Peer review of the pesticide risk assessment of the active substance Trichoderma asperellum ICC012

Abstract

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Sweden, and co‐rapporteur Member State, France, for the pesticide active substance Trichoderma asperellum ICC012 are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of Trichoderma asperellum ICC012 as a fungicide on tomato, lettuce and grapes. 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. Issues that could not be finalised are identified.

SUMMARY

Commission Implementing Regulation (EU) No 844/2012 lays down the procedure for the renewal of the approval of active substances submitted under Article 14 of Regulation (EC) No 1107/2009. The list of those substances is established in Commission Implementing Regulation (EU) No 686/2012 as amended by Commission Implementing Regulation (EU) No 2016/183. Trichoderma asperellum ICC012 is one of the active substances listed in that Regulation.

In accordance with Article 1 of Regulation (EU) No 844/2012, the rapporteur Member State (RMS), Sweden, and co‐rapporteur Member State (co‐RMS), France, received an application from Isagro S.p.A. for the renewal of approval of the active substance Trichoderma asperellum ICC012.

An initial evaluation of the dossier on Trichoderma asperellum ICC012 was provided by the RMS in the renewal assessment report (RAR) and subsequently, a peer review of the pesticide risk assessment on the RMS evaluation was conducted by EFSA in accordance with Article 13 of Commission Implementing Regulation (EU) No 844/2012. The following conclusions are derived.

The uses of Trichoderma asperellum ICC012 according to the representative uses as a fungicide on tomato and lettuce, in the field and in the greenhouse (permanent) and non‐permanent protected structures (walk‐in tunnels) via soil spray, and on grapes in the field via spray, as proposed at EU level, result in a sufficient fungicidal efficacy against the target pests.

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 identity, biological properties of the microbial active substance, physical and technical properties of the representative formulation and analytical methods.

In the area of human health, no potential for infectivity/pathogenicity of Trichoderma asperellum ICC012 has been identified in immuno‐competent humans based on the available data. The available evidence was considered sufficient to exclude the presence of metabolites of toxicological concern for humans and mammals. No data gaps were identified and risk from non‐dietary exposure to metabolites is considered unlikely.

In the area of residues, no concerns are anticipated under the proposed conditions of use and the consumer risk assessment can be finalised. Criterion III outlined in the guidance (SANCO/11188/2013 Rev. 2) was considered met for Trichoderma asperellum ICC012.

In relation to fate and behaviour in the environment, Trichoderma asperellum ICC012 can be expected to persist and multiply in soil in concentrations considerably higher than the natural background levels. A data gap is identified regarding the production and environmental concentrations of secondary metabolites of potential concern (peptaibols and 6‐PP) by Trichoderma asperellum ICC012 following representative uses. As a result, the environmental exposure in soil and surface water for these metabolites cannot be finalised.

In the area of ecotoxicology, it is not possible to conclude on the infectivity and pathogenicity for non‐target arthropods other than bees. In addition, the risk assessment for non‐target organisms, other than wild mammals and birds, exposed to potentially produced secondary metabolites of potential concern could not be finalised.

BACKGROUND

Commission Implementing Regulation (EU) No 844/2012, ¹ (hereinafter referred to as ‘the Regulation’), lays down the provisions for the procedure of the renewal of the approval of active substances, submitted under Article 14 of Regulation (EC) No 1107/2009. ² This regulates for the European Food Safety Authority (EFSA) the procedure for organising the consultation of Member States, the applicant(s) and the public on the initial evaluation provided by the rapporteur Member State (RMS) and/or co‐rapporteur Member State (co‐RMS) in the renewal assessment report (RAR), and the organisation of an expert consultation where appropriate.

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

In accordance with Article 1 of the Regulation, the RMS, Sweden, and co‐RMS, France, received an application from Isagro S.p.A. for the renewal of approval of the active substance Trichoderma asperellum ICC012. Complying with Article 8 of the Regulation, the RMS checked the completeness of the dossier and informed the applicant, the co‐RMS (France), the European Commission and EFSA about the admissibility.

The RMS provided its initial evaluation of the dossier on Trichoderma asperellum ICC012 in the RAR, which was received by EFSA on 31 March 2021 (Sweden, 2021).

In accordance with Article 12 of the Regulation, EFSA distributed the RAR to the Member States and the applicant, Isagro S.p.A., for consultation and comments on 10 June 2021. EFSA also provided comments. In addition, EFSA conducted a public consultation on the RAR. EFSA collated and forwarded all comments received to the European Commission on 10 August 2021. At the same time, the collated comments were forwarded to the RMS for compilation and evaluation in the format of a reporting table. The applicant was invited to respond to the comments in column 3 of the reporting table. The comments and the applicant's response were evaluated by the RMS in column 3.

The need for expert consultation and the necessity for additional information to be submitted by the applicant in accordance with Article 13(3) of the Regulation were considered in a tele‐conference between EFSA and the RMS on 17 February 2022. 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 potential effects on human/mammalian health and potential effects on non‐target organisms.

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

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

A final consultation on the conclusions arising from the peer review of the risk assessment took place with Member States via a written procedure in August–September 2026.

This conclusion report summarises the outcome of the peer review of the risk assessment of the active substance and the formulation for representative uses, evaluated on the basis of the representative uses of Trichoderma asperellum ICC012 as a fungicide on tomato, lettuce and grapes, as proposed by the applicant. In accordance with Article 12(2) of Regulation (EC) No 1107/2009, risk mitigation options identified in the RAR and considered during the peer review, if any, are presented in the conclusion.

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 RAR;

• the reporting table (08 September 2021);

• the evaluation table (08 September 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 RAR, including its revisions (Sweden, 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 asperellum ICC012 is a wild‐type ascomycetous fungus deposited in the CABI culture collection (Bioscience International Mycological Institute‐Egham, UK) with the Accession Number IMI CC No. 392716 as a Patent deposit under the Budapest treaty.

The microbial pest control product (MPCP) for the representative uses for the evaluation is ‘REMEDIER’ a wettable powder formulation (WP) containing 1.5 × 10⁷–1.5 × 10⁸ CFU/g (nominal content of 3.5 × 10⁷ CFU/g) of Trichoderma asperellum ICC012 and 1.5 × 10⁷–1.5 × 10⁸ CFU/g (nominal content of 3.5 × 10⁷ CFU/g) of Trichoderma gamsii ICC080.

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, including the co‐formulants in this formulation, was considered in the overall assessment during the peer review. None of the co‐formulants is an unacceptable co‐formulant listed in Annex III of Regulation (EC) No 1107/2009. ³ One co‐formulant is a currently approved active substance under Regulation (EC) No 1107/2009, however, as it is approved for a different function, it is not expected to contribute to the efficacy of the product as fungicide. ^{4 , 5}

Trichoderma gamsii ICC080 was considered as an active substance in accordance with Regulation (EC) No 1107/2009. ⁶

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. A proposal for classification of the formulation according to Regulation (EC) 1272/2008 was provided by the applicant and assessed by the RMS (please see Volumes 3 MP of the RAR).

The representative EU uses evaluated were professional uses in greenhouse (permanent) and non‐permanent protected structures (walk‐in tunnels) and in field by soil spray on tomato and lettuce and by spray on grape for the control of soil‐borne fungal pathogens and esca diseases caused by Phytophthora, Phaemoniella and Phaeoacremonium 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 asperellum ICC012 according to the representative uses proposed at EU level results in a sufficient efficacy to control soil‐borne fungal and esca diseases, following the guidance document SANCO/2012/11251‐rev. 4 (European Commission, 2014).

CONCLUSIONS OF THE EVALUATION

General aspects

With regard to mammalian toxicity, the toxicological profile of the formulation for representative uses was discussed in the Pesticides Peer Review Teleconference (TC) 159 ⁷ (see Section 3). Acute toxicity studies were available with the formulation for representative uses ‘REMEDIER’.

With regard to the co‐formulants contained in ‘REMEDIER’, sufficient toxicological data were available for all components, except for one component (present in limited amount in the final formulation). For this one, the experts considered that the available toxicological information does not sufficiently address the genotoxicity and repeated dose toxicity over the long‐term. Thus, this component might be considered for further assessment (data gap, Section 10). The collected information (not covering all endpoints), including information from the existing uses other than plant protection products, under regulated EU frameworks, did not highlight any concern (see Section 10).

The availability of ecotoxicity data with the formulation for representative uses was discussed at the Pesticides Peer Review Teleconference (TC) 161 ⁸ (refer to Section 6). The experts also discussed the data retrieval search and the available data for the individual components and no concerns were identified. ⁹ Nevertheless, pending on the outcome on identified missing data for mammalian toxicology for one of the components in the formulation for representative uses, further consideration to non‐target organisms may be necessary.

1. SPECIFICATION OF THE MICROORGANISM, PHYSICAL AND TECHNICAL PROPERTIES AND METHODS OF ANALYSIS

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

The minimum and maximum content of Trichoderma asperellum ICC012 in the microbial pest control agent (MPCA) as manufactured in the technical powder was 1.0 × 10⁹–1.0 × 10¹⁰ CFU/g, respectively. The specification was based on batch data from industrial plant production. The content of microbial contaminants of the MPCP was below the limits defined in the Working Document on Microbial Contaminant Limits (European Commission, 2012).

The proposed identification method at strain level was based on sequence analysis of the internal transcribed spacer 1 (ITS1) and translation‐elongation factor 1 (tef1) regions, but it was considered insufficient. The whole genome sequence is available for an unequivocal identification of T. asperellum ICC012 at strain level.

It was demonstrated that the formulation for representative uses is stable when it is stored for 15 months at room temperature (25°C) in its commercial packaging. A data gap was set for MPCP flammability data (see Section 10).

Acceptable methods were available for the determination of the microorganism the content of contaminating microorganisms in MPCA as manufactured (MPCA‐AM) and MPCP. Residue definitions were not set for Trichoderma asperellum ICC012 (see Sections 4 and 6) therefore, monitoring methods are not required.

The presence of secondary metabolites was not investigated in the technical material nor in the formulation, and no analytical method was provided.

2. BIOLOGICAL PROPERTIES OF THE MICROORGANISM

Trichoderma asperellum ICC012 is a wild‐type strain, non‐modified fungus originally isolated in 1987 from suppressive soil of central Italy. It was initially identified as Trichoderma harzianum. During its evaluation, the taxonomy of Trichoderma spp. was revised, and based on molecular genetic data, ICC012 was reclassified as Trichoderma asperellum. It can exist as a saprotroph in the soil, parasitise other fungi, inhabit plant tissues as an endophyte and may affect the occurrence of certain nematodes.

Historical background: Historically Trichoderma species have been used as microbial biological control agents in agriculture, but also for the production of enzymes and other chemicals, in food industries, wine and beer industries, textile industries, medical applications and bioremediation.

Natural occurrence and geographical distribution: Trichoderma asperellum is a soil‐borne fungus naturally occurring ubiquitously in soils all over Europe.

The target organisms for the representative uses are a broad range of pathogens, including the soil‐borne pathogens belonging to Phytophthora spp., Rhizoctonia spp., Fusarium spp., Pythium spp., Phaemoniella chlamydospora and Phaeoacremonium inflatipes.

The mode of action of Trichoderma spp. used as plant protection products includes competition for nutrients, mycoparasitism, production of antifungal compounds and cell wall‐degrading enzymes, as well as promotion of plant growth and nutrient uptake. Trichoderma spp. can also establish persistent root colonisation, including limited penetration of root tissues and induce localised and systemic plant resistance.

Life cycle: No sexual stage is known for Trichoderma asperellum. The fungus reproduces asexually by conidiation, including microcycle conidiation. Under favourable conditions, conidiospores germinate to form hyphae and mycelia, followed by spore production. Under adverse conditions, thick‐walled chlamydospores are formed as survival structures. Generation time is highly variable under natural conditions and may range from tens to hundreds of days.

Genetic stability: As a mitotically reproducing asexual fungus, Trichoderma asperellum ICC012 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.

Host specificity: Several Trichoderma species are fungal pathogens used as plant protection products. There are no known human and 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, but these species are not closely related to Trichoderma asperellum ICC012.

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). Some of these recent studies have shown that also several isolates of Trichoderma asperellum may cause ear rot disease to maize when the plant is previously wounded or damaged (e.g. by insects). The extent to which Trichoderma asperellum ICC012 can also be pathogenic to maize or other non‐target plants is currently unknown.

Infectivity, dispersal and colonisation ability: Trichoderma asperellum ICC012 is able to grow under a wide range of environmental conditions, including varying salinity, pH and carbon sources. Growth was observed across the tested pH range (2–10), with an optimum at pH 4–5. According to non‐GLP data, optimal growth occurred between 15°C and 35°C, while no growth was observed at 37°C.

Antifungal susceptibility: GLP studies on Trichoderma asperellum ICC012 with several antimycotic agents allowed determination of minimum inhibitory concentrations (MICs) for amphotericin B, voriconazole and caspofungin, representing three different modes of action. No MICs could be established for ketoconazole, fluconazole, itraconazole and flucytosine, as growth inhibition was not observed at the highest concentrations tested. As EUCAST breakpoints for Trichoderma species are unavailable, susceptibility or resistance to these antifungal agents could not be concluded. Based on available information, the strain is not known to produce antibiotics used in human or veterinarian medicine.

Secondary metabolites of (potential) concern: Based on whole genome sequencing analysis and literature search, Trichoderma asperellum ICC012 can produce peptaibols (including a 14‐mer peptaibol and a short peptaibol like compound) and 6‐pentyl‐2H‐pyran‐2‐one (6‐pentyl‐2‐pyrone, 6‐PP) as secondary metabolites of potential concern. Conversely it lacks the genetic capacity to produce trichothecenes, diketopiperazine‐like compounds, polyketides, anthraquinones, cytochalasans or camptothecin. No analytical determination of secondary metabolites has been carried out in the MPCA‐AM or in the formulation. Further discussion on the relevance for mammalian health is provided in Section 3.

3. POTENTIAL EFFECTS ON HUMAN/MAMMALIAN HEALTH

The toxicological profile of Trichoderma asperellum ICC012 and its metabolites was discussed at the Pesticides Peer Review Teleconference (TC) 159 (31 January 2025).

3.1. Mammalian infectivity and pathogenicity of the microorganism and sensitisation effects

As regards medical information, there is no evidence that Trichoderma species causes infection in immuno‐competent healthy humans. No adverse health effects have been reported in workers as a result of exposure to Trichoderma asperellum ICC012 during its production and handling.

Trichoderma asperellum 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, 2025).

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 asperellum ICC012 shall be regarded as potential sensitisers. Therefore, the non‐specific labelling with the warning phrase ‘Contains Trichoderma asperellum ICC012. 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 are no known specific human or animal (pets or livestock) pathogens within the genus Trichoderma, however Trichoderma species can act as opportunistic human pathogens.

No signs of toxicity or pathogenicity have been detected (technical grade material) after acute administration via oral, intratracheal and intraperitoneal route in rats of the active substance Trichoderma asperellum ICC012. Microbial analysis of faeces, fluids and tissues/organs was only investigated after intratracheal exposure and demonstrated full clearance (no infectivity) of the active organism. This is supported by growth temperature data. No signs of mortality or toxicity have been observed in rats after acute oral, dermal and inhalation administration of the product (REMEDIER).

Skin and eye irritation has been observed in rabbits after exposure to the product, however the effect was mild and reversible.

The use of personal protective equipment (PPE) and respiratory protective equipment (RPE) for the operators and workers can be considered as non‐specific risk mitigation measure considering that microorganisms are potential sensitisers.

It is concluded that Trichoderma asperellum ICC012 has no potential for infectivity/pathogenicity in immuno‐competent humans based on the available data.

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

The secondary metabolites produced by Trichoderma asperellum ICC012 that may be of potential toxicological concern include peptaibols and the volatile compound 6‐pentyl‐2H‐pyran‐2‐one (6‐pentyl‐2‐pyrone, 6‐PP).

Regarding peptaibols, 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, they are unlikely to be metabolites of potential concern for human health.

It is noted that 6‐PP (6‐pentyl‐2H‐pyran‐2‐one) is a volatile organic compound authorised as a food flavouring substance (FL no. 10.031) by Commission Implementing Regulation (EU) No 872/2012. ¹⁰ No analytical identification of the 6‐PP demonstrating its production by Trichoderma asperellum ICC012 is available (see Section 2). Based on the assessment as a flavouring substance, a no observed adverse effect level (NOAEL) of 12.1 mg/kg bw per day was established in a 90‐day study in rats with 6‐PP, and it was concluded not to pose safety concern at estimated levels of intake as flavouring substance (EFSA CEF Panel, 2011) (see Section 4). Available literature information indicates that it would not be of toxicological concern, with the exclusion of possible local effects in the respiratory system such as irritation and inflammation.

Adverse effects in the respiratory tract of 6‐PP are not expected to be of concern for non‐dietary exposure, considering that personal protective equipment (PPE) is required for microbial PPPs. For bystanders and residents, the non‐dietary exposure resulting from the supported uses is not a concern considering that a safe consumption level has been identified for the food flavouring and that the levels in the field (i.e. during/after application) are not expected to trigger an adverse effect by inhalation. Further considerations are reported in Section 4.

In conclusion, under the proposed conditions of use of the representative formulation ‘REMEDIER’, no metabolites of concern for human health associated with Trichoderma asperellum ICC012 were identified based on the available information.

4. RESIDUES

The assessment in the residue section is considering the Commission guidance SANCO/11188/2013 Rev. 2 (European Commission, 2015). Trichoderma asperellum ICC012 is included in Annex IV of Regulation (EC) No 396/2005.

Trichoderma asperellum ICC012 is not approved as a basic substance under Regulation (EC) No 1107/2009 (Criterion I of the SANCO Guidance) and is not listed in Annex I of Regulation (EC) No 396/2005 (Criterion II).

Trichoderma asperellum ICC012 harbours the genes encoding for peptaibols production. While some uncertainties are flagged in Section 3.2, peptaibols seem to be unlikely to be of concern based on the provided information. Noting the evolving field of peptaibols, in future assessments thorough substance specific information might therefore be required.

The potential production of metabolite 6‐PP does not raise a concern for consumers. This conclusion is supported by a previous assessment of 6‐PP as a food flavouring (see Section 3.2), in which no safety concerns were identified at an estimated intake of 84 μg/person per day. Should Trichoderma asperellum ICC012 produce 6‐PP, residues on crops are likely to be very low, if present at all. Consequently, dietary exposure is expected to be well below the intake level established as safe by the EFSA CEF Panel in its assessment of 6‐PP as a flavouring.

Based on available data, it can be concluded that Trichoderma asperellum ICC012 has no hazardous properties, therefore Criterion III of the above‐mentioned guidance can be considered to be met.

Occurrence and potential in‐situ formation of these metabolites in lettuce, tomatoes and grapes intended for consumption in line with the representative uses was not investigated and is not required.

The representative uses are soil spray treatments before transplanting or at the time of planting of tomato and lettuce plants and spray treatments for grapes after pruning up to late budding. All treatments are performed at an early vegetation stage and well before edible plant parts are formed. Nonetheless, dietary consumer exposure to viable cells of Trichoderma asperellum ICC012 and its metabolites including those potentially formed in‐situ cannot be excluded because dispersed treated soil containing viable cells of Trichoderma asperellum ICC012 can deposit onto edible plant parts during their development and growth. Particularly for lettuce, Trichoderma asperellum ICC012 can deposit, persist and potentially grow during formation of edible lettuce heads. Therefore, Criterion V of the above‐mentioned Commission guidance is not considered to be met.

Supporting information on dispersion of viable residues of Trichoderma atroviride SC1 following soil treatment reports significant higher residues in treated (100 times higher in bottom and 10 times higher in top leaves of grapevine plants) than in untreated plants. In another study, no viable residues of Trichoderma species on eggplants (surface and flesh) were found following two soil spray treatments in the open field with Trichoderma harzianum (now Trichoderma asperellum ICC012) and Trichoderma viride (now Trichoderma gamsii ICC080) prior to planting of eggplants.

Based on the available information, there is insufficient evidence to conclude whether exposure to viable and/or non‐viable residues, which are of no concern, linked to the representative uses of Trichoderma asperellum ICC012 is lower, equal to or higher than concentrations naturally occurring. It can therefore not be concluded whether Criterion IV of the above‐mentioned guidance is met.

Overall, the consumer risk assessment can be finalised by noting the absence of hazardous properties of Trichoderma asperellum ICC012.

5. ENVIRONMENTAL FATE AND BEHAVIOUR

Satisfactory information has been provided in relation to potential interference of Trichoderma asperellum ICC012 with the analytical systems for the control of the quality of drinking water provided for in Directive 98/83/EC ¹¹ (see specific Annex VI decision‐making criteria in Part II of Commission Regulation (EU) No 546/2011 ¹² ). As these methods require pathogenic bacteria to be identified and confirmed as absent, it was considered unlikely that filamentous fungi or their conidia would interfere with methodologies used for such determinations.

5.1. Fate and behaviour in the environment of the microorganism and any other forms

The RAR presented general information regarding properties of the genus Trichoderma spp. Evidence from peer‐reviewed scientific literature indicates that Trichoderma may persist in soil over winter, a process facilitated by the formation of chlamydospores.

Overall, the information retrieved from open literature showed that Trichoderma species can persist in soil for periods exceeding 2 years. Several studies indicate that, following a single application, population densities decline towards background levels (10³–10⁵ CFU/g_soil) within approximately 1 year. However, other studies demonstrated that introduced populations may remain above indigenous background levels for longer periods. It should be noted that persistence, survival and growth of the microorganism are influenced by abiotic and biotic factors, and population densities may fluctuate naturally over time. However, for representative field uses and uses in non‐permanent protected structures involving repeated applications over multiple years, a robust risk assessment based on accumulated plateau concentrations would have been needed in accordance with Part B, point 2.7.7 of Regulation (EU) No 546/2011. Pending the information identified as missing a finalised risk assessment is not available. For uses in permanent greenhouse, the soil exposure can be considered not relevant (OECD 67). Predicted environmental densities (PED) in soil have been calculated relevant for all representative uses (see Appendix A). These values can be used for a risk assessment. As repeated applications across multiple years will occur, further data might be required to determine the potential accumulation levels of Trichoderma asperellum ICC012 in soil over time. This may require attention just because of the recently identified uncertainty associated with the pathogenicity of some Trichoderma asperellum strains to maize (see Section 2).

No specific studies on the persistence and multiplication in surface water and sediment of Trichoderma asperellum ICC012 were available. Published peer‐reviewed literature studies presented in the RAR indicated that spores of Trichoderma species can survive in aquatic environments under favourable conditions. However, accumulation is expected to be frequently prevented due to competition with aquatic fungi in most natural surface water systems. Trichoderma asperellum ICC012 has been assessed as not pathogenic to aquatic organisms (see Section 6). Predicted environmental densities (PED) in surface water were provided based on the loading through spray drift (see Appendix A).

Inadequate information was provided on the survival, competitiveness and population dynamics of Trichoderma asperellum ICC012 in air, however the survival, competitiveness and population dynamics of Trichoderma asperellum ICC012 in air is expected to be limited as the strain under evaluation is a soil organism. Nevertheless, conidia and spores of Trichoderma asperellum ICC012 may be dispersed by air to nearby areas surrounding the application site. Exposure to the air compartment and to other compartments through air cannot be excluded from the field and non‐permanent greenhouse uses.

No specific study on the mobility in soil of Trichoderma asperellum ICC012 was available in the dossier. However, literature data presented in the RAR indicate that Trichoderma species can migrate a few meters horizontally and a few decimetres vertically from the application site within few weeks after the last application. Reading across from these studies, the horizontal and vertical mobility of Trichoderma asperellum ICC012 in soil is expected to be limited, although some dispersal to adjacent soil habitats cannot be excluded under the representative field and non‐permanent greenhouse uses. Given the recently identified concerns regarding the pathogenicity of certain Trichoderma asperellum strains to maize crops (see Section 2), potential harmful effects on non‐target plants in the vicinity of the treated crops cannot be excluded on basis of the available information.

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

Based on the genome sequencing study, Trichoderma asperellum ICC012 has the capacity to produce two types of peptaibols and 6‐PP, whereas the production of other type of metabolites commonly associated with Trichoderma species and strains can be excluded (see Section 2).

Since hazard of these metabolites to non‐target organism is not fully characterised (see Section 6), potential concerns cannot be ruled out and further information on environmental production and exposure is necessary, therefore a data gap is identified since it is not known to what extent Trichoderma asperellum ICC012 will produce the identified secondary metabolites of potential concern and the concentrations of these substances (i.e. peptaibols and 6‐PP) potentially present in soil and surface water after application of the product according to the representative uses, leading to an issue that could not be finalised (see Sections 6 and 9.1). As no concern was identified for metabolites in mammalian toxicology assessment, groundwater exposure assessment is not required (see Section 3.2).

6. POTENTIAL EFFECTS ON NON‐TARGET ORGANISMS

Some aspects of the ecotoxicology risk assessment, particularly the ecotoxicological profile of the formulation for representative uses, were discussed at the Pesticides Peer Review Experts' Teleconference 161 (February 2025).

6.1. Birds and mammals

No studies were available for birds with either the active substance or the formulation for representative uses ‘REMEDIER’. However, one study (5‐day exposure, 30 days observation) was available for birds with the microorganism Trichoderma afroharzianum strain T‐22. During the peer‐review, this study was deemed suitable for assessing Trichoderma asperellum ICC012, and the available information was considered sufficient to finalise the assessment of pathogenicity of Trichoderma asperellum ICC012 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 the Trichoderma asperellum ICC012 is infective or pathogenic to birds and wild mammals (see also Section 3).

The available literature studies and whole genome sequencing analyses revealed the potential for Trichoderma asperellum ICC012 to produce some secondary metabolites of potential concern (see Section 2). The hazard characterisation in the human/mammalian toxicology section of those secondary metabolites did not identify any concern (see Section 3.2). Therefore, a low risk can be concluded for wild mammals for all intended uses. For birds, EFSA considered that based on the conclusion reached for mammals and the lack of reported adverse effects in the published literature, secondary metabolites potentially produced by this strain are unlikely to be of concern. Therefore, a low risk for birds can be concluded for all intended uses.

6.2. Aquatic organisms

Chronic studies with the active substance were available for fish, aquatic invertebrates, algae and macrophytes. The only study available with the formulation for the representative uses ‘REMEDIER’, was an acute study in aquatic invertebrates.

Sufficient information was available to finalise the assessment of pathogenicity for T. asperellum ICC012 for all aquatic taxa. Based on the data provided, there is no indication that the Trichoderma asperellum ICC012 is infective or pathogenic to aquatic organisms.

No indication is available with regards to the production of peptaibols and 6‐PP in the aquatic environments and no analytical determination of these metabolites in the product is available. The available peer‐reviewed open literature data indicate that peptaibols can be toxic for aquatic invertebrates, however, these data do not provide information suitable for hazard characterisation. As sufficient 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 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 assessment for secondary metabolites could be considered as finalised.

6.3. Bees

Acute oral and contact studies are available with Trichoderma asperellum ICC012. One chronic study is available with the formulation for the representative uses. Additional published studies of acute and chronic exposure with other Trichoderma spp. are available for bees and were considered supportive.

In the acute studies with the active substance and the formulation no adverse effects were observed. The available studies on other Trichoderma spp. were of adequate duration and can be considered relevant for the assessment of pathogenicity for the T. asperellum ICC012. Based on the results of the chronic study with the formulation for representative uses and the studies with other Trichoderma spp., no clear and consistent indication of infectivity and pathogenicity is derived. Based on the data provided, there is no indication that the Trichoderma asperellum ICC012 is infective or pathogenic to bees.

It is noted that no information was available to demonstrate whether the potentially produced metabolites of potential concern were present in the studies. 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), therefore the risk assessment for secondary metabolites could not be finalised for honey bees for the representative uses in field and non‐permanent structures (see also Section 5.2). The RMS disagreed and considered the risk assessment for secondary metabolites to be finalised. Based on the representative use in permanent structures and in line with EFSA (2015), minimal exposure to secondary metabolites is expected, hence a low risk can be concluded for bees for the intended uses in permanent structures.

6.4. Non‐target arthropods other than bees

One study (7‐day duration) is available with the formulation for representative uses ‘REMEDIER’ with Typhlodromus pyri. In this study, adverse effects on reproduction were reported. From the available results, it is not possible to exclude that the effects are due to pathogenicity, since the study duration is shorter than that recommended in the test guideline OPPTS 885.4340. ¹³

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 T. asperellum ICC012, nevertheless the lack of pathogenicity cannot be concluded from these studies as it was not addressed adequately and adverse effects are reported.

It is noted that no information was available to demonstrate whether the potentially produced metabolites of potential concern were present in the studies. The available information is not considered sufficient to finalise the assessment of toxicity, infectivity and pathogenicity of T. asperellum ICC012 to non‐target arthropods other than bees. Given the insufficient information, the adverse effects reported, and the low margin of safety, a low risk cannot be concluded for the intended uses in field and in non‐permanent structures (data gap leading to issues not finalised, see Section 9.1). The RMS also considered the risk assessment for secondary metabolites to be finalised. Based on the representative use in permanent structures and in line with EFSA (2015), minimal exposure to the active substance and to secondary metabolites is expected, hence a low risk can be concluded for non‐target arthropods other than bees for the intended uses in permanent structures.

6.5. Soil organisms

No studies are available with soil macro‐organisms, other than earthworms. For earthworms, one study (14‐day duration) with the active substance is available, and no adverse effects are reported. However, no studies were conducted with the formulation for representative uses.

Additional studies on earthworms with other Trichoderma spp. were provided. These studies were accepted to be used in the assessment for T. asperellum ICC012. No adverse effect is indicated, and no indication of infectivity or pathogenicity is reported.

The available data were considered sufficient to finalise the infectivity and pathogenicity assessment of T. asperellum ICC012 to earthworms. A low risk from infectivity and pathogenicity of T. asperellum ICC012 to earthworms can therefore be concluded for all representative uses.

It is noted that no information was available to demonstrate whether the potentially produced metabolites of potential concern were present in the studies. 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), therefore the risk assessment for secondary metabolites could not be finalised for earthworms for the representative uses in field and non‐permanent structures (see also Section 5.2). The RMS disagreed and considered the risk assessment for secondary metabolites to be finalised. Based on the representative use in permanent structures and in line with EFSA (2015), minimal exposure to secondary metabolites is expected, hence a low risk can be concluded for earthworms for the intended uses in permanent structures.

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 all intended uses.

6.6. Additional information

During the peer‐review, further data on the potential infectivity and pathogenicity of Trichoderma asperellum ICC012 were requested. 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 asperellum ICC012 to other strain or Trichoderma spp. (and vice versa) is uncertain. Therefore, with the available data, it cannot be concluded whether Trichoderma asperellum ICC012 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
T. asperellum ICC012	Low risk for earthworms and soil microorganisms for all intended uses
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	Biological (pesticidal) activity/relevance	Hazard identified	Consumer RA triggered	Human health relevance
	Step 2	Step 3a.	Steps 3b. and 3c.	Steps 4 and 5
Trichoderma asperellum ICC012	Not assessed (quantitative limit applicable only for chemical pesticides)	Yes	–	Not assessed	No
Secondary metabolite of (potential) concern	–	–	–	–	No

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

^b FOCUS scenarios or relevant lysimeter.

TABLE 3.

Surface water and sediment.

Compound (name and/or code)	Ecotoxicology
Trichoderma asperellum ICC012	Low risk to aquatic organisms
Secondary metabolites of potential concern	Risk assessment not finalised

TABLE 4.

Air.

Compound (name and/or code)	Toxicology
Trichoderma asperellum ICC012	No evidence of toxicity, pathogenicity or infectivity in rat after acute intratracheal administration (LD50 > 1.1 × 107 cfu/animal).
6‐PP (volatile compound)	Authorised as a food flavouring substance (FL no. 10.031) by Commission Implementing Regulation (EU) No 872/2012.
	Adverse effects in the respiratory tract (irritation and histamine release)

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 (Table 5). 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.

TABLE 5.

Risk mitigation measures proposed for the representative uses assessed.

Representative use	All representative uses
Operator exposure	In the absence of a quantitative risk assessment, the use of 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

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.

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 ¹⁴ 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 (see Section 5.2), their levels present in the environment after application, and their potential toxicity in order to conclude on the risk assessment for non‐target terrestrial organisms (honey bees, non‐target arthropods other than bees, earthworms, other soil macro‐organisms) and non‐target aquatic organisms (fish, freshwater invertebrates, algae and aquatic plants), leading to an assessment not finalised (see Sections 5.2 and 6) considering the identified data gap:

   1. Pending on further investigations on the production of secondary metabolites (see Section 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 terrestrial non‐target organisms (honey bees, non‐target arthropods other than bees, earthworms, other soil macro‐organisms), relevant for the representative field use, and aquatic organisms (fish, freshwater invertebrates, algae and aquatic plants other than algae, relevant for all representative uses).
2. Satisfactory information was not available for the potential infectivity, pathogenicity and adverse effects to non‐target arthropods other than bees (see Section 6):

   1. Data and information for the assessment of the potential infectivity and pathogenicity to non‐target arthropods other than bees (relevant for the field and non‐permanent structures representative uses evaluated; see Sections 5 and 6).

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 concerns and the risks identified that may be applicable for some but not for all uses or risk assessment scenarios.

Representative use		Lettuce	Tomatoes	Grapes
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
Risk to wild non‐target terrestrial vertebrates	Risk identified
	Assessment not finalised	X c ,1	X c ,1	X
Risk to wild non‐target terrestrial organisms other than vertebrates	Risk identified
	Assessment not finalised	X c ,1,2	X c ,1,2	X1,2
Risk to aquatic organisms	Risk identified
	Assessment not finalised	X1	X1	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

Note: The superscript numbers relate to the numbered points indicated in Sections 9.1 and 9.2. Where there is no superscript number, see Sections 2, 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).

^c Relevant only for field uses and uses in non‐permanent structures.

(If a particular condition proposed to be taken into account to manage an identified risk, as listed in Section 7, 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:

• For one component of the formulation for representative uses ‘REMEDIER’, genotoxicity and repeated dose toxicity information over the short‐ and long‐term were not available; therefore, in order to allow a final conclusion on the safety assessment of ‘REMEDIER’, genotoxicity and repeated dose toxicity data for this component (short‐ and long‐term) might be considered for further assessment (to be confirmed by Member States when assessing applications for PPP authorisation; relevant for all representative uses evaluated; see Section ‘General aspects’).

• Flammability data for the formulation ‘REMEDIER’ were not provided (relevant for all representative uses evaluated; see Section 1).

• Information on the identity of the individual secondary metabolites produced by Trichoderma asperellum ICC012 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).

• Further literature data on the potential infectivity and pathogenicity of Trichoderma asperellum ICC012 to reptiles.

ABBREVIATIONS

CFU

colony forming units

Co‐RMS

co‐rapporteur Member State

ECHA

European Chemicals Agency

EEC

European Economic Community

EPPO

European and Mediterranean Plant Protection Organization

GLP

Good Laboratory Practice

LDD₅₀

lethal dietary dose; median

MIC

minimum inhibitory concentration

MPCA

active agent of the microbial pest control product

MPCA‐AM

MPCA as manufactured

MPCP

microbial pest control product

MS

Member State

NOAEL

no observed adverse effect level

OECD

Organisation for Economic Co‐operation and Development

PED

predicted environmental densities

PPE

personal protective equipment

ppp

plant protection product

QPS

qualified presumption of safety

RAR

Renewal Assessment Report

RPE

respiratory protective equipment

WP

wettable powder

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2017‐00143

COPYRIGHT FOR NON‐EFSA CONTENT

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NOTE/UPDATE

This scientific output, approved on 28 September 2026, supersedes the previous output published on 9 January 2013 (EFSA, 2013).

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.2026.10380.

APPENDIX B. Clarification of the wording used in Section 6

Wording used in Section  6 of this conclusion to communicate 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. , Batista Leite, S. , Binaglia, M. , Castoldi, A. F. , Chavez Capilla, T. , Chiusolo, A. , Colagiorgi, A. , Colas, M. , Crivellente, F. , De Lentdecker, C. , De Magistris, I. , Fabrega, J. , Fait, G. , Ferilli, F. , Giner Santonja, G. , Gouliarmou, V. , … Scattareggia Marchese, A. (2026). Peer review of the pesticide risk assessment of the active substance Trichoderma asperellum ICC012 . EFSA Journal, 24(11), e10380. 10.2903/j.efsa.2026.10380