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REACH Authorisation
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Authorisation

Application for Authorisation submitted: the examination and opinion-making process

► Trialogue

The basis for the opinion development in RAC and SEAC is the documentation provided by the applicant as part of the Application for Authorisation process. On top of the application itself, the rules on Authorisation have established that applicants for Authorisation may contribute to the Authorisation process through their responses to Committees’ requests for additional information, through the Rapporteurs and through their ability to comment on the draft opinions.

ECHA and the Member States have since identified the need for additional discussions, on for example alternatives that were presented during the Public Consultation. They have set up an an application ‘Trialogue’ between the applicant and the RAC and SEAC rapporteurs in the opinion-making procedure. The Trialogue allows rapporteurs to discuss with applicants any information on alternatives generated through public consultation or any other technical or scientific issues with the application.

Rapporteurs may also invite to the Trialogue those third parties who submitted information to the Public Consultation that is of particular interest and relevance to the application. Stakeholder observers of RAC and SEAC will be invited to attend the Trialogue to provide scrutiny and transparency, although applicants and third parties will have the opportunity to argue that information to be discussed is confidential and that observers should be excluded from any parts of the meeting when that information might be discussed.

Do prepare for the Trialogue well in advance of the submission of the Application for Authorisation. It will be important, to be prepared to respond to any third party suggestions related to alternatives.

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