DNEL (Derived No-Effect Level):
The DNEL is an exposure limit value, i.e., a derived exposure level below which the substance does not impair human health (Art. 17 ChemV in conjunction with Annex 1 REACH). It is used for risk characterization under chemicals legislation. DNELs consider multiple routes of uptake (inhalative, oral, dermal) and also multiple population groups (e.g., consumers, workers, young people, etc.). DNEL values do not consider socioeconomic aspects or considerations of technical feasibility.
- A more detailed description of all DNEL types can be found in English in the document "Manual to the Simple European Calculator Of DNEL (SECO-DNEL Tool 1.0 (XLSM, 876 kB, 24.02.2016))."
Support for small companies:
The worker DNELs are communicated in the safety data sheets together with a description of protective measures (exposure scenarios). These protective measures recommended by the manufacturer ensure that the worker DNELs are met. The company must therefore implement these measures accordingly to protect the health of employees (Art. 55 ChemV). A user company can assume that it does not exceed the worker DNELs if it complies with these protective measures.
Legal basis:
Art. 17 and 55 ChemV
Publication location:
The relevant DNELs must be listed in Section 8.1 of the Safety Data Sheet (SDS). The DNELs are published on the website of the European Chemicals Agency (ECHA). For better overview, the German Statutory Accident Insurance provides an Excel list of worker DNELs: www.dguv.de/ifa/gestis/gestis-dnel-liste.
Worker DNELs for Substances of Very High Concern (SVHC):
The use of such substances is generally prohibited, but the federal government can grant company-specific exemptions under conditions. Lawful use of SVHCs without Swiss exemption may only take place if they are used in accordance with EU authorization. The DNEL values for assessing an exemption application correspond to those of ECHA (Committee for Risk Assessment, RAC).
SECO-DNEL-Tool for deriving DNELs (for manufacturers)
SECO supports manufacturers of chemicals in deriving DNELs with an easy-to-use Excel tool "Simple European Calculator Of DNEL." This implements all relevant steps of the ECHA Guidance R.8 "Characterisation of dose [concentration]-response for human health" (2012) for the derivation of DNELs.
