Ingredients: Permitted Health Claims in Malaysia Nurul Hidayati Mohd - - PowerPoint PPT Presentation

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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

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Food Safety and Quality Division Ministry of Health Malaysia

34th Scientific Conference – Healthy Nutrition: Key to Disease Prevention 3-4 July 2019, Hotel Istana Kuala Lumpur

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Regulatory Update on Functional Ingredients: Permitted Health Claims in Malaysia

Nurul Hidayati Mohd Nasir1 & Tee E-Siong2 Food Safety and Quality Division, Ministry of Health Malaysia1; Nutrition Society of Malaysia2

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Food Safety and Quality Division Ministry of Health Malaysia

  • 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

  • f other components in foods

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FUNCTIONAL FOOD/INGREDIENTS

Essential characteristic and attributes

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Food Safety and Quality Division Ministry of Health Malaysia

  • 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

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FUNCTIONAL FOOD/INGREDIENTS

Essential characteristic of functional food

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Food Safety and Quality Division Ministry of Health Malaysia

  • 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

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FUNCTIONAL FOOD/INGREDIENTS

Functional foods are not nutraceuticals or supplement

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Food Safety and Quality Division Ministry of Health Malaysia

  • 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

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FUNCTIONAL FOOD/INGREDIENTS

The terminology of functional ingredients

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Food Safety and Quality Division Ministry of Health Malaysia

  • 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

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FUNCTIONAL FOOD/INGREDIENTS

Regulatory Approach

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Food Safety and Quality Division Ministry of Health Malaysia

  • 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

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FUNCTIONAL FOOD/INGREDIENTS

Use of “other food component” terms

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Food Safety and Quality Division Ministry of Health Malaysia

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Food Safety and Quality Division Ministry of Health Malaysia

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Food Safety and Quality Division Ministry of Health Malaysia

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Food Safety and Quality Division Ministry of Health Malaysia

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Food Safety and Quality Division Ministry of Health Malaysia

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Other food component 2'-Fucosyllactose (2’-FL) Slowly Digestible Starch (SDS) Isomaltooliogoscharide (IMO) Dietary fiber Isomaltodextrin (IMD)

New approval of “Permitted Added Nutrient”

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Food Safety and Quality Division Ministry of Health Malaysia

  • 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

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FUNCTIONAL FOOD/INGREDIENTS

Application for use of new “other food components”

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Food Safety and Quality Division Ministry of Health Malaysia

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Food Safety and Quality Division Ministry of Health Malaysia

  • “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

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FUNCTIONAL FOOD/INGREDIENTS

Use of health claims “other food components”

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Food Safety and Quality Division Ministry of Health Malaysia

  • 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

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FUNCTIONAL FOOD/INGREDIENTS

Use of health claims “other food components”

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Food Safety and Quality Division Ministry of Health Malaysia

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Permitted Claims*

Nutrient content claim Nutrient comparative claim Nutrient function claim Other function claim Nutrient enrichment or fortification claim “Nutritious” Claim

Prohibited Claims

Disease risk reduction claim Prevent, alleviate, treat or cure disease, disorder or other physiological function Provide an adequate source of all essential nutrients Doubt the safety of similar food. Arouse or exploit fear in consumer Cannot be substantiated

CLAIMS ON FOOD LABELS

* Must meet condition required for making claims

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Food Safety and Quality Division Ministry of Health Malaysia

  • 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

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Application for use of new health claim – “other function claim”

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Food Safety and Quality Division Ministry of Health Malaysia

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Food Safety and Quality Division Ministry of Health Malaysia

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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:

  • Protein
  • 9 Vitamins (A, B1, B2, B12, C, D,

E, Folate, Niacin)

  • 5 Minerals (Ca, Fe, I, Mg, Zn)

♦ 29 other function claims for “other food components” such as:

  • Lutein, Beta-glucan, Plant Sterol

etc.

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Food Safety and Quality Division Ministry of Health Malaysia

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OTHER FUNCTION CLAIM

“OTHER FOOD COMPONENTS”

Nutrient Claim Beta glucan Beta glucan from (state the source) helps lower or reduce cholesterol* Inulin and

  • ligofructose

(fructo-

  • ligosaccharide)

Inulin helps increase intestinal bifidobacteria and helps maintain a good intestinal environment* Oligofructose (fructo-oligosaccharide) helps increase intestinal 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 * Specific condition required

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Food Safety and Quality Division Ministry of Health Malaysia

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OTHER FUNCTION CLAIM

“OTHER FOOD COMPONENTS”

Nutrient Claim Bifidobacterium lactis Bifidobacterium lactis helps improve a beneficial intestinal microflora* Bifidobacterium lactis may help to reduce the incidence of diarrhea* DHA and ARA DHA and ARA may contribute to the visual development of infant* HAMRS High Amylose Maize Resistant Starch (HAMRS) helps improve / promote colonic/bowel/intestinal function/ environment* Isomaltulose Isomaltulose is slowly hydrolysed to glucose and fructose, and therefore it provides longer lasting energy compared to sucrose* Isomaltulose is a slowly released source of energy compared to sucrose* Isomaltulose provides longer lasting energy compared to sucrose* Isomaltulose is slowly hydrolysed to glucose and fructose, compared with sucrose*

With prior written approval of the ‘Director’ * Specific condition required

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Food Safety and Quality Division Ministry of Health Malaysia

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OTHER FUNCTION CLAIM

“OTHER FOOD COMPONENTS”

Nutrient Claim Oat soluble fibre (beta- glucan) Oat soluble fibre (beta- glucan) helps to lower the rise of blood glucose provided it is not consumed together with other food* Oligosaccharide mixture containing 90%(wt/wt) GOS and 10% (wt/wt) lcFOS Oligosaccharide mixture containing 90%(wt/wt) GOS and 10% (wt/wt) lcFOS is prebiotic* Oligosaccharide mixture containing 90%(wt/wt) GOS and 10% (wt/wt) lcFOS is bifidogenic* Oligosaccharide mixture containing 90%(wt/wt) GOS and 10% (wt/wt) lcFOS helps increase intestinal bifidobacteria and helps maintain a good intestinal environment* Oligosaccharide mixture containing 90%(wt/wt) GOS and 10% (wt/wt) lcFOS helps to improve the gut/ intestinal immune system of babies / infant*

With prior written approval of the ‘Director’ * Specific condition required

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Food Safety and Quality Division Ministry of Health Malaysia

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Nutrient Claim Nutrient Claim Oligofructose- inulin mixture Oligofructose-inulin mixture containing containing shorter chain inulin (oligofructose DP 3-9) and longer chain inulin (inulin DP ≥10) in a 50:50 ratio ± 10% each helps to increase calcium absorption and increase bone mineral density when taken with calcium rich food* Lutein As a predominant macular pigment in the retina, Lutein is able to filter blue light and may protect the eye* Patented cooking

  • il blend

Patented cooking oil blend helps to increase HDL Cholesterol and improve HDL/LDL cholesterol ratio*

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Food Safety and Quality Division Ministry of Health Malaysia

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OTHER FUNCTION CLAIM

“OTHER FOOD COMPONENTS”

Nutrient Claim Plant sterol / plant stanol Plant sterol / plant stanol helps lower or reduce cholesterol* Polydextrose Polydextrose is bifidogenic* Polydextrose helps increase intestinal bifidobacteria and helps maintain a good intestinal microflora* Resistant dextrin / Resistant maltodextrin Resistant dextrin / Resistant maltodextrin is a soluble dietary fibre that helps to regulate / promote regular bowel movement especially

  • f people with a tendency to constipation*

Soy protein Soy protein helps to reduce cholesterol* Sialic acid Sialic acid is an important component of brain tissues*

With prior written approval of the ‘Director’ * Specific condition required

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Food Safety and Quality Division Ministry of Health Malaysia

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OTHER FUNCTION CLAIM (NEW)

“OTHER FOOD COMPONENTS”

Nutrient Claim Beta palmitin Beta palmitin contributes to increase calcium absorption* Beta palmitin contributes to increase fat absorption* Beta glucan from yeast Beta glucan from yeast may help to support immune system associated with cold* Beta glucan from barley soluble fiber Beta glucan from barley soluble fiber helps lower the rise of blood glucose provided it is not consumed together with other food* Beta glucan from barley soluble fiber contributes to the reduction of the rise in blood glucose provided it is not consumed together with

  • ther food*

With prior written approval of the ‘Director’ * Specific condition required

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Food Safety and Quality Division Ministry of Health Malaysia

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OTHER FUNCTION CLAIM (NEW)

“OTHER FOOD COMPONENTS”

Nutrient Claim Calcium 3- hydroxy-3-methyl butyrate monohydrate (CaHMB) Calcium 3-hydroxy-3-methyl butyrate monohydrate (CaHMB) helps to regain strength* Calcium 3-hydroxy-3-methyl butyrate monohydrate (CaHMB) support tissue building* D-Ribose D-ribose helps to promote energy recovery during or after physical activities* Slow Digestible Starch (SDS) A food containing slowly digestible starch (SDS), consumed as part

  • f the normal first meal of the day, releases carbohydrates gradually

and provides energy throughout the morning*

With prior written approval of the ‘Director’ * Specific condition required

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Food Safety and Quality Division Ministry of Health Malaysia

Specific conditions required for “other function claim”

  • Minimum amount of the relevant “food component” that must be present
  • Additional labelling requirements, if relevant
  • Restriction to selected foods, if relevant

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CONDITIONS : OTHER FUNCTION CLAIM

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Food Safety and Quality Division Ministry of Health Malaysia

  • MOH proposed a new regulation – supplemented food

– Published on website for public engagement

  • Require pre-market approval – application fee of RM1000, non

refundable

  • Approved product will be given a registration number
  • May contain permitted “other food components” in the “permitted

added nutrients” list Table 1 of the Twelfth Schedule

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Supplemented Food – a proposed new regulation

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Food Safety and Quality Division Ministry of Health Malaysia

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  • Similarity to functional food/ingredients

– Use of “other food components” – Expected to perform physiological role beyond classical nutritional functions

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Food Safety and Quality Division Ministry of Health Malaysia

  • Functional foods//ingredients are bioactive components in foods that

serve physiological roles – Beyond meeting basic nutritional requirements – May indeed possess beneficial effects on health

  • There must be opportunities for industry to carry out R&D

– To explore new functional ingredients that may be beneficial to health

  • However, marketing of functional foods some times run ahead of

scientific substantiation – Many claims of beneficial effects without proper scientific proof

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Conclusion

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Food Safety and Quality Division Ministry of Health Malaysia

  • Regulatory system must be in place to regulate functional

foods/ingredients through health claims – Permit only claims that are adequately substantiated – To avoid misleading/unsubstantiated claims to the public

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Conclusion

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Food Safety and Quality Division Ministry of Health Malaysia

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