Deadline setting in dossier and substance evaluation decisions
Deadline setting in dossier and substance evaluation decisions
In substance and dossier evaluation, the decisions include a deadline by which the addressees of the decisions are expected to update their registration dossiers with the requested information. The deadline setting is an important part of the decision-making process involving ECHA, the addressees of the decisions, and the Member States.
For transparency and clarity, ECHA publishes the standard deadlines used in evaluation decisions and explains:
- how the deadline is set in the adopted decision,
- what are the possibilities to influence the deadline, and
- the various scenarios that can happen during decision-making.
The deadlines for REACH endpoints are indicated in the Standard deadlines table.
The table lists the endpoints in REACH Annexes. Some endpoints have a specified OECD or EU test guideline indicated in column 1 of the respective Annex to fulfil the information requirement. For some endpoints, the OECD or EU test guideline to be followed is indicated in ECHA’s guidance documents for information requirements. The table covers the main studies requested under dossier evaluation and substance evaluation; other studies with their own deadline may still apply.
The following principles are generally followed when deadlines are assigned for dossier evaluation decisions.
All deadlines for each individual study in the table take into account:
- time required to conduct the requested experimental study,
- procedural time needed to contract the study to a laboratory and to prepare a dossier update based on the study results, including any considerations to update the chemical safety report and to update the dossier based on the requirements in the CLP Regulation. This procedural time depends on the complexity of the study/studies and varies between 3-9 months.
- The deadlines are indicative but might change based on case specific considerations, e.g. additional parameters measured.
- In cases where more than one study is requested in a decision, the longest deadline is given for all the studies in the decision. For example, if a Fish Early-Life Stage toxicity study and an Extended One-Generation Reproductive Toxicity (EOGRT) study are requested, the deadline for the EOGRT study is set as the deadline of the whole decision.
In such case, only one procedural time period as explained above under point 2 is granted for all studies requested under the decision. - In cases where the difference between the shortest and longest deadline of individual studies is 12 months or more, ECHA may request some studies to be provided by applying their respective, shorter deadline, rather than the longest deadline. This would then result in more than one deadline per decision.
- If the requested studies must be conducted sequentially (e.g. results of a study feed to the design or choice of another study), the deadline is extended to allow sequential testing. For example, if in vitro mutagenicity studies must be done before in vivo mutagenicity studies, the time required to conduct each study is summed up. However, the procedural time is not duplicated. The deadlines for most commonly requested sequential testing are provided in the Deadlines for sequential testing table.
- ECHA is aware of the current long queues in laboratories for the most often requested endpoints. Therefore, ECHA exceptionally adds 6 or 12 months, depending on the complexity of the requested studies, to the standard deadline in the table. This additional time is given in all draft decisions until further notice, and this extension is indicated in the decisions.
- 90 additional days are given in the final decision to agree on the test performer according to Article 53 of REACH in cases where more than one addressee is requested to provide the same studies on the same substance.
- 7 additional days are given in final decisions, during which ECHA considers the notified adopted decision to be received by the addressees, according to the terms and conditions of REACH-IT.
- Addressees of the draft decisions can request deadline extensions as part of their comments to the draft decision. They must be accompanied by an appropriate justification and appropriate documentary evidence so that ECHA can take such requests into account. Documentary evidence are typically quotes or statements from laboratories indicating the available slots in their work plans.
- MSCAs can propose amendments to the deadline similarly as on any other element of the draft decision. Addressees of the draft decision have an opportunity to comment those proposals for amendments during the standard commenting period.
- ECHA cannot alter the deadline of a decision after it has been adopted and notified to the addressees.