Bernd van der Meulen

Conclusions and Way Forward

Legislatures should ensure that all elements of a robust responsive and principles based regulatory system for food safety governance are in place and applicable to nanofoods. The scientific community must proceed in identifying risks and methods of detection and risk assessment. Risk assessment authorities should achieve mutual recognition.

La Base Del Derecho Alimentario Europeo: Una Reflexión Crítica Sobre El Concepto De Alimento No Seguro (The Foundation of European Food Law: A Critical Reflection on the Concept of Unsafe Food)

Spanish Abstract: La noción más importante, tras diez años de la reforma de la legislación relativa a la seguridad alimentaria de la Unión Europea, se codifica en el Artículo 14(1) del Reglamento (CE) 178/2002: No se comercializarán los alimentos que no sean seguros. En la mayoría de las disposiciones de la legislación alimentaria de la UE se desarrolla esta noción, principalmente en los párrafos que siguen al artículo 14. Esta contribución analiza el Artículo 14 y razona su interpretación de acuerdo con el texto. English Abstract: This paper is a Spanish language continuation of: B.M.J. van der Meulen, The Core of Food Law, European Food and Feed Law Review 3/2012, pp. 117-125. It has been made at the request of AIBADA, Asociación Iberoamericana para el Derecho Alimentario. The most fundamental notion underlying twelve years of reform of EU food safety law has been codified in Article 14 (1) of Regulation (EC) 178/2002: food shall not be placed on the market if it is unsafe. This notion has been elaborated in most of the rest of EU food law, first and foremost in the other paragraphs of Article 14. This paper analyses Article 14 and argues in favour of a text-conform interpretation.

Chapter 6 – Regulatory Burdens

The regulatory model we propose may raise concerns from the perspectives of regulatory burdens and/or WTO compatibility. Burdens could be decreased through different measures such as: including the option to exclude entire categories of products or processes from the scope of approval requirements when initial concerns no longer exist; chosing generic schemes which are less burdensome than specific schemes; support by the public sector; mutual recognition of risk assessment; government compliance with procedural requirements and compliance assistance. Ultimately, global harmonization of approval procedures at the level of JECFA/Codex Alimentarius could considerably reduce the number of procedures to be followed worldwide.

Nano-Specific Regulation

It is possible to regulate nanofoods with recourse to a definition of nanotechnology. If however, nano-specific provisions are desired, a delineation of the concept is needed. Such delineation should focus on the properties of the product rather than the process that has created it. For safety regulation, we propose to follow the lead of the EU Regulation on food additives. For labelling and traceability, however, it may be unavoidable to take the process into account. We propose a provision addressing processes that have the intention to create particles or constructs below 300 nm. Usually in defining nanotechnology a cut-off at 100 nm is used. If this cut-off is correct, the margin we propose will not cause problems. If it is not, the margin of error may be captured.

Requirements for Food Safety Regulation

Fundamental principles of food safety governance include the principles of safety (no harm) and the principle of science-based decision making. In nanofoods, absence of data and inconclusiveness of risk assessment pose challenges to science-based decision making. Here authorization requirements and the precautionary principle may play a role. To be able to adapt to uncertainties and increasing understanding, the regulatory system needs to be responsive, the private sector needs to be responsible and the public sector needs to be communicative.

Safety Frame Applied to Food Applications of Nanotechnology

Any robust framework of food safety governance needs to address the following topics: the food business, in particular its responsibilities for safety and liability; the product, in particular its safety both in terms of category and condition; the processes applied in production (hygiene) and trade (tracing); and communication to the consumer through labelling. Other topics that need to be addressed include food contact materials. n nSafe food is a responsive concept suitable as a basis in principle-based regulation of nanofood. In so far as a definition of nanofood is needed, it should focus on novel properties rather than dimensions used as cut-off.

A Responsive Regulatory System

A regulatory system is responsive to the extent that it is capable to increasingly give meaning to the vague notions in the law. To this end in some form precedents must play a role in the system along with transparency and accountability. Decisions must be thoroughly substantiated and open to administrative and judicial review.

Case-by-Case Premarket Approval

A proven way to deal with emerging risks is to require favorable risk assessment as a condition to market access. So long as nanofoods are difficult to define, it is better to connect such requirement to ‘newness’ than to nanotechnology. The objective of nanotechnology is to achieve new properties. It is on these properties that the regulatory system should focus. To combine the best of two worlds – generic and specific approval schemes – an approval scheme for nanofoods should be generic but grant the first applicant a temporary monopoly. Products within the scheme should be approved on a case-by-case basis using data provided by the sponsor. It should be considered to allow a risk-benefit analysis where certain benefits can outweigh certain risks. Also a way out of the scheme like the US-American exemption for GRAS substances deserves consideration. For a system to be responsive, it is crucial that it is handled in a transparent discursive manner.