If an active substance contained in a plant protection product has been designated a Candidate for Substitution, a “comparative assessment” will be required for product authorisation.
The European Commission has created a list of Candidates for Substitution – active substances that are approved under the plant protection products regulation (Regulation (EC) No. 1107/2009) but whose properties nevertheless indicate a relatively high risk for human health or the environment. The aim is to substitute these substances, where possible, with products containing lower-risk substances or with non-chemical control methods. The regulation requires that Member States must perform comparative assessment to identify alternative products and that such assessments should be performed at the latest at renewal or amendment of the product authorisation.
The list of Candidates for Substitution is available here.
Comparative assessment is conducted at the national rather than the zonal level. Member States ask registration holders to provide information on the uses of their product and the available alternative products, summarised using a template. The information provided must address non-chemical alternatives, the adequacy of chemical diversity to minimise the occurrence of resistance, the impact of substitution on the product’s minor uses, the economic and practical disadvantages of alternative controls, and the safety of alternative controls. Experience has shown that the key information is often the product’s minor uses and the available chemical diversity. The Member State authority then completes the comparative assessment and determines whether substitution would be appropriate.
If your plant protection product contains one of these active substances, you will need to conduct a comparative assessment for renewal or amendment (label extension to include additional uses) of your authorisation. The team at Kerona Scientific can help; contact us via firstname.lastname@example.org or +353 (0)1 849 5284.