What is a novel food?
A novel food is a food or food ingredient that does not have a significant history of consumption within the European Union before 15 May 1997. This definition is part of Regulation (EC) No 258/97 (the ‘Novel Foods Regulation’).
Before any novel food is approved for use on the European market, it must be rigorously assessed for safety. In the UK, the assessment of novel foods is carried out by an independent committee of scientists, appointed by the Food Standards Agency. This committee is called the Advisory Committee on Novel Foods and Processes (ACNFP).
Assessment is also required for any food that has been produced using a novel production process (this is a process that was not used before 15 May 1997), if that process significantly changes the nature of the food.
The FSA is the Competent Food Assessment Body (also known as the ‘Competent Authority’) and it provides secretariat support for the ACNFP.
How do I know if a particular food is novel?
If a food has not been consumed in the European Union (EU) to a significant degree prior to 15 May 1997, then it is likely to be novel.
There is no single list that includes all novel foods, or a list that includes all foods that are not novel. However, there are a number of online lists that you can check, or you can ask for information to be sent to you, to help you to find out the status of a food. More about these sources can be found in the checklist via the link below.
The FSA also publishes letters that have been sent to interested parties when the status of a particular novel food has been queried. More information about some products that are being reviewed, or have been reviewed, can be found on the ‘Unauthorised novel foods’ page.
If the checklist and web page at the links below do not help you to find out the status of a food, you can complete an enquiry form (see link below) and email it to the FSA Novel Foods Unit at firstname.lastname@example.org
The company applying for a novel food to be authorised is responsible for proving that food’s history of use. The European Commission has published guidance to help companies that have information that may demonstrate a significant history of consumption in the EU prior to 15 May 1997.
How are novel foods assessed?
Novel food applications are initially assessed by an European Union (EU) member state that will prepare an initial assessment report. This report is sent to other EU member states, via the European Commission. Member states then have a limited time to comment on the assessment, and accept or object it.
If there are objections, the company applying may be invited to discuss the concerns with the member states, or the Commission may seek an assessment from the European Food Safety Authority.
When the assessment is completed, the Commission will prepare a decision which will grant, or refuse, the authorisation of the food. This decision is then subjected to a vote at an appropriate Commission regulatory committee meeting. If no objections are made to the initial report, the EU member state responsible for the initial assessment can decide whether to authorise (or reject) the novel food.
If your company wants to submit a novel food application:
How can I find out whether a novel food is authorised?
The Commission has also published a list of novel food and novel food ingredients that have been refused authorisation.
If a novel food has been authorised, does my company also need to seek an approval?
Yes. This is because a novel food authorisation is only ever issued to the company that is applying. However, it is often possible to request an opinion on ‘equivalence’ from a European Union (EU) member state if:
- your product is similar to, or the same as, the authorised product, and
- you want to use your product in the same way as the authorised product
For more information about notifications made via the ‘substantial equivalence’ route, refer to our guidance at the link below.
Are chia seeds a novel food?
Yes, they are. Chia seeds, which are from an herbaceous plant related to sage, were originally approved in 2007 for use in bread products (up to a maximum of 5% content). Since then, The Chia Company gained approval in 2013 to market chia seeds for other uses (see Commission Decision 2013/50/EU).
If your company wanted to market chia seeds for those same other uses, then your company would need to submit its own application. This is because any novel food authorisation is specific to the company applying for that authorisation. The chia seeds application by your company can be done by a simplified procedure called ‘substantial equivalence’, if company only wants to use the food categories that are specified in The Chia Company's decision. See examples of authorisations issued via the substantial equivalence route on the ACNFP site.
If you are interested in using chia seeds for a wider range of food categories, then a full novel food assessment will be required.
Are stevia leaves a novel food?
Yes. They are an unauthorised novel food ingredient.
There is increased interest in the use of stevia-based products in the European Union (EU), after certain highly purified extracts of stevia leaf were authorised, in 2011, for use as sweeteners. This use is as a food additive, and not as a novel food or novel food ingredient. The food additive is called steviol glycosides (E960), and food additives have specific purity criteria that manufacturers must comply with.
Stevia leaves themselves are not considered to be a food additive but, as a food ingredient, they require a novel food authorisation before they can be legally marketed in the EU. To date, no such authorisation has been issued.
Is mesquite a novel food?
Yes, it is. Mesquite (Prosopsis pallida) is a tree, mainly found in South America. Meal (flour) made from its seed pods has been sold in the UK. In 2011, we sent a letter to interested parties asking for information on a history of consumption for mesquite in the European Union before 15 May 1997.
We did not receive significant information in response to our request. Subsequently, we advised that mesquite would be considered novel.
Is ginseng a novel food?
No. There are a number of different varieties of the ginseng plant. Panax ginseng variety is known to have been used for human consumption within the European Union prior to May 1997, which means it is not a novel food. Ginseng root is the part of the plant mainly used, often in dried form.
Of the other ginseng varieties, the Panax notoginseng, Panax pseudoginseng and Panax quinquefolius varieties have only been used as food supplements so, while these can be used in food supplements, a novel food authorisation would be required to extend use of these ginseng varieties in other foods.
Are Goji berries and Acai berries novel foods?
No, they are not. These do not appear in the novel food catalogue published by the European Commission.
The catalogue shows food and food ingredients whose 'novel' status has been reviewed at EU level.
Is Moringa oleifera a novel food?
The status of this product on the EC catalogue is currently uncertain. Our records indicate that Moringa leaves and pods are not a novel food. Moringa pods (known as ‘drumsticks’) are readily available in the UK and are consumed by the UK Asian population. The drumsticks are eaten cooked and the flesh and seeds (if they are soft) are scooped out and eaten, while the drumstick casing is discarded.
We do not have official evidence to confirm the non-novel status of the pods. This means we have no robust evidence that the pods had a significant history of consumption before 15 May 1997. We would, however, say it is unlikely these pods are novel because the large Asian population that consumes this as a food has resided in the UK for decades.
Here is some advice relating to specific parts of the Moringa plant:
- Seeds – we do not hold official information on Moringa seeds but these are found within the pods and may be eaten as part of the pod contents if they are soft or discarded if they are hard. The seeds should be treated as part of the pod as with any other fruit.
- Bark, roots, gum or juice – our records also suggest that the bark, roots, gum or juice of Moringa may be medicinal and we would advise you to contact the Medicines and Healthcare Products Regulatory Agency (MHRA) for advice in the first instance if you are interested in marketing any of these.
- Oil – we do not hold any information relating to the use of Moringa oil in foods before 15 May 1997. We would advise that this oil may be novel unless a significant history of consumption can be demonstrated.
The above advice might help you. However, if it is your intention to market extracts of Moringa, then our advice would be that they may well fall within the scope of the Novel Foods Regulation (the only exception being simple water extracts of non-novel plant parts).
The above advice might help you. However, if it is your intention to market extracts of Moringa, then our advice would be that they may fall within the scope of the Novel Foods Regulation (the only exception being simple water extracts of non-novel plant parts).
Are whole insects or worms novel foods?
Insects and other whole animals are currently exempt from the scope of the Novel Foods Regulation. This exemption is mainly because the wording of the existing Commission regulation does not mention whole animals such as insects. However, this will change with the final agreement of the revised novel food regulation expected by the end of this year. In future, insects, and similar whole animals that are currently marketed as foods in the European Union (EU) will require a novel food safety assessment, unless they have been consumed to a significant degree in the EU prior to 15 May 1997. We expect the revised regulation to include transition period of two years to allow operators to adapt to the changes.
In view of this, if you are planning to market insects or other whole animals in the UK as food, it may be sensible to confirm whether they were on the market in the EU to a significant degree prior to 15 May 1997. See the Commission guidance on demonstrating a significant history of consumption.
Intelligence gathered in the UK in 2011 identified a number of species that may have been on the UK market before May 1997, although this information is yet to be verified at EU level.
Will there be a new regulation to replace the current one?
Yes. In 2013 the European Commission published a proposal for an updated regulation. This was similar to the 2008 proposal, which failed to gain agreement in 2011 because member states and the European Parliament could not agree a common approach to the regulation and labelling of meat and milk from cloned animals and, in particular, their descendants. It includes:
- A single risk assessment carried out by the European Food Safety Authority.
- An alternative approach for the assessment of traditional foods from non-EU (third) countries, based on traditional safe food use.
The default position will be generic authorisations. This means an authorisation can be used by not only the company that has applied but other companies too, subject to new data protection periods in certain circumstances. Separate proposals from the European Commission have been issued considering the regulation of products from cloned animals.
Negotiations on the new novel food proposal between the European Parliament, Council and the European Commission have been ongoing since 2013. It is expected that an agreement will be finalised on the text of the revised regulation by the end of the year with a two year transition period.