EC Adopts Reg Clarifying REACH Joint Submission, Data-Sharing Duties

Data-sharing agreements between members of substance information exchange forums should itemize costs for studies supporting REACH registration, justify such costs and include reimbursement mechanisms to adjust parties' shares when new co-registrants join, the EC says. The recently published regulation also reinforces REACH's "one substance, one registration" principle underpinning joint submissions.

An implementing regulation newly adopted by the European Commission seeks to ensure that joint registrations cover all uses of a given chemical under the EU's Registration, Evaluation, Authorization and Restriction of Chemicals law, while clarifying parameters for "fair, transparent and non-discriminatory" data cost sharing.

Published Jan. 6 in the EU's Official Journal and slated to go into effect Jan. 26, the regulation "sets rules to make sure that the data-sharing agreements in substance information exchange forums (SIEFs) are clear and comprehensive," according to a release from the European Chemicals Agency, which oversees REACH.

Use of joint submissions and data sharing have been critical components of REACH since its inception, with related provisions built into the regulation to optimize the program's efficiency and avoid unnecessary testing per the "one substance, one registration" principle.

However, the new regulation "reinforces" ECHA's role in requiring that all registrants of the same substance file jointly.

An update to the online REACH-IT registration tool in late spring will bar registrations outside of joint submissions, ECHA says.

According to the EC, REACH provisions for data sharing and joint submission "have not been used to their full potential" to date, based on what the agency has seen in registrations under 2010 and 2013 deadlines for phase-in chemicals.

"This has been especially prejudicial for small and medium-size enterprises," it notes.

European manufacturers and importers of phase-in substances in volumes exceeding 1 ton but no more than 100 tons per year must register with ECHA by May 31, 2018. The agency has been working to mobilize affected companies, urging them to join with SIEFs and identify lead registrants within their groups by consulting related pages in REACH-IT.

At this stage in the game, a company's substance may have been registered already under previous deadlines by firms producing or importing it in higher volumes. In any event, newcomers to SIEF consortia likely will benefit from data shared by the group to support their joint submission, or have data to offer the group themselves in support of substance safety.

In the implementing regulation, the EC states: "In order for the system of data sharing … to operate effectively, it is necessary to promote good management practices and to ensure the efficient functioning of agreements pertaining to sharing such data."

The regulation lays out rules to guide such agreements, specifying that shared costs between SIEF members should only be for information they are obliged to submit toward REACH registration. The EC notes that, for example, SIEF members do not need to pay for data that goes beyond the requirements for their tonnage band.

Viable shared expenses may include "any cost that was required for performing an existing study or is required for performing a new study, whether relating to preparing the necessary specifications, contracting with a laboratory or monitoring its performance," the EC says.

Contracts Should Itemize Costs, Provide For Reimbursement

Shared data and associated costs should be itemized in group agreements and accompanied by explanations detailing how the information will serve to satisfy REACH requirements, according to the regulation.

Agreements also should incorporate reimbursement models enabling SIEF members' respective share in costs to be adjusted when other registrants join at a later stage. From the outset, the EC advises companies to estimate the number of potential registrants for a given substance and future additional information requirements and build such projections into cost-sharing models.

The EC says requirements for cost itemization and reimbursement mechanisms may be waived in cases where all parties to existing agreements consent. However, potential registrants looking to join an established cost-sharing agreement should be allowed to request a reimbursement scheme, it notes.

Potential newcomers to group agreements also have a right to request a "breakdown" of studies and administrative costs that make up the price for a joint registration.

Annual records of costs incurred and compensation received should be kept by participants for a minimum of 12 years following a study's submission to demonstrate that expenses are justified and adequately distributed, the EC says, adding that members operating under existing data-sharing agreements "should make every effort to establish proof of costs incurred before the entry into force of this regulation."

ECHA notes in its release that while all registrants of the same substance must file joint submissions, certain scenarios may call for individual registrants to submit their own data. "For example, if there are disagreements about the selection of data, an opt-out for those data points is possible," but the joint registration must remain intact, the agency says.

Updates are planned for ECHA's IT tools, related guidance documents and other support materials to reflect changes under the implementing regulation, according to ECHA. Such refinements will serve SIEFs jointing registering new chemicals down the line, in addition to companies facing the final REACH deadline for phase-in substances.

The agency launched a dedicated web portal in late 2014 to assist companies subject to the 2018 deadline for low-volume phase-in chemical use, which is expected to generate the highest number of registrations under REACH to date (Also see "ECHA Launches REACH 2018 Web Portal For Low-Tonnage Registrants" - HBW Insight, 20 Oct, 2014.).