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Good morning, Ladies and Gentlemen,
I am very pleased to deliver the opening address at the International Conference: Risk Analysis and its Role in the European Union, organised by my Directorate-General for Health and Consumer Protection of the European Commission.
Risk Analysis, a notion which two decades ago was relatively unfamiliar, has become common usage today in many fields of science, regulation and, of course, in the media as well. Hence, it has firmly entered the realm of public debate.
What is Risk Analysis? It is a concept comprising three distinct categories, generally referred to as risk assessment, risk management and risk communication. These three elements of risk analysis alone or jointly will be the subject of interest and, I am certain, of constructive debate during the next two days. A distinguished faculty of high international repute will deal with various facets of this issue.
Therefore, it is neither my task nor my intention prematurely to enter the debate and try to pre-empt the discourse between experts. Rather, as the Commissioner responsible for health and consumer protection, I will try to focus on the political and societal aspects of the issue.
The European Commission regulates a wide variety of substances, products and processes. In exercising this function, it has responsibilities for the entire breadth of the risk analysis process. While the theoretical principles of risk analysis are strikingly similar regardless whether its subject is insurance, air traffic or food safety, its specific rules and practical procedures are distinctly different and highly characteristic for the target area.
In the vast array of subjects within the field of our regulatory mission, food safety has become a focal point of interest, an issue of great political significance. In fact, food safety is among the issues of highest priority for the entire Commission. Therefore, I would like to use food safety as the paradigm to demonstrate our interest in and explain our approach to the application of risk analysis.
This, of course, without implying a lack of dedication to promote the cause of consumer protection regarding the safety of other items, such as toys, cosmetic products, pesticides etc, within the scope of our regulatory responsibility.
With our food we are ingesting every day thousands of chemicals and billions of micro-organisms. The popular idiom "you are what you eat" is not without considerable wisdom. A plethora of chemicals in our food is the life-long just-in-time supplier of building elements for our body to grow or to constantly replace damaged or aged cells and tissues. It is also the source of energy to function in our daily activities. Most of what we eat is not only innocuous, but clearly beneficial indeed, indispensable for normal life. The often carelessly used phrase "chemicals in food" erroneously infers that chemicals are, in principle, undesirable.
Toxicology and microbiology have taught us how to distinguish between deleterious and beneficial chemicals as well as between pathogenic and useful micro-organisms, respectively.
In recent years, these disciplines, together with others, provided a steadily widening scientific basis for risk analysis. This has enhanced our ability to address and to resolve issues of consumer protection with increasing success and reliability. In forging our regulatory measures to protect public health, we have made great use of advice derived from this interdisciplinary source of scientific information.
Why the sudden upsurge of interest in risk analysis? There are several reasons for this phenomenon. To begin with, science has rapidly developed during the last decades resulting in a virtually exponential increase of knowledge and information. Not surprisingly, however, this development neither proceeded at the same pace nor progressed to the same extent in all disciplines.
To demonstrate this let me give you a topical example: In the area of food safety, earlier regulation of potentially toxic substances sought to eliminate their presence in food to what was analytically confirmed as zero.
However, with the development of extremely sensitive, modern analytical methods it became inescapably obvious that this undoubtedly sound principle, often referred to as the principle of zero tolerance, could not literally be maintained. Particularly not in light of the recognition that levels of residues and contaminants in food that were deemed zero yesterday, could - if analysed by new trace-analytical methods - suddenly turn out to be easily and accurately measurable quantities today. It can safely be predicted that this tendency to detect and accurately measure ever-decreasing concentration of chemicals will continue in the future. Hence, it would be quite a futile effort to try to engage in the perennial redefinition of zero. Most of all, it would be quite unnecessary as well.
Therefore, the question properly asked is not whether minuscule amounts of chemical substances are present, but whether they have any relevance to human health. Risk analysis, which has come of age in recent years, can guide us to make this crucial distinction. Indeed we have for quite some time been gaining experience in the process of using methods of risk analysis in our daily work.
Establishing acceptable daily intake (ADI) levels and maximum residue limits (MRLs) are just two pertinent examples.
A further reason for the heightened global focus on risk analysis derives from our international commitments, especially under the disciplines of the World Trade Organisation. The "Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement)" assigns risk assessment a pivotal role, which gains manifest significance in the course of dispute settlement procedures.
Our own recent communication on the precautionary principle stresses likewise the importance of risk analysis. With this document, the European Commission made an important contribution to the lengthy international discussion on this subject underlining that we regard the precautionary principle as an integral part of the second stage, risk management and, thus, an important aspect of a structured approach to risk analysis.
In preparation of regulatory measures, the European Commission heavily relies on scientific advice originating from different sources. One of the most important of these sources is our system of scientific committees. In recent years, with increasing complexity and sophistication of both science and legislation, it became evident that the mechanisms of the past cannot satisfy the needs of the present and the future. Therefore, in 1997, in the aftermath of the BSE crisis, the European Commission took decisive steps to deal with the deficiencies of the past and to introduce measures to enhance the integrity and the effectiveness of its scientific advisory mechanisms.
Currently eight scientific committees are devoted among others to issues of food safety, animal nutrition, animal health and welfare, plant protection, cosmetics, chemicals as well as medicinal products and medical devices, respectively. A multidisciplinary ninth group, the Scientific Steering Committee has an overriding co-ordination function. In addition, it is dealing with issues overlapping the area of mandate of several scientific committees, such as the harmonisation of principles and procedures of risk analysis across the entire system of scientific committees, numerous BSE-related topics and emerging health issues.
By successfully exercising their advisory function, in particular while preparing scientific opinions, these committees are operating clearly in the field of risk assessment.
Short after taking office, as I already mentioned, the new Commission determined food safety as one of its highest priorities within its work programme. With the publication on 12 January 2000 of our "White Paper on Food Safety", a radically new approach is proposed to assure that the EU has one of the highest standards of food safety in the world.
A key element of the White Paper, which is highly pertinent to the theme of this Conference, is the proposal to establish an independent European Food Authority. It states "The role of an Authority must be defined in the context of the process of risk analysis, which comprises risk assessment, risk management and risk communication."
While the White Paper proposes particular responsibilities for both risk assessment and communication on food safety issues to the European Food Authority, it leaves no doubt as to the firm view that "risk management must be left to an institutional framework with full political accountability", i.e., the Commission, the Parliament and the Council.
This is now neither the time nor the place to discuss the White Paper's proposals in detail. However, the work currently carried out by the five Scientific Committees concerned with food safety will be a core part of the new Authority. Accordingly, in preparation for the establishment of the European Food Authority, which is expected to be in place by 2002, the role and the structure of the current system of scientific committees will undergo a further thorough review.
Notwithstanding the outcome of this review, I can assure you today that the European Food Authority will be "based on the principles of the highest levels of independence, of scientific excellence and of transparency in operation."
Although risk assessment is an extremely powerful tool, it is not the silver bullet. Faulty or fraudulent science cannot be replaced or corrected by good risk analysis. On the contrary, mathematical models of extrapolation often used while performing risk analysis can, by multiplying the error, even further distort the truth. This is why this Commission is determined to acquire the best possible scientific advice that is available at any given time. We must prevail in this endeavour to secure reliable and solid risk assessments on which to base our risk management measures.
While exercising our regulatory function, we are fully aware of our great societal responsibility. Simply to decline authorisation, or ban authorised products already on the market, would be ill-conceived, misguided consumer protection.
Regulation always entails limitation, both for individual citizens as well as for public and private institutions. Limitations should invariably be imposed for the benefit of the community at large and limitations themselves should be limited to the unavoidably necessary extent.
As we have seen, intelligently applied, risk analysis can be our useful companion in fulfilling our mission in achieving that goal. We are and ought to remain accountable for our action or inaction in public service. Should we procrastinate in face of real danger, we would recklessly violate our foremost task to protect public health. Should we, on the other hand, be too glib about thwarting the development or prohibiting the marketing of ultimately safe and useful products, we would inexcusably disregard our dues towards society. Thereby needlessly endangering the livelihood of others and undermining the very basis of our collective prosperity.
The role of risk analysis in this context is both to provide objective guidance and to underpin our reasoning while attempting to strike the right balance in real life.
This is particularly the case for the application of biotechnology. I believe that everybody agrees that the use of GMOs has a huge potential, already well recognised in the area of medicines. However, the public debate has been more focused on potential risks to human health of applying biotechnology to food.
Furthermore, the public has raised concerns about ethical aspects, lack of consumer information and potential adverse effects on the environment.
I believe that it is important to address all these factors - and not only the potential risk and benefits for human health - in the risk analysis process for foods derived from GMOs.
Undoubtedly, science is a necessary, but in itself, insufficient basis of regulation. Therefore, science-based regulation should never be misunderstood to mean science converted, at its face value, into regulation. It must be clearly recognised by all stakeholders what, in general and in specific cases, science can deliver and what it cannot.
On the basis of best science and regulation, risks can be managed, can be contained, but they cannot ever be eliminated.
Zero risk is and will remain an unattainable aim. Rather, all human activities are fraught with risks. Even inactivity is not devoid of risk.
An objective scientific risk assessment is the indispensable prerequisite for successful risk management that, in turn, can provide a reliable basis for effective consumer protection while regulating a large variety of substances, products and processes.
Better understanding of risk will help us to be better regulators. This Conference provides an excellent opportunity for both.
An ever increasing number of national, supranational and international documents, including those in effect in the European Union, mandate or recommend the use of risk analysis. I am therefore very pleased that timely issues of this burgeoning discipline can be debated here in such a gathering of internationally recognised experts.
With these remarks, ladies and gentlemen, I intended to express my interest in and demonstrate my support for this Conference.
Before concluding, I would like to thank Director General Robert J Coleman and his associates for having taken the initiative to organise this Conference and assemble a programme that promises us two exciting and intellectually stimulating days.
I wish you all successful acquisition of new knowledge and information as well as inspiring exchange of views in a fruitfully pleasant atmosphere.