Question

What is the regulatory status of Inulin & FOS in Malaysia, China, Sri Lanka, Philippines, Indonesia, Thailand & Singapore for use in baby foods? For which age groups is it permitted (e.g. infants, older infants, young children)? To which type of foods can it be added & at which dosage? Finally, are there any approved claims that can be used?

ANSWER

Overview of Inulin/FOS regulatory status & use of claims for infants & toddlers in various ASEAN countries

Malaysia

Inulin FOS
Is it approved? Yes
For which age of babies/ toddlers?
  • Infant: 0-12 months of age
  • Young children: 12 months – 3 years
For which products & dosage?
  • Infant formula: 0.4g per 100ml on a ready-to-drink basis
    **The component (inulin and oligofructose/fructo-oligosaccharide) shall not exceed 0.6g per 100ml
  • Follow-up formula (suitable for infants after sixth months on and young children)
What is the approved claim
  • Inulin/fructo-oligosaccharide helps increase intestinal bifidobacteria and helps maintain good intestinal environment
  • Inulin/fructo-oligosaccharide is bifidogenic
  • Inulin/fructo-oligosaccharide is prebiotic

Reference

Ministry of Health. (2017). Food Regulations 1985.

 

Philippines

Inulin FOS
Is it approved? Yes

Registration required for all kinds of food.
(Below mentioned categories all classified as High-risk food products)

For which age of babies/ toddlers?
  • Infant: 0-12 months of age
  • Young children: 1-3 years
For which products & dosage?
  • Formulated Complementary Foods
  • Processed Cereal-Based Foods for Infants and Young Children
  • Canned Baby Foods
  • Provided it has been proven to be suitable and safe for their intended purposes & comply with Codex Guidelines.
  • Infant Formula and Formulas for Special Medical Purposes Intended for Infants
  • Permitted if able to provide other benefits that are similar to outcomes of populations of breastfed babies & compliance with Codex Guidelines.
What is the approved claim No claims are currently permitted.

Nutrition and Health Claims should be evaluated (& approved) by FDA based on compliance with Codex Guidelines.

References

Codex Alimentarius Commission. (2017a). Standard for Canned Baby Foods (Codex Stan 73-1981).

Codex Alimentarius Commission. (2017b). Guidelines on Formulated Complementary Foods for Older Infants and Young Children (CAC/GL 8-1991).

Codex Alimentarius Commission. (2017c). Standard for Processed Cereal-Based Foods for Infants and Young Children (Codex Stan 74-1981).

Codex Alimentarius Commission. (2016). Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants (Codex Stan 72-1981).

 

China

Inulin FOS
Is it approved? No Yes
For which age of babies/ toddlers? No
  • Infant: 0-12 months of age
  • Young children: 1-3 years
  • Children: 3 years and above (usually until 6 or 7 years old)
For which products & dosage? No
  • Infant formula – 0-12 months
  • Older infant formula – 6-12 months
  • Infant cereal supplement food – 6-12 months
  • Young children formula – 1-3 years

 

Used alone or in combination (including Oligolactose (lactose source), Polyfructose (chicory source) & Raffinose (Beet source), the total amount should not exceed 64.5g/kg.

 

Note: The amount used is limited to powdery products, which are converted to the corresponding dilution factor in the liquid state

 

“Infant formula” refers to liquid or powder products made only through physical methods, of which the main material is milk and milk protein products (in the case of milk-based infant formula), or soybean and soybean products (in the case of soybean-based infant formula), supplemented with a proper amount of vitamin, minerals and other supplementary materials, which are applicable to normal infants, where the energy and nutrition can satisfy the requirements of growth and development of normal infants of 0-6 months old.

 

Infant cereal supplement food is applicable for infants and young children, above 6 months.

  • Formulated milk Powder (above 3 years of age): ≤64.5g/kg

 

“Formulated milk powder” is defined as raw milk (sheep) milk or its processed products as the main raw material, adding other raw materials, with or without adding food additives and nutrient enhancers, processed into a powdery product with a milk solid content of not less than 70%”

What is the approved claim No
  • Dietary fiber helps maintain normal bowel function
  • Dietary fiber is a low energy substance
  • “Source of” or “Contains dietary fiber”
  • “High” or “rich in dietary fiber”

References

National Health and Family Planning Commission of the People’s Republic of China. (2014). National Food Safety Standard – Standard for Use of Food Nutrition Fortification (GB14880-2014).

National Health and Family Planning Commission of the People’s Republic of China. (2011). National Food Safety Standard for Nutrition Labelling of Prepackaged Food (GB 28050-2011).

 

Singapore

Inulin FOS
Is it approved? Yes
For which age of babies/ toddlers?
  • Infant: 0-12 months of age
For which products & dosage?
  • Infant formula
  • Infant milk formula/ infant milk preparation (≤12 months of age).

 

Galacto-oligosaccharides, long chain inulin and oligofructose produced from inulin, in an amount not exceeding a total level of 0.8 g per 100 ml of infant formula.

What is the approved claim Only claims referring the presence of the Galacto-oligosaccharides (GOS), Long chain inulin & Oligofructose are allowed in infant formula.

Note that claims should not in any way imply that the infant formula is enriched, fortified, or is an excellent source of these ingredients.

 

Acceptable claims: “With inulin”, “Added with GOS”, “Contains GOS”

 

Additional info: Prebiotic blend of Galacto-oligosaccharides and long chain Fructo-oligosaccharide – claim only for food for children, 3 to 6 years of age: “Prebiotic blend (galacto-oligosaccharides and long chain fructo-oligosaccharides) support the child’s natural defences”

CriteriaThe combination of Galacto-oligosaccharides and long chain Fructo-oligosaccharide present in the product must be in ratio of 9:1

References

Agri-Food & Veterinary Authority of Singapore. (2019). Food Regulations (Sale of Food Act). Regulation 252.

Agri-Food & Veterinary Authority of Singapore. (2010). A Guide to Food Labelling and Advertisements.

 

Indonesia

Inulin FOS
Is it approved? Yes

inulin from chicory

For which age of babies/ toddlers?
  • Older Infant: 7-11 months of age
  • Young children: 1-3 years
For which products & dosage?
  • Advanced Formula for ages 7 – 11 months: max 5 g/day
  • Advanced Formula for ages 1-3 years: max 16 g/day
What is the approved claim Claims are prohibited for infants (unless specifically regulated).

Claims referring to the presence of dietary fiber: “source of” or “high/rich in” are permitted for foods intended for young children.

 

Nutritional claims:

  • Soluble dietary fiber (psyllium, beta glucan from oats and / or barley, inulin from chicory and pectin from fruits) can help maintain the functions of the digestive tract
  • Soluble dietary fiber (psyllium, beta glucan from oats and / or barley, inulin from chicory and pectin from fruits) can help reduce blood cholesterol levels if accompanied by a diet low in saturated fat and low cholesterol
  • Insoluble food fiber can help facilitate bowel movements (laxatives), if accompanied by drinking enough water

References

Badan Pengawas Obat dan Makanan Republik Indonesia. (2010). Peraturan Pengelompokan Produk Formula Bayi dan Formula Lanjutan (Nomor HK.00.05.52.0085).

Badan Pengawas Obat dan Makanan Republik Indonesia. (2016). Peraturan Acuan Label Gizi (Nomor 9 Tahun 2016).

Badan Pengawas Obat dan Makanan Republik Indonesia. (2016). Peraturan Pengawasan Klaim Pada Label Dan Iklan Pangan Olahan (Nomor 13 Tahun 2016).

 

Sri Lanka

Inulin FOS
Is it approved? No Yes (SLS-1381 (2009)
For which age of babies/ toddlers? No Older Infant: 6-12 months of age
For which products & dosage? No Follow up formula intended for weaning diet.

FOS and GOS may be added to the follow-up formula in the following manner: 0.8g /100ml in a combination of oligogalactosyl lactose (90%) and high molecular weight oligofrucosyl sucrose (10%)

What is the approved claim No No

References

Sri Lanka Standards Institute. (2007). Sri Lanka Standards 651: 2007. Infant formula.

Sri Lanka Standards Institute. (2009). Follow up formula (SLS 1381).

Sri Lanka Standards Institute. (2011). Food supplement for infants and children, cereal based (SLS-1036).

 

Thailand

Inulin FOS
Is it approved? Yes
For which age of babies/ toddlers?
  • Infant: 0-12 months of age
  • Older infant: 6-12 months of age
  • Young children: 1-3 years
For which products & dosage?
  • Modified Milk for Infant and modified Milk of Uniform Formula for Infant and Children.
  • Food for Infant and Food of Uniform Formula for Infant and Small Children.
  • Supplementary Food for Infants and Young Children.

 

Dosage: follow regulation of Codex advisory lists of nutrient compounds for use in foods for special dietary uses intended for infants and young children CAC/GL 10-1979.

Thai FDA does not have a maximum limit but has reference information about the proper consumption for that food product. Manufacturer needs to have GMP.

What is the approved claim Prebiotic claims are not yet approved – can apply if we are interested.

Dietary Fiber claim: Increased stool bulks in digestive tract helps stimulate bowel movement.

References

Food and Drug Administration Thailand. (2008). Announcement of the Food and Drug Administration Re: Declaration of Nutrient Function Claim.

Ministry of Public Health Thailand. (1994). Notification of the MOPH No.156, B.E. 2537 (1994) Re: Modified Milk for Infant and Modified Milk of Uniform Formula for Infant and Children.

Ministry of Public Health Thailand. (1994). Notification of the MOPH No. 157, B.E. 2357 (1994) Re: Food for Infant and Food of Uniform Formula for Infant and Small Children.

Ministry of Public Health Thailand. (1994). Notification of the MOPH No. 158, B.E. 2357 (1994) Re: Supplementary Food for Infants and Young Children.

Ministry of Public Health Thailand. (1998).Notification of the MOPH No. 182, B.E. 2541 (1998) Re: Nutrition Labelling.

Ministry of Public Health Thailand. (2003).ปริมาณสารอาหารอ้างอิงที่ควรได้รับประจำ วันสำ หรับคนไทย พ.ศ. 2546/Dietary Reference Intake for Thais 2003.

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