New rules on novel food and novel ingredients will apply from 1 January 2018 as a result of updated EU legislation in this area. The updated rules will enhance regulatory conditions so that businesses can more easily bring new and innovative food to the EU market, while still maintaining a high level of food safety for European consumers.
What is a "Novel Food"?
Currently a Novel Food is defined by Regulation (EC) No 258/97 concerning novel foods and novel food ingredients as a "food or food ingredient (including process) not on the EU market to a significant degree prior to 15 May 1997". A Novel Food can be a newly developed, innovative food or a food produced using new technologies and production processes. It also includes food traditionally eaten outside of the EU.
An important distinction to note is that food additives, flavourings, enzymes, genetically modified food or feed and extraction solvents are not considered Novel Foods and are governed by separate legislation.
The premise behind legislating for Novel Food is that it should only be approved for use in the EU if it does not present a risk to public health, is not nutritionally disadvantageous when replacing a similar food and is not misleading to the consumer.
Labelling of Novel Food
Novel Food is subject to the general labelling requirements laid down in Regulation (EU) No 1169/2011 on the provision of food information to consumers. However, there may be additional requirements for the labelling of specific Novel Foods, for example the requirement to attach a warning label that the food is not recommended for certain vulnerable groups. The label must mention the name of the food, and, where appropriate, specify the conditions of use. Any nutrition and health claim being made in relation to the food must be clear, accurate and based on scientific evidence.
What changes are being introduced?
Regulation (EU) 2015/2283 on novel foods was published in November 2015 and amends and repeals the existing EU legislation on Novel Foods.
Given that technological developments and scientific advancements have evolved considerably within the food industry since the initial legislation for Novel Food was introduced in 1997, it was considered necessary to update the rules in this area. In terms of application, the new legislation retains the same "cut-off" date of 15 May 1997 for the definition of Novel Food. However, significant changes are being introduced such as:
- an updated risk assessment procedure;
- the creation of a speedier and more efficient centralised authorisation system;
- a simplified approval route for traditional foods from third countries;
- the expansion of Novel Food and Novel Ingredient categories; and
- the governing of Novel Food processing technologies.
In addition, the use of engineered nanomaterials will require a Novel Food authorisation before being used in foodstuffs. Their safety will be assessed by the European Food Safety Authority and applicants will be obliged to demonstrate that the most up-to-date methods have been used for testing the engineered nanomaterials for which an authorisation is sought for.
To assist with the advancement of innovative research and development within the food industry a data protection regime is being introduced, which will offer legal protection of information and data gathered by applicants in support of their application for a Novel Food. It will not be possible to use newly developed scientific evidence and proprietary data for the benefit of another application for 5 years after the Novel Food has been authorised.
The new Novel Food Regulation will have direct effect across the Member States of the EU from 1 January 2018, meaning that it will not need any national transposing measures to apply. Organisations that are active in the area of Novel Foods should start to consider the impact of the changes outlined above on their business ahead of this date.