FOOD ADDITIVES
CONTENTS REGULATORY DEVELOPMENTS WITH EUROPEAN HEALTH CLAIMS INTRODUCTION HEALTH CLAIM AUTHORISATIONS ON-HOLD ARTICLE 13 1 CLAIMS CHILDREN’S DEVELOPMENT AND HEALTH CLAIMS NON-AUTHORISED CLAIMS WITH POSITIVE OPINIONS GENERIC CLAIMS VS BRANDS NUTRIENT PROFILES GENERIC DESCRIPTORS CHALLENGING AREAS BALANCE OF HEALTH CLAIM APPROVALS IN RELATION TO A HEALTHY DIET REVISIONS TO EFSA GUIDANCE COMMERCIAL VALUE OF HEALTH CLAIMS CONCLUSIONS SOURCES OF FURTHER INFORMATION AND ADVICE REFERENCES PART ONE AUTHORISED DISEASE RISK REDUCTION CLAIMS AND PROPRIETARY CLAIMS AUTHORISED EU HEALTH CLAIMS FOR PHYTOSTEROLS INTRODUCTION TO DIETARY PHYTOSTEROLS AND CHOLESTEROL LOWERING VIEWS OF MEDICAL AND SCIENTIFIC BODIES ON PHYTOSTEROLS REGULATORY CLASSIFICATION OF FOODS WITH ADDED PHYTOSTEROLS AND MANDATORY LABELLING SAFETY OF PHYTOSTEROLS AUTHORISED HEALTH CLAIMS IN EUROPE RELATED TO PHYTOSTEROLS SELECTION OF SOURCES OF FURTHER INFORMATION AND ADVICE ON PHYTOSTEROLS AUTHORISED EU HEALTH CLAIM FOR SLOWLY DIGESTIBLE STARCH CHARACTERISATION OF SDS AUTHORISED EU HEALTH CLAIM OTHER RELEVANT LEGISLATION IMPORTANCE/POTENTIAL OF THE CLAIM IN PRODUCT DEVELOPMENT CONSUMER ISSUES CONCLUSION AUTHORISED EU HEALTH CLAIM FOR COCOA FLAVANOLS CHARACTERISATION OF COCOA AND ITS FLAVANOLS COCOA FLAVANOLS AND EU HEALTH CLAIMS COMMERCIALISATION OF HEALTH CLAIM – GUILT-FREE INDULGENCE? FUTURE TRENDS IN SCIENTIFIC RESEARCH PART TWO INGREDIENTS WITH PERMITTED ‘GENERAL FUNCTION’ HEALTH CLAIMS AUTHORISED EU HEALTH CLAIMS FOR OAT AND BARLEY GRAIN FIBRE AUTHORISED ARTICLE 13 1 CLAIM SUMMARY OF SUBSTANTIATING EVIDENCE FAECAL BULKING CLAIMS: SOME GENERAL CONSIDERATIONS CONDITIONS OF USE, WARNING LABELS AND SAFETY ISSUES CONSUMER ISSUES AND HOW THE CLAIMS ARE BEING USED IN PRACTICE FUTURE TRENDS AUTHORISED EU HEALTH CLAIMS FOR WHEAT BRAN FIBRE AUTHORISED ARTICLE 13 1 CLAIMS FOR WBF HOW THE CLAIMS ARE BEING USED IN PRACTICE AUTHORISED EU HEALTH CLAIM FOR RYE FIBRE CHARACTERISATION OF THE FOOD AUTHORISED EU HEALTH CLAIMS CLAIMS NOT PERMITTED FOR RYE FIBRE OTHER SCIENTIFIC REVIEWS ON THE HEALTH EFFECTS OF RYE FIBRE AUTHORISED EU HEALTH CLAIM FOR RED YEAST RICE CHARACTERISATION OF RED YEAST RICE AND MONACOLIN K HEALTH EFFECTS OF RED YEAST RICE LEGISLATIVE STATUS OF RED YEAST RICE ANALYSIS OF THE TWO EFSA OPINIONS ON RED YEAST RICE (ARTICLES 13 1 AND 13 5) INTEREST OF THE RED YEAST RICE HEALTH CLAIMS FOR THE FOOD SUPPLEMENT MARKET AUTHORISED EU HEALTH CLAIMS ON PECTINS STRUCTURE AND FUNCTION OF PECTINS FOOD SOURCES OF PECTINS THE EFSA’S SCIENTIFIC ASSESSMENT OF PECTIN’S HEALTH EFFECTS OTHER POTENTIAL BENEFITS RELEVANT EUROPEAN LEGISLATION PERTAINING TO THE USE OF PECTINS IN FOOD AND FOOD SUPPLEMENTS AUTHORISED EU HEALTH CLAIMS FOR GLUCOMANNAN, GUAR GUM AND HYDROXYPROPYL METHYLCELLULOSE CHARACTERISATION OF GLUCOMANNAN, GUAR GUM AND HPMC AUTHORISED EUROPEAN HEALTH CLAIMS FOR GLUCOMANNAN, GUAR GUM AND HPMC CONSUMER PERCEPTION AND UNDERSTANDING OF HEALTH CLAIMS IMPORTANCE AND POTENTIAL OF GLUCOMANNAN, GUAR GUM AND HPMC HEALTH CLAIMS IN PRODUCT DEVELOPMENT AUTHORISED EU HEALTH CLAIM FOR FRUCTOSE CHARACTERISATION OF FRUCTOSE AUTHORISED EU HEALTH CLAIM ON FRUCTOSE POTENTIAL OF THE CLAIM IN PRODUCT DEVELOPMENT PART THREE FOODS AND NUTRIENTS WITH PERMITTED ‘GENERAL FUNCTION’ HEALTH CLAIMS LINOLEIC (18:2N-6) AND N-3 A-LINOLENIC (18:3N-3) ACIDS BACKGROUND EFSA POSITIVE OPINIONS AND EC-AUTHORISED HEALTH CLAIMS FOR N-6 LINOLEIC AND N-3 LINOLENIC ACIDS POSSIBLE FUTURE AREAS FOR POSITIVE OPINIONS AND EC AUTHORISATION FOR LA AND ALA AND HEALTH EFFECTS GENERAL CONCLUSIONS SOURCES OF FURTHER INFORMATION AUTHORISED EU HEALTH CLAIMS FOR DHA AND EPA CHARACTERISATION AND SOURCES AUTHORISED HEALTH CLAIMS NON-AUTHORISED HEALTH CLAIMS SOURCE CLAIMS DIETARY INTAKES OTHER CONSIDERATIONS CONSUMER CONCERNS AUTHORISED EU HEALTH CLAIM FOR FOODS WITH A LOW OR REDUCED CONTENT OF SATURATED FATTY ACIDS CHARACTERISATION OF THE SUBSTANCE AUTHORISED EU HEALTH CLAIM: LOW OR REDUCED SFAS POTENTIAL IMPACT OF THE CLAIM ON PRODUCT DEVELOPMENT AUTHORISED EU HEALTH CLAIM FOR FOODS WITH A LOW OR REDUCED CONTENT OF SODIUM CHARACTERISATION OF SODIUM/SALT SODIUM/SALT IN THE DIET – WHAT IS THE ISSUE? HOW THE CLAIM IS BEING USED IN PRACTICE POTENTIAL OF THE CLAIM IN PRODUCT DEVELOPMENT AND FUTURE TRENDS AUTHORISED EU HEALTH CLAIM FOR DRIED PLUMS/PRUNES PROCESS FOR AUTHORISATION OF THE CLAIM CHARACTERISATION TARGET POPULATION CLAIM WORDING SUBSTANTIATING EVIDENCE CONDITIONS OF USE MECHANISM OF ACTION COMMERCIAL IMPORTANCE OF THE CLAIM AND FUTURE TRENDS INTRODUCTION THIS CHAPTER COVERS DEVELOPMENTS IN THE REGULATION OF HEALTH CLAIMS IN EUROPE SINCE SEPTEMBER 2013, WHEN THE EQUIVALENT CHAPTER WAS COMPLETED FOR VOLUME 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 REDUC- TION CLAIMS, OR VIA THE ARTICLE 14 1(B) ROUTE FOR CHILDREN’S HEALTH AND DEVELOPMENT CLAIMS THE AUTHORISATION PROCEDURES ARE OUTLINED IN BINNS (2014)