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European Commission - Fact Sheet (MEMO/15/5875), 16 November 2015
A copy of the agreed Regulation can be seen at: http://data.consilium.europa.eu/doc/document/PE-38-2015-INIT/en/pdf
The new novel food Regulation that has been agreed today, aims to improve 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. It will offer European consumers the benefit of a broader choice of food and a more favourable environment for Europe's agri-food industry – the second largest employment sector in Europe – to benefit from innovation, which in turn is good for growth and jobs.
What is novel food?
Novel food is defined as food that has not been consumed to any significant degree in the EU before May 1997 (when the first novel food legislation entered into force). This can be newly developed, innovative food or food produced using new technologies and production processes as well as food traditionally eaten outside of the EU. Recently approved novel foods include oil from Buglossoides arvensis, rapeseed protein and coriander seed oil.
Are they authorised in the EU?
Between 1997 and 2014, there have been around 170 applications for authorisation across the EU (7-10 applications/year). So far around 90 novel foods have been authorised for use.
Authorised novel food includes products traditionally eaten in non-EU countries such as chia seeds (high in omega-3 fatty acids), and food produced using the latest technological innovations such as heat-treated milk products fermented with Bacteroides xylanisolvens (DSM 23964). Other examples include "salatrim" a reduced-energy fat, DHA-rich oil from microalgae, a high-pressure fruit juice (which is an example of a food derived from new production processes).
For a full list of authorised novel food, see: http://ec.europa.eu/food/food/biotechnology/novelfood/authorisations_en.htm.
Why did the Commission revise the novel food legislation?
The current rules date back almost 20 years. Since then, technological developments and scientific advice have evolved considerably. Therefore, to reduce the current length (3 and a half years on average) for the authorisation procedure, EU rules needed to be updated. A previous revision was proposed by the Commission back in 2008, but agreement could not be reached between the Council and the European Parliament.
What are the main changes?
The new Regulation increases the efficiency of the authorisation procedure, enables a quicker delivery of safe, innovative food to market and removes unnecessary barriers to trade, whilst ensuring a high level of food safety.
It creates a centralised authorisation system, which will allow greater certainty for applicants seeking an authorisation for novel food and will simplify and speed up the authorisation process.
The European Food Safety Authority (EFSA) will conduct a scientific risk assessment for the novel food application, while the Commission will manage the files of each applicant and put forward a proposal for the authorisation of a novel food which is found to be safe.
To facilitate trade of traditional food from non-EU countries, which are considered novel foods in the EU, the new Regulation also introduces a more appropriate assessment procedure for food new to the EU. If the traditional food in question can historically be demonstrated as being safe and there are no safety concerns raised by EU Member States or EFSA, that traditional food will be allowed to be placed on the market on the basis of a notification from the food business operator.
Data protection provisions are also included in the new Regulation. Newly developed scientific evidence and proprietary data will not be able to be used for the benefit of another application for 5 years after the novel food has been authorised.
What are the conditions for authorisation?
Novel food will only be approved for use in the EU if they do not present a risk 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. The authorisation sets out the conditions for their use, their designation as a food/food ingredient and labelling requirements.
Do novel foods need to be labelled?
Novel food is subject to the general labelling requirements laid down in (Regulation (EC) No 1169/2011). Specific additional requirements for the labelling of novel food may also apply to properly inform the consumer i.e.: warning labels that the novel 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 must be compatible with the Health and Nutrition Claims Regulation (EC) No 1924/2006 (see MEMO/06/200).
What are nanomaterials and what are the conditions for their use in food?
Nanomaterials are materials engineered at the scale of atoms and molecules. The new Regulation specifies that engineered nanomaterials defined in the new legislation, require a Novel Food authorisation before being used in foodstuffs. Their safety will be assessed by the European Food Safety Authority. The applicants must also demonstrate that most up-to-date test methods have been used for testing the engineered nanomaterials for which an authorisation is sought for.
Are insects covered by the new Regulation?
Insects are already widely consumed around the world. In the EU, insects fall within the definition of novel food as food ingredients isolated from animals. Parts of insects (such as legs, wings, head, etc.) also fall within this definition.
The new legislation clarifies that also whole animals, such as whole insects, if not consumed to a significant degree by humans in the EU prior to 15 May 1997 (cut-off date of the Regulation), these fall also under the definition of novel food.
Are there any applications in the pipeline and will they be affected by the new rules?
Over recent years, there have been around 7-10 applications per year for novel food authorisations across the EU. There are several applications, such as Ecklonia cava phlorotannins, xylo-oligosaccharide and spray dried extract of Terminalia ferdinandiana EXELL, that are currently being assessed by the Member States. Those applications, which are not finalised by the time the new Regulation applies, will be governed by the new Regulation. This means the Commission will take care of the finalisation of those requests.
Can Member States approve or ban novel food independently of the EU?
No. The Novel Food Regulation lays down harmonised measures for the authorisation of novel food, which means that once a foodstuff is approved for marketing in the EU, it can be sold in any EU Member State. However, an EU 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. The Member State authorities must inform the Commission, which then carries out an investigation into the protective measure of the EU 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.
Will the new Regulation affect innovation in the food sector?
The aim of the new Regulation is to make the authorisation procedure for novel food simpler, faster and more efficient, so that innovative food which is safe to consume can be put on the market faster. 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.
What happens next?
After today’s agreement, the new Regulation has to be formally adopted by the European Parliament and the Council before its publication in the Official Journal of the European Union.
When will the new rules apply?
The new rules apply two years from the date of entry into force of the new Regulation (around end 2017).
See also: 16 November 2015 NOVEL FOODS - Commissioner for Health and Food Safety Vytenis Andriukaitis welcomes the political agreement on novel food