Health Claim Strategies for Food and Drinks Companies.pdf
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1、 1 Health Claim Strategies for Food and Drinks Companies Learning from EFSA review standards and how manufacturers can use food law as a competitive advantage Reference Code: BI00061-009 Publication Date: November 2012 2 About the author Dr Stoffer Loman is CEO at NutriClaim, a specialist consultanc
2、y firm providing services at the interface of nutrition sciences and regulatory affairs to the food business industry. He is a specialist health claims consultant devoted to the development of successful health claims strategies “from cradle to market.“ He is a trained Nutritionist (MSc) from Wageni
3、ngen University, the Netherlands, and obtained a PhD in Immunology and Cell Biology (Academic Medical Center, University of Amsterdam, the Netherlands). He has worked for over 10 years in the food supplement industry as a science communicator and health educator with a strong focus on scientific eva
4、luation and communication of health benefits of (food) ingredients. NutriClaim was founded in 2007, the same year that the EU health claims regulation entered into force. To date, Dr Loman has been involved in over 20 health claims projects. As per fall 2012, three health claim applications prepared
5、 by NutriClaim have been evaluated by EFSA. EFSA established cause and effect for all three of them. Disclaimer Copyright 2012 Datamonitor This report is published by Datamonitor (the Publisher). This report contains information from reputable sources and although reasonable efforts have been made t
6、o publish accurate information, you assume sole responsibility for the selection, suitability and use of this report and acknowledge that the Publisher makes no warranties (either express or implied) as to, nor accepts liability for, the accuracy or fitness for a particular purpose of the informatio
7、n or advice contained herein. The Publisher wishes to make it clear that any views or opinions expressed in this report by individual authors or contributors are their personal views and opinions and do not necessarily reflect the views/opinions of the Publisher. 3 Table of contents About the author
8、 2 Disclaimer 2 Health claim strategies for food and drinks companies 6 Introduction 6 About this report 6 The claims evaluation and authorization process 7 EFSA evaluation 7 Review by European Commission and member states 8 Authorization by European Parliament 8 Other EU and national provisions rem
9、ain in place 9 Case of EPA and DHA 9 Case of krill oil 10 Case of melatonin 10 The case of monacolin K 11 The permitted health claims list 12 Claims for vitamins and minerals 12 Claims related to high profile health benefits 14 Immunity 14 Digestive health 15 Body weight management 16 Blood glucose
10、management 17 Regulation adoption: the fallout 20 Longstanding health claims to be removed 20 Glucosamine claims rejected 20 Conjugated linoleic acid applications fail 21 Goodbye CoQ10 claims 21 4 Potential manufacturer response 22 Areas of uncertainty remain 23 Are all claims in the non-authorized
11、list false? 23 Are all authorized claims in the community register true? 23 Phrasing an authorized health claim 26 Guidance by national enforcement authorities 27 UK 27 Belgium 28 Netherlands 28 France 28 Linguistic factors 29 Future claims landscape 30 Market opportunities 30 Achieving credibility
12、30 Vitamins and minerals to dominate health categories 30 Market challenges 32 How to move a claims strategy forward 33 What does it take to get a health claim approved? 33 Generating new data 34 Choosing the right trial partner 35 Academia versus CROs: SWOT analyses 35 Conclusions 38 Appendix 40 Sc
13、ope 40 Methodology 40 Glossary/abbreviations 40 Bibliography/references 41 5 Table of figures Figure 1: Health claim regulation timeline, 200712 7 Figure 2: Substance distribution of EU authorized health claims 12 Figure 3: Hierarchy of scientific evidence 24 Figure 4: SWOT analysis for an academic
14、group as a trial partner 36 Figure 5: SWOT analysis for a CRO as a trial partner 37 Table of tables Table 1: EU authorized health claims and related health relationships for zinc 13 Table 2: EU authorized health claims pertaining to the immune system 15 Table 3: EU authorized health claims pertainin
15、g to digestive health 16 Table 4: EU authorized health claims pertaining to body weight management 17 Table 5: EU authorized health claims pertaining to blood glucose management 19 Table 6: EU authorized health claims for which EFSA found no evidence of deficiency in the EU population leading to imp
16、aired function of the health relationship 25 Table 7: EU authorized health claims related to micronutrients and reduction of tiredness and fatigue 26 Table 8: What does it take to get a health claim approved? 34 Table 9: Requirements for successful, pertinent clinical trial 38 6 Health claim strateg
17、ies for food and drinks companies Introduction The evolution of more stringent regulations has become the single biggest challenge to the functional food and drinks industry. In Europe, the introduction of the EU Nutrition and Health Claims Regulation (NHCR; EC Regulation 1924/2006) on July 1, 2007
18、has transformed the average development program for a new functional ingredient because manufacturers must now supply scientific evidence to support any associated health claims. The NHCR was introduced in an effort to harmonize current regulation and to help protect consumers from the increasing nu
19、mber of misleading health claims made on foodstuffs. Within the regulation, health claims have been stratified by type. There are five primary types of claims: Nutrition claims (Article 8): claims relating to the properties of a product, such as “low in fat.“ Based on generally accepted science (Art
20、icle 13.1): these include claims related to the growth and development of the body, psychological and behavioral functions, and those related to satiety and/or impacting the availability of energy from the diet. New and therefore not established areas of health claims that can also request proprieta
21、ry data protection (Article 13.5). Disease risk reduction (Article 14). Claims related to child development and health (Article 14). About this report This report provides an overview of the process created by the adoption of the NHCR. More significantly, however, the content summarizes the results
22、of the new legislation in terms of what health claims have been approved and what this will mean for the existing functional food landscape. The report considers what 7 options now face manufacturers in this sector, what strategies can be employed to navigate the new regulations, and what opportunit
23、ies have emerged through the course of the changing regulatory environment. The claims evaluation and authorization process Implementation of the NHCR brought a commitment to adopt a list of permitted health claims, based on an assessment of any submitted evidence by the European Food Safety Authori
24、ty (EFSA). Figure 1: Health claim regulation timeline, 200712 EC Regulation 1924/2006 on nutrition and health claims made on foods is implemented EFSA finalizes evaluation of all claims, other than botanicals, having missed original January 2010 deadline July 2007 June 2011 Dec 5 2011 Member states
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