Foundations of EU Food Law and Policy

Ten Years of the European Food Safety Authority

Alberto Alemanno, Simone Gabbi

• Publisher: Routledge
• Year: 2016
• Print ISBN:
  9781409467212
• eBook ISBN:
  9781317133681
• Topic: Derecho
• Subtopic: Derecho penal

This volume presents the viewpoints of academics, food lawyers, industry and consumer representatives as well as those of EU policymakers on the first ten years of activity of one of the most prominent European agencies. Its broader purpose, however, is to discuss the future role played by EFSA within the rapidly-evolving area of EU food law and policy. By revisiting and discussing the milestones in the history of EFSA, the collection provides forward-looking views of food leaders and practitioners on the future scientific and regulatory challenges facing the European Union. In particular, by presenting a critical assessment of the agency's activities within its different areas of work, the book offers readers a set of innovative tools for evaluating policy recommendations and better equips experts and the public to address pressing regulatory issues in this emotive area of law and policy. Despite its celebratory mood, the book's focus is more about the future than the past of EU food law and policy. Each chapter discusses how EFSA's role has evolved and identifies what it should have done differently while presenting an overall assessment of how the agency has discharged its mandate.

PART I
EFSA From Within

Section 1 The Genesis

Section 2 Scientific Advice

Section 3 Scientific Communication

Section 1: The Genesis

Chapter 1
The Genesis of EFSA and the First 10 Years of EU Food Law

David Byrne

The President of the EU Commission, Romano Prodi, presented the make-up of the new Commission to the European Parliament on 21 July 1999. During the speech setting out his ambitions for his period in office, he made specific reference to the establishment of an independent food agency. Although there had been repeated calls for such an initiative throughout the 1990s, this was the first expression of a political commitment to do so. In passing, President Prodi referred to the highly regarded FDA in the US as an example.

The political climate at that time was heavily influenced by the many food safety scares around Europe, the most serious being BSE and dioxin. Public confidence in food and in politicians plummeted and governments fell. There was also widespread concern that the competent authorities in some member states were not acting in a fully transparent manner. This was the impetus that led to the demand for a food agency at EU level capable of operating independently, to which the Commission responded.

DG Sanco, the newest Directorate of the Commission, had just been established, for which I had political responsibility as Commissioner for Health and Consumer Protection. A number of additional competences fell under the responsibility of this new Directorate, including food safety and animal health and welfare. Policy development and legal drafting in the area of food law thus became the responsibility of DG Sanco.

A White Paper on Food Safety¹ was quickly drafted and published in January 2000. It was intended as a consultation document in preparation for the anticipated new food law. It set out the broad outlines of what a new framework law should contain, and called for the creation of an independent agency by 2002 – The European Food Authority (EFA). (It is an interesting historical detail that the name was changed to include the word ‘Safety’ during the legislative process at the suggestion of the late Philip Whitehead MEP, who performed the task of Rapporteur with considerable skill and commitment.)

The key tasks identified in the White Paper² were independent scientific advice on the assessment of risk, and a shared responsibility with the Commission for the communication of risk to the public. In stating that ‘there must be a clear separation between risk management and risk assessment’, it was recommended that the function of risk management should remain with the Commission and the law-making political institutions of the EU. This was an indication that an EU version of the FDA was not intended. In advancing its justification for this decision, the White Paper stated that a transfer of regulatory powers to an independent authority could lead to an unwarranted dilution of democratic accountability.

Although this recommendation caused some small degree of controversy, it is a position I promoted and publicly advocated at that time. I believed that the appetite for risk (the core of risk management), is a legitimate concern of the public, and is best determined by decision-making at the political level by those responsible and accountable to the public, albeit with the advice of the risk assessor.

In further justification of the separation of risk assessment and risk management, the White Paper referred to the legal advice available to the Commission to the effect that the Treaties mandated the Commission to perform the functions of regulation and control and that the delegation of such powers to a regulatory body would require Treaty changes. In any event, the budgetary considerations associated with any such delegation of powers would render such a move quite impractical.

The White Paper³ also called for an integrated approach, from farm to table, with food operators having primary responsibility for food safety. It pointed to the need for a credible system of traceability and promised monitoring, enforcement procedures and infringement actions. Considerable emphasis was placed on the need to provide scientific advice which was independent, excellent and transparent. A concern of fundamental importance was identified in the statement that ‘if consumer confidence is to be regained, the Authority will need not only to act independently of outside pressures but to be accepted as doing so by all parties concerned.’ The ideas contained in the White Paper were not only innovative but were also well reasoned. These ideas formed the basis of the General Food Law (Reg. 178/2002)⁴ which established EFSA and allowed it to commence its work on time in January 2002.

Many factors influenced the drafting of the General Food Law, not least the issues surrounding the outbreak of the so-called Beef War in October 1999, when France, on the scientific advice of its national food safety agency, announced a ban on the importation of British beef. This advice directly contradicted the opinion of the Scientific Steering Committee (SSC), whose opinion was relied upon by the Commission in permitting the free circulation of British beef throughout the European Union on the strict conditions of the Date Based Export Scheme (DBES).⁵ This ban was a clear breach of EU law and amounted to a significant challenge to the Commission which had entered upon its mandate only two weeks previously.

An appropriate response was demanded. The initiation of infringement proceedings against France was one obvious course of action open to the Commission. However, conscious of the fact that consumer confidence was at stake, I favoured another course by requesting the French authorities to make available their scientific advice to enable the SSC in Brussels make a new evaluation. Within weeks the SSC declared that they found no reason to change their previously expressed scientific opinion on the safety of British beef exported under the DBES. In the interests of transparency I invited members of the SSC to a press conference in order to provide an explanation of their opinion in public. Further discussions ensued between Commission officials and the French administration which reduced the areas of disagreement but failed to reach a satisfactory conclusion. Consequently, it then became necessary for the Commission to institute infringement proceedings against France. Ultimately the CJEU found in the Commission’s favour, thereby requiring France to comply with EU law and lift the ban on the importation of British beef.

As France failed to comply, further proceedings were launched pursuant to Article 228⁶ seeking the payment of financial penalties to enforce compliance. This resulted in France eventually lifting the ban. However, as the Commission had sought payment of penalties from the date of the prospective order in the Art. 228 proceedings rather than from a date subsequent to the order of the Court in the infringement proceedings, this resulted in no penalties being paid. Nor did the Commission make any claim for payment of a lump sum. Although financial sanctions could have been sought from the earlier date, it had been the practice of the Commission in Art. 228 proceedings not to do so. I requested a review of this practice. It emerged that there was some legal doubt as to whether the Commission could seek the payment of a lump sum and daily penalties. This doubt was quickly resolved in Case C-304/02 Commission v France⁷ when the Court confirmed that two kinds of financial sanctions (penalty and lump sum) can apply cumulatively for the same infringement, and applied this principle in that case for the first time. This decision led to the publication of a Commission Communication on the application of Art. 228 (SEC/2005/1658)⁸ in which the Commission announced its change of practice by notifying its intention to include in applications under Art. 228 a request for:

– A penalty by day of delay after the delivery of the Judgement under Art. 228.

And

– A lump sum penalising the continuation of the infringement between the first Judgement on non-compliance and the Judgement delivered under Art. 228.

There is little doubt that such an approach will encourage earlier compliance with orders of the CJEU. Therefore it must be acknowledged that the Beef War led to greater legal certainty. It also led to important improvements in the sometimes turbulent interactions between science, law and politics. It became clear that we needed to put in place dispute resolution mechanisms capable of producing non-confrontational speedy outcomes to resolve such differences in the future. At stake was the confidence of the European consumer.

The ambition expressed in the White Paper that EFSA is to ‘become the scientific point of reference for the whole union’ was carried through to the General Food Law, where in Art. 22 (2)⁹ it states, ‘The Authority shall provide scientific advice and scientific and technical support for the Communities’ legislation and policies in all fields which have a direct or indirect impact on food and food safety.’ Thus the scientific opinions, which are required to be furnished by EFSA, form the scientific basis of Community legislation.

It is further provided in the regulation that on carrying out these tasks, EFSA is required to act ‘in close cooperation with the competent bodies in the member states carrying out similar tasks to those of the authority’ (Art. 22.7). This consultative process is further reinforced by Art. 30,¹⁰ which establishes a mandatory procedure where EFSA has identified diverging scientific opinions, ‘with a view to either resolving the divergence or preparing a joint document clarifying the contentious scientific issues and identifying the relevant uncertainties involved’. Once again, in the interests of transparency, this document must be made public. By this device, the scientists from the bodies concerned, together with EFSA, will either resolve the differences or, at the very least, clarify the uncertainties for the Commission acting as the risk manager. In the event of such uncertainty, the Commission can then have recourse to Art. 7¹¹ in the specific circumstances where the Precautionary Principle may be invoked.

To further reinforce this network of cooperation and conciliation, an Advisory Forum is established by Art. 27 to form a link between EFSA and the member states. In effect, it is composed of representatives from the national food agencies with a mission to ensure close cooperation between those entities. The Advisory Forum is also conferred with a function in the resolution of diverging scientific opinions in circumstances identified in Art. 30.

For me, the intent and effect of the General Food Law is to create for EFSA a position of scientific pre-eminence in Europe by reliance on the subtle interaction of Arts. 6(3), 22, 30 and 27. It is to be hoped that this approach helps to foster a respectful relationship between scientists by putting in place a mechanism for the achievement of consensus or alternatively an agreement on the precise reason for the divergence or uncertainty. This is done under full transparency in the knowledge that consumer confidence cannot be mandated; it can only be earned. These provisions are designed to achieve that end.

Over the years, EFSA has put in place a number of initiatives, such as the Strategy for Cooperation and Networking between the EU Member States and EFSA, a stakeholder’s forum, and th...

Table of contents

• Cover Page
• Half Title Page
• Title Page
• Copyright Page
• Table of Contents
• List of Figures, Tables and Boxes
• Notes on Contributors
• List of Abbreviations
• Foreword by Catherine Geslain-Lanéelle
• Acknowledgements
• Introduction: Foundations of EU Food Law and Policy
• PART I EFSA FROM WITHIN
• PART II EFSA FROM OUTSIDE
• Index