Q&As

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REACH

Authorisation

c) Format and content of authorisation

I consider that the substance that I will apply for has a threshold. What if RAC disagrees with my assessment?
RAC intends to develop "reference DNELs" and "reference dose response relationships" for substances that have been listed in Annex XIV. The intention is to make these available before the latest application date has expired (see Q&A 752).
 
If you disagree with RAC's view you can justify this in your application. RAC will evaluate this during the opinion making process.
 
If RAC has not made the "reference DNELs" or ""reference dose response relationships" available before the latest application date it will do so during the opinion making. In any case, you and RAC will need to clarify the possible scientific issues relating to the thresholdness of the substance during the opinion making process.
 
If a threshold cannot be demonstrated, it is not possible to apply based on Article 60(2) in relation to adequate control. However, the application can be evaluated based on Article 60(4). In this case ECHA strongly recommends that the application contains a socio-economic analysis(see Q&A 617).

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