Peer review of the pesticide risk assessment of the active substance caprylic acid

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, Greece, and co‐rapporteur Member State, Austria, for the pesticide active substance caprylic acid 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 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of caprylic acid as a herbicide in ornamentals against weeds, and field spray applications on soil around ornamental and trees, and on sidewalks/pavements against moss. Missing information identified as being required by the regulatory framework is listed.

SUMMARY

Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659, 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. Caprylic acid 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), Greece, and co‐rapporteur Member State (co‐RMS), Austria, received an application from SBM Développement SAS for the renewal of approval of the active substance caprylic acid.

An initial evaluation of the dossier on caprylic acid 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 2018/1659. The following conclusions are derived.

The uses of caprylic acid according to the representative uses as a herbicide in ornamentals against weeds, and field spray applications on soil around ornamentals and trees, and on sidewalks/pavements against moss, as proposed at EU level result in a sufficient herbicidal 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, physical–chemical and technical properties of the active substance and the formulation for representative uses and analytical methods.

With regard to mammalian toxicology, no issues that could not be finalised nor that need to be included as critical areas of concern were identified.

No concerns were identified in the residue section. A consumer risk assessment for caprylic acid was not deemed to be necessary since health‐based guidance values were not needed to be established. Caprylic acid meets criteria 3, 4 and 5 of the five assessment criteria according to the Commission guidance SANCO/11188/2013 Rev. 2.

The environmental exposure assessment for caprylic acid was conducted based on a read‐across from pelargonic acid (nonanoic acid), which is considered scientifically justified due to their high structural and chemical similarity.

In the area of ecotoxicology, critical areas of concern or issues not finalised were not identified.

Caprylic acid does not meet the criteria for endocrine disruption for humans and non‐target organisms according to points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605.

BACKGROUND

Commission Implementing Regulation (EU) No 844/2012, as ¹ amended by Commission Implementing Regulation (EU) No 2018/1659, 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). Furthermore, in accordance with Article 13(3a), where the information available in the dossier is not sufficient to conclude the assessment on whether the approval criteria for endocrine disruption are met, additional information can be requested to be submitted in a period of a minimum of 3 months, not exceeding 30 months, depending on the type of information requested.

In accordance with Article 1 of the Regulation, the RMS, Greece, and co‐RMS, Austria, received an application from SBM Développement SAS for the renewal of approval of the active substance Caprylic acid. Complying with Article 8 of the Regulation, the RMS checked the completeness of the dossier and informed the applicant, the co‐RMS (Austria), the European Commission and EFSA about the admissibility.

The RMS provided its initial evaluation of the dossier on Caprylic acid in the RAR, which was received by EFSA on 27 April 2021 (Greece, 2022).

In accordance with Article 12 of the Regulation, EFSA distributed the RAR to the Member States and the applicant, SBM Développement SAS, for consultation and comments on 3 March 2023. 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 2 May 2023. At the same time, the collated comments were forwarded to the RMS for compilation and evaluation in the format of a reporting table. In addition, the applicant was invited to respond to the comments received. 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 teleconference between EFSA, the RMS and the European Commission on 6 September 2023. On the basis of the comments received, the applicant's response to the comments and the RMS's evaluation thereof, it was concluded that additional information should be requested from the applicant, and that EFSA should conduct an expert consultation in the areas of mammalian toxicology, environmental fate and behaviour and ecotoxicology.

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

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

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 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 Caprylic acid as a herbicide in ornamentals against weeds, and on soil around ornamentals and trees and on sidewalks/pavements against moss, 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 B. In addition, the considerations as regards the cut‐off criteria for Caprylic acid according to Annex II of Regulation (EC) No 1107/2009 are summarised 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 (6 September 2023);

• the evaluation table (28 September 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 (Greece, 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 ACTIVE SUBSTANCE AND THE FORMULATION FOR REPRESENTATIVE USES

The active substance for this assessment is caprylic acid. Caprylic acid is a trivial name (no ISO common name) of octanoic acid (IUPAC name).

The formulation for the representative uses was Désherb'nat®, an oil‐in‐water emulsion (EW) containing 564 g/L of pure caprylic acid.

The information on the active substance and the formulation for representative uses, including the co‐formulants in these formulations, 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 nor considered as an active substance in accordance with Regulation (EC) No 1107/2009. 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 formulations according to Regulation (EC) 1272/2008 was provided by the applicant and assessed by the RMS (please see Volumes 3 CP of the RAR).

The representative uses evaluated for ‘Désherb'nat®’ comprise field spray applications as a herbicide in ornamentals against weeds and field spray applications on soil around ornamental and trees and on sidewalks/pavements against moss. Full details of the good agricultural practices (GAPs) can be found in the list of end points in Appendix B. Data were submitted to conclude that the representative uses of caprylic acid proposed at EU level result in a sufficient herbicidal efficacy against the targeted weeds following the guidance document SANCO/2012/11251‐rev. 4 (European Commission, 2014b).

General aspects

With regard to the mammalian toxicity of the formulation for representative uses ‘DESHERB'NAT’, studies and/or information addressing acute toxicity were available. With regard to the co‐formulants contained in ‘DESHERB'NAT’, sufficient toxicological data were available for all components, but one (present well below 10% in the final formulation). For this component, the experts considered that the available toxicological information did not sufficiently address the repeated dose toxicity potential of ‘DESHERB'NAT’ over the long term and this might be considered for further assessment (see Section 10). It is noted that this component is listed as cosmetic (Regulation (EC) No 1223/2009 and Com Decision (EU) 2022/677). 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.

The availability of ecotoxicity data with the formulation for representative uses was discussed at the Pesticides Peer Review Experts' Teleconference (TC) 173 in May 2025 (refer to Section 5). ⁵ The experts also discussed the data retrieval search and the available data for the individual components. The experts concluded that no concerns were identified except for a co‐formulant for which sufficient data were not available to conclude for its long‐term effects. The need for further ecotoxicity data should be reconsidered once the toxicology data are available.

A data gap has been identified for a proper review of the scientific peer‐reviewed open literature on the active substance and its relevant metabolites, dealing with side effects on health and published within the 10 years before the date of submission of the dossier, to be conducted and reported in accordance with EFSA guidance on the submission of scientific peer‐reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009 (EFSA, 2011).

1. IDENTITY, PHYSICAL/CHEMICAL/TECHNICAL PROPERTIES AND METHODS OF ANALYSIS

The following guidance documents were followed in the production of this conclusion: European Commission (2000a, 2000b, 2010).

The minimum purity of caprylic acid as manufactured is 980 g/kg. Industrial scale batch data from more than one manufacturing source were available. Lead (Pb), arsenic (As), mercury (Hg) and cadmium (Cd) were considered relevant impurities specified at the following maximum levels ⁶ : 0.6 mg/kg for Pb, 0.4 mg/kg for As and Hg and 0.02 mg/kg for Cd (See Section 2). A data gap is set for batch data to demonstrate compliance with the proposed lead, arsenic, mercury and cadmium specification levels and for validated analytical methods with a sufficient low limits of quantification (LOQs) for the proposed specification levels (see Section 10).

The proposed reference specification was based on the batch data from the source that contained the highest number of impurities, but it should be considered as provisional since the provided data were non‐GLP and the analysis of the significant and relevant impurities was performed with non‐validated analytical methods (data gap, see Section 10). ⁷ For one of the manufacturing sources of caprylic acid, a data gap was set for additional quality control (QC) data to support the representativeness of the batches analysed and for batch data on the content of the relevant impurity cadmium (see Section 10). Based on these data gaps, it is proposed to consider the proposed specifications as provisional. A FAO specification does not exist for caprylic acid.

The main data regarding the identity of caprylic acid and its physical and chemical properties are given in Appendix B.

Adequate methods are available for the generation of data required for the risk assessment. Methods of analysis are available for the determination of the active substance in all technical materials and the formulation for representative uses. Validated methods were not available for the analysis of impurities in one manufacturing source (data gap, see Section 10). A data gap was set for validated methods for the determination of the relevant impurities lead, arsenic, mercury and cadmium in the formulation for the representative uses (see Section 10). Methods for the analysis of residues in food and feed of plant and animal origin, in body fluids, body tissues, air and ground/drinking water are not required as no residue definition was set. A data gap was set for validated analytical methods for monitoring caprylic acid in soils and surface water (see Section 10).

2. MAMMALIAN TOXICITY

The assessment is based on the following guidance documents: European Commission (2012), EFSA (2014, 2017), and ECHA (2017).

Caprylic acid was discussed at the Pesticides Peer Review Experts' meeting Teleconference 164 in March 2025.

Regarding the proposed reference specification, the impurities lead, arsenic, mercury and cadmium ⁸ are identified as relevant impurities, being heavy metals of known toxicological concern, and maximum levels are proposed. It is stressed in the EFSA opinion for food additive that the current specifications limits for Pb, As and Hg in fatty acids as food additive (E 570) (Commission Reg 231/2012) are not sufficiently protective (EFSA ANS Panel, 2017). ⁹ Consequently, lower values were considered and set based on the values proposed by the applicant (see Section 1).

For inorganic arsenic, the EFSA CONTAM Panel derived a BMDL₀₅ ¹⁰ of 0.06 μg/kg bw per day based on increased incidence of skin cancer (EFSA CONTAM Panel, 2024). For lead, the EFSA CONTAM Panel derived a BMDL₀₁ ¹¹ of 0.5 μg/kg bw per day for neurodevelopmental effects in children (close to the BMDL₁₀ ¹² for nephrotoxic effects in adults) (EFSA CONTAM Panel, 2010). In both cases, the EFSA CONTAM Panel (2012) recommended a margin of exposure (MOE) approach. ¹³ For inorganic mercury, the lowest health‐based guidance value (HBGV) derived by the EFSA CONTAM Panel (2012) is the tolerable weekly intake (TWI) of 4 μg/kg bw (corresponding to 0.57 μg/kg bw per day), based on kidney effect.

Caprylic acid (C₈) is a linear saturated fatty acid. Fatty acids, including caprylic acid, are authorised in the EU as a food additive (E 570) ¹⁴ and their safety was re‐evaluated by EFSA in 2017 (EFSA ANS Panel, 2017). Fatty acids are primarily regarded as nutrients and they are present in all living organisms. They have a main role in energy metabolism and they are essential structural components of every cell.

No specific ADME studies for caprylic acid were available in the renewal dossier. However, the metabolic pathways of fatty acids are well established and similar for all of them. Fatty acids are rapidly absorbed (> 80%) and widely distributed. They are either metabolised completely for energy production giving rise to water and carbon dioxide or converted to fat suitable for storage. They do not produce any metabolites and they have no potential for accumulation.

No new toxicological studies were submitted for caprylic acid by the applicant. Based on the publicly available data, there is no indication of acute oral, dermal and inhalation toxicity. Caprylic acid has a harmonised classification as skin corrosive [Skin Corr. 1C; H314] according to the Regulation (EU) No 1272/2008. ¹⁵ This harmonised classification also covers the eye irritating effect of caprylic acid. Caprylic acid is concluded not being a skin sensitiser based on a weight of evidence approach (ECHA, 2012). Caprylic acid has no phototoxic potential as fatty acids do not absorb electromagnetic radiation in the range of 290–700 nm.

Based on the available genotoxicity data, the substance is unlikely to be genotoxic. Testing for photomutagenicity is not required for caprylic acid, since its UV/vis molar extinction coefficient is below 1000 L × mol⁻¹ × cm⁻¹.

As fatty acids are natural body constituents, toxicological studies, e.g. short‐term, long‐term, reproductive (fertility/development) toxicity and neurotoxicity studies, are not necessary and can be waived.

As regards medical data, there is no evidence of adverse effects from consumption of total fatty acids as food contents at 821 mg/kg bw per day through diet (ECHA, 2012).

Health‐based guidance values (ADI, ARfD, (A)AOEL) cannot be established on the basis of the data submitted and they are not required in view of the lack of adverse effects from consumption of at least 821 mg/kg bw per day through diet (ECHA, 2012).

Dermal absorption values of caprylic acid in the representative product (DESHERB'NAT) are the default values for this type of formulation (EW), in line with the EFSA guidance (EFSA, 2017): 25% for the concentrate, 70% for the in‐use dilution.

The non‐dietary exposure estimates were calculated with the EFSA model (EFSA, 2022) for representative uses in low ornamentals and amenity grassland. Predictions for operators, using manual hand‐held, knapsack and vehicle mounted applications, are below the background dietary exposure level (821 mg/kg bw per day) with the use of standard workwear. For the workers, exposure estimates are below the background dietary exposure level even without workwear during re‐entry activities, according to the EFSA calculator (2022). Predictions for resident exposure (children and adults), including recreational exposure for entry onto amenity grassland, are below the background dietary exposure level without specific risk mitigation measures. Regarding the acute exposure, in the absence of an acute health‐based guidance value, the exposure assessment for residents covers also bystander.

Regarding the non‐dietary exposure to heavy metals ¹⁶ (As, Pb and Hg), based on the proposed maximum levels (see Section 1) and the representative uses, the calculated estimates do not exceed the respective BMDLs or TWI (MoE ranging from 1 to 23,354). It is noted that such estimates are provisional as there are several uncertainties such as the applicability to heavy metals of the default dermal absorption value used for fatty acids, the unknown actual levels of these metal impurities in the five‐batch analysis due to the lack of validated analytical methods (see data gaps in Section 1) and the limitations of the approach of comparing non‐dietary exposure estimates with tolerable intake levels for heavy metals.

3. RESIDUES

The active substance caprylic acid is proposed as a herbicide for non‐food uses.

Residue data and studies with ‘caprylic acid’ have not been provided by the applicant based on the argument that caprylic acid is naturally occurring in plants and animals and residues remaining on/in plants and animals from use as active substance would be indistinguishable from fatty acids from other sources. EFSA agrees that no studies are necessary considering also the reason that the representative uses are on non‐food plants only.

With regard to the five assessment criteria according to the Commission guidance SANCO/11188/2013 Rev. 2 (European Commission, 2015) for potential inclusion of an active substance in Annex IV of Regulation (EC) No 396/2005, i.e. approval as basic substance (criterion 1), listed in Annex I of Regulation (EC) No 396/2005 (criterion 2), having no identified hazardous properties (criterion 3), natural exposure is higher than the one linked to the use as plant protection product (criterion 4) and consumer exposure is not expected considering the representative uses (criterion 5), three criteria were considered to be met for caprylic acid for the following reasons:

• ‐Health‐based guidance values are not required for caprylic acid (criterion 3).
• ‐the natural exposure to caprylic acid through consumption of plant and animal fats from which it will be released during digestion can be considered to result in higher amounts of caprylic acid than the one linked to the use as plant protection product (criterion 4).
• ‐from the representative uses, consumer exposure is not expected (criterion 5).

It is noted that caprylic acid is not approved as a basic substance (criterion 1) and not listed in Annex I of Regulation (EC) No 396/2005 (criterion 2).

4. ENVIRONMENTAL FATE AND BEHAVIOUR

Caprylic acid was discussed at the Pesticides Peer Review Experts' TC 166 in March 2025, in concomitance with two other fatty acids. ¹⁷

The environmental exposure assessment for caprylic acid was conducted based on a read‐across from pelargonic acid, which is considered scientifically justified due to their high structural and chemical similarity (EFSA, 2025). Both substances are naturally occurring saturated fatty acids with linear carbon chains (C8 for caprylic acid and C9 for pelargonic acid), sharing similar physicochemical properties and undergoing the same degradation pathway (i.e. β‐oxidation leading to shorter chain fatty acids and ultimately to mineralisation). Additionally, both substances exhibit similar environmental behaviour and are considered to degrade rapidly in various environmental compartments. Therefore, the fate and behaviour data available for pelargonic acid have been considered appropriate and conservative for deriving key endpoints for caprylic acid, including degradation, adsorption and ready biodegradability.

The rates of dissipation and degradation in the environmental matrices investigated were estimated using FOCUS (2006) kinetics guidance. In soil, caprylic acid is expected to be degraded by microorganisms by a sequential elimination of C2 fragments, indicating that major soil metabolites of the fatty acid pelargonic acid would be other fatty acids with shorter chains which further degrade to the final product CO₂. In soil laboratory incubations under aerobic conditions in the dark, caprylic acid is expected to exhibit very low to low persistence, based on data extrapolated from studies conducted with pelargonic acid. Mineralisation of the aniline ring ¹⁴C radiolabel to carbon dioxide accounted for 69%–73% applied radioactivity (AR) after 7 days. The formation of unextractable residues (not extracted by acetonitrile/water) for this radiolabel accounted for 13%–22% AR after 7 days. It was concluded that studies on degradation products were not required. Anaerobic conditions are not likely to occur for the representative uses of caprylic acid, which involve applications from spring through to autumn in non‐agricultural areas such as sidewalks, ornamental lawns and public parks. Even in the hypothetical case of anaerobic conditions occurring, extensive biodegradation via the same metabolic route (β‐oxidation) as under aerobic conditions is expected. Therefore, it was concluded that an anaerobic soil degradation study was not needed. Due to the fast microbial degradation of caprylic acid under aerobic soil conditions, soil photolysis is not considered to be a relevant route of degradation.

Caprylic acid was considered to exhibit very high to low mobility in soil, based on adsorption endpoints derived from pelargonic acid. A relationship between the adsorption of pelargonic acid and soil pH was observed. It was agreed that the adsorption values to be used for soils with pHCaCl₂ ≤ 6.2 would be 95 mL/g (1/n = 1), while for soils with pH > 6.2, it was agreed that a geometric mean value of 8.4 mL/g (1/n = 0.987) should be selected.

An aerobic mineralisation study in surface water (OECD 309, 2004) and a water/sediment study (OECD 308, 2002) were not submitted for caprylic acid. However, a River Die‐Away test investigating biodegradation of fatty acids with different chain lengths (C8–C18) in natural river water is available. The results demonstrated rapid degradation for C8 (caprylic acid) and C10 (capric acid) fatty acids, with DT₅₀ values in the range of 0.5–2.9 days, and no clear correlation between chain length and persistence. Based on these data and taking into account the high chemical similarity between caprylic and pelargonic acid, the majority of experts at Pesticides Peer Review Experts' TC 166 supported the use of a DT₅₀ value of 1.6 days, derived from the degradation of C10 fatty acids, as representative for caprylic acid in surface water. This value is considered conservative and appropriate for use in calculations of predicted environmental concentration (PEC) in surface water and in sediment.

Information on the natural background concentrations of caprylic acid in water and sediment in EU surface water bodies, as well as an assessment of the impact of residues resulting from the representative uses of the PPP on these background levels, was not available (data gap, see Section 10).

For the representative non‐agricultural uses of caprylic acid, the aquatic exposure assessment was performed considering its physicochemical properties, the application method (i.e. manual or motorised handheld sprayers) and the relevant exposure routes. Given the substance's water solubility (0.6–6.3 g/L), caprylic acid is considered miscible with water, and PEC values are expressed in μg/L as concentrations in the water column. The exposure assessment was based on FOCUS steps 1–2 (using version 3.2 of the FOCUS calculator), and higher tier refinements following the agreed procedure discussed during the Pesticides Peer Review Experts' TC 166. Experts agreed that spray drift and volatilisation/atmospheric redeposition represent the primary exposure routes to surface water. Run‐off and drainage were excluded from the assessment in line with national practices (e.g. in France), where non‐agricultural uses typically involve only a fraction of the total treated area, significantly limiting the potential for water body contamination via these pathways. In particular, due to the ‘permeable zones only’ restriction in the GAP for use in industrial areas, HardSPEC simulations were not required. Deposition from spray drift, expressed as percent of the applied dose, was based on the German Julius‐Kühn Institute (JKI) spray drift values for use in home/garden, assuming field sprayers with crop heights < 50 cm and a 1‐m baseline distance. Calculations were carried out for buffer zones of 5, 10, 15 and 20 m. No crop interception was applied, as the use of a 40% interception value was not considered justified for these non‐agricultural uses. All deposition values were generated using the EVA 3 tool, and run‐off and drainage inputs were excluded from all calculations. Information on the proportion of the treated area for each non‐agricultural representative use involving localised (non‐uniform) applications was not available (data gap, see Section 10). Whereas this information is not essential to finalise the risk assessment, still it would allow to refine the available exposure calculations.

The necessary groundwater exposure assessments were appropriately carried out using FOCUS (European Commission, 2014a) scenarios and the models PEARL 4.4.4, PELMO 5.5.3. For the formulation ‘DESHERB'NAT’, considering the intended uses on weeds for localised applications in non‐agricultural areas (e.g. sidewalks, pavements, ornamental flowers and shrub/tree beds), predicted environmental concentrations of caprylic acid in groundwater (PECgw) were calculated assuming uniform application over the entire treated area as no data on the actual treated surface was available (data gap, see Section 10). In the modelling, 0% crop interception has been considered due to the worst‐case assumption with the treatment of almost bare soil in all relevant use cases and by taking into consideration the soil pH dependency of the adsorption behaviour of caprylic acid. Three distinct application patterns were defined depending on the type of weeding or moss control use, involving highest application rates applied either across two (spring‐early summer and autumn‐early winter) or three (spring, summer and autumn) separate periods within the year, with varying frequencies and intervals between applications. For each FOCUS scenario, the highest PECgw value across the different simulations was retained as the representative endpoint for the groundwater assessment.

• For FOCUS groundwater scenarios represented by soils with pH ≤ 6.2, PECgw values remained below the parametric drinking water limit of 0.1 μg/L for all representative uses and application timings.

• For FOCUS groundwater scenarios represented by soils with pH > 6.2, exceedances of the 0.1 μg/L trigger were predicted for some representative uses/application patterns:

  • ○
    Weeding 1 pattern (4 × 45.12 kg a.s./ha in two treatment periods): PECgw values above the parametric drinking water limit of 0.1 μg/L were predicted in more than half of the relevant FOCUS groundwater scenarios for all the representative uses covered by this application pattern. Concentrations above 10 μg/L were also predicted in at least one relevant FOCUS groundwater scenario for the uses in parks, public gardens or sidewalks/pavements, industrial areas (use #1 in the GAP), ornamental flower beds (use #7 in the GAP), ornamental trees as plantations weeding (use #5 in the GAP) and ornamental trees as weeding nurseries (use #8 in the GAP). The maximum PECgw predicted was 63.94 μg/L in the Jokioinen scenario, with PELMO model during Period 2, i.e. from May to October (late).
  • ○
    Weeding 2 pattern (2 × 45.12 kg a.s./ha separated by 5 days and simulated in three alternative application windows): PECgw values above the parametric drinking water limit of 0.1 μg/L were predicted in more than half of the relevant FOCUS groundwater scenarios for all the representative uses. For use #7 in the GAP (ornamental flowers), PECgw values above 10 μg/L were also predicted in at least one relevant FOCUS groundwater scenario. The maximum PECgw predicted for ornamental trees was 3.52 μg/L in the Jokioinen scenario, with the PELMO model during Period 3 (i.e. absolute application dates 01/09; 06/09).
  • ○
    Moss destruction (2 × 29.89 kg a.s./ha): PECgw values exceeded 0.1 μg/L in 4/9 FOCUS groundwater scenarios. The maximum concentration (1.66 μg/L) was predicted for the Kremsmünster scenario using PELMO during Period 1 (i.e. absolute application dates 15/03; 20/03).

The applicant provided appropriate information to address the potential effect of water treatment processes on the nature of the residues that might be present in surface water and groundwater, when abstracted for drinking water. No harmful by‐products are expected to be formed during water treatment (ozonation or chlorination). ¹⁸ However, a data gap was identified for the availability and assessment in the RAR of two pelargonic acid studies referred to in support of the read‐across approach used to address the potential impact of caprylic acid on water treatment processes, as these studies were not included, reported or discussed in the RAR for caprylic acid (see Section 10).

The PEC in soil, surface water, sediment and groundwater covering the representative uses assessed can be found in Appendix B of this conclusion. A key to the wording used to describe the persistence and mobility of the compounds assessed can be found in Appendix C of this conclusion.

5. ECOTOXICOLOGY

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

Caprylic acid was discussed during the Pesticides Peer Review Experts' Teleconferences 167 (17–21 March 2025), 172 (22 May 2025) and 173 (19–21 and 23 May 2025).

All the available ecotoxicological data concern studies performed with a formulation, 11ELM‐AC‐3, similar to the representative formulation. At TC 167, the acceptability of using endpoints from different formulations of fatty acids for the assessment of caprylic acid and the representative formulation was discussed. ¹⁹ It was agreed that a read‐across from 11ELM‐AC‐3 to the representative formulation is acceptable.

For the risk assessment for caprylic acid, a read‐across from pelargonic acid (nonanoic acid) (EFSA, 2025) was considered scientifically justified due to their high structural and chemical similarity.

Acute and long‐term toxicity studies on birds with the active substance or the representative formulation were not available. For mammals, an acute toxicity study was available with the active substance. Long‐term studies on mammals were available with the formulation for representative uses. The acute and long‐term risk assessment for birds and mammals was discussed during the Pesticides Peer Review Experts' Teleconference 167 (March 2025). ²⁰ Considering (i) caprylic acid is included in the list of fatty acids (E570) authorised as food additives in the European Union (EU) in accordance with Annex II and Annex III to Regulation (EC) No 1333/2008, with no safety concern at the reported uses and use levels (EFSA, 2017), (ii) caprylic acid is readily biodegradable, reducing the likelihood of long‐term exposure to birds and mammals, (iii) birds and mammals are naturally exposed through their diet to a variety of fatty acids, to which capric acid is very structurally and chemically similar, (iv) avian feeding studies showed no adverse effects on health and reproductive performance, (v) the amount of caprylic acid ingested by birds and mammals due to the proposed intended uses as plant protection product is expected to be a small fraction of their natural diet, a low acute and long‐term risk to birds and wild mammals was concluded for all representative uses based on a qualitative weight‐of‐evidence (WoE) approach.

For aquatic organisms, acute and long‐term toxicity studies were available. The selection of the endpoints, the use of data on pelargonic acid for the assessment of caprylic acid and the approach to the risk assessment were discussed at the Pesticides Peer Review Experts' Teleconference 172 and 173 (May 2025). ²¹

For fish, acute toxicity studies were available with a comparable formulation, 11ELM‐AC‐3, while one long‐term toxicity study was available with pelargonic acid. For aquatic invertebrates, one acute toxicity study is available with the formulation 11ELM‐AC‐3, while long‐term data were only available with pelargonic acid. For algae and macrophytes, toxicity data were available with the formulation 11ELM‐AC‐3. The available aquatic risk assessment indicated for caprylic acid a low acute and chronic risk to fish, aquatic invertebrates, algae and higher plants from caprylic acid for all intended uses, when using a buffer zone of 20 m (for applications up to 45.12 kg a.s./ha per treatment) or 15 m (for applications up to 29.89 kg a.s./ha).

No metabolite requiring further assessment in the aquatic compartment was identified.

For honey bees, no study was available with the active substance. Acute oral and contact, and adult chronic toxicity studies are available with the formulation 11ELM‐AC‐3. A risk assessment according to SANCO guidance document (European Commission, 2002) was available, based on which low acute risk from oral and contact exposure to honey bees was concluded for all representative uses. A risk assessment following EFSA guidance document (2013) was available, and a low risk was concluded for adjacent crop, plants in the field margin, and succeeding crops scenarios. A high risk to honey bees was identified at tier‐I from exposure to weeds in the treated field. The risk assessment for honey bees was discussed by the experts ²² and further reflected by EFSA. ²³ Caprylic acid is intended to be used as a non‐selective herbicide in non‐agricultural areas (e.g. parks, pavements, public gardens, industrial sites and for moss/soil treatment around ornamental trees). These uses are not fully represented in the exposure scenarios described in EFSA guidance document for bees (2013). A problem formulation re‐evaluation was therefore conducted to determine which exposure scenarios are relevant for the risk assessment. Based on the intended uses and environmental fate characteristics of caprylic acid, only the treated crop and adject vegetation scenario were considered relevant by EFSA for the risk assessment of bees. A quantitative assessment for these scenarios is available. For the chronic risk assessment, considering the intended uses, the nature of the substance and DT50, chronic exposure is not expected. A low risk to honey bees can be concluded for all intended uses.

The toxicity to non‐target arthropods other than bees was investigated using the formulation 11ELM‐AC‐3. Specifically, tier‐I data on the two indicator species, Typhlodromus pyri and Aphidius rhopalosiphi, were available. Extended laboratory tests were available for Aphidius rhopalosiphi (one aged‐residues study) and Chrysoperla carnea (one aged‐residues study and one fresh leaves, 2‐D study).

The tier‐I risk assessment indicated high in‐ and off‐field risk for all relevant species, without using mitigation measures. The refined risk assessment was discussed at the Pesticides Peer Review Experts' Teleconference 167 (March 2025). ²⁴ It was agreed that considering the available information from the aged‐residues study with A. rhopalosiphi, the rapid degradation in soil limiting exposure for soil‐dwelling organisms (DT50 < 2 days), and the quick non‐selective burn‐down effect which would limit the need for repeated applications on the same spot in quick succession, a low in‐field risk could be concluded. Regarding the off‐field risk assessment, a low off‐field risk is concluded if mitigation measures equivalent to 5 m are used.

Toxicity data for earthworms, other soil macro‐organisms and soil microorganisms were not available for the active substance. Data for earthworms and soil microorganisms were available for the representative formulation. The endpoint for the risk assessment of earthworms was discussed by the experts. ²⁵ The available risk assessment indicated a low risk for earthworms, soil macro‐organisms and soil microorganisms.

For the assessment of non‐target terrestrial plants, suitable toxicity data investigating the effects of exposure to the formulation 11ELM‐AC‐3 on seedling emergence and vegetation and vigour were available. The selection of the endpoints was discussed by the experts. ²⁶ Based on the available data and risk assessment, a low risk to non‐target terrestrial plants was concluded for all representative uses.

A low risk to organisms involved in sewage treatment processes was concluded for the representative uses as exposure of sewage treatment plants is unlikely.

6. ENDOCRINE DISRUPTION PROPERTIES

The endocrine‐disrupting properties (ED) of caprylic acid for human and non‐target organisms were discussed in the Peer Review Experts Meeting TC 172 (March 2025). ²⁷

With regard to the assessment of the endocrine disruption potential of fatty acids – caprylic acid for humans and non‐target organisms (NTOs) according to the ECHA/EFSA guidance (2018), the oestrogen, androgen, steroidogenesis and thyroid (EATS)‐mediated adversity/activity were not sufficiently investigated. ²⁸ The submission of further (eco)toxicological data was considered as not scientifically necessary based on the following: (i) fatty acids are ubiquitous in the environment, (ii) there is a lack of toxicological concern based on both the available data with surrogate substances (e.g. fatty acids – pelargonic acid (EFSA, 2025)) and on the knowledge on the toxicological properties of fatty acids, (iii) caprylic acid is included in the list of fatty acids (E570) authorised as food additives in the European Union (EU) in accordance with Annex II and Annex III to Regulation (EC) No 1333/2008, with no safety concern at the reported uses and use levels (EFSA ANS Panel, 2017). In addition, there is negative evidence of EATS‐mediated activity in ToxCast, also supported by the negative outcome from the in silico quantitative structure–activity relationship (QSAR) applications. Overall, when considering all the available evidence, it was considered unlikely that fatty acids – caprylic acid have endocrine‐disrupting properties for both humans and non‐target organisms.

Considering the above, it can be concluded that fatty acid – caprylic acid does not meet the criteria for endocrine disruption for humans and non‐target organisms according to points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605. ²⁹

7. OVERVIEW OF THE RISK ASSESSMENT OF COMPOUNDS 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
Caprylic acid	Low risk to soil macro‐ and microorganisms

TABLE 2.

Groundwater. ^a

Compound (name and/or code)	> 0.1 μg/L at 1 m depth for the representative uses b Step 2	Biological (pesticidal) activity/relevance Step 3a	Hazard identified Steps 3b and 3c	Consumer RA triggered Steps 4 and 5	Human health relevance
Caprylic acid	No, for soils with pH ≤ 6.2 for all the representative uses For soils with pH > 6.2: Uses #1, #2, #3, #4, #5, #6, #7 and #8: > 0.1 μg/L in more than half of the relevant FOCUS groundwater scenarios (depending on the representative application pattern); concentrations > 10 μg/L predicted for uses #1, #2, #3, #4, #7 and for ornamental tress uses #5, and #8. Use #9: > 0.1 μg/L in 4/9 FOCUS groundwater scenarios (max. 1.66 μg/L in Kremsmünster scenario with FOCUS PELMO).	Yes	–	–	Yes

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

^b FOCUS scenarios or relevant lysimeter. Ranges indicated for FOCUS scenarios include the result from the model giving the highest concentration at each scenario, as needed to comply with European Commission (2014a) guidance.

TABLE 3.

Surface water and sediment.

Compound (name and/or code)	Ecotoxicology
Caprylic acid	Low risk to aquatic organisms

TABLE 4.

Air.

Compound (name and/or code)	Toxicology
Caprylic acid	LC50 > 5 mg/L

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

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

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

8.1. Particular conditions proposed for the representative uses evaluated (Table 5)

TABLE 5.

Risk mitigation measures proposed for the representative uses assessed.

Representative use	Weeds around ornamentals and public and industrial areas	Moss treatment
Risk to aquatic organisms	Buffer zone of 20 meters (for applications up to 45.12 kg a.s./ha per treatment)	Buffer zone of 15 meters (for applications up to 29.89 kg a.s./ha)
Risk to non‐target arthropods other than bees	Mitigation measures equivalent to 5 meters

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, ³⁰ and if the issue is of such importance that it could, when finalised, become a concern (which would also be listed as a critical area of concern if it is of relevance to all representative uses).

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

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

No issues or assessments that could not be finalised have been identified.

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 area of concern was 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		Foliar spraying
		Weeds around ornamentals and public and industrial areas	Moss treatment
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
Risk to wild non‐target terrestrial organisms other than vertebrates	Risk identified
	Assessment not finalised
Risk to aquatic organisms	Risk identified
	Assessment not finalised
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 Based on classification made in the context of this evaluation procedure under Regulation (EC) No 1107/2009. It should be noted that harmonised classification and labelling is formally proposed and decided in accordance with Regulation (EC) No 1272/2008.

^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:

• For one component of the formulation for representative uses ‘DESHERB'NAT’, long‐term repeated dose toxicity information was not available; therefore, in order to allow a final conclusion on the safety assessment of ‘DESHERB'NAT’, repeated dose toxicity data for this component (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’).

• Proper review of the scientific peer‐reviewed open literature on the active substance and its relevant metabolites, dealing with side effects on health and published within the 10 years before the date of submission of the dossier, to be conducted and reported in accordance with EFSA guidance on the submission of scientific peer‐reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009 (EFSA, 2011) (see Section ‘General aspects’).

• Batch data to demonstrate compliance with the proposed lead, arsenic, mercury and cadmium specification levels and for their respective validated analytical methods with a sufficient low LOQs, i.e. at least 20% lower than the corresponding proposed specification levels (relevant for all uses, see Section 1).

• For one of the active substance manufacturing sources, GLP batch analysis data of at least five representative batches, analysed using validated analytical methods for the content of the active substance and impurities were not provided (relevant for all uses, see Section 1).

• For one of the active substance manufacturing sources, additional quality control data to support the representativeness of the batches analysed and for batch data on the content of cadmium were not provided (relevant for all uses, see Section 1).

• Validated methods were not available for the analysis of impurities in one manufacturing source (relevant for all uses, see Section 1).

• Validated methods were not provided for the determination of the relevant impurities arsenic, lead, mercury and cadmium in the formulation for the representative uses (relevant for all uses, see Section 1).

• Validated analytical methods for monitoring caprylic acid (octanoic acid) in soils and surface water (relevant for all uses, see Section 1).

• Information on the natural background concentrations of caprylic acid in water and sediment in EU surface water bodies, as well as an assessment of the impact of residues resulting from the representative uses of the PPPs on these background levels, was not available (relevant for all representative uses evaluated; see Section 4).

• Availability and assessment in the RAR of two pelargonic acid studies referred to in support of the read‐across approach used to address the potential impact of caprylic acid on water treatment processes (relevant for all representative uses evaluated; see Section 4).

• Information on the proportion of the treated area for each non‐agricultural representative use involving localised (non‐uniform) applications was not available (relevant for all representative uses evaluated; see Section 4).

ABBREVIATIONS

ε

decadic molar extinction coefficient

1/n

slope of Freundlich isotherm

ADE

actual dermal exposure

ADI

acceptable daily intake

AMA

Amphibian Metamorphosis Assay

a.s.

active substance

AST

aspartate aminotransferase (SGOT)

AV

avoidance factor

BUN

blood urea nitrogen

bw

body weight

CAS

Chemical Abstracts Service

DAR

draft assessment report

DAT

days after treatment

DT₅₀

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

DT₉₀

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

dw

dry weight

ECHA

European Chemicals Agency

EEC

European Economic Community

FAO

Food and Agriculture Organization of the United Nations

FID

flame ionisation detector

FIR

food intake rate

FOB

functional observation battery

FOCUS

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

GAP

Good Agricultural Practice

GC

gas chromatography

GM

geometric mean

HQ

hazard quotient

HR

hazard rate

ISO

International Organization for Standardization

iv

intravenous

LOQ

limit of quantification

M/L

mixing and loading

MCV

mean corpuscular volume

mm

millimetre (also used for mean measured concentrations)

mN

milli‐newton

MOA

mode of action

MOE

Margin of exposure

MS

mass spectrometry

NOEL

no observed effect level

NPD

nitrogen–phosphorus detector

OECD

Organisation for Economic Co‐operation and Development

OM

organic matter content

Pa

pascal

PEC

predicted environmental concentration

PEC_air

predicted environmental concentration in air

PEC_gw

predicted environmental concentration in groundwater

PEC_sed

predicted environmental concentration in sediment

PEC_soi

predicted environmental concentration in soil

PEC_sw

predicted environmental concentration in surface water

pF2

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

PIE

potential inhalation exposure

pK_a

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

P_ow

partition coefficient between n‐octanol and water

PPE

personal protective equipment

ppm

parts per million (10⁻⁶)

PT

proportion of diet obtained in the treated area

PTT

partial thromboplastin time

QSAR

quantitative structure–activity relationship

r ²

coefficient of determination

RAR

Renewal Assessment Report

RBC

red blood cells

REACH

Registration, Evaluation, Authorisation of Chemicals Regulation

SC

suspension concentrate

SD

standard deviation

SFO

single first‐order

SMILES

simplified molecular‐input line‐entry system

t_1/2

half‐life (define method of estimation)

TK

technical concentrate

TWA

time‐weighted average

UV

ultraviolet

W/S

water/sediment

WBC

white blood cell

WHO

World Health Organization

λ

Wavelength

AUTHOR CONTRIBUTIONS

Under Regulation 178/2002, the Scientific Panel is the author of the scientific output. Contributions include: Working Groups who provide the draft assessment which is reviewed and adopted by the Panel; EFSA staff members who provide scientific support including inter alia data collection and analysis and literature searching; and other contributors such as staff of national food safety agencies, EFSA trainees and interim staff members who have contributed meaningfully to the work.

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2020‐00165

COPYRIGHT FOR NON‐EFSA CONTENT

EFSA may include images or other content for which it does not hold copyright. In such cases, EFSA indicates the copyright holder and users should seek permission to reproduce the content from the original source.

NOTE/UPDATE

This scientific output, approved on 29 September 2026, supersedes the previous output published on 07 January 2013 (EFSA, 2013).

Supporting information

APPENDIX B List of end points for the active substance and the formulations for representative uses

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

Properties		Conclusion
CMR	Carcinogenicity (C)	Caprylic acid is not considered to be a carcinogen (category 1A or 1B) according to point 3.6.3 of Annex II of Regulation (EC) No 1107/2009, based on: Harmonised classification according to Regulation (EC) No 1272/2008 and its Adaptations to Technical Process [Table 3.1 of Annex VI of Regulation (EC) No 1272/2008 as amended]: ATP07, no classification for carcinogenicity
	Mutagenicity (M)	Caprylic acid is not considered to be a mutagen according to point 3.6.2 of Annex II of Regulation (EC) No 1107/2009, based on: Harmonised classification according to Regulation (EC) No 1272/2008 and its Adaptations to Technical Process [Table 3.1 of Annex VI of Regulation (EC) No 1272/2008 as amended]: ATP07, no classification for mutagenicity
	Toxic for Reproduction (R)	Caprylic acid is not considered to be toxic for reproduction according to point 3.6.4 of Annex II of Regulation (EC) No 1107/2009, based on: Harmonised classification according to Regulation (EC) No 1272/2008 and its Adaptations to Technical Process [Table 3.1 of Annex VI of Regulation (EC) No 1272/2008 as amended]: ATP07 no classification for reproductive toxicity
Endocrine disrupting properties		Caprylic acid is not considered to meet the criteria for endocrine disruption for human health and non‐target organisms according to points 3.6.5 and 3.8.2 of Annex II of Regulation No 1107/2009, as amended by Commission Regulation (EU) 2018/605.
POP	Persistence	Caprylic acid is not considered to be a persistent organic pollutant (POP) according to point 3.7.1 of Annex II of Regulation (EC) 1107/2009.
	Bioaccumulation
	Long‐range transport
PBT	Persistence	Caprylic acid is not considered to be a persistent, bioaccumulative and toxic (PBT) substance according to point 3.7.2 of Annex II of Regulation (EC) 1107/2009.
	Bioaccumulation
	Toxicity
vPvB	Persistence	Caprylic acid is not considered to be a very persistent, very bioaccumulative substance according to point 3.7.3 of Annex II of Regulation (EC) 1107/2009.
	Bioaccumulation

APPENDIX B. List of end points for the active substance and the formulations for representative uses

Appendix B can be found in the online version of this output (‘Supporting information’ section): https://doi.org/10.2903/j.efsa.2026.10381.

APPENDIX C. Clarification of the wording used in Sections 4 and 5

Wording EFSA used in section  4 of this conclusion, in relation to DT and K _oc ‘classes’ exhibited by each compound assessed

Wording	DT50 normalised to 20°C for laboratory incubations 31 or not normalised DT50 for field studies (SFO equivalent, when biphasic, the DT90 was divided by 3.32 to estimate the DT50 when deciding on the wording to use)
Very low persistence	< 1 day
Low persistence	1 to < 10 days
Moderate persistence	10 to < 60 days
Medium persistence	60 to < 100 days
High persistence	100 days to < 1 year
Very high persistence	A year or more

Note: These classes and descriptions are unrelated to any persistence class associated with the active substance cut‐off criteria in Annex II of Regulation (EC) No 1107/2009. For consideration made in relation to Annex II, see Appendix A.

Wording	Koc (either KFoc or Kdoc) mL/g
Very high mobility	0–50
High mobility	51–150
Medium mobility	151–500
Low mobility	501–2000
Slight mobility	2001–5000
Immobile	> 5000

Note: Based on McCall et al. (1980).

Wording used in Section 5 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.

APPENDIX D. Used compound codes

Code/trivial name a	IUPAC name/SMILES notation/InChiKey b	Structural formula c
Caprylic acid	octanoic acid O=C(O)CCCCCCC WWZKQHOCKIZLMA‐UHFFFAOYSA‐N
Pelargonic acid	nonanoic acid O=C(O)CCCCCCCC FBUKVWPVBMHYJY‐UHFFFAOYSA‐N
Capric acid	decanoic acid OC(=O)CCCCCCCCC GHVNFZFCNZKVNT‐UHFFFAOYSA‐N

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

^b ACD/Name 2024.2.3, ACD/Labs 2024.2.3 (File Version N25E41, Build 142837, 21 January 2025).

^c ACD/ChemSketch 2024.2.3, ACD/Labs 2024.2.3 (File Version C45H41, Build 142855, 22 January 2025).

EFSA (European Food Safety Authority) , Álvarez, F. , Arena, M. , Auteri, D. , Leite, S. B. , Binaglia, M. , Castoldi, A. F. , Capilla, T. C. , Chiusolo, A. , Colagiorgi, A. , Colas, M. , Crivellente, F. , De Lentdecker, C. , De Magistris, I. , Fabrega, J. , Fait, G. , Ferilli, F. , Santonja, G. G. , Gouliarmou, V. , … Becirovic, A. (2026). Peer review of the pesticide risk assessment of the active substance caprylic acid. EFSA Journal, 24(11), e10381. 10.2903/j.efsa.2026.10381