Article 5 Scientific requirements for the risk assessment of genetically modified food and feed for applications submitted under Articles 5(3) and 17(3)
United Kingdom
Information, including studies, required to accompany the application as referred to in Article 5(3)(a) to (f) and (h) and in Article 17(3)(a) to (f) and (h) of Regulation (EC) No 1829/2003 shall be provided in accordance with the scientific requirements for the risk assessment of genetically modified food and feed set out in Annex II to this Regulation.
By way of derogation from paragraph 1, an application may be submitted that does not satisfy all the requirements of that paragraph provided that:
particular information is not necessary owing to the nature of the genetic modification or of the product; or
it is not scientifically necessary, or technically possible to supply such information.
The applicant shall submit reasoned justification for the derogation.
Paragraphs 1 and 2 shall not prevent the F1Food Safety Authority to request, where appropriate, the applicant to supplement the particulars accompanying the application as provided for in Articles 6(2) and 18(2) of Regulation (EC) No 1829/2003.
Annotations
Textual amendments
- F1
Words in Art. 5(3) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 50; 2020 c. 1, Sch. 5 para. 1(1)