Regulatory Developments

REACH:  EU Publishes Regulation Regarding REACH Joint Submission of Data and Data Sharing

January 11, 2016

On January 6, 2016, the European Union (EU) published its Commission Implementing Regulation (EU) 2016/9 regarding the joint submission of data and data sharing under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) in the Official Journal of the European Union. The European Commission (EC) Competent Authorities for REACH and CLP (CARACAL) has been developing this Regulation to clarify further what is meant by determining data sharing in a "fair, transparent, and non-discriminatory manner" associated with the sharing and joint submission of information and also the costs relating to a registrant's obligation to share information in accordance with REACH.

Many of the requirements set forth in the Regulation may be already in place in existing Substance Information Exchange Forums' (SIEF) data-sharing agreements. Nevertheless, the Commission found based on information collected following the 2010 and 2013 REACH registration deadlines that "data sharing and joint submission have not been used to their full potential, their implementation falling short of expectations." The Commission found that these problems were "especially prejudicial to small and medium size enterprises." The requirements set forth apply prospectively as well as retroactively, meaning that all companies that are parties to REACH data-sharing agreements are affected by this new Regulation.

With regard to transparency, Regulation Article 2 includes the following provisions:

  • Registrants and SIEF participants "shall make every effort to reach an agreement on the sharing of information." Such an agreement must be "clear and comprehensible to all parties," and shall include:
     
    • The itemization of the data to be shared, including the cost of each data item, a description indicating the information requirements in Regulation (EC) No 1907/2006 to which each cost corresponds and a justification of how the data to be shared satisfies the information requirement;
       
    • The itemization and justification of any cost of creating and managing the data-sharing agreement and the joint submission of information between registrants of the same substance as required by Regulation (EC) No 1907/2006 (hereinafter referred to as "administrative costs") applicable for that data-sharing agreement; and
       
    • A cost-sharing model, which shall include a "reimbursement mechanism."
       
  • Parties to an agreement executed before the date of entry into force of this Regulation can waive their obligation to itemize data by unanimous consent. A future registrant shall not be bound by an existing waiver, however, and thus can either provide signed consent or request itemization.
     
  • Upon request from a potential registrant, the existing registrant(s) should provide, "without undue delay," all relevant costs as described above that were incurred after the date of entry into force of this Regulation. Registrants also must provide upon request proof of the cost of any study completed before the date of entry into force of this Regulation, and must "make every effort" to provide itemization of all other relevant costs, including administrative costs and study costs, not covered by other information required to be provided and incurred before the date of entry into force of this Regulation.
     
  • Existing registrants that have submitted a joint registration must document yearly any further costs incurred in relation to the operation of their data-sharing agreement and any compensation received from new registrants. Such documentation shall be kept for a minimum of 12 years following the latest submission of a study and made available free of charge upon request from any party to the data-sharing agreement.
     
  • Registrants without detailed cost documentation must "make every effort to collate proof, or to make the best approximation, of such costs and compensation for each year since the commencement of that agreement."

With regard to fairness and non-discrimination, Regulation Article 4 provides:

  • Any registrant shall only be required to share in costs of information that such registrant is obliged to submit to satisfy its registration requirements.
     
    • Costs to be shared can include:
       
      • Costs that are "required for performing an existing study or [are] required for performing a new study, whether relating to preparing the necessary specifications, contracting with a laboratory or monitoring its performance." Costs of fulfilling a REACH information requirement not involving testing studies should also be included.
         
      • Administrative costs (defined in Article 2 as the cost of creating and managing the data-sharing agreement and the joint submission of information between registrants of the same substance as required by Regulation (EC) No 1907/2006).
         
      • Costs resulting from a potential substance evaluation decision.
         
      • Costs for future additional information requirements for that substance. Note that compensation sought for the possibility to cover future additional information costs must be justified and indicated separately from other costs in the data-sharing agreement.
         
    • Costs that are not to be shared include:
       
      • Study costs and administrative costs that are not relevant to the information that a party is obliged to submit for registration under that Regulation (e.g., vertebrate studies).
         
      • Information for the purpose of establishing substance sameness between previous registrants and potential registrants.
         
  • Registrants must agree on a fair cost-sharing model that applies to all registrants, including "future registrants joining the data-sharing agreement at a later stage." Specifically, the following factors shall be considered in agreeing on a particular cost-sharing model: (1) the number of potential registrants estimated to register for that substance; and (2) the possibility of future additional information requirements for that substance, other than those resulting from a potential substance evaluation decision.
     
  • A reimbursement mechanism must be developed with a "method of proportional redistribution to each participant of their share of costs paid where a potential registrant joins that agreement in the future." The reimbursement mechanism must consider the following factors: (1) the possibility of future additional registration requirements for that substance, other than those resulting from a potential substance evaluation decision; and (2) the economic viability of certain reimbursements where the costs of reimbursements are higher than the amount to be reimbursed.
     
  • Parties to an agreement executed before the date of entry into force of this Regulation can waive their obligation to include a reimbursement mechanism by unanimous consent. A future registrant shall not be bound by an existing waiver, and thus can either provide signed consent or obtain the inclusion of a reimbursement mechanism in the cost-sharing model.

With regard to the "One Substance, One Registration" (OSOR) principle, Regulation Article 3 states:

  • Without prejudice to the "opt-out" provisions in REACH Articles 11(3) and 19(2), the European Chemicals Agency (ECHA) shall ensure that all registrants of the same substance are part of the same registration. This provision is intended to reinforce the OSOR principle by "emphasizing the role of the Agency in ensuring that all submissions of information regarding the same substance are part of the same registration under that Regulation."
     
  • In cases where ECHA has given a potential registrant permission to refer to certain information pursuant to REACH Articles 27(6) and 30(3), it shall ensure that any subsequent submission of information by that potential registrant is part of the existing joint submission for that substance. These provisions also ensure consistency with the OSOR principle by ensuring that any separate opt-out submission is still part of the existing registration for that substance.

With regard to dispute resolution, Regulation Article 5 states:

  • When settling data-sharing disputes, ECHA shall take account of the parties' compliance with the obligations addressed in Articles 2, 3, and 4 of the Regulation.

Discussion

The Regulation seeks to "promote good management practices" and "ensure the efficient functioning of agreements" related to data-sharing. The requirements set forth in the Regulation are intended to further the OSOR principle, ensure transparency and fairness in data-sharing agreements, and end excessive charges. The Regulation furthers its goals of promoting transparency and fairness by ensuring that a cost-sharing model and reimbursement mechanism are in place when future registrants provide additional compensation and by eliminating concerns that potential registrants pay for studies that are not required of them under REACH.

ECHA will have a greater role in requiring registrants to submit a joint registration when there are multiple registrants for the same substance. ECHA stated that the new REACH-IT, to be launched in Spring 2016, will not allow registrations outside of joint submissions in such circumstances. Furthermore, ECHA will update its IT tools, Data Sharing Guidance, and other support materials to reflect the changes. Additionally, the Directors' Contact Group (DCG) will revise its recommendations to take account of the Regulation. These measures will clarify remaining ambiguities and streamline processes further.

The Regulation will enter into force on January 26, 2016. All agreements to be executed after this date must be in compliance with these new requirements. All SIEFs and other parties with existing data-sharing agreements also are affected by this Regulation and must decide whether to waive the obligations to itemize data or include a reimbursement mechanism in the cost-sharing model. It should be noted that there must be unanimous consent by all parties for a waiver to be effective, and in those cases the parties may not avoid the need for such provisions since any future registrant is not bound by such waiver and can request data itemization or a reimbursement mechanism. Registrants also now have annual recordkeeping requirements, the absence of which will have consequences regarding the lack of transparency for cost-sharing purposes. All SIEF participants or other registrants with data-sharing agreements should review this Regulation carefully and begin the process to review existing practices and agreements for consistency with the new requirements.


 
THE ACTA GROUP
Beijing, China | Manchester, U.K. | Washington, D.C.
 
Contact | Twitter | Legal Disclosures | Privacy
©2018 The Acta Group All Rights Reserved.