New support page and formats for authorisation review reports

ECHA/NI/17/19

ECHA has published a new support page on review reports for authorisation along with updated application formats that can be used both for applications for authorisation and for review reports. ECHA has also published a format for the explanatory note that should be included in review reports.

Helsinki, 13 June 2017 – As an authorisation holder, if you need to continue using a substance of very concern listed on the Authorisation List after the end of your time-limited review period, you can re-apply by submitting a review report to ECHA.

In other words, the Commission can extend the authorisation decisions, if you show that:

• the risks are adequately controlled or the benefits of authorisation are higher that the remaining risks, and
• that suitable alternatives are still unavailable after the review period ends.

You will need to submit the review report to the Agency at least 18 months before the expiry of the review period.

As part of the review report, you should update all of the documents you submitted in the original application for authorisation. These updates describe what has changed and how you have implemented the conditions or monitoring arrangements of the Commission’s authorisation decision.

To aid the public consultation, opinion development and decision-making, you are also requested to submit an explanatory note, which briefly explains what is different in the review report compared to the original application.