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'Novel foods' are foods that have not been widely consumed in the European Union before 15 May 1997. Novel foods either do not have any 'history of consumption', or are produced using new processes which result in one or more of the following:

• changes to the food's composition
• changes to the food's nutritional value
• undesirable substances in the food
• changes to the way in which the food is metabolised

Using high-pressure processing as an alternative to heat pasteurisation is an example of a novel food process. Novel foods can include different types of products - for example:

• oils and other extracts or concentrates including from existing foods
• new carbohydrates and protein sources
• seeds and berries

Reasons for the development of novels foods

Food companies may want to introduce novel foods for different reasons, This may be, for example, because:

• they can produce them more efficiently
• they provide health benefits for consumers

Are novel foods regulated?

Before a novel food can be legally marketed, it must have a pre-market safety assessment and authorisation. The assessment and authorisation ensure that the novel foods:

• are safe
• are not misleading to the consumer
• do not replace other foods in a way that would nutritionally disadvantage consumers 

There are two possible routes for authorisation of novel foods:

• a simplified application for traditional foods from countries outside the UK or EU
• a full application for all other novel foods

Novel foods legislation

The current EU regulation on novel foods was introduced in 2018. The regulation:

• expanded the categories of novel foods
• introduced a simplified, centralised authorisation procedure
• introduced a simplified assessment for traditional foods from non-EU countries
• established a
• included data protection provisions for certain innovative novel foods

Find out more about the .

To apply for an authorisation of a novel food in Great Britain, use the UK's .

Researching public opinion on novel foods

The Food Standards Agency protects consumers' interests in relation to food matters, keeping up to date with public opinion about emerging food technologies. Their research shows that the public is still wary of novel food technologies, including genetically modified food and animal cloning.

The Novel Foods Regulation sets out details for how novel foods, ingredients and processes are approved for use. The regulation defines a novel food as one that wasn't sold to any significant extent in the European Union before 15 May 1997.

The scope of the regulation

The regulation covers a wide range of food and food ingredients, including those that:

• have a new or intentionally modified primary molecular structure
• consist of - or are isolated from - micro-organisms, fungi or algae
• consist of, are isolated from, or produced from minerals
• consist of, are isolated from, or produced from plants or their parts (but not food and food ingredients obtained by traditional propagating or breeding methods with a history of safe food use)
• are produced using a new process that leads to significant changes in their composition or structure affecting their nutritional value, their metabolism or the level of undesirable substances they contain

Food and food ingredients covered by the regulation must not:

• be dangerous to consumers
• mislead consumers
• be so different from the food or food ingredients that they're intended to replace that normal consumption of them would be nutritionally disadvantageous

When the regulation does not apply

If a food or food ingredient was sold commercially in at least one EU member state before 15 May 1997, the regulation on novel foods does not apply. The product can be marketed anywhere else in the EU.

Exemptions from the regulation

Some products are exempt from the regulation because they're regulated by other directives. These include:

• food additives
• flavourings
• extraction solvents used to produce food and food ingredients
• genetically modified organisms

It is your responsibility to know if the novel foods regulation applies to a product you want to sell. To help you determine novel status, you may want to check or the European Commission's .

To apply for an authorisation of a novel food in Great Britain, use the UK's .

Novel foods, ingredients and processes covered by the Novel Foods Regulation must have a pre-market safety assessment before they are authorised for use throughout the European Union.

This applies to any food and food ingredient that hadn't been used in the EU for human consumption to a significant degree before May 1997 - see what are novel foods.

To apply for an authorisation of a novel food in Great Britain, use the UK's .

Process for authorisation of a novel food in Northern Ireland

If you intend to market a novel food which has not yet been authorised, you will need to apply for authorisation. There are two authorisation routes under the relevant EU regulation. In both cases, you must provide a dossier of information and submit it to the European Commission (EC) through their .

Traditional foods from countries outside the UK or EU

This is a simplified route for food products that are new to the EU but have a safe history of consumption within their country of origin. This route offers reduced data requirements and a shorter process of assessment than that of other non-traditional novel food.

The European Food Safety Authority (EFSA) provides guidance on .

Full application for all other novel foods

For all novel foods other than traditional foods, application will require a full set of information to be submitted to the EC which will then ask the EFSA to carry out a safety assessment where appropriate. The food safety assessment will look at things like:

• composition
• nutritional value
• metabolism
• intended use
• presence of unwanted substances such as contaminants
• production process - if the final composition of a food changes in production this can make it a novel food
• toxicology assessment
• allergen assessment

Once the safety assessment is complete, the EC will form an opinion on the novel food. If the opinion is positive, they will add food to the , which means you can then market it in the EU.

Before applying for authorisation, read the EFSA's .

Food from cloned animals, for example meat, eggs or milk, falls under the scope of the EU . Under the regulation, cloning is considered a novel production technique and is subject to authorisation.

To apply for an authorisation of a novel food in Great Britain, use the UK's .

What is cloning?

Cloning is a process that produces genetically identical individuals without genetic modification.

Cloning is common in horticulture, for example - growing plants from a cutting or a graft produces genetic copies of the original plants. Some microorganisms - such as amoebas, and insects - such as greenfly, also clone themselves naturally.

Scientists have developed a way to clone cattle and other farm animals using a technique known as 'somatic cell nuclear transfer' (SCNT). SCNT doesn't occur naturally.

The use of this technique in mammals raises animal welfare concerns. However, in terms of food safety, there is no evidence to suggest any difference between products from healthy clones and those from healthy conventionally-bred animals.

How is cloning regulated?

To date, cloning is not used for commercial production of food in the EU. No company has ever applied to sell food from cloned animals on the EU market.

If this happens in the future, any products obtained from cloned animals would be considered novel foods. As such, they would need to be safety assessed and authorised by the EU before they could be legally placed on the EU market.

Read more about regulation of novel foods and find out how novel foods are assessed.

Food Standards Agency (FSA) research

The FSA has researched public attitudes towards cloning and the possibility that the offspring of cloned animals could enter the food chain. The survey found that areas of consumer concern included:

• food safety
• animal welfare issues
• a lack of trust in the organisations with an interest in cloning

The report concluded that the public would only accept the idea of buying and eating food from clones and their offspring if these concerns had been addressed.

Read the FSA's report on .

Food consisting of, or containing, engineered nanomaterials is considered novel food. As such, it requires pre-market approval and authorisation before it can be legally placed on the market.

What is nanotechnology?

Engineered nanotechnology is a developing science. It is the manufacture and use of materials and structures in very small sizes, measured using the 'nanometre scale'. A nanometre is one-millionth of a millimetre.

Use of nanotechnology in food

Nanomaterials are not new. They could be used in food production to enhance the taste, colour, flavour, texture and consistency of a variety of foods, as well as their shelf life and traceability. A number of new processes and materials derived from nanotechnology can provide answers to such needs.

Regulation of nanotechnology in food applications

Before any novel food or ingredient made using nanotechnology can be legally marketed, it must undergo a safety assessment and approval.

At present, the regulation on novel foods doesn't state that particle size needs to be considered as part of the assessment. Updates to law may change this to make the stance on nanotechnology clearer.

In addition to the Novel Food Regulation, several other regulations cover the use of nanomaterials in the food sector, including:

• The Food Information to Consumers Regulation that sets the rules for the labelling of food ingredients. It requires that you must clearly indicate any engineered nanomaterials in food with 'nano' in brackets after its name in the ingredient list.
• The Food Additives Regulation lays down a list of approved food additives, enzymes and flavourings. If there are changes in the production process or in the starting materials of an already approved food additive, it will be considered a different additive and will need to be re-evaluated. A significant difference in the starting materials is, for example, a change in particle size, including through the use of nanotechnology.
• Several regulations that aim to make sure that harmful chemicals are not released into the food, such as the general food contact materials legislation, as well as the Plastic Food Contact Materials Regulation.

The European Food Safety Authority (EFSA) is responsible for the risk assessment of the use of nanomaterials in food and feed placed in the EU market, as well as in food contact materials. Read more about .

To apply for an authorisation of a novel food in Great Britain, use the UK's .

Research into nanotechnology

The Food Standards Agency (FSA) has carried out research into new ways in which nanotechnology might affect food in the UK. The research considered:

• the potential chemical migration into food when materials and articles in contact with food use the technology
• the possible use of nanomaterials as food additives or ingredients
• consumer safety
• the need for regulatory controls

Read the FSA's reports on , the , and .