CHAPTER III

AUTHORISATION PROCEDURES FOR A NOVEL FOOD
SECTION II

Specific rules for traditional foods from third countries

Opinion of the Food Safety Authority on a traditional food from a third country
Article 17
1
The Food Safety Authority must adopt its opinion within six months from the date of receipt of a valid application.
2
In assessing the safety of a traditional food from a third country, the Food Safety Authority must consider the following matters—
a
whether the history of safe food use in a third country is substantiated by reliable data submitted by the applicant in accordance with Articles 14 and 16;
b
whether the composition of the food and the conditions of its use do not pose a safety risk to human health in Great Britain;
c
where the traditional food from the third country is intended to replace another food, whether it does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.
3
The Food Safety Authority must forward its opinion to the appropriate authority and the applicant.
4
In duly justified cases, where the Food Safety Authority requests additional information from the applicant, the six month period provided for in paragraph 1 may be extended. After consulting the applicant, the Food Safety Authority must specify a period within which that additional information is to be provided and the six month period provided for in paragraph 1 is extended by that additional period.
5
Where the additional information referred to in paragraph 4 is not provided to the Food Safety Authority within the additional period referred to in that paragraph, the Food Safety Authority must draw up its opinion on the basis of the available information.
6
Where an applicant submits additional information on its own initiative, it must send that information to the Food Safety Authority. In such cases, the Food Safety Authority must give its opinion within the six month period provided for in paragraph 1.
7
The Food Safety Authority must make the additional information provided in accordance with paragraphs 4 and 6 available to the appropriate authority.
Art. 17 substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 23 (as amended by S.I. 2020/1504, regs. 1(2), 15(5)); 2020 c. 1, Sch. 5 para. 1(1)