1. IADSA SCIENTIFIC FORUM, MOSCOW, 17-18 June 2009 The European Union Perspective on Risk/Benefit Professor Dr. Arpad Somogyi Berlin - Brussels - Budapest Berlin - Brussels - Budapest

2. IADSA SCIENTIFIC FORUM, MOSCOW, 17-18 June 2009 Treaty of Amsterdam (1. May ‘99) TITLE XIII PUBLIC HEALTH Article 152 (1) A high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities.

3. IADSA SCIENTIFIC FORUM, MOSCOW, 17-18 June 2009 Brussels, 12 January 2000 COM (1999) 719 final WHITE PAPER ON FOOD SAFETY

4. IADSA SCIENTIFIC FORUM, MOSCOW, 17-18 June 2009 Legal Basis REGULATION (EC) No 178/2002 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety

5. IADSA SCIENTIFIC FORUM, MOSCOW, 17-18 June 2009 This Regulation...establishes common principles and responsibilities, the means to provide a strong science base, efficient organisational arrangements and procedures to underpin decision-making in matters of food and feed safety. These organisational procedures should make it possible…to determine the most effective measures on the basis of the best scientific information.

6. IADSA SCIENTIFIC FORUM, MOSCOW, 17-18 June 2009 Science : “the state of knowing: knowledge as distinguished knowledge as distinguished from ignorance or from ignorance or misunderstanding” misunderstanding” Merriam-Webster's Collegiate Dictionary (1998)

7. IADSA SCIENTIFIC FORUM, MOSCOW, 17-18 June 2009

8. “ It is recognised that scientific risk assessment alone cannot, in some cases, provide all the information on which a risk management decision should be based, and that other factors relevant to the matter under consideration should legitimately be taken into account including societal, economic, traditional, ethical and environmental factors and the feasibility of controls.”

9. IADSA SCIENTIFIC FORUM, MOSCOW, 17-18 June 2009

10. Regulation is based on Science Science Laws and Laws and Social Values Social Values Richard Bates

11. IADSA SCIENTIFIC FORUM, MOSCOW, 17-18 June 2009 Marquardt, Schäfer, Lehrbuch der Toxicologie, 2nd ed., WVG Stuttgart (2004)

12. IADSA SCIENTIFIC FORUM, MOSCOW, 17-18 June 2009

13. Should risk analysis and benefit analysis require the same level of scientific confidence? Yes! But how to ascertain that?

14. IADSA SCIENTIFIC FORUM, MOSCOW, 17-18 June 2009

15. “When a food or food substance is associated with both potential health risks and benefits, and particularly when the levels of intake associated with risk and benefit are close, there is a need to define an intake range within which the balance of risk and benefit is acceptable for risk management purposes.” EFSA Scientific Colloquium Summary Report 6: Risk-Benefit Analysis of Foods – Methods and Approaches, 2006

16. IADSA SCIENTIFIC FORUM, MOSCOW, 17-18 June 2009 Guidance document should deal with the following topics: Problem formulation Definitions and language to be used Conversion of animal data to human situation Methods and approaches Potential pitfalls

17. IADSA SCIENTIFIC FORUM, MOSCOW, 17-18 June 2009 The Scientific Committee of EFSA established in 2007 Working Group on Human Health Risk-Benefit Assessment of Foods Working Group on Human Health Risk-Benefit Assessment of Foods “To prepare a guidance document for performing risk- benefit assessments of food related to human health risks and human health benefits.” This is a currently on-going activity with the aim to adopt the guidance document by early 2010. Draft will be available for public consultation later in the current year

18. IADSA SCIENTIFIC FORUM, MOSCOW, 17-18 June 2009 Terms of Reference Situations for which RBA may be appropriate Guidance on problem formulation Consideration of methods and approaches needed to assess risks and benefits and how to compare them (common scale of measurement) Scope and objective, harmonised language Usefulness of toxicological, nutritional and epidemiological data to assess risks and benefits Extrapolation of animal and other data to the human situation Identification of potential limitations of any RBA Review of ongoing activities Recommendations on future initiatives to overcome current limitations

19. IADSA SCIENTIFIC FORUM, MOSCOW, 17-18 June 2009

20. Risk: The probability of an adverse effect in an organism, system, or (sub)population in reaction to exposure to an agent (IPCS, 2004) Benefit: Probability of a positive health effect and/or the probability of a reduction of an adverse health effect in a group of individuals in reaction to exposure to an agent.

21. IADSA SCIENTIFIC FORUM, MOSCOW, 17-18 June 2009 “Risk means a probability of an adverse health effect and the severity of that effect, consequential to a hazard;” “Risk assessment means a scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation”

22. IADSA SCIENTIFIC FORUM, MOSCOW, 17-18 June 2009 What benefit means? Benefit means a favourable health effect … small or big effect? And what benefit assessment means? Benefit assessment means a scientifically based process consisting of X steps:… what are they?

23. IADSA SCIENTIFIC FORUM, MOSCOW, 17-18 June 2009 Benefit means a probability of a favourable health effect and the measure of that effect, consequential to a benefaction; Benefit assessment means a scientifically based process consisting of four steps: benefaction identification, benefaction characterisation, exposure assessment and benefit characterisation Are these nonsensical definitions? Yes, they are!!!

24. IADSA SCIENTIFIC FORUM, MOSCOW, 17-18 June 2009 Risk is a probability Risk analysis is a well established procedure with a defined and fairly sophisticated structure Benefit is a property Benefit analysis is currently ill defined without an established structure and characterised by ambiguities

25. IADSA SCIENTIFIC FORUM, MOSCOW, 17-18 June 2009

26. I am very grateful to Dr. Djien Liem Responsible official in charge of the Scientific Committee and the Advisory Forum of the European Food Safety Authority for his kind permission to use some of his slides in my presentation