CHAPTER IIIU.K.AUTHORISATION PROCEDURES FOR A NOVEL FOOD

SECTION IU.K.General rules

[F1Article 10U.K.[F2Procedure 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.]

Textual Amendments

[F10Article 11U.K.Opinion of the Food Safety Authority

1.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.

2.In assessing the safety of novel foods, the Food Safety Authority must, where appropriate, consider whether—

(a)the novel food concerned is as safe as food from a comparable food category already placed on the market within Great Britain;

(b)the composition of the novel food and the conditions of its use do not pose a safety risk to human health in Great Britain;

(c)a novel food, which is intended to replace another food, does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.

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

4.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.

5.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.

6.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.

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

Textual Amendments

[F11Article 12U.K.Authorisation of a novel food F12...

1.Within seven months from the date of publication of the Food Safety Authority's opinion, the appropriate authority must [F13determine the authorisation status] of a novel food, taking into account the following—

(a)the conditions provided for in points (a) and (b) of Article 7 and, where applicable, in point (c) of that Article;

(b)any relevant provision of [F14assimilated direct] legislation, including the precautionary principle as referred to in Article 7 of Regulation (EC) No. 178/2002;

(c)the Food Safety Authority's opinion;

(d)any other legitimate factors relevant to the application under consideration.

2.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).

[F152A.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.]]

Textual Amendments

Article 13U.K.Implementing acts laying down administrative and scientific requirements for applications

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Textual Amendments