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EEA Workshop on Emerging Contaminants 4-5 Dec 2011, Copenhagen. Andrea Altieri – Emerging Risk Unit. EFSA’s Work on Contaminants and Emerging Risks. Outline. EFSA introduction Overview of EFSA work on contaminants Emerging Risk Identification. EFSA. - Founding regulation 178/2002
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EEA Workshop on Emerging Contaminants 4-5 Dec 2011, Copenhagen Andrea Altieri – Emerging Risk Unit EFSA’s Work on Contaminants and Emerging Risks
Outline • EFSA introduction • Overview of EFSA work on contaminants • Emerging Risk Identification
EFSA - Founding regulation 178/2002 • Mission EFSA is the keystone of EU risk assessment regarding food and feed safety, nutrition, animal health and welfare, plant and environmental health. In close co-operation with national authorities and in open consultation with its stakeholders, EFSA provides independent scientific advice and clear communication on existing and emerging risks. Parma (IT) - No responsibility for food safety legislation - No task in food safety/quality controls, labelling or other such issues - No substitute for national authorities
Introduction The CONTAM Panel The CONTAM Panel delivers scientific opinions on contaminants in food and feed, associated areas and undesirable substances not covered by another EFSA Panel • Chemical compounds which are not intentionally added to food and feed, • Chemical compounds naturally found in food and feed, • Chemical compounds occurring during thermal food and feed processing, • Non-authorised substances in feed and food. The CONTAM Panel: 21 members Chair: Dr. Josef Schlatter (CH) Vice-chairs: Dr. Diane Benford (UK) and Prof. Dr. Rolaf van Leeuwen (NL)
Risk assessment paradigm HAZARD IDENTIFICATION EXPOSURE ASSESSMENT HAZARD CHARACTERISATION ADME, acute/sub/chronic toxicity, animal/human data, mechanism of action, BMD modeling, health based guidance values... Levels in relevant food groups, food consumption data, dietary exposure, specific groups of the population, time trends… RISK CHARACTERIZATION Relate exposure to a chemical in a given population with toxicological effects and concludes on the likelihood of adverse effects.
EFSA’s risk assessments on Brominated Flame Retardants(BRF) in Food - The EC requested EFSA for a scientific opinion on the risk to human health related to the presence of BFRsin food, including PBBs, PBDEs, HBCDDs, TBBPA and other phenols,and emerging BFRs. - BFR are mixtures of man made chemicals added to a variety of products to make them less flammable, e.g. plastics, textile, electronic equipment . • Toxicity for humans, • For PBDEs and PBBs, identify congeners of toxicological relevance with particular reference to those occurring in food, • Carry out an exposure assessment on the basis of the occurrence data obtained in the EU monitoring exercise (2006), and other data that might be available, • Consider exposure for specific groups of the population, and indicate the relative importance of non-dietary sources, • Take into account biomonitoring data, • Identify data gaps.
The CONTAM Panel concluded that: PBBs: The risk of the European population from exposure to PBBs through the diet is of no concern. As the production and use of PBBs in most countries was terminated in the 1970s, it is not likely that today non-dietary sources would contribute substantially to exposure of the European population. • PBDEs: • For BDE-47, -153 and -209 current dietary exposure is unlikely to raise a health concern. For BDE-99 for young children (1-3 years) this assessment indicates a potential health concern for dietary exposure to this congener. • Non-dietary exposure, PBDEs, particularly BDE-209, in house and car dust, can be an important source of exposure for children. • Further epidemiological studies of PBDEs are required focusing on the relevant tox endpoints and with suitable estimates of human exposure. • Ongoing risk assessments: • TBBPA and other phenols(estimated end of 2011) • Other BFRs, including emerging ones (estimated 2012)
Other selected activities of potential interest for EEA • Scientific report of the Endocrine Active Substances (EAS) Task Force • Cross cutting issue (e.g. bisphenol A, isoflavones, pesticides, horm. res.) • The state-of-play (e.g. scientific and regulatory setting) • Need for a common transparent risk assessment approach • Criteria for determining EAS and testing standards • Significance of the low-dose exposure • Priority list, sources and routes of exposure • Nanotechnology: Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain • Physico-chemical characterization requirements • Testing approaches for hazard identification and characterization (e.g. in vitro studies and repeated 90-day oral tox studies in rodents) • Pesticides: • Monitoring program of pesticides (e.g. annual reports) • Peer review evaluation of Maximum Residue Levels • Evaluation of applications
Outline • EFSA introduction • Overview of EFSA work on contaminants • EMRISK Unit activities
Emerging Risks Mandate and Definition Mandate REGULATION (EC) No 178/2002 EFSA definition of emergingrisk « An emergingrisk to human, animal and/or plant healthisunderstood as a riskresultingfrom a newlyidentifiedhazardto which a significantexposuremayoccur or from an unexpectednew or increasedsignificantexposureand/or susceptibility to a knownhazard » (EFSA SC, 2007) Article 34 Identification of emerging risks The Authority shall establish monitoring procedures for systematic searching for, collecting, collating and analysing information and data with a view to the identification of emerging risks in the fields within its mission […] 14 14
EMRISK ongoing activities • Emerging Risks Identification: • Develop methodology and procedures • e.g. best practices for emerging risks identification • Data collection and tool development • e.g. Scientific. Lit, Experts, RASFF, Media, Trade, Chemical Hazard DB • Data monitoring, analysis and evaluation • e.g. identification of emerging risks • Exchange of information • e.g. MS-Network, Stakeholders, Experts WG • Preparedness for Urgent Advice: • EFSA crisis handling procedures • EFSA crisis preparedness activities
Milestones Building a capacity for ER identification: • EMRISK Project, 2006 • Scientific Committee Opinion, 2006 • EFSA Definition of “Emerging Risk”, 2007 • Establishment of the EMRISK unit, 2008 • ESCO WG on Emerging Risks, 2009 • EMRISK Technical Report on the Emerging Risks 2010 • EFSA Colloquium on Emerging Risks 2010 • EFSA WG on Methodology for ERI, 2012 http://www.efsa.europa.eu/en/supporting/pub/114e.htm
Data collection: data sources and tools Expert consultations (e.g. panel members) • Monitoring tools for the Rapid Alert System • IT applications for data analysis (RASFF) • Identify trends and first-time notification • Media monitoring (JRC-Medisys) • European Media Monitor • Now screens about 90,000 news articles per day in 50 languages • It is fully automatic, 24/7, real-time and updated every 10min • Trade data (Eurostat Comext) • Trends in volumes traded • New trading partners • New commodities • Database on Chemical Hazards • Database providing essential information of all chemical hazards assessed by EFSA since its foundation. http://www.efsa.europa.eu/en/efsajournal/pub/1449.htm
Climate change and mycotoxins: future scenarios The risk of aflatoxin contamination in wheat, maize and rice due to A. flavus was modelled according to different climate change scenarios. Current situation Scenario I Scenario II AF risk in maize Predictions could be used by risk managers to take adequate prevention and control measures to mitigate risks of aflatoxin contamination.
Future challenges: OMICs in Risk assessment Objective: “State of the art of Omics technologies and potential applications in food and feed safety” Objective 1: A review of the available scientific evidence on the state of art of Omics technologies in risk assessment. Objective 2: A database summarising the application of OMICs technologies to the risk assessment of chemical and biological hazards in food and feed safety; Objective 3: Application of Omics to hazard and emerging risk identification; Objective 4: A foresight study on the potential future developments of Omics technologies and possible implications for risk assessment in food and feed safety; Timelines: Delivery of the final report and databases by 2013.
Cumulative risk assessment and Chemical Mixtures • EFSA Scientific Colloquium on Cumulative risk assessment of pesticides to Human Health (EFSA, 2006) • Scientific Opinion on Risk Assessment for a Selected Group of Pesticides from the Triazole Group to Test Possible Methodologies to Assess Cumulative Effects from Exposure through Food from these Pesticides on Human Health (EFSA, 2009) • Internal task force with staff members from Science Directorates established by EMRISK. Specific aims : • Review frameworks from national and international risk assessment bodies and EFSA for human risk assessment of chemical mixtures. • Prepare a scientific report summarising frameworks for risk assessment of chemical mixtures in food and feed with road map/recommendations for future work in EFSA. • Present outcome to the Sc Committee for further consideration
Urgent requests received Intentional adulteration • Melamine in food and feed (2007) • Melamine in infant milk (2008) • Nicotine in wild mushrooms (2009) • Chlormequat in table grapes (2010) Accidental contamination • 4-methlybenzophenone in breakfast cereals (2009) • Escherichia coli in sprouted seeds (2011) • Mineral oil in sunflower oil (2008) • Dioxins in pork meat (2008) Natural phenomena • Volcanic ash (2010) Response from <1 to 30 days
Thank you New seat in Parma!