REACH: Taking Steps to Register Preregistered Substances

By: Annelie Struessmann, PhD, CONUSBAT

Posted: January 13, 2009

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The participants in the SIEF will be the potential registrants and data holders, which includes early registrants. Potential registrants are manufacturers, importers and only representatives of non-EU manufacturers. Any manufacturer or importer may appoint a third party representative, especially when a company does not want to disclose commercial secrets.

The third party representative is responsible for tasks relating to data and cost sharing, while the responsibility for the registration remains with the nominating legal entity. The third party representative should not be confused with only representatives, who are legally responsible for the registration.

In addition, the role of an independent third party exists and is different than a third party representative. Independent third parties act as trustees for a consortium or a group of companies in cases where participants need to preserve information, such as confidential data on know-how and figures for cost sharing, or where areas are tangent to the EC competition rules.

Key Summary:
• The first deadline for registration of preregistered substances is November 30, 2010;
• This deadline applies to high volume substances and substances constituting high risks to humans and the environment;
• The subsequent step to preregistration is identification of the SIEFs since REACH requires the exchange of existing test data;
• The organizational form of a SIEF is left to the participants;
• REACH requires the costs of sharing information to be fair, transparent and non discriminatory;
• Any manufacturer or importer may appoint a third party representative for data and cost sharing in a SIEF;
• When appointing a third party representative the legal responsibility for the registration remains with the nominating entity;
• Independent third parties and third party representatives should not be confused;
• Independent third parties act as trustees for a consortium or a group of companies where confidential data is exchanged or where areas are tangent to the EC competition rules.

Do you have further questions? Visit C&T magazine's REACH Round Table.