Switch to flexible approach for assessing cancerous agents proposed

The committee calls for a more harmonised and transparent approach to assessing and regulating genotoxic and carcinogenic substances in food.

Ingredients should not be approved for deliberate addition to foods or for use earlier in the supply chain if they leave residues that are both gene altering and and cancer-causing, the scientific panel says.

The committee calls for regulators to balance the potential risk to health a substance may cause, to the actual benefits its provides to the food product.

Recent discoveries on pervasive substances such as acrylamide, which is caused by the frying process, have left regulators and industry confused as to how to deal with them.

It could also harmonise the different standards of asessement used by various EU food regulators, making it easer for processors to serve the same food throughout the bloc.

New and more sensitive detection methods means that an increasing number of foods are being found with very low levels of genotoxic and carcinogenic substances causing a problem in setting priorities for action on eliminating the most dangerous ones, the panel stated in its report

The panel acknowledges that one of the most difficult issues in food safety is to advise on potential risk to human health when it is found that substances that are both carcinogenic and genotoxic are present in food and their presence cannot be readily eliminated or avoided.

Undesirable substances occur in food as an inherent natural constituent in the food plant or as contaminant through their presence in the environment, through fungal contamination or through preparation processes.

Regulators in EU member countries and around the world currently use several approaches to assess the risk of substances with genotoxic and carcinogenic properties, the scientific committee noted in its report.

Since in almost all cases no adequate human epidemiological data are available, data from high-dose animal bioassays are used, requiring extrapolation to the low levels to which humans are generally exposed. However, the science behind the different extrapolation methods is very much debated and often it is advised that the exposure to substances which are both genotoxic and carcinogenic should be as low as reasonably achievable, the committee stated.

Until now the EU's risk assessors have based their advice on the principle of keeping the exposure to such substances at the lowest possible level. However the ALARA principle (“as low as reasonably achievable”) is too blunt an instrument and may place undue restrictions on how food is produced or processed.

"A disadvantage of this approach is that it cannot be used to compare risks posed by different substances,"​ the panel stated. "Furthermore, the application of the ALARA principle does not take into account the effectiveness of a substance and the actual, sometimes extremely low, level of occurrence in food."​

In making decisions to ban or restrict potentially gene altering or cancerous substances in foods, the EU's regulatory system should switch to a comparative analysis that prioritises the most risky dangers and sets allowable levels of ingredients based on actual levels in products, the scientific panel stated in its report.

ALARA also does not provide the risk manager with an adequate basis for setting priorities for action, either with regard to urgency or the extent of measures that may be necessary.

"Improvements in analytical methods with respect to sensitivity and specificity leading to even lower detection limits will increase the number of substances detected in food including those that are both genotoxic and carcinogenic,"​ the panel stated. "Overall, there is an obvious need for a harmonised, scientific, transparent and justifiable approach when risks are assessed by the scientific committee and the scientific panels of the European Food Safety Authority."​

The new system of assessment would use a concept called “margin of exposure” (MOE), a methodology that does enable the comparison of the risks posed by different genotoxic and carcinogenic substances.

An MOE for a particular chemical that would be considered acceptable is a societal judgement and primarily the responsibility of risk managers, rather than risk assessors. Risk assessors have the responsibility to inform risk managers about the quality of the hazard characterisation and intake data, the uncertainties inherent in the data used and the magnitude of the MOEs. The risk assessors should also advise the risk managers on the interpretation of the magnitude of the MOE.

MOE takes into account differences in potency of the substances concerned and consumption patterns in the population. The scientific committee recommends MOE be used as a harmonised methodology for assessing the risk of genotoxic and carcinogenic substances which may be found in food and feed, regardless of their origin.

"It is for the risk manager to decide if the magnitude of the MOE is acceptable, and if further action is needed taking into consideration additional aspects, such as the feasibility of removing the substance from the food supply,"​ the committee stated. "The MOE approach could be applied for instance to environmental contaminants, substances occurring naturally in foods and those resulting from food preparation or manufacturing processes – acrylamide would be a case in point."​

The committee also says substances which are both genotoxic and carcinogenic should not be approved for deliberate addition to foods or for use earlier in the food chain, if they leave residues which are both genotoxic and carcinogenic in food.

"The margin of exposure approach can be applied in cases where substances that are both genotoxic and carcinogenic have been found in food, irrespective of their origin, where there is a need for guidance on the possible risks to those who are, or have been, exposed,"​ the committee stated.

Recent decisions on genotoxic and carcinogenic substances indicate the difficulty in setting standards for maximum levels in foods. EFSA is currently wading through the risk assessment of 1m000 flavouring substances. The latest decision concluded that seven out of eight in the latest batch need more data to determine ‘reliable exposure’.

The evaluation dealt with eight aryl-substituted saturated and unsaturated primary alcohol, aldehyde, carboxylic acid and ester derivatives, Five of the eight flavouring substances in the present group have been reported to occur naturally in a wide range of food items.

In the case of acrylamide, science and the industry have been uncertain about what approach to take. The naturally occuring chemical hit the headlines in 2002 when scientists at the Swedish Food Administration first reported unexpectedly high levels of the potential carcinogen in carbohydrate-rich foods cooked at high temperatures.

Until then acrylamide was known only as a highly reactive industrial chemical, present also at low levels for example in tobacco smoke. Studies indicate that the chemical causes cancer in rats,. Toxicological data suggested that this substance might be – directly or indirectly - carcinogenic also for humans.

The news, and surrounding controversy over the chemical, jolted the EU's food industry into tackling the issue by looking at ways processing can reduce the levels of acrylamide.

A wide range of cooked foods – prepared industrially, in catering, or at home – contain acrylamide at levels between a few parts per billion (ppb) to over 1000 ppb. The foods include bread, fried potatoes and coffee as well as specialty products like potato crisps, biscuits, crisp bread, and a range of other heat-processed products.

Acrylamine has become subject to regulation in California. The EU's food industry association has made moves to bring in voluntary reductions by its members as a means of avoiding the situation occuring in the US.

There, the state government is suing nine top food manufacturers over their reluctance to issue warnings that some popular snacks could contain the chemical.

Attorney general Bill Lockyer argues that the state's anti-toxics law, Proposition 65, requires companies to warn consumers about products containing chemicals known to cause cancer or birth defects.

Acrylamide, a carcinogen that is created when starchy foods are baked, roasted, fried or toasted, was placed on the list in 1990. But some food companies remain reluctant to highlight the potential danger in snack products such as fries and potato chips.