Peer review of the pesticide risk assessment for the active substance metazachlor in light of confirmatory data submitted

Abstract

The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, the United Kingdom, for the pesticide active substance metazachlor are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory data regarding the groundwater exposure of metabolites and their toxicological relevance triggering an assessment. The conclusions were reached on the basis of the evaluation of the representative uses of metazachlor as a herbicide on winter and spring rapeseed and on ornamental trees and shrubs. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Concerns are identified.

Summary

Metazachlor was included in Annex I to Directive 91/414/EEC on 1 August 2009 by Commission Directive 2008/116/EC, 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. It was a specific provision of the approval that the applicant was required to submit to the European Commission further data on potential groundwater contamination from several metabolites. Indeed, conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 in vulnerable zones, where appropriate. If metazachlor is classified under Directive 67/548/EEC as ‘limited evidence of a carcinogenic effect’, the Member States concerned shall request the submission of further information on the relevance of the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 with respect to cancer. Information shall be provided to the Commission within 6 months from the notification of such a classification decision.

Metazachlor was formally classified under Regulation (EC) No 1272/2008 as suspected of causing cancer (category 2, H351).

In accordance with the specific provision, the applicant, BASF SE and Feinchemie (Makhteshim Agan) submitted an updated dossier in February 2012, which was evaluated by the designated rapporteur Member State (RMS), the United Kingdom, in the form of an addendum to the draft assessment report. In compliance with guidance document SANCO 5634/2009‐rev. 4.5 (European Commission, 2011), the RMS distributed the addendum to Member States, the applicant and the European Food Safety Authority (EFSA) for comments on 10 September 2013. Following the first commenting round, a revised version of the annex to the addendum was distributed for comments to Member States, the applicant and EFSA on 26 February 2016. The RMS collated all comments in the format of a reporting table, which was submitted to EFSA on 8 August 2016. EFSA added its scientific views on the specific points raised during the commenting phase in column 4 of the reporting table and finalised the Technical Report in August 2016 (EFSA, 2016).

Following consideration of the comments received, the European Commission requested EFSA to organise a peer review of the evaluation by RMS of the confirmatory data submitted in relation to the groundwater exposure of metabolites and their toxicological relevance triggering an assessment.

In the mammalian toxicology area, it was concluded that metabolites 479M04, 479M08 and 479M12 are not relevant up to stage 3 of step 3 of the guidance document on the assessment of the relevance of metabolites in groundwater (European Commission, 2003), while metabolites 479M09 and 479M11 are relevant should they occur in groundwater above the parametric drinking water limit of 0.1 μg/L according to environmental exposure assessment. Additionally, acceptable daily intake (ADI) values were established to perform step 5 refined risk assessments for non‐relevant metabolites.

With the predicted levels in groundwater for metabolites 479M04, 479M08 and 479M12, the potential exposure of consumers to drinking water abstracted from groundwater is individually around or less than 1% of the ADI for all considered consumer groups (infant, child, adult). Therefore, total intakes from food and the drinking of groundwater considering the chronic consumer exposure scenarios are expected to be well below the established toxicological reference values also in view of the previously obtained results for consumer dietary exposure considering the representative uses of metazachlor (EFSA, 2008a).

Information to address the confirmatory data requirements for metazachlor and its soil metabolites regarding the groundwater leaching potential was submitted by the applicant. This information include new aerobic soil degradation studies for metabolites 479M04, 479M09, 479M11 and 479M12, new studies on the adsorption behaviour of metabolites 479M09, 479M11 and 479M12, new predicted environmental concentrations in groundwater (PEC_gw) with FOCUS groundwater modelling, third party monitoring studies, and a very comprehensive approach to refine the groundwater leaching assessment following the recommendations for the tiered approach outlined in FOCUS (2009). The potential for groundwater exposure above the parametric drinking water limit of 0.1 μg/L is expected to be high in geoclimatic and use situations represented by all the relevant FOCUS groundwater scenarios for all the metabolites. In contrast, in none of the 48 groundwater samples taken at four sites in the targeted monitoring study conducted in Germany, where metazachlor was applied on oilseed rape, 479M09 and 479M11 were detected. However, the number of these good quality monitoring sites is too low to conclude that the results of the higher tier groundwater monitoring data can override the lower tier FOCUS modelling results for metazachlor and its metabolites in a regulatory context. Therefore, a critical area of concern was identified for potential ground water contamination by the metabolite 479M09 and 479M11 that, with the available toxicological information, have to be considered toxicologically relevant. A data gap was identified for satisfactory information on the hydrogeological characteristics of the targeted monitoring sites in France in order to properly assess the vulnerability of the selected monitoring scenarios. Finally, the new FOCUS groundwater modelling, based on the peer reviewed agreed endpoints, was repeated for winter and spring oil seed rape only. This is identified as a groundwater exposure assessment not finalised for the representative uses in ornamental trees and shrubs.

Background

Metazachlor was included in Annex I to Directive 91/414/EEC1 on 1 August 2009 by Commission Directive 2008/116/EC2, and has been deemed to be approved under Regulation (EC) No 1107/20093 in accordance with Commission Implementing Regulation (EU) No 540/20114, as amended by Commission Implementing Regulation (EU) No 541/20115. The European Food Safety Authority (EFSA) previously finalised a Conclusion on this active substance (EFSA, 2008a).

It was a specific provision of the approval that the applicant was required to submit to the European Commission further data on potential groundwater contamination from several metabolites. Indeed, conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 in vulnerable zones, where appropriate. If metazachlor is classified under Directive 67/548/EEC6 as ‘limited evidence of a carcinogenic effect’, the Member States concerned shall request the submission of further information on the relevance of the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 with respect to cancer. Information shall be provided to the Commission within 6 months from the notification of such a classification decision.

Metazachlor was formally classified under Regulation (EC) No 1272/20087 as suspected of causing cancer (category 2, H351).

In accordance with the specific provision, the applicant, BASF SE and Feinchemie (Makhteshim Agan) submitted an updated dossier in February 2012, which was evaluated by the designated rapporteur Member State (RMS), the United Kingdom, in the form of an addendum to the draft assessment report. In compliance with guidance document SANCO 5634/2009‐rev.4.5 (European Commission, 2011), the RMS distributed a first version of the addendum (United Kingdom, 2013) to Member States, the applicant and EFSA for comments on 10 September 2013. Then, in compliance with guidance document SANCO 5634/2009‐rev. 4.5 (European Commission, 2011), a revised version of the addendum to Member States, the applicant and EFSA was distributed for comments on 26 February 2016. The RMS collated all comments in the format of a reporting table, which was submitted to EFSA on 8 August 2016. EFSA added its scientific views on the specific points raised during the commenting phase in column 4 of the reporting table and finalised the Technical Report in August 2016 (EFSA, 2016).

Following consideration of the comments received, the European Commission requested EFSA to organise a peer review of the evaluation by RMS of the confirmatory data submitted in relation to the groundwater exposure of metabolites and their toxicological relevance triggering an assessment.

The addendum and the reporting table were discussed at the Pesticides Peer Review Meeting on mammalian toxicology and environmental fate in February 2017. Details of the issues discussed, together with the outcome of these discussions were recorded in the meeting reports.

A final consultation on the conclusions arising from the peer review took place with Member States via a written procedure in March–April 2017.

The conclusions laid down in this report were reached on the basis of the peer review of the RMS's evaluation of the confirmatory data submitted on relevance groundwater metabolites and their exposure assessment. A key supporting document to this conclusion is the peer review report, which is a compilation of the documentation developed to evaluate and address all issues raised in the peer review. The peer review report (EFSA, 2017) comprises the following documents, in which all views expressed during the course of the peer review, including minority views, can be found:

• the report of the scientific consultation with Member State experts;

• the comments received on the draft EFSA conclusion.

Given the importance of the addendum to the assessment report and its annex (United Kingdom, 2013, 2016) and the peer review report, these documents are considered as background documents to this conclusion.

It is recommended that this conclusion report and its background documents would not be accepted to support any registration outside the European Union (EU) for which the applicant has not demonstrated to have regulatory access to the information on which this conclusion report is based.

The active substance and the formulated product

Metazachlor is the ISO common name for 2‐chloro‐N‐(pyrazol‐1‐ylmethyl)acet‐2′,6′‐xylidide (IUPAC).

The representative formulated products for the evaluation were ‘Butisan S (BAS 479 22H)’, and ‘Fuego’, both suspension concentrates (SC) containing 500 g/L metazachlor.

The representative uses evaluated comprise foliar spraying on winter and spring rapeseed and on ornamental trees and shrubs (nursery, ornamental trees, shrubs and forest) against annual weeds and grass weeds,. Full details of the Good Agricultural Practice (GAP) can be found in the list of end points in Appendix A.

Conclusions of the evaluation

In line with the provisions of Commission Directive 2008/116/EC, the applicant has submitted further data on potential groundwater contamination from several metabolites including risk mitigation measures and monitoring programmes to verify potential groundwater contamination from the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 in vulnerable zones, where appropriate. If metazachlor is classified under Directive 67/548/EEC as ‘limited evidence of a carcinogenic effect’, the Member States concerned shall request the submission of further information on the relevance of the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 with respect to cancer. Information shall be provided to the Commission within 6 months from the notification of such a classification decision. The Risk Assessment Committee of the European Chemical Agency (ECHA) in its Opinion of 8 March 2011 (ECHA, 2011) confirmed that metazachlor should be classified as suspected of causing cancer (category 2, H351) and therefore this point was further considered.

The assessment of the information was presented in a confirmatory data addendum and its annex (United Kingdom, 2013, 2016). The conclusions laid down in this report were reached on the basis of the peer review of the RMS's evaluation of the confirmatory data submitted on the groundwater exposure of metabolites and their toxicological relevance triggering an assessment.

Mammalian toxicity

The toxicological relevance of groundwater metabolites of metazachlor was discussed during the Pesticides Peer Review Meeting 151 in February 2017.

Classification of metazachlor as Carc Cat 2, H351 ‘suspected of causing cancer’, has been adopted under Reg. (EC) No 1272/20087 (updated in its 3rd adaptation to technical progress8). Thus, an assessment of the toxicological profile of metabolites is necessary to assess whether the metabolites may share the carcinogenic potential of the parent metazachlor in accordance with the guidance document on the assessment of the relevance of metabolites in groundwater (European Commission, 2003).

During the expert Meeting 151, it was concluded that metabolites 479M04 (BH 479‐4) and 479M08 (BH 479‐8) are not relevant up to stage 3 of step 3 of the guidance document (European Commission, 2003) since they do not share the early events associated with the carcinogenic effects observed with the parent, metazachlor. It had been previously agreed that the metabolite 479M12 (BH 479‐12) is not relevant, but 479M09 (BH 479‐9) and 479M11 (BH 479‐11) are relevant groundwater metabolites (EFSA, 2008a) should they occur in groundwater above the parametric drinking water limit of 0.1 μg/L according to environmental exposure assessment.

Additionally, since triggered following the exposure assessment with regard to metabolites 479M04, 479M08 and 479M12 in line with step 4 of the guidance document (European Commission, 2003) (see residues Section), the following acceptable daily intake (ADI) values were established to perform a step 5 refined risk assessment for non‐relevant metabolites: 0.33 mg/kg body weight (bw) per day for 479M04, based on a 90‐day study in mice, applying an uncertainty factor (UF) of 1,000 to account for the limited data set; 0.2 mg/kg bw per day for 479M08, based on the developmental no observed adverse effect level (NOAEL) of 195 mg/kg bw per day from a developmental toxicity study in rats, applying the same UF of 1,000 to account for the limited data set; and 0.38 mg/kg bw per day for 479M12, based on the rat, 28‐day and mouse, 90‐day studies, UF 1,000 applied to account for the limited data set.

Residues

With regard to the occurrence of metabolites 479M04, 479M08 and 479M12 in groundwater above the parametric drinking water limit of 0.1 μg/L using FOCUS modelling and taking into account the provisions for exposure assessments to be conducted in line with step 4 of the guidance document (European Commission, 2003), potential consumer exposure from both sources, groundwater and treated commodities has to be taken into account. Therefore, consumer intake assessments were conducted for metabolites 479M04, 479M08 and 479M12, either of which being a groundwater and plant metabolite.

At the stage of finalisation of the peer review (EFSA, 2008a), the residue definition for dietary risk assessment was proposed as the sum of metazachlor and its metabolites containing the 2,6‐dimethylaniline moiety, expressed as metazachlor for all crop categories. The proposal took into account that the toxicological information provided on several plant metabolites suggested that these metabolites could be considered in the consumer risk assessment of comparable toxicity to the parent compound. In view of the toxicological information recently assessed on metabolites 479M04 (BH 479‐4), 479M08 (BH 479‐8) and 479M12 (BH 479‐12) (see Section mammalian toxicology), it appears that compared to the formerly proposed reference values for the metabolites the newly proposed ADI values are higher by a factor of at least 2.5 considering 479M08, a major plant metabolite in oilseed rape. However, for other plant metabolites currently also included in the risk assessment residue definition, e.g. 479M11 (BH 479‐11, found > 0.01 mg/kg in rotational crops), it cannot be confirmed that they are of different toxicity compared to metazachlor. In addition, in the majority of residue trials a common moiety method was used to determine residues of compounds containing the 2,6‐dimethylaniline moiety, and therefore, an amendment of the residue definition for dietary risk assessment considering the less critical toxicological reference values for metabolites 479M04, 479M08 and 479M12 is not possible with the available data and the conclusion of the peer review remains unchanged. The dietary exposure from food (representative uses) considering residues of metazachlor and its metabolites containing the 2,6‐dimethylaniline moiety using the reference values for metazachlor was < 1% ADI and < 0.1% acute reference dose (ARfD) (EFSA, 2008a).

The consumer exposure assessment with regard to groundwater potentially used as drinking water is based on the default assumptions laid down in the WHO Guidelines (WHO, 2011) for drinking water quality for (a) a 60‐kg adult drinking 2 L of water per day, (b) a 10‐kg child drinking 1 L of water per day and (c) a 5‐kg bottle‐fed infant drinking 0.75 L of water per day. With the predicted levels in groundwater, the consumer exposure for the metabolites 479M04, 479M08 and 479M12 individually is around or less than 1% ADI for all considered consumer groups. Therefore, total intakes (from food and the drinking of groundwater) considering the chronic consumer exposure scenarios are expected to be well below the established toxicological reference values.

Fate and behaviour

Metazachlor was discussed at the Pesticides Peer Review Meeting 152 in February 2017.

Information to address the confirmatory data requirements for metazachlor and its soil metabolites regarding the groundwater leaching potential was submitted by the applicant. This information include new aerobic soil degradation studies for metabolites 479M04 (BH 479‐4), 479M09 (BH 479‐9), 479M11 (BH 479‐11) and 479M12 (BH 479‐12), new studies on the adsorption behaviour of metabolites 479M09, 479M11 and 479M12, new predicted environmental concentrations in groundwater (PEC_gw) with FOCUS groundwater modelling, third party monitoring studies, and a very comprehensive approach to refine the groundwater leaching assessment following the recommendations for the tiered approach outlined in FOCUS (2009).

In soil laboratory incubations under aerobic conditions in the dark, metazachlor exhibits low to moderate persistence forming the major (> 10% applied radioactivity (AR)) metabolites 479M04 (max. 16.2% AR) and 479M08 (max. 21.6% AR). The persistence of these two metabolites ranged from moderate to very high for 479M04 and medium to very high for 479M08. Metabolite 479M11 (which exhibited moderate persistence) was present at levels that trigger a groundwater exposure assessment (> 5% AR in two consecutive sampling dates, max. 7.5% AR). Other metabolites identified were detected in smaller amounts 479M09 (max. 5.3% AR, moderate persistence in soil) and 479M12 (max. 2.8% AR, medium to high persistence). Mineralisation of the phenyl ring radiolabel to carbon dioxide accounted for about 7% AR after 100 days. The formation of unextractable residues for this radiolabel accounted for 43% AR after 91–100 days. In anaerobic soil incubations, metabolite 479M06 (BH 479‐6) occurred in amounts greater than 10% AR (max. 8.2–18.5% AR at day 68–120). For the intended use of metazachlor applied in the autumn to oilseed rape, periods of anaerobic conditions will occur in practice. However, the incidence of periods when conditions would be truly anaerobic for longer than 30 days would be very rare. Therefore, an environmental exposure assessment for this metabolite is not considered necessary.

Field soil dissipation studies where parent metazachlor was applied to bare soil or seeded oilseed rape before emergence were carried out at five sites in Germany, two sites in Spain and one site in Sweden. In addition, metabolite 479M08 was applied as test substance to bare soil in two sites in Germany. The persistence of metazachlor was low to moderate and showed no tendency to move into deeper layers of soil in amounts measurable by the soil methods. Metabolites 479M04 and 479M08, which exhibited moderate to medium and moderate to high persistence, respectively. These two metabolites, at least in some trials, showed a tendency to move into the deeper soil layers. After the application of metabolite 479M08 the compound could be detected up to 1 year after application in one trial. Additionally, it could be found in soil layers down to 75 cm.

Metazachlor exhibited medium high mobility in soils, while the mobility of metabolites 479M04, 479M06 and 479M08 was high to very high and the mobility of metabolites 479M09, 479M11 and 479M12 was very high. There was no evidence that the adsorption of metazachlor and of its metabolites was pH dependent. In a 2‐year lysimeter study carried out in northern Germany, metazachlor was applied in the first year only to the soil surface as a spray 15 days after an oilseed rape crop was sown in September at a rate equivalent to 1 kg a.s./ha. Parent metazachlor was not determinable (limit of detection 0.04 μg/L) in any leachate sample. In contrast, the maximum annual average concentration of 479M04 was 21.4 μg/L (parent equivalents). In the leachate samples, metabolite 479M12 was present at up to 3.6 μg/L, 479M08 was up to 17.3 μg/L, 479M09 was up to 3.3 μg/L and 479M11 was up to 2.5 μg/L (note these concentrations are not annual averages).

The necessary groundwater exposure assessments were appropriately carried out using FOCUS (2009) scenarios and the models PEARL 4.4.4 and PELMO 4.4.3 for the active substance metazachlor and the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12. It should be noted that the available simulations assume an application every third year only and used a Q10 of 2.2, which is not in line with the current EFSA (2008b) and a Walker equation coefficient of 0.7.

For metazachlor, the potential for groundwater exposure from the representative uses on spring and winter oilseed rape above the parametric drinking water limit of 0.1 μg/L was concluded to be low in geoclimatic situations that are represented by all FOCUS groundwater scenarios (six scenarios for winter oilseed rape and three scenarios for spring oilseed rape). The potential for groundwater exposure by the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 was however concluded to be high over a wide range of geoclimatic conditions represented by the FOCUS groundwater scenarios (see Table 1). It should be noted that the new FOCUS groundwater modelling based on the peer reviewed agreed input parameters, did not include the representative use on ornamental trees and shrubs (considering apples as the surrogate crop to be selected for FOCUS calculations). This is identified as an issue not finalised.

Table 1.

Results from the FOCUS modelling as well as the targeted monitoring data from Germany

	Metazachlor	479M04		479M08		479M09
FOCUS modelling results (winter oil seed rape)
Number of scenarios > 0.1 μg/L	0/6	6/6		6/6		6/6
Number of scenarios > 10 μg/L	0/6	0/6		2/6		0/6
Range (μg/L)	< 0.001	3.78–6.29		6.19–14.18		0.37–1.37
FOCUS modelling results (spring oil seed rape)
Number of scenarios > 0.1 μg/L	0/3	3/3		3/3		3/3
Number of scenarios > 10 μg/L	0/3	0/3		0/3		0/3
Range (μg/L)	< 0.001	1.53–5.15		3.57–8.92		0.13–0.52
Monitoring data
Germany (targeted monitoring, 4 sitesa, 48 samples)
Detection > 0.1 μg/L (% of analysed samples)	n.a.	52%		54%		0%
Max. value (μg/L)	n.a.	1.80		6.76		< 0.05
	479M11		479M12
FOCUS modelling results (winter oil seed rape)
Number of scenarios > 0.1 μg/L	6/6		6/6
Number of scenarios > 10 μg/L	0/6		1/6
Range (μg/L)	0.24–1.43		3.64–15.74
FOCUS modelling results (spring oil seed rape)
Number of scenarios > 0.1 μg/L	3/3		3/3
Number of scenarios > 10 μg/L	0/3		0/3
Range (μg/L)	0.24–0.48		3.04–7.78
Monitoring data
Germany (targeted monitoring, 4 sitesa, 48 samples)
Detection > 0.1 μg/L (% of analysed samples)	0%		23%
Max. value (μg/L)	< 0.05		0.16

n.a.: not analysed.

^aOnly four groundwater monitoring sites in Germany were considered by the Pesticide Peer Review Meeting 152 suitable regarding monitoring site quality criteria to address the groundwater exposure of metazachlor for the applied representative uses.

In the framework of the confirmatory data assessment, a very comprehensive approach to refine the groundwater leaching assessment was submitted by the applicant. The information submitted include two targeted groundwater monitoring studies for the metabolites of metazachlor (one conducted in Germany and one in France), an assessment of the vulnerability of the monitoring sites, a vulnerability assessment for the area of intended use and, finally, the vulnerability of monitoring scenarios was compared with the vulnerability of the intended use areas. The experts’ meeting (Pesticide Peer Review Meeting 152) discussed to what extent these monitoring data should be taken into account in the groundwater risk assessment. It was acknowledged that although in the FOCUS Groundwater Guidance (2009) a list of the quality criteria for monitoring data is provided, a specific EU Guidance on the implementation of these quality criteria would be helpful in harmonising the evaluation process.

The discussion over the French targeted groundwater monitoring study was supported by the evaluation performed at the national level in France and reported by the French expert during the meeting. Of the 20 sites monitored in France, four sites were considered to have low vulnerability based on evidence of substance use, soil column properties and connection to groundwater/sampling location and the weather conditions. The other 16 sites were considered by the national geological experts in France to be vulnerable and associated with oilseed rape use. However, the experts noted that the reporting of the hydrogeological characteristics of the French monitoring sites provided by the applicant in the dossier was insufficient to conduct an appropriate evaluation of the data. Therefore, a data gap was identified. For the German sites (22 in total), good quality information on the hydrogeological situation was reported by the applicant. Taking into consideration the in‐depth evaluation reported by the national German expert during the meeting, the experts concluded that only four locations (wells Schlamersdorf, Schoenkamp, Damm and Berge) are considered suitable regarding monitoring site quality criteria (as described by FOCUS Groundwater, 2009) to address the groundwater exposure of metazachlor for the applied representative uses. In these hydrogeological vulnerable situations that are typical for oilseed rape cultivation in Germany, the results of the targeted groundwater monitoring study show that residues of the relevant metabolites 479M09 and 479M11 are all below limit of quantification (LOQ) (< 0.05 μg/L) at all sampling points and all points in time. In the same monitoring period, 52% of the analysed samples for metabolite 479M04 were above 0.1 μg/L, 54% of the analysed samples for metabolite 479M08 were above 0.1 μg/L and 23% of the analysed samples for metabolite 479M12 were above 0.1 μg/L.

As had been agreed previously in the context of the use of residue levels in samples taken from the saturated zone (EFSA, 2011), it was considered appropriate to compare regulatory triggers with concentrations measured in individual samples and not with the annual averages that are relevant when assessing concentrations in leachate recharge leaving the upper layers of the soil column.

A summary of the monitoring and modelling results are presented in the following bullets and in Table 1.

479M04: The potential for groundwater exposure above the parametric drinking water limit of 0.1 μg/L is expected to be high in geoclimatic and use situations represented by all the relevant FOCUS groundwater scenarios and in the targeted monitoring study in Germany.

479M08: The potential for groundwater exposure above the parametric drinking water limit of 0.1 μg/L is expected to be high in geoclimatic and use situations represented by all the relevant FOCUS groundwater scenarios and in the targeted monitoring study in Germany. In geoclimatic conditions represented by 2/6 FOCUS groundwater scenarios for winter oilseed rape use, concentrations (80th percentile annual average recharge concentrations moving below the top 1 m) of the non‐relevant metabolite 479M08 were predicted to be above 10 μg/L.

479M09: The potential for groundwater exposure above the parametric drinking water limit of 0.1 μg/L is expected to be:

• 1–  high in geoclimatic and use situations represented by all the relevant FOCUS groundwater scenarios.
• 2–  low in geoclimatic and use situations represented by targeted monitoring in Germany.

479M11: The potential for groundwater exposure above the parametric drinking water limit of 0.1 μg/L is expected to be:

• 1–  high in geoclimatic and use situations represented by all the relevant FOCUS groundwater scenarios.
• 2–  low in geoclimatic and use situations represented by targeted monitoring in Germany.

479M12: The potential for groundwater exposure above the parametric drinking water limit of 0.1 μg/L is expected to be:

• 1–  high in geoclimatic and use situations represented by all the relevant FOCUS groundwater scenarios.
• 2–  intermediate in geoclimatic and use situations represented by the targeted monitoring in Germany.
• 3–  in geoclimatic conditions represented by 1/6 FOCUS groundwater scenarios for winter oilseed rape use, concentrations (80th percentile annual average recharge concentrations moving below the top 1 m) of the non‐relevant metabolite 479M12 were predicted to be above 10 μg/L.

The peer review concluded also that the read across from these French and German field testing sites with their periods of investigation to other regions of Europe is of limited use in this case, and that the third party monitoring data from national authority in Germany can be considered as providing only supportive information.

At the meeting of experts, it was recalled that the FOCUS groundwater guidance (2009) indicates that 90% of analyses obtained from at least 20 locations targeted to the pesticide of interest would need to be < 0.1 μg/L to demonstrate that the potential for groundwater exposure from the representative uses is low. Therefore, in the case of metazachlor, only four sites were available when consideration is made of the information provided by the applicant that could be peer reviewed by EFSA and member states experts. Overall, the experts agreed that the monitoring data have utility to describe the leaching potential of metazachlor and its metabolites. However, when considering FOCUS groundwater guidance (2009), the number of good quality monitoring sites is too low to conclude that the results of the higher tier groundwater monitoring data override the lower tier FOCUS modelling results for metazachlor and its metabolites in a regulatory context. Based on the available information in the Mammalian Toxicology Section, metabolite 479M04, 479M08 and 479M12 are considered not toxicological relevant. Metabolites 479M09 and 479M11 are relevant from the toxicological point of view as it cannot be excluded that they share the carcinogenic potential of the parent compound.

Overview of the risk assessment of compounds listed in residue definitions triggering assessment of effects data for the environmental compartments (Tables 2–3)

Table 2.

Soil

Compound (name and/or code)	Persistence
Metazachlor	Low to moderate persistence Single first‐order (SFO) DT50 3.1–25.3 days (20°C, 40% MWHC soil moisture) (Field dissipation studies: SFO DT50 2.0–14.4 days; 20°C, pF 2 soil moisture)
479M04	Moderate to very high persistence SFO DT50 22.4–578 days (20°C, 40–60% MWHC soil moisture) (Field dissipation studies, moderate to medium persistence: SFO DT50 49.9–66 days; 20°C, pF 2 soil moisture)
479M08	Medium to very high persistence SFO DT50 60.2–375 days (20°C, 40–60% MWHC soil moisture) (Field dissipation studies, moderate to high persistence: SFO DT50 43.4–116.4 days; 20°C, pF 2 soil moisture)
479M09	Moderate persistence SFO and biphasic kinetic: DT50 13.8–39.0 days (DT90 45.9–129 days; 20°C, 40% MWHC soil moisture)
479M11	Moderate persistence SFO and biphasic kinetic: DT50 21.0–52.4 days (DT90 69.8–174 days; 20°C, 40% MWHC soil moisture)
479M12	Medium to high persistence SFO DT50 63–148 days (20°C, 40% MWHC soil moisture)

DT₅₀: period required for 50% dissipation; MWHC: maximum water‐holding capacity; DT₉₀: period required for 90% dissipation.

Table 3.

Groundwater

Compound (name and/or code)	Mobility in soil	> 0.1 μg/L at 1 m depth for the representative uses(a)	Pesticidal activity	Toxicological relevance
Metazachlor	Medium to high mobility 53.8–220 mL/g	FOCUS: No Lysimeter: No	Yes	Yes
479M04	High to very high mobility 1–94 mL/g	FOCUS: Yes 6/6 FOCUS scenarios > 0.1 μg/L (3.78–6.29 μg/L) Lysimeter: Yes The trigger value of 0.1 μg/L was exceeded in the lysimeter study available (max. annual average concentration 21.4 μg/L) and in 52% of the samples in targeted monitoring study in Germany, concentrations up to 1.80 μg/L	No	No, up to stage 3 of step 3 of the guidance (European Commission, 2003) ADI 0.33 mg/kg bw per day
479M08	Very high mobility 4–78.5 mL/g	FOCUS: Yes 6/6 FOCUS scenarios > 0.1 μg/L (6.2–14.2 μg/L) 2/6 FOCUS scenarios > 10 μg/L for winter oilseed rape (Chateaudun and Hamburg scenarios) Lysimeter: Yes The trigger value of 0.1 μg/L was exceeded in the lysimeter study available (max. concentration in two leachate samples 5.8–12 μg/L), and in 54% of the samples in targeted monitoring study in Germany, concentrations up to 6.76 μg/L	No	No, up to stage 3 of step 3 of the guidance (European Commission, 2003) ADI 0.2 mg/kg bw per day
479M09	Very high mobility 4.9–6.8 mL/g	FOCUS: Yes 6/6 FOCUS scenarios > 0.1 μg/L (0.37–1.37 μg/L) Lysimeter: Yes The trigger value of 0.1 μg/L was exceeded in the lysimeter study available (max. concentration in two leachate samples 1.3–3.3 μg/L) In all the 48 samples of the targeted monitoring study in Germany, concentrations < 0.1 μg/L	No	Yes, since it cannot be excluded to share the carcinogenic potential of the parent
479M11	Very high mobility 18.1–23.5 mL/g	FOCUS: Yes 6/6 FOCUS scenarios > 0.1 μg/L (0.24–1.43 μg/L) Lysimeter: Yes The trigger value of 0.1 μg/L was exceeded in the lysimeter study available (max. concentration in two leachate samples 0.8–2.5 μg/L) In all the 48 samples of the targeted monitoring study in Germany, concentrations < 0.1 μg/L	No	Yes, since it cannot be excluded to share the carcinogenic potential of the parent
479M12	Very high mobility 5.1–12 mL/g	FOCUS: Yes 6/6 FOCUS scenarios > 0.1 μg/L (3.38–15.74 μg/L) 1/6 FOCUS scenarios > 10 μg/L for winter oilseed rape (Chateaudun scenario) Lysimeter: Yes The trigger value of 0.1 μg/L was exceeded in the lysimeter study available (max. concentration in two leachate samples 0.4–3.6 μg/L), and in 23% of the samples in targeted monitoring study in Germany, concentrations up to 0.16 μg/L	No	No, up to stage 3 of step 3 of the guidance (European Commission, 2003) ADI 0.38 mg/kg bw per day

At least one FOCUS scenario or relevant lysimeter.

Data gaps

This is a list of data gaps identified in the focussed peer review process of confirmatory data. Data gaps identified in the previously finalised EFSA conclusion on the active substance (EFSA, 2008a) that were not part of the focussed peer review process of confirmatory data remain unchanged.

• More information on the hydrological conditions of the targeted groundwater monitoring sites in France in order to perform an appropriate vulnerability assessment (relevant for all representative uses; date of submission: unknown; see Fate and Behaviour Section).

• A groundwater exposure assessment for metazachlor and its metabolites from the representative use on ornamental trees and shrubs (relevant for the representative use on ornamental trees and shrubs; date of submission: unknown; see Fate and Behaviour Section).

1. Issues that could not be finalised

An issue is listed as an issue that could not be finalised where there is not enough information available to perform an assessment, even at the lowest tier level, for the representative uses in line with the Uniform Principles in accordance with Article 29(6) of Regulation (EC) No 1107/2009 and as set out in Commission Regulation (EU) No 546/20119, and where the issue is of such importance that it could, when finalised, become a concern (which would also be listed as a critical area of concern if it is of relevance to all representative uses).

• 1The groundwater exposure assessment for metazachlor and its metabolites from the representative use on ornamental trees and shrubs based on the agreed peer reviewed endpoints could not be finalised.

2. Critical areas of concern

An issue is listed as a critical area of concern where there is enough information available to perform an assessment for the representative uses in line with the Uniform Principles in accordance with Article 29(6) of Regulation (EC) No 1107/2009 and as set out in Commission Regulation (EU) No 546/2011, and where this assessment does not permit to conclude that, for at least one of the representative uses, it may be expected that a plant protection product containing the active substance will not have any harmful effect on human or animal health or on groundwater or any unacceptable influence on the environment.

An issue is also listed as a critical area of concern where the assessment at a higher tier level could not be finalised due to lack of information, and where the assessment performed at the lower tier level does not permit to conclude that, for at least one of the representative uses, it may be expected that a plant protection product containing the active substance will not have any harmful effect on human or animal health or on groundwater or any unacceptable influence on the environment.

• 2Groundwater metabolites 479M09 and 479M11, that are considered toxicologically relevant based on the available data, are indicated to be above the parametric drinking water limit of 0.1 μg/L in vulnerable groundwater situations represented by the geoclimatic situations of all the relevant FOCUS groundwater scenarios (see mammalian toxicology and fate and behaviour Sections).

3. Overview of the concerns identified for each representative use considered (Table 4)

Table 4.

Overview of concerns

Representative use		Winter oilseed rape	Spring oilseed rape	Ornamental trees and shrubs
Consumer risk	Risk identified
	Assessment not finalised
Groundwater exposure to active substance	Legal parametric value breached
	Assessment not finalised			X1
Groundwater exposure to metabolites	Legal parametric value breached	X2	X2
	Parametric value of 10 μg/La breached	2/6 FOCUS scenario
	Assessment not finalised			X1

FOCUS: Forum for the Co‐ordination of Pesticide Fate Models and their Use.

Columns are grey if no safe use can be identified. The superscript numbers relate to the numbered points indicated in Sections 1 and 2 under the Concerns Section.

^aValue for non‐relevant metabolites prescribed in SANCO/221/2000‐rev. 10 final, European Commission (2003).

Abbreviations

1/n

slope of Freundlich isotherm

a.s.

active substance

ADI

acceptable daily intake

AOEL

acceptable operator exposure level

AR

applied radioactivity

ARfD

acute reference dose

bw

body weight

CAS

Chemical Abstracts Service

CIPAC

Collaborative International Pesticides Analytical Council Limited

DSC

differential scanning calorimetry

DT₅₀

period required for 50% dissipation (define method of estimation)

DT₉₀

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

ECD

electron capture detector

ECHA

European Chemicals Agency

EEC

European Economic Community

EINECS

European Inventory of Existing Commercial Chemical Substances

ELINCS

European List of New Chemical Substances

FAO

Food and Agriculture Organization of the United Nations

FID

flame ionisation detector

FOCUS

Forum for the Co‐ordination of Pesticide Fate Models and their Use

GAP

Good Agricultural Practice

GC

gas chromatography

GCPF

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

HPLC

high‐pressure liquid chromatography or high‐performance liquid chromatography

HPLC–MS

high‐pressure liquid chromatography–mass spectrometry

ILV

independent laboratory validation

ISO

International Organization for Standardization

IUPAC

International Union of Pure and Applied Chemistry

K_doc

organic carbon linear adsorption coefficient

K_Foc

Freundlich organic carbon adsorption coefficient

LC

liquid chromatography

LC₅₀

lethal concentration, median

LC–MS

liquid chromatography–mass spectrometry

LC–MS/MS

liquid chromatography with tandem mass spectrometry

LD₅₀

lethal dose, median; dosis letalis media

LOAEL

lowest observable adverse effect level

LOQ

limit of quantification (determination)

M&K

Maximisation test of Magnusson & Kligman

MS

mass spectrometry

MSD

mass selective detector

MWHC

maximum water‐holding capacity

NOAEL

no observed adverse effect level

OECD

Organisation for Economic Co‐operation and Development

OM

organic matter content

PEC

predicted environmental concentration

PEC_air

predicted environmental concentration in air

PEC_gw

predicted environmental concentration in groundwater

PEC_sed

predicted environmental concentration in sediment

PEC_soil

predicted environmental concentration in soil

PEC_sw

predicted environmental concentration in surface water

PHI

preharvest interval

P_ow

partition coefficient between n‐octanol and water

r²

coefficient of determination

RMS

rapporteur Member State

SC

suspension concentrate

SFO

single first‐order

SMILES

simplified molecular‐input line‐entry system

t_1/2

half‐life (define method of estimation)

TSH

thyroid‐stimulating hormone (thyrotropin)

UV

ultraviolet

w/w

weight per unit weight

WHO

World Health Organization

Appendix A – List of end points for the active substance and the representative formulation

Identity, Physical and Chemical Properties, Details of Uses, Further Information

Physical and chemical properties (Annex IIA, point 2)

Summary of representative uses evaluated (Metazachlor)

Crop and/or situationa	Member State or Country	Product name	F G or Ib	Pests or group of pests controlledc	Formulation		Application				Application rate per treatment			PHI (days)l	Remarksm
					Typed, e, f	Conc. of a.s. g/Li	Method kindf, g, h	Growth stage & seasonj	Number min–maxk	Interval between applications (min)	kg a.s./hL min–max	water L/ha min–max	kg a.s./ha min–max
BASF
Rapeseed, winter, spring	South EU	Butisan S (BAS 479 22H)	F	Annual weeds	SC	500	SP	00–09	1	Not relevant	0.17–0.5	200–600	1.0	Winter – end of January in year of harvest Spring – before 10th true leaf	Pre‐emergence, waiting period determined by use pattern [1]
Rapeseed, winter, spring	South EU	Butisan S (BAS 479 22H)	F	Annual weeds	SC	500	SP	10–18	1	Not relevant	0.17–0.5	200–600	1.0	Winter – end of January in year of harvest Spring – before 10th true leaf	Post‐emergence, waiting period determined by use pattern [1]
Rapeseed, winter, spring	North EU	Butisan S (BAS 479 22H)	F	Annual weeds	SC	500	SP	00–09	1	Not relevant	0.17–0.5	200–600	1.0	Winter – end of January in year of harvest Spring – before 10th true leaf	Pre‐emergence, waiting period determined by use pattern [1]
Rapeseed, winter, spring	North EU	Butisan S (BAS 479 22H)	F	Annual weeds	SC	500	SP	10–18	1	Not relevant	0.17–0.5	200–600	1.0	Winter – End of January in year of harvest Spring – before 10th true leaf	Post‐emergence, waiting period determined by use pattern [1]
MAK‐FSG
Winter rape	GE	FUEGO	F	Grass weeds, particularly annual meadow grass, and broadleaved weeds	SC	500	Spraying	Early post‐emergence (BBCH 10‐13)	1	Not relevant	0.25	300	0.75	F	Not stated [1]
Northern White Cedar (Thuja occidentalis), Rhododendron (Rhododendron spp.), privet (Ligustrum spp.) lilac (Syringa spp.), alder (Alnus glutinosa), grey willow (Salix cinerea), sea‐buckthorn (Hippophae rhamnoides), Norway spruce (Picea abies)	GE	FUEGO	F	Grass weeds, particularly annual meadow grass, and broadleaved weeds	SC	500	Spraying	Early post‐emergence of the weeds (BBCH 11–12)	1	Not relevant	0.25	300	0.75	na	The available risk assessment cover intended uses applied for with only one application every three years [1]

[1] Metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 have the potential to contaminate groundwater under a wide range of geoclimatic conditions. Metazachlor classification has been decided by RAC as Carc.Cat 2 (adopted in 3rd ATP). 479M04, 479M08/18 and 479M12 are considered ‘non‐relevant’ in relation to carcinogenicity and in relation to general toxicity. Metabolites 479M09 and 479M11 are likely to possess the liver carcinogenic potential of the parent compound and are similar to the parent in relation to toxicity in general.

*: For uses where the column ‘Remarks’ is marked in grey further consideration is necessary.

Uses should be crossed out when the notifier no longer supports this use(s).

^a For crops, the EU and Codex classifications (both) should be taken into account; where relevant, the use situation should be described (e.g. fumigation of a structure).

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

^c E.g. biting and suckling insects, soil born insects, foliar fungi, weeds.

^d E.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR).

^e GCPF Codes ‐ GIFAP Technical Monograph No 2, 1989.

^f All abbreviations used must be explained.

^g Method, e.g. high‐volume spraying, low‐volume spraying, spreading, dusting, drench.

^h Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plant and type of equipment used must be indicated.

ⁱ g/kg or g/L. Normally the rate should be given for the active substance (according to ISO) and not for the variant in order to compare the rate for same active substances used in different variants (e.g. fluoroxypyr). In certain cases, where only one variant is synthesised, it is more appropriate to give the rate for the variant (e.g. benthiavalicarb‐isopropyl).

^j Growth stage at 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.

^k Indicate the minimum and maximum number of application possible under practical conditions of use.

^l The values should be given in g or kg whatever gives the more manageable number (e.g. 200 kg/ha instead of 200,000 g/ha or 12.5 g/ha instead of 0.0125 kg/ha.

^m PHI: minimum pre‐harvest interval.

Methods of Analysis

Analytical methods for the active substance (Annex IIA, point 4.1)

Analytical methods for residues (Annex IIA, point 4.2)

Classification and proposed labelling with regard to physical and chemical data (Annex IIA, point 10)

Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point 5.1)

Acute toxicity (Annex IIA, point 5.2)

Short term toxicity (Annex IIA, point 5.3)

Genotoxicity ‡ (Annex IIA, point 5.4)

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Reproductive toxicity (Annex IIA, point 5.6)

Reproduction toxicity

Developmental toxicity

Neurotoxicity (Annex IIA, point 5.7)

Other toxicological studies (Annex IIA, point 5.8)

Medical data ‡ (Annex IIA, point 5.9)

Summary (Annex IIA, point 5.10)

Dermal absorption ‡ (Annex IIIA, point 7.3)

Exposure scenarios (Annex IIIA, point 7.2)

Classification and proposed labelling with regard to toxicological data (Annex IIA, point 10)

Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Route of degradation in soil ‐ Supplemental studies (Annex IIA, point 7.1.1.1.2)

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Laboratory studies ‡ (BASF/FSG)
Parent	Aerobic conditions
Soil type	pH		t °C/% MWHC	DT50/DT90 a (days)	DT50 (days) 20°C pF 2/10 kPa	St. (r2)	Method of calculation
Li 35b – loamy sandb	6.4		20/40	13.6/45.2	11.9	0.99	SFO (MCM)
LUFA 2.2 – loamy sand	5.7		20/40	25.3/84.0	25.3	0.98	SFO (MCM)
Limb'hof, Li 10 – sandy loam	6.7		20/40	8/26.6	5.8	0.994	SFO (MCM)
Bruch Ost – sandy clay loam	7.2		20/40	10.3/34.2	8.2	0.997	SFO (MCM)
Speyerer Wald – loamy sand	5.7		20/40	12.5/41.5	10.7	0.985	SFO
Bruch West – sandy clay loam*	7.2		10/40	19.7/65.4	7.2	0.998	SFO (MCM)
	7.2		20/40	6.2/20.6	5.0	0.99	SFO (MCM)
	7.2		30/40	3.1/10.3	5.5	0.993	SFO (MCM)
Speyer 2.2 – loamy sand	5.9		20/40	7.2/23.9	7.2	0.999	SFO
Speyer 2.1 – sand	6.0		ca 20/40	17.6/58.4	17.2	0.941	SFO
Eigenboden – sandy silt loam	6.6		ca 20/40	21.9/72.7	15.7	0.803	SFO
Speyer 2.3 – sandy loam*	6.0		ca 20/40	10.9/36.2	9.8	0.871	SFO
	6.0		10/40	35.8/118.9	14.7	0.977	SFO
Geometric mean/median					10.8/11.3

MWHC: maximum water‐holding capacity; DT₅₀: period required for 50% dissipation; DT₉₀: period required for 90% dissipation; SFO: single first‐order; MCM: multicompartment model.

*: All DT₅₀ values from study averaged prior to inclusion in overall geomean calculation.

^a DT₉₀ values calculated by multiplying DT₅₀ values by 3.32 since DT₅₀ values are calculated using single first‐order kinetics.

^b For this soil (Li 35b), the metabolite BF 479‐11 had an experimental half life of 41.3 days, resulting in a half life ref of 36.2 days.

479M04	Aerobic conditions (BASF/FSG)
Soil type	pH		t °C/% MWHC	DT50/DT90 b (days)	f. f. kdp/kf	DT50 (days) 20°C pF 2/10 kPa	St. (r2)	Method of calculation
*, aLi 35b – loamy sand	6.4		20/40	578/1919	0.169	507	0.99	SFO (MCM)
LUFA 2.2 – loamy sand	5.7		20/40	Uncertain value RSD too high			0.98	SFO (MCM)
Limb'hof, Li 10 – sandy loam	6.7		20/40	Uncertain value RSD too high			0.994	SFO (MCM)
Bruch Ost – sandy clay loam	7.2		20/40	102.8/341.3	0.158	82.3	0.997	SFO (MCM)
Bruch West – sandy clay loam*	7.2		20/40	90.1/299.1	0.200	72.1	0.999	SFO (MCM)
	7.2		30/40	59.3/196.9	0.276	104.4	0.993	SFO (MCM)
Bruch West – sandy clay loam*	7.2		10/40	277.3/920.6	N/A	93.7	0.92	SFO
	7.2		20/40	70.7/234.7	N/A	52.6	0.97	SFO
	7.2		30/40	47.5/157.7	N/A	77.7	0.99	SFO
Bruch Ost – clayey loam	7.6		20/40	Uncertain values with poor data fit			0.62	SFO
LUFA 2.2 – loamy sand	6.0		20/40	Uncertain values with poor data fit			0.36	SFO
Limb'hof, Li 10 – loamy sand	6.4		20/40	161.2/535.2	N/A	108.6	0.90	SFO
aSpeyer 2.1 – sand	5.7		20/50	296/983	N/A	286	0.978	SFO
Speyer 2.2 – loamy sand	6.0		20/50	Poor data fit			0.539	SFO
Speyer 2.3 – sandy loam	7.6		20/50	214/710.5	N/A	183	0.956	SFO
Speyer 2.3 – sandy loam	6.5		20/60	43.3/143.9	N/A	39.0	0.9837	SFO
Speyer 3A – loam	7.0		20/60	22.4/74.5	N/A	19.2	0.9704	SFO
Speyer 5M – sandy loam	7.1		20/60	50.6/168.1	N/A	48.83	0.9668	SFO
LUFA 2.2 – loamy sandd	6.2		20/40	249/827	N/A	189.8	–c	SFO
LUFA 3A – loamd	7.8		20/40	53.4/178	N/A	30.3	–c	SFO
Li 10 – loamy sandd	7.0		20/40	126.5/420	N/A	104.8	–c	SFO
Geometric mean/medianb						76.3/77.2

MWHC: maximum water‐holding capacity; DT₅₀: period required for 50% dissipation; DT₉₀: period required for 90% dissipation; SFO: single first‐order; MCM: multicompartment model.

* All DT₅₀ values from study averaged prior to inclusion in overall geomean calculation.

^a DT₅₀ longer than twice the study length.

^b DT₉₀ values calculated by multiplying DT₅₀ values by 3.32 since DT₅₀ values are calculated using single first‐order kinetics.

^c χ2 values were 3.2% (LUFA 2.2 soil), 8.7% (LUFA 3A soil), and 5.1% (Li 10 soil).

^d Metabolite dosed study.

479M08	Aerobic conditions (BASF/FSG)
Soil type	pH		t °C/% MWHC	DT50/DT90 b (days)	f. f. kdp/kf	DT50 (days) 20°C pF 2/10 kPa	St. (r2)	Method of calculation
aSpeyer 2.2 – loamy sand	5.7		20/40	331/1100	N/A	331	0.7234	SFO
Speyer 3A – loam	7.1		20/40	60.15/199.7	N/A	51.01	0.971	SFO
PTRL – clay loam	6.8		20/40	180/597.6	N/A	133.2	0.9220	SFO
aSpeyer 2.1 – sand	5.7		20/50	375/> 1,000	N/A	362	0.769	SFO
Speyer 2.2 – loamy sand	6.0		20/50	Poor data fit			0.066	SFO
Speyer 2.3 – sandy loam	7.6		20/50	Poor data fit			0.697	SFO
Speyer 2.3 – sandy loam	6.5		20/60	105.8/351.5	N/A	95.33	0.9667	SFO
Speyer 3A – loam	7.0		20/60	60.8/202.0	N/A	52.11	0.9875	SFO
Speyer 5M – sandy loam	7.1		20/60	110.2/366.1	N/A	106.3	0.9600	SFO
Geometric mean/medianb						123.2/106.3

MWHC: maximum water‐holding capacity; DT₅₀: period required for 50% dissipation; DT₉₀: period required for 90% dissipation; SFO: single first‐order.

^a DT₅₀ longer than twice the study length.

^b DT₉₀ values calculated by multiplying DT₅₀ values by 3.32 since DT₅₀ values are calculated using single first‐order kinetics.

479M09	Aerobic conditions (BASF)
Soil type	pH	T (oC)/% MWHC	DT50/DT90 (days)	DT50 (days) 20°C pF 2/10 kPa	χ2 (%)	Method of calculation
LUFA 2.2 – loamy sand	6.2	20/40	19.0/63	16.4	4.0	SFO
LUFA 5M – sandy loam	7.9	20/40	39.0/129	25.9	3.0	SFO
Li 10 – loamy sand	7.0	20/40	13.8/45.9	11.4*	11.9	DFOP M0 = 103.5 k1 = 8.057 k2 = 0.026 g = 0.666
Geometric mean				16.9

MWHC: maximum water‐holding capacity; DT₅₀: period required for 50% dissipation; DT₉₀: period required for 90% dissipation; SFO: single first‐order.

* Back calculated from overall DT₉₀ value according to FOCUS kinetics guidance.

479M11	Aerobic conditions (BASF)
Soil type	pH	T (oC)/% MWHC	DT50/DT90 (days)	DT50 (days) 20°C pF 2/10 kPa	χ2 (%)	Method of calculation
LUFA 2.2 – loamy sandb	6.2	20/40	52.4/174	39.9*	9.6	FOMC M0 = 98.97 α = 0.5134 β = 1.989
LUFA 3A – loamb	7.8	20/40	28.4/94.3	16.1*	4.5	DFOP M0 = 100.1 k1 = 0.6541 k2 = 0.01791 g = 0.459
Li 10 – loamy sandb	7.0	20/40	21.0/69.8	17.4*	7.6	DFOP M0 = 100.1 k1 = 0.6619 k2 = 0.02343 g = 0.487
Li 35b – loamy sand	6.4	20/40	41.3/137.1	36.2a	–	SFO
Geometric mean				25.2

MWHC: maximum water‐holding capacity; DT₅₀: period required for 50% dissipation; DT₉₀: period required for 90% dissipation; SFO: single first‐order.

* Back calculated from overall DT₉₀ value according to FOCUS kinetics.

^a Value from parent applied study (see footnote to parent data table).

^b Metabolite dosed study.

479M12	Aerobic conditions (BASF) metabolite dosed study
Soil type	pH	T (oC)/% MWHC	DT50/DT90 (days)	DT50 (days) 20°C pF 2/10 kPa	χ2 (%)	Method of calculation
LUFA 2.2 – loamy sand	6.2	20/40	63/210	54.3	6.2	SFO
LUFA 5M – sandy loam	7.9	20/40	140/465	93.0	4.0	SFO
Li 10 – loamy sand	7.0	20/40	148/492	122.5	7.0	SFO
Geometric mean				85.2

Field studiesa (BASF)
Parent	Aerobic conditions
Soil type (indicate if bare or cropped soil was used)	Location (country or USA state)	pH		Depth (cm)	DT50 (days) actual	DT90 (days)a actual	St. (r2)	DT50 (days) Norm.*	Method of calculation
Sandy loam	Bothkamp (DE)	6.5		0–25	15.0	49.8	0.959	9.8	SFO (MCM)
Slightly loamy sand	Havixbeck (DE)	6.5		0–25	7.3	24.2	0.994	5.1	SFO (MCM)
Sandy silty loam	Lippetal‐Brockhausen (DE)	6.7		0–25	12.2	40.5	0.995	7.5	SFO (MCM)
Sandy loam	Niederhofen (DE)	6.1		0–10	12.4	41.2	0.999	8.4	SFO (MCM)
Sand	Utrera (ES)	6.5		0–10	2.8	9.3	0.992	2.0	SFO (MCM)
Loamy sand	Manzanilla (ES)	7.5		0–25	8.2	27.2	0.974	6.4	SFO (MCM)
Silty sand	Grossharrie (DE)	6.0		0–10	10.9	36.2	0.983	8.4	SFO (MCM)
Loamy sand	Bjärred (SE)	6.1		0–50	21.3	70.7	0.924	14.4	SFO (MCM)
Geometric mean/median					9.8/11.5			6.8/8.0

DT₅₀: period required for 50% dissipation; DT₉₀: period required for 90% dissipation; SFO: single first‐order; MCM: multicompartment model.

* Normalised DT₅₀ values were corrected to 20°C using a Q10 value of 2.2 and Walker equation coefficient of 0.7, but were not corrected for soil moisture content.

^a DT₉₀ values calculated by multiplying DT₅₀ values by 3.32 since DT₅₀ values are calculated using single first‐order kinetics.

479M04	Aerobic conditions (BASF)
Soil type	Location	pH	Depth (cm)	DT50 (days) actual	DT90 (days)a actual	St. (r2)	DT50 (days) Norm.*	Method of calculation
Slightly loamy sand	Havixbeck (DE)	6.5	0–37	138.7	460.5	0.994	54.6	SFO (MCM)
Sandy loam	Niederhofen (DE)	6.1	0–10	52.8	175.3	0.999	49.9	SFO (MCM)
Silty sand	Grossharrie (DE)	6.0	0–50	65.8	218.5	0.983	66	SFO (MCM)
Geometric mean/median				78.4/65.8			56.4/54.6

DT₅₀: period required for 50% dissipation; DT₉₀: period required for 90% dissipation; SFO: single first‐order; MCM: multicompartment model.

* Normalised DT₅₀ values were corrected to 20°C using a Q10 value of 2.2 and Walker equation coefficient of 0.7, but were not corrected for soil moisture content.

^a DT₉₀ values calculated by multiplying DT₅₀ values by 3.32 since DT₅₀ values are calculated using single first‐order kinetics.

479M08	Aerobic conditions (BASF)
Soil type	Location	pH	Depth (cm)	DT50 (days) actual	DT90 (days)a actual	St. (r2)	DT50 (days) Norm.*	Method of calculation
Loamy sand	Meckenheim (DE)	5.3	0–75	171	567.7	0.768	116.4	SFO
Silty sandy loam	Lippetal‐Brockhausen (DE)	6.4	0–50	59.7	198.2	0.933	43.4	SFO
Silty sand	Grossharrie (DE)	6.0	0–50	108.8	361.2	0.983	NC	SFO (MCM)
Geometric mean/median				103.6/108.8			71.1/79.9

DT₅₀: period required for 50% dissipation; DT₉₀: period required for 90% dissipation; SFO: single first‐order; MCM: multicompartment model; NC: not calculated.

* Normalised DT₅₀ values were corrected to 20°C using a Q10 value of 2.2 and Walker equation coefficient of 0.7, but were not corrected for soil moisture content.

^a DT₉₀ values calculated by multiplying DT₅₀ values by 3.32 since DT₅₀ values are calculated using single first‐order kinetics.

Laboratory studies ‡
Parent	Anaerobic conditions (BASF/FSG)
Soil type	pH	t °C/% MWHC	DT50/DT90 (days)	DT50 (days) 20°C pF 2/10 kPa	St. (r2)	Method of calculation
Li 35b – sandy loam	6.5	20/flooded soil	25/83	N/A	0.995	SFO
German standard soil 2.2 – sandy loam	5.8	20/flooded soil	11.6/38.5	N/A	0.994	SFO
Geometric mean			17.0

MWHC: maximum water‐holding capacity; DT₅₀: period required for 50% dissipation; DT₉₀: period required for 90% dissipation; SFO: single first‐order.

Soil adsorption/desorption (Annex IIA, point 7.1.2)

Parent ‡ (BASF/FSG)
Soil Type	OC %	Soil pH	Kd (mL/g)	Koc (mL/g)	Kf (mL/g)	Kfoc (mL/g)	1/n	r2
Pfungstadt – loam	0.58	7.3	–	–	0.48368	83.4	0.848	0.9879
Neuhofen – loamy sand	2.66	7.2	–	–	2.2026	82.8	0.798	0.9958
LUFA – sand	0.51	7.0	–	–	0.3699	72.5	0.877	0.9955
Speyer 2.1 – sand	0.56	6.0	0.37	66.1	–	–	–	–
Speyer 2.2 – loamy sand	2.27	6.1	1.659	73.1	–	–	–	–
Speyer 2.3 – sandy loam	1.18	6.6	0.560	47.4	–	–	–	–
Agroplan – sandy silt	1.75	6.0	0.511	29.2	–	–	–	–
Borstel – silty sand	1.29	6.3	–	–	1.251	97.0	0.91	0.9985
Rendzina Soest – loamy silt	4.10	7.5	–	–	2.656	64.8	0.93	0.9999
LUFA 2.2 – loamy sand	2.30	5.7	–	–	1.787	77.7	0.94	0.9996
LUFA 2.3 – sandy loam	1.20	6.5	–	–	0.646	53.8	0.93	0.9970
1 – clay loam	1.4	6.8	–	–	2.2	157.1	0.7	NR
2 – clay loam	1.2	7.2	–	–	2	166.7	0.72	NR
3 – loam	1.9	6	–	–	3.3	173.7	0.82	NR
4 – clay	2	7	–	–	4.4	220.0	0.68	NR
5 – sandy clay loam	0.7	7.3	–	–	0.81	115.7	1.2	NR
6 – sandy clay loam	1.4	7.4	–	–	1.1	78.6	1.1	NR
7 – clay loam	1.7	7.3	–	–	1.5	88.2	0.75	NR
8 – sandy clay loam	2.2	6.5	–	–	3.1	140.9	0.88	NR
9 – sandy clay loam	1.3	6.6	–	–	2	153.8	0.89	NR
10 – clay loam	1.5	6.8	–	–	3.1	206.7	0.74	NR
11 – silty clay loam	1.2	5	–	–	1.5	125.0	1.0	NR
12 – sandy loam	2.4	6.4	–	–	2.7	112.5	0.79	NR
13 – sandy clay loam	2	6.4	–	–	2.2	110.0	0.70	NR
14 – clay loam	1.4	6.4	–	–	2.1	150.0	0.76	NR
15 – clay	2.2	6.8	–	–	2.4	109.1	1.0	NR
16 – sandy clay loam	2.2	6.6	–	–	3.8	172.7	0.79	NR
17 – sandy loam	0.6	6.3	–	–	0.89	148.3	0.95	NR
18 – sandy clay loam	1.5	6.6	–	–	2.1	140.0	0.91	NR
Median*					–	110	0.877	–
pH dependence, Yes or No			No

NR: not reported.

* Median K_oc value was derived from combined set of K_foc and K_doc values (therefore n = 29). Averaging K_doc and K_foc values is acceptable in this specific case because the values are similar and 1/n is close to 1. For 1/n value, n = 25.

479M04 ‡ (BASF/FSG)
Soil type	OC %	Soil pH	Kd (mL/g)	Koc (mL/g)	Kf (mL/g)	Kfoc (mL/g)	1/n	r2
LUFA 2.1 – sand	0.7	5.8	–	–	0.014	2	1.058	0.9365
LUFA 2.2 – sand/loamy sand	2.5	5.8	–	–	0.053	2	0.983	0.9976
LUFA 2.3 – sandy loam	1.0	6.8	–	–	0.024	2	1.027	0.9914
Limburgerhof Bruch West – sandy loam	1.5	7.5	–	–	0.008	1	0.745	0.7528
Limburgerhof Bruch Ost – sandy loam	3.1	7.0	–	–	0.5602	18	0.6369	0.9437
LUFA 2.1 – sand	0.7	6.1	–	–	0.659	94	1.538	0.9855
LUFA 2.2 –loamy sand	2.29	6.0	–	–	1.5702	69	1.439	0.9764
LUFA 2.3 – sandy loam	1.34	6.9	–	–	0.1181	9	0.7799	0.9485
BBA 2.1 – sand	0.49	5.7	0.145	29.6	–	–	–	–
BBA 2.2 – silty sand	1.48	6.0	0.135	9.1	–	–	–	–
BBA 2.3 – silty sand	0.76	7.0	0.136	17.9	–	–	–	–
Median*					–	9.1	1.0	–
pH dependence (yes or no)			No

* Median K_oc value was derived from combined set of K_foc and K_doc values (therefore n = 11). Averaging K_doc and K_foc values is acceptable in this specific case because the values are similar and 1/n is close to 1. For the 1/n value, n = 8.

479M08 ‡ (BASF/FSG)
Soil type	OC %	Soil pH	Kd (mL/g)	Koc (mL/g)	Kf (mL/g)	Kfoc (mL/g)	1/n	r2
LUFA 2.1 – sand	0.7	5.8	–	–	0.037	5	0.811	0.9934
LUFA 2.2 – sand/loamy sand	2.5	5.8	–	–	0.129	5	0.904	0.9996
LUFA 2.3 – sandy loam	1.0	6.8	–	–	0.058	6	0.806	0.9945
Limburgerhof Bruch West – sandy loam	1.5	7.5	–	–	0.063	4	0.833	0.9942
Limburgerhof Bruch Ost – clay loam	0.5	5.8	–	–	0.3927	78.5	0.727	0.9804
LUFA 2.1 – loamy sand	2.4	6.0	–	–	0.3674	15.3	1.117	0.9957
LUFA 2.2 –sandy loam	1.1	6.5	–	–	0.3130	28.5	0.829	0.9815
LUFA 2.3 – sandy loam	3.27	7.8	–	–	0.3263	10.0	1.103	0.9771
BBA 2.1 – sand	0.49	5.7	0.05	10.2	–	–	–	–
BBA 2.2 – silty sand	1.48	6.0	0.156	10.5	–	–	–	–
BBA 2.3 – silty sand	0.76	7.0	0.043	5.7	–	–	–	–
Median*					–	10	0.831	–
pH dependence (yes or no)			No

* Median K_oc value was derived from combined set of K_foc and K_doc values (therefore n = 11). Averaging K_doc and K_foc values is acceptable in this specific case because the values are similar and 1/n is close to 1. For the 1/n value, n = 8.

479M06 ‡ (BASF)
Soil Type	OC %	Soil pH	Kd (mL/g)	Koc (mL/g)	Kf (mL/g)	Kfoc (mL/g)	1/n	r2
LUFA 2.1 – sand	0.7	5.8	–	–	0.363	52	0.924	0.9998
LUFA 2.2 – sand/loamy sand	2.5	5.8	–	–	1.562	62	0.928	0.9998
LUFA 2.3 – sandy loam	1.0	6.8	–	–	0.575	57	0.907	0.9999
Limburgerhof Bruch West – sandy loam	1.5	7.5	–	–	0.666	44	0.905	1.0
Median					–	54	0.92	–
pH dependence (yes or no)			No

479M09 ‡ (BASF)
Soil Type	OC %	Soil pH (CaCl2)	Kd (mL/g)	Koc (mL/g)	Kf (mL/g)	Kfoc (mL/g)	1/n	r2
La Gironda – silt clay loam	3.84	7.5	–	–	0.188	4.9	0.891	0.9841
LUFA 2.2 – loamy sand	1.72	5.7	–	–	0.099	5.8	0.965	0.9808
Li 10 – loamy sand	0.73	6.0	–	–	0.050	6.8	0.826	0.9925
Arithmetic mean					0.112	5.8	0.897	–
pH dependence (yes or no)			No

479M11 ‡ (BASF)
Soil Type	OC %	Soil pH (CaCl2)	Kd (mL/g)	Koc (mL/g)	Kf (mL/g)	Kfoc (mL/g)	1/n	r2
LUFA 2.2 – loamy sand	1.84	5.6	–	–	0.367	20.0	1.005	0.9726
LUFA 3A – loam	3.15	7.0	–	–	0.571	18.1	0.698	0.9624
Li 10 – loamy sand	0.91	6.4	–	–	0.214	23.5	0.873	0.9435
Arithmetic mean					0.384	20.5	0.859	–
pH dependence (yes or no)			No

479M12 ‡ (BASF)
Soil Type	OC %	Soil pH (CaCl2)	Kd (mL/g)	Koc (mL/g)	Kf (mL/g)	Kfoc (mL/g)	1/n	r2
La Gironda – silt clay loam	3.84	7.5	–	–	0.197	5.1	0.997	0.9871
LUFA 2.2 – loamy sand	1.72	5.7	–	–	0.167	9.7	0.927	0.9808
Li 10 – loamy sand	0.73	6.0	–	–	0.087	12.0	0.962	0.9919
Arithmetic mean					0.150	8.9	0.963	–
pH dependence (yes or no)			No

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

PEC (ground water) (Annex IIIA, point 9.2.1)

Groundwater modelling input parameters

Parameter	Units	Metazachlor	479M04	479M08	479M09	479M11	479M12
Physicochemical parameters
Molecular weight	g/mol	277.75	273.29	323.37	349.41	305.4	303.27
Water solubility (20°C)	mg/L	450	1,000a
Saturated vapour pressure (20°C)	Pa	9.6 × 10−5	1 × 10−9 b
Degradation parameters
Formation fraction	–	–	0.100 from metazachlor	0.112 from metazachlor	0.060 from metazachlor	0.143 from metazachlor	1.000 from BH 479‐4
DegT50, soil (normalised to 20°C)	d	6.8c	56.4c	116.4c	16.9d	25.2d	85.2d
Arrhenius activation energy	KJ/mol	54.12
Exponent of moisture correction function	–	0.7
Q10 factor	–	2.2*
Sorption parameters
Kf,oc	mL/g	110	9.1	10	5.8	20.5	8.9
Kf,om	mL/g	63.8	5.3	5.8	3.4	11.9	5.2
Freundlich exponent (1/n)	–	0.877	1.000	0.831	0.897	0.859	0.963
Crop related parameters
Crop uptake factor	–	0.5	0.0e

^a No measured value available, therefore, a conservative default value for leaching was used.

^b No measured value available, therefore, the default value of the model was used.

^c From field study data (normalised DT₅₀ values were corrected to 20°C, but were not corrected for soil moisture content). For metabolite 479M08, the longest field DT₅₀ value was used for modelling in the EFSA conclusion. It is the longer of two field study values available and it is noted that the formation and decline of this metabolite does not impact on any other metabolite PEC_GW value in the modelling. It was decided not to change the endpoint from that used for groundwater modelling in the EFSA conclusion.

^d From laboratory study data.

^e Default value.

* It should be noted that a proper normalisation of the DT₅₀ values should be based on the new agreed Q10 value of 2.58 in accordance with EFSA (2008a) and a Walker equation coefficient of 0.7.

PEC_gw – FOCUS modelling results

FOCUS PEARL 4.4.4

Scenario	PECgw (μg/L)
	Metazachlor	479M04	479M08	479M09	479M11	479M12
Winter oilseed rape
Châteaudun	< 0.001	5.190	14.177	0.401	0.292	15.742
Hamburg	< 0.001	6.292	10.108	1.327	1.209	6.644
Kremsmünster	< 0.001	3.984	7.567	0.516	0.562	5.365
Okehampton	< 0.001	3.601	6.194	0.662	0.871	3.640
Piacenza	< 0.001	4.046	7.184	0.886	1.056	4.686
Porto	< 0.001	3.714	6.801	0.731	0.822	4.008
Spring oilseed rape
Jokioinen	< 0.001	5.149	8.917	0.413	0.220	7.775
Okehampton	< 0.001	2.702	5.238	0.233	0.375	3.958
Porto	< 0.001	1.534	3.568	0.080	0.110	3.043

Results: FOCUS PELMO 4.4.3

Scenario	PECgw (μg/L)
	Metazachlor	479M04	479M08	479M09	479M11	479M12
Winter oilseed rape
Châteaudun	< 0.001	4.956	12.450	0.373	0.237	12.929
Hamburg	< 0.001	6.293	10.649	1.366	1.247	6.250
Kremsmünster	< 0.001	4.837	8.448	0.719	0.663	6.247
Okehampton	< 0.001	4.037	6.572	0.811	0.998	3.379
Piacenza	< 0.001	5.434	8.518	1.280	1.433	5.189
Porto	< 0.001	3.777	6.319	0.898	1.316	3.412
Spring oilseed rape
Jokioinen	< 0.001	4.969	8.397	0.515	0.274	7.403
Okehampton	< 0.001	2.765	5.397	0.318	0.475	3.664
Porto	< 0.001	1.736	3.747	0.128	0.239	2.815

A data gap is identified for PEC_gw calculations for the representative uses on nursery, ornamental trees, shrubs and forests

Residues requiring further assessment

Monitoring data, if available (Annex IIA, point 7.4)

Points pertinent to the classification and proposed labelling with regard to fate and behaviour data

Appendix B – Used compound codes

1.

Code/trivial namea	Chemical name/SMILES notation	Structural formula
479M04 BH 479‐4	[(2,6‐Dimethylphenyl)(1H‐pyrazol‐1‐ylmethyl)amino](oxo)acetic acid O=C(N(Cn1cccn1)c2c(C)cccc2C)C(=O)O
479M08 BH 479‐8 479M18 BH 479‐18	2‐[(2,6‐Dimethylphenyl)(1H‐pyrazol‐1‐ylmethyl)amino]‐2‐oxoethanesulfonic acid O=C(CS(=O)(=O)O)N(Cn1cccn1)c2c(C)cccc2C Sodium 2‐[(2,6‐dimethylphenyl)(1H‐pyrazol‐1‐ylmethyl)amino]‐2‐oxoethanesulfonate [Na+].O=C(CS([O‐])(=O)=O)N(Cn1cccn1)c2c(C)cccc2C
479M09 BH 479‐9	({2‐[(2,6‐Dimethylphenyl)(1H‐pyrazol‐1‐ylmethyl)amino]‐2‐oxoethyl}sulfinyl)acetic acid O=C(CS(=O)CC(=O)O)N(Cn1cccn1)c2c(C)cccc2C
479M11 BH 479‐11	N‐(2,6‐Dimethylphenyl)‐2‐(methylsulfinyl)‐N‐(1H‐pyrazol‐1‐ylmethyl)acetamide O=C(CS(C)=O)N(Cn1cccn1)c2c(C)cccc2C
479M12 BH 479‐12	3‐Methyl‐2‐[oxalo(1H‐pyrazol‐1‐ylmethyl)amino]benzoic acid O=C(N(Cn1cccn1)c2c(C)cccc2C(=O)O)C(=O)O
479M16 M16	3‐({2‐[(2,6‐Dimethylphenyl)(1H‐pyrazol‐1‐ylmethyl)amino]‐2‐oxoethyl}sulfinyl)‐2‐hydroxypropanoic acid O=C(CS(=O)CC(O)C(=O)O)N(Cn1cccn1)c2c(C)cccc2C
479M06 M06 BH s479‐6	N‐(2,6‐Dimethylphenyl)‐N‐(1H‐pyrazol‐1‐ylmethyl)acetamide O=C(C)N(Cn1cccn1)c2c(C)cccc2C

SMILES: simplified molecular‐input line‐entry system.

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

Suggested citation: EFSA (European Food Safety Authority) , Brancato A, Brocca D, Bura L, Byers H, Chiusolo A, Court Marques D, Crivellente F, De Lentdecker C, De Maglie M, Egsmose M, Erdos Z, Fait G, Ferreira L, Goumenou M, Greco L, Istace F, Jarrah S, Kardassi D, Leuschner R, Lythgo C, Magrans JO, Medina P, Miron I, Molnar T, Nougadere A, Padovani L, Parra Morte JM, Pedersen R, Reich H, Sacchi A, Santos M, Serafimova R, Stanek A, Sturma J, Tarazona J, Terron A, Theobald A, Vagenende B, Verani A and Villamar‐Bouza L, 2017. Conclusion on the peer review of the pesticide risk assessment for the active substance metazachlor in light of confirmatory data submitted. EFSA Journal 2017;15(6):4833, 48 pp. 10.2903/j.efsa.2017.4833