Nutrition-related labelling, composition and standards from 1 January 2021

Guide

Last updated 5 January 2021

The following guidance applies only to Northern Ireland (NI). The full guidance, applicable to England, Scotland, Wales as well and NI, is available here.

The Protocol on Ireland/Northern Ireland means that European Union (EU) legislation relating to nutrition related labelling, composition, and standards (as detailed in Annex 2 to the Protocol) continues to be directly applicable in Northern Ireland after the end of the transition period.

Businesses should note, however, that under the Protocol, in Northern Ireland, the Food Standards Agency (FSA) is not able to submit:

Businesses seeking to submit any of the above applications 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 guidance below.

Nutrition and health claims


Background: nutrition and health claims within the European Union
Regulation (EC) No. 1924/2006 sets out the legal framework for businesses wanting to make nutrition and/or health claims on their products. This is to ensure that claims made about a product are accurate and consumers are not misled. Nutrition and health claims are required to be based on scientific evidence and may only be used in commercial communications if they have been authorised following scientific assessment of substantiating evidence.

The Community Register of nutrition and health claims made on foods, lists all authorised and rejected claims set out in EU legislation:

  • Permitted nutrition claims that may be made on foods as listed in the Annex to Regulation (EC) No. 1924/2006.
  • Authorised health claims that may be made on foods, other than those referring to the reduction of disease risk and to children's development and health as listed in the Annex to Commission Regulation (EU) No. 432/2012.
  • Permitted reduction of disease risk claims and claims referring to children's development and health as set out in various Commission Regulations.
  • Rejected health claims as set out in various Commission Regulations.

An application to use a claim that is not authorised and listed in the Commission Register for use in the EU, may be submitted via a Member State to the European Commission (EC) for consideration. The European Food Safety Authority's (EFSA) Panel on Nutrition, Novel Food, and Food Allergens (NDA) conducts the scientific assessment of applications for new claims. EFSA's scientific opinion is taken into consideration by the EC when deciding whether to authorise or reject an application.

Making a nutrition and health claim in the EU or Northern Ireland
From 1 January 2021, Great Britain will have a separate system for authorising nutrition and health claims for the GB market (England, Scotland and Wales).

Businesses wishing to make new nutrition and health claims in the EU or Northern Ireland market following the end of the transition period must continue to comply with the requirements of Regulation (EC) No. 1924/2006.

Food business operators wishing to submit applications for new claims in the EU or Northern Ireland from 1 January 2021 should refer to the extensive guidance on making nutrition and health claims in the European Union published by EFSA.

Vitamins, minerals and certain other substances


Background: addition of vitamins, minerals and certain other substances to food within the EU
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 is 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.

Modifying the community register on the addition of vitamins and minerals and of certain other substances to foods in the EU and Northern Ireland
From 1 January 2021, GB will have its own GB nutrition and health claims register, as well as GB register for adding vitamins and minerals to food.

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

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 should 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.

Foods for specific groups (FSG)


Background: requirements for FSG within the EU
Regulation (EU) No. 609/2013 sets out general compositional and information requirements of food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control ('foods for specific groups') provides for the making of EU tertiary legislation to set out specific requirements, and establishes a Union List of substances that may be added to these foods.

It is important to note that EU legislation relating to FSG is currently in a transitional phase. Until 20 July 2016, these foods were regulated as 'Foods for Particular Nutritional Uses' or PARNUTs, under Directive 2009/39. The Directive set out the general framework for foods for particular nutritional uses and empowered the EC to make specific Directives setting out requirements on composition and labelling.

Regulation (EU) No. 609/2013 repealed Directive 2009/39 and the concept of PARNUTs. The Regulation deals with four specific categories of foods:

  • infant and follow-on formulae
  • processed cereal-based foods and baby foods
  • food for special medical purposes
  • total diet replacement for weight control

Under Regulation (EU) No. 609/2013 the EC was empowered to adopt delegated acts with respect to specific compositional and information requirements for these categories of foods. Commission Regulations have now been made for each category except for processed cereal based foods and baby foods, however, only delegated regulations for foods for special medical purposes and infant and follow-on formula will be in force from 1 January 2021. The EU legislation for total diet replacement for weight control comes into force in 2022.

To allow food businesses time to adapt to the new regime from the old PARNUTs regime, a transitional period was introduced and the new specific rules do not yet fully apply. The date of application of the new rules is different for each category of foods. Anything that does not apply on 1 January 2021 will not become part of GB legislation, but will apply in NI from the date of application.

This means from 1 January 2021, FSG will be regulated by the framework contained in Regulation (EU) No 609/2013. Foods for special medical purposes, and infant and follow-on formula (except those manufactured from protein hydrolysates until 21 February 2021), will be entirely regulated under the new regime (Regulation (EU) No 609/2013, Delegated Regulation 2016/128, and Delegated Regulation 2016/127). Complementary foods and TDRs will continue to be regulated by the specific directives that were made under Directive 2009/39/EC.

Further to this Regulation (EU) No. 609/2013 includes an Annex which consolidates lists of substances that may be added to products included within the categorisation of FSG. This Annex is known as the Union List.

Modifying the Union List in the EU and Northern Ireland
From 1 January 2021, GB will have its own GB List and modification processes.

Food business operators wishing to add substances to FSGs in the EU or Northern Ireland following the end of the transition period must continue to comply with the requirements of Regulation (EU) No. 609/2013 and other applicable delegated regulations and Directives.

Food business operators who wish for additional substances to be considered for inclusion in the Union List, which applies to the EU and Northern Ireland, from 1 January 2021 should refer to the extensive guidance on the addition of substances for specific nutritional purposes, specifically administrative guidance on submissions for safety evaluation of substances added for specific nutritional purposes in the manufacture of foods.

Notification of foods for special medical purposes (FSMP) and infant and follow-on formula (IFFOF)
Food Standards Agency will remain the designated Competent Authority in Northern Ireland from 1 January 2021. This means that notification forms for FSMPs, along with a model of the label for the product, and any other information that may be reasonably requested to establish compliance with Regulation (EU) 2016/128 must be sent to: nutritionlegislation-ni@food.gov.uk

Notifications forms for infant formula and follow-on formula based on protein hydrolysates or containing other substances than those listed in Annex II of 2016/127, along with a model of the label for the product, and any other information that may be reasonably requested to establish compliance with Regulation (EU) 2016/127 must be sent to: nutritionlegislation-ni@food.gov.uk

Food supplements


Background: food supplements within the EU
Food supplements in Northern Ireland are currently regulated by Food Supplements Regulations (Northern Ireland) 2003.

These Regulations cross refer to the Annex of the Directive 2002/46/EC, which sets out rules for vitamins and minerals used in food supplements. The Directive contains a list of permitted vitamins and minerals in Annex I. The permitted forms of those vitamins and minerals is listed in Annex II.

The Directive contains a power for the EC to update the lists in the Annexes, to set purity criteria, and to set maximum and minimum amounts for vitamins and minerals that may be used in food supplements.

Modifying annex of the Directive 2002/46/EC in the EU and Northern Ireland
From 1 January 2021, GB will have its own list of vitamins and minerals for use in food supplements and modification processes.

Food business operators wishing to add vitamins and minerals to food supplements in the EU or Northern Ireland following the end of the transition period must continue to comply with the un-amended requirements of Annex of the Directive 2002/46/EC and/or Food Supplements Regulations (Northern Ireland) 2003.

Food business operators who wish for additional of vitamins and minerals and their sources to be included in the Annex of the Directive 2002/46/EC, which applies to the EU and Northern Ireland, from 1 January 2021 should refer to the extensive food supplements guidance on submissions for safety evaluation of substances added for specific nutritional purposes in the manufacture of foods.

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 the new guidance document on nutrition-related labelling, composition and standards from 1 January 2021, the above parts of which are relevant for Northern Ireland.

First published 23 November 2020