ECHA’s report of its 2014 activities, published in February, highlights the outcome of compliance checks and recurring shortcomings encountered in registration dossiers including testing proposals. It also discusses further activities carried out during the year and provides recommendations to registrants to improve dossier quality. This summary will highlight key areas from the report.
Frequent Issues in Dossiers:
Compliance checks continued to be carried out due to the high number of dossiers submitted for the 2013 REACH deadline. These checks are carried out on randomly selected dossiers, which impacts a minimum of 5% of submissions in each tonnage band.
ECHA has stated that the dossier quality is improving but further progress is required. If ECHA finds a data gap or an incorrect use of a data waiving justification in a dossier that it has reviewed, it will request missing information from the registrant.
Most of the issues highlighted in the report related to substance identity, exposure assessment and risk characterisation, pre-natal developmental toxicity studies, sub-chronic toxicity studies, and physicochemical properties.
Testing Proposals and Compliance Checks:
In 2014 ECHA concentrated on the evaluation of testing proposals submitted for the 2013 deadline. Dossiers with testing proposals are automatically targeted for compliance checks; ECHA’s aim was to evaluate the quality of all these testing proposals. A total of 770 proposals were submitted for the 2013 deadline. ECHA has so far evaluated 239 of these dossiers and took 129 decisions; 112 were accepted by ECHA, 16 modifications were required and one proposal was rejected outright.
New Compliance Check Strategy:
ECHA plans to focus its compliance checks primarily on hazardous substances and substances of concern in high tonnage bands, as well as evaluating critical endpoints. This is in line with the aim of REACH to protect man and the environment from dangerous chemicals. ECHA has also recently increased its transparency by publishing a list of substances that may be selected for compliance check.
Key Recommendations to Registrants:
• A registration/joint registration must be for only one substance and must include all relevant information for that substance. Correct substance ID is key.
• Robust study summaries must be clear, including tabular data and testing proposals.
• Adaptation of QSAR/Read-across must be accurate and comparable to the test it aims to replace. Justification is required for the similarity in chemical structure.
• Ensure the uses and conditions of use in the CSR are realistic; perhaps include use-maps.
• Use ECHA’s guidance manuals and tools (e.g. for REACH-IT and IUCLID).
• Early preparation for 2018 deadline is crucial.
For further information, see full ECHA report: