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Paper Prepared for The Mentor Group
The Forum for US – EU Legal – Economic Affairs
Helsinki, September 1998
Note: This paper reflects the opinions of the author, and not necessarily those of the European Commission
In recent years food safety has attracted increasing public concern, in the European Union and elsewhere, both as regards traditional food and new products. Food scares have led to waves of distrust in public authorities, who have reacted, with strong, but not always well-conceived actions. Public debates on such issues as the use of genetically modified organisms (GMOs) for the production of food and medicines have been plagued by emotional overtones that have not helped real understanding of the issues at stake.
Governments have found themselves compelled to take increasing responsibility for the protection of public health and safety as it is affected by food. National requirements, which have grown up over many years in different national environments, have not always been consistent. On the EU level, this has led to barriers to the free circulation of food in the internal market; on the international level it has led to trade disputes and frictions. The recent disputes between the European Union and the United States on hormone treated meat, bovine somatotropin hormone in dairy products, and genetically modified organisms are cases in point.
How then, has EU food policy sought to provide appropriate conditions for this important economic activity to develop in a climate of public confidence and security for the consumer? The objectives of this paper are to set out the principles of EU food policy and discuss certain aspects with a view to improving understanding and to opening a discussion on possible improvements.
EU food policy falls under two major headings in the EU Treaty: the common agricultural policy (CAP: Art.43/EC) and the internal market (Arts.100 and 100a/EC).
Thus some products are covered by the rules of the common agricultural policy, while others are covered by the rules of the internal market. The division corresponds roughly to that between primary and processed foodstuffs. However, there are exceptions, whose logic is part of the history of the European Union. Although the principles relating to food are often similar, there are differences of detail and procedure between these two policy areas.
I will ignore distinctions between the two areas where they only concern forms of words, but will draw attention to policy differences, where these arise.
I. 1. The objective and basic principles of European food policy
The objective of European food policy is to establish and maintain a single market in foodstuffs. This is the foundation for the viability and competitiveness of the European food industry, which needs a broad and open market to develop, to innovate and to compete with its counterparts from other areas of the world. This objective is inextricably linked with the establishment and maintenance of a high level of protection of public health, of safety and of consumer protection.
In achieving this objective, the European Union has brought to an end the divergence of the food legislation of its Member States, by the adoption of common legislation (under the CAP), or of harmonising legislation (for the internal market).
Two basic principles underpin EU legislation. First, the primary responsibility for the safety of the food rests with industry, producers and suppliers. Second, consumers are to be provided with essential and accurate information, so that they may make informed choices about the food they choose to buy or to consume. In addition, where health risks justify particular high levels of protection, as determined by parliament and consumer demands, detailed rules are prescribed. These set the level of safety to be achieved and, in appropriate cases, the method to be used. These measures are subject to two general requirements: that they should be based on science; and that the measure should be proportionate to the risk.
I. 2. Legal Architecture
Art. 3/EC lays down the general activities of the EU, including the common agricultural policy and the internal market.
The common agricultural policy provides for the replacement of national legislation in its field by common European legislation. This is adopted under Art. 43 of the EC Treaty. Although some scope for national measures remains, where the EU legislation has left an issue to be resolved in this way, such measures are of relatively minor importance.
Under the internal market, the EU has a substantial body of law which provides for an area without internal frontiers, in which goods can circulate freely. This operates through a cascade of provisions.
Art. 30/EC prohibits Member States from establishing or maintaining quantitative restrictions on imports and all measures that may have an equivalent effect. However, by way of exception to this principle, Art. 36/EC defines limited grounds on which restrictive national measures may be imposed inter alia for the protection of the health and life of humans. However, such measures should not constitute a means of arbitrary discrimination or a disguised restriction to trade between Member States.
The reference to "measures having equivalent effect" and the exceptional nature of the measures provided for in Art. 36/EC give teeth to these provisions. The European Court of Justice has given a broad interpretation to the former and a narrow interpretation to the latter. In particular, the celebrated Cassis de Dijon ruling of 1979 established that products, which can be legally put on sale in one Member State, must be allowed access to the market of another Member State, unless the latter has a higher level of protection of its citizens. This ruling effectively reverses the burden of proof, by requiring a Member State, which does not want to accept such a product on its market, to demonstrate why compliance with the requirements of another Member State would not adequately protect its citizens. It thereby establishes the principle of the mutual recognition of laws.
Where national measures do not aim to achieve the same level of protection (or where there is sufficient confusion to create uncertainty in the market place), the principle of mutual recognition is insufficient to ensure free movement. In this case, Art. 100a/EC provides for national requirements to be harmonised across the European Union. In proposing such measures, the Commission is required to take as a base a high level of health, safety, environmental and consumer protection. The aim of harmonisation is to achieve the free movement of the products and, where this can be achieved without full identity of measures, EU law makes this possible. In such cases it is still possible for the Member States to adopt additional legislation, provided that it does not infringe the principle of mutual recognition for products from other Member States. Further, the most commonly used instrument for harmonisation is the directive, a measure addressed to the Member States, which requires them to adapt their national regulations, but may leave them a considerable margin as to how that is to be done.
The on-going debate on the principle of subsidiarity, now incorporated in the Treaty as Art. 3b, is to be seen in the light of these provisions. Subsidiarity requires that, except in areas of common policy (such as the common agricultural policy), the European Union should only act insofar as its aims cannot be achieved by the Member States. It will be clear from what has been said that, even before the principle was made explicit, the Treaty applied subsidiarity to the internal market. European Union harmonising legislation is a last resort, only brought into play when Member States are unable to mutually recognise the equivalence of their levels of protection. This leaves harmonisation as the only way to maintain the internal market.
Since 1985, application of the principle of mutual recognition has enabled many directives relating to free movement of goods to be limited to setting generic "essential requirements" and conformity assessment procedures, leaving the definition of the details of technical solutions to industry, to be incorporated in non-mandatory harmonised standards. This New Approach has not so far been used in food legislation. There has been reluctance to allow sensitive details of food safety to be determined by standards bodies, operating outside the governmental framework, who have little tradition or experience of handling these matters. Nevertheless, inspiration has been drawn from the New Approach, insofar as policy has concentrated on horizontal directives, which in the main lay down broad principles and minimise specific detail. For example, measures establishing the principles of food hygiene and labelling leave Member States free to adopt stricter rules where these do not restrict the operation of the internal market. Non-mandatory guidance has also been used to complement some of the legislation.
I. 3. The legislative process
All EU legislative acts relating to foodstuffs have to be adopted on the basis of a proposal of the European Commission. Measures relating to agricultural produce, adopted on the basis of Art. 43/EC, follow the consultation procedure, that is they are adopted by the Council of Ministers after consultation of the European Parliament. Measures based on Art. 100a/EC are adopted by co-decision, a procedure in which the final text has to be agreed by Council and the European Parliament. This usually involves two readings in each institution and, in the case of diverging positions, a conciliation procedure. Although this can be time consuming, it is not very different from the procedure followed in most bi-cameral legislatures.
Under Art. 145/EC, the Council confers on the Commission powers for the implementation of the rules it lays down. These powers are exercised with the assistance of a committee of experts from the Member States, which has to be consulted before any implementing measure is adopted by the Commission. The Commission has implementing powers covering many technical issues in the field of food legislation. Art 145 refers to implementation and does not establish a distinction between legislative and executive decisions. In practice, decisions, on what powers to confer upon the Commission, and what powers are reserved for full Council and Parliamentary procedure, have been taken ad hoc, reflecting the sensitivity of the issue for national parliaments and public opinion, rather than any clear distinction between legislative and executive functions.
The Scientific Committee for Food provides the scientific advice to underpin the legislative process in Europe. The Committee is composed of independent experts, invited for their excellence and profile in a particular field. The independence, robustness and transparency of the Committee’s opinions is a major element in the credibility of legislation. This advice is founded on the three principles of risk analysis: the scientific assessment of risk, the choice of a risk management strategy, and the communication of the risk. Other scientific committees are also involved in certain aspects of food policy.
Risk assessment is about dangerous events and their probability distribution. Scientific data is gathered, and centres of excellence capable of carrying out specific risk assessment work are identified, through a programme of scientific co-operation managed by the Commission’s services.
Risk management, the crucial part of the process, concerns decision making on the different types of risks. It requires transparent procedures and appropriate involvement of the different components of democratic government. Many of the recent controversies have involved argument about this appropriate involvement and it often proves difficult to find an acceptable basis for risk management.
The communication of risk is making full information available to all participants in the process in an unbiased form.
In 1997, responsibility for the management of scientific committees was separated from responsibility for the legislative services which they advise. I will come back to these issues later.
I. 4. Principal instruments
European food legislation can be divided into three main families.
The first, comprising most of the legislation, relates to product safety. It covers such areas as food hygiene, additives, solvents, materials in contact with food, contaminants, novel foods, and the control system. Many of these measures are horizontal in nature, establishing requirements across a wide range of products or processes. However, there are several vertical, or product specific, food safety measures; for example for food hygiene. Although there is one horizontal directive, thirteen vertical hygiene directives, for products of animal origin, co-exist with it.
The second family concerns consumer information. This is mainly provided through labelling. Horizontal measures set out rules for providing truthful, essential and meaningful information for the consumer. Specific labelling requirements have recently been added, covering quantitative declaration of ingredients and novel foods.
The third concerns quality requirements. Such measures are particularly common in the agricultural area. The protection of quality is, in a sense, akin to consumer information. Examples include vertical directives for honey, sugar, chocolate, milk products, dietetic foods and special regionally produced foods or brands.
I. 5. International aspects
The two most important arenas for foodstuffs regulation are the World Trade Organisation (WTO) and the Codex Alimentarius.
From 1947, the rules for international trade in commodities, including agricultural products and foodstuffs, were progressively refined through several "rounds" of negotiation under the auspices of the General Agreement on Tariffs and Trade (GATT). In 1995, this was succeeded by the World Trade Organisation.
Efforts to establish a complete framework for international trade in foodstuffs have been fraught with difficulty. Work has focused on the balance between the protection of human, plant and animal health and the desire to trade commodities freely. Thus successive GATT rounds allowed signatories to adopt measures which they deemed necessary to protect health, as long as these were not arbitrary, or unjustifiably restrictive, or disguised restrictions on trade. However, what may be considered as necessary was not defined.
Meanwhile, the Codex Alimentarius (a body under the aegis of the UN FAO and WHO) was formed in 1962, to facilitate the development of trade in foodstuffs and to reap its economic benefits. It has elaborated non-obligatory standards, recommendations and guidelines aimed at food safety and fair trade. Until recently it was left for governments to decide on the relevance of these to their national legislation.
The Uruguay Round, completed in 1994, included, in particular, the Sanitary and Phyto-Sanitary (SPS) Agreement. This changed the relevance of Codex Alimentarius standards. The Agreement requires members to use the standards of Codex Alimentarius as a basis for their national rules, in health-related areas such as hygiene, additives, and residues of veterinary drugs and pesticides. Members may introduce measures which result in a higher level of health protection than afforded by the Codex standard, where there is scientific justification, based on an assessment of risk. Other factors may also be taken into account when setting the level of health protection, provided that negative trade effects are avoided. These include, for example, the feasibility of official controls, sampling methods or economic factors. In addition, the Agreement lays down the mechanism for settling disputes between trading partners. The Codex Alimentarius codes and standards are, therefore, reference texts under this Agreement and signatories are required to participate actively in developing them. The texts are particularly relevant where cases are brought in front of the World Trade Organisation’s disputes panel.
The Technical Barriers to Trade (TBT) Agreement also falls under the competence of the WTO. This originated under the Tokyo Round of negotiations completed in 1979 and complements SPS by covering those aspects of food legislation not within the scope of SPS, for example, commodity standards and labelling.
The EU legislation respects its obligations under WTO and, where relevant, is in line with Codex Alimentarius.
I. 6 Control and enforcement
For the internal market to function efficiently requires confidence that the food industry respects its obligations. In turn, this requires that compliance is adequately monitored and enforced by the official control authorities. Responsibility for the control and enforcement of EU rules rests with the Member States.
The controls applied by the national authorities have been harmonised at EU level by a framework directive. This lays down general principles for the inspection, sampling and control of foodstuffs. It also provides for inspectors to be empowered to examine, record and seize or destroy foodstuffs which are unsafe or otherwise non-compliant. The framework Directive requires the Member States to inform the Commission of their control activities and provides for EU-wide co-ordination through annual control programmes. In addition, the Karolus programme provides for exchange of control officials. Administrative co-operation has been built in, to increase mutual confidence, understanding and effectiveness.
Controls are also undertaken at Union level. These are targeted at ensuring the adequacy and equivalence of the controls applied by the national authorities and involve teams of officials from the Commission in checking that the national systems are capable of meeting these goals.
The particular dangers arising from zoonotic diseases, like salmonellosis, tuberculosis and viral contaminants, have led the Commission’s veterinary inspectorate to control and approve establishments in third countries which produce food of animal origin for export to the European Union. Such products are also controlled at the point of entry into the European Union. However, in the main, food of non-animal origin has not been subject to this type of control nor is the importation of these foodstuffs into the EU restrictive.
In recent years food policy at international level has been moving in a new direction, towards industry taking the responsibility for the control of the foodstuffs it produces, backed up by official control systems. The European foodstuffs industry has been at the forefront of the development of preventive food safety systems, in particular the Hazard Analysis and Critical Control Point system (HACCP), which requires the industry itself to identify and control potential safety hazards. Control measures are decided and applied by industry, with a view to producing safe food. The national authorities check that the controls are adequate. Although initially introduced by industry and employed in a non-mandatory manner, the success of this approach has led to it being included in several directives.
In 1996, the Commission decided to launch a public consultation on food law. This aimed to examine the effectiveness of food legislation from three angles: the provision of a high level of protection and safety; the functioning of the internal market; and the provision of a simple and rational legal framework within which industry and trade would prosper.
The BSE crisis has added a new dimension to the discussion, since it led to a questioning of the competence and independence of public authorities and the effectiveness of the control system in protecting the consumer. A Committee of Inquiry was set up by the European Parliament, which pointed to a number of weaknesses in the existing system. In particular, it criticised the system of control, and called for full separation of legislation, controls and scientific assessment at all levels of the system. The principal concern of the Committee was to ensure that safety considerations and consumer protection would always be given priority in the formation of legislation.
In spring 1997, the Commission separated the responsibility for the management of the scientific committees and the control activities from the services responsible for legislation. Measures were also adopted to improve the performance of each control service and to strengthen their independence, transparency and effectiveness.
At the same time, the Green Paper on the general principles of food law in the European Union was published. A major conference was held in November that year, and more than 150 written comments were received by the Commission services. As a result the Commission is now preparing proposals for a comprehensive framework law for food and the adaptation of existing Community foodstuffs measures.
The discussion that follows concentrates on possible scope for development in three areas:
II. 1. The Regulatory Approach
European food legislation has evolved over the last thirty years reflecting a blend of scientific, societal, political and economic forces. Although many provisions have been developed in a comprehensive and co-ordinated manner, it cannot be denied that others have been introduced in an ad hoc way, responding to the food safety concern, internal market problem or political issue of the day. This has sometimes resulted in over-complex or fragmented measures. At the same time, there has sometimes been a lack of consistency. In some cases, legislation has been prescribed down to the last detail, without enough attention to the principle of proportionality.
Further, the principle that responsibility for safety rests with the industry has not been uniformly respected. In some areas, the legislator has taken responsibility, by introducing precise requirements for production processes, process approval and product authorisation. If this is sometimes justified by pointing to high health risk, it cannot be denied that there are cases with a relatively high health risk where it is not done, and where the legislator has been content to set objectives and goals, leaving the rest to industry.
Whereas the complexity of food production and distribution argues for an even-handed and proportionate approach covering the whole food chain, the different objectives of the common agricultural policy and the internal market have, to some extent, encouraged practices to diverge. Yet the strength of a chain depends on all its links and there is a need for integration of measures from the farm gate through to the consumer. There is no point in controlling one part of the food chain if contamination is better controlled elsewhere. To some extent, it is a matter of indifference whether improvement is achieved by the greater use of horizontal measures or by better co-ordination and prioritisation of the measures applied to each link in the chain.
The hygiene area illustrates this problem. On the one hand, thirteen product-specific hygiene directives cover products of animal origin, from production to the point of distribution, and lay down detailed requirements. On the other hand, one horizontal hygiene directive covers all other products, with requirements based on goals, intended results, good hygiene practices and HACCP principles. This directive covers vegetal products throughout the chain and even includes products of animal origin after the point of distribution. It imposes the responsibility for the safety of food and the prevention of unacceptable risks to the consumer on the industry. At the same time, it allows industry the flexibility to meet its obligations by the most appropriate means available, and to respond quickly to new pathogens or contaminants while providing a basis for innovation.
This challenges industry, particularly smaller businesses, to maintain a good technical understanding of food safety. The production of voluntary sectoral guidelines on hygiene practices and HACCP, produced by industry in conjunction with the competent authority, provides the basis for common understanding. Backed up by effective controls, this approach can ensure a high level of health protection.
Of course inconsistencies, unnecessary detail and rigid procedures reflect, to some extent, the difficulty of reconciling Member States' divergent views on issues of high public concern. But they do not always facilitate compliance, and there is no question that they increase costs for industry. They can also be a source of trade barriers within the internal market. In certain cases, so many requirements and safeguards have been introduced that decision taking has become very slow and difficult. The sensitive area of using GMOs in food production is a case in point. This case also serves to illustrate another point: that what may appear to be an unjustifiable barrier to international trade reflects in reality a difficulty in finding acceptable domestic compromises. Such a situation gives rise, first and foremost, to an adverse impact on the European economy. It reduces consumers’ choice and the potential for the industry to use or develop technologies, or produce foods accepted in other parts of the world. Job creation and growth are stifled and standards of living are lowered.
The legislative process can also be excessively cumbersome. It can take several years to pass from the conceptual stage to the implementation phase of detailed technical requirements at Community level.
Of course, safeguard measures exist to cover immediate dangers to health. These can be adopted very rapidly. But the desire to ensure the highest level of safety has sometimes led to very complex implementing procedures. Indeed, the approval process itself shares features of legislative procedures so that the criteria established in general legislation can be questioned and sometimes modified. Even after a decision is taken, Member States can still challenge these individually, through recourse to one of the safeguards contained in the Treaty for the protection of fundamental public policy interests, or challenge the decision in the Court of Justice.
The requirement that decisions be based on science is also less straightforward to meet than may appear. For scientific advice to the legislator to be useful, it has to meet the three Rs: it has to be relevant, reliable and rapid.
Relevance requires that questions are appropriately formulated, so that the answers obtained are sufficiently precise and focused. This is not always easy. To give an example, asking whether a particular organism or additive is fully safe, meaning zero risk, would almost invariably produce a negative answer. On the other hand, an alternative question, based on a definition of acceptable levels of risk, could be seen as pre-judging the issue.
Reliability can also raise difficult questions. In many cases, available evidence may not be sufficient to evaluate the possible risks.
Nor is it easy to ensure that advice is rapid, meaning that is timely for the decision-making process. In some cases, legislation requires specific decisions to be taken before particular products can be marketed, but does not specify a fixed time limit for these to be taken. This can lead to serious delays, in particular where the implementing power has not been delegated to the Commission. The case of the procedure for the approval of a new additive illustrates the problem. A detailed file has to be submitted to the scientific committee for evaluation. Only after successful completion of this evaluation, which may take up to two years, can the legislative process be initiated. This follows the co-decision procedure, which, in turn, is unlikely to take much less than two years. This is a very long procedure compared to that which applies to the approval of additives in other parts of the world. Yet it is hard to see how this delay is justified in terms of extra safety achieved.
Thus there is room and a need to streamline the regulatory system, and to improve both the availability and timeliness of scientific advice to it. One possibility would be to make a clearer distinction between general legislation, establishing criteria and requirements, and implementing powers that can be delegated to the Commission. Of course, the committee procedures for the exercise of these delegated powers provide for the involvement of the Member States. Full transparency of the procedure can go a long way to meet the concerns of the European Parliament and consumers.
The practice of other countries also points to effective approaches. For example, in the USA, the Food and Drug Administration (FDA) develops and applies food legislation, from horizontal measures to detailed approvals, including pre-market approval of additives and other ingredients. It does this through its Centre for Food Safety and Applied Nutrition, acting as an agency. It is advised by its own scientists, as well as by other advisory committees. Approval is administrative and does not require Congress to regulate. Australia and Canada have similar mechanisms.
In all these cases, there seems to be a high level of public confidence in the systems for food legislation and control.
Their main strength seems to lie in their political independence, in the sense that, while both elected and un-elected representatives of interest groups are kept fully informed, they cannot directly influence specific decisions. Once this separation is achieved, the issue of keeping the preparation of legislation apart from controls and scientific advice may appear less relevant.
Such a mechanism is not foreign to the European Union. The European Agency for the Evaluation of Medicinal Products (EMEA) is primarily responsible for the scientific evaluation of applications for a European marketing authorisation, for medicinal products. This includes those derived from biotechnology and other high technology and covers products for use on both animals and humans. For other products, the EMEA arbitrates where mutual recognition of national marketing authorisations between the Member States is not possible through a decentralised procedure. The EMEA also reinforces the safety of medicines through pharmacovigilance and co-ordinates the scientific resources made available by the authorities of the Member States.
All decisions are formally taken by the Commission as implementing decisions of a general regulation which sets out criteria and procedures. The committee structure involves the Member States and their scientific services in every phase of the authorisation process, this procedure has enabled the agency to ensure rapid decisions and, at the same time, to ensure the highest standards of scientific excellence for health protection. The European Parliament appoints two representatives on the Executive Board of the Agency, and regularly discusses reports on its activities.
II. 2. Meeting Consumer Concerns
Consumer concern about food safety is rising world-wide. Food scares have dented consumers’ confidence in the legislation, scientific advisors, and the food industry. The US has suffered from this no less than Europe. Scares have led to President Clinton’s "Food Safety Initiative", with a budget of $43 million in 1998 with a further $101 million requested for 1999. In the European Union, they have led to the re-organisation of the Commission services. The European Union has felt these problems to the full.
Although consumer pressure is a positive drive to action, disproportionate perception of risk may be counterproductive, diverting attention from areas of higher, but less emotive and less publicised difficulty. Food scares can precipitate changes in policy and organisation focusing on the current problem, while undermining the environment in which to develop solutions to longer-term issues. Change can too easily be driven by heightened perceptions which obscure reality. Consumer attitudes towards new processes, new technologies and new products, are often marked by public scepticism of scientific evidence and the motives of those involved. Consumers’ perceptions are the critical issue of risk communication.
Consumers’ perceptions are essential for the good functioning of markets and product acceptability. The difficulty is to ensure that these perceptions reflect available scientific evidence and do not lead to an undermining of the science- based approach.
Food safety in developed countries has never been higher. Yet there seems to be a growing demand that food should always be fully safe to eat and that the consumer should be assured of zero risk. This is simply not realistic. But the problem is to convince the consumer of this. Certainly, better communication about food safety and potential risk is needed. But this may not be sufficient. We need to be clear about the facts and risks involved and inform consumers that it is simply impossible to eliminate risk completely. Greater involvement of consumers’ representatives in the decision making process, bringing increased transparency and better understanding of the issues could help. The European Union has an advisory committee for food which includes consumers and industry. The committee has not met very frequently and it could provide such a forum.
A case can be made that scientific committee proceedings should be fully transparent and publicised, in order to satisfy consumers that their particular concerns have been taken into account. International comparison points to many interesting examples of the involvement of all interested parties in the formulation of legislation, with procedures entailing extensive public consultation before enactment, often reinforced with an obligation to give satisfaction to every special concern. The involvement of interested parties in all stages of the risk analysis and legislative processes in the United States, Australian, New Zealand and other systems, offers impressive examples.
II. 3. Scientific advice
Legislators should have access to as wide a range of scientific expertise as possible in order to obtain the best available and up to date advice. This is important for consumer protection, legislative correctness and, where measures are contemplated outside of those of the Codex Alimentarius, the ability for these to withstand international scrutiny.
The restructuring of the Commission’s services, in the wake of the BSE crisis, has increased confidence that the scientific advice is independent from the proponents of legislation. Yet there are disadvantages in this change, insofar as it makes communication and co-ordination more difficult.
A weakness in the European system is the limitation in the resources available to the scientific committees. Their members, invited for their independence and excellence, are not employed by the Commission. As a result, meetings have to be infrequent. Further, the committee can be requested to address a very wide range of issues. There may only be one or two members with expertise in any particular area. In these circumstances, it may not be unfair to question the robustness of the scientific advice from time to time. At the very least, the limits on resources can make it difficult for the committee to provide timely advice and can delay legislation.
Further, science itself has limitations. Although science forms the basis of objective decision making and therefore legislation, science itself is a dynamic field, where opinions and advice always contain an element of uncertainty. Scientific opinion can change in the light of new information and new studies. Hazards may emerge where they did not previously exist. Scientific advice and the measures based on it may need to be adjusted accordingly.
Often there is little scientific data available. For new hazards, information on health risks may be poorly understood, patchy, or even contradictory and misleading. This does not exempt governments from their responsibility to provide measures to protect consumers’ health. Where early indications suggest severe risks, a precautionary approach may point to temporary measures, pending fuller investigation. However, this possibility should be confined to clearly defined circumstances.
The need to develop measures to protect consumers’ health raises the question, which is exercising minds around the world, of how to determine acceptable levels of risk, when all other legitimate factors have been taken into account. Even when science is recognised as the cornerstone, there may be demands, due to ethical, religious, or environmental considerations, or arising from specific control and production methods, to go further in protective measures than the purely scientific evidence suggests is necessary.
It may still be necessary to balance scientifically identifiable risks with society’s assessment of what it will tolerate. Risk management will be greatly helped by the development of international methods for determining acceptable risk and food safety objectives around which legislative targets can be set. This is an area in which the Codex Alimentarius and SPS have been occupied and to which the European Union has participated fully.
The preceding discussion makes it clear that, while the problems and critical aspects of the present system of food legislation are well identified, no easy solution is available. To place issues in a proper perspective one should first of all recognise that the EU system of food legislation has in the main been very successful at ensuring a high level of safety and consumer protection and at the same time keeping the internal market open. However, we cannot be complacent. Recent events have exposed weaknesses in the system that need to be addressed, to strengthen consumer confidence, to dispel emerging threats to the internal market, and to minimise international trade frictions. The following areas are those where in my view there is room for improvement.
(i) The general degree of legislation needs to be reviewed in the context of a framework directive, which would define general measures for the marketing of safe and wholesome food. The review would focus on the necessity for, and proportionality of, the legislation in this context.
(ii) There seem to be grounds to argue for greater reliance on horizontal measures, setting out general principles rather than the precise method by which they are to be achieved. This would help remove detailed provisions that restrict innovation and provide industry with the scope to choose between alternative ways to reach the same objective, while not in any way detracting from food safety.
(iii) Measures should be consistent and proportional throughout the production chain, regardless of whether they are part of the common agricultural policy or the internal market. Following the farm to fork approach, the food industry needs to be addressed with one voice.
(iv) The mechanisms for providing and using scientific advice need to address the three Rs, to make it at the same relevant, reliable, and rapid. Perhaps we have to think laterally here, addressing such questions as:
(v) Approval mechanisms for implementation and for technical modifications that are not fundamental in nature can certainly be speeded up, as shown by such models as the EMEA and the FDA.
(vi) Ways need to be found to integrate consumers better into the process, improving their understanding of issues, their role in the formation of legislation, and thus their acceptance of decisions.
Looming large in the background, a more fundamental question needs to be addressed, concerning the very organisation of the institutions entrusted with the protection of public safety in this domain. Do we consider suitable and appropriate the present system, where legislation is not clearly distinguished from implementing decisions, and implementing decisions are taken by political bodies with procedures of a legislative nature? Or should we consider moving in the direction of systems, existing in other countries, that seem to be able to combine effective decision-making with strong public confidence?
In spring 1997, President Santer addressed the European Parliament on the need to overhaul the present system. Reference was made during the debate to the attractions and benefits of agency systems like, for example, the US FDA.
Not much discussion of this has taken place since. It seems to me that this debate is well worth undertaking.