What happens to my dossier next?

Approximately 25.000 dossiers for 4.300 substances have been submitted to ECHA until December 1, 2010. What is the next step to follow?

The next step for ECHA will be the evaluation on the quality of the dossiers.

ECHA will evaluate at least five percent of the dossiers and will also focus on dossiers that e.g.

•    have different classification or study summaries in joint submissions
•    do not meet the requirements of Annex VII
•    contain waiving statements or are based on other substances data
      like e.g. “read across”
•    contain testing proposals for Annex VII or VIII
•    are for a substance that is difficult to test based on its chemical
      and physical properties
•    are in a bad quality, discovered e.g. in the testing proposals.

Discovering missing information, wrong or insufficient declarations, ECHA will inform the registrant(s) and will set an appropriate time-limit for submitting the required information.

However, registrants will also be granted a period of 30 days to interact with ECHA by commenting on ECHA’s decision or the decision of the Member State Committee.

Most deficiencies discovered by ECHA are based on non-specified substance identity, inadequate justified applications for QSAR, read across or grouping, incomplete exposure scenarios or inadequate justification for discrepancies of the information within annex VII to XI.

New challenges for the 2013 registration period

The first registration period has ended December 1, 2010, and most of the substances manufactured or imported by a company in high tonnages, i.e. above 1.000 tonnes per year, have been registered. SIEFs were often lead and supported by big companies and the global players.

For the coming registration period in 2013 a lot of medium-sized and small companies have to fulfill their registration duties. For them, REACH obligations may be a huge challenge regarding the capacity of personal, expertise and financials.

A company not having made their registration experience with the first wave in 2010 will discover several difficulties on the way to a successful registration.

A larger number of registrants, missing experience and expertise from the Lead Registrant as well as the other SIEF members may protract and bloat the whole process. Experienced companies as well as competent authorities recommend to start with preparations for the 2013 registrations in early 2011 and to seeking help and support in time when discovering unforeseen questions and issues.