CHAPTER IIREQUIREMENTS FOR PLACING NOVEL FOODS ON THE MARKET WITHIN F1GREAT BRITAIN

F2Article 6Requirement for authorisation

Only novel foods authorised by the appropriate authority in accordance with this Regulation may be placed on the market within Great Britain as such, or used in or on foods, in accordance with the conditions of use and the labelling requirements specified in the authorisations concerned.

Article 7General conditions for F3authorisation of novel foods

The F4appropriate authority must only authorise F5a novel food if it complies with the following conditions:

  1. (a)

    the food does not, on the basis of the scientific evidence available, pose a safety risk to human health;

  2. (b)

    the food's intended use does not mislead the consumer, especially when the food is intended to replace another food and there is a significant change in the nutritional value;

  3. (c)

    where the food is intended to replace another food, it does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.

F6Article 8Initial establishment of the Union list

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Article 9F7Obligations of the appropriate authority in relation to the procedure for determining authorisation status and content of an authorisation

1.

The F8appropriate authority must F9determine the authorisation status of a novel food in accordance with the rules laid down in:

(a)

Articles 10, 11 and 12 and, where applicable, Article 27; or

(b)

Articles 14 to 19.

F102.

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3.

F11The authorisation of a novel food shall include the specification of the novel food and, where appropriate:

(a)

the conditions under which the novel food may be used, including in particular any requirements necessary to avoid possible adverse effects on particular groups of the population, the exceeding of maximum intake levels and risks in case of excessive consumption;

(b)

additional specific labelling requirements to inform the final consumer of any specific characteristic or food property, such as the composition, nutritional value or nutritional effects and intended use of the food, which renders a novel food no longer equivalent to an existing food or of implications for the health of specific groups of the population;

(c)

post-market monitoring requirements in accordance with Article 24.