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REACH

Data Sharing

A. Data sharing, general

How can communication within a joint submission be facilitated?

At an early stage, the co-registrants 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 existing and/or potential new co-registrants.

Detailed information on how to organise and improve communication between co-registrants can be found in the Guidance on data sharing.

Can I continue using SIEFs after the registration deadline of 2018 and what is the difference between a substance information exchange forum (SIEF) and a consortium?

There are several possible ways in which companies can organise their cooperation under REACH. These 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).  

Participation in a SIEF (substance information exchange forum) was mandatory for phase-in substances until the last REACH registration deadline of 31 May 2018. After the end of the phase-in period, however, the Commission Implementing Regulation 2019/1692 of 9 October 2019 encourages co-registrants to use similar informal communication platforms to enable them to meet their continuing registration and data sharing obligations under REACH and Commission Implementing Regulation 2016/9. 

Membership of a consortium is, on the other hand,  entirely voluntary. If some or all participants of one or more informal communication platforms 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 EU competition rules. 

Additional information on forms of cooperation can be found in the Guidance on data sharing.

What is a letter of access (LoA) under 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.

I am having difficulty cooperating with a previous registrant. What can I do?

It is the common responsibility of the potential and the existing registrant(s) to negotiate and agree on the content of the joint registration dossier, submitted by a lead registrant. In the case of information submitted less than 12 years prior to the inquiry, Article 27 of the REACH Regulation requires that both potential and previous registrants make every effort to reach an agreement on the sharing of the data and its costs in a fair, transparent and non-discriminatory way. You can find here practical advice on data sharing negotiations. 

In case you fail to reach such an agreement, you may, as a last resort measure, contact ECHA in accordance with Article 27(5) of the REACH Regulation. Please find more details under point 5 here.

How are the costs of data shared and can I receive support from ECHA if costs do not seem justified?
The costs 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.
 
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 make every effort to reach an agreement on data sharing and its costs in a fair, transparent and non-discriminatory manner. Registrants need to share the costs of information that they are required to submit to satisfy their registration requirements. Companies cannot be forced to pay for studies that they do not need. 
 
ECHA has published generic advice on what to take into account during the data-sharing negotiations. Additionally, practical advice for data sharing negotiations is available.
 
ECHA will not participate in the discussions between (potential) registrants and has no remit in regulating or assessing the costs of sharing data. ECHA 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 detail on data-sharing disputes, please refer to the corresponding page on ECHA’s website.
 
The Guidance on data sharing provides more details. 
B. Data sharing, registration

How do I get access to data submitted more than 12 years ago for notifications under Directive 67/548/EEC?

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). 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. 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, you can contact ECHA to request such data in accordance with Article 25(3) of REACH. Note that you are required to:

  1. 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;
  2. Provide a description of why you need the data and how you intend to use it (e.g. for read-across);
  3. Submit a declaration that "The data provided shall be only used for registration purposes under the REACH Regulation";
  4. 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.

Do I have any data-sharing obligations after I have submitted my registration?
You can have further duties to share data even after you have submitted your registration. This can happen in the following cases:
 
  • When potential registrants are informed of the previous and other potential registrants (and vice versa) by ECHA following an inquiry pursuant to Article 26 REACH;
  • After the successful submission of the registration dossier, whenever new information becomes available. In such cases, according to Article 22 REACH, registrants 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 chemical safety report;
  • As a consequence of dossier evaluation by ECHA (compliance check or the assessment of a testing proposal) or 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. For substance evaluation cases, these 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.
How to obtain data submitted less than 12 years previously from a previous registrant?

The situation:

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 it concerns vertebrate or non-vertebrate animal studies.

The process:

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 Q&A 102 for access to data submitted more than 12 years previously. 

What can I do to extend the waiting period of the new registrant to benefit from the provisions of Article 27(8)?

The situation:

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 process:

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.

If I have pre-registered but cease to manufacture or import before the deadline, do I still have obligations?

The objectives of data-sharing are to avoid the duplication of work and in particular to reduce testing involving animals. These objectives are still fully relevant after the end of the phase-in scheme. Therefore, it is in line with the objectives of data sharing under REACH, as well as in the interest of potential registrants and in your own interest (as you will get compensated) to share data with potential registrants.

Can I use existing study reports for my registration without having the owner’s consent?

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 3.3.3.8.

Do potential registrants of a substance in a low tonnage band need to apply the classification and labelling attributed to the same substance at a higher tonnage band, if they have no access to the relevant study? Do they have to contribute to the cost of this study?

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).

I need data for a read-across. How can I contact the Lead Registrant of another joint submission?

There is no formal procedure to get in contact with the joint submission of another substance for read-across purposes. You can look up the details in our dissemination portal for registered substances, and contact any of the registrants whose name appears, asking for the lead registrant’s contact details. You can then contact them in order to find a data sharing agreement.
Alternatively, you can use our contact forms and request ECHA to share your contact details with the lead registrant of the joint submission of interest. We will then contact the said lead registrant and encourage them to contact you.

Please note that data sharing between different substances for read-across purposes is not mandatory. However, the Commission Implementing Regulation (EU) 2016/9 of 5 January 2016 on joint submission of data and data sharing underlines the benefits of data sharing between different substances. Therefore, data sharing between similar substances is strongly recommended, but it cannot be imposed by ECHA.

C. Third Party Representative (TPR)

Can a third party representative register?

No, under REACH, a third party representative (TPR) cannot register. A TPR can be appointed by a manufacturer, importer or downstream user for data sharing issues and discussions with other manufacturers, importers or, where relevant, downstream users. Unlike an only representative, a TPR only plays a part in the negotiations between the (potential) registrants, while the appointing company remains responsible for complying with its registration obligations.

What should I do if I change my Third Party Representative (TPR)?

If a (potential) registrant changes its Third Party Representative (TPR), the new TPR will have to create a REACH-IT account (provided he does not have one yet).
In case of a change of TPR, the following steps have to be taken by the (potential) registrant in order to update the details of its TPR:

To update a TPR in a registration submission: Go to menu -> Search -> Reference numbers -> Input the number in the search criteria -> Click on the results -> Click on Edit under Third party representative -> Add the new TPR.

No fee is required if the TPR is updated in a registration dossier.

Can I hide my identity in the registered substances page on the ECHA website using a third party representative?

No. The identity of the registrant will be published unless a confidentiality claim on the identity of the registrant is included in the registration dossier and the justification accepted as valid by the Agency.

A third party representative (TPR) can only be used to represent potential registrants in discussions with other manufacturers, importers and downstream users on data sharing and the joint submission of data as specified in Article 4 of REACH. The identity of the TPR is not published on the ECHA website. It will only be visible in:

  • the potential registrants tab in the REACH-IT co-registrants page, if included in a successful inquiry notification;
  • the registrants tab in the REACH-IT co-registrants page, if included in a successful registration dossier;
  • and in the joint submission, if included during creation (lead registrant) or confirmation (member registrant) of the joint submission in REACH-IT.
What should I do if I do not want to reveal my identity to my competitors?

You can nominate a Third Party Representative (TPR) to represent you in the joint submission discussions and in data sharing activities. This will keep your company name confidential vis-à-vis other co-registrants.

NB: The manufacturer or importer legally remains the registrant. The TPR must not be confused with the third party holding information (i.e. data holders), nor with an Only Representative. The TPR must also not be confused with the possibility to keep confidential the registrant’s name for registration purposes (Article 10(a)(xi) REACH).

For more information, see the Guidance on data sharing, section 3.2.3.1. Q&A 352 explains how to assign a TPR in REACH-IT.

During the Inquiry process: We display on the co-registrants page in REACH-IT the contact details of the TPR to registrants and successful inquirers. However, we communicate the result of the inquiry process to the inquirer and not to a designated TPR.

After the Inquiry result/ after Registration: It is also possible to appoint a TPR acting on behalf of the registrant after having registered a substance for data-sharing negotiations. You can appoint or change your TPR by updating your registration dossier. See Q&A 0063.

A TPR ensures that the potential registrant does not appear on the co-registrants page. To ensure confidentiality of the same company after the registration number has been granted, see Q&A 401.

D. Data sharing, downstream user

Can a downstream user share data?

Yes, they can, and are encouraged to do so if they hold significant data that will be valuable for registrants when compiling their registration dossiers. In practice, downstream users have to submit certain information (substance identification, contact details) to ECHA to be recognised as a data holder for a substance, after which ECHA puts them in contact with the potential registrants.

Data holders are entitled to be compensated for their data used for registration. More detailed information is available in the Guidance on data sharing, Section 3.2.3.2.

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