Consejo práctico para los nuevos FIIS
Once you have found your co-registrants and agreed on the substance sameness with them, you need to agree on how to work together to share the responsibilities and costs of registration.
Remember that the organisation and progress of the substance information exchange forum (SIEF) is the shared responsibility of you and your co-registrants. The following steps can help you to understand how to cooperate within your SIEF or other form of contract.
These Dos and Don'ts can help make your cooperation with other co-registrants smoother.
Organise your SIEF
Although you find your co-registrants via REACH-IT, the tool has not been designed as communication platform. Therefore, you should agree on how you will arrange the communication of the SIEF outside REACH-IT. Depending on the size of the SIEF, you may choose to send emails or create a separate discussion forum on SIEF issues.
It is important that all pre-registrants are able to follow the SIEF discussions and progress even though they may be passive in the SIEF.
You and your co-registrants need to agree on how to work together. This is the basis for all cooperation and impacts your individual tasks and responsibilities. In the end, it also determines whether or not you succeed with your REACH registration.
You can have a SIEF agreement to lay down how you want to cooperate in your SIEF. Some industry associations provide recommendations and templates that you can use.
If your substance is registered by only a few companies and you do not expect many newcomers, you can also agree to work without such an agreement.
Remember that you may receive requests to share data after 2018, and that you may be requested to provide additional data during substance or dossier evaluation. Therefore, make sure that the agreement with your co-registrants goes beyond the 2018 registration deadline.
Try to estimate the workload needed for the registration process.
In a small SIEF with companies registering only in the lowest tonnage band, you might have less work than in a big SIEF where many companies are dealing with extensive data requirements. In a small SIEF, however, the work has to be done with fewer people.
Decide how to share the work: it can be shared equally between all SIEF members, or you can agree that one SIEF member or a smaller group of the SIEF members takes a prominent role. You can also agree to hire a consultant to manage the SIEF and assist you in preparing the joint registration. Have a look at the Checklist to hire a consultant on ECHA's website.
Combined approaches are also possible. For example a SIEF member could take responsibility for the administrative or management aspects, while a consultant takes on the responsibilities and tasks related to the more technical or scientific aspects.
Some industry associations already host dedicated REACH groups or consortia for substances, which could be related or similar to yours. They may be willing to add your substance to the scope of their existing registration or provide an opportunity for read-across of data. The first step is to contact them for substance sameness discussions. The contact details of the industry associations that are ECHA's accredited stakeholder organisations are available on ECHA's website.
If it is agreed that one SIEF member takes a prominent role or that a consultant will be appointed, this work should typically be compensated by the other SIEF members. You need to agree on how to organise invoicing and payments for costs resulting from SIEF management. This is different from sharing the costs of data, but could also serve as a good basis for the actual data-sharing agreement in the future.
All co-registrants are responsible for scheduling the SIEF work and making sure that progress is made to meet the deadline. All co-registrants are also responsible for the content of the joint parts of the registration as well as the content of their own parts of the registration.
However, you need to agree on one of you taking the role of the lead registrant. In practice, the formal appointment of the lead registrant can happen after the dossier has been prepared, but the sooner you agree on this the better.
What is the duty of the lead registrant as defined in REACH?
The responsibility of the lead registrant is to submit the joint registration first, with the agreement of the other SIEF participants. The other co-registrants will become member registrants of the joint registration.
The task of the lead registrant should not be mixed with the preparation of the registration dossier and managing other tasks in the SIEF. This is a shared responsibility of all co-registrants. Any other tasks are optional and can be shared between the SIEF members or even outsourced.
How does the lead registrant fulfil this duty in practice?
The lead registrant needs to create a Joint Submission Object in REACH-IT, submit the joint part of the registration (lead dossier) and distribute the security token numbers to the members so that they can join the joint registration by submitting their own registration (member dossier). In other words, members do not submit a full dossier, but in their registration refer to the information included in the lead dossier.
How to select the lead registrant?
There are several options. It may be that one company naturally has a higher interest in registering the substance than the others and that company volunteers.
You may also choose the co-registrant who has most of the data on the substance already available or the one who has most information requirements to fulfil. You can even try a lottery if no other means work.
In any case, you will need to come to an agreement between all co-registrants. ECHA will not be able to assist you on agreeing on who will be the lead registrant.
What if the SIEF cannot agree on a lead registrant or if no SIEF member volunteers to take this role?
Do not spend too much time on this issue because you will risk that some other tasks will not be managed on time. In practice, the formal appointment of the lead registrant can happen after the dossier has been prepared. You can also consider the following :
- If you and your co-registrants will be involved in many SIEFs together, you can divide the lead registrant tasks so that everybody takes a similar share of the work;
- You can agree on outsourcing the actual work although one company still needs to be formally nominated as the lead registrant.
Gather the data
Note: The advice here relates to the organisational aspects of data gathering.
To find out which data is available in the SIEF, you can survey all the SIEF members, for example, based on the data exchange form that can be found in Annex I of the Guidance on data sharing.
Next, one of the SIEF members or an external expert could be tasked with conducting an in-depth literature search to identify data available outside the SIEF.
To find support for your potential read-across strategy, you may consult ECHA's website (Search for chemicals) on substances already registered, as well as the Global Portal to Information on Chemical Substances hosted by the OECD (eChemPortal).
When you plan to use existing data for your registration, you will always need to consider intellectual property rights.
Based on this information, you can develop an inventory of all available data and their copyright statuses.
Learn more about the information requirements that apply to the tonnage band of the substance you manufacture or import (1-10 or 10-100 tonnes per year), and the type of registration (standard or intermediate) you need on the page "Information to be shared for registration".
Assess the relevance, reliability and adequacy of the available data to see that it is fit for purpose. You need to have a complete data set that satisfies the information requirements you need for your registration. It may also be that several studies exist in your SIEF that cover the same information requirement. All relevant data should be submitted in the registration.
Compare the data you have to the information requirements and make an inventory of the data that is missing for a complete registration.
Keep in mind that performing tests on animals is the last resort to fill in a data gap - all alternative methods need to be considered first. You will also have to be able to demonstrate that you have done that.
Agree in the SIEF how to proceed to fill in the data gaps: for example, whether an alternative to testing could be used (e.g. read-across or QSAR), if not, what tests to conduct, which laboratory to use and who in the SIEF is in charge of obtaining the information.
If you agree that there is a need to perform additional tests but there is no volunteer in the SIEF, or you cannot agree for other reasons who should perform the tests, ECHA can help you to assign the responsibility to a certain SIEF member.
If you need to use data which is not owned by a SIEF member, you need an agreement from the data owner. This agreement may be a specific Letter of Access (LoA) or a Licence to Use. Note that this agreement is separate from the data-sharing agreement among the SIEF members.
It is recommended that such an agreement is valid for all co-registrants including future ones. This would allow co-registrants to use the data without having to individually negotiate access to it.
Share the costs
Each individual study comes with a price. This price can consist of the costs for performing a test, costs for buying access to required data or costs of satisfying your information requirement with a non-testing method. If there are no invoices available for an item, the costs for performing the test again can give an indication of the value of the test.
Besides the cost of data itself, non-study costs will also need to be shared. These can relate to:
- a specific study (e.g. the costs for administering the contract with a laboratory to conduct a new test or a contract with an external data holder to get access to an existing study)
- the technical dossier preparation (inserting information into the IUCLID dossier)
- the administration of the SIEF (you may have already formally agreed on that in the SIEF agreement)
- the administration of the joint submission (distribution of security token to the members, post-registration communication, managing the reimbursement scheme)
The division of costs as study costs or non-study costs may vary across SIEFs, depending on how the responsibilities and tasks were allocated. For example:
- the administrative costs related to a laboratory test may in some cases be considered as part of the study costs, and would not appear in the non-study costs;
- depending on the cooperation model of the SIEF, the costs related to SIEF management (before submission of the dossier) and joint submission management (moment of registration and period after the registration) may not be separated.
No matter what the costs are called or how they are allocated, it is important that they are recorded transparently.
You can also consider agreeing on:
- Chemical safety report (CSR): For registrations above 10 tonnes per year, you need to submit a chemical safety report in addition to IUCLID dossier. You can prepare it jointly with your co-registrants or by yourself. If you decide to prepare your own CSR, you should not pay costs related to the preparation of your co-registrants' CSR. For registrations between 1-10 tonnes per year, a CSR is not required.
- Guidance on safe use of the substance: As a CSR is not needed for registrations between 1–10 tonnes per year, you will need to submit more information in the guidance on safe use section of your registration dossier. You may consider sharing the costs of preparing the guidance on safe use jointly with your co-registrants.
Study and non-study costs need to be shared in a fair, transparent and non-discriminatory manner.
There are several models on how to determine the value of data for REACH purposes. The basis is always the actual cost of data, while the decrements or increments applied to that cost need to be agreed among SIEF members.
Remember that you only need to pay for the studies you need for your registration. Your needs depend on your registration type (standard or intermediate) and tonnage band (1-10 or 10-100 tonnes per year). Your co-registrants might not have the same information requirements as you.
The Cost sharing chapter of the Guidance on data sharing provides more information on study valuations for REACH registration. For more summarised information, have a look at the factsheet Typical cost elements in data-sharing negotiations.
If you and your co-registrants do not manage to agree on data-sharing, you may as a last resort file a data-sharing dispute with ECHA. For more information, see the web page Data-sharing disputes in practice.
Agree on a cost-sharing mechanism that is fair, transparent and non-discriminatory to potential future co-registrants. They will have to contribute to the costs of the joint registration but will also have a right to challenge your original choices if something is not clear.
Be prepared to answer the questions of newcomers, justify your cost-sharing model and the SIEF decisions on the dossier content.
To anticipate the questions you may need to answer, you can have a look at the web page Practical advice for data-sharing negotiations.
The individual proportion of the costs depends on how many co-registrants share the data. It makes a significant difference if the costs are shared between 2 or 200 registrants.
The number of co-registrants who share the costs may not be clear when you are preparing your registration. This means that the calculation of the price is based on the current number of co-registrants.
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.
Having a reimbursement scheme is mandatory, unless you unanimously agree not to have one. In some cases, running a reimbursement scheme may be more costly than the potential reimbursement. If there is no reimbursement scheme, you need to be able to clearly justify it to your future co-registrants showing the mutual benefits of such a choice.
While the SIEF agreement is optional, you are must have a formal data-sharing agreement. You should include at least information about the substance sameness criteria you apply, scientific dossier content (intrinsic properties of the substance), the method of calculating the cost-sharing and information on the reimbursement scheme and future costs.
Fases de REACH 2018
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