Modification, suspension and revocation of authorisation
Article 12
1. The applicant or any business operator using the authorised substance or materials or articles containing the authorised substance may, in accordance with the procedure laid down in Article 9(1), apply for modification of the existing authorisation. 2. The application shall be accompanied by the following: (a) a reference to the original application; (b) a technical dossier containing the new information in accordance with the guidelines referred to in Article 9(2); (c) a new complete summary of the technical dossier in a standardised form. 3. On its own initiative or following a request from a Member State or the Commission, the Authority shall evaluate whether the opinion or the authorisation is still in accordance with this Regulation, in accordance with the procedure laid down in Article 10, where applicable. The Authority may, where necessary, consult the applicant. 4. The Commission shall examine the opinion of the Authority without delay and prepare a draft specific measure to be taken. 5. A draft specific measure modifying an authorisation shall specify any necessary changes in the conditions of use and, if any, in the restrictions attached to that authorisation. 6. A final specific measure on the modification, suspension or revocation of the authorisation shall be adopted in accordance with the procedure referred to in Article 23(2).