Use of Human Data in DNEL / DMEL Derivation

In December 2007, ECETOC and TNO, with the support of the European Chemicals Bureau (ECB), held a workshop to discuss the role that available human data should play in DNEL development. The workshop was attended by representatives of the MSs, the EU’s Scientific Committees, NGOs and industry. A key conclusion of the Workshop was that although the REACH Technical Guidance Document (Chapter R8) recognised the value that human data (HD) provide in interpreting the nature of health effects, the TGD included no guidance that specifically addressed how these data should subsequently be used for setting DNELs and DMELs.

As a consequence ECETOC and TNO were requested by ECB to develop a text that would allow for available human data to be appropriately incorporated into the REACH process for DNEL development. During H1/08, ECETOC and TNO worked with a small Peer Review Panel (PRP), drawn from Member State (MS) nominees, to develop a suitable text which might then form the basis for MS adoption at the Stakeholder Expert Group (SEG). The final PRP text and supporting RCOM documentation are attached. The text does not represent unanimity across the PRP, and a face-to-face meeting was proposed to discuss the issues raised in the RCOM. As ECB transferred its responsibilities to ECHA in June 2008, the non-finalised documentation was delivered to ECHA in September 2008.

ECHA have recently announced its intention to use the documents partially developed by the PRP to develop a revision to the IR&CSA TGD that would be submitted to an appropriate Partner Expert Group (PEG) later in 2009, for likely incorporation into the TGD in mid 2010. ECETOC and TNO welcome this development. However, both ECETOC and TNO remain conscious that the documents developed in 2008 are still unavailable to those SIEFs and Consortia which are currently developing DNELs for 2010 submissions.

Recognising that the contents have not yet undergone widespread discussion across all MSs, these documents are being made available in order that SIEFs and Consortia are able to benefit from the work invested by the PRP in 2008. It should be noted that the documents do not represent approved ECHA guidance and that there remain areas where no unanimous position could be identified within the PRP (e.g. the magnitude of Assessment Factors considered appropriate for human data). Despite such uncertainties, it is ECETOC’s/TNO’s belief that the documents do serve to enhance the basis by which the REACH processes can be assured that DNELs continue to be based on the best interpretation of available information and data.

It should also be noted that the ECETOC report on a “Framework for the Integration of Human and Animal Data in Chemical Risk Assessment” to which the documents refer has now been published (TR104).