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Editor-in-chief: Maurizio Roncaccia
Editors: Paul Trouth and Päivi Jokiniemi
Article related to: REACH
Guest column: Sharing data – why is it so hard?
On 26 January 2016, the European Commission’s Implementing Regulation on data sharing entered into force. Together with ECHA’s new data-sharing guidance, this gave joint registrants and particularly small and medium-size enterprises (SMEs) clear instructions on what information they can expect and legally request from lead registrants. Perhaps even more importantly, it confirmed that they do not have to accept or agree to the existing data-sharing agreement if they do not believe it is ‘fair, transparent and non-discriminatory'.
Lead registrants getting better
Overall, there has been a positive response to the new data-sharing requirements. Many lead registrants or consortia now provide a complete breakdown of costs after a period of time, or apologise for not yet having all the necessary information available. To allow the joint submission to progress without further delay, they highlight the reimbursement clause to allow the purchase and release of the token that the member registrants require to enable them to submit their registrations to ECHA.
Alex Paul. Image: The REACH Centre.
How to improve?
However, even a year after entry into force, it is clear that lead registrants and consortia still have some way to go to improve their cost-sharing mechanisms, justifications and response times to data-sharing enquiries. Understandably, there are situations where providing a complete breakdown of costs is challenging for the lead registrant. This could be because the registration was submitted by a third party consultant who did not adequately break down invoices, or that the registration has been transferred or sold since its original submission as far back as 2008.
Potential registrants - particularly SMEs - are often under resourced and may not be able to seek legal advice to determine if the costs for letters of access are ‘fair, transparent and non-discriminatory’. In that case, what can they do? First of all, if a lead registrant is slow in responding to a request, joint registrants should remind them that they are legally obliged to provide a full itemisation of costs ‘without undue delay’.
Once in receipt of a cost breakdown, joint registrants should assess whether they have been provided with all the necessary information, including a complete breakdown per tonnage band, of any administrative, scientific and technical costs. A reasonable justification for any additional costs such as inflation, risk premiums or advantage compensation should also be provided by the lead registrant, and joint registrants should consider if a payment for a category approach can be justified by savings made elsewhere.
When initiating the data-sharing request, applicants should present clear arguments for their request and refer to the Implementing Regulation, the latest version of ECHA's Guidance on data sharing and ECHA's decisions on data-sharing disputes. They should also keep a full record of any communication as this evidence will be necessary if a data-sharing dispute is taken to ECHA. This is particularly important as ECHA has found in favour of companies who have faced a lack of transparency about cost breakdowns.
How to break down the costs?
Data-sharing mechanisms and what can be considered best practice is relatively straightforward for a recent registration where a full itemisation of the technical, scientific and administrative costs are available.
All three costs should be broken down per tonnage band and for each endpoint so that registrants only pay for the data they require, while only those registering above 10 tonnes per year should pay for the chemical safety report (CSR). Set up in a spreadsheet, straightforward calculation of letter of access costs is possible, or to calculate future refunds after new members join the joint submission. Companies are reminded that they cannot negotiate an individual or reduced rate, or consider that their payment will immediately reduce data-sharing costs.
New registrants should also be made aware about potential future costs for any new testing needed – for example if the substance is evaluated as part of the Community rolling action plan (CoRAP). Registrants should understand that there is no way to legally avoid sharing the costs, even if they stop manufacturing or importing the substance. For SMEs, future liabilities running into tens or hundreds of thousands of euros may make the difference between a commercially successful and viable substance, or financial complications.
Dr Alex Paul joined The REACH Centre (TRC) in 2011 where he is employed as a Managing Regulatory Consultant. Alex oversees TRC’s Regulatory Services including securing, coordinating and delivering REACH and BPR services to only representative clients and industry.
The REACH Centre is a private limited company with the head office based in Lancaster, UK. It was founded in 2007 and provides chemicals regulatory management advice and compliance services to industry and government across the globe. https://www.thereachcentre.com/