The Novel Food (Amendment) (EU Exit) Regulations 2019

Amendment of Regulation 2015/2283

16.  For Article 10, substitute—

“Procedure for authorising the placing on the market of a novel food and updating the list

1.   The procedure for authorising the placing on the market within the United Kingdom of a novel food and updating the list 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 update 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 the United Kingdom of a novel food and updating the list as provided for in Article 9 ends when the appropriate authority prescribes an update of the list in respect 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 an update of the list where the appropriate authority considers that an update is not justified.

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