Update on the ECHA data sharing web pages

News Alert
ECHA/NA/10/44
Media enquiries: ECHA Press

ECHA's data sharing web pages have been updated. They explain now also how companies can contact ECHA when data on vertebrate animal studies are not shared in a SIEF, before or after the submission of the joint registration dossier. There is a new web form available to notify this type of data sharing dispute to ECHA.

Helsinki, 30 July 2010 - To facilitate finding information relating to data sharing disputes, ECHA has transferred the information contained in its web pages to a Questions & Answers on Data sharing and related
disputes.

Potential registrants of the same substance must share at least data involving tests on vertebrate animals in order to meet their information requirements for the purpose of registration. It is the responsibility of the negotiating parties to make every effort to reach an agreement on the costs of sharing that information in a fair, transparent and non discriminatory way.

ECHA can assist companies that, in spite of their efforts, have failed to reach an agreement on data sharing. However, the parties involved should exhaust all options for negotiations before seeking ECHA assistance.

Potential registrants involved in a data sharing dispute shall always obtain a decision from ECHA granting the permission to proceed with registration in spite of the dispute, before submitting their registration dossier.

As a result, ECHA encourages particularly all SIEF members to implement their data sharing obligations in a timely manner. Especially in relation to registrations required by 1 December 2010, negotiations must be conducted without delay, even if the joint submission dossier is still being completed. Potential registrants subject to the first registration deadline should exhaust the negotiations and inform ECHA about any disputes before the end of September 2010, if they wish to obtain a decision from ECHA before that deadline.

The applicant will have to complete a webform and will have to provide appropriate documentary evidence to demonstrate the efforts made to reach agreement. ECHA will then contact the other negotiating party to get its feedback. ECHA will then assess the efforts of all the parties to meet their obligation to reach an agreement on sharing the data. Finally, ECHA will decide whether granting or not a permission to refer to the data disputed in order to proceed with the registration.

The registrants or potential registrants that do not comply with their data sharing obligations may also be subject to financial penalty by the enforcement authorities of the Member State where they are established.