Foods, Nutrients and Food Ingredients with Authorised EU Health Claims

Volume 3

Michele Sadler

• Publisher: Woodhead Publishing
• Year: 2017
• Print ISBN:
  9780081009222
• eBook ISBN:
  9780081010068
• Topic: Law
• Subtopic: Administrative Law
• Index: Law

Foods, Nutrients and Food Ingredients with Authorized EU Health Claims, Volume Three, provides an overview of how health claims are regulated in the European Union, along with detailed scientific and regulatory information about permitted health claims for foods and ingredients. The latest volume in this series focuses on regulatory coverage from EC 1924/2006, including the most recently authorized claims. Topics discussed include sections on the Authorized reduction of disease risk claims, including calcium, calcium with Vitamin D, Vitamin D, Folic Acid, Limicol® and MUFA and PUFA., health claims based on emerging science, recent regulatory announcements, and finally, general function claims. The book represents the go-to resource for R&D managers and technical managers in the food and beverage and dietary supplements industry, product development managers, health professionals and academic researchers in the field. - Provides a comprehensive overview of foods and food substances that have achieved approved health claims in Europe under Regulation EC 1924/2006 - Covers properties and applications of each ingredient, as well as evidence for the health claim and how it benefits consumers - Outlines the importance of each claim in product development and marketing, and in regulatory issues, such as conditions of use

Part One

Regulatory Background

Chapter 1: European health claims: regulatory developments

Chapter 2: Consumers and health claims

1

European health claims: regulatory developments

Michele J. Sadler Rank Nutrition Ltd, Bethersden, Kent, United Kingdom

Abstract

Recent developments, concerning the regulation of health claims in Europe have been a slowing of health-claim applications through the available application routes i.e. for reduction of disease risk claims, children’s development and health claims, and for claims based on newly developed scientific evidence and/or requesting the protection of proprietary data. There has been no further progress with setting nutrient profiles or with agreeing the status of health claims for ‘botanicals’, and these two issues are subject to a wide-ranging review. EFSA has published revised guidance to assist with health-claim applications. However, the remit of the expert panels is being revised reflecting the reduced number of health claim applications. The potential impact of Brexit on health claims is considered, as this may result in divergence in health claims regulation between the United Kingdom and the European Union depending on the final relationship that is negotiated between the UK and the EU.

Keywords

health claims

regulation

botanicals

nutrient profiles

guidance

Brexit

1.1. Introduction

This chapter discusses developments since January 2015 relating to the regulation of health claims in Europe, which is governed by the Nutrition and Health Claims Regulation (EU, 2006a). The equivalent chapter in Volume 2 (Sadler, 2015) covers regulatory developments from September 2013, while developments prior to that are covered in Volume 1 (Binns, 2014).

Recent developments of note are a slower rate of new health claim applications through the available application routes (EU, 2006a):

• Article 13.5: claims based on newly developed scientific evidence and/or requesting the protection of proprietary data.

• Article 14.1(a): reduction of disease risk claims.

• Article 14.1(b): children’s development and health claims.

Of the candidate ‘general function’ claims previously submitted by Member States (prior to 31 January 2008) under Article 13.1 (Binns, 2014), over 2000 claims for ‘botanicals’ remain on-hold, pending a wide-ranging regulatory review. The requirement in the Nutrition and Health Claims Regulation (EU, 2006a) to set nutrient profiles, such that foods not meeting certain nutritional criteria would not be able to carry health claims, is also under review. Though rules have been published to apply for generic descriptors, at the time of writing, none have as yet been approved. These issues are discussed along with other general trends, reference to new guidance documents, and possible effects of the changing political landscape, particularly in the United Kingdom in light of the decision to leave the European Union (so-called Brexit).

1.2. Health claim applications

The slower pace of new health claim applications reflects the associated difficulty, the uncertainty and the high costs of both undertaking new studies and compiling applications which have resulted in less commercial interest in winning health claim approvals in Europe. Of applications that have been made, negative EFSA opinions continue to outweigh positive ones, and the time taken to authorise claims remains variable, depending on particular issues that require discussion. The numbers of authorised and non-authorised health claims by category as of July 2017 are shown in Table 1.1.

Table 1.1

Number of authorised and non-authorised health claims by category (as of July 2017)

Category (article)	Authorised	Non-authorised
13.1 ‘General function claims’	229	1875
13.5 Claims based on newly developed scientific evidence	6	108
13.5 Claims based on proprietary data	5
14.1(a) Reduction of disease risk claims	14	24
14.1(b) Children’s development and health claims	12	44
Number of 13.5 and 14.1(a) and (b) health claims under discussion following receipt of the EFSA opinion is ∼50

1.2.1. Article 13.5 claims

1.2.1.1. Authorisations based on newly developed scientific data

Two claims were authorised in the first half of 2017, too late for inclusion in Volume 3. These were for creatine in conjunction with resistance training and ‘improvement in muscle strength’ in adults aged over 55 years, and for lactitol and ‘maintenance of normal defecation’. Lactitol has since received novel foods approval for nutritional or physiological purposes, for use in capsule or tablet forms of food supplements intended for adults at a maximum daily dose of 20 g.

Four Article 13.5 applications that are also not the subject of new chapters were for claims that had already been assessed with a favourable outcome under Article 13.1. They related to two claims: one for non-fermentable carbohydrates and ‘consumption of foods/drinks containing [name of all used non-fermentable carbohydrates] instead of fermentable carbohydrates...

Table of contents

• Cover
• Title page
• Table of Contents
• Copyright
• Dedication
• List of contributors
• Preface
• Part One: Regulatory Background
• Part Two: Authorised Reduction of Disease Risk Claims
• Part Three: Health Claims Based on Emerging Science and Proprietary Claims
• Part Four: General Function Claims
• Index