Threshold of toxicological concern
Increasing numbers of substances present at low and very low concentrations in food and feed are now detectable due to improved analytical methods. However, for many such substances there are little or no toxicological data available. There is an increased need to assess the potential health significance of these previously undetectable trace substances but it is not always possible to generate toxicological data on every single substance found in the diet.
The Threshold of Toxicological Concern ( TTC Prahová hodnota toxikologického rizika (TTC) je skríningový nástroj, ktorý poskytuje konzervatívne limitné hodnoty expozície, ak nie sú k dispozícii dostatočné toxikologické údaje špecifické pre chemikáliu. Ide o vedecky podložený prístup na stanovenie priorít pre chemikálie s nízkou úrovňou expozície, ktoré si vyžadujú viac údajov v porovnaní s tými, pri ktorých nie je možné predpokladať významné riziko pre ľudské zdravie.) approach has been developed to qualitatively assess the risk of low-level substances in the diet. It can be used for an initial assessment of a substance to determine whether a comprehensive risk assessment is required. It is an important science-based approach for prioritising assessment of those chemicals with low-level exposures that require more data over those that can be presumed to present no appreciable human health risk.
Latest
June 2019 – EFSA published new guidance on use of threshold of toxicological concern (TTC) approach in food safety assessment. The document takes into account the latest scientific developments in the field and was finalised following a public consultation with EFSA’s stakeholders. It is intended to help guide EFSA’s scientists in the use of the TTC approach as a screening and prioritisation tool for the safety assessment of chemicals, when hazard (toxicological) data are incomplete and human exposure can be estimated as low. Importantly, the TTC approach is not applicable where substance-specific data exist or where they are required under EU legislation.
FAQ
EFSA’s Scientific Committee has carefully considered the applicability of the TTC approach to endocrine-active substances, including those that could have “low-dose effects”. It concluded that:
- If there are data showing that an endocrine-active substance has adverse effects, then the TTC approach should not be applied and a full risk assessment should be carried out based on these data.
- If there are data showing that a substance has endocrine activity but the relevance to human health is unclear, then a decision should be made by risk assessors on a case-by-case basis whether or not to apply the TTC approach.
- There is currently extensive work going on at an EU-level about how scientists should define and assess endocrine-active substances; once finalised, the impact of this work will need to be considered in relation to the use of the TTC approach.
EFSA has found that the TTC approach adequately protects infants and children. Broadly speaking, this is because the TTC values are expressed according to body weight and therefore take into account the lower body weights of infants and children.
EFSA also noted that in the first weeks of life young infants are capable of metabolising and eliminating substances, particularly when exposures are low, and that the differences between young infants and children or adults in this respect are small enough not to invalidate the use of the TTC approach.
However, EFSA does recommend that if the estimated exposure is in the range of the TTC value for young infants, additional considerations, such as predicted metabolism, frequency and duration of exposure, need to be made, on a case-by-case basis, to determine whether the TTC approach can be relied on.