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The Future of Article 13.1 Claims
In the three years since the European Union (EU) began implementing its Nutrition and Health Claims Regulation (NHCR), many elements are still unclear. At the top of that list is how to assess Article 13.1 health claims-an issue that has left the European functional food industry at loggerheads with the body mandated to scientifically assess the claims, the European Food Safety Authority (EFSA).
One of the key areas of contention is that the NHCR prescribes three distinct procedures for the scientific assessment of the different types of claims, included as a reflection of proportionality. However, in practice, these three different distinct procedures have been ignored by EFSA in favor of one procedure, which is more appropriate for pharmaceutical evaluations than for claims based on generally accepted scientific evidence, Article 13.1 claims.
EFSA, with its reliance on intervention trials, is now requesting pharmaceutical-style dossiers-something that was never communicated when the regulation came into force and which was not intended for foods. In some cases, this requirement is even impossible to provide. The consequence is that claims are unfairly rejected as the totality of available data is not being considered, and the extent to which a cause-and-effect relationship between the claim and the substance is established is being ignored. Instead, EFSA is asking for conclusive evidence of a cause-and-effect relationship.
Concerns exist around whether this pharmaceutical-style approach to assessing the scientific evidence is suitable for food research at all. For example, EFSA recently gave an unfavorable opinion to dietary fiber claims, as it will only investigate the evidence supporting a claim for one isolated substance. This unfavorable opinion is quite surprising, as fiber is generally promoted as a healthy dietary component for maintaining a healthy digestive system in many national health policies.
Additionally, certain types of claims whose assessment has been shown to be completely incompatible with the EFSA criteria have now been removed from the process until solutions are found for their appropriate evaluation. These include claims for botanicals, due to a discrepancy over the assessment of efficacy with traditional herbal medicinal products; and claims for probiotics, which, in the absence of any guidance from EFSA, had been deemed to have been insufficiently characterized.
An essential difference between nutrition and pharmaceuticals is that pharmaceuticals are developed to treat, cure, or prevent disease, whereas the primary goal of nutrition is to maintain and, if possible, improve health.
The WHO defines health as “a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.”1 However, the EFSA approach to assessing Article 13.1 claims appears to be biased towards effects on reductions of disease-risk factors and almost exclusively relies on randomized controlled trials that show measurable and meaningful improvements of health-leaving more-general health effects referring to maintenance, rather than improvement, of physiological functions unaddressed.
Across the European industry, there are calls for the claims-assessment process to be halted, and for claims that have received negative EFSA opinions to be allowed to be resubmitted for evaluation based on a more-appropriate approach that considers the totality and a weighing of the evidence towards a more-balanced assessment. This is especially the case in light of the September 2010 publication of an economic-impact assessment commissioned by the European Health Claims Alliance (ECHA). The impact assessment predicts that the market for substances other than vitamins and minerals may decrease by about 25% (about €1 billion at retail level) if the European Commission decides to follow EFSA’s current opinions.
Employment generation is expected to fall by about 13,300 full-time equivalents (FTEs), equal to 18% of total employment in the market for substances other than vitamins and minerals (and this excludes the impact on employment in the retail sector). Barriers to entry into the food supplement sector are expected to increase; levels of innovation will likely fall; third-country suppliers will increase their EU market share; and the viability of many EU businesses, notably SMEs, would be threatened.
The Regulation will in the end fail to meet its objectives, including consumer protection, as consumers would also lose out from reduced choice and possibly higher prices. In addition, this leaves consumers vulnerable to suppliers outside of the EU who can avoid EU legislation requirements in the country of origin, where potentially misleading claims exist.
Ultimately, it is the European Commission that will need to propose whether to follow EFSA’s opinions. The implementation of the NHCR is a learning process, and its consequences will only become fully clear as the process progresses. However, it is becoming clear that the regulation is not encouraging an environment that stimulates innovation across the food sector, as the pharmaceutical-like standard required for scientific data limits chances of success, which may make companies more hesitant to invest in research. This will certainly have the effect of less research being commissioned in academic centers-and some fields of research being abandoned completely.
1 WHO. Preamble to the Constitution of the World Health Organization as adopted by the International Health Conference. 1946.