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An agreement on cost sharing usually requires parties to agree on:
- Reliability, relevance and adequacy of the data ("Data Quality");
- Economic value of the data ("Data Valuation"); and
- How the agreed value is shared among parties ("Cost Allocation and Compensation").
Registrants need to share the costs of information that they are required to submit to satisfy their registration requirement. Companies cannot be forced to pay for studies that they do not need, nor can they be forced to pay before they actually need them in their respective tonnage band, i.e. before their registration deadline.
Whenever the (potential) registrant requests data earlier, they need to pay when they receive the data. Other elements might be considered as well.
Registrants need to make every effort to reach an agreement on data sharing and its cost in a fair, transparent and non-discriminatory manner.
The Guidance on data sharing provides more details: http://echa.europa.eu/guidance-documents/guidance-on-reach.
Additionally, practical advice for data sharing negotiations is available: http://echa.europa.eu/support/registration/working-together/practical-advice-for-data-sharing-negotiations.
You can have further duties to share data after you have submitted your registration. This can happen when:
- new potential registrants join the substance information exchange forum (SIEF) as late pre-registrants of a phase-in substance;
- the potential registrant of a non phase-in substance or a potential registrant of a phase-in substance who did not pre-register is informed of the previous and other potential registrants (and vice versa) by ECHA following an inquiry;
- after the successful submission of the registration dossier whenever new information becomes available. In such a case, according to Article 22 of REACH, registrants will have to update the joint registration dossier. This may require prior data sharing and may have an impact on decisions on the classification and labelling. It can also lead to the need to change the CSR.
- as a consequence of the submitted dossier evaluation by ECHA (compliance check or the assessment of a testing proposal) or the substance evaluation. These processes may lead to a request to submit further information, which would need to be addressed among all registrants of the same substance, and namely in the case of substance evaluation are not necessarily limited to the tonnage band related information requirements. Registrants should agree on the generation of requested information and on the sharing of the data and costs. In certain cases, also registrants who ceased manufacture may be requested to provide additional information. Therefore, data sharing does not only apply to "existing" studies but also to studies which will be needed to ensure that the registration is compliant with REACH.
When a registrant does not own a study report that they require for their registration, they need to agree with its owner on the conditions of using the study report for REACH registration purposes. The owner of the data and the registrant are free to define the rights that will be granted.
If the robust study summary of a study has already been submitted to ECHA, a registrant can, for instance, refer to that study in their dossier, provided that they have permission to do so. In that context, the registrant and the data owner must agree on the conditions of the right to refer. The LoA is a term often used to describe the agreement on the sharing of data and granting a right to refer. The intellectual property rights of the data owner must in any case be respected by the potential registrant.
The cost of shared data for each substance may vary significantly, depending on the costs of the studies involved, the number of registrants sharing the data and other factors.
ECHA has published generic advice on what to take into account during the data-sharing negotiations: http://echa.europa.eu/regulations/reach/registration/data-sharing/practical-advice-for-data-sharing-negotiations.
ECHA will not participate in the discussions between (potential) registrants and has no remit in regulating or assessing the cost of shared data. ECHA therefore cannot assist a potential registrant in its negotiations with previous registrants or data owners. As a last resort, ECHA can assist in resolving data-sharing disputes between existing and potential registrants.
For further details, please refer to the Data sharing pages on ECHA’s website: http://echa.europa.eu/regulations/reach/registration/data-sharing/data-sharing-disputes/data-sharing-disputes-in-practice.
The substance has been registered but the relevant studies were submitted less than 12 years before the inquiry. ECHA informs the potential registrant of the names and addresses of the previous registrants but cannot provide a copy of the (robust) study summaries. Rights and obligations - For the purposes of data sharing, the potential registrant will need to contact the previous registrants (and/or the other inquirers) identified by ECHA.
A request for sharing information must be made for any studies involving vertebrate animals. However, a potential registrant has to request data from the previous registrants if that data does not involve testing on vertebrate animals. The previous registrant and the potential registrant have to make every effort to reach an agreement on the sharing of the data requested and its costs. The obligation to make every effort applies to any information requested, whether they concern vertebrate or non-vertebrate animal studies.
Once a data sharing request for studies submitted less than 12 years ago has been made, both the previous and potential registrants must make every effort:
- to reach an agreement on the sharing of the information requested by the potential registrant;
- to ensure that the costs of sharing the information are determined in a fair, transparent and non-discriminatory way.
See FAQ 102 for access to data submitted more than 12 years previously.
A previous registrant and a potential registrant have agreed on the sharing of information submitted less than 12 years previously or, following a data-sharing dispute, ECHA grants the potential registrant a permission to refer to the data. Rights and obligations - Ahead of the submission of their registration dossier by the potential registrant, the previous registrant may, according to Article 27(8), ask ECHA to extend the registration waiting period by an additional four months. Accordingly, the potential registrant, upon receipt of confirmation of the successful registration, will have to wait for an extra period of four months before being entitled to manufacture or import the substance.
The previous registrant can make the request to ECHA using the following email address: datasharing (at) echa.europa.eu. The previous registrant will need to provide the Communication number (such as INQ-C-xxxxxxxxxx-xx-xx) received from ECHA following the inquiry of the potential registrant. As a result, ECHA will inform, through REACH-IT, the potential registrant that the previous registrant requested to extend the registration waiting period by an additional four months.
ECHA may check the effective data sharing with the potential registrant.
Upon receipt of their registration number, the potential registrant will have to wait until the expiry of the additional waiting period before being entitled to manufacture or import the substance on the European market.
The use of published data to satisfy your information requirements requires you to have the right to refer to the full study report. Therefore, if you want to refer to a published full study report in your registration dossier, you have to check with the copyright owner to what extent you are allowed to use it in your own dossier.
In this case, you should negotiate a license or other form of agreement (e.g. letter of access) that will allow you to refer to the published data. For efficiency reasons, such an agreement should ensure that all the members of the joint submission have the right to refer to the data.
Copyright covers only the form of expression but not the facts and data included in the work. Therefore, facts and data can be included in the dossier without the consent of the copyright owner provided that the text of the study is not copied as such into your registration dossier. In other words, you can use the data to produce your own study summary but you have to make appropriate references and quotations to the original study to acknowledge the source of information. In addition, also in cases where you produce the study summary yourself, you must have the right to refer to the full study report for your registration. For more information, see the Guidance on data sharing, section 188.8.131.52.
All potential registrants of a substance must examine all available information and apply the relevant classification and labelling for their substance as it has been mutually agreed within their SIEF.
If they disagree with this classification, they may decide to ‘opt-out’ from this information requirement and propose a different classification, as long as they appropriately justify their decision (Article 11(3)(c), REACH).
Nevertheless, potential registrants of a substance in a low tonnage band do not have to contribute to the cost of a study if this study is not required for a registration in their tonnage band (Article 11(2), REACH).
Communication within a substance information exchange forum (SIEF) is greatly helped if one participant agrees to be a coordinator. The coordinator can propose how to organise the exchange of information on the substance.
At an early stage, the SIEF can already agree that one company takes over the organisation of the information exchange and the preparation of the joint submission. This is not, however, compulsory, as REACH does not set any conditions in this respect.
Where the information for exchange is considered commercially sensitive by one or more potential registrants (e.g. because of an impurity content that can indicate a production process), they can, for example, propose a confidentiality agreement or the use of an independent third party or trustee who can handle the confidential information on behalf of the potential registrants. Any other form of organisation is equally possible as long as it is agreed by all SIEF participants.
Detailed information on how to organise the SIEF and improve communication within SIEFs can be found in the Guidance on data sharing [Guidance under review – what to link do now? Also consider linking to homepage for practical info on SIEF formation?]: http://echa.europa.eu/guidance-documents/guidance-on-reach.
REACH-IT provides substance web pages, which support pre-substance information exchange forums (pre-SIEFs).
These pages have two free-text fields for posting information on creating SIEFs.
The first field is for the SIEF Formation Facilitator (SFF) who can use this to post messages on creating a SIEF and give contact details and information on further communication tools (e.g. dedicated industry websites).
The second field is for all pre-registrants of the substance. All messages are the exclusive responsibility of the authors and ECHA will not verify, approve or disapprove of their contents.
Potential registrants should work towards forming SIEFs as soon as possible, to ensure that there is enough time to organise data sharing and prepare the registration dossiers. The Guidance on data sharing explains how and when a SIEF is formed in more detail: http://echa.europa.eu/guidance-documents/guidance-on-reach.
A data holder is any person holding information or data relevant to a phase-in substance and who is willing to share it.
Data holders include:
- Manufacturers, importers and only representatives of non-EEA manufacturers of phase-in substances in quantities of less than one tonne per year who have not pre-registered;
- Downstream users of phase-in substances;
- Third parties holding information on phase-in substances;
Any party for which ECHA has information submitted under the Plant Protection Products Directive (91/414/EC) or the Biocidal Products Directive (98/8/EC) that meet the conditions established in Article 15 of REACH.
Data holders can sign-up in REACH-IT with a view to becoming a participant in the SIEF for that substance and can provide information to other SIEF members by submitting any or all of the relevant information listed in Article 28(1) to ECHA. More information can be found in 'The SIEF Participants' section of the Guidance on data sharing: http://echa.europa.eu/guidance-documents/guidance-on-reach.
SIEFs and consortia are two different concepts and must be clearly differentiated.
A SIEF regroups all pre-registrants of the same substance (and other data holders where relevant) and participation is mandatory for actors specified in Article 29 of REACH.
However, REACH does not define the way in a SIEF must cooperate to meet their obligations, nor does it regulate possible forms of cooperation between them for SIEF or other purposes.
There are several possible forms of cooperation that companies can choose to organise their cooperation under REACH. The forms of cooperation can vary from loose ways of cooperating (e.g. IT tools to communicate between all members of a joint submission) to more structured and binding models (e.g. consortia created by means of contracts).
It is often claimed that "consortium" must be formed (or consortium agreements signed) to organise the activities within a SIEF such as data sharing and the joint submission of data. This is not the case. It is participants not mandatory to form or be part of a consortium even if in certain cases (some) registrants may agree about the need to form one.
Consortium formation does not replace a SIEF. Participation in a SIEF is mandatory whilst membership of a consortium is entirely voluntary and may not necessarily regroup all participants of a particular SIEF, but may regroup only some of them or participants of more than one SIEF.
If some or all participants of one or more SIEFs decide to form a consortium, they are free to decide the arrangements regarding scope, purpose, duration, conditions for membership or leaving etc. as long as these do not contravene the Community competition rules. In addition, the members of the consortium must cooperate with any SIEF members that are not participants in the consortium or agreement.
Additional information on forms of cooperation can be found in the Guidance on data sharing: http://echa.europa.eu/guidance-documents/guidance-on-reach.
You cannot leave a SIEF. Even if your company ceases its activities with respect to the substance, you still remain a participant of the SIEF.
You are required to share information that you hold in accordance with the data-sharing provisions of REACH. However, you do not have to participate in any submission (or update) made by the members of the SIEF, nor in any additional related costs.
During the pre-SIEF phase, you can de-activate yourself from the pre-SIEF in REACH-IT to show that you are not interested in registering the substance. Even as a non-active participant, you may still be required to share your data.
Yes and, in practice, when you pre-registered phase-in substances with either the same name or same chemical identifiers as other potential registrants, REACH-IT automatically placed you in the same pre-SIEF with them. The SIEF is formed when the pre-registrants agree that they are intending to register the same substance.
If you register a phase-in substance before 1 June 2018 without previously pre-registering it, you will also enter the corresponding SIEF.
If you are a potential registrant of a phase-in substance but have not pre-registered, you must submit an inquiry to ECHA.
Information on SIEF participants and their obligations is given in the Guidance on Data sharing: http://echa.europa.eu/guidance- documents/guidance-on-reach.
ECHA has no role in forming the substance information exchange forums (SIEFs), neither confirming nor rejecting the creation of a particular SIEF. It is the SIEF participants’ responsibility to precisely define precisely the substance for which a SIEF will be formed.
The SIEF formation facilitator (SFF) is not formally recognised in the REACH Regulation, while the lead registrant (LR) is specifically foreseen and necessary for joint registrations.
Acting as an SFF is voluntary and not legally binding, i.e. the legal entity volunteering is taking the initiative to contact the others within the pre-SIEF. Potential registrants are not obligated to use a SFF to form a SIEF. They may even bypass the SFF to begin pre-SIEF discussions, if the SFF does not act.
In contrast, the SIEF must select a lead registrant who submits the joint registration before the other registrants in the SIEF can submit their individual (“member”) dossiers for registration.
Additional guidance on the role of the SFF is provided in the Guidance on data sharing http://echa.europa.eu/guidance-documents/guidance-on-reach.
A SIEF Formation Facilitator (SFF) cannot demand fees for their services unless this has been mutually agreed. An SFF is expected to contact other participants in the pre-SIEF to help the exchange of information and data which is required to form a SIEF. SFFs have no management role beyond facilitating discussions, and they have no legal basis to force other pre-SIEF participants to cooperate with them.
REACH data-sharing (and joint submission) obligations concern only multiple registrants of the same substance. Therefore, there is no legal mechanism to force different SIEFs to share the data.
Each request for access to studies across different SIEFs will have to be negotiated on a case-by-case basis by the concerned companies.
Further guidance on inter-SIEF rules can be found in Section 3.2.7 - 'Inter-SIEF rules (grouping, read-across)' of the Guidance on data sharing: http://echa.europa.eu/guidance-documents/guidance-on-reach.
If SIEF participants cannot agree who performs the new test (because there is a lack of volunteers or because there is more than one volunteer), they can make a request for ECHA (https://comments.echa.europa.eu/comments_cms/article302.aspx) to designate a registrant to perform the test. On the basis of objective criteria, ECHA will select the registrant who will perform the study.
For the 2018 registration deadline, it can be anticipated that the selection in most cases will be done randomly given the lack of significant differences among the potential registrants.
After the test is performed, all members of the SIEF, who require the study, contribute to its costs with the share corresponding to the number of participating potential registrants.
This procedure applies to situations where SIEF members agree that the test is needed but not if SIEF members disagree on whether the testing is required or justified.
More details are available in section 3.4.1 of the Guidance on Data sharing (https://echa.europa.eu/documents/10162/13631/guidance_on_data_sharing_en.pdf).
You can nominate a third party representative (TPR) to represent you in the joint submission and in data-sharing activities.
NB: The manufacturer or importer legally remains the pre-registrant or registrant. The TPR must not be confused with the third party holding information (i.e. data holders) nor with an only representative.
You can show your passive role to your co-registrants in REACH-IT. However, even as a non-active participant to the pre-SIEF, you may still be asked to share data in the SIEF.
The pre-registration and the registration obligation are not affected by the deactivation done in the pre-SIEF in REACH-IT. If you plan to continue manufacturing or importing the substance above one tonne per year after the registration deadline in 2018, you have to register it.
Even if you are passive during the SIEF work, you have the shared responsibility of the data submitted as part of the joint registration. Therefore, you need to understand the data and agree on it with your co-registrants even if you are not actively engaged in compiling it.
More information on deactivating in REACH-IT can be seen in Q&A 347.
As you have pre-registered, you have become part of the SIEF for the substance. Other SIEF members may request information for the purposes of registration from you. If you possess such information, you will have to provide it upon request and subject to financial compensation, if applicable.
When submitting an inquiry, you show the data requirements needed for the tonnage band you intend to register.
You will then receive access to the co-registrants page in REACH-IT, which gives you information on the previous and potential registrants (inquirers) as well as access to information regarding the pre-SIEF (namely on other potential registrants who are pre-SIEF members, i.e. who (late) pre-registered but have not yet registered).
Additionally, ECHA specifies whether (some of) the data has been submitted more than 12 years ago.
It is important to distinguish the date of submission from the date of the performance of the study, which pre-dates the submission itself. The 12-year rule applies from the moment the particular study is submitted, regardless of when it was performed.
Additionally, the date a specific test result was submitted to the competent authority is not necessarily the same as the original notification date.
Indeed, the test may have been submitted afterwards (e.g. after a tonnage band increase up to the next level of testing) and hence the 12-year period may not yet have expired. Further information can be found in the new (draft) Guidance on data sharing chapter ‘4.6.1. The “12-year rule” ‘.
The study summaries or robust study summaries submitted in the framework of a registration of the same substance under REACH at least 12 years previously are attached as an annex to the ECHA communication sent to the inquirer. However, the information in the endpoint summaries that ECHA provides may not be sufficient to pass the technical completeness check (TCC), because:
- certain data were not migrated into the required IUCLID format and will need to be manually corrected; and/or
- certain administrative information may be missing in some fields or sections.
Similarly, the quality of the data provided needs to be assessed by the potential registrant. You may need to contact the previous registrant to
ask for more details or may consider other sources to obtain better information if quality is too low.
ECHA also informs the previous registrants that an inquiry about one of their substances has been submitted.
If you are interested in receiving data submitted more than 12 years ago to use for read-across [add reference to read-across Q&A?], you can contact ECHA to request such data in accordance with Article 25(3). Note that you are required to:
- Show your real intentions to register or update your registration dossier, by providing ECHA with the pre-registration numbers, registration numbers or inquiry numbers and the EC number for your substances;
- Provide a description of why you need the data and how you intend to use it (e.g. for read-across);
- Submit a declaration that "The data provided shall be only used for registration purposes under the REACH Regulation";
- List the endpoints that you would require information for.
Also note that access to data does not provide ownership of the data. According to REACH, any data submitted more than 12 years previously can only be used for the purposes of registration.
Any potential registrant of a non-phase-in substance or of a phase-in substance which has not been pre-registered has to inquire from ECHA, whether a registration has already been made for the same substance (Article 26 of the REACH Regulation).
A registrant willing to update its dossier has to also previously submit an inquiry (Article 12(2) of the REACH Regulation).
This is to ensure that data are shared by all registrants of the same substance, and that the joint submission obligation can be met.
In accordance with REACH, studies involving vertebrate animals should not be repeated and available studies need to be shared.
The inquiry and its outcome will depend on whether the data concerning a prior registration, if any, has been submitted more or less than 12 years before the date of the inquiry:
Figure 1: Data sharing process following an inquiry
Further details on the inquiry procedure can be found on ECHA’s website at: http://echa.europa.eu/regulations/reach/substance-registration/inquiry.
Following an inquiry the potential registrant will receive a communication from ECHA on whether the substance has previously been registered (or notified under Directive 67/548/EC on classification, labelling and packaging of dangerous substances). In that case, ECHA will inform the potential registrant of the names and addresses of the previous registrants and, if appropriate, other inquirers. This communication will enable the potential registrant to request the sharing of existing data.
If the potential registrant did not, at the time of the inquiry, list the endpoints they require to register, ECHA will only inform them about the identity of previous registrants.
In the inquiry, the potential registrant can indicate to ECHA the information requirements applicable to them.
- See FAQ 102 for further information if studies were submitted at least 12 years previously.
- See Q&A 424 for further information if studies were submitted less than 12 years previously (see Q&A 424)
Note that if studies have been submitted less than 12 years previously, the potential registrant has to request directly from the previous registrants the (robust) study summaries they require to register. Such a request must be made for any studies involving vertebrate animals. However, a request may be made for studies not involving vertebrate animals.