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Focus on Regulation

Draft EU List of Authorised Novel Foods Published

The European Commission has published a draft implementing Regulation setting out the proposed official EU list of authorised novel foods.

A ‘novel food’ is a food or ingredient that has not been consumed to a significant degree in the EU prior to 15 May 1997. These include products traditionally eaten outside the EU prior to this date, such as chia seeds, argan oil and noni fruit juice, as well as foods produced using innovative processes, such as UV-treated mushrooms.

Currently, food manufacturers looking to use a novel food or ingredient in their products have to obtain prior authorisation from the first country in the EU in which the food/ingredient will be marketed. That authorisation applies across the EU but is personal to the applicant, so other companies wishing to use the same food/ingredient have to apply for a separate authorisation.

A new centralised authorisation procedure will replace the current system from 1 January 2018, under the new Novel Foods Regulation (EU) 2015/2283, making it easier and quicker for businesses to use innovative novel foods and ingredients in the EU. Applications will be submitted to the Commission and assessed by the European Food Safety Authority (EFSA) as to whether the food or ingredient presents a risk to public health, is not nutritionally disadvantageous compared to any food or ingredient it could be used to replace, and is not misleading to consumers. If authorised, the food or ingredient will be added to the official list and businesses can then use that novel food or ingredient in the EU without having to apply for their own authorisation. There will also be a simplified approval route for traditional foods from outside the EU.

The draft implementing Regulation includes all novel foods and ingredients that have previously been authorised for use by Member State competent authorities, their conditions for use, specifications, and any additional specific labelling or other requirements.

The Commission has until 1 January 2018, when the new Novel Foods Regulation comes into effect, to adopt the finalised implementing Regulation. Any application for authorisation under the current system that has not received final approval by the relevant Member State before the implementing Regulation is formally adopted will automatically be treated as an application under the new centralised procedure. Where a risk assessment has already been completed by a Member State and no objections have been raised by other Member States or the Commission, the EFSA will not carry out a second assessment.

The full text of the draft implementing Regulation is available here and the consultation closes on 2 November 2017.