The procedure for F3determining the authorisation status of a novel food F4... provided for in Article 9 must start either on the initiative of the appropriate authority or following an application to the appropriate authority by an applicant. The appropriate authority must make the summary of the application, based on the information referred to in points (a), (b) and (e) of paragraph 2 of this Article, publicly available.

Upon request by the appropriate authority, the Food Safety Authority must give its opinion as to whether the F5proposed determination of authorisation status is liable to have an effect on human health.

When test methods are applied to engineered nanomaterials as referred to in points (a) (viii) and (ix) of Article 3(2), an explanation must be provided by the applicants of their scientific appropriateness for nanomaterials and, where applicable, of the technical adaptations or adjustments that have been made in order to respond to the specific characteristics of those materials.

The procedure for authorising the placing on the market within Great Britain of a novel food F6... as provided for in Article 9 ends when the appropriate authority F7determines the authorisation status of that novel food in accordance with Article 12.

By way of derogation from paragraph 5, the appropriate authority may terminate the procedure at any stage, and decide not to proceed with F8a determination of the authorisation status of the novel food concerned where the appropriate authority considers that F9a determination is not justified.

The applicant may withdraw its application at any time, thereby terminating the procedure.

Where the appropriate authority requests an opinion from the Food Safety Authority, it must forward the valid application to the Food Safety Authority without delay, and not later than one month after having verified its validity. The Food Safety Authority must adopt its opinion within nine months from the date of receipt of a valid application.

The Food Safety Authority must forward its opinion to the appropriate authority and, where applicable, to the applicant.

In duly justified cases, where the Food Safety Authority requests additional information from the applicant, the nine month period provided for in paragraph 1 may be extended. After consulting the applicant, the Food Safety Authority must specify a period within which that additional information is to be provided.

Where the additional information referred to in paragraph 4 is not provided to the Food Safety Authority within the additional period referred to in that paragraph, the Food Safety Authority must draw up its opinion on the basis of the available information.

Where an applicant submits additional information on its own initiative, it must send that information to the Food Safety Authority. In such cases, the Food Safety Authority must give its opinion within the nine month period provided for in paragraph 1.

The Food Safety Authority must make the additional information provided in accordance with paragraphs 4 and 6 available to the appropriate authority.

Where the appropriate authority has not requested an opinion from the Food Safety Authority in accordance with Article 10(3), the seven month period provided for in paragraph 1 of this Article starts from the date on which the valid application is received by the appropriate authority in accordance with Article 10(1).

Where the appropriate authority determines the authorisation status of a novel food, the appropriate authority must specify the date on which the authorisation, modification, suspension or revocation is to have effect and communicate the determination to the Food Safety Authority, and the Food Safety Authority must update the domestic list referred to in Article 3B accordingly.

The appropriate authority must forward the valid notification provided for in Article 14 without delay, and not later than one month after having verified its validity, to the Food Safety Authority.

Within four months from the date on which a valid notification under Article 14 is received by the appropriate authority, the Food Safety Authority may issue to the appropriate authority duly reasoned safety objections to the placing on the market within Great Britain of the traditional food concerned.

The appropriate authority must inform the applicant of any duly reasoned safety objection as soon as it is issued.

Where no duly reasoned safety objections have been issued in accordance with paragraph 2 within the time limit laid down in that paragraph, the appropriate authority must authorise the placing on the market within Great Britain of the traditional food concerned F20... without delay. The F21authorisation must specify that it concerns a traditional food from a third country. Where applicable, certain conditions for use, specific labelling requirements, or post market monitoring requirements may be specified.

Where duly reasoned safety objections have been issued in accordance with paragraph 2, the appropriate authority must not authorise the placing on the market within Great Britain of the traditional food concerned F22.... In that case, the applicant may submit an application to the appropriate authority in accordance with Article 16.

The Food Safety Authority must adopt its opinion within six months from the date of receipt of a valid application.

The Food Safety Authority must forward its opinion to the appropriate authority and the applicant.

In duly justified cases, where the Food Safety Authority requests additional information from the applicant, the six month period provided for in paragraph 1 may be extended. After consulting the applicant, the Food Safety Authority must specify a period within which that additional information is to be provided and the six month period provided for in paragraph 1 is extended by that additional period.

Where the additional information referred to in paragraph 4 is not provided to the Food Safety Authority within the additional period referred to in that paragraph, the Food Safety Authority must draw up its opinion on the basis of the available information.

Where an applicant submits additional information on its own initiative, it must send that information to the Food Safety Authority. In such cases, the Food Safety Authority must give its opinion within the six month period provided for in paragraph 1.

The Food Safety Authority must make the additional information provided in accordance with paragraphs 4 and 6 available to the appropriate authority.

By way of derogation from paragraph 1, the appropriate authority may, having taken account of the Food Safety Authority's opinion and any other legitimate factors relevant to the F28authorisation under consideration, terminate the procedure at any stage and decide not to F29authorise the placing on the market of the traditional food where it considers that authorisation is not justified. The appropriate authority must inform the applicant of the reasons for F30its decision.

The applicant may withdraw its application referred to in Article 16 at any time, thereby terminating the procedure.

Where the appropriate authority determines the authorisation status of a traditional food, the appropriate authority must specify the date on which the authorisation, modification, suspension or revocation is to have effect and communicate the determination to the Food Safety Authority, and the Food Safety Authority must update the domestic list referred to in Article 3B accordingly.