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EUROPEAN COMMISSION
Directorate-General for Environment
Green Economy
Chemicals
Directorate-General for Internal Market, Industry, Entrepreneurship and SME's
Resources Based, Manufacturing and Consumer Goods Industries
REACH
Chemicals Industry
Brussels, 11 March 2015
Doc. CA/05/2015
17th Meeting of Competent Authorities for REACH and CLP (CARACAL)
26 – 27 March 2015
Room Sicco Mansholt (MANS), Building CHARLEMAGNE, Brussels, Belgium
Concerns:
Implementing Act on Data-Sharing in REACH
Agenda Point:
18.1
Action Requested:
The CARACAL MS are invited to take note of this document for discussion.
Written comments on this document should be sent by 13 April 2015 to [email protected]
and [email protected] and [email protected]
Art
No:
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Article Title
Wording of Provisions (02/03/15)
Aim & Scope 1. The objective of this Regulation is to put efficiently into effect the provisions on joint submission of data
and data sharing set out in Title II and III of Regulation (EC) No 1907/2006 (“REACH Regulation”). Costs
associated with the sharing and joint submission of information in accordance with Titles II and III of the
REACH Regulation shall be determined in a fair, transparent and non-discriminatory manner.
2. This Regulation is based on the principle enunciated in Articles 27(3) and 30(1) of the REACH Regulation
that costs relating to a registrant's obligation to share information in accordance with that Regulation shall be
determined in a fair, transparent and non-discriminatory way.
This Regulation is also based on the principles enunciated in Articles 11(1) and 19(1) of the REACH
Regulation that, where the same substance is registered by multiple registrants, certain information shall be
submitted first by only one registrant acting with the agreement of the other assenting registrants.
Any person and/or entity required to share and submit information pursuant to the REACH Regulation shall
comply with the provisions established by this Regulation.
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Definitions
For the purposes of this Regulation:
1. Data-sharing agreement: means an agreement to share data for the purposes of fulfilling a registrant's
obligations under the REACH Regulation.
2. Administrative cost: means any cost of creating, managing and updating the data set fulfilling the
information requirements imposed by the REACH Regulation, including the cost related to the generation of
information from non-testing studies;
3. Study cost: means any cost that was required for performing an existing study or required for performing a
new testing study, whether relating to preparing the necessary specifications, contracting with a laboratory or
monitoring its performance
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Transparency
1. Where multiple registrants of the same substance are obliged to share information in accordance with their
duties under the REACH Regulation, they shall reach an agreement on a cost-sharing model that shall be
transparent to all potential registrants and existing registrants.
2. In relation to substances already registered, a potential registrant requesting the sharing of a study or a set of
studies in accordance with Articles 27 or 30 of the REACH Regulation shall receive from the existing
registrant(s), without undue delay, a description of the study costs. For information other than the one
relating to testing studies, a potential registrant requesting the sharing of such information in accordance
with the REACH Regulation shall receive from the existing registrant(s), without undue delay, a description
of the administrative costs related to that information. In relation to study costs, the information
requirements in the REACH Regulation to which the study corresponds shall be indicated. The potential
registrant may waive his right to obtain such itemisation of the costs by providing his signed consent to the
existing registrant(s). For administrative costs and study costs not covered by article 30(1) of the REACH
Regulation incurred before the entry into force of this Regulation, the existing registrant(s) shall make every
effort to provide justification of those costs if requested by the potential registrant.
3. Any data-sharing agreement concluded after the entry into force of the present regulation shall describe the
costs incurred at the time of the signature, distinguishing both study costs and administrative costs. In
relation to study costs, the description shall indicate the information requirements in the REACH Regulation
to which each study corresponds. Any data-sharing agreement concluded before the entry into force of the
present regulation shall be amended in order to indicate the study costs and administrative costs as described
above, unless the registrants concerned unanimously agree to the contrary. For administrative costs and
study costs not covered by article 30(1) of the REACH Regulation incurred before the entry into force of this
Regulation, the existing registrant(s) shall make every effort to provide itemisation of those costs if
requested by the potential registrant.
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4. Where existing registrants of the same substance have shared information and submitted it jointly in
accordance with the REACH Regulation, they shall document yearly any further administrative and study
costs incurred in relation to the operation of their data-sharing agreement and any compensation received
from subsequent registrants. The documentation shall clearly distinguish study costs from administrative
costs. Both study and administrative costs shall be itemised in the documentation so that every party to a
data-sharing agreement may identify whether a particular cost relates to an information requirement that he
is required to fulfil under the REACH Regulation or if the cost relates to general administrative expenses.
Without prejudice to the operation of any other provisions in the REACH Regulation, such annual
documentation shall be kept for a minimum of 12 years following the latest submission of a study and shall
be made available, free of charge, upon request from any party to the data-sharing agreement concerned or
upon request from the Agency or a Member State, in accordance with Article 36(1) of the REACH
Regulation.
5. In the absence of detailed documentation of costs incurred or compensation received before the entry into
force of this Regulation, parties to that agreement shall make every effort to collate proof, or the best
approximation, of such costs and compensation for each year since the commencement of that agreement.
This documentation shall be made available free of charge upon request from any party to the data-sharing
agreement concerned within reasonable time and in full consideration of the requirements related to
applicable registration deadlines.
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Fairness and 1. Where multiple registrants of the same substance are obliged to share information in accordance with their
Nonduties under the REACH Regulation, they shall reach an agreement on a fair cost-sharing model that shall
Discriminatio
apply to all registrants without discrimination, including future registrants.
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In agreeing on a particular cost-sharing model, consideration could be given to factors such as: the number
of potential registrants estimated to register for that substance; and the possibility of future additional
information requirements for that substance.
2. In the event that a cost-sharing model includes provisions to cover the possibility of future additional
information requirements for that substance, any compensation deriving from such provisions must be
justified and indicated separately from administrative and study costs in the estimate and in the contract for
that data-sharing agreement.
3. A reimbursement mechanism shall be envisaged in every cost-sharing model and, inter alia, may take
account of the following factors: the possibility of future additional registration requirements for that
substance; a method of proportional redistribution to each party of their share of fees paid where a potential
registrant joins that agreement in the future; and the economic viability of certain reimbursements where the
costs of reimbursement are higher than the amount to be reimbursed.
4. Parties to a data-sharing agreement that already exists on the date of entry into force of this Regulation may
waive their obligation to include a reimbursement mechanism in their cost-sharing model if all parties to that
agreement give their signed consent to the waiver.
A future potential registrant to that existing data-sharing agreement shall not be bound by the waiver and
shall have the right to obtain the inclusion of a reimbursement mechanism in the cost-sharing model in
accordance with this Regulation, unless he also gives his signed consent to the waiver.
5. In accordance with Articles 27(3) and 30(1) of the REACH Regulation, any registrant for a substance shall
only be required to share in the costs of information that such registrant is obliged to submit to the Agency to
satisfy their registration requirements under that Regulation.
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6. This Regulation should be without prejudice to the full and complete application of the Community
competition rules.
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Dispute
Resolution
1. All the registrants of the same substance shall submit jointly the information as specified in Articles 11(1)
and 19(1) of the REACH Regulation. Existing registrants and potential registrants of the same substance
shall therefore make every effort to agree on the joint submission of data in a fair, transparent and nondiscriminatory manner, even where a potential registrant intends to submit certain information separately in
accordance with Article 11(3) and 19(2) of the REACH Regulation.
2. If an existing registrant refuses to enable a potential registrant to join the submission of data regarding the
same substance, the Agency shall permit the potential registrant to join the existing submission, subject to
the granting of a permission to refer to part or the entirety of the data concerned in accordance with Article
27(5) or 30(3) of the REACH Regulation and, if necessary, subject to the demonstration that an agreement
has been reached on the sharing of the remainder of data, or subject to the demonstration that the potential
registrant submits the information required in accordance with Article 11(3) and 19(2) of the REACH
Regulation.
3. In its assessment of the parties’ efforts to find a fair, transparent and non-discriminatory agreement on the
sharing of data and their cost in a dispute under Article 27(5) or 30(3) of the REACH Regulation, the
Agency shall take account of the parties’ compliance with the obligations set out in Articles 3 and 4 of the
present Regulation.
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