How is the classification of food additives established?

Julie
Updated 9 hours ago by Julie

An additive is classified as red (high-risk) 🔴 on Yuka if all three of the following criteria are met:

Serious health effects

The additive itself, or contaminants potentially present in the additive, are associated with serious adverse health effects. Serious effects are defined as those likely to significantly 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, or DNA damage.

High level of evidence

The link between an additive and its toxic effects is supported by robust evidence derived from:

  • An official classification by a recognized authority (IARC, ECHA, ANSES, etc.) and/or
  • A body of converging scientific evidence from multiple complementary methodological approaches (animal studies, in vitro experiments, epidemiological studies, etc.).
Estimated exposure of concern

Under realistic consumption conditions, the estimated consumer exposure may reach or exceed levels considered of concern for health, or leave an insufficient margin of safety. The assessment notably takes into account:

  • The estimated concentration of the additive in products,
  • The frequency and quantities of consumption of these products as part of a typical diet,
  • 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.

The level of exposure is considered of concern for health when at least one of the following situations is observed:

  • A potential exceedance of the Acceptable Daily or Weekly Intake (ADI, TWI, etc.) established by a risk assessment authority (notably EFSA or JECFA),
  • An exceedance of a risk level identified in a study presenting a high level of evidence according to toxicological standards established by official bodies such as IARC, JECFA, EFSA, or INERIS,
  • The absence of an exposure threshold that can be considered safe for health. This applies in particular to certain substances, especially those presenting a genotoxic risk, for which 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 safe threshold—i.e., a dose below which the harmful effect disappears—can be scientifically established.

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An additive is classified as orange (moderate risk) 🟠 when one of the above criteria is not fully met. For example, the available scientific data may be insufficient to establish a strong consensus, even though a potentially harmful effect of concern for health has been identified. Similarly, 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. In these situations, the risk is considered suspected, not established.

An additive is classified as green (risk-free) 🟢 when it is considered safe for human health at the doses commonly used in food, based on the scientific data available to date.

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