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DNEL (Derived No-Effect Level)

Definition

A Derived No-Effect Level (DNEL) is the level of exposure to a substance above which humans should not be exposed. DNELs are derived by registrants as part of the Chemical Safety Assessment (Annex I) and are reported in the Chemical Safety Report. DNELs are substance-specific and route-specific (inhalation, dermal, oral) and distinguish between workers and the general population. They appear in Safety Data Sheet Section 8 and serve as reference values for risk characterisation.

Source

REACH Regulation (EC) No 1907/2006, Annex I, Section 1.3; ECHA Guidance on Information Requirements and Chemical Safety Assessment.

Practical Explanation (Compliance Context)

Downstream users must compare their estimated exposure values against the DNEL to determine whether the risk characterisation ratio (RCR = estimated exposure / DNEL) is below 1.0, indicating adequate control. If the RCR exceeds 1.0, additional risk management measures are required or the use is not adequately controlled. DNELs are the primary benchmark for worker and consumer risk characterisation in REACH.

Related Terms

Further Reading