An additive is classified as red (high-risk) 🔴 on Yuka if all three of the following criteria are met:
1. Serious health effects
The additive itself, or contaminants potentially present in the additive, is associated with serious adverse health effects. Serious effects are defined as those likely to increase the risk of chronic or severe diseases, such as cancer, cardiovascular diseases, type 2 diabetes, or toxicity affecting one or more target organs (for example: pancreas, liver, kidneys). Serious effects also include complex biological or metabolic disruptions, such as effects on the endocrine, reproductive, or nervous systems, attention and behavioral disorders, and DNA damage.
2. High level of evidence
The link between an additive and at least one of its serious health effects is supported by robust evidence derived from:
- An opinion or official classification by a recognized authority (IARC, EFSA, ECHA, ANSES, Santé Canada, JECFA, FDA, OEHHA, etc.) and/or
- A body of converging scientific evidence from complementary methodological approaches (animal studies, in vitro experiments, epidemiological studies, etc.).
3. Estimated exposure of concern
The estimated consumer exposure may reach or exceed levels of concern for health, or leave an insufficient margin of safety, for all or part of the population (including for certain age groups or specific regions).
Our exposure assessment notably takes into account, depending on the available data:
- The estimated concentration of the additive in products (declared usage data, analytical data, maximum permitted values, health authorities' estimates),
- The frequency and quantities of consumption of these products (market research data and/or food consumption databases),
- The accumulation of exposure due to the presence of the additive in many commonly consumed products,
- Different population groups, including infants, children, adolescents, adults, pregnant women, and older adults.
Yuka's scientific team considers the level of exposure of concern for health when at least one of the following situations is observed, for all or part of the population:
- A potential exceedance of the Acceptable Daily or Weekly Intake (ADI or TWI) established by a risk assessment authority (notably EFSA or JECFA),
- An exceedance of a level at which adverse effects have been demonstrated in one or more studies presenting a high degree of evidence according to toxicological standards established by official bodies (such as IARC, JECFA, EFSA, or INERIS), but which have not been taken into account in official evaluations,
- The absence of an exposure threshold that can be considered safe for health. For certain substances, especially those presenting a genotoxic risk, even very low exposure may theoretically lead to a harmful effect. In such cases, risk assessment authorities recommend reducing exposure to the lowest level possible, as no dose can be considered completely harmless.
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An additive is classified as orange (moderate risk) 🟠 when the three above criteria are not fully met. For example, the available scientific data indicate a potential harmful effect, but are insufficient to characterize the risk with a satisfactory degree of certainty. Similarly, estimated dietary exposure levels may be considered significant without reaching levels deemed particularly concerning or likely to exceed a health risk threshold.
An additive is classified as yellow (limited risk) 🟡 when the associated health effects are considered less concerning, such as digestive discomfort, allergenic potential, a possible contribution to overweight, or moderate effects on the gut microbiota. It is also classified in this category when an observed adverse effect is meaningful, but the level of scientific evidence remains insufficient to date. In these situations, the risk is considered suspected.
An additive is classified as green (risk-free) 🟢 when to date, no risk to human health at the doses used in food has been identified by scientific sources presenting a high degree of evidence, as described above.
