The global value of substance data


Craig R. Kelly
TSGE Consulting, Knaresborough, United Kingdom


Buying access to study reports is an every-day part of the modern chemical regulatory process in Europe. These provide the science behind hazard and risk assessment. The substance data assembled for EU REACH is the best available data. The REACH study data-holders have experienced many complications in Korean data negotiations. Following this and with the continued global drive for more REACH like regulations, it’s time to consider a central global data access to improve use of the best data globally.


Mandatory sharing of vertebrate regulatory studies in the REACH regulation

REACH compliance requires data, in order to stay on the market (1). Data requirements are proscribed and extensive. Sharing data access reduces costs to the industry, avoids unnecessary vertebrate testing and is a principle of ‘one substance, one registration’ concept (2). Joint registrants rely on the lead registrant to collect, review, assess and select the highest quality data set to submit. In return, data owners are compensated in a fair and transparent manner (3) and though optional, typically REACH joint registrants share all available technical test data on substance hazard properties, as well as mandatory vertebrate toxicology test data. This eases the regulatory burden and improves efficiency (REACH Article 33) for both joint-submitters and regulator, while providing the best available data for each substance (REACH; Article 25).

In REACH, the substance data is summarised and submitted electronically to ECHA in International Uniform Chemical Inform ...