From April 2020, ECHA will check that use and exposure information as well as risk characterisation is included in chemical safety report (CSR) for registered chemicals.
The checks of the chemical safety report will be based on the uses reported in registration dossiers.
ECHA will be checking the completeness of chemical safety reports for any registrations where the substance tonnage band is more than 10 tonnes per year and the substance is classified as hazardous to the environment or human health, or has persistent, bioaccumulative and toxic properties. The registration dossier will not be checked for the CSR in case that company is part of a joint submission and so rely on the chemical safety report submitted in the lead registrant dossier.
The new checks on the chemical safety report will only verify that the required elements are present and will not look at the adequacy of the information submitted. The checks will be carried out for both initial dossiers and their updates.
If the chemical safety report cannot be opened or is written in a language other than one of the official EU languages, it will be considered incomplete and CSR submission will fail.
There will be some changes to the computer-based completeness checks, too. To make sure that the standard information requirements described in REACH Articles VII-X are met, ECHA is improving the way the elements for key hazard endpoints are checked. More explicit checks will be carried out for the following endpoints: mutagenicity, reproductive toxicity and degradation.
Information related to the substance life cycle will also be checked as part of the computer-based verification. This means that the checks will detect if, based on the use description, the registration should also include information about article service life.
Since these changes will become part of the computerised checks, they will also be included in the updated IUCLID Validation assistant which is recommended to be used before submitting the data to ECHA.
The improved completeness check will start to apply at the end of April following the release of a new version of IUCLID.
More information – REACH Registration on Ekotox: https://ekotox.eu/reach-registration/
Actual Ekotox webinars: https://reachtraining.eu/en/seminars
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Ekotoxikologické centrum CZ
Centrum Ekotoksykologiczne (PL)
Ekotoxikologické centrum Bratislava, s.r.o. (SK)
Tomášikova 10/F, 821 03 Bratislava
Tel.: +421 (2) 4594 3712, 4594 5223