Ministero della Salute Risk management of mycotoxin presence in food products:major unsolved points Directorate General for food hygiene and safety and for nutrition Dr Monica CAPASSO
Risk management Regulation (EC) 178/2002 Articolo 6 Risk analysis 1. In order to achieve the general objective of a high level of protection of human health and life, food law shall be based on risk analysis except where this is not appropriate to the circumstances or the natureofthe measure. 2. Risk assessment shall be based on the available scientific evidence and undertaken in an independent, objective and transparent manner. Recital (17) Regulation 178/2002 Where food law is aimed at the reduction, elimination or avoidance of a risk to health, the three interconnected components of risk analysis risk assessment, risk management, and risk communication provide a systematic methodology for the determination of effective, proportionate and targeted measures or other actions to protect health 3. Risk management shall take into account the results of risk assessment, and in particular, the opinions of the Authority.2, other factors legitimate to the matter under consideration and the precautionary principle where the conditions laid down in Article 7(1) are relevant, in order to achieve the general objectives of food law established in Article 5. 2
Risk management The process, distinct from risk assessment, of weighing policy alternatives, in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options (Codex Alimentarius Commission, procedural manual, XXV edition) The primary goal of the management of risks associated with food is to protect public health by controlling such risks as effectively as possible through the selection and implementation of appropriate measures» (Report of a Joint FAO/WHO Consultation 1997) 3
Risk management ELEMENTS OF RISK MANAGEMENT (Report of a Joint FAO/WHO Consultation, 1997) Risk evaluation Identification of a food safety problem. Establishment of a risk profile. Ranking of the hazard for risk assessment and risk management priority. Establishment of risk assessment policy for conduct of risk assessment. Commissioning of risk assessment. Consideration of risk assessment result. 4
Risk management B. Risk management option assessment Identification of available management options. Selection of preferred management option, including consideration of an appropriate safety standard. Final management decision. C. Implementation of management decision D. Monitoring and review Assessment of effectiveness of measures taken. Review risk management and/or assessment as necessary. 5
Risk management and Risk assessment: critical points The risk assessments can reach the following results: 1) quantitative estimation of the risk at specified exposure levels, 2) definition of Health Based Guidance Values (HBGVs), eg TDI-tolerable daily intake; ARfD-acute toxicity dose 3) definition of Margin of Exposure (MOE) (eg for genotoxic carcinogens), 4) probabilistic approach (range of responses and exposures), 5) definition of TTC (threshold of toxicological concern) approach, etc. (when toxicological data are lacking) The above-mentioned results provide advice for risk managers and are characterized by different and elevated number of uncertainties (eg in the case 1) : uncertainty due to exposure estimation calculated by chemical concentration and food consumption data uncertainties concerning chemical concentration uncertainties concerning food consumption data 6
Risk management and risk assessment: critical points Some other examples: 1) HBGV (eg TDI-tolerable daily intake, ARfD-acute toxicity dose) HBGVs: the relative values do not represent a perfect demarcation line. It is not possible to say that exposure above the HBGV represent a non safe level of exposure because of numerous uncertainties relative to the definitions of HBGV. Moreover, levels for chronic exposure (based on conservative assumptions) could not have any health consequence in case of short exceedance; 2) Margin of Exposure (MOE) (BMD/exposure; BMD= benchmark dose) MOEs: The acceptability of a MOE (BMD/exposure; BMD= benchmark dose)could be a risk management decision. So, the risk assessment should provide information on the nature, magnitude, and possible consequences of the inherent uncertainties and variability in both the toxicological and exposure data. Some considerations can assist the risk manager regarding an appropriate MOE level:..es RP( reference points : eg BMD benchmark dose ) from animal or human studies. A smaller MOE may be acceptable when a MOE is derived from a human study, depending on the quality of the study 7
Risk management and risk assessment: critical points So, the uncertainties from risk assessment can condition the risk management decisions 8
Mycotoxin risk management Mycotoxin risks can be managed by regulatory acts or by agricultural and public health provisions: 1. Maximum levels 2. Guidelines/Guidance/Codes of practice in pre-harvest and post-harvest (eg «Code of practice for the prevention and reduction of micotoxin contaminantion in cereals», CAC/RCP 51-2003) 3. Dietary advice/labeling 4. Mitigation strategies (eg by defining target level and stimulating the industry to reach them) 5. Public Health Alerts and Recalls 6. Education/Training (for all stakeholders: local/regional Authorities, industry, consumers) 7. Research (to develop methods to detect mycotoxins eg modified forms; to collect toxicological data where they are lacking eg Alternaria spp toxins; to study the effects of food processing and so on) 9
Risk management: critical points Regulated mycotoxins Official Control Plans Data Evaluation and Exposure Evaluation No risks Risks* Further actions: - Specific monitoring plans to collect further data - Further actions: regulatory or not *Critical Point: Risk also in case of general compliance to maximum limits of regulation (EC) 1881/2006. For example : Total exposure of toddlers, other children and children to deoxynivalenol (DON) in cereal based food could reach TDI (Tolerable daily Intake) =1000 ng/kg bw /die (a project of the Italian National Institute of Health concerning the exposure evaluation to different mycotoxins of sensible populations groups) 10
Risk management: critical points Regulated mycotoxins Official Control Plans Non compliances Problems relative to the pre-harvest and post harvest Implementation of Hygiene regulation EC 852/2004 and moreover Good Agriculture Practice, Good Manufacturing Practice, Good Distribution Practice So, notwithstanding regulatory measures, there are still cases for which it is extremely important to act at level of good agricultural practice, good storage and processing to prevent mycotoxin contamination risk Critical Points: coordination among different competent Autorithies (Agricultural Authorities, Health Authorities); implementation of Good Practices 11
Risk management: non regulated mycotoxins and critical points Non Regulated mycotoxins 2017:waiting for the results) Monitoring Plans (First publication in Italy in Draft Guideline for risk management For example, use of HBGVs or MoE / TTC approaches for further exposure evaluation. Results: - - Exposure evaluation >HBGVs (eg TWI -Tolerable Weekly Intake-, ochratoxin A in not regulated food) -or MOE>10000 (eg aflatoxin B1, sterygmatocistin)? How higher? Further regulatory - or TTC>2.5 ng/kg bw /die (eg Alternaria toxins: or not actions alternariol (AOH), monomethyl ether (AME)) 12
Risk management: Italian pluriannual official control Plan of mycotoxins in food (2016-2018) The plan aims to provide indications to the Regional Authorities and the Autonomous Provinces on the official control of the "mycotoxins" contaminant in food products. It also aims to plan and coordinate the activities aimed at both the verification of compliance with the law and the assessment of consumer exposure. It is focused on sampling activities for the production / processing / distribution phases of specific food products. 13
Mycotoxin risk management in Italy : step of «monitoring and review» Publication, in 2016, of the italian pluriannual official control Plan of mycotoxins in foods Results: 56 non compliant samples, mainly AFM1 in cheeses (total 2794 samples in NSIS system ) Awaiting for the exposure evalutation from Italian national Institute of Health On the basis of the results of the exposure evaluation: further actions (eg plan review) 14
(maize contaminated by Aspergillus) Thank you for your attention 15