Novel foods

Novel foods are foods that have not been consumed to a significant degree in the European Union before 15 May 1997. This includes foods with no history of consumption and foods produced using new processes that change the product.

A food, ingredient or process may be novel if it:

• changes the composition of the food
• changes the nutritional value
• changes how the food is metabolised in the body
• leads to the presence of undesirable substances in the food

Examples of novel foods or processes

Examples of novel foods include:

• new oils, extracts or concentrates from existing foods, for example, new seed oils, plant extracts or sterol/stanol ingredients in cholesterol-lowering spreads
• new carbohydrates and protein sources, such as insect protein, algae‑based ingredients or plant protein isolates used in meat alternatives
• seeds, berries and other plant products not traditionally eaten in the EU, such as chia or baobab
• foods with significantly changed composition, for example, UV-treated bread, to increase vitamin D

Examples of novel food technology and processes include:

• nanotechnology - used to improve texture, shelf life or packaging performance
• high-pressure processing instead of traditional heat pasteurisation - used to make chilled juices or ready‑to‑eat meats safer and last longer

Why do businesses develop novel foods

Food businesses may develop novel foods because they:

• can be produced more efficiently
• offer new health or nutritional benefits
• have improved shelf life or functionality

If you are considering a new ingredient or process, you must be aware of the rules around novel food regulation and authorisation.

Novel foods regulation controls which new foods and food processes can be placed on the market. A food is novel if it was not sold to a significant degree in the European Union before 15 May 1997.

The novel foods regulation applies to:

• foods with a new or intentionally modified molecular structure
• foods consisting of, or isolated from, micro-organisms, fungi or algae
• foods consisting of, isolated from or produced from minerals
• foods consisting of, isolated from or produced from plants or their parts (except foods obtained by traditional propagating practices with a safe history of use)
• foods resulting from a new production process that significantly changes composition or structure, affecting nutritional value, metabolism or the level of undesirable substances

Engineered nanomaterials, certain animal‑derived foods (for example, cultured meat and some insect products), and some new forms of vitamins and minerals are also treated as novel foods under the same regulation.

The regulation requires that novel foods be safe for consumers and properly labelled, so as not to mislead consumers. If novel food is intended to replace another food, it must not differ in a way that the consumption of the novel food would be nutritionally disadvantageous for the consumer

Exemptions from the novel food regulation

If a food or ingredient has a proven history of safe use as food and was sold commercially in at least one EU member state before 15 May 1997, it is generally not considered a novel food.

Regulatory context for novel foods in Great Britain and Northern Ireland

In Northern Ireland, EU Regulation (EU) 2015/2283 on novel foods continues to apply. The Novel Foods Regulations (Northern Ireland) 2017 sets out how the EU rules are applied and enforced. Authorisations are granted at the EU level and listed on the Union list of authorised novel foods.

In Great Britain, novel foods are authorised under the GB regime. Businesses apply through the UK-regulated products application service. Some GB-authorised products may be supplied into NI via the Northern Ireland retail movement scheme, subject to scheme conditions.

How to check if your product falls under novel food regulation

It is your responsibility to know if the novel foods regulation applies to a product you want to sell. If you are not sure whether a food or ingredient is considered novel in Northern Ireland, you should:

• read the official EU guidance on novel food
• check the EU novel food catalogue and the Union list to see if a similar product is listed

For GB authorisation, look at the Food Standards Agency (FSA) guidance to understand how novel products are classified and assessed.

If you remain unsure regarding the novel food status of your product, you should follow the procedure for the determination of novel food status, and contact the competent authority of the Member State where you first intend to place your product on the market.

Food business operators must provide the necessary information to the Member State to enable it to determine whether or not a food falls within the scope of the regulation. Before you can place novel foods on the market, they must undergo safety assessment and authorisation.

Novel food law requires all novel foods to undergo a formal safety assessment and authorisation before they can be placed on the market. There are two main routes for the authorisation of novel foods under the regulation that applies in Northern Ireland and Europe.

Authorisation of traditional foods from countries outside NI or the EU

This is a simplified route for foods that are new to the EU or NI, based on a documented history of their safe use in their country of origin. Businesses apply through an online notification to the European Commission. This route has reduced dossier requirements and a shorter assessment process than for other novel foods. Read the European Food Safety Authority (EFSA) guidance on the authorisation of traditional foods from third countries.

Full application for all non-traditional novel foods

For all non-traditional novel foods, you must submit a full application to the European Commission through their e-submission food chain platform. For your application, you must prepare a detailed dossier describing the food, production, uses, consumers and safety rationale. Once the Commission has validated the application, they will ask EFSA to carry out a scientific safety assessment. 

The safety assessment for a full application normally covers:

• composition
• nutritional value
• metabolism
• intended use and target consumers
• presence of undesirable substances, such as contaminants
• production process and any changes to the final composition
• toxicology
• allergenicity

If the assessment is favourable, the product will be added to the Union list of authorised novel foods and can be lawfully marketed in the EU subject to any conditions of use.

If you want to market a novel food in NI that is not yet authorised in the EU, read the full guidance on procedures to request a novel food authorisation.

Novel food authorisation in Great Britain

In Great Britain, novel foods are authorised under the UK-regulated products framework, using the Food Standards Agency (FSA) risk assessment. Businesses apply for authorisation through the UK-regulated products application service. GB also maintains its own list of authorised regulated food and feed products.

If you plan to sell in both Great Britain and Northern Ireland/EU, you will need to be aware of the relevant Windsor Framework or Unfettered Market Access requirements.

For GB products moving into NI, you may need both GB and EU novel food authorisations, unless the goods are moving under the Northern Ireland Retail Movement Scheme (NIRMS). Under the Windsor Framework, some GB-authorised pre-packed retail products may be supplied into Northern Ireland via the NIRMS, subject to scheme conditions and product scope.

Novel foods produced in Northern Ireland must follow EU Regulation (EU) 2015/2283, however can be placed onto the GB market, provided they are Qualifying Northern Ireland Goods.

What this means for NI food businesses

If you place products directly on the Northern Ireland market, you must comply with EU novel foods rules and ensure the product is on the EU Union list, unless the product is moved under NIRMS. If you develop or import a new product, you may need:

• an EU novel food authorisation for NI/EU markets, and
• a GB novel food authorisation for sales in Great Britain

Read more about novel food regulation that applies in NI and GB and keep up to date with the FSA’s guidance on novel food authorisation.

Nanotechnology and animal cloning are emerging technologies that can affect the food chain and may therefore fall under the novel food regulation, requiring safety assessments and authorisation before they can be 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. Because very small particles can behave differently from larger forms of the same substance, applications in the food and feed chain involving engineered nanomaterials are subject to specific risk assessments.

Nanotechnology in food and feed

Nanomaterials can be used in foods, food supplements, food contact materials and animal feed. Their purpose can vary. For example, they can be used to change texture, improve stability and shelf-life, or deliver nutrients.

Regulation of nanotechnology in food production

Under the EU novel food regulation, any food that consists of, contains, or uses engineered nanomaterials as an ingredient is treated as a novel food and must be authorised and safety-tested before it can be marketed in the Northern Ireland and European Union. Great Britain follows a similar, but separate, regulated food framework. Read more on novel food regulation.

If you intend to use nanotechnology in a food, feed or food contact material, you must check if the material is already authorised for use and if the nanoform is covered. Where a nanoform is not already authorised, you will need to apply for novel food authorisation, providing detailed characterisation of the nanomaterial and data on exposure, toxicology and any nanospecific hazards in line with relevant safety guidance.

Nanomaterials can also be regulated under other regimes without always coming through the novel food route, depending on how they are used. These regimes could be related to:

• Labelling - If you use an engineered nanomaterial as an ingredient, you must show ‘nano’ in brackets after its name in the ingredients list.
• Additives - If you significantly change an approved food additive by using nanotechnology or altering particle size, it is treated as a new additive and must be re‑evaluated before use.
• Food contact materials, including plastics – If you use substances in nanoform in food contact materials, they must be safety tested and authorised to ensure harmful chemicals do not migrate into food.

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 and Northern Ireland market. The Food Standards Agency and other UK authorities control nanomaterials in food and feed in GB.

Under the Windsor Framework, certain GB‑approved foods (which could include products using nanomaterials) can move from GB to NI via the Northern Ireland Retail Movement Scheme (NIRMS), subject to scheme conditions.

Cloning in food and feed

Cloning is a reproductive technology used to produce genetically identical copies of animals. Scientific reviews have found no evidence that food from healthy animal clones is different from food from healthy conventionally bred animals, but there are ongoing concerns about the health and welfare of the cloned animals.

Regulation of cloning in food production

Cloning of farm animals is not currently used for commercial food production in the EU. If a business wanted to sell food from cloned animals on the EU market in future, any food from cloned animals would be treated as a novel food and could not be sold in the EU or Northern Ireland unless it had been safety assessed and authorised.

Cloning of farm animals is also subject to wider rules on food hygiene and on the protection of animals kept for farming purposes, which businesses would need to comply with if commercial cloning were ever introduced. EU institutions have debated stricter rules on cloning for many years, and a range of stakeholders still call for a broad ban on cloning for farming and on imports of food from cloned animals and their descendants.

This is an area businesses should keep under review, particularly livestock breeders, meat and dairy producers, importers of live animals or genetic material, and retailers sourcing animal products from outside the EU/UK.

Plant cloning 

Plant cloning is a long established, routine technique in agriculture and horticulture, and it is not regulated in the same way as animal cloning. The underlying legal framework is complex, but plant cloning is generally accepted and managed under standard plant health, seeds/propagating material and (where relevant) genetically modified organisms or plant‑breeding rules rather than any special cloning law.