Elinor McCartney, President of Pen & Tec Consulting Group, reviews the successes and failures so far in gaining EFSA approval for food nutrition and health claims.
Introduction
The nutrition and health claims regulation (NHC), introduced in 2006, has had sweeping effects on the food and food supplement industry in Europe [1]. The purpose of the regulation is to ensure that any claims made to consumers on foods, beverages and food supplements are based on high quality science underpinned by an EFSA (European Food Safety Authority) evaluation, and to eliminate exaggerated, fraudulent or unsubstantiated claims. As a first step, the food industry was invited to propose, via EU Member States, food claims already supported by good science (Article 13.1 ‘GAS’ claims, Generally Accepted Science). In excess of 40,000 proposals were received and these were reduced to around 4,500 by eliminating duplicates and ‘out-of-scope’ claims. EFSA began to evaluate the remaining claims and so far 229 ‘GAS’ claims are permitted on foods, mostly relating to vitamins and minerals with well-established and generally-accepted essential dietary functions, supported by substantial published research dating back several decades.
![Table 1. Summary of authorised claims on EU foods (derived from the EU register on nutrition and health claims)]()
Most proposed ‘GAS’ claims were rejected, for example all claims on probiotics, except for a single ‘GAS’ claim in relation to live yoghurt cultures and improved lactose digestion. Today the total number of approved claims, including Article 13.1 ‘GAS’, Article 13.5 ‘new’ science, Article 14(1)a ‘reduction of disease risk’ and Article 14(1)b ‘children’s development/health’ is 259 out of 2,276 assessed claims, a success rate of only 11%. A large number of claims relating to plant derivatives (‘botanical’ claims) are currently on hold (ca. 2,150), pending resolution of the debate r![Table 2. Summary of non-authorised claims on EU foods (derived from the EU register on nutrition and health claims)]()
egarding possible conflicts with claims permitted under the traditional herbal medicines legislation. Only 6 claims related to ‘new’ science have been approved (Article 13.5) and 25 claims relating to reduction of disease risks or children’s development and health.Examples and the current status of NHC claims are summarised in Tables 1 and 2 [2].
Reasons for NHC failures
The initial Article 13.1 GAS claims review was a type of ‘grandfathering’ process, which allowed a number of claims on foods after an initial check by EFSA of supporting literature. Hence it is not surprising that most GAS claims involve vitamins and minerals and their established roles in human health and nutrition. The grandfathering process also allowed the EU to remove wilder marketing claims from European food products.
The high initial failure rate during the GAS ‘grandfathering’ process was related to several factors:
- Failure to characterise the nutrient, substance or food to EFSA’s satisfaction
- Inappropriate claims wording
- Over-reliance on published papers that did not meet EFSA’s requirements (e.g. did not test the nutrient, substance or food that was the subject of the claim)
- Over-reliance on in vitro work to substantiate claims
- Lack of good-quality, well-controlled human studies, specifically designed for an EFSA NHC evaluation
- Improbable claims.
The probiotic sector, both food supplements and foods, had a disappointing introduction to NHC and initial claims attempts were frustrated by EFSA’s rejection of most probiotics due to insufficient strain characterisation. EFSA soon clarified that probiotic strains differed in efficacy and hence NHC claims would be strain-specific. The EC (European Commission) allowed notifiers to resubmit GAS claims with updated strain characterisation data, but this only extended the period until final delisting of the majority of claims, this time due to over-reliance on ‘generic’ literature that did not test the specific strains to which claims were attributed, or due to flaws in study designs, such as inadequate blinding.
Post-GAS – challenges of an EFSA evaluation
EFSA has issued a number of guidance documents for applicants attempting claims authorisations under NHC and plans to update these as necessary with the benefit of experience [3]:
- Scientific and technical guidance
- General guidance
- Guidance for health claims related to gut and immune function
- Guidance on health claims related to antioxidants, oxidative damage and cardiovascular health
- Guidance on the scientific requirements for health claims related to appetite ratings, weight management and blood glucose concentrations
- Guidance on the scientific requirements for health claims related to bone, joints, skin and oral health
- Guidance on the scientific requirements for health claims related to physical performance
- Guidance on the scientific requirements for health claims related to functions of the nervous system, including psychological functions.
The food industry is also learning from EFSA experiences to date and, whereas fewer applications have been submitted since the GAS grandfathering period, the quality of applications has improved in many respects, for example:
- Most food products submitted under NHC are characterised to EFSA’s satisfaction,
- Fewer applications are rejected due to inadequate claims wordings
- Applications are supported by data specific to the food product under evaluation,
- The quality of supporting studies has improved,
- Applicants are paying more attention to EFSA guidance on appropriately controlled study designs, reporting complete data sets and the quality of statistical analyses.
Nutrient profiles – a pending NHC challenge for food business operators
Article 4 of NHC foresees the setting of nutrient profiles, which will determine whether foods are eligible or not to bear claims on the basis of their nutrient composition. Nutrient profiles will be based primarily on the content of nutrients for which excessive intakes in the overall diet are not recommended, especially fat, saturated fatty acids, trans-fatty acids, sugars and salt/sodium. This objective has proved complex despite an EFSA opinion in 2008 on this subject [4]. For the time being, NHC stipulates that claims may not be made on beverages with more than 1.2% alcohol, but may be permitted where only a single nutrient exceeds the nutrient profile. There is considerable debate about the wisdom of setting nutrient profiles for individual foods, when it is more important to consider the quality of the diet as a whole. The EC plans to readdress the issue of nutrient profiles by 2019, a decade later than initially envisaged. Nevertheless, the spectre of nutrient profiles may help drive innovation in the food industry, as food scientists focus on developing healthier snacks with, for example, higher fibre and lower salt, sugar and unhealthy fats, but still offering good taste.
Conclusions on NHC and recommendations to applicants
The NHC has succeeded in removing the more extravagant marketing claims made to EU consumers on food products, but the food industry is critical of both EC and EFSA for the current difficulties in obtaining NHC claims, even when good quality human intervention studies are used to support applications. It is difficult for smaller food businesses to fund the studies necessary and even major players with adequate budgets have failed to convince EFSA under NHC. On the other hand, EFSA is revising guidance documents, such as those on gut health and immune function, and introducing overarching guidance on, for example, statistical approaches. There have been a number of success stories, such as the use of ex vivo data (more economical to generate in comparison with ‘full’ in vivo studies) to justify claims relating to a range of water-soluble tomato concentrates and maintenance of platelet aggregation, thus contributing to normal blood flow [5].
Whereas the food and food supplement industry has had to adjust marketing strategies in compliance with NHC and has exhibited considerable creativity in this respect, regulators are policing food claims with renewed zeal and are applying dissuasive fines for promotional texts for consumers that are considered non-compliant.
It seems that the future will see a higher number of successful applications, such as the recent positive EFSA opinion on native chicory inulin and maintenance of normal defecation by increased stool frequency [6].
In general applicants are advised to build NHC dossiers from the ‘bottom-up’:
- Set commercial objectives according to what can be achieved with the EC/EFSA NHC framework
- Plan projects according to relevant EFSA NHC guidance
- Run EFSA-compliant studies
- Refine claims wording according to data generated
- Adjust marketing strategies accordingly.
Elinor McCartney, PhD, MBA is President of Pen & Tec Consulting Group
Tel: +34-93-675-8015 Email: elinor@pentec-consulting.eu Web: www.pentec-consulting.eu
References
- EC (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. OJ L 404, 30.12.2006, p. 9. http://eur-lex.europa.eu
- EC (2015) EU register on nutrition and health claims. http://ec.europa.eu/nuhclaims/
- EFSA guidance for applicants on health claims. Available to download from the EFSA NDA web pages: http://www.efsa.europa.eu/en/nda/ndaguidelines.htm
- EFSA (2008) NDA opinion on the setting of nutrient profiles for foods bearing nutrition and health claims pursuant to Article 4 of the Regulation (EC) No 1924/2006. The EFSA Journal (2008) 644, 1-44. http://www.efsa.europa.eu
- EFSA (2009) NDA opinion on water-soluble tomato concentrate (WSTC I and II) and platelet aggregation. The EFSA Journal (2009) 1101, 1-15. http://www.efsa.europa.eu
- EFSA (2015) NDA opinion on the substantiation of a health claim related to “native chicory inulin” and
