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. As REACH was established, there were many reports scaring industry of the high costs in doing every single study listed, but first it is important to look at Annex XI which 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. There are options in IUCLID to request waivers, but full justification is needed.

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.

If there are insufficient data to complete the CSR adequately, then it should be prepared as well as possible and updated as new data become available.

The Spirit of REACH is that we take a scientific approach to testing and there should be 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.

Testing need not be done in Europe and although EU / OECD guidelines are recommended, other valid test methods are acceptable and for ‘difficult’ substances (eg UVCBs, unstable materials etc) test methods will need to be adapted. Good Laboratory Practice (GLP) should be followed for new environmental or toxicity testing, but good data performed and reported to high standards will be accepted even if not to GLP. Repeating any sort of animal test is discouraged.