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.