PART 3 Amendment of retained direct EU legislation

Amendment of Regulation 1935/2004

18.  For Article 9, substitute—

“Application for authorisation of a new substance

1.   To obtain the authorisation referred to in Article 8(1), the following procedure applies—

(a) an application is to be submitted to the appropriate authority accompanied by the following—

(i) the name and address of the applicant;

(ii) a technical dossier containing the information specified in the guidelines for the safety assessment of a substance to be published by the Food Safety Authority;

(iii) a summary of the technical dossier;

(b) the appropriate authority must—

(i) acknowledge receipt of the application in writing to the applicant within 14 days of its receipt; the acknowledgement must state the date of receipt of the application;

(ii) inform the Food Safety Authority without delay;

(iii) make the application and any supplementary information supplied by the applicant available to the Food Safety Authority.

2.   The Food Safety Authority must publish detailed guidelines concerning the preparation and the submission of the application.”.