ECHA

ECHA assigns a submission number to each received dossier. This number is used as a reference in all correspondence relating to this registration until a registration number is assigned. Dossier submission and all correspondence are done via REACH-IT.

Administrative checks

All dossiers undergo administrative checks called ‘‘Business Rules'' checks to ensure that the dossiers fulfil the pre-requisites for ECHA to handle them. ECHA verifies that the dossiers are in the appropriate IUCLID format and that certain administrative information is consistent with the submission type.

Passing the business rules only confirms that the dossier is accepted for processing, and does not mean that the registration is finalised yet. If there is a business rules failure, the registrant would need to correct the dossier and submit it again.

After the dossier has been accepted for processing, the next step is the technical completeness check. At this stage, the dossier is checked to certify that all the required information is included. If there is any missing information, the registrant will be given a reasonable deadline to re-submit a complete dossier. Only one additional submission attempt is allowed in this case.

In parallel to the technical completeness check, the invoice is sent to the registrant via REACH-IT and must be paid within the given due dates.

Decision

Once the technical completeness check is successful and the invoice is paid, the dossier is considered complete and a registration number is assigned. The registration date is the date of the registration dossier's submission.

If there is a second completeness check failure or a failure in paying the relevant fee, the dossier is rejected.

Publishing information from dossiers

ECHA is publishing information included in the registrations dossiers on its website. This will then be freely available for all European citizens so they can be informed of any potential risks of the chemicals that they are using.

The information published covers the identity of the substance, the results of studies on its intrinsic properties and hazard profiles, the levels where no adverse effects are expected for human health or the environment, its classification and labelling, as well as guidance on its safe use.

If not claimed confidential, ECHA will also publish on the substance degree of purity essential for classification and labelling, total tonnage band, (robust) study summaries, information in the safety data sheet and the trade name.

Under certain circumstances, the IUPAC name can be claimed confidential. In these cases, the registrant must provide a public name that the ECHA can use for dissemination purposes.

Before submitting their dossiers, registrants have the opportunity to request that certain data be kept confidential and to check what information will be publicly available. Requesting confidentiality applies only to a limited set of data and requires a justification, which will be evaluated by ECHA.

Communication in the supply chain

Companies that supply registered substances need to include the registration number and exposure scenarios in the safety data sheets that are to be provided to their customers.

Safety data sheets have to be updated in the following cases:

• As soon as the company has new information on hazards or risk management measures related to the substance
• Once an authorisation has been granted or refused
• Once a restriction has been imposed

Registration update

Registrants have a responsibility to keep their dossiers updated. Some of the reasons to update a registration are a change of the substance composition, the increase of the tonnage band or the availability of additional information, for example, related to classification and labelling. The company information and other administrative information also need to be updated.

The new information has to be submitted to ECHA without undue delay.

For some types of update a fee is charged.