Peer review of the pesticide risk assessment of the active substance Trichoderma asperellum T34

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 Italy for the pesticide active substance Trichoderma asperellum T34 are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2020/103. The conclusions were reached on the basis of the evaluation of the representative uses of T. asperellum T34 as a fungicide on ornamentals, tomato, sweet pepper, aubergine, cucumber, melon, watermelon, zucchini and pumpkin. 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 were identified.

SUMMARY

Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2020/103, 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 2018/155. T. asperellum T34 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), Italy, received an application from Biocontrol Technologies S.L. for the renewal of approval of the active substance T. asperellum T34.

An initial evaluation of the dossier on T. asperellum T34 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, as amended by Commission Implementing Regulation (EU) No 2020/103.

At the time of submission of additional information, the applicant, Biocontrol Technologies S.L., via a statement dated 31 January 2025, and subsequently in a letter dated 6 May 2026, informed the European Commission, EFSA, the RMS and all EU Member States to formally withdraw its support for the ‘Xilon’ formulation from the renewal EU peer‐review process of T. asperellum T34, while maintaining its support for the active substance and the ‘T34 Biocontrol WP’ formulation. As a result, the assessments in relation to the representative uses of the ‘Xilon’ formulation have been considered obsolete.

The following overall conclusions were derived by the peer review.

The proposed uses of T. asperellum T34 as a fungicide (applied in permanent greenhouses either via long dip (root dip), incorporation into growing media, spraying growing media or drip irrigation) on ornamentals, solanaceae (such as tomato, sweet pepper and aubergine) and cucurbitaceae (such as cucumber, melon, watermelon, zucchini and pumpkin), 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 formulation for representative uses and analytical methods. Insufficient data was submitted to draw a conclusion about the production and toxicity of secondary metabolites of potential concern by T. asperellum T34. However, the three different MPCA‐AM are produced and purified with methods that differ in several critical aspects, and it cannot be guaranteed that the three materials will be identical with respect to the content of metabolites of potential concern.

In the area of mammalian toxicology, the available evidence was not considered sufficient to exclude the production of metabolites of toxicological concern and the risk assessment of mammalian toxicity cannot be concluded.

In the area of residues, data gaps were identified for qualitative and quantitative information on the occurrence of emodin a metabolite of potential concern including potential in‐situ production following treatments under conditions of the representative uses. The consumer risk assessment cannot be finalised.

In relation to fate and behaviour in the environment, T. asperellum T34 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 strain produces metabolites of potential concern and the environmental exposure to them.

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

BACKGROUND

Commission Implementing Regulation (EU) No 844/2012, ¹ amended by Commission Implementing Regulation (EU) No 2020/103 ² (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. ³ 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 Italy received an application from Biocontrol Technologies S.L. for the renewal of approval of the active substance T. asperellum T34. Complying with Article 8 of the Regulation, the RMS checked the completeness of the dossier and informed the applicant, the co‐RMS (Italy), the European Commission and EFSA about the admissibility.

The RMS provided its initial evaluation of the dossier on T. asperellum T34 in the RAR, which was received by EFSA on 20 March 2024 (Sweden, 2024).

In accordance with Article 12 of the Regulation, EFSA distributed the RAR to the Member States and the applicant, Biocontrol Technologies S.L., for consultation and comments on 16 May 2024. 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 15 July 2024. 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 13 December 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, physical/chemical/technical properties and methods of analysis, potential effects on human/mammalian health, environmental fate and behaviour, 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.

At the time of submission of additional information, the applicant, Biocontrol Technologies S.L., via a statement dated 31 January 2025, and subsequently in a letter dated 6 May 2026, informed the European Commission, EFSA, the RMS and all EU Member States to formally withdraw its support for the ‘Xilon’ formulation from the renewal EU peer‐review process of T. asperellum T34, while maintaining its support for the active substance and the ‘T34 Biocontrol WP’ formulation. As a result, the assessments in relation to the representative uses of the ‘Xilon’ formulation have been considered obsolete.

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 June 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 T. asperellum T34 as a fungicide (applied in permanent greenhouses either via long dip (root dip), incorporation into growing media, spraying growing media, or drip irrigation) on ornamentals, solanaceae (such as tomato, sweet pepper and aubergine) and cucurbitaceae (such as cucumber, melon, watermelon, zucchini and pumpkin), 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 for representative uses 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 (9 January 2025);

• the evaluation table (29 June 2026);

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

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

• the comments received on the draft EFSA conclusion.

Given the importance of the RAR, including its revisions (Sweden, 2026), 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

The identity of T. asperellum T34 was discussed at the Pesticides Peer Review Experts' Teleconference (TC) 181 (September 2025).

T. asperellum T34 was isolated from a natural compost‐peat mix that was commercially available. It is a wild‐type ascomycetous fungus deposited in the Spanish Type Culture Collection (Colección Española de Cultivos Tipo) under accession number CECT 20417. No area of concern was identified with respect to the identity of the microorganism.

Two different formulated products were initially notified for the renewal of T. asperellum T34: a wettable powder ‘T34 Biocontrol WP’ and granular formulation ‘Xilon’. During the peer review, the applicant informed that they are no longer supporting the ‘Xilon’ formulation as part of the renewal EU peer‐review of T. asperellum T34. As a result, the assessments in relation to the representative uses of the ‘Xilon’ formulation have been considered obsolete. The minimum and maximum content of the active microorganism is between 1.0 × 10⁹ CFU/g and 2.68 × 10⁹ CFU/g for ‘T34 Biocontrol WP’.

The information on the active substance and the formulation for representative uses, including the co‐formulants in the ‘T34 Biocontrol WP’ 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, ⁴ however one co‐formulant ⁵ is a component of a currently approved active substance under Regulation (EC) 1107/2009. ⁶

Details on the composition of the formulations 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(s) 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 against Fusarium spp. on protected ornamentals in permanent greenhouses via long dip (root dip) or soil growing media application either by spraying, incorporation or through drip irrigation system, and professional uses against Pythium spp. on solanaceae and cucurbits in permanent greenhouses via soil growing media application either by spraying, incorporation or through drip irrigation system. 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 T. asperellum T34 according to the representative uses proposed at EU level results in a sufficient fungicidal efficacy against the targeted pests, following the guidance document SANCO/2012/11251‐rev. 4 (European Commission, 2014).

CONCLUSIONS OF THE EVALUATION

General aspects

The toxicological profile of the formulation for representative uses was discussed at the Pesticides Peer Review Experts' Teleconference (TC) 184 in September 2025 ⁷ (see Section 3). With regard to mammalian toxicity, sufficient information was available for the formulation for representative uses ‘T34 Biocontrol WP’. Studies were performed to address acute toxicity/pathogenicity and infectiveness, skin and eye irritancy and skin sensitisation. With regard to the co‐formulants contained in ‘T34 Biocontrol WP’, sufficient toxicological data were available for all components. The experts considered that the available toxicological information did sufficiently address the genotoxicity, repeated dose toxicity and carcinogenicity potential of ‘T34 Biocontrol WP’ over the short‐ and long‐term. An alert was identified for one component added in this formulation (present in significant amount in the final formulation). The alert is related to the specific target organ toxicity via repeated exposure by inhalation for which a proposal for classification as STOT RE 1 is identified. ⁸

The availability of ecotoxicity data with the formulation for representative uses was discussed at the Pesticides Peer Review Experts' Teleconference (TC) 185 in September 2025 ⁹ (see Section 6). The experts also discussed the data retrieval search and the available data for the individual components. Considering the reasoning agreed by the experts, no concerns were identified for the formulation for representative uses ‘T34 Biocontrol WP’.

A data gap has been identified for a thorough search of the scientific peer‐reviewed open literature on the microbial active substance and its metabolites of (potential) concern, dealing with toxicological and side effects on health, the environment and non‐target species and published within the 10 years before the date of submission of the dossier, to be conducted and reported in accordance with the EFSA guidance on the submission of scientific peer‐reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009 (EFSA, 2011) (data gap, see Section 10).

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, 2012a; EFSA FEEDAP Panel, 2018.

The minimum and maximum content of T. asperellum T34 in the microbial pest control agent as manufactured (MPCA‐AM) was 1.0 × 10¹⁰ CFU/g and 2.15 × 10¹⁰ CFU/g, respectively. The specification was based on batch data from industrial scale plant production of the two production sites that remain active (Factory 2 and Factory 3). The only manufacturing site active at the time of first authorisation (Factory 1) has discontinued the production of T. asperellum T34.

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

A phylogenetic study confirmed that strain T34 belongs to the species T. asperellum, 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 T34 could be distinguished from other T. asperellum strains.

Whole genome sequence (WGS) and its analysis with respect to genes encoding metabolites of potential concern is not available for T. asperellum T34. During Pesticides Peer Review Experts' Teleconference (TC) 185 in September 2025, Member State experts and EFSA agreed with the RMS conclusions that insufficient data was submitted to draw a conclusion about the production of secondary metabolites of potential concern by T. asperellum T34 (data gap, see Section 9.1). The three different MPCA‐AM are produced and purified with methods that differ in several critical aspects and it cannot be guaranteed that the three materials will be identical with respect to the content of metabolites of potential concern.

The formulation ‘T34 Biocontrol WP’ can be considered stable for a maximum of 15 months when stored at 20°C and ordinary pressures in its commercial packaging. However, satisfactory information on the stability of the packaging has not been provided (data gap, see Section 10).

Acceptable methods were available for the determination of the microorganism in the MPCAs‐AM and MPCP and for determination of the content of contaminating microorganisms in MPCAs‐AM and MPCP. Residue definitions were not set for T. asperellum T34, therefore, monitoring methods are not required (see Sections 4 and 6).

2. BIOLOGICAL PROPERTIES OF THE MICROORGANISM

T. asperellum T34 is a wild‐type strain, non‐modified fungus originally isolated in 2002 from a commercially available natural compost‐peat mix.

Historical background: Historically Trichoderma species have been used as microbial 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.

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

The target organisms for the representative uses are Fusarium spp. in ornamentals and Pythium spp. in solanaceae and cucurbits.

Mode of action: T. asperellum T34 encompasses a combination of direct and indirect mechanisms to control plant pathogens, including infection of the target organism (mycoparasitism), induction of plant defence responses (ISR), competition for resources and space, secretion of carbohydrate degrading enzymes and antibiosis.

Life cycle: There are no sexual forms known for T. asperellum T34. 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 survival strategy. In natural environment, a universal generation time cannot be defined due to variability in growth conditions that may range from tens to hundreds of days.

Genetic stability: As a mitotically reproducing asexual fungus, T. asperellum T34 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 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 pathogenic plant 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, n.d.). 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; Pallavi et al., 2025; Pfordt et al., 2024; Pfordt & von Tiedemann, 2025; Pfordt, 2025; Pfordt et al., 2025a, 2025b; Sanna et al., 2022). Some of these recent studies have shown that also several isolates of T. asperellum may cause ear rot disease to maize when the plant is previously wounded or damaged (e.g. by insects). In the peer‐reviewed scientific paper of Pfordt et al. (2025a) it was shown that T. asperellum T34 caused the highest disease severity (88%) among the different T. asperellum strains tested.

Infectivity, dispersal and colonisation ability: T. asperellum T34 is able to grow under a wide range of environmental conditions. In particular, T. asperellum T34 was observed to have a pH tolerance with survival observed at all pH from 4 to 9. The available data indicate the optimal growth temperature to be < 36°C. The fungus does not have an endophytic habit and has a very good ability at colonising plant root cells and a large variety of plant media. Further information on infectivity in mammals is reported in Section 3.

Antifungal susceptibility: T. asperellum T34 was susceptible to antifungals of all three classes (echinocandines, azoles and polyenes) tested at concentrations of 8 μg/mL or below.

Secondary metabolites of (potential) concern: Based on the available literature, several metabolites of potential concern can be produced by T. asperellum strains, such as peptaibols, diketopiperazine‐like compounds (e.g. gliovirin), volatile organic compounds [e.g. 6‐pentyl‐alpha‐pyrone (6‐PP) and 2H‐pyran‐2‐one], halobacillin and trichodones. According to the literature, it is noted that some Trichoderma species have the genetic capacity of producing other secondary metabolites of potential concern known for the genus such as anthraquinones (e.g. potentially genotoxic emodin), polyketides, trichothecens, cytochalasans and camptothecin; however, this was not fully investigated for the strain T34, neither in the literature review nor via genomic analysis or validated analytical determination (see Section 1), hence the production of such metabolites cannot be excluded (data gap, see above). Only a screening analysis on the MPCP was carried out, showing the presence of peptaibols. Further discussion on the relevance for mammalian health is provided in Section 3.

3. POTENTIAL EFFECTS ON HUMAN/MAMMALIAN HEALTH

The toxicological profile of T. asperellum T34 and its metabolites was discussed at the Pesticides Peer Review Experts' Teleconference (TC) 184 in September 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. However, Trichoderma species can act as opportunistic human pathogens. No adverse health effects have been reported in workers as a result of exposure to T. asperellum T34 during its production and handling.

T. 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 taxonomic complexity and safety considerations.

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 T. asperellum T34 shall be regarded as potential sensitisers. Therefore, the non‐specific labelling with the warning phrase ‘Contains T. asperellum T34. 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 infection has been reported (see medical information reported in this section).

No signs of treatment‐related toxicity or pathogenicity were observed in rats following acute exposure to the active substance T. asperellum T34 via oral, inhalation and intraperitoneal routes. Microbial analysis of faeces, fluids and tissues/organs was investigated after both oral and intratracheal administrations and demonstrated full clearance (no infectivity) of the active organism.

Skin and eye irritation have been investigated in rabbit. After exposure to the formulation of representative uses ‘T34 Biocontrol WP’, minor or transient effects (not meeting classification criteria) were observed. Skin sensitisation was observed in guinea pig and considering the amount of the active substance in the product, the default warning phrase ‘Microorganisms may have the potential to provoke sensitising reactions’ is considered sufficient.

It is concluded that T. asperellum T34 has low potential for infectivity/pathogenicity in humans based on the available data.

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

Among the metabolites of potential concern, T. asperellum T34 has been demonstrated to produce peptaibols (see Section 2).

Toxicological information from the literature was submitted on peptaibols only. No information has been submitted on the other metabolites that might be produced by T. asperellum T34 (data gap, see Sections 2 and 10).

For peptaibols cytotoxicity has been observed in vitro in boar sperm cells, porcine kidney cells and somatic cells. No further toxicological data have been submitted by the applicant. It is known that peptaibols cause low acute toxicity in vivo. Therefore, based on the available limited information they are unlikely to be metabolites of potential concern for human health.

It is known that, based on an EFSA Scientific Opinion (EFSA ANS Panel, 2018), aloe‐emodin (belonging to the anthraquinone family and structurally related to emodin), is a potential genotoxic compound. Consequently, the concentration of emodin should be kept below 0.1% in the MPCA/MPCP. The lack of WGS analysis and analytical determination does not allow to exclude potential concerns based on exposure considerations (data gap, see Sections 2 and 9.1).

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 T. asperellum T34 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/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 from 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.

The RMS, Member States and EFSA are of the opinion that the available information is not sufficient to conclude on the production and identification of other metabolites (including individual metabolites belonging to various families/groups) by T. asperellum T34 (see Sections 2 and 9.1). Pending their identification, further investigations on their toxicological properties might be needed to conclude on the safety of non‐dietary exposure to the product (data gap, see Section 9.1).

4. RESIDUES

With regard to the five assessment criteria according to the Commission guidance SANCO/11188/2013 Rev. 2 (European Commission, 2015) for potential inclusion in Annex IV of Regulation (EC) No 396/2005, ¹¹ i.e. approval as basic substance (criterion I); listed in Annex I of Regulation (EC) No 396/2005 (criterion II); having no identified hazardous properties (criterion III); natural exposure from other uses in the food chain and/or natural exposure is higher than the one linked to the use as a plant protection product (criterion IV); and consumer exposure is not expected linked to the mode of application (criterion V), none of the criteria was considered to be met.

For the assessment of consumer safety, criteria III (absence of hazardous properties) and IV (exposure lower than natural background) are particularly relevant.

T. asperellum T34 presents data gaps regarding emodin, a metabolite of potential concern (see Section 3.2). While literature indicates that T. asperellum strains can produce several secondary metabolites, including compounds with known hazardous properties (e.g. emodin), this has not been specifically investigated for strain T34. In particular, no genomic analysis (e.g. WGS) is available to confirm the presence or absence of genes involved in the production of emodin (see Section 2), and therefore its potential formation cannot be excluded. Therefore, it also cannot be concluded that no hazardous properties are associated with T. asperellum T34 (criterion III).

Furthermore, the residue assessment is not adequately addressed. The critical representative uses for consumer exposure are drip irrigation treatments on solanaceous fruiting vegetables (tomatoes, sweet peppers and aubergines) and cucurbits with edible peel (cucumbers and zucchini) and inedible peel (melons, watermelons and pumpkins), up to BBCH 89 (ripe harvest stage). The mode of application does not preclude the presence of viable, metabolically active cells of T. asperellum T34 on edible commodities. As such, viable residues may produce metabolites of potential concern (e.g. emodin) in situ. Therefore, the presence of such viable residues may contribute to non‐viable residue levels on edible commodities. In addition, T. asperellum T34 can persist and multiply in soil at concentrations considerably higher than natural background levels (see Section 5.1), further increasing the uncertainty regarding potential residue levels. Occurrence and potential in‐situ formation of metabolites, in particular emodin, a metabolite of potential concern (see Section 3.2), on edible plant parts in line with the representative uses were not investigated (data gap, see Section 9.1). In contrast, 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/day. Should T. asperellum T34 produce 6‐PP, consideration of the final application rate before harvest and average EU crop yields (FAO, 2026) for the representative uses, the results of secondary metabolite production experiments with Trichoderma strains in the literature, and the high volatility of metabolite 6‐PP, indicate that 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. For emodin, however, no residue data are available to identify specific application timings within the GAP ranges (BBCH 00–10, BBCH 10–89 or application to the growing medium before sowing/planting) that would allow a conclusion that viable and non‐viable residue levels would be insignificant, which prevents a conclusion that, for at least one representative use on crops for human consumption, exposure would be comparable to natural background levels (criterion IV).

Consequently, based on the available information, it cannot be concluded that residues, either non‐viable residues, notably emodin or viable T. asperellum T34 cells capable of producing emodin in situ on edible commodities, would occur at levels that do not raise concerns for consumer health. Therefore, the dietary consumer risk assessment cannot be finalised (see Section 9.1). It is to be noted that the RMS outlined that ‘the lack of conclusion regarding metabolites of concern was considered as a general data gap, without identifying data gaps for individual metabolites, since this did not allow to determine whether a consumer risk assessment was required’.

5. ENVIRONMENTAL FATE AND BEHAVIOUR

Satisfactory information is available in relation to potential interference of T. asperellum T34 with the analytical systems for the control of the quality of drinking water provided for in Directive 98/83/EC ¹² (see specific Annex VI decision‐making criteria in Part II of Commission Regulation (EU) No 546/2011 ¹³ ). 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

In relation to the persistence and multiplication in soil, the information available in peer‐reviewed scientific literature studies indicates that Trichoderma spp. may persist overwinter and that this is achieved through formation of chlamydospores. The study submitted in the original dossier about persistence of T. asperellum T34 in the plant growing substrates (peat and coir fibre) in greenhouse, showed that a maximum concentration of around 10⁵ CFU/mL substrate is reached by T. asperellum T34 after application (increasing to this level when lower application levels were used), and that this level was maintained for the 4 months of the study duration.

Overall, information in the open literature provided in the dossier, showed that Trichoderma species can persist in soil for more than 2 years [see for example Oskiera et al., 2017; summarised in Volume 3 – B.8 (MA)]. These data are considered sufficient to conclude that T. asperellum T34 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 microorganism and that there are natural fluctuations in the population densities. Therefore, information on infectivity and pathogenicity to non‐target organisms is necessary (see Section 6). According to information provided by the applicant, the formulation ‘T34 Biocontrol WP’ is only intended for permanent greenhouses as at the time of the renewal application only uses in permanent greenhouses were authorised. However, the applicant informed that ‘T34 Biocontrol WP’ has recently been (after 2020) approved for field uses in lettuce and potato in some Member States. EFSA emphasises that those uses are neither supported nor assessed within the frame of this renewal assessment. For these field uses approved in some Member States, the applicant would need to demonstrate that available PEDs in soil do address plateau levels after application in repeated seasons.

A study investigated the mobility in soil of T. asperellum T34, with the highest levels of the microorganism identified within the 0–20 cm and the 80–100 cm depth horizons. The concentration on the deeper horizon was attributed to the presence of a clay layer. The study evidences the potential vertical mobility of T. asperellum T34 in soil. Another study investigated the vertical movement of T. asperellum T34 in greenhouse plant growing media. This study showed that the plant growth media behaves as a filter and reduces the concentration of the T. asperellum T34 in the leachates to between 80 and 130 times less than its concentration present in the plant growth media. Available scientific literature data indicate that Trichoderma species can migrate a few meters horizontally and a few decimetres vertically from the application site. Reading across from these studies, the horizontal and vertical mobility of T. asperellum T34 in soil is expected to be limited.

Two specific study addressing the persistence and multiplication in surface water of T. asperellum T34 were provided. One of the studies had a duration of 23 days and the other study was prolonged up to 64 days. In these studies, fate of T. asperellum T34 was investigated in microcosms simulating ground and surface water. T. asperellum T34 remained viable for 2 months after inoculation in river and spring water systems (in absence of sediment), that simulate surface and ground water respectively. The level of CFU/mL water did not change over the first month in any of the systems. In the river water system, the level of CFU/mL water increased slightly during the second month of the longer study. Count of germinated spores was relatively low and only observed over the first month. This is considered to demonstrate the limited proliferation capacity of T. asperellum T34 in surface water environment. Studies performed in water‐sediment systems have not been provided. Peer‐reviewed scientific literature studies presented in the RAR indicate that Trichoderma species can survive in aquatic environments under favourable conditions. Several Trichoderma species have been identified in aquatic media (marine and fresh water), including strains of T. asperellum.

Considering the method of application of the formulated product ‘T34 Biocontrol WP’ – namely long dip (root dip) or soil growing media application either by spraying, incorporation or through drip irrigation in permanent greenhouses – emissions to surface water via spray drift or other exposure routes (EFSA, 2014) are considered low. PEDsw calculated with the greenhouse scenario assuming 0.1% emission results in 2.7 × 10⁴ CFU/L when six applications are considered at once (application rate of 5 kg/ha/application for use in Solanaceae) (See Appendix A). The applicant has clarified that uses are supported exclusively in permanent greenhouses; therefore, uses in the field or in non‐permanent greenhouses are not considered here.

A study evaluating the aerial dispersion of T. asperellum T34 in a greenhouse with T34‐treated (by drip irrigation) plant growth medium, was provided by the applicant. The study shows presence of T. asperellum T34 in the air of a greenhouse in which the organism has been applied six times, via the drip irrigation system, to the crops grown in plastic bags over a period of 2 years. The strain represented 7% of the Trichoderma spp. and 2% of the isolated fungi (trapped on petri dishes with Trichoderma‐selective medium). These results can be considered representative for drip irrigation uses in greenhouses with crops grown in plastic bags (thus, limited air‐soil exposure). Although inadequate information was provided on the survival, competitiveness and population dynamics of T. asperellum T34 in air, survival and competitiveness is 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 open air compartment and to other compartments through air can be considered minimal for the ‘T34 Biocontrol WP’ representative uses in permanent greenhouses in which the product is applied to soil or growing media by incorporation or direct application, as long as used growing media is adequately managed and disposed of.

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

During the Pesticides Peer Review Experts' Teleconference (TC) 185 in September 2025, Member State experts and EFSA agreed with the RMS conclusions that insufficient data was submitted to draw a conclusion about the production and toxicity of secondary metabolites of potential concern and their expected environmental levels (see data gap in Sections 1 and 3).

EFSA also emphasises that there is not enough information regarding the quantification of the metabolites of potential concern that might be in the MPCA‐AM/MPCP or produced in situ. In situ production of metabolites could be relevant depending on the type of metabolite of potential concern and its toxicity/ecotoxicity properties. For the metabolites of potential concern, it will need to be assessed if such metabolites might fulfil the criteria according to Part B section 7 (iv) of Commission Regulation (EU) No 283/2013 ¹⁴ to assess if further data requirements and corresponding risk assessment according to Commission Regulation (EU) No 283/2013, part A, section 7 is required.

6. POTENTIAL EFFECTS ON NON‐TARGET ORGANISMS

6.1. Birds and mammals

One 30‐day study is available for birds with the formulation for representative uses ‘T34 Biocontrol WP’. While infectivity and pathogenicity were not per se investigated, no adverse effects were reported in the available study. In addition, considering that the use of ‘T34 Biocontrol WP’ will be in permanent protected structures only, exposure of birds can be considered minimal and low risk was concluded.

Studies investigating acute effects of the active substance and the formulation for representative uses ‘T34 Biocontrol WP’ on rats are available. Based on the data provided, there is no indication that T. asperellum T34 is infective or pathogenic to wild mammals (see also Section 3). Considering that the use of ‘T34 Biocontrol WP’ will be in permanent protected structures only, exposure of mammals was considered minimal and low risk was concluded.

Based on the representative uses in permanent structures and in line with EFSA (2015), minimal exposure to secondary metabolites is expected, hence low risk can be concluded for birds and mammals.

6.2. Aquatic organisms

For fish, one 30‐day study with the active substance and one 96‐hour study with the formulation ‘T34 Biocontrol WP’ are available. The study with the active substance was discussed with Member State experts. ¹⁵ Considering the uncertainties identified in the study, the experts at the meeting agreed that it is not possible to determine whether the observed effects are due to pathogenicity, secondary metabolites or to a physical effect of the spores. The available study with the formulation ‘T34 Biocontrol WP’ was considered acceptable but reliable with restrictions as there are uncertainties with regards to the actual exposure. In addition, the study was considered too short to assess infectivity and pathogenicity.

For aquatic invertebrates, one 21‐day study with the active substance and one acute study with the formulation ‘T34 Biocontrol WP’ are available. While some adverse effects were observed in the study with the active substance, it is not possible to determine whether the observed effects are due to pathogenicity, secondary metabolites or to a physical effect of the spores. The available study with the formulation ‘T34 Biocontrol WP’ was considered acceptable but not long enough to assess infectivity and pathogenicity.

For fish and aquatic invertebrates, considering the proposed uses in permanent greenhouses for ‘T34 Biocontrol WP’, PEDsw were calculated to be at least 2000 times lower (see details in Vol. 3 MP B8 for ‘T34 Biocontrol WP’) than the concentrations at which adverse effects were observed, thus a low risk can be concluded for pathogenicity to fish and aquatic invertebrates.

For algae and aquatic plants, no study is available with the active substance. One study is available with the formulation ‘T34 Biocontrol WP’ for algae and one for plants. No evidence of infectivity or pathogenicity was reported.

The available data indicate that T. asperellum T34 can potentially produce secondary metabolites of potential concern, including peptaibols (see Sections 2 and 3.2). The available peer‐reviewed open literature data indicate that peptaibols can be toxic to aquatic invertebrates. No exposure assessment is available with regard to these secondary metabolites in the aquatic environments and no analytical determination of these metabolites in ‘T34 Biocontrol WP’ was provided. 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) (data gap leading to an issue not finalised, see Section 9.1).

6.3. Bees

Only one reliable acute contact and oral study with the active substance T. asperellum T34 is available for honey bees.

The available evidence and the risk assessment for honey bees were discussed with Member State experts. ¹⁶ For the formulation for representative uses ‘T34 Biocontrol WP’, a low risk can be concluded for the use in permanent protected structures considering minimal exposure to the active substance and to potentially produced secondary metabolites of potential concern.

6.4. Non‐target arthropods other than bees

Studies are available with the formulation for representative uses ‘T34 Biocontrol WP’ with Typhlodromus pyri and Aphidius rhopalosiphi. The duration of the studies was considered too short (7 days and 48 h, respectively) to assess infectivity or pathogenicity. No mortality or abnormal behaviour were observed.

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 low risk can be concluded for non‐target arthropods.

6.5. Soil organisms

One 56‐day study with the formulation for representative uses ‘T34 Biocontrol WP’ is available with earthworms. No adverse effects were reported.

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 low risk can be concluded for earthworms.

One study with the formulation for representative uses ‘T34 Biocontrol WP’ is available for soil microorganisms. The study used fluorescent Pseudomonas. A reduced microbial biomass was noted. However, based on the available information, it is not possible to separate the effects of the growth media from those of the active substance. Nevertheless, 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 low risk can be concluded for soil microorganisms.

6.6. Additional information

During the peer‐review, EFSA identified literature studies carried out with Trichoderma harzianum (now Trichoderma afroharzianum) strains T39 and T12 reporting pathogenicity to maize. 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 T. asperellum T34 to other strain or Trichoderma spp. (and vice versa) is uncertain. Therefore, with the available data, it cannot be concluded whether T. asperellum T34 has the potential to exert a pathogenic effect on terrestrial plants.

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

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 asperellum T34	Low risk for earthworms and soil microorganisms.
Secondary metabolites of potential concern	Low risk for earthworms and soil microorganisms.

TABLE 2.

Groundwater.

Compound (name and/or code)	> 0.1 μg/L at 1 m depth for the representative uses a 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 asperellum T34	Not assessed (quantitative limit applicable only for chemical pesticides)	Yes	–	–	Yes
Secondary metabolites of potential concern (including emodin)	Open	Open	Emodin: genotoxic Other metabolites: Open	Open	Open

^a FOCUS scenarios or relevant lysimeter.

TABLE 3.

Surface water and sediment.

Compound (name and/or code)	Ecotoxicology
Trichoderma asperellum T34	Low risk for 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 asperellum T34	No evidence of toxicity, pathogenicity or infectivity in rat after acute intratracheal administration (LC50 value of > 2.03 mg/L).
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).
2H‐pyran‐2‐one (volatile compound)	Open

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 (see Table 5). 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 uses	professional uses of ‘T34 Biocontrol WP’ on protected ornamentals in permanent greenhouses via long dip (root dip) or soil growing media application either by spraying, incorporation or through drip irrigation system
	and
	professional uses of ‘T34 Biocontrol WP’ on solanaceae (such as tomato, sweet pepper and aubergine) and cucurbits (such as cucumber, melon, watermelon, zucchini and pumpkin) in permanent greenhouses via soil growing media application either by spraying, incorporation or through drip irrigation system
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

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 ¹⁷ 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. Non‐dietary risk assessment (relevant for operators and workers only) for the secondary metabolites of potential concern (including emodin, potential genotoxic compound) cannot be concluded considering the identified data gap (see Section 3):

   1. Lack of data on the production of secondary metabolites of potential concern relevant for non‐dietary exposure (including e.g. chemical determination) (relevant for all representative uses, see Sections 2 and 3.2). In case a metabolite becomes of concern based on identified production, additional toxicological evidence might be needed (relevant for all representative uses with the formulation ‘T34 Biocontrol WP’; see Sections 1, 6).
2. The dietary consumer risk assessment cannot be finalised considering the identified data gap (see Section 4):

   1. Further qualitative and quantitative information is needed on residues of emodin, a potentially toxicologically relevant metabolite in edible plant commodities, including a potential in‐situ production in relation to the representative uses of T. asperellum T34; in case of identified production, additional toxicological evidence might be needed (relevant for all representative uses on edible plant commodities, except ornamentals, with the formulation ‘T34 Biocontrol WP’; see Section 4).
3. Satisfactory information was not available on the production of secondary metabolites (see Sections 1 and 5.2), their levels present in the environment after application and their potential toxicity in order to conclude on the risk assessment for aquatic organisms leading to an assessment not finalised (see Sections 5.2 and 6) considering the identified data gap.

   1. Pending 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 aquatic organisms (fish, freshwater invertebrates, algae and aquatic plants other than algae) (relevant for all representative uses with the formulation ‘T34 Biocontrol WP’; see Section 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 uses		‘T34 Biocontrol WP’
		Edible plant commodities	Ornamentals	Edible plant commodities	Ornamentals	Edible plant commodities	Ornamentals	Ornamentals
		Incorporation into growing media		Spraying growing media (seed trays and multipots)		Soil/growing media irrigation (e.g. drip irrigation)		Root dip (long dip)
		in permanent greenhouses only
Operator risk	Risk identified
	Assessment not finalised	X1	X1	X1	X1	X1	X1	X1
Worker risk	Risk identified
	Assessment not finalised	X1	X1	X1	X1	X1	X1	X1
Resident/bystander risk	Risk identified
	Assessment not finalised
Consumer risk	Risk identified
	Assessment not finalised	X2		X2		X2
Risk to wild non‐target terrestrial vertebrates	Risk identified
	Assessment not finalised
Risk to wild non‐target terrestrial organisms other than vertebrates	Risk identified
	Assessment not finalised
Risk to aquatic organisms	Risk identified
	Assessment not finalised	X3	X3	X3	X3	X3	X3	X3
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 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 thorough search of the scientific peer‐reviewed open literature (in accordance with the EFSA guidance on the submission of scientific peer‐reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009) on the microbial active substance and its metabolites of (potential) concern, dealing with toxicological and side effects on health, the environment and non‐target species is not available (relevant for all representative uses with formulation ‘T34 Biocontrol WP’; see Section on ‘General aspects’).

• The purity of the starting materials as specified by the suppliers (besides one co‐formulant), and clarity on whether all starting materials are commercially available are not available (relevant for manufacturer/factory 2; see confidential evaluation table for manufacturer/factory 2).

• Satisfactory information on the stability of the packaging after storage of the formulation ‘T34 Biocontrol WP’ has not been provided (relevant for all representative uses with formulation ‘T34 Biocontrol WP’; see Section 1).

ABBREVIATIONS

a.s.

active substance

bw

body weight

CFU

colony forming units

Co‐RMS

co‐rapporteur Member State

DM

dry matter

EEC

European Economic Community

FAO

Food and Agriculture Organization of the United Nations

FOCUS

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

GAP

Good Agricultural Practice

ISO

International Organization for Standardization

ISSR

inter‐simple sequence repeat

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

PPE

personal protective equipment

QPS

qualified presumption of safety

RAPD

random amplification of polymorphic DNA

RAR

renewal assessment report

REACH

Registration, Evaluation, Authorisation of Chemicals Regulation

RMM

risk mitigation measures

RMS

rapporteur Member State

RPE

respiratory protective equipment

WGS

whole genome sequence

WHO

World Health Organization

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2020‐00633

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NOTE/UPDATE

This scientific output, approved on 30 June 2026, supersedes the previous output published on 3 May 2012 (EFSA, 2012).

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.2026.10235.

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. , 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. , Santonja, G. G. , Gouliarmou, V. , Ippolito, A. , Istace, F. , … Villamar‐Bouza, L. (2026). Peer review of the pesticide risk assessment of the active substance Trichoderma asperellum T34 . EFSA Journal, 24(7), e10235. 10.2903/j.efsa.2026.10235