Peer review of the pesticide risk assessment of the active substance mecoprop‐P

Abstract

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, the United Kingdom, and co‐rapporteur Member State, Ireland, for the pesticide active substance mecoprop‐P are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of mecoprop‐P as a herbicide on winter and spring wheat (including durum and spelt), barley, rye, oats and triticale. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Summary

Commission Implementing Regulation (EU) No 844/2012 (hereinafter referred to as ‘the Regulation’) lays down the procedure for the renewal of the approval of active substances submitted under Article 14 of Regulation (EC) No 1107/2009. The list of those substances is established in Commission Implementing Regulation (EU) No 686/2012. Mecoprop‐P is one of the active substances listed in Regulation (EU) No 686/2012.

In accordance with Article 1 of the Regulation, the rapporteur Member State (RMS), the United Kingdom, and co‐rapporteur Member State (co‐RMS), Ireland, received an application from Nufarm for the renewal of approval of the active substance mecoprop‐P. Complying with Article 8 of the Regulation, the RMS checked the completeness of the dossier and informed the applicant, the co‐RMS, the European Commission and the European Food Safety Authority (EFSA) about the admissibility.

The RMS provided its initial evaluation of the dossier on mecoprop‐P in the renewal assessment report (RAR), which was received by EFSA on 1 April 2016. In accordance with Article 12 of the Regulation, EFSA distributed the RAR to the Member States and the applicant, Nufarm, for comments on 6 June 2016. EFSA also provided comments. In addition, EFSA conducted a public consultation on the RAR. EFSA collated and forwarded all comments received to the European Commission on 9 August 2016.

Following consideration of the comments received on the RAR, it was concluded that additional information should be requested from the applicant and that EFSA should conduct an expert consultation in the areas of mammalian toxicology and ecotoxicology.

In accordance with Article 13(1) of the Regulation, EFSA should adopt a conclusion on whether mecoprop‐P can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council.

The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of mecoprop‐P as a herbicide on winter and spring wheat (including durum and spelt), barley, rye, oats and triticale, as proposed by the applicant. Full details of the representative uses can be found in Appendix A of this report.

The use of mecoprop‐P according to the representative uses proposed at the European Union (EU) level results in a sufficient herbicidal efficacy against the target weeds.

A data gap was identified for a search of the scientific peer‐reviewed open literature on the aqueous photolysis metabolite o‐cresol.

In the section identity, physical/chemical properties, analytical methods data gaps were identified for logP data for two metabolites, for monitoring (chiral) methods for the determination of mecoprop‐P residues in all matrices (open for animal matrices pending decision on the residue definition) and for an enforcement method in body fluids and tissues. It was proposed to update the reference specification of the first approval.

In the mammalian toxicology area, data gaps have been identified with regard to the toxicity of some impurities in the proposed renewal specification, because the batches used in the toxicological studies do no support all the impurities, and with regard to the toxicological data on the metabolite carboxy‐mecoprop‐P (CCPP) and 4‐glucosyl‐MPP.

In the residue section, the consumer risk assessment cannot be finalised due to the outstanding data to confidently address the nature and magnitude of residues in plant and animal matrices. Further information is also requested on the potential residues of mecoprop‐P and its degradation products in pollen and bee products for human consumption resulting from residues taken up by honeybees from crops at blossom.

The data available on environmental fate and behaviour are sufficient to carry out the required environmental exposure assessments at EU level for the representative uses assessed. For the representative use on winter cereals under the vulnerable conditions represented by the Okehampton FOCUS groundwater scenario, there is the potential for the active substance mecoprop‐P to be present in shallow groundwater above the parametric drinking water limit of 0.1 μg/L. A data gap was identified as the potential for the R isomer to racemise to the RS mixture in the soil, water/sediment and air compartments was not adequately addressed.

In the area of ecotoxicology in the absence of a long term toxicity study on birds, a data gap to further address the long‐term toxicity and risk to birds, and an issue that could not be finalised were identified. A high long‐term risk to wild mammals for mecoprop‐P was concluded for all representative uses (critical area of concern). Data gaps were identified for further information to address the risk to birds and mammals for the pertinent plant metabolites, the risk to aquatic organisms for mecoprop‐P and for metabolite o‐cresol, and to address the risk to soil microorganisms for mecoprop‐P. Finally, a data gap was identified for a risk assessment in line with the EFSA Guidance on bees risk assessment for honeybees for mecoprop‐P and its pertinent metabolites.

Background

Commission Implementing Regulation (EU) No 844/20121 (hereinafter referred to as ‘the Regulation’) lays down the provisions for the procedure of the renewal of the approval of active substances, submitted under Article 14 of Regulation (EC) No 1107/20092. This regulates for the European Food Safety Authority (EFSA) the procedure for organising the consultation of Member States, the applicant and the public on the initial evaluation provided by the rapporteur Member State (RMS) and/or co‐rapporteur Member State (co‐RMS) in the renewal assessment report (RAR), and the organisation of an expert consultation where appropriate.

In accordance with Article 13 of the Regulation, unless formally informed by the European Commission that a conclusion is not necessary, EFSA is required to adopt a conclusion on whether the active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 within 5 months from the end of the period provided for the submission of written comments, subject to an extension of up to 8 months where additional information is required to be submitted by the applicant(s) in accordance with Article 13(3).

In accordance with Article 1 of the Regulation, the RMS, the United Kingdom, and co‐RMS, Ireland, received an application from Nufarm for the renewal of approval of the active substance mecoprop‐P. Complying with Article 8 of the Regulation, the RMS checked the completeness of the dossier and informed the applicant, the co‐RMS (Ireland), the European Commission and EFSA about the admissibility.

The RMS provided its initial evaluation of the dossier on mecoprop‐P in the RAR, which was received by EFSA on 1 April 2016 (United Kingdom, 2016).

In accordance with Article 12 of the Regulation, EFSA distributed the RAR to the Member States and the applicant, Nufarm, for consultation and comments on 6 June 2016. EFSA also provided comments. In addition, EFSA conducted a public consultation on the RAR. EFSA collated and forwarded all comments received to the European Commission on 9 August 2016. At the same time, the collated comments were forwarded to the RMS for compilation and evaluation in the format of a reporting table. The applicant was invited to respond to the comments in column 3 of the reporting table. The comments and the applicant's response were evaluated by the RMS in column 3.

The need for expert consultation and the necessity for additional information to be submitted by the applicant in accordance with Article 13(3) of the Regulation were considered in a telephone conference between EFSA and the RMS on 27 September 2016. On the basis of the comments received, the applicant's response to the comments and the RMS's evaluation thereof, it was concluded that additional information should be requested from the applicant, and that EFSA should conduct an expert consultation in the areas of mammalian toxicology and ecotoxicology.

The outcome of the telephone conference, together with EFSA's further consideration of the comments, is reflected in the conclusions set out in column 4 of the reporting table. All points that were identified as unresolved at the end of the comment evaluation phase and which required further consideration, including those issues to be considered in an expert consultation, were compiled by EFSA in the format of an evaluation table.

The conclusions arising from the consideration by EFSA, and as appropriate by the RMS, of the points identified in the evaluation table, together with the outcome of the expert consultation and the written consultation on the assessment of additional information, where these took place, were reported in the final column of the evaluation table.

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

This conclusion report summarises the outcome of the peer review of the risk assessment of the active substance and the representative formulation, evaluated on the basis of the representative uses of mecoprop‐P as a herbicide on winter and spring wheat (including durum and spelt), barley, rye, oats and triticale, as proposed by the applicant. A list of the relevant end points for the active substance and the formulation is provided in Appendix A.

In addition, a key supporting document to this conclusion is the peer review report (EFSA, 2017), which is a compilation of the documentation developed to evaluate and address all issues raised in the peer review, from the initial commenting phase to the conclusion. The peer review report comprises the following documents, in which all views expressed during the course of the peer review, including minority views, where applicable, can be found:

• the comments received on the RAR;

• the reporting table (27 September 2016);

• the evaluation table (12 April 2017);

• the report(s) of the scientific consultation with Member State experts (where relevant);

• the comments received on the assessment of the additional information (where relevant);

• the comments received on the draft EFSA conclusion.

Given the importance of the RAR, including its revisions (United Kingdom, 2017), and the peer review report, both documents are considered as background documents to this conclusion and thus are made publicly available.

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 that it has regulatory access to the information on which this conclusion report is based.

The active substance and the formulated product

Mecoprop‐P is the ISO common name for (R)‐2‐(4‐chloro‐o‐tolyloxy)propionic acid (IUPAC).

The unresolved isomeric mixture of this substance has the ISO common name mecoprop.

The representative formulated product for the evaluation was ‘Mecoprop‐P K 600’, a soluble concentrate (SL) containing 600 g/L mecoprop‐P.

The representative uses evaluated were spray applications in winter and spring wheat (including durum and spelt), barley, rye, oats and triticale, to control broadleaved weeds. Full details of the Good Agricultural Practices (GAPs) can be found in the list of end points in Appendix A.

Data were submitted to conclude that the use of mecoprop‐P according to the representative uses proposed at EU level results in a sufficient herbicidal efficacy against the target weeds following the guidance document SANCO/2012/11251‐rev. 4 (European Commission, 2014b).

A data gap has been identified for a search of the scientific peer‐reviewed open literature on the aqueous photolysis metabolite o‐cresol and synonyms relevant to the scope of the application for renewal, dealing with side effects the environment and non‐target species and published within the 10 years before the date of submission of the dossier, to be conducted and reported in accordance with EFSA guidance on the submission of scientific peer‐reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009 (EFSA, 2011).

1. Identity, physical/chemical/technical properties and methods of analysis

The following guidance documents were followed in the production of this conclusion: SANCO/3029/99‐rev. 4 (European Commission, 2000a), SANCO/3030/99‐rev. 4 (European Commission, 2000b) and SANCO/825/00‐rev. 8.1 (European Commission, 2010).

The new proposed reference specification for mecoprop‐P is based on batch data from industrial scale production. The minimum purity of the technical material is 890 g/kg. There is no FAO specification available for mecoprop‐P. The impurity 4‐chloro‐2‐methylphenol (PCOC) is considered a relevant impurity with a maximum amount of 5 g/kg. The batches used in the toxicological assessment support the proposed renewal specification, but not the original reference specification (See Section 2). The batches used in ecotoxicological testing support both the proposed renewal specification and the original reference specification. As a consequence, it is recommended to update the reference specification of the first approval.

The assessment of the data package revealed no issues that need to be included as critical areas of concern with respect to the identity, physical, chemical and technical properties of mecoprop‐P or the representative formulation; however, data gaps were identified for logP data for metabolites HMCPP and o‐cresol (see Section 5) The main data regarding the identity of mecoprop‐P, and its physical and chemical properties are given in Appendix A.

Adequate methods are available for the generation of pre‐approval data required for the risk assessment. Methods of analysis are available for the determination of the active substance and the relevant impurity in the technical material and in the representative formulation.

The residue definition for monitoring for food and feed of plant origin was set as mecoprop‐P. The existing liquid chromatography–mass spectrometry (LC–MS/MS) method for monitoring determines the total mecoprop content, present as acid, esters or conjugates, with a limit of quantification (LOQ) of 0.01 mg/kg, expressed as mecoprop in all commodity groups. The method is not enantioselective. As a consequence, a data gap was identified for a monitoring method (chiral method) for plant commodities.

The existing LC–MS/MS method for monitoring residues in food and feed of animal origin determines the total mecoprop content, present as acid, esters or conjugates, with a LOQ of 0.01 mg/kg, expressed as mecoprop. The method is not enantioselective. Pending on the final decision on the residue definition for monitoring in animal matrices, a data gap might be identified for a monitoring method (chiral method) of the compound of the residue definition in animal matrices.

The monitoring residue definition for soil, water and air is mecoprop‐P. LC–MS/MS methods are available enabling the determination of residues of mecoprop and the corresponding esters in soil, water and air with LOQs of 0.01 mg/kg in soil, 0.02 μg/L in surface water and 0.28 μg/m³ in the air, respectively; however, the methods are not enantioselective. As a consequence, a data gap was identified for monitoring (chiral) methods for mecoprop‐P in the environmental matrices.

A data gap was identified for a monitoring method for the determination of mecoprop‐P residues in body fluids and tissues.

2. Mammalian toxicity

The following guidance documents were followed in the production of this conclusion: SANCO/221/2000‐rev. 10‐final (European Commission, 2003a), SANCO/10597/2003‐rev. 10.1 (European Commission, 2012) and Guidance on dermal absorption (EFSA PPR Panel, 2012).

Mecoprop‐P was discussed at the Pesticides Peer Review Experts' Meeting 151 in February 2017.

The relevance of some individual impurities in comparison with the toxicological profile of the parent compound has not been fully addressed and therefore a data gap has been identified to address the relevance of the other impurities present in the technical specifications. 4‐Chloro‐2‐methylphenol (PCOC) has a classification by the European Chemicals Agency (ECHA) for respiratory irritancy, skin corrosion and acute inhalation toxicity, and is considered to be a relevant impurity.

Mecoprop‐P is rapidly and extensively absorbed after oral administration being mostly eliminated with urine with a half‐life less than 8 h. Mecoprop‐P is largely excreted as a parent material, and it is mainly distributed in the thyroid, kidney, blood and plasma. Acute toxicity studies were performed using mecoprop‐P, while some of the long‐term studies were performed on the racemate mecoprop. During the experts' consultation, it was agreed on the toxicity bridging between the two isomers of mecoprop; studies on the racemate were considered applicable to the mecoprop‐P isomer because the toxicity of the isomer mixture was found to be equivalent to the toxicity of the P isomer in the repeat dose studies. Mecoprop‐P has a harmonised classification3 and labelling Category 4 for acute oral toxicity with the hazard statement H302 – harmful if swallowed. In addition, it is classified Category 1 for eye irritancy/corrosion with the hazard statement H318 – causes serious eye damage. Low acute toxicity was observed when mecoprop‐P was administered by the dermal or inhalation routes; no skin irritation and skin sensitisation were attributed to the active substance. Mecoprop‐P is proposed for classification Category 1 for eye irritancy/corrosion with the hazard statement H318 – causes serious eye damage. Mecoprop‐P did not have any phototoxic effect and therefore photomutagenicity testing is not required.

The main target organs of mecoprop‐P in the repeat dose studies are the kidneys in rats, mice and dogs, liver in mice and blood cells in dogs. The relevant short‐term no adverse effect level (NOAEL) is 4 mg/kg body weight (bw) per day from the 90‐day study in dogs, based on decreased red blood cells and packed cell volume and supported also by the NOAEL of 4.4 mg/kg bw per day from the 7‐week study in rats, based on increase in absolute and relative kidney weight, increase in blood urea nitrogen and decreased cholesterol. The relevant long‐term NOAEL is 1 mg/kg bw per day from the 2‐year study in rats, based on increased kidney weight. Mecoprop‐P did not present genotoxic potential in vivo and had equivocal evidence of clastogenicity in mammalian cells in vitro. No evidence of carcinogenicity was observed in rats and the slight increase in hepatocellular carcinoma in mouse females was considered equivocal, of limited relevance for humans and not sufficient for classification. Reproduction and fertility were not affected by mecoprop‐P administration; however, differently from the previous evaluation, mecoprop‐P is proposed for classification3 for developmental toxicity Category 2 H361, based on the increased late resorption in the rabbit study. This proposal was based on a more detailed evaluation of the late resorption findings in the developmental toxicity study in the rabbit and considering that the developmental NOAEL was lower than the maternal NOAEL. The RMS disagreed, since the magnitude of the effect observed was not considered enough for classification of the substance. There was no evidence of neurotoxic effects or immunotoxicity induced by Mecoprop‐P treatment in studies provided. No specific studies were provided for evaluation of endocrine disrupting potential and it was noted by the experts that the reproductive studies could not be used for this evaluation. However, no adverse effects that could be related to an endocrine disruptor mode of action were observed in the other repeated dose studies or mentioned in the open literature. Hence, the conditions of the interim provisions of Annex II, point 3.6.5 of Regulation (EC) No 1107/2009 concerning human health for the consideration of endocrine disrupting properties are not met and mecoprop‐P is unlikely to be an endocrine disruptor.

The metabolite hydroxymethyl‐mecoprop‐P (HMCPP) showed lower acute toxicity than the parent, even though just a study summary was submitted and not the full study report. In repeated dose studies, HMCPP showed to be less toxic than the parent; HMCPP was also negative in Ames test and negative in the in vivo micronucleus test. However, RMS considered the in vivo micronucleus test unreliable, due to the reporting errors in the study. Insufficient information was available to conclude on the toxicity (including genotoxicity) of carboxy‐mecoprop‐P (CCPP) and 4‐glucosyl‐MPP metabolites and therefore a data gap was identified.

The acceptable daily intake (ADI) of mecoprop‐P is 0.01 mg/kg bw per day with no change in the ADI value compared to SANCO/3065/99‐Final (European Commission, 2003b), based on the NOAEL of 1 mg/kg bw per day for kidney changes in the 2‐year study in rats and applying an uncertainty factor (UF) of 100. The acceptable operator exposure level (AOEL) is 0.04 mg/kg bw per day with no change in the AOEL value compared to (European Commission, 2003b), based on the NOAEL of 4.0 mg/kg bw per day for haematological changes observed in the 90‐day study in dog and applying an uncertainty factor (UF) of 100 with no correction for oral absorption. The acute acceptable operator exposure level (AAOEL) and acute reference dose (ARfD), not set in the previous review report assessment (European Commission, 2003b), are both 0.2 mg/kg bw per day based on the NOAEL of 20 mg/kg bw per day for the increased incidence of late resorption in the rabbit developmental study and applying an UF of 100.

In the absence of dermal absorption study with the representative product, it was agreed to use the default dermal absorption values of 25% for the concentrate and 75% for all dilutions. On the basis of the German model estimates, the risk to operators resulting from the proposed use of ‘Mecoprop‐P K 600’ was calculated to be at 99% of the AOEL for an operator wearing gloves during mixing/loading, and gloves, coveralls and sturdy footwear during application. According to the UK model, the predicted bystander and resident exposure to vapour is calculated to be 10% of the AOEL for an adult and 21% of the AOEL for a child. The predicted bystander and resident exposure to spray drift is calculated to be equivalent to 20% of the AOEL. Using the EFSA calculator, the predicted exposure of residents (sum of all pathways) is exceeding the AOEL, whereas the exposure of bystanders is only exceeding the AOEL for children exposed to spray drift. It is noted that the use of the EFSA calculator was not mandatory at the time of submission the renewal dossier. According to the EUROPOEM II model and the EFSA calculator, the exposure estimates for the worker inspecting treated crops (wearing workwear) are above the AOEL.

3. Residues

The assessment in the residue section is based on the OECD guidance document on overview of residue chemistry studies (OECD, 2009), the OECD publication on MRL calculations (OECD, 2011), the European Commission guideline document on maximum residue level (MRL) setting (European Commission, 2011) and the Joint Meeting on Pesticide Residues (JMPR) recommendations on livestock burden calculations (JMPR, 2004, 2007).

Metabolism of mecoprop‐P in primary crops was investigated upon foliar application on the cereals/grass (wheat) crop group using ¹⁴C‐mecoprop‐P labelled on the benzene ring. The active substance was applied post‐emergence on wheat, at growth stage BBCH 32 at a dose rate of 1.4 kg a.s./ha (1.2 N rate). The total radioactive residues accounted for 11.67 mg eq/kg in the whole green plants, 0.165 mg eq/kg in wheat grain and 10 mg eq/kg in wheat straw at harvest. The parent compound was identified at a level of 4.1% total radioactive residue (TRR) in immature green plant, 2.4% TRR in wheat grain and 22% TRR in wheat straw. Four weeks after application, the predominant compounds of the total residues in the whole green plant were identified as HMCPP (free and glucoside conjugated) (26.3% TRR; 3.06 mg eq/kg), CCPP (10% TRR; 1.16 mg eq/kg) and 4‐glucosyl‐MPP (26.2% TRR; 3.05 mg eq/kg). It is noted that the way the 4‐glucosyl‐MPP compound is formed in cereal whole plant is unclear and further clarification on the structure and the formation pathway of 4‐glucosyl‐MPP in plants should be provided (data gap). In mature wheat grain besides the identified minor metabolite CCPP (6% TRR; 0.01 mg eq/kg), the major part of the radioactive residues was characterised as a polar fraction that globally accounted for 42.4% TRR (0.07 mg eq/kg) and was shown to be constituted of several components that did not exceed each 0.013 mg eq/kg. In wheat straw, metabolites HMCCP and CCPP were recovered at levels of 11.8% TRR (1.18 mg eq/kg) and 14.2% TRR (1.42 mg eq/kg), respectively. Further characterisation of the unidentified radioactive fractions in wheat grain and straw demonstrated that the residues were found to be mainly incorporated into the natural plant constituents (sugars, lignin).The metabolic pathway of mecoprop‐P was considered as adequately depicted and the residue definition for monitoring for cereal grain is proposed as mecoprop‐P only. For risk assessment, several aspects were considered to derive the residue definition: (1) the significant proportions and concentrations of HMCPP and CCPP recovered in wheat straw, the identified CCPP compound in wheat grain and (2) although HMCPP under its conjugated form and 4‐glucosyl‐MPP were not relevant in regard to the representative uses on cereal small grains where only grain and straw are considered as feed items, their respective contribution to the animal dietary intakes when animals are exposed to residues in grass which is an authorised use (EFSA, 2013a) and where these compounds could represent a significant part of the residues have to be considered. The residue definition for risk assessment for cereal whole plant, grain and straw is provisionally set as mecoprop‐P, HMCPP (free and conjugated), CCPP and 4‐glucosyl‐MPP. A data gap is therefore identified for sufficient NEU and SEU GAP‐compliant residue trials to address the magnitude of residues of these compounds in cereals whole plant, grain and straw and supported by acceptable storage stability data. Pending the outcome of the requested residue field data, further consideration on the toxicity profile of CCPP and 4‐glucosyl‐MPP may be needed and the residue definition for risk assessment for the representative uses will be revised accordingly. HMCPP has been demonstrated to be less toxic than the parent compound (see Section 2). Meanwhile, provisional conversion factors for risk assessment of 4 for cereal grain, 2.2 for cereal straw and 6 for cereal whole plant (forage) were derived from the metabolism study.

Since mecoprop‐P showed a very low to moderate persistence in soil (DT₉₀ 20–33 days), confined rotational crop metabolism studies are not triggered.

A complete residue data set compliant with the SEU GAP is available on wheat and barley, while only four residue trials on wheat and barley and compliant with the NEU GAP were provided with a possible extrapolation to rye, oats and triticale. The residue data are supported by acceptable storage stability data where mecoprop‐P was shown to be stable for up to 12 months in wheat grain, straw and whole green plant. Based on the metabolism data, a no residue situation can not however be concluded on in cereal grain and sufficient residue trials on cereal grain and compliant with the NEU and SEU GAP on cereals are therefore requested for the determination of mecoprop‐P residues at a lower limit of determination (0.01 mg/kg) (data gap). Meanwhile a provisional MRL of 0.05 mg/kg (at the limit of quantification (LOQ)) is derived for cereal grain.

The requirement for standard hydrolysis studies on the nature of the residues in processed cereal grain should be reconsidered pending the outcome of the requested residue trials to address the magnitude of residues of the different relevant compounds in cereal grain.

The metabolism in livestock was investigated in lactating goats with ¹⁴C‐(U‐phenyl)‐mecoprop‐P only at nominal doses of 0.13 and 1.27 mg/kg bw per day, respectively. Mecoprop‐P was extensively excreted in urine and faeces and only 0.02% and < 0.01% of the administered radioactivity was recovered, respectively, in milk and tissues. The total residues in fat and muscle were very low (< 0.01 mg eq/kg) and no further metabolites' identification was attempted in those matrices. At the highest dose, the total residues in kidney and liver amounted to 0.097 mg eq/kg and 0.031 mg eq/kg, respectively. In kidney, parent mecoprop‐P was recovered under its free and conjugated forms (48% TRR) alongside unknown compounds that globally accounted for 13.2% TRR (0.013 mg eq/kg). Mecoprop‐P was not recovered in liver and milk while unidentified compounds were detected at significant proportions in liver (54.7% TRR; 0.017 mg eq/kg) and in milk (29.6% TRR, 0.004 mg eq/kg). Mecoprop‐P was the major compound of the total residues in urine and faeces accounting for 97% TRR and 94% TRR, respectively. EFSA acknowledges that the goat metabolism study was not conducted in accordance with the current guidance recommendations in view of the low rate of metabolites' identification in liver, kidney and milk and the metabolism of mecoprop‐P in ruminants cannot be sufficiently depicted based on the current data. A data gap was set to provide all analytical evidence available in the raw data from the goat metabolism study for further metabolites' identification in ruminants' matrices. Since it cannot be concluded on whether the metabolism in rat and ruminants are similar, the need for a pig metabolism study is not excluded. The need for a poultry metabolism study addressing the fate of mecoprop‐P residues will be reconsidered based on the outcome of the requested NEU and SEU residue trials on cereal grain analysing mecoprop‐P residues at a lower limit of determination (0.01 mg/kg) (see data gap). Furthermore, pending upon the respective contribution of HMCPP (free and conjugated), CCPP and 4‐glucosyl‐MPP to the livestock dietary burden (data gap) and their relative toxicity, the need for metabolism studies in poultry and ruminants addressing the potential transfer and behaviour of these compounds in animal matrices will have to be reconsidered. The need for a fish metabolism study will also have to be reconsidered pending upon the outcome of the requested residue trials on cereal grain and analysing for all the relevant compounds. Currently, residue definitions for monitoring and risk assessment for products of animal origin cannot be proposed. A ruminant feeding study conducted with mecoprop‐P only was also submitted and analysing for the magnitude of residues of parent mecoprop‐P, HMCPP and CCPP. It is acknowledged that if significant transfer of residues of HMCPP (free and conjugated), CCPP and 4‐glucosyl‐MPP into animal commodities is observed, the magnitude of these compounds or their degradation products should be further investigated in livestock feeding studies dosing with a representative mixture of mecoprop‐P and all relevant compounds in feed items.

For the time being, a consumer risk assessment can only be conducted for plant matrices on a provisional basis. Long‐term or short‐term intake concerns were not identified for the consumers since the highest chronic and acute intakes accounted for 20.6% of the ADI (Danish child) and 1.4% of the ARfD (wheat). The consumer risk assessment is, however, not finalised for the products of animal origin considering the outstanding data to perform a comprehensive livestock exposure assessment. Experimental information was not available regarding the potential racemisation of mecoprop‐P (R‐isomer) into the RS‐isomer mixture of mecoprop. Though this potential might be expected to be low, a data gap was identified (see Sections 4 and 7). However, the impact of any potential isomeric conversion on the consumer toxicological burden can be considered as negligible considering that both isomers share the same toxicity profile.

The proposed provisional residue definition for risk assessment for cereals has been changed compared to the residue definition that was agreed in the review of the existing MRLs for mecoprop‐P (EFSA, 2013a). Furthermore, the livestock exposure assessment will need to be reconsidered in the light of the outcome of the data gaps identified during the peer review. Meanwhile, an acute intake concern was not identified considering the tentative MRLs and the ARfD of 0.2 mg/kg bw in the exposure calculation.

Residue data in pollen and bee products were not provided. Although cereals are considered of low attractiveness to bees for pollen collection, metabolism data indicate non‐negligible translocation of the residues throughout the plant parts as attested by TRRs observed in cereals grains (0.165 mg eq/kg) at an application rate of 1.41 kg/ha (1.2 N). It is therefore not excluded that residues of mecoprop‐P and its relevant metabolites can be present in pollen and bee products and further information is requested (data gap).

4. Environmental fate and behaviour

As the analytical methods used in the available fate and behaviour studies did not discriminate mecoprop‐P (R) and mecoprop‐M (S) isomers, the applicant was requested to address the potential for racemisation of mecoprop‐P in environmental matrices under natural conditions. The only information provided on this was that racemisation was not expected as high temperatures and the presence of acidic metal species to catalyse transformation to the S isomer would be necessary. While this is plausible, an expectation is not sufficient information for a regulatory assessment. Consequently, a data gap was identified (see Section 7). However, it is considered unlikely that the uncertainty on the contribution to the total residues levels of the S isomer metabolite formed would change the conclusion of high aquatic risk (see Section 5). The rates of dissipation and degradation in the environmental matrices investigated were estimated using the FOCUS (2006) kinetics guidance. In soil laboratory incubations under aerobic conditions in the dark, mecoprop‐P exhibited very low to moderate persistence, forming no transformation products at levels that triggered identification and further assessment (all chromatically resolved components except mecoprop accounted for < 5% applied radioactivity (AR)). Mineralisation of the phenyl ring ¹⁴C radiolabel to carbon dioxide accounted for 40–51% AR after 100–191 days. The formation of unextractable residues (not extracted by acidified acetonitrile) for this radiolabel accounted for 43–51% AR after 100 days.

Mecoprop‐P exhibited very high to medium mobility in soil. It was concluded that the adsorption of mecoprop‐P was pH dependent, with adsorption decreasing as pH increased. In a lysimeter study of 2 years duration, mecoprop‐P and 4‐chloro‐o‐cresol in leachate accounted for < 0.03 μg/L in individual leachate samples. It should be noted that this study may not cover the higher leaching potential for metabolites that might be encountered under neutral or alkaline soil conditions.

In laboratory incubations in dark aerobic natural sediment water systems, mecoprop‐P exhibited moderate to high persistence, forming no transformation products at levels that triggered identification and further assessment (all chromatically resolved components except mecoprop accounted for < 5% AR). The unextractable sediment fraction (not extracted by acetonitrile including soxhlet extraction) was a sink for the phenyl ring ¹⁴C radiolabel, accounting for 10–32% AR at study end (98–100 days). Mineralisation of this radiolabel accounted for 13–58% AR at the end of the study. The rate of decline of mecoprop‐P in a laboratory sterile aqueous photolysis experiment was faster (low persistence) relative to that which occurred in the aerobic sediment water incubations. The photolysis metabolite o‐cresol was formed at a maximum of 30% AR and exhibited moderate persistence. The necessary surface water and sediment exposure assessments (predicted environmental concentrations (PEC) calculations) were carried out for mecoprop‐P and the metabolite o‐cresol, using the FOCUS (2001) step 1 and step 2 approach (version 2.1 of the Steps 1‐2 in FOCUS calculator). For the active substance mecoprop‐P, appropriate step 3 (FOCUS, 2001) and step 4 calculations were available.4 The step 4 calculations appropriately followed the FOCUS (2007) guidance, with no‐spray drift buffer zones of up to 10 m being implemented for the drainage scenarios (representing a 38–86% spray drift reduction), and combined no‐spray buffer zones with vegetative buffer strips of up to 10 m (reducing solute flux in run‐off by 60% and erosion runoff of mass adsorbed to soil by 85%) being implemented for the run‐off scenarios. Calculations were also presented for vegetative filter strips of 20 m (reducing solute flux in run‐off by 80% and erosion runoff of mass adsorbed to soil by 95%). The SWAN tool (version 1.1.4) was appropriately used to implement these mitigation measures in the simulations. However, risk managers and others may wish to note that while run‐off mitigation is included in the step 4 calculations available, the FOCUS (2007) report acknowledges that for substances with K _Foc < 2,000 mL/g (i.e. mecoprop‐P), the general applicability and effectiveness of run‐off mitigation measures had been less clearly demonstrated in the available scientific literature, than for more strongly adsorbed compounds.

The necessary groundwater exposure assessments were appropriately carried out using FOCUS (European Commission, 2014a) scenarios and the models PEARL 4.4.4, PELMO 5.5.3 and MACRO 4.4.2.4 The potential for groundwater exposure from the representative uses by mecoprop‐P above the parametric drinking water limit of 0.1 μg/L was concluded to be low in geoclimatic situations that are represented by all six FOCUS scenarios for spring planted cereals and eight of the nine FOCUS groundwater scenarios for autumn planted (winter) cereals. At the scenario Okehampton, 80th percentile annual average recharge concentrations moving below 1 m were predicted to be 0.115 μg/L.

The applicant provided appropriate information to address the effect of water treatments processes on the nature of the residues that might be present in surface water, when surface water is abstracted for drinking water. The conclusion of this consideration was that both mecoprop‐P and o‐cresol would be transformed to small two carbon chain compounds such as acetic/oxalic acids or formic acid/carbon dioxide and chloride salts, due to oxidation at the disinfection stage of usual water treatment processes.

The PEC in soil, surface water, sediment and groundwater covering the representative uses assessed can be found in Appendix A of this conclusion.

5. Ecotoxicology

The risk assessment was based on the following documents: European Commission (2002a,b), SETAC (2001), EFSA (2009) and EFSA PPR Panel (2013).

Mecoprop‐p was discussed at the Peer Review Experts' meeting 154 (February, 2017).

As reported in Section 4, the potential for the R isomer to racemise to the RS mixture in the soil and water compartments was not adequately addressed; however, it is considered unlikely that the uncertainty on the contribution to the total residues levels of the S isomer metabolite formed would change the conclusion of high aquatic risk (see also Section 4).

A low acute risk to birds for mecoprop‐P was concluded for all representative uses. The only available long‐term endpoint for birds was based on a subchronic study. It is noted that a study in line with the OECD 206 Test Guideline was indicated as being under development by the applicant. Considering the uncertainties in the currently available long‐term endpoint for birds, a data gap for the full report of this study, which may provide a relevant endpoint to be used in the long‐term avian risk assessment, was identified (data gap). By performing a provisional risk assessment with the available data and by using the LD₅₀/10, the latter being lower than the available subchronic endpoint, a low long‐term risk to birds was concluded for all representative uses.

A low acute risk to wild mammals for mecoprop‐P was concluded for all the representative uses. During the Peer Review Experts’ meeting 154, the experts agreed to use the NOAEL of 8.5 mg/kg bw per day in the long‐term risk assessment for wild mammals. By using this endpoint, a high long‐term risk to wild mammals was concluded for all representative uses of mecoprop‐P. The available refinement, DT₅₀ based on residues trials, was discussed and agreed during the Peer Review Experts’ meeting 154; however, it was not sufficient to address the risk identified for small insectivorous and omnivorous mammals and large herbivorous mammals (data gap). A risk assessment for the exposure via bioaccumulation was not triggered for mecoprop‐P. It is noted that in the case of the surface water metabolite o‐cresol, the available logP_ow (< 3) was reported as being retrieved from the literature. The relevant sources of this data were not summarised in the RAR (data gap). By considering the metabolites as 10 times more toxic than the parent compound, a high acute and long‐term chronic risk to birds could not be excluded for the plant metabolite HMCPP for all the representative uses while a high long‐term risk could not be excluded for metabolite CCPP for all the representative uses (data gap). It is noted that the RMS disagreed with this data gap being the high risk identified exclusively for the scenario ‘Large herbivorous bird “goose”’ which is considered as not relevant for the representative uses by the RMS. By considering the metabolites as 10 times more toxic than the parent compound, a high acute and long‐term risk to mammals could not be excluded for the plant metabolite CCPP for all representative uses (data gap). A low risk from consumption of contaminated water was concluded for both birds and wild mammals.

With regard to aquatic organisms, a high risk to aquatic plants (Myriophyllum spicatum) for mecoprop‐P was concluded for 1/5 FOCUS scenarios for the use on spring cereals and for 2/9 FOCUS scenarios for the use on winter cereals when appropriate risk mitigation measures are considered (data gap). A low risk to aquatic invertebrates (acute and chronic), fish (acute and chronic) and algae was concluded for all the representative uses. Regarding the surface water metabolite o‐cresol, by considering it as 10 times more toxic than the parent, a low risk was concluded for aquatic invertebrates (acute and chronic), fish (acute and chronic) and algae for all representative uses whilst a high risk could not be excluded for aquatic plants. It is noted that steps 3 and 4 FOCUS exposure estimates were not available for this metabolite (data gap).

In the case of honeybees, acute toxicity data, chronic toxicity data (including an assessment of effects on the hypopharyngeal gland (HPG)) and larval single exposure data for the active substance were available. A study on brood development in line with Oomen et al. (1992) was available for the formulation ‘Mecoprop‐P L 600’. Only the acute risk assessment according to the European Commission Guidance (2002a) was conducted. Since EFSA (2013b) was not taken note, the RMS did not use it while performing the bees risk assessment. It is, however, noted that (2002a) does not provide a risk assessment scheme addressing the chronic risk to adult honeybees and the risk to honeybee brood; the latter are covered by EFSA (2013b). In consideration of the above, and of the fact that the available high tier study on bee brood development is considered of limited use according to EFSA (2013b), a data gap has been identified. It is additionally noted that the examination of the HPG in the chronic toxicity study revealed statistically significant reduction in the acini diameter between all the test item groups and the control group, therefore, a no observed effect dose (NOED) could not be derived.

At the first tier level, a high risk for non‐target arthropods (Aphidius rhopalosiphi) following in‐field exposure was concluded while a low risk was concluded in the case of the off‐field exposure. Extended and/or aged residues tests were available for A. rhopalosiphi, Chrysoperla carnea and Aleochara bilineata. By using this data in line with ESCORT 2, a low risk was concluded for all species except A. bilineata. The highest tested dose in the A. bilineata test was below the maximum application rate, however, considering that at that application rate the effects on reproduction accounted for 2.8% and that a low off‐field risk was concluded, overall a low risk non‐target arthropods could be concluded.

A low risk to earthworm and other soil macroorganisms was concluded for all the representative uses of mecoprop‐P. In the absence of a valid study to address the effects of mecoprop‐P to soil microorganisms, a data gap was identified; it is noted that the RMS disagreed with this data gap.

The probabilistic risk assessment for non‐target terrestrial plants was discussed and agreed at the Peer Review experts’ meeting 154. A low risk to non‐target terrestrial plants for mecoprop‐P was concluded for all the representative uses provided that mitigation measures are implemented.

On the basis of the available data, the risk was considered low for organisms in sewage treatment plants.

With regard to the endocrine disruption potential, as discussed in Section 2, it is unlikely that mecoprop‐P is an endocrine disruptor in mammals; however, no firm conclusion can be drawn regarding fish and birds.

6. Overview of the risk assessment of compounds listed in residue definitions triggering assessment of effects data for the environmental compartments (Tables 1–4)

Table 1.

Soil

Compound (name and/or code)	Persistence	Ecotoxicology
Mecoprop‐P	Very low to moderate persistence Single first‐order and biphasic kinetics DT50 6–10.1 days (DT90 19.9–33.6 days, 20°C, 75% 1/3 bar WHC)	Data gap

DT₅₀: period required for 50% dissipation; DT₉₀: period required for 90% dissipation.

Table 4.

Air

Compound (name and/or code)	Toxicology
Mecoprop‐P	Rat inhalation LC50 > 2.13 mg/L (4‐h exposure, whole body), no classification required

LC₅₀: lethal concentration, median.

Table 2.

Groundwater

Compound (name and/or code)	Mobility in soil	> 0.1 μg/L at 1 m depth for the representative usesa	Pesticidal activity	Toxicological relevance
Mecoprop‐P	Very high to medium mobility K Foc 12–167 mL/g, pH dependent	For winter cereals, 1/9 FOCUS groundwater scenarios at 0.115 μg/L	Yes	Yes

K _Foc: Freundlich organic carbon adsorption coefficient.

^aAt least one FOCUS scenario or a relevant lysimeter.

Table 3.

Surface water and sediment

Compound (name and/or code)	Ecotoxicology
Mecoprop‐P	High risk for 1/5 FOCUS scenarios (use on spring cereals) High risk for 2/9 FOCUS scenarios (use on winter cereals)
o‐cresol	Data gap

7. Data gaps

This is a list of data gaps identified during the peer review process, including those areas in which a study may have been made available during the peer review process but not considered for procedural reasons (without prejudice to the provisions of Article 56 of Regulation (EC) No 1107/2009 concerning information on potentially harmful effects).

• A search of the scientific peer‐reviewed open literature regarding the aqueous photolysis metabolite o‐cresol and synonyms relevant to the scope of the application for renewal, dealing with side‐effects on the environment and non‐target species and published within the last 10 years before the date of submission of dossier, conducted and reported in accordance with (EFSA, 2011) was not available (relevant for all representative uses evaluated; submission date proposed by the applicant: unknown; see Section 4).

• LogP data for metabolites HMCPP and o‐cresol (relevant for all representative uses evaluated; submission date proposed by the applicant: unknown; see Sections 1 and 5).

• Monitoring method (chiral method) for the determination of mecoprop‐P residues in plant commodities (relevant for all representative uses evaluated; submission date proposed by the applicant: unknown; see Section 1).

• Monitoring methods (chiral methods) for the determination of mecoprop‐P residues in soil, water and air (relevant for all representative uses evaluated; submission date proposed by the applicant: unknown; see Section 1).

• Enforcement method for the determination of mecoprop‐P residues in body fluids and tissues (relevant for all representative uses evaluated; submission date proposed by the applicant: unknown; see Section 1).

• Two impurities in the proposed renewal specification have not been adequately assessed because they were not shown to be present in adequate levels in batches used in the toxicological studies and there is insufficient information on their toxicity. The toxicity and relevance of these impurities in the technical specification should be addressed (relevant for all representative uses evaluated; submission date proposed by the applicant: unknown; see Section 2).

• Toxicological data on the CCPP and 4‐glucosyl‐MPP metabolites (relevant for all representative uses evaluated; submission date proposed by the applicant: unknown; see Section 2).

• Clarification on the structure and the formation pathway of 4‐glucosyl‐MPP compound in plants (relevant for all representative uses evaluated; submission date proposed by the applicant: unknown; see Section 3).

• Sufficient NEU and SEU GAP‐compliant residue trials on cereals whole plant, grain and straw to address the magnitude of residues of mecoprop‐P, HMCPP (free and conjugated), CCPP and 4‐glucosyl‐MPP and supported by acceptable storage stability data (relevant for all representative uses evaluated; submission date proposed by the applicant: unknown; see Section 3).

• NEU and SEU GAP‐compliant residue trials on cereal grain for the determination of mecoprop‐P residues at a lower limit of determination (0.01 mg/kg) (relevant for all representative uses evaluated; submission date proposed by the applicant: unknown; see Section 3).

• The livestock dietary burden calculation to be revised based on the outcome of the requested residue trials to determine the magnitude of mecoprop‐P, HMCPP (free and conjugated), CCPP and 4‐glucosyl‐MPP in feed items and considering also their relative toxicity (relevant for all representative uses evaluated; submission date proposed by the applicant: unknown; see Section 3).

• All analytical evidence available in the raw data from the goat metabolism study for further metabolites’ identification in ruminants’ matrices (relevant for all representative uses evaluated; submission date proposed by the applicant: unknown; see Section 3).

• Determination of the residues in pollen and bee products for human consumption resulting from residues taken up by honeybees from crops at blossom with regards to mecoprop‐P and its degradation products (relevant for all representative uses evaluated; submission date proposed by the applicant: unknown; see Section 3).

• The potential for the R isomer to racemise to the RS mixture in the soil, water/sediment and air compartments, plants and animals was not adequately addressed (relevant for all representative uses evaluated; submission date proposed by the applicant: unknown; see Sections 3 and 4).

• Full report of the study performed according to the OECD 206 Test Guideline to further address long‐term endpoint and risk to birds (relevant for all representative uses evaluated, submission date proposed by the applicant: first‐second quarter of 2017; see Section 5).

• Further information to address the long‐term risk to small insectivorous and omnivorous mammals and large herbivorous mammals for mecoprop‐P and to fish‐eating birds and mammals for o‐cresol (relevant for all representative uses evaluated, submission date proposed by the applicant: unknown; see Section 5).

• Further information to address the acute and long‐term risk to wild mammals for the plant metabolite CCPP (relevant for all representative uses evaluated, submission date proposed by the applicant: unknown; see Section 5).

• Further information to address the acute and long‐term risk to birds for the plant metabolite HMCPP and the long‐term risk to birds for the plant metabolite CCPP (relevant for all representative uses evaluated, submission date proposed by the applicant: unknown; see Section 5).

• Further information to address the risk to aquatic plants (Myriophyllum spicatum) for mecoprop‐P and metabolite o‐cresol (relevant for all representative uses evaluated, submission date proposed by the applicant: unknown; see Section 5).

• A risk assessment for mecoprop‐P and its pertinent metabolites for honeybees according to EFSA (2013b) (relevant for all representative uses evaluated, submission date proposed by the applicant: unknown; see Section 5).

• Further information to address the risk to soil microorganisms for mecoprop‐P (relevant for all representative uses evaluated, submission date proposed by the applicant: unknown; see Section 5).

8. Particular conditions proposed to be taken into account to manage the risk(s) identified

• Mitigation measures (e.g. 5 m non‐spray buffer zone or 5 m vegetated buffer strip) are necessary to mitigate the risk to aquatic organisms for the use on winter cereals for FOCUS scenarios D3, D4, D5, D6, R1, R3, R4 and for FOCUS scenarios D3, D4, D5, R4 for the use on spring cereals (see Section 5).

• Mitigation measures (e.g. 5 m non‐spray buffer zone) are necessary to mitigate the risk to non‐target terrestrial plants for all the representative uses (see Section 5).

• Operators should wear personal protective equipment (PPE) (gloves) during the phases of mixing/loading, and gloves, coveralls and sturdy footwear during application with a tractor‐mounted/trailed field crop sprayer equipment in cereals (see Section 2).

9. Concerns

9.1. Issues that could not be finalised

An issue is listed as ‘could not be finalised’ if 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 546/20115 and if 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).

An issue is also listed as ‘could not be finalised’ if the available information is considered insufficient to conclude on whether the active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

• 1The consumer risk assessment cannot be finalised due to the outstanding data to confidently address the nature and magnitude of residues in plant and animal matrices (see Section 3).
• 2The long‐term risk to birds for mecoprop‐P cannot be finalised (see Section 5).

9.2. Critical areas of concern

An issue is listed as a critical area of concern if 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 if this assessment does not permit the conclusion 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 if the assessment at a higher tier level could not be finalised due to lack of information, and if the assessment performed at a lower tier level does not permit the conclusion 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 if, in the light of current scientific and technical knowledge using guidance documents available at the time of application, the active substance is not expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

• 3A high long‐term risk to wild mammals for mecoprop‐P was concluded for all representatives uses (see Section 5).
• 4Worker exposure is predicted to be above the AOEL for all representative uses.

9.3. Overview of the concerns identified for each representative use considered

(If a particular condition proposed to be taken into account to manage an identified risk, as listed in Section 8, has been evaluated as being effective, then ‘risk identified’ is not indicated in Table 5).

Table 5.

Overview of concerns

Representative use		Spring cereals	Winter cereals
Operator risk	Risk identified
	Assessment not finalised
Worker risk	Risk identified	X4	X4
	Assessment not finalised
Resident/bystander risk	Risk identified
	Assessment not finalised
Consumer risk	Risk identified
	Assessment not finalised	X1	X1
Risk to wild non‐target terrestrial vertebrates	Risk identified	X3	X3
	Assessment not finalised	X2	X2
Risk to wild non‐target terrestrial organisms other than vertebrates	Risk identified
	Assessment not finalised
Risk to aquatic organisms	Risk identified	1/5 FOCUS scenarios	2/9 FOCUS scenarios
	Assessment not finalised
Groundwater exposure to active substance	Legal parametric value breached		1/9 FOCUS scenarios
	Assessment not finalised
Groundwater exposure to metabolites	Legal parametric value breached
	Parametric value of 10 μg/L breached
	Assessment not finalised

Columns are grey if no safe use can be identified. The superscript numbers relate to the numbered points indicated in Sections 9.1 and 9.2. Where there is no superscript number, see Sections 2–6 for further information.

Abbreviations

a.s.

active substance

AAOEL

acute acceptable operator exposure level

ADI

acceptable daily intake

AOEL

acceptable operator exposure level

AR

applied radioactivity

ARfD

acute reference dose

bw

body weight

DT₅₀

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

DT₉₀

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

ECHA

European Chemicals Agency

EEC

European Economic Community

EUROPOEM

European Predictive Operator Exposure Model

FAO

Food and Agriculture Organization of the United Nations

FOCUS

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

GAP

Good Agricultural Practice

HPG

hypopharyngeal glands

ISO

International Organization for Standardization

IUPAC

International Union of Pure and Applied Chemistry

JMPR

Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Expert Group on Pesticide Residues (Joint Meeting on Pesticide Residues)

K _Foc

Freundlich organic carbon adsorption coefficient

LC₅₀

lethal concentration, median

LC–MS/MS

liquid chromatography with tandem mass spectrometry

LD₅₀

lethal dose, median; dosis letalis media

LOQ

limit of quantification

M/L

mixing and loading

MRL

maximum residue level

MS

mass spectrometry

NEU

northern Europe

NOAEL

no observed adverse effect level

NOED

no observed effect dose

NOEL

no observed effect level

OECD

Organisation for Economic Co‐operation and Development

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

pre‐harvest interval

P_ow

partition coefficient between n‐octanol and water

PPE

personal protective equipment

RAR

renewal assessment report

RMS

rapporteur Member State

SEU

southern Europe

SMILES

simplified molecular‐input line‐entry system

TRR

total radioactive residue

UF

uncertainty factor

WHC

water‐holding capacity

WHO

World Health Organization

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

1.

Appendix A can be found in the online version of this output (‘Supporting information’ section): https://doi.org/10.2903/j.efsa.2017.4832.

Appendix B – Used compound codes

1.

Code/trivial namea	Chemical name/SMILES notation	Structural formula
mecoprop	(RS)‐2‐(4‐chloro‐o‐tolyloxy)propionic acid Clc1cc(C)c(OC(C)C(=O)O)cc1
HMCPP Hydroxymethyl‐mecoprop‐P	(2S)‐2‐[4‐chloro‐2‐(hydroxymethyl)phenoxy]propanoic acid Clc1cc(CO)c(O[C@@H](C)C(=O)O)cc1
CCPP carboxy‐mecoprop‐P	2‐[(1S)‐1‐carboxyethoxy]‐5‐chlorobenzoic acid Clc1cc(c(O[C@@H](C)C(=O)O)cc1)C(=O)O
4‐glucosyl‐MPP	(2S)‐2‐[4‐(d‐glucopyranosyloxy)‐2‐methylphenoxy]propanoic acid O=C(O)[C@H](C)Oc2ccc(OC1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O)cc2C
o‐cresol	2‐methylphenol Cc1ccccc1O
4‐chloro‐o‐cresol	4‐chloro‐2‐methylphenol Cc1cc(ccc1O)Cl
PCOC 4‐chloro‐2‐methylphenol	4‐chloro‐2‐methylphenol Cc1cc(Cl)ccc1O

SMILES: simplified molecular‐input line‐entry system.

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

Supporting information

List of end points for the active substance and the representative formulation

Suggested citation: EFSA (European Food Safety Authority) , Arena M, Auteri D, Barmaz S, Bellisai G, 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, Ippolito A, 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, Sharp R, Stanek A, Streissl F, Sturma J, Szentes C, 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 of the active substance mecoprop‐P. EFSA Journal 2017;15(5):4832, 23 pp. 10.2903/j.efsa.2017.4832