In deciding whether a food was consumed in significant quantities in the EU before 1997, various aspects must be taken into account. Since this factor plays a central role in the classification of a food in question, the EU also deals with the subject in a separate technical document.
It is important to emphasize, however, that the existence of the conditions for the correct classification of the food must be examined individually for each food. Although there may be cases where significant consumption is obvious based on the “history” of the food (e.g. extensive sales data are available), in general the “whole picture” must be examined.
Let us see the aspects that must be examined in order to be able to decide whether a food was consumed in significant quantities in the EU before or not, since the latter can be considered as novel foods.
1.) Information on use as food
In addition to the composition of the food, the following basic information must be available in order to demonstrate the relationship between the documentation on the consumption of the food and the product, and these are
- Latin name
- indication of the parts used as food before 1997
- form / concentration of the product (e.g. liquid, extract)
2.) Documentation
Reliable and stable information and data from cited sources are necessary to prove that the food in question was lawfully placed on the market in the EU before 1997.
Individual data that contain information on only a part of the consumption (e.g. import lists that do not indicate the intended use of a product) are generally not sufficient or suitable for this verification, but a wide range of information must be relied on.
Member State food regulations may also need to be taken into account when assessing a significant quantity (e.g. which part or form of a fruit was consumed previously).
3.) Geographical factors
Some foods may have been consumed to different extents in different EU member states, so it is important to clarify the geographical framework within which a food was generally and widely consumed.
Unfortunately, a food can also be exempted from the obligation to be authorised as a novel food based on proof of significant consumption within an EU member state.
4.) Amount of consumption
The higher the amount of consumption of a given food, the easier it is to prove a significant level of consumption.
What is considered to be an exceptionally high consumption of a food largely depends on the nature of the food (e.g. a small amount of a spice can be a large amount).
In addition to the amount of consumption, the availability of the food on the market can also be decisive, i.e. whether the product was available to a wide range of consumers.
5.) Purpose of use
The purpose of use of a product must be considered to be consumption as food from the outset.
This means that a product that was used in significant quantities in the EU before 1997 for non-food purposes (e.g. animal feed) cannot be taken into account.
6.) Special consumer groups, conditions of use
The food must have been consumed in significant quantities as part of the general eating habits of the average consumer. This may be a product consumed on special occasions (e.g. festive occasions), but it cannot be a product sold to a group of people with special needs (e.g. dieters).
7.) Use of a different part of the food or in a different form, or new technologies
Compared to the significant amount of consumption of the food that can be determined for the period before 1997, the use of a different part of the food or in a different form, or the production of a new technology, may justify the need to authorize the product as a novel food.
8.) Accessibility
a) Locality
Only the consumption of food that has been legally placed on the market in an EU member state can be examined.
Here, the accessibility by consumers (special sales channels or general store sales) must also be taken into account.
b) Time frame
The availability of the product over years must also be examined, i.e. whether the consumption can be considered continuous or only periodic, and to what extent continuous consumption can be considered current.
Determining the status of a novel food cannot usually be decided by giving yes/no answers, but may require a lot of and extensive additional information, and requires the involvement of a specialist – including one with legal knowledge.
It is not impossible, the first Hungarian novel food, sorghum syrup, has already been licensed! The licensee of the novel food can sell it exclusively in the EU for 5 years!