On April 3, 2012, the European Chemicals Agency (ECHA) released Version 2.0 of its Guidance on Data Sharing to provide further assistance to companies placing substances onto the European Union (EU) market under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation (EC regulation 1907/2006). The revised Guidance, available online, is a must read for entities wishing to optimize and protect their investment in chemical testing data.
The original version of this Guidance was one of the first guidance documents published by ECHA in 2007. ECHA states that the Guidance has been greatly amended and updated to take into consideration “lessons learned” from the 2010 registration process. ECHA released a draft version of the revised Guidance in July 2011. Bergeson & Campbell, P.C.’s memorandum on the draft is available online.
Major changes proposed in the draft version and retained in the final version include provisions on phase-in substance Inquiry Dossiers and late registrations (previously the Guidance concentrated primarily on the pre-registration period (June – December 2008)); guidance on data sharing disputes (REACH Article 30) and available legal remedies; and clarifying data ownership issues, as many entities asserted data ownership when in fact they did not legally own the data in 2010.
Key points that ECHA has added to the new version of the Guidance from the initial draft revision include the following:
- New ‘NB’ (Nota Bene) boxes have been included throughout the document to highlight key areas from each section of the Guidance. This breaks the Guidance down into smaller, more manageable sections which may be useful to companies without large REACH and regulatory teams.
- New subsections have been added at 3.3.7. and 4.7.8. to address the scenario where new co-registrants need to join an existing joint submission. Specifically, ECHA states:If a joint registration dossier already exists some of the steps described above may be omitted (e.g. steps 3.3.3.6 and 3.3.3.7). The potential registrant must then contact the existing (lead) registrant(s) and negotiate on the conditions of joining the joint submission dossier that has already been submitted by the lead registrant on behalf of the other assenting registrants. The potential and the previous registrant(s) (or their representative(s)) must make every effort to agree on the sharing of the information and of its costs in a fair, transparent and non-discriminatory manner. However, if the potential registrant does not agree on the choice of information for certain endpoints (e.g. he may have some studies of his own), he may decide to opt-out for these particular endpoints, but still must be part of the joint submission. For more details on the conditions of the opt-out, please consult Chapter 6.3 of this guidance.
- Also in Section 3, a new Subsection 3.2.6.2. provides more detail on Substance Information Exchange Forum (SIEF) agreements and possible elements that could be included in such agreements. The revised draft has already proposed to include additional guidance outlining in detail the process for data sharing within the SIEF for phase-in substances where an Inquiry has been submitted.
- Section 5 (Cost Sharing) now includes additional language to explain that the section “covers the sharing of cost related to studies, but other costs related to SIEF activities need to be considered in cost sharing models.” Section 5.5.5. (Cost Sharing as a “Non-Static” Process) discusses elements that may trigger variations in the cost-sharing model, including a variable number of co-registrants and the need for additional registration requirements.
- Section 8 (Forms of Cooperation) includes new examples of cooperation, including the option of a SIEF functioning without forming a consortium.
- References to the legal text and articles of REACH link the Guidance with the legal requirements in a more concise manner, which will make data sharing disputes a little easier for some companies. In addition, a new Annex listing all documents mentioned in the Guidance has been added.
- The diagrams and flow charts have been made easier to understand (e.g., Figure 4 “Data Sharing within the SIEF,” Figure 7 (“Article 30(3) Procedure”), to assist companies with data sharing.
- In Section 3.3.3.8 (Sharing of the Cost of the Data), ECHA had in the initial revised draft discussed issues related to the concepts of the “right to refer,” and “legitimate possession” as discussed in Article 10. In the revised Guidance, ECHA has added the following:ECHA, on its dissemination website, reminds potential registrants that “pursuant to Article 10 of the REACH Regulation, robust study summaries and study summaries disseminated in […] portal may only be used for the purpose of satisfying the minimum information requirements in a registration where the potential registrant is in legitimate possession of the full study report or has permission to refer to the full study report.” Furthermore “reproduction or further distribution of the information is subject to copyright laws and might require the permission of the owner of that information.” Finally the information disclosed is not enough to ensure reliable data which would be of good quality and relevance to fulfil the REACH data requirements.
- The Annexes of the Guidance have been amended to be clearer and include better examples for companies to use. New cost sharing examples have been included, crucially a clearer example of how to calculate the shared cost of study data. The examples for volume factors and new parties (examples 9 and 10) have been replaced with new examples from those included in the draft.