Developing the scientific basis for Exposure Based Adaptations (EBA) - Technical Report No. 137

137 6 Developing in the scientific basis for EBA The data requirements for a high-volume substance are substantial and resource intensive to meet, and if these were required for all registered substances, they would place a substantial burden on the registrants of low-volume substances relative to the value of the substances on the marketplace. [...] The provisions in column 2 are endpoint specific and may be contingent on the physical/chemical properties of the substance, the availability of data for other endpoints, the classification of a substance and/ or the potential for exposure. [...] 137 25 Developing in the scientific basis for EBA c) the comparison of the derived DNEL with the results of the exposure assessment shows that exposures are always well below the derived DNEL; Implementing the exposure-based adaptation Although this adaptation gives the only opportunity to use a risk assessment to adapt data requirements in annexes VIII – X, it is implemented in a way that makes i. [...] c) the comparison of the derived DNEL with the results of the exposure assessment shows that exposures are always well below the derived DNEL; This criterion introduces the need for the risk assessment but sets the expectation that exposures be well below the DNEL without adequately defining what this means. [...] The burden of proof to demonstrate “low” exposure is a function of the length of the supply chain and complexity of the use pattern: the less diverse and the lower the number of uses, the greater the likelihood that EBA criteria will be met.