If an adequate control route is inapplicable, i.e. the risk arising from further use of the sub-stance is not adequately controlled. This is the case when the estimated exposure exceeds the DNEL (Derived No-Effect Level) for health or exceeds the PNEC (Predicted No-Effect Concentration) for the environment.
An adequate control route is also ruled out when a substance falls under one of the following categories in Annex 1.17 ORRChem:
• CMR (carcinogenic, mutagenic or toxic for reproduction) for which it is not possible to determine a threshold value
• substances of equally very high concern for which it is not possible to determine a threshold value
• PBT (persistent, bioaccumulative and toxic) or vPvB (very persistent, very bioaccumulative) substances and
• as well as substances of high concern having PBT or vPvB properties (e.g. endocrine disruptors).
Here, it is not possible to derive DNEL or PNEC levels.
If a suitable alternative for the requested use is available to the applicant then a derogation cannot be granted via the socio-economic route.