There may be some doubt over whether a food or ingredient is novel or not.
For example,it may be intended to market it in a different form to that already sold in the EU - in a capsule or as a pill rather than as part of a conventional food - or it may be derived from a closely related organism, or there may have been a slight change of production process which has altered the level of certain impurities.
A change of production process confers novelty upon the food under the regulation because of the change in impurity profile and this is a separate category requiring an application for approval.
If the applicant considers their product is not novel, a formal enquiry can be made to the competent authority of the Member State where the product is intended for first marketing.
The objective is to receive a 'not novel' letter in return.