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

Abstract

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State the Netherlands, for the pesticide active substance pendimethalin are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory information in the area of ecotoxicology. The conclusions were reached on the basis of the evaluation of the representative uses of pendimethalin as a herbicide on cereals, pulse and carrots. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and/or literature in the dossier peer reviewed, are presented. Concerns are identified.

SUMMARY

Pendimethalin was renewed on 1 September 2017 by Commission Implementing Regulation (EU) No 2017/1114, as amended by Commission Implementing Regulations (EU) 2019/724 and 2020/2007.

Pendimethalin fulfils the criteria as persistent (P) and toxic (T) in accordance with the criteria provided for in points 3.7.2.1 and 3.7.2.3 of Annex II to Regulation (EC) 1107/2009 respectively, it meets the conditions of indent 2 of point 4 of Annex II and therefore shall be re‐approved pursuant to Article 24 of Regulation (EC) No 1107/2009 as a candidate for substitution.

As a result of the renewal of approval process, a specific provision was set requiring the applicant to submit confirmatory information to the European Commission, the Member States and EFSA as regards:

1. The potential for bioaccumulation, in particular a reliable BCF value for bluegill sunfish (Lepomis macrochirus), by 31 December 2018.

2. The effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater are abstracted for drinking water, within a period of 2 years of the publication by the Commission of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.

In accordance with the specific provision, the applicants, BASF SE and ADAMA Agriculture B.V., submitted an updated dossier related to point 1 only in January 2019, which was evaluated by the designated rapporteur Member State (RMS), the Netherlands, in the form of a revised renewal assessment report (RAR). In compliance with the guidance document SANCO 5634/2009‐rev.6.1, the RMS distributed the revised RAR to Member States, the applicants and EFSA for comments on 26 May 2021. The RMS collated all comments in the format of a reporting table, which was submitted to EFSA on 21 September 2021 along with the revised RAR on 5 October. EFSA added its scientific views on the specific points raised during the commenting phase, leading to the Technical Report finalised on 4 November 2021 (EFSA, 2021).

The applicants provided three additional fish bioconcentration studies which were assessed as reliable and confirmed that the BCF value is species dependent. In the EFSA (2021), it was proposed to discuss at an experts' meeting how to express BCF values ‐whether as active substance or total radioactive residues – alongside the pendimethalin potential for bioaccumulation and to agree on the BCF value for calculating exposure in fish‐eating birds and mammals. Following the considerations presented in the EFSA Technical Report (EFSA, 2021), the European Commission requested EFSA to organise a peer review, including an expert consultation to review the bioaccumulation properties of pendimethalin, using a weight‐of‐evidence approach.

In addition, EFSA was asked to provide a BCF value for pendimethalin making use of all available information. When performing its task EFSA would take into account all relevant regulatory guidance documents, including the ongoing work at the time of issuing the mandate, regarding the update to ECHA Guidance on the application of the CLP criteria: PBT/vPvB and PMT/vPvM. Consideration and any uncertainties used to reach the outcome should be documented.

The following conclusions were drawn:

The available evidence indicates that pendimethalin might be considered a persistent (P) bioaccumulative (B) and toxic (T) or PBT substance. The P criterion may be considered fulfilled for soil and potentially for the aquatic environmental compartment sediment using the available reliable data (see section 4, EFSA, 2016). For the B criterion, the majority of experts at the Pesticides Peer Review TC 161 (3–6 February 2025) agreed that the data were indicative of meeting the B criteria but concluded that it cannot be confirmed (see Section 1). The T classification is clear from the available reliable data regarding the toxicity exerted by pendimethalin on aquatic species, particularly to algae (see section 5, EFSA, 2016).

BACKGROUND

Pendimethalin approval was renewed on 1 September 2017 by Commission Implementing Regulation (EU) No 2017/1114, ¹ as amended by Commission Implementing Regulations (EU) 2019/724 ² and 2020/2007. ³ EFSA previously finalised a Conclusion on this active substance on 17 March 2016 in the EFSA Journal (EFSA, 2016).

Pendimethalin fulfils the criteria as persistent (P) and toxic (T) in accordance with the criteria provided for in points 3.7.2.1 and 3.7.2.3 of Annex II to Regulation (EC) 1107/2009 ⁴ respectively, it meets the conditions of indent 2 of point 4 of Annex II and therefore shall be re‐approved pursuant to Article 24 of Regulation (EC) No 1107/2009⁴ as a candidate for substitution.

A specific provision of the renewal of approval indicated that the applicant was required to submit confirmatory information to the European Commission, the Member States and EFSA as regards:

1. The potential for bioaccumulation, in particular a reliable BCF value for bluegill sunfish (Lepomis macrochirus), by 31 December 2018.

2. The effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater are abstracted for drinking water, within a period of 2 years of the publication by the Commission of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.

In accordance with the specific provision, the applicants, BASF SE and ADAMA Agriculture B.V., submitted an updated dossier relating to point 1 in January 2019 which was evaluated by the designated rapporteur Member State (RMS), the Netherlands, in the form of a revised renewal assessment report (the Netherlands, 2021). In compliance with the guidance document SANCO 5634/2009‐rev.6.1 (European Commission, 2013), the RMS distributed the revised RAR to Member States, the applicant and the EFSA for comments on 26 May 2021. The RMS collated all comments in the format of a reporting table, which was submitted to EFSA on 2 September 2021. EFSA added its scientific views on the specific points raised during the commenting phase, leading to the Technical Report finalised on 4 November 2021 (EFSA, 2021). The Technical Report from EFSA summarised the outcome of the consultation process organised by the RMS, the Netherlands, and presented EFSA's scientific views and conclusions on the individual comments received.

To address the potential for bioaccumulation, in particular a reliable BCF value for bluegill sunfish (Lepomis macrochirus), the applicants provided three additional fish bioconcentration studies which were assessed as reliable and confirmed that the BCF value is species dependent. It was proposed to discuss at an experts' meeting, whether the BCF values should be expressed in terms of parent substance or total radioactive residues. Irrespective of the discussion outcome, one of the available BCF values exceeds the trigger value of 2000 specified in Annex II, point 3.7.2.2, of Regulation 1107/2009. In addition, the RMS provided argumentation regarding the potential for bioaccumulation; it was suggested to discuss the potential for bioaccumulation in an expert meeting and to agree on the BCF value to be used in the calculation of the exposure to fish‐eating birds and mammals.

Following consideration presented in the EFSA Technical Report (EFSA, 2021), the European Commission requested EFSA to organise a peer review, including an expert consultation to review the bioaccumulation properties of pendimethalin, using a weight of evidence approach as experimental data from more than one species is available and should be considered in the process of the risk assessment.

In addition, EFSA is asked to provide a BCF value for pendimethalin making use of all available information. When performing its task EFSA would take into account all relevant regulatory guidance documents, including the ongoing work at the time of issuing the mandate, regarding the update to ECHA Guidance on the application of the CLP criteria: PBT/vPvB and PMT/vPvM. Consideration and any uncertainties used to reach the outcome should be documented.

The revised RAR (Netherlands, 2021) and the Technical Report were discussed at the Pesticides Peer Review Meeting on ecotoxicology in February 2025. Details of the issues discussed, together with the outcome of these discussions were recorded in the meeting report.

A final consultation on the conclusions arising from the peer review took place with Member States via a written procedure in April 2025.

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 in relation to The potential for bioaccumulation, in particular a reliable BCF value for bluegill sunfish (Lepomis macrochirus). 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, from the compilation of comments in the reporting table to the conclusion. The peer review report (EFSA, 2025) 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 RAR including its updated volumes (Netherlands, 2025) 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 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

Pendimethalin is the ISO common name for N‐(1‐ethylpropyl)‐2,6‐dinitro‐3.4‐xylidene (IUPAC).

The representative formulated products for the evaluation were ‘Stomp aqua’ (code BAS 455 48 H) a capsule suspension (CS) containing 455 g/L pendimethalin and ‘Pendimethalin 400 SC’ (code AG‐P4‐400 SC) a suspension concentrate containing 400 g/L pendimethalin.

The representative uses evaluated comprise of outdoor foliar spraying against broad leaved weeds and grasses in cereals, carrot, beans and peas. Full details of the GAP can be found in the list of end points in Appendix A (EFSA, 2016).

1. CONCLUSIONS OF THE EVALUATION

The applicant submitted to the Commission, by the deadline of 31 December 2018, three new fish bioconcentration studies. These were performed with three species (Lepomis macrochirus, Salvelinus alpinus × fontinalis and Pimephales promelas).

The assessment of the newly provided information was presented in the revised RAR on pendimethalin confirmatory data (Netherlands, 2021). The RMS concluded that the newly available fish bioconcentration studies were reliable and added to the existing data set for bioconcentration and bioaccumulation that was available in the RAR of 2015. For the aquatic environment, this consists of four fully reliable fish BCF studies, an additional fish bioconcentration factor (BCF) study that was not fully reliable but supportive, two fish biomagnification studies where the exposure was via spiked food and two mesocosm studies where bioaccumulation and biomagnification were assessed. The RMS also provided an updated assessment of the bioaccumulation potential of pendimethalin. On the basis of the peer review of the confirmatory data assessment, EFSA published a technical report (EFSA, 2021) suggesting that the data be discussed in an experts meeting. These discussions took place at Pesticides Peer Review TC 161 (3–6 February 2025).

The experts agreed with the assessment of the RMS that the bioconcentration study (2003/1033759) performed with zebrafish was not fully reliable but could be considered in an overall weight‐of‐evidence approach. ⁵

Since a range of values BCF were available for fish (361 to 3311 L/kg), the experts discussed which value should be selected for the calculation of the exposure to fish‐eating birds and mammals. The experts agreed with the approach of the RMS to calculate the range of exposure by using the highest and lowest of the available BCF values. ⁶ The resulting risk assessment indicated low risk to fish‐eating birds and mammals using both the highest and lowest BCF values together with FOCUS step 2 exposure estimates.

The available newly submitted fish BCF studies and the weight‐of‐evidence assessment were discussed during the meeting. ⁷ The experts focussed the assessment of Bioaccumulation (B) criterion in the context of the Persistence, Bioaccumulation and Toxicity (PBT) assessment required according to Regulation 1107/2009. All experts agreed that one of the available reliable fish BCF values was 3311 L/kg (normalised for lipid and growth). This value is above the trigger value of 2000 for concluding B according to Regulation 1107/2009. The BCF value is less than the trigger value of 5000 for concluding very bioaccumulative. Other available evidence (fish biomagnifications studies, mesocosm studies, terrestrial bioaccumulation studies, bioaccumulation in mammals) cannot be directly compared to the criteria but were considered not to be indicating bioaccumulation.

The mandate provided to EFSA (Ref. Ares(2024)4424148‐19/06/2024 ⁸ ) requested that the assessment of bioaccumulation should take into account all relevant regulatory guidance documents, including the ongoing work at the time of issuing the mandate, regarding the update to ECHA Guidance on the application of the CLP criteria: PBT/vPvB and PMT/vPvM. The ECHA Guidance was finalised and available to the experts during the meeting (ECHA, 2024). However, the guidance indicates that, to reach a conclusion the integration of the evidence would need to be considered by the ECHA Risk Assessment Committee. Furthermore, the experts noted that the working document from the European Commission (European Commission, 2012) does not provide an interpretation of the application of the weight‐of‐evidence in cases where fish BCF studies are available which give differing results. Consequently, the majority of experts ⁹ agreed that the data for the bioaccumulation potential of pendimethalin should be considered as indicative of meeting the B criteria but the final conclusion could not be confirmed.

2. CONCERNS AND RELATED DATA GAPS FOR THE REPRESENTATIVE USES EVALUATED

2.1. 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 one or more of 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 ¹⁰ 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.

The following issues or assessments that could not be finalised have been identified, together with the reasons including the associated data gaps where relevant, which are reported directly under the specific issue to which they are related:

No further issues were identified in the present peer review process of confirmatory data assessment beyond those noted in (EFSA, 2016 ).

2.2. 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 the 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.

The following critical areas of concern are identified in addition to those specified in (EFSA, 2016 ). Any associated data gaps, where relevant, are reported directly under the specific critical area of concern to which they are related:

1. The available evidence indicates that pendimethalin might be considered a persistent (P) bioaccumulative (B) and toxic (T) or PBT substance. The P criterion may be considered fulfilled for soil and potentially for the aquatic environmental compartment sediment using the available reliable data (see section 4, EFSA, 2016). For the B criterion, the majority of experts at the Pesticides Peer Review TC 161 (3–6 February 2025) agreed that the data were indicative of meeting the B criteria but concluded that it cannot be confirmed (see Section 1). The T classification is clear from the available reliable data regarding the toxicity exerted by pendimethalin on aquatic species, particularly to algae (see section 5, EFSA, 2016).

3. OVERVIEW OF THE CONCERNS IDENTIFIED FOR EACH REPRESENTATIVE USE CONSIDERED

In addition to the issues indicated in table 5, section 9.3 of EFSA (2016), the substance might be considered a persistent (P) bioaccumulative (B) and toxic (T) or PBT substance in accordance with 3.7.2 of Annex II to Regulation (EC) No 1107/2009.

4. LIST OF OTHER OUTSTANDING ISSUES

Remaining data gaps not leading to critical areas of concern or issues not finalised but considered necessary to comply with the data requirements, and which are relevant for some or all of the representative uses assessed at EU level. Although not critical, these data gaps may lead to uncertainties in the assessment and are considered relevant.

These data gaps refer only to the representative uses assessed and are listed in the order of the sections:

None identified in the present peer review process of confirmatory data assessment.

ABBREVIATIONS

a.s.

active substance

BCF

bioconcentration factor

bw

body weight

CAS

Chemical Abstracts Service

CIPAC

Collaborative International Pesticides Analytical Council Limited

ECHA

European Chemicals Agency

EINECS

European Inventory of Existing Commercial Chemical Substances

ELINCS

European List of New Chemical Substances

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

ISO

International Organization for Standardization

IUPAC

International Union of Pure and Applied Chemistry

NOAEC

no observed adverse effect concentration

OECD

Organisation for Economic Co‐operation and Development

PBT

persistence, bioaccumulation and toxicity

POP

persistent organic pollutant

RAR

renewal assessment report

RMS

rapporteur Member State

SMILES

simplified molecular‐input line‐entry system

SSL

steady state lipid

TER

toxicity exposure ratio

TWA

time‐weighted average

WHO

World Health Organization

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2024‐00427

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APPENDIX A. Consideration of cut‐off criteria for pendimethalin according to Annex II of Regulation (EC) No 1107/2009 of the European Parliament and of the Council

Properties		Conclusion a
POP	Persistence	Pendimethalin is not considered to be a persistent organic pollutant (POP) according to point 3.7.1 of Annex II of Regulation (EC) 1107/2009
	Bioaccumulation
	Long‐range transport
PBT	Persistence	The available evidence indicates that pendimethalin might be considered a persistent (P) bioaccumulative (B) and toxic (T) PBT substance according to point 3.7.2 of Annex II of Regulation (EC) 1107/2009
	Bioaccumulation
	Toxicity
vPvB	Persistence	Pendimethalin is not considered to be a very persistent, very bioaccumulative substance according to point 3.7.3 of Annex II of Regulation (EC) 1107/2009
	Bioaccumulation

^a Origin of data to be included where applicable (e.g. EFSA, ECHA RAC, Regulation).

APPENDIX B. List of end points for the active substance and the representative formulation relevant for the confirmatory data assessed

Identity, Physical and Chemical Properties, Details of Uses, Further Information (Regulation (EU) N° 283/2013, Annex Part A, points 1.3 and 3.2)

Identity (Regulation (EU) N° 283/2013, Annex Part A, point 1)

Summary of representative uses evaluated (EFSA Journal 2016;14(3):4420)

Crop and/or situation a	Member state or country	Product name	F G or I b	Pests or group of pests controlled c	Formulation		Application				Application rate per treatment			PHI (days) i	Remarks: m
					Type d , e , f	Conc. of as g/L i	Method kind f , g , h	Growth stage & season j	Number max k	Interval between applications (min)	L product/ ha max	Water L/ha min max	g a.s./ha max
Wheat (repre‐sents small grain cereals)	AT, BE, CZ, DK, DE, GR, IT, IE, LU, PT, SI, ES, UK	Stomp aqua	F	Broadleaved weeds and grasses	CS	455	Spray	Pre‐ or post‐em (BBCH 00–29) autumn	1	–	3.5	100–400	1593	n.a.
Carrot	AT, BE, CZ, DK, ET, DE, GR, IT, IE, LV, LT, LU, PO, PT, SI, ES, UK	Stomp aqua	F	Broadleave weeds and grases	CS	455	Spray	Pre‐ or post‐em (BBCH 00–14)	1	–	3.5	100–600	1593	42
Carrot	DE, SI,	Stomp aqua	F	Broadleave weeds and grases	CS	455	Spray	Pre‐ + post‐em (BBCH 12–13)	2	14–35	1.75 + 1.75	200–400	796 + 796	42	Split application 1.75 pre + 1.75 post at BBCH 12–13
Green bean	DE, SI	Stomp aqua	F	Broadleave weeds and grases	CS	455	Spray	Pre‐em	1	–	3.5	200–400	1593	n.a.
Dry bean	AT, CZ, ET,DE, IT, LV, LU, PT, SI	Stomp aqua	F	Broadleave weeds and grases	CS	455	Spray	Pre‐ or post‐em (BBCH 00–13)	1	–	3.5	200–600	1593	n.a.
Green pea	AT, DK, DE	Stomp aqua	F	Broadleave weeds and grases	CS	455	Spray	Pre‐ or post‐em (BBCH 00–13)	1	–	Pre 3.0 Post 3.5	200–400	Pre 1365 Post 1593	56
Green pea	DK	Stomp aqua	F	Broadleave weeds and grases	CS	455	Spray	BBCH 12 + BBCH 14	2	F*	1.0	200–400	455	56	Total per crop/season: 910 g a.s./ha *In the current registration of this product in Denmark, no interval is mentioned
Dry pea	AT, BE, BG, CZ, DK, ET, DE, GR, IT, IE, LV, LT, LU, PO, PT, ES, UK	Stomp aqua	F	Broadleave weeds and grases	CS	455	Spray	Pre‐sowing, pre‐em or post‐em (BBCH 00–13)	1	–	3.5	100–600	1593	56
Dry pea	DK	Stomp aqua	F	Broadleave weeds and grases	CS	455	Spray	BBCH 12 + BBCH 14	2	F*	1.0	200–400	455	56	Total per crop/season: 910 g a.s./ha *In the current registration of this product in Denmark, no interval is mentioned

^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 sucking insects, soil born insects, foliar fungi, weeds

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

^e CropLife International Technical Monograph no 2, 6th Edition. Revised May 2008. Catalogue of pesticide

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

^k Indicate the minimum and maximum number of applications 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

Risk from bioaccumulation and food chain behaviour
Risk envelope: Winter cereals, pre‐emergence, 1 × 1.6 kg a.s./ha
Indicator or focal species	Time scale	DDD (mg/kg bw per day)	TER	Trigger
Earthworm‐eating birds	Long‐term	1.75 or 5.26	35 or 11.7	5
Earthworm‐eating mammals	Long‐term	2.13 or 6.4	14 or 4.7	5
Fish‐eating birds (FOCUS Step 1, (TWA21d))	Long‐term	10.7 / 1.2	5.8/51.3	5
Fish‐eating mammals (FOCUS Step 1, (TWA21d))	Long‐term	9.5 / 1.0	3.2/30	5
Fish‐eating mammals (FOCUS Step 2, (TWA21d))	Long‐term	9.5 / 1.0	6.6/–	5
Higher tier (earthworm‐eating birds): When the highest BAF of 2.44 is used, the TER is just under the cut‐off value. However, considering the fact that the study from which the BAF of 2.44 was derived is considered less reliable, and the results of the range‐finding study (Study 8.1.3/03) were also closer to 1 (1.24), a low risk was concluded on a weight‐of evidence approach suggests that that the risk to earthworm‐eating mammals is acceptable Higher tier (fish‐eating mammals): Not needed For mammals, when the FOCUS Step 1 TWA 21d is used, the risk is low using the lowest BCFfish, but high using the highest value. However, when the FOCUS Step 2 TWA 21d value of 9.676 × 10–3 is used the risk is low (TER = 6.6)
Risk from consumption of contaminated water
Puddle scenario, screening step Application rate (1600 g a.s./ha)/17.5 (birds) or 30 (mammals) < 3000 (koc ≥ 500 L/kg); TER calculation not necessary

	Active substance
logPO/W	5.2
Uptake/depuration kinetics BCF (normalised to growth and 5% lipid content, except where indicated otherwise)	L. macrochirus: 3311 L/kg O. mykiss: 361 L/kg D. rerio: 1179 L/kg (not fully reliable value and not normalised for growth) P. promelas: 1078 L/kg S. alpinus: 1480 L/kg
Higher tier study
Two outdoor mesocosm studies with a.s. pedimethalin targeted at bioconcentration are available. As additional information, two dietary exposure BCF studies are also available (see below)
Exposure via diet
Species	Endpoint a	Value
Lepomis macrochirus (dietary bioaccumulation/biomagnification)	BMFKGL	0.1054
Oncorhynchus mykiss (dietary bioaccumulation/biomagnification)	BMFKGL	0.0402
	BMFSSL	0.0423
Outdoor mesocosms (test substance: pendimethalin a.s.)
Leuciscus idus melanotus (bioaccumulation, outdoor mesocosm enclosures, single treatment 5 μg a.s./L, static spiked water), 28 day exposure	BCFactual conc at day 2	337.2
	BCFtwaconc	207
	BCFnom	97.3
	Mean BCFactual conc	199
Aquatic community in outdoor mesocosms including fish (Leuciscus idus); single treatment 10 μg a.s./L, static, spiked water, 134 d exposure	No evidence of biomagnification of either pendimethalin, its metabolites or equivalent radioactivity within the aquatic food chain NOEC fish: 0.0050 mg a.s./L	–

Note: For the dietary studies (BMF) the lipid correction is between food and fish, for the aqueous exposure studies (BCF) it concerns a normalisation to a 5% lipid content in fish (see OECD 305 (2012)).

^a BAF, bio‐accumulation factor; KGL: kinetic BCF or BMF, growth and lipid corrected; SSL: steady state, lipid corrected.

APPENDIX C. Used compound codes

Code/trivial name a	IUPAC name/SMILES notation/InChiKey b	Structural formula c
Pendimethalin	N‐(1‐ethylpropyl)‐2,6‐dinitro‐3.4‐xylidene [O‐][N+](=O)c1c(C)c(C)cc([N+]([O‐]) = O)c1NC(CC)CC CHIFOSRWCNZCFN‐UHFFFAOYSA‐N

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

^b ACD/Name 2018.2.2 ACD/Labs 2018 Release (File version N50E41, Build 103230, 21 July 2018).

^c ACD/ChemSketch 2018.2.2 ACD/Labs 2018 Release (File version C60H41, Build 106041, 7 December 2018).

EFSA (European Food Safety Authority) , Álvarez, F. , Arena, M. , Auteri, D. , Colagiorgi, A. , De Lentdecker, C. , De Magistris, I. , Ferilli, F. , Giner Santonja, G. , Halling, K. , Ippolito, A. , Kardassi, D. , Kienzler, A. , Linguadoca, A. , Molnar, T. , Rizzuto, S. , Sharp, R. , Szentes, C. , Tiramani, M. , … Villamar‐Bouza, L. (2025). Peer review of the pesticide risk assessment for the active substance pendimethalin in light of confirmatory data submitted. EFSA Journal, 23(7), e9511. 10.2903/j.efsa.2025.9511