There is just 5 months to go to the Tier 2 registration deadline of May 31st 2013.

While most companies who have an obligation to submit a joint registration will be concerned about Letter of access, ECHA and consultant fees, an important task is often overlooked is to prepare an analytical dataset for the substance(s) that require registration. This task often ends up being on the critical path to completing a joint registration in time. This articles aims to provide to some useful tips to ensure that you plan for this activity.

SIEF/Consortium Engagement:

The first port of call is the SIEF (substance information exchange forum) or Consortium for the substance to ensure that your substance is the same as registered by the Lead Registrant. Most substance SIEF’s will share with all pre-registrants of the same substance a Substance Identification Profile (SIP). The SIP is what the lead members of the SIEF have agreed to be the minimum purity for substance.

As a potential registrant, if your substance agrees with the purity profile as outlined by the SIP, then you can proceed and register your substance as part of the joint submission created by the SIEF for the substance. However, if your substance falls outside of the purity levels agreed within the SIP, then you may need to provide a justification for this or even possibly submit a full registration on your own.

Secondly, request the SIEF/Consortium to provide guidance on a recommended analytical dataset to be included in your registration dossier. Most SIEFs and Consortia will provide guidance on this as the Lead members will have already filed their registration dossiers. SIEF/Consortium guidance is especially useful when registering an inorganic substance as the required techniques for this type of substance is not clearly outlined in the guidance documentation.

Locate a source for the data:

In the instance that you have access to the required data in house or from your supplier, make sure to perform a QC on this data and ensure that

  • a sufficient description of the method used is included, (to allow reproduction if necessary)
  • information on the conditions of this analysis is outlined
  • The sample and substance id is clearly marked
  • The results are clearly outlined
  • Interpretation of the results are made including peak assignments where necessary

If you do not have access to analytical data, then substance characterisation will need to be completed by a contract research organisation or laboratory. Analytical does not need to be prepared according to GLP or any specific standards. Simply, a detailed description of the methods used needs to be included. This should provide registrants with a lot more potential options to use for contract research.

For more information on this minefield contact us for a free 30 minute consultation.