Food Fraud: Emerging Risk of Brilliant Blue FCF
Brilliant Blue FCF is authorised on both sides of the Atlantic and, in the United States, is expected to be gone from the food supply by the end of 2026. Here is what the regulators actually say, and what that date means for anyone whose recipe book still contains it.
Brilliant Blue FCF, known as FD&C Blue No. 1 in the United States and E 133 in the European Union, is the synthetic dye behind the vivid blue in drinks, sweets and iced biscuits. It is one of the most stable colours available to a formulator, it is approved by both EFSA and the FDA, and it is also on the list the FDA asked industry to stop using by the end of 2026.
What is Brilliant Blue FCF?
Brilliant Blue FCF is a synthetic triarylmethane colour, listed as E 133 in the European Union and as FD&C Blue No. 1 in the United States. It was originally derived from coal tar and is now manufactured from petroleum feedstocks. Its appeal to a formulator is stability: the shade holds under light, heat and a wide pH range, which is why it survives pasteurisation and a year on a shelf when a plant-derived blue would not.
Because it is water-soluble and intensely coloured, it is used at very low inclusion rates. That is also why it is hard to spot by eye in a finished product and why its presence is a documentary question rather than a visual one.
Where is Brilliant Blue FCF used?
It runs across a broad spectrum of products, and it appears in categories where our own monitoring has repeatedly recorded colour-related non-compliance:
- Fruit juices
- Flavoured sweets
- Chocolate and confectionery bars
- Biscuits
- Fizzy drinks
- Syrups and molasses
It is also used outside food, in cosmetics and in some pharmaceutical coatings, for the same reason: the colour does not move.
Why do manufacturers use it?
Appearance drives purchase, and a blue that stays blue is commercially useful. Natural alternatives exist, but they are more expensive, less stable and harder to match batch to batch. That trade-off is the whole reason a synthetic colour is chosen, and it is also why substituting one is not a paperwork exercise.
Approval is not the end of the question. A colour can be authorised, correctly declared and still be the subject of an adulteration case somewhere in the supply chain, which is a different failure from the additive itself being unsafe.
Is Brilliant Blue FCF safe?
EFSA re-evaluated Brilliant Blue FCF in 2010 and set an acceptable daily intake of 6 mg per kilogram of body weight per day. That replaced the 10 mg/kg allocated by the Scientific Committee for Food in 1984, which had itself replaced the 12.5 mg/kg set by JECFA in 1970. The new figure was derived from a no-observed-adverse-effect level of 631 mg/kg per day in a chronic rat study, with an uncertainty factor of one hundred applied.[1]
The Panel also estimated dietary exposure and concluded that at the maximum reported levels of use, refined intake estimates sit below that acceptable daily intake.[1] In regulatory terms the colour is authorised and the exposure is judged to be within the limit.
What effects are reported, and what does the evidence support?
Three concerns come up repeatedly about this colour. They are worth taking one at a time, because the evidence behind them is not the same.
Hyperactivity in children. This is the question asked most often, and the evidence people are thinking of is about other colours. Since 2010 the European Union has required foods containing six specific colours to carry the statement that they "may have an adverse effect on activity and attention in children": tartrazine (E 102), quinoline yellow (E 104), sunset yellow FCF (E 110), carmoisine (E 122), ponceau 4R (E 124) and allura red AC (E 129).[2] The requirement followed the Southampton study published in 2007.[3] Brilliant Blue FCF is not on that list and was not among the colours that study tested, so a claim that Blue 1 in particular drives hyperactivity does not rest on that evidence.
Allergic and hypersensitivity reactions. Individual reactions to synthetic colours — skin rashes, and asthma-type symptoms in people already sensitive — are reported and are rare. They are not specific to this colour, and EFSA derived the acceptable daily intake from toxicological endpoints in animal studies rather than from hypersensitivity.[1] Anyone who reacts to one synthetic colour is usually advised to read labels for the whole group, not for E 133 alone.
Digestive effects. Brilliant Blue FCF is poorly absorbed from the gut and the great majority of an ingested dose leaves the body unchanged, which is why systemic effects are not expected at dietary intakes. Reports of digestive discomfort are individual and anecdotal rather than established, and EFSA recorded no such effect at the intakes it assessed.[1]
An additive is approved or it is not. A supplier declaration is a different question.
iComplai reads more than 150,000 sources against the raw materials, origins and suppliers a food company actually buys. You can follow food fraud cases involving illegal dyes, list the products recorded against those dyes over the years, see which countries and which manufacturing origins they cluster in, and read the forecast for where the next ones are likely to appear — while there is still time to act, rather than after the product is on the market.
See how colour risk is trackedWhat changes for Blue 1 by the end of 2026?
On 22 April 2025 the US Department of Health and Human Services and the FDA announced a plan to remove petroleum-based synthetic dyes from the American food supply. Two colours, Citrus Red No. 2 and Orange B, are having their authorisation revoked outright. Six more are to be eliminated by working with industry, on a voluntary basis, by the end of 2026: FD&C Green No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 2 and Blue No. 1.[4]
Voluntary is doing real work in that sentence. Nothing becomes illegal on 31 December 2026, and the European authorisation is unaffected. But several of the largest manufacturers have already committed to removing synthetic colours from their ranges, and the practical effect is that a US-facing product still carrying Blue 1 in 2027 will be conspicuous.
For a quality or procurement team the work is not the decision, it is the lead time. A colour swap changes shade, cost, specification and often the supplier, and each of those is a change that has to be requalified. Knowing which products and which suppliers are affected is the first step, and it is a question about the recipe book rather than about the dye.
Brilliant Blue FCF FAQ
Is Brilliant Blue FCF banned?
No. Brilliant Blue FCF is authorised in the European Union as E 133 and in the United States as FD&C Blue No. 1. In April 2025 the FDA and HHS asked industry to remove it, along with five other petroleum-based dyes, from the US food supply by the end of 2026. That request is voluntary and the colour remains legal while it runs.
What is the acceptable daily intake for Brilliant Blue FCF?
EFSA set an acceptable daily intake of 6 mg per kilogram of body weight per day in its 2010 re-evaluation, down from the 10 mg/kg previously allocated by the Scientific Committee for Food in 1984. The figure comes from a no-observed-adverse-effect level of 631 mg/kg per day in a chronic rat study, with a hundredfold uncertainty factor applied.
Does Brilliant Blue FCF cause hyperactivity in children?
The EU requires a warning about effects on activity and attention in children on six colours: E 102, E 104, E 110, E 122, E 124 and E 129. Brilliant Blue FCF is not one of them and was not among the colours tested in the Southampton study that prompted that rule. Claims that link Blue 1 specifically to hyperactivity are not supported by that evidence.
Which foods contain Brilliant Blue FCF?
It appears in fruit juices, flavoured sweets, chocolate and confectionery bars, biscuits, fizzy drinks, and syrups and molasses. It is also used outside food, in cosmetics and in some medicines, because the shade is stable in light and heat.
What should a manufacturer using Blue 1 do now?
Establish where the colour sits in the recipe book, which of those products are sold into the United States, and what the reformulation path is for each. The end of 2026 is the date the FDA has named, and a colour swap changes shade, cost and often the supplier, so the lead time is the constraint rather than the decision itself.
If you buy or approve this colour for a living
Then the question is not whether E 133 is safe. It is when you last checked that your supplier's declaration still matches what arrives, and how you will know which of your products have to change before the end of 2026.
Talk to iComplaiWhere these claims come from
[1] EFSA Panel on Food Additives and Nutrient Sources added to Food. Scientific Opinion on the re-evaluation of Brilliant Blue FCF (E 133) as a food additive. EFSA Journal, 2010. efsa.onlinelibrary.wiley.com
[2] Regulation (EC) No 1333/2008 on food additives, Annex V: colours requiring the additional labelling statement. eur-lex.europa.eu
[3] EFSA. Evaluation of the Southampton study on food additives and child behaviour. efsa.europa.eu
[4] US Department of Health and Human Services and FDA. Phase-out of petroleum-based synthetic dyes, 22 April 2025. hhs.gov