Requirements for the Placing on the Market of Novel Foods
Before novel foods can be placed on the market, they must go through a notification or authorisation procedure. Applications are to be submitted to the Federal Institute for Consumer Protection and Food Safety (BVL). (cf. Novel Foods Regulation).
If the characteristics of the novel foods differ from those of conventional products, the consumers must be informed of this by means of corresponding labelling.
The products covered by the scope of the Novel Foods Regulation may only be placed on the market if, within the framework of the notification or authorisation procedure, it has been proved that they do not
- present a danger for the consumer,
- mislead the consumer or
- differ from the convention products which they are intended to replace to such an extent that their normal consumption would be nutritionally disadvantageous for the consumer.
The two procedures for the placing on the market of novel foods can be described as follows:
Authorisation procedure pursuant to Article 4 of the Novel Foods Regulation
compulsionary for foods and food ingredients,
- with a new or intentionally modified primary molecular structure
- to which a production process not currently used has been applied
and for all other products which are not substantially equivalent to existing products.
Notification procedure pursuant to Article 5 of the Novel Foods Regulation
applicable to foods and ingredients,
-
which are substantially equivalent to existing products as regards their composition, nutritional value, metabolism, intended use and the level of undesirable substances contained therein.
Novel Foods Labelling requirements
Article 8 of Regulation (EC) No 258/97 requires that the consumer be given, by means of specific labelling, the following information about:
- any characteristic or food property such as composition, nutritional value or nutritional effects and intended use of the food which has been demonstrated to render a novel product no longer equivalent to an existing food or food ingredient on the basis of a scientific assessment and using an appropriate analysis of existing data including a reference to the method used to obtain the changes;
- the presence of new material which may have implications for the health of certain groups of the population (e.g. material with allergenic potential);
- the presence of new material which may give rise to ethical concerns.
Control of compliance with the labelling requirements is the task of the competent authorities of the federal states (Länder).
