Date: Jul 23, 2007
Wondering how you can meet your REACH obligations by strategically advantaging the HPV data you worked so hard to develop?
Well, OECD recently provided some guidance. In its most recent update to its Manual for Investigation of HPV Chemicals, Chapter 1: Procedures, including the use of the electronic discussion groups and the on-line HPV database, OECD offers "Annex 1: Synergies between REACH and the OECD HPV chemicals program." The document was prepared by OECD based on the agreements reached in the OECD Existing Chemicals Programme up to March 2007.
The document discusses how the output of the OECD HPV Chemicals Programme can contribute to REACH implementation, especially with regard to Registration, Evaluation, and the Preparation of Annex XV dossiers.
Many of the requirements for preparing the REACH dossier in the registration phase are similar to requirements of the OECD HPV Chemicals Programme. Some key points include:
All substance-related information will be entered into IUCLID 5. Any SIDS dossiers in IUCLID 4 should be directly importable. Dossiers prepared in Word but using the OECD Harmonized templates will be consistent with the IUCLID 5 format and easily entered.
Consistent guidance is applied when waiving information requirements using the chemical category approach or (Q)SARs.
Any new information is to be generated using the OECD Test Guidelines.
When writing the Chemical Safety Report (CSR), formats and the content requirements for the hazard assessment portion are fully compatible with those of the OECD SIDS Initial Assessment Report (SIAR).
However, the CSR will by necessity require additional information than the SIAR (e.g., specific exposures for intended uses, and risk assessment and risk management evaluations).
If a SIDS Dossier and SIAR exist prior to the registration deadline for REACH, these documents should be used to prepare the Registration Dossier. Significant deviations from the content, conclusions and recommendations within the agreed SIDS Dossier and SIAR would need to be explained.
In preparing and submitting SIDS Documents for the OECD HPV Chemicals Programme, data owners do not lose their data ownership rights under REACH, even after publication of the SIDS Documents by UNEP Chemicals, i.e. robust study summaries published through the OECD HPV Chemicals Programme cannot be used for registration under REACH without the prior consent of the data owner.
EU-Member States and the Agency, when setting priorities for substance evaluation under REACH will take into account the recommendation made by the OECD HPV Chemicals Programme and use the agreed conclusions of the hazard assessment for the evaluation.
There are two types of evaluations under REACH. The first is dossier evaluation, in which the Agency simply performs a compliance check and/or may check the testing proposal. The second type is the substance evaluation, in which the Agency coordinates with the individual EU Member States to more closely review the dossier and CSR.
As a result of the substance evaluation, a draft evaluation decision will be prepared. This is comparable to the outcome of the SIDS Initial Assessment Meeting (SIAM).
If the SIDS dossier and SIAR has already been approved at SIAM, the Agency will not need to review the completeness of the Registration dossier for the SIDS endpoints
For substances where no further information beyond the SIAM-approved assessment is provided to REACH, if the SIAM concluded that the substance was low priority for further work due to its low hazard profile, then it is not likely that the Agency will identify further information needs during dossier evaluation in relation to SIDS endpoints.
The recommendation options under REACH are very similar to the current SIAR recommendations. For REACH Registration, the registration dossier will either include a testing proposal or not. Using the terminology of the OECD, the registration dossier (prepared by the manufacturer/importer) will propose, among other things, that either:
(1) the chemical currently needs no further work (under REACH); or
(2) a - the chemical needs further work (under REACH): more hazard information is needed
At the dossier evaluation phase, the Agency will either confirm this proposal or reject it. At its own initiative, an EU Member State may initiate substance evaluation and conclude with any of the following recommendations:
(2) a - the chemical needs further work (under REACH): more hazard information is needed;
(2) b - the chemical needs further work (under REACH): more exposure information is needed;
(2) c - the chemical needs further work (under REACH): a risk assessment should be carried out;
If the recommendation is that further information needs to be generated (i.e., (2) a or b), then this must be based on reasons of suspicion that the substance presents a risk. If the recommendation is that a risk assessment needs to be carried out (i.e., (2) c), then this can be done by the authorities as part of the restrictions procedure.
The OECD document provides guidance specifically for use of the OECD SIDS assessments (SIARs). It does not discuss the use of dossiers and assessment plans prepared for the US HPV Challenge program. Because the submissions for the US program did not go through the rigorous SIAM review process, it is possible that the robustness of the data analysis will not meet the strict SIAR and REACH standards. Therefore, US HPV Challenge dossiers will need to be reviewed on a case-by-case basis for use in the REACH program.
The scientists and attorneys at Keller and Heckman LLP are leaders in the worldwide management of chemicals. We closely monitor HPV, REACH, SAICM and other programs and advise our clients on the best options for their businesses. For more information contact Herb Estreicher.
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