CHAPTER I

Applications for authorisation
SECTION 1

Requirements for applications for authorisation of genetically modified food and feed
Article 2
1
Without prejudice to Article 5(3) and (5) and Article 17(3) and (5) of Regulation (EC) No 1829/2003, and taking into account the guidance of the Food Safety Authority provided for in Articles 5(8) and 17(8) of that Regulation, applications for authorisation submitted in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 (the applications) shall comply with the requirements of paragraphs 1 to 4 of this Article and with Articles 3 and 4 of this Regulation.
2
In supplying the information required under Article 5(3)(b) and Article 17(3)(b) of Regulation (EC) No 1829/2003, the application shall clearly identify the products covered by it in accordance with Articles 3(1) and 15(1) of that Regulation. Where the application is limited to either food or feed use, it shall contain a verifiable justification explaining why the authorisation should not cover both uses in accordance with Article 27 of Regulation (EC) No 1829/2003.
3
The application shall clearly state which parts of the application are considered to be confidential, together with a verifiable justification in accordance with Article 30 of Regulation (EC) No 1829/2003. Confidential parts shall be submitted in separate documents.
4
The application shall specify, in supplying the information required under Article 5(3)(c) and Article 17(3)(c) of Regulation (EC) No 1829/2003, whether the information included in the application may be notified as such to the biosafety clearing house under the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (the Cartagena Protocol) approved by Council Decision 2002/628/EC .
If the application may not be notified as such, it shall include the information which complies with Annex II to the Cartagena Protocol and which may be notified to the biosafety clearing house by the appropriate authority as provided in Article 44 of Regulation (EC) No 1829/2003 in a separate and clearly identified document.
5
Paragraph 4 shall not apply to applications concerning only food and feed produced from genetically modified organisms (GMOs) or containing ingredients produced from GMOs.
Article 3
1
The application shall include the following:
a
the monitoring plan referred to in Article 5(5)(b) and Article 17(5)(b) of Regulation (EC) No 1829/2003, ...;
b
in supplying the information required under Article 5(5)(a) and Article 17(5)(a) of Regulation (EC) No 1829/2003, a proposal for labelling complying with the requirements of Annex IV to Directive 2001/18/EC of the European Parliament and of the Council ;
c
in supplying the information required under Article 5(5)(a) and Article 17(5)(a) of Regulation (EC) No 1829/2003, a proposal for a unique identifier for the GMO in question, developed in accordance with Commission Regulation (EC) No 65/2004 ;
d
a proposal for labelling ..., where a proposal for specific labelling is needed in accordance with Article 5(3)(f) and Article (g) and 17(3)(f) and (g) of Regulation (EC) No 1829/2003;
e
a description of a method(s) of detection, sampling and event specific identification of the transformation event, as provided for in Article 5(3)(i) and Article 17(3)(i) of Regulation (EC) No 1829/2003, in accordance with Annex I to this Regulation;
f
a proposal for post-market monitoring regarding the use of the food for human consumption or the feed for animal consumption, as provided for in Article 5(3)(k) and Article 17(3)(k) of Regulation (EC) No 1829/2003, and according to the characteristics of the products concerned, or a verifiable justification to the effect that a post-market monitoring is not necessary.
2
Points (a), (b) and (c) of paragraph 1 shall not apply to applications concerning only food and feed produced from GMOs or containing ingredients produced from GMOs.
Article 4
1
Samples of the food and feed and their control samples which are to be submitted in accordance with Article 5(3)(j) and Article 17(3)(j) of Regulation (EC) No 1829/2003 shall be in accordance with the requirements set out in Annexes I and II to this Regulation.
The application shall be accompanied by information concerning the place where the reference material developed in accordance with Annex II may be found.
2
The summary to be provided in accordance with Article 5(3)(l) and Article 17(3)(l) of Regulation (EC) No 1829/2003 shall:
a
be presented in an easily comprehensible and legible form;
b
not contain parts which are considered to be confidential.
OJ L 201, 31.7.2002, p. 48.
OJ L 106, 17.4.2001, p. 1.
OJ L 10, 16.1.2004, p. 5.
Words in Art. 2(1) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 43(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 2(4) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 43(b); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 3(1)(a) omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 44(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 3(1)(d) omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 44(b); 2020 c. 1, Sch. 5 para. 1(1)