Commentaries: Art. 14b

Data which it is not scientifically necessary to supply or which it is not technically possible to generate need not be provided. The justification for adaptations to data requirements shall be stated in the application.
The FDHA, in consultation with DETEC and the EAER, shall define when the waiving of data requirements is justified on the basis of likely exposure; in so doing, it shall take into consideration delegated acts adopted by the European Commission in accordance with Article 21 paragraph 3 of Regulation (EU) No 528/2012¹.
The Notification Authority shall indicate the data which does not need to be provided because:
1. it has been published by the ECHA; or
2. it is accessible to the Notification Authority under an international treaty.

Art. 14b