Regulatory Update on Functional Ingredients: Permitted Health Claims in Malaysia Nurul Hidayati Mohd Nasir 1 & Tee E-Siong 2 Food Safety and Quality Division, Ministry of Health Malaysia 1 ; Nutrition Society of Malaysia 2 34 th Scientific Conference – Healthy Nutrition: Key to Disease Prevention 3-4 July 2019, Hotel Istana Kuala Lumpur Food Safety and Quality Division 1 Ministry of Health Malaysia
FUNCTIONAL FOOD/INGREDIENTS Essential characteristic and attributes • Foods provide nutrient to nourish the body and prevent deficiencies – Protein, carbohydrate, fat, vitamins minerals • Besides nutrients there is a large variety of other food components that may be beneficial to health – These are bioactive components in foods – Able to regulating the physiological processes of the body eg serving as antioxidants – Serve physiological roles beyond provision of simple nutrients requirements – Therefore increasing interest in the potential health significance of other components in foods Food Safety and Quality Division 2 Ministry of Health Malaysia
FUNCTIONAL FOOD/INGREDIENTS Essential characteristic of functional food • These food components are known as functional ingredients or phytonutrients • Foods containing these ingredients are functional foods • No unanimously accepted global definition • A generally accepted understanding is – Functional foods are foods that provide health benefits beyond basic nutrition – By virtue of physiological active food components (functional ingredients or bioactive components) present in these foods – Bioactive components can either be naturally occurring or added to the food • Similar in appearance to conventional foods and intended to be consumed as part of a normal diet Food Safety and Quality Division 3 Ministry of Health Malaysia
FUNCTIONAL FOOD/INGREDIENTS Functional foods are not nutraceuticals or supplement • Nutraceutical are bioactive ingredients isolated or purified from foods • Generally sold as medicinal forms, not usually associated with food – e.g. capsules, tablets • Expected to have physiological benefit or provide protection against chronic disease – Nutraceuticals considered as sub-set of dietary/health supplement – Nutraceuticals are not generally considered as functional foods Food Safety and Quality Division 4 Ministry of Health Malaysia
FUNCTIONAL FOOD/INGREDIENTS The terminology of functional ingredients • The terms “functional foods/ingredients” is not commonly used in regulations or legal systems • Nevertheless there must be regulatory control of these food/ingredients – To protect interest of consumers – To ensure claims are based on scientific evidence – To prevent fraudulent practices and non-permitted health claims • The approach by regulatory agencies towards these food/ingredients is therefore focused on – Health claims permitted and – Their scientific substantiation Food Safety and Quality Division 5 Ministry of Health Malaysia
FUNCTIONAL FOOD/INGREDIENTS Regulatory Approach • The term “functional ingredients/foods” not used • MOH allows “other food components” to be added to foods • Permits health claims, on pre-approval basis • Supplemented foods – proposed regulation Food Safety and Quality Division 6 Ministry of Health Malaysia
FUNCTIONAL FOOD/INGREDIENTS Use of “other food component” terms • Regulates the “nutrients” that may be added to food – Table I of Twelfth Schedule is a positive list of nutrients that may be used – List included vitamins, minerals, fatty acids, amino acids etc • Recognized that other component in food (not nutrients) may possess physiological functions beyond basic nutrition • Regulation 26 amended to include “other food component” – Table I of Twelfth Schedule includes variety of bioactive components – All by applications from food industry Food Safety and Quality Division 7 Ministry of Health Malaysia
Food Safety and Quality Division 8 Ministry of Health Malaysia
Food Safety and Quality Division 9 Ministry of Health Malaysia
Food Safety and Quality Division 10 Ministry of Health Malaysia
Food Safety and Quality Division 11 Ministry of Health Malaysia
New approval of “Permitted Added Nutrient” Other food component 2'- Fucosyllactose (2’ -FL) Slowly Digestible Starch (SDS) Isomaltooliogoscharide (IMO) Dietary fiber Isomaltodextrin (IMD) Food Safety and Quality Division 12 Ministry of Health Malaysia
FUNCTIONAL FOOD/INGREDIENTS Application for use of new “other food components ” • Industry may apply to MOH for “other food components” to be added to positive list of “added nutrients” • Use a stipulated application form with 18 items including – Detailed information on chemical structure, chemical and physical properties – Method of manufacture and analytical method – Physiological role – Benefits of adding the “nutrient” to the food with scientific substantiation – All safety data Food Safety and Quality Division 13 Ministry of Health Malaysia
Food Safety and Quality Division 14 Ministry of Health Malaysia
FUNCTIONAL FOOD/INGREDIENTS Use of health claims “other food components ” • “other food component listed as “permitted added nutrient” may apply to make health claims – Health claims – other function claim – are permitted since 2003 • A positive list of 29 other function claims for bioactive ingredients with proven physiological functions • All arising from petitions from industry • Health claim and positive list of permitted probiotic strains gazetted in April 2017 • Disease risk reduction claims are not permitted in Malaysia Food Safety and Quality Division 15 Ministry of Health Malaysia
FUNCTIONAL FOOD/INGREDIENTS Use of health claims “other food components ” • A positive list 29 other function claims for non-nutrients or bioactive components include: – Several dietary fibres eg high amylose maize resistant starch, inulin, GOS, FOS, oligosaccharide mixture, beta-glucan, polydextrose – Isomaltulose – Soy protein, sterols, lutein, DHA/ARA – D-ribose – Slowly digestible starch (SDS) – Calcium 3-hydroxyl-3-methyl butyrate monohydrate (CaHMB) • 1 additional other function claim in the process of gazettement – Galactooligosaccharide (GOS), and polydextrose (PDX) mixture Food Safety and Quality Division 16 Ministry of Health Malaysia
CLAIMS ON FOOD LABELS Permitted Claims* Prohibited Claims Nutrient content claim Disease risk reduction claim Prevent, alleviate, treat or cure Nutrient comparative claim disease, disorder or other physiological function Nutrient function claim Provide an adequate source of all essential nutrients Other function claim Doubt the safety of similar food. Arouse or exploit fear in consumer Nutrient enrichment or fortification claim Cannot be substantiated “Nutritious” Claim * Must meet condition required for making claims Food Safety and Quality Division 17 Ministry of Health Malaysia
Application for use of new health claim – “other function claim” • Industry may apply to MOH for “other function claims” to be added to positive list of permitted claims • The intended “other food component” must be listed in the “permitted added nutrient” list • Use a stipulated application form with 18 items especially – State clearly the proposed text for the other function claim – Provide sound scientific evidences to support the claim – Proposed the minimum level that the nutrient must be present before the claim can be made • Level at which the nutrient is effective in bringing about the proposed claim • Provide scientific justification why this level is proposed Food Safety and Quality Division 18 Ministry of Health Malaysia
Food Safety and Quality Division 19 Ministry of Health Malaysia
NUTRIENT FUNCTION CLAIM & OTHER FUNCTION CLAIM ~ Malaysia adopts a “positive list” approach ~ Include “classical nutrient” and “other food component” ~ Only claims on this list are permitted [Reg.18E(14)] ~ Total of 52 function claims permitted (as at Dec 2010) ♦ 23 function claims for “classical nutrient” such as: ♦ 29 other function claims for “other • Protein food components” such as: • 9 Vitamins (A, B1, B2, B12, C, D, • Lutein, Beta-glucan, Plant Sterol E, Folate, Niacin) etc. • 5 Minerals (Ca, Fe, I, Mg, Zn) Food Safety and Quality Division 20 Ministry of Health Malaysia
OTHER FUNCTION CLAIM “OTHER FOOD COMPONENTS” Nutrient Claim Beta glucan Beta glucan from (state the source) helps lower or reduce cholesterol* Inulin and Inulin helps increase intestinal bifidobacteria and helps maintain a oligofructose good intestinal environment* (fructo- Oligofructose (fructo-oligosaccharide) helps increase intestinal oligosaccharide) bifidobacteria and helps maintain a good intestinal environment* Inulin is bifidogenic* Oligofructose (fructo-oligosaccharide) is bifidogenic* Inulin is prebiotic* (2009) Oligofructose (fructo-oligosaccharide) is prebiotic * (2009) Gazetted : P.U.(A) 88/2003 & P.U.(A) 306/2009 Food Safety and Quality Division 21 * Specific condition required Ministry of Health Malaysia
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