Navigating the Nutrition and Health Claims Regulation

Abstract

An aspect of many of the papers in this issue of Nutrition Bulletin is the requirement for robust evidence if claims are to be made linking a nutrient, food or ingredient of a food with a particular beneficial effect. Examples include papers on fluoride (Ruxton & Bond 2015), vitamin D (Buttriss 2015a), fibre (Buttriss 2015b), plant bioactives (Kay 2015) and, in particular, a paper that describes an EC-funded project (REDICLAIM) that aims to understand the impact of European Regulation on the substantiation and use of new general claims and ‘reduction of disease risk’ claims in foods and drinks (Raats et al. 2015). REDICLAIM is seeking to understand the impact the Regulation is having on use of ‘reduction of disease risk’ claims, the main issues and hurdles regarding substantiation and use of these claims, and the level of awareness of legal obligations with regard to the use of claims, amongst relevant stakeholders. A modelling exercise will also be conducted to estimate the possible health and economic impacts in the general population of a ‘reduction of disease risk’ claim. In the September issue (Buttriss 2015c), we summarised the claims process and reported on some of the ongoing challenges being faced in the implementation of the Nutrition and Health Claims Regulation [Regulation (EC) No 1924/2006], even in situations where a positive opinion on the underpinning science has been given by the European Food Safety Authority (EFSA), the wording of a claim has been approved by the European Commission (EC) and the claim has been incorporated into the official list of approved claims. The Regulation harmonises the provisions related to nutrition and health claims and establishes rules governing the European Community authorisation of health claims made on foods and drinks. To help those considering submitting applications for new claims under the Regulation, EFSA has been consulting on an updated draft of the General Scientific Guidance for Stakeholders on Health Claim Applications; the consultation ended on 11 September 2015. Guidance documents have been available since 2007 (www.efsa.europa.eu/en/nda/ndaclaims.htm). Before the adoption of the new guidance document, account will be taken of the responses received during the public consultation. Once adopted, the new guidance will supersede the guidance published in 2011 (www.efsa.europa.euenefsajournalpub2135.htm) and the pre-submission guidance published in 2007. The draft guidance draws on experience gained during EFSA's evaluation of health claims and takes into account the outcomes of public consultations conducted previously that identified issues such as general principles, and administrative and procedural aspects related to the evaluation process that needed further clarification in order to assist applicants in preparing and submitting their applications for the scientific evaluation of health claims. Another source of information for would-be applicants, specifically written with the needs of small- and medium-sized enterprises (SMEs) in mind, has been developed within the EC-funded BACCHUS project (FP7-312090). The BACCHUS project focuses on developing rigorous science to support potential health claims in relation to a range of bioactives and cardiovascular health. The BACCHUS Best Practice Guide for Nutrition and Health Claims can be found at http://bit.ly/1MUm1YR. In addition to including guidance on the application process, the guide also summarises some work conducted within the BACCHUS project on the experiences of SMEs with the health claims process.