(fra kommisjonsforordningen)

(1) Pursuant to Regulation (EU) 2024/1938, the contents of an application for authorisation as an establishment importing into the Union substances of human origin (SoHO) are to enable the compatibility and comparability of the information contained in the application. To achieve a high level of compatibility and comparability of that information, uniform conditions for an application for authorisation as an importing SoHO establishment should be laid down. In particular, the information to be provided together with the application or upon request by the SoHO competent authorities should be further detailed. 

(2) The processing of personal data through the filing of applications is subject to the provisions of Regulation (EU) 2016/679 of the European Parliament and of the Council and, for Union institutions, bodies, offices and agencies, of Regulation (EU) 2018/1725 of the European Parliament and of the Council. 

(3) The retention periods of personal data to be provided pursuant to Annexes I and II to this Regulation are set out in Annex II to Commission Implementing Regulation (EU) 2025/1467. 

(4) The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 and delivered an opinion on 26 June 2026. 

(5) As Regulation (EU) 2024/1938 applies from 7 August 2027, this Regulation should apply from the same date. 

(6) The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 79(1) of Regulation (EU) 2024/1938,