There are different criteria for determining whether a food was consumed in significant quantities in the EU before 1997. Since this factor is central to the classification of a food, the EU has a specific technical document on the subject.
However, it is important to stress that the conditions for the correct classification of a food must be assessed individually for each food. While there may be cases where significant consumption is evident from the 'history' of the food (e.g. extensive sales data available), in general the 'whole picture' needs to be examined.
Let's look at the aspects that we need to consider in order to decide whether a food has been consumed in the EU in significant quantities in the past or not, as the latter can be considered as novel foods.
1) Information on food use
In addition to the composition of the food, the following basic information must be provided in order to demonstrate the link between the food consumption documentation and the product
- Latin name
- the marking of parts used as food before 1997
- the form/concentration of the product (e.g. liquid, extract)
2.) Documentation
Reliable information and data from cited sources are needed to demonstrate that the food in question was legally marketed in the EU before 1997.
Individual data that only contain information on a single detail of consumption (e.g. import lists that do not reveal the intended use of a product) are usually not sufficient or suitable to justify this, but a wide range of information needs to be relied upon.
It may also be necessary to take into account national food regulations when assessing the significant quantity (e.g. what part or form of a fruit has been consumed in the past).
3.) Geographical factors
Some foods may have been consumed to different extents in different EU countries, so it is important to clarify the geographical context in which a food was commonly and widely consumed.
Food can be exempted from the obligation to be authorised as a novel food even on the basis of evidence of significant consumption within an EU Member State.
4.) Consumption volume
The higher the amount of the food consumed, the easier it is to prove that consumption was significant.
What is considered to be an exceptionally high consumption of a food also depends to a large extent on the nature of the food (e.g. less spice can be too much).
In addition to the volume of consumption, the market availability of the food, i.e. whether the product was available to a wide range of consumers, can also be a determining factor.
5.) Purpose of use
The intended use of a product should be deemed to be consumption as food.
In other words, products that were not used for food (but e.g. for animal feed) in significant quantities in the EU before 1997 cannot be taken into account.
6) Specific consumer groups, conditions of use
The food had to be consumed in significant quantities as part of the average consumer's overall dietary habits. It could be consumed on special occasions (e.g. festive occasions) but not sold to a special needs group (e.g. dieters).
7) Use of other parts or other forms of food or new technologies
The use of a different part of the food, or a different form of the food, or the production of the food using a new technology, compared to the significant consumption of the food that can be established for the period before 1997, may justify the need to authorise the product as a novel food.
8.) Accessibility
- a) Locality
Only food that is legally marketed in an EU Member State can be tested.
Here, consumer accessibility (special distribution channels or general shop sales) should also be taken into account.
- b) Time frame
The availability of the product over a number of years should also be examined, i.e. whether consumption is continuous or intermittent, and the extent to which continuous consumption can be considered current.
9) Questionnaire - decision support application
Not easy! That's why an EU decision-facilitating diagram has been produced to help you answer the above questions and make an initial decision on whether the product you want to market is a novel food.
Determining the status of a novel food is often not a yes/no decision, but may require a lot of additional and extensive information and the involvement of a specialist, including legal expertise.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
