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“Reach” ing an agreement on data sharing


Dr Knoell Consult Ltd., 22 Cathedral Road, Cardiff, CF11 9LJ, United Kingdom


Now that the 2013 REACH deadline has passed, it will be the turn of smaller companies to make registrations before June 2018. While some registrants will be able to purchase letters of access to joint registrations submitted earlier, others will find that they will become the lead registrant. Although REACH places an obligation on data holders to share data, it does not lay down rules for how this should be accomplished in a fair, transparent and non-discriminatory manner. Companies who are new to negotiating data sharing agreements are advised to consider the suitability and quality of data that they wish to share and the cost elements contributing to the cost of a letter of access to a complete dossier.

With the second phase of registrations under REACH (1) completed in 2013, attention must now turn towards the final deadline for phase-in substances of 1st June 2018. With the large production volume substances already registered (mainly by larger companies), it will be the turn of an increasing number of small and medium sized businesses (SMEs) to bear the responsibility as lead registrants to submit the registrations.
The cost to companies of complying with REACH is high and this is of particular concern to the SMEs which form the majority of EU businesses. Between 2010 and 2013, ECHA reported an increase from 14% to 20% of SMEs making REACH registrations (2, 3), while at the same time reporting that the ratio of joint registrants to lead registrants had fallen from 6.7 in 2010 to just 2.9 in 2013. These data suggest that an increasing number of SMEs will be making REACH registrations in the period up to 2018. Many of these SMEs will have to take on the task alone as substances become more specialised and the opportunities for cost sharing with joint registrants become fewer.
The European Commission is aware of the concerns of SMEs and has taken steps to reduc ...