A food supplement that contains even one of six colours, tartrazine (E 102), quinoline yellow (E 104), sunset yellow FCF (E 110), azorubine/carmoisine (E 122), ponceau 4R (E 124) or allura red AC (E 129), must carry additional information on its label: the name or E number of the colour followed by the sentence “may have an adverse effect on activity and attention in children”. That is the rule in Article 24 read with Annex V of Regulation (EC) No 1333/2008, applicable since 20 July 2010. The duty has no quantitative threshold and does not depend on whether the product targets children. The two exceptions in the Annex (marking of meat and eggshells, and beverages above 1.2% alcohol) do not cover supplements.
The warning is one layer. The second layer is the use levels in food category 17 of Annex II. In solid supplements (17.1), E 104 and E 124 may reach at most 35 mg/kg, or 10 mg/kg in chewable form. E 110 is limited to 10 mg/kg. All Group III colours together with E 104, E 110 and E 124 must not exceed 300 mg/kg. In liquid supplements (17.2), E 104, E 110 and E 124 are each limited to 10 mg/kg and the combined Group III limit is 100 mg/kg. A product can therefore carry a correct warning and still be non-compliant, or stay within the limits and lack the required information.
1. What Article 24 and Annex V require
Article 24(1) of Regulation 1333/2008 states that the labelling of food containing the food colours listed in Annex V shall include the additional information set out in that Annex. Annex V has a single “Information” column for all six colours. Its official English wording is: ‘name or E number of the colour(s)’: may have an adverse effect on activity and attention in children.
The part in quotation marks is a placeholder, not text to be copied. The label shows the actual name or number, for example “E 129: may have an adverse effect on activity and attention in children” or “Allura red AC: may have…”. Where several listed colours are present, the provision uses the plural (“colour(s)”), so a single sentence may name all of them, e.g. “E 110, E 129: may have…”.
| Colour (name in the English version of the Regulation) | E number | Group in Annex II Part B | Individual limit in category 17 |
|---|---|---|---|
| Tartrazine | E 102 | Group III | none, only the combined Group III limit |
| Quinoline yellow | E 104 | outside the groups, counted in the Group III total (footnote 61) | 17.1: 35 mg/kg, chewable form 10 mg/kg; 17.2: 10 mg/kg |
| Sunset yellow FCF/Orange yellow S | E 110 | outside the groups, counted in the Group III total (footnote 61) | 17.1: 10 mg/kg; 17.2: 10 mg/kg |
| Azorubine, carmoisine | E 122 | Group III | none, only the combined Group III limit |
| Ponceau 4R, cochineal red A | E 124 | outside the groups, counted in the Group III total (footnote 61) | 17.1: 35 mg/kg, chewable form 10 mg/kg; 17.2: 10 mg/kg |
| Allura red AC | E 129 | Group III | none, only the combined Group III limit |
The exceptions sit in a footnote to Annex V, added by Commission Regulation (EU) No 238/2010. They cover foods where the colour was used for health or other marking on meat products or for stamping or decorative colouring of eggshells, and beverages containing more than 1.2% alcohol by volume. None of these situations applies to a capsule, tablet, gummy or liquid supplement.
2. “Azo dyes” is the wrong shorthand
In industry, Annex V is often called “the azo dye list”. That is inaccurate in both directions. Quinoline yellow (E 104) is not an azo dye, yet it is on the list. Conversely, other azo colours permitted in category 17 through Group III, such as brilliant black PN (E 151) or brown HT (E 155), are not on the list. The list is closed and names the six colours tested in the so-called Southampton study (section 7). The E number decides, not the chemical structure.
Likewise, carminic acid and carmine (E 120) belong to Group III but need no warning. Group II colours used in solid supplements at quantum satis, such as anthocyanins (E 163), carotenes (E 160a) or beetroot red (E 162), are also outside Annex V. Titanium dioxide (E 171) is no longer authorised; see our article on E 171 in supplement capsules.
3. Limits in category 17: individual and combined
Category 17 of Annex II Part E splits supplements into solid (17.1) and liquid (17.2). Both subcategories exclude food supplements for infants and young children, so these entries are no basis for colouring such products. The introductory part of category 17 states that the maximum levels for colours refer to the food supplement ready for consumption, prepared following the manufacturer’s instructions. For products to be dissolved or diluted, the dilution factor must be communicated together with the instructions for use.
| Item | 17.1 solid supplements | 17.2 liquid supplements |
|---|---|---|
| Group III (incl. E 102, E 122, E 129) combined | 300 mg/kg | 100 mg/kg |
| E 104 | 35 mg/kg; chewable form 10 mg/kg | 10 mg/kg |
| E 110 | 10 mg/kg | 10 mg/kg |
| E 124 | 35 mg/kg; chewable form 10 mg/kg | 10 mg/kg |
| Footnote 61 | The total quantity of E 104, E 110, E 124 and the Group III colours shall not exceed the maximum listed for Group III. | |
| Footnote 69 | Aluminium from all aluminium lakes: at most 150 mg/kg. | |
Footnote 61 is the most frequent source of error. Each colour can be within its own limit while the sum still exceeds the combined one. The examples below are hypothetical and do not concern specific products.
| Product (hypothetical) | Colours in mg/kg of product ready for consumption | Assessment |
|---|---|---|
| Gummies (17.1, chewable form) | E 129: 120; E 110: 8; E 124: 9 | Compliant. E 110 ≤ 10, E 124 ≤ 10 (chewable), sum 137 ≤ 300. Warning required for E 110, E 124 and E 129. |
| Chewable tablet (17.1) | E 104: 30 | Non-compliant. In chewable form the E 104 limit is 10 mg/kg. The same amount in a tablet to be swallowed would be permitted (35). |
| Syrup (17.2) | E 129: 95; E 110: 10 | Non-compliant. Each colour is within its own limit, but the sum of 105 exceeds 100 mg/kg (footnote 61). |
Converting to a portion helps when talking to formulators. A 2.5 g gummy at 120 mg/kg E 129 contains 0.3 mg of the colour. The limit, however, is expressed in mg/kg of product, not per portion, so compliance is assessed for the whole mass of the product ready for consumption.
4. Where and how to place the warning
Article 24(2) refers to Article 13(2) of Directive 2000/13/EC. The Directive has been repealed, and Article 53(2) of Regulation 1169/2011 requires references to it to be construed as references to Regulation 1169/2011. The counterpart of former Article 13(2) is Article 13(1) of Regulation 1169/2011. The information must be marked in a conspicuous place so that it is easily visible, clearly legible and, where appropriate, indelible. It must not be hidden, obscured, detracted from or interrupted by other written or pictorial matter.
The minimum x-height (1.2 mm, or 0.9 mm on packaging whose largest surface is under 80 cm²) in Article 13(2) and (3) formally covers the particulars of Article 9(1). The Annex V warning stems from a different act, but printing it in at least the same font size is the safe practice. An inspector will assess legibility under Article 13(1), and a font smaller than the rest of the mandatory particulars easily becomes an objection.
The warning does not replace the list of ingredients. In the list, the colour must be designated by the category name followed by its specific name or E number (Annex VII Part C of Regulation 1169/2011), e.g. “colour: allura red AC” or “colour: E 129”. The warning is an additional, separate particular. We described a similar construction, additional information next to the ingredients list, for the caffeine warning in Annex III.
The Regulation gives the wording in every official language. For a given market, the wording of that language version of Annex V is used. Paraphrases such as “not recommended for children” or “may affect behaviour” do not meet the obligation, because the Annex sets the content of the information.
5. Online shops: the warning before purchase
Article 2(2)(c) of Regulation 1169/2011 defines mandatory food information as the particulars that Union provisions require to be provided to the final consumer. The Annex V warning fits that definition. For prepacked food sold by distance communication, Article 14(1)(a) requires mandatory food information (except the date of minimum durability) to be available before the purchase is concluded, on the shop page or through other clearly identified means, at no extra cost. Point (b) requires all mandatory particulars at the moment of delivery.
In practice, a label photo on which the sentence cannot be read is weak evidence of compliance. It is better to repeat the warning as text on the product page, next to the ingredients list.
6. Shells, coatings and carry-over: when a colour is “in” the supplement
A colour in a hard-capsule shell, a tablet coating or a dragée is an ingredient of the finished supplement. The category 17 limit refers to the whole product ready for consumption, and Annex V refers to the food that contains the colour. The fact that only the shell is coloured does not remove the warning. When buying ready-made capsules, you need the exact colour composition of the shell, not just its shade.
Carry-over is harder. Article 20(b)(i) of Regulation 1169/2011 exempts from the ingredients list an additive present solely because it was contained in an ingredient, in line with the carry-over principle of Article 18(1)(a) and (b) of Regulation 1333/2008, provided it serves no technological function in the final product. That exemption covers only the ingredients list. Article 24 and Annex V do not repeat it, and they have no quantitative threshold. The cautious reading is that an Annex V colour present through carry-over still triggers the warning. We are not aware of a CJEU judgment or Commission guidance resolving this differently. The simplest route is a supplier specification that excludes the six Annex V colours from raw materials.
7. The science behind the warning: Southampton, EFSA and ADIs
The list of six colours comes from the study by McCann et al. published in The Lancet in 2007 (370:1560–1567). It was a randomised, double-blind, placebo-controlled crossover trial in 153 three-year-olds and 144 eight-to-nine-year-olds from the general population. The children drank a beverage with sodium benzoate and one of two colour mixes. The authors reported a small increase in a hyperactivity score, with results differing between mixes and age groups.
EFSA’s AFC Panel assessed the study in 2008. It found limited evidence of a small effect of the mixtures on the activity and attention of some children. The effects were inconsistent, it was impossible to identify which additive caused them, and their clinical significance was unclear. The results therefore could not be a basis for altering the ADIs. In its re-evaluations of November 2009, the ANS Panel lowered the ADIs for E 104 (to 0.5 mg/kg bw/day), E 124 (to 0.7 mg/kg bw/day) and, temporarily, E 110 (to 1 mg/kg bw/day), but for reasons other than the Southampton study, based on animal toxicology studies. In 2014 EFSA set an ADI of 4 mg/kg bw/day for E 110. The ADIs for E 102, E 122 and E 129 remained unchanged.
The takeaway for operators: the Annex V warning is not an EFSA finding of causation. It is a risk-management decision by the Union legislator, written into Regulation 1333/2008 itself. The argument “EFSA did not confirm harm” therefore does not remove the warning, and compliance with the limits does not replace the label information.
8. What the rules do not decide
- There is no quantitative threshold below which the warning becomes unnecessary. An analysis showing a trace of the colour gives no basis for omitting the information.
- The Regulation does not specify where on the pack the warning goes (front or back). It requires visibility and legibility. The safest place is the same field as the ingredients list.
- The Regulation does not provide for voluntarily “neutralising” the information. A note such as “safe for children” next to the warning would be assessed against Article 7 of Regulation 1169/2011 as potentially misleading.
- A statement “no artificial colours” is voluntary information. It is subject to Articles 7 and 36 of Regulation 1169/2011. It is not covered by Annex V and does not follow from it.
9. Typical operator mistakes
- The template “‘name or E number of the colour(s)’: may have…” copied literally, without naming the actual colour.
- A warning only on products “for children”, although the duty covers every food containing a listed colour.
- Ignoring a colour in the capsule shell or tablet coating because “it is not in the fill formula”.
- Checking only the individual limits for E 104, E 110 and E 124 without adding Group III (footnote 61).
- Applying the 35 mg/kg limit for E 104 or E 124 to gummies and chewable tablets instead of 10 mg/kg.
- Treating the list as “all azo dyes”: a warning for E 151 and none for E 104.
- A warning visible only in a label photo in the online shop, illegible before purchase.
10. Checklist: Annex V colours in a food supplement
- Colour inventory: obtain from suppliers the full colour composition of the fill, shell, coating and coloured raw materials, with E numbers.
- Compare with Annex V: check whether any of E 102, E 104, E 110, E 122, E 124, E 129 is present, regardless of quantity.
- Classify the category: establish whether the product is 17.1 (solid) or 17.2 (liquid) and whether it is in chewable form.
- Individual limits: check E 104, E 110 and E 124 in mg/kg of product ready for consumption.
- Combined limit: add up E 104, E 110, E 124 and Group III colours; compare with 300 mg/kg (17.1) or 100 mg/kg (17.2).
- Aluminium lakes: if you use lakes, check aluminium from all lakes, at most 150 mg/kg.
- Label content: ingredients list with the category “colour” and the name or E number, plus a separate warning naming the colour in the Annex V wording of the market language, in a legible font.
- Distance selling: repeat the warning as text on the product page, available before purchase.
Frequently asked questions
Does an adult supplement with E 129 also need the warning about children?
Yes. Article 24 and Annex V of Regulation 1333/2008 tie the duty to the presence of the colour in the food, not to the target group. The exceptions cover only meat and egg marking and beverages above 1.2% alcohol.
Is “contains azo dyes” enough?
No. Annex V requires the name or E number of the specific colour and the sentence “may have an adverse effect on activity and attention in children”. Besides, E 104 is not an azo dye, yet it is on the list.
What is the E 110 limit in capsules and gummies?
In solid (category 17.1) and liquid (17.2) supplements, the E 110 limit is 10 mg/kg of product ready for consumption. E 110 also counts towards the combined Group III limit: 300 mg/kg in 17.1 and 100 mg/kg in 17.2.
Does a colour only in the capsule shell require the warning?
Yes. The shell is part of the supplement ready for consumption. The category 17 limits and the Annex V duty refer to the whole product.
Does the warning mean EFSA found these colours harmful?
No. In 2008 EFSA judged the evidence from McCann et al. limited and insufficient to change the ADIs. The warning is a decision of the Union legislator written into Regulation 1333/2008 and applies regardless of EFSA’s assessments.
Glossary
- Annex V
- Closed list of six colours (E 102, E 104, E 110, E 122, E 124, E 129) whose presence requires additional label information.
- Group III
- Colours with a combined maximum limit in Annex II Part B of Regulation 1333/2008, incl. E 100, E 102, E 120, E 122, E 129, E 131, E 133, E 151, E 155.
- Footnote 61
- Rule in category 17: the sum of E 104, E 110, E 124 and Group III must not exceed the Group III limit.
- Chewable form
- A supplement form (e.g. gummies, chewable tablets) for which category 17.1 sets lower limits for E 104 and E 124.
- Carry-over
- Presence of an additive in a product solely because it was contained in an ingredient (Article 18 of Regulation 1333/2008).
- ADI
- Acceptable daily intake, set by EFSA in mg/kg body weight per day.
Conclusion
A supplement with a colour needs two independent checks. First: does the product, including shell and coating, contain any of the six Annex V colours? If so, the label and the online product page must give its name or E number with the statutory sentence on activity and attention in children. Second: are the amounts within the limits of category 17.1 or 17.2, summed under footnote 61 and with the lower limits for chewable forms? A simple way to avoid both problems is to replace these colours with Group II colours, but that is a formulation decision that must be checked for colour stability and each colour’s own conditions of use.
Primary sources
- Regulation (EC) No 1333/2008 on food additives, consolidated text 02008R1333-20260818, Arts 18, 24, 35, Annex II Parts B and E category 17, Annex V. EUR-Lex
- Commission Regulation (EU) No 238/2010 of 22.3.2010 amending Annex V to Regulation 1333/2008 (OJ L 75, 23.3.2010, p. 17). EUR-Lex
- Commission Regulation (EU) No 232/2012 of 16.3.2012 on the conditions of use and use levels for E 104, E 110 and E 124 (OJ L 78, 17.3.2012, p. 1). EUR-Lex
- Regulation (EU) No 1169/2011, consolidated text 02011R1169-20250401, Arts 2(2)(c), 7, 13, 14, 20, 36, 53, Annex VII Part C. EUR-Lex
- McCann D. et al., Food additives and hyperactive behaviour in 3-year-old and 8/9-year-old children in the community, The Lancet 2007;370(9598):1560–1567. DOI
- EFSA AFC Panel, Assessment of the results of the study by McCann et al. (2007), EFSA Journal 2008;6(3):660. DOI
- EFSA ANS Panel, re-evaluations of E 124, E 104 and E 110, EFSA Journal 2009;7(11):1328, 1329, 1330. E 124, E 104, E 110
- EFSA ANS Panel, Reconsideration of the temporary ADI and refined exposure assessment for Sunset Yellow FCF (E 110), EFSA Journal 2014;12(7):3765. DOI
- EFSA news of 12.11.2009, “EFSA updates safety advice on six food colours”. EFSA