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MEMO/08/17

Brussels, 14 January 2008

Questions and Answers on Novel Foods

What are novel foods?

Novel Foods are defined as those not consumed to any significant degree in the EU prior to May 1997 (when the first Novel Foods legislation entered into force). They can be newly developed, innovative foods, food produced using new technologies and production processes or food which has been traditionally consumed outside of the EU.

What novel foods have been authorised for the EU market?

To date (1 December 2007), there have been 86 applications (7-10 applications/year). So far 22 novel foods have been authorised for use in the EU. The authorised novel foods include products traditional to third countries such as "noni juice" (made from a Tahitian plant), and foods produced using the latest technological innovations such as oils and dairy products enriched with phytosterols/phytostanols to reduce cholesterol. Other examples include "salatrim" a reduced-energy fat, DHA-rich oil, a high-pressure fruit juice (which is an example of a food derived from new production processes).

Only 3 applications have been refused under the Novel Foods Regulation, and these were largely due to missing data in the dossier or safety concerns.
For the full list of authorised novel foods, see:

http://ec.europa.eu/food/food/biotechnology/novelfood/authorisations_en.htm

Why is the Commission revising the legislation for novel foods?
A stakeholder consultation carried out in 2002, showed the need to update the current provisions for novel food, in line with new technological developments and scientific advice. The aim is to increase the efficiency of the authorisation procedure, enable a quicker delivery of safe, innovative food to the market and remove unnecessary barriers to trade, while still ensuring food safety. The Regulation also needs to be revised to reflect the fact that it no longer covers GMOs, which have been dealt with under separate legislation since 2003 (see:

http://ec.europa.eu/food/food/biotechnology/gmfood/legisl_en.htm).

What are the main changes being introduced?

The proposed Regulation seeks to create a centralised authorisation system, which will allow greater clarity for applicants seeking authorisation for a novel food and will simplify and speed up the process for authorisation.

The European Food Safety Authority (EFSA) will be responsible for carrying out the risk assessment on the novel food applications, while the Commission will manage the dossiers of each applicant, putting forward a proposal for the authorisation of novel foods which are found to be safe. The "one door – one key" approach will be taken for the approval of novel foods, just as it will be for food additives, food enzymes and food flavourings (see IP/06/1074). This means that .the applicant may make one application for approval covering all the possible uses of the substance in question.

In order to remove any barriers to trade caused by the long authorisation process for traditional foods from third countries, the draft Regulation also introduces a more proportionate safety assessment procedure for such foods which have not been traditionally consumed in Europe. If the history of safe use of the food in a third country can be demonstrated, and there are no objections from Member States or EFSA, the food will be allowed to be placed on the market on the basis of a notification from the third country operator.

Data protection provisions are also included in the proposal. Newly developed scientific evidence and proprietary data will not be allowed to be used for the benefit of another application for 5 years after the novel food has been authorised.

What are the requirements for a novel food to be authorised for use in the EU?

Novel foods will only be approved for use in the EU if they do not present a danger to public health, are not nutritionally disadvantageous when replacing a similar food and are not misleading to the consumer. They must undergo a scientific assessment prior to authorisation, to ensure their safety and the authorisation sets out, as appropriate, the conditions for their use, the designation as a food and/or food ingredient and the labelling requirements.

What are the labelling requirements for novel foods?

Novel foods are subject to the general labelling requirements (Directive 2000/13/EC). Specific additional requirements for the labelling of novel foods may also apply, if necessary to properly inform the consumer. The label must mention the name of the food, and, where appropriate, specify the conditions of use. Any nutrition and health claim should only made in accordance with the Health and Nutrition Claims Regulation 1924/2006 (see MEMO/06/200).

Will the legislation affect innovation in the food sector?

The aim of the revised Regulation is to make the authorisation procedure for novel foods simpler, faster and more efficient, so that innovate foods which are safe to consume can be put on the market in the shortest time possible. Moreover, the data protection provisions will help to protect the interests of companies which produce new, innovative products, and should help to encourage innovation in the food sector.

Are there any novel food applications in the pipeline at the moment?

Over recent years, there have been around 7-10 applications per year for novel food authorisations across the EU. Examples of applications for authorisation which are currently in the pipeline are "Baobab" (a dried fruit pulp traditionally eaten in Africa), kiwiberri concentrate (commonly used in China, Japan, Korea and Siberia) and CLA (conjugated linoleic acid) which claims to have some health benefits.

Can Member States ban / approve a novel food independently of the EU?

No. The Novel Foods Regulation lays down harmonised measures for the authorisation of novel foods, which means that once a foodstuff is approved for marketing in the EU, it can be sold in any Member State. However, a Member State can suspend or provisionally restrict the marketing and use of any novel food if they believe it to constitute a health hazard according to the safeguard provisions of the General Food Law (Regulation (EE) No 1782/2002). The Member State authorities must inform the Commission, which then carries out an investigation into the protective measure of the Member State. If a food is found to pose any risk to consumers, the Commission can immediately suspend its authorisation for marketing in the EU.


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