CHAPTER IIIAUTHORISATION PROCEDURES FOR A NOVEL FOOD

SECTION IGeneral rules

F1Article 10F2Procedure for determining authorisation status

1.

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.

2.

The application for an authorisation must include—

(a)

the name and address of the applicant;

(b)

the name and description of the novel food;

(c)

the description of the production process;

(d)

the detailed composition of the novel food;

(e)

scientific evidence demonstrating that the novel food does not pose a safety risk to human health;

(f)

where appropriate, the analysis method;

(g)

a proposal for the conditions of intended use and for specific labelling requirements which do not mislead the consumer or a verifiable justification why those elements are not necessary.

3.

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.

4.

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.

5.

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.

6.

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.

7.

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