GB based applicant awaiting an EU Commission decision for an application for authorisation

If you are a GB based company that had submitted an authorisation application to ECHA, before the relevant EU latest application date (LAD), and it is in the final decision stage at the end of the transition period (TP)  ie

The Secretary of State for Defra will make a decision on the basis of the opinion ECHA sent to the European Commission. The decision will be taken subject to the consent of the Devolved Administrations where it involves matters of devolved competence.

To take advantage of this, applicants will have to:

You want to You need to By when
maintain your use or supply for a use i (in reliance with Article 56 (1) (d) of EU REACH) 1. Notify the Defra Secretary of State of the application;
2. supply the Secretary of State with copies of the application, the information included in it, and any other information provided to ECHA by the applicant for the authorisation which was material to the formation of ECHA's opinion;
3. give the Secretary of State copies of the opinions ECHA sent to the applicant.
End of the TP + 180 days

The information required by (i) - (iii) should be submitted by email to [email protected] in the format that you submitted to (or received from) ECHA. Defra will confirm receipt of the information relating to the authorisation application and provide further information about the process after performing some basic completion checks.

There is no fee for this and you can continue to use or supply the substance in reliance with Article 56 (1) (d) of EU REACH as long as the necessary information is provided to the Secretary of State within 180 days of the end of the transition period.

GB-based downstream user of a GB-based application in the final decision stage (as described above)

GB-based downstream users of GB-based applicants whose application is in the final decision stage can continue to use the substance, provided the GB based applicant provides the information described above to Defra within the given deadline.

You have to notify the Agency within three months of the first time the substance was delivered to you. This obligation applies after the authorisation decision has been published by the Secretary of State.

The information you need to submit consists of:

You may also submit information about the typical annual volume and the number of staff using the substance. Furthermore, you may provide a brief additional description about your use and any involvement in potential substitution activities.

If the authorisation decision requires you to submit specific data, eg on exposure, you will need to provide this to the Agency by the deadline set in the decision.

This information should be submitted by e-mail in IUCLID 6 format to [email protected] using the subject 'GB Authorisation - DU notification'.

 
Updated 2021-08-10