The aim of this programme is to underpin the development of the risk assessment process in order to ensure the safety of chemicals in food.
The programme will support the Agency's Strategic Plan in the following areas:
- ensure that chemicals present in food do not compromise food safety.
- safety assessment processes that protect consumers, are robust, and are applied rigorously – specifically to 'fund research to reduce uncertainties and improve our understanding of food safety issues'.
- safety assessment which is open, transparent and based on the best available science.
The programme's scientific aims are:
1. Developing better approaches and tools for use in risk assessment of food chemicals. This includes:
- Developing approaches to food risk assessment that take into account variability and uncertainty.
- Developing integrated approaches which take due account of human data, in vivo data, in vitro data and expert judgement as appropriate.
- Developing appropriate model systems to assist risk assessment.
- Developing and validating biomarkers of exposure to improve estimates of internal exposure to food chemicals in support of risk assessment.
- Identifying and applying biomarkers of potential adverse (and on occasion beneficial) effects of food chemicals, or mixtures of chemicals in food. In combination with biomarkers of exposure, these tools should help advance and refine the risk assessment process.
2. Carrying out toxicological investigations to support risk assessment of food chemicals in response to the advice of expert committees.
Research in this programme will seek to:
- Develop relevant in vitro systems that may serve as alternatives to some testing in animals.
- Refine uncertainty factors used in estimating acceptable or tolerable intakes of food chemicals.
- Investigate possible associations between cancer and chemical carcinogens that occur unavoidably in food.
- Obtain better information on the bioavailability and action of plant constituents that may have the potential to act both as chemoprotectants and also cause adverse health effects. The effect will depend on the constituent's form and intake levels.
- Investigate whether specific populations or groups are at greater risk of adverse health effects from dietary constituents, due to genetic, environmental or other factors.
- Develop and refine biomarkers of exposure and effect in order to reduce the uncertainty in the risk assessment process.
- Develop suitable methodology for assessing the combined effects of mixtures of food chemicals, and in particular to consider possible additive, antagonistic or synergistic responses and thus improve the risk assessment process. (Further work in this area will be funded through the T10 programme.)
- Improve understanding of the toxicological effects of food chemicals of concern to the Agency, especially in response to the recommendations of independent scientific committees.
On completion the programme should have:
- Provided robust scientific information to support refinement of the risk assessment process.
- Provided sound scientific data, and in particular robust information on internal exposure, to support the risk assessment by scientific advisory committees of food chemicals of specific concern to the Agency.
- Provided consumers from a broad range of categories with accessible high quality information to make informed choices about their diet and balance the risks and benefits of a particular dietary choice.
- Highlighted areas where further research is needed to ensure consumers are adequately protected from adverse health effects of food chemicals.
The research programme will provide the underlying research means to improve risk assessment for food chemicals (or mixtures of chemicals in food) of particular concern (eg those with potential to cause adverse health effects, and for which no other organisation has responsibility. The ultimate aim is to decrease uncertainty in risk assessment.
Specifically the programme will:
- Investigate the aetiology and progression of diet-related cancers with a view to providing better-targeted advice. This includes work on genetic polymorphisms that may influence individual susceptibility to dietary carcinogens (especially colon cancer) and other dietary influences on the development of cancers. This work will help the Agency to provide information more targeted to individual needs, thus increasing the level of personal choice.
- Consider possible risks (or benefits) from the consumption of mixtures of chemicals. This, together with the results from the new T10 research programme entitled Mixtures, Toxicology and Exposure, will help formulate policy and provide advice to consumers who are concerned about 'cocktail' effects. It will also provide more generic information to help consider the effect of exposure to mixtures of contaminants both from food and other routes.
- Develop model systems for use in the toxicological assessment of food contaminants and additives. This will help meet ethical concerns and comply with Government policy by reducing the use of experimental animals and providing cost-effective primary screens.
- Consider the validity and possible refinements of uncertainty factors used in risk assessment both at the generic and the chemical-specific level. Safety guidelines for intakes of food chemicals incorporate uncertainty factors to allow for the possibility that the average person may be more sensitive than the experimental animals used to determine toxicity, and that some people will be more sensitive than the average. Current uncertainty factors lack a sound scientific basis. Improving the basis of the uncertainty factors will make considerable contribution towards the risk assessment of food chemicals both for regulatory and non-regulatory purposes.
Benefits to be gained from this programme
- Refinement of current methods for assessing food chemical hazards. In particular this will focus on developing better biomarkers of toxicological effect and on either validating current, or developing new, experimentally-based uncertainty factors.
- Advances in the science, understanding and approach to assessing hazards from mixtures of chemicals by developing novel techniques for this purpose.
- Establishment of whether certain groups are more or less susceptible to the harmful effects of certain food chemicals.
- Robust information on optimal dietary intakes of plant chemicals that have been identified as having both adverse and beneficial effects, including differences that may reflect differences in susceptibility, in order to support advice to the public.
- Refined risk assessment of food chemicals that have been highlighted by independent expert committees as being of concern.
- Provision of better information regarding the risks due to unavoidable carcinogens found in the diet and possible means of reducing these risks.