- 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
► Strategy for defining and defending the uses applied for:
The purpose of the ‘Use(s) applied for’ is to define the scope of the Authorisation that is being requested.
Broadly speaking, there are two general strategies to prepare and submit an Application for Authorisation, either individually or collectively:
- Group several detailed uses for the substance requiring Authorisation in a general use descriptor covered by an existing exposure scenario (for example a broad category such as ‘functional plating’). The advantages of this approach are one dossier, reduced costs and application fees.
- Define specific uses within a generic use descriptor so that a more detailed Application for Authorisation can be prepared. For example: a specific surface treatment process within the broad category of functional plating which integrates key parameters such as specific functional requirements. However, consortia set up to prepare the Authorisation dossiers may not wish to cover unique uses, obliging the companies concerned to prepare their own application.
- Identified use: the use developed by the substance registrants in the Registration dossier
- Use applied for: the use developed by the applicants in the Application for Authorisation and for which the Authorisation is granted
- Broad Information on Uses: is the definition of the ‘use applied for’ developed by ECHA after an application has been submitted. It is published on ECHA’s website for public consultation on alternatives
An application dossier that is broad may be too complex in scope and may lead to tensions between companies. Although uses may be similar, companies may have a different long-term vision, for example.
Although perhaps more expensive, a more specific dossier may be necessary when there are risks of dissent within the supply chain or with competitors. It may offer the advantage of discouraging generic inputs on alternatives. Public consultations and SEAC/RAC reviews can be more targeted.
Hint: draft “Broad Information on Uses” as you would like ECHA to publish them and measure the risks of the different options.