Foods, Nutrients and Food Ingredients with Authorised EU Health Claims

Volume 2

Michele Sadler

• Publisher: Woodhead Publishing
• Year: 2015
• Print ISBN: 9781782423829
• eBook ISBN: 9781782424031
• Topic: Medicine
• Subtopic: Administrative Law

The second volume of Foods, nutrients and food ingredients with authorised EU health claims continues from Volume 1, which provided a comprehensive overview of many of the permitted health claims for foods and nutrients approved under European Regulation EC 1924/2006. This new volume discusses more of the health claims authorised to date for use in the EU. The chapters cover details of various permitted claims, such as the approved wording, conditions of use, the target group for the claims, the evidence for the claimed health benefits, and where appropriate details of other relevant legislation, consumer-related issues and future trends.The book opens with an overview of regulatory developments relating to health claims. Part One reviews authorised disease risk reduction claims and proprietary claims. The second part investigates ingredients with permitted 'general function' claims, with chapters examining ingredients such as red yeast rice, glucomannan and guar gum. The final section of the book explores foods and nutrients with permitted health claims, including chapters on authorised EU health claims for prunes, foods with low or reduced sodium or saturated fatty acids, and claims for essential and long chain polyunsaturated fatty acids.- Building on volume 1, this title ensures that the area of EU health claims in food is comprehensively covered- Chapters are devoted to individual food ingredients and substances, covering the range of issues related to health claims- Health-promoting products are an increasing consumer trend in product development and this book provides key information on these advances

1

Regulatory developments with European health claims

M. Sadler Rank Nutrition Ltd., Ashford, UK

Abstract

Since Chapter 1 in the first volume of this series was completed (September 2013), the key developments have been further health claim authorisations and the publication of more positive European Food Safety Authority opinions through the available application routes, that is, 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. European Commission guidance has been published, setting out the rules for generic descriptor applications. However, there has been no further progress with setting nutrient profiles. A number of challenging areas for health claims have emerged, such as joint-health claims, appetite and satiety claims, immune function claims and claims for gut bacteria. A comparison is made of authorised health claims in the area of heart health with dietary recommendations for a heart-healthy diet.

Keywords

EFSA

Health claim

European Parliament

WHO

Round Table Model

EU.

1.1 Introduction

This chapter covers developments in the regulation of health claims in Europe since September 2013, when the equivalent chapter was completed for Volume 1 (Binns, 2014).

The key developments since that time include a continuing flow of new health claim applications through the available application routes, that is, for

• Reduction of disease risk claims (Article 14.1a)

• Children’s development and health claims (Article 14.1b)

• Claims based on newly developed scientific evidence and/or requesting the protection of proprietary data (Article 13.5)

These have resulted in the publication of various positive European Food Safety Authority (EFSA) opinions and authorisation of a number of new health claims. The general trends are discussed.

A number of Article 13.1 ‘general function’ claims remain on hold, pending other decisions, scientific opinions or developments with related legislation. While there has been a lack of progress with setting nutrient profiles, rules have been published for applications for generic descriptors. Forthcoming revisions to EFSA guidance and the commercial value of health claims are touched on. The chapter also explores different versions of a communication tool, comparing EU-authorised health claims relating to heart health with World Health Organization (WHO)/Food and Agriculture Organization of the United Nations (FAO) overall dietary recommendations for a heart-healthy diet.

1.2 Health claim authorisations

Since the publication of EU Regulation 432/2012 (EU, 2012), authorising the list of Article 13.1 ‘general function’ health claims, applications for health claims must either be made via the Article 13.5 route (claims based on newly developed scientific evidence and/or proprietary data), via the Article 14.1(a) route for disease risk reduction claims, or via the Article 14.1(b) route for children’s health and development claims. The authorisation procedures are outlined in Binns (2014).

Changes to the procedure for authorising health claims under Regulation (EC) No. 1924/2006 (EU, 2006a) are due to occur in the future. The implementation measures currently proceed through the ‘regulatory procedure with scrutiny’, which allows a 3-month scrutiny period for the European Parliament (EP) to raise objections to the draft regulations for proposed claims. Under the Lisbon treaty, two new forms of implementing measures were introduced, known as ‘delegated acts’ and ‘implementing acts’. The European Commission is gradually moving to this new system. In 2013, the Commission sent a proposal to the EP listing existing legislation, which included, amongst others, the Nutrition and Health Claims Regulation, for which the implementing rules will in the future be developed through ‘implementing acts’ or ‘delegated acts’. The proposal was voted on by the EP in February 2014, but it has not yet been approved by the European Council. The delay is because the new regulation is being incorporated into the Commission’s ‘Better Regulation Initiative’, announced in December 2014. In 2015, the Commission is due to publish a proposal for an inter-institutional agreement that will update and strengthen how the Parliament, Council and Commission work together to improve the quality of regulation, and the expectation is that the pending delegated and implementing acts will be incorporated within this new agreement. Under the new system, for ‘delegated acts’ (relevant to health claims), the time allowed for the EP to intervene will be reduced from 3 to 2 months. There are examples where claims with a positive EFSA opinion have not been authorised, and cases where the Parliament has been in a position to influence the outcome of certain claim approvals; hence, changes to the scrutiny procedures are of relevance to the authorisation procedures for claims.

The ‘claims’ Regulation 1924/2006 (EU, 2006a) indicates that another possible route for changes to the community list of permitted claims is via Article 13.4. This would be ‘on the Commission’s own initiative or following a request by a Member State’. However, there is no formal process by which this particular route is ‘open’ for applications, with no specific guidance as to the format of an application, no defined timelines by which the scientific assessment would take place and no requirement for dialogue where necessary with the applicant, all of which is available for applications via Articles 13.5 and 14. Hence, this route has not been tried or tested.

With a steady flow of new applications, EFSA opinions are issued on a regular basis (for example, 37 opinions were issued in 2014), demonstrating the continued commercial interest in winning health claim approval in Europe. However, negative opinions considerably outweigh positive ones, and the time taken to authorise claims is very variable, depending on particular points for discussion. Issues that have delayed the authorisation of claims include clarity over the nutrient or substance that is the subject of the claim, the target group, and the conditions of use, as well as agreeing the authorised wording of claims.

As of December 2014, the numbers of authorised and non-authorised health claims by category are shown in Table 1.1.

Table 1.1

Numbers of authorised and non-authorised health claims by category (as of December 2014)

Category	Authorised	Non-authorised
13.1 ‘General function claims’	229	1874
13.5 Claims based on newly developed scientific evidence	1	84
13.5 Claims based on proprietary data	4
14.1(a) Reduction of disease risk claims	14	20
14.1(b) Children’s development and health claims	11	36

At any one time, numerous positive and negative EFSA opinions are undergoing authorisation procedures. Some of the opinions are taking much longer to gain approval or rejection than was initially foreseen. For example, an EFSA opinion for two related Article 14.1(a) reduction of disease risk claims that was issued in July 2009 (EFSA, 2009) was finally authorised in November 2014 (EU, 2014a), thus taking more than 5 years to fully complete the authorisation processes. In contrast, a positive EFSA opinion published at the end of July 2013, also for a reduction of disease risk claim (EFSA, 2013), was authorised in November 2014 (EU, 2014b). These claims will be the subject of chapters in Volume 3.

The aforementioned prolonged authorisations were related to the challenge of setting the conditions of use. The claims were for calcium alone, and for calcium with vitamin D in relation to reduction of loss of bone mineral in post-menopausal women, which is a risk factor for osteoporotic bone fractures. EFSA determined that there is no difference between dietary and supplemental calcium and vitamin D intakes with respect to slowing the reduction in bone mineral density in the target population, and that scientific evaluation thus applied to all forms of calcium and vitamin D. However, as the application was for supplemental intake of calcium and vitamin D, from the evidence provided, EFSA was unable to determine the effective daily intake on which the conditions of use could be set. EFSA was tasked to publish a separate opinion on appropriate daily intakes. These were determined as 1200 mg calcium and 800 IU (20 μg) vitamin D/day from all sources (EFSA, 2010a). This opinion was published in 2010. However, in view of the high intakes involved, EFSA was then asked to...

Table of contents

• Cover image
• Title page
• Table of Contents
• Copyright
• List of contributors
• Woodhead Publishing Series in Food Science, Technology and Nutrition
• Preface
• 1: Regulatory developments with European health claims
• Part One: Authorised disease risk reduction claims and proprietary claims
• Part Two: Ingredients with permitted ‘general function’ health claims
• Part Three: Foods and nutrients with permitted ‘general function’ health claims
• Index