- Faze registracije
- 7. Kako se organizirati za potrebe ažuriranja dosjea
- Respect the deadlines for updating
Respect the deadlines for updating
Respect the deadlines for updating
Respect the deadlines for updating top
When you receive an evaluation decision requesting you to add information to your registration, you must provide this information by the deadline given in the evaluation decision.
When your knowledge on the substance or its use changes, you must update your registration on your own initiative without undue delay. The deadlines to perform the expected dossier updates have been clarified in the Commission Implementing Regulation (EU) 2020/1435 and are summarised in the following table:
|Change that triggers the need for updating||Deadline to submit the update||Starting point for the deadline|
|Any change in the status of the registrant, such as being a manufacturer, an importer or a producer of articles, or in their identity, such as their name or address.||3 months||Counted from the day when the specific change takes effect.|
|Any change in the composition of the substance.||3 months||Counted from the date when the manufacture or import begins with the change in the substance composition.|
|Changes in the annual or total quantities manufactured or imported by the registrant.||3 months/6 months (in case of testing proposals)||When no new data needs to be generated, you have 3 months to submit an updated dossier. This is to be counted from the date when the higher tonnage band has been reached.
If new data needs to be generated and the registration falls under Annexes VII or VIII of REACH you have 3 months to initiate negotiations with a test lab to generate the missing data.
If the information requirements fall under Annexes IX or X of REACH, you have 6 months to update the registration to include the testing proposals for the missing data counted from the date when you identify the need to perform one or more of the tests listed in those annexes.
|New identified uses and new uses advised against for which the substance is manufactured or imported.||3 months||For a new identified use, it is counted from the date when you receive all the information needed to carry out the risk assessment.
For a new use advised against, it is counted from the date when the information on the risks associated with that use is available to you.
|New knowledge of the risks of the substance to human health or the environment of which the registrant may reasonably be expected to have become aware which leads to changes in the safety data sheet (SDS) or the chemical safety report (CSR).||6 months||Counted from the date when you become aware or may reasonably be expected to have become aware of the new knowledge in question.|
|Any change in the classification and labelling of the substance.||
||In case of a new or modified self-classification the deadline is counted from the date when the decision to change the classification and labelling of the substance is taken.|
|Any update or amendment of the CSR or the Guidance on safe use.||12 months||Counted from the date when the need to update or amend the CSR or the Guidance on safe use is identified.|
|The registrant identifies the need to perform a test listed in Annex IX or Annex X, in which cases a testing proposal must be submitted.||6 months/12 months||6 months counted from the date when the registrant identifies the need to perform one or more of the tests listed in Annex IX or of X of REACH.
If the testing proposal developed addresses a group of substances, the dossier must be submitted to ECHA by no later than 12 months after the date when the registrant or registrants identify the need to perform one or more tests listed in Annex IX or Annex X or REACH.
|Any change in the access granted to information in the registration.||3 months||Counted from the date when the change occurred.|
Further examples that require an update (e.g. cases when the update require further testing, updates as a consequence of an update on the Annexes of REACH, updates within a joint submission) and explanation on how to calculate the deadline when multiple updates are required are explained in the ‘Guidance on Registration’