INTRODUCTION | LEGAL BACKGROUND | HISTORY OF THE LEGISLATION | BASIS OF REACH | EXEMPT MATERIALS | DEFINITIONS | PRE-REGISTRATION | SIEF FORMATION | SUBSTANCE SAMENESS | DATA EVALUATION | CONSIDERING NEW TESTING | THE EXPOSURE SCENARIO | RISK ASSESSMENT | COMMUNICATION |
REGISTRATION PROCESS | SPECIAL CASES | DOWNSTREAM USER OBLIGATIONS | AUTHORISATION AND RESTRICTION | AFTER REGISTRATION | ABBREVIATIONS

SUBSTANCE SAMENESS (OR ‘EQUIVALENCE’)

The initial evaluation of the substance is essential for all those registering a chemical substance and who need to demonstrate that their substance has the same identity (and purity) as other members of the SIEF or those who have already registered. Likewise, to file an Inquiry to ECHA for a new substance, substance identity details are required. PPORDs also need such analysis.

The basic requirements are spectral evaluation (typically IR, UV-Vis, NMR or MS) and this can be requested even in cases where it is not possible to interpret the results to least provide a ‘fingerprint’ for future reference. Chromatography and other analysis including HPLC, GC, MS, X-Ray diffraction etc. are required as appropriate for the type of substance The analysis must be sufficient to demonstrate that the substance you are registering is equivalent to others in the same SIEF who you are sharing the registration with.

These need reporting by all registrants as an attachment to Section 1.4 of IUCLID 5, where a report is needed to prove that the substance you are registering is indeed what you claim it to be (ie. Specific structure, isomeric profile, crystal structure etc). There is also the chance to add results of analysis for different batches or by using different methods. This can include quality control results.