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Data Sharing

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.

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