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.
CONTROVERSIAL CLAIMS
Despite the lack of nutrient profiles, a number of claims have recently not been authorised because they could be misleading to consumers regarding advice to reduce sugar intakes. These include five claims for glucose and energyyielding metabolism that were given a positive opinion by EFSA but were refused authorisation. Additionally, four claims for caffeine were vetoed by the European Parliament because of concerns about the high sugar content of energy drinks that would be likely to carry such claims. These claims now remain on hold. Hence, despite the absence of nutrient profiles, it seems that other means are being used to restrict claims on foods that are not in line with dietary recommendations. CHILDREN’S CLAIMS
In addition to the 12 children’s development and health claims that have been authorised to date, positive EFSA opinions have been issued for 25 or so proposed claims for micronutrients and omega-3 fatty acids targeted at infants and children up to three years of age. Authorisation for these claims is complicated by EFSA’s proposed conditions of use which refer in part to the compositional criteria for regulated food categories that now fall within the Foods for Specific Groups Regulation.4 Hence, authorisation of claims for mandatory nutrients in regulated products, i.e. infant and followon formulae5 and processed cereal-based food and baby food, is being considered in parallel with implementation of the Foods for Specific Groups Regulation,4 particularly in relation to compositional requirements. For normal foodstuffs intended for infants and young children, EFSA’s proposed conditions of use are at least 15% of the reference values for nutrition labelling. However, the nutrient reference values (NRVs), or reference intakes (RIs) for vitamins and minerals, are based on adult requirements. Whilst the need to set NRVs and RIs for young children has been discussed recently, nothing has yet been proposed. Adding to these dilemmas, from 2020/21 all claims will be prohibited on infant formula products, and hence it has been questioned whether health claims should be allowed
on regulated and non-regulated products (supplements and young child formulae) for infants and young children. The Commission has consulted on these issues and the outcome is awaited. VERY LOW CALORIE DIETS (VLCDS)
Regulation of VLCDs within the Foods for Specific Groups Regulation,4 does not allow for health claims on such products and hence the proposed health claim for ‘reduction in body weight’ which is currently on-hold, is due to be refused authorisation. CLAIMS IN COMMUNICATIONS TO HEALTHCARE PROFESSIONALS
A further development relates to a German court case, requesting clarification about the applicability of the Nutrition and Health Claims Regulation1 to business communications targeted at healthcare professionals. The Advocate General concluded that the Regulation should apply to such communications, the key issue being whether the foods per se are intended for the final consumer, and not the communication. This opinion is not binding on the courts, but is influential in any judgements and is, therefore, of concern since it differs from our interpretation in the UK. SAFETY CONCERNS
A further issue relates to safety concerns that have been raised about particular substances that are the subject of claims or proposed claims. There is provision to assess their safety under the Addition of Vitamins and Minerals and of Certain Other Substances to Foods Regulation.6 Article 8 of this Regulation sets out a process whereby a substance of potential concern can be placed in one of three categories: Part A - prohibited, Part B - with specified conditions, or Part C - under scrutiny for four years. If a substance is listed in Part C there is an 18-month period to submit safety information and a nine-month period for EFSA to give its opinion. A proposed claim for hydroxyanthracene derivatives and improvement of bowel function has been awarded a positive EFSA opinion. However, Member States raised concerns about its safety and under the Article 8 procedure and www.NHDmag.com November 2017 - Issue 129
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PUBLIC HEALTH
. . . the number of applications has fallen with fewer claims being put forward for assessment. In the future, the impact of Brexit could result in divergence of how nutrition and health claims are regulated between the UK and the EU . . . EFSA has been requested to assess available information on its safety. EFSA has also been asked for a scientific opinion on the safety of monacolins in red yeast rice under the same procedure. This substance already has an authorised claim. The safety concern relates to the possible presence of citrinin, a nephrotoxic mycotoxin, in red yeast rice. EFSA’s opinion is due to be published in 2018.
made, to date no terms have yet been approved. One possibility initially considered was the term ‘probiotic’, but the Commission is standing by its initial view that ‘probiotic’ is a health claim. It is, therefore, unlikely that the term will be given generic descriptor status and it will most probably not be able to be used on labels again until the evidence merits an authorised health claim.
GENERIC DESCRIPTORS
CONCLUSIONS
Article 1.4 of the Nutrition and Health Claims Regulation1 makes provision for the use of generic descriptors, (defined as, ‘denominations which have traditionally been used to indicate a particularity of a class of foods or beverages’) that could imply an effect on human health - e.g. tonic water, digestive biscuit, cough drop, etc. Article 1.4 allows a derogation that such terms can be used without having to be accompanied by a related nutrition or health claim. Generic descriptors potentially cover terms perceived as nutrition claims as well as health claims. Application rules for generic-descriptor status were published in September 2013. Though a number of applications have been
Over 10 years since the Nutrition and Health Claims Regulation was published, a number of provisions in the Regulation are still not in place. Parts of the Regulation are currently subject to evaluation, which, in the case of nutrient profiles, will determine whether or not they are implemented at all and in the case of botanical claims, will determine how these are to be assessed. Meanwhile, the number of applications has fallen with fewer claims being put forward for assessment. In the future, the impact of Brexit could result in divergence of how nutrition and health claims are regulated between the UK and the EU and this will be discussed more fully in next month’s issue.
References 1. EU, 2006. Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. Official Journal of the European Union 30.12.2006, L 404 2. Sadler M. European Health Claims: Regulatory Developments. In Foods, Nutrients and Food Ingredients with Authorised EU Health Claims, Volume 3. Ed. MJ Sadler. Woodhead Publishing, 2017, Chapter 1 3. EFSA 2008. Panel on Dietetic Products, Nutrition and Allergies (NDA). The setting of nutrient profiles for foods bearing nutrition and health claims pursuant to Article 4 of the Regulation (EC) No 1924/2006. EFSA Journal 2008; 644:1-44 4. EU, 2013. Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009. Official Journal of the European Union 26.6.2013, L181/35 5. EU, 2016. Commission Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding. Official Journal of the European Union 2.2.2016, L25/1 6. EU, 2006. Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods. Official Journal of the European Union, 20 December 2006
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