REACH - the challenges in 2011 and beyond

As the first wave of notifications to the European Chemicals Agency (ECHA) has now passed it is important to identify some of the challenges and considerations for 2011 and beyond.

• ECHA will be evaluating a minimum of 5% of the submitted dossiers. Those who submitted in November 2010 should be starting to hear back from ECHA regarding the evaluation of their dossiers. ECHA has now published its report on evaluation listing the most common shortcomings found in the submitted dossiers. ECHA have recommended that registrants review this report and take a pro-active approach to updating their dossiers, taking into consideration the comments made.
  
• Many of the dossiers submitted by the November 2010 deadline will contain Annex XI and X testing proposals, all of these proposals will be reviewed by ECHA. As part of the need to minimise animal testing, ECHA will publish on its website a list of substances for which testing proposals have been submitted. Once the testing proposal has been published 3rd parties have 45 days to submit 'scientifically valid information' and studies which address the substance and endpoint in question and which could be taken into account by ECHA in preparing its decision on the testing proposal. Registrants should hear back about the status of their testing proposals from ECHA by December 2012 for all registrations received by 1 December 2010.
• With ECHA recently recommending that eight substances of very high concern should be subject to authorisation, EU or EAA producers or importers of articles containing substances on the candidate list for Substances of Very High Concern (SVHC) may need to submit a notification to ECHA. This is required under REACH article 7 (2) when the substance is present in the articles in quantities over one tonne per producer or importer per year and if the substance is present in those articles above a concentration of 0.1% (w/w).
  
  For any substance included in the candidate list before 1st December 2010, the notifications will have to be submitted not later than 1 June 2011 - if the substance is included in the candidate list after this date then the notifications have to be submitted no later than 6 months after the inclusion.
• Companies may start to receive exposure scenarios (ES) as part of the new safety data sheet requirements, these ES derived from the Chemical Safety Report (CSR) include operational conditions, risk management measures and routes of exposure workers, the public and the environment. Once received the ES has to be reviewed by the downstream users (DU) to check several key issues:

1. has their use been covered;
2. does the way the use has been described in the ES match the way the DU uses the substance; and
   
   
3. do the Risk Management Measures (RMM) described in the ES compare to how the DU protects their workers, consumers or the environment.
   

If the use has not been covered the DU has 6 months to report this to ECHA and may be obliged to create their own CSR. The DU has 12 months to comply with the ES once the SDS containing the registration number and ES has been received.

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