In Europe, for authorisation of a health claim, applicants must follow the procedures in the legislation and in the guidelines for submission of a dossier set out by the European Food Safety Authority. The Functional Foods in Europe (FUFOSE) and Process for the Assessment of Scientific Support for Claims on Foods (PASSCLAIM) projects underpinned the laws and provided criteria against which the quality of the totality of the available data could be judged. Whereas the regulations and PASSCLAIM require an assessment of the extent to which cause and effect can be demonstrated between a food category, a food or constituent and a health benefit, the European Food Safety Authority requires conclusive evidence of cause and effect. This latter standard of proof and a focus on randomised controlled trials done on isolated components and using validated physiological biomarkers may not always be appropriate to assess nutrition science. The aims of this paper are to address the strengths and weaknesses of different sources of evidence that contribute to the totality of the available data, to undertake a critical examination of the application of a drug-like assessment model in evidence-based nutrition and to encourage research on new biomarkers of health and homeostatic adaptability. There is a need for (a) a robust and pragmatic scientific framework for assessing the strength, consistency and biological plausibility of the evidence, and (b) consumer understanding research on claims that use qualifying language and/or graphics to reflect the weight of evidence. Such scientific, policy and communication approaches are proportionate and could help stimulate academic research, promote fair trade and product innovation and contribute to consumer education about food and health.

Representatives of the developers of modern agricultural biotechnology are proposing a tiered approach for conducting non-target organism risk assessment for genetically modified (GM) plants in Europe. The approach was developed by the Technical Advisory Group of the EuropaBio Plant Biotechnology Unit (http://www.europabio.org/TAG.htm) and complements other international activities to harmonize risk assessment. In the European Union (EU), the principles and methods to be followed in an environmental risk assessment for the placing on the market of GM plants are laid out in Annex II of Directive 2001/18/EC on the deliberate release into the environment of GMOs, Commission Decision 2002/623/EC and Regulation (EC) No. 1829/2003. Additional information is provided in the European Food Safety Authority guidance document of 2004. However, risk assessment for effects to non-target organisms could benefit from further clarification and remains the subject of much discussion in Europe. The industry-wide approach developed by EuropaBio is based on the fundamental steps of risk evaluation, namely hazard and exposure assessment. It follows a structured scheme including assessment planning, product characterization and assessment of hazard/exposure (Tier 0), single high dose and dose response testing (Tier 1), refined hazard characterization and exposure assessment (Tier 2) and further refined risk assessment experiments (Tier 3). An additional tier (Tier 4) was included to reflect the fact that post-market activities such as monitoring are required under Directive 2001/18/EC. The approach is compatible with conditions of commercial release in the EU and around the world.