The General Principles of EU Food Law: Precaution

© 2004-2005 William Charteris
www.billcharteris.com
www.imperialconsulting.net

The ‘precautionary principle’ may be generally stated as: ‘uncertainty should not be used to delay protection’. According to this principle, when a risk assessment concludes that “the possibility of harmful effects on health is identified but scientific uncertainty persists”, provisional risk management measures necessary to ensure a high level of health protection in the Community may be adopted, while waiting for other scientific information to complement the assessment. The measures adopted on the basis of the precautionary principle must be temporary, proportionate, and no more restrictive of trade than is required. They must be reviewed within a reasonable period of time, depending on the nature of the risk to life and health identified and the type of scientific information needed to clarify the scientific uncertainty and to conduct a more comprehensive assessment.

REG 178/2002 provides the first legally binding definition of this principle in Community law; essentially reaffirming the guidelines provided in the February 2000 Commission Communication. The judgment of the ECFI in Pfizer Animal Health SA v. Council defines the circumstances under which the principle can be invoked. In its judgment, the ECFI stated that “ …a preventive measure cannot properly be based on a purely hypothetical approach to the risk, founded on mere conjecture which has not been scientifically verified … Rather, it follows from the Community Courts’ interpretation of the precautionary principle that a preventive measure may be taken only if the risk, although the reality and extent thereof have not been ‘fully’ demonstrated by conclusive scientific evidence, appears nevertheless to be adequately backed up by the scientific data available at the time when the measure was taken”. However, the scope of the precautionary principle (just like ‘subsidiarity’ and ‘proportionality’) remains vague with the result that “it is for the decision-makers and ultimately the courts to flesh out the principle”. This situation is certainly unfortunate and likely to exacerbate even further the current debate on the scope of the precautionary principle within and between the EU and US.

The application of the “precautionary principle” is an important component of the EU’s approach to food safety. Whereas the US continues to rely on “sound science”, considering neither “other factors” nor the precautionary principle, the EU bases its legislation on “sound science” in conjunction with the precautionary principle every time there is scientific uncertainty over the safety of a particular product. In recent years the EU has relied heavily on this principle in the area of food policy and endured trade disputes with the US (e.g. beef from hormone treated animals, GM food and feed, etc.) and other countries. The main argument against the invocation of this principle is that, by providing a basis for action in the face of scientific uncertainty, it may be easily invoked to adopt protectionist measures. The judgment of the ECFI is that the precautionary principle “is not a joker or wild card that can be played at any moment as a pretext for unjustified measures” and Margot Wallstrom’s denial that Europe uses the precautionary principle as a way of evading international obligations arising in particular from WTO agreements go some way to addressing the legitimate concerns of the EU’s trading partners.

This abstract is taken from a paper entitled 'A comparison between the EU and US approaches to food safety and an evaluation of the respective strengths and weaknesses of each system', which was published on April 11, 2005. The paper comprises 12,500 words and 39 references. Individual copies of the paper may be requested by e-mail from the author.

The General Principles of EU Food Law: Risk Analysis

© 2004-2005 William Charteris
www.billcharteris.com
www.imperialconsulting.net

With the adoption of REG 178/2002, the General Principles of Food Law (Articles 5 to 10) entered into force on February 21, 2002. Existing food law principles and procedures must be adapted by January 1, 2007 to comply with the general framework established by the regulation.

Together with national laws, REG 178/2002 establishes the rights of consumers to safe food and to accurate and honest information. Its seeks to ensure a high level of protection of human life and health, while taking into account the protection of animal health and welfare, plant health, and the environment. In addition, it establishes in EU law that the three inter-related components (assessment, management, and communication ) of risk analysis provide the basis for food law in relation to the measure under consideration. Moreover, it establishes a framework for the greater involvement of stakeholders at all stages in the development of food law and establishes the mechanisms necessary to increase consumer confidence in food law.

‘Risk’ is generally understood to describe the probability that some undesirable event may occur. It is sometimes used to describe the combination of that probability (e.g. frequent, likely, occasional, seldom, and unlikely) and the corresponding consequence of the event (e.g. catastrophic, critical, moderate, and negligible). Risk is a dominant feature of our society. In modern life, we are exposed to a broad range of possible hazards, the assessment and management of which are complex, costly, plagued by uncertainty, and often controversial. Risk analysis is necessarily a snapshot of the information available at the time that a particular decision is made. The level of treatment depends on both the importance of the risk and the costs of the mitigation measures.

‘Risk assessment’ is the process of evaluation of the likelihood and severity (and attendant uncertainties) of an adverse effect/event occurring following exposure to a hazard. It comprises hazard identification, characterization, exposure assessment, and risk characterization. A major risk assessment (e.g. dioxin, lead, etc.) can be very costly and require multidisciplinary scientific expertise and vast amounts of data to produce a quantitative expression of risk that can be used as a basis for making clear risk management decisions despite the uncertainty.

In European food law practice, the risk assessment process is mandated by REG 178/2002, with EFSA being charged with promoting and coordinating the development of uniform risk assessment methodologies, but its procedures and methodologies are not standardized. Rather, it is subject to various national and international guidelines which dynamically seek to harmonize the approach taken by various bodies in the face of scientific advances and thereby achieve a consistently high standard of risk assessment and risk communication going forward.

Risk assessment is constrained by the available scientific evidence and associated uncertainties with the result that the ‘Precautionary Principle’ and ‘science policy’ also play a very important role in risk management decisions. Recognizing the pervasiveness of scientific uncertainty, the European Commission has issued a communication on the Precautionary Principle. In it, the Commission considers the application of the Precautionary Principle to be part of risk management, when scientific uncertainty precludes a full assessment of the risk and when decision-makers consider that the chosen level of environmental protection or of human, animal, and plant health may be in jeopardy.

This abstract is taken from a paper entitled 'Uncertainty and risk', which was published on December 20, 2004. The paper comprises 3,900 words and 25 references. Individual copies of the paper may be requested by e-mail from the author.

Europe’s BSE and nvCJD crises

© 2004-2005 William Charteris
www.billcharteris.com
www.imperialconsulting.net

Prion diseases are a group of transmissible animal and human neurodegenerative diseases. They are uniformly fatal and characterized by a long incubation period and a multi-focal neuropathology involving spongiform changes, neuronal loss, astrogliosis, and the accumulation of the pathological or ‘structurally aberrant, protease-resistant’ conformers of the prion protein (PrP^res) in the brain and to a lesser extent in other organs. This toxic gain of function of an aberrant form of a constitutively expressed protein and associated failure to clear these proteins from the brain induces neuronal dysfunction and leads to death.

The most common human TSE is CJD, which is classified epidemiologically as sporadic or classic, familial, iatrogenic, and variant or new-variant. Even the most frequent form, sCJD, is very rare. It appears to be evenly distributed worldwide exhibiting an incidence of circa one individual per million per year. BSE is classified as a TSE, variants of which include scrapie in sheep and chronic wasting disease in deer and elk. In 1996, UK government scientists announced that the ‘‘most likely explanation” for 10 cases (median age, 28 years) of nvCJD was ‘‘exposure to BSE’’. nvCJD is distinguished from the sCJD by the much younger median age of affected patients, its clinical features and neuropathology, and the biochemical properties of the PrP^res. A recent estimate of the mean incubation period for nvCJD following consumption of an infectious dose of BSE-infected beef by a genetically susceptible individual (MM homozygote) is 16.7 years (95% confidence interval, 8–30 years).

The BSE epidemic, which began in the early 1980s, and the associated nvCJD epidemic are now, with high probability, in decline. Although 95% of cases occurred in the UK, the economic impact has been felt throughout Europe and will continue indefinitely. In present value terms, it is estimated at €100 billion with up to 10% of the annual value of beef output having been lost. Of prime importance has been the permanent damage to consumer confidence not just in beef, but in all foods. In addition, the reputation of the scientific establishment for providing objective and independent information has been severely damaged in the public mind, and government authorities have been perceived as protecting sectoral interests rather than the public in general.

Until the outbreak of the BSE crisis, Community regulation on food safety lacked a coherent concept of risk regulation. Nevertheless, the scientific committee-based food safety regulatory approach appeared to function generally well and both national authorities and the Commission were satisfied. However, the BSE epidemic shattered this confidence. The BSE crisis revealed deficiencies in beef industry practices, public food safety structures, and the ad hoc approach followed by the Community. It highlighted the need for a more conceptual, risk analysis-based approach to food safety regulation, a concept which explicitly recognizes that risk regulation is permeated by social and political considerations and is based on negotiation and deliberation with civil society.

Recent reports of secondary nvCJD transmission via blood products obtained from donors who were incubating the disease are of concern because of a potentially large number of blood donors who might have been exposed to BSE and may be infectious but clinically asymptomatic. The blood donor deferral policies instituted by blood transfusion agencies in Europe and elsewhere are expected to greatly minimize the risk of secondary transmission due to such low-level endemicity.

No proven treatment for human and animal TSE exists. Back-calculation modelling suggests the likelihood that almost 1·6 million infected cattle entered the human food chain during the BSE crisis. Treatment of animal by-products at 133^oC at 3 bar for a minimum of 20 min will destroy prions, but for food and blood products there are no ‘feasible’ processes to destroy the agent.

This abstract is taken from a paper entitled 'A critical review of the evolution of scientific advice to the Commission on food safety since the formation of the European Economic Community', which was published on December 6, 2004. The paper comprises 5,500 words and 47 references. Individual copies of the paper may be requested by e-mail from the author.

Europe’s new food safety order

© 2004-2005 William Charteris
www.billcharteris.com
www.imperialconsulting.net

The Consumer Health and Protection portfolio was first established in 1999 by Commission President Romano Prodi. In January 2000, the White Paper on Food Safety was published. It outlined a new EU food strategy that has now largely been put in place. Three of the legislative measures proposed therein form the backbone of the Community’s new food safety infrastructure. The first, Regulation 178/2002, was adopted on January 28 2002 and applies in full from January 1 2005. It set out the general principles of EU food law, provided the legal basis for the establishment of EFSA, and established a Rapid Alert System for the notification of food/feed-derived risks to human health and set down clear procedures for the handling by the Commission and the Member States of food safety emergencies and crises. The second, which comprises a package of five measures, was adopted on April 29 2004 and will come into effect on January 1 2006 (except for animal health rules). The package updates and consolidates the seventeen existing hygiene directives. It introduces a single, transparent hygiene policy applicable to all food (including imported food) throughout the food chain, reaffirms and clarifies that the primary legal responsibility for food safety lies with food business operators, mandates the use of the HACCP system by all non-primary food operators, and mandates the implementation of a system of product traceability and recall throughout the food chain. This package will be augmented by the adoption of the feed hygiene regulation in 2005, which will introduce a similar hygiene policy that is applicable to all animal feedstuffs (including imported feed) throughout the feed chain. The third, Regulation 882/2004, was adopted on April 29 2004 and will come into effect on January 1 2006. It introduces a longitudinally integrated system of risk monitoring and control across the entire food and feed chains (including imported food and feed) with associated performance criteria for national authorities and administrative enforcement measures in the event of non-compliance. It also mandates the provision of assistance to developing countries in meeting import requirements. It augments a range of existing controls already in place for BSE, zoonoses, etc. Collectively, the actions proposed in the White Paper represent the most significant advance in the development of an integrated food safety policy since the founding of the Community and constitute a credible basis for reinforcing consumer protection. The implementation of the legislative actions will necessarily raise costs throughout the food and feed chains. Higher food prices will be accepted by consumers only if they result in greater food safety and greater confidence in its control throughout the food chain. The effectiveness and robustness of the ‘new food safety order’ in this regard will be proven in the fullness of time. The enlargement of the Community will likely test it to the full.

This abstract is taken from a paper entitled 'An analysis of the main developments in EU food safety policy since 1999 that have helped to reinforce consumer protection', which was published on January 7, 2005. The paper comprises 5,500 words and 47 references. Individual copies of the paper may be requested by e-mail from the author.

The provision of scientific advice to the Commission on food safety

© 2004-2005 William Charteris
www.billcharteris.com
www.imperialconsulting.net

Science and technology play an increasingly influential role in almost every aspect of modern life, including the formulation of policy and regulatory decisions, particularly on sensitive issues involving consumer health and safety. Almost every aspect of modern political governance is impacted to a greater or lesser degree by science with the result that policy issues are becoming increasingly complex and increasingly dependent on the use of expert scientific advice to inform policy-making at all levels.

EFSA became operational in 2003. In May 2003, the five Scientific Committees that had provided the Commission with scientific advice on food safety were transferred to EFSA. At the same time, the Scientific Steering Committee’s TSE/BSE responsibilities were transferred to EFSA. The Scientific Committees and the eight permanent Scientific Panels fulfill EFSA’s risk assessment and communication responsibilities, being responsible for providing expert scientific opinions to the Community Legislature and to the Commission in the policy areas of health, research, environment, and agriculture. They are all statutory, fixed-term advisory bodies that are governed by Codes of Practice and formal guidelines.

The scientific opinions of EFSA are not legally binding on Community institutions but must be taken into account when drafting a Community measure. In addition, EFSA must exercise ‘vigilance’ in order to identify at an early stage any potential source of divergence between its scientific opinions and those issued by national food agencies. Moreover, EFSA has a duty of co-operation within the EU such that when a conflict exists, it is ‘obliged to co-operate’ either to resolve differences or arrive at a consensus. Clearly, EFSA has not been entrusted with the power to act as the ultimate body of scientific advice in the EU, the practical consequences of which may be far reaching. The introduction of a mere duty of co-operation seems to fall short in providing an effective answer to the fundamental question of the relationships between EFSA and the national authorities responsible for food safety issues. In this regard, the institution of an EFSA Advisory Forum, as a mechanism for exchange of information between national authorities and EFSA, is unlikely to prove decisive in overcoming the difficulties arising from divergent European and national scientific opinions. Accordingly, it will fall to the ECJ, and not EFSA, to solve these conflicts by striking a legally acceptable balance between European and national values (incl. risk perception).

The role of scientific advice depends greatly upon the purpose for which it is sought, and the functions which it fulfils. Consequently, a diversity of approaches has been developed for its delivery. This diversity has been further broadened by the disciplinary areas which it addresses and by the governmental and cultural contexts in which it operates. As the use of scientific advice to policy making has increased, the problematic nature of providing and dealing with it has been highlighted causing concern over its utility and validity. While in the past the opinions of experts may have been readily accepted by both policy makers and the public, this is no longer the case. In addition, the greater involvement of society and the increased profile of ethical considerations place enormous pressure on “experts” to deliver the ‘right’ advice.

In the UK and Canada in particular, these problems have stimulated the development of guidelines for the generation and use of scientific advice. In the EU, however, the vast majority of all types of scientific advisory organizations have no formal policy response for the provision of scientific advice. However, the Commission has initiated the development of a common system of scientific and technical reference for EU policy implementation within the context of the ERA, requiring an alignment of methods and greater comparison and harmonization of results across the EU. One concrete action in this direction is the recent adoption of guidelines on the collection and use of expertise in the light of the TSAS Report. These guidelines address the quality of advice, the issue of openness, and the effectiveness of advisory procedures. This initiative on scientific advice is taking place within the wider debate on European governance and increasing engagement throughout the EU. Good governance is seen to be underpinned by five principles: openness, participation, accountability, effectiveness, and coherence.

This abstract is taken from a paper entitled 'A critical review of the evolution of scientific advice to the Commission on food safety since the formation of the European Economic Community', which was published on December 6, 2004. The paper comprises 2,500 words and 33 references. Individual copies of the paper may be requested by e-mail from the author.

Two eras in the evolution of scientific advice on food safety to the European Commission

© 2004-2005 William Charteris
www.billcharteris.com
www.imperialconsulting.net

1997 may be used simplistically to delineate two eras in the evolution of scientific advice on food safety to the Commission. This year corresponds with the BSE crisis and the most substantive reform of the entire system of scientific advice undertaken by the Commission in its history. It is indicative of that period in time when the governance of food safety became contested and when the free movement of foodstuffs could no longer be the overriding principle of food law became widely accepted.

Prior to 1997, the scientific advice provided by the Scientific Committee for Food related to the elaboration of common rules concerning the composition, production, characteristics, packaging, and labeling of foodstuffs, and assisted in the implementation of an ‘economic’ policy whose objective was achieving the free movement of foodstuffs within the internal market. After 1997, the scientific advice provided by the newly-established food safety committees of DG SANCO initially and EFSA finally related to multidimensional consumer health and protection issues, and has assisted in the implementation of a common, risk analysis based ‘food safety’ policy whose objective is achieving a high level of consumer protection and the free movement of safe, wholesome foodstuffs.

Although the provision of scientific advice (risk assessment) has been separated from the promulgation of legislation (risk management) since 1997, EFSA has not been empowered to act as the ultimate body of scientific advice in the EU, the practical consequences of which may be far reaching. In this regard, the institution of an EFSA Advisory Body, as a mechanism for exchange of information between national authorities and EFSA, is unlikely to prove decisive in overcoming the difficulties arising from divergent European and national scientific opinions. Accordingly, it will fall to the ECJ, and not EFSA, to solve these conflicts by striking a legally acceptable balance between European and national values (incl. risk perception).

This abstract is taken from a paper entitled 'A critical review of the evolution of scientific advice to the Commission on food safety since the formation of the European Economic Community', which was published on December 6, 2004. The paper comprises 2,500 words and 33 references. Individual copies of the paper may be requested by e-mail from the author.

The enlarged EU and the vision of Jean Monnet for a peaceful Europe

© 2004-2005 William Charteris
www.billcharteris.com
www.imperialconsulting.net

The geopolitical boundaries of Europe have never been permanently defined. Jean Monnet once said, ‘Europe has never existed; one has genuinely to create Europe’. He and his colleagues believed fervently in full scale European union – political, economic, and military. As of 2004, the fulfillment of this vision remains an enormously successful work-in-progress which involves an enlarged EU of 25 Member States and 4 candidate countries. The European integration movement has delivered half a century of stability, peace, and prosperity by peaceful and democratic means since the Schumann declaration of May 9th 1950. It has helped to raise living standards, built a single market, launched the euro, and strengthened Europe's voice in the world and ability to compete effectively in the global economy. In recent years, it has renewed its efforts to create a unified political and security identity more in line with its commercial and economic power. Full scale military union remains to be achieved. Thus, the moral and political vision of the founding fathers of Europe of full scale European union has not and may never be achieved in the strictest sense of the word. Europe will be less divided than for generations past and remain a work-in-progress subject to the vagaries of a myriad of internal and external factors that have the potential to undermine internal cohesion and further enlargement. As long as the USA remains militarily strong and economically prosperous, NATO will be preserved and the EU will continue to enlarge and integrate by measured steps. The enlarged EU of 2004 may thus be regarded as an important step towards fulfilling the vision of Jean Monnet and his colleagues for a peaceful ‘Europe’.

This abstract is taken from a paper entitled 'Does the enlarged European Union fulfil the vision of Jean Monnet and his colleagues for a peaceful Europe?', which was published on November 1, 2004. The paper comprises 2,000 words and 13 references. Individual copies of the paper may be requested by e-mailing the author.

Welcome

Bill Charteris

Welcome to my reg affairs blog.

I intend to critically examine various aspects of EU food law, both existing and pending, in this blog. Where appropriate and time permitting, I will make reference to food law in other jurisdictions, particularly the USA.
I welcome constructive comments and will make every effort to engage with contributors on all aspects of food law.

Regards,
Bill Charteris.

www.billcharteris.com
www.imperialconsulting.net