Thymol is a new active substance for which in accordance with Article 6(2) of Council Directive 91/414/EEC the United Kingdom (hereinafter referred to as the ‘RMS’) received an application from Eden Research PLC for approval. Complying with Article 6(3) of Directive 91/414/EEC, the completeness of the dossier was checked by the RMS. The European Commission recognised in principle the completeness of the dossier by Commission Implementing Decision 2011/266/EU of 2 May 2011.
The RMS provided its initial evaluation of the dossier on thymol in the Draft Assessment Report (DAR), which was received by the EFSA on 30 June 2011. The peer review was initiated on 11 July 2011 by dispatching the DAR for consultation of the Member States and the applicant Eden Research PLC.
Following consideration of the comments received on the DAR, it was concluded that EFSA should conduct an expert consultation in the areas of mammalian toxicology and environmental fate and behaviour and EFSA should adopt a conclusion on whether thymol can be expected to meet the conditions provided for in Article 5 of Directive 91/414/EEC, in accordance with Article 8 of Commission Regulation (EU) No 188/2011.
The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of thymol as a fungicide on table and wine grapes, as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report.
In the area of identity, physical/chemical/technical properties and methods of analysis data gaps were identified for methods for soil, water and air and also for a relevant impurity in the formulation.
In the mammalian toxicology section, the data package was insufficient to set reference values and no background human exposure data (to naturally occurring thymol) were available (data gap). Therefore the operator, worker and bystander risk assessment could not be performed, and this was identified as a critical area of concern.
In the residue section a data gap was identified to provide additional storage stability data to cover the maximum storage time interval of the samples in the residue trials. The consumer risk assessment could not be conducted due to the lack of toxicological reference values for thymol, and this was identified as a critical area of concern.
No reliable data or information have been submitted on the route and rate of degradation of thymol in soil. Since thymol is readily biodegradable, and based on its chemical structure, the waiver for the route of degradation in soil was accepted. For the exposure assessment, it was accepted to use worst case defaults as proposed by REACH guidance. Since the groundwater exposure assessment, performed with default values, shows that the regulatory limit of 0.1 µg / L is exceeded in nine of the nine scenarios, data gaps have been identified for a study on the rate of degradation of thymol under aerobic conditions, and a batch soil adsorption/desorption study in four soils. On the basis of the available data, a critical area of concern has been identified for potential groundwater contamination by thymol.
A high risk was identified for aquatic organisms, leading to a critical area of concern. The risk assessment for birds and mammals could not be finalised on the basis of the available data, and data gaps were identified.