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REduction of DIsease risk” CLAIMs on food and drinks

Final Report Summary - REDICLAIM (REduction of DIsease risk” CLAIMs on food and drinks)

Executive Summary:
Differences in legislation related to providing health-related information have varied widely before the common European Union (EU) legislation on claims. This has acted not only as barrier against free movement of goods and fair competition, but has also as a potential barrier to investing in health-related research to produce products that have specific health outcomes, including those contributing to disease risk reduction. Reports of studies investigating labelling of pre-packaged foods in EU countries showed that while 7-14% of foods were labelled with health claims, reduction of disease risk’ claims were present on less than 1% of the investigated items. The European Regulation on nutrition and health claims on foods [Nutrition and Health Claims Regulation (hereafter NHCR) is a harmonising law allowing health claims on foods to be made in a uniform manner throughout the Member States of the European Union (EU). Upon its introduction, the EC stated that the main objectives of the proposed
Regulation were to: (1) achieve a high level of consumer protection by providing further voluntary information, beyond the mandatory information foreseen by EU legislation; (2) improve the free movement of goods within the internal market; increase legal security for economic operators; (3) ensure fair competition in the area of foods; and (4) promote and protect innovation in the area of foods.

REDICLAIM seeks to understand the way in which the European 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 and associated legislation has had and continues to have an impact on the substantiation and use of “reduction of disease risk” claims on food and drinks. To achieve this REDICLAIM will:
(1) Seek to understand the (a) main issues and hurdles concerning substantiation and use of “reduction of disease risk” claims on food and drinks; (b) level of awareness about legal obligations with regard to “reduction of disease risk” claims on food and drinks among the relevant stakeholders; and
(2) Produce a three-fold study of the impact of nutrition and health claims legislation specific to “reduction of disease risk” claims on food and drinks on: (a) The claim substantiation process, (b) Health research and/or innovation in the food chain, and (c) Nutrition economic models to determine health impact.
Project Context and Objectives:
The programme of work is being conducted through six Work Packages (WPs):
WP1 brings together a community of interested stakeholders (e.g. industry, regulatory bodies, clinical trial specialists, scientists, health professionals and civil society) to reflect on project findings at key stages of the project.
WP2 (Establishing the regulatory frameworks) is (1) mapping the regulatory framework and decision-making process for health and nutrition claims at EU level; (2) mapping and analysing the implementation of the regulatory framework for 'reduction of disease risk' claims at Member State level; and (3) mapping and analysing the evidence of compliance to enable research into impacts of legislation on innovation.
WP3 (Exploring the interaction between legislation and health research and/or innovation in the food chain) is (1) identifying research carried out on beneficial interactions between the presence or absence of a food component and cardio-vascular function(s) in the body; (2) exploring food manufacturers' willingness/capability to exploit new research findings in cardio-vascular health related innovation processes; and (3) exploring the role of health claim regulation as a facilitator or barrier to research-based innovation aimed at developing products based on new findings and risk reduction of diseases.
WP4 (Ascertaining the interaction between legislation and the claim substantiation process) is conducting (1) a comparison of legislation of EU with that in other developed countries; (2) an investigation of known assessments of health claim applications and reasons for rejections and (3) case studies on applicants’ experiences of the health claim application process with focus on positively and negatively assessed applications.
WP5 (Nutrition economic models for food constituents associated with 'reduction of disease risk' claims) is using nutrition economic modelling methods to calculate the potential health and economic impact of 'reduction in disease risk' claims on the general population by establishing the proportion of the population with suboptimal consumption of the food (constituent) of interest and the impact of optimal consumption levels on disease burden and health care costs.
WP6 (Project management) ensures effective technical coordination and project management is implemented and sustained to successfully complete all aspects of the proposal.
REDICLAIM results will contribute to: (1) the development of an evidence base of the process by which health and nutrition claims are made and controlled by regulatory frameworks; (2) the effectiveness of their control by regulation; (3) the establishment of recommendations for government, industry and the scientific community with a view to conducting the necessary research and development of such products. The aim of this will be to achieve both effective compliance with better regulation and, to contribute to the enhancement of innovative and competitive products.
Project Results:
Based on the desk research and interviews conducted in WP2, the conclusions and recommendations are: (1) The provision of better guidelines and Codes of Practice at national level which give clearer information on i) scientific evidence necessary for a successful claim, and ii) appropriate wording of claims was recommended.; (2) Retaining the role of national authorities is recommended as they appear to be providing a useful service in checking the validity of the dossier; (3) The authorisation process needs to be controlled and expedited; (4) Differentials in enforcement are potentially an issue to be addressed in the future; and (5) The role of the EU in the promotion of public health policies.
Based on the desk research, interviews, and survey conducted in WP3 and WP4 the following recommendations were identified to support the preparation of applications for new health claims in the EU: (1) Consider the EFSA’s extensive guidance documents on the submission and substantiation of health claims: (2) Consider previous EFSA’s Opinions, particularly those published since the last revision of a specific guidance concerning the health outcome in question; (3) Consider the novelty of the food (constituent) and the novelty of the science providing the evidence; (4) Consider the results of key EU-funded research projects dealing with health claims; (5) Evaluation time can be shortened considerably if the health claim application (dossier) contains details of all pertinent data; (6) Data protection is possible when the scientific substantiation is primarily based on companies’ own data; (7) In the process of scientific evaluation of a health claim, the safety of a food (constituent) is not systematically assessed; (8) Assure that the food (constituent) can be sufficiently characterized; (9) A health claim’s wording must reflect the scientific evidence and should be comparable with already authorized claims (where applicable); (10) The claimed effect should be clearly defined and relevant for human health; (11) For all claims other than those based on the essentiality of nutrients, the substantiation of a health claim should primarily be based on good quality human efficacy studies; (12) The proposed conditions of use should reflect the conditions in which the studies used for substantiating the claim were conducted; (13) The application should provide the totality of the available scientific data; and (14) The successful scientific substantiation of a health claim does not ensure its authorization. The outcome of this process provides key references and highlights the issues needing to be properly addressed in all phases of the authorization of new claims – from deciding whether to apply at all for a new heath claim and the formulation of its wording, establishing and collecting the supporting evidence, through to the post-evaluation process, when the final specification of the health claim is formally incorporated into the Annex of the regulation. In WP5 a modelling approach was used to explore the effectiveness and cost-effectiveness of the ‘reduction in disease risk’ claim related to plant sterols. This modelling used the consumption of plant sterol-enriched margarine-type spreads for the prevention of CVD in people hypercholesterolemia in England, when compared to a normal diet, as the case study. As such, undertaking any modelling in the public health space clearly involves broader considerations than would be the case for the modelling of a purely clinical issue. If the model used in a public health setting is too simplistic, it will be inappropriate and have poor validity and credibility. A conceptual modelling framework approach for public health economic evaluation has highlighted four key principles for good practice: systems approach; understanding the problem/causal relations for the model structure; stakeholder involvement; systematic understanding of the determinants of health.

Potential Impact:
The European Regulation on Nutrition and Health Claims of 2006 provides a common regulation, allowing health claims to be made on foods in a uniform manner throughout the member states of the European Union. When introduced, the European Commission stated that the main objectives of the proposal were to: (1) achieve a high level of consumer protection by providing further voluntary information, beyond the mandatory information foreseen by EU legislation; (2) improve the free movement of goods within the internal market; (3) increase legal security for economic operators; (4) ensure fair competition in the area of foods; and (5) promote and protect innovation in the area of foods.
This action aimed to analyse whether these set goals have been achieved or whether they are regarded as achievable by stakeholders based on their opinions on how the legislation has been implemented. The action concentrated mainly in risk reduction claims which represent a type of claim that can give well-specified benefits to the consumers and provide a possibility to food industry to create products that can be differentiated from competitors.
High level of consumer protection has been one of the central aims in health claim legislation by requiring that all health claims are based on scientific substantiation and approved beforehand, thereby creating a positive list on claims that can be used in the European market. However, the impact of the legislation depends on how the legislation is implemented and regulated in different EU member states. REDICLAIM identified regulatory gaps and developed guidelines for the effective regulation of health claims which enable and enhance innovation while meeting the consumer and ethical perspectives.
Differences in legislation related to providing health-related information have varied widely before the common EU legislation on claims. For food industry this has acted not only as barrier against free movement of goods and fair competition, but also as a lower interest in investing in health-related research to produce products that have specific health outcomes, including those with contributing to risk reduction. In REDICLAIM we explored whether the legislation has promoted food industry’s interest in producing more innovative, science-based products that would respond to the needs of European citizens. REDICLAIM identified regulatory factors that encourage and hamper innovation in European food industry and come out with propositions that can promote more radical innovations in European food industry which in the long run will contribute to the competitiveness of the food industry.
List of Websites:
www.rediclaim.eu