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

DATA EVALUATION - CLASSIFICATION AND LABELLING AND THE ROBUST SUMMARY

Having spent time and money gathering, assessing or generating data, there needs to be a reasonable attempt to do something useful with it. The minimum is to look at the answers and propose a classification (the SIEF should make a proposal as part of a joint registration), but as part of the registration process, it is necessary to make a ‘Robust Summary’ ; the basics are handled by the IUCLID 5 Software, but to give it real value, it is necessary to tie together the test data – the physic-chemistry, toxicology and environmental data are all linked and cannot be considered in isolation.

The proposed classification and labelling is entered into Section 2 of IUCLID and the conclusions will be published in the Classification and Labelling Inventory. This is done in accordance with GHS principles, outlined in the CLP Regulation (EC) No 1272/2008. The robust summaries (ie. The data end points presented as stand-alone summaries of data, including conclusions) will also be publicly available for registered substances. This newly public information will be a basis for down-stream suppliers of chemicals to ensure that the classification is correct.

If the data are not considered adequate for classification or to complete the Chemical Safety Report, further data generation (testing, modelling, read-across etc) is needed.

Part of the conclusion for data evaluation will be the Derived No-Effect Level (DNEL) or Minimal effect (DMEL) for health effects from different routes of administration and also the Predicted No-Effect Concentration (PNEC) for environmental endpoints. DNEL / DMEL and PNECs will be established by the SIEF for each substance and will need to be communicated on Safety Data Sheets; it is important to get these right as a very low DNEL or PNEC could mean that difficult risk management measures need to be proposed to keep exposure to below these levels.

When working in a SIEF for a joint registration, data considered adequate to avoid new testing will have a value to the SIEF and the owners of such data will be entitled to compensation if sharing access to the data. Even if not sharing access (eg for non-animal testing where sharing access is not compulsory), the data will still be required to complete the robust summary and classification. Data for hazardous substances must be made public – even if other members do not have access to use the data for their registration, the data cannot be kept as confidential.