SUNIVO REACH Newsletter(5)

ISSUE 5-24th March 2009

Liability related to data sharing

In addition to obligations of SIEF Participants laid down in REACH and sanctions contemplated by the Member States for non compliance with those obligations, national law will govern the liability of SIEF Participants (and other REACH actors). The liability of SIEF Participants may be engaged, for example, in cases of misrepresentation of the quality of the studies provided to other participants in SIEFs, or that of a Lead Registrant engaged for failure to register a substance in time (unless the failure can be attributed to other SIEF members). These issues are not dealt with by REACH, and can be affected by contractual arrangements between parties, subject to national law. As a general rule, private parties are free to organise their relationship by contract and to organise their contractual liability, subject to the mandatory provisions of the national law of the Member States that, for example, may rule that some liabilities cannot be contracted out. Below is a list of issues that the different categories of SIEF should be careful about when sharing information under REACH as they may trigger their liability:

● Potential Registrants are liable towards the authorities for the content of their own registration. But they may also be liable towards other Potential Registrants (within or outside a SIEF) for example for misrepresentations related to the ownership or the quality of studies or information provided.

● With regards to independent Third Party Representatives and Only Representatives, it is advisable to specify a clear allocation of obligations and responsibilities by contract between the SIEF or non-EU manufacturer and his representative. It should be noted that such contractual arrangements cannot eliminate the responsibility of an Only Representative under REACH and can only affect the relationship between the Only Representative and the non-EU manufacturer.

● Similarly, it seems advisable for companies using independent Third Parties to exchange confidential information to make contractual arrangements between the affected companies and the independent Third Party.

● Lead Registrants will prepare the part of the dossier which will be submitted jointly on behalf and with the agreement of the other registrants. Technically, only the Lead Registrant will submit the joint part of the dossier on the REACH IT system.

● Data Holders, as other SIEF Participants, should be mindful of property rights and quality issues when making representations and granting rights on studies available to them.

SUNIVO Recommendation: Unless a consortium has legal personality, consortium members will generally be jointly liable towards Third Parties. Respective liability of consortium members between themselves can be organized in the Consortium agreement.

Sources: European Chemicals Agency (ECHA)

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