REACH Registration 2013 & Substance Identity

The deadline for industry to register all phase-in substances manufactured or imported in the EU at and above 100 tonnes and below 1000 tonnes a year under REACH is 31. May 2013.

If you have followed the ECHA time line for the next registration deadline under the EU chemical regulation REACH, your company should have carried out substance identification for the substance to be registered by now!

Substance identity was defined by the European Chemicals Agency (ECHA) as the first issue in their Evaluation Report 2011. Accuracy in the Substance ID data provided in the registration dossier in 2010 was found by ECHA to be ambiguous in many cases. Define your substance precisely and according to the ECHA guidelines and save your company a lot of hassle, money, time and the risk of not being allowed to market your substance in the EU.
REACH dossiers are filtered by ECHA, when the substance to be registered is not clearly identified in the submitted registration dossier. Hence, the likelihood of your submitted dossier being selected for a compliance check is higher and hazard data provided is under more scrutiny, if the substance ID data in your dossier is not clear. Testing proposals with unclear or lacking substance identification data will end up back on your desk for revision.

Why is it so extremely important to get your substance identity correctly done and submitted to ECHA? A registration of a chemical substance under REACH is based on the identity of the registered substance. The data your company provides determines whether you pre-registered the correct substance, you are taking part in the relevant SIEF and you are about to register the right substance. Hence, substance identification is an essential part for the valuation processes and needs to be unambiguous and accurate according to the ECHA Evaluation Report 2011.

Regardless of whether your company is buying a Letter of Access (LoA) for a joint registration as a member of a SIEF, is a consortium member, is registering a new substance via the REACH inquiry process, or is submitting a dossier for an intermediate substance, in each case you as the registrant, on your own and separately from the other registrants, have to define your substance according to the REACH criteria in your individual part of the registration dossier.
Whether your company is dealing with a mono, or multi constituent substance, or with substances of unknown or variable composition, complex reaction products or biological materials (UVCB), the appropriate substance identification data will have to be generated at an early stage of preparing for your REACH registration submission, if you do not have these data available in-house already.

Based on the expertise of SGS, having carried out substance identification for a multitude of substances and clients, we advise you to take action now, as laboratory capacity can run very tight when it comes close to the registration deadline. That is why we at SGS encourage all 2013 registrants to start with their substance identification now, to ensure you have all required data in time for the submission deadline.

Important to keep in mind is that analytical results alone will not suffice ECHA to fulfil the substance identity requirements. All the data on identity and composition in your registration dossier needs to be supported by appropriate analytical information and description of the methodology. Both qualitative and qualitative analytical data is required to confirm your substance’s ID reproducibly.

Hence, clear substance identification is a pre-requisite for a successful REACH registration.

Contact us at SGS for a free offer to carry out the necessary analytical testing on your substances and provide you with all the information needed for the individual part of your REACH registration dossier!

Contact details:

Dr. Anne Kleinkauf
REACH Consultant
Quality Management
SGS INSTITUT FRESENIUS GmbH
t +49(30)84718271
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Register and join one of our free REACH Webinars on “Registration 2013 & Substance identification”

11. May 2012
10:00 – 11:00 am Europe Summer Time (Paris, GMT+02:00) - in English

15. June 2012
4:00 – 5:00 pm Europe Summer Time (Paris, GMT+02:00) - in English