Peer review of the pesticide risk assessment of the active substance Trichoderma harzianum T78

Abstract

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, The Netherlands, for the pesticide active substance Trichoderma harzianum T78 and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of Trichoderma harzianum T78 as a fungicide on lettuce. 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. Data gaps are identified.

SUMMARY

Trichoderma harzianum T78 is a new active substance for which, in accordance with Article 7 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council, the rapporteur Member State (RMS), The Netherlands, received an application from Symborg Business Development S.L. on 26 February 2020 for approval. In addition, the applicant submitted an application for inclusion of the substance in Annex IV of Regulation (EC) No 396/2005. Complying with Article 9 of the Regulation, the completeness of the dossier was checked by the RMS and the date of admissibility of the application was recognised as being 4 September 2020.

An initial evaluation of the dossier on Trichoderma harzianum T78 was provided by the RMS in the draft assessment report (DAR), and subsequently, a peer review of the pesticide risk assessment on the RMS evaluation was conducted by EFSA in accordance with Article 12 of Regulation (EC) No 1107/2009. The following conclusions are derived.

The uses of Trichoderma harzianum T78 according to the representative use on lettuce, in field crops via overall drench, drenching equipment and drip irrigation system for the control of Sclerotinia spp., as proposed at EU level result in sufficient fungicide efficacy against the target pest.

The assessment of the data package revealed no issues that could not be finalised or that need to be included as critical areas of concern with respect to the identity of the active substance, physical and technical properties of the representative formulation and analytical methods.

In the area of mammalian toxicology, the available evidence was considered sufficient to exclude the presence of secondary metabolites of potential concern. No data gaps were identified and risk from non‐dietary exposure to the secondary metabolites is considered unlikely.

In the area of residues, no data gaps were identified. An MRL application for inclusion of Trichoderma harzianum T78 into Annex IV of Regulation (EC) No 396/2005 was assessed and one criterion of the five provided in the applicable guidance was considered to be met.

In relation to fate and behaviour in the environment, Trichoderma harzianum T78 can be expected to persist and multiply in soil in concentrations considerably higher than the natural background levels, taking into account repeated applications over the years. Currently, the available information is insufficient to determine whether the metabolites known to be produced (particularly peptaibols) meet the criteria set out in Part B, Section 7(iv) of Commission Regulation (EU) No 283/2013 and on their presence in the microbial pest control product (MPCP) and/or their in‐situ production in the environment. A data gap was identified for the exposure of secondary metabolites of potential concern for the environmental compartments.

In the area of ecotoxicology, the risk assessment to non‐target organisms exposed to potentially produced secondary metabolites of potential concern could not be finalised.

BACKGROUND

Regulation (EC) No 1107/2009 of the European Parliament and of the Council ¹ (hereinafter referred to as ‘the Regulation’) lays down, inter alia, the detailed rules as regards the procedure and conditions for approval of active substances. This regulates for the European Food Safety Authority (EFSA) the procedure for organising the consultation of Member States and the applicant for comments on the initial evaluation in the draft assessment report (DAR), provided by the rapporteur Member State (RMS), and the organisation of an expert consultation, where appropriate.

In accordance with Article 12 of the Regulation, EFSA is required to adopt a conclusion on whether an active substance can be expected to meet the approval criteria provided for in Article 4 of the Regulation (also taking into consideration recital (10) of the Regulation) within 120 days from the end of the period provided for the submission of written comments, subject to an extension of 30 days where an expert consultation is necessary, and a further extension of up to 150 days where additional information is required to be submitted by the applicant(s) in accordance with Article 12(3).

Trichoderma harzianum T78 is a new active substance for which, in accordance with Article 7 of the Regulation, the RMS, the Netherlands (hereinafter referred to as the ‘RMS’), received an application from Symborg Business Development S.L. on 26 February 2020 for approval of the active substance Trichoderma harzianum T78. In addition, the applicant submitted an application for inclusion of the substance in Annex IV of Regulation (EC) No 396/2005. Complying with Article 9 of the Regulation, the completeness of the dossier was checked by the RMS and the date of admissibility of the application was recognised as being 4 September 2020.

The RMS provided its initial evaluation of the dossier on Trichoderma harzianum T78 in the DAR, which was received by EFSA on 29 March 2024 (The Netherlands, 2024). The peer review was initiated on 10 July 2024 by dispatching the DAR to the Member States and the applicant, Symborg Business Development S.L., for consultation and comments. EFSA also provided comments. In addition, EFSA conducted a public consultation on the DAR. The comments received were collated by EFSA and 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 12(3) of the Regulation were considered in a tele‐conference between EFSA and the RMS on 14 November 2024. 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 identity, potential effects on human/mammalian health and potential effects on non‐target organisms.

The outcome of the teleconference, 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.

In accordance with Article 12 of the Regulation, EFSA should adopt a conclusion on whether Trichoderma harzianum T78 can be expected to meet the approval criteria provided for in Article 4 of the Regulation, taking into consideration recital (10) of the Regulation.

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 2026.

This conclusion report summarises the outcome of the peer review of the risk assessment on the active substance and the formulation for representative uses evaluated on the basis of the representative uses of Trichoderma harzianum T78 as a fungicide on lettuce as proposed by the applicant. In accordance with Article 12(2) of Regulation (EC) No 1107/2009, risk mitigation options identified in the DAR and considered during the peer review, if any, are presented in the conclusion.

Furthermore, this conclusion also addresses the requirement for an assessment by EFSA under Article 12 of Regulation (EC) No 396/2005, provided that the active substance will be approved under Regulation (EC) No 1107/2009 without restrictions affecting the residue assessment. In the event of a non‐approval of the active substance or an approval with restrictions that have an impact on the residue assessment, the Annex IV proposal from this conclusion might no longer be relevant and a new assessment under Article 12 of Regulation (EC) No 396/2005 will be required.

A list of the relevant end points for the active substance and the formulation is provided in Appendix A.

A key supporting document to this conclusion is the peer review report (EFSA, 2026), 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 DAR;

• the reporting table (14 November 2024);

• the evaluation table (19 March 2026);

• the reports 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 DAR, including its revisions (The Netherlands, 2025), 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 and its background documents would not be accepted to support any registration outside the EU for which the applicant has not demonstrated that it has regulatory access to the information on which this conclusion report is based.

THE MICROBIAL ACTIVE SUBSTANCE AND THE FORMULATION FOR REPRESENTATIVE USES

Trichoderma harzianum T78 is a wild‐type ascomycetous fungus deposited in the Spanish Type Culture Collection (Colección Española de Cultivos Tipo) under accession number CECT 20714.

The formulated product for the representative uses for the evaluation was ‘Trichoderma harzianum T78 SC’, a soluble concentrate (SC). The content of the active microorganism is equivalent to a nominal content of 3 × 10¹¹ CFU/L. The minimum and maximum content are 9.0 × 10¹⁰ CFU/L and 9.0 × 10¹¹ CFU/L, respectively.

There is not any area of concern with respect to the identity of the microorganism.

The information on the active substance and the formulation for representative uses was considered in the overall assessment during the peer review. Details on the composition of the formulation cannot be reported in conclusions because of the provisions in Article 63(2)(d) of Regulation (EC) No 1107/2009; however, this information was fully available and evaluated during the peer review. No classification with respect to physical chemical data, toxicology and the environment according to Regulation (EC) 1272/2008 was proposed by the applicant or the RMS (please see Volumes 3 CP of the DAR).

The representative EU uses evaluated were professional uses on lettuce, in field crops via overall drench, drenching equipment and drip irrigation system for the control of Sclerotinia spp. Full details of the GAP can be found in the list of end points in Appendix A.

Data were submitted to conclude that the use of Trichoderma harzianum T78 according to the representative uses proposed at EU level results in a sufficient efficacy to control the soil‐borne pathogen, following the guidance document SANCO/10054/2013‐rev. 3 (European Commission, 2013).

In relation to the scientific peer‐reviewed open scientific literature search performed on the microbial active substance and its metabolites of (potential) concern, a data gap has been identified for the inclusion in the dossier of a study requested during the peer review (data gap, see Section 10).

1. SPECIFICATION OF THE MICRO‐ORGANISM, PHYSICAL AND TECHNICAL PROPERTIES AND METHODS OF ANALYSIS

The following guidance documents were followed in the production of this conclusion: European Commission (2000, 2012a) and EFSA FEEDAP Panel (2018).

The minimum and maximum content of Trichoderma harzianum T78 in the microbial pest control agent as manufactured (MPCA‐AM) was 9.0 × 10⁷ CFU/mL and 9.0 × 10⁸ CFU/mL, respectively. The specification was based on batch data from industrial scale plant production. The microbial pest control agent as manufactured (MPCA‐AM) and the microbial pest control product (MPCP) are the same; therefore, the specification was set on the MPCP based on batch data from industrial plant production.

The content of microbial contaminants in the MPCA‐AM/MPCP were below the limits defined in the Working Document on Microbial Contaminant Limits (European Commission, 2012b).

A phylogenetic study confirmed that strain T78 belongs to the species Trichoderma harzianum, based on sequence analysis of the internal transcribed spacer 1 (ITS1), translation‐elongation factor 1 (tef1) and RNA polymerase II (rpb2) regions. Using Random Amplified Polymorphic DNA (RAPD) technique, the strain T78 could be distinguished from other T. harzianum strains.

Based on WGS analysis, the production of some secondary metabolites is plausible (see Section 2) and the presence of benzoic acid and peptaibols in the MCPA‐AM/MPCP is confirmed by a screening study in one of the batches. However, confirmation and quantification by analysis of several batches under GLP is not available. Estimated level of benzoic acid in the screening study is considered to be of no concern; however, quantification on several batches is not available (data gap, see Section 9.1). EFSA is of the view that benzoic acid can be considered as a relevant impurity (see Section 3.2) and requires inclusion in the specification and monitoring (see Section 3). It was not possible to conclude if the identified peptaibols were metabolites of potential concern, since the actual peptaibols produced by Trichoderma harzianum T78 are not identified, which prevents a definitive assessment. Data on the actual peptaibols produced by Trichoderma harzianum T78 and the amounts in the MPCA‐AM/MPCP need to be provided to conclude the assessment of its potential concern with respect to human and animal health and ecotoxicology hazard (data gap, see Section 9.1).

The formulation can be considered stable for a maximum of 6 months when stored at 20°C (ambient temperature) and ordinary pressures in its commercial packaging. Stability of the formulation for representative uses was also investigated for 18 weeks at 30 ± 2°C; most of the characteristics remained within limits, but the active substance content showed a substantial decrease falling below the product specification. Low temperature stability study was considered not successfully complete and reliable by the RMS (data gap, see Section 10).

Acceptable methods were available for the determination of the microorganism in the MPCA and MPCP and for the determination of the content of contaminating microorganisms in MPCA‐AM and MPCP. Residue definitions were not set for Trichoderma harzianum T78; therefore, monitoring methods are not required (see Sections 4 and 6).

2. BIOLOGICAL PROPERTIES OF THE MICRO‐ORGANISM

Trichoderma harzianum T78 is a wild‐type strain, non‐modified fungus originally isolated in 2002 from a compost elaborated mainly with vine pruning mixed with offcuts of pepper and aerobic sludge from the water purification plant of Molina de Segura in Murcia (Spain). Its fungicide activity (e.g. against Fusarium) was proved in several scientific papers.

Historically, Trichoderma species have been used as biological control agents in agriculture, but also for enzyme and secondary metabolites production in food industries, wine and beer industries, textile industries, medical applications and bioremediation. Trichoderma harzianum is a soil‐borne fungus naturally occurring ubiquitously in soils all over Europe.

The target organism for representative use is Sclerotinia sp. in lettuce. The mode of action of Trichoderma harzianum T78 encompasses a combination of direct and indirect mechanisms to control plant pathogens, including infection of the target organism (mycoparasitism), induction of plant defence responses, competition for resources and space, secretion of carbohydrate degrading enzymes and antibiosis by secondary metabolites.

Regarding the life cycle, there are no sexual forms known for Trichoderma harzianum T78. Its primary mode of asexual reproduction is conidiation, including micro cycle conidiation. Under favourable conditions of temperature, pH and humidity, conidiospores germinate and develop into hyphae, which then form abundant mycelia. Conidiogenous cells (phialides) differentiate into conidiophores, leading to the production and maturation of spores. Under harsh conditions, such as drought or nutrient deficiency, the fungus produces thick‐walled chlamydospores as a survival strategy. In a natural environment, a universal generation time cannot be defined due to variability in growth conditions and may range from tens to hundreds of days.

As a mitotically reproducing asexual fungus, Trichoderma harzianum T78 is not expected to have the potential for transfer of genetic material to other organisms. However, asexual genetic recombination may occur upon direct contact and fusion of fungal hyphae.

Regarding host specificity, several Trichoderma species are fungal pathogens used in biocontrol. There are no known human or animal pathogens within the genus Trichoderma. However, opportunistic human pathogenicity has been reported for several species. Some Trichoderma spp. are the causative agents of green mould on cultivated mushrooms.

Trichoderma afroharzianum has recently been reported as a plant pathogenic fungus on maize (Zea mays) in several regions of Europe, where it has been associated with ear rot disease. The first cases were described in 2018, and the species is currently included in the EPPO Alert List as a causal agent of ear rot on maize (EPPO RS 2022/087; 2023/194; 2024/140, 2025). In addition to the references cited in the EPPO reports, recent publications in peer‐reviewed journals and on preprint servers have provided further evidence on the pathogenicity of Trichoderma strains on maize (Harish et al., 2025; Pfordt et al., 2024; Pfordt, Douanla‐Meli, Schäfer, et al., 2025; Pfordt, Douanla‐Meli, Voll, et al., 2025; Pfordt & von Tiedemann, 2025). The extent to which Trichoderma harzianum T78 can also be pathogenic to maize or other non‐target plants is currently unknown.

The antifungal susceptibility of Trichoderma harzianum T78 to at least two groups of antifungal agents (Anidulafungin and Amphotericin B) has been demonstrated. The transfer of antimicrobial resistance genes in fungi is considered negligible.

Secondary metabolites of (potential) concern: based on literature, Trichoderma harzianum spp. can produce secondary metabolites of potential concern belonging to various classes including peptaibols, volatile organic compounds (VOC), terpenoids, benzopyrans and polyketides. The whole genome sequencing analysis (WGS) confirmed that the strain can produce peptaibols; it lacks the genetic capacity to produce Gliotoxin (diketopiperazine‐like compound), 6‐PP, trichodermin and harzianum A (trichothecenes) and emodin, chrysophanol and pachybasin (anthraquinones).

The genetic capacity of producing other metabolites of potential concern known for the genus (e.g. benzoic acid) was not fully investigated in the genome due to the unknown Biosynthetic Gene Cluster.

However, in a screening study, the presence of peptaibols and benzoic acid was confirmed without any validated quantification (data gap, see Section 1).

EFSA notes that the production and the identity of the individual secondary metabolites belonging to the family/groups above‐mentioned were not fully investigated (see Section 10). Further discussions on the relevance for human/mammalian health and potential effects on non‐target organisms are provided in Sections 3.2 and 6. A comprehensive list of metabolites of potential concern potentially produced by Trichoderma harzianum T78 is provided in Appendix A.

3. POTENTIAL EFFECTS ON HUMAN/MAMMALIAN HEALTH

3.1. Mammalian infectivity and pathogenicity of the micro‐organism and sensitisation effects

As regards medical information, there is no evidence that Trichoderma species cause infection in immuno‐competent healthy humans; however, Trichoderma species can act as opportunistic human pathogens. No adverse health effects have been reported in workers as a result of exposure to Trichoderma harzianum T78 during its production and handling.

Trichoderma harzianum species is not included in the EFSA qualified presumption of safety (QPS) list, as filamentous fungi are currently excluded from QPS evaluation due to safety and complexity considerations (EFSA BIOHAZ Panel, 2024).

Current methods for testing dermal sensitisation are not suitable for microorganisms, and no validated test methods exist for assessing sensitisation via inhalation. Based on their characteristics, microorganisms such as Trichoderma harzianum T78 shall be regarded as potential sensitisers. Therefore, the non‐specific labelling with the warning phrase ‘Contains Trichoderma harzianum T78. Microorganisms may have the potential to provoke sensitising reactions’ is recommended.

Due to their pathogenic effects on other fungi, several Trichoderma species are used in biocontrol. There is no known specific human or animal (pets or livestock) pathogen within the genus Trichoderma, while some opportunistic infections have been reported (see medical information reported in this section).

No signs of toxicity or pathogenicity have been detected after acute administration via oral, inhalation intraperitoneal routes in rats of Trichoderma harzianum T78. Microbial analysis of faeces, fluids and tissues/organs was investigated after oral, intratracheal and intraperitoneal exposure and demonstrated full clearance (no infectivity) of the active organism.

Skin and eye irritation has been investigated on reconstructed human epidermis (skin) and on isolated chicken eye. No effects have been observed after the application of Trichoderma harzianum T78.

It is concluded that Trichoderma harzianum T78 has no potential for infectivity/pathogenicity in humans based on the available data.

3.2. Mammalian toxicity of the metabolites of (potential) concern

Among the secondary metabolites of potential concern, Trichoderma harzianum T78 can produce peptaibols. For these secondary metabolites, cytotoxicity has been observed in vitro in boar sperm cells, porcine kidney cells and somatic cells which raises the question of a possible in vivo toxicity to humans. However, low acute toxicity in rodents and ruminants has been reported for some of them, questioning the relevance of the observed in vitro effects. Based on the available information, it is concluded that they are unlikely to be metabolites of concern for human health.

It is acknowledged that limited information has been provided on the identity of other secondary metabolites produced by Trichoderma harzianum T78 and that the biological/toxicological properties of various groups of metabolites are partially unknown, including the individual peptaibols potentially produced by this microorganism (see Sections 1 and 10).

In addition, benzoic acid was identified in the screening only (see Sections 1 and 2). Benzoic acid has a harmonised classification ² (H315 causes skin irritation; H318 causes serious eye damage; H372 causes damage to lungs through prolonged or repeated inhalative exposure). It is also worth noting that fetotoxicity was observed in rats with a NOAEL of 500 mg/kg bw per day and an ADI of 5 mg/kg bw per day (EFSA FEEDAP Panel, 2016; European Commission, 2002) was set both for benzoic acid and its salts.

On this basis, and considering the harmonised classification, EFSA is of the view that benzoic acid (although it is a primary metabolite) can be considered as a relevant impurity due to its hazardous properties but is considered of no concern for this assessment as the estimated level in the MPCA‐AM/MPCP is below the level triggering the classification of the mixture. Inclusion in the specification and monitoring are required. On the contrary, RMS and MSs supported ³ the view that benzoic acid is a primary metabolite common to many microorganisms, should not be considered as a toxicologically relevant impurity and is not of concern due to the method of application (drip irrigation) (see also further considerations in Section 4).

RMS and Member States (MSs) supported the view that no metabolites of concern for human health associated with Trichoderma harzianum T78 under the proposed conditions of use of the representative formulation are identified.

EFSA is of the view that no concerns are identified for non‐dietary exposure to ‘Trichoderma harzianum T78 SC’, based on the available toxicological information (see Section 2).

In situ production of secondary metabolites of potential toxicological concern (see Section 2) cannot be excluded based on the available data, and if demonstrated, further toxicological investigations might be needed (see Section 4).

4. RESIDUES

The assessment in the residue section is considering the Commission guidance SANCO/11188/2013 Rev. 2 (European Commission, 2015). Trichoderma harzianum T78 is not approved as a basic substance under Regulation (EC) No 1107/2009 (criterion I). It is also not listed in Annex I of Regulation (EC) No 396/2005 (criterion II).

Trichoderma harzianum T78 was discussed at the Pesticides Peer Review Experts' Teleconference 184 in September 2025 (see Section 3). Secondary metabolites of concern for human health were not identified (see Section 3.2). Benzoic acid is well known as a natural product of microbial fermentation in food and therefore considered not to be of concern under the conditions of use. It can subsequently be concluded that there are no identified hazardous properties under the proposed conditions of use (criterion III of the guidance is fulfilled). With regard to peptaibols, it is recommended to identify strain‐specific compounds in future because this heterogeneous group is rapidly evolving and certain compounds seem relevant for medical treatments (see Sections 1, 3.2 and 5.2).

The representative uses foresee treatments of lettuce until BBCH 59 covering the commercial maturity (BBCH 47–49). Information on levels of Trichoderma harzianum T78 on edible commodities is insufficient to conclude whether the natural exposure is higher, lower or equal to the one linked to the use as a plant protection product (criterion IV of the guidance is not fulfilled). It is to be noted that levels in soil due to treatments were considered as significantly higher than the naturally occurring background level (see Section 5.1). Furthermore, consumer exposure cannot be excluded considering the representative uses (criterion V of the guidance is not fulfilled).

With regard to the five assessment criteria according to the Commission guidance SANCO/11188/2013 Rev. 2 (European Commission, 2015) for potential inclusion of active substances in Annex IV of Regulation (EC) No 396/2005, criterion III is considered to be met for the representative uses, while the other four criteria are not considered met for Trichoderma harzianum T78.

Based on the available information, there is no identified health concern for the consumer under the proposed conditions of use. Therefore, the consumer risk assessment is finalised.

5. ENVIRONMENTAL FATE AND BEHAVIOUR

Satisfactory information has been provided in relation to potential interference of Trichoderma harzianum T78 with the analytical systems for the control of the quality of drinking water provided for in Directive 98/83/EC (see specific Annex VI decision‐making criteria in Part II of Commission Regulation (EU) No 546/2011 ⁴ ). Filamentous fungi such as Trichoderma or their conidia are not expected to interfere with methodologies used for such determinations.

5.1. Fate and behaviour in the environment of the micro‐organism and any other forms

In relation to the persistence and multiplication in soil, the information provided in peer‐reviewed scientific literature studies indicates that Trichoderma spp. may persist overwinter and that this is achieved through formation of chlamydospores.

Numerous reports from open peer‐reviewed literature are provided in this section of the dossier, most of them more relevant to efficacy and investigating diverse species and strains within the genus Trichoderma. Some studies investigated the tolerance of these species to the pH range and temperature. Several species and strains of Trichoderma are shown to be capable of growing up to 40°C, whereas optimum growth is achieved in the range of 15–25°C.

Only few of these studies are directly investigating Trichoderma harzianum T78. In one of them, the salt tolerance and its ability of this strain to grow in saline soils is demonstrated.

Overall, information retrieved from the open literature showed that Trichoderma species can persist in soil for more than 2 years (see, e.g. Oskiera et al., 2017 summarised and referred in Vol 3 B8). These data are considered sufficient to conclude that Trichoderma harzianum T78 can persist and multiply in soil in concentrations considerably higher than the natural background levels, taking into account repeated applications over the years. It is acknowledged that there are many abiotic and biotic factors influencing persistence, survival and growth of the micro‐organism and that there are natural fluctuations in the population densities. Therefore, good information on infectivity and pathogenicity to non‐target organisms is necessary (see Section 5). Predicted environmental densities (PED) in soil have been calculated relevant for the representative uses (see Appendix A).

No specific study on mobility in soil of Trichoderma harzianum T78 was available in the dossier. However, literature data presented in the DAR indicate that Trichoderma species can migrate a few metres horizontally and a few decimetres vertically from the application site. Reading across from these studies, the horizontal and vertical mobility of Trichoderma harzianum T78 in soil is expected to be limited, although some dispersal to adjacent soil habitats cannot be excluded from the representative uses.

No specific study on the persistence and multiplication in surface water and sediment of Trichoderma harzianum T78 was available. Peer‐reviewed literature studies presented in the DAR have shown that Trichoderma species are able to survive in aquatic environments under favourable conditions. However, in most natural surface water systems, germination and population growth are likely inhibited in most cases due to limited availability of nutrients or competition with aquatic fungi. Consequently, EFSA concluded that the information is sufficient to conclude the strain not being expected to persist and multiply in surface water in concentrations considerably higher than the natural background levels, taking into account repeated applications over the years for the representative use. Considering the method of application of the formulated product – drench or drip irrigation, it is assumed that emissions to surface water from spray drift and other routes of exposure, when used in open field, are not significant or relevant for the environmental risk assessment.

Although inadequate information was provided on the survival, competitiveness and population dynamics of Trichoderma harzianum T78 in air, survival and competitiveness are expected to be limited as the strain under evaluation is a soil organism. Whereas conidia and spores of Trichoderma may be dispersed by air, exposure to the air compartment and to other compartments through air can be excluded from the representative uses as soil direct application by drench and drip irrigation.

5.2. Fate and behaviour in the environment of secondary metabolite(s) of (potential) concern produced by the micro‐organism under relevant conditions

Based on the genome sequencing study and the screening analytical investigation of the MPCA and MPCP, Trichoderma harzianum T78 has the capacity to produce peptaibols. The genome analysis allows to exclude the production of other types of metabolites usually associated with strains and species of the genus Trichoderma. According to genomic analysis (see Section 2), it lacks the genetic capacity to produce Gliotoxin, 6‐PP, trichodermin, harzianum A, emodin, chrysophanol and pachybasin. It should be noted that not all metabolites reported in the literature were included in the screening, and only a subset was quantified in the MPCA‐AM/MPCP (see Section 1). Furthermore, no information is available on the potential in situ production of secondary metabolites by Trichoderma harzianum T78 following application. Peptaibols have been identified in the MPCA‐AM/MPCP; however, actual peptaibols produced by Trichoderma harzianum T78 are not known, which prevents any further assessment at this stage (see Section 1).

Since the identity and hazard of metabolites expected to be produced by Trichoderma harzianum T78 are not fully characterised (see Sections 1, 3.2 and 6), potential concerns cannot be ruled out. A data gap is identified for satisfactory information on the production of secondary metabolites considering their levels present in the environment after product application in order to conclude on the exposure of these metabolites to the environment (soil, surface water, groundwater or air) after application of the product according to the representative use. Available data do not allow to exclude that such metabolites might fulfil the criteria according to Part B section 7 (iv) of Commission Regulation (EU) No 283/2013, namely:

• –the relevant metabolite is stable outside the microorganism;
• –a toxic effect of the relevant metabolite is independent of the presence of the microorganism;
• –the relevant metabolite is expected to occur in the environment in concentrations considerably higher than under natural conditions.

Therefore, data for Trichoderma harzianum T78 potentially produced secondary metabolites of potential concern (e.g. peptaibols, VOC, terpenoids) in relation to these criteria are necessary to assess if further data requirements and corresponding risk assessment according to Commission Regulation (EU) No 283/2013, part A, section 7 (standard data requirements and assessment mandatory for chemical plant protection active substances) are triggered. Consequently, this resulted in a data gap leading to an issue that could not be finalised (see Sections 2, 6 and 9.1).

6. POTENTIAL EFFECTS ON NON‐TARGET ORGANISMS

A key to the wording used to communicate the outcome of the environmental risk assessment can be found in Appendix B of this conclusion.

6.1. Birds and mammals

No studies were available for birds with the active substance. Nevertheless, peer‐reviewed open literature studies were available with other Trichoderma spp. During the peer review, a read‐across was deemed suitable for use in the assessment of Trichoderma harzianum T78, and the available information was considered sufficient to finalise the assessment of infectivity and pathogenicity of Trichoderma harzianum T78 to birds. The available data do not indicate that the active substance is infective or pathogenic to birds.

A study investigating acute effects of the active substance on the rat was also available. Based on the data provided, there is no indication that Trichoderma harzianum T78 is infective or pathogenic to wild mammals (see also Section 3).

The available literature studies and whole genome sequencing analyses revealed the potential for Trichoderma harzianum T78 to produce various secondary metabolites, including peptaibols. In vitro data showing adverse effects of peptaibols are available from peer‐reviewed literature. It is concluded that the limited available information does not allow to exclude potential concerns. Hence, the hazard characterisation and exposure assessment of secondary metabolites potentially produced by Trichoderma harzianum T78 could not be finalised with the limited data set (see also Section 5.2). The RMS disagreed and considered the risk assessments for secondary metabolites could be considered as finalised. For birds and wild mammals, a low risk cannot be concluded for the representative uses (data gap leading to an issue not finalised, see Section 9.1). The RMS disagreed and considered the risk assessments for secondary metabolites could be considered as finalised. ⁵

6.2. Aquatic organisms

Studies with Trichoderma harzianum T78 are available with fish, aquatic invertebrates and algae. In addition, studies with other Trichoderma spp. are available on aquatic organisms and were deemed suitable for the assessment of infectivity and pathogenicity of the active substance. The available data do not indicate that the active substance is infective or pathogenic to aquatic organisms. Considering the application techniques, it could also be expected that exposure of aquatic organisms to the active substance will be minimal. Hence, it can be concluded that the active substance is not expected to be of concern for infectivity and pathogenicity for aquatic organisms.

Studies on potentially produced secondary metabolites of potential concern were available for butanolide. No adverse effect was highlighted in the available studies with butanolide. Nevertheless, the available data indicate that the Trichoderma harzianum T78 can produce other secondary metabolites of potential concern, including peptaibols (see Sections 2 and 3.2). No indication is available with regard to the exposure of these secondary metabolites to the aquatic environments and no adequate analytical determination of these metabolites in the testing materials is available. The available peer‐reviewed open literature data indicate that peptaibols can be toxic for aquatic invertebrates. Toxicity data were not available for potentially produced secondary metabolites of potential concern to perform a hazard characterisation (data gap leading to an issue not finalised, see Section 9.1). The risk assessment for secondary metabolites could not be finalised for aquatic organisms (fish, freshwater invertebrates, algae and aquatic plants other than algae) for the representative uses (see also Section 5.2). The RMS disagreed and considered the risk assessments for secondary metabolites could be considered as finalised based on the lack of infectivity and pathogenicity of Trichoderma harzianum T78.

6.3. Bees

An acute contact and oral study with the active substance Trichoderma harzianum T78 is available for honey bees. Peer‐reviewed open literature studies with other Trichoderma spp. are also available for honey bees and other non‐Apis species. The available evidence was discussed at the Pesticides Peer Review Experts' Teleconference 185. ⁶ Considering (i) the short duration of the contact and oral toxicity studies with Trichoderma harzianum T78, (ii) the data from other Trichoderma spp. indicating mortality after 4 days, (iii) the lack of microscopic observations and (iv) the lack of suitable additional controls in the study with the active substance, the experts agreed that the available study with the active substance is not sufficient to conclude the assessment for infectivity and pathogenicity. Nevertheless, the experts considered that the available literature data indicate low adversity to bees and that exposure will be limited considering the application methods (i.e. drip irrigation and drenching). Overall, the experts agreed that the available weight of evidence is sufficient to conclude that the active substance is not expected to be infective nor pathogenic to honey bees.

It is noted that no information was available demonstrating that the potentially produced secondary metabolites of potential concern were present in the test materials used in the available studies. Toxicity data were not available to perform a hazard characterisation for potentially produced secondary metabolites of potential concern (data gap leading to an issue not finalised, see Section 9.1). The risk assessment for secondary metabolites could not be finalised for honey bees for the representative uses (see also Section 5.2). The RMS disagreed and considered that the risk assessments for secondary metabolites could be considered as finalised.

6.4. Non‐target arthropods other than bees

Studies of adequate duration are available with the formulation for representative uses with Typhlodromus pyri, Poecilus cupresus and Aleochara bilineata. No significant effects on reproduction were reported in the tests. Additional literature studies were provided on the effects produced by Trichoderma spp. on non‐target arthropods other than bees. These studies were considered in the assessment for Trichoderma harzianum T78. No indication of infectivity or pathogenicity was observed in the studies. The available information is considered sufficient to finalise the assessment of infectivity and pathogenicity of Trichoderma harzianum T78 to non‐target arthropods other than bees.

The available information is not considered sufficient to finalise the assessment of toxicity for potentially produced secondary metabolites of potential concern to non‐target arthropods other than bees. A low risk cannot be concluded for the representative uses (data gap leading to an issue not finalised, see Section 9.1). The RMS disagreed and considered the risk assessments for secondary metabolites could be considered as finalised based on the lack of infectivity and pathogenicity of Trichoderma harzianum T78.

6.5. Soil organisms

One study with the representative formulation is available with earthworms. No adverse effects are reported. Additional studies on earthworms with other Trichoderma spp. were provided. These studies were accepted to be used in the assessment for Trichoderma harzianum T78. No adverse effect is indicated, and no indication of infectivity or pathogenicity is reported.

The risk assessment was discussed at the Pesticides Peer Review Experts' Teleconference 185. ⁷ The available data were considered sufficient to finalise the infectivity and pathogenicity assessment of Trichoderma harzianum T78 to earthworms. The experts at the meeting discussed the available studies with nematodes. Overall, while no adverse effects to beneficial nematodes were indicated by the available information, some effects on parasitic nematodes were noted.

Toxicity data were not available for secondary metabolites to perform a hazard characterisation (data gap leading to an issue not finalised, see Section 9.1). The risk assessment for secondary metabolites could not be finalised for earthworms for the representative uses (see also Section 5.2). The RMS disagreed and considered that the risk assessments for secondary metabolites could be considered as finalised.

Studies with the active substance, the representative formulation and other Trichoderma spp. are available for soil microorganisms. Limited, transient or no effects were reported in the studies. The available information is considered sufficient to finalise the risk assessment. A low risk can be concluded for soil microorganisms for the representative uses.

6.6. Additional information

During the peer review, EFSA identified one literature study carried out with Trichoderma harzianum (now Trichoderma afroharzianum) strains T39 and T12 reporting pathogenicity to maize was identified. It should be noted that plant pathogens should be generally considered host‐ and strain‐specific. Hence, extrapolation from maize to other non‐target terrestrial plants and from Trichoderma harzianum T78 to other strains or Trichoderma spp. (and vice versa) is uncertain. Therefore, with the available data, it cannot be concluded whether Trichoderma harzianum T78 has the potential to exert a pathogenic effect on terrestrial plants.

7. OVERVIEW OF THE RISK ASSESSMENT OF THE ORGANISM OR METABOLITES OF (POTENTIAL) CONCERN LISTED IN RESIDUE DEFINITIONS TRIGGERING ASSESSMENT OF EFFECTS DATA FOR THE ENVIRONMENTAL COMPARTMENTS (TABLES 1, 2, 3, 4)

TABLE 1.

Soil.

Compound (name and/or code)	Ecotoxicology
Trichoderma harzianum T78	Low risk for soil organisms
Secondary metabolites of potential concern	Risk assessment not finalised for earthworms

TABLE 2.

Groundwater. ^a

Compound (name and/or code)	> 0.1 μg/L at 1 m depth for the representative uses b , Step 2	Biological (pesticidal) activity/relevance, Step 3a.	Hazard identified, steps 3b. and 3c.	Consumer RA triggered, steps 4 and 5	Human health relevance
Trichoderma harzianum T78	–	–	–	–	Yes
Secondary metabolites		Data gap, see Section 9.1	Data gap, see Section 9.1		Data gap, see Section 9.1

^a Assessment according to European Commission guidance of the relevance of groundwater metabolites (2003).

^b FOCUS scenarios or relevant lysimeter.

TABLE 3.

Surface water and sediment.

Compound (name and/or code)	Ecotoxicology
Trichoderma harzianum T78	Low risk for non‐target aquatic organisms
Secondary metabolites of potential concern	Risk assessment not finalised for all non‐target aquatic organisms

TABLE 4.

Air.

Compound (name and/or code)	Toxicology
Trichoderma harzianum T78 (conidia, spores)	No evidence of toxicity, pathogenicity or infectivity after acute administration via oral, inhalation intraperitoneal routes (LC50 > 6.68 × 107 cfu/rat)

8. PARTICULAR CONDITIONS PROPOSED TO BE TAKEN INTO ACCOUNT BY RISK MANAGERS

Risk mitigation measures (RMMs) identified following consideration of Member State (MS) and/or applicant's proposal(s) during the peer review, if any, are presented in this section. These measures applicable for human health and/or the environment leading to a reduction of exposure levels of operators, workers, bystanders/residents, environmental compartments and/or non‐target organisms for the representative uses are listed below. The list may also cover any RMMs as appropriate, leading to an acceptable level of risks for the respective non‐target organisms.

It is noted that final decisions on the need of RMMs to ensure the safe use of the plant protection product containing the concerned active substance will be taken by risk managers during the decision‐making phase. Consideration of the validity and appropriateness of the RMMs remains the responsibility of MSs at product authorisation, taking into account their specific agricultural, plant health and environmental conditions at national level (Table 5).

TABLE 5.

Risk mitigation measures proposed for the representative uses assessed.

Representative use	Lettuce
	Drip irrigation/drenching
Operator exposure	In the absence of a quantitative risk assessment, the use of non‐specific personal and respiratory protective equipment (PPE/RPE) for the operators and workers might be considered to reduce the exposure (and the risk of adverse effects due to the sensitisation potential of microorganisms)
Worker exposure

9. CONCERNS AND RELATED DATA GAPS

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 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 ⁸ 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:

1. Satisfactory information was not available on the production of secondary metabolites, their levels present in the environment after application and their potential toxicity in order to conclude on the risk assessment for all non‐target organisms, leading to an assessment not finalised considering the identified data gaps:

   1. Quantification of the relevant impurity benzoic acid in at least five MPCA‐AM/ MPCP batches is not available (see Sections 1, 5.2 and 6).
   2. Information on the identity of the actual peptaibols produced by the Trichoderma harzianum T78 and found to be present in the MPCA‐AM/MPCP is not available (see Sections 1, 5.2 and 6).
   3. Pending on further investigations on the production of secondary metabolites (see Sections 1 and 5.2) and their levels present in the environment after application, further considerations will have to be given to their potential toxicity (see Section 6) in order to conclude on the risk assessment for all non‐target organisms.

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 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, together with any associated data gaps, where relevant, which are reported directly under the specific critical area of concern to which they are related:

No critical areas of concern have been identified.

9.3. Overview of the concerns identified for each representative use considered (Table 6)

TABLE 6.

Overview of concerns reflecting the issues not finalised, critical areas of concern and the risks identified that may be applicable for some but not for all uses or risk assessment scenarios.

Representative use		Lettuce
		Drip irrigation/drenching
Operator risk	Risk identified
	Assessment not finalised
Worker risk	Risk identified
	Assessment not finalised
Resident/bystander risk	Risk identified
	Assessment not finalised
Consumer risk	Risk identified
	Assessment not finalised	Finalised
Risk to wild non‐target terrestrial vertebrates	Risk identified
	Assessment not finalised	X1
Risk to wild non‐target terrestrial organisms other than vertebrates	Risk identified
	Assessment not finalised	X1
Risk to aquatic organisms	Risk identified
	Assessment not finalised	X1
Groundwater exposure to active substance	Legal parametric value breached
	Assessment not finalised
Groundwater exposure to metabolites	Legal parametric value breached a
	Parametric value of 10 μg/L b breached
	Assessment not finalised	X1

Note: The superscript numbers relate to the numbered points indicated in Section 9.1. Where there is no superscript number, see Sections 2, 7 for further information.

^a When the consideration for classification made in the context of this evaluation under Regulation (EC) No 1107/2009 is confirmed under Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008.

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

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 6.

10. 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:

• A complete and reliable MPCP long‐term shelf‐life test at low temperature is not available (see Section 1).

• The following study still needs to be added to the dossier (see Section ‘The microbial active substance and the formulation for representative uses’ and the Evaluation Table section 2 in the Peer Review Report (EFSA, 2026)):

  • Bingke Bai, Chang Liu Chengzhong Zhang, Xuhui He, Hongrui Wang, Wei Peng, Chengjian Zheng. Trichoderma species from plant and soil: An excellent resource for biosynthesis of terpenoids with versatile bioactivities. Journal of Advanced Research, 49, July 2023, Pages 81–102 https://doi.org/10.1016/j.jare.2022.09.010.

• Information on the identity of the individual secondary metabolites produced by Trichoderma harzianum T78 is not available, as the identification of the individual metabolites belonging to the recognised classes of secondary metabolites has not been provided (see Sections 2 and 3).

ABBREVIATIONS

a.s.

active substance

AAOEL

acute acceptable operator exposure level

AChE

acetylcholinesterase

ADE

actual dermal exposure

ADI

acceptable daily intake

AF

assessment factor

AhR

aryl hydrocarbon receptor

AMA

Amphibian Metamorphosis Assay

AOEL

acceptable operator exposure level

AOP

adverse outcome pathway

AP

alkaline phosphatase

AR

androgen receptor

AR

applied radioactivity

ARfD

acute reference dose

ARSEF

ARS Collection of Entomopathogenic Fungal Cultures

ARSTTA

Stably Transfected Human Androgen Receptor Activation Assay

AST

aspartate aminotransferase (SGOT)

AUC

area under the blood concentration/time curve

AV

avoidance factor

BCF

bioconcentration factor

BLAST

Basic Local Alignment Search Tool

bp

base pair

BUN

blood urea nitrogen

bw

body weight

C&L

classification and labelling

CABI

Centre for Agricultural Bioscience International

CAS

Chemical Abstracts Service

CFU

colony‐forming units

ChE

cholinesterase

CHO

Chinese hamster ovary cells

CI

confidence interval

CIPAC

Collaborative International Pesticides Analytical Council Limited

CL

confidence limits

cm

centimetre

Cmax

concentration achieved at peak blood level

CNCM

Collection Nationale de Cultures de Micro‐organismes

d

day

DAA

days after application

DAR

draft assessment report

DAS‐ELISA

double‐antibody sandwich enzyme‐linked immunosorbent assay

DAT

days after treatment

DDD

daily dietary dose

DM

dry matter

DNA

deoxyribonucleic acid

DT₅₀

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

DT₉₀

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

dw

dry weight

EAS

oestrogen, androgen and steroidogenesis modalities

EbC₅₀

effective concentration (biomass)

EC₅₀

effective concentration

ECHA

European Chemicals Agency

EEC

European Economic Community

EINECS

European Inventory of Existing Commercial Chemical Substances

ELINCS

European List of New Chemical Substances

ELISA

Enzyme‐linked immunosorbent assay

EMDI

Estimated maximum daily intake

EPPO

European and Mediterranean Plant Protection Organization

ER₅₀

emergence rate/effective rate, median

ErC₅₀

effective concentration (growth rate)

ERO

ecological recovery option

ERSTTA

Stably Transfected Human Oestrogen Receptor‐alpha Transcriptional Activation Assay

ETO

ecological threshold option

ETR

exposure toxicity ratio

ETR_acute

exposure toxicity ratio for acute exposure

ETR_HPG

exposure toxicity ratio for effects on honeybee hypopharygeal glands

ETR_larvae

exposure toxicity ratio for chronic exposure

ETR_larvae

exposure toxicity ratio for larvae

ETS

external transcribed spacer

EUROPOEM

European Predictive Operator Exposure Model

f(twa)

Time‐weighted average factor

FAO

Food and Agriculture Organization of the United Nations

FID

flame ionisation detector

FIR

food intake rate

FOB

functional observation battery

FOCUS

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

FSTRA

Fish Short‐Term Reproduction Assay

FTIR

Fourier transform infrared spectroscopy

g

gram

GAP

Good Agricultural Practice

GC

gas chromatography

GC‐FID

gas chromatography with flame ionisation detector

GC‐MS

gas chromatography – mass spectrometry

GC‐NPD

gas chromatography with nitrogen phosphorus selective detector

GCPF

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

GC‐TEA

gas chromatography with thermal energy analyser

GGT

gamma glutamyl transferase

GM

geometric mean

GPC

gel permeation chromatography

GS

growth stage

GSH

glutathione

h

hour(s)

ha

hectare

Hb

haemoglobin

Hct

haematocrit

HGPRT

hypoxanthine‐guanine phosphoribosyl transferase

hL

hectolitre

HPG

hypopharygeal glands

HPLC

high‐pressure liquid chromatography or high‐performance liquid chromatography

HPLC‐ELCD

high performance liquid chromatography with electro chemical detector

HPLC‐ELS

high performance liquid chromatography with evaporative light scattering detector

HPLC‐MS

high‐pressure liquid chromatography–mass spectrometry

HPLC‐MS/MS

high‐performance liquid chromatography with tandem mass spectrometry

HPLC‐UV

high‐performance liquid chromatography with ultra violet detector

HQ

hazard quotient

HQ_contact

hazard quotient for contact exposure

HR

hazard rate

ICP‐AES

inductively coupled plasma atomic emission spectroscopy

ICP‐OES

inductively coupled plasma optical emission spectroscopy

IEDI

international estimated daily intake

IESTI

international estimated short‐term intake

IGS

intergenic spacer (nontranscribed spacer)

ILV

independent laboratory validation

IMI

International Mycological Institute [CABI Bioscience, Eggham, UK (formerly International Mycological Institute; same as CMI)].

ISO

International Organization for Standardization

ISSR

inter‐simple sequence repeat

ITS

internal transcribed spacer

IUPAC

International Union of Pure and Applied Chemistry

iv

intravenous

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_doc

organic carbon linear adsorption coefficient

K_Foc

Freundlich organic carbon adsorption coefficient

kg

kilogram

L

litre

LAGDA

Larval Amphibian Growth and Development Test

LC

liquid chromatography

LC₅₀

lethal concentration, median

LC‐MS

liquid chromatography–mass spectrometry

LC‐MS/MS

liquid chromatography with tandem mass spectrometry

LD₅₀

lethal dose, median; dosis letalis media

LDD₅₀

lethal dietary dose; median

LDH

lactate dehydrogenase

LH

luteinizing hormone

LOAEL

lowest observable adverse effect level

LOD

limit of detection

LOQ

limit of quantification

m

metre

M

mol

M&K

Maximisation test of Magnusson & Kligman

M/L

mixing and loading

MAF

multiple application factor

MCH

mean corpuscular haemoglobin

MCHC

mean corpuscular haemoglobin concentration

MCV

mean corpuscular volume

MEOGRT

Medaka Extended One‐Generation Reproduction Test

mg

milligram

mL

millilitre

MLST

multi‐locus sequence typing

mm

millimetre (also used for mean measured concentrations)

mN

milli‐newton

MOA

mode of action

MPCA

active agent of the microbial pest control product

MPCA‐AM

MPCA as manufactured

MPCP

microbial pest control product

MRL

maximum residue level

MS

mass spectrometry

MSDS

material safety data sheet

MTD

maximum tolerated dose

MUCL

Mycothèque de l'Université Catholique de Louvain

MWHC

maximum water‐holding capacity

NCBI

National Center for Biotechnology Information

NCYC

National Collection of Yeast Cultures

NESTI

national estimated short‐term intake

ng

nanogram

NOAEC

no observed adverse effect concentration

NOAEL

no observed adverse effect level

NOEC

no observed effect concentration

NOEL

no observed effect level

NPD

nitrogen–phosphorus detector

OECD

Organisation for Economic Co‐operation and Development

OM

organic matter content

Pa

pascal

PCR

polymerase chain reaction

PD

proportion of different food types

PDA

Potato Dextrose Agar

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

PED

Predicted environmental densities

pF2

pF value of 2 (suction pressure that defines field capacity soil moisture)

pH

pH‐value

PHED

pesticide handler's exposure data

PHI

preharvest interval

PIE

potential inhalation exposure

pK_a

negative logarithm (to the base 10) of the dissociation constant

P_ow

partition coefficient between n‐octanol and water

PPE

personal protective equipment

ppm

parts per million (10⁻⁶)

ppp

plant protection product

PT

proportion of diet obtained in the treated area

PTT

partial thromboplastin time

qRT‐PCR

quantitative Reverse‐Transcription Polymerase Chain reaction

QSAR

quantitative structure–activity relationship

QuEChERS

quick, easy, cheap, effective and safe method

QuPPe‐Method

Quick Method for the Analysis of residues of numerous Highly Polar Pesticides in Foods of plant Origin

r²

coefficient of determination

RAC

regulatory acceptable concentration

RAPD‐PCR

random amplification of polymorphic DNA

RAR

Renewal Assessment Report

RBC

red blood cells

rDNA

ribosomal deoxyribonucleic acid

REACH

Registration, Evaluation, Authorisation of Chemicals Regulation

RFLP

restriction fragment length polymorphism

RMMs

risk mitigation measures

RPE

respiratory protective equipment

rRNA

ribosomal ribonucleic acid

RT‐PCR

reverse transcription‐polymerase chain reaction

RUD

residue per unit dose

S

svedberg, S (10⁻¹³ s)

SAR

systemic acquired resistance

SCAR

sequence characterised amplified region

SD

standard deviation

SFO

single first‐order

SMILES

simplified molecular‐input line‐entry system

SPG

specific protection goal

SSD

species sensitivity distribution

SSR

simple sequence repeat

STMR

supervised trials median residue

t_1/2

half‐life (define method of estimation)

TC

technical material

tef1

translation elongation factor 1 α gene

TER

toxicity exposure ratio

TER_A

toxicity exposure ratio for acute exposure

TER_LT

toxicity exposure ratio following chronic exposure

TER_ST

toxicity exposure ratio following repeated exposure

TK

technical concentrate

TLV

threshold limit value

Tmax

time until peak blood levels achieved

TMDI

theoretical maximum daily intake

ToxCAST

(US EPA) Toxicity Forecaster

TRR

total radioactive residue

TSH

thyroid‐stimulating hormone (thyrotropin)

TWA

time‐weighted average

UDS

unscheduled DNA synthesis

UF

uncertainty factor

USDA‐ARS

U.S. Department of Agriculture, Agriculture Research Service

UV

ultraviolet

VNTR

variable number tandem repeat

W/S

water/sediment

w/v

weight per unit volume

w/w

weight per unit weight

WBC

white blood cell

WHO

World Health Organization

ε

decadic molar extinction coefficient

λ

wavelength

μg

microgram

μm

micrometre (micron)

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2020‐00616

COPYRIGHT FOR NON‐EFSA CONTENT

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Supporting information

APPENDIX A List of end points for the active substance and the formulation for representative uses

APPENDIX A. List of end points for the active substance and the formulation for representative uses

Appendix A can be found in the online version of this output (‘Supporting information’ section): https://doi.org/10.2903/j.efsa.2026.10197.

APPENDIX B. Clarification of the wording used in Section 6

Wording used in Section 6 of this conclusion to communicate the outcome of the environmental risk assessment.

Wording	Interpretation
Low risk	A low risk to the non‐target organism was indicated based on screening, Tier 1 or higher Tier assessment.
High risk	A high risk to the non‐target organism was indicated based on either Tier 1 or higher Tier assessment.
High risk not excluded	Only a screening level assessment was available, which did not show a low risk. This assessment is not considered to confirm a high risk to the non‐target organism.
Pending an identified data gap in another section, further consideration may be needed	Based on the available information, it is not known if a risk assessment for non‐target organisms is triggered.

EFSA (European Food Safety Authority) , Álvarez, F. , Arena, M. , Auteri, D. , Leite, S. B. , Binaglia, M. , Castoldi, A. F. , Chiusolo, A. , Colagiorgi, A. , Colas, M. , Crivellente, F. , De Lentdecker, C. , De Magistris, I. , Egsmose, M. , Fait, G. , Ferilli, F. , Giner Santonja, G. , Gouliarmou, V. , Ippolito, A. , Istace, F. , … Villamar‐Bouza, L. (2026). Peer review of the pesticide risk assessment of the active substance Trichoderma harzianum T78 . EFSA Journal, 24(7), e10197. 10.2903/j.efsa.2026.10197