goat liver 0.05* 0.05* 0.05* Further consideration is needed (g) 1014040 Goat kidney 0.05* 0.05* 0.05* Further consideration is needed (g) 1016010 Poultry muscle 0.05* 0.05* 0.05* Further consideration is needed (g) 1016020 Poultry fat 0.05* - 0.05* Further consideration is needed (c) 1016030 Poultry liver 0.05* 0.05* 0.05* Further consideration is needed (g) 1020010 Cattle milk 0.05* 0.01* 0.01* Further consideration is needed (g) 1020020 Sheep milk 0.05* 0.01* 0.01* Further consideration is needed (g) 1020030 Goat milk 0.05* 0.01* 0.01* Further consideration is needed (g) 1030000 Birds' eggs 0.05* 0.05* 0.05 Further consideration is needed (d) - Other products of plant and animal origin See App C.1 - - Further consideration is needed (l) (*): Indicates that the MRL is set at the limit of analytical quantification. (a): MRL is derived from the existing CXL, which is not sufficiently supported by data but for which no risk to consumers is identified (assuming the existing residue definition); GAP evaluated at EU level is not supported by data and, although a no-residue situation is likely and no major risk for the consumers is expected, an exceedance of the CXL cannot be excluded (combination B-V in Appendix D). (b): GAP evaluated at EU level is not supported by data but no risk to consumers was identified for the existing EU MRL; existing CXL is covered by the existing EU MRL (combination C-III in Appendix D). (c): Tentative MRL is derived from a GAP evaluated at EU level, which is not fully supported by data but for which no risk to consumers was identified; no CXL is available (combination E-I in Appendix D). (d): MRL is derived from the existing CXL, which is not sufficiently supported by data 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). (e): GAP evaluated at EU level is not supported by data. Although a no-residue situation is likely and no major risk for the consumers is expected, an exceedance of the enforcement LOQ of 0.01 mg/kg derived in the framework of this review cannot be excluded while the LOQ of 0.05 mg/kg currently established in legislation might not be sufficiently protective; no CXL is available (combination C-I in Appendix D). (f): MRL is derived from the existing CXL, which is not sufficiently supported by data but for which no risk to consumers is identified (assuming the existing residue definition); there are no relevant authorisations or import tolerances reported at EU level (combination A-V in Appendix D). (g): Tentative MRL is derived from a GAP evaluated at EU level, which is not fully supported by data but for which no risk to consumers was identified; existing CXL is covered by the tentative MRL (combination E-III in Appendix D). (h): GAP evaluated at EU level is not supported by data but no risk to consumers was identified for the existing EU MRL; no CXL is available (combination C-I in Appendix D). EFSA Journal 2015;13(1):3972 7
Review of the existing MRLs for (i): GAP evaluated at EU level is not fully supported by data and a risk to consumers cannot be excluded; CXL is also not sufficiently supported by data and a risk to consumers cannot be excluded. Either a specific LOQ or the default MRL of 0.01 mg/kg may be considered (combination D-IV in Appendix D). (j): GAP evaluated at EU level is not supported by data and a risk to consumers cannot be excluded for the existing EU MRL; no CXL is available. Either a specific LOQ or the default MRL of 0.01 mg/kg may be considered (combination B-I in Appendix D). (k): GAP evaluated at EU level is not supported by data. Although a no-residue situation is likely and no major risk for the consumers is expected, an exceedance of the enforcement LOQ of 0.02 mg/kg derived in the framework of this review cannot be excluded while the LOQ of 0.05 mg/kg currently established in legislation might not be sufficiently protective; CXL is not sufficiently supported by data and a risk to consumers cannot be excluded (combination B-IV in Appendix D). (l): There are no relevant authorisations or import tolerances reported at EU level; no CXL is available. Either a specific LOQ or the default MRL of 0.01 mg/kg may be considered (combination A-I in Appendix D). EFSA Journal 2015;13(1):3972 8
Review of the existing MRLs for TABLE OF CONTENTS Abstract... 1 Summary... 2 Background... 10 Terms of reference... 11 The active substance and its use pattern... 11 Assessment... 12 1. Methods of analysis... 12 1.1. Methods for enforcement of residues in food of plant origin... 12 1.2. Methods for enforcement of residues in food of animal origin... 12 2. Mammalian toxicology... 13 3. Residues... 13 3.1. Nature and magnitude of residues in plant... 13 3.1.1. Primary crops... 13 3.1.2. Rotational crops... 28 3.2. Nature and magnitude of residues in livestock... 29 3.2.1. Dietary burden of livestock... 29 3.2.2. Nature of residues... 30 3.2.3. Magnitude of residues... 31 4. Consumer risk assessment... 32 4.1. Consumer risk assessment without consideration of the existing CXLs... 32 4.2. Consumer risk assessment with consideration of the existing CXLs... 34 Conclusions and recommendations... 37 Documentation provided to EFSA... 45 References... 45 Appendix A Good Agricultural Practices (GAPs)... 47 Appendix B Pesticide Residues Intake Model (PRIMo)... 53 Appendix C Existing EU maximum residue limits (MRLs) and Codex Limits (CXLs)... 59 Appendix D Decision tree for deriving MRL recommendations... 65 Appendix E List of metabolites and related structural formula... 67 Abbreviations... 68 EFSA Journal 2015;13(1):3972 9
Review of the existing MRLs for BACKGROUND Regulation (EC) No 396/2005 4 establishes the rules governing the setting and the review of pesticide MRLs at European level. Article 12(2) of that regulation stipulates 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 2008. As was included in Annex I to the above mentioned directive on 01 January 2002, EFSA initiated the review of all existing MRLs for that active substance and a task with the reference number EFSA-Q-2008-531 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 all uses authorised within the EU, and uses authorised in third countries that have 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 gain an overview of the pesticide residues data that have been considered for the setting of the existing MRLs, EFSA developed the Pesticide Residues Overview File (PROFile). The PROFile is an inventory of all pesticide residues data relevant to the risk assessment and 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. United Kingdom, the designated rapporteur Member State (RMS) in the framework of Directive 91/414/EEC, was asked to complete the PROFile for. The requested information was submitted to EFSA on 30 March 2011 and subsequently checked for completeness. On 02 April 2013, after having clarified some issues with EFSA, the RMS provided a revised PROFile. A draft reasoned opinion was issued by EFSA on 19 May 2014 and submitted to Member States (MS) for commenting. All MS comments received by 25 July 2014 were evaluated and considered by EFSA in the finalisation of the reasoned opinion. 4 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC. OJ L 70, 16.3.2005, p. 1-16. 5 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market. OJ L 230, 19.8.1991, p. 1-32. EFSA Journal 2015;13(1):3972 10
Review of the existing MRLs for 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 Diquat is the ISO common name for 1,1 -ethylene-2,2 -bipyridyldiylium (IUPAC). Diquat can also be used as a bromide salt, dibromide, which is the ISO common name for 1,1'-ethylene-2,2'- bipyridyldiylium dibromide (IUPAC). Diquat (MW: 184.24) Diquat dibromide (MW: 344.04) Diquat belongs to the group of quaternary ammonium herbicides. It may be used as a pre-harvest crop desiccant or as a broad-spectrum non-selective contact herbicide to control before or at early post-emergence. Diquat interacts with the electron transfer components associated with photosystem I, which causes inhibition of photosynthesis. Plants sprayed with are desiccated by destruction of the cell membranes. Diquat was evaluated in the framework of Directive 91/414/EEC with United Kingdom being the designated rapporteur Member State (RMS). The representative uses supported for the peer review process was pre-harvest crop desiccation and herbicide terrestrial weed control. 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 2001/21/EC, 6 which entered into force on 01 January 2002. The expiry date for inclusion in Annex I was extended until 31 December 2015 by means of Commission Directive 2010/77/EU. 7 According to Regulation (EU) No 540/2011, 8 is deemed to have been approved under Regulation (EC) No 1107/2009. 9 This approval is restricted to uses as terrestrial herbicide or desiccant only. As EFSA was not yet involved in the peer review of, an EFSA conclusion on this active substance is not available. The EU MRLs for are established in Annexes II and IIIB of Regulation (EC) No 396/2005. Since the entry into force of that regulation, EFSA issued a reasoned opinion on the modification of 6 Commission Directive 2001/21/EC of 05 March 2001 amending Council Directive 91/414/EEC to include as active substance. OJ L 69, 10.2.2001, p. 17-21. 7 Commission Directive 2010/77/EU of 10 November 2010 amending Council Directive 91/414/EEC as regards the expiry dates for inclusion in Annex I of certain active substances. OJ L 293, 11.11.2010, p. 48-57. 8 Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances. OJ L 153, 11.6.2011, p. 1-186. 9 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. OJ 309, 24.11.2009, p. 1-50. EFSA Journal 2015;13(1):3972 11
Review of the existing MRLs for the existing MRL for in borage (EFSA, 2012) but due to the chronic exposure concerns and the data gaps identified by EFSA, the modification of the MRL was not legally implemented for this crop. All existing EU MRLs, which are established for the parent compound only, are summarised in Appendix C.1 to this document. CXLs for were also established by the Codex Alimentarius Commission and are reported in Appendix C.2 to this reasoned opinion. These CXLs refer to the same residue definition. For the purpose of this MRL review, the critical uses of currently authorised within the EU have been collected by the RMS and reported in the PROFile. The additional GAPs reported during the consultation of Member States were also considered. The overall use pattern of consists of uses as a crop desiccant (foliar application) and uses as a herbicide for weed control (soil application) in different crop categories (see Appendix A). 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 the RMS, the Draft Assessment Report (DAR) and its addendum prepared under Council Directive 91/414/EEC (United Kingdom, 1996, 1999), the Review Report on (EC, 2001), the JMPR Evaluation reports (FAO, 1994, 2013), the previous reasoned opinion on (EFSA, 2012) as well as the evaluation reports submitted during the consultation of Member States (France, 2014; Germany, 2014; Netherlands, 2014; United Kingdom, 2014). The assessment is performed in accordance with the legal provisions of the Uniform Principles for Evaluation and Authorisation of Plant Protection Products adopted by Commission Regulation (EU) No 546/2011 10 and the currently applicable guidance documents relevant for the consumer risk assessment of pesticide residues (EC, 1996, 1997a-g, 2000, 2010a,b, 2011 and OECD, 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 HPLC-UVD was evaluated and validated for the determination of with an LOQ of 0.01 mg/kg in high water content matrices (potatoes), an LOQ of 0.05 mg/kg in high oil content matrices (rape seed) and an LOQ of 0.02 mg/kg in dry commodities (barley grain) (United Kingdom, 1999). Since the method used in high water content commodities involved extraction of residues by reflux with sulphuric acid, the validation data submitted for high water content matrices are also valid for high acid content matrices. Nevertheless, an ILV and a confirmatory method are still required for all commodities of plant origin whilst for hops, a fully validated analytical method is required. EFSA notes that analytical methods for the determination of in plant commodities have been submitted for the renewal of the approval of this active substance under Regulation (EU) No 1141/2010 11 but were not considered in this reasoned opinion since these methods have not yet been peer reviewed. 1.2. Methods for enforcement of residues in food of animal origin During the peer review under Directive 91/414/EEC, an analytical method using HPLC-UVD was evaluated and validated for the determination of with an LOQ of 0.05 mg/kg in muscle, liver, kidney and fat whilst for milk, the method was validated at an LOQ of 0.01 mg/kg. An analytical 10 Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products. OJ L 155, 11.06.2011, p. 127-175. 11 Commission Regulation (EU) No 1141/2010 of 7 December 2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances, OJ L 322, 8.12.2010, p. 10-19. EFSA Journal 2015;13(1):3972 12
Review of the existing MRLs for method using GLC-ECD was used for the determination of in eggs with an LOQ of 0.01 mg/kg (United Kingdom, 1996). Nevertheless, a confirmatory method and an ILV are missing and are required for livestock matrices. 2. Mammalian toxicology The toxicological assessment of was peer reviewed under Directive 91/414/EEC and toxicological reference values were established by the European Commission (EC, 2001). These toxicological reference values are summarised in Table 2-1. Table 2-1: Overview of the toxicological reference values Diquat Source Year Value Study relied upon Safety factor ADI EC 2001 0.002 mg/kg bw per d 2 year rat study 100 ARfD EC 2001 Not necessary 3. Residues 3.1. Nature and magnitude of residues in plant 3.1.1. Primary crops 3.1.1.1. Nature of residues Metabolism of was investigated for foliar application on fruits and fruiting vegetables (tomatoes), pulses and oilseeds (oilseed rape), root and tuber vegetables (potatoes) and cereals (barley, oats, wheat, maize), all using 14 C-labelled (United Kingdom, 1996). The characteristics of these studies are summarised in Table 3-1. In foliar treated maize and tomatoes, no breakdown of the parent occurred when the plants were maintained in darkness whilst a rapid degradation of was observed when the treated plants were exposed to sunlight. Indeed, only 14 % of the applied radioactivity was recovered in maize after 6 days of exposure to sunlight against 87 % of the applied radioactivity under darkness. In tomatoes, a similar degradation pattern of the parent molecule was shown with up to 91 % of recovered total residues in tomatoes under darkness while under natural daylight, only 52 % of the total applied radioactivity was recovered. No further metabolites identification was however attempted in any of these crops. It was concluded that the degradation of is rather a photochemical than a metabolic process. Following foliar spray application on potato plants, low levels of total radioactive residues were recovered in the tubers (0.02 mg eq/kg) suggesting negligible translocation from the treated haulms into the tubers. Only was identified as the predominant compound of the total residues. No other metabolite was identified. After 14 C- foliar treatment on rape seed plants, the total radioactive residues accounted for 0.48-0.66 mg eq/kg in the meal and <0.003 mg eq/kg in the oil when the seeds were harvested 7 days after treatment. 78 % of the extracted radioactive residues from the rape seed meal were identified as unchanged. No attempts were made to characterize or identify the radioactive residues in the seeds. EFSA Journal 2015;13(1):3972 13
Review of the existing MRLs for 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 Method, F or G (a) Tomatoes n.r. Foliar spray, F/G Potatoes n.r. Foliar spray, F Oilseed rape seed n.r. Foliar spray, F Application and sampling details Rate (kg a.s./ha) 200 µg/plant No Sampling (DAT) 1 0, 1, 2, 4, 5, 6, 8 1.68 1 Tubers: 14 0.3, 0.6, 1.2 1 Seeds: 7 Whole plant: 14 Remarks Limited identification of metabolites in the edible parts of the crops was identified as the main deficiency in the reported studies. Cereals Barley, oats n.r. Foliar spray, F Wheat n.r. Foliar spray, F Maize n.r. Foliar spray, F/G 0.3, 0.6, 1.1 1 Grain and straw: 7, 14 10.2 1 Grain, straw and chaff: 7 200 µg/plant (a): Outdoor/field application (F) or glasshouse/protected/indoor application (G) n.r.: Not reported. 1 0, 1, 2, 4, 5, 6, 8 In cereals at harvest, the total radioactive residues ranged between 48-136 mg eq/kg in straw, 3.7-17.7 mg eq/kg in grain and 168 mg eq/kg in chaff. Diquat remained the predominant compound of the total residues in straw (up to 44.4 % TRR), in grain (up to 42.4 % TRR) and in chaff (22.5 % TRR) whilst the metabolite TOPPS 12 resulting from photodegradation accounted for up to 16.5 % TRR in straw, 13.4 % TRR in grain and 9 % TRR in chaff. The monopyridone 13 and dipyridone 14 metabolites were also recovered but only at minor levels (<10 % TRR and <1 % TRR, respectively) in grain, straw and chaff. The remaining radioactivity was shown to be incorporated into natural products. It is highlighted that the available plant metabolism studies reported in the DAR only cover the use as a crop desiccant (foliar application) and not the use of herbicide for weed control (soil application). Although not reported in detail in the JMPR Evaluation report, metabolism data related to a single application of 14 C- to tomato seeds that had been sown, showed that the total residues in mature fruit and leaves harvested 112 days after application were recovered at a trace level (<0.001 and 0.002 mg eq/kg, respectively) (FAO, 2013). Furthermore, EFSA is of the opinion that the submitted confined rotational crop studies on leafy crops, root and tuber vegetables and cereals following a bare soil application of may also cover the use of herbicide for weed control in primary crops (see section 3.1.2.2). The available metabolism studies following the use of as a crop desiccant demonstrated that may undergo photochemical degradation with the formation of the main photodegradation 12 1-oxo-1,2,3,4-tetrahydropyrido[1,2-a]pyrazin-5-ium (TOPPS); see also Appendix E 13 4-oxo-6,7-dihydro-4H-dipyrido[1,2-a:2',1'-c]pyrazin-8-ium; see also Appendix E 14 6,7-dihydrodipyrido[1,2-a:2',1'-c]pyrazine-4,9-dione; see also Appendix E EFSA Journal 2015;13(1):3972 14
Review of the existing MRLs for metabolite identified as TOPPS in cereal straw and grain. Diquat monopyridone and dipyridone metabolites were also identified but only as minor degradation products. Following soil application as a herbicide for weed control, significant residues are not expected in the edible parts of the crops since the strong adsorption of to soil precludes any molecule degradation in soil and therefore uptake by the plants (United Kingdom, 1996; FAO, 2013). There is no clear evidence whether TOPPS metabolite is present in the rat metabolism whilst monopyridone and dipyridone were tentatively characterized in the rat urine. It is therefore concluded that insufficient toxicological data were submitted to conclude on the toxicological profile of these metabolites (United Kingdom, 1996). Meanwhile, in the absence of toxicological data regarding these metabolites, TOPPS, monopyridone and dipyridone were assumed to have the same toxicological profile than the parent compound. Based on the metabolic pattern of depicted in the different categories of crops as a crop desiccant, EFSA is of the opinion that the metabolism of was sufficiently addressed in cereals (wheat, barley) only and proposes to define the residue for enforcement of cereals as the sum of and its salts expressed as. For risk assessment, the residue definition is proposed on a tentative basis as the sum of, its salts and TOPPS expressed as. In light of the toxicological profile of TOPPS, the decision on whether and TOPPS should be considered together in the residue definition for risk assessment or separately may be revised in the future. Meanwhile, based on the metabolism study on cereals, EFSA derived on a tentative basis a conversion factor of 1.5 for enforcement to risk assessment in cereals. Furthermore, in view of the deficiencies identified in the metabolism studies regarding the limited characterization and identification of radioactive residues in fruit crops, pulses and oilseeds and root and tuber vegetables, EFSA considers that metabolism data covering 2 additional crop categories are required in order to fully address the metabolism of as a crop desiccant in the plants. Meanwhile, the residue definitions derived for cereals are tentatively applied to all commodities of plant origin. Also on a tentative basis, the conversion factor for risk assessment in cereals is applied to all plant commodities where is applied as a crop desiccant. Where is applied to the soil, a no-residue situation is expected and a conversion factor for risk assessment is not considered necessary. EFSA highlights that the validity of the available metabolism studies as well as the proposed residue definition for enforcement and risk assessment in plants may be reconsidered in the framework of the possible renewal of the approval of this active substance under Regulation (EU) No 1141/2010. 3.1.1.2. Magnitude of residues According to the RMS, the active substance is authorised in northern and southern Europe for both soil and foliar treatments in a large number of crops (see Appendix A). To assess the magnitude of residues resulting from these GAPs, EFSA considered all residue trials reported in the PROFile, including residue trials evaluated in the framework of the peer review (UK, 1996) and additional data submitted during the consultation of Member States (France, 2014; Germany, 2014; United Kingdom, 2014). All available residue trials that comply with the authorised GAPs, are summarised in Table 3-2. The number of residue trials and extrapolations were evaluated in accordance with the European guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs (EC, 2011). For most of the reported GAPs, no residue trials are available. Consequently, neither MRLs nor risk assessment values can be derived for the crops listed below and the following data gaps were identified: Citrus fruit, pome fruit, tree nuts and stone fruit: 4 residue trials on apples and 4 residue trials on stone fruits compliant with the southern outdoor GAP are required with a possible extrapolation to citrus fruit, tree nuts, pome fruits and stone fruits. Regarding the northern EFSA Journal 2015;13(1):3972 15
Review of the existing MRLs for outdoor GAP on apples, pears, cherries and plums, 2 additional residue trials on apples and 4 residue trials on stone fruits compliant with the northern outdoor GAP are required. Blackberries, raspberries, currants (red, black and white) and gooseberries: According to the current guidelines, 4 trials on strawberries and 4 trials on grapes, blackcurrants or other berries, all compliant with the northern outdoor GAP, are required to be extrapolated to these crops. Since 4 residue trials are available on strawberries, 4 residue trials are still required on blackcurrants to support the northern outdoor GAP on blackberries, raspberries, currants (red, black and white) and gooseberries. Miscellaneous fruits (persimmon, passion fruit, bananas, mangoes, papaya and cherimoya): 4 residue trials on each of three representative crops for this group, including banana, and compliant with the southern outdoor GAP are required for this crop group. Beetroot, carrots, celeriac, horseradish, Jerusalem artichokes, parsnip, parsley root, radishes, salsify, swedes and turnips: 8 residue trials on carrots compliant with the northern outdoor GAP are required with a possible extrapolation to the other root and tuber vegetables crops, except sugar beet. Furthermore, 8 residue trials on carrots compliant with the southern outdoor GAP are also required with a possible extrapolation to turnips. Onions and garlic: 7 additional residue trials on onions compliant with the southern outdoor GAP are required with a possible extrapolation to garlic. Tomatoes, peppers, cucurbits with edible peel and cucurbits with inedible peel: 8 residue trials on tomatoes and 8 residue trials on cucumbers compliant with the southern outdoor GAP are required with a possible extrapolation to peppers, melons, pumpkins and watermelons. Furthermore, 8 residue trials on tomatoes and 8 residue trials on cucumbers compliant with the northern outdoor GAP are also required with a possible extrapolation to gherkins, courgettes, melons and pumpkins. Flowering and head brassica: 8 residue trials on head cabbage and 8 residue trials on cauliflower compliant with the northern outdoor GAP are required. Furthermore, 8 residue trials on head cabbage and 8 residue trials on cauliflower compliant with the southern outdoor GAP are also required. An extrapolation to flowering and head brassica is possible. Kohlrabi: 4 residue trials compliant with the southern outdoor GAP are required. Lettuces and salad plants, spinaches and similar leaves, and leafy brassica: 8 residue trials on lettuce compliant with the northern outdoor GAP (with a possible extrapolation to lettuce and salad plants, spinaches and similar leaves, and leafy brassica) and 8 residue trials compliant with the southern outdoor GAP (with a possible extrapolation to leafy brassica) are required. Herbs and edible flowers: 4 residue trials on any herb (except bay leaves, sage, rosemary and thyme) compliant with the northern outdoor GAP are required with a possible extrapolation to the other herbs crops. Furthermore, 4 residue trials on parsley to support the southern outdoor GAP on this crop are also required. Legume vegetables: 8 residue trials on green beans (with pods) or on green peas (with pods) compliant with the northern outdoor GAP are required with a possible extrapolation to fresh legume vegetables. Celery, cardoon, fennel and rhubarb: 4 residue trials on celery compliant with the northern outdoor GAP are required with a possible extrapolation to cardoon, fennel and rhubarb EFSA Journal 2015;13(1):3972 16
Review of the existing MRLs for provided that the GAPs are similar (BBCH or PHI value). Additionally, 4 residue trials on celery compliant with the southern outdoor GAP are also required. Globe artichokes: 4 residue trials compliant with the northern outdoor GAP and 4 residue trials compliant with the southern outdoor GAP are required. Leek: 8 residue trials compliant with the northern outdoor GAP and 4 residue trials compliant with the southern outdoor GAP are required. Olives for oil production: 8 residue trials compliant with the southern outdoor GAP are required. Sugar beet roots and tops: 8 residue trials compliant with the northern outdoor GAP (soil application) and 8 residue trials compliant with the southern outdoor GAP (pre-harvest foliar application) are required. Potatoes, sweet potatoes: 7 residue trials compliant with the northern outdoor GAP and 8 residue trials compliant with the southern outdoor GAP on potatoes are required, with a possible extrapolation to sweet potatoes provided that the GAPs are similar (PHI). Maize: 6 residue trials compliant with the northern outdoor GAP and 8 residue trials compliant with the southern outdoor GAP are required. Wheat: 8 residue trials compliant with the southern outdoor GAP are required. When is used as herbicide for weed control at early post-emergence, at a pre-flowering stage or as a soil directed spray closed to harvest between rows of established crops, a no-residue situation can be anticipated in these crops since neither direct contact with the edible parts of the crops nor uptake of by the plant roots is expected (see sections 3.1.1.1. and 3.1.2.2.). In these conditions, the number of requested residue trials may be reduced provided that the expected no-residue situation can be confirmed. Furthermore, it is noted that for numerous crops, the respective northern and southern outdoor GAPs were not properly reported with regards to the BBCH growth stage, the PHI value and/or the number of applications. They should therefore be further clarified. For the remaining crops, sufficient residue trials are available to derive tentative MRLs and risk assessment values and the following considerations were made by EFSA: Table and wine grapes: 4 residue trials compliant with the southern outdoor GAP are available. Additional residue trials are not required in view of the expected no-residue situation, and MRL and risk assessment values can be derived from the southern outdoor data. Strawberries: 5 residue trials compliant with the northern outdoor GAP are available, out of which 3 residue trials were carried out at a LOQ of 0.05 mg/kg. Additional residue trials for the northern outdoor GAP are not required in view of the expected no-residue situation. However, the southern outdoor GAP is not properly reported as the PHI is not defined and residue trials are not available to support this GAP. This GAP should therefore be further clarified and a complete residue data set is required to support the southern outdoor GAP. Meanwhile, tentative MRL and risk assessment values can be derived from the northern outdoor data. Asparagus: 4 residue trials compliant with the northern outdoor GAP are available, out of which 2 trials were conducted at an LOQ of 0.05 mg/kg. Considering however that application is performed on the field after the previous harvest and that residues in rotational EFSA Journal 2015;13(1):3972 17
Review of the existing MRLs for crops are not expected to exceed the LOQ, the no-residue situation can be confirmed for the northern outdoor GAP and no further residue trials are required to support this GAP. However, the southern outdoor GAP is not properly reported (number of application not specified) and residue trials are not available to support this GAP. This GAP should therefore be further clarified and a complete residue data set is required to support the southern outdoor GAP. Meanwhile, tentative MRL and risk assessment values can be derived from the northern outdoor data. Pulses (beans, lentils, peas and lupins): A sufficient number of residue trials, performed on dry peas and supporting the northern outdoor GAP is available with a possible extrapolation to dry beans, lentils and lupins. Although tentative MRL and risk assessment values can be derived from the northern outdoor data, 8 residue trials on dry beans compliant with the southern outdoor GAP are still required. Furthermore, the northern outdoor GAP on dry lentils and the southern outdoor GAP on dry beans are not properly reported since the number of applications is not defined and should be addressed. Poppy seed, sesame seed, sunflower seed, rape seed, mustard seed, borage: 17 residue trials on rape seed and 5 residue trials on sunflower seed are available to support the northern outdoor GAP for these oilseed crops. 3 additional residue trials on sunflower seed compliant with the northern outdoor GAP are in principle still required. However, considering the high number of residues trials available for rape seed and the homogeneous results obtained from sunflower seed and rape seed, further trials are not deemed necessary and MRL and risk assessment values can be derived from the northern outdoor data. However, the southern outdoor GAP is not supported by residues trials and the southern outdoor GAP on rape seed is not properly reported since the number of applications and the PHI values are not defined and should be addressed. 8 residue trials on rape seed and 8 residue trials on sunflower seed compliant with the southern outdoor GAP are therefore still required. Hempseed: The number of residue trials supporting the northern outdoor GAP is in principle not compliant with the data requirements for this minor crop (4 residue trials on rape seed and 4 residue trials on sunflower seed). However, considering the high number of residues trials available for rape seed and the homogeneous results obtained from sunflower seed and rape seed, further trials are not deemed necessary Barley and oats: A sufficient number of combined residue trials on barley and oats and supporting the northern outdoor GAP is available. The southern outdoor GAP on oats is not properly reported since the number of applications and the PHI are not defined. This GAP should therefore be further clarified. Furthermore, residue trials compliant with the southern outdoor GAP on oats are not available. 8 residue trials compliant with the southern outdoor GAP on oats are required. Meanwhile, tentative MRL and risk assessment values can be derived from the combined northern outdoor residue data on barley and oats. It is also highlighted that since the reported residue trials for the crops where is applied as a desiccant analysed the parent compound only, a tentative conversion factor of 1.5 for risk assessment derived from the cereals metabolism data was provisionally applied to all these plant commodities. Sufficient residue trials analysing the residues of and TOPPS in compliance with the proposed residue definition for risk assessment are therefore required on all these crops. For the uses when is applied to the soil and a no-residue situation is expected, a conversion factor for risk assessment was not considered relevant. 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 was demonstrated for a period of 46 months (temperature not specified) in commodities with high water content (carrot, cabbage) and for a period of 18 months in dry commodities (wheat grain) (United Kingdom, 1999). In the JMPR evaluation report, the frozen storage stability of was demonstrated in high water content EFSA Journal 2015;13(1):3972 18
Review of the existing MRLs for (carrot, lettuce, potato), high oil content (soya bean), dry commodities (wheat, sorghum, rice) and in straw for a minimum of 6 months when stored at -20 C (FAO, 1994). Furthermore, acceptable storage stability data on in high water content (spinach, potato), high oil content (rape seed), high acid content (orange fruit), dry commodities (wheat grain, lentils) and straw for up to 24 months were submitted in a more recent JMPR evaluation report (FAO, 2013). According to the RMS, the residue trial samples reported in the PROFile on table and wine grapes, onions, sunflower seed, rape seed, and hops (dried) were stored in compliance with the storage conditions reported above. For apples, strawberries, asparagus, pulses (dry), linseed, barley and oats grain and straw and maize, the storage conditions of the residue samples were not specified in the DAR (UK, 1996). However, it is assumed that storage of residues trials samples for more than 2 years is unusual. This information is therefore considered as desirable only and degradation of residues during storage of the trial samples is not expected. Consequently, the available residues data are considered sufficient to derive MRL proposals as well as risk assessment values for table and wine grapes, strawberries, asparagus, pulses, linseed, poppy seed, sesame seed, sunflower seed, rape seed, mustard seed, borage, hempseed, barley and oats grain, and hops (dried). For all other crops reported in the framework of this review, data were insufficient to derive MRLs (see also Table 3-2). Moreover, considering the data gaps that were identified regarding plant metabolism, residues trials data and analytical methods, all MRL proposals should be considered on a tentative basis only. Where several uses are authorised for one commodity, the final MRL proposal was derived from the most critical use and indicated in bold in Table 3-2. Tentative MRLs were also derived for feed crops (cereal straw) in view of the future need to set MRLs in feed items. EFSA Journal 2015;13(1):3972 19
Review of the existing MRLs for Table 3-2: Overview of the available residue trials data Commodity Residue region (a) Outdoor /Indoor Individual trial results Enforcement (sum of and its salts expressed as ) Application as a herbicide for weed control (soil application) Citrus fruit Tree nuts Pome fruit Stone fruit Table and wine grapes Risk assessment (sum of, its salts and TOPPS expressed as ) Median residue (b) Highest residue (c) MRL proposal Median CF (d) Comments NEU Outdoor <0.01; <0.01 - - - - - Trials compliant with GAP (United Kingdom, 1996); no authorized use on quinces, medlar, loquat, apricots and peaches in northern Europe. SEU Outdoor - - - - - - No trial compliant with GAP. SEU Outdoor <0.01; <0.01; <0.05; <0.05-0.01 0.01 0.01* (tentative) (e), (f), (g) 1.0 Trials compliant with GAP (United Kingdom, 1996). Strawberries NEU Outdoor <0.01; <0.01; <0.05; <0.05; <0.05-0.01 0.01 0.01* (tentative) (e), (f), (g) 1.0 Trials compliant with GAP (PROFile). Blackberries raspberries Currants Gooseberries Persimmon Passion fruit Bananas Mangoes Papaya Cherimoya SEU Outdoor - - - - - - No trial compliant with GAP. NEU Outdoor - - - - - - No trial compliant with GAP. NEU Outdoor - - - - - - No trial compliant with GAP. SEU Outdoor - - - - - - No trial compliant with GAP. EFSA Journal 2015;13(1):3972 20
Review of the existing MRLs for Commodity Beetroot Carrots Celeriac Horseradish Jerusalem artichokes Parsnip Parsley root Radishes Salsify Swedes Turnips Garlic Onions Tomatoes Peppers Cucurbits with edible peel Cucurbits with inedible peel Flowering brassica Head brassica Residue region (a) Outdoor /Indoor Individual trial results Enforcement (sum of and its salts expressed as ) Risk assessment (sum of, its salts and TOPPS expressed as ) Median residue (b) Highest residue (c) MRL proposal Median CF (d) Comments NEU Outdoor - - - - - - No trial compliant with GAP. SEU Outdoor - - - - - - No trial compliant with GAP. Only carrots and turnips are authorized in southern Europe. SEU Outdoor <0.02 - - - - - Trial compliant with GAP (PROFile). NEU Outdoor - - - - - - No trial compliant with GAP. No authorized use on tomatoes, peppers, cucumbers and watermelons in northern Europe. SEU Outdoor - - - - - - No trial compliant with GAP. No authorized use on gherkins and courgettes in southern Europe. NEU Outdoor - - - - - - No trial compliant with GAP. SEU Outdoor - - - - - - No trial compliant with GAP. EFSA Journal 2015;13(1):3972 21
Review of the existing MRLs for Commodity Residue region (a) Outdoor /Indoor Individual trial results Enforcement (sum of and its salts expressed as ) Risk assessment (sum of, its salts and TOPPS expressed as ) Median residue (b) Highest residue (c) MRL proposal Median CF (d) Comments Kohlrabi SEU Outdoor - - - - - - No trial compliant with GAP. Lettuces and salad plants Spinaches and similar leaves Leafy brassica Herbs and edible flowers NEU Outdoor - - - - - - No trial compliant with GAP. SEU Outdoor - - - - - - No trial compliant with GAP. Only authorised use on lettuce and leafy brassica in southern Europe. NEU Outdoor - - - - - - No trial compliant with GAP. SEU Outdoor - - - - - - No trial compliant with GAP. Only the use on parsley is authorized in southern Europe. Legume vegetables NEU Outdoor - - - - - - No trial compliant with GAP. Asparagus NEU Outdoor <0.05; <0.05; <0.01; <0.01 Celery Cardoon Fennel Rhubarb - 0.01 0.01 0.01* (tentative) (e), (f), (g) 1.0 Trials compliant with GAP (PROFile). SEU Outdoor - - - - - - No trial compliant with GAP. NEU Outdoor - - - - - - No trial compliant with GAP. SEU Outdoor - - - - - - No trial compliant with GAP. No authorized use on cardoon, fennel and rhubarb in southern Europe. Globe artichokes NEU Outdoor - - - - - - No trial compliant with GAP. SEU Outdoor - - - - - - No trial compliant with GAP. Leek NEU Outdoor - - - - - - No trial compliant with GAP. SEU Outdoor - - - - - - No trial compliant with GAP. EFSA Journal 2015;13(1):3972 22
Review of the existing MRLs for Commodity Olives for oil production Residue region (a) Outdoor /Indoor Individual trial results Enforcement (sum of and its salts expressed as ) Risk assessment (sum of, its salts and TOPPS expressed as ) Median residue (b) Highest residue (c) MRL proposal Median CF (d) Comments SEU Outdoor - - - - - - No trial compliant with GAP. Sugar beet root NEU Outdoor - - - - - - No trial compliant with GAP. Sugar beet tops NEU Outdoor - - - - - - No trial compliant with GAP. Fodder beet root NEU Outdoor - - - - - - No trial compliant with GAP. Fodder beet tops NEU Outdoor - - - - - - No trial compliant with GAP. Application as a pre-harvest crop desiccant Potatoes NEU Outdoor 0.03 - - - - - Trial compliant with GAP (Germany, 2014). SEU Outdoor - - - - - - No trial compliant with GAP. Sweet potatoes NEU Outdoor - - - - - - No trial compliant with GAP. SEU Outdoor - - - - - - No trial compliant with GAP. Pulses NEU Outdoor 3 <0.02; 2 0.03; 0.04; 4 <0.05; 3 0.05; 2 0.06; 0.10; 0.15-0.05 0.15 0.20 (tentative) (e), (f) 1.5 (h) GAP-compliant residue trials (United Kingdom, 1996). Rber= 0.11 Rmax= 0.13 OECD= 0.18 SEU Outdoor - - - - - - No trial compliant with GAP; no authorised use on lentils, peas and lupins (dry) in southern Europe. EFSA Journal 2015;13(1):3972 23
Review of the existing MRLs for Commodity Residue region (a) Outdoor /Indoor Individual trial results Enforcement (sum of and its salts expressed as ) Risk assessment (sum of, its salts and TOPPS expressed as ) Median residue (b) Highest residue (c) MRL proposal Linseed NEU Outdoor 0.65; 2.8; 0.10; 3.90-1.73 3.9 10 (tentative) (e), (f) Poppy seed Sesame seed Sunflower seed Rape seed Mustard seed Borage NEU Outdoor Rape seed: 0.42; 0.05; 0.07; 0.07; 0.06; 0.2 <0.05; 0.24; 0.44; 0.43; 0.35; <0.05; 0.14; <0.05; 0.09; 0.15; 0.14 Sunflower seed: 0.15; 0.11; 0.11; 0.08; 0.46-0.14 0.46 0.8 (tentative) (e), (f) Median CF (d) Comments 1.5 (h) GAP-compliant residue trials on linseed (France, 2014) Rber= 7.25 Rmax= 11.07 OECD= 9.02 1.5 (h) GAP-compliant residue trials on rape seed and sunflower seed with a possible extrapolation to poppy seed, sesame seed, mustard seed and borage (United Kingdom, 1996, 2014; Germany, 2014). Rber= 0.78 Rmax= 0.69 OECD= 0.99 SEU Outdoor - - - - - - No trial compliant with GAP; no authorised use on poppy seed and mustard seed in southern Europe. Hempseed NEU Outdoor Rape seed: 0.42; 0.10; 0.08; 0.03; 0.02; 0.12; 0.05; 0.48; 0.26; 0.16 Sunflower seed: 0.15; 0.19; 0.46-0.15 0.48 0.9 (tentative) (e), (f) 1.5 (h) Trials on rape seed and sunflower seed compliant with GAP on hempseed (Germany, 2014; United Kingdom, 2014) Rber=0.68 Rmax= 0.63 OECD= 0.84 EFSA Journal 2015;13(1):3972 24
Review of the existing MRLs for Commodity Barley grain Oats grain Barley straw Oats straw Residue region (a) Outdoor /Indoor Individual trial results Enforcement (sum of and its salts expressed as ) NEU Outdoor Barley: 0.47; 0.72; 0.86; 1.1; 1.2; 1.2; 1.2; 1.5; 1.8; 3.5; 4.2; 5.5 Oats: 0.75; 0.9; 0.93; 1.1; 1.7 Risk assessment (sum of, its salts and TOPPS expressed as ) Median residue (b) Highest residue (c) MRL proposal - 1.10 5.50 8 (tentative) (f) Median CF (d) Comments 1.5 (h) Combined residue trials on barley and oats compliant with GAP (United Kingdom, 1996). Rber=3.50 Rmax= 5.13 OECD= 7.23 SEU Outdoor - - - - - - No trial compliant with GAP; no authorised use on barley in southern Europe. NEU Outdoor Barley: 4.9; 12 Oats: 0.78; 7.9; 9.1; 15; 22-9.10 22 40 (tentative) 1.5 (h) Combined residue trials on barley and oats compliant with GAP (United Kingdom, 1996). Rber=30 Rmax= 33.84 OECD= 37.99 SEU Outdoor - - - - - - No trial compliant with GAP; no authorised use on barley in southern Europe. Maize NEU Outdoor <0.05; <0.05 - - - - - Trials compliant with GAP (United Kingdom, 1996). SEU Outdoor - - - - - - No trial compliant with GAP. Wheat grain SEU Outdoor - - - - - - No trial compliant with GAP. Wheat straw SEU Outdoor - - - - - - No trial compliant with GAP. Hops (dried) NEU Outdoor <0.01; <0.01; <0.01-0.01 0.01 0.01* (tentative) (e), (f) 1.5 (h) Trials compliant with GAP (United Kingdom, 1999). EFSA Journal 2015;13(1):3972 25
Review of the existing MRLs for Commodity Residue region (a) Outdoor /Indoor Individual trial results Enforcement (sum of and its salts expressed as ) Risk assessment (sum of, its salts and TOPPS expressed as ) Median residue (b) Highest residue (c) MRL proposal Median CF (d) Comments Sugar beet root SEU Outdoor - - - - - - No trial compliant with GAP. Sugar beet tops SEU Outdoor - - - - - - No trial compliant with GAP. (a): NEU (Northern and Central Europe), SEU (Southern Europe and Mediterranean), EU (i.e. outdoor use) or Import (country code) (EC, 2011). (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. (e): Lack of acceptable metabolism data in plants to derive a general residue definition for enforcement and risk assessment. (f): Analytical methods for enforcement of residues in plants are not fully validated or missing. (g): An MRL of 0.01* mg/kg is derived since a no residue situation is expected in view of the use pattern (soil application as a herbicide) and sufficient trials were performed at the lower LOQ. (h): Tentative conversion factor for enforcement to risk assessment derived from the metabolism data on cereals. (*): Indicates that the MRL is set at the limit of analytical quantification. EFSA Journal 2015;13(1):3972 26
Review of the existing MRLs for 3.1.1.3. Effect of industrial processing and/or household preparation The effect of processing on the nature of has not been investigated in the framework of the peer review. Although no residues above the LOQ are expected in the edible parts of the crops treated with the active substance as a herbicide for weed control, significant residue levels are expected when is used as a crop desiccant in the following crops: potatoes, sweet potatoes, pulses (dry), oilseeds, cereals and hops (dried). A processing study simulating representative hydrolytic conditions for pasteurisation (20 minutes at 90 C, ph 4), boiling/brewing/baking (60 minutes at 100 C, ph 5) and sterilisation (20 minutes at 120 C, ph 6) is therefore required. The nature of the TOPPS metabolite under standard hydrolytic conditions also needs to be investigated. Meanwhile, it is proposed to apply, on a tentative basis, the same residue definition for enforcement and risk assessment as for primary crops. Studies investigating the magnitude of residues in processed commodities of cereals and oilseeds were reported in the framework of the peer review (United Kingdom, 1996, 1999) and by the JMPR (FAO, 1994, 2013). An overview of all available processing studies is available in Table 3-3. However, all processing factors should be regarded as indicative only because processed commodities were analysed for parent compound only (while no information is available on the nature of residues in processed commodities) and some processing factors are not supported by a sufficient number of studies (a minimum of 3 studies is normally required). Table 3-3: Overview of the available processing studies Processed commodity Number of studies Median PF (a) Median CF (b) Comments Residue definition for enforcement: sum of and its salts, expressed as (tentative) Residue definition for risk assessment: sum of, its salts and TOPPS expressed as (tentative) Indicative processing factors (limited dataset and/or tentative residue definition) Barley brewing malt 3 0.48 1.5 (United Kingdom, 1996, 1999) Beer 3 0.03 1.5 (United Kingdom, 1996, 1999) Wheat bran 6 2.1 1.5 (United Kingdom, 1996, 1999) Wheat white flour 7 0.41 1.5 (United Kingdom, 1996, 1999) Wheat white bread 6 0.5 1.5 (United Kingdom, 1996, 1999) Wheat whole-meal flour 2 0.85 1.5 (United Kingdom, 1996, 1999) Wheat whole-meal bread 1 0.75 1.5 (United Kingdom, 1996, 1999) Sunflower crude oil 10 <0.48 1.5 (FAO, 1994, 2013) Sunflower meal 9 1.2 1.5 (FAO, 1994, 2013) Rape seed crude oil 9 0.03 1.5 (FAO, 1994, 2013) Rape seed refined oil 4 <0.03 1.5 (FAO, 1994, 2013) Rape seed meal 10 0.58 1.5 (FAO, 1994, 2013) Soya bean crude oil 4 <0.07 1.5 (FAO, 1994, 2013) Soya bean refined oil 2 <0.07 1.5 (FAO, 2013) Soya bean meal 4 1 1.5 (FAO, 1994, 2013) (a): The median processing factor is obtained by calculating the median of the individual processing factors of each processing study. (b): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual conversion factors of each processing study. EFSA Journal 2015;13(1):3972 27
Review of the existing MRLs for 3.1.2. Rotational crops 3.1.2.1. Preliminary considerations All crops under consideration, except the permanent crops (orchards, cane fruit, other small fruits and berries, miscellaneous fruit, grapes and asparagus), may be grown in rotation. According to the soil degradation studies evaluated in the framework of the peer review, DT 90f value for could not be reached. The DT 50f was reached after 10 to 20 years demonstrating the strong adsorption of to soil (EC, 2001). Furthermore, the metabolite TOPPS resulting from photodegradation of was also shown to be persistent (estimated DT 50 ranging between 28 and 757 days). According to the European guidelines on rotational crops (EC, 1997b), further investigation of residues in rotational crops is relevant. 3.1.2.2. Nature of residues The metabolism of in rotated leafy crops (lettuce), root and tuber crops (carrots) and cereals (wheat) has been evaluated (United Kingdom, 1996; FAO, 2013). A confined rotational crop study investigating the nature of residues following different plant-back intervals is available. The characteristics of this study are summarised in Table 3-4. Table 3-4: Summary of available metabolism studies in rotational crops Crop group Crop Label position Method, F or G (a) Leafy vegetables Lettuce n.r. Bare soil application, G Root and tuber vegetables Carrots n.r. Bare soil application, G Cereals Wheat n.r. Bare soil application, G Application and sampling details Rate (kg a.s./ha) (a): Outdoor/field application (F) or glasshouse/protected/indoor application (G) (b): Plants washed prior analysis. n.r.: Not reported. Sowing intervals (DAT) 1.1 30, 120, 365 1.1 30, 120, 365 1.1 30, 120, 365 Harvest Intervals (DAT) n.r. n.r. n.r. Remarks (b) Carrots were peeled. Roots and leaves sampling. Straw, chaff and grain sampling. The total radioactive residues were below the detection limit of the method (<0.008 mg/kg) (the LOQ of the method was not reported) in all the edible parts of the rotated crops at all plant back intervals, except in carrot leaves (0.017 mg eq/kg 365 DAT) and in wheat straw (up to 0.024 mg eq/kg 120, 365 DAT). Identification of metabolites was therefore not attempted. Due to the fact that residues are strongly bound to the soil components, significant uptake by the plants is not expected. It is therefore concluded that the residues in soil will not contribute significantly to the residues in succeeding crops. Based on the confined rotational crop metabolism study and considering that the total annual application rate of within the EU ranges between 0.4 kg a.s./ha and 2 kg a.s./ha (potatoes) and the fact that bare soil treatment was applied (interception of residues by the primary crops is in practice expected at a rate of 50-80 %), it can be concluded that a specific residue definition is not required for rotational crops and that no significant residue levels (<0.01 mg/kg) in the edible parts of EFSA Journal 2015;13(1):3972 28
Review of the existing MRLs for the rotated crops are expected, provided that is applied in compliance with the GAPs reported in Appendix A. 3.2. Nature and magnitude of residues in livestock 3.2.1. Dietary burden of livestock Diquat 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 summarised in Table 3-5. For sunflower and rape seed meal, the indicative processing factors derived under section 3.1.1.3 have been included in the calculation. It is highlighted that for several feed items, no residue data were available (e.g. citrus fruit, potatoes, carrots, turnips, Chinese cabbage, head cabbage, kale, maize grain, wheat grain and straw, sugar/fodder beet roots/tops and leaves). The animal intake of residues via these commodities has therefore not been assessed and may have been underestimated. However, this is not expected to have a major impact on the outcome of the dietary burden considering the major contribution of cereal grain and straw. Table 3-5: 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, its salts and TOPPS expressed as (tentative) Pulses (dry) 0.075 Median residue CF 0.075 Median residue CF Sunflower seed meal 0.234 Median residue PF CF 0.234 Median residue PF CF Rape seed meal 0.113 Median residue PF CF 0.113 Median residue PF CF Barley & oats grain 1.65 Median residue CF 1.65 Median residue CF Barley & oats straw 13.65 Median residue CF 33 Highest residue CF The results of the calculations are reported in Table 3-6. The calculated dietary burdens for all groups of livestock were found to exceed the trigger value of 0.1 mg/kg DM. Further investigation of residues is therefore required in all commodities of animal origin. Table 3-6: Results of the dietary burden calculation Median dietary burden (mg/kg bw per d) Maximum dietary burden (mg/kg bw per d) Highest contributing commodity Max dietary burden (mg/kg DM) Risk assessment residue definition: sum of, its salts and TOPPS expressed as (tentative) Trigger exceeded (Y/N) Dairy ruminants 0.158 0.321 Barley straw 8.94 Y Meat ruminants 0.381 0.863 Barley straw 20.1 Y Poultry 0.094 0.094 Barley grain 1.49 Y Pigs 0.07 0.07 Barley grain 1.80 Y EFSA Journal 2015;13(1):3972 29
3.2.2. Nature of residues Review of the existing MRLs for The nature of residues in commodities of animal origin was investigated in the framework of Directive 91/414/EEC (United Kingdom, 1996). Reported valid metabolism studies included one study in lactating cows and two studies in laying hens using 14 C-labelled. The characteristics of these studies are summarised in Table 3-7. Additional metabolism studies on lactating ruminants and laying hens were also conducted using a mixture of 14 C-labelled and its photodegradation products (TOPPS, monopyridone, dipyridone) the animals are actually exposed to when they are fed with desiccated crops. These studies were not further considered because the dosing levels were not reported. Table 3-7: Summary of available metabolism studies in livestock Group Species Label position Lactating ruminants Laying poultry n.r.: Not reported. No of animal Application details Rate Cow n.r. 1 30 mg/kg diet Hen n.r. n.r. 4-5 mg/kg diet n.r. 3 2.4 mg/kg bw per d Duration (days) Commodity Sample details Time 7 Milk Daily Urine and faeces Tissues Daily Sacrifice (4 hours after last dosing) 5 Eggs Daily Excreta Tissues Daily Sacrifice (7 hours after last dosing) 4 Eggs Daily Excreta Tissues Daily Sacrifice (19 hours after last dosing) Lactating cows were dosed with 30 mg/kg diet of 14 C-labelled, corresponding to approximately 1.5 times the exposure of meat ruminant. The study demonstrated that transfer of residues to milk and tissues was minor as was poorly absorbed and excreted mainly unchanged in the excreta (91 % of the total dose) whilst in milk, only 0.015 % of the administrated radioactivity was recovered. The highest residue levels were found in liver (0.052 mg eq/kg) and in kidney (0.077 mg eq/kg) whilst the total residues were recovered at a trace level in milk (0.004 mg eq/kg), in muscle (up to 0.005 mg eq/kg) and in fat (0.002 mg eq/kg). In milk, was shown to be extensively degraded and accounted for only 13 % of TRR. The metabolites TOPPS and monopyridone were also identified and occurred at a level of 5.8 % of TRR (<0.01 mg eq/kg) and 13 % of TRR (<0.01 mg eq/kg), respectively. The major part of the radioactivity was incorporated into natural compounds such as lactose and proteins (50 % of TRR). In liver and kidney, remained the predominant compound of the total residues (77 % and 52 % of TRR, respectively) along with monopyridone metabolite (29 % of TRR - 0.015 mg eq/kg and 14 % of TRR - <0.01 mg eq/kg, respectively). No metabolites identification was attempted in muscle and fat due to the very low levels of recovered residues. Laying hens were dosed with either 5 mg/kg diet (first study) or with 2.4 mg/kg bw per d (second study) corresponding respectively to 3 and 25 times the calculated dietary burden for poultry. In the first study, the total radioactive residues were recovered at a trace level in all matrices (<0.01 mg/kg) EFSA Journal 2015;13(1):3972 30
Review of the existing MRLs for except in egg yolk (0.021 mg eq/kg). Metabolites identification was therefore investigated in egg yolk only and demonstrated that both the parent compound and TOPPS were the predominant components of the total residues, accounting for up to 39 % of TRR and 61 % of TRR (0.012 mg eq/kg), respectively. Furthermore, the metabolite monopyridone was also present but at a lower level (up to 7 % of TRR). In the second study, was shown to be excreted mainly unchanged in the faeces (up to 94.5 % of the total dose). The highest residue levels were recovered in liver and kidney (up to 0.045 mg eq/kg and 0.058 mg eq/kg, respectively) whilst the total radioactive residues were at a trace level in muscle (0.003 mg eq/kg), fat (0.004 mg eq/kg) and in egg white and yolk (0.004 and <0.001 mg eq/kg, respectively). In liver, the parent compound constituted 48 % of the total residues along with other minor identified metabolites; e.g. TOPPS, monopyridone and dipyridone (<10 % of TRR). In kidney, was more extensively metabolised and accounted only for 12 % of TRR. Diquat monopyridone was the predominant compound of the total residues (15 % of TRR - <0.01 mg/kg) whilst TOPPS and dipyridone were not present in significant proportions (<10 % of TRR - <0.01 mg eq/kg). It is noted that for both matrices, a major part of the radioactivity remained unidentified (40 % and 60 % of TRR in liver and kidney, respectively) with no further characterization attempt of the total residues. No identification was conducted in muscle and fat based on the very low recovered residue levels. The metabolism studies on both ruminants and poultry showed that parent compound is the only significant residue in muscle, fat and milk. In liver, kidney and eggs however, the presence of the predominant metabolites TOPPS, monopyridone and dipyridone indicated an extensive degradation of the parent compound. The general metabolic pathways in rodents and ruminants were found to be comparable, involving successive oxidations followed by cleavage of the parent molecule. The metabolic pattern of in ruminants can therefore be extrapolated to pigs. Insufficient toxicological data were submitted to conclude on the toxicological profile of TOPPS, monopyridone and dipyridone (United Kingdom, 1996). However, considering that the ruminants and poultry metabolism studies were performed at an overdosed rate for ruminants (1.5 times) and at a highly exaggerated rate for poultry (25 times) compared to the calculated dietary burden, the actual levels of the identified metabolites are not expected to exceed 0.01 mg/kg in any matrix at the calculated dietary burden (see also section 3.2.1). There is therefore no need to include these metabolites in the residue definition for risk assessment. The residue definition for enforcement and risk assessment in livestock matrices is proposed as and its salts expressed as. The conclusions reached by EFSA reflect the views of the RMS and are also in line with those of the JMPR (FAO, 1994, 2013). Since log P o/w of is lower than 3 (EC, 2001), EFSA concludes that the residue in commodities of animal origin is not fat soluble. This was confirmed by the similar order of magnitude of residues in fat compared to fat free muscle. EFSA highlights that in the framework of the renewal of the approval of this active substance, the available metabolism data and the proposed residue definitions for enforcement and risk assessment in livestock matrices might be reconsidered. 3.2.3. Magnitude of residues According to the above mentioned metabolism studies, it is concluded that, after exposure to the maximum dietary burden (about 1.5 and 25 times lower than the dose levels in the metabolism studies on ruminants and poultry, respectively; see also section 3.2.1), residue levels in ruminants and poultry are expected to remain below the enforcement LOQ of 0.01 mg/kg in milk and eggs and below the enforcement LOQ of 0.05 mg/kg in muscle, fat, liver and kidney. Hence, no livestock feeding study is triggered, and MRLs and risk assessment values for the relevant commodities in ruminants and EFSA Journal 2015;13(1):3972 31
Review of the existing MRLs for poultry can be established at the LOQ level. Considering that a confirmatory method and an ILV are still required for enforcement purposes, these MRLs are tentative only. 4. Consumer risk assessment In the framework of this review, only the uses of reported by the RMS in Appendix A were considered, however the use of was previously also assessed by the JMPR (FAO, 1994, 2013). The CXLs, resulting from these assessments by JMPR and adopted by the CAC, are now international recommendations that need to be considered by European risk managers when establishing MRLs. In order to facilitate consideration of these CXLs by risk managers, the consumer exposure was calculated both with and without consideration of the existing CXLs (see Appendix C.2). 4.1. Consumer risk assessment without consideration of the existing CXLs Chronic exposure calculation for all crops reported in the framework of this review was performed using revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo) (EFSA, 2007). Input values for the exposure calculations were derived in compliance with Appendix D and are summarised in Table 4-1. The (tentative) median residue values selected for chronic intake calculations are based on the residue levels in the raw agricultural commodities reported in section 3. For those commodities where data were insufficient to derive an MRL in section 3, EFSA considered the existing EU MRL for an indicative calculation. In order to take into consideration the occurrence of TOPPS, these input values for parent were multiplied by a conversion factor of 1.5 when is authorised for use as a desiccant on the relevant crop. The contributions of other commodities, for which no GAP was reported in the framework of this review, were not included in the calculation. Acute exposure calculations were not carried out because an ARfD was not deemed necessary for this active substance. Table 4-1: Input values for the consumer risk assessment (without consideration of CXLs) Commodity Input value Chronic risk assessment Comment Risk assessment residue definition: sum of, its salts and TOPPS expressed as (tentative) Citrus fruit Tree nuts Pome fruit Stone fruit 0.05 EU MRL (a) Table and wine grapes 0.01* Median residue (tentative) (b) Strawberries 0.01* Median residue (tentative) (b) Blackberries Raspberries Currants (red, black and white) Gooseberries Persimmon Passion fruit Bananas Mangoes Papaya Cherimoya 0.05 EU MRL (a) Potatoes 0.075 EU MRL CF (a) Sweet potatoes 0.075 EU MRL CF (a) EFSA Journal 2015;13(1):3972 32
Review of the existing MRLs for Commodity Other root and tuber vegetables Garlic Onions Tomatoes Peppers Cucurbits with edible peel Cucurbits with inedible peel Flowering brassica Head brassica Leafy brassica Kohlrabi Lettuces and salad plants Spinaches and similar leaves Herbs and edible flowers Legume vegetables Input value Chronic risk assessment Comment 0.05 EU MRL (a) Asparagus 0.01* Median residue (tentative) (b) Cardoon Celery Fennel Globe artichokes Leek Rhubarb 0.05 EU MRL (a) Pulses, dry 0.075 Median residue CF (tentative) (b) Linseed 2.59 Median residue CF (tentative) (b) Poppy seed Sesame seed Sunflower seed Rape seed Mustard seed Borage 0.21 Median residue CF (tentative) (b) Hempseed 0.23 Median residue CF (tentative) (b) Olives for oil production 0.05* EU MRL (a) Barley grain Oats grain 1.65 Median residue CF (tentative) (b) Maize grain 1.5 EU MRL CF (a) Wheat grain 0.075 EU MRL CF (a) Hops (dried) 0.015 Median residue CF (tentative) (b) Sugar beet root 0.075 EU MRL CF (a) Swine muscle 0.05* Median residue (tentative) (c) Swine fat 0.05* Median residue (tentative) (c) Swine liver 0.05* Median residue (tentative) (c) Swine kidney 0.05* Median residue (tentative) (c) Ruminant muscle 0.05* Median residue (tentative) (c) Ruminant fat 0.05* Median residue (tentative) (c) Ruminant liver 0.05* Median residue (tentative) (c) EFSA Journal 2015;13(1):3972 33
Review of the existing MRLs for Commodity Input value Chronic risk assessment Comment Ruminant kidney 0.05* Median residue (tentative) (c) Poultry muscle 0.05* Median residue (tentative) (c) Poultry fat 0.05* Median residue (tentative) (c) Poultry liver 0.05* Median residue (tentative) (c) Ruminant milk 0.01* Median residue (tentative) (c) Bird s eggs 0.01* Median residue (tentative) (c) (*): Indicates that the input value is proposed at the limit of analytical quantification. (a): Use reported by the RMS is not supported by data; the existing EU MRL (multiplied by a conversion factor for risk assessment when the authorisation includes a desiccant use) is used for indicative exposure calculations. (b): Use reported by the RMS is not fully supported by data but the risk assessment values derived in section 3 are used for indicative exposure calculations. (c): Dietary burden relevant to this commodity of animal origin, resulting from the GAPs reported by the RMS, is not fully supported by data; the risk assessment value derived in section 3 is used for indicative exposure calculations. The calculated exposures were compared with the toxicological reference value derived for (see Table 2-1); detailed results of the calculations are presented as EU scenario 1 in Appendix B.1. The highest chronic exposure was calculated for the Irish adult, representing 383 % of the ADI (IE adult). A second intake calculation was therefore performed, excluding the authorizations on maize and barley since these crops are the main contributors to the chronic dietary intake. According to the results of this second calculation (see Appendix B.2 EU scenario 2), the highest chronic exposure declined to 152 % of the ADI (UK toddler). EFSA emphasizes that the exceedance of the ADI observed in the second calculation (EU scenario 2) is mainly driven by the existing EU MRLs in plant commodities which are established at the current LOQ of 0.05 mg/kg with an ADI exhaustion ranging between 31 % and 75 %. Considering that this concerns authorisations of where a no-residue situation is likely and that lower LOQs were derived in section 1.1 for certain crop groups, a third calculation was conducted including the lower LOQs of 0.01 mg/kg for high water content and acidic commodities and 0.02 mg/kg for dry commodities. According to the results of this third calculation (see Appendix B.3 EU scenario 3), the highest chronic exposure declined to 61 % of the ADI (UK infant). Based on the above calculations, EFSA concludes that for all crops major uncertainties remain due to the data gaps identified in section 3. However, considering tentative MRLs or existing EU MRLs in the exposure calculation did not indicate a major risk to consumers, except for maize and barley which were identified as the major contributors to the chronic exposure. Furthermore, the current LOQ of 0.05 mg/kg might not be sufficiently protective to consumers, in particular for high water content, acidic and dry commodities where it is expected that lower LOQs can be achieved in routine enforcement. Although authorisations of in these commodities are likely to result in a noresidue situation, an exceedance of the lowered LOQs cannot be excluded in the absence of appropriate residues trials supporting those authorisations. 4.2. Consumer risk assessment with consideration of the existing CXLs In order to include the CXLs in the calculations of the consumer exposure, all data relevant to the consumer exposure assessment have been collected from JMPR evaluations and reported in Appendix C.2 to this document. These CXLs were compared with the EU MRL proposals in compliance with Appendix D and input values resulting from this comparison are summarised in Table 4-2. Regarding the CXLs for lentils, barley, oats, wheat and commodities of animal origin, it is noted that appropriate risk assessment values could not be retrieved by EFSA and that these CXLs can therefore EFSA Journal 2015;13(1):3972 34
Review of the existing MRLs for not be considered as supported by data. For these commodities, the CXL was included for an indicative calculation. Furthermore, the JMPR did not assess the occurrence of TOPPS in plant commodities and the data gaps on plant metabolism and analytical methods identified by EFSA in the framework of this review also apply to the CXLs for plant commodities. The CXLs can therefore only be considered on a tentative basis and input values for parent were multiplied by a conversion factor of 1.5 when is authorised for use as a desiccant on the relevant crop. Table 4-2: Input values for the consumer risk assessment (with consideration of CXLs) Commodity Input value Chronic risk assessment Comment Risk assessment residue definition: sum of, its salts and TOPPS expressed as (tentative) Citrus fruit Pome fruit Stone fruit 0.02 Median residue (CXL, tentative) (a) Tree nuts 0.05* EU MRL (b) Table and wine grapes 0.01* Median residue (tentative) (c) Strawberries 0.05 Median residue (CXL, tentative) (a) Blackberries Raspberries Currants (red, black and white) Gooseberries 0.01* Lowered enforcement LOQ (d) Kumquats 0.02 Median residue (CXL, tentative) (a) Persimmon Passion fruit Mangoes Papaya Cherimoya 0.01* Lowered enforcement LOQ (d) Bananas 0.02 Median residue (CXL, tentative) (a) Potatoes 0.075 Median residue (CXL, tentative) x CF (a) Sweet potatoes 0.015 Lowered enforcement LOQ x CF (d) Other root and tuber vegetables Garlic Onions 0.01* Lowered enforcement LOQ (d) Solanacea 0.01* Median residue (CXL, tentative) (c) Cucurbits with edible peel Cucurbits with inedible peel Flowering brassica Head brassica Leafy brassica Kohlrabi Lettuces and salad plants Spinaches and similar leaves Herbs and edible flowers Legume vegetables 0.01* Lowered enforcement LOQ (d) Asparagus 0.01* Median residue (tentative) (c) EFSA Journal 2015;13(1):3972 35
Review of the existing MRLs for Cardoon Celery Fennel Globe artichokes Leek Rhubarb Beans, dry Lentils, dry Commodity Input value Chronic risk assessment Comment 0.01* Lowered enforcement LOQ (d) 0.075 Median residue CF (tentative) (c) Peas, dry 0.075 Median residue (CXL, tentative) CF (a) Lupins, dry 0.075 Median residue CF (tentative) (c) Linseed 2.59 Median residue CF (tentative) (c) Poppy seed Sesame seed Mustard seed Borage 0.21 Median residue CF (tentative) (c) Sunflower seed 0.17 Median residue (CXL, tentative) CF (a) Rape seed 0.74 Median residue (CXL, tentative) CF (a) Soya bean 0.045 Median residue (CXL, tentative) CF (a) Hempseed 0.23 Median residue CF (tentative) (c) Olives for oil production 0.05* EU MRL (b) Barley grain 7.5 CXL CF (d) Oats grain 1.65 Median residue CF (tentative) (c) Wheat grain 3 CXL CF (e) Coffee beans 0.02* Median residue (CXL, tentative) CF (c) Hops (dried) 0.015 Median residue CF (tentative) (c) Sugar beet root 0.015 Lowered enforcement LOQ CF (d) Swine muscle 0.05* Median residue (tentative) (f) Swine fat 0.05* Median residue (tentative) (f) Swine liver 0.05* Median residue (tentative) (f) Swine kidney 0.05* Median residue (tentative) (f) Ruminant muscle 0.05* Median residue (tentative) (f) Ruminant fat 0.05* Median residue (tentative) (f) Ruminant liver 0.05* Median residue (tentative) (f) Ruminant kidney 0.05* Median residue (tentative) (f) Poultry muscle 0.05* Median residue (tentative) (f) Poultry fat 0.05* Median residue (tentative) (f) Poultry liver 0.05* Median residue (tentative) (f) Ruminant milk 0.01* Median residue (tentative) (f) Bird s eggs 0.05 CXL (e) (*): Indicates that the input value is proposed at the limit of analytical quantification. EFSA Journal 2015;13(1):3972 36
Review of the existing MRLs for (a): CXL is not sufficiently supported by data; the corresponding risk assessment value (multiplied by a conversion factor for risk assessment when the authorisation includes a desiccant use) is used for indicative exposure calculations. (b): Use reported by the RMS is not supported by data; the existing EU MRL (multiplied by a conversion factor for risk assessment when the authorisation includes a desiccant use) is used for indicative exposure calculations. (c): Use reported by the RMS is not fully supported by data but the risk assessment values derived in section 3 are used for indicative exposure calculations. (d): Use reported by the RMS is not supported by data and the existing EU MRL currently established at the LOQ of 0.05 mg/kg may not be sufficiently protective to European consumers (see section 4.1); the lowered LOQ for enforcement purposes derived in section 1.1 (multiplied by a conversion factor for risk assessment when the authorisation includes a desiccant use) is used for indicative exposure calculations. (e): CXL is not supported by data; the existing CXL (multiplied by a conversion factor for risk assessment when the authorisation includes a desiccant use) is used for indicative exposure calculations. (f): Dietary burden relevant to this commodity of animal origin, resulting from the GAPs reported by the RMS, is not fully supported by data; the risk assessment value derived in section 3 is used for indicative exposure calculations. Chronic exposure calculations were also performed using revision 2 of the EFSA PRIMo and the calculated exposures were compared with the toxicological reference value derived for (see Table 2-1); detailed results of the calculations are presented as EU/Codex scenario 1, in Appendix B.4. The highest chronic exposure was calculated for WHO cluster diet B, representing 1433 % of the ADI, wheat and barley being the major contributors to the dietary intake. A second exposure calculation was therefore performed, excluding the CXLs on these two crops. According to the results of this second calculation (see Appendix B.5 EU/Codex scenario 2), the highest chronic exposure declined to 82 % of the ADI for Dutch children. Hence it is concluded that uncertainties remain for all CXLs as they are not well supported by data. Nevertheless, inclusion of these CXLs in the exposure calculation did not indicate any major risk to European consumers, except for wheat and barley. CONCLUSIONS AND RECOMMENDATIONS CONCLUSIONS The toxicological profile of was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI being established at 0.002 mg/kg bw per day. An ARfD was not deemed necessary. The metabolism of in primary crops was investigated in fruit crops (tomatoes), root and tuber vegetables (potatoes), pulses and oilseeds (rape seed) and in cereals (wheat, barley) following foliar spray application representative of the pre-harvest use of as a desiccant. Following soil application as a herbicide for weed control, it is agreed that the submitted confined rotational crop studies on leafy crops, root and tuber vegetables and cereals following a bare soil application of may also cover the use of as an herbicide for weed control in primary crops. The residue definition for enforcement is proposed as and its salts expressed as only. For risk assessment, the residue definition is proposed as the sum of, its salts and TOPPS expressed as on a tentative basis and, based on the metabolism study in cereals, EFSA derived a tentative conversion factor of 1.5 for enforcement to risk assessment that applies to all crops groups when is applied as a crop desiccant. Where is applied to the soil as a herbicide, a no residue situation is expected and a conversion factor for risk assessment is not considered necessary. Furthermore, in view of the deficiencies identified in the metabolism studies regarding the limited characterization and identification of the radioactive residues in fruit crops, pulses and oilseeds and root and tuber vegetables, metabolism data covering 2 additional categories of crops are required in order to fully address the metabolism of as a crop desiccant in plants. A validated analytical method for enforcement of the residue definition is available but a confirmatory method and an ILV are still required. The analytical method was also not sufficiently validated in hops. EFSA Journal 2015;13(1):3972 37
Review of the existing MRLs for Regarding the magnitude of the residues in primary crops, the available residues data are considered sufficient to derive MRL proposals as well as risk assessment values for table and wine grapes, strawberries, asparagus, pulses dry, linseed, poppy seed, sesame seed, sunflower seed, rape seed, mustard seed, borage, hempseed,, barley and oats and hops (dried). For all other uses reported in the framework of this review, data were insufficient to derive MRLs. Moreover, considering the data gaps that were identified regarding plant metabolism, residues trials data and validation of the analytical methods, all the MRL proposals should be considered on a tentative basis only. A processing study to address the nature of and TOPPS residues under the standard hydrolysis conditions is not available and is therefore required. Meanwhile, it is proposed, on a tentative basis, to apply the same residue definition for enforcement and risk assessment as for primary crops. Studies investigating the magnitude of residues in processed commodities of cereals and oilseeds were also reported. Tentative processing factors for enforcement and risk assessment were derived for barley, wheat and oilseeds processed commodities. A specific residue definition for rotational crops is not deemed necessary and it was concluded that significant residues in rotational crops are not expected provided that is applied in compliance with the authorized uses reported in Appendix A. Based on the uses reported by the RMS, significant dietary intakes were calculated for dairy and meat ruminants, poultry and pigs. However, at the calculated dietary burden, the total residues are not expected to exceed the LOQ of the method in ruminant or poultry matrices. The residue definition for enforcement and risk assessment in livestock matrices is therefore proposed as the sum of and its salts, expressed as only. Although not fully validated, analytical methods for enforcement of the proposed residue definition in animal commodities are available. Feeding studies were not triggered because the residue levels in ruminants and poultry commodities are expected to remain below the enforcement LOQ of 0.01 mg/kg in milk and eggs and below the LOQ of 0.05 mg/kg in muscle, fat, liver and kidney. Chronic consumer exposure resulting from the authorised uses reported in the framework of this review was calculated using revision 2 of the EFSA PRIMo. For those commodities where data were insufficient to derive an MRL, EFSA considered the existing EU MRL for an indicative calculation. The highest chronic exposure was calculated for the Irish adult, representing 383 % of the ADI (IE adult), maize and barley being the main contributors to the chronic dietary intake. Furthermore, EFSA identified that the current LOQ of 0.05 mg/kg might not be sufficiently protective to consumers, in particular for high water content, acidic and dry commodities where it is expected that lower LOQs can be achieved in routine enforcement. Further calculations were therefore carried out excluding authorisations on maize and barley and including the lower LOQs of 0.01 mg/kg for high water content and acidic commodities and 0.02 mg/kg for dry commodities. According to the results of this calculation, the highest chronic exposure declined to 61 % of the ADI (UK infant). However, although authorisations of in the relevant commodities are likely to result in a no-residue situation, an exceedance of the lowered LOQs cannot be excluded in the absence of appropriate residues trials supporting those authorisations. Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs have also been established for. Additional calculations of the consumer exposure, considering these CXLs, were therefore carried out and the highest chronic exposure was calculated for WHO cluster diet B, representing 1433 % of the ADI, wheat and barley being the major contributors to the dietary intake. A second exposure calculation was therefore performed, excluding the CXLs on these two crops. According to the results of this second calculation, the highest chronic exposure declined to 82 % of the ADI for Dutch children. Acute exposure calculations were not carried out considering that an ARfD was not deemed necessary for this active substance. EFSA Journal 2015;13(1):3972 38
Review of the existing MRLs for RECOMMENDATIONS 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 of the reasoned opinion (see summary table). None of the MRL values listed in the table are recommended for inclusion in Annex II to the Regulation as they are not sufficiently supported by data. In particular, all tentative MRLs or existing EU MRLs need to be confirmed by the following data: a confirmatory method and an ILV for enforcement of in commodities of plant and animal origin; a fully validated analytical method for enforcement of in hops (dried); representative studies investigating the metabolism of in 2 additional crop groups different from cereals; toxicological data on the major plant metabolite TOPPS; additional residues trials supporting authorisations and/or further clarifications on authorisations in tree nuts and olives for oil production (conducted with appropriate LOQs); where is applied as a crop desiccant, residue trials analysing the residues in compliance with the proposed risk assessment residue definition; a processing study simulating representative hydrolytic conditions for pasteurisation (20 minutes at 90 C, ph 4), boiling/brewing/baking (60 minutes at 100 C, ph 5) and sterilisation (20 minutes at 120 C, ph 6) addressing the nature of and TOPPS residues in processed commodities. It is highlighted, however, that some of the MRLs derived result 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 MRLs derived but which might have an impact on national authorisations: additional residues trials supporting the authorizations on strawberries, asparagus, dry pulses, poppy seed, sesame seed, sunflower seed, rape seed, mustard seed, borage and oats (conducted with appropriate LOQs). 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. Member States are in any case recommended to withdraw or modify their authorized uses on maize and barley in view of the identified chronic intake concern. Furthermore, although a no-residue situation is likely for the remaining commodities listed in the summary table and no major chronic concern is expected for these crops, the enforcement LOQ of 0.05 mg/kg currently established in legislation might not be sufficiently protective and a reduction of those LOQs to 0.01 mg/kg in high water content and acidic commodities, and 0.02 mg/kg in dry commodities is advisable. However, an exceedance of these lowered LOQs cannot be completely excluded and further confirmation is required by means of the following data: additional residue trials supporting authorisations and/or further clarifications on authorisations in citrus fruits, pome fruits, stone fruits, blackberries, raspberries, currants, gooseberries, persimmon, passion fruit, bananas, mangoes, papaya, cherimoya, potatoes, sweet potatoes, other root and tuber vegetables, garlic, onions, tomatoes, peppers, cucurbits EFSA Journal 2015;13(1):3972 39
Review of the existing MRLs for with edible peel, cucurbits with inedible peel, brassica vegetables, lettuces and salad plants, spinaches and similar leaves, herbs and edible flowers, legume vegetables, celery, cardoon, fennel, rhubarb, globe artichokes, leek, sugar beets and wheat (conducted with appropriate LOQs). For these commodities risk managers will need to decide whether authorisations need to be withdrawn or whether the higher LOQ for enforcement can be maintained pending availability of the missing data. A minor deficiency was also identified in the assessment but this deficiency is not expected to impact either on the validity of the MRLs derived or on the national authorisations. The following data are therefore considered desirable but not essential: a confirmation that the maximum storage time interval of the samples of the residue trials on apples, strawberries, asparagus, pulses (dry), linseed, barley and oats grain and straw and maize did not exceed 24 months. SUMMARY TABLE Code number Commodity Existing EU MRL Existing CXL MRL Outcome of the review Enforcement residue definition (existing): Enforcement residue definition (proposed): sum of and its salts, expressed as Comment 0110000 Citrus fruit 0.05* 0.02* 0.02 Further consideration is needed (a) 0120000 Tree nuts 0.05* 0.02* 0.05* Further consideration is needed (b) 0130000 Pome fruit 0.05* 0.02* 0.02 Further consideration is needed (a) 0140000 Stone fruit 0.05* 0.02* 0.02 Further consideration is needed (a) 0151000 Table and wine grapes 0.05* - 0.01* Further consideration is needed (c) 0152000 Strawberries 0.05* 0.05* 0.05 Further consideration is needed (d) 0153010 Blackberries 0.05* - - Further consideration is needed (e) 0153030 Raspberries 0.05* - - Further consideration is needed (e) 0154030 Currants (red, black and white) 0.05* - - Further consideration is needed (e) 0154040 Gooseberries 0.05* - - Further consideration is needed (e) 0161040 Kumquats 0.05* 0.02* 0.02 Further consideration is needed (f) 0161060 Persimmon 0.05* - - Further consideration is needed (e) 0162030 Passion fruit 0.05* - - Further consideration is needed (e) EFSA Journal 2015;13(1):3972 40
Review of the existing MRLs for Code number Commodity Existing EU MRL Existing CXL MRL Outcome of the review Comment 0163020 Bananas 0.05* 0.02* 0.02 Further consideration is needed (a) 0163030 Mangoes 0.05* - - Further consideration is needed (e) 0163040 Papaya 0.05* - - Further consideration is needed (e) 0163060 Cherimoya 0.05* - - Further consideration is needed (e) 0211000 Potatoes 0.05* 0.1 0.1 Further consideration is needed (a) 0212020 Sweet potatoes 0.05* - - Further consideration is needed (e) 0213000 Other root and tuber vegetables 0.05* - - Further consideration is needed (e) 0220010 Garlic 0.05* - - Further consideration is needed (e) 0220020 Onions 0.05* - - Further consideration is needed (e) 0231010 Tomatoes 0.05* 0.01* 0.01* Further consideration is needed (a) 0231020 Peppers 0.05* 0.01* 0.01* Further consideration is needed (a) 0231030 Aubergines 0.05* 0.01* 0.01* Further consideration is needed (f) 0231040 Okra (lady s finger) 0.05* 0.01* 0.01* Further consideration is needed (f) 0232000 Cucurbits with edible peel 0.05* - - Further consideration is needed (e) 0233000 Cucurbits with inedible peel 0.05* - - Further consideration is needed (e) 0241000 Flowering brassica 0.05* - - Further consideration is needed (e) 0242000 Head brassica 0.05* - - Further consideration is needed (e) 0243000 Leafy brassica 0.05* - - Further consideration is needed (e) 0244000 Kohlrabi 0.05* - - Further consideration is needed (e) 0251000 Lettuces and salad plants 0.05* - - Further consideration is needed (e) 0252000 Spinaches and similar leaves 0.05* - - Further consideration is needed (e) 0256000 Herbs and edible flowers 0.05* - - Further consideration is needed (e) EFSA Journal 2015;13(1):3972 41
Review of the existing MRLs for Code number Commodity Existing EU MRL Existing CXL MRL Outcome of the review Comment 0260000 Legume vegetables 0.05* - - Further consideration is needed (e) 0270010 Asparagus 0.05* - 0.01* Further consideration is needed (c) 0270020 Cardoon 0.05* - - Further consideration is needed (e) 0270030 Celery 0.05* - - Further consideration is needed (e) 0270040 Fennel 0.05* - - Further consideration is needed (e) 0270050 Globe artichokes 0.05* - - Further consideration is needed (e) 0270060 Leek 0.05* - - Further consideration is needed (e) 0270070 Rhubarb 0.05* - - Further consideration is needed (e) 0300010 Beans (dry) 0.2 0.2 0.2 Further consideration is needed (g) 0300020 Lentils (dry) 0.2 0.2 0.2 Further consideration is needed (g) 0300030 Peas (dry) 0.2 0.3 0.3 Further consideration is needed (d) 0300040 Lupins (dry) 0.2-0.2 Further consideration is needed (c) 0401010 Linseed 5-10 Further consideration is needed (c) 0401030 Poppy seed 0.1* - 0.8 Further consideration is needed (c) 0401040 Sesame seed 0.1* - 0.8 Further consideration is needed (c) 0401050 Sunflower seed 1 0.9 0.9 Further consideration is needed (d) 0401060 Rape seed 2 1.5 1.5 Further consideration is needed (d) 0401070 Soya bean 0.2 0.3 0.3 Further consideration is needed (f) 0401080 Mustard seed 0.5-0.8 Further consideration is needed (c) 0401120 Borage 0.1* - 0.8 Further consideration is needed (c) 0401140 Hempseed 0.5-0.9 Further consideration is needed (c) 0402010 Olives for oil production 0.05* - 0.05* Further consideration is needed (h) EFSA Journal 2015;13(1):3972 42
Review of the existing MRLs for Code number Commodity Existing EU MRL Existing CXL MRL Outcome of the review Comment 0500010 Barley 10 5 - Further consideration is needed (i) 0500030 Maize 1 - - Further consideration is needed (j) 0500050 Oats 2 2 8 Further consideration is needed (g) 0500090 Wheat 0.05* 2 - Further consideration is needed (k) 620000 Coffee beans 0.1* 0.02* 0.02* Further consideration is needed (f) 0700000 Hops (dried) 0.1* - 0.01* Further consideration is needed (c) 0900010 Sugar beet root 0.05* - - Further consideration is needed (e) 1011010 Swine muscle 0.05* 0.05* 0.05* Further consideration is needed (g) 1011020 Swine fat 0.05* - 0.05* Further consideration is needed (c) 1011030 Swine liver 0.05* 0.05* 0.05* Further consideration is needed (g) 1011040 Swine kidney 0.05* 0.05* 0.05* Further consideration is needed (g) 1012010 Bovine muscle 0.05* 0.05* 0.05* Further consideration is needed (g) 1012020 Bovine fat 0.05* - 0.05* Further consideration is needed (c) 1012030 Bovine liver 0.05* 0.05* 0.05* Further consideration is needed (g) 1012040 Bovine kidney 0.05* 0.05* 0.05* Further consideration is needed (g) 1013010 Sheep muscle 0.05* 0.05* 0.05* Further consideration is needed (g) 1013020 Sheep fat 0.05* - 0.05* Further consideration is needed (c) 1013030 Sheep liver 0.05* 0.05* 0.05* Further consideration is needed (g) 1013040 Sheep kidney 0.05* 0.05* 0.05* Further consideration is needed (g) 1014010 Goat muscle 0.05* 0.05* 0.05* Further consideration is needed (g) 1014020 Goat fat 0.05* - 0.05* Further consideration is needed (c) 1014030 Goat liver 0.05* 0.05* 0.05* Further consideration is needed (g) EFSA Journal 2015;13(1):3972 43
Review of the existing MRLs for Code number Commodity Existing EU MRL Existing CXL MRL Outcome of the review Comment 1014040 Goat kidney 0.05* 0.05* 0.05* Further consideration is needed (g) 1016010 Poultry muscle 0.05* 0.05* 0.05* Further consideration is needed (g) 1016020 Poultry fat 0.05* - 0.05* Further consideration is needed (c) 1016030 Poultry liver 0.05* 0.05* 0.05* Further consideration is needed (g) 1020010 Cattle milk 0.05* 0.01* 0.01* Further consideration is needed (g) 1020020 Sheep milk 0.05* 0.01* 0.01* Further consideration is needed (g) 1020030 Goat milk 0.05* 0.01* 0.01* Further consideration is needed (g) 1030000 Birds' eggs 0.05* 0.05* 0.05 Further consideration is needed (d) - Other products of plant and animal origin See App C.1 - - Further consideration is needed (l) (*): Indicates that the MRL is set at the limit of analytical quantification. (a): MRL is derived from the existing CXL, which is not sufficiently supported by data but for which no risk to consumers is identified (assuming the existing residue definition); GAP evaluated at EU level is not supported by data and, although a no-residue situation is likely and no major risk for the consumers is expected, an exceedance of the CXL cannot be excluded (combination B-V in Appendix D). (b): GAP evaluated at EU level is not supported by data but no risk to consumers was identified for the existing EU MRL; existing CXL is covered by the existing EU MRL (combination C-III in Appendix D). (c): Tentative MRL is derived from a GAP evaluated at EU level, which is not fully supported by data but for which no risk to consumers was identified; no CXL is available (combination E-I in Appendix D). (d): MRL is derived from the existing CXL, which is not sufficiently supported by data 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). (e): GAP evaluated at EU level is not supported by data. Although a no-residue situation is likely and no major risk for the consumers is expected, an exceedance of the enforcement LOQ of 0.01 mg/kg derived in the framework of this review cannot be excluded while the LOQ of 0.05 mg/kg currently established in legislation might not be sufficiently protective; no CXL is available (combination C-I in Appendix D). (f): MRL is derived from the existing CXL, which is not sufficiently supported by data but for which no risk to consumers is identified (assuming the existing residue definition); there are no relevant authorisations or import tolerances reported at EU level (combination A-V in Appendix D). (g): Tentative MRL is derived from a GAP evaluated at EU level, which is not fully supported by data but for which no risk to consumers was identified; existing CXL is covered by the tentative MRL (combination E-III in Appendix D). (h): GAP evaluated at EU level is not supported by data but no risk to consumers was identified for the existing EU MRL; no CXL is available (combination C-I in Appendix D). (i): GAP evaluated at EU level is not fully supported by data and a risk to consumers cannot be excluded; CXL is also not sufficiently supported by data and a risk to consumers cannot be excluded. Either a specific LOQ or the default MRL of 0.01 mg/kg may be considered (combination D-IV in Appendix D). (j): GAP evaluated at EU level is not supported by data and a risk to consumers cannot be excluded for the existing EU MRL; no CXL is available. Either a specific LOQ or the default MRL of 0.01 mg/kg may be considered (combination B-I in Appendix D). (k): GAP evaluated at EU level is not supported by data. Although a no-residue situation is likely and no major risk for the consumers is expected, an exceedance of the enforcement LOQ of 0.02 mg/kg derived in the framework of this review cannot be excluded while the LOQ of 0.05 mg/kg currently established in legislation might not be sufficiently protective; CXL is not sufficiently supported by data and a risk to consumers cannot be excluded (combination B-IV in Appendix D). (l): There are no relevant authorisations or import tolerances reported at EU level; no CXL is available. Either a specific LOQ or the default MRL of 0.01 mg/kg may be considered (combination A-I in Appendix D). EFSA Journal 2015;13(1):3972 44
DOCUMENTATION PROVIDED TO EFSA Review of the existing MRLs for 1. Pesticide Residues Overview File (PROFile) on prepared by the rapporteur Member State United Kingdom in the framework of Article 12 of Regulation (EC) No 396/2005. Submitted to EFSA on 30 March 2011. Last updated on 02 April 2013. REFERENCES EC (European Commission), 1996. Appendix G. Livestock Feeding Studies. 7031/VI/95 rev.4. EC (European Commission), 1997a. Appendix A. Metabolism and distribution in plants. 7028/IV/95- rev.3. EC (European Commission), 1997b. Appendix B. General recommendations for the design, preparation and realization of residue trials. Annex 2. Classification of (minor) crops not listed in the Appendix of Council Directive 90/642/EEC. 7029/VI/95-rev.6. EC (European Commission), 1997c. Appendix C. Testing of plant protection products in rotational crops. 7524/VI/95-rev.2. EC (European Commission), 1997d. Appendix E. Processing studies. 7035/VI/95-rev.5. EC (European Commission), 1997e. Appendix F. Metabolism and distribution in domestic animals. 7030/VI/95-rev.3. EC (European Commission), 1997f. Appendix H. Storage stability of residue samples. 7032/VI/95- rev.5. EC (European Commission), 1997g. Appendix I. Calculation of maximum residue level and safety intervals. 7039/VI/95. As amended by the document: classes to be used for the setting of EU pesticide maximum residue levels (MRLs). SANCO 10634/2010. EC (European Commission), 2000. Residue analytical methods. For pre-registration data requirement for Annex II (part A, section 4) and Annex III (part A, section 5 of Directive 91/414. SANCO/3029/99-rev.4. EC (European Commission), 2001. Review report for the active substance. Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 12 December 2000 in view of the inclusion of in Annex I of Council Directive 91/414/EEC. SANCO/1688/VI/97- Final, 22 March 2001. EC (European Commission), 2010a. Classes to be used for the setting of EU pesticide Maximum Residue Levels (MRLs). SANCO 10634/2010 Rev. 0, finalised in the Standing Committee on the Food Chain and Animal Health at its meeting of 23-24 March 2010. EC (European Commission), 2010b. Residue analytical methods. For post-registration control. SANCO/825/00-rev.8-1. EC (European Commission), 2011. Appendix D. Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs. 7525/VI/95-rev.9. EFSA (European Food Safety Authority), 2007. Reasoned opinion on the potential chronic and acute risk to consumers health arising from proposed temporary EU MRLs according to Regulation (EC) No 396/2005 on Maximum Residue Levels of Pesticides in Food and Feed of Plant and Animal Origin. 15 March 2007. The EFSA Journal 2007, 32r, 1 1141. Available online: http://www.efsa.europa.eu/en/scdocs/doc/32r.pdf EFSA (European Food Safety Authority), 2012. Reasoned opinion on the modification of the existing MRL for in borage (including echium (Echium plantagineum)). EFSA Journal 2012;10(5):2711, 24 pp. doi:10.2903/j.efsa.2012.2711 EFSA Journal 2015;13(1):3972 45
Review of the existing MRLs for EURL (European Union Reference Laboratories for Pesticide Residues), 2013. Data pool on method validation for pesticide residues. Status on 25 June 2013. Available online: www.eurl-pesticidesdatapool.eu FAO (Food and Agriculture Organization of the United Nations), 1994. Diquat. In: Pesticide residues in food 1994. Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Expert Group on Pesticide Residues. FAO Plant Production and Protection Paper 131, 814 pp.. FAO (Food and Agriculture Organization of the United Nations), 2009. Submission and evaluation of pesticide residues data for the estimation of Maximum Residue Levels in food and feed. Pesticide Residues. 2nd Ed. FAO Plant Production and Protection Paper 197, 264 pp. FAO (Food and Agriculture Organization of the United Nations), 2013. Diquat. In: Pesticide residues in food 2013. Evaluations. Part I. Residues. FAO Plant Production and Protection Paper 219, 625 pp. France, 2014. Evaluation Report prepared under Article 12 of Regulation (EC) No 396/2005 on authorised uses to be considered for the review of the existing MRLs for abamectin, July 2014. Germany, 2014. Evaluation Report prepared under Article 12 of Regulation (EC) No 396/2005 on authorised uses to be considered for the review of the existing MRLs for abamectin, July 2014. Netherlands, 2014. Evaluation Report prepared under Article 12 of Regulation (EC) No 396/2005 on authorised uses to be considered for the review of the existing MRLs for abamectin, July 2014. OECD (Organisation for Economic Co-operation and Development), 2011. OECD MRL Calculator: User Guide. In: Series on Pesticides No 56. ENV/JM/MONO(2011)2, 01 March 2011. United Kingdom, 1996. Draft assessment report on the active substance prepared by the rapporteur Member State United Kingdom in the framework of Council Directive 91/414/EEC, March 1996. United Kingdom, 1999. Addendum to the draft assessment report on the active substance prepared by the rapporteur Member State United Kingdom in the framework of Council Directive 91/414/EEC, May 1999. United Kingdom, 2014. Evaluation Report prepared under Article 12 of Regulation (EC) No 396/2005 on authorised uses to be considered for the review of the existing MRLs for abamectin, July 2014. EFSA Journal 2015;13(1):3972 46
Review of the existing MRLs for APPENDIX A GOOD AGRICULTURAL PRACTICES (GAPS) Critical outdoor GAPs for Northern Europe Crop Region Outdoor/ Member state Pest controlled Formulation Application PHI or Indoor or country waiting Common name Scientific name Type Content Method Growth stage Number Interval (days) Rate period Min. Max. Min. Max. Min. Max. Unit (days) Conc. Unit From BBCH Apples Malus domesticus NEU Outdoor SE Pears Pyrus communis NEU Outdoor SE Cherries Prunus cerasus, Prunus avium NEU Outdoor SE Plums Prunus domestica NEU Outdoor SE Strawberries Fragaria x ananassa NEU Outdoor FI control of 'runners' Blackberries Rubus fruticosus NEU Outdoor SE Raspberries Rubus idaeus NEU Outdoor SE Currants (red, black and white) Ribes nigrum, rubrum NEU Outdoor SE Gooseberries Ribes uva-crispa NEU Outdoor SE Potatoes Tuber form Solanum Spp NEU Outdoor SE, BE, CZ, IE, UK Until BBCH Comments (max. 250 characters) 0 59 1 1 0.20 0.40 kg a.i./ha Use is pre-flowering 0 59 1 1 0.20 0.40 kg a.i./ha Use is pre-flowering 0 59 1 1 0.20 0.40 kg a.i./ha Use is pre-flowering 0 59 1 1 0.20 0.40 kg a.i./ha Use is pre-flowering 0 55 1 1 0.60 0.80 kg a.i./ha Tractor spray, inter-row (between shields). GAPs authorized in other MSs with applications occurring from BBCH GS 91 (senescence, beginning of dormancy). 0 59 1 1 0.20 0.40 kg a.i./ha Use is pre-flowering 0 59 1 1 0.20 0.40 kg a.i./ha Use is pre-flowering 0 59 1 1 0.20 0.40 kg a.i./ha Use is pre-flowering 0 59 1 1 0.20 0.40 kg a.i./ha Use is pre-flowering dessicant SL 200.0 g/l Foliar treatment - spraying 43 49 1 2 7 14 0.80 1.00 kg a.i./ha 4 CZ and IE have GAP of 1 kg as/ha (7-14 days PHI) but neither submitted data. SE has (pending!) GAP of 0.8 kg as/ha and shorter PHI (4 days). BE GAP mentions a max. dose of 0.8-1.0 kg as/ha (total of 2 applications), PHI: 4 days Sweet potatoes Ipomoea batatas NEU Outdoor UK dessicant SL 200.0 g/l Foliar treatment - spraying 0 99 1 1 0.80 0.80 kg a.i./ha 4 Beetroot Beta vulgaris subsp. Vulgaris NEU Outdoor NL annual broadleaved Carrots Daucus carota NEU Outdoor NL annual broadleaved Celeriac Apium graveolens var. rapaceum NEU Outdoor NL annual broadleaved Horseradish Armoracia rusticana NEU Outdoor NL annual broadleaved Jerusalem artichokes Helianthus tuberosus NEU Outdoor NL annual broadleaved Parsnips Pastinaca sativa NEU Outdoor NL annual broadleaved Parsley root Petroselinum crispum NEU Outdoor NL annual broadleaved Radishes Salsify Swedes Raphanus sativus var. saitvus Tragopogon porrifolius Brassica napus var. napobrassica NEU Outdoor NL annual broadleaved NEU Outdoor NL annual broadleaved NEU Outdoor NL annual broadleaved Turnips Brassica rapa NEU Outdoor NL annual broadleaved EFSA Journal 2015;13(1):3972 47
Review of the existing MRLs for Critical outdoor GAPs for Northern Europe Crop Region Outdoor/ Member state Pest controlled Formulation Application PHI or Indoor or country waiting Common name Scientific name Type Content Method Growth stage Number Interval (days) Rate period Min. Max. Min. Max. Min. Max. Unit (days) Gherkins Cucumis sativus NEU Outdoor NL annual broadleaved Courgettes Cucurbita pepo var. melopepo NEU Outdoor NL annual broadleaved Melons Cucumis melo NEU Outdoor NL annual broadleaved Pumpkins Cucurbita maxima NEU Outdoor NL annual broadleaved Broccoli Cauliflower Brussels sprouts Head cabbage Brassica oleracea var. italica Brassica oleracea var. botrytis Brassica oleracea var. gemmifera Brassica oleracea convar capitata NEU Outdoor NL annual broadleaved NEU Outdoor NL annual broadleaved NEU Outdoor NL annual broadleaved NEU Outdoor NL annual broadleaved Chinese cabbage Brassica pekinensis NEU Outdoor NL annual broadleaved Kale Kohlrabi Brassica oleracea convar. Acephalea Brassica oleracea convar. acephala, var. gongylodes NEU Outdoor NL annual broadleaved NEU Outdoor NL annual broadleaved Lamb's lettuce Valerianella locusta NEU Outdoor NL annual broadleaved Lettuce Lactuca sativa NEU Outdoor NL annual broadleaved Scarole (broad-leaf endive) Cichorium endiva NEU Outdoor NL annual broadleaved Cress Lepidium sativum NEU Outdoor NL annual broadleaved Land cress Barbarea verna NEU Outdoor NL annual broadleaved Rocket, Rucola Red mustard Leaves and sprouts of Brassica spp Eruca sativa (Diplotaxis spec.) Brassica juncea var. rugosa NEU Outdoor UK annual broadleaved NEU Outdoor NL annual broadleaved Brassica spp NEU Outdoor NL annual broadleaved Spinach Spinacia oleracea NEU Outdoor NL annual broadleaved Purslane Portulaca oleracea NEU Outdoor NL annual broadleaved Beet leaves (chard) Beta vulgaris NEU Outdoor NL annual broadleaved Conc. Unit From BBCH SL 200.0 g/l Foliar treatment - general (see Chervil Anthriscus cerefolium NEU Outdoor UK SL 200.0 g/l Foliar treatment - general (see Chives Celery leaves Allium schoenoprasum Apium graveolens var. seccalinum NEU Outdoor UK SL 200.0 g/l Foliar treatment - general (see NEU Outdoor UK SL 200.0 g/l Foliar treatment - general (see Parsley Petroselinum crispum NEU Outdoor UK SL 200.0 g/l Foliar treatment - general (see Until BBCH Comments (max. 250 characters) 1 1 0.44 kg a.i./ha 7 NL GAP as a pre-emergence application at a dose of 0.4 kg a.s./ha considered as being less critical than the UK GAP. 1 1 0.44 kg a.i./ha 7 1 1 0.44 kg a.i./ha 7 1 1 0.44 kg a.i./ha 7 1 1 0.44 kg a.i./ha 7 EFSA Journal 2015;13(1):3972 48
Review of the existing MRLs for Critical outdoor GAPs for Northern Europe Crop Region Outdoor/ Member state Pest controlled Formulation Application PHI or Indoor or country waiting Common name Scientific name Type Content Method Growth stage Number Interval (days) Rate period Min. Max. Min. Max. Min. Max. Unit (days) Conc. Unit From BBCH Sage Salvia officinalis NEU Outdoor UK SL 200.0 g/l Foliar treatment - general (see Rosemary Rosmarinus officinalis NEU Outdoor UK SL 200.0 g/l Foliar treatment - general (see Thyme Thymus spp. NEU Outdoor UK SL 200.0 g/l Foliar treatment - general (see Basil Ocimum basilicum NEU Outdoor UK SL 200.0 g/l Foliar treatment - general (see Bay leaves (laurel) Laurus nobilis NEU Outdoor UK SL 200.0 g/l Foliar treatment - general (see Tarragon Artemisia dracunculus NEU Outdoor UK SL 200.0 g/l Foliar treatment - general (see Beans (with pods) Phaseolus vulgaris, NEU Outdoor NL annual broadleaved Beans (without pods) Phaseolus vulgaris NEU Outdoor NL annual broadleaved Peas (with pods) Pisum sativum NEU Outdoor NL annual broadleaved Peas (without pods) Pisum sativum NEU Outdoor NL annual broadleaved Lentils (fresh) Lens culinaris syn. L. esculenta NEU Outdoor NL annual broadleaved Asparagus Asparagus officinalis NEU Outdoor SE, NL Cardoons Cynara cardunculus NEU Outdoor NL annual broadleaved Celery Apium graveolens var. dulce NEU Outdoor SE, NL Fennel Foeniculum vulgare NEU Outdoor NL annual broadleaved Globe artichokes Cynara scolymus NEU Outdoor NL annual broadleaved Leek Allium porrum NEU Outdoor NL annual broadleaved Rhubarb Rheum x hybridum NEU Outdoor SE, NL Until BBCH 1 1 0.44 kg a.i./ha 7 1 1 0.44 kg a.i./ha 7 1 1 0.44 kg a.i./ha 7 1 1 0.44 kg a.i./ha 7 1 1 0.44 kg a.i./ha 7 1 1 0.44 kg a.i./ha 7 Comments (max. 250 characters) 0 39 1 1 0.20 0.40 kg a.i./ha n.a. 0 8 1 1 0.40 0.50 kg a.i./ha 0 39 1 1 0.20 0.40 kg a.i./ha Beans (dry) Phaseolus vulgaris NEU Outdoor FR, SE dessicant SL 200.0 g/l Foliar treatment - spraying 1 1 0.60 kg a.i./ha 4 Lentils (dry) Lens culinaris syn. L. esculenta NEU Outdoor CZ dessicant SL 200.0 g/l Foliar treatment - spraying 0.40 kg a.i./ha 6 Peas (dry) Pisum sativum NEU Outdoor FR, SE dessicant SL 200.0 g/l Foliar treatment - spraying 1 1 0.60 kg a.i./ha 4 Lupins Lupinus spp. NEU Outdoor FR, UK desiccant SL 200.0 g/l Foliar treatment - spraying 1 1 0.60 kg a.i./ha 4 Linseed Linum usitatissimum NEU Outdoor FR, UK dessicant SL 200.0 g/l Foliar treatment - spraying 1 1 0.60 kg a.i./ha 7 Poppy seed Papaver somniferum NEU Outdoor UK dessicant SL 200.0 g/l Foliar treatment - spraying 1 1 0.60 kg a.i./ha 7 Sesame seed Sesamum indicum syn. S. orientale NEU Outdoor UK dessicant SL 200.0 g/l Foliar treatment - spraying 1 1 0.60 kg a.i./ha 7 Sunflower seed Helianthus annuus NEU Outdoor UK dessicant SL 200.0 g/l Foliar treatment - spraying 1 1 0.60 kg a.i./ha 7 Rape seed Brassica napus NEU Outdoor BE, CZ, SE, UK dessicant SL 200.0 g/l Foliar treatment - spraying 1 1 0.60 kg a.i./ha 7 Mustard seed Brassica nigra NEU Outdoor UK dessicant SL 200.0 g/l Foliar treatment - spraying 1 1 0.60 kg a.i./ha 7 Borage Borago officinalis NEU Outdoor UK dessicant SL 200.0 g/l Foliar treatment - spraying 1 1 0.60 kg a.i./ha 7 Hempseed Cannabis sativa NEU Outdoor UK dessicant SL 200.0 g/l Foliar treatment - spraying 1 1 0.60 kg a.i./ha 5 Barley Hordeum spp. NEU Outdoor UK dessicant SL 200.0 g/l Foliar treatment - spraying 1 1 0.80 kg a.i./ha 4 EFSA Journal 2015;13(1):3972 49
Review of the existing MRLs for Critical outdoor GAPs for Northern Europe Crop Region Outdoor/ Member state Pest controlled Formulation Application PHI or Indoor or country waiting Common name Scientific name Type Content Method Growth stage Number Interval (days) Rate period Min. Max. Min. Max. Min. Max. Unit (days) Conc. Unit From BBCH Maize Zea mays NEU Outdoor BE dessicant SL 200.0 g/l Foliar treatment - spraying 89 1 1 0.40 0.80 kg a.i./ha 7 Oats Avena fatua NEU Outdoor UK dessicant Foliar treatment - spraying 1 1 0.80 kg a.i./ha 4 Hops Humulus lupulus NEU Outdoor DE dessicant SL 200.0 g/l Foliar treatment - spraying 38 1 1 1.00 kg a.i./ha 14 Sugar beet Beta vulgaris NEU Outdoor UK Fodder beet Beta vulgaris NEU Outdoor NL n.a.: not applicable Until BBCH Comments (max. 250 characters) 9 1 1 0.80 kg a.i./ha n.a. early post-emergence 1 1 0.40 kg a.i./ha n.a. Before emergence Critical outdoor GAPs for Southern Europe Crop Region Outdoor/ Member state Pest controlled Formulation Application PHI or Indoor or country waiting Common name Scientific name Type Content Method Growth stage Number Interval (days) Rate period Min. Max. Min. Max. Min. Max. Unit (days) Conc. Unit From BBCH Grapefruit Citrus paradisi SEU Outdoor EL, IT Oranges Citrus sinensis SEU Outdoor EL, IT Lemons Citrus limon SEU Outdoor EL, IT Limes Citrus aurantifolia SEU Outdoor EL, IT Mandarins Citrus reticulata SEU Outdoor EL, IT Almonds Prunus dulcis SEU Outdoor IT Brazil nuts Bertholletia excelsa SEU Outdoor IT Cashew nuts Anacardium occidentale SEU Outdoor IT Chestnuts Castanea sativa SEU Outdoor IT Coconuts Cocos nucifera SEU Outdoor IT Hazelnuts Corylus avellana SEU Outdoor IT Macadamia Macadamia ternifolia SEU Outdoor IT Pecans Carya illinoensis SEU Outdoor IT Pine nuts Pinus pinea SEU Outdoor IT Pistachios Pistachia vera SEU Outdoor IT Walnuts Juglans regia SEU Outdoor IT Until BBCH Comments (max. 250 charachters) 1 1 0.66 1.00 kg a.i./ha 30 Application when up to 20 cm high 1 1 0.66 1.00 kg a.i./ha 30 Application when up to 20 cm high 1 1 0.66 1.00 kg a.i./ha 30 Application when up to 20 cm high 1 1 0.66 1.00 kg a.i./ha 30 Application when up to 20 cm high 1 1 0.66 1.00 kg a.i./ha 30 Application when up to 20 cm high 1 3 0.66 1.00 kg a.i./ha 30 IT does not specify which tree nuts (IT states use is on 'tree crops'). EL has same GAP except only one application and specify almonds, hazelnuts, pine nuts, chestnuts, walnuts. 1 3 0.66 1.00 kg a.i./ha 30 1 3 0.66 1.00 kg a.i./ha 30 1 3 0.66 1.00 kg a.i./ha 30 1 3 0.66 1.00 kg a.i./ha 30 1 3 0.66 1.00 kg a.i./ha 30 1 3 0.66 1.00 kg a.i./ha 30 1 3 0.66 1.00 kg a.i./ha 30 1 3 0.66 1.00 kg a.i./ha 30 1 3 0.66 1.00 kg a.i./ha 30 1 3 0.66 1.00 kg a.i./ha 30 EFSA Journal 2015;13(1):3972 50
Review of the existing MRLs for Critical outdoor GAPs for Southern Europe Crop Region Outdoor/ Member state Pest controlled Formulation Application PHI or Indoor or country waiting Common name Scientific name Type Content Method Growth stage Number Interval (days) Rate period Min. Max. Min. Max. Min. Max. Unit (days) Conc. Unit From BBCH Apples Malus domesticus SEU Outdoor IT Pears Pyrus communis SEU Outdoor IT Quinces Cydonia oblonga SEU Outdoor IT Medlar Mespilus germanica SEU Outdoor IT Loquat Eriobotrya japonica SEU Outdoor IT Apricots Prunus armeniaca SEU Outdoor IT Cherries Prunus cerasus, Prunus avium SEU Outdoor IT Peaches Prunus persica SEU Outdoor IT Plums Prunus domestica SEU Outdoor IT Table grapes Vitis euvitis SEU Outdoor IT Wine grapes Vitis euvitis SEU Outdoor IT Strawberries Fragaria x ananassa SEU Outdoor PT Persimmon Diospyros kaki SEU Outdoor PT Passion fruit Passiflora edulis SEU Outdoor PT Bananas Musa x paradisica SEU Outdoor FR, PT Mangoes Mangifera indica SEU Outdoor PT Papaya Carica papaya SEU Outdoor PT Cherimoya Annona cherimola SEU Outdoor PT Potatoes Tuber form Solanum Spp Until BBCH Comments (max. 250 charachters) 1 3 0.66 1.00 kg a.i./ha 30 IT does not specify which pome fruits (IT states use is on 'orchards'). EL has same GAP except only one application and specify apples, pears, quinces 1 3 0.66 1.00 kg a.i./ha 30 1 3 0.66 1.00 kg a.i./ha 30 1 3 0.66 1.00 kg a.i./ha 30 1 3 0.66 1.00 kg a.i./ha 30 1 3 0.66 1.00 kg a.i./ha 30 1 3 0.66 1.00 kg a.i./ha 30 1 3 0.66 1.00 kg a.i./ha 30 1 3 0.66 1.00 kg a.i./ha 30 1 3 0.66 1.00 kg a.i./ha 30 IT states use is on 'vines'. EL has same GAP except only one application. 1 3 0.66 1.00 kg a.i./ha 30 1 1 0.30 0.80 kg a.i./ha 1 1 0.30 0.80 kg a.i./ha No PHI stated 1 1 0.30 0.80 kg a.i./ha No PHI stated 1 1 0.30 0.80 kg a.i./ha 3 1 1 0.30 0.80 kg a.i./ha No PHI stated 1 1 0.30 0.80 kg a.i./ha No PHI stated 1 1 0.30 0.80 kg a.i./ha No PHI stated SEU Outdoor FR, IT Dessicant SL 200.0 g/l Foliar treatment - spraying 1 1 0.66 1.00 kg a.i./ha FR do not state minimum application rate. Sweet potatoes Ipomoea batatas SEU Outdoor PT Dessicant SL 200.0 g/l Foliar treatment - spraying 1 1 0.30 0.80 kg a.i./ha No PHI stated Carrots Daucus carota SEU Outdoor ES, PT Turnips Brassica rapa SEU Outdoor PT Garlic Allium sativum SEU Outdoor PT Onions Allium cepa SEU Outdoor ES, PT Tomatoes Lycopersicum esculentum SEU Outdoor PT 1 1 0.30 0.80 kg a.i./ha 1 1 0.30 0.80 kg a.i./ha 1 1 0.30 0.80 kg a.i./ha 15 1 1 0.30 0.80 kg a.i./ha 15 1 1 0.30 0.80 kg a.i./ha EFSA Journal 2015;13(1):3972 51
Review of the existing MRLs for Critical outdoor GAPs for Southern Europe Crop Region Outdoor/ Member state Pest controlled Formulation Application PHI or Indoor or country waiting Common name Scientific name Type Content Method Growth stage Number Interval (days) Rate period Min. Max. Min. Max. Min. Max. Unit (days) Peppers Capsicum annuum, var grossum and var. longum Conc. Unit From BBCH SEU Outdoor ES, PT Cucumbers Cucumis sativus SEU Outdoor PT Melons Cucumis melo SEU Outdoor PT Pumpkins Cucurbita maxima SEU Outdoor PT Watermelons Citrullus lanatus SEU Outdoor PT Broccoli Cauliflower Brussels sprouts Head cabbage Brassica oleracea var. italica Brassica oleracea var. botrytis Brassica oleracea var. gemmifera Brassica oleracea convar capitata SEU Outdoor PT SEU Outdoor PT SEU Outdoor PT SEU Outdoor PT Chinese cabbage Brassica pekinensis SEU Outdoor PT Kale Kohlrabi Brassica oleracea convar. Acephalea Brassica oleracea convar. acephala, var. gongylodes SEU Outdoor PT SEU Outdoor PT Lettuce Lactuca sativa SEU Outdoor PT Parsley Petroselinum crispum SEU Outdoor PT Asparagus Asparagus officinalis SEU Outdoor IT Celery Apium graveolens var. dulce SEU Outdoor ES, PT Globe artichokes Cynara scolymus SEU Outdoor PT Leek Allium porrum SEU Outdoor PT Until BBCH 1 1 0.30 0.80 kg a.i./ha 15 1 1 0.30 0.80 kg a.i./ha 1 1 0.30 0.80 kg a.i./ha 1 1 0.30 0.80 kg a.i./ha 1 1 0.30 0.80 kg a.i./ha 1 1 0.30 0.80 kg a.i./ha 1 1 0.30 0.80 kg a.i./ha 1 1 0.30 0.80 kg a.i./ha 1 1 0.30 0.80 kg a.i./ha 1 1 0.30 0.80 kg a.i./ha 1 1 0.30 0.80 kg a.i./ha 1 1 0.30 0.80 kg a.i./ha 1 1 0.30 0.80 kg a.i./ha Comments (max. 250 charachters) 1 1 0.30 0.80 kg a.i./ha 120 Early post-emergence 0.40 0.80 kg a.i./ha 30 1 1 0.30 0.80 kg a.i./ha 15 1 1 0.30 0.80 kg a.i./ha 1 1 0.30 0.80 kg a.i./ha Beans (dry) Phaseolus vulgaris SEU Outdoor EL Dessicant SL 200.0 g/l Foliar treatment - spraying 0.80 kg a.i./ha 10 EL GAP states 'beans' - assume this is beans (pulses) Rape seed Brassica napus SEU Outdoor PT Dessicant SL 200.0 g/l Foliar treatment - spraying 0.30 0.80 kg a.i./ha Olives for oil production Olea europaea SEU Outdoor El, IT 0.66 1.00 kg a.i./ha 30 IT state: 'Preparation and maintenance of circles around olive trees' Maize Zea mays SEU Outdoor ES Dessicant SL 200.0 g/l Foliar treatment - spraying 0.30 0.60 kg a.i./ha 15 Oats Avena fatua SEU Outdoor PT Dessicant SL 200.0 g/l Foliar treatment - spraying 0.30 0.60 kg a.i./ha Wheat Triticum aestivum SEU Outdoor PT Dessicant SL 200.0 g/l Foliar treatment - spraying 0.30 0.60 kg a.i./ha Sugar beet Beta vulgaris SEU Outdoor ES Dessicant SL 200.0 g/l Foliar treatment - spraying 0.80 kg a.i./ha 15 n.a.: not applicable EFSA Journal 2015;13(1):3972 52
Review of the existing MRLs for APPENDIX B PESTICIDE RESIDUES INTAKE MODEL (PRIMO) Appendix B.1 EU scenario 1 including all EU MRL proposals resulting from the GAPs reported by the RMS Appendix B.2 EU scenario 2 including all EU MRL proposals resulting from the GAPs reported by the RMS (except maize and barley) Appendix B.3 EU scenario 3 including demonstrated safe EU MRL proposals resulting from the GAPs reported by the RMS Appendix B.4 EU/Codex scenario 1 including demonstrated safe EU MRL proposals and all CXLs Appendix B.5 EU/Codex scenario 2 including demonstrated safe EU MRL proposals and demonstrated safe CXLs EFSA Journal 2015;13(1):3972 53
APPENDIX B.1 EU SCENARIO 1 INCLUDING ALL EU MRL PROPOSALS RESULTING FROM THE GAPS REPORTED BY THE RMS Review of the existing MRLs for Diquat Status of the active substance: Included Code no. LOQ (mg/kg bw): 0.05 proposed LOQ: Toxicological end points ADI (mg/kg bw/day): 0.002 ARfD (mg/kg bw): n.n. Source of ADI: COM Source of ARfD: COM Year of evaluation: 2001 Year of evaluation: 2001 Prepare workbook for refined calculations Undo refined calculations Chronic risk assessment - refined calculations TMDI (range) in % of ADI minimum - maximum 28 383 No of diets exceeding ADI: 10 Highest calculated TMDI values in % of ADI MS Diet Highest contributor to MS diet (in % of ADI) Commodity / group of commodities 2nd contributor to MS diet (in % of ADI) Commodity / group of commodities 3rd contributor to MS diet (in % of ADI) Commodity / group of commodities ptmrls at LOQ (in % of ADI) 383.0 IE adult 172.1 Maize 102.4 Barley 19.1 Linseed 39.3 313.5 WHO Cluster diet B 185.5 Maize 32.0 Wheat 23.1 Barley 50.1 200.5 UK Infant 76.9 Maize 37.8 Sugar beet (root) 20.9 Oats 41.0 183.1 WHO cluster diet E 66.8 Barley 41.6 Maize 14.8 Wheat 26.7 153.9 UK Toddler 85.8 Sugar beet (root) 14.7 Wheat 13.1 Potatoes 31.3 134.9 NL child 22.1 Potatoes 17.8 Wheat 15.8 Apples 71.7 132.1 WHO cluster diet D 39.8 Maize 24.4 Wheat 18.2 Barley 22.6 131.2 DE child 30.2 Apples 16.9 Oats 15.4 Wheat 75.1 126.9 WHO Cluster diet F 49.6 Barley 13.5 Wheat 12.8 Potatoes 24.4 102.2 WHO regional European diet 27.2 Barley 15.1 Potatoes 11.1 Wheat 31.0 95.8 PT General population 35.6 Maize 20.0 Potatoes 14.7 Wheat 16.5 94.7 FR toddler 19.8 Milk and cream, 19.0 Potatoes 9.8 Wheat 64.2 93.2 DK child 32.6 Oats 20.6 Wheat 9.1 Potatoes 30.8 88.5 ES child 21.6 Maize 16.6 Wheat 6.9 Potatoes 40.2 86.4 ES adult 40.6 Barley 8.8 Wheat 6.2 Maize 25.4 82.0 NL general 30.9 Barley 10.3 Potatoes 7.8 Wheat 26.4 63.1 FR infant 15.5 Potatoes 12.9 Milk and cream, 6.6 Carrots 44.2 60.0 SE general population 90th percentile 15.6 Potatoes 12.0 Wheat 6.2 Milk and cream, 32.3 48.5 UK vegetarian 14.2 Sugar beet (root) 7.7 Wheat 5.1 Potatoes 13.8 48.0 IT kids/toddler 24.9 Wheat 3.6 Tomatoes 3.4 Potatoes 16.1 46.1 LT adult 11.9 Potatoes 7.5 Oats 4.9 Barley 16.9 41.6 UK Adult 15.0 Sugar beet (root) 6.3 Wheat 5.2 Potatoes 10.4 38.6 FR all population 12.3 Wheat 4.2 Potatoes 3.5 Sunflower seed 17.9 36.9 DK adult 9.5 Oats 7.6 Wheat 5.5 Potatoes 14.3 35.0 IT adult 15.5 Wheat 2.9 Tomatoes 2.3 Potatoes 14.6 30.9 FI adult 7.0 Oats 4.6 Potatoes 3.7 Wheat 11.5 27.7 PL general population 12.9 Potatoes 5.1 Apples 2.2 Tomatoes 14.5 Conclusion: The estimated Theoretical Maximum Daily Intakes based on MS and WHO diets and ptmrls were in the range of 27.7 % to 383 % of the ADI. For 10 diets the ADI is exceeded. Further refinements of the dietary intake estimates have not been performed. A public health risk can not be excluded at the moment. EFSA Journal 2015;13(1):3972 54
Review of the existing MRLs for APPENDIX B.2 EU SCENARIO 2 INCLUDING ALL EU MRL PROPOSALS RESULTING FROM THE GAPS REPORTED BY THE RMS (EXCEPT MAIZE AND BARLEY) Diquat Status of the active substance: Included Code no. LOQ (mg/kg bw): 0.05 proposed LOQ: Toxicological end points ADI (mg/kg bw/day): 0.002 ARfD (mg/kg bw): n.n. Source of ADI: COM Source of ARfD: COM Year of evaluation: 2001 Year of evaluation: 2001 Prepare workbook for refined calculations Undo refined calculations Chronic risk assessment - refined calculations TMDI (range) in % of ADI minimum - maximum 27 152 No of diets exceeding ADI: 6 Highest calculated TMDI values in % of ADI MS Diet Highest contributor to MS diet (in % of ADI) Commodity / group of commodities 2nd contributor to MS diet (in % of ADI) Commodity / group of commodities 3rd contributor to MS diet (in % of ADI) Commodity / group of commodities ptmrls at LOQ (in % of ADI) 151.9 UK Toddler 85.8 Sugar beet (root) 14.7 Wheat 13.1 Potatoes 31.3 123.6 UK Infant 37.8 Sugar beet (root) 20.9 Oats 19.4 Milk and cream, 41.0 121.8 NL child 22.1 Potatoes 17.8 Wheat 15.8 Apples 71.7 119.0 DE child 30.2 Apples 16.9 Oats 15.4 Wheat 75.1 108.5 IE adult 19.1 Linseed 15.0 Oats 13.3 Sweet potatoes 39.3 104.9 WHO Cluster diet B 32.0 Wheat 10.1 Potatoes 7.8 Sunflower seed 50.1 94.7 FR toddler 19.8 Milk and cream, 19.0 Potatoes 9.8 Wheat 64.2 93.2 DK child 32.6 Oats 20.6 Wheat 9.1 Potatoes 30.8 74.7 WHO cluster diet E 14.8 Wheat 14.4 Potatoes 7.8 Oats 26.7 74.2 WHO cluster diet D 24.4 Wheat 15.2 Potatoes 5.8 Oats 22.6 67.9 WHO Cluster diet F 13.5 Wheat 12.8 Potatoes 12.2 Oats 24.4 66.7 ES child 16.6 Wheat 6.9 Potatoes 6.3 Milk and cream, 40.2 64.0 WHO regional European diet 15.1 Potatoes 11.1 Wheat 3.2 Swine: Meat 31.0 63.1 FR infant 15.5 Potatoes 12.9 Milk and cream, 6.6 Carrots 44.2 60.0 SE general population 90th percentile 15.6 Potatoes 12.0 Wheat 6.2 Milk and cream, 32.3 57.7 PT General population 20.0 Potatoes 14.7 Wheat 3.0 Sunflower seed 16.5 47.5 NL general 10.3 Potatoes 7.8 Wheat 3.7 Oranges 26.4 46.3 UK vegetarian 14.2 Sugar beet (root) 7.7 Wheat 5.1 Potatoes 13.8 45.2 IT kids/toddler 24.9 Wheat 3.6 Tomatoes 3.4 Potatoes 16.1 40.6 LT adult 11.9 Potatoes 7.5 Oats 4.7 Apples 16.9 39.6 ES adult 8.8 Wheat 3.5 Potatoes 3.2 Oranges 25.4 39.2 UK Adult 15.0 Sugar beet (root) 6.3 Wheat 5.2 Potatoes 10.4 38.1 FR all population 12.3 Wheat 4.2 Potatoes 3.5 Sunflower seed 17.9 36.9 DK adult 9.5 Oats 7.6 Wheat 5.5 Potatoes 14.3 32.9 IT adult 15.5 Wheat 2.9 Tomatoes 2.3 Potatoes 14.6 27.6 PL general population 12.9 Potatoes 5.1 Apples 2.2 Tomatoes 14.5 27.0 FI adult 7.0 Oats 4.6 Potatoes 3.7 Wheat 11.5 Conclusion: The estimated Theoretical Maximum Daily Intakes based on MS and WHO diets and ptmrls were in the range of 27 % to 152 % of the ADI. For 6 diets the ADI is exceeded. Further refinements of the dietary intake estimates have not been performed. A public health risk can not be excluded at the moment. EFSA Journal 2015;13(1):3972 55
Review of the existing MRLs for APPENDIX B.3 EU SCENARIO 3 INCLUDING DEMONSTRATED SAFE EU MRL PROPOSALS RESULTING FROM THE GAPS REPORTED BY THE RMS Diquat Status of the active substance: Included Code no. LOQ (mg/kg bw): 0.05 proposed LOQ: Toxicological end points ADI (mg/kg bw/day): 0.002 ARfD (mg/kg bw): n.n. Source of ADI: COM Source of ARfD: COM Year of evaluation: 2001 Year of evaluation: 2001 Prepare workbook for refined calculations Undo refined calculations Chronic risk assessment - refined calculations TMDI (range) in % of ADI minimum - maximum 6 61 No of diets exceeding ADI: --- Highest calculated TMDI values in % of ADI MS Diet Highest contributor to MS diet (in % of ADI) Commodity / group of commodities 2nd contributor to MS diet (in % of ADI) Commodity / group of commodities 3rd contributor to MS diet (in % of ADI) Commodity / group of commodities ptmrls at LOQ (in % of ADI) 61.2 UK Infant 20.9 Oats 19.4 Milk and cream, 7.6 Sugar beet (root) 38.5 60.6 IE adult 19.1 Linseed 15.0 Oats 3.4 Wheat 21.9 56.0 NL child 14.7 Milk and cream, 8.8 Oats 7.1 Wheat 45.8 54.7 DK child 32.6 Oats 8.3 Wheat 6.3 Milk and cream, 22.0 52.0 DE child 16.9 Oats 7.1 Milk and cream, 6.2 Wheat 33.1 48.3 WHO Cluster diet B 12.8 Wheat 7.8 Sunflower seed 4.8 Olives for oil production 38.2 47.8 UK Toddler 17.2 Sugar beet (root) 10.3 Milk and cream, 5.9 Wheat 40.8 44.0 FR toddler 19.8 Milk and cream, 3.9 Wheat 3.8 Potatoes 42.3 40.6 WHO cluster diet E 7.8 Oats 6.2 Rape seed 5.9 Wheat 22.1 37.5 WHO Cluster diet F 12.2 Oats 5.4 Wheat 3.3 Rape seed 20.4 34.6 WHO cluster diet D 9.8 Wheat 5.8 Oats 5.2 Sunflower seed 22.6 34.5 ES child 6.7 Wheat 6.3 Milk and cream, 3.5 Bovine: Meat 31.5 30.3 WHO regional European diet 4.5 Wheat 3.2 Swine: Meat 3.0 Potatoes 23.7 26.6 FR infant 12.9 Milk and cream, 3.1 Potatoes 1.4 Bovine: Meat 26.4 21.5 PT General population 5.9 Wheat 4.0 Potatoes 3.0 Sunflower seed 15.1 20.9 NL general 3.3 Milk and cream, 3.1 Wheat 2.6 Oats 17.8 20.6 DK adult 9.5 Oats 3.0 Wheat 2.7 Milk and cream, 11.1 20.4 LT adult 7.5 Oats 2.4 Swine: Meat 2.4 Potatoes 12.5 19.9 SE general population 90th percentile 6.2 Milk and cream, 4.8 Wheat 3.1 Potatoes 19.9 19.2 ES adult 3.5 Wheat 2.5 Milk and cream, 1.9 Bovine: Meat 17.3 19.1 FR all population 4.9 Wheat 3.5 Sunflower seed 2.0 Wine grapes 15.5 17.2 UK vegetarian 4.0 Oats 3.1 Wheat 2.8 Sugar beet (root) 11.7 14.8 IT kids/toddler 10.0 Wheat 0.7 Tomatoes 0.7 Potatoes 14.0 14.4 FI adult 7.0 Oats 2.8 Milk and cream, 1.5 Wheat 7.2 12.8 UK Adult 3.0 Sugar beet (root) 2.5 Wheat 1.5 Milk and cream, 10.5 10.2 IT adult 6.2 Wheat 0.6 Tomatoes 0.5 Potatoes 9.7 6.0 PL general population 2.6 Potatoes 1.0 Apples 0.4 Tomatoes 5.7 Conclusion: The estimated Theoretical Maximum Daily Intakes (TMDI), based on ptmrls were below the ADI. A long-term intake of residues of Diquat is unlikely to present a public health concern. EFSA Journal 2015;13(1):3972 56
Review of the existing MRLs for APPENDIX B.4 EU/CODEX SCENARIO 1 INCLUDING DEMONSTRATED SAFE EU MRL PROPOSALS AND ALL CXLS Diquat Status of the active substance: Included Code no. LOQ (mg/kg bw): 0.05 proposed LOQ: Toxicological end points ADI (mg/kg bw/day): 0.002 ARfD (mg/kg bw): n.n. Source of ADI: COM Source of ARfD: COM Year of evaluation: 2001 Year of evaluation: 2001 Prepare workbook for refined calculations Undo refined calculations Chronic risk assessment - refined calculations TMDI (range) in % of ADI minimum - maximum 18 1433 No of diets exceeding ADI: 26 Highest calculated TMDI values in % of ADI MS Diet Highest contributor to MS diet (in % of ADI) Commodity / group of commodities 2nd contributor to MS diet (in % of ADI) Commodity / group of commodities 3rd contributor to MS diet (in % of ADI) Commodity / group of commodities ptmrls at LOQ (in % of ADI) 1432.7 WHO Cluster diet B 1280.3 Wheat 105.0 Barley 10.1 Potatoes 28.3 1097.1 WHO cluster diet D 975.5 Wheat 82.5 Barley 15.2 Potatoes 12.4 1010.2 IT kids/toddler 997.0 Wheat 4.0 Barley 3.4 Potatoes 5.2 960.5 WHO cluster diet E 591.5 Wheat 303.8 Barley 21.9 Rape seed 17.6 883.6 DK child 825.7 Wheat 32.6 Oats 9.1 Potatoes 16.2 877.3 IE adult 465.3 Barley 344.3 Wheat 19.1 Linseed 21.0 820.1 WHO Cluster diet F 540.0 Wheat 225.6 Barley 12.8 Potatoes 16.6 795.9 NL child 711.2 Wheat 22.1 Potatoes 14.7 Milk and cream, 42.6 703.5 ES child 665.3 Wheat 6.9 Potatoes 6.3 Milk and cream, 27.8 688.1 DE child 616.7 Wheat 16.9 Oats 12.1 Apples 38.3 650.1 UK Toddler 587.7 Wheat 17.2 Sugar beet (root) 13.1 Potatoes 37.2 632.0 PT General population 587.8 Wheat 20.0 Potatoes 11.3 Barley 7.5 631.0 IT adult 620.3 Wheat 3.5 Barley 2.3 Potatoes 4.5 612.5 WHO regional European diet 445.0 Wheat 123.8 Barley 15.1 Potatoes 19.1 557.7 ES adult 352.2 Wheat 184.5 Barley 3.5 Potatoes 15.8 514.6 FR all population 493.3 Wheat 4.2 Potatoes 2.7 Sunflower seed 11.4 512.4 SE general population 90th percentile 480.3 Wheat 15.6 Potatoes 6.2 Milk and cream, 16.5 480.4 NL general 311.0 Wheat 140.5 Barley 10.3 Potatoes 15.6 465.7 UK Infant 393.1 Wheat 20.9 Oats 19.4 Milk and cream, 37.7 454.9 FR toddler 393.4 Wheat 19.8 Milk and cream, 19.0 Potatoes 41.2 334.7 UK vegetarian 307.2 Wheat 7.3 Barley 5.1 Potatoes 9.5 325.7 DK adult 302.0 Wheat 9.5 Oats 5.5 Potatoes 8.7 277.3 UK Adult 251.4 Wheat 9.9 Barley 5.2 Potatoes 8.5 210.4 LT adult 157.8 Wheat 22.4 Barley 11.9 Potatoes 10.4 174.9 FI adult 147.6 Wheat 8.8 Barley 7.0 Oats 6.6 168.1 FR infant 126.1 Wheat 15.5 Potatoes 12.9 Milk and cream, 26.2 17.8 PL general population 12.9 Potatoes 2.0 Apples 0.4 Tomatoes 4.6 Conclusion: The estimated Theoretical Maximum Daily Intakes based on MS and WHO diets and ptmrls were in the range of 17.8 % to 1433 % of the ADI. For 26 diets the ADI is exceeded. Further refinements of the dietary intake estimates have not been performed. A public health risk can not be excluded at the moment. EFSA Journal 2015;13(1):3972 57
Review of the existing MRLs for APPENDIX B.5 EU/CODEX SCENARIO 2 INCLUDING DEMONSTRATED SAFE EU MRL PROPOSALS AND DEMONSTRATED SAFE CXLS Diquat Status of the active substance: Included Code no. LOQ (mg/kg bw): 0.05 proposed LOQ: Toxicological end points ADI (mg/kg bw/day): 0.002 ARfD (mg/kg bw): n.n. Source of ADI: COM Source of ARfD: COM Year of evaluation: 2001 Year of evaluation: 2001 Prepare workbook for refined calculations Undo refined calculations Chronic risk assessment - refined calculations TMDI (range) in % of ADI minimum - maximum 13 82 No of diets exceeding ADI: --- Highest calculated TMDI values in % of ADI MS Diet Highest contributor to MS diet (in % of ADI) Commodity / group of commodities 2nd contributor to MS diet (in % of ADI) Commodity / group of commodities 3rd contributor to MS diet (in % of ADI) Commodity / group of commodities ptmrls at LOQ (in % of ADI) 82.1 NL child 22.1 Potatoes 14.7 Milk and cream, 8.8 Oats 49.7 76.5 UK Infant 20.9 Oats 19.4 Milk and cream, 12.2 Potatoes 41.6 72.9 DE child 16.9 Oats 12.1 Apples 9.6 Potatoes 44.5 71.2 IE adult 19.1 Linseed 15.0 Oats 8.6 Potatoes 24.4 71.1 WHO cluster diet E 21.9 Rape seed 14.4 Potatoes 7.8 Oats 23.5 66.2 DK child 32.6 Oats 9.1 Potatoes 8.3 Wheat 24.5 65.4 FR toddler 19.8 Milk and cream, 19.0 Potatoes 3.9 Wheat 45.1 63.2 UK Toddler 17.2 Sugar beet (root) 13.1 Potatoes 10.3 Milk and cream, 43.1 60.3 WHO Cluster diet B 12.8 Wheat 10.1 Potatoes 6.1 Sunflower seed 41.1 59.9 WHO Cluster diet F 12.8 Potatoes 12.2 Oats 11.5 Rape seed 22.0 48.9 WHO cluster diet D 15.2 Potatoes 9.8 Wheat 5.8 Oats 22.2 48.2 WHO regional European diet 15.1 Potatoes 4.5 Rape seed 4.5 Wheat 23.6 44.1 ES child 6.9 Potatoes 6.7 Wheat 6.3 Milk and cream, 34.4 43.2 FR infant 15.5 Potatoes 12.9 Milk and cream, 2.5 Apples 27.5 38.9 PT General population 20.0 Potatoes 5.9 Wheat 2.5 Oats 13.4 37.0 SE general population 90th percentile 15.6 Potatoes 6.2 Milk and cream, 4.8 Wheat 21.3 32.1 NL general 10.3 Potatoes 3.3 Milk and cream, 3.1 Wheat 18.7 31.7 LT adult 11.9 Potatoes 7.5 Oats 2.4 Swine: Meat 12.0 26.7 DK adult 9.5 Oats 5.5 Potatoes 3.0 Wheat 11.7 24.5 ES adult 3.5 Wheat 3.5 Potatoes 2.5 Milk and cream, 19.3 23.7 FR all population 4.9 Wheat 4.2 Potatoes 2.7 Sunflower seed 16.3 23.3 UK vegetarian 5.1 Potatoes 4.0 Oats 3.1 Wheat 12.6 19.9 FI adult 7.0 Oats 4.6 Potatoes 2.8 Milk and cream, 8.1 19.2 IT kids/toddler 10.0 Wheat 3.4 Potatoes 0.9 Apples 15.2 18.5 UK Adult 5.2 Potatoes 3.0 Sugar beet (root) 2.5 Wheat 11.0 17.8 PL general population 12.9 Potatoes 2.0 Apples 0.4 Tomatoes 4.6 13.3 IT adult 6.2 Wheat 2.3 Potatoes 0.8 Apples 10.7 Conclusion: The estimated Theoretical Maximum Daily Intakes (TMDI), based on ptmrls were below the ADI. A long-term intake of residues of Diquat is unlikely to present a public health concern. EFSA Journal 2015;13(1):3972 58
Review of the existing MRLs for APPENDIX C EXISTING EU MAXIMUM RESIDUE LIMITS (MRLS) AND CODEX LIMITS (CXLS) Appendix C.1 Existing EU MRLs Appendix C.2 Existing CXLs EFSA Journal 2015;13(1):3972 59
Review of the existing MRLs for APPENDIX C.1 EXISTING EU MRLS FOR DIQUAT (Pesticides - Web Version - EU MRLs - File created on 07/03/2013 15:20) Code number Groups and examples of individual products to which the MRLs apply (a) Diquat 100000 1. FRUIT FRESH OR 0,05* FROZEN; NUTS 110000 (i) Citrus fruit 0,05* 110010 Grapefruit (Shaddocks, 0,05* pomelos, sweeties, tangelo, ugli and other hybrids) 110020 Oranges (Bergamot, bitter 0,05* orange, chinotto and other hybrids) 110030 Lemons (Citron, lemon ) 0,05* 110040 Limes 0,05* 110050 Mandarins (Clementine, 0,05* tangerine and other hybrids) 110990 Others 0,05* 120000 (ii) Tree nuts (shelled or 0,05* unshelled) 120010 Almonds 0,05* 120020 Brazil nuts 0,05* 120030 Cashew nuts 0,05* 120040 Chestnuts 0,05* 120050 Coconuts 0,05* 120060 Hazelnuts (Filbert) 0,05* 120070 Macadamia 0,05* 120080 Pecans 0,05* 120090 Pine nuts 0,05* 120100 Pistachios 0,05* 120110 Walnuts 0,05* 120990 Others 0,05* 130000 (iii) Pome fruit 0,05* 130010 Apples (Crab apple) 0,05* 130020 Pears (Oriental pear) 0,05* 130030 Quinces 0,05* 130040 Medlar 0,05* 130050 Loquat 0,05* 130990 Others 0,05* 140000 (iv) Stone fruit 0,05* 140010 Apricots 0,05* 140020 Cherries (sweet cherries, 0,05* sour cherries) 140030 Peaches (Nectarines and 0,05* similar hybrids) 140040 Plums (Damson, greengage, 0,05* mirabelle) 140990 Others 0,05* Code number Groups and examples of individual products to which the MRLs apply (a) Diquat 150000 (v) Berries & small fruit 0,05* 151000 (a) Table and wine grapes 0,05* 151010 Table grapes 0,05* 151020 Wine grapes 0,05* 152000 (b) Strawberries 0,05* 153000 (c) Cane fruit 0,05* 153010 Blackberries 0,05* 153020 Dewberries (Loganberries, 0,05* Boysenberries, and cloudberries) 153030 Raspberries (Wineberries ) 0,05* 153990 Others 0,05* 154000 (d) Other small fruit & 0,05* berries 154010 Blueberries (Bilberries 0,05* cowberries (red bilberries)) 154020 Cranberries 0,05* 154030 Currants (red, black and 0,05* white) 154040 Gooseberries (Including 0,05* hybrids with other ribes species) 154050 Rose hips 0,05* 154060 Mulberries (arbutus berry) 0,05* 154070 Azarole (mediteranean 0,05* medlar) 154080 Elderberries (Black 0,05* chokeberry (appleberry), mountain ash, azarole, buckthorn (sea sallowthorn), hawthorn, service berries, and other tree berries) 154990 Others 0,05* 160000 (vi) Miscellaneous fruit 0,05* 161000 (a) Edible peel 0,05* 161010 Dates 0,05* 161020 Figs 0,05* 161030 Table olives 0,05* 161040 Kumquats (Marumi 0,05* kumquats, nagami kumquats) 161050 Carambola (Bilimbi) 0,05* 161060 Persimmon 0,05* 161070 Jambolan (java plum) (Java apple (water apple), 0,05* Code number Groups and examples of individual products to which the MRLs apply (a) Diquat pomerac, rose apple, Brazilian cherry (grumichama), Surinam cherry) 161990 Others 0,05* 162000 (b) Inedible peel, small 0,05* 162010 Kiwi 0,05* 162020 Lychee (Litchi) (Pulasan, 0,05* rambutan (hairy litchi)) 162030 Passion fruit 0,05* 162040 Prickly pear (cactus fruit) 0,05* 162050 Star apple 0,05* 162060 American persimmon 0,05* (Virginia kaki) (Black sapote, white sapote, green sapote, canistel (yellow sapote), and mammey sapote) 162990 Others 0,05* 163000 (c) Inedible peel, large 0,05* 163010 Avocados 0,05* 163020 Bananas (Dwarf banana, 0,05* plantain, apple banana) 163030 Mangoes 0,05* 163040 Papaya 0,05* 163050 Pomegranate 0,05* 163060 Cherimoya (Custard apple, 0,05* sugar apple (sweetsop), llama and other medium sized Annonaceae) 163070 Guava 0,05* 163080 Pineapples 0,05* 163090 Bread fruit (Jackfruit) 0,05* 163100 Durian 0,05* 163110 Soursop (guanabana) 0,05* 163990 Others 0,05* 200000 2. VEGETABLES FRESH 0,05* OR FROZEN 210000 (i) Root and tuber vegetables 0,05* 211000 (a) Potatoes 0,05* 212000 (b) Tropical root and tuber 0,05* vegetables 212010 Cassava (Dasheen, eddoe (Japanese taro), tannia) 0,05* Code number Groups and examples of individual products to which the MRLs apply (a) Diquat 212020 Sweet potatoes 0,05* 212030 Yams (Potato bean (yam 0,05* bean), Mexican yam bean) 212040 Arrowroot 0,05* 212990 Others 0,05* 213000 (c) Other root and tuber 0,05* vegetables except sugar beet 213010 Beetroot 0,05* 213020 Carrots 0,05* 213030 Celeriac 0,05* 213040 Horseradish 0,05* 213050 Jerusalem artichokes 0,05* 213060 Parsnips 0,05* 213070 Parsley root 0,05* 213080 Radishes (Black radish, 0,05* Japanese radish, small radish and similar varieties) 213090 Salsify (Scorzonera, Spanish 0,05* salsify (Spanish oysterplant)) 213100 Swedes 0,05* 213110 Turnips 0,05* 213990 Others 0,05* 220000 (ii) Bulb vegetables 0,05* 220010 Garlic 0,05* 220020 Onions (Silverskin onions) 0,05* 220030 Shallots 0,05* 220040 Spring onions (Welsh onion 0,05* and similar varieties) 220990 Others 0,05* 230000 (iii) Fruiting vegetables 0,05* 231000 (a) Solanacea 0,05* 231010 Tomatoes (Cherry tomatoes, 0,05* ) 231020 Peppers (Chilli peppers) 0,05* 231030 Aubergines (egg plants) 0,05* (Pepino) 231040 Okra, lady s fingers 0,05* 231990 Others 0,05* 232000 (b) Cucurbits - edible peel 0,05* 232010 Cucumbers 0,05* 232020 Gherkins 0,05* 232030 Courgettes (Summer squash, 0,05* marrow (patisson)) 232990 Others 0,05* EFSA Journal 2015;13(1):3972 60
Review of the existing MRLs for Code number Groups and examples of individual products to which the MRLs apply (a) Diquat 233000 (c) Cucurbits-inedible peel 0,05* 233010 Melons (Kiwano ) 0,05* 233020 Pumpkins (Winter squash) 0,05* 233030 Watermelons 0,05* 233990 Others 0,05* 234000 (d) Sweet corn 0,05* 239000 (e) Other fruiting vegetables 0,05* 240000 (iv) Brassica vegetables 0,05* 241000 (a) Flowering brassica 0,05* 241010 Broccoli (Calabrese, Chinese 0,05* broccoli, Broccoli raab) 241020 Cauliflower 0,05* 241990 Others 0,05* 242000 (b) Head brassica 0,05* 242010 Brussels sprouts 0,05* 242020 Head cabbage (Pointed head 0,05* cabbage, red cabbage, savoy cabbage, white cabbage) 242990 Others 0,05* 243000 (c) Leafy brassica 0,05* 243010 Chinese cabbage (Indian 0,05* (Chinese) mustard, pak choi, Chinese flat cabbage (tai goo choi), Peking cabbage (petsai), cow cabbage) 243020 Kale (Borecole (curly kale), 0,05* collards) 243990 Others 0,05* 244000 (d) Kohlrabi 0,05* 250000 (v) Leaf vegetables & fresh 0,05* herbs 251000 (a) Lettuce and other salad 0,05* plants including Brassicacea 251010 Lamb s lettuce (Italian 0,05* cornsalad) 251020 Lettuce (Head lettuce, lollo 0,05* rosso (cutting lettuce), iceberg lettuce, romaine (cos) lettuce) 251030 Scarole (broad-leaf endive) 0,05* (Wild chicory, red-leaved chicory, radicchio, curly leave endive, sugar loaf) 251040 Cress 0,05* 251050 Land cress 0,05* 251060 Rocket, Rucola (Wild 0,05* rocket) 251070 Red mustard 0,05* 251080 Leaves and sprouts of Brassica spp (Mizuna) 0,05* Code number Groups and examples of individual products to which the MRLs apply (a) Diquat 251990 Others 0,05* 252000 (b) Spinach & similar 0,05* (leaves) 252010 Spinach (New Zealand 0,05* spinach, turnip greens (turnip tops)) 252020 Purslane (Winter purslane 0,05* (miner s lettuce), garden purslane, common purslane, sorrel, glassworth) 252030 Beet leaves (chard) (Leaves 0,05* of beetroot) 252990 Others 0,05* 253000 (c) Vine leaves (grape 0,05* leaves) 254000 (d) Water cress 0,05* 255000 (e) Witloof 0,05* 256000 (f) Herbs 0,05* 256010 Chervil 0,05* 256020 Chives 0,05* 256030 Celery leaves (fennel leaves, 0,05* Coriander leaves, dill leaves, Caraway leaves, lovage, angelica, sweet cicely and other Apiacea) 256040 Parsley 0,05* 256050 Sage (Winter savory, 0,05* summer savory, ) 256060 Rosemary 0,05* 256070 Thyme ( marjoram, oregano) 0,05* 256080 Basil (Balm leaves, mint, 0,05* peppermint) 256090 Bay leaves (laurel) 0,05* 256100 Tarragon (Hyssop) 0,05* 256990 Others 0,05* 260000 (vi) Legume vegetables 0,05* (fresh) 260010 Beans (with pods) (Green 0,05* bean (French beans, snap beans), scarlet runner bean, slicing bean, yardlong beans) 260020 Beans (without pods) (Broad 0,05* beans, Flageolets, jack bean, lima bean, cowpea) 260030 Peas (with pods) (Mangetout 0,05* (sugar peas)) 260040 Peas (without pods) (Garden 0,05* pea, green pea, chickpea) 260050 Lentils 0,05* 260990 Others 0,05* 270000 (vii) Stem vegetables (fresh) 0,05* Code number Groups and examples of individual products to which the MRLs apply (a) Diquat 270010 Asparagus 0,05* 270020 Cardoons 0,05* 270030 Celery 0,05* 270040 Fennel 0,05* 270050 Globe artichokes 0,05* 270060 Leek 0,05* 270070 Rhubarb 0,05* 270080 Bamboo shoots 0,05* 270090 Palm hearts 0,05* 270990 Others 0,05* 280000 (viii) Fungi 0,05* 280010 Cultivated (Common 0,05* mushroom, Oyster mushroom, Shi-take) 280020 Wild (Chanterelle, Truffle, 0,05* Morel,) 280990 Others 0,05* 290000 (ix) Sea 0,05* 300000 3. PULSES, DRY 0,2 300010 Beans (Broad beans, navy 0,2 beans, flageolets, jack beans, lima beans, field beans, cowpeas) 300020 Lentils 0,2 300030 Peas (Chickpeas, field peas, 0,2 chickling vetch) 300040 Lupins 0,2 300990 Others 0,2 400000 4. OILSEEDS AND OILFRUITS 401000 (i) Oilseeds 401010 Linseed 5 401020 Peanuts 0,1* 401030 Poppy seed 0,1* 401040 Sesame seed 0,1* 401050 Sunflower seed 1 401060 Rape seed (Bird rapeseed, 2 turnip rape) 401070 Soya bean 0,2 401080 Mustard seed 0,5 401090 Cotton seed 0,1* 401100 Pumpkin seeds 0,1* 401110 Safflower 0,1* 401120 Borage 0,1* 401130 Gold of pleasure 0,1* 401140 Hempseed 0,5 401150 Castor bean 0,1* 401990 Others 0,1* 402000 (ii) Oilfruits 402010 Olives for oil production 0,05* Code number Groups and examples of individual products to which the MRLs apply (a) Diquat 402020 Palm nuts (palmoil kernels) 0,1* 402030 Palmfruit 0,1* 402040 Kapok 0,1* 402990 Others 0,1* 500000 5. CEREALS 500010 Barley 10 500020 Buckwheat 0,05* 500030 Maize 1 500040 Millet (Foxtail millet, teff) 1 500050 Oats 2 500060 Rice 0,05* 500070 Rye 0,05* 500080 Sorghum 0,05* 500090 Wheat (Spelt Triticale) 0,05* 500990 Others 0,05* 600000 6. TEA, COFFEE, HERBAL 0,1* INFUSIONS AND COCOA 610000 (i) Tea (dried leaves and 0,1* stalks, fermented or otherwise of Camellia sinensis) 620000 (ii) Coffee beans 0,1* 630000 (iii) Herbal infusions (dried) 0,1* 631000 (a) Flowers 0,1* 631010 Camomille flowers 0,1* 631020 Hibiscus flowers 0,1* 631030 Rose petals 0,1* 631040 Jasmine flowers 0,1* 631050 Lime (linden) 0,1* 631990 Others 0,1* 632000 (b) Leaves 0,1* 632010 Strawberry leaves 0,1* 632020 Rooibos leaves 0,1* 632030 Maté 0,1* 632990 Others 0,1* 633000 (c) Roots 0,1* 633010 Valerian root 0,1* 633020 Ginseng root 0,1* 633990 Others 0,1* 639000 (d) Other herbal infusions 0,1* 640000 (iv) Cocoa (fermented beans) 0,1* 650000 (v) Carob (St John s bread) 0,1* 700000 7. HOPS (dried), including 0,1* hop pellets and unconcentrated powder 800000 8. SPICES 0,1* 810000 (i) Seeds 0,1* 810010 Anise 0,1* 810020 Black caraway 0,1* 810030 Celery seed (Lovage seed) 0,1* EFSA Journal 2015;13(1):3972 61
Review of the existing MRLs for Code number Groups and examples of individual products to which the MRLs apply (a) Diquat 810040 Coriander seed 0,1* 810050 Cumin seed 0,1* 810060 Dill seed 0,1* 810070 Fennel seed 0,1* 810080 Fenugreek 0,1* 810090 Nutmeg 0,1* 810990 Others 0,1* 820000 (ii) Fruits and berries 0,1* 820010 Allspice 0,1* 820020 Anise pepper (Japan pepper) 0,1* 820030 Caraway 0,1* 820040 Cardamom 0,1* 820050 Juniper berries 0,1* 820060 Pepper, black and white 0,1* (Long pepper, pink pepper) 820070 Vanilla pods 0,1* 820080 Tamarind 0,1* 820990 Others 0,1* 830000 (iii) Bark 0,1* 830010 Cinnamon (Cassia ) 0,1* 830990 Others 0,1* 840000 (iv) Roots or rhizome 0,1* 840010 Liquorice 0,1* 840020 Ginger 0,1* 840030 Turmeric (Curcuma) 0,1* 840040 Horseradish 0,1* 840990 Others 0,1* 850000 (v) Buds 0,1* 850010 Cloves 0,1* 850020 Capers 0,1* 850990 Others 0,1* 860000 (vi) Flower stigma 0,1* 860010 Saffron 0,1* 860990 Others 0,1* 870000 (vii) Aril 0,1* 870010 Mace 0,1* 870990 Others 0,1* 900000 9. SUGAR PLANTS 0,05* 900010 Sugar beet (root) 0,05* 900020 Sugar cane 0,05* 900030 Chicory roots 0,05* 900990 Others 0,05* 1000000 10. PRODUCTS OF ANIMAL ORIGIN- TERRESTRIAL ANIMALS 1010000 (i) Meat, preparations of meat, offals, blood, animal fats fresh chilled or frozen, salted, in brine, dried or smoked or processed as 0,05* Code number Groups and examples of individual products to which the MRLs apply (a) Diquat flours or meals other processed products such as sausages and food preparations based on these 1011000 (a) Swine 0,05* 1011010 Meat 0,05* 1011020 Fat free of lean meat 0,05* 1011030 Liver 0,05* 1011040 Kidney 0,05* 1011050 Edible offal 0,05* 1011990 Others 0,05* 1012000 (b) Bovine 0,05* 1012010 Meat 0,05* 1012020 Fat 0,05* 1012030 Liver 0,05* 1012040 Kidney 0,05* 1012050 Edible offal 0,05* 1012990 Others 0,05* 1013000 (c) Sheep 0,05* 1013010 Meat 0,05* 1013020 Fat 0,05* 1013030 Liver 0,05* 1013040 Kidney 0,05* 1013050 Edible offal 0,05* 1013990 Others 0,05* 1014000 (d) Goat 0,05* 1014010 Meat 0,05* 1014020 Fat 0,05* 1014030 Liver 0,05* 1014040 Kidney 0,05* 1014050 Edible offal 0,05* 1014990 Others 0,05* 1015000 (e) Horses, asses, mules or 0,05* hinnies 1015010 Meat 0,05* 1015020 Fat 0,05* 1015030 Liver 0,05* 1015040 Kidney 0,05* 1015050 Edible offal 0,05* 1015990 Others 0,05* 1016000 (f) Poultry -chicken, geese, 0,05* duck, turkey and Guinea fowl-, ostrich, pigeon 1016010 Meat 0,05* 1016020 Fat 0,05* 1016030 Liver 0,05* 1016040 Kidney 0,05* 1016050 Edible offal 0,05* 1016990 Others 0,05* 1017000 (g) Other farm animals 0,05* Code number Groups and examples of individual products to which the MRLs apply (a) Diquat (Rabbit, Kangaroo) 1017010 Meat 0,05* 1017020 Fat 0,05* 1017030 Liver 0,05* 1017040 Kidney 0,05* 1017050 Edible offal 0,05* 1017990 Others 0,05* 1020000 (ii) Milk and cream, not 0,05* concentrated, nor containing added sugar or sweetening matter, butter and other fats derived from milk, cheese and curd 1020010 Cattle 0,05* 1020020 Sheep 0,05* 1020030 Goat 0,05* 1020040 Horse 0,05* 1020990 Others 0,05* 1030000 (iii) Birds eggs, fresh 0,05* preserved or cooked Shelled eggs and egg yolks fresh, dried, cooked by steaming or boiling in water, moulded, frozen or otherwise preserved whether or not containing added sugar or sweetening matter 1030010 Chicken 0,05* 1030020 Duck 0,05* 1030030 Goose 0,05* 1030040 Quail 0,05* 1030990 Others 0,05* 1040000 (iv) Honey (Royal jelly, pollen) 1050000 (v) Amphibians and reptiles (Frog legs, crocodiles) 1060000 (vi) Snails 1070000 (vii) Other terrestrial animal products (*) Indicates lower limit of analytical determination EFSA Journal 2015;13(1):3972 62
Review of the existing MRLs for APPENDIX C.2 EXISTING CXLS FOR DIQUAT Commodity code Commodity name Values adopted by the CCPR Residue definition 110010 Grapefruit Diquat and its salts expressed as 110020 Oranges Diquat and its salts expressed as 110030 Lemons Diquat and its salts expressed as 110040 Limes Diquat and its salts expressed as 110050 Mandarins Diquat and its salts expressed as 120030 Cashew nuts Diquat and its salts expressed as 130010 Apples Diquat and its salts expressed as 130020 Pears Diquat and its salts expressed as 130030 Quinces Diquat and its salts expressed as 130040 Medlar Diquat and its salts expressed as 130050 Loquat Diquat and its salts expressed as 140010 Apricots Diquat and its salts expressed as 140020 Cherries Diquat and its salts expressed as 140030 Peaches Diquat and its salts expressed as 140040 Plums Diquat and its salts expressed as 152000 Strawberries Diquat and its salts expressed as 161040 Kumquats Diquat and its salts expressed as 163020 Bananas Diquat and its salts expressed as 211000 Potatoes Diquat and its salts expressed as 231010 Tomatoes Diquat and its salts expressed as 231020 Peppers Diquat and its salts expressed as 231030 Aubergines (egg plants) Diquat and its salts expressed as 231040 Okra, lady s fingers Diquat and its salts expressed as 300010 Beans (dry) Diquat and its salts expressed as 300020 Lentils (dry) Diquat and its salts expressed as 300030 Peas (dry) Diquat and its salts expressed as CXL Residue definition 0.02 * Sum of, its salts and TOPPS expressed as 0.02 * Sum of, its salts and TOPPS expressed as 0.02 * Sum of, its salts and TOPPS expressed as 0.02 * Sum of, its salts and TOPPS expressed as 0.02 * Sum of, its salts and TOPPS expressed as 0.02 * Sum of, its salts and TOPPS expressed as 0.02 * Sum of, its salts and TOPPS expressed as 0.02 * Sum of, its salts and TOPPS expressed as 0.02 * Sum of, its salts and TOPPS expressed as 0.02 * Sum of, its salts and TOPPS expressed as 0.02 * Sum of, its salts and TOPPS expressed as 0.02 * Sum of, its salts and TOPPS expressed as 0.02 * Sum of, its salts and TOPPS expressed as 0.02 * Sum of, its salts and TOPPS expressed as 0.02 * Sum of, its salts and TOPPS expressed as 0.05 * Sum of, its salts and TOPPS expressed as 0.02 * Sum of, its salts and TOPPS expressed as 0.02 * Sum of, its salts and TOPPS expressed as 0.1 Sum of, its salts and TOPPS expressed as 0.01 * Sum of, its salts and TOPPS expressed as 0.01 * Sum of, its salts and TOPPS expressed as 0.01 * Sum of, its salts and TOPPS expressed as 0.01 * Sum of, its salts and TOPPS expressed as 0.2 Sum of, its salts and TOPPS expressed as 0.2 Sum of, its salts and TOPPS expressed as 0.3 Sum of, its salts and TOPPS expressed as Summary of CXLs for (dibromide) in plant commodities Critical values of the JMPR evaluation STMR (-P) HR (-P) Default variability factor Reduced variability factor STMR Risk assessment values as calculated by EFSA HR Median peeling factor Median conversion factor 0.000 0.000 3 n.c. 0.020 0.020 n.k. 1.00 2013 0.000 0.000 3 n.c. 0.200 0.020 n.k. 1.00 2013 0.000 0.000 3 n.c. 0.020 0.020 n.k. 1.00 2013 0.000 0.000 3 n.c. 0.020 0.020 n.k. 1.00 2013 0.000 0.000 3 n.c. 0.020 0.200 n.k. 1.00 2013 Year Based on EU GAP only? Other comments 0.000 0.000 3 n.c. 0.020 0.020 n.a. 1.00 2013 No No information on the GAP. Data extrapolated from other tree crops (citrus, apples, banana and coffee) treated by direct spray application to. The same CXL applies also to Cajou (pseudofruit) and cashew apple. 0.000 0.000 3 n.c. 0.020 0.020 n.a. 1.00 2013 Yes Trials on apples performed according to Slovakian GAP. 0.000 0.000 3 n.c. 0.020 0.020 n.a. 1.00 2013 0.000 0.000 3 n.c. 0.020 0.020 n.a. 1.00 2013 0.000 0.000 3 n.c. 0.020 0.020 n.a. 1.00 2013 0.000 0.000 3 n.c. 0.020 0.020 n.a. 1.00 2013 0.000 n.c. 3 n.c. 0.020 0.020 n.a. 1.00 2013 0.000 n.c. 3 n.c. 0.020 0.020 n.a. 1.00 2013 0.000 n.c. 3 n.c. 0.020 0.020 n.a. 1.00 2013 0.000 n.c. 3 n.c. 0.020 0.020 n.a. 1.00 2013 0.000 n.c. n.k. n.c. 0.050 0.050 n.a. 1.00 2013 Yes Trials on strawberries performed in UK and overdosed compared to the Sweden GAP (1.4N). n.c. n.c. n.c. n.c. 0.020 0.020 n.a. 1.00 n.a. No Extrapolation from citrus fruit approved by the CCPR 2014 without involvement of JMPR. 0.000 0.000 3 n.c. 0.020 0.020 n.k. 1.00 2013 No Trials performed in central America compliant with GAP. 0.050 0.060 3 n.c. 0.05 0.06 n.a. 2 2013 No Trials performed in USA according to the GAP (pre-harvest desiccation). 0.000 0.000 n.k. n.c. 0.010 0.010 n.a. 1.00 2013 Yes Trials on tomatoes perfomed in Spain and compliant with GAP. Overdosed trials confirmed a no residue situation. 0.000 0.000 n.k. n.c. 0.010 0.010 n.a. 1.00 2013 0.000 0.000 n.k. n.c. 0.010 0.010 n.a. 1.00 2013 0.000 0.000 n.k. n.c. 0.010 0.010 n.a. 1.00 2013 Comments on the JMPR evaluation Trials overdosed and compliant with GAP performed in Brazil. Direct spray application to. n.c. n.c. 1 n.c. 0.1 0.2 n.a. 2 1994 Yes Trials were conducted in Germany according to GAP. n.c. n.c. 1 n.c. n.k. 0.19 n.a. 2 1994 No Trials were conducted in Canada according to GAP. It is unclear which data complied with the GAP, therefore no STMR could be estimated. 0.050 n.c. n.k. n.c. 0.050 0.15 n.a. 2 2013 Yes Trials performed in Europe according to Slovakian GAP (preharvest desiccation). No No No information on the GAP. Data extrapolated from other tree crops (citrus, apples, banana and coffee) treated by direct spray application to. EFSA Journal 2015;13(1):3972 63