The Commission has produced a draft Implementing Regulation which sets out prescriptive rules on how data-sharing and joint submissions under Regulation 1907/2006 ("REACH") should proceed. It will lead to changes in how applicants negotiate and further administrative burden.
The Commission received feedback from Member States, ECHA and stakeholders that data-sharing and joint registration provisions were not being utilised fully. It concluded that additional rules were required to ensure data is shared or jointly submitted in a fair, transparent and non-discriminatory manner.
2. New provisions
2.1 Article 2: transparency
Currently, multiple registrants of the same substance or participants in a Substance Information Exchange Forum must make every effort to ensure costs are shared. The draft Regulation contains the more onerous obligation to make every effort to reach a data-sharing agreement, which must include a list of data to be shared, the cost of each item, itemisation of all administrative costs and a cost-sharing model, including a reimbursement mechanism. Parties to existing data-sharing agreements and new joiners will be able to waive their obligation to the above only by unanimous consent. New joiners will be given the right to request itemisation of all study and administration costs incurred.
Under the draft Regulation, registrants that have already jointly submitted shared information will be required to make every effort to collate proof (or best estimates) of costs incurred and document yearly any further costs. This proof will need to be kept for 12 years from the latest submission of a study and made available for free to any party within a reasonable time.
The new provisions will thus mean data owners will need to provide more documentary evidence of costs incurred and compensable.
2.2 Article 3: one substance, one registration
ECHA will be required to ensure all registrants of the same substance are part of the same registration. ECHA will ensure that subsequent submissions by potential registrants requesting information under Articles 27(6) and 30(3) of REACH will form part of the existing joint registration.
2.3 Article 4: fairness and non-discrimination
The draft Regulation provides that REACH Articles 27(3) and 30(1) concerning costs-sharing also applies to administrative costs. The cost-sharing model will apply to all registrants of that substance including future ones. If parties cannot agree a cost-sharing model they will be required to pay an equal share of the costs, including a reimbursement mechanism as if agreed as above
2.4 Article 5: dispute resolution
Under the draft Regulation, ECHA will take parties' compliance with the above new requirements into account when settling any data-sharing disputes, which is strong incentive to comply.
The draft Regulation will place additional records-keeping requirements on REACH registrants. Many registrants may have been keeping accurate records on study and administration costs as a matter of good practice already. For others it may prove more burdensome and may disproportionately affect SMEs, which would defeat one of the aims of the draft Regulation. Arguably the provisions are retrospective as new joiners will have the right to request the itemisation of data and administration costs.
The new provisions should encourage registrants to reach fairer agreements as costs are split equally and new registrants reimbursed anyway if they cannot agree.
The REACH Committee voted in favour of this text on 22 October and the final version will be published in the Official Journal early in 2016. It will come into force on the twentieth day following publication.
For further information or questions please contact Koen Van Maldegem and Claudio Mereu.
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