One of the major objectives of data sharing within REACH is to avoid duplicate testing, including vertebrate animal testing. Data sharing can be done by formation of SIEF or consortia by the Indian exporters and manufacturers. While the formation of SIEF is obligatory for all the manufacturers exporting similar chemicals to the EU, formation of consortia is a voluntary initiative.

"Before testing is carried out", participants in a SIEF inquire whether a relevant study is available within the SIEF. If it is available, the participants shall request that study (in the case of tests on vertebrate animals) and may request data (in the case of information not involving tests on vertebrate animals). This request for missing information then triggers the obligation for the data owner to provide proof of its cost and further data sharing obligations.

In practice, however, it may often be more practical to use more direct forms of co-operation to gather required information, to agree on the necessary data package and on classification and labelling, and to prepare for the joint submission of data. This can involve a joint review of all available data (including publicly available data). This more complete exchange may allow participants to determine and agree on classification and labelling, draft study summaries, agree on testing proposals, jointly draft a chemical safety report, agree on guidance for safe use, etc. Consequently, it is recommended that SIEF members work together in the identification of existing information (including publicly available data) and data needs, the generation of new information, and the preparation of the joint registration dossier (“collective route”).

Data Holders will receive a financial compensation for the data they share with potential registrants. As Data Holders are not expected to register the substance, they do not have in a strict sense “a share” in the registration of the substance and therefore are not involved in the preparation of the joint registration dossier. Likewise, they are not required to pay any cost linked to the preparation of the dossier or related to the organization of the data-sharing among SIEF members.

Dispute resolution in data sharing

The REACH Regulation sets out a specific procedure in case the owner of a study refuses to provide proof of costs of the study or the study itself within a month from the request. The procedure differs for data on vertebrate or non-vertebrate animals.

Data on vertebrate animals

The owner of the study will not be able to proceed with his registration until he provides the requested information and he could be penalized (penalties to be laid down by Member States). In cases where the data holder refuses to provide proof of the cost of the study or the study itself, the potential registrant requesting the information will be able to register without fulfilling the relevant information requirements, which he has to explain in the dossier.

Within 12 months from the submission of the registration dossier, ECHA may, however, decide that the missing test must be carried out by the registrant that did not have access to the available study. In addition, if within this period of 12 months a relevant study has been submitted by another registrant, ECHA shall give him permission to refer to such study (the owner of the second study is entitled to compensation if he makes available the full study report).

Data on non-vertebrate animals

The other SIEF Participants must proceed with registration as if no relevant study is available in the SIEF. They will therefore have to carry out the test in order to obtain the information needed to meet the requirements of the registration dossier. However, the owner of the study who refused to provide proof of cost or the study will be penalized (penalties to be laid down by Member States).

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