Modification of the existing maximum residue levels for glyphosate in borage and corn gromwell seeds

Transcription

1 REASONED OPINION APPROVED: 15 April 2016 PUBLISHED: 29 April 2016 doi: /j.efsa Modification of the existing maximum residue levels for glyphosate in borage and corn gromwell seeds Abstract European Food Safety Authority (EFSA) In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) the United Kingdom received an application from the company Technology Crops Ltd to modify the existing maximum residue level (MRL) for the active substance glyphosate. To accommodate for the intended use of glyphosate on corn gromwells, the United Kingdom proposed to raise the existing MRL on borage seeds from 0.1 mg/kg to 10 mg/kg, since the MRL for corn gromwell seeds in the above cited Regulation is covered by the value set on borage seeds. According to EFSA the data are sufficient to derive a MRL proposal of 10 mg/kg by extrapolation from trials on oilseed rape. Adequate analytical enforcement methods are available to control the residues of glyphosate in the seeds under consideration. Based on the risk assessment results, EFSA concludes that the proposed use of glyphosate on corn gromwells will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk. European Food Safety Authority, 2016 Keywords: glyphosate, oilseeds, MRL application, consumer risk assessment Requestor: European Commission Question number: EFSA-Q Correspondence: pesticides.mrl@efsa.europa.eu EFSA Journal 2016;14(4):4468

2 Suggested citation: EFSA (European Food Safety Authority), Reasoned opinion on the modification of the existing maximum residue levels for glyphosate in borage and corn gromwell seeds. EFSA Journal 2016;14(4):4468, 20 pp. doi: /j.efsa ISSN: European Food Safety Authority, 2016 Reproduction is authorised provided the source is acknowledged. The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. 2 EFSA Journal 2016;14(4):4468

3 Summary In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) the United Kingdom received an application from the company Technology Crops Ltd to modify the existing maximum residue level (MRL) for the active substance glyphosate to accommodate for the intended use on corn gromwells in the United Kingdom. Since the MRL for corn gromwell seeds in the above cited Regulation is covered by the value set on borage seeds, it is proposed to raise the existing value for borage seeds from 0.1 mg/kg to 10 mg/kg. The United Kingdom drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005 which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 7 July EFSA bases its assessment on the revised evaluation report, the Draft Assessment Report (DAR) prepared under Directive 91/414/EEC and the renewal assessment report (RAR) prepared in accordance with Commission Regulation (EU) No 1141/2010, the Commission review report on glyphosate, the conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate, the Joint Meeting on Pesticide Residues (JMPR) evaluation report as well as the conclusions from previous EFSA opinions on glyphosate. The toxicological profile of glyphosate was initially assessed in the framework of the peer review under Directive 91/414/EEC where an acceptable daily intake (ADI) of 0.3 mg/kg bw per day was proposed and no acute reference dose (ARfD) was allocated. These toxicological values were reconsidered in 2015, in the framework of the peer review for the renewal of the approval of the active substance where an ADI and an ARfD of 0.5 mg/kg bw per day were proposed. In the framework of the peer review for the renewal of the approval, the metabolism of glyphosate in primary crops was investigated in conventional (fruit, root, pulses/oilseeds, cereal, miscellaneous crop groups) and glyphosate tolerant crops (root, pulses/oilseeds, cereal crop groups). From these studies two different residue definitions for monitoring were proposed 1) as sum glyphosate and N-acetyl glyphosate, expressed as glyphosate for plants with glyphosate tolerant varieties available on the market and considering that glyphosate alone is not an appropriate maker for some GAT-modified plants, 2) as glyphosate, for the other plant commodities. For risk assessment the definition was agreed as sum glyphosate, N-acetyl glyphosate, AMPA and N-acetyl-AMPA expressed as glyphosate, and considering that the N-acetyl glyphosate and N-acetyl-AMPA are relevant only for the tolerant crops containing the GAT modification. Since borage (corn gromwell) glyphosate tolerant plants are not expected to be present on the market, EFSA proposes to maintain the existing residue definition for enforcement limited to glyphosate only and to consider for risk assessment the sum of glyphosate and AMPA expressed as glyphosate. The residue definitions for enforcement and risk assessment will be reconsidered in the framework of the MRLs review under Article 12 of Regulation (EC) No 396/2005. EFSA concludes that the submitted residue trials on oilseed rapes are sufficient to derive a MRL proposal of 10 mg/kg, extrapolated to borage (corn gromwell) seeds. Adequate analytical enforcement methods are available to monitor the residues of glyphosate at the validated LOQ of 0.05 mg/kg. Processing studies were not submitted and are not required in view of the limited contribution of corn gromwell and borage seeds to the total theoretical maximum daily intake (TMDI). Based on the available information on the nature and magnitude of residues in rotational crops, EFSA concludes that residues are not expected to be present in rotational crops, provided that the active substance is applied to corn gromwells according to the proposed GAP. Residues of glyphosate in commodities of animal origin were not assessed since the crops under consideration are normally not fed to livestock. The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo) and considering the current ADI value of 0.3 mg/kg bw per day. To calculate the chronic exposure, EFSA updated the latest risk assessment of glyphosate with the median residue level (STMR) derived for borage seeds and the STMRs proposed for sweet corns and sugar beet roots in a previous EFSA assessment. The highest chronic intake was calculated to be 47% of the ADI (WHO Cluster B). The long-term exposure estimation should be regarded as preliminary and will be 3 EFSA Journal 2016;14(4):4468

4 further refined in the framework of the Article 12 MRL review, when full information on authorised uses supported by data will be available to EFSA. Furthermore, EFSA performed the acute exposure calculation using ARfD of 0.5 mg/kg bw proposed in the framework of the peer review for the renewal of the approval and consumption data reported for another minor oilseed (safflower seeds) in absence of specific data on borage or corn gromwell seeds. Based on this conservative estimation, the highest acute exposure for the intended use on corn gromwell represented the 5% of the ARfD. EFSA concludes that the proposed use of glyphosate on corn gromwells will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a health risk to consumers. EFSA proposes to amend the existing MRL as reported in the summary table below. Code (a) Commodity Existing EU MRL (mg/kg) Proposed EU MRL (mg/kg) Comment/justification Enforcement residue definition: Glyphosate (conventional plants) Borage seeds (corn gromwell seeds) (a): Commodity code number according to Annex I of Regulation (EC) No 396/ Supported by extrapolation from NEU trials on oilseed rape 4 EFSA Journal 2016;14(4):4468

5 Table of contents Abstract... 1 Summary... 3 Background... 6 The active substance and its use pattern... 6 Assessment Method of analysis Methods for enforcement of residues in food of plant origin Methods for enforcement of residues in food of animal origin Mammalian toxicology Residues Nature and magnitude of residues in plant Primary crops Nature of residues Magnitude of residues Effect of industrial processing and/or household preparation Rotational crops Nature and magnitude of residues in livestock Consumer risk assessment Conclusions and recommendations References Abbreviations Appendix A Good Agricultural Practice (GAPs) Appendix B Used compound codes EFSA Journal 2016;14(4):4468

6 Background Regulation (EC) No 396/ (hereinafter referred to as the Regulation ) establishes the rules governing the setting of pesticide maximum residue levels (MRLs) at European Union (EU) level. Article 6 of the Regulation lays down that any party having a legitimate interest or requesting an authorisation for the use of a plant protection product in accordance with Directive 91/414/EEC, 2 repealed by Regulation (EC) No 1107/2009, 3 shall submit to a Member State, when appropriate, an application to modify a MRL in accordance with the provisions of Article 7 of the Regulation. The United Kingdom, hereafter referred to as the evaluating Member State (EMS), received an application from the company Technology Crops Ltd 4 to modify the existing MRL for the active substance glyphosate in corn gromwell seeds, which are covered by the MRL set on borage seeds in the Regulation. This application was notified to the European Commission and the European Food Safety Authority (EFSA) and was subsequently evaluated by the EMS in accordance with Article 8 of the Regulation. After completion, the evaluation report was submitted to the European Commission and to EFSA on 7 July The application was included in the EFSA Register of Questions with the reference number EFSA-Q and the following subject: Glyphosate Modification of existing MRLs in borage seeds The United Kingdom proposed to raise the existing MRL of glyphosate on borage seeds from the value of 0.1 mg/kg to 10 mg/kg to accommodate for the intended foliar use on corn gromwells. During the assessment of the application, EFSA identified some data gaps which were essential to conclude on the consumer risk assessment. Thus, EFSA asked for clarifications which were provided by the applicant and evaluated by the EMS in a new evaluation report submitted on 20 November Upon reception of these data, EFSA proceeded with the assessment of the application and the revised evaluation report as required by Article 10 of the Regulation. In accordance with Article 10 of Regulation (EC) No 396/2005, EFSA shall, based on the evaluation report provided by the EMS, provide a reasoned opinion on the risks to the consumer associated with the application. The revised evaluation report submitted by the EMS (United Kingdom, 2015) and the exposure calculations using the EFSA Pesticide Residues Intake Model (PRIMo) are considered as supporting documents to this reasoned opinion and, thus, are made publicly available. In accordance with Article 11 of the Regulation, the reasoned opinion shall be provided as soon as possible and at the latest within 3 months (which may be extended to 6 months if more detailed evaluations need to be carried out) from the date of receipt of the application. If EFSA requests supplementary information, the time limit laid down shall be suspended until that information has been provided. The active substance and its use pattern Glyphosate is the ISO common name for N-(phosphonomethyl)glycine (IUPAC). The chemical structures of the active substance and its main metabolites are reported in Appendix B. Glyphosate was first evaluated in the framework of Directive 91/414/EEC and included in Annex I of this Directive by Directive 2001/99/EC 5 which entered into force on 1 July 2002 for use as herbicide. 1 Regulation (EC) No 396/2005 of the 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, , p Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market. OJ L 230, , p 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 L 309, , p Technology Crops Limited, Tumblers Green, Gowers Farm, CM77 8AZ, Braintree, United Kingdom. 5 Commission Directive 2001/99/EC of 20 November 2001 amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include glyphosate and thifensulfuron-methyl as active substances, OJ L 304, , p EFSA Journal 2016;14(4):4468

7 In accordance with Commission Implementing Regulation (EU) No 540/ glyphosate is approved under Regulation (EC) No 1107/2009, repealing Directive 91/414/EEC. The peer review of the active substance for renewal of the approval under Regulation (EU) No 1141/ has been finalised (EFSA, 2015) but the decision on the renewal of the approval has not yet been taken at EU level. The representative uses evaluated in the peer review for the renewal of the approval were foliar applications against emerged annual, perennial and biennial weeds in all crops, pre/post-planting (pre-emergence) and foliar spraying for desiccation on cereals and oilseeds (pre-harvest). The EU MRLs for glyphosate are established in Annexes II and IIIB of Regulation (EC) No 396/2005. Since the entry into force of the Regulation, EFSA has issued three reasoned opinions on the modification of MRLs for glyphosate and assessed the acceptability of Codex maximum residue limits (CXLs). The EFSA proposals have been considered in the preparation of EU legislation. The MRL changes that were reported in the EU legislation since the entry into force of the Regulation are summarised in Table 1. Table 1: Overview of the MRL changes since the entry into force of Regulation (EC) No 396/2005 Procedure (a) Considered by Regulation Remarks Art. 10 (EFSA, 2009) Not necessary Maize, soya beans, products animal origin Art. 10 (EFSA, 2012a) (EU) No 441/2012 Lentils Art. 43 (EFSA, 2012b) (EU) No 293/2013 Implementation of CXLs (CAC 2012) Art. 10 (EFSA, 2013) Not necessary Rape seeds Art. 43 (EFSA, 2014) Not implemented EU reservation on CXL (CAC 2014) (a): Art. 10: Assessment of MRL application according to Article 6 to 10 of Regulation (EC) No 396/2005. Art. 43: EFSA scientific opinion according to Article 43 of Regulation (EC) No 396/2005. Codex Alimentarius has established CXLs for a range of commodities, but not for borage seeds. The details of the GAP for the intended use of glyphosate on corn gromwells (conventional crop) are given in Appendix A. Assessment EFSA has based its assessment on the revised evaluation report submitted by the EMS (United Kingdom, 2015), the draft assessment report (DAR) prepared under Directive 91/414/EEC (Germany, 1998) and the renewal assessment report (RAR) and its addendum prepared under Regulation (EU) No 1141/2010 (Germany, 2013, 2015), the Commission review report on glyphosate (European Commission, 2002), the conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate (EFSA, 2015), the JMPR evaluation report (FAO, 2011) as well as the conclusions from previous EFSA opinions on glyphosate (EFSA, 2009, 2012a, 2012b, 2013, 2014). The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation and the Authorisation of Plant Protection Products adopted by Commission Regulation (EU) No 546/ and the currently applicable guidance documents relevant for the consumer risk assessment of pesticide residues (European Commission, 1996, 1997a g, 2000, 2010a, b, 2015; OECD, 2011). 6 Commission Implementing Regulation (EU) No 540/2011 of 23 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, , p 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, , p 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, , p EFSA Journal 2016;14(4):4468

8 1. Method of analysis 1.1. Methods for enforcement of residues in food of plant origin Analytical methods for the determination of glyphosate residues in plant commodities were assessed during the peer review for the renewal of approval, which concluded that glyphosate and N-acetylglyphosate can be enforced at the limit of quantification (LOQ) of 0.05 mg/kg in all commodity groups (EFSA, 2015). The lack of confirmatory method for N-acetyl-glyphosate in high water, high fat content matrices and dry commodities highlighted in the conclusion of the peer review is of no relevance for corn gromwell seeds, which belongs to high oil content group. EFSA concludes that sufficiently validated analytical methods are available to enforce the proposed MRL for glyphosate in borage seeds according to the existing residue definition (glyphosate) and possibly, according to the residue definition proposed during the peer review for the renewal of approval (sum of glyphosate and N-acetyl-glyphosate, expressed as glyphosate) Methods for enforcement of residues in food of animal origin Analytical methods for the determination of residues in food of animal origin are not assessed in the current application since borage and corn gromwell seeds are normally not used as feed items. 2. Mammalian toxicology The toxicological profile of the active substance glyphosate was assessed during the initial peer review under Directive 91/414/EEC (Germany, 1998; European Commission, 2012) and reconsidered in the framework of the peer review for the renewal of the approval (EFSA, 2015). New toxicological reference values for glyphosate were endorsed by the Standing Committee on Plants, Animals Food and Feed (PAFF) in December The toxicological reference values derived for glyphosate are compiled in Table 2. Table 2: Overview of the current and revised toxicological reference values Source Year Value Study Safety factor Glyphosate Current toxicological reference values ADI European mg/kg bw per day Long-term studies, rat 100 ARfD Commission 2012 Not allocated (not necessary) Revised toxicological reference values ADI EFSA mg/kg bw per day Developmental toxicity, rabbit 100 ARfD EFSA mg/kg bw Developmental toxicity, rabbit 100 Toxicological studies on AMPA demonstrated that this metabolite shows a similar toxicological profile to glyphosate and the toxicological reference values of the latter apply. However, data gaps were identified for toxicological information on the metabolites N-acetyl glyphosate and N-acetyl-AMPA, included in the residue definition for risk assessment for the genetically modified (GM) plants containing the GAT 9 modification. It is noted that JMPR established an ADI of 1.0 mg/kg bw per day for the sum of glyphosate, N-acetyl glyphosate, AMPA and N-acetyl-AMPA and considered as unnecessary to set an ARfD (FAO, 2011). 9 GAT: Glyphosate N-acetyltransferase, protein obtained by the introduction of a gene from Bacillus licheniformis, giving rise to N-acetyl glyphosate which denotes no herbicidal activity. 8 EFSA Journal 2016;14(4):4468

9 3. Residues 3.1. Nature and magnitude of residues in plant Primary crops Nature of residues The metabolism of glyphosate in primary crops was re-assessed during the peer review for the renewal of the approval in conventional and glyphosate tolerant crops containing CP4-EPSPS 10 and GOX 11 modifications belonging to different crop groups as well as on GM soyabean, maize and oilseed rape containing the GAT modification. The information available on non-tolerant and glyphosate tolerant primary crop metabolism was peer reviewed by EFSA (EFSA, 2015) and an overview is presented in Table 3. Table 3: Summary of available metabolism studies in plants (conventional crops) Crop groups Crops Applications Sampling Comments Non-tolerant crops Soil or foliar, g/ha 17 wks Mandarin Hydroponic, 10 mg/l solution 1, 2 wks Foliar, 1 4 mg/leaf 1 to 8 wks Almond, Soil, g/ha 16 wks Walnut, Pecan Foliar, mg/leaf 14, 35 DAT Soil, g/ha 6, 12 wks Apple Trunk, mg/plant 8, 14 DAT Foliar, mg/4-5 leaves 1 to 10 wks Fruit Soil, 2 (total 8000 g/ha) 14, 365 DALA Soil, g/ha 7 DAT Soil, g/ha 42, 84 DAT Grape Trunk, mg/plant 42, 84 DAT Hydroponic, 5, 10, 20 or 40 mg/l solution 10, 21, 42 DAT Foliar, 2 (tot 0.03 g/ha) 14 DALA Foliar, , 0.06 or 0.12 mg/plant 1 to 10 wks Avocado Onto the leaf, rate not reported 1.5 wks Supporting Into fruit peduncle, a cpm solution Not reported information Soil, dpm 9 to 128 DAT Supporting Potato Root Foliar, mg/plant 1 to 34 DAT information Sugar beet Soil, g/ha 4, 6, 8 wks Cotton, Soya Soil, g/ha 4, 6, 8 wks Pulses/ bean Hydroponic, equivalent to 2240 g/ha 4, 10, 18 DAT oilseeds Soyabean Hydroponic, 2.4 to 2.65 mg/l solutions 6 to 28 DAT Barley, Oat, Soil, g/ha 4, 6, 8 wks Rice, Sorghum Hydroponic, mg/l solution 7, 14, 28 DAT Cereal Soil, g/ha 4, 6, 8 wks Maize, Wheat Hydroponic, equivalent to 2240 g/ha 4, DAT Hydroponic, 0.6 mg/l solutions 6 to 28 DAT Wheat Foliar, g/ha 7 DAT Soil, g/ha 4, 6, 8 wks Hydroponic, 1.1, 3.6 or 11.1 mg/l solution 21 DAT Coffee Stern application, 700 g solution 5 wks Miscella Foliar, or dpm 4 to 23 wks -neous Soil, g/ha, pre-planting 195, 354 DAT Informative Sugar cane Soil, or 6700 g/ha, post-planting 0, 91, 83 DAT only Foliar, or g/ha, post-emergence 40-42, 44, 47 DAT 10 CP4-EPSPS: Tolerance to glyphosate obtained by the introduction of a gene that code for the expression of a modified 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) protein, insensitive towards glyphosate inhibition. 11 GOX: Glyphosate oxidoreductase, protein obtained by the introduction of a gene acting by breaking down glyphosate to AMPA and glyoxylate which have no herbicidal activity. 9 EFSA Journal 2016;14(4):4468

10 Table 4: Summary of available metabolism studies in plants (glyphosate tolerant crops) Crop groups Crops Applications Sampling Comments Glyphosate tolerant crops modification Foliar, g/ha, BBCH DAT CP4-EPSPS Oilseed Foliar, g/ha, 14 and 22 days after planting 79 DALA or GOX rape Soil, 4500 g/ha pre-emergence g/ha at BBCH 12, 15 and 7 days pre-harvest At BBCH 69, 87, 89 (7 DALA) GAT Pulses/ Soil, g/ha, pre-emergence 56, 84, 104 DAT CP4-EPSPS oilseeds Foliar, or g/ha, BBCH 23 35, 63, 83 DAT Soya bean Foliar, g/ha, BBCH 23 and 51 13, 41, 61 DALA Soil, 3400 g/ha pre-emergence g/ha at BBCH 61, 65, 14 days pre-harvest 36 DAT soil, 82 DAT2, 14 DALA GAT Cotton Foliar, g/ha, BBCH 14 and 51 27, 158 DAT CP4-EPSPS Root Sugar Soil, g/ha, pre-emergence 160 DAT CP4-EPSPS beet Foliar, g/ha, BBCH 14 and DAT Foliar, 2 ca. 900 g/ha, BBCH 16 and 19 3, 49-53, 83 DAT CP4-EPSPS Cereal Maize or GOX Soil, 4300 g/ha pre-emergence g/ha at 48 DATsoil, 59 GAT BBCH 31, 39 and 87 DAT2, 7 DALA Wks: weeks after (last) application, DAT: day after treatment; DAT2, day after 2nd (foliar) treatment, DALA: day after last application, dpm: disintegrations per minute, and cpm, counts per minute, as measurement of radioactivity with no conversion. Conventional and glyphosate tolerant crops containing the CP4-EPSPS and GOX modification showed a similar metabolic pattern with residues mainly composed of the parent glyphosate and its metabolite AMPA. In contrast, in the crops containing the GAT modification the metabolic pathway was different, as the parent compound was extensively metabolised to N-acetyl-glyphosate and its N-acetyl-AMPA metabolite. Based on these studies, the peer review for the renewal of the approval proposed the two following plant residue definitions for monitoring: sum glyphosate and N-acetyl glyphosate expressed as glyphosate for plants with glyphosate tolerant GM varieties available on the market (mostly maize, oilseed rape and soya bean) and considering that glyphosate alone is not an appropriate maker for some GAT-modified plants; glyphosate, for the other plant commodities. Alternatively, a common residue definition for all commodities could also be proposed. The current residue definition set in Regulation (EC) No 396/2005 is glyphosate parent compound. For risk assessment, the residue definition was proposed as: sum glyphosate, N-acetyl glyphosate, AMPA and N-acetyl-AMPA expressed as glyphosate and considering that the N-acetyl glyphosate and N-acetyl-AMPA metabolites are relevant for the tolerant crops containing the GAT modification (EFSA, 2015). For the use on the crop under consideration, EFSA concludes that the metabolism of glyphosate is sufficiently addressed. Since the submitted residue trials were conducted on conventional oilseed rapes and since borage (corn gromwell) glyphosate tolerant plants are not expected to be present on the market, EFSA proposes to maintain the existing residue definition for enforcement limited to glyphosate only and to consider for risk assessment the residue definition as sum glyphosate and AMPA expressed as glyphosate. Both residue definition for enforcement and risk assessment will be reconsidered in the framework of the review of the existing MRLs under Article 12 of Regulation (EC) No 396/2005, already initiated at EFSA level Magnitude of residues In support to the intended use on corn gromwells, residue trials carried out on conventional oilseed rapes in Germany during 1986 and in the United Kingdom between 1988 and 1992 were submitted. In addition to glyphosate, a number of samples was analysed for AMPA, which was never detected above the LOQ of 0.05 mg/kg EFSA Journal 2016;14(4):4468

11 Part of these trials were carried out in single locations using in parallel the same experimental conditions at different application rates (1400 and 1500 g/kg) and the highest residue value within the 25% supported dose rate was selected per location for MRL calculation. EFSA disregarded the results from the trials conducted at non-compliant application rates of glyphosate (namely 72, 2000, 2800/2900 and 5800 g/kg), which were proportionally recalculated to the GAP rate by the EMS (United Kingdom, 2015), since a sufficient number of GAP-compliant trials (± 25% nominal application rate) was submitted. EFSA derived a MRL proposal of 10 mg/kg, extrapolated to borage (corn gromwell) seeds in accordance with the current guidance (European Commission, 2015). The results of the residue trials, the related risk assessment input values (highest residue, median residue) and the MRL proposal are summarised in Table 5. Since AMPA was never quantified in the samples analysed for, it was not possible to derive conversion factors (CF) for risk assessment. Residues of glyphosate and AMPA were found to be stable at 18/20 C for at least 24 months in all matrix types. The samples from the trials conducted in the United Kingdom were stored for a maximum period of 21 months under conditions for which integrity of the samples was demonstrated, whereas no information on the storage of the four trials conducted in Germany is available. Since results were in the range of the other trials, the lack of information is considered as a minor deficiency and accepted. EFSA concludes that the residue data are valid with regard to storage stability. According to the EMS, the analytical methods used to analyse the residue trial samples have been sufficiently validated and were proven to be fit for purpose (United Kingdom, 2015). EFSA concludes that the data are sufficient to derive the following MRL proposal: 10 mg/kg borage (corn gromwell) seeds in NEU (extrapolation from trials on oilseed rapes) 11 EFSA Journal 2016;14(4):4468

12 Table 5: Overview of the available residues trials data Crop (GAP) Oilseed rape ( g/ha, PHI 14 days) Region/ Indoor (a) Residue levels observed in the supervised residue trials (b) (mg/kg) NEU Mo: 0.06; 0.3; 0.3; 2 0.4; 0.04; 0.6; 0.7; 0.9; 1.0; 1.3; 2.8; 5.1; 6.8 RA: 0.11; 0.35; 0.35; ; 0.045; 0.65; 0.75; 0.95; 1.05; 1.35; 2.85; 5.15; 6.85 Recommendations/comments (c) Underlined values: samples with no information on storage conditions. AMPA: 5 < 0.05 mg/kg. For RA, it is assumed that AMPA residues were < 0.05 mg/kg also on the samples not analysed for. MRL OECD : 0.9.6/10.0 Extrapolation to borage seeds (corn gromwell seeds) MRL proposal (mg/kg) HR (d) (mg/kg) 10 (6.80) (a): NEU: Outdoor trials conducted in northern Europe, SEU: Outdoor trials conducted in southern Europe, Indoor: indoor EU trials or Country code: if non-eu trials. (b): Individual residue levels considered for MRL calculation are reported in ascending order. Mo: residue level according to the monitoring residue definition: glyphosate (conventional crops). RA: residue level according to the residue definition for risk assessment: sum glyphosate and AMPA expressed as glyphosate (conventional crops). (c): Any information/comment supporting the decision and OECD MRL calculation (unrounded/rounded values). (d): HR: Highest residue level according to the residue definition for risk assessment (within brackets: HR Mo; highest residue according to the monitoring residue definition). (e): STMR: Median residue level according to residue definition for risk assessment (within brackets: STMR Mo; median residue according to the monitoring residue definition) STMR (e) (mg/kg) (0.65) EFSA Journal 2016;14(4):4468

13 Effect of industrial processing and/or household preparation Standard hydrolysis studies simulating the effect on the nature of glyphosate residues under processing conditions representative of pasteurisation, boiling and sterilisation showed that glyphosate is hydrolytically stable under the standard conditions. Thus, for processed commodities, the same residue definition as for raw agricultural commodities (RAC) is applicable (EFSA, 2015). Studies investigating the effect of processing on the magnitude of glyphosate residues in processed rapeseeds were assessed in the conclusion on the peer review for the renewal of the approval and processing factors (PF) of 0.14 for crude oil and 0.13 for refined oil were proposed for glyphosate but CF for risk assessment could not be calculated (EFSA, 2015). Additional studies were not provided in the framework of this MRL application and are not requested due to the insignificant contribution of corn gromwell seeds to the total theoretical maximum daily intake (TMDI) Rotational crops Corn gromwells can be grown in rotation with other plants and therefore the possible occurrence of residues in succeeding crops resulting from the use on primary crops has to be assessed. The soil degradation studies demonstrated that the degradation rate of glyphosate is moderate with a maximum field DT 90 of 163 days (EFSA, 2015), above the trigger value of 100 days. Thus, further studies investigating the nature and magnitude of the compound uptake in rotational crops are required (European Commission, 1997c). Studies on the nature and magnitude of glyphosate residues in rotational crops were assessed in the framework of the peer review for the renewal of the approval and it was concluded that the metabolism in rotational crops is similar to the metabolism in primary crops and that significant residues of glyphosate or AMPA are not expected in rotational crops when the active substance is applied on primary crops up to a total annual dose rate of 2160 g/ha (EFSA, 2015). Since the application rate for the crop under consideration in this MRL application is limited to a maximum of 1440 g/ha (0.65N the maximum rate tested in the rotational crop studies), EFSA concludes that residues are not expected to be present in rotational crops, provided that the active substance is applied to corn gromwells according to the proposed GAP Nature and magnitude of residues in livestock As the crop under consideration is normally not fed to livestock, the nature and magnitude of glyphosate residues in livestock is not assessed in the framework of this application (European Commission, 1996). 4. Consumer risk assessment The consumer risk assessment was performed with revision 2 of the EFSA PRIMo. This exposure assessment model contains the relevant European food consumption data for different sub-groups of the EU population 12 (EFSA, 2007). To calculate the chronic exposure, EFSA updated the latest risk assessment conducted in a previous EFSA reasoned opinion (EFSA, 2013) with the STMR derived for borage seeds from the residue trials reported in Table 5 and for sweet corns and sugar beet roots from adopted CXLs (EFSA, 2012b). This long-term exposure should be regarded as preliminary and will be further refined in the framework of the Article 12 MRL review, when full information on authorised uses supported by data will be available to EFSA. The input values used for the dietary exposure calculation are summarised in Table The calculation of the long-term exposure (chronic exposure) is based on the mean consumption data representative for 22 national diets collected from MS surveys plus 1 regional and 4 cluster diets from the WHO GEMS Food database; for the acute exposure assessment the most critical large portion consumption data from 19 national diets collected from Member States surveys are used. The complete list of diets incorporated in EFSA PRIMo is given in its reference section (EFSA, 2007) EFSA Journal 2016;14(4):4468

14 Table 6: Input values for the consumer dietary exposure assessment Commodity Input (mg/kg) Chronic exposure assessment Comment Acute exposure assessment Input (mg/kg) Comment Risk assessment residue definition: Sum glyphosate, AMPA and expressed as glyphosate (conventional crops) Borage seeds 0.7 STMR (see Table 5) 6.9 HR (see Table 5) Sweet corn (a) 0.3 STMR (FAO, 2011, EFSA, 2012b) Acute risk assessment undertaken with Sugar beet roots (a) 3.4 STMR (FAO, 2011, EFSA, 2012b) the crop under consideration using the ARfD proposed during the peer review (EFSA, 2015). Other plant and animal commodities See Table 4.1 of the Reasoned opinion on the import tolerance for glyphosate in genetically modified oilseed rape (EFSA, 2013). (a): Glyphosate tolerant crops containing the EPSPS gene (EFSA, 2012b). The estimated exposure was then compared with the toxicological reference value derived for glyphosate currently in force (Table 2). The results of the intake calculation using the EFSA PRIMo is a key supporting document and is made publicly available as a background document to this reasoned opinion. A long-term consumer intake concern was not identified for any of the European diets incorporated in the EFSA PRIMo. The total chronic intake calculated accounted for up to 47% of the ADI of 0.3 mg/kg bw per day (WHO Cluster diet B). Since consumption data for this minor oilseed are not reported in the PRIMo model, its contribution to the total consumer exposure could not be estimated. With regard to the revised toxicological reference values (EFSA, 2015), the chronic risk assessment conducted with the current ADI covers the revised ADI, which value is significantly higher. In anticipation to the entry into force of the ARfD, EFSA performed the acute consumer exposure assessment using consumption data reported for another minor oilseed, safflower seed (as stated, no consumption data are available for borage seeds) and the HR of 6.9 mg/kg (see Table 5). Based on this conservative estimation, the maximum acute exposure for the intended use on corn gromwell represented 5% of the ARfD of 0.5 mg/kg bw. EFSA concludes that the proposed use of glyphosate on corn gromwells will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk. Conclusions and recommendations The information submitted was sufficient to propose the MRL summarised in the table below: Code (a) Commodity Existing EU MRL (mg/kg) Proposed EU MRL (mg/kg) Comment/justification Enforcement residue definition: Glyphosate (conventional plants) Borage seeds (corn gromwell seeds) (a): Commodity code number according to Annex I of Regulation (EC) No 396/ Supported by extrapolation from NEU trials on oilseed rapes 14 EFSA Journal 2016;14(4):4468

15 References EFSA (European Food Safety Authority), Reasoned opinion on the potential chronic and acute risk to consumers health arising from proposed temporary EU MRLs. EFSA Journal 2007;5(3):32r, 1141 pp. doi: /j.efsa r EFSA (European Food Safety Authority), Reasoned opinion on the modification of the residue definition of glyphosate in genetically modified maize grain and soybeans, and in products of animal origin. EFSA Journal 2009;7(9):1310, 42 pp. doi: /j.efsa EFSA (European Food Safety Authority), 2012a. Reasoned opinion on the modification of the existing MRL for glyphosate in lentils. EFSA Journal 2012;10(1):2550, 25 pp. doi: /j.efsa EFSA (European Food Safety Authority), 2012b. Scientific support for preparing an EU position in the 44th Session of the Codex Committee on Pesticide Residues (CCPR). EFSA Journal 2012;10(7):2859, 155 pp. doi: /j.efsa EFSA (European Food Safety Authority), Reasoned opinion on the import tolerance for glyphosate in genetically modified oilseed rape. EFSA Journal 2013;11(11):3456, 30 pp. doi: /j.efsa EFSA (European Food Safety Authority), Scientific support for preparing an EU position in the 46th Session of the Codex Committee on Pesticide Residues (CCPR). EFSA Journal 2014;12(7):3737, 182 pp. doi: /j.efsa EFSA (European Food Safety Authority), Conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate. EFSA Journal 2015;13(11):4302, 107 pp., doi: /j.efsa European Commission, Appendix G. Livestock Feeding Studies. 7031/VI/95-rev.4. European Commission, 1997a. Appendix A. Metabolism and distribution in plants. 7028/IV/95-rev.3. European Commission, 1997b. Appendix B. General recommendations for the design, preparation and realisation 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. European Commission, 1997c. Appendix C. Testing of plant protection products in rotational crops. 7524/VI/95-rev.2. European Commission, 1997d. Appendix E. Processing studies. 7035/VI/95-rev.5. European Commission, 1997e. Appendix F. Metabolism and distribution in domestic animals. 7030/VI/95-rev.3. European Commission, 1997f. Appendix H. Storage stability of residue samples. 7032/VI/95-rev.5. European Commission, 1997g. Appendix I. Calculation of maximum residue level and safety intervals. 7039/VI/95. European Commission, 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. European Commission, Review report for the active substance glyphosate. Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 29 June 2001 in view of the inclusion of glyphosate in Annex I of Council Directive 91/414/EEC. Glyphosate 6511/VI/99- final, 21 January 2002, 56 pp. 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 March European Commission, 2010b. Residue analytical methods. For post-registration control. SANCO/825/00-rev EFSA Journal 2016;14(4):4468

16 European Commission, Appendix D. Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs. 7525/VI/95-rev FAO (Food and Agriculture Organization of the United Nations), 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), Glyphosate. In: Pesticide residues in food 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 211, Germany, Draft assessment report on the active substance glyphosate prepared by the rapporteur Member State Germany in the framework of Council Directive 91/414/EEC. December Germany, Renewal assessment report on the active substance glyphosate prepared by the rapporteur Member State Germany in the framework of Commission Regulation (EU) No 1141/2010, December Available online: Germany, Final addendum to the renewal assessment report on the active substance glyphosate prepared by the rapporteur Member State Germany in the framework of Commission Regulation (EU) No 1141/2010, October Available online: OECD (Organisation for Economic Co-operation and Development), OECD MRL calculator: spreadsheet for single data set and spreadsheet for multiple data set, 2 March In: Pesticide Publications/Publications on Pesticide Residues. Available online: United Kingdom, Evaluation report on modification of MRLs for glyphosate in corn gromwell seeds prepared by the evaluating Member State United Kingdom under Article 8 of Regulation (EC) No 396/2005, 20 November 2015, 63 pp EFSA Journal 2016;14(4):4468

17 Abbreviations a.s. ADI ARfD BBCH bw CAC CF CIPAC CXL DALA DAR DAT DT 90 EMS FAO GAP GCPF GM HR ISO IUPAC JMPR LOQ MRL NEU OECD PAFF PF PHI PRIMo RAC RAR RMS SANCO SL active substance acceptable daily intake acute reference dose growth stages of mono- and dicotyledonous plants body weight Codex Alimentarius Commission conversion factor for enforcement to risk assessment residue definition Collaborative International Pesticide Analytical Council Codex maximum residue limit days after last application draft assessment report days after treatment period required for 90 % dissipation (define method of estimation) evaluating Member State Food and Agriculture Organization of the United Nations Good Agricultural Practice Global Crop Protection Federation (formerly International Group of National Associations of Manufacturers of Agrochemical Products (GIFAP)) Genetically modified highest residue International Organization for Standardization International Union of Pure and Applied Chemistry Joint FAO/WHO Meeting on Pesticide Residues limit of quantification maximum residue level northern Europe Organisation for Economic Co-operation and Development Standing Committee on Plants, Animals, Food and Feed (formerly: Standing Committee on the Food Chain and Animal Health; SCFCAH) processing factor pre-harvest interval (EFSA) Pesticide Residues Intake Model raw agricultural commodity renewal assessment report rapporteur Member State European Commission s Directorate-General for Health and Consumers soluble concentrate 17 EFSA Journal 2016;14(4):4468

18 STMR TMDI WHO wks supervised trials median residue theoretical maximum daily intake World Health Organization week(s) 18 EFSA Journal 2016;14(4):4468

19 Appendix A Good Agricultural Practice (GAPs) Crop and/or situation (a) Corn gromwells MS or NEU/SEU or Country F G or I (b) Pest or group of pests controlled (c) Formulation Application Application rate per treatment type (d-f) NEU F Weeds SC conc. a.s. (i) 480 g/l Method kind (f-h) Vehicle mounted hydraulic sprayer Growth stage & season (j) Seed: <30% moisture Number min-max (k) Interval minmax g/hl min-max Water L/ha min-max g/ha min-max PHI (days) (l) Remarks (m) Remarks: (a) For crops, EU or other classifications, e.g. Codex, should be used; where relevant, the usage situation should be described (e.g. fumigation of a structure) (b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) (c) e.g. biting and sucking insects, soil-born insects, foliar fungi, weeds (d) e.g. wettable powder (WP), water soluble granule (WG) (e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 (f) all abbreviations must be explained (g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants. type of equipment used must be indicated (i) (j) (k) (l) (m) g/kg or µg/l Growth stage at last treatment (Meier U, Growth Stages of mono- and dicotyledonous plants. BBCH Monograph, 2nd Ed., Federal Biological Research Centre of Agriculture and Forestry, Braunschweig, Germany, 2001), including where relevant, information on season at time of application The minimum and maximum number of application possible under practical conditions of use must be provided PHI - minimum pre-harvest interval Remarks may include: Extent of use/economic importance/restrictions 19 EFSA Journal 2016;14(4):4468

20 Modification of the existing MRLs for glyphosate in borage corn and gromwell seeds Appendix B Used compound codes Code/Trivial name Chemical name Structural formula glyphosate N-acetyl-glyphosate AMPA N-acetyl-AMPA N-(phosphonomethyl)glycine N-acetyl-N-(phosphonomethyl)glycine (aminomethyl)phosphonic acid (acetamidomethyl)phosphonic acid HO O OH O N H 2 NH O CH 3 N O P O P O OH O OH P OH OH OH OH O P OH NH HO H 3 C 20 EFSA Journal 2016;14(4):4468