REACH 2018 Get organised with your co-registrants – SIEF management and data sharing

Purpose of this presentation This presentation, with notes, was prepared by ECHA, the European Chemicals Agency, to assist you in preparing a presentation about REACH 2018, i.e. the last registration deadline of phase-in substances. The intention is that you can select relevant slides and modify them as necessary to suit your audience, whether it is management, workers, environmental health and safety professionals, authorities etc. You may use it without additional permission. This presentation gives a brief overview of phase 3 (Get organised with your co-registrants) of ECHA’s REACH 2018 Roadmap. It belongs to a series of presentations relating to REACH 2018, which are on ECHA’s website. We welcome your comments and suggestions at: reach-2018@echa.europa.eu. Legal notice: The information contained in this presentation does not constitute legal advice and does not necessarily represent in legal terms the official position of the European Chemicals Agency. The European Chemicals Agency does not accept any liability with regard to the contents of this document. Release: May 2017

REACH registration 2018 Phase 3 activities Agree on how to work together Select the lead registrant Gather the data Share the costs Prepare for newcomers There are five activities in this phase of preparing your registration.

Agree on how to work together Communication in the SIEF Principle: all pre-registrants must be able to follow the SIEF discussions and progress Use the SIEF formation facilitator’s message field in pre-SIEF pages in REACH-IT Cooperation Model SIEF agreements available from industry associations (optional) Consortium is a possible form of cooperation but not a REACH requirement All co-registrants are to be treated the same way regardless of the cooperation form The first activity for you and your co-registrants in this phase is to agree how to work together. REACH-IT is not a communication platform for you and your co-registrants. Therefore, you need to agree on how you will arrange the communication of the SIEF. For example, by email or an online discussion forum. It is important that all pre-registrants, even the passive ones, are able to follow the discussions and progress in the SIEF. The message field in the pre-SIEF pages in REACH-IT can be used by the SIEF Formation Facilitator and is a good option for this type of communication. As a basis for your cooperation, you can set up a SIEF agreement. Some industry associations provide recommendations and templates that you can use. SIEF agreements are not mandatory though and if your SIEF, for example, only has a few members you can also agree to work without such an agreement. Note that in contrast, a cost-sharing agreement with a reimbursement scheme is mandatory. Remember that you may also receive requests to share data after the 2018 registration deadline and that you may be requested to provide additional data after registration during substance or dossier evaluation. Therefore, make sure that the agreement with your co-registrants goes beyond the 2018 registration deadline.

Agree on how to work together Responsibilities and tasks sharing the work? hiring a consultant? forming a consortium? Financial aspects invoicing and payment for work done Two other important aspects to agree on are responsibilities and tasks, and financial aspects. You and your co-registrants need to decide how to share the work in the SIEF. The work can be shared equally between all SIEF members, you can agree that one or more SIEF members take a more prominent role, or you can outsource part or all of the work. Once you have agreed who does what, you need to agree how this work will be compensated by the other SIEF members. You also need to agree on how to organise invoicing and payments for costs resulting from SIEF management.

Select the lead registrant All registrants are responsible for the progress in the SIEF and the content of the registration Lead registrant: has a few specific tasks in REACH-IT related to managing the joint submission and submitting the joint part of the registration first will act with the agreement of the co-registrants When to select the lead: as early as possible; at the latest at the time of submission do not let these discussions get in the way of the SIEF work All co-registrants are responsible for scheduling the SIEF work and making sure that it progresses and meets the deadline. All co-registrants are also responsible for: the content of the joint parts of the registration the content of their own part of the registration However, it is important to agree on who will be the lead registrant. The lead registrant will have specific tasks in REACH-IT such as: setting up the joint submission submitting the join part of the registration first distributing the REACH-IT security tokens to the members so they can submit their own part of the registration The other co-registrants will become member registrants of the joint registration. The lead registrant acts with the agreement of the other registrants. The role cannot be taken unilaterally. If it has been taken abusively in your SIEF, collect evidence and inform ECHA. If you cannot reach an agreement on the lead registrant, you should nevertheless continue with the SIEF work to not put your registration at risk. The formal appointment of the lead registrant can happen after the dossier itself has been prepared. LR

Gather data Make an inventory of the data you have in the SIEF data on the substance from own studies from the literature data on similar substances (for read-across) data that can be waived (e.g. study not scientifically justified) including the data ownership and copyright aspects Evaluate the data relevance/reliability/adequacy Next, make an inventory of all the data available on the substance with all the SIEF members. Remember that you will need to be in legitimate possession of the data you use, also if it is publicly available on the internet. Include the data ownership and copyright aspects in your inventory and the conditions you negotiated for using this data in your registration. Check that your data is fit for purpose in terms of relevance, reliability and accuracy.

Gather data Identify data gaps Fill in data gaps is there information you need that you don’t have? Fill in data gaps generate new data consider alternative methods (read-across, QSAR, …) new tests on vertebrates only as a last resort buy from an owner outside the SIEF including the data ownership and copyright aspects Consider preparing the CSR and guidance on safe use jointly Agree in the SIEF how to proceed to fill in the data gaps. Keep in mind that performing tests on animals must be the last resort. Alternative methods need to be considered first and you will have to show that you have done that. Alternative methods include for example in vitro testing, read-across, QSAR and weight of evidence. If you find that you can fill your data gap with data which is not owned by a SIEF member, you need to agree on it its use with the data owner (for example a letter of access or a license to use). Negotiate such an agreement for all co-registrants together, including future co-registrants. If you come to the conclusion that the test needs to be conducted to fill in the data gap, then you need to agree in the SIEF which laboratory to use and who in the SIEF will be in charge of having the test conducted. Beyond data gathering you should also agree if you will prepare the chemical safety report and the guidance on safe use of the substance individually or jointly. At the end of this step, you should have a complete set of good data that satisfies the information requirements for your registration. Useful links: Practical Guide for SME managers and REACH Coordinators (https://echa.europa.eu/practical-guides)

Share costs Cost-sharing principles: all costs need to be shared in a fair, transparent and non-discriminatory way registrants only need to pay for the data they need for their registration under specified conditions, a registrant may submit certain data separately if justified Itemise, justify and set a price for each of the data items all other costs related to the joint registration Establish a cost-sharing model Agree on a reimbursement scheme Document in a data-sharing agreement The cost-sharing model should clearly outline the cost breakdown. It lists the costs related to tests (study costs) and administrative work (non-study costs), and shows the price in relation to the information you require for your registration. Non-study costs can relate to: a specific study, for example, the costs for the administration of contracts with a laboratory the dossier preparation the general administration of the substance information exchange forum/joint submission All items should be justified. A reimbursement scheme will make sure that the costs are equally shared. Each time a new potential registrant buys access to the data, the overall costs for each co-registrant will reduce. When and how frequently the price is re-calculated needs to be agreed.

Prepare for newcomers Cost-sharing model must be fair, transparent and non-discriminatory towards potential registrants Decide who will take care of questions by newcomers Include a reimbursement mechanism in your cost-sharing model Since potential newcomers will have to contribute to the cost of the joint registration, they also have a right to challenge your choices if something is not clear or when they find it unfair. Be prepared to answer newcomers’ questions, explaining your cost-sharing model and the SIEF decisions on the content of the dossier. Establish a reimbursement scheme to redistribute the costs as the number of contributing co-registrants increases. Each time a new registrant buys access to the data, the overall cost for each co-registrant will decrease. When and how frequently the prices will be recalculated, needs to be agreed in the SIEF.

Data-sharing disputes If you and your co-registrants cannot reach an agreement on data sharing: make sure you can show that you have made all efforts in the negotiations (asking and replying) file a data-sharing dispute with ECHA as a last resort you will still need to submit in a joint registration If you and your co-registrants do not manage to reach an agreement on data-sharing, you may, as a last resort, file a data-sharing dispute with ECHA. Before filing a dispute you should make sure you can show that you have made all efforts in the negotiations asking for clarification on the items of concern to you and replying to questions from the other parties. Be aware that, even after a data-sharing dispute, you will still need to be part of a joint registration. Useful links: Data-sharing disputes in practice: https://echa.europa.eu/support/registration/working-together/data-sharing-disputes/data-sharing-disputes-in-practice.

Take away messages Many new SIEFs will need to be formed for 2018 Share the information you have on your substance with your co-registrants Be fair, transparent and non-discriminatory in: your communication with your co-registrants sharing the work setting prices for data and work done Support is available at https://echa.europa.eu/reach-2018