The impact of Brexit on food supplements and specialized food products – Regulatory Focus

| 27 July 2022 | By Sam Jennings, BSc, FIFST | 3499 This article examines the impact of diverging regulations and practices for food supplements and specialized food products since the UK left the EU market in 2020.Keywords Brexit, divergence, food supplements, UK, Northern IrelandBackground and introductionOn 23 June 2016, the UK, comprising England, Northern Ireland, Scotland, and Wales, held a referendum on whether the UK should remain in the EU or leave. Based on an overall majority of 51.9% on a turnout of 72.2%,1 the UK government decided to leave the EU (Table 1). This move became known as Brexit, a term derived from Britains exit (England, Scotland, and Wales, form Great Britain).After almost 5 years of discussion and negotiation between the UK and the EU, the UK officially left the EU on 31 January 2020, with a subsequent 11-month transition period ending on 31 December 2020. The UK had to implement all EU legislation published during those transitional 11 months but had no input into its preparation.Part of the negotiations with the EU focused on resolving the issue of Northern Irelands border with the Republic of Ireland, which would remain an EU member state. Neither country wanted to create a hard border between them and risk a recurrence of the decades-long conflict in Northern Ireland, known as "the Troubles and which had ended with the Good Friday agreement in 1998.2 To prevent a recurrence of the conflict, the UK and EU signed the Northern Ireland Protocol,3 which situated a border running roughly north-south through the Irish Sea, between Northern Ireland and GB, rather than having a hard border between the two countries.At the time of writing, in terms of most laws, including those relating to food, Northern Ireland has to continue to follow EU rules, but with no say in their production, whereas GB can follow its own rules. This means that businesses in GB that want to market their goods across the whole of the UK must comply with EU rules for the products that are shipped to Northern Ireland. Similarly, businesses from countries outside of the UK and EU that want to market their goods in the UK, must check their products compliance across two sets of rules, those for GB and those for the EU.When the transition period ended the EU legislation that had applied since 31 December 2020 was kept in GB and is referred to as retained EU law. This retained EU law continues to apply in GB, but future amendments can be made to it under UK rules. Although any such amendments apply only in GB, Northern Ireland has a voice in what the amendments will be. To add to the complications, food safety and standards are devolved matters in the UK, which means that each of its 4 member nations sets its own laws in these areas. The member nations have agreed upon the UK Common Frameworks4 to limit the potential for divergence within GB. However, the frameworks are nonlegislative arrangements for co-operation between the nations, so future internal divergence cannot be completely ruled out. Any EU laws that came into effect before 31 December 2020, but which applied from 1 January 2021 or later, do not apply in GB. Similarly, any amendments to EU legislation that have been made since 1 January 2021 do not apply in GB. However, all these laws apply in Northern Ireland.The immediate impact of BrexitThe effects of Brexit were felt by food businesses based in GB from day one, 1 January 2021, when foods that were to be exported to the EU, or moved to Northern Ireland, had to demonstrate compliance with all of the EUs sanitary and phytosanitary (SPS) controls5 and the label of the food product had to include a food business address based in Northern Ireland or one of the EUs 27 member states.Although the UK had been following all the SPS rules and moving their goods to the EU with no barriers until 31 December 2020, the EU border controls implemented full physical checks on all applicable consignments from GB from 1 January 2021. In terms of food (dietary) supplements and specialized food products, every product that contained an ingredient of animal origin that is, for which an ingredient, or the starting material for the ingredient, was originally sourced from an animal was affected. This had a direct impact on products containing ingredients such as milk powders, collagen, fish oils, or glucosamine, for example. The exporters of those products had to obtain a health certificate for the products being shipped and pre-notify the consignment to the border control post, where the consignment was stopped and checked at the EU border. The same system of health certification, prenotification, and checks at the border occurred for products shipped from GB to Northern Ireland. In the early days of 2021, there were numerous problems with certification; border rejections occurred regularly, owing to documentary errors; and the supply of some goods to Northern Ireland as well as to the EU was affected.6,7GB did not implement reciprocal border controls on goods entering from the EU after the transition period ended. Various dates were given, and subsequent postponements made, for GB border controls on EU goods during the nearly 16 months following Brexit, then, on 28 April 2022, the UK government announced8 that the entire system for GB border controls for all imports (EU and non-EU) would be revised. A target operating model is to be published in the fall of 2022, setting out the intended new regime of border import controls. The end of 2023 currently targeted as the revised introduction date for the new controls. Thus, at the time of writing, more than 18 months on from the UK leaving the EU, food products continue to enter GB from the EU with no barriers at the border.Regarding the food business address, within the UK and EU, the label of a food product must carry the address of the food business or importer who takes full responsibility for placing the product on the market. It has to be a physical address to which mail can be delivered. To market a food product in GB, the address can be based in any of the four UK member nations. However, as already noted, to market a food product in Northern Ireland, the address must be based in Northern Ireland or an EU member state. The UK put in place a transition period for the business address on food labels for products in GB, which comes to an end on 30 September 2022. Until that date, food products can be marketed with just an EU address on the label, but from 1 October 2022, food labels must also include a UK business address.9 However, the requirement for a Northern Ireland or EU member state address on the label for foods entering Northern Ireland or the EU from GB applied from 1 January 2021.Global impact of Brexit The impact of Brexit is also being felt globally as international businesses realize the rules for the UK and EU are no longer the same. There is divergence across a number of laws affecting food supplements and specialized food products, including the composition and labelling of those products and differences in the import requirements.One of the areas of divergence is in novel foods. Legislation on novel foods has been in force in the UK and EU for more than 25 years and requires that food ingredients entering the market after May 1997 must have official approval before they can be sold. The novel food Regulation (EU) 2015/228310 covers all products marketed under food law and differs from those in many countries outside the UK and EU, whereas Regulation (EU) 2017/247011 established the list of novel foods. At the time of writing, there had been 32 amendments to Regulation (EU) 2017/2470 since 1 January 2021, authorizing new novel foods, extending the permitted use of previously authorized foods, or revising other aspects relating to previously authorized foods (e.g., labelling requirements, specifications, etc.). During that time, the UK has made just one revision to the retained list,12 modifying one previously authorized novel food and adding four new novel foods to the list. Novel foods that have been authorized by the EU since 1 January 2021 can be included in foods intended for the EU market or for the Northern Ireland market. They cannot be used as ingredients in foods intended for the GB market until such time as authorization occurs also for GB. Thus, when marketing food supplements or specialized food products in the UK and EU, food businesses must ensure the ingredients they select are permitted in both regions and are used and labelled appropriately for the intended markets.Another area of divergence, which currently has most impact on food supplements, but where the impact is likely to extend into specialized food products, is that relating to the restriction or prohibition of certain nonmicronutrient ingredients used for nutritional or physiological purposes and known as other substances. These substances are controlled under Article 8 of Regulation (EC) 1925/200613 on the addition of vitamins and minerals and of certain other substances to foods, known as the fortified foods regulation. Most of this regulation does not apply to food supplements, but the controls on other substances apply to all foods including food supplements. Article 8 provides a procedure by which EU member states can submit to the European Commission for any substance for which there are safety concerns, supported by accompanying data demonstrating such concerns. Before Brexit, two substances, Ephedra species and Yohimbe (Pausinystalia yohimbe), had been prohibited for use in foods under the Article 8 procedure, and those prohibitions applied in GB, Northern Ireland, and the EU. However, since 1 January 2021, the EU has implemented prohibitions on the presence of hydroxyanthracene derivatives (HAD) in aloe preparations, and restrictions on the use of monacolins from red yeast rice. These prohibitions and restrictions apply in Northern Ireland and the EU, but not in GB. A number of other substances are currently going through the Article 8 process in the EU, with restrictions anticipated later in 2022 on the use of green tea catechins in foods. Meanwhile, GB is undertaking its own risk analyses of HAD, monacolins and green tea catechins, and the outcomes of these risk analyses will be seen in due course.Remaining with active ingredients, divergence has already occurred in relation to the vitamin and mineral sources that may be used in food supplements and in those permitted for use in certain specialized food products.Within the UK and EU, there are lists of vitamins and minerals that are allowed to be incorporated in food supplements and of the approved sources for those vitamins and minerals.14,15 If a vitamin or mineral is not on the list, it cannot be included in a food supplement (e.g., vanadium). In addition, if the source of a vitamin or mineral is not on the permitted list, it cannot be used. The EU has added two new sources to its permitted list since the UKs departure (nicotinamide riboside chloride and magnesium citrate malate),16 although they are yet to be added to the GB permitted list. Thus, food supplements containing these sources can be marketed in the EU and in Northern Ireland, but not currently in GB.There are similar lists of permitted vitamins, minerals, and their sources for general foods other than food supplements,17 but, at the time of writing, divergence had not yet occurred in those lists. However, certain specialized food products (i.e., food for infants and young children, for special medical purposes, and total diet replacement for weight control) have their own list of permitted vitamins and minerals, with their permitted sources.18 Divergence has occurred in the latter list regarding the permitted foods in which calcium-L-methylfolate can be used, with the EU extending its use to include infant and follow-on formula, baby food, and processed cereal-based food.19 This extension of use applies also in Northern Ireland, but within GB, this folate source can be used only in food for special medical purposes and for total diet replacement for weight control.Foods for infants and young children are not the only specialized food products for which Brexit has had a direct impact on the composition. When considering food products that replace the total diet for weight control, Delegated Regulation (EU) 2017/1798 implements some compositional changes and is due to apply in the EU and, thus, in Northern Ireland, from 27 October 2022. It will not, however, apply in GB. That said, because the UK government was fully involved and committed to the introduction of these changes while the UK was a member of the EU, the intention is to make legislation across GB that will mirror this delegated regulation as closely as possible. At the time of writing, it was not clear whether this GB legislation would be published by 27 October 2022.Increasing divergence is being seen in other compositional areas, with perhaps the highest profile being the recent EU ban on the use of the technological food additive E 171 titanium dioxide in foods.20 The transition period for implementation of the ban ends on 7 August 2022, after which no new food products containing titanium dioxide can be placed on the market in the EU or in Northern Ireland. However, the UK scientific committees did not agree with the European Food Safety Authoritys (EFSAs) conclusions about the risk titanium dioxide poses to consumers,21 and the UK is undertaking its own risk assessment of this food additive. The outcome of this assessment is expected in the first quarter of 2023. Meanwhile, foods containing titanium dioxide can continue to be placed on the GB market. There have been other revisions made by the EU to Regulation (EC) No 1333/200822 on food additives and to Commission Regulation (EU) No 231/2012,23 which presents specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008. At the time of writing, no revisions had been made to the retained versions of these regulations for GB.Divergence is also being seen in regard to: authorizations of genetically modified organisms (GMOs) or substances produced from GMOs;24,25 permitted flavoring substances for use in foods;26 the chemical contaminants for which controls are laid down and the maximum permitted levels for those contaminants in foods being placed on the market;27 and in the maximum residue levels for pesticides in food.28 Since the UK left the EU, numerous revisions have been made in all these areas by the EU, which apply also to Northern Ireland, but similar extensive revisions have not been occurring in relation to GB.Another area of compositional divergence that will be seen in coming months and years is the control of enzymes used for technological purposes in foods. Such enzymes are controlled by Regulation (EC) No. 1332/2008,29 but there is currently no list of authorized food enzymes. Applications for the EU list of enzymes are in the process of undergoing risk assessment by EFSA, whereas the European Commission has published an interim EU Public Registerof all food enzymes for which a valid application has been submitted.30 This register applies also in Northern Ireland. Meanwhile, the UK authorities have yet to issue a call for applications for a GB list, thus it is expected that the EU list of authorized food enzymes will be published long before that for GB. Once the EU list is in place, only food enzymes on that list will be permitted to be used for technological purposes for foods intended for the EU and Northern Ireland markets.In addition to compositional divergence, some of which has already been addressed in this article, divergence is starting to occur in the areas of food labelling and claims, affecting food supplements and specialized food products.The units that must be used for declaring the amounts of vitamins and minerals in food supplements are laid down in law.31,15 These are very similar to those for other foods, but one point of difference has been for copper, for which the designated unit was micrograms for food supplements, but milligrams for all other foods. After Brexit, the EU revised the legislation relating to food supplements, changing the unit for declaring copper to milligrams, so it is in line with all other foods.32 The UK has undertaken a limited technical consultation on changing the unit for copper, but the proposed legislation for implementing this change has yet to be published for public consultation. Thus, food supplements containing copper that are marketed across GB, Northern Ireland, and the EU currently require dual labelling, with the quantity declared as both micrograms and milligrams.In the health claims arena, the EU authorized a health claim for carbohydrate solutions in April 2021, stating, Carbohydrate solutions contribute to the improvement of physical performance during a high-intensity and long-lasting physical exercise in trained adults.33 This claim can be used on carbohydrate solutions that comply with the relevant conditions and restrictions of use and are marketed in the EU and in Northern Ireland. However, it cannot be used on such products in GB. To be used within GB, an application for the claim would have to be submitted to the UK authorities for assessment by the UK Nutrition and Health Claims Committee.34 If the application receives a positive opinion from the committee, it will then be discussed and agreed to by the four UK nations, then published as an official statutory instrument. At the time of writing, the original submitter of this health claim has not applied for its use within GB.Both the EU and the UK are looking at various issues that could affect the labelling of food supplements and/or certain specialized food products in the future. These include topics such as front-of-pack labelling, sustainability (eco) labelling, and precautionary allergen labelling. If any eventual proposals become mandatory, as opposed to voluntary, in either region, it will become increasingly difficult to have the same label on a product that is marketed across the whole of the UK and in the Republic of Ireland, even if the areas of compositional divergence can be resolved.ConclusionThe success of Brexit is currently open ended. There are numerous complexities associated with Brexit and its impact in some areas is only just becoming known. It is clear that divergence began on day one of Brexit and is increasing rapidly.Acronymns and abbreviationsGMOs, genetically modified organisms; HAD, hydroxyanthracene derivatives; SPS, sanitary and phytosanitary.

About the authorSam Jennings, BSc, FIFST, has worked at Berry Ottaway & Associates Ltd for more than 20 years. She provides advice to industry and governments globally on scientific, technical, and regulatory aspects of food, particularly supplements, specialized foods, and their ingredients. Jennings is a Fellow of the Institute of Food Science & Technology in the UK. She is chair of the UK governments Office for Product Safety & Standards Business Expert (Food Standards & Labelling) Group, and has been advising the Council for Responsible Nutrition UK on technical and regulatory matters for more than 15 years. Jennings can be reached at spj@berryottaway.co.ukDisclaimer This article reflects the personal opinion and experience of the author. It should not be construed as an official position by any organization with which the author is affiliated.Citation Jennings S. The impact of Brexit on food supplements and specialized food products. Regulatory Focus. Published online xx July 2022.ReferencesAll references were accessed and/or verified on xx July 2022.

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The impact of Brexit on food supplements and specialized food products - Regulatory Focus