CHAPTER II

GENETICALLY MODIFIED FOOD
Section 1

Authorisation and supervision

Application for authorisation
Article 5
1
To obtain the authorisation referred to in Article 4(2), an application shall be submitted in accordance with the following provisions.
2
The application must be sent to the Food Safety Authority, who must—
a
acknowledge receipt of the application, and confirm the date of its receipt, in writing to the applicant within 14 days of its receipt;
b
make the summary of the dossier referred to in paragraph 3(1) available to the public.
3
The application shall be accompanied by the following:
a
the name and the address of the applicant;
b
the designation of the food, and its specification, including the transformation event(s) used;
c
where applicable, the information to be provided for the purpose of complying with Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (hereinafter referred to as the Cartagena Protocol);
d
where applicable, a detailed description of the method of production and manufacturing;
e
a copy of the studies, including, where available, independent, peer-reviewed studies, which have been carried out and any other material which is available to demonstrate that the food complies with the criteria referred to in Article 4(1);
f
either an analysis, supported by appropriate information and data, showing that the characteristics of the food are not different from those of its conventional counterpart, having regard to the accepted limits of natural variations for such characteristics and to the criteria specified in Article 13(2)(a), or a proposal for labelling the food in accordance with Article 13(2)(a) and (3);
g
either a reasoned statement that the food does not give rise to ethical or religious concerns, or a proposal for labelling it in accordance with Article 13(2)(b);
h
where appropriate, the conditions for placing on the market the food or foods produced from it, including specific conditions for use and handling;
i
methods for detection, sampling (including references to existing official or standardised sampling methods) and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food and/or in foods produced from it;
j
samples of the food and their control samples, and information as to the place where the reference material can be accessed;
k
where appropriate, a proposal for post-market monitoring regarding use of the food for human consumption;
l
a summary of the dossier in a standardised form.
4
In the case of an application relating to a GMO for food use, references to ‘food’ in paragraph 3 shall be interpreted as referring to food containing, consisting of or produced from the GMO in respect of which an application is made.
5
In the case of GMOs or food containing or consisting of GMOs, the application shall also be accompanied by:
a
the complete technical dossier supplying the information required by Annexes III and IV to Directive 2001/18/EC and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC or, where the placing on the market of the GMO has been authorised under part C of Directive 2001/18/EC, a copy of the authorisation decision;
b
a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC, including a proposal for the duration of the monitoring plan; this duration may be different from the proposed period for the consent.
In such case, Articles 13 to 24 of Directive 2001/18/EC shall not apply.
6
Where the application concerns a substance, the use and placing on the market of which is subject, under other provisions of assimilated law, to its inclusion on a list of substances registered or authorised to the exclusion of others, this must be stated in the application and the status of the substance under the relevant legislation must be indicated.
7
The appropriate authority, having first consulted the Food Safety Authority, may prescribe rules concerning the preparation and presentation of the application.
8
The Food Safety Authority must publish detailed guidance to assist the applicant in the preparation and the presentation of the application.
Art. 5(2) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 9(a); 2020 c. 1, Sch. 5 para. 1(1)
Art. 5(7) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 9(c); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 5(8) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 9(d); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 5(6) substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 11 para. 5(a)