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

CONSIDERING NEW TESTING

The Annexes VII – X of REACH describing test data are frightening. There have been many reports scaring industry of high costs and more worrying, but Annex XI tells you how to avoid testing. Effectively, the requirement for industry is to do sufficient testing and data assessment (modelling, read across etc) to justify the end points listed in the respective Annexes VII – X. For example, if your substance is water soluble and biodegrades rapidly, it is most likely justifiable to avoid most, if not all, of the terrestrial ecotoxicity testing described in Annexes IX and X.

New animal testing not explicitly required in Annex VII or VIII should be proposed to, and agreed by, ECHA before starting. Even if testing is required, but there is no capacity at laboratories, it can be stated on the IUCLID 5 input that testing is planned or in progress. In these cases, we would also be unable to complete the CSR, but we can give it our best effort and then update as the new data became available.

The Spirit of REACH is that we take a scientific approach to testing and we should have sufficient justification to meet the objectives of each Annex. This is known as the ‘intelligent testing strategy’ and guidance on how to approach testing is provided by ECHA.