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? |
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For which products & dosage? |
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What is the approved claim |
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Reference
Ministry of Health. (2017). Food Regulations 1985.
Philippines
Inulin | FOS | |
Is it approved? | Yes
Registration required for all kinds of food. |
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For which age of babies/ toddlers? |
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For which products & dosage? |
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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 |
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For which products & dosage? | No |
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” 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%” |
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What is the approved claim | No |
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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? |
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For which products & dosage? |
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. |
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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” Criteria: The 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 |
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For which age of babies/ toddlers? |
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For which products & dosage? |
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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:
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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? |
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For which products & dosage? |
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. |
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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.