CHAPTER I

Applications for authorisation
SECTION 1

Requirements for applications for authorisation of genetically modified food and feed
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.
OJ L 106, 17.4.2001, p. 1.
OJ L 10, 16.1.2004, p. 5.
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)