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

RISK ASSESSMENT - THE CSR

The CSR is a formatted Risk Assessment and the template and guidance is available in the ECHA guidance. Part A includes making the declaration that you have communicated risk management measures to your customer.

There are various models to help write the CSR, including the data extraction CSR tool on IULCID 5, the CHESAR tool, the TRA tool and EUSES. However, running these models and not understanding the science is dangerous and the science behind the models must be understood.

The conclusions to the CSR are numerical ‘risk characterisation ratios’ (RCR).

Sharing exposure scenarios and the CSR as part of the joint submission will also allow cost and time savings and joint registrants can opt in or opt out of joint CSR; the decision to be part of a joint CSR or not can be based on commercial reasons in that it has a short term potential to save time and money and perhaps improve the chances of having a compliant dossier. However, the technical implications of sharing the CSR may be far-reaching and costly in the long term.

Many lead registrant and consultants are simply following guidance and using conclusions from models (and feel under pressure to do so) and these can lead to incorrect estimates of DNELs, PNECs, exposure and ultimately leading to inappropriate risk management. Due to guidance erring on the side of caution, there is actually a significant chance of risk management measures being recommended that are not needed and that may be expensive to implement.