Nutrition Labelling UK Post-Deal Guidance

by
Harmonised StandardsUK Post-Deal Published Guidance
Guidance

Nutrition legislation information sheet

Updated 31 December 2020

EU nutrition laws

From 1 January 2021, new regulation is an autonomous matter for both the UK and EU as 2 separate legal and regulatory systems.

Nutrition-related labelling, composition and standards guidance has been produced for businesses about practical changes that have been made in the UK from 1 January 2021.

Important information

If you are a food business operator, the information in this document will help you understand the specific nutrition-related rules you must comply with if you are providing nutrition information on food and drinks, or selling food supplements, fortified foods, foods making health claims or nutrition claims and Food for Specific Groups (FSG), for example, food for infants and young children (infant formula, follow-on formula and weaning foods), food for specific medical purposes (FSMP), and total diet replacement for weight control.

If after reading this information your query is not resolved, please seek further advice from your local authority Trading Standards or Environmental Health office.

If you are a consumer with a complaint about a product, please contact the Citizens Advice Consumer Helpline (CACH) Advice Guideline For Consumers

Citizens Advice has an agreement with Trading Standards to help you report a problem to them.

If you are a local authority enforcement officer, please refer your enquiry to your local and neighbouring Authorities. If your enquiry is not resolved, the matter should be referred to your Regional Liaison Group. The Knowledge Hub’s Food Standards and Labelling Group is also a useful forum to seek advice. If the Regional Liaison Group or Knowledge Hub is not able to answer the query, it should be forwarded to the National Food Standards & Labelling Focus Group. Information relating to the process of referring queries involving food standards and labelling issues can be found on the Knowledge Hub and on the Food Standards Agency (FSA) website

a) Registering a food business (for food businesses)

If you are selling food products, which includes all the food categories listed above, you must register your business with the environmental health or trading standards service at your local authority. For further advice you are advised to speak to the food law enforcement office in your local authority. This tool will help you find your nearest Trading Standards office. You can download an application form on the FSA website.

There is useful information about setting up your business at:

You may also wish to consider establishing a Primary Authority Partnership with a single local authority.

b) Guidance documents

Many questions about nutrition and general food labelling on food and drinks, food supplements, fortified foods, nutrition and health claims, and Food for Specific Groups (for example, infant formula, follow-on formula, weaning foods, food for specific medical purposes, and total diet replacement for weight control) will be answered by the following guidance documents:

c) The Department of Health and Social Care

The Department of Health and Social Care (DHSC) is unable to authorise the composition or labelling of individual products. For advice on a specific product, including the checking of labels and interpretation of nutrition legislation, you must contact the food law enforcement office in your local authority. This tool will help you find your nearest Trading Standards office.

d) The Food Standards Agency

The Food Standards Agency (FSA) is responsible for policy on food safety, food hygiene, (including allergens labelling), imported foods, novel foods and genetically modified food. Advice on these issues for businesses can be obtained from your local enforcement authority. Other enquiries on FSA lead policy issues should be forwarded to helpline@food.gov.uk.

e) Novel foods

If you think an ingredient or a food may be novel – for example, it does not have a significant history of consumption in the UK or European Union prior to 15 May 1997 – we recommend that you check its status with the Food Standards Agency.

f) The Department for Environment, Food and Rural Affairs

The Department for Environment, Food and Rural Affairs (Defra) is responsible for policy on general food labelling (for example, other than nutrition and allergens labelling rules). This includes the provisions of the retained Regulation (EU) No 1169/2011 relating to areas such as ingredients listing and country of origin labelling. Advice on these issues for businesses can be obtained from your local enforcement authority. Other enquires on Defra lead policy issues such as questions about upcoming regulations, and requests to change existing laws should be forwarded to helpline@defra.gov.uk.

g) Medicines and Healthcare products Regulatory Agency

Where the regulatory status of a product is uncertain, responsibility falls to the Medicines and Healthcare products Regulatory Agency (MHRA) to determine whether it is a medicine. Please contact the Medicines Borderline Section borderline_medicine@mhra.gov.uk using the Medicines Borderline advice form. MHRA has produced a guide to what is a medicinal product, which may also be useful.

h) E-learning

E-Learning – Food labelling course for you. This e-learning course has been developed by the Food Standards Agency with Defra and DHSC. It will provide you with a general understanding of current food labelling legislation: E Learning

i) Other useful sources of advice and information

These should not necessarily be considered as DHSC recommendations:

1. Nutrition Labelling

1.1 Regulation of nutrition labelling

Nutrition labelling is regulated at a European level by retained Regulation (EU) No. 1169/2011 on the provision of food information to consumers. Retained Regulation (EU) No 1169/2011 is enforced in England by The Food Information Regulations 2014. Similar legislation applies in Scotland, Wales and Northern Ireland.

Mandatory nutrition labelling applies to most prepacked food. Retained Regulation (EU) No 1169/2011 also contains rules governing the provision of voluntary nutrition information in the following circumstances: “repeat” nutrition information on the “front of pack” of prepacked foods, nutrition labelling for non-prepacked foods, and nutrition (energy) labelling for alcoholic drinks.

The nutrition labelling rules do not apply to:

In addition, the nutrition labelling rules in retained Regulation (EU) No 1169/2011 apply without prejudice to retained Regulation (EU) No 609/2013 on Food for Specific Groups (FSG) and its Delegated Regulations and the Directives on foods for nutritional uses (PARNUTS). In other words, where there are separate nutrition labelling provisions in the FSG legislation or PARNUTS Directives, these will take precedence over the retained Regulation (EU) No 1169/2011 requirements.

See technical guidance on compliance with the nutrition-related provisions of retained Regulation (EU) No 1169/2011.

1.2 Key dates for application of nutrition labelling provisions

From 13 December 2016, it became mandatory to provide (‘back of pack’) nutrition labelling for prepacked food, subject to certain exemptions contained in Annex V of retained Regulation (EU) No 1169/2011. These exemptions relate mainly to minimally processed foods and those with little nutritional value.

1.3 Mandatory (back of pack) labelling

The mandatory nutrition declaration comprises: energy value (in both kilojoules (kJ) and kilocalories (kcal)) plus amounts (in grams (g)) of fat, saturates, carbohydrate, sugars, protein and salt.

The mandatory nutrition declaration can be supplemented, on a voluntary basis, with information on the amounts (in grams (g)) of one or more of the following: mono-unsaturated; poly-unsaturated; polyols; starch; fibre; any of the vitamins or minerals listed in point 1 of Part A of Annex XIII, and present in significant amounts as defined in point 2 of Part A of Annex XIII.

The main changes in nutrition labelling from the previous legislation are:

  • the term “salt” must be used since it is more readily comprehensible to consumers than “sodium”
  • fibre is no longer a mandatory nutrient, although it can be declared on a voluntary basis
  • the order of the mandatory nutrients has changed, for example, protein moves from second to second last (see Annex XV for full order of the mandatory and supplementary nutrients)

1.4 Front of pack nutrition labelling

Certain key nutrition information may be repeated on a voluntary basis on the “front of pack” (principal field of vision).

Front of pack nutrition information must be in one of the following formats:

  • energy value (kJ and kcal) alone
  • energy value (kJ and kcal) plus amounts (in grams) of fat, saturates, sugars and salt (energy + 4)

For further details on “front of pack” labelling, please see guidance on front of pack nutrition labelling.

1.5 Non-prepacked food

There is no requirement for nutrition information to be provided for food sold non-prepacked. But if provided voluntarily, it must be in one of the following formats:

  • The full “mandatory” nutrition declaration (energy value plus amounts of fat, saturates, carbohydrate, sugars, protein and salt)
  • Energy value only
  • Energy value plus amounts of fat, saturates, sugars and salt (energy + 4)

1.6 Alcoholic drinks

Retained Regulation (EU) No 1169/2011 exempts all alcoholic drinks from mandatory nutrition labelling. Further guidance can be found on the FSA website. There have been discussions regarding the development of voluntary initiatives to provide ingredient and nutrition information. This section will be further updated after 1 January 2021.

In the meantime, it is possible to provide a voluntary energy declaration (in kJ and kcal) on alcoholic drinks without the need to provide the full list of (‘back of pack’) nutrients, which would otherwise be mandatory on prepacked food. Alternatively, you may provide a full (“back of pack”) nutrition declaration on a voluntary basis on alcoholic drinks.

1.7 New terminology

‘Reference intakes’ (RIs) have replaced ‘guideline daily amounts’ (GDAs) for energy and the mandatory nutrients. RIs have also replaced ‘recommended daily allowances’ (RDAs) for vitamins and minerals.

2. Food supplements

2.1 Registering/licensing food supplements in the UK

There is no requirement to register food supplements in the UK. As long as they comply with the law (the law specific to food supplements and all other applicable food law) then they are permitted for sale. It is the responsibility of the manufacturer, importer or retailer to ensure that they comply with the law. Food supplements are regulated in the UK under the Directive 2002/46/EC as well as all other applicable food law. Please check the Legislation website for any version changes.

This is implemented in national law by The Food Supplements (England) Regulations 2003, which has been amended several times to reflect updates to the Annexes of permitted vitamin and mineral substances. There is equivalent legislation in Scotland, Wales and Northern Ireland. The Regulations do not control the use of substances other than vitamins and minerals added to food supplements, but any other ingredients used must be safe for human consumption and not be injurious to health.

2.2 Maximum levels of vitamins and minerals in food supplements

The UK does not have any national legislation on setting maximum levels for vitamins and minerals used in food supplements. However, we do have voluntary guideline safe upper levels which are based upon a report issued in 2003 by the Expert Group on Vitamins and Minerals (EVM), “Safe Upper Levels for Vitamins and Minerals”.

2.3 Prohibited ingredients in food supplements in the UK

Many products which are freely sold in other countries are not permitted or are considered to be medicinal or novel in the UK. Before you place your product on the market, you are advised to contact the Medicines and Healthcare products Regulatory Agency (MHRA) to check if the product, any of its ingredients, or claims, are considered medicinal. Food supplements are not permitted to contain medicinal ingredients, therefore the MHRA will determine if your product is medicinal.

Imported food supplements may need to be relabelled and possibly reformulated to meet UK composition and labelling standards, therefore it would be prohibited to sell any products directly imported that are not in compliance with UK food legislation. For further advice you are advised to speak to the food law enforcement office in your local authority.

Find your local Trading Standards office

2.4 Medicinal claims and products

See paragraph (g) of this document.

2.5 Novel foods

See paragraph (e) of this document.

2.6 National rules in the UK for certain substances

You should also be aware that there is additional national legislation in the UK which:

  • prohibits the sale of any food consisting of or containing Kava-kava (including food supplements)
  • places restrictions on the addition of tryptophan to food and the sale of food containing tryptophan which permits the addition of only laevorotary tryptophan (L-Tryptophan) to food supplements subject to purity and dose criteria

Please find links to the legislation relating to England below. Equivalent legislation exists in Scotland, Wales and Northern Ireland.

Kava-kava:

The Kava-kava in Food (England) Regulations 2002

The Kava-kava in Food (England) (Amendment) Regulations 2004

Tryptophan:

The Tryptophan in Food (England) Regulations 2005

The Food Supplements: Guidance and FAQs includes guidance to the legislation on the composition and labelling of food supplements as well as nutrition labelling requirements.

2.7 General food labelling

Food supplements also have to comply with many of the general food labelling requirements. Please see section 1.

3. Fortified foods / Vitamin and minerals added to food

Fortified foods are foods that contain added vitamins, minerals or other substances with a nutritional or physiological effect. This may have been achieved through voluntary fortification by food businesses, in products such as breakfast cereals and soft drinks, or through mandatory fortification, such as is required by The Bread and Flour Regulations 1998.

3.1 Registering/licensing fortified foods in the UK

There is no requirement to register or licence fortified foods in the UK. It is the responsibility of the manufacturer, importer or retailer to ensure that they comply with the law. Businesses are advised to contact their local Trading Standards or Environmental Health office.

3.2 Regulating fortified foods

Fortified foods are regulated by retained Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods. Annex I of the Regulation is a list of vitamins and minerals which may be added in fortified foods. Annex II is a list of the sources of vitamins and minerals which may be used. Annex I and Annex II have been amended by retained Regulation (EC) 1170/2009, retained Regulation (EU) No 1161/2011 and retained Regulation (EU) No 119/2014 to include additional substances. Annex III is a list of substances whose use in foods is prohibited, restricted or under Community scrutiny. The regulations are implemented in the UK by The Addition of Vitamins, Minerals and Other Substances (England) Regulations 2007 and equivalent legislation in Scotland, Wales and Northern Ireland.

For further information see:

DHSC guidance to compliance with Regulation (EC) No. 1925/2006 on the addition of vitamins and minerals and certain other substances to food

3.3 New substances which need adding to the list

In preparation for the UK’s withdrawal from the EU, the UK government and Devolved Administrations in Scotland and Wales adopted the Community Register of Vitamins, Minerals, and Certain Other Substances as it exists on 1 January 2021 (GB VMS Register).

The GB VMS Register has effect across the whole of GB from 1 January 2021.

Further information is available in the nutrition-related labelling, composition and standards from January 2021 document. This documents includes information on adding new substances to the Register.

3.4 Substances prohibited, restricted or under community scrutiny

Article 8 of retained Regulation (EC) No 1925/2006 gives the possibility to put under scrutiny, to restrict and, if necessary, to prohibit the use of substances added to foods or used in the manufacture of foods under conditions that would result in the ingestion of amounts greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers.

Prior to the UK leaving the EU, the Commission received a request from a member state to initiate the procedure under Article 8 of the Regulation for Ephedra species (Ephedra spp.) and for yohimbe (Pausinystalia yohimbe). The following available information was submitted to the European Food Safety Authority (EFSA) for a safety assessment:

These decisions still stand.

Annex III of Regulation (EC) No 1925/2006 has been amended by retained Regulation (EU) 2015/403, placing Ephedra herb and its preparations in Part A of Annex III (prohibited substances), and by retained Regulation (EU) 2019/650, placing Yohimbe bark and its preparations originating from Yohimbe in Part A of Annex III (prohibited substances).

Following EFSA’s scientific assessment of trans fats in 2018, retained Commission Regulation (EU) 2019/649 places trans fats in Part B of Annex III (restricted substances). The Addition of Vitamins, Minerals and Other Substances (England) (Amendment) Regulations 2020 will result in the prohibition of trans fats (other than trans fat naturally occurring in fat of animal origin) exceeding 2 grams per 100 grams of fats from 1 April 2021.

Details of other Article 8 substances under scrutiny and decisions will be published on the GB VMS Register.

3.5 Community register

UK government and Devolved Administrations in Scotland and Wales will maintain the GB VMS Register on the additions of vitamins and minerals and of certain other substances to foods.

Any amendments to the GB VMS Register will be communicated via regular bulletins published on post-transition period information for the health and care sector.

Further information on GB VMS Register available in the nutrition-related labelling, composition and standards from January 2021 document.

4. Nutrition and health claims made on food

4.1 Nutrition and health claims legislation

Voluntary nutrition or health claims must comply with the requirements of retained Regulation (EC) No 1924/2006[KH1] on nutrition and health claims made on food.

Guidance to compliance with European Regulation (EC) No 1924/2006 is available at the link below together with a very short ‘quick start guide’ designed to serve as an entry point to the guidance. The guidance is designed to help you comply with the Regulation if you choose to make a nutrition or health claim for a food product: Guidance to compliance with Regulation (EC) No 1924/2006.

A nutrition claim is a claim that states, suggests or implies that a food has beneficial nutritional properties, such as ‘low fat’ or ‘high in fibre’. A health claim is any claim that states, suggests or implies that health benefits can result from consuming a given food, such as ‘helps build strong bones’. Retained regulation (EC) No 1924/2006 applies to nutrition claims and health claims made in commercial communications, including labels, leaflets, websites and advertisements. Claims must also comply with general food labelling legislation that prohibits any claim that a food has the property of preventing, treating or curing a human disease or any reference to such a property.

Retained Regulation (EC) No 1924/2006 requires nutrition and health claims to be authorised and listed in a Community Register. Previously the Community Register of nutrition and health claims made on foods, lists all authorised and rejected claims set out in legislation

All nutrition and health claims that are listed in the Community Register, as of 1 January 2021, have been adopted and included in the Great Britain Nutrition and Health Claims Register (GB NHC Register).

For clarity, the Register also lists those health claims for which applications for authorisation have been unsuccessful – these claims are listed as non-authorised and may no longer be used.

Further information on nutrition and health claims and the GB NHC Register is available in the nutrition-related labelling, composition and standards from January 2021 document.

4.2 Nutrition claims

Nutrition claims that are not in the Register but would be understood to have the same meaning to consumers as a listed claim may be used. For example, ‘rich in protein’ is likely to have the same meaning to consumers as ‘high in protein’ and can therefore be used on foods that meet the criteria to use that claim. Claims not on the list, such as ‘low carbohydrate’ or ‘cholesterol-free’, cannot be used.

4.3 Health claims

Only authorised health claims listed in the Great Britain Nutrition and Health Claims Register may be used in the GB market from 1 January 2021. The only exceptions to this are:

  • general, non-specific claims (subject to the conditions of Article 10.3 of retained Regulation (EC) No. 1924/2006)
  • trademarks or brand names that are also health claims (subject to the conditions of Article 1.3 and Article 28.2 of retained Regulation (EC) No. 1924/2006)

Authorised claims may be used subject to their conditions of use and in compliance with the relevant requirements of retained Regulation (EC) No 1924/2006.

Further information on health claims and ‘On hold’ claims can be found in the Nutrition-related labelling, composition and standards from January 2021 document.

Our bulletin provides further information relating to on hold claims.

Local enforcement officers are able to easily identify on hold health claims by accessing our spreadsheet on the Knowledge Hub website

See other bulletins for updates relating to information on nutrition and health claims made on food.

4.4 Principles that should be respected when authorised health claims are made

Some flexibility of wording for authorised health claims is possible provided that its aim is to help consumer understanding, considering factors such as linguistic and cultural variations and the target population. A document setting out the principles that should be respected when authorised health claims are made, but the wording used is not exactly as authorised. See: principles on flexibility of wording for health claims.

The same principles should be respected whenever authorised claims are used in commercial communications whether in labelling, presentation or advertising and in whatever medium including on websites, radio and television. Retained regulation (EC) No 1924/2006 also controls general references to overall health and well-being, such as ‘healthy’ or ‘super food’ and the DHSC guidance to compliance provides advice on the use of such terms in section 5.1.

Article 10 of retained Regulation (EC) No 1924/2006 requires some specific conditions to be met when a health claim is made.

4.5 New health claim dossiers

If you wish to submit a new health claim application you should read the nutrition-related labelling, composition and standards from January 2021 document.

4.6 Nutrient profiles

Retained regulation (EC) No 1924/2006 requires a nutrient profile to be established as one of the criteria that foods must meet to make claims. The establishment of nutrient profiles aims to prevent claims masking the true nature of foods and so misleading consumers who are trying to make healthy dietary choices. The Regulation required nutrient profiles to be established by January 2009, but this deadline was not met, and a new deadline has not yet been set.

Food law enforcement in the UK is the responsibility of local authorities and where false or misleading information is provided, enforcement action may be taken by the local authority.

You may wish to contact your relevant local authority to seek a view on whether your particular product labelling and claims comply with retained Regulation (EC) No 1924/2006. This tool will help you find your nearest office.

5. Food for Specific Groups (FSG) formerly known as Foods Intended for Particular Nutritional Uses (PARNUTS)

5.1 Food for specific groups

Retained Regulation (EU) No 609/2013 on Food for Specific Groups (FSG) came into effect in July 2016. Food for Specific Groups comprises of infant and follow-on formula, processed cereal-based food and baby food, food for special medical purposes and total diet replacement for weight control.

Previously these foods were regulated under Directive 2009/39/EC on PARNUTS. This Directive created specific Directives that set out the composition and labelling rules for these categories. Directive 2009/39/EC was repealed by retained Regulation (EU) No 609/2013, which is currently in a transitional phase.

The FSG Regulation lays down general requirements. In terms of labelling, there are only general requirements established for not misleading the consumer or attributing to the food the property of preventing, treating or curing a human disease. There are additional requirements for infant formula and follow-on formula which require the labelling, presentation and advertising to be designed so as not to discourage breastfeeding and must not include pictures or text idealising the use.

Under the FSG Regulation, Delegated Regulations are being adopted that cover the specific compositional and information requirements for the following 4 food categories:

  • infant and follow-on formula
  • processed cereal-based food and baby food
  • food for special medical purposes
  • total diet replacement for use in energy restricted diets for weight control

The transitional phase means that some of the Directives under Directive 2009/39/EC continue to apply until the new FSG Delegated Regulations have been adopted and are in force.

Food categories where Directives under Directive 2009/39/EC currently apply are:

Food categories where Delegated Regulations under Regulation (EU) No 609/2013 currently apply are:

  • infant and follow-on formula (except those manufactured from protein hydrolysates). This is covered by retained Delegated Regulation (EU) 2016/127. This came into force on 22 February 2020.
  • food for special medical purposes. This is covered by retained Delegated Regulation (EU) 2016/128. This came into force on 22 February 2019 and 22 February 2020 in respect of FSMP for infants.

In summary, the FSG Regulation:

  • aims to protect specific vulnerable groups of consumers by regulating the content and marketing of food products specifically created for them. It also aims to increase legal clarity for business and to facilitate correct application of the rules
  • sets general compositional and labelling rules and requires the commission to adopt, through delegated acts, specific compositional and labelling rules for the above foods
  • transfers rules on gluten-free foods and very low gluten under retained Regulation (EU) No 1169/2011 on food information to consumers (EU FIC) in order to ensure clarity and consistency
  • establishes that foods previously regulated under the PARNUTS framework, such as meal replacement products for weight control, will be treated as general foods and regulated under retained Regulation (EC) No 1924/2006 on nutrition and health claims

Food for other population groups are regulated as regular foodstuffs under general food law. Commission reports on young-child formulae (‘growing-up milks’) and food intended for sports people have concluded that there is no necessity for specific provisions for these products. Since 20 July 2016, young-child formulae and food intended for sportspeople are exclusively covered by horizontal rules of food law.

5.2 Infant formula and follow-on formula

Infant formula and follow-on formula are products designed to satisfy the specific nutritional requirements of healthy infants and young children.

Infant formula is suitable from birth and is the only food which can be marketed as satisfying by itself the nutritional requirements of infants during the first months of life. Follow-on formulae are foods intended for older infants when appropriate complementary feeding is introduced and constituting the principal liquid element in a progressively diversified diet of such infants.

Retained Delegated Regulation (EU) 2016/127 which provides the detailed labelling and compositional rules for infant and follow-on formula was adopted on 25 September 2015 and came into force on 22 February 2020. This is enforced in England by The Food for Specific Groups (Food for Special Medical Purposes for Infants, Infant Formula and Follow-on Formula) (Information and Compositional Requirements) (Amendment etc.) (England) Regulations 2020. Similar legislation applies in Scotland, Wales and Northern Ireland.

Until 22 February 2021, infant and follow-on formula manufactured from protein hydrolysates will continue to be regulated by Directive 2006/141/EC, implemented by The Infant Formula and Follow-on Formula (England) Regulations 2007 (as amended). After this date, they must comply with retained Delegated Regulation (EU) 2016/127.

In summary, retained Delegated Regulation (EU) 2016/127:

  • prohibits nutrition and health claims being made on infant formula
  • strengthens the requirement for infant and follow-on formula labels to be clearly distinct from each other
  • updates the compositional requirements to reflect the latest scientific evidence, including the mandatory addition of Docosahexaenoic acid (DHA)

The DHSC guidance notes on Infant and Follow-on Formula Regulations are currently being updated to reflect the Regulation.

5.3 Processed cereal-based foods and baby foods

These are foods which fulfill the requirements of infants and young children while they are being weaned. They are also used as a supplement to the diet of young children for their progressive adaptation to ordinary food.

These foods are regulated in England by The Processed Cereal-based Foods and Baby Foods for Infants and Young Children (England) Regulations 2003. Similar legislation applies in Scotland, Wales and Northern Ireland. These Regulations implement Directive 2006/125/EC.

The FSG Regulation requires the Commission to adopt, through Delegated Regulations specific compositional and labelling rules for processed cereal-based foods and baby foods, which will replace Directive 2006/125/EC. Until the finalisation of the Delegated Regulations, the rules of Directive 2006/125/EC remain applicable.

5.4 Food for special medical purposes (FSMP)

Foods for special medical purposes (FSMP) are for the dietary management of a specific disease, disorder or medical condition. These are specialist foods intended for the exclusive or partial feeding of people whose nutritional requirements cannot be met by normal foods.

Retained Delegated Regulation (EU) 2016/128 replaced Directive 1999/21/EC, providing the detailed labelling and compositional rules for FSMP.

In summary, the Delegated Regulation:

  • updates existing rules on FSMP, taking account of scientific developments and new legislation on food information to consumers
  • prohibits nutrition and health claims on FSMP. This is to avoid inappropriate promotion of these specialist products which are for use under medical supervision
  • extends to FSMP intended for infants and young children the same rules on pesticides that apply to infant formula and baby foods
  • requires the addition of Docosahexaenoic acid (DHA) for infant milks marketed as FSMP
  • requires the presentation of FSMP for infants to be clearly distinct from infant and follow-on formula
  • places restrictions on advertising of infant milks marketed as FSMP

Retained Delegated Regulation (EU) 2016/128 is enforced in England by: The Food for Specific Groups (Information and Compositional Requirements) (England) Regulations 2019 and The Food for Specific Groups (Food for Special Medical Purposes for Infants, Infant Formula and Follow-on Formula) (Information and Compositional Requirements) (Amendment etc.) (England) Regulations 2020. There is similar legislation in Scotland, Wales and Northern Ireland.

5.5 Foods for total diet replacement for weight control

Low and very low-calorie diet foods are specially formulated foods which replace the whole of the diet. Foods for total diet replacement for weight control are regulated in Great Britain by The Foods Intended for Use in Energy Restricted Diets for Weight Reduction Regulations 1997 (as amended). There is similar legislation in Northern Ireland (NI).

These Regulations implement Directive 96/8/EC. Since July 2016, Directive 96/8/EC no longer applies to foods presented as a replacement for one or more meals of the daily diet.

Directive 96/8/EC is set to be replaced by retained Delegated Regulation (EU) 2017/1798 on total diet replacement for weight control. The retained Delegated Regulation was adopted on 2 June 2017 and is set to apply from 27 October 2022.

5.6 Addition of substances to FSG for specific nutritional purposes

Nutritional substances belonging to the following categories: vitamins, minerals, amino acids, carnitine and taurine, nucleotides, choline and inositol, that may be used in the manufacture of food for specific groups are laid down in the Annex to retained Regulation (EU) No 609/2013. The category of food which each substance may be added to is specified in the Annex.

5.7 Notification procedures

When an FSMP, infant formula or follow-on formula based on protein hydrolysates or containing other substances than those listed in Annex II of retained Regulation (EU) 2016/127 are placed on the market, food business operators are required to notify the competent UK authority where the product is being marketed. DHSC is centrally coordinating notification forms for all 3 GB nations for the purposes of notifying each of the applicable competent UK GB authorities.

The competent UK GP authorities are the Food Standards Agency in Northern Ireland, Food Standards Scotland and the Welsh Government.

Food business operators must complete a notification form and forward a model of the product label for.

  • new or updated formulations of Infant formula
  • follow-on formula containing substances other than those listed in Annex II of retained Delegated Regulation (EU) 2016/127
  • food for special medical purposes (FSMP)

FSMP notification is required under retained Delegated Regulation (EU) 2016/128 and is enforced in England by: The Food for Specific Groups (Information and Compositional Requirements) (England) Regulations 2019 and The Food for Specific Groups (Food for Special Medical Purposes for Infants, Infant Formula and Follow-on Formula) (Information and Compositional Requirements) (Amendment etc.) (England) Regulations 2020.

Infant formula and follow-on formula (where necessary) notification is required under retained Delegated Regulation (EU) 2016/127 and is enforced by The Food for Specific Groups (Food for Special Medical Purposes for Infants, Infant Formula and Follow-on Formula) (Information and Compositional Requirements) (Amendment etc.) (England) Regulations 2020.

Until 22 February 2021, infant formula manufactured from protein hydrolysates will continue to be notified under The Infant Formula and Follow-on Formula (England) Regulations 2007 (as amended). There is similar legislation in Scotland, Wales and Northern Ireland.

Please see the notification form.

Further information is available on notifying FSMPs, infant formula and follow-on formula can be found in the Nutrition-related labelling, composition and standards from January 2021 document.

5.8 Foods for sports people

There is no specific legislation on foods intended to meet the expenditure of intense muscular effort, especially for sports people, general food law therefore applies. Products presented as ‘food supplements’ need to comply with Directive 2002/46/EC. All products presented for sports people need to ensure that any nutrition or health claims made are compliant with the retained Regulation (EC) No 1924/2006 and the GB NHC Register.

5.9 Foodstuffs suitable for people intolerant to gluten

The rules on use of the statements ‘gluten-free’ and ‘very low gluten’ have been incorporated into retained Regulation (EU) No 1169/2011 on the provision of food information to consumers. Further consideration will be given to how people that are intolerant to gluten are adequately informed of the difference between a food that is specially produced, prepared and/or processed in order to reduce the gluten content and other food that is made exclusively from ingredients naturally free of gluten.

The FSA is responsible for policy on allergens generally. See: food allergen labelling and gluten advice for consumers.

5.10 Diabetic foods

There are no specific rules regulating ‘diabetic foods’.

Prior to the UK leaving the EU, the Commission published a report in 2008 on foods for persons suffering from carbohydrate metabolism disorders (COM (2008) 392), which stated that specialised foods for diabetics are not necessary. This report resulted in the Commission, European Parliament and Member States agreeing to remove diabetic foods from the scope of the Framework Directive 2009/39/EC. The FSG Regulation reiterated that specific compositional requirements would not be developed for foods for diabetics due to lack of scientific evidence. This confirms that there is no specific category of dietetic products that may make claims of their suitability for diabetics. These products are regulated under general food law, including that on general labelling and nutrition and health claims. These decisions still stand.

Government advice is that people with diabetes should consume a healthy balanced diet and do not require specialist foods. Food labelling terms indicating suitability for diabetics are not specifically permitted under food law and DHSC considers them to be not helpful and possibly misleading. Many of the products bearing such phrases are inherently high in fat and calories and run counter to current dietary recommendations for a healthy balanced diet.

Alternative informative claims have been approved under the nutrition and health claims legislation. See the GB NHC Register – for example, ‘no added sugar’, ‘Consumption of foods/drinks containing <name of sugar replacer> instead of sugar* induces a lower blood glucose rise after their consumption compared to sugar-containing foods/drinks’. *In the case of D-tagatose and isomaltose this should read ‘other sugars’.

5.11 FSG legislation summary

In summary, specific rules have been set out by Directives and Delegated Regulations for the following groups of dietary foods.

Infant formula and follow on formula:

Processed cereal based foods and baby foods (weaning foods):

Food for special medical purposes:

Foods for total diet replacement for weight control:

  • Directive 96/8/EC on foods intended for use in energy-restricted diets for weight reduction. Since July 2016, this no longer applies to foods presented as a replacement for one or more meals of the daily diet
  • retained Delegated Regulation (EU) 2017/1798 on the specific compositional and information requirements for total diet replacement for weight control (which is set to apply from 27 October 2022)

Contact details

​If you have any questions or comments on this guidance, please contact the Nutrition Legislation Team at nutritionlegislation@dhsc.gov.uk