Regulation 20 Application for a food and feed marketing authorisation

(1)

A person may apply for a food and feed marketing authorisation under this regulation if—

(a)

the precision bred organism is an organism in respect of which a precision bred confirmation is in force^f1;

(b)

the person is able to demonstrate that the relevant precision bred organism belongs to a species that has a history of safe food use in accordance with paragraph (2);

(c)

the person is able to demonstrate that the application of modern biotechnology to the precision bred organism does not introduce genetic changes that are expected to—

(i)

significantly alter the nutritional quality of the organism as it is being consumed as food or feed at the date of the application in a way that is likely to be disadvantageous to the consumer;

(ii)

significantly elevate the toxicity of any food or feed produced from the precision bred organism;

(iii)

alter the allergenicity of any food or feed produced from the precision bred organism;

(iv)

introduce any additional features that may affect the safety of any food or feed produced from the precision bred organism.

(2)

In paragraph (1)(b), “history of safe food use” means that the safety of the species in question as food has been confirmed with compositional data and from experience of continued food use in the customary diet of a significant number of people in the United Kingdom or the European Union beginning before 15th May 1997.

(3)

A person may apply to the Food Standards Agency for a food and feed marketing authorisation under this regulation by making an application containing the information specified in paragraph 1 of Schedule 4.

(4)

The information provided pursuant to paragraph (3) must be sufficiently detailed to allow the Food Standards Agency to assess the application having regard to the nature and scale of the application.

(5)

The application may be accompanied by any other information that the applicant considers relevant.

(6)

If an applicant is not established in Great Britain, the applicant must appoint a representative who is established in Great Britain in the application.

(7)

Upon receipt of an application under paragraph (1), the Food Standards Agency must, as soon as reasonably practicable—

(a)

acknowledge receipt of the application;

(b)

verify whether the application contains the information specified in paragraph 1 of Schedule 4 (as read with paragraph (4) of this regulation).

(8)

If, notwithstanding any further information provided pursuant to regulation 24, the application does not contain the information specified in paragraph 1 of Schedule 4, the Food Standards Agency must advise the applicant that the application is invalid.

Annotations

Footnotes

f1: “In force” in respect of a precision bred confirmation is defined in section 5(5) of the Act.