Once you have submitted your registration dossier, ECHA checks that all the necessary information is included. In April 2020, we will expand our checks to cover, among other things, chemical safety reports. Is yours complete?
From April 2020, we will check that use and exposure information as well as risk characterisation is included in your chemical safety report (CSR). This information has to be there because it forms the basis for risk management measures that companies communicate through their supply chains and need to follow to protect their workers and the environment. The checks of the chemical safety report will be based on the uses you have reported in your registration dossier. We 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. Your registration dossier will not be checked for the CSR if you are part of a joint submission and you 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 your submission will fail.
Why the change is needed
We previously improved the completeness check rules in 2016 when some automated, computer-based checks were revised and some manual checks were added. Based on this experience, we expect that additional manual checks on chemical safety reports will further improve the data availability in REACH registrations. For authorities this means that they will have a better basis for prioritising substances that need further regulatory action, whereas companies will be in a better position to communicate appropriate information to their customers. Information on uses is also published on ECHAs website if they have not been claimed confidential.
The new rules do not mean that any of the legal requirements in REACH would change, we simply improve the way ECHA checks that the requirements have been met.
Use Chesar to prepare your chemical safety report
Since chemical safety reports are text documents attached to IUCLID dossiers, a computer-based verification of that information is not possible. A group of ECHA staff will carry out the checks manually following standard instructions to guarantee that each check is performed using the same principles. As the checks are manual, the Validation assistant available in IUCLID will not be able to report on completeness issues found in your chemical safety report.
When preparing your CSR, we recommend using the Chemical Safety Assessment and Reporting tool, Chesar. Chesar contains a workflow that guides you in filling in the necessary information consistently. It helps you address all reported uses, routes of exposure and environmental compartments, in line with the outcome of the hazard assessment. Once you have finalised your chemical safety assessment, you can automatically create a chemical safety report that you can attach to your IUCLID dossier. As Chesar exchanges data with IUCLID, the information recorded in your IUCLID dossier will be consistent with that in your chemical safety report.
Although ECHA recommends you to use Chesar, it is not mandatory. Any chemical safety report format is accepted as long as you have included all information listed in REACH and the reader can clearly identify all the main elements.
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, we are 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.
New rules apply from end of April 2020
The improved completeness check will start to apply at the end of April following the release of a new version of IUCLID.
It is good to keep in mind that the new rules apply both to new registrations and registration updates. This means that your update may not pass the completeness check anymore, even though your previous registration did. However, if your update would be considered as incomplete, it does not directly impact your current registration. It means that the information you intended to submit to ECHA needs to be amended and resubmitted before it applies to your registration and can be taken into account by authorities.
To ensure that you have included all required information in your registration dossier, start by checking it with the Validation assistant before submitting anything to ECHA. The tool is being updated and the latest version will be included in the April release of IUCLID. In addition, an updated version of the document supporting users in the areas of manual verification is expected to be available on the ECHA website by the end of February. If you are not yet doing so, consider using Chesar for your chemical safety assessment and report as this will decrease the chance of incompleteness. We recommend companies to also have a look at our recent webinar and related Q&As on the revised completeness check to get further help. If you have case-specific questions, a team of ECHA experts can be reached through a contact form on our website.