Q.01

What food supplement regulations apply in the UK and EU?

EU food supplements are governed by Directive 2002/46/EC, which sets the definition, the permitted vitamins and minerals and the labelling rules. Several horizontal EU regulations apply on top: General Food Law 178/2002, Food Information to Consumers 1169/2011, Nutrition and Health Claims 1924/2006, Fortified Foods 1925/2006 (for its prohibited and restricted substances), and Novel Foods 2015/2283. Great Britain kept the same structure. The Directive applies through national regulations (the Food Supplements Regulations 2003 for England, Wales and Scotland), the EU regulations continue as assimilated GB law, and the Food Safety Act 1990 sits underneath. Northern Ireland follows EU law under the Windsor Framework.

Approach: I read the current EU consolidated texts and, for GB, the Food Safety Act 1990, the GB Nutrition and Health Claims Register and the FSA CBD product list. The GB Food Supplements Regulations 2003 and the GB vitamin and mineral register are not in the datasets, so those points come from GOV.UK and FSA guidance pages I opened.

EU

Directive 2002/46/EC (consolidated text 02002L0046-20251126)

  • Scope: it covers food supplements "marketed as foodstuffs and presented as such", which "shall be delivered to the ultimate consumer only in a pre-packaged form". It does not apply to medicinal products under Directive 2001/83/EC [1].
  • Definition: a food supplement is a concentrated source of nutrients or other substances with a nutritional or physiological effect, sold in dose form (capsules, tablets, sachets, ampoules, drop bottles and similar). "Nutrients" means vitamins and minerals [2].
  • Composition (Art. 4): "Only vitamins and minerals listed in Annex I, in the forms listed in Annex II, may be used." Member States may keep existing national bans on vitamins and minerals, or forms, that are not listed [3].
    • Annex I lists 13 vitamins and 17 minerals, including copper, boron and silicon [4].
    • Annex II lists the permitted forms [5].
  • Maximum and minimum amounts (Art. 5): the Directive says these "shall be set" per recommended daily portion, based on upper safe levels and intake from other foods, and adopted by the Commission [6]. The consolidated text I read contains no numerical limits. The DHSC guidance (updated 2 November 2021) says "No levels have been set at European level" (GOV.UK).
  • Labelling (Arts. 6-9):
    • The product must be sold under the name "food supplement".
    • It must not be claimed to prevent, treat or cure disease.
    • The label must show: the categories of nutrients or substances; the recommended daily portion; a warning not to exceed it; a statement that supplements are not a substitute for a varied diet; and a "keep out of reach of young children" statement [7].
    • The label must not state or imply that a balanced and varied diet cannot provide enough nutrients [8].
    • Amounts must be given as numbers per daily portion, and vitamins and minerals also as a percentage of reference values [9]. Declared values are averages based on the manufacturer's analysis [10].
  • Notification (Art. 10): Member States "may require" notification of placing on the market, with a model of the label [11].
  • Market access and safeguards:
    • Member States shall not restrict trade in products that comply with the Directive (Art. 11) [12].
    • They may temporarily suspend a product on health grounds (Art. 12) [13].

Other EU rules that apply to supplements

InstrumentWhat it means for supplements
General Food Law 178/2002Food "shall not be placed on the market if it is unsafe" (Art. 14) [14]. Food business operators are responsible for compliance and must verify it (Art. 17) [15].
Food Information to Consumers 1169/2011The mandatory nutrition declaration section does not apply to supplements under Directive 2002/46/EC (Art. 29) [16]. For caffeine, supplements give the content per recommended daily portion (Annex III) [17].
Nutrition and Health Claims 1924/2006Applies "without prejudice to" Directive 2002/46/EC [18]. Health claims are prohibited unless authorised and listed under Art. 13 or 14. The label must carry a varied-diet statement, the quantity needed for the effect, and warnings where appropriate (Art. 10) [19].
Fortified Foods 1925/2006 (consolidated 02006R1925-20251126)Its vitamin and mineral provisions do not apply to food supplements (Art. 1(2)) [20]. Its Annex III procedure covers "other substances" added to foods in general (Art. 8) [21].
Novel Foods 2015/2283See below.

Fortified Foods Annex III in detail [22]:

  • Part A, prohibited: aloe-emodin, danthron, emodin, ephedra herb, Aloe leaf preparations containing hydroxyanthracene derivatives, and yohimbe bark.
  • Part B, restricted:
    • Green tea extracts: the daily portion must contain under 800 mg EGCG, with mandatory warnings.
    • Red yeast rice: each daily portion must provide under 3 mg monacolins, with mandatory warnings.
  • Part C, under scrutiny: green tea extracts, red yeast rice monacolins, and hydroxyanthracene-containing Rhamnus, Cassia senna and Rheum preparations.

Novel Foods 2015/2283 in detail

  • A novel food is one not consumed to a significant degree in the EU before 15 May 1997.
  • Supplement-specific categories:
    • vitamins and minerals made by a new production process, or containing engineered nanomaterials (Art. 3(2)(a)(ix));
    • a food used only in supplements before 1997 that is now intended for other foods (Art. 3(2)(a)(x)) [23].
  • Only novel foods authorised and on the Union list may be placed on the market (Art. 6) [24].

UK

Regulations by nation (GOV.UK food supplements page, last updated 2 July 2018):

NationSupplement-specific rulesLabelling rulesPolicy lead
EnglandFood Supplements (England) Regulations 2003Food Information Regulations 2014DHSC
WalesFood Supplements (Wales) Regulations 2003Food Information (Wales) Regulations 2014Welsh Government
ScotlandFood Supplements (Scotland) Regulations 2003Food Information (Scotland) Regulations 2014Food Standards Scotland
Northern IrelandFood Supplements Regulations (Northern Ireland) 2003, subject to the Windsor FrameworkFood Information Regulations (Northern Ireland) 2014Food Standards Agency

The same page says:

  • Labels must use the term "food supplement".
  • Sellers must "register as a Food Business Operator (FBO) with your local authority".

Rules since EU exit (DHSC guidance notes, updated 2 November 2021, GOV.UK):

  • EU nutrition regulations were retained in GB law under the European Union (Withdrawal) Act 2018.
  • The GB lists of permitted vitamins and minerals, and of their permitted forms, are Schedules 1 and 2 to the Nutrition (Amendment etc.) (EU Exit) Regulations 2019.
  • In Northern Ireland, EU nutrition law "continues to be directly applicable".
  • There are no statutory maximum levels. Advisory guidance follows the Expert Group on Vitamins and Minerals report.
  • A product presented for treating or preventing disease, or that restores, corrects or modifies physiological function, is a medicinal product. The MHRA decides borderline cases.

Other GB sources

  • GB register on adding vitamins and minerals to foods (DHSC, applies to England, Scotland and Wales, updated 12 January 2021): it includes the "certain other substances that are prohibited or restricted for use in foods", the GB counterpart of the EU Annex III.
  • Food Safety Act 1990:
    • Offences for selling food not of the nature, substance or quality demanded (s. 14) [25].
    • Offences for labels, advertisements or presentation that falsely describe food or are likely to mislead (s. 15) [26].
    • The power to make regulations on composition and labelling (s. 16), which may amend Regulation 1169/2011 [27].
  • Health claims: the DHSC GB Nutrition and Health Claims Register has its own GB status, "Authorised for use in Great Britain". For example, "Vitamin D has a role in the process of cell division" is an Art. 13(1) claim under Regulation 432/2012, and the food must be at least a "source of" vitamin D [28].
  • Novel foods:
    • Novel foods placed on the GB market must be authorised under assimilated Regulation (EU) 2015/2283 and appear on the FSA's authorised products register.
    • Novel foods in Northern Ireland must go through the EU authorisation process.
    • Source: FSA guidance Placing innovative foods on the market in Great Britain, 12 March 2026.
    • I couldn't open the FSA novel foods guidance page itself (food.gov.uk).
  • CBD:
    • The FSA list for England and Wales tracks each CBD product linked to a novel food application as Validated, Removed or Awaiting evidence. Being on the list is not an authorisation [29][30][31].
    • The FSA's CBD guidance applies to England and Wales only and was updated 28 August 2026.

Main EU vs GB differences:

  • GB uses its own lists and registers (permitted vitamins and minerals, health claims, novel foods), authorised by GB ministers. They are no longer the EU Union lists.
  • Northern Ireland stays aligned with EU law.
  • Neither regime has statutory EU or GB-wide maximum levels for vitamins and minerals.

I can also pull national maximum levels for particular EU countries (France, Italy and Luxembourg are in the datasets) or check whether a specific ingredient or claim is permitted in each market.

Q.02

What must food supplement labels say?

A food supplement label in the EU must carry the name "food supplement" plus five fixed particulars under Article 6(3) of Directive 2002/46/EC: the nutrient or substance categories, the recommended daily portion, a "do not exceed" warning, a varied-diet statement and a "keep out of reach of young children" statement. Nutrient amounts go on as numbers per daily portion. The general food labelling particulars of Regulation (EU) 1169/2011 (FIC) also apply, except the nutrition declaration. Great Britain applies the same particulars through regulation 6 of the Food Supplements Regulations 2003, and Northern Ireland applies the EU Directive directly.

Approach: I read the current EU consolidated texts of Directive 2002/46/EC, FIC 1169/2011, Claims Regulation 1924/2006 and Fortified Foods Regulation 1925/2006. The GB Food Supplements Regulations 2003 are not in the datasets and legislation.gov.uk would not open, so the GB points come from the DHSC guidance notes on GOV.UK.

EU: supplement-specific wording (Directive 2002/46/EC)

  • Name (Art. 6(1)): products "shall be" sold under the name "food supplement" [7].
  • Mandatory particulars (Art. 6(3)): the labelling "shall bear" [7]:
    • (a) the names of the categories of nutrients or substances that characterise the product, or an indication of their nature;
    • (b) the portion recommended for daily consumption;
    • (c) a warning not to exceed the stated recommended daily dose;
    • (d) a statement that food supplements should not be used as a substitute for a varied diet;
    • (e) a statement that the product should be stored out of the reach of young children.
  • Amounts (Art. 8):
    • Nutrients and other substances "shall be declared" in numerical form, using the Annex I units for vitamins and minerals.
    • Amounts are given per recommended daily portion.
    • Vitamins and minerals are also given as a percentage of the reference values [9]. The reference values (NRVs) for adults are in FIC Annex XIII, for example vitamin D 5 µg and iron 14 mg [32].
  • Declared values (Art. 9): these are averages based on the manufacturer's analysis. The percentage of reference values "may also be given in graphical form" [10].
  • What the label must not say:
    • It "must not" claim that the product prevents, treats or cures a human disease (Art. 6(2)) [7].
    • It "shall not" state or imply that a balanced and varied diet cannot provide enough nutrients (Art. 7) [8].
  • Label notification (Art. 10): Member States "may require" the manufacturer or the person placing the product on the market to send them a model of the label [11].

EU: general particulars from FIC 1169/2011

  • Mandatory list (Art. 9(1)) [33]:
    • name of the food;
    • list of ingredients;
    • Annex II allergens;
    • quantity of certain ingredients;
    • net quantity;
    • date of minimum durability or "use by" date;
    • any special storage conditions or conditions of use;
    • name and address of the responsible food business operator;
    • country of origin where Art. 26 requires it;
    • instructions for use where needed.
  • Nutrition declaration: the FIC nutrition declaration section "shall not apply" to foods under Directive 2002/46/EC (Art. 29) [16]. The Directive's Art. 8 declaration replaces it.
  • Allergens (Art. 21): allergens are emphasised in the ingredients list, for example by font, style or background colour. Where there is no ingredients list, the label uses "contains" followed by the allergen [34].
  • Legibility (Art. 13):
    • Particulars must be in a conspicuous place and must not be hidden or interrupted.
    • Minimum x-height is 1.2 mm, or 0.9 mm where the largest surface is under 80 cm².
    • The name and net quantity must be in the same field of vision [35].
    • Where the largest surface is under 10 cm², only the name, allergens, net quantity and date are mandatory on the pack (Art. 16(2)) [36].
  • Language (Art. 15): a language easily understood where the product is marketed. Member States may require particular official languages [37].
  • Fair information (Art. 7): food information must not mislead and must not attribute disease prevention, treatment or cure to the product [38].
  • Who is responsible (Art. 8): the operator under whose name the product is marketed, or the EU importer if that operator is not established in the Union [39].

EU: extra wording that depends on the product

TriggerRequired label text
Caffeine added for a physiological purpose (FIC Annex III 4.2)"Contains caffeine. Not recommended for children or pregnant women", in the same field of vision as the name. For supplements, caffeine content is given per recommended daily portion [17]
Sweeteners or aspartame; more than 10% added polyols (FIC Annex III 2)"with sweetener(s)"; "contains a source of phenylalanine" or "contains aspartame (a source of phenylalanine)"; "excessive consumption may produce laxative effects" [40]
Added plant sterols or stanols (FIC Annex III 5)"with added plant sterols/stanols", plus warnings including "consumption of more than 3 g/day … should be avoided" [17]
Green tea extracts with EGCG (Reg. 1925/2006 Annex III Part B)Maximum daily portions; a warning against 800 mg EGCG a day or more; EGCG per portion; and three warnings: other green tea products on the same day, pregnant or lactating women and under-18s, and an empty stomach [22]
Red yeast rice monacolins (same Annex)Maximum daily portions; a warning against 3 mg monacolins a day or more; content per portion; and four warnings: pregnant or lactating women, under-18s and over-70s; seek a doctor's advice; cholesterol-lowering medication; other red yeast rice products [22]
Any health claim (Reg. 1924/2006 Art. 10(2))The claim must be authorised. The label must add: a statement on the importance of a varied and balanced diet and a healthy lifestyle; the quantity and pattern of consumption needed for the effect; where appropriate, who should avoid the product; and a warning where excess intake is a risk [19]

Great Britain and Northern Ireland

The DHSC guidance notes (updated 2 November 2021, GOV.UK) say:

  • Name: "the term 'food supplement' must appear on the label". It may be qualified, for example "containing vitamins and minerals".
  • Mandatory particulars (regulation 6): the same five as EU Art. 6(3): category names, recommended daily portion, a "do not exceed" warning, the varied-diet statement and the "out of the reach of young children" statement.
  • Amounts: regulation 6(2)(f) requires the amount of each vitamin, mineral or other substance to be stated, adding up all sources. Units follow Annex I of the Directive, and amounts may also be given as a percentage of the RDA.
  • Prohibited wording: no mention, express or implied, that a balanced and varied diet cannot provide enough nutrients.
  • Presentation (regulation 7): information must be "easy to understand, clearly legible and indelible" and must not be hidden or interrupted.
  • Notification: the UK "has taken the decision not to request prior notification".
  • Northern Ireland: EU law "continues to be directly applicable", so the Directive's wording applies as written.

General labelling in GB comes from the Food Information Regulations 2014 and the equivalent Welsh and Scottish regulations (GOV.UK, last updated 2 July 2018). In GB, health claims must be on the GB Nutrition and Health Claims Register rather than the EU lists, as covered in the previous answer.

I couldn't open the current revised text of the Food Supplements (England) Regulations 2003 on legislation.gov.uk, so the GB wording above is from DHSC's guidance, not the statutory text.

Q.03