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Health and Consumer Protection

Speeches Commissioner Byrne

Address by David Byrne on the Precautionary Principle in the domain of human health and food safety
The Economist Conferences "Colloque sur le principe de Précaution organisé par The Economist avec la collaboration de l’Institut Servier", Venue: Salon Dauphine, Place Maréchal De Lattre de Tassigny, 75016 Paris, 1.30pm - 9 th November, 2000

I would like to thank the organisers for their kind invitation to participate in this important conference this afternoon on the precautionary principle.

This topic is of major importance to the Community and it is in all our interests to foster a general understanding of this principle both within the Community and internationally. This conference therefore gives me an ideal opportunity to outline the Commissions view on the precautionary principle, its initiatives relating to the principle and other relevant activities.

The Commission’s interest in this principle arises from its role as a risk manager. It had identified that the precautionary principle was evolving in different policy areas in such a manner that the principle itself was becoming misunderstood, leading to potential intentional or unintentional abuse.

Therefore, we took the lead in bringing together the various views found in different fields, and following much reflection and consultation, published a Communication on the Precautionary Principle in February of this year. I will return to the Communication and our views expressed in it later.

One important message that we believe places the principle in its correct context is that this principle must not be viewed in isolation outside of the overall framework of risk analysis : in the opinion of the European Commission, the principle can only be considered within such a framework and when certain pre-requisite conditions are satisfied.

Earlier this year the Commission also published a White Paper on Food Safety in which it outlined its future orientation on risk analysis and the precautionary principle in relation to food safety. In line with the ambitious programme we have established for food safety measures, the Commission yesterday adopted a proposal for a Regulation on General Food Law and the establishment of a European Food Authority.

This Regulation reflects the Commission’s support for the principles of risk analysis and the precautionary principle, and provides for the organisational procedures and structures to meet the commitments of the White Paper. I will also come back to this very important initiative.

As the Commissioner responsible for health and consumer safety, I am constantly faced with the challenge of balancing the freedom and rights of individuals, industry and organisations with the need to reduce the risk of adverse effects to human, animal or plant health or the environment. Finding the correct balance so that science-based, proportionate, non-discriminatory, transparent and coherent actions are taken, requires a structured decision-making process with detailed scientific and other objective information within the overall framework of risk analysis.

Many risks are complex and multifaceted and the challenge is not only to characterise them but also to identify the correct action to protect health. In doing so, we need to ensure that there is consistency between measures and objectivity in the manner in which decisions are made.

The principles and procedures that make up the overall risk analysis process provide a guiding framework within which such consistency and objectivity can be achieved.

One priority for me has been the promotion of the acceptance of the three inter-related principles of risk analysis: the scientific assessment of risk, the management of risk and the communication of risk, in the field of food safety, health and consumer protection, within the Community and internationally.

Indeed, the Commission has played an active role in revising the framework of risk analysis principles within the Codex Alimentarius, which, within the framework of the United Nations organisation, is responsible for the development of standards and codes for the international trade of foods.

The European Commission has insisted that consideration is given to the precautionary principle in Codex. Discussion are still underway on some of the detail and technical aspects but the Commission will continue to push for a general international acceptance and consensus on risk analysis principles, and in particular, the role of the precautionary principle.

The Commission has also promoted risk analysis principles in other international discussions, for example, in the Agreement on the Application of Sanitary and Phytosanitary measures (the SPS) in the context of the World Trade Organisation.

As you know, the precautionary principle is recognised in the SPS agreement. We are also discussing these issues in the Transatlantic Dialogues for both businesses and consumers and in the discussions within the EU/US Transatlantic Economic Partnership.

It is also important that we step up our dialogue with developing countries as they increasingly perceive our high sanitary standards as barriers to trade. International understanding on these issues is important as agriculture and food trade is so important for the European Union.

But what do we mean by the precautionary principle? We are occasionally faced with situations where an initial scientific evaluation of available information reveals an unacceptable risk but there is some uncertainty or lack of scientific information on some key aspects.

It is these specific circumstances, where an unacceptable risk to health has been identified but further scientific information, data or even research is needed to arrive at a more complete assessment of risk, then the precautionary principle comes into its own.

As I said earlier, the Commission’s Communication on the Precautionary Principle published in February describes the use of this principle in a range of policy areas. It places the precautionary principle within a structured approach to the analysis of risk, and in particular the management of risk.

The Communication establishes guidelines for the application of the precautionary principle in order to build a common understanding of how to assess, appraise, manage, and communicate risk where science is not yet fully able to evaluate it.

The Communication also establishes within its guidelines the checks necessary to avoid inappropriate use of the principle and to prevent it being used as a disguised form of trade protectionism.

For the precautionary principle to be relevant, two pre-conditions have to be in place:

- potentially dangerous effects deriving from a phenomenon, product or process have been identified, and

- that scientific evaluation does not allow the risk to be determined with sufficient certainty.

It is up to the risk managers to decide if the precautionary principle therefore should be invoked. Judging what is an "acceptable" level of risk for society is an eminently political responsibility. Decision-makers faced with an unacceptable risk, scientific uncertainty and public concerns have a duty to find answers.

In some cases, the right answer may be not to act or at least not to introduce a binding legal measure. A wide range of initiatives is available in the case of action, going from a legally binding measure to recommendations for extra controls or the launch of a research project.

The precautionary principle has an enormous impact on the direction and the tenet of our overall policy in food law. The Commission is committed to developing food law based on internationally agreed standards. Where these do not give the high level of protection required in the Community, we will ensure that measures are consistent with the SPS Agreement and based on sound risk assessments.

Also in line with SPS, the Commission will continue to consider provisional measures based on the precautionary principle where a risk may undermine the high level of protection and further scientific information is needed to undertake a complete risk assessment. This is, for example, the basis for the new proposal we presented before the summer on the ban on hormones used as growth promoters, for five out of the six hormones.

The European Commission is convinced that measures based on the precautionary principle should comply with the basic principles for all other legislation and be: proportional to the chosen level of protection, non-discriminatory in their application, consistent with similar measures already taken, based on an examination of the potential benefits and costs of action or lack of action, subject to review , in the light of new scientific data, and indicate responsibility for producing the scientific evidence necessary for a more comprehensive risk assessment.

One thing I'd like to clear up now is that the European Commission does not believe that the precautionary principle is a substitute or excuse for seeking zero risk. Zero risk is rarely found, and in the vast majority of cases we are in the field of managing and controlling risk.

The Communication was not intended to be the final word on the precautionary principle. In fact, it is a document that tries to stir the debate, to open up the issue generally, and in particular provide the basis for discussions in the Council and European Parliament. In both institutions there has been a high level of support for the Communication. In fact, a resolution on the precautionary principle is being prepared for the European Council in Nice in December.

Let me now turn to the proposal the Commission adopted yesterday for a regulation laying down the general principles of food law and establishing a European Food Authority.

As Commissioner responsible for policy in this area, I was delighted that the Commission was able to adopt such a far reaching and comprehensive proposal.

The proposal contains concrete measures aimed at the re-establishment of consumer confidence in the safety of the European food supply and the tools needed in the 21 st century to ensure safe food.

The proposal provides for a modern, dynamic and effective legal framework for food safety, based on robust science and to support this, the correct administrative structures where consumer health is the driving force.

The Regulation lays down the legitimate objectives and definitions of food law with the primary aim being to ensure a high level of health protection. It underlines the commitment to ensure that food law shall be based on high quality, transparent, independent scientific advice, following the three components of risk analysis. It includes the conditions under which the precautionary principle may be considered.

For the first time at the European level, a regulation will provide a clear definition of food in order to increase consistency and legal security, which will form the basis for all future measures on food. Most importantly the Regulation provides an overarching requirement that only safe food be placed on the market and that the right of individuals to have access to safe food only is ensured.

One of the key aspects of this Regulation is that the traceability of foods, and their ingredients shall be ensured through all parts of the food producing chain from the farm to the consumer. This should include, where relevant to food safety, the feed given to food producing animals.

The establishment of a European Food Authority is also foreseen in the regulation. The Authority would provide the scientific risk assessment on all matters relating, either directly or indirectly, to food safety. It will also have strong risk communication responsibilities.

The broad mandate we have proposed will enable the Food Authority to have an overview of the food chain and provide a coherent scientific basis for the Community’s policy and legislation in this area, including the evaluation of all aspects of genetically modified organisms, even where these are not intended for food or feed use. The Commission considers that this flexible approach ensures the best use of scarce resources and avoids wasteful and confusing duplication of scientific evaluations

The rapid alert system , will also be operated by the Authority, which will collaborate with the Commission in the management of crises in the food and feed sector.

The proposed organisational structures will facilitate the involvement of the Authority’s many and diverse stakeholders, independence from external pressures, transparency and accountability to the democratic institutions.

The European food Authority will include an Advisory Committee comprising representatives of the analogous Member States’ bodies. The Authority will provide the central co-ordination for the efforts and resources of the food authorities and agencies in the Member States through active networks, providing the central hub to such networks.

In this Regulation, the principles of risk analysis are established in a concrete manner in relation to food law in the Community. The European Food Authority will provide the structures and mechanisms in relation to the scientific and technical evaluation which are necessary to underpin food and related legislation. The three components of risk analysis will continue to underpin food law.

As you can see, the Commission has identified an ambitious programme to meet the needs for safe food and to ensure consumer confidence. I am pleased to be responsible for this area at this challenging time. I intend to continue pursuing the objective of ensuring that European citizens have access to the safest food supply in the world, that European citizens can rightly have confidence in the principles on which we develop our policies and the institutions monitoring and controlling food safety.

The precautionary principle is an important tool in this context.

However, it is only one instrument and the proposal adopted yesterday by the Commission indicates to you the importance we attach to finding concrete solutions to the complex matter of food safety.

Merci beaucoup de votre attention. Je suis très heureux de pouvoir à présent dialoguer avec vous.


Speeches Commissioner Byrne



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