Modification of the existing maximum residue levels for triclopyr in oranges, lemons and mandarins.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriphar SA submitted a request to the competent national authority in Ireland to modify the existing maximum residue levels (MRLs) for the active substance triclopyr in oranges, lemons and mandarins. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for these commodities. Adequate analytical methods for enforcement are available to control the residues of triclopyr in the plant matrices under consideration at the validated LOQ of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of triclopyr according to the reported agricultural practice is unlikely to present a risk to consumer health.

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, Agriphar SA submitted an application to the competent national authority in Ireland (evaluating Member State, EMS) to modify the existing maximum residue levels (MRLs) for the active substance triclopyr in oranges, lemons and mandarins. The EMS drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 5 May 2014. To accommodate for the intended EU foliar and post‐harvest uses of triclopyr, the EMS proposed to lower the existing tentative MRL from 0.1 to 0.08 mg/kg.

EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation. EFSA identified data gaps, which were requested from the EMS. On 20 June 2022, the EMS submitted a revised evaluation report, which replaced the previously submitted evaluation report.

Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC, the data evaluated under previous MRL assessments, and the additional data provided by the EMS in the framework of this application, the following conclusions are derived.

The metabolism of triclopyr was investigated in crops belonging to the groups of fruit crops, root crops and cereals/grasses after foliar and soil applications. A new metabolism study in fruit crops (oranges) after post‐harvest drenching was submitted in the present MRL application. Studies on the effect of processing on the nature of triclopyr (hydrolysis studies) were not performed and are not deemed necessary considering that triclopyr residues in the oranges, lemons and mandarins treated according to the intended uses were found below the trigger level below 0.1 mg/kg. Investigations of residues of triclopyr in rotational crops are not required in the framework of this application.

Based on the metabolic pattern identified in the metabolism studies in primary crops, a general residue definition for plant products was proposed by the MRL review as ‘triclopyr’ both for enforcement and risk assessment after foliar applications. The results of the new metabolism study confirm that triclopyr is the only relevant residue found in post‐harvest treated oranges (fruit crop). For the crops assessed in this application, EFSA concluded that the metabolism of triclopyr in primary crops has been sufficiently addressed and the previously derived residue definitions are applicable.

Sufficiently validated analytical methods are available to quantify residues according to the residue definition for enforcement. The methods enable quantification of residues at or above 0.01 mg/kg in the crops assessed (LOQ). The available residue trials are sufficient to derive an MRL proposal of 0.07 mg/kg for orange, lemon and mandarin fruits. Residue data allowed to derive a median peeling factor of 0.33.

The by‐product citrus dried pulp can be used as feed item. Therefore, the potential carryover of residues of triclopyr into commodities of animal origin was further assessed. The livestock dietary burdens as estimated by the MRL review were recalculated according to the OECD methodology and the revised default processing factors, considering the existing uses of triclopyr. For the calculation of the exposure to triclopyr residues in citrus dried pulp, the existing MRL of 0.1 mg/kg tentatively set in grapefruits, oranges, lemons and mandarins was used as an input value. The estimated livestock dietary burdens exceeded the trigger value of 0.1 mg/kg DM for all relevant animal species, except poultry layers, and were affected by the new calculation methodology. However, citrus dried pulp is not among the major contributing commodities in the critical diets of ruminants and pigs and it is not usually fed to poultry. Moreover, the intended use on oranges, lemons and mandarins is covered by the calculations, and therefore, a modification of the existing MRL in products of animal origin is not necessary in the context of the present application. The livestock exposure to triclopyr residues and the potential carry‐over of residues into commodities of animal origin will be reassessed in the framework of the MRL review confirmatory data, when full information on authorised uses of triclopyr will be available to EFSA.

The toxicological profile of triclopyr was assessed in the framework of the EU pesticides peer review under Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of 0.03 mg/kg body weight (bw) per day and an acute reference dose (ARfD) of 0.3 mg/kg bw.

The consumer risk assessment was performed with revision 3.1 of the EFSA Pesticide Residues Intake Model (PRIMo). The short‐term exposure assessment was performed only with regard to the commodities assessed in the present MRL application. For oranges, lemons and mandarins, the short‐term exposure accounted individually for a maximum of 0.7% of the ARfD. The long‐term exposure assessment performed in the MRL review was updated using the median residue value for oranges, lemons and mandarins derived from the submitted residue trials and for kiwi fruits from a previous MRL application. To these fruits with inedible peel, the peeling factors were applied to refine the exposure. The highest estimated long‐term dietary intake accounted for 5% of the ADI (NL toddler diet). The contribution of residues of triclopyr to the overall long‐term exposure was up to 0.13% of the ADI for oranges. The chronic exposure calculation should be regarded as indicative since for certain commodities, only tentative MRLs could be derived during the MRL review. Nevertheless, the margin of safety for the chronic exposure is sufficiently large to cover this lack of information in the context of the current application.

EFSA concluded that the proposed uses of triclopyr on oranges, lemons and mandarins will not result in a consumer exposure exceeding the toxicological reference values and, therefore, are unlikely to pose a risk to consumers' health.

The peer review of the renewal of approval of triclopyr in accordance with Regulation (EC) No 1107/2009 is ongoing and, therefore, the conclusions reported in this reasoned opinion might need to be reconsidered in the light of the outcome of the peer review.

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

Full details of all end points and the consumer risk assessment can be found in Appendices B–D.

Assessment

The European Food Safety Authority (EFSA) received an application to modify the existing maximum residue levels (MRLs) for triclopyr in oranges, lemons and mandarins. The detailed description of the intended foliar and/or post‐harvest uses of triclopyr in these citrus fruits, which are the basis for the current MRL application, is reported in Appendix A.

Triclopyr is the ISO common name for 3,5,6‐trichloro‐2‐pyridyloxyacetic acid (IUPAC). The chemical structures of the active substance and its main metabolite are reported in Appendix E.

Triclopyr was evaluated in the framework of Directive 91/414/EEC with Ireland designated as the original rapporteur Member State (RMS) for the representative uses as a foliar treatment on pasture, non‐recreational amenity grassland. The draft assessment report (DAR) prepared by the RMS has been peer reviewed by EFSA (EFSA, 2006). Triclopyr was approved for the use as herbicide on 1 June 2007. Afterwards, the conditions of use of the active substance were amended, in particular by restricting its use with a total application per year of maximum 480 g active substance per hectare. The process of renewal of the approval is currently ongoing.

The EU MRLs for triclopyr are established in Annex II of Regulation (EC) No 396/2005 . The review of existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (MRL review) has been performed (EFSA, 2017) and the proposed modifications have been implemented in the MRL legislation. After completion of the MRL review, EFSA has issued one reasoned opinion on the modification of the MRL for triclopyr in kiwi fruits (EFSA, 2020). The proposal from this reasoned opinion has been considered in recent MRL regulation.

In accordance with Article 6 of Regulation (EC) No 396/2005, Agriphar SA submitted an application to the competent national authority in Ireland (evaluating Member State, EMS) to modify the existing maximum residue levels (MRLs) for the active substance triclopyr in oranges, lemons and mandarins. The EMS drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 5 May 2014. To accommodate for the intended uses of triclopyr, the EMS proposed to lower the existing tentative MRL from 0.1 to 0.08 mg/kg.

EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation. EFSA identified data gaps, which were requested from the EMS. On 20 June 2022, the EMS submitted a revised evaluation report (Ireland, 2013 as revised in 2022), which replaced the previously submitted evaluation report.

EFSA based its assessment on the evaluation report submitted by the EMS (Ireland, 2013) as revised up to its final version in 2022, the draft assessment report (DAR) and its addendum (Ireland, 2003, 2005) prepared under Directive 91/414/EEC, the Commission review reports on triclopyr and its revision (European Commission, 2006, 2014), the conclusion on the peer review of the pesticide risk assessment of the active substance triclopyr (EFSA, 2006), as well as the conclusions from previous EFSA opinions on triclopyr, including the reasoned opinion on the MRL review according to Article 12 of Regulation (EC) No 396/2005 (EFSA, 2017, 2020).

For this application, the data requirements established in Regulation (EU) No 544/2011 and the guidance documents applicable at the date of submission of the application to the EMS are applicable (European Commission, 1997a,b,c,d,e,f,g, 2000, 2010a,b, 2017; OECD, 2011, 2013). The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation and the Authorisation of Plant Protection Products adopted by Commission Regulation (EU) No 546/2011 .

The peer review of the renewal of approval of triclopyr in accordance with Regulation (EC) No 1107/2009 is ongoing and, therefore, the conclusions reported in this reasoned opinion might need to be reconsidered in the light of the outcome of the peer review.

A selected list of end points of the studies assessed by EFSA in the framework of this MRL application including the end points of relevant studies assessed previously, is presented in Appendix B.

The evaluation report submitted by the EMS (Ireland, 2013; as revised in 2022) and the exposure calculations using the EFSA Pesticide Residues Intake Model (PRIMo) are considered as supporting documents to this reasoned opinion and, thus, are made publicly available as background documents to this reasoned opinion.

Residues in plants

Nature of residues and methods of analysis in plants

Nature of residues in primary crops

The metabolism of triclopyr was investigated in primary crops belonging to the group of fruit crops (foliar and soil application), root crops (foliar and soil application) and cereal/grass crops (foliar application) in the framework of the EU pesticides peer review and the MRL review (EFSA, 2006, 2017). Triclopyr, free and conjugated, was the main residue in target primary crops (68% TRR in the apple pulp, 64–75% TRR in radish, 47–78% in grass). The toxicologically relevant metabolite 3,5,6‐trichloropyridinol (3,5,6‐TCP) was identified in low proportions in root crops only (up to 3% TRR).

A new metabolism study after post‐harvest treatment of triclopyr in fruit crops was assessed in the framework of this MRL application (Ireland, 2013). The study was conducted on orange fruits drenched in a solution containing radiolabelled triclopyr for ca. 40 s followed by drying for ca. 30 min. The treatment rate (target 2 g/hL per tonne fruit) tested is representative (1 N) of the intended application rate of the current MRL request. Samples of fruits were collected after treatment and over a period of storage for up to 42 days after treatment (DAT). Samples were kept at room temperature in the dark.

The fruits were rinsed with acetonitrile/water (1/1; v/v) and separated into peel and pulp. Afterwards, the radioactivity was extracted from the homogenised peel and pulp three times with a mixture of acetonitrile/water (8/2; v/v). The solid was combusted to determine the total radioactive residues by summing it up with that of the extracts. Alkaline hydrolysis was conducted on the 42‐DAT extract from orange peel. According to the EMS, the extraction and analysis techniques were capable to release conjugated forms of triclopyr. Identification and characterisation of more than 90% TRR was achieved.

In the whole unrinsed fruits, the total radioactivity accounted for 0.14, 0.17, 0.20 and 0.17 mg eq/kg at 0, 3, 14 and 42‐DAT, respectively; Triclopyr was the major component (99.3% TRR at 0‐DAT to 85.8% TRR at 42‐DAT). The main portions of the applied radioactivity remained in the rinses and the condensate solutions, consisting mainly of parent triclopyr. In the fruit, total radioactivity was mainly distributed in the peel (0.03–0.15 mg eq/kg, from 4.5% to 25% TRR). In the pulp, radioactivity was low (≤ 0.001 mg eq/kg, 0.2–0.5% TRR depending on the sampling time) and therefore not further characterised.

The metabolism study showed that triclopyr undergoes very limited metabolisation after post‐harvest application. The low‐level components observed (nine unknown metabolites, individually max. 5.3% TRR, 0.009 mg eq/kg at 42‐DAT) in extracts of orange peel were identified as glucoside and aspartic acid conjugates of triclopyr.

Based on the results of the study submitted, EFSA concluded that the metabolism of triclopyr after post‐harvest drenching is sufficiently elucidated in fruit crops. Triclopyr was the only relevant residue found in post‐harvest treated oranges. Further studies investigating the nature of triclopyr in the primary crops under consideration are therefore not required.

Nature of residues in rotational crops

Triclopyr is proposed for foliar and/or post‐harvest uses on citrus fruits, which are permanent crops. Therefore, no further consideration on the nature of the active substance in rotational crops is required in the context of the present MRL application.

Nature of residues in processed commodities

Since residues in the raw agricultural commodities are expected to be below the trigger value of 0.1 mg/kg, investigation on the nature of residues of triclopyr in processed commodities is not required for the crops under assessment (European Commission, 1997d).

Analytical methods for enforcement purposes in plant commodities

Analytical methods for the determination of triclopyr residues in plants commodities were assessed during the MRL review and in a previous MRL application (EFSA, 2017, 2020). Sufficiently validated methods based on HPLC‐MS/MS, including a method using QuEChERS technique, are available to determine residues of triclopyr in high‐acid content commodities, to which citrus fruits belong. The methods allow quantifying residues of triclopyr at or above the LOQ of 0.01 mg/kg.

Storage stability of residues in plants

The storage stability of triclopyr in plants under frozen conditions was assessed in high‐water content commodities in the framework of the EU pesticides peer review (EFSA, 2006) and in high‐acid and high‐water content commodities in a previous EFSA opinion (EFSA, 2020). Based on these studies, residues of triclopyr were found to be stable for up to 12 months at −18°C in high‐acid content matrices, to which group the commodities under assessment belong.

Proposed residue definitions

Based on the metabolic pattern identified in metabolism studies, EFSA proposed to define the residue for enforcement and risk assessment as ‘triclopyr’ in all plant commodities (EFSA, 2017). The results of the new metabolism study confirm that triclopyr is the only relevant residue found in post‐harvest treated oranges. Residue definitions were not set for rotational crops and processed products as not triggered. The residue definition for enforcement set in Regulation (EC) No 396/2005 is identical with the above‐mentioned residue definition.

Taking into account the intended uses in the present MRL application and the results of the new metabolism study submitted, EFSA concluded that the above‐mentioned residue definitions are also applicable to the post‐harvest uses in fruits.

Magnitude of residues in plants

Magnitude of residues in primary crops

In support of the MRL application, the applicant submitted the results of residue field trials in oranges and post‐harvest use trials on oranges and mandarins. In some of the trials, residues were also measured in the pulp and were always < LOQ, except in one residue trial after foliar application (0.04 mg/kg). Residues of triclopyr in the edible portion of these commodities are unlikely to occur as shown in the available metabolism studies and confirmed by the residue trials on fruits assessed in a previous EFSA opinion (EFSA, 2020).

The samples of these residue trials were stored under conditions for which integrity of the samples has been demonstrated. According to the assessment of the EMS, the methods used were sufficiently validated and fit for purpose. For the HPLC‐MS/MS method used to analyse residues from the field study on oranges, extraction efficiency data were provided and were considered adequate (Ireland, 2013).

It is noted that samples taken after foliar application of triclopyr on oranges were also analysed for 3,5,6‐trichloropyridinol (3,5,6‐TCP). This metabolite of triclopyr was never quantified in the pulp but occasionally detected in the peel and therefore in the whole fruit samples (at 0.02 mg/kg) of two trials. Also in three untreated samples, 3,5,6‐TCP was found above the LOQ of 0.01 mg/kg (up to 0.07 mg/kg just after treatment, at 0‐DAT). According to the field history, the previous use of products containing triclopyr, chlorpyrifos and/or chlorpyrifos‐methyl (all forming 3,5,6‐TCP metabolite) was not recorded and therefore potential contamination of untreated samples with triclopyr test item could be excluded. The EMS assumed that contamination might have occurred due to drift onto the experimental plots from neighbouring lands sprayed with these pesticides (Ireland, 2013). EFSA considered this a possible explanation since these trials resulted to be properly conducted.

Oranges, lemons, mandarins. EU GAP: Post‐harvest drench, 1 × 2 g/ton fruit, withholding interval 3 days

The results of eight GAP‐compliant residue trials on oranges (4 trials) and mandarins (4 trials) were provided. All trials were conducted in Spain on the same date in four different premises. The fruits were drenched, let dried and then subject to degreening, cleaning, brushing, waxing and packaging to simulate normal commercial practice. For the MRL setting, EFSA selected the average value of analytical replicates in line with agreed methodology (EFSA, 2015; FAO, 2016).

The applicant proposed to extrapolate the residue data on oranges and mandarins to oranges, lemons and mandarins. According to the EU guidance, an extrapolation of residue data on oranges and mandarins to the whole group of citrus is possible and, consequently, also to single commodities of the group (European Commission, 2017). The available information is sufficient to derive an MRL proposal of 0.07 mg/kg for the intended post‐harvest use on oranges, lemons, mandarins. It is also noted that the existing MRL in these crops is higher (0.1 mg/kg) and derived on a tentative basis in the framework of the MRL review.

Oranges. SEU GAP: Foliar spray, 1 × 37.5 g/ha, PHI 32 days

The applicant submitted the results of nine field trials on oranges performed in different SEU countries. All trials were carried out in a single season but in several different geographical locations in the southern Europe and therefore the deviation from the requirement of trials being performed over two growing seasons is considered minor. The results of these trials allow deriving an MRL proposal of 0.06 mg/kg for the foliar use on oranges indicating that foliar treatment is less critical than post‐harvest use in oranges in terms of residue levels.

Magnitude of residues in rotational crops

Investigation of the magnitude of residues of triclopyr in rotational crops is not required in the context of the present MRL application. The intended preharvest use is on orange fruits which are permanent crops not expected to be grown in rotation with other crops. The other intended uses are post‐harvest.

Magnitude of residues in processed commodities

Specific processing studies with citrus fruits were not provided and are not required since residues of triclopyr exceeding 0.1 mg/kg were not observed in the commodities under assessment. Furthermore, their individual chronic exposure is not expected to exceed 10% of the ADI (European Commission, 1997d; see also Section 3).

Residue data submitted allow calculating peeling factors for oranges and mandarins after the intended foliar and post‐harvest uses (Ireland, 2013). The peeling significantly reduces residue levels in fruits, which were always < LOQ in the fruit pulp, with the exception of one residue trial after foliar use. No significant difference regarding the distribution of residues among peel and pulp between fruits was observed. The derived median peeling factor is reported in Appendix B.1.2.3.

Proposed MRLs

The available data are considered sufficient to derive an MRL proposal as well as risk assessment values for oranges, lemons and mandarins. The intended foliar use on oranges showed to be less critical for residues than the intended post‐harvest use.

In Section 3, EFSA assessed whether residues of triclopyr resulting in oranges, mandarins and lemons from the intended post‐harvest use are likely to pose a consumer health risk.

Residues in livestock

The by‐product citrus dried pulp may be used for feed purposes. Hence, it was necessary to investigate whether the livestock intake of residues from citrus dried pulp obtained from fruits treated according to the intended uses of triclopyr would have an impact on the residues expected in food of animal origin.

The most recent animal dietary burden was indicatively calculated in the framework of the MRL review (EFSA, 2017). It was now recalculated considering the default processing factors (PF) for various feed items and livestock feeding tables listed in the OECD Guidance (OECD, 2013) which had in a meanwhile replaced the feeding table reported in SANCO 7031/VI/95 (European Commission, 1996). It is noted that citrus dried pulp previously was not included in the list of feed items. For the calculation of the exposure to triclopyr residues from the intake of citrus dried pulp, the existing MRL of 0.1 mg/kg tentatively set in grapefruits, oranges, lemons and mandarins was used (no refined value available) since this value is higher than the median residue (0.03 mg/kg) derived from the residue trials submitted to support the intended post‐harvest use on oranges, lemons and mandarins. The default PF of 10 was applied to estimate the residue level in the dried pulp. The input values for the exposure calculations for livestock are presented in Appendix D.1.

The results of the dietary burden calculations are presented in Section B.2. Considering the existing uses of triclopyr assessed in the MRL review, the new calculation methodology has an impact on the previously estimated dietary burdens. The exposure estimate is lower for ruminants and increased for 7% in pigs, but it is driven by the existing use on grass assessed in the MRL review. The dietary burden in poultry (all diets) which was not triggered under the MRL review, now exceeds the trigger value of 0.1 mg/kg DM, because of the existing use in rice and residues in its by‐product bran/pollard. Citrus dried pulp is not a poultry feed item (OECD, 2013). Moreover, based on the results of the overdosed hen metabolism study with triclopyr (81 times higher the calculated dietary burden) assessed in the MRL review, quantifiable residues in poultry edible products are not expected and the setting of MRL in poultry tissues and eggs is currently not required.

The intended uses on oranges, lemons and mandarins assessed in the framework of this application are covered by these updated calculations which are carried out using the existing MRL on certain citrus fruits. Taking into account that citrus dried pulp is not among the major contributing commodities identified in the critical diets of ruminants and pigs, a modification of the existing MRL in products of animal origin is not necessary.

The livestock exposure to triclopyr residues and the potential carry‐over of residues into commodities of animal origin and the subsequent potential formation of metabolite 3,5,6‐TCP, will be reassessed in the framework of the MRL review confirmatory data, when the data gaps identified in the MRL review will be addressed and a full information on the authorised uses of triclopyr will be available to EFSA.

In animal commodities, two separate risk assessment residue definitions were proposed by the MRL review (EFSA, 2017):

triclopyr;

3,5,6‐TCP and its conjugates, expressed as 3,5,6‐TCP.

It was noted that metabolite 3,5,6‐TCP, which was observed in significant amounts in the ruminant metabolism study with triclopyr, may also be generated in animals from the use of two other active substances, chlorpyrifos and chlorpyrifos‐methyl.

Consumer risk assessment

EFSA performed a dietary risk assessment for the agreed residue definitions for risk assessment in plant and animal matrices using revision 3.1 of the EFSA PRIMo (EFSA, 2018, 2019a). This exposure assessment model contains food consumption data for different subgroups of the EU population and allows the acute and chronic exposure assessment to be performed in accordance with the internationally agreed methodology for pesticide residues (FAO, 2016).

The toxicological reference values for triclopyr used in the risk assessment (i.e. ADI and ARfD values) were derived in the framework of the EU pesticides peer review (European Commission, 2006). For the metabolite 3,5,6‐TCP, included in a separated residue definition for risk assessment for products of animal origin, different toxicological reference values are set requiring a separate risk assessment for residues in the commodities of animal origin.

In the framework of the MRL review (EFSA, 2017), EFSA performed a separate consumer risk assessment for 3,5,6‐TCP and its conjugates, from the uses of chlorpyrifos, chlorpyrifos methyl and triclopyr. The exposure calculation did not indicate a risk to consumers. In plant commodities, metabolite 3,5,6‐TCP is unlikely to be present after the application of triclopyr. It is mainly expected to occur following the use of chlorpyrifos or chlorpyrifos‐methyl which are no longer authorised for use as pesticides in the EU. Therefore, an update of the chronic risk assessment performed in the MRL review for 3,5,6‐TCP is not necessary.

The input values used in the exposure calculations are summarised in Appendix D.2.

Short‐term (acute) dietary risk assessment

The short‐term risk assessment was performed only with regard to oranges, lemons and mandarins, being the commodities assessed in the present MRL application. The estimation of the exposure is based on the highest residue (HR) derived from the post‐harvest supervised trials submitted, multiplied by the derived peeling factor of 0.33.

For oranges, lemons and mandarins, the short‐term exposure accounted for a maximum of 0.7% of the ARfD (highest for oranges).

Long‐term (chronic) dietary risk assessment

The comprehensive long‐term exposure assessment performed in the framework of the MRL review was recently revised in the EFSA assessment of an MRL application for kiwi fruits, (EFSA, 2020). In that calculation, the existing tentative MRL of 0.1 mg/kg was included as an input value for grapefruits, oranges, lemons and mandarins and the estimated long‐term exposure to triclopyr residues accounted for up to 6% of the ADI (NL toddler).

EFSA is now updating the above‐mentioned calculation by replacing the previous input value at the existing MRL of 0.1 mg/kg with the STMR value of 0.03 mg/kg as derived for oranges, lemons and mandarins from the residue trials submitted in support of this MRL application; the peeling factor of 0.33 was applied to the input value for oranges, lemons and mandarins and a peeling factor of 1 was applied to the input value for kiwi fruits. The contributions of commodities for which no GAP was reported in the framework of the MRL review were not included in the calculation.

The estimated long‐term exposure to triclopyr residues accounted for up to 5% of the ADI (NL toddler). The contribution of residues expected in oranges, lemons and mandarins is up to the 0.13% of the ADI (highest for oranges).

Overall conclusions

Based on the results of the consumer exposure assessment, EFSA concludes that the existing EU uses and the intended uses of triclopyr on oranges, lemons and mandarins will not result in acute or chronic consumer exposure exceeding the toxicological reference values for triclopyr and therefore are unlikely to pose a risk to consumers' health.

The chronic exposure calculation should be regarded as indicative. An updated long‐term consumer risk assessment shall be performed in the framework of the assessment of the MRL review confirmatory data for triclopyr when the identified missing information regarding certain authorised uses and additional residue data will be available to EFSA. Nevertheless, the margin of safety for the chronic exposure is sufficiently large to cover this lack of information in the context of the current application.

For further details on the exposure calculations, a screenshot of the report sheet of the PRIMo is presented in Appendix C.

Conclusion and Recommendations

The data submitted in support of this MRL application were found to be sufficient to derive an MRL proposal of 0.07 mg/kg for oranges, lemons and mandarins in support of the intended post‐harvest use; the derived MRL proposal is lower than the existing tentative MRL. A risk management decision is required on whether to lower the existing MRL of 0.1 mg/kg derived tentatively in the framework of the MRL review.

Based on the consumer exposure assessment, EFSA concludes that the existing EU uses as well as the intended uses of triclopyr in oranges, lemons and mandarins will not result in acute or chronic consumer exposure exceeding the toxicological reference values and, therefore, are unlikely to pose a risk to consumers' health.

The chronic exposure calculation should be regarded as indicative since for certain commodities, only tentative MRLs could be derived during the MRL review. Nevertheless, the margin of safety for the chronic exposure is sufficiently large to cover this lack of information in the context of the current application.

The peer review of the renewal of approval of triclopyr in accordance with Regulation (EC) No 1107/2009 is ongoing and, therefore, the conclusions reported in this reasoned opinion might need to be reconsidered in the light of the outcome of the peer review.

The MRL recommendations are summarised in Appendix B.4.

active substance

acceptable daily intake

applied radioactivity

acute reference dose

growth stages of mono‐ and dicotyledonous plants

body weight

Codex Alimentarius Commission

Chemical Abstract Service

Codex Committee on Pesticide Residues

European Committee for Standardisation (Comité Européen de Normalisation)

conversion factor for enforcement to risk assessment residue definition

critical GAP

Collaborative International Pesticide Analytical Council

(EU) Communication & Information Resource Centre Administrator

Communication and Information Resource Centre for Administrations, Businesses and Citizens

capsule suspension

coefficient of variation (relative standard deviation)

Codex maximum residue limit

days after last application

draft assessment report

days after treatment

dry matter

dustable powder

powder for dry seed treatment

period required for 90% dissipation (define method of estimation)

dry weight

emulsifiable concentrate

electron capture detector

estimated daily intake

evaluating Member State

residue expressed as a.s. equivalent

electrospray ionisation

EU Reference Laboratory (former Community Reference Laboratory (CRL))

Food and Agriculture Organisation of the United Nations

flame ionisation detector

fluorescence detector

flame photometric detector

Good Agricultural Practice

gas chromatography

Global Crop Protection Federation (formerly International Group of National Associations of Manufacturers of Agrochemical Products (GIFAP))

gas chromatography with electron capture detector

gas chromatography with flame ionisation detector

gas chromatography with flame photometric detector

gas chromatography with mass spectrometry

gas chromatography with tandem mass spectrometry

gas chromatography with nitrogen/phosphorous detector

Good Laboratory Practice

granule

growth stage

high performance liquid chromatography

high performance liquid chromatography with mass spectrometry

high performance liquid chromatography with tandem mass spectrometry

high performance liquid chromatography with ultra‐violet detector

highest residue

international estimated daily intake

international estimated short‐term intake

independent laboratory validation

International Programme of Chemical Safety

International Organisation for Standardisation

International Union of Pure and Applied Chemistry

Joint FAO/WHO Meeting on Pesticide Residues

organic carbon adsorption coefficient

liquid chromatography

lowest observed adverse effect level

limit of detection

limit of quantification

maximum residue level

Member States

mass spectrometry detector

tandem mass spectrometry detector

molecular weight

northern Europe

no observed adverse effect level

nitrogen/phosphorous detector

Organisation for Economic Co‐operation and Development

Standing Committee on Plants, Animals, Food and Feed

plant back interval

processing factor

pre‐harvest interval

partition coefficient between n‐octanol and water

(EFSA) Pesticide Residues Intake Model

(EFSA) Pesticide Residues Overview File

Quick, Easy, Cheap, Effective, Rugged, and Safe (analytical method)

statistical calculation of the MRL by using a non‐parametric method

statistical calculation of the MRL by using a parametric method

risk assessment

raw agricultural commodity

residue definition

rapporteur Member State

relative potency factor

Directorate‐General for Health and Consumers

suspension concentrate

Standing Committee on Plants, Animals, Food and Feed (formerly: Standing Committee on the Food Chain and Animal Health; SCFCAH)

southern Europe

water‐soluble granule

soluble concentrate

water‐soluble powder

supervised trials median residue

total applied radioactivity

theoretical maximum daily intake

total radioactive residue

ultraviolet (detector)

water‐dispersible granule

World Health Organisation

wettable powder

yield factor

mixed CS and SC formulation

Appendix A – Summary of intended GAP triggering the amendment of existing EU MRLs

or I

Appendix B – List of end points

B.1.Residues in plants

B.1.1. Nature of residues and analytical methods for enforcement purposes in plant commodities

B.1.1. 1. Metabolism studies, analytical methods and residue definitions in plants

B.1.1.2. Stability of residues in plants

Tentative

B.1.2. Magnitude of residues in plants

B.1.2.1. Summary of residues data from the supervised residue trials

B.1.2.2. Residues in rotational crops

B.1.2.3. Processing factors

B.2. Residues in livestock

Dietary burden calculation according to OECD, 2013.

B.3. Consumer risk assessment

B.4. Recommended MRLs

Appendix C – Pesticide Residue Intake Model (PRIMo)

Appendix D – Input values for the exposure calculations

D.1. Livestock dietary burden calculations

D.2. Consumer risk assessment

Appendix E – Used compound codes

Code (a)	Commodity	Existing EU MRL (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: Triclopyr
0110020	Oranges	0.1 (ft)	Risk management decision	The submitted data are sufficient to derive an MRL proposal of 0.07 mg/kg based on the intended post‐harvest use. The SEU foliar use is also supported by a less critical residue data set. Risk management decision shall be taken whether the tentative MRL of 0.1 mg/kg (with footnote) shall be maintained until the assessment of the MRL review confirmatory data is finalised or the MRL is lowered to the value of 0.07 mg/kg, which is sufficiently supported by data and for which no consumer intake concerns were identified.
0110030	Lemons	0.1 (ft)	Risk management decision	The submitted data are sufficient to derive an MRL proposal of 0.07 mg/kg based on the intended post‐harvest use Risk management decision shall be taken whether the tentative MRL of 0.1 mg/kg (with footnote) shall be maintained until the assessment of the MRL review confirmatory data is finalised or the MRL is lowered to the value of 0.07 mg/kg, which is sufficiently supported by data and for which no consumer intake concerns were identified
0110050	Mandarins

MRL: maximum residue level; SEU: southern Europe.

Commodity code number according to Annex I of Regulation (EC) No 396/2005.

ft: The European Food Safety Authority identified some information on residue trials as unavailable. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.

Crop and/or situation	NEU, SEU, MS or country	F G or I (a)	Pests or group of pests controlled	Preparation		Application				Application rate per treatment				PHI (days)(d)	Remarks
				Type (b)	Conc. a.s. (g/kg)	Method kind	Range of growth stages & season (c)	Number min–max	Interval between application (days) min–max	g a.s./hL min–max	Water (L/ha) min–max	Rate min–max	Unit
Oranges	EU	Ι	Growth Regulator	ST	100	Post‐harvest treatment ‐ drenching	From BBCH 85	1	n.a.			2	g a.s./ton	3	2 g/hL at a rate of 100 L water/ton fruit. Application 3 days before commercialisation.
Oranges	SEU	F	Growth Regulator	ST	100	Foliar treatment ‐ broadcast spraying	After BBCH 80	1	n.a.	1–1.5	1,500–2,500	37.5	g a.s./ha	32	Just after colour break. Colour break starts at BBCH > 80.
Oranges	SEU	F	Growth Regulator	ST	100	Foliar treatment ‐ broadcast spraying	After BBCH 80	1	n.a.		2000–2,500	37.5	g a.s./ha	40	Just after colour break. Colour break starts at BBCH > 80.
Mandarins	EU	Ι	Growth Regulator	ST	100	Post‐harvest treatment ‐ drenching	From BBCH 85	1	n.a.			2	g a.s./ton	3	2 g/hL at a rate of 100 L water/ton fruit. Application 3 days before commercialisation.
Lemons	EU	Ι	Growth Regulator	ST	100	Post‐harvest treatment ‐ drenching	From BBCH 85	1	n.a.			2	g a.s./ton	3	2 g/hL at a rate of 100 L water/ton fruit. Application 3 days before commercialisation.

MRL: maximum residue level; GAP: Good Agricultural Practice; NEU: northern European Union; SEU: southern European Union; MS: Member State; a.s.: active substance; ST: water soluble tablets; n.a.: not applicable.

Outdoor or field use (F), greenhouse application (G) or indoor application (I).

CropLife International Technical Monograph no 2, 7th Edition. Revised March 2017. Catalogue of pesticide formulation types and international coding system.

Growth stage range from first to last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 3‐8263‐3152‐4), including, where relevant, information on season at time of application.

PHI: minimum preharvest interval.

Primary crops (available studies)	Crop groups	Crops	Application	Sampling (DAT)	Comment/Source
	Fruit crops	Apples	Foliar, 1 × 650 g a.s./ha	21	Radiolabelled active substance: 14C‐triclopyr (EFSA, 2006)
			Soil, 2 × 1.1 kg a.s./ha	14
		Oranges	Post‐harvest drench, 1 × 2 g/hL per tonne fruit (rate of 100 mL/kg oranges) for ca. 40 s.	30 min, 3 14, 42	Radiolabelled active substance: [pyridyl‐2‐14C]‐triclopyr (Ireland, 2013)
	Root crops	Radishes	Foliar, 1 × 27 g a.s./ha	8	Radio‐labelled active substance: 14C‐triclopyr (EFSA, 2006)
			Soil, 1 × 1.1 kg a.s./ha	7
	Cereals/grass crops	Ryegrass	Foliar, 1 × 2.24 kg a.s./ha	0, 3, 7, 14, 30, 60, 91
			Foliar, 1 × 4.5 kg a.s./ha	91
Rotational crops (available studies)	Crop groups	Crops	Application	PBI (DAT)	Comment/Source
	Root/tuber crops	Turnips	Bare soil, 0.56 kg a.s./ha	36	Radiolabelled active substance: 14C‐triclopyr (EFSA, 2006)
	Leafy crops	Lettuce	Bare soil, 0.56 kg a.s./ha	36
	Cereal (small grain)	Wheat	Bare soil, 0.56 kg a.s./ha	36
	Pulses/oilseeds	Green beans	Bare soil, 0.56 kg a.s./ha	36
Processed commodities (hydrolysis study)	Conditions		Stable?		Comment/Source
	Pasteurisation (20 min, 90°C, pH 4)		Not triggered
	Baking, brewing, boiling (60 min, 100°C, pH 5)		Not triggered
	Sterilisation (20 min, 120°C, pH 6)		Not triggered
	Other processing conditions		n.a.

Plant products (available studies)	Category	Commodity	T (°C)	Stability period		Compounds covered	Comment/Source
				Value	Unit
	High water content	Apple	−18	12	Months	Triclopyr	EFSA (2020)
		Grass	−20	48	Months	Triclopyr	Tentative (a) EFSA (2006)
	Dry/High starch	–	–	–	–	–
	High acid content	Kiwi	−18	12	Months	Triclopyr	EFSA (2020)
		Mandarin	−18	12	Months	Triclopyr	EFSA (2020)

The validation of the method of analysis used in the study investigating the storage stability of triclopyr was missing (data gap) (EFSA, 2006, 2017).

Commodity	Region/Indoor (a)	Residue levels observed in the supervised residue trials (mg/kg)	Comments/Source	Calculated MRL (mg/kg)	HR (b) (mg/kg)	STMR (c) (mg/kg)	CF (d)
Oranges	SEU	4 × < 0.01; 3 × 0.01; 0.03; 0.04	Residue trials on oranges compliant with the GAP. Pulp: 8 × < 0.01; 0.04 mg/kg Residues of 3,5,6‐TCP: 7 × < 0.01, 2 × 0.02 (9 × < 0.01 mg/kg in the pulp)	0.06	0.04	0.01	n.a.
Oranges, lemons, mandarins	Indoor (Po‐use)	2 × 0.02; 5 × 0.03; 0.05	Residue trials on oranges and mandarins compliant with the GAP. MRL proposal based on the options HR, mean + 4SD (OECD calculator) Pulp: 4 × < 0.01 mg/kg	0.07	0.05	0.03	n.a.

GAP: Good Agricultural Practice; Po‐use: post‐harvest use; MRL: maximum residue level; n.a.: not applicable; HR: highest residue; SD: standard deviation.

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.

Highest residue. The highest residue for risk assessment refers to the whole commodity and not to the edible portion.

Supervised trials median residue. The median residue for risk assessment refers to the whole commodity and not to the edible portion.

Conversion factor to recalculate residues according to the residue definition for monitoring to the residue definition for risk assessment.

Processed commodity	Number of valid studies (a)	Processing Factor (PF)		CFP (b)	Comment/Source
		Individual values	Median PF
Orange, peeled	3 2	Foliar: 0.33; < 1; 1 Po‐use: 0.33; 0.34	0.33 (c)	–	Ireland (2013)
Mandarin, peeled	2	Po‐use: 0.29; 0.33	0.29 (c)	–	Ireland (2013)

Studies with residues in the RAC at or close to the LOQ were disregarded (unless concentration may occur).

Conversion factor for risk assessment in the processed commodity; median of the individual conversion factors for each processing residues trial.

Lowest value as best estimate of peeling factor since residues in the pulp were always < LOQ of 0.01 mg/kg, except one trial.

Relevant groups (subgroups)	Dietary burden expressed in				Most critical diet(a)	Most critical commodity(b)		Trigger exceeded (Yes/No)	DB calculated using old feeding tables (EFSA, 2017)
	mg/kg bw per day		mg/kg DM					0.10	Max burden
	Median	Maximum	Median	Maximum				mg/kg DM	mg/kg DM
Cattle (all diets)	0.729	1.430	18.94	37.18	Dairy cattle	Grass	Forage (fresh)	Yes	77.8
Cattle (dairy only)	0.729	1.430	18.94	37.18	Dairy cattle	Grass	Forage (fresh)	Yes	76.7
Sheep (all diets)	0.990	1.953	29.70	58.58	Ram/Ewe	Grass	Forage (fresh)	Yes	Not calculated
Sheep (ewe only)	0.990	1.953	29.70	58.58	Ram/Ewe	Grass	Forage (fresh)	Yes	Not calculated
Swine (all diets)	0.148	0.288	6.40	12.48	Swine (breeding)	Grass	Forage (fresh)	Yes	11.6
Poultry (all diets)	0.008	0.008	0.11	0.11	Poultry broiler	Rice	Bran/pollard	Yes	Not triggered
Poultry (layer only)	0.004	0.004	0.06	0.06	Poultry layer	Rice	Bran/pollard	No	Not triggered

bw: body weight; DM: dry matter; DB: dietary burden.

When one group of livestock includes several subgroups (e.g. poultry ‘all’ including broiler, layer and turkey), the result of the most critical subgroup is identified from the maximum dietary burdens expressed as ‘mg/kg bw per day’.

The most critical commodity is the major contributor identified from the maximum dietary burden expressed as ‘mg/kg bw per day’.

Code (a)	Commodity	Existing EU MRL (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: Triclopyr
0110020	Oranges	0.1 (ft)	Risk management decision	The submitted data are sufficient to derive an MRL proposal of 0.07 mg/kg based on the intended post‐harvest use. The SEU foliar use is also supported by a less critical residue data set. Risk management decision shall be taken whether the tentative MRL of 0.1 mg/kg (with footnote) shall be maintained until the assessment of the MRL review confirmatory data is finalised or the MRL is lowered to the value of 0.07 mg/kg, which is sufficiently supported by data and for which no consumer intake concerns were identified.
0110030	Lemons	0.1 (ft)	Risk management decision	The submitted data are sufficient to derive an MRL proposal of 0.07 mg/kg based on the intended post‐harvest use. Risk management decision shall be taken whether the tentative MRL of 0.1 mg/kg (with footnote) shall be maintained until the assessment of the MRL review confirmatory data is finalised or the MRL is lowered to the value of 0.07 mg/kg, which is sufficiently supported by data and for which no consumer intake concerns were identified.
0110050	Mandarins

MRL: maximum residue level; SEU: southern Europe.

Commodity code number according to Annex I of Regulation (EC) No 396/2005.

ft: The European Food Safety Authority identified some information on residue trials as unavailable. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.

Feed commodity	Median dietary burden		Maximum dietary burden
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Risk assessment residue definition: Triclopyr
Grass, forage (fresh)	7.80	STMR (EFSA, 2017)	15.40	HR (EFSA, 2017)
Grass, hay	27.30	STMR × PF (3.5) (a) (EFSA, 2017)	53.90	HR × PF (3.5) (a) (EFSA, 2017)
Grass, silage	12.48	STMR × PF (1.6) (a) (EFSA, 2017)	24.64	HR × PF (1.6) (a) (EFSA, 2017)
Apple, pomace wet	0.25	STMR (0.05) × PF (5) (a) (EFSA, 2017)	0.25	STMR (0.05) × PF (5) (a) (EFSA, 2017)
Grapefruits, oranges, lemons, mandarins, dried pulp (b)	1.00	EU MRL (0.1) × PF (10) (a) (EFSA, 2017)	1.00	EU MRL (0.1) × PF (10) (a) (EFSA, 2017)
Rice, bran/pollard	1.00	STMR (0.10) × PF (10) (a) (EFSA, 2017)	1.00	STMR (0.10) × PF (10) (a) (EFSA, 2017)

STMR: supervised trials median residue; HR: highest residue; PF: processing factor.

In the absence of processing factors supported by data, default processing factors (in bracket) were, respectively, included in the calculation to consider the potential concentration of residues in these commodities.

For the dried pulp of citrus, the calculation is performed with the tentative existing MRL of 0.1 mg/kg (no refined value available) since it is higher than the STMR of 0.03 mg/kg derived for oranges, lemons and mandarins according to the intended uses assessed in this application.

Commodity	Chronic risk assessment		Acute risk assessment (a)
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Oranges	0.01	STMR (0.03) × PF (0.33)	0.02	HR (0.05) × PF (0.33)
Grapefruits	0.10	EU MRL (EFSA, 2017)	0.10	EU MRL (EFSA, 2017)
Lemons	0.01	STMR (0.03) × PF (0.33)	0.02	HR (0.05) × PF (0.33)
Mandarins	0.01	STMR (0.03) × PF (0.33)	0.02	HR (0.05) × PF (0.33)
Apples (b)	0.05	STMR (EFSA, 2017)	0.05	HR (EFSA, 2017)
Pears (b)	0.05	STMR (EFSA, 2017)	0.05	HR (EFSA, 2017)
Apricots (b)	0.05	STMR (EFSA, 2017)	0.05	HR (EFSA, 2017)
Peaches (b)	0.05	STMR (EFSA, 2017)	0.05	HR (EFSA, 2017)
Kiwi fruits	0.03	STMR (0.03) × PF (1) (EFSA, 2020)	0.06	HR (0.06) × PF (1) (EFSA, 2020)
Rice grain (b)	0.10	STMR (EFSA, 2017)	0.21	HR (EFSA, 2017)
Swine meat	0.01	STMR (LOQ) (EFSA, 2017)	0.01	HR (LOQ) (EFSA, 2017)
Swine fat	0.01	STMR (LOQ) (EFSA, 2017)	0.01	HR (LOQ) (EFSA, 2017)
Swine liver	0.01	STMR (LOQ) (EFSA, 2017)	0.01	HR (LOQ) (EFSA, 2017)
Swine kidney	0.01	STMR (LOQ) (EFSA, 2017)	0.01	HR (LOQ) (EFSA, 2017)
Swine, ed. offal (c)	0.01	STMR (LOQ) (EFSA, 2017)	0.01	HR (LOQ) (EFSA, 2017)
Ruminant meat	0.03	STMR (EFSA, 2017)	0.05	HR (EFSA, 2017)
Ruminant fat	0.03	STMR (EFSA, 2017)	0.05	HR (EFSA, 2017)
Ruminant liver	0.03	STMR (EFSA, 2017)	0.05	HR (EFSA, 2017)
Ruminant kidney	0.03	STMR (EFSA, 2017)	0.08	HR (EFSA, 2017)
Ruminant, ed offal (c)	0.03	STMR (EFSA, 2017)	0.08	HR (EFSA, 2017)
Equines, other farmed animals' meat (c)	0.03	STMR (EFSA, 2017)	0.05	HR (EFSA, 2017)
Equines, other farmed animals' fat (c)	0.03	STMR (EFSA, 2017)	0.05	HR (EFSA, 2017)
Equines, other farmed animals' liver (c)	0.03	STMR (EFSA, 2017)	0.05	HR (EFSA, 2017)
Equines, other farmed animals' kidney (c)	0.03	STMR (EFSA, 2017)	0.08	HR (EFSA, 2017)
Equines, other farmed animals' ed. offal (c)	0.03	STMR (EFSA, 2017)	0.08	HR (EFSA, 2017)
Milks	0.01	STMR (LOQ) (EFSA, 2017)	0.01	HR (LOQ) (EFSA, 2017)

MRL: maximum residue level; STMR: supervised trials median residue; HR: highest residue; PF: processing factor; LOQ: limit of quantification.

Input values for the commodities which are not under consideration for the acute risk assessment are reported in grey.

Input values for these commodities were set on a tentative basis from GAPs evaluated in the MRL review, which are not fully supported by data (EFSA, 2017).

To comply with Regulation (EU) 2021/590 where the MRL set for pigs and ruminant kidney was extrapolated to edible offal and the MRLs set for ruminant tissues extrapolated to equines and other farmed animals, EFSA applied in the calculation the STMRs derived in the MRL review.

Code/trivial name (a)	IUPAC name/SMILES notation/InChiKey (b)	Structural formula (c)
Triclopyr	[(3,5,6‐trichloro‐2‐pyridyl)oxy]acetic acid Clc1cc(Cl)c(Cl)nc1OCC(=O)O REEQLXCGVXDJSQ‐UHFFFAOYSA‐N
3,5,6‐Trichloropyridinol (3,5,6‐TCP)	3,5,6‐trichloropyridin‐2‐ol Clc1cc(Cl)c(Cl)nc1O WCYYAQFQZQEUEN‐UHFFFAOYSA‐N

IUPAC: International Union of Pure and Applied Chemistry; SMILES: simplified molecular‐input line‐entry system; InChiKey: International Chemical Identifier Key.

The metabolite name in bold is the name used in the conclusion.

ACD/Name 2020.2.1 ACD/Labs 2020 Release (File version N15E41, Build 116563, 15 June 2020).

ACD/ChemSketch 2020.2.1 ACD/Labs 2020 Release (File version C25H41, Build 121153, 22 March 2021).