The term placing on the market is defined in the Directive as ‘making available to third parties whether in return for payment or free of charge’
Where European Union (EU) wide marketing approval is being sought for Genetically Modified (GM) products, the Competent Authorities of all Member States must be consulted. An application for the proposed placing on the market of GM products may be submitted to any one of the 25 Member States. The Competent Authority in receipt of the application becomes the evaluating or lead Competent Authority and will assess the application initially and forward a copy of the application and its assessment report to the EU Commission. The EU Commission in turn will forward the application and assessment report to the Competent Authorities of the other Member States.
Therefore there are two procedures for handling a Part C application
1. In the first instance the application is submitted to the Environmental Protection Agency (EPA) or Irish Competent Authority. The EPA assesses the application and forwards the application and assessment report to the EU Commission i.e. where the EPA is the evaluating Competent Authority.
The following flow chart provides an overview of the procedure involved where an application for a Part C Deliberate Release is submitted to the EPA and the EPA acts as the evaluating Competent Authority.
Part C Deliberate Release flow chart and timeframes
2. In the second instance the application is submitted to another Member State who carries out the initial assessment and forwards the application and assessment report to the EU Commission. The EU Commission in turn forwards the application and assessment report to the other EU Member States including Ireland i.e. where the EPA is not the evaluating Competent Authority.
The following flow chart provides an overview of the procedure involved where an application for a Part C deliberate release is submitted to a Member State other than Ireland
To date Ireland has never acted in the capacity of evaluating or lead Competent Authority.
