Brilliant Blue FCF and its daily intake limit
What it found
The authors set a new acceptable daily intake for Brilliant Blue FCF of 6 mg per kg of body weight per day.
They also estimated how much people actually take in from food.
What they found
Animal and lab studies
New daily intake limit
From a long-term rat study, the authors identified a level of 631 mg/kg body weight per day with no harmful effects. Applying a 100-fold safety factor, they set a new acceptable daily intake of 6 mg/kg body weight per day.
Other findings
Intake at maximum use
When Brilliant Blue FCF is used at the highest reported levels, refined estimates of how much people take in are below the new acceptable daily intake of 6 mg/kg body weight per day.
Intake in children
Using less refined estimates, average intake for adults and children and higher-level intake for adults are below the acceptable daily intake. However, higher-level intake for children goes above it.
What the authors conclude
“The Panel established a new ADI to Brilliant Blue FCF equal to 6 mg/kg bw/day.”
Also in their conclusions
- They concluded that the available data give reason to revise the acceptable daily intake of 10 mg/kg body weight per day set in 1984.
- They established a new acceptable daily intake of 6 mg/kg body weight per day.
- They concluded that at the maximum reported levels of use, refined intake estimates are lower than the new acceptable daily intake.
How it was done
Brilliant Blue FCF had been assessed before, most recently in 1984 when an acceptable daily intake of 10 mg/kg body weight per day was set. New data on how it is absorbed, broken down, and its toxicity gave reason to look at that limit again.
The authors reviewed studies on how Brilliant Blue FCF is absorbed, distributed, broken down and removed from the body, as well as tests for gene damage, short-term and long-term toxicity, effects on reproduction and development, and cancer. They used a long-term rat study to set a new acceptable daily intake and compared it with estimates of how much people take in from food.
What it can’t tell you
- We summarised it from the abstract only.
- This is a safety assessment based on existing studies, not a new experiment in people.
- The intake estimates are based on assumptions about how much food containing Brilliant Blue FCF people eat, so they cannot show actual intakes for any one person.
The paper
- Title
- Scientific Opinion on the re-evaluation of Brilliant Blue FCF (E 133) as a food additive
- Type
- Scientific opinion of the European Food Safety Authority
- Evidence
- Animals and lab studies
- Summarised from
- Abstract only
- Cite
- EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) (2010). Scientific Opinion on the re-evaluation of Brilliant Blue FCF (E 133) as a food additive. EFSA journal. European Food Safety Authority. doi:10.2903/j.efsa.2010.1853Free full textPubMed 42079524DOI
Summary written 26 Sep 2026. Check it against the paper before it changes what you eat. How we summarise papers · Report an error