Guidance

Fortified foods: guidance to compliance on European Regulation (EC) No. 1925/2006 on the addition of vitamins and minerals and certain other substances to food

Updated 8 January 2021

Applies to England

Nutrition law

Following the UK’s departure from the EU on 31 January 2020, the UK entered a time-limited transition period until 31 December 2020. Now the transition period has ended, Regulation is an autonomous matter for both the UK and EU as 2 separate legal and regulatory systems. The government remains committed to promoting robust food standards nationally and internationally, to protect consumer interests, and to ensure that consumers can have confidence in the food they buy.

Section 1 of this guidance outlines for businesses those changes relating to the addition of vitamins and minerals and certain other substances to food from 1 January 2021.

Executive summary

Introduction

On 30 December 2006 Regulation (EC) 1925/2006 of the European Parliament and of the Council of the European Union on the addition of vitamins and minerals and of certain other substances to food was published. This legislation sets out compositional and labelling requirements, including lists of vitamins and minerals, which can voluntarily be added to foods, such as breakfast cereals and soft drinks.

On 1 January 2021 ‘The Nutrition (Amendment etc.) (EU Exit) Regulations 2019’ and ‘The Nutrition (Amendment etc.) (EU Exit) Regulations 2020’ transferred responsibilities from EU organisations involved in the risk assessment and risk management processes covered by nutrition legislation to bodies in Great Britain (GB); and fixed inoperability’s of retained Regulation (EC) 1925/2006 that would otherwise have arisen.

The information set out in this document aims to provide non-statutory guidance on the rules, which apply to fortified food under these Regulations and outline what businesses must do if they add vitamins and minerals and other substances to food.

This guidance is due to be updated to fully incorporate the exit bulletin and any previous legislative changes. Section 1 of this guidance reflects changes to processes from 1 January 2021.

The Department of Health and Social Care has responsibility for national and EU legislation on fortified food within England. The responsibility for the policy area of fortified foods legislation in Wales has moved to the Welsh Assembly. The Food Standards Agency devolved administrations of Scotland, and Northern Ireland are responsible for national legislation in their own administrations where separate but similar regulations apply.

Intended audience

This guidance is aimed at all businesses that manufacturer, process, distribute, use, sell or import food voluntarily fortified with vitamins and minerals, and local authorities who are responsible for enforcing the legislation in this area.

Legislation on fortified food is implemented on a devolved basis, however this guidance applies across the UK.

Purpose of the guidance

This guidance is designed to help you comply with the regulations.

Section 1: guidance from 1 January 2021

1.1 Using this guidance

This section is to be read in conjunction with the remainder of the guidance and any relevant bulletins which remain relevant and useful, with exception to any references to the EU, in helping businesses comply.

The Protocol on Ireland/Northern Ireland (NIP) means that EU legislation relating to nutrition, as detailed in Annex 2 to the NIP, continues to be directly applicable in Northern Ireland.

From 1 January 2021, EU Regulations and tertiary legislation relating to nutrition have been under the powers contained within the European Union (Withdrawal) Act 2018 as UK law. That EU legislation is subsequently amended by the Nutrition (Amendment etc.) (EU Exit) Regulations 2019 and the Nutrition (Amendment etc.) (EU Exit) Regulations 2020.

The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 and the Nutrition (Amendment etc.) (EU Exit) Regulations 2020 transferred responsibilities from EU organisations involved in the risk assessment and risk management processes covered by nutrition legislation to bodies in Great Britain (GB).

They also made practical changes, that resulted from this transfer to: applications; frameworks for the scientific evaluation of applications/dossiers/files; and the factors taken into consideration when a risk management decision is required.

Businesses seeking to submit requests for change, scientific dossiers, or files in accordance with the legislation covered by this guidance for consideration in the GB market should prepare those applications and requests in line with the advice in this section and submit them to the Department of Health and Social Care (DHSC). DHSC will ensure that all documents are shared with the appropriate authorities in Scotland, and Wales, and Northern Ireland and, once deemed valid, the applicable expert committees.

Information is shared with Northern Ireland as all nutrition issues continue to be considered on a 4-nation basis: and importantly, officials and Ministers in Northern Ireland continue to play a vital role in policy development under the arrangements agreed in the UK-wide common framework for NLCS. Northern Ireland’s full participation in risk assessment and risk management processes ensure that any decisions taken in GB (England, Scotland and Wales) account for the potential impacts across the UK.

1.2 Appropriate authorities

The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 transferred functions and powers previously held by the European Commission to legislate to give effect to a decision, such as whether to authorise applications for new health claims, to the following appropriate authorities.

The appropriate authorities are in:

• England: the Secretary of State

• Scotland: the Scottish Ministers

• Wales: the Welsh Ministers

Each appropriate authority may, therefore: make legislation equivalent to that which the European Commission would have made previously. However, the Nutrition (Amendment etc.) (EU Exit) Regulations 2019 also provide concurrent powers for the UK Secretary of State to legislate for the whole of GB where devolved administrations in Scotland and Wales agree.

Note: functions and powers held by the European Commission have not been transferred to Northern Ireland. However, officials and Ministers in Northern Ireland continue to play a vital role in policy development under the arrangements agreed in the UK-wide common framework for NLCS. Therefore, references are included in this guidance to ‘appropriate UK authorities’ where Northern Ireland officials and Ministers are involved in risk assessment or risk management.

The Food Standards Agency (FSA) remains the designated Competent Authority in Northern Ireland.

1.3 Common Framework for NLCS

Officials from the UK government and the devolved administrations in Scotland, Wales, and Northern Ireland have jointly developed a UK-wide Common Framework for NLCS in preparation for the end of the Transition Period.

As a devolved policy area NLCS is one of several identified in the UK government Frameworks Analysis which required more detailed discussion to explore whether a common framework agreement was needed to manage potential divergence within the UK after EU Exit; and the governance and decision-making processes required for effective joint working and implementation.

Officials across all 4 nations have worked together to develop the NLCS Common Framework, which was provisionally agreed at the Joint Ministerial Committee (EN) on 3 September 2020.

Risk assessment and risk management (policy development) mechanisms

NLCS risk assessments consider the impact on a UK-wide basis aiming to deliver a consistent approach and process for businesses and enforcement authorities across the UK (with capacity maintained for nation specific assessments where appropriate).

Decisions based on both scientific opinion and those wider risk management considerations are made by the appropriate authority (namely the Secretary of State, Scottish, Welsh, Ministers or as appropriate with consent from the devolved administrations) through the establishment of 4-nation working arrangements which build on existing consensus-based policy making.

While Ministers retain the right to take individual decisions for their nation on areas within the scope of the NLCS Framework, the opportunity for consistency of approach across administrations is always sought in the first instance and where agreed, common policy recommendations made.

The ability to diverge where appropriate and proportionate is retained, while taking account of the impact on consumer safety and confidence, and the functioning of the UK internal market in reaching a final decision.

Dispute prevention and dispute resolution

Every effort is made at working level to resolve any disagreements in difference of approach. It is anticipated that the need for dispute resolution in areas within scope of the Nutrition Framework is unlikely. However, should it be needed, the dispute resolution established by the NLCS Framework will come into play.

1.4 Lists and registers

Where regulations requires a list or register to be established, each Appropriate Authority must produce and maintain a list or register.

Decisions made by the appropriate authorities as set out above, will result in the GB lists and registers needing to be updated periodically.

For convenience and clarity GB lists and registers, which consolidate all lists produced and maintained by the appropriate authorities, are available on the register on adding vitamins and minerals to foods for food business operators and other interested parties.

Businesses may submit requests for change or dossiers in support of these lists being amended for consideration for use on the GB market to DHSC mailboxes, unless stated otherwise in this guidance. DHSC will centrally coordinate applications.

1.5 Northern Ireland

The Northern Ireland Protocol was published in October 2019 as part of the Withdrawal Agreement to address the “unique circumstances on the island of Ireland”.

The UK government published a Command Paper on its approach to the NIP on 20 May 2020 and further information can be found there, in addition to business guidance on GOV.UK.

The NIP was designed as a practical solution to avoiding a hard border on the island of Ireland, whilst ensuring that the UK, including Northern Ireland, could leave the EU as a whole. It therefore included, a number of special provisions which apply only in Northern Ireland, for as long as the NIP is in force.

The NIP means that EU legislation relating to nutrition, as detailed in Annex 2 to the NIP, continues to be directly applicable in Northern Ireland.

Section 3 of existing UK guidance remains relevant and useful in complying with the compositional and labelling requirements set out in EU law when read alongside the updates in this section relevant in Northern Ireland;

With regards to trade going from Northern Ireland to the rest of the UK: this has not changed. Northern Ireland businesses continue to be able to place their goods on the market throughout the rest of the United Kingdom without new restrictions.

Businesses should note, however, that under the Protocol, in Northern Ireland, the FSA is not able to submit: scientific dossiers concerning the modification of: the Community Register on the addition of vitamins and minerals and of certain other substances to foods.

Businesses seeking to submit any of the aforementioned requests for change or scientific dossiers in respect to authorisation for the Northern Ireland or EU27 markets should forward them to the European Commission in accordance with the following:

Northern Ireland’s full participation in risk assessment and risk management processes ensures that any decisions taken in GB (England, Scotland and Wales) account for the potential impacts across the UK.

1.6 Addition of vitamins, minerals and certain other substances to food within the EU from 1 January 2021

Retained Regulation (EC) No. 1925/2006 stipulates which vitamins and minerals may be added to foods, sets out the safety assessment processes for certain other substances, and outlines how new substances may be considered for inclusion in the Annexes. It also outlines the compositional and labelling requirements for foods that have substances added to them:

• Annex I lists vitamins and minerals that may be added to foods

• Annex II lists vitamin formulations and mineral substances which may be added to foods

• Annex III lists:

  • in Part A, substances that are prohibited from use in the manufacture of foods as it is deemed to have a harmful effect on health

  • in Part B, substances which may only be used in the manufacture of foods subject to the conditions of use specified as it is deemed to have a harmful effect on health

  • in Part C, substances which may be used in the manufacture of foods but where scientific uncertainty exists over the possibility that they represent a risk to health

The European Commission was responsible for establishing and maintaining a Community Register on the addition of vitamins, minerals, and certain other substances to foods.

EU tertiary legislation, Commission Implementing Regulation (EU) No. 307/2012, sets out implementing rules for considering substances that should be prohibited or restricted in foods under Article 8 of Regulation (EC) No. 1925/2006.

1.7 Changes to requirements regarding the addition of vitamins, minerals and certain other substances to food in GB from 1 January 2021

In amending Regulation (EC) No 1925/2006 the Nutrition (Amendment etc) (EU Exit) Regulations 2019 and the Nutrition (Amendment etc) (EU Exit) Regulations 2020 made a number of practical changes to the regulatory framework. This section sets out how GB’s system works when accounting for those practical changes.

The rest of this guidance (sections 2 to 9) remains relevant and useful in helping food businesses to comply with the retained Regulation (EC) No. 1925/2006.

The NIP means that EU legislation relating to the addition of vitamins, minerals and certain other substances to food continues to be directly applicable in Northern Ireland.

Given this, sections 2 to 9 of this guidance remain applicable in helping food businesses to comply with Regulation (EC) No. 1925/2006, when read alongside updates in this section relevant to Northern Ireland, such as Modifying the Community Register on the addition of vitamins and minerals and of certain other substances to foods in the European Union and Northern Ireland.

1.8 GB Register of Vitamins, Minerals, and Certain Other Substances

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 existed on 1 January 2021, henceforth it is known as the GB VMS Register.

The GB VMS Register lists:

• the vitamins and minerals which may be added to foods as listed in Annex I of retained Regulation (EC) No. 1925/2006

• the vitamin formulations and mineral substances which may be added to foods as listed in Annex II of retained Regulation (EC) No. 1925/2006

• the maximum and minimum amounts of vitamins and minerals which may be added to foods and any associated conditions set in accordance with Article 6 of retained Regulation (EC) No. 1925/2006

• information regarding enactments applicable in any part of Great Britain on either:

  • the mandatory addition of vitamins and minerals to specified foods or categories of foods

  • the prohibition or restriction on the use of certain other substances in the manufacture of specified foods

• any restrictions on the addition of vitamins and minerals as set out in Article 4 of retained Regulation (EC) No. 1925/2006

• information about the substances referred to in Annex III of retained Regulation (EC) No. 1925/2006 (Part A: prohibited substances, Part B: restricted substances) and the reasons for their inclusions therein

• information about the substances listed in Annex III, Part C, of retained Regulation (EC) No. 1925/2006 whose use is generally allowed as referred to in Article 8(5)

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

Communication of changes

Any amendments to the GB VMS Register are communicated via regular bulletins published on GOV.UK.

1.9 Modifying the GB VMS Register

Modifying Annexes I and II

Article 3.3 of retained Regulation (EC) No. 1925/2006, allows for the appropriate GB authorities to make regulations to specify modifications to Annex I (vitamins and minerals which may be added to foods) and Annex II (the vitamin formulations and mineral substances which may be added to foods) after taking into consideration the opinion of an expert committee. Prior to making any modifications to the Annexes of retained Regulation (EC) No. 1925/2006, the appropriate UK authorities will consult with interested parties.

Food business operators, or other interested parties, that wish for vitamin and mineral substances to be considered for inclusion in the Annexes may submit a scientific dossier concerning the safety and bioavailability of the individual substance for consideration for use in the GB market by the appropriate UK authorities to the DHSC mailbox (which centrally coordinates dossiers for all 4 GB nations).

To minimise disruption to business, we (The UK government and the devolved administrations in Scotland and Wales) recommend that, until further notice, scientific dossiers supporting the addition of a vitamin or mineral to the GB Register continue to be completed in line with administrative guidance produced by the European Commission.

Modifying Annex III Part C

Annex III Part C of retained Regulation (EC) No. 1925/2006, includes other substances where scientific uncertainty exists over the possibility that they represent a risk to health. This is a temporary listing to allow for further scientific data to be gathered.

Within 4 years of a substance being listed in Annex III Part C of retained Regulation (EC) No. 1925/2006, the appropriate UK authorities will, in consultation with one another and taking into consideration an expert committee on any files submitted for evaluation, decide whether to generally allow the substance in question or add it to the list in Annex III Part A or Part B.

During this period food business operators or any other interested parties that wish to demonstrate the safety of a substance listed in Annex III Part C of retained Regulation (EC) No. 1925/2006, may submit a file to an expert committee (via the process outlined in the following paragraph); in accordance with the procedures set out in retained Commission Implementing Regulation (EU) No. 307/2012. The file shall be based on relevant guidance documents that have been adopted or endorsed by an expert committee designated by the appropriate UK authorities for matters related to vitamins, minerals, and certain other substances.

We therefore recommend that, until further notice, files concerning a substance listed in Annex III Part C of retained Regulation (EC) No. 1925/2006, are submitted for GB consideration by the appropriate GB authorities to the DHSC mailbox (which centrally coordinates files for all GB nations). Further to this we recommend that files continue to be completed in line with administrative guidance produced by the European Commission.

We recommend that submitted dossiers not considered by the EU before the 31 December 2020, are submitted to the DHSC mailbox (which centrally coordinates dossiers for all GB nations) for consideration by the appropriate UK authorities if the applicant wishes for that modification to also be applicable in the GB market.

The appropriate UK authorities will identify an appropriate domestic scientific advisory committee that the dossier should be sent to for evaluation.

The expert committee will assess whether the file is valid for the purpose of conducting a safety assessment of the substance in question within 30 days from receipt of the file. If the file is not considered valid the committee shall inform the food business operator or interested party that has submitted the file and the appropriate UK authorities, indicating the reasons why the file is not considered valid.

The expert committee shall provide its opinion on any valid files within 9 months from the date of receipt of a valid file but may, if necessary, request supplementary information from the food business operator or interested party. A request for supplementary information must be satisfied within 15 days, and extends the time limit by which the expert committee shall provide its opinion by 3 months.

The resulting opinion given by the expert committee will be taken into account when the GB authorities decide whether the substance can continue to be allowed to be used in food, or restricted by adding it to Part B of Annex III, or prohibited by adding it to Part A of retained Regulation (EC) No. 1925/2006. There are no restrictions on use during this scrutiny period.

Only files submitted for evaluation within 18 months of a substance being added to Part C of Annex III of retained Regulation (EC) No. 1925/2006, shall be taken into account by an expert committee as being a valid file for the purposes of a decision taken by the appropriate UK authorities.

Risk assessment

Scientific advice previously provided by the European Food Safety Authority in relation to vitamins, minerals, and certain other substances will be sought from existing scientific advisory committee committees in the UK.

A scientific advisory committee will be identified by the appropriate UK authorities as necessary depending on the nature of the scientific advice required.

Risk management

Risk management functions related to vitamins, minerals, and certain other substances is assumed by the appropriate UK authorities.

1.9 Domestic enforcement provisions

Legislation which provided for enforcement of retained Regulation (EC) No. 1925/2006 in each part of the United Kingdom’s prior to its withdrawal from the European Union still applies.

1.10 Modifying the Community Register on the addition of vitamins and minerals and of certain other substances to foods in the European Union and Northern Ireland

From 1 January 2021 GB has its own GB VMS Register and modification process.

Food business operators wishing to add vitamins and minerals to food in the EU or Northern Ireland from the 1 January 2021 must also continue to comply with the requirements currently laid out in of Regulation (EC) No. 1925/2006.

We recommend that food business operators wishing to request the inclusion of vitamins and minerals in the Community Register in the EU or Northern Ireland from 1 January 2021 refer to the extensive guidance on the addition of vitamins and minerals published by the European Commission. This guidance relates specifically to administrative guidance on submissions for safety evaluation of substances added for specific nutritional purposes in the manufacture of foods.

Requests for the inclusion of new nutritional substances should be submitted to the European Commission. Guidance on the procedure that should be followed for the submission of requests for substances to be considered for inclusion in the permitted list is available on the European Commission’s website.

Section 2: introduction and summary

This guidance will tell you what you must do to comply with this Regulation if you choose to add a vitamin or mineral to your food product. It also explains how the Regulation will control the addition of other substances, which could pose a potential risk to health. This guidance is not designed to be read cover to cover, rather you should use it as a tool, following the steps relevant to you. Where you see a ê you will need to select the appropriate statement to continue to the relevant section.

While only the courts can give a definitive interpretation of the law, in preparing this guidance we have had to interpret certain provisions, based on consultation with stakeholders. The guidance is not legally binding and should therefore be read together with the relevant legislation listed in appendix 2. Additional sources of advice and information that can help you comply with the law are detailed in appendix 3.

2.1 Addition of vitamins and minerals

European Regulation (EC) No. 1925/2006 on the addition of vitamins and minerals and of certain other substances to food was published on 30 December 2006. This Regulation lists the vitamins and minerals that can voluntarily be added to food. If you plan to add a vitamin or mineral to your product you should consult your Home Authority or Primary Authority.^{[footnote 1]} In addition, you should familiarise yourself with Regulation 1925/2006 and use this guidance to ensure you meet with the requirements of the Regulation.

In addition the Regulation puts in place certain restrictions, most notably prohibiting the addition of vitamins and minerals to non-processed foods and beverages containing more than 1.2% by volume of alcohol. It also sets minimum amounts that must be present following addition and puts in place provisions to set maximum amounts.

If a vitamin or mineral is added to food you must also provide nutrition labelling as per Directive 90/496/EEC on nutrition labelling for foodstuffs.

The Regulation does not apply to mandatory addition or where addition is required by law. Nor does it apply to vitamin and mineral Food Supplements or the use of substances for additive purposes, which are controlled by specific legislation.

In addition the Regulation puts in place certain restrictions, most notably prohibiting the addition of vitamins and minerals to non-processed foods and beverages containing more than 1.2% by volume of alcohol. It also sets minimum amounts that must be present following addition and puts in place provisions to set maximum amounts.

If a vitamin or mineral is added to food you must also provide nutrition labelling as per Directive 90/496/EEC on nutrition labelling for foodstuffs.

The Regulation does not apply to mandatory addition or where addition is required by law. Nor does it apply to vitamin and mineral Food Supplements or the use of substances for additive purposes, which are controlled by specific legislation.

2.2 What do I need to do to add vitamins and minerals to my product?

You need to:

• ensure the vitamin or mineral you wish to add is listed in Annex I of the Regulation

• ensure the vitamin formulation or mineral substance you wish to use is listed in Annex II

• ensure the amount present complies with maximum and minimum levels where these are set, or where none are set you should ensure a sufficient quantity is present to have the intended effect, and that no more is present than is safe to be consumed as part of a varied diet

• comply with the labelling requirements

• comply with the other conditions of the Regulation as outlined in sections 4 and 5 of this guidance

2.3 Use of other substances

The Regulation puts in place a process to control other substances where it is considered that these could pose a potential risk to human health. This control will be by way of either a prohibition or restriction on the substance’s use in food. Food business operators will need to check the Community Register for updates to Annex III of the Regulation to ensure that the ingredients they use or plan to use are not controlled in this way. For further information please see section 6.

2.4 Date of application

Although the Regulation applied from 1 July 2007 transitional measures mean that certain aspects of the Regulation will not apply until a later date. For further information on transitional periods please see section 7.

Section 3: background and scope

3.1 Introduction

Regulation (EC) No. 1925/2006 stipulates which vitamins and minerals may be added to foods, sets out the safety assessment processes for certain other substances, and outlines how new substances may be considered for inclusion in the Annexes. It is the first piece of specific legislation to deal with the voluntary addition of vitamins and minerals and certain other substances to food.

It also outlines the compositional and labelling requirements for foods that have substances added to them:

• Annex I lists vitamins and minerals that may be added to foods

• Annex II lists vitamin formulations and mineral substances which may be added to foods

• Annex III lists:

  • in Part A, substances that are prohibited from use in the manufacture of foods as it is deemed to have a harmful effect on health

  • in Part B, substances which may only be used in the manufacture of foods subject to the conditions of use specified as it is deemed to have a harmful effect on health

  • in Part C, substances which may be used in the manufacture of foods but where scientific uncertainty exists over the possibility that they represent a risk to health

Prior to this Regulation becoming law the relevant UK legislation governing the voluntary addition of vitamins and minerals and certain other substances to food had been the Food Safety Act 1990 and Article 14 of European Regulation 178/2002, which make it an offence to render food injurious to human health or place on the market food that is unsafe.

The Regulation seeks to protect people from consuming quantities of any vitamin, mineral or other substance, which could be harmful to health.

3.2 Addition of vitamins and minerals to food (Article 1)

The Regulation seeks to control the voluntary addition of vitamins and minerals to food. It recognises that vitamins and minerals are added to food for a variety of purposes, such as to improve the nutritional status of the population or to take into account vitamin deficiencies.

The Regulation does not affect existing national rules regarding the mandatory fortification of flour and margarine (Recital paragraph 3) or the use of trace quantities of vitamins or minerals in alcoholic drinks as authenticity markers (Recital paragraph 13). It will not apply to the use of vitamins and minerals in food supplements (Directive 2002/46/EC) or where they are required to be added to food under Directive 2009/39/EC relating to foodstuffs for particular nutritional uses. Where vitamins or minerals are added to a food for an additive purpose the Regulation will not apply, however the addition will need to meet with the controls on the use of additives in Regulation (EC) No. 1333/2008.

The Regulation also recognises that vitamins and minerals may be added to food to restore levels lost during processing. Additions of this kind must, nevertheless, comply with the general conditions of the Regulation and be authorised substances from the Annexes, in a form that is bio-available to the human body, conform to the conditions on maximum amounts and where appropriate on minimum amounts. If a claim is to be made on a vitamin or mineral that has been restored after processing losses (such as ‘contains’, ‘source of’ etc), this must comply with the requirements in the annex to Regulation (EC) No. 1924/2006 on nutrition and health claims. However, where claims are not to be made, there may be good reason to restore with a lower minimum amount. Food business operators should be able to substantiate this.

3.3 Other substances (Article 8)

The Regulation puts in place a mechanism to allow ingredients that represent a potential risk to health to be assessed, including a safety assessment by the European Food Safety Authority (EFSA), and where necessary prohibited or restricted.

3.4 Legislation controlling the addition of vitamins and minerals and certain other substances to food (Article 1)

For certain products specific legislation already exists that controls composition and in these cases both this and the Regulation (EC) No. 1925/2006 Regulation will apply. However, in some cases this legislation contains requirements for the addition of vitamins, minerals or certain other substances to food. In such cases these mandatory rules will take precedence over the Regulation (EC) No. 1925/2006 Regulation. Examples of products which are controlled by specific legislation are given below:

• supplements

• foods for specific groups (FSG – for example, infant formula, medical foods and so on)

• novel foods and Novel food ingredients

• genetically modified food

• food additives and flavourings

• oenological practices and processes

For full details of the legislation controlling these and where to find further information please see appendix 2.

3.5 Addition of vitamins and minerals vs certain other substances

The Regulation deals with the addition of vitamins and minerals and certain other substances to food in 2 distinct sections. The guidance therefore follows the same approach.

If you wish to add a vitamin or mineral to your product please go to section 4.

If you want to ensure that any other substance is not controlled by the Regulation please go to section 6.

Section 4: foods to which vitamins and minerals can be added

4.1 Introduction

The Regulation on the addition of vitamins and minerals and certain other substances to food (AVM Regulation) controls the voluntary addition of vitamins and minerals to food. It lists the vitamins and minerals that can be added to food and puts in place minimum amounts and provisions to set maximum amounts in the future.

For certain products there are additional considerations or restrictions that should be taken into account before a vitamin or mineral can be added. Further details are given below and you should assure yourself that your product is not affected by these restrictions before proceeding.

4.2 Voluntary and mandatory fortification

Under UK legislation the addition of vitamins and minerals to flour and margarine is mandatory and are not affected by the Regulation (Recital paragraph 3). Under the Regulation the government is responsible for notifying the Commission of the requirements for mandatory fortification in the UK. For further information on mandatory fortification please see the following legislation. For full links to this legislation please see appendix 2.

• The Bread and Flour Regulations 1998

• The Spreadable Fats (Marketing Standards) Regulations 1995

While it is mandatory to fortify these products, it is also possible to voluntarily add additional vitamins and minerals. You must, however, ensure that you also meet with the requirements on the mandatory fortification as well as those for voluntary fortification.

4.3 Foods to which vitamins and minerals cannot be added (Article 4)

Vitamins and minerals cannot be added to unprocessed foodstuffs such as fruits, vegetables, meat, poultry and fish.

Vitamins and minerals cannot be added to beverages that contain more than 1.2% by volume of alcohol. There is one exception to this requirement for certain traditional wines, which could not be produced without the addition of certain minerals. There are specific conditions associated with this exemption, including a prohibition on claims, which are explained in full in section 9, question 7 (on tonic wine).

The Regulation contains provisions that allow further specific restrictions to be set in future. These will be based on scientific evidence and will be set by the European Commission.

• If your product complies with the requirements outlined above please go to section 5 for further information about the addition of vitamins and minerals to food.

Section 5: adding vitamins and minerals to food

5.1 Introduction

Having read section 4 you should be confident that the restrictions in the Regulation will not affect the addition of vitamins and minerals to your product. We will now look at which vitamins and minerals, and forms of these, can be added to food.

The Regulation permits only those vitamins and minerals listed in Annex I to be added to food, and requires that these be in a bio-available form.

You will need to check (using the link below) that the vitamin or mineral you wish to add is listed in the Annex. The Annex can be found of the GB VMS Register.

If the vitamin or mineral you wish to add is listed please go to section 5.2.

If it is not on this list please go to section 5.3.

5.2 Vitamins and minerals listed in Annex I (Article 3)

If the vitamin or mineral you wish to add is listed in Annex I, you will now need to verify that the chosen source, the vitamin formulation or mineral substance is also listed in Annex II. For example, if you wanted to add vitamin B1 to your product you can actually use either thiamin hydrochloride or thiamin mononitrate as ingredients, both of which are forms of vitamin B1. Please see the European Commission website for an up-to-date copy of Annex II and check to see if the vitamin formulation or mineral substance you want to add is listed.

• If the vitamin formulation or mineral substance is listed in Annex II please go to section 5.4. This section gives additional information to help you comply with the Regulation.

• If the vitamin formulation or mineral substance that you wish to add is not on the list in Annex II please see section 5.3.

5.3 Vitamins and minerals not listed in Annex I or Annex II (Article 3)

Vitamins and minerals not listed in Annex I and vitamin formulations or mineral substances not listed in Annex II cannot be voluntarily added to food (please see section 7 for details of transitional periods). It is, however, possible to make additions to the Annex (Article 3(3)). This will be done by the European Commission, which is required by the Regulation to consult with interested parties including food business operators and consumer groups on any changes. For further information and advice on making additions to the Annex, the Commission has published administrative guidance for applicants and a Community Register.

Once the vitamin, mineral, vitamin formulation or mineral substance has been added to the Annex and is permitted for use in food, the product will need to comply with the additional conditions outlined in section 5.4.

5.4 Further conditions on the addition of vitamins and minerals to food

If you have reached this section your product should comply with the restrictions in section 4 and the vitamin or mineral you want to add is listed in Annex I and is in a form listed in Annex II. Detailed below are several other aspects of the Regulation that you will need to comply with to add the vitamin or mineral to your product.

5.5 Minimum amounts (Article 6(6))

To ensure that fortification is beneficial to health, the Regulation requires that the final food contain a significant amount of a vitamin or mineral, as defined by Directive 90/496/EEC on nutrition labelling of foodstuffs, which defines a significant amount as 15% of the RDA per 100 g or 100ml. Minimum amounts will apply to the total level of the vitamin or mineral, including amounts already present in the food.

Where vitamins and minerals are added to food to restore levels lost during processing and a claim is to be made on a vitamin or mineral that has been restored after processing losses (such as ‘contains’, ‘source of’ etc), this must comply with the requirements in the annex to Regulation 1924/2006 on nutrition and health claims. However, where claims are not to be made, and where there is good reason, it is possible to restore with an amount below 15% of the RDA. Food business operators should be able to substantiate this.

The Regulation contains provisions allowing different minimum amounts to be set for specific foods or categories of food where these are considered necessary. An up-to-date list of minimum amounts that differ from the significant amount will be published in the Community Register, We would strongly advise you check this to ensure you comply with the correct minimum amount.

5.6 Maximum amounts (Article 6)

In addition to the setting of minimum amounts the Regulation also puts in place provisions that require the European Commission to set maximum levels to avoid over-consumption of vitamins or minerals, which might have an adverse effect on health. The European Commission is required by the Regulation to take into account the following information when doing this:

• the upper safe levels of vitamins and minerals established by scientific risk assessment based on generally accepted scientific data, taking into account, as appropriate, the varying degrees of sensitivity of different groups of the population

• the intake of vitamins and minerals from other dietary sources, including supplements and foods subject to mandatory fortification.

Where the intake of a vitamin or mineral is already close to the upper safe level only a limited amount will be available for voluntary addition. Only in these cases will the following information be considered when deciding to which products addition should be allowed and by how much:

• the contribution of individual products to the overall diet of the population in general or to sub-groups of the population

• the nutrient profile of the product established as provided for by Regulation (EC) No 1924/2006 on nutrition and health claims made on foods

Once maximum levels have been set they will be published in the Community Register. Vitamin or minerals should not be added at levels that exceed the maximum amounts. It is worth noting that, just as with minimum levels, maximum levels will apply to the total amount of a vitamin or mineral in the product after addition and will take into account naturally present levels.

5.7 Labelling (Article 7)

The Regulation requires nutrition labelling to be provided whenever a vitamin or mineral has been voluntarily added to a product. Nutrition labelling should be that specified in Article 4(1), group 2 of Directive 90/496/EEC and should include the total amounts of the vitamins and minerals that have been added to the food together with the amount already (naturally) present in the food.

The labelling of the product must not state, suggest or imply that appropriate amounts of vitamins and minerals cannot be provided within a balanced and healthy diet. It should also not mislead or deceive consumers about the true nutritional merit of a food.

If you wish to make a claim referring to the vitamin or mineral content of the products please consult Regulation (EC) No 1924/2006.

5.8 Purity criteria (Article 5)

Purity criteria define the chemical characteristics of each of the vitamin and mineral substances listed in Annex II. They define in law the chemical structure and properties of each formulation or substance. Only formulations or substances that meet with the conditions of the purity criteria can be added to food.

Where purity criteria already exist in European legislation, these will apply to the substances in Annex II. For example Directive 2008/84/EC, laying down specific purity criteria on food additives other than colours and sweeteners, includes purity criteria for ascorbic acid, an additive used to regulate acidity in foods. L-ascorbic acid is also listed in Annex II as a vitamin formulation for vitamin C. When L-ascorbic acid is voluntarily added to food as a source of vitamin C the purity criteria in Directive 2008/84/EC will apply.

Where purity criteria do not already exist in European legislation the Regulation requires such criteria to be set. Until this is completed any purity criteria recommended by international bodies, such as Codex, shall apply. The Regulation will also allow national rules to apply during this period, some of which may set stricter criteria. There are currently no purity criteria that are specific to the UK; however, if you are planning on exporting your products to other Member States, you will need to consider any purity criteria they have in place.

Checklist for adding vitamins and minerals to food

You can only add vitamins and minerals to your product if all the following are true:

• your product is not an unprocessed foodstuff

• your product is not an alcoholic beverage containing more than 1.2% by volume of alcohol

• existing legislation does not already control the addition of vitamins and minerals to your product, for example compositional requirements under PARNUTS legislation

• you are not adding the vitamin or mineral to your product for any reason other than to restore or to supplement the nutritional benefit of the product (if it is being added for any other function it may be controlled by additives legislation)

• the vitamin or mineral you want to add is listed in Annex I

• the vitamin or mineral substance you want to add is listed in Annex II

• the vitamin or mineral will be present in the product at a significant amount after addition, unless for restorative purposes, which you can substantiate and no claim is made

• the levels you wish to add are within maximum levels for vitamins and minerals where specified

• there are no product specific restrictions for the addition of vitamins and minerals

• you have provided nutrition labelling (group 2) including details of the vitamin or mineral added

• there is no indication in the labelling of the product that appropriate levels of the vitamin or mineral could not be gained from a healthy balanced diet

• the labelling does not mislead the consumer about the true nutritional benefit of the product

• any claims made about the vitamin or mineral content comply with the conditions set out in Regulation (EC) No 1924/2006 on nutrition and health claims

Section 6: addition of certain other substances to food

6.1 Introduction

The Food Safety Act 1990 and Article 14 of European Regulation 178/2002^{[footnote 2]}, make it an offence to render food injurious to human health or place on the market food that is unsafe, but they do not put in place controls on specific ingredients for which there may be safety concerns. As no legislation exists to control such ingredients at a European level, Member States have had to take individual action. For example, in the UK the Kava Kava in Food Regulations 2002 prohibits the use of this substance in foods.

The AVM Regulation will be available for possible future control, at the European level, of a wide range of ingredients, which could represent a potential risk to consumers. This control will be carried out on a case by case basis as and when the need arises. The control of certain other substances will be in all foods, including food supplements. When the Regulation was adopted there were no proposals to control any specific substances.

It is worth noting that this is not the only piece of legislation that controls the addition of substances to food. European legislation does exist which controls the composition of certain categories of food, for example jam (Directive 2001/113/EC). While this indicates that a distinction can be drawn between ingredients in some foods and certain other substances controlled by this Regulation, the definition of “substances other than vitamins and minerals that have a nutritional or physiological effect” is broad and could include food ingredients. You will need to ensure that you comply with all relevant legislation.

6.2 How will other substances be controlled by the Regulation? (Article 8)

The Regulation will only control other substances that present a potential risk to consumers’ health. The Regulation defines ‘other substances’ as a substance other than a vitamin or mineral that has a nutritional or physiological effect. The substance must also have been added to a food or used as an ingredient in a food, which results in more of that substance being ingested than under normal conditions or via a balanced diet.

If there is concern that a substance may represent a potential risk to consumers the European Food Safety Authority (EFSA) will carry out an assessment of available information. Based on this assessment the European Commission will take a decision on its use in food, which will fall into one of the following 4 categories:

The substance or ingredient containing the substance is deemed to have a harmful effect on health and its addition to food or its use in the manufacture of foods is prohibited. These substances will be listed in Part A of Annex III.

The substance or ingredient containing the substance is deemed to have a harmful effect on health and its addition to food or its use in the manufacture of foods will only be allowed under the conditions specified. These substances and the conditions of use will be listed in Part B of Annex III.

The substance or ingredient containing the substance could have a harmful effect on health, but there is some uncertainty. These substances and the conditions on their use will be listed in Part C of Annex III. See section 6.3 for further information.

The substance or ingredient containing the substance is deemed safe and can continue to be used in food without control.

Once these rules are established, you must ensure you do not add substances, or ingredients containing substances, listed in Part A of Annex III, or if they are in Part B or C that they meet any conditions imposed.

6.3 Other substances listed in Annex III, Part C (Article 8)

Part C of Annex III will include other substances where scientific uncertainty exists over the possibility that they represent a risk to health. This is a temporary listing to allow for further scientific data to be gathered.

Having been added to Part C, there will be a 4-year time limit during which EFSA will issue an opinion on the substance and the Commission will reach a decision on its future use in food. During this period food business operators or any other interested parties can submit scientific data to EFSA demonstrating the safety of the substance. The resulting EFSA opinion will be taken into account when the Commission decide whether the substance can continue to be allowed to be used in food or restricted by adding it to Part B of Annex III or prohibited by adding it to Part A. We understand that there will be no restrictions on use during this scrutiny period.

Section 7: when do I need to comply with the regulation?

7.1 Introduction

In order to help industry comply with the Regulation, some of its requirements do not take immediate effect. It is therefore important to familiarise yourself with the following transitional periods and key dates, by which time you will need to comply with the various requirements of the Regulation.

7.2 Transitional periods (Article 17 and 18)

The Regulation came into force on 19 January 2007. This is the date on which the Regulation officially became law and which will trigger other time periods and transitional periods in the Regulation.

The requirements of the Regulation applied from 1 July 2007. From this date products should meet the requirements of the Regulation, unless there are specific transitional measures in place. Further information about transitional periods and when specific elements of the Regulation will take effect are given below.

7.3 Transitional period for vitamins and minerals not in the Annex

Vitamins and minerals not listed in Annex I or forms not listed in Annex II can continue to be used until 19 January 2014, as long as they were used in food that was marketed on 19 January 2007 and a dossier in support of their use was submitted, via a Member State, before 19 January 2010. If, before 19 January 2014, the Commission reach a negative decision on its use it will no longer be permitted to be added to food.

During this period Member States can continue to enforce national restrictions or bans on the trade of products to which it has been added. Once it is included in either Annex I or Annex II Member States must permit it on their market (Article 17(2)).

7.4 Transitional period for maximum and minimum levels

Member states can continue to apply existing national provisions on maximum and minimum levels until these are set at the European level (Article 17(3)).

Section 8: enforcement

8.1 Enforcement

The enforcement of food law in the UK is the responsibility of Local Authorities and in some instances Port Health Authorities. In each of the UK countries a domestic Regulation or Statutory Instrument^{[footnote 3]} is required to designate “competent authorities” who will enforce the requirements of the legislation as well as put in place enforcement and penalties. In the UK it is Trading Standards Departments or Environmental Health Departments or equivalent in the Local Authority of the food business operator that are responsible for enforcing the requirements of the Regulation.

Trading Standards Officers (TSOs) and Environmental Health Officers (EHOs) or any other authorised officer of the local authority (as appropriate) would initiate any legal proceedings in connection with a product that they consider to be in breach of the Regulation.

For advice on specific products, including the checking of labels, please contact your local TSO or EHO, the details of which can be obtained on the Food Standards Agency’s website.

8.2 Home authority principle

The Home Authority Principle allows local authorities to work with a business to provide consistent and coordinated Trading Standards and food enforcement services across the UK. It assists these businesses that have outlets in more than one local authority and distribute goods and/or services beyond the boundaries of one local authority. Further information can be found on the Local Government Association website

8.3 Primary authority scheme

The government’s statutory Primary Authority scheme came into force on 6 April 2009 and introduces provisions for businesses, charities or other organisations that operate across more than one site to enter into a partnership agreement with a single authority for it to become that organisation’s Primary Authority. The existing Home Authority principle will continue to operate across the UK, particularly in Scotland and Northern Ireland where the Primary Authority scheme does not apply to food law enforcement functions which are devolved. Further information about the Primary Authority scheme can be found online.

8.4 Safeguard measures (Article 13)

The safeguard measures give Member States powers to temporarily suspend or restrict a product that they strongly believe endangers human health, despite it complying with this Regulation. If any such action is taken the Member State must inform the Commission and other Member States.

Where appropriate, EFSA will give an opinion on the suspension or restriction. The Commission, via the Standing Committee, will then reach a decision on whether the suspension or restriction should apply at EU level. If the decision is that such action is not necessary the original Member State must stop its national suspension or restriction.

Section 9: questions and answers

9.1 Scope

Does the Regulation apply to supplements?

Use of vitamins and minerals in food supplements are controlled by Directive 2002/46/EC relating to food supplements (Article 1). However, the use of ‘certain other substances’ in supplements is controlled by this Regulation.

Does it cover the use of fortified ingredients?

No. The Commission has confirmed that the Regulation will only apply to the direct addition of vitamins and minerals to food, not the use of a fortified ingredient. However, when the vitamin or mineral is initially added to the ingredient it will need to comply with the requirements of the Regulation.

Does it cover the addition of fluoride to tap water?

No. The Regulation applies to the addition of vitamins and minerals to food as defined by European Regulation 178/2002. Under this definition water is only a food after the point of compliance as defined by Directive 98/83/EC (as amended). As water only becomes a food when it emerges from the tap, is put into the bottle or container or when it is added to a food, the addition of fluoride before this stage is not controlled by the Regulation.

Does the Regulation apply to the use of sodium chloride as an ingredient?

No. Recital paragraph 10 clarifies that the use of sodium chloride as an ingredient will not be covered by the AVM Regulation.

Does this Regulation apply to the use of authenticity markers?

No. Recital paragraph 13 clarifies that the Regulation does not apply to the use of vitamins and minerals in trace quantities as authenticity markers in alcoholic drinks.

9.2 Restrictions and requirements

Vitamins and minerals are fundamental to the production of tonic wine, as this is an alcoholic drink can it still be produced?

Yes. Article 4 states that products referred to in Article 44(6) and (13) of Council Regulation (EC) No 1493/1999, on the common organisation of the wine market, can have vitamins and minerals added to them. This will only apply to products which were on the market prior to the adoption of the Regulation and as long as the Commission has been notified. These products, which include tonic wine, are not permitted to make any nutrition or health claims.

What if a vitamin or mineral is not covered by Directive 90/496/EEC and nutrition labelling cannot be provided?

For vitamins and minerals where no recommended daily allowance (RDA) is established under Directive 90/496/EC, in order to comply with the labelling requirements in Regulation 1925/2006, food business operators must be able to substantiate the amount added for the purposes required and label with the total vitamin and mineral content.

How and when will maximum levels be set?

This is outlined in Article 6 which requires the upper safe level and the levels of vitamins and minerals already consumed via the diet to be considered. This will include vitamins and minerals consumed from food, but also food supplements. When food supplements legislation was adopted in 2002 it put in place provisions to set maximum and minimum levels for supplements. In order to set appropriate maximum and minimum levels for both fortified foods and supplements the Commission intend to set them at the same time and issued a discussion paper to start this process.

Sections 5.5 and 5.6 of this guidance gives further information about the setting of minimum and maximum levels respectively.

What will happen if a vitamin or mineral is not in the Annex of this Regulation, but has been added to the list in the supplements Directive?

Although the list of vitamins and minerals in the Annex was originally taken from the Supplements Directive 2002/46/EC, any additions will now need to be assessed independently. If you would like to have a vitamin or mineral added to the Annex please visit the European Commission’s website, which includes administrative guidance on how this should be done.

9.3 Authorisation process

How will substances be added to the Annexes?

The Commission will take advice from EFSA and propose additions to the Annexes to Standing Committee, where decisions are taken on qualified majority voting. The European Parliament may scrutinise decisions taken here.

Who is the competent authority in the UK?

The Department of Heath is the competent authority in England and Wales and represents the UK in EU negotiations. The Food Standards Agency is the competent authority for policy decisions in Scotland and Northern Ireland. Enforcement is the responsibility of local authorities (see section 8).

Will any vitamin, mineral, vitamin formulation or minerals substance ever be taken off the list in the Annex?

Article 3(3) of the Regulation does allow for the list to be amended, with decisions made by the Standing Committee. The European Parliament may scrutinise decisions taken here.

Article 4 says that vitamins and minerals cannot be added to unprocessed foods. What is meant by an unprocessed foodstuff?

Recital paragraph 12 explains that the Regulation prohibits the addition of vitamins and minerals to unprocessed foods to prevent consumers from being confused about the natural nutritional value of fresh foods. Regulation (EC) 852/2004 on hygiene of foodstuffs defines processing as “any action that substantially alters the initial product, including heating, curing, maturing, drying, marinating, extraction, extrusion or a combination of these processes” and unprocessed products as “products that have not undergone processing, and includes products that have been divided, parted, severed, sliced, boned, minced, skinned, ground, cut, cleaned, trimmed, husked, milled, chilled, frozen, deep-frozen or thawed”. Therefore, in the majority of cases it should be easy to distinguish between products that are unprocessed and so cannot have vitamins or minerals added to them, such as fruit, vegetables and meat, and products that are processed, such as bread, flour, margarine and most breakfast cereals.

Appendix 1

Section	What it means/Guidance
Recital 1	Sets the purpose of the Regulation - to harmonise legislation on the addition of vitamins and minerals and certain other substances to food.
Recital 2	Clarifies that national rules on the addition of other substances to food can apply where Community rules do not exist.
Recital 3	Justifies why mandatory fortification cannot currently be controlled at the Community level.
Recital 4	Clarifies that certain products and processes require vitamins and minerals to be added to food and are not controlled by the Regulation.
Recital 5	Clarifies that the Regulation should not apply to food supplements, which are already controlled by European legislation.
Recital 6	Gives additional reasons why vitamins and minerals could be added to food.
Recital 7	Explains the benefits of fortified foods.
Recital 8	Explains why additional vitamins and minerals may be required.
Recital 9	Clarifies why there needs to be a positive list of vitamins and minerals that can be added to food.
Recital 10	Clarifies the need for a positive list of vitamin and mineral substances. It also clarifies that the use of sodium chloride as an ingredient is not covered by the Regulation.
Recital 11	Explains why revisions to the lists should be done by the Commission.
Recital 12	Explains why the addition of vitamins and minerals to certain foods should be restricted.
Recital 13	Clarifies that the Regulation will not apply to the use of trace quantities of vitamins and minerals as authenticity markers.
Recital 14	Justifies the need for maximum levels.
Recital 15	Sets the criteria that should be considered when setting maximum levels.
Recital 16	Justifies the need for minimum levels.
Recital 17	Explains that the Commission should be responsible for setting maximum and minimum levels.
Recital 18	Explains that the Labelling Requirements in this Regulation will apply in addition to Directive 2000/13/EC and without prejudice to Regulation (EC) No 1924/2006.
Recital 19	Explains why nutrition labelling should be compulsory where vitamins and minerals have been added to food.
Recital 20	Explains why the Regulations should be available to control other substances.
Recital 21	Highlights the need for additional means of monitoring the addition of vitamins and minerals to food.
Recital 22	Clarifies that the Regulation complies with Article 5 of the treaty.
Recital 23	Explains how the Commission should be given the necessary powers to implement the Regulation.
Article 1	Sets the objective of the Regulation and the products and instances of addition to which it does not apply.
Article 2	Defines “Authority” and “other substance”.
Article 3	The vitamins and minerals that can be added to food and the reasons why these can be added.
Article 4	Foods to which vitamins and minerals cannot be added.
Article 5	Requirements and mechanism for setting purity criteria.
Article 6	Requires fortified products to comply with maximum and minimum levels and dictates how these will be set.
Article 7	Labelling requirements.
Article 8	Puts in place provisions to control with the use of other substances, which could pose a risk to human health.
Article 9	Dictates the role and content of the Community Register.
Article 10	Prevents Member States adopting national legislation, which would prevent the free movement of goods that comply with the controls on the addition of vitamins and minerals in this Regulation.
Article 11	Member States are required to notify the Commission of relevant national legislation.
Article 12	The Commission’s requirements following notification under Article 11.
Article 13	Allows Member States to have national rules, controlling substances which they believe endanger human health and the requirements for controlling this at a Community level.
Article 14	Defines the Committee procedure.
Article 15	Allows Member States to request manufacturers notify of new foods to which vitamins, minerals or other substances in Annex III have been added.
Article 16	Requires the Commission to provide a report on the effects of implementing the Regulation.
Article 17	Transitional measures.
Article 18	Entry into force and application dates.
Annex I	List of permitted vitamins and minerals.
Annex II	List of permitted vitamin and mineral substances.
Annex III	List of controlled other substances.

Appendix 2

Associated Legislation

The following table gives details of other legislation, associated with this Regulation and where to find more information.

Legislation	Further information
Regulation (EC) No 1925/2006 of the European Parliament and of the Council of the European Union on the addition of vitamins and minerals and of certain other substances to foods	Full copy of the text
Regulation (EC) No 1924/2006 of the European Parliament and of the Council of the European Union on nutrition and health claims made on foods	Full copy of the text
Food Safety Act 1990 (as amended)	Full copy of the text
Food Labelling Regulations 1996 (as amended)	Food Labelling Regulations 1996 Guidance Notes
Directive 2009/39/EC (formerly Directive 89/398/EEC) relating to foodstuffs intended for particular nutritional uses	Food for Particular Nutritional Uses: Guidance Notes
Directive 90/496/EEC on nutrition labelling for foodstuffs	Nutrition Labelling Guidance Notes
Novel foods legislation	Information on the Novel Process from the European Commission website, FSA website and FSA guidance
GM legislation	Information on GM and GM legislation from the European Commission website, FSA website and FSA guidance
Additives legislation	Food Additives Legislation Guidance Notes
Council Regulation (EC) No 1493/1999 on the common organisation of the market in wine	Full copy of the text
The Bread and Flour Regulations 1998	Full copy of the text
The Spreadable Fats (Marketing Standards) Regulations 1995	Full copy of the text
Directive 2002/46/EC relating to food supplements	Food Supplements Guidance notes

Appendix 3

Sources of information

For further information about food safety please visit the Food Standards Agency website.

For further information about healthy eating advice please see NHS Choices.

For further information about the enforcement of food law please visit the Local Government Association website.

For further information about what is considered a medicine and their control please visit the Medicines and Healthcare products Regulatory Agency website.

Contacts

The Department of Health and Social Care does not authorise or check the composition or labelling of individual products. For advice on specific products, including the checking of labels, please contact your local Trading Standards or Environmental Health office, the details of which can be obtained on the Food Standards Agency’s website.

If you require further advice relating to these Guidance Notes, please contact:

England

Nutrition Legislation Team
Obesity, Food and Nutrition Branch
Population Health Directorate
Department of Health and Social Care
39 Victoria Street
London SW1H 0EU

Tel: 020 7972 4340
DHSC mailbox

Scotland

Food Standards Scotland
4th Floor
Pilgrim House
Old Ford Road
Aberdeen AB11 5RL

Tel: 01224 285126
Food Standards Scotland mailbox

Wales

Health Improvement Division
Welsh Government
Cathays Park
Cardiff
CF10 3NQ

Welsh Government mailbox

Copies of the legislation mentioned in these guidance notes are available from The Stationery Office:

Tel: +44 (0)333 200 2425
www.legislation.gov.uk

Appendix 4

Glossary

Annex I

The list of vitamins and minerals that can be added to food.

Annex II

The list of vitamin and mineral substances that can be added to food.

Annex III

The list of certain other substances controlled by the Regulation.

AVM Regulation

The European Regulation on the addition of vitamins and minerals and of certain other substances to food.

Commission

European Commission

Community

European Community

Community Register

Centralised source of information about the Regulation, including the list of vitamins and minerals that can be added to food.

Department

Department of Health and Social Care

EFSA

European Food Safety Authority (referred to as the Authority in the Regulation)

EU

European Union

Food business operator

The natural or legal persons responsible for ensuring that the requirements of food law are met within the food business under their control.

Mandatory fortification

Where the addition of vitamins and minerals to food is required by law.

Nutrition claim

Any claim which states, suggests or implies that a food has particular beneficial nutritional properties due to the energy it provides, provides at a reduced or increased rate, does not provide or the nutrients or other substances it contains, contains in reduced or increased proportions or does not contain.

Other substance

A substance other than a nutrient that has a nutritional or physiological effect.

Scope

The products and type of addition the Regulation controls.

Standing Committee

European Commission’s Standing Committee on the Food Chain and Animal Health (SCoFCAH).

Transitional period

A period of time set by the Regulation, during which its requirements will not apply.

1. The Home Authority and Primary Authority schemes are described at section 8.2 and 8.3 ↩

2. Regulation 4 of the General Food Regulations creates offences for breaches of certain Articles in Regulation (EC) 178/2002, including Article 14(1) (food safety). ↩

3. Statutory Instrument 2007 No. 1631, The Addition of Vitamins and Minerals and Other Substances (England) Regulations 2007 (as amended); Statutory Instrument 2007 No. 325, The Addition of Vitamins and Minerals and Other Substances (Scotland) Regulations 2007 (as amended); Statutory Instrument 2007 No. 1984 (w.165), The Addition of Vitamins and Minerals and Other Substances (Wales) Regulations 2007 (as amended); Statutory Rules 2007 No.301, The Addition of Vitamins and Minerals and Other Substances (Northern Ireland) Regulations 2007 (as amended) ↩