{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T03:58:29Z","timestamp":1787025509234,"version":"build-2736575974"},"reference-count":31,"publisher":"Wiley","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["EFS2","EFSA Journal"],"published-print":{"date-parts":[[2024,4]]},"abstract":"<jats:p>Abstract The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Malta, for the pesticide active substance clove oil are reported. The context of the peer review was that required by Regulation (EC) No 1107\/2009 of the European Parliament and of the Council. The conclusions for the amendment of approval were reached on the basis of the evaluation of the representative use of clove oil as a preharvest nematicide on tomatoes and cucumbers (permanent greenhouse use). The representative use evaluated for the renewal of approval of clove oil was as post\u2010harvest fungicide and bactericide on apples, pears and peaches (indoor uses). The reliable endpoints appropriate for use in regulatory risk assessment are presented. Endpoints not relevant to the scope of the proposed amendment of approval conditions will be addressed in the context of the renewal of approval procedure of clove oil running in parallel (AIR IV, EFSA Q\u20102016\u201000809). Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.<\/jats:p>","DOI":"10.2903\/j.efsa.2024.8671","type":"journal-article","created":{"date-parts":[[2024,4,5]],"date-time":"2024-04-05T05:09:41Z","timestamp":1712293781000},"source":"Crossref","is-referenced-by-count":2,"title":["Peer review of the pesticide risk assessment of the active substance clove oil"],"prefix":"10.2903","volume":"22","author":[{"name":"European Food Safety Authority (EFSA)","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fernando","family":"\u00c1lvarez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Arena","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Domenica","family":"Auteri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sofia Batista","family":"Leite","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Binaglia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna Federica","family":"Castoldi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arianna","family":"Chiusolo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angelo","family":"Colagiorgi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mathilde","family":"Colas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federica","family":"Crivellente","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chloe","family":"De\u00a0Lentdecker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabella","family":"De\u00a0Magistris","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Egsmose","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriella","family":"Fait","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Franco","family":"Ferilli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Varvara","family":"Gouliarmou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katrin","family":"Halling","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laia Herrero","family":"Nogareda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessio","family":"Ippolito","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frederique","family":"Istace","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samira","family":"Jarrah","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dimitra","family":"Kardassi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aude","family":"Kienzler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Lanzoni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto","family":"Lava","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renata","family":"Leuschner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alberto","family":"Linguadoca","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jochem","family":"Louisse","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Lythgo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oriol","family":"Magrans","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iris","family":"Mangas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Mio\u010d","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ileana","family":"Miron","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tunde","family":"Molnar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Padovani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincenzo","family":"Padricello","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martina","family":"Panzarea","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan Manuel","family":"Parra\u00a0Morte","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simone","family":"Rizzuto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anamarija","family":"Romac","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Agn\u00e8s","family":"Rortais","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miguel","family":"Santos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rositsa","family":"Serafimova","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rachel","family":"Sharp","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Csaba","family":"Szentes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Terron","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne","family":"Theobald","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manuela","family":"Tiramani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giorgia","family":"Vianello","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Villamar\u2010Bouza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","reference":[{"key":"10.2903\/j.efsa.2024.8671_ref1","doi-asserted-by":"crossref","unstructured":"EFSA (European Food Safety Authority) . (2008). Opinion on a request from EFSA related to the default Q10 value used to describe the temperature effect on transformation rates of pesticides in soil. EFSA Journal, 6(1), 622. https:\/\/doi.org\/10.2903\/j.efsa.2008.622","DOI":"10.2903\/j.efsa.2008.622"},{"key":"10.2903\/j.efsa.2024.8671_ref2","doi-asserted-by":"crossref","unstructured":"EFSA (European Food Safety Authority) . (2009). Guidance on risk assessment for birds and mammals on request from EFSA. EFSA Journal, 7(12), 1438. https:\/\/doi.org\/10.2903\/j.efsa.2009.1438","DOI":"10.2903\/j.efsa.2009.1438"},{"key":"10.2903\/j.efsa.2024.8671_ref3","doi-asserted-by":"crossref","unstructured":"EFSA (European Food Safety Authority) . (2011). Submission of scientific peer\u2010reviewed open literature for the approval of pesticide active substances under regulation (EC) No 1107\/2009. EFSA Journal, 9(2), 2092. https:\/\/doi.org\/10.2903\/j.efsa.2011.2092","DOI":"10.2903\/j.efsa.2011.2092"},{"key":"10.2903\/j.efsa.2024.8671_ref4","doi-asserted-by":"crossref","unstructured":"EFSA (European Food Safety Authority) . (2012a). Conclusion on the peer review of the pesticide risk assessment of the active substance clove oil. EFSA Journal, 10(1), 2506. https:\/\/doi.org\/10.2903\/j.efsa.2012.2506","DOI":"10.2903\/j.efsa.2012.2506"},{"key":"10.2903\/j.efsa.2024.8671_ref5","doi-asserted-by":"crossref","unstructured":"EFSA (European Food Safety Authority) . (2012b). Conclusion on the peer review of the pesticide risk assessment of the active substance eugenol. EFSA Journal, 10(11), 2914. https:\/\/doi.org\/10.2903\/j.efsa.2012.2914","DOI":"10.2903\/j.efsa.2012.2914"},{"key":"10.2903\/j.efsa.2024.8671_ref6","doi-asserted-by":"crossref","unstructured":"EFSA (European Food Safety Authority) . (2013). EFSA guidance document on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees). EFSA Journal, 11(7), 3295. https:\/\/doi.org\/10.2903\/j.efsa.2013.3295","DOI":"10.2903\/j.efsa.2013.3295"},{"key":"10.2903\/j.efsa.2024.8671_ref7","doi-asserted-by":"crossref","unstructured":"EFSA (European Food Safety Authority) . (2014a). Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products. EFSA Journal, 12(10), 3874. https:\/\/doi.org\/10.2903\/j.efsa.2014.3874","DOI":"10.2903\/j.efsa.2014.3874"},{"key":"10.2903\/j.efsa.2024.8671_ref8","doi-asserted-by":"crossref","unstructured":"EFSA (European Food Safety Authority) . (2014b). Guidance document on clustering and ranking of emissions of active substances of plant protection products and transformation products of these active substances from protected crops (greenhouses and crops grown under cover) to relevant environmental compartments. EFSA Journal, 12(3), 3615. https:\/\/doi.org\/10.2903\/j.efsa.2014.3615","DOI":"10.2903\/j.efsa.2014.3615"},{"key":"10.2903\/j.efsa.2024.8671_ref9","unstructured":"EFSA (European Food Safety Authority) . (2015). Technical report on the outcome of the pesticides peer review meeting on general recurring issues in ecotoxicology. EFSA Supporting Publication, 2015:EN\u2010924. 62 pp. https:\/\/doi.org\/10.2903\/j.efsa.2015.EN\u2010924"},{"key":"10.2903\/j.efsa.2024.8671_ref10","unstructured":"EFSA (European Food Safety Authority) . (2017a). Technical report on the outcome of the consultation with member states, the applicant and EFSA on the pesticide risk assessment for clove oil in light of confirmatory data. EFSA Supporting Publication, 2017:EN\u20101193. 24 pp. https:\/\/doi.org\/10.2903\/sp.efsa.2017.EN\u20101193"},{"key":"10.2903\/j.efsa.2024.8671_ref11","doi-asserted-by":"crossref","unstructured":"EFSA (European Food Safety Authority) , Buist, H., Craig, P., Dewhurst, I., HougaardBennekou, S., Kneuer, C., Machera, K., Pieper, C., Court Marques, D., Guillot, G., Ruffo, F., & Chiusolo, A. (2017b). Guidance on dermal absorption. EFSA Journal, 15(6), 4873. https:\/\/doi.org\/10.2903\/sp.efsa.2017.4873","DOI":"10.2903\/j.efsa.2017.4873"},{"key":"10.2903\/j.efsa.2024.8671_ref12","unstructured":"EFSA (European Food Safety Authority) . (2024). Peer review report to the conclusion regarding the peer review of the pesticide risk assessment of the active substance clove oil. www.efsa.europa.eu"},{"key":"10.2903\/j.efsa.2024.8671_ref13","doi-asserted-by":"crossref","unstructured":"EFSA PPR Panel (EFSA Panel on Plant Protection Products and their Residues) . (2013). Guidance on tiered risk assessment for plant protection products for aquatic organisms in edge\u2010of\u2010field surface waters. EFSA Journal, 11(7), 3290. https:\/\/doi.org\/10.2903\/j.efsa.2013.3290","DOI":"10.2903\/j.efsa.2013.3290"},{"key":"10.2903\/j.efsa.2024.8671_ref14","unstructured":"European Commission . (2000). Residues: guidance for generating and reporting methods of analysis in support of pre\u2010registration data requirements for Annex II (Part A, Section\u00a04) and Annex III (Part A, Section\u00a05) of Directive 91\/414. SANCO\/3029\/99\u2010rev. 4, 11 July 2000."},{"key":"10.2903\/j.efsa.2024.8671_ref15","unstructured":"European Commission . (2002). Guidance Document on Terrestrial Ecotoxicology Under Council Directive 91\/414\/EEC. SANCO\/10329\/2002\u2010rev. 2 final, 17 October 2002."},{"key":"10.2903\/j.efsa.2024.8671_ref16","unstructured":"European Commission . (2003). Guidance Document on Assessment of the Relevance of Metabolites in Groundwater of Substances Regulated under Council Directive 91\/414\/EEC. SANCO\/221\/2000\u2010rev. 10 final, 25 February 2003."},{"key":"10.2903\/j.efsa.2024.8671_ref17","unstructured":"European Commission . (2010). Guidance document on residue analytical methods. SANCO\/825\/00\u2010rev. 8.1, 16 November 2010."},{"key":"10.2903\/j.efsa.2024.8671_ref18","unstructured":"European Commission . (2011). Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs. SANCO 7525\/VI\/95\u2010rev. 9. March 2011. pp. 1\u201346."},{"key":"10.2903\/j.efsa.2024.8671_ref19","unstructured":"European Commission . (2013). Guidance document on data requirements on efficacy for the dossier to be submitted for the approval of new active substances contained in plant protection products. SANCO\/10054\/2013\u2010rev. 3, 11 July 2013."},{"key":"10.2903\/j.efsa.2024.8671_ref20","unstructured":"European Commission . (2014). Assessing potential for movement of active substances and their metabolites to ground water in the EU. Report of the FOCUS Workgroup. EC Document Reference SANCO\/13144\/2010\u2010v. 3, 613 pp., as outlined in Generic guidance for tier 1 FOCUS groundwater assessment, v. 2.2, May 2014."},{"key":"10.2903\/j.efsa.2024.8671_ref21","unstructured":"European Commission . (2015). Guidance document on criteria for the inclusion of active substances into Annex IV of Regulation (EC) No. 396\/2005. SANCO\/11188\/2013, rev. 2, 14 September 2015."},{"key":"10.2903\/j.efsa.2024.8671_ref22","unstructured":"FOCUS (Forum for the Co\u2010ordination of Pesticide Fate Models and their Use) . (2001). FOCUS surface water scenarios in the EU evaluation process under 91\/414\/EEC. Report of the FOCUS Working Group on Surface Water Scenarios. EC Document Reference SANCO\/4802\/2001\u2010rev. 2, 245 pp., as updated by Generic guidance for FOCUS surface water scenarios, v. 1.4, May 2015."},{"key":"10.2903\/j.efsa.2024.8671_ref23","unstructured":"FOCUS (Forum for the Co\u2010ordination of Pesticide Fate Models and their Use) . (2006). Guidance document on estimating persistence and degradation kinetics from environmental fate studies on pesticides in EU Registration Report of the FOCUS Work Group on Degradation Kinetics. EC Document Reference SANCO\/10058\/2005\u2010v. 2.0, 434 pp., as updated by the Generic guidance for Estimating Persistence and Degradation Kinetics from Environmental Fate Studies on Pesticides in EU Registration, v. 1.1."},{"key":"10.2903\/j.efsa.2024.8671_ref24","unstructured":"JMPR (Joint Meeting on Pesticide Residues) . (2004). Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group on Pesticide Residues, Rome, Italy, 20\u201329 September 2004, 383 pp."},{"key":"10.2903\/j.efsa.2024.8671_ref25","unstructured":"JMPR (Joint Meeting on Pesticide Residues) . (2007). Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group on Pesticide Residues, Geneva, Switzerland, 18\u201327 September 2007, 164 pp."},{"key":"10.2903\/j.efsa.2024.8671_ref26","unstructured":"Malta . (2021). Draft Assessment Report (DAR) on the active substance clove oil prepared by the rapporteur Member State Malta, in the framework of Regulation (EC) No 1107\/2009, October 2021. www.efsa.europa.eu"},{"key":"10.2903\/j.efsa.2024.8671_ref27","unstructured":"Malta . (2023). Revised draft assessment report (DAR) on clove oil prepared by the rapporteur member state Malta in the framework of regulation (EC) No 1107\/2009, October 2023. www.efsa.europa.eu"},{"key":"10.2903\/j.efsa.2024.8671_ref28","unstructured":"McCall, P. J., Laskowski, D. A., Swann, R. L., & Dishburger, H. J. (1980). Measurements of sorption coefficients of organic chemicals and their use in environmental fate analysis. In: Test protocols for environmental fate and movement of toxicants. In: Proceedings of the 94th annual meeting of the American Association of Official Analytical Chemists (AOAC). October 21\u201322, Washington, DC. pp. 89\u2013109."},{"key":"10.2903\/j.efsa.2024.8671_ref29","unstructured":"OECD (Organisation for Economic Co\u2010operation and Development) . (2009). Guidance document on overview of residue chemistry studies. ENV\/JM\/MONO(2009)31, 28 July 2009."},{"key":"10.2903\/j.efsa.2024.8671_ref30","unstructured":"OECD (Organisation for Economic Co\u2010operation and Development) . (2011). OECD MRL calculator: Spreadsheet for single data set and spreadsheet for multiple data set, 2 march 2011. In: Pesticide Publications\/Publications on Pesticide Residues. www.oecd.org"},{"key":"10.2903\/j.efsa.2024.8671_ref31","unstructured":"SETAC (Society of Environmental Toxicology and Chemistry) , Candolfi, M. P., Barrett, K. L., Campbell, P. J., Forster, R., Grandy, N., Huet, M. C., Lewis, G., Oomen, P. A., Schmuck, R., & Vogt, H. (Eds.). (2001). Guidance document on regulatory testing and risk assessment procedures for plant protection products with non\u2010target arthropods. ESCORT 2 workshop."}],"container-title":["EFSA Journal"],"original-title":[],"link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.2903\/j.efsa.2024.8671","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/onlinelibrary.wiley.com\/wol1\/doi\/10.2903\/j.efsa.2024.8671\/fullpdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,20]],"date-time":"2026-05-20T15:30:50Z","timestamp":1779291050000},"score":1,"resource":{"primary":{"URL":"http:\/\/doi.wiley.com\/10.2903\/j.efsa.2024.8671"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,4]]},"references-count":31,"journal-issue":{"issue":"4"},"URL":"https:\/\/doi.org\/10.2903\/j.efsa.2024.8671","relation":{},"ISSN":["1831-4732","1831-4732"],"issn-type":[{"value":"1831-4732","type":"print"},{"value":"1831-4732","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,4]]}}}