ECHA recently presented Substance Sameness for REACH Registrationa webinar outlining the importance of substance identification and sharing of data for the 2013 registration deadline. While this is a very pertinent issue for companies that have a registration deadline for a phase-in substance in 2013, it also has consequences for companies who do not have an obligation to register until 2018. It is important to confirm at an early stage in the registration process that the substance you intend to register is the same as all the other potential registrants.
Substance Identification Profiles and SIEFs
Most substance SIEF’s (substance information exchange forum) 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 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.
What analytical data is needed?
The other aspect of SIP is that it outlines what the analytical data needs to confirm as part of the registration dossier. Each registrant, either as Lead or as Joint registrant, needs to include a set of analytical data in their registration to confirm their substance identity and purity. Typically spectral data such as UV, IR and NMR and also a set of chromatography data needs to be included. The SIP will act as a guideline as what the set of analytical data should adhere to.
For companies that do not manufacture the substance that they intend to register, i.e. Importers and Only Representatives; these companies should pass the SIP back up the supply chain to their supplier and request the supplier to confirm that the substance meets the criteria outlined in the SIP.
For all of the reasons as outlined, it is very important to ensure that all potential registrants check the SIP before proceeding with registration, regardless of your registration deadline.
If you have any doubts about your obligations under REACH please dont hesitate to contact the experts at H2 Compliance for a free consultation or more resources to help your company stay compliant and maintain EU market access.
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