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Help for registrants still blocked by data sharing disputes

News Alert
ECHA/NA/10/73
Media enquiries: ECHA Press

Helsinki, 26 November 2010 - Until 30 November at noon (Helsinki time), companies can request ECHA's help when they cannot agree with a previous registrant on sharing the costs of data already registered.

ECHA provide assistance to potential registrants having lodged a data sharing dispute until close to the registration deadline.

ECHA allow them to submit a registration dossier, even if the final decision has not been taken on their data sharing complaint. This is a temporary solution to enable these potential registrants to submit dossiers while their data sharing dispute is still awaiting resolution.

In any case, these potential registrants must be able to demonstrate that they have made every effort to share the cost of submitted data in a fair, transparent and non discriminatory way and that the other party did not make such efforts.

The data sharing dispute procedure requires to fill in the Article 30(3) form on ECHA's website and to provide all the documentary evidence requested.

Although the registrant is able to submit a dossier following the instructions provided by ECHA, he will fail the technical completeness check (TCC). However, ECHA gives him a deadline (TCC deadline) by which he must submit all the information needed to complete his registration dossier – including the missing data.

Then, one of the following two scenarios will happen:

  1. If ECHA decides to grant him permission to refer to the disputed data, ECHA will provide him with a copy of the (robust) study summaries available in our database, so that he can fulfil his other REACH obligations. However, his registration will only be successful if he is able to submit, before the TCC deadline, the data not involving testing on vertebrate animals. He will then be granted a registration number, after paying his invoice.
  2. If ECHA decides not to grant him permission to refer to the disputed data or if he is not able to submit the non-vertebrate animal test data, he will fail the check performed at the TCC deadline and will not receive a registration number. From then on restrictions may apply to his production or import activities for the substance (see section 1.6.2.3 of the Guidance on Registration), and other legal consequences may apply.