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Modification of the temporary maximum residue level for mepiquat in oyster mushrooms

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, Finland, hereafter referred to as the evaluating Member State (EMS), received an application from BASF SE to modify the temporary maximum residue level (MRL) for the active substance mepiquat in cultivated fungi based on monitoring data. Mepiquat residues in mushrooms do not result from the use of the active substance on mushrooms, but from the uptake of residues via the growth substrate composed of cereal straw that has been treated with mepiquat. Based on a total of 74 samples on oyster mushrooms, three different MRL proposals were derived. A risk management decision is required, considering the acceptable non‐compliance rate, in order to decide which temporary MRL is the most appropriate to cover the presence of mepiquat chloride residues in oyster mushrooms. The exposure to residues of mepiquat chloride at the levels observed in the monitoring data on cultivated oyster mushrooms, which were the basis for deriving the MRL proposals, is unlikely to present a risk to consumer health.


Summary
In accordance with Article 6 of Regulation (EC) No 396/2005, BASF SE submitted an application to the competent national authority in Finland (evaluating Member State, EMS) to modify the existing temporary maximum residue level (MRL) for the active substance mepiquat in cultivated fungi based on monitoring data. Mepiquat residues in mushrooms do not result from the use of the active substance on mushrooms, but from the uptake of residues via the growth substrate composed of cereal straw that has been treated with mepiquat. 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 11 March 2019. The EMS proposed to set a specific temporary MRL of 0.7 mg/kg for oyster mushrooms by including a footnote to the commodity 'cultivated fungi' classified in the MRL food classification under code '0280010'; for other cultivated fungi, except oyster mushrooms, the existing temporary MRL of 0.09 mg/kg should be maintained.
The metabolism of mepiquat following foliar application in primary crops has been investigated in three different crop groups; furthermore, studies on the metabolic behaviour in rotational crops which were grown in soil treated with mepiquat are available. Overall, mepiquat chloride was the major residue and therefore a general plant residue definition for enforcement and risk assessment was proposed in the framework of the MRL review which covers 'the sum of mepiquat and its salts, expressed as mepiquat chloride'. These residue definitions for enforcement and risk assessment are also applicable to cultivated fungi.
Sufficiently validated analytical methods are available to quantify residues of mepiquat chloride in fungi at or above 0.01 mg/kg (limit of quantification (LOQ)).
According to the data provided by the applicant, residues of mepiquat chloride are more likely to occur in oyster mushrooms (Pleurotus ostreatus) compared to other genera, such as Agaricus spp., since the cultivation substrate for this variety consists almost exclusively of cereal straw. Therefore, oyster mushroom was considered the worst-case for residue contamination.
In support of the MRL application, the applicant provided monitoring data on oyster mushrooms provided by food business operators which cover the period from 2015 until 2019. Based on the results of 74 samples on oyster mushrooms and in line with the methodology developed by the Food and Agriculture Organization of the United Nations (FAO) for the setting of extraneous MRLs (EMRL), different MRL proposals were derived.
Monitoring data on 928 samples of cultivated fungi submitted to EFSA in the framework of Article 32 of Regulation (EC) No 396/2005 (official national control programmes), which cover the period from 2014 to 2017, confirmed that the existing MRL of 0.09 mg/kg is sufficient for cultivated fungi other than oyster mushrooms.
The results from an experimental study conducted with oyster mushrooms grown in the presence of a known concentration of residues of mepiquat chloride in wheat straw were submitted. For the transfer from straw to oyster mushrooms, an indicative median transfer factor of 1.2 was calculated. In order to derive a robust transfer factor, additional studies would be required. However, this study gives an indication that significantly higher residues compared to those observed in monitoring data might be expected for oyster mushrooms, taking into account that in the supervised field trials on cereals the median residue concentration of mepiquat chloride in straw was 4.2 mg/kg, with maximum results up to 50 mg/kg, resulting in median and highest residue concentrations in oyster mushrooms of 5 and 60 mg/kg, respectively.
The toxicological profile of mepiquat was assessed in the framework of the EU pesticides peer review and the data were sufficient to derive an acceptable daily intake (ADI) of 0.2 mg/kg body weight (bw) per day and an acute reference dose (ARfD) of 0.3 g/kg bw for mepiquat chloride.
The consumer risk assessment was performed with revision 3.1 of the EFSA Pesticide Residues Intake Model (PRIMo) using the median and highest residue value observed in the monitoring data (74 samples) on oyster mushrooms for the chronic and the acute exposure, respectively. In the absence of specific consumption data for oyster mushrooms, the consumption data for cultivated fungi which cover all varieties of cultivated mushrooms were used. Based on the results of the consumer risk assessment, EFSA concluded that the exposure to residues of mepiquat chloride at the levels observed in the monitoring data on cultivated oyster mushrooms is unlikely to present a risk to consumer health. The consumer risk assessment is affected by non-standard uncertainties. EFSA recommended to generate further data to derive definitive MRLs for mepiquat in oyster mushrooms and increase the robustness of the dietary risk assessment.
The peer review of the renewal of the approval of mepiquat 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 temporary MRL as reported in the summary table below.

Assessment
The use of mepiquat is authorised for cereals, leading to residues in cereal straw. The presence of mepiquat chloride in cultivated fungi is resulting from residues in cereal straw, which is used as a substrate to cultivate mushrooms.
Mepiquat belongs to the class of quaternary ammonium compounds with the ISO common name for 1,1-dimethylpiperidinium (IUPAC). For plant protection product formulations, the variant mepiquat chloride is used as an active ingredient. The chemical structure of the active substance, its salt and its main metabolite is reported in Appendix E.
Mepiquat was evaluated in the framework of Directive 91/414/EEC 1 with the United Kingdom designated as rapporteur Member State (RMS). The representative use assessed was the use as a plant growth regulator in cereals for stem stabilisation. The draft assessment report (DAR) prepared by the RMS has been peer reviewed by the European Food Safety Authority (EFSA, 2008). Mepiquat was approved 2 for the use as a plant growth regulator on 1 March 2009. The process of renewal of the first approval is currently ongoing.
The European Union (EU) maximum residue levels ( (EFSA, 2016). 5 In 2018, EFSA has issued two reasoned opinions on the modification of MRLs for mepiquat in oilseeds and animal products. The proposals from these reasoned opinions have been considered in the EU MRL legislation. 6 In accordance with Article 6 of Regulation (EC) No 396/2005, BASF submitted an application to the competent national authority in Finland (evaluating Member State, EMS) to modify the existing temporary MRL for the active substance mepiquat in cultivated fungi, based on monitoring data. 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 EFSA on 11 March 2019. The EMS proposed to set a separate temporary MRL of 0.7 mg/kg for oyster mushrooms and to keep the existing temporary MRL of 0.09 mg/kg for other cultivated fungi.
EFSA based its assessment on the evaluation report submitted by the EMS (Finland, 2019) as well as the conclusions of the EU pesticides peer review and from previous EFSA opinions on mepiquat (EFSA, 2008(EFSA, , 2015(EFSA, , 2016(EFSA, , 2018b. 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 7 .
As the EU pesticides peer review for the renewal of approval of the active substance in accordance with Regulation (EC) No 1107/2009 is not yet finalised, the conclusions reported in this reasoned opinion should be taken as provisional and 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, are presented in Appendix B.
The evaluation report submitted by the EMS (Finland, 2019), the exposure calculations using the EFSA Pesticide Residues Intake Model (PRIMo) and the Excel tables reporting the results of the monitoring sampling and analyses (data from EU monitoring and business operators) provided in support of the application are considered as supporting documents to this reasoned opinion and, thus, are made publicly available as background documents to this reasoned opinion.

1.
Residues in plants 1.1. Nature of residues and methods of analysis in plants 1.1.1. Nature of residues in primary crops The nature of mepiquat residues in primary crops following foliar applications of mepiquat chloride has been investigated in three crop groups (fruits, pulses/oilseeds and cereals/grass). These studies were assessed in the framework of the EU pesticide peer review and the MRL review of the active substance (EFSA, 2008(EFSA, , 2015. Limited metabolism was observed in all tested crops with mepiquat chloride representing the predominant component (72 to 90%) of the total radioactive residues (TRR).
Specific studies on the metabolism of mepiquat in mushrooms are not available. Since the metabolic profile of the active substance was seen to be similar in the three crops group investigated, in accordance with the current guidelines, a general residue definition was derived by EFSA, which also covers cultivated fungi (EFSA, 2016). Although not required according to the data requirements, it would be desirable to investigate the nature of residues in fungi, considering that the metabolism might be different in fungi growing as saprophytic organism.

Nature of residues in rotational crops
A confined rotational crop study using wheat, radish and lettuce planted in soil treated with mepiquat chloride was assessed during the EU pesticide peer review and the MRL review (EFSA, 2008(EFSA, , 2015. The accumulation of radioactivity in the plants indicated uptake of residues from the soil to wheat and radishes, but not in lettuce (where total residue was below limit of quantification (LOQ) at each plant-back interval (PBI)). The only compound identified was mepiquat chloride at levels below 0.01 mg/kg (except in wheat chaff, at 120 PBI). The remaining extractable radioactivity as well as the non-extractable radioactivity were concluded to be probably associated to metabolites (free, conjugated or incorporated into natural plant products) resulting from the fragmentation of the ring.
The residues of mepiquat in rotational crops are not of relevance for the assessment of the current application, as cultivated fungi are not grown in rotation with other plants. However, rotational crop metabolism studies provide useful information on the uptake of mepiquat chloride from soil by plants.

Nature of residues in processed commodities
The effect of processing on the nature of mepiquat residues was investigated in the framework of the EU pesticides peer review and it was demonstrated that mepiquat chloride remained stable under the standard hydrolysis conditions representative of pasteurisation, baking/brewing/boiling and sterilisation (EFSA, 2008).

Methods of analysis in plants
Analytical methods using liquid chromatography with tandem mass spectrometry (LC-MS/MS) detection were considered sufficiently validated for monitoring mepiquat chloride in plant commodities at or above the LOQ of 0.01 mg/kg (EFSA, 2018b). The reported LOQ is expressed as mepiquat chloride.
As mushrooms belong to the high-water content commodity group, EFSA confirms the previous conclusion that sufficiently validated analytical methods are available to control mepiquat chloride residues in cultivated fungi (EFSA, 2016).

Stability of residues in plants
Mepiquat chloride has been demonstrated to be stable for a period up to 24 months when stored at ≤ À20°C in high-water content matrices (EFSA, 2008), to which mushrooms belong.

Proposed residue definitions
Based on the results of the metabolism in primary and rotational crops and the hydrolysis studies, the following general residue definition for both monitoring and risk assessment in all plant commodities has been proposed in the framework of the MRL review (EFSA, 2015): • Sum of mepiquat and its salts, expressed as mepiquat chloride The residue definition for enforcement of mepiquat in Regulation (EC) No 396/2005 is identical as the above-mentioned residue definition.

Magnitude of residues in plants
In support of the MRL application, Finland assessed monitoring data on cultivated mushrooms, including oyster mushrooms, provided by food business operators (see Section 1.2.1.1). The samples were analysed in private laboratories. In addition, Finland assessed the data collected by EFSA in the framework of Article 32 of Regulation (EC) No 396/2005 (see Section 1.2.1.2). For these monitoring data, no information was available on condition and length of storage of the samples. However, the lack of this information was considered having a negligible impact, since samples from surveys are usually analysed within a few days after sampling (EFSA, 2016).
All residues were expressed as mepiquat chloride. 8 Furthermore, the EMS assessed the results of an experimental study conducted with oyster mushrooms grown in the presence of a known concentration of residues of mepiquat chloride in wheat straw (see Section 1.2.1.3).

Cultivated Oyster mushrooms
The EMS compiled monitoring data (n = 74) on mepiquat chloride in oyster mushrooms (Pleurotus ostreatus) from two different sources: The samples were originated from the Netherlands (55 samples), Poland (9 samples), Belgium (5), Germany (2 samples), Hungary (2 samples) and from the United Kingdom (1 sample). In 84% of the samples, mepiquat chloride was quantified (≥ LOQ), 45% of the samples showed residues higher than the existing MRL of 0.09 mg/kg. The highest residue value accounted for 2.95 mg/kg.
A histogram showing the distribution of mepiquat chloride residues found in these monitoring data, the overview of the monitoring sampling and the summary statistic to derive the MRL proposals according to the FAO methodology for extraneous MRLs (EMRL) and the approach outlined in Regulation (EU) 283/2013 9 are presented in Appendix B.

Cultivated mushrooms other than oyster mushrooms
The EMS compiled monitoring data (n = 306) from mushroom varieties different than oyster from two different sources: The samples were originated from the Netherlands (80 samples), Poland (22 samples), Belgium (2 samples), Germany (37 samples), France (40 samples), Italy (4 samples), Ireland (40 samples), United Kingdom (62 sample) and from Ireland/UK (19 samples). This data package showed a much lower percentage of samples exceeding the current MRL of 0.09 mg/kg (2% MRL exceedance). The highest residue value accounted for 0.24 mg/kg. These data give an indication that levels and frequency of mepiquat chloride residues differ among the mushroom varieties and that oyster mushrooms can be considered as worst-case for residue contamination.
A histogram showing the distribution of the mepiquat chloride residues, the overview of data and the summary statistic are presented in Appendix B.

Cultivated mushrooms from unknown varieties
In the framework of Article 32 of Regulation (EC) No 396/2005 (official national control programmes), monitoring data were submitted to EFSA. Among these data, which covered the reference period from 2014 to 2017, mepiquat results in cultivated mushrooms are available for 928 10 samples; details on the mushroom variety analysed were not reported.
These samples originated from 15 EU Member States (869 samples) and from non-EU countries (31 samples); for 28 samples the origin was unknown. Overall, 50% of the samples contained quantifiable residues of mepiquat chloride; 2% of the samples exceeded the current MRL of 0.09 mg/kg. The highest residue value observed was 0.85 mg/kg.
A histogram showing the distribution of the mepiquat chloride residues, the overview of data and the summary statistic are presented in Appendix B.

Transfer of mepiquat chloride residues from straw to oyster mushrooms
The applicant provided an experimental study investigating the uptake of mepiquat chloride residues in oyster mushrooms grown on wheat straw previously treated with mepiquat chloride.
The study was performed with P. ostreatus (oyster mushrooms), since compared to other cultivated mushroom varieties, oyster mushrooms are expected to lead to the highest residues of mepiquat chloride, since this variety is usually grown on a substrate that contains a higher amount of straw. For oyster mushrooms, the substrate is constituted of 95% of straw, whereas the substrate of Agaricus mushrooms is only 15% of straw (Finland, 2019). Thus, the oyster mushrooms were considered to be the worst-case for residue transfer.
The wheat straw used in the experiment was obtained from a northern EU field trial on wheat treated with mepiquat chloride according to the authorised Good Agricultural Practice (GAP) for wheat (1 9 0.76 kg/ha at BBCH 49); the same GAP was assessed to derive the current MRL for wheat grain (see Appendix A). Residues of mepiquat chloride observed in wheat straw at harvest ranged from 12.7 to 31.9 mg/kg; the baled straw used as a substrate for the cultivation of oyster mushrooms contained 22.5 mg/kg of mepiquat chloride.
Oyster mushrooms were cultivated directly onto the treated baled straw. At maturity, fungi samples were collected (from three baled straw, three flushes per bailed straw) and analysed for residues of mepiquat chloride. According to the EMS, the analytical method used to analyse the samples has been sufficiently validated and residue data were valid with regard to storage stability (Finland, 2019). The residue concentrations measured in oyster mushrooms ranged from 5.2 mg/kg to 44.3 mg/kg with a median residue concentration of 26.6 mg/kg. A median transfer factor of 1.2 was derived from three individual trials with 3 harvests, respectively.
In the supervised residue trials on cereals conducted according to the same GAP and assessed in the framework of the MRL review, residues of mepiquat chloride in wheat straw ranged from 2.64 to 50.1 mg/kg (STMR value 28.3 mg/kg) in the NEU. Additional results for wheat straw cultivated in SEU are available, ranging from 1.11 to 7.79 mg/kg (STMR value 3.92 mg/kg). For barley straw, the residues in NEU ranged from 1.1 mg/kg to 5.9 mg/kg (STMR value 2.34 mg/kg) and in SEU from 0.46 mg/kg to 3.35 mg/kg (STMR value 1.83 mg/kg) (EFSA, 2015).
Combining these results, the overall STMR and the HR for cereal straw was 4.2 mg/kg and 50.1 mg/kg for the NEU and 2.4 mg/kg and 7.8 mg/kg for the SEU. 11 Taking into account the indicative median transfer factor derived from the experimental study provided by the applicant, the median and highest residue concentrations in oyster mushrooms are calculated to be 5 and 60 mg/kg, respectively.
Based on the results of the supervised field trials on cereals assessed in the MRL review and the results of the transfer study described above, significantly higher residues compared to those observed in monitoring data might be expected in oyster mushrooms.

Magnitude of residues in rotational crops
Not relevant for the current assessment.

Magnitude of residues in processed commodities
Studies investigating the effect of processing on the magnitude of mepiquat chloride residues in processed cultivated fungi have not been submitted and are not required, considering the low contribution of residues in this crop to the total calculated consumer exposure.

Proposed temporary MRLs
To derive MRL proposals from the available monitoring data in oyster mushrooms provided by food business operators, EFSA used the methodologies developed by FAO (2016). EFSA calculated four different MRL options, i.e. the residue concentration corresponding to 95th, 97.5th, 99th percentile and the concentration that covers the 95th percentile of the data population at the 95% confidence level (approach laid down in Regulation (EU) No 283/2013 and reported in European Commission (2018)). For sake of consistency, the method to estimate percentiles from monitoring data on cultivated fungi used in the previous EFSA opinion (EFSA, 2016; considering a data set of 524 samples) was the same as the one applied in the present opinion. 12 The MRL of 0.7 mg/kg at the 95th percentile derived by the EMS excluding the extreme values might be an alternative option as it leads to a lower MRL value and the number of non-compliances is very low (5%). Since the consumer risk assessment to be carried out is unaffected by the choice, it is proposed to risk manager to decide which of these options should be considered for the modification of the existing temporary MRL in oyster mushrooms.
The calculated values were rounded to the class of MRL setting according to SANCO 16340/2010 (European Commission, 2010). The different MRL proposals expressed as mepiquat chloride are summarised below.
The available data demonstrated that for oyster mushrooms, higher residues of mepiquat chloride are expected than in other mushrooms species. The monitoring data from national programmes (928 samples) confirmed the existing temporary MRL for cultivated fungi (2% non-compliance rate observed in monitoring data from EU pesticide residue monitoring). The monitoring data provided by food business operators on mushrooms other than oyster mushrooms gave similar result (2% noncompliance rate).
In Section 3, EFSA assessed whether residues on cultivated fungi are likely to pose a consumer health risk.

Residues in livestock
Not relevant for the current assessment. Cultivated fungi are not used as feed items.

Consumer risk assessment
The consumer risk assessment was performed with revision 3.1 of the EFSA Pesticide Residues Intake Model (PRIMo). This exposure assessment model contains the relevant European food consumption data for different subgroups of the EU population (EFSA, 2018a). Since the PRIMo model does not contain specific consumption data for oyster mushrooms, the exposure calculation was performed using consumption data for cultivated fungi which cover all varieties of cultivated mushrooms. The estimated exposure was compared with the toxicological reference values derived for mepiquat chloride during the EU pesticides peer-review (European Commission, 2008).

Long-term (chronic) dietary risk assessment
The most recent long-term exposure assessment performed by EFSA (2018c) was updated with the median residue value observed in the monitoring data on oyster mushrooms assessed in this MRL application. For the remaining commodities of plant and animal origin, the supervised trial median residues (expressed as mepiquat chloride) derived for the authorised uses of mepiquat were used as input values.
The estimated long-term dietary intake of mepiquat chloride was in the range of 0.1-7% of the ADI (maximum for Dutch toddlers). The contribution of cultivated fungi accounted for up to 0.01% of the ADI (Irish adults).
The chronic risk assessment is affected by non-standard uncertainties.
• Specific consumption data for oyster mushrooms (P. ostreatus) are not available. The calculations were performed assuming that the median residue found in oyster mushrooms is representative for all cultivated mushrooms, which is expected to lead to a light overestimation of the exposure.
• The calculation was performed using the median residue observed in monitoring data on oyster mushrooms provided by the food business operators instead of the STMR value derived from field residue trials.

Short-term (acute) dietary risk assessment
The acute exposure assessment was performed only with regard to the commodity under assessment, considering the highest residue value observed in the monitoring data on oyster mushrooms (data provided by food business operators). The default variability factor of 7 included in the PRIMo 3.1 model was used in the calculation (scenario 1). It is expected that for mushrooms a lower unit-to-unit variability might be appropriate. Therefore, a second scenario was calculated using a variability factor of 3 (scenario 2). In both scenarios, no acute consumer risk was identified for oyster mushrooms (17% and 11% of the ARfD, respectively, Belgian toddlers).
The acute risk assessment is affected by the following non-standard uncertainties: • Specific consumption data for oyster mushrooms (P. ostreatus) are not available; the exposure calculations were performed using the large portion consumption data reported for all mushroom varieties.
• Information on the unit-to-unit variability expected in oyster mushrooms is not available.
• The calculation was performed using the highest residue concentration observed in the monitoring data on oyster mushrooms provided by the food business operators (i.e. 2.95 mg/ kg). The transfer study (see Section 1.2.1.3) and the information from supervised residue trials in cereal straw give an indication that significantly higher residues might occur in oyster mushrooms (up to 60 mg/kg) when mepiquat is applied according to the critical GAP (cGAP) (EFSA, 2015). Therefore, it cannot be excluded that the short-term exposure may be higher than the exposure calculated from the submitted monitoring data.
For further details on the exposure calculations, a screenshot of the Report sheet of the PRIMo is presented in Appendix C and the input values for the calculation in Appendix D.

Conclusion and Recommendations
Based on the results of a total of 74 samples on oyster mushrooms analysed by food business operators between 2015 and 2019, different MRL proposals were derived using the methodologies recommended by the FAO (2016). A risk management decision is required, considering the acceptable non-compliance rate, in order to decide which temporary MRL is appropriate.
EFSA concluded that the exposure to residues at the levels observed from the monitoring data collected on cultivated oyster mushrooms (data provided by food business operators) is unlikely to present a risk to consumer health.
In order to derive a definitive MRL for oyster mushrooms and to reduce the uncertainties of the dietary risk assessment, EFSA recommends the following: • To perform residue trials that allow a reliable prediction of expected residues in oyster mushrooms cultivated on straw that contains residue concentrations of mepiquat chloride resulting from authorised uses of mepiquat in cereals; • Alternatively, further studies to investigate the transfer of residues from straw to oyster mushrooms to derive a more robust transfer factor; • Studies investigating the unit-to-unit variability of mepiquat chloride residues in individual mushrooms to reduce the uncertainties related to the acute risk assessment; • Moreover, it would be desirable to investigate the nature of residues in fungi, considering that in fungi growing as saprophytic organism, metabolism might be different.
Furthermore, possible risk management restrictions might be discussed to reduce the occurrence of mepiquat chloride in cultivated mushrooms, such as restrictions to cultivate mushrooms in mepiquatfree straw (or, alternatively, to set a threshold residue limit for mepiquat chloride for straw used as substrate in mushroom cultivation), in order to avoid contamination of oyster mushrooms and other fungi cultivated in cereal straw.
The Appendix A -Summary of intended GAP triggering the amendment of existing EU MRLs Not relevant for mushrooms, since a direct treatment of cultivated fungi is not proposed.
Critical GAPs assessed in the framework of the MRL review for mepiquat for cereals, leading to residues in straw (EFSA, 2015).   The estimated long-term dietary intake (TMDI/NEDI/IEDI) was below the ADI. The long-term intake of residues of Mepiquat (sum of mepiquat and its salts, expressed as mepiquat chloride) is unlikely to present a public health concern.
Rye Sunflower seeds Wheat Mepiquat (sum of mepiquat and its salts, expressed as mepiquat chloride)