The threshold of toxicological concern (TTC) is a pragmatic risk assessment tool that is based on the principle of establishing a human exposure threshold value for all chemicals, below which there is a very low probability of an appreciable risk to human health. The concept that there are levels of exposure that do not cause adverse effects is inherent in setting acceptable daily intakes (ADIs) for chemicals with known toxicological profiles. The TTC principle extends this concept by proposing that a de minimis value can be identified for many chemicals, in the absence of a full toxicity database, based on their chemical structures and the known toxicity of chemicals which share similar structural characteristics. The establishment and application of widely accepted TTC values would benefit consumers, industry and regulators. By avoiding unnecessary toxicity testing and safety evaluations when human intakes are below such a threshold, application of the TTC approach would focus limited resources of time, cost, animal use and expertise on the testing and evaluation of substances with the greatest potential to pose risks to human health and thereby contribute to a reduction in the use of animals. An Expert Group of the European branch of the International Life Sciences Institute-ILSI Europe-has examined the TTC principle for its wider applicability in food safety evaluation. The Expert Group examined metabolism and accumulation, structural alerts, endocrine disrupting chemicals and specific endpoints, such as neurotoxicity, teratogenicity, developmental toxicity, allergenicity and immunotoxicity, and determined whether such properties or endpoints had to be taken into consideration specifically in a step-wise approach. The Expert Group concluded that the TTC principle can be applied for low concentrations in food of chemicals that lack toxicity data, provided that there is a sound intake estimate. The use of a decision tree to apply the TTC principle is proposed, and this paper describes the step-wise process in detail. Proteins, heavy metals and polyhalogenated-dibenzodioxins and related compounds were excluded from this approach. When assessing a chemical, a review of prior knowledge and context of use should always precede the use of the TTC decision tree. The initial step is the identification and evaluation of possible genotoxic and/or high potency carcinogens. Following this step, non-genotoxic substances are evaluated in a sequence of steps related to the concerns that would be associated with increasing intakes. For organophosphates a TTC of 18microg per person per day (0.3 microg/kg bw/day) is proposed, and when the compound is not an OP, the TTC values for the Cramer structural classes III, II and I, with their respective TTC levels (e.g. 1800, 540 and 90 microg per person per day; or 30, 9 and 1.5 microg/kg bw /day), would be applied sequentially. All other endpoints or properties were shown to have a distribution of no observed effect levels (NOELs) similar to the distribution of NOELs for general toxicity endpoints in Cramer classes I, II and III. The document was discussed with a wider audience during a workshop held in March 2003 (see list of workshop participants).

Structure-Based Thresholds of Toxicological Concern (TTC): Guidance for Application to Substances Present at Low Levels in the Diet

The safety assessment of chemicals added or found in food has traditionally made use of data from in vivo studies performed on experimental animals. The nature and amount of data required to carry out a risk assessment is generally stipulated either in the different food legislations or in sectoral guidance documents. However, there are still cases where no or only limited experimental data are available or not specified by law, for example for contaminants or for some minor metabolites from active substances in plant protection products. For such cases, the Threshold of Toxicological Concern (TTC) can be applied. This review explores the use of the TTC approach in food safety in the European Union in relation to the different food sectors, legal requirements and future opportunities.

/pdf/application-of-the-threshold-of-toxicological-concern-ttc-in-31uh5q2vmt.pdf

Application of the Threshold of Toxicological Concern (TTC) in Food Safety: Challenges and Opportunities

Food antimicrobial agents (FAA) provide the first food defence system against pathogens for processed food products. In addition, they function as an antioxidant in preventing colour and taste changes for food safety and quality. Muslim consumers are concerned about the source of FAA which may contain non-permissible ingredients according to Islam including pig and unslaughtered permissible animal sources. They also raise concerns about the increasing risk of toxicity when the FAA is consumed and the possibility of the FAA rendering organoleptic effect on the food. The application of the FAA protects the food from microbial contamination and indirectly combats emerging devastating diseases. Hence, halal FAA (HFAA) can be introduced so that Muslim consumers can accept FAA usage. Generally, HFAA is categorised according to ingredient sources such as animal, plant, bacteria, or synthetic origins. There are doubts on the halal status of animal-origin FAA as the source might be originating from pig, unslaughtered animal, human, or origins which are filthy. The animal-origin FAA shows strong antimicrobial properties against Gram-positive and negative pathogens, as well as toxicity and organoleptic issues. Thus, the FAA should be used within the allowable range. HFAA has become one of the most studied FAAs due to these issues. Many HFAAs are produced from animals without the full verification of halal status. This review presents an overview of the origins and challenges of HFAA production. Furthermore, this study also highlights how FAA could be verified as halal which is the theme of future research in HFAA development.

/pdf/halal-antimicrobials-in-food-a-review-on-prospects-and-1og7457hig.pdf

Halal antimicrobials in food: A review on prospects and challenges of antimicrobials from animal sources

This chapter provides an overview of the Threshold of Toxicological Concern (TTC) concept and the ways in which it has been applied, or proposed for application, in the EU-wide risk assessment of chemicals in food. The basis of the TTC approach is described in relation to key historical developments, including policy and research initiatives.

Alternative Approaches for the Assessment of Chemicals in Food

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Alternative Approaches for the Assessment of Chemicals in Food