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Denehurst Chemical Safety Ltd

REACH SIEF support ('trustee')

After pre-registration, organisations intending to register substances will need to work together to share test data and to agree classification and labelling end points - this will be through a Substance Information Exchange Forum (SIEF).  Organisations working together within a SIEF may form a consortium to share costs and to agree working practices.

Denehurst is able to work within a SIEF to provide independent advice on registration strategy, review of data and end point assessment for classification.

A SIEF Management Service is also available

SIEF Formation - early problems and issues from January 2009

Life in a SIEF - things to consider

Keeping key commercial information confidential - the 'Trustee'

SIEF Training - training courses on being in a SIEF; technical and personal skills

SIEF support service

Organisations who pre-register chemical substances will be informed by the European Chemical Agency which other organisations have also pre-registered and all interested parties will be invited to join a substance information exchange forum (SIEF).  The main purpose of this SIEF is to ensure that all existing test data on vertebrates is shared and that there is no duplication of new test work on animals.  A second objective of the SIEF is to agree on the hazard classification of the the substance to prevent different suppliers of substances having different labelling.

The group of organisations working together is effectively a 'consortium' and beyond the legal requirements for sharing data within a SIEF, there is little guidance available - industry will be free to work together (within the limits of anti-competition laws) in any way they see fit that meets the requirements of the SIEF.   

The concept of working with competitors to share work is going to cause a number of problems, not least the idea of having to trust other companies to work with you fairly at times when sharing costs.  Many legal firms are giving good advice on how to work within competition laws and this advice generally includes making notes of all meetings of the SIEF and even having independent observers.  The reality is, however, that many of the decisions of a SIEF will be made by telephone and e mail as to arrange meetings within all SIEFs for every decision will be impossible - if you have 50 substances to register, that could be 50 SIEFs and suddenly your whole life is one long meeting.

Denehurst is offering a service to help support SIEFs though independent review of data, finding gaps in data, proposing classification and completion of the IUCLID dossier - through use of technical support within a SIEF, there is less need for time consuming meetings.  Links have been established with specialist toxicologists and enironmental scientists to help cover this support.

Denehurst has already been involved in consortia support under the Existing Substances Regulation in Europe and has also helped broker data share agreements for repeat Notifications under NONS. 

Denehurst Chemical Safety Ltd - supporting industry