Novel foods (including CBD and hemp)

Novel foods explained, including restrictions on their use and an explanation of the legal status of foods containing CBD and the permitted uses of hemp

Note: although the United Kingdom has left the European Union, certain pieces of legislation (formally known as 'retained EU law') will still apply until such time as they are replaced by new UK legislation; this means that you will still see references to EU regulations in our guidance.

This guidance is for England and Wales

This guidance relates to both the manufacture and sale of prepacked food, food that is prepacked for direct sale, non-prepacked food (food sold loose etc), and food sold from catering establishments (cafs, restaurants, etc).

Country definitions

The following terms are used throughout this guidance:

• United Kingdom (UK): England, Scotland, Wales and Northern Ireland
• Great Britain (GB): England, Scotland and Wales
• Northern Ireland (NI)
• European Union (EU): there are 27 Member States of the EU, including Ireland but not any of the UK countries

What are novel foods?

For the purpose of this guide only, and for the purpose of highlighting the difference between 'food' and 'novel food', foodis defined as:

• food and food ingredients that come from plants,animals and other sources, have been produced by traditional growing,raising or propagating methods, and have a history of safe consumption by humans in the EU or the UK before 15 May 1997

By contrast, a novel food is any food or food ingredient that has not been eaten to a significant degreeby people within the EU or the UK prior to 15 May 1997, and also fits into one of the following categories:

• food / ingredients produced from animals thatdonot meet the definitionof 'food' above
• food / ingredients produced from plants thatdonot meet the definition of 'food' above exceptfood from plantsthat dohave a history of safe consumption in the EU or the UK prior to 15 May 1997but have beenproduced through non-traditional meansthat do not affect the following:
  • the composition / structure of the food
  • the nutritional value
  • how the foodis turned into energy by the body (metabolism)
  • the undesirable substances the food contains
• food / ingredients that have been subjected to a production process that is not currently being used on that food / ingredient, and significantly changes its composition or structure, nutritional value, how it is turned into energy by the body (metabolism), or the undesirable substances that it contains*
• food / ingredients with a new or modified molecular structure*
• food /ingredients that are, or come from, micro-organisms, fungi or algae
• food / ingredientsthat are, or come from, minerals*
• food / ingredients that are, or come from, cell culture or tissue culturesfrom animals, plants, micro-organisms, fungi or algae
• food / ingredients consisting of, or containing,engineered nanomaterials (100 nm or less)*
• vitamins, minerals and other substances used in food supplements, food intended for infants and young children, food for special medical purposes and foods intended astotal diet replacements, that have been subjected to a production process not used in the EU or the UKprior to 15 May 1997*
• food / ingredients that haveonly been used in food supplements within the EU or the UK prior to 15 May 1997, when they are intended to be used in foods other than food supplements*

[*See 'Traditional foods' below for more information on the asterisked text.]

What is the significance of being a novel food?

Novel foods cannot be used in food unless they have been through an approval process to check that:

• they do not present a danger to consumers
• their use does not mislead consumers
• they are not so different from the foods or food ingredients that they are intended to replace that their consumption would be nutritionally disadvantageous to consumers (in other words, that choosing to eat them over traditional foods would not leave consumers lacking in vital nutrients)

These are checked in a process referred to as a safety assessment.

If a food / ingredient you wish to use is a novel food, and has not yet been authorised, you must not use it in, or as, food.

When using an ingredient that you know or suspect meets all or part of the definition above, you should research whether the food / ingredient is a novel food. Things to look out for include unusual ingredients, ingredients from outside the EU or the UK (andnot in common usage within the EU or the UK), or an ingredient that is common but being used in a new or different way (for example, Chia seed oil rather than Chia seed).

Identifying a novel food

If you are concerned that a food / ingredient might be a novel food, you can do the following (preferably in this order) to check its novel status:

1. Check the list of authorised novel foods
2. Check the Novel Food Catalogue
3. Conduct online research

1. Check the list of authorised novel foods
The list of authorised novel foods can be found in the Annex to Regulation (EC) 2017/2470 establishing the Union list of novel foods (see 'Key legislation' below). To search for the common or scientific name of the food / ingredient on the web page use Ctrl-F (on Windows computers) or Cmd-F (on Macs).

The legislation is updated regularly but the most recent updates can be found at the bottom of theUnion list of novel foods page on the European Commission website.

2. Check the Novel Food Catalogue
Foods that have been through a safety assessmentcan be found listed in the Novel Food Catalogue.

The catalogue is arranged in alphabetical order and can be searched with keywords.

When searching you must use the scientific name of the food / ingredient - for example, if you want to find pomegranate you have to search for 'Punica granatum'. You can find the scientific name by searching 'scientific name of X' online.

Each entry will have one of four icons below the text:

	The food / ingredient is not a novel foodbut its use may be restricted in some EU Member States.
	The food / ingredient can be used in food supplements but cannot be used in other foods without going through the authorisation process.
	The food / ingredient is a novel food and cannot be used until a safety assessment has been completed.
	The product may be a novel food, but more information is required before a decision can be made.

If you want to use a food / ingredient displaying the '?' icon you should contact your local trading standards servicefor furtheradvice.

3. Conduct online research
If you are unable to find the food / ingredient in the authorised list or the catalogue, you can research it online.

The best place to start is to search 'What is X?' online and use the results to try and determine if the product was commonly eaten in the EU or the UK prior to 15 May 1997.

If your research leaves you in any doubt as to whether the food is novel, you should contact your local trading standards service for advice.

If your research shows that the substance is a food additive you can check the European Food Additives Database to see if it is listed.

The database specifies what types of food each additive can be used in. If it can be used in categories outside of food supplements, then it is not a novel food. If it can only be used in food supplements, then it may still be novel; check its status in the Novel Food Catalogue.

Novel food authorisation

If you want to use an unauthorisednovel food you must apply for authorisation.

The first step will always be to determine whether the food is novel (see 'Identifying a novel food' above).

If your research conclusively shows that the food is not novel there is nothing more you need to do.

If your research is inconclusive, and you have concerns that the food may be novel, you will need to go through a consultation process (referred to as an Article 4 request), which will determine whether the food is novel.

Your local trading standards service will be able to offer some advice on whether you need a consultationbut you may ultimately have to discuss it with the Food Standards Agency (FSA) Novel Foods Team (novelfoods@food.gov.uk).

If either your research or the consultation process determines that the food is novel, you must apply for authorisationand will need to gather and submit enough evidence to prove that the food meets the three criteria in 'What is the significance of being a novel food?' above.

If you don't provide sufficient evidence to conclusively meet the criteria, the food will not be authorised.

The evidence you submit should be specific to your product; therefore gathering together publicly available information will not be sufficient. Any business seeking approval for a novel food will probably need to conduct independent scientific research (which will be beyond the technical / financial means of some small and medium-sized businesses).

Making an application is free; however, the process of gathering and submitting the evidence is expensive and takes a long time to complete, although there is a simplified process for traditional foods with a history of safe consumption (see below).

For more information on the authorisation process and what information your application should contain, please visit the novel foods page of the Food Standards Agency website.

If you wish to place a novel food on the GB market you must follow the GB regulated product authorisation process.

If you wish to place a novel food on the EU or NI market you must follow the EU novel food authorisation process.

Traditional foods

Traditional foods are those from countries outside the UK orEU witha history of safe consumption for 25 years or more. A history of safe consumption is more than anecdotal evidence and must be based on both compositional data and evidence of use.

A traditional food must alsomeetthe definition of novel foodin 'What are novel foods?' above, except for those items marked with an asterisk (*);foods that are / contain the asterisk-marked items are not considered to be traditional foods.

Additionally, traditional foodsmust be the products of primary production (rearing, growing, harvesting, milking,farmed animal production, hunting, fishing and the harvesting of wild products).

A novel food application for a traditional foodrequires less information to be submitted than a normal novel food application and has a streamlined process of approval.

Guidance on preparing an application for a traditional foodcan be found in this scientific opinion from the European Food Safety Authority (EFSA).

Should you wish to make an application for a traditional food to be sold in GB you will have to make your application through the GB Regulated Products Application Service;if you wish to make an application for sale inNI or the EU you will have to make an application following the EU process.

CBD-based foods and food supplements

Cannabidiol (CBD) is a type of cannabinoid isolated from cannabis plants or produced synthetically.

CBD is increasingly being used in foods and food supplements; this section of the guidance explains the legal status of using CBD in this way.

ARE CBD-BASED FOODS / FOOD SUPPLEMENTS CONTROLLED DRUGS?

Cannabis sativa L is the most common strain of cannabis in the EU; it contains many cannabinoids, one of which is CBD. The most widely known cannabinoid is tetrahydrocannabinol (THC) which causes the 'high' associated with cannabis use.

THC and other cannabinoids are controlled drugs; their possession, use in manufacture, etc is a criminal offence under the Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001.

CBD can be isolated from other cannabinoids present in Cannabis sativa L, and in its pure form it is not a controlled drug.

Extraction and purification of CBD is a complicated and expensive process. If the CBD is contaminated with other controlled cannabinoids, at any detectable level, the product is a controlled drug and its possession, use in manufacture, etc is a criminal offence.

A licence can be obtained to grow low-THC hemp (less than 0.2% THC) from which CBD can be extracted. However, this does not mean that the final product may contain up to 0.2% THC; if THC is present at any detectable level the product is a controlled drug.

ARE CBD-BASED FOODS / FOOD SUPPLEMENTS MEDICINAL PRODUCTS?

The definition of a medicinal product has two parts, as follows:

• any substance administered to treat or diagnose an illness or medical condition
• any substance that claims to be able to prevent or treat disease (including pain relief)

Medicinal claims are significantly different to health claims, although the two are often confused. Please refer to 'Nutrition and health claims' for more information.

If the product meets either part of the definition it is treated as a medicinal product. It will need to be authorised by the Medicines and Health Care products Regulatory Agency (MHRA) and will be subject to strict rules on composition and labelling.

The Department of Health and Social Care (DHSC) has now accepted clinical evidence that cannabis and CBD can be used to treat certain illnesses and medical conditions; as such, cannabis-derived medicinal products (CDMP) are now available on prescription.

However, the levels of CBD recorded in the clinical evidence is usually many times more than is typically present in CBD-based food / food supplements. This means that CBD-based food / food supplements are not typically able to provide the medicinal benefits seen in the evidence. Merely containing CBD is not enough for the product to be classed as a medicinal product.

Provided the product makes no claims about treating or preventing illness (including pain relief), the product is not a medicinal product.

Claims can be in any form, including:

• writing - for example, a statement that states or implies a medical benefit
• pictures - for example, a picture of a heart or a red cross
• sounds - for example, the sound of a heart monitor

Claims that are made elsewhere than on the product (website, social media, publications, etc) may result in the product being classed as a medicinal product.

If you have any concerns about whether your product is a medicinal product, please contact the MHRA Borderline Products Team on 02030 806000.

Please refer to the MHRA document A Guide to What is a Medicinal Product for further information.

ARE CBD-BASED FOODS / FOOD SUPPLEMENTS NOVEL FOODS?

The CBD industry has been unable to provide sufficient evidence that CBD and other cannabinoids have been consumed to a significant degree within the EU prior to 15 May 1997.

CBD, and cannabinoids in general, are novel foods and cannot be legally included in food or food supplements until a safety assessment has been completed and the use as a novel food has been authorised.

ARE CBD-BASED FOODS / FOOD SUPPLEMENTS LEGAL?

Due to their classification as novel foods, they cannot be legally sold until they have been authorised.

The FSA allowed CBD products meeting the following criteria to continue to be sold in England, Wales and NI until 31March 2021:

• the food is safe
• the food is not contaminated with other cannabinoids
• the food is correctly labelled
• the food was placed on the market in England, Wales or NI before 13 February 2020

This relaxation of the rules did not apply to any new products placed on the marketafter 13February 2020, or to products that wereplaced on the market in the EUbut not in England, Wales, or NI. For information about Scotland, please see the Food Standards Scotland website.

For all CBD food / food supplements on sale before 31 March 2021, a validated (see below) novel foodsapplication for authorisation must have been made by that date. If a validated application was not made, the products must be removed from sale, pending possible future authorisation.

If you wish to place your product on the GB market you must follow the GB regulated product authorisation process.

If you wish to place your product on the EU or NI market you must follow the EU novel food authorisation process.

As stated above, the evidence you submit should be specific to your product and will likely need to be based on independent scientific research that will be beyond the means of many small and medium-sized businesses. If you submit an argument based on pre-existing, publicly available information, this will not be accepted as sufficient evidence and the application will be dismissed.

If you intend to submit an application you should discuss the contentwith the FSA Novel Foods Team beforehand so that they can offer advice on whether your application contains sufficient detail and what additional information you might need to include. Liaising with the FSAdoes not guarantee that your application will be successful.

Applications for authorisation must be validated (confirmed to meet a minimum standard capable of satisfying a safety assessment), a process that can take up to 30 days. Validated applications will then be subjected to a safety assessment that will determine whether the product can be authorised for sale. A validated application does not mean that the application will be authorised. Any products that are not subsequentlyauthorised must be removed from sale.

The FSA has published a list of CBD products identifying products for which validated applications have been received and those that have not yet met the full legal requirements for validation but have the potential to become validated within a specified time limit (referred to as 'on-hold'). The FSA has advised local authorities that CBD-based products that do not appear on these lists should be removed from sale from 1April.

Any CBDfood / food supplement that meets the criteria listed at the beginning of this section and for which anapplication for authorisation was submitted by 31March 2021 (which has subsequently been validated) can continue to be sold while the authorisation process is ongoing.

For more information please refer tothe latest FSA update (19 April 2021).

For further advice on making a novel food application for CBD-based foods / food supplementsplease contact the FSA Novel Foods Team via novelfoods@food.gov.uk.

ARE CBD-BASED FOODS / FOOD SUPPLEMENTS SAFE?

So far the evidence is inconclusive; however, the Committee on Toxicology (COT) has found evidence of potential adverse health effects and as a result the FSA has issued safety guidance. It is particularly important to note that, for healthy adults, the recommended maximum dose is 70 mg a day (approximately 28 drops of 5% oil).

Hemp-based foods / food supplements

Hemp / industrial hemp / low-THC industrial hemp is a product of cannabis plants that contain less than 0.2% THC. Licences to cultivate and process such plants can be obtained from the Home Office.

Cannabis is a controlled drug; however, this classification does not apply to certain parts of the cannabis plant, and therefore these parts (and anything made from them) are not controlled drugs. The parts of the plant to which the classification does not apply are:

• seeds
• plant fibre
• mature stalk

Cannabis has a significant history of consumption in the EU prior to 15 May 1997. This means that the cannabis plant itself (Cannabis sativa L) is not a novel food, and as such those parts of the plant not controlledby other legislation (seeds / plant fibre / mature stalk) can be used in food, providing the following conditions are met:

• the material comes from low-THC cannabis plants
• the business has any licences necessary to process the product
• the purpose of consuming the product is something other than ingesting a controlled drug - for example, to add flavour, aroma, etc
• the cannabis cannot be extracted from the product and consumed in sufficient quantities to pose a risk to health
• the entire product contains less than 1 mg of THC
• the product is not contaminated with other cannabinoids

Trading standards

For more information on the work of trading standards services - and the possible consequences of not abiding by the law - please see 'Trading standards: powers, enforcement and penalties'.

Key legislation

• Misuse of Drugs Act 1971
• Food Safety Act 1990
• Misuse of Drugs Regulations 2001
• Human Medicines Regulations 2012
• Regulation (EU) 2015/2283 on novel foods
• Novel Foods (Wales) Regulations 2017
• Regulation (EU) 2017/2468 on traditional foods from third countries
• Regulation (EU) 2017/2470 establishing the Union list of novel foods
• Novel Foods (England) Regulations 2018

Last reviewed / updated: May 2021

In this update

Information added regarding the ongoing process for authorisation and sale of CBD products

Please note

This information is intended for guidance; only the courts can give an authoritative interpretation of the law.

The guide's 'Key legislation' links may only show the original version of the legislation, although some amending legislation is linked to separately where it is directly related to the content of a guide. Information on amendments to legislation can be found on each link's 'More Resources' tab.

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