PUBLIC HEALTH
UPDATE ON HEALTH CLAIMS Michèle Sadler RNutr Rank Nutrition Ltd Michèle is Director of Rank Nutrition Ltd, which provides nutrition consultancy services to the food industry. Michèle has a BSc in Nutrition (University of London), a PhD in Biochemistry and Nutritional Toxicology (University of Surrey), and is a Registered Nutritionist.
Under the Nutrition and Health Claims Regulation,1 266 health claims have been approved to date for use in the EU. These include 12 claims for children’s development and health, 14 reduction of disease risk claims, five claims based on proprietary data and 235 general function claims of which six are based on newly developed scientific evidence. However, since the early days of the Regulation, the number of applications has fallen considerably, reflecting the high costs of undertaking new studies and uncertainty of the outcome of health claim applications. Negative EFSA opinions far outweigh positive opinions and, in extreme cases, it has taken four to five years to authorise claims, highlighting the unpredictability of the process.2 REFIT
In view of the high level of criticism levelled at the Regulation,1 certain aspects are currently subject to a REFIT (regulatory fitness and performance) evaluation in the EU, which began in October 2015. REFIT is a rolling programme in which EU Regulations are reviewed to ensure they are ‘fit for purpose’. The particular aspects under review are botanical claims and nutrient profiles. Botanical claims The assessment of over 2,000 general function claims for botanical substances remains on hold in order to decide what approach to take. The REFIT evaluation will examine whether the current rules are adequate and how the assessment of botanical claims interacts with the regulatory framework on plants and their preparations. There are currently conflicting approaches whereby clinical studies are required in the Nutrition and Health Claims Regulation, which assesses foods, and the legal acceptance in other Regulations of ‘traditional’ use 52
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evidence for therapeutic indications in medicinal products. This inconsistency needs to be addressed in order to resolve the current situation. The evaluation may extend to further regulatory issues, such as safety requirements. Nutrient profiles As provided for in the Regulation,1 nutrient profiles were due to be set by January 2009. In general terms, these would restrict claims on foods that are not in line with dietary recommendations. If a food fails on one of the criteria, a nutrition claim can still be made provided it is accompanied by a statement ‘High [xx nutrient] content’. However, there is no such derogation for health claims and a food failing on any of the criteria cannot bear a health claim. EFSA published guidance on how setting the profiles might be approached.3 However, because of the complexities involved, no agreement was reached and over eight years since they were due, nutrient profiles have still not been set. The European Parliament has even voted for their elimination. However, consumer organisations, a number of multinational companies and various health bodies remain in favour of setting profiles. The aims of the REFIT evaluation are to consider whether or not nutrient profiles are justified and whether the provisions in the Nutrition and Health Claims Regulation1 are sufficient. The results of the evaluation exercise are due in early 2018 and the action plan and final report are expected in 2019.