The European Food Safety Authority has created a methodology to improve risk-based classification of Rapid Alert System for Food and Feed (RASFF) notifications on chemical contaminants.
The methodology was developed to evaluate contaminants from food contact materials (FCM), pharmacologically active substances and other contaminants in food, according to the European Food Safety Authority (EFSA). It is based on the assessment of toxicological properties and dietary exposure.
The results can be classified as no risk; low probability of adverse health effects or low concern for public health; potential risk; or risk.
Examples of chemical contaminants are heavy metals such as mercury, cadmium, lead and arsenic; industrial and environmental including polycyclic aromatic hydrocarbons, dioxins, mineral oils and 3-MCPD; migration of organic substances from FCM like formaldehyde, melamine and phthalates; mycotoxins and other biotoxins such as aflatoxin, ochratoxin A, zearalenone, patulin and tropane alkaloids; and residues of veterinary medicinal products like antibiotics and malachite green.
The methodology aims to provide criteria that can support the decision to notify in RASFF while increasing harmonization in the evaluation process. The approach can be applied to most situations when an analytical result is of potential concern or a non-compliance is detected in food or for FCM.
Exceeding a legal limit does not systematically trigger a RASFF notification in accordance with EU Regulation 16/2011. An evaluation on level of risk is needed to decide if there should be one. The three basic levels of risk are: no risk, not serious risk, and serious risk.
Because of varying levels of scientific support and interpretations of risk between member states, there was a need for more guidance to harmonize risk evaluation, according to officials. Improved guidance on risk evaluation is expected to lead to more consistent classifications of RASFF notifications into alert or information notifications. Alerts are more of a priority because of the higher health risk.
RACE and decision trees
The “Rapid Assessment of Contaminant Exposure” (RACE) tool was developed. It uses consumption information from the EFSA Comprehensive European Food Consumption Database to provide estimates of acute and chronic exposure from single foods and compares the result to the relevant toxicological reference points.
The tool requires eight input parameters and generates an Excel output file. Output values are colored differently to indicate existence or absence of a potential risk.
It should be made available to registered users such as RASFF network members to collect feedback and improve the tool, officials said. Further developments should consider automatic retrieval from sources of toxicological information.
During 2011 to 2016, there were 85 residues of veterinary medicinal products; 96 chemical substances belonging to RASFF classification categories of heavy metals; mycotoxins; industrial contaminants; other chemical contaminations; and 34 substances related to food contact materials reported.
A working group of external experts and EFSA staff used EFSA guidance documents, other scientific outputs from the agency, and scientific literature as the basis for the work. RASFF contact points were consulted three times.
They created two decision trees depending on if legal limits are exceeded or if an analytical result shows potential concern and one for pharmacologically active substances that takes into account if the substance is authorized or not.
The working group proposed that when a potential risk is identified, risk managers/RASFF network members should decide on the type of notification required, taking into account the rate of exceedance of a health based guidance value; the population exposed; severity of the effect on human health and the specific population groups; duration of exposure; and characteristics of the food in which the contaminant occurs.
(To sign up for a free subscription to Food Safety News, click here.)