Review of the existing maximum residue levels for chlormequat according to Article 12 of Regulation (EC) No 396/2005

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1 REASONED OPINION APPROVED: 24 February 2016 PUBLISHED: 7 March 2016 doi: /j.efsa Review of the existing maximum residue levels for chlormequat according to Article 12 of Regulation (EC) No 396/2005 Abstract European Food Safety Authority (EFSA) 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 chlormequat. In order to assess the occurrence of chlormequat 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 (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers. European Food Safety Authority, 2016 Keywords: chlormequat, MRL review, Regulation (EC) No 396/2005, consumer risk assessment, quaternary ammonium, plant growth regulator Requestor: European Commission Question number: EFSA-Q Correspondence: pesticides.mrl@efsa.europa.eu EFSA Journal 2016;14(3):4422

2 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), Reasoned opinion on the review of the existing maximum residue levels for chlormequat according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2016;14(3):4422, 47 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(3):4422

3 Summary Chlormequat was included in Annex I to Directive 91/414/EEC on 1 December 2009 by Commission Directive 2009/37/EC, amended by Commission Directive 2010/2/EU, and has been deemed to be approved under Regulation (EC) No 1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011. As the active substance was approved after the entry into force of Regulation (EC) No 396/2005 on 2 September 2008, EFSA is required to provide a reasoned opinion on the review of the existing MRLs for that active substance in compliance with Article 12(1) of the aforementioned regulation. In order to collect the relevant pesticide residues data, EFSA asked the United Kingdom, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile) and to prepare a supporting evaluation report. The PROFile and evaluation report provided by the RMS were made available to the Member States. A request for additional information was addressed to the Member States in the framework of a completeness check period which was initiated by EFSA on 24 June 2015 and finalised on 11 September After having considered all the information provided, EFSA prepared a completeness check report which was made available to Member States on 13 October Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission and the additional information provided by the RMS and Member States, EFSA prepared in December 2015 a draft reasoned opinion, which was circulated to Member States for consultation via a written procedure. Comments received by 3 February 2016 were considered during the finalisation of this reasoned opinion. The following conclusions are derived. The metabolism of chlormequat chloride has been investigated in cereals as well as in rotational crops. A similar metabolism was depicted in these studies with chlormequat being the only relevant compound identified. Hydrolysis studies simulating beer brewing (100 C, ph 4 for 120 minutes) and bread making (100 C, ph 5 for 40 minutes) showed that processing conditions relevant for cereals are not expected to degrade the parent compound significantly but a general residue definition for processed commodities could not be derived in the absence of standard hydrolysis studies. Therefore, a residue definition for cereal crops for monitoring and risk assessment was proposed as the sum of chlormequat and its salts, expressed as chlormequat chloride. The residue definition derived for cereals was also deemed appropriate for pears and cultivated fungi where carry-over of unchanged parent compounds may occurs. A validated analytical method for this residue definition in high water content, dry commodities and cereal straw is available. The available residue trials data were considered sufficient to derive MRL proposals as well as risk assessment values for all primary crops under evaluation, except for grass which residue trials were not available. Based on the metabolism studies, no significant residues levels of chlormequat are expected in the investigated rotational crops (cereals, roots, pulses and oilseeds and leafy crops), the main part of the radioactivity being incorporated in the plant matrix. However, EFSA derived MRLs proposals in order to cover unintentional carry-over of residues in pears (due to former uses) and cultivated fungi (grown on substrate composed of cereals straw treated with chlormequat). Different options for MRLs were derived on the basis on monitoring data and different methodologies. A risk management decision should still be taken on the level of these MRLs and the period of their applicability. In addition, studies investigating the magnitude of residues in processed commodities of wheat, barley and oats allowed EFSA to derive robust processing factors for wheat (bran, flour and bread), barley (pot/pearl, malt and beer) and oat flakes. Chlormequat is authorised for use in cereals which might be fed to livestock. The metabolism of chlormequat was investigated in lactating goats and laying hens. As metabolic pathways are expected to be similar in ruminants and pigs, the results of the goat metabolism study could be extrapolated to swine. From these studies, EFSA proposed a general residue definition for monitoring and risk assessment in livestock commodities as the sum of chlormequat and its salts, expressed as chlormequat chloride. A validated analytical method for enforcement of the proposed residue definition in commodities of animal origin is available. Based on the available feeding studies for ruminants and poultry, MRLs and risk assessment values were derived in ruminants, swine and poultry products. 3 EFSA Journal 2016;14(3):4422

4 Chronic and acute consumer exposure resulting from the authorised uses reported in the framework of this review and the possible carry-over in non-treated pears and cultivated fungi (considering the most protective assumption) was calculated using revision 2 of the EFSA PRIMo. The highest chronic exposure represented 28.9% of the ADI (Danish children) and the highest acute exposure amounted to 33.1% of the ARfD (wheat). Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs have also been established for chlormequat. Additional calculations of the consumer exposure, considering these CXLs, were therefore carried out and the highest chronic exposure represented 29.3% of the ADI (Danish children) and the highest acute exposure amounted to 62.3% of the ARfD (milk and milk products). 4 EFSA Journal 2016;14(3):4422

5 Table of contents Abstract... 1 Summary... 3 Background... 6 Terms of reference... 7 The active substance and its use pattern... 7 Assessment Residues in plants Nature of residues and methods of analysis in plants Nature of residues in primary crops Nature of residues in rotational crops Nature of residues in processed commodities Methods of analysis in plants Stability of residues in plants Proposed residue definitions Magnitude of residues in plants Magnitude of residues in primary crops Magnitude of residues in rotational crops and carry-over in specific crops Magnitude of residues in cereals grown in rotation Carry -over of residues in pears due to former authorised uses Carry-over of residues in cultivated fungi grown on cereals straw Magnitude of residues in processed commodities Proposed MRLs Residues in livestock Nature of residues and methods of analysis in livestock Magnitude of residues in livestock Consumer risk assessment Consumer risk assessment without consideration of the existing CXLs Consumer risk assessment with consideration of the existing CXLs Conclusions Recommendations References Abbreviations Appendix A Summary of authorised uses considered for the review of MRLs Appendix B List of end points Appendix C Input values for the exposure calculations Appendix D Decision tree for deriving MRL recommendations Appendix E Used compound code(s) Appendix F Overview of the monitoring data used for deriving MRLs EFSA Journal 2016;14(3):4422

6 Background Regulation (EC) No 396/ establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. Article 12(1) of that Regulation stipulates that EFSA shall provide within 12 months from the date of the inclusion or non-inclusion of an active substance in Annex I to Directive 91/414/EEC 2 a reasoned opinion on the review of the existing MRLs for that active substance. Chlormequat was included in Annex I to Council Directive 91/414/EEC on 1 December 2009 by means of Commission Directive 2009/37/EC 3 (amended by Commission Directive 2010/2/EU 4 ), and has been deemed to be approved under Regulation (EC) No 1107/2009, 5 in accordance with Commission Implementing Regulation (EU) No 540/ (amended by Commission Implementing Regulation (EU) No 541/ ). Therefore, EFSA initiated the review of all existing MRLs for that active substance. 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. The United Kingdom, as designated rapporteur Member State (RMS) in the framework of Directive 91/414/EEC, was asked to complete the PROFile for chlormequat and to prepare a supporting evaluation report (United Kingdom, 2011). The PROFile and the supporting evaluation report were submitted to EFSA on 24 June 2011 and made available to the Member States. A request for additional information was addressed to the Member States in the framework of a completeness check period which was initiated by EFSA on 24 June 2015 and finalised on 11 September Additional evaluation reports were submitted by Austria, France, Greece, Italy, Sweden and the United Kingdom (Austria, 2015; France, 2015; Greece, 2015; Italy, 2015; Sweden, 2015; United Kingdom, 2015) and after having considered all the information provided by RMS and Member States, EFSA prepared a 1 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, , p Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market. OJ L 230, , p Repealed by Regulation (EC) No 1107/ Commission Directive 2009/37/EC of 23 April 2009 amending Council Directive 91/414/EEC to include chlormequat, copper compounds, propaquizafop, quizalofop-p, teflubenzuron and zeta-cypermethrin as active substances. OJ L 104, , p Commission Directive 2010/2/EU of 27 January 2010 amending Council Directive 91/414/EEC as regards an extension of the use of the active substance chlormequat. OJ L 24, , 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 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, , p Commission Implementing Regulation (EU) No 541/2011 of 1 June 2011 amending Implementing Regulation (EU) No 540/2011 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 EFSA Journal 2016;14(3):4422

7 completeness check report which was made available to all Member States on 13 October Further clarifications were sought from Member States via a written procedure in November Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission and the additional information provided by the Member States, EFSA prepared in December 2015 a draft reasoned opinion, which was submitted to Member States for commenting via a written procedure. All comments received by 3 February 2016 were evaluated and considered by EFSA during the finalisation of the reasoned opinion. The evaluation reports submitted by the RMS (United Kingdom, 2011, 2015), and the evaluation reports submitted by Member States France, Greece, Italy, and Sweden (France, 2015; Greece, 2015; Italy, 2015; Sweden, 2015) are considered as supporting documents to this reasoned opinion and, thus, are made publicly available. In addition, key supporting documents to this reasoned opinion are the completeness check report (EFSA, 2015b) and the Member States consultation report (EFSA, 2016). These reports are developed to address all issues raised in the course of the review, from the initial completeness check to the reasoned opinion. Also the chronic and acute exposure calculations for all crops reported in the framework of this review performed using the EFSA Pesticide Residues Intake Model (PRIMo) are key supporting documents and made publicly available. Considering the importance of the completeness check and consultation report, all documents are considered as background documents to this reasoned opinion and, thus, are made publicly available. 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 Chlormequat is the ISO common name for 2-chloroethyltrimethylammonium (IUPAC). Chlormequat belongs to the group of quaternary ammonium compounds which are used as plant growth regulators. Chlormequat acts as an inhibitor of the biosynthesis of gibberellins. It is absorbed and translocated throughout the plant. Chlormequat is a growth retardant used on cereals to reduce unwanted longitudinal shoot growth without lowering plant productivity. The chemical structure of the active substance and its main metabolites are reported in Appendix E. Chlormequat was evaluated in the framework of Directive 91/414/EEC with the United Kingdom designated as rapporteur Member State (RMS). The representative uses supported for the peer review process were foliar spraying applications with conventional spraying devices on winter and spring wheat, winter and spring barley, triticale, durum wheat, spelt wheat, rye and oats. Following the peer review, which was carried out by EFSA, a decision on inclusion of the active substance in Annex I to Directive 91/414/EEC was published by means of Commission Directive 2009/37/EC which entered into force on 1 December 2009 and was amended by Commission Directive 2010/2/EU. According to Regulation (EU) No 540/2011, chlormequat is deemed to have been approved under Regulation (EC) No 1107/2009. This approval is restricted to uses as plant growth regulator only. The EU MRLs for chlormequat are established in Annexes II and IIIB of Regulation (EC) No 396/2005 and CXLs for active substance were also established by the Codex Alimentarius Commission (CAC). An overview of the MRL changes that occurred since the entry into force of the Regulation mentioned above is provided below. 7 EFSA Journal 2016;14(3):4422

8 Table 1: Overview of the MRL changes since the entry into force of Regulation (EC) No 396/2005 Procedure Legal implementation Remarks MRL application (EFSA, 2009) (EC) No 822/2009 (a) Modification of existing MRL in pears MRL application (EFSA, 2014a) (EU) No 737/2014 (b) Modification of existing MRLs in pears, cereals and commodities of animal origin (a): Commission Regulation (EC) No 822/2009 of 27 August 2009 amending Annexes II, III and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for azoxystrobin, atrazine, chlormequat, cyprodinil, dithiocarbamates, fludioxonil, fluroxypyr, indoxacarb, mandipropamid, potassiu Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for azoxystrobin, atrazine, chlormequat, cyprodinil, dithiocarbamates, fludioxonil, fluroxypyr, indoxacarb, mandipropamid, potassium tri-iodide, spirotetramat, tetraconazole, and thiram in or on certain products. OJ L 239, , p (b): Commission Regulation (EU) No 737/2014 of 24 June 2014 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for 2-phenylphenol, chlormequat, cyflufenamid, cyfluthrin, dicamba, fluopicolide, flutriafol, fosetyl, indoxacarb, isoprothiolane, mandipropamid, metaldehyde, metconazole, phosmet, picloram, propyzamide, pyriproxyfen, saflufenacil, spinosad and trifloxystrobin in or on certain products. OJ L 155, , p For the purpose of this MRL review, the critical uses of chlormequat currently authorised within the EU have been collected by the RMS and reported in the PROFile. The additional GAPs reported by Member States during the completeness check were also considered. The details of the authorised GAPs for chlormequat are given in Appendix A. The RMS did not report any use authorised in third countries that might have a significant impact on international trade. Assessment EFSA has based its assessment on the PROFile submitted by the RMS, the evaluation report accompanying the PROFile (United Kingdom, 2011), the draft assessment report (DAR) and its addendum prepared under Council Directive 91/414/EEC (United Kingdom, 2007, 2008), the conclusion on the peer review of the pesticide risk assessment of the active substance chlormequat (EFSA, 2009, 2014b), the JMPR Evaluation report (FAO, 2010), the previous reasoned opinions on chlormequat (EFSA, 2009, 2014a) as well as the evaluation reports submitted during the completeness check (Austria, 2015; France, 2015; Greece, 2015; Italy, 2015; Sweden, 2015; United Kingdom, 2015). The assessment is performed in accordance with the legal provisions of the uniform principles for evaluation and authorisation of plant protection products as set out in Commission Regulation (EU) No 546/ and the currently applicable guidance documents relevant for the consumer risk assessment of pesticide residues (European Commission, 1996, 1997a- 1997g, 2000, 2010a, 2010b, 2011 and OECD, 2011). More detailed information on the available data and on the conclusions derived by EFSA can be retrieved from the list of end points reported in Appendix B. 1. Residues in plants 1.1. Nature of residues and methods of analysis in plants Nature of residues in primary crops The metabolism of chlormequat chloride in cereals was evaluated in the framework of the peer review under Directive 91/414/EEC. During the peer review, there were discussions on whether this study (with application at growth stage BBCH 71) was representative for the authorised uses where applications can be made between BBCH 30 and 49. This was deemed acceptable considering that the 8 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(3):4422

9 PHI of 118 days for grain and straw was long enough to enable a representative degradation of the parent compound in the different parts of the crop. The metabolism study demonstrated that chlormequat is the main compound identified in straw (78-81 % TRR; mg/kg) and grain (28-30 % TRR; mg/kg). To a minor extent, oxidation into betain has also been shown in straw and grain (3-5 % TRR; 0.05 mg eq/kg). Betain is found in biochemical pathways of the body and is of no toxicological concern. Residues, incorporated mainly in the lignin fraction (for grain and straw) and the starch fraction (in grain), have also been found Nature of residues in rotational crops Two rotational crop studies using radishes, carrots, lettuce, wheat and green beans were assessed during the peer review (EFSA, 2008). The treatments were made on bare soil at application rates covering the critical good agricultural practices (GAPs) reported in this review: 1.3N in the first study and 1N in the second study. For both studies, residues levels in radishes, carrots, lettuce and beans were low; the maximum total radioactivity was observed in radish roots (0.037 mg eq/kg) after 1.3N rate and remained below 0.01 mg/kg after 1N rate. However, significant levels of radioactivity were found in wheat after a 1.3N-rate treatment with 0.34 mg eq/kg in straw and 0.20 mg eq/kg in grain. In the second study performed at 1N rate, the total residues uptake was lower but still significant with mg eq/kg in grain and mg eq/kg in straw. During the peer review, it has been noted that the results of the first and the second study were considerably different and further clarification was required. This issue has been solved in the framework of previous MRL application where these discrepancies were explained by the different ways of preparing soil to simulate ploughing in the second study (EFSA, 2014a). Further identification of the metabolites was attempted in the samples of the first study (lettuce, radish and wheat). It was concluded that the residues was composed of low levels chlormequat and of unidentified polar peeks, mainly corresponding to incorporation into the matrix. Therefore, the metabolic pattern in rotational crops was not found to differ from the primary crop metabolism and a specific residue definition was not deemed necessary (EFSA, 2008) Nature of residues in processed commodities The effect of processing on the nature of chlormequat chloride was investigated in the framework of the peer review in studies simulating beer brewing (100 C, ph 4 for 120 minutes) and bread making (100 C, ph 5 for 40 minutes) (EFSA, 2008). Under both conditions a decline of 9-14 % of the AR and a formation of four minor degradation products was observed. All degradation products were individually below 5 % of the applied radioactivity and a further characterisation was not undertaken. EFSA concluded that for the processing conditions relevant for cereals, the parent compound will be the main residue of concern in processed commodities and therefore the same residue definition as in raw commodity is applicable. Nevertheless, in order to derive a general residue definition for processed commodities, additional studies investigating the nature of chlormequat under sterilisation and pasteurization conditions would be needed Methods of analysis in plants During the peer review, an analytical method using HPLC with tandem mass spectrometry detection (HPLC-MS/MS) was validated for the determination of chlormequat in dry commodities (cereal grain) and high water content commodities (apple and cereal forage) with an LOQ of 0.05 mg/kg (as chlormequat chloride). This method was also validated for enforcement in cereals straw with an LOQ of 0.5 mg/kg (as chlormequat chloride). An independent laboratory validation is also available for these matrices and as the method was validated for to different mass transitions, a confirmatory method is not required (EFSA, 2008) Stability of residues in plants During the peer review, storage stability of chlormequat was demonstrated for a period of 24 months at 18 C in dry commodities (wheat grain) and in wheat straw (EFSA, 2008). In the same framework, other studies also demonstrated the stability of chlormequat in processed commodities of cereals (bran, whole grain bread, malt and beer) for a period of 13 months at 18 C. 9 EFSA Journal 2016;14(3):4422

10 Proposed residue definitions The peer review concluded that the residue definition in cereals for enforcement and risk assessment shall be set as the sum of chlormequat and its salts, expressed as chlormequat-chloride (EFSA, 2008). The residue definition which was established in Regulation (EC) No 396/2005 was set as chlormequat (calculated as cation). In the framework of the present review, EFSA confirms that the initial proposal should be implemented to express the residues as chlormequat-chloride, which is in line with the toxicological reference values. This residue definition is limited to cereals. Metabolism studies are not available for fruits and mushrooms. There are no authorised GAPs for these crops but chlormequat residues in pears and mushrooms need to be carefully assessed in the framework of the MRL review due to the carry-over from soil to pears and to the potential transfer from cereals to cultivated fungi. The carry-over in pears was only observed for the unchanged parent compound and seems to be caused by the slow degradation and subsequent accumulation of parent chlormequat in the stem of the trees (EFSA, 2014a). In addition, the nature of residues in rotational was found to be similar as in primary crops. Therefore, the uptake of chlormequat in cultivated fungi is not expected to affect the nature of the residues in this crop. A similar case was assessed for mepiquat and the residue definition (unchanged parent compound) which was proposed for other crops was extended to fungi as well (EFSA, 2015a). Therefore, the residue definition derived for cereals is also deemed appropriate for pears and cultivated fungi Magnitude of residues in plants Magnitude of residues in primary crops To assess the magnitude of chlormequat residues resulting from the reported GAPs, EFSA considered all residue trials reported in the framework of the peer review (EFSA, 2008) or in the framework of a previous MRL application (EFSA, 2014a) and additional data submitted during the completeness check (France, 2015; Greece, 2015; Italy, 2015). All residue trial samples considered in this framework were stored in compliance with the conditions for which storage stability was demonstrated. Decline of residues during storage of the trial samples is therefore not expected. 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 (European Commission, 2011). Residue trials on barley, oats, rye and wheat show that residue levels may differ considerably in the different cereals, even for similar GAPs (e.g. oats and rye). This behaviour has already been observed for other plant growth regulator and was also highlighted during the peer review of chlormequat (EFSA, 2008). Therefore, the GAPs authorised on barley, oats, rye and wheat are evaluated independently, although they could have been assessed together according to the extrapolation rules. The available data on barley, oats, rye and wheat are sufficient to derive MRL and risk assessment values for these crops but the following considerations were made by EFSA: For barley (northern zone) and wheat (northern and southern zone), the GAP reported by France (1x0.6 kg as/ha at BBCH 49) was identified as the critical GAP based on the residue levels observed in grains. This GAP was therefore considered to derive MRLs in barley and wheat grains. For straw however, the GAPs reported by Austria and the United Kingdom for the northern zone (1x1.5 kg as/ha at BBCH 37), and by Italy and Greece for the southern zone (1x1.5 kg as/ha at BBCH 32), were found to induce higher residue levels than the French GAP. Therefore, these GAPs were considered to derive MRLs in barley and wheat straw. Barley grain: the number of residue trials supporting the northern GAP is not compliant with the data requirements for this crop (6 trials instead of 8). Although appropriate MRL and risk assessment values can be derived from the southern GAP, 2 additional trials compliant with the northern GAP are still required. Oats (grain and straw): the number of residue trials supporting the southern GAP is not compliant with the data requirements for this crop (7 trials instead of 8). Although appropriate MRL and risk assessment values can be derived from the northern GAP (which is also more 10 EFSA Journal 2016;14(3):4422

11 critical), 1 additional trial compliant with the southern GAP is still deemed desirable (minor deficiency). Rye (grain and straw): the number of residue trials supporting the southern GAP is not compliant with the data requirements for this crop (7 trials instead of 8). Although appropriate MRL and risk assessment values can be derived, 1 additional trial compliant with the southern GAP is still deemed desirable (minor deficiency). Wheat (straw): the number of residue trials supporting the northern GAP is not compliant with the data requirements for this crop (7 trials instead of 8). Although appropriate MRL and risk assessment values can be derived, 1 additional trial compliant with the northern GAP is still deemed desirable (minor deficiency). A GAP on grass (for seed production only) is authorised in Sweden. Residue trials are not available to support this GAP and EFSA made the following consideration: Grass: Normally, EFSA does not consider uses on seed production to derive MRL because significant residues in crops grown after are usually not expected. Nevertheless, considering that chlormequat is a systemic active substance which also shows unexpected behaviour in cereals (see above), possible occurrence of residues in grass is not excluded in this particular case. Therefore, EFSA is of the opinion that this issue should be assessed properly by means of additional residues trials compliant with this GAP (minimum 4 trials) Magnitude of residues in rotational crops and carry-over in specific crops There are no studies investigating the magnitude of residue in rotational crops. However, the metabolism studies provided quantitative information on residues uptake in the different crops investigated (see section 1.1.2). Based on these studies, the experts concluded that residues uptake of chlormequat in rotational crops may only occur in cereals, all other crops being out of concerns (EFSA, 2008). In addition to residues uptakes in cereals planted as rotational crops, EFSA also assessed residue uptake of chlormequat resulting from other specific situations: residues in pears carried over from former authorised uses and residues in cultivated fungi grown on cereals straw Magnitude of residues in cereals grown in rotation The two available metabolism studies, respectively performed at 1.3 and 1N rate, indicate that the total radioactivity in rotated cereals might be significant. However, it is also observed that residue levels of unchanged parent compound are very low in grain and straw, the remainder being mainly incorporated into plant matrix (see also section 1.1.2). In the first study (1.3N), the parent compound did not account for more than mg/kg in grain and for less than 0.06 mg/kg in cereal straw. In the second study (1N), total residues in grain and straw were so low (<0.07 mg eq/kg) that further identification were not performed. Also assuming that the ploughing simulated in these studies is representative of soil preparation in practice, the residue levels of chlormequat in cereals grown as rotation is not expected to exceed the LOQ. Furthermore, it is also highlighted that for the four main small grain cereals (barley, oat, rye and wheat), MRLs of 3-15 mg/kg and mg/kg were respectively derived in grain and straw, which should in any case largely cover any residue uptakes in these crops Carry - over of residues in pears due to former authorised uses Currently the use of chlormequat in pears is no longer authorised within the EU but carry-over of chlormequat residues from uses formerly authorised in Belgium and in the Netherlands may still occur. This issue was already assessed by EFSA (2009, 2014) and a temporary MRL of 0.1 mg/kg was set on the basis of the Belgian and Dutch monitoring data (from 2004 to 2012). This proposal needs to be updated considering the new proposed residue definition (expressing residues as chlormequatchloride; see also section 1.1.6) and adding the recent monitoring data for 2013 and Since the carry-over of chlormequat residues in pears has only been observed in Belgium and in the Netherlands, only the pears produced in these countries were considered. Results obtained before 2004 were not included in the assessment since these data might reflect a situation where chlormequat was still used on pears. In line with the approach already followed by EFSA (2014), a distinction between targeted and non-targeted monitoring data is made EFSA Journal 2016;14(3):4422

12 The non-targeted monitoring data taken into account in the previous assessment (EFSA, 2014a) were provided by national safety authorities of Belgium and the Netherlands (from 2004 to 2012). However, these data did not include the monitoring results for pears produced in Belgium or Netherlands that have been analysed in other Members States. In the framework of the present review, EFSA updated the assessment by taking on board the monitoring results for pears produced in Belgium and Netherlands also analysed in other Member States for the years 2011, 2012, 2013 and Therefore, compared to the previous assessment of EFSA (2014), the present reasoned opinion includes additional data for years 2011 and 2012 as well as the recent data for 2013 and An overview of all non-targeted data considered in this review is available in Appendix F.1. EFSA took into account the targeted data already available in the previous opinion which include controls performed by the Dutch fruit growers association (from 2004 to 2012) and Belgian growers association (from 2010 to 2012). During the completeness check, more recent targeted monitoring data (2013 and 2014) were provided by Belgium and Netherlands and are therefore taken on board in this review. An overview of all targeted data considered in this review is available in Appendix F.2. For non-targeted and targeted monitoring data, decline curves were calculated as in the previous assessment, for means and 95th percentiles (see figures 1-1 and 1-2). It is acknowledged that calculation could have been carried out considering higher percentiles than the 95th one. However, considering that a general decrease of residues is observed for targeted and non-targeted samples, and given the low variability of the data, EFSA is on the opinion that using percentile 95 is justified. This approach was also agreed upon during the previous assessment. In the monitoring programs, the data were collected and expressed as chlormequat cation, in accordance with the current residue definition. Therefore, the data are recalculated as chlormequat-chloride to comply with the proposed residue definition, applying the molecular factor of Residue levels y = 2E+121e x R² = y = 3E+97e x R² = Year Mean value 95th percentile Expon. (Mean value) Expon. (95th percentile) Figure 1-1: Decline of residues based on non-targeted monitoring data for pears produced in Belgium and Netherlands from 2004 to 2014 (expressed as chlormequat-chloride). 9 Based on the molecular mass of g.mol (chlormequat-chloride) and g/mol (chlormequat cation) 12 EFSA Journal 2016;14(3):4422

13 Residue levels y = 2E+62e x R² = y = 5E+77e -0.09x R² = Mean value 95th percentile Expon. (Mean value) Expon. (95th percentile) Figure 1-2: Decline of residues based on targeted monitoring data for pears produced in Belgium and Netherlands from 2004 to 2014 (expressed as chlormequat-chloride) Year The two figures above show that residue levels in pears have been declining over the years. The degradation trend already observed previously is therefore confirmed by the most recent data. As in the previous assessment, the decline trend can be approached by an exponential model. This model presents a low fit for the targeted data (R²=0.54) but a relatively good fit when considering the nontargeted data (R²=0.87); in any case the exponential model is the most protective scenario as it simulates a slow degradation of residues throughout the years. Contrary to what was observed for years , the residue levels observed in for the targeted and non-targeted monitoring data are in the same range. This means that the residues uptakes in orchards which have been exposed to chlormequat contamination are now closer to the concentrations that can be found in any pears grown in Belgium or Netherlands. Nevertheless, the decline curves indicate that residues above the LOQ of 0.05 mg/kg (for chlormequat-chloride) are still occurring in samples of 2013 and 2014 and may still be present in Therefore, although chlormequat uptakes in pears are still decreasing, risk managers may have interest to keep a temporary MRL above LOQ Carry - over of residues in cultivated fungi grown on cereals straw Chlormequat is not used on cultivated fungi. However, considering that high residue levels are expected in cereals straw (see section 1.2.1), residues in mushrooms may occur via the uptake of chlormequat from growth substrate composed of cereal straws that have been previously treated with chlormequat. As for mepiquat, a restriction should be considered to avoid the use of cereals straw treated with chlormequat as horticultural growth medium or as mulch. Considering that restrictions are not currently applied for such practices, risk manager may have interest to set an MRL for chlormequat in cultivated fungi. As it was done for mepiquat (EFSA, 2015a), different MRL proposals were derived based on the monitoring data collected in national control programs during the years 2011, 2012, 2013, 2014 (n=654). A detailed summary of the monitoring data considered in this assessment is available in Appendix F.3. It is noted that the data were collected and expressed as chlormequat cation, in accordance with the current residue definition. Residues at or above the LOQs were observed in a total of 149 samples, corresponding to 23% of the samples analysed. To derive a MRL on the basis of monitoring data, EFSA relies on the methodology proposed by FAO in its Plant production and Protection Paper 197 (FAO, 2009), which proposes two different approaches. The first approach is used for setting extraneous MRLs and considers all the monitoring data. The upper bound approach, considering the observations at LOQ as positive values, 13 EFSA Journal 2016;14(3):4422

14 was followed in line with the current recommendations. Regarding which percentile (95, 97.5, 99 or 99.5) should be considered, the recommendations are not clear. Therefore, the four values were calculated. The second approach is based on the methodology used for deriving MRLs in spices, only taking into account samples where residues above LOQ were quantified; the other results are disregarded. In this approach, the MRL is estimated by considering the upper confidence interval of the 95th percentile. Consequently, five different MRLs can be estimated, depending on the methodology (see table 2). The monitoring results are expressed as chlormequat cation, which is not in line with residue definition proposed in the present review. Therefore, the molecular factor of 1.29 was applied to recalculate the percentiles estimations as chlormequat-chloride. These results allow deriving MRL and risk assessment values in accordance with the proposed residue definition. Table 2: MRL estimations for chlormequat in cultivated fungi on the basis of monitoring data. Expressed as chlormequat cation (a) Expressed as chlormequat chloride (b) Method 1 (for setting EMRLs): considering all samples Number of samples 654 Max Min Mean th percentile th percentile th percentile th percentile Method 2 (spices approach): only considering samples LOQ Number of samples ( LOQs) 149 Max Min Mean th percentile Upper confidence interval 2.12 (c) 2.73 (a): Results as reported in the national monitoring programs are expressed in accordance with the current residue definition. (b): Results recalculated to fit with the proposed residue definition, applying the molecular factor of 1.29 (c): Upper confidence interval for the percentile 95 was estimated by means of SAS statistics Magnitude of residues in processed commodities Studies investigating the magnitude of residues in processed commodities of wheat, barley and oats were reported in the framework of the peer review (EFSA, 2008). An overview of all available processing studies is available in Appendix B Robust processing factors for wheat (bran, flour and bread), barley (pot/pearl, malt and beer) and oat flakes were derived. Further processing studies are not required as they are not expected to affect the outcome of the risk assessment. However, if more robust processing factors were to be required by risk managers, in particular for enforcement purposes, additional processing studies would be needed Proposed MRLs Consequently, the available data are considered sufficient to derive MRL proposals as well as risk assessment values for all primary crops under evaluation, except for grass for which residue trials were not available. Tentative MRLs were also derived for cereal straw in view of the future need to set MRLs in feed items. Additionally, EFSA also derived MRLs proposals in order to cover unintentional carry-over of residues in pears (due to former uses) and cultivated fungi (grown on substrate composed of cereals straw 14 EFSA Journal 2016;14(3):4422

15 treated with chlormequat). Nevertheless, a risk management decision should still be taken on the level of these MRLs and the period of their applicability (see the different proposals in Table 3). - Pears: Based on targeted data, and assuming an exponential degradation curve, there are indications that an MRL of 0.07 mg/kg would allow encompassing 95% of the residues in 2015 and Based on the non-targeted monitoring data, the same approach would result in an MRL <0.05 mg/kg. Therefore, the EFSA proposal for a temporary MRL in pears is 0.07 mg/kg. - Cultivated fungi: As a consequence of the different methodologies presented in section , five options for MRL proposals are available for risk managers. Table 3: MRL proposals based on monitoring data (expressed as chlormequat-chloride). MRLs proposals in pears MRL approximation (a) MRL proposal Option 1: anticipated percentile 95 in 2016 based on targeted data Option 2: estimated percentile 95 in 2015 based on targeted data Option 3: anticipated percentile 95 in 2015 based on non-targeted data * Option 4: anticipated percentile 95 in 2016 based on non-targeted data * MRLs proposals in cultivated fungi Option 1 (EMRL approach) considering the 95th percentile Option 2 (EMRL approach) considering the 97.5th percentile Option 3 (EMRL approach) considering the 99th percentile Option 4 (EMRL approach) considering the 99.5th percentile Option 5 (spices approach): upper confidence interval of percentile 95 MRL approximation (a) MRL proposal Residues in livestock Chlormequat is authorised for use on cereals and grass that might be fed to livestock. Livestock dietary burdens were therefore calculated for different groups of livestock using the agreed European methodology (European Commission, 1996). The input values for all relevant commodities have been selected according to the recommendations of JMPR (FAO, 2009) and are summarised in Appendix C. The dietary burdens calculated for all groups of livestock were found to exceed the trigger value of 0.1 mg/kg DM. Behaviour of residues was therefore assessed in all commodities of animal origin. Since residue data were not available for grass, the animal intake of chlormequat residues via this feed item has not been assessed and may have been underestimated. Depending on the assessment of residues in grass, the dietary burden for ruminants might need to be updated in the future Nature of residues and methods of analysis in livestock The metabolism of chlormequat chloride in livestock (goats and hens) was evaluated in the framework of the peer review under Directive 91/414/EEC. In lactating goats, the majority of the applied radioactivity was found in excreta while it accounted for only 0.13 % in tissues. TRR in tissues ranged from 0.03 mg eq/kg (fat) to 1.45 mg eq/kg (kidney). Chlormequat accounted for 42 %, 83 %, 76 % and 4 % of TRR in the organic extracts of liver, kidney, muscle and milk respectively. No further metabolites were identified. Similar results were observed in laying hens. In tissues, the TRR ranged from 0.06 mg eq/kg (fat) to 0.36 mg/kg (liver). Organic extraction recovered 65 % of TRR in liver and kidney, 75 % in muscle and % in egg yolk, but only 6 % in egg white and 15 % in fat. Only in one of the egg yolk samples a substantial amount of the radioactive residues (0.21 mg eq/kg, 21.6 %) remained unextracted. Chlormequat was the only identified component of the residue (EFSA, 2008) EFSA Journal 2016;14(3):4422

16 The peer review concluded that after oral administration of chlormequat chloride to goats or hens, residues are rapidly excreted. Only small amounts of residues are transferred to tissues, milk or eggs (EFSA, 2008). The metabolism in ruminants and rats proceeds according to a similar pathway. Therefore, a general residue definition for the risk assessment and enforcement in livestock was set as the sum of chlormequat and its salts, expressed as chlormequat chloride (EFSA, 2008). The metabolism studies also confirmed that chlormequat residues are not fat-soluble. In the framework of a previous MRL application, an analytical method using HPLC-MS/MS and its ILV were validated for the determination of chlormequat chloride in animal matrices (EFSA, 2014a). This assessment also referred to the confirmatory data which were provided following the conclusion of the peer review (EFSA, 2014b). This method was validated for an LOQ of 0.01 mg/kg in meat, fat, kidney, milk and eggs and for an LOQ of 0.05 mg/kg in liver; LOQs refer to chlormequat chloride. In the same dossier, a confirmatory method was also provided and validated. Therefore, a sufficiently validated analytical method is available for enforcement of chlormequat chloride in animal commodities. The storage stability of chlormequat chloride residues in animal matrices (milk, meat and eggs) has been investigated in the framework of the peer review and results indicated that chlormequat residues are stable for 12 months when stored at -18 C (EFSA, 2008) Magnitude of residues in livestock During the peer review, validated feeding studies investigating the magnitude of chlormequat residues in lactating cows and laying hens were reported (EFSA, 2008). For cows, three dose levels (0.38, 1.09 and 3.75 mg chlormequat chloride/ kg bw per day) were tested. The same was done for hens with the following dose levels: 0.38, 1.14 and 3.8 mg chlormequat chloride/ kg bw per day. During the peer review, further. The samples in the above mentioned studies were stored in compliance with the conditions for which storage stability was demonstrated. Therefore, results of these studies allowed EFSA to derive MRLs and risk assessment values for ruminants, swine and poultry products in compliance with the latest recommendations on this matter (FAO, 2009). The overview of the study results used to derive the risk assessment values and the MRL proposals are summarised in Appendix B Consumer risk assessment In the framework of this review, only the uses of chlormequat reported by the RMS in Appendix A and carry-over in specific crops were considered. However the use of chlormequat was previously also assessed by the JMPR (FAO, 1994, 2000). 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 Consumer risk assessment without consideration of the existing CXLs Chronic and acute exposure calculations for all crops reported in the framework of this review were 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 the decision tree reported in Appendix D. Hence, for barley, oat, rye and wheat grains, where an MRL could be derived by EFSA in the framework of this review, input values were derived according to the internationally agreed methodologies (FAO, 2009). In addition, chlormequat residues that may occur in non-treated pears and cultivated fungi (see section 1.2.2) were also taken into account in the consumer risk assessment. For these crops, MRLs were derived from monitoring data. Therefore, the chronic and acute risk assessments were performed in line with these proposals. For the chronic risk assessment, the calculation is based on the average residues levels observed in monitoring data (considering an upper bound approach). For the acute risk assessment, the MRLs derived from monitoring data were directly considered in the calculation. As several options were proposed to risk manager, EFSA assessed the most conservative ones which are 0.07 mg/kg (for pears) and 3 mg/kg (for cultivated fungi) EFSA Journal 2016;14(3):4422

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