- 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?
Application for Authorisation submitted: the examination and opinion-making process
► RAC and SEAC Opinion
Based on their assessment of the merits of the Application for Authorisation, RAC and SEAC will provide to the European Commission an opinion on whether or not the Authorisation should be granted for the use(s) applied for by the applicant.
Article 60 (8) of REACH states clearly that the duration of the time-limited review of any Authorisation shall be determined on a case-by-case basis. The length of the review period will be determined by the quality of the arguments and data presented by the applicant.
The normal length considered for the review should be seven years as this is considered long enough to take benefit from technical progress toward substitution and to carry out R&D in order to identify, refine and deploy technically and economically feasible alternatives. It is also considered that the review process (report and decision process) will take three years.
RAC and SEAC may agree on proposing a longer review period that may be twelve years to take into consideration long investment cycles in capital intensive industries, excessive costs of alternatives, proven history of unfruitful R&D, disproportionately high economic benefits compared to low remaining risks.
A shorter review period of four years for example may be considered when the Analysis of Alternatives did not convince that there are no suitable alternatives or when the impacts of the Authorisation or its refusal are unclear.