In a Nutshell
Application milestonesRoadmap for preparing an Application Authorisation
- Three suggested principles
- Strategy for defining and defending the uses applied for
- Major steps in the preparation of the Application
- Indicative timeline in the preparation of the Application
- Chemical Safety Report
- Analysis of Alternatives
- Substitution Plan
- Socio-Economic Analysis
- Administrative information
- Public Consultation on Alternatives
- RAC and SEAC opinion
- EU Commission Decision
- The Authorisation is granted: what now?
Roadmap for preparing an application for Authorisation
► Three suggested principles:
Strategy based on clear, circumscribed assessment steps
- Avoid faulty scope and lack of focus. Application dossiers that are too comprehensive and potentially confusing may affect their acceptance by the relevant ECHA committees
- Ensure best quality within the available limited time
- Be aware of the potential societal bias against the substance under scrutiny
- Remember - the dossier and key arguments (e.g. alternatives) will be considered critically by an array of reviewers and third parties. These include NGOs and competitors with a clear agenda to phase out the substance in question
- Consider third party involvement to increase credibility and quality of the dossier
3. Independence of key assessments
- Set up a process to provide a balanced opinion on the critical steps of the Application for Authorisation such as the Analysis of Alternatives, the SEA and all hazard assessments (of substance and potential alternatives)
Do first make sure you and your partners
- 1. Have the right focus for the assessment steps and scope
- 2. Aim at highest possible credibility
- 3. Consider how to ensure independence of key assessments.
Do not overestimate the time ECHA Committee rapporteurs and members will have to gauge the quality of your arguments.
Do not underestimate the capacity of third parties to harm your dossier.