CHAPTER IICOMMON PROCEDURE
Article 3Main stages of the common procedure
1.
The common procedure for F1determining the authorisation status of a substance may be started either on the initiative of the F2Authority or following an application. Applications may be made F3... by an interested party, who may represent several interested parties, in accordance with the conditions provided for by F4Regulation 234/2011. Applications shall be sent to the F5appropriate authority.
2.
The F6appropriate authority shall seek the opinion of the F7Authority, to be given in accordance with Article 5.
However, for F8a determination of the authorisation status of a substance described in Article 2B(1)(b) or (c), the F6appropriate authority shall not be required to seek the opinion of the Authority if F9any changes as a result of the determination in question are not liable to have an effect on human health.
F103.
The common procedure is to end with the appropriate authority F11determining the authorisation status of the substance concerned, in accordance with Article 7.
4.
By way of derogation from paragraph 3, the F12appropriate authority may end the common procedure and decide not to proceed with F13determining the authorisation status of a substance, at any stage of the procedure, if it judges that such F14a determination is not justified. Where applicable, it shall take account of the opinion of the Authority, F15..., any relevant provisions of F16assimilated law and any other legitimate factors relevant to the matter under consideration.
In such cases, where applicable, the F17appropriate authority shall inform the applicant F18... directly, indicating in its letter the reasons for not F19determining the authorisation status of the substance concerned.
Article 4Initiating the procedure
1.
On receipt of an application to F20determine the authorisation status of a substance, the F21appropriate authority:
(a)
shall acknowledge receipt of the application in writing to the applicant within 14 working days of receiving it;
(b)
where applicable, shall as soon as possible notify the Authority of the application and request its opinion in accordance with Article 3(2).
F22...
F232.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Article 5Opinion of the Authority
1.
The Authority shall give its opinion within nine months of receipt of a valid application.
2.
The Authority shall forward its opinion to the F24appropriate authority and, where applicable, the applicant.
Article 6Additional information concerning risk assessment
1.
In duly justified cases where the Authority requests additional information from applicants, the period referred to in Article 5(1) may be extended. After consulting the applicant, the Authority shall lay down a period within which this information can be provided F25....
2.
If the additional information is not sent to the Authority within the additional period referred to in paragraph 1, the Authority shall finalise its opinion on the basis of the information already provided.
3.
Where applicants submit additional information on their own initiative, they shall send it to the Authority F26.... In such cases, the Authority shall give its opinion within the original period without prejudice to Article 10.
F274.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Article 7F28Determination of authorisation status and amendment of sectoral food laws
F291.
Within nine months of receiving the opinion of the Authority, the appropriate authority must F30determine the authorisation status of the substance concerned, taking into account the opinion of the Authority, any relevant provisions of F31assimilated law and any other legitimate factors relevant to the matter under consideration.
In those cases where the Authority has not given an opinion, the nine month period starts from the date the appropriate authority receives a valid application.
F32(1A.
Where the appropriate authority makes a determination as to the authorisation status of a substance:
(a)
the appropriate authority must:
(i)
specify the date on which the authorisation, modification, suspension or revocation is to have effect; and
(ii)
communicate the determination to the Authority;
(b)
the Authority must update the domestic list referred to in Article 2C accordingly.
F332.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F343.
4.
5.
On grounds of efficiency, the measures designed to amend non-essential elements of each sectoral food law, inter alia, by supplementing it, relating to the F38authorisation of substances generally and for F39modifying conditions, specifications or restrictions associated with the F40authorisation of substances generally, F41may be prescribed by the appropriate authority after seeking advice from the Authority.
F426.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Article 8Additional information concerning risk management
1.
Where the F43Authority requests additional information from applicants on matters concerning risk management, it shall determine, together with the applicant, a period within which that information can be provided. In such cases, the period referred to in Article 7 may be extended accordingly. F44...
2.
If the additional information is not sent within the additional period referred to in paragraph 1, the F45Authority shall act on the basis of the information already provided.