In response to a request from the European Commission, EFSA has developed a guidance document that provides the information necessary to perform the risk assessment of plant protection active substances that contain stereoisomers in its composition as active components or impurities.
The guidance should also be used for active substances that without containing any stereogenic element may generate transformation products or metabolites that do contain them. Current data requirements in the EU regulatory framework (Regulation (EC) No 1107/2009) already establish that the substance tested should match the technical specifications (including its isomeric composition) and that formation and effects of metabolites, degradation and transformation products should be investigated (which certainly includes the case when transformation products are stereoisomers). The guidance is to be used by pesticides applicants and Member States in the preparation of dossiers containing isomers and in the evaluation of such substances by the Member States and EFSA. The issue of the evaluation of substances containing stereoisomers has also attracted the attention of consumers organizations and general public. Therefore, it is appropriate to carry out a public consultation to collect the views of stakeholders and citizens and give them the opportunity to request clarifications.
Interested parties are invited to submit written comments by 20 May 2019. Please use the electronic template provided to submit comments and refer to the line and page numbers. In case you encounter technical issues while filling-in the public consultation form, please make sure you first clean the browser’s history or switch browser. To submit additional data to support your comments or files, there is an upload function available in the tool (maximum file size 1 MB). You can also contact the Pesticide Residues Unit’s functional mailbox email@example.com.
Please note that comments will not be considered if they:
• Are submitted after the closing date of the public consultation;
• Are not related to the contents of the document;
• Contain complaints against institutions, personal accusations, irrelevant or offensive statements or material;
• Are related to policy or risk management aspects, which are out of the scope of EFSA’s activity.
EFSA will assess all comments which are submitted in line with the criteria above. The comments will be further considered by the relevant EFSA Panel and taken into consideration if found to be relevant.
Persons or entities participating in the EFSA Public Consultation are responsible for ensuring that they hold all the rights necessary for their submissions and consequent publication by EFSA. Comments should inter alia be copyright cleared taking into account EFSA’s transparency policy and practise to publish all submissions. In case your submission reproduces third party content in the form of charts, graphs or images, please ensure that the required prior permissions of the right holder have been obtained.
Publication of contributions
All comments submitted will be published. Comments submitted by individuals in a personal capacity will be presented anonymously. Comments submitted formally on behalf of an organisation will appear with the name of the organisation.