On the 26th of January 2016 the new Regulation (EU) No 2016/9 entered into force. It defines extensively the terms of transparency, fairness and non-discrimination of data-sharing agreements for the registration of chemical substances according to the REACH – Regulation (EC) No 1907/2006.
Background
The REACH Regulation requires manufacturers and importers to share and submit data to ECHA (European Chemical Agency). EU Authorities concluded, based on prior registration deadlines and information from stakeholders, that the principles of the REACH Regulation have not been used to their maximum potential, prejudicing small and medium manufacturers.
The European Commission aims to establish clear rules for an efficient implementation of the REACH system to promote good management practices and to ensure the efficient functioning of the data-sharing agreements.
Transparency criteria
According to Article 2 of the Regulation (EU) No. 2016/9 the data-sharing agreements between the participants of the Substance Information Exchange Forum (SIEF) shall be clear and comprehensible to all parties and are to include:
- The division per items of the data to be shared, including the data cost, and the description of the costs of the REACH Regulation requirements;
- Justification on how the shared data satisfies the REACH requirements;
- Itemization and justification of any cost of creating and managing the data-sharing agreement and the joint submission of information;
- A cost-sharing model, including reimbursement mechanism.
Potential registrants of a substance for which a data-sharing agreement has already been reached by previous registrants shall not be bound by an existing waiver without their consensus, and shall have the right to request the division per items as per the new Regulation criteria.
Registrants that have shared information and submitted it together shall document yearly further costs in relation of their data-sharing activity. This documentation shall be kept for a period of twelve years following the latest submission and made available free of charge to any party of the data-sharing agreement.
One substance, one registration criteria
According to the Article 3 of the Regulation (EU) No. 2016/9 ECHA will have a stronger role to make sure that multiple registrants of the same substance will be part of the same registration process under the REACH provisions. What is excluded is the case of disagreements on the selection of data, in which an opt-out for those data points is still possible.
According to ECHA, in spring 2016 the new REACH-IT will not allow registrations outside of joint submissions. In addition ECHA will update its IT tools, Data Sharing Guidance, and other support materials, including the Directors’ Contact Group (DCG) recommendations with the aim of removing remaining ambiguities and streamlining processes further.
Fairness and non-discrimination
According to Article 4 of the Regulation (EU) No. 2016/9, any registrant, including the ones joining at a later stage, shall only be required to share costs of the information that they must submit to satisfy REACH provisions.
The following factors shall be considered in agreeing on a particular cost-sharing model:
- Number of potential registrants estimated to register for that substance;
- Possibility of future additional information requirements for that substance;
- Justification for any costs rather than the ones resulting from a potential evaluation decision;
- If such a cost-sharing model cannot be reached, each participant shall pay an equal share of the costs required for their participation.
A reimbursement system shall be envisaged in every cost-sharing model, and shall include a method of proportional redistribution for participants that join the agreement in the future.
The reimbursement system should take into account the following factors:
- The possibility of future additional requirements for that substance;
- The viability of the reimbursement where its cost is higher than the amount to be reimbursed.
The reimbursement model can also be included in the agreement established previously by the parties interested. A potential registrant who intends to participate in an existing agreement shall have the right to obtain the inclusion of the reimbursement mechanism in accordance with the new Regulation criteria.
Conclusions
All parties interested, including beauty products industry operators and other registrants should review this Regulation carefully and reconsider existing agreements to achieve compliance with regulatory requirements.
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