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What is the current regulation for Choline (especially Choline bitartrate & Choline dihydrogen citrate) in Asian countries (e.g. Malaysia, Indonesia, Thailand, Sri Lanka, Philippines & China), especially for baby food? Is there a minimum dosage that should be used when added to baby food? Are there any health claims that can be used?

March 18, 2019
ANSWER

Philippines

According to Updated List of Food Additives (Bureau Circular No. 2006-016), choline (in form of choline bitartrate and choline chloride) is one of the additives permitted to use in food in general.

According to Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants (Codex Stan 72-1981), choline is part of the essential composition of infant formula and it must be added at minimum amount of 7mg/100 kcal and the GUL (Guidance Upper Levels) is 50mg/100kcal. However, GUL (Guidance Upper Levels) are for nutrients without sufficient information for science-based risk assessment. These levels are values derived on the basis of meeting nutritional requirements of infants and an established history of apparent safe use. It should serve as a guide for manufacturers and these should not be interpreted as goal values. Nutrients for infant formulas should not exceed the GUL.

Based on Codex, a health claim mentioning choline’s nutrient function can be proposed if enough study can be provided. Declaring this claim on packaged foods will depend upon the approval of FDA Philippines.

References

Codex Alimentarius Commission. (2007). Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants (Codex Stan 72-1981).

Republic of the Philippines Department of Health. (2014). Rules and Regulations Governing the Labeling of Prepackaged Food Products Distributed in the Philippines (AO No. 2014-0030).

Republic of the Philippines Department of Health. (2006). Updated List of Food Additives (Bureau Circular No. 2006-016).

Republic of the Philippines Department of Health. (1984). Regulatory Guidelines Concerning Food Additives (AO No. 88-A s s.1984).

 

Thailand

Choline bitartrate or Choline chloride, is classified as nutrients and the according to Thai Recommended Daily Intake for age of 6 years and above should not exceed 3,400 mg/day. There is no health claim permitted for Choline.

For baby food, we have two notifications from FDA as follows;

i. Notification of MOPH No. 157(B.E. 2537(1994) Re: Food for Infant and Food of Uniform Formula for infant and Small Children

  • Food for infant means a food for aimed for feeding infant of 1 day old till 12 mounts old in lieu of or in substitution of mother’s milk. According to the notification, Choline should be used at minimum 7 mg/100 kcal. However, the maximum level is not specified. There is no any nutrition and health claims permitted for Choline.
  • Food of uniform formula for infant and small children means a food aimed for feeding infant from 6 months old till 12 months old or children from 1 year old till 3 years old. Dietary reference intake (DRI) is 150 mg/day.

ii. Notification of MOPH No. 158(B.E. 2537(1994) Re: Supplementary Food for Infants and Young Children

  • Supplement Food for Infants and Young Children means a food intended to supplement nutrition value and to create familiarizations in eating normal food for infants from the age of the 6 months up to 12 months or young children from the age of 1 year up to 3 years.
  • 6-12 months, Dietary reference intake (DRI) is 150 mg/day.
  • 1-3 years, Dietary reference intake (DRI) is 200 mg/day.

References

Ministry of Public Health Thailand. (1994). Notification of MOPH No. 157(B.E. 2537(1994) Re: Food for Infant and Food of Uniform Formula for infant and Small Children.

Ministry of Public Health Thailand. (1994). Notification of MOPH No. 158(B.E. 2537(1994) Re: Supplementary Food for Infants and Young Children.

 

Malaysia

According to Regulation 389 of Food Regulation 1985, Choline bitartrate is one of the permitted added nutrients in food; but Choline dihydrogen citrate is not.

Choline is mandatory to be added in infant formula but it is optional for canned food for infants and processed cereal-based foods for infants. Infant formula shall contain Choline in amount not less than 7mg per 100kcal but maximum dosage is not prescribed.

(Note: Where the maximum amount of nutrient is not prescribed, the total daily intake of that nutrient arising from its uses in accordance with good manufacturing practice, does not present a hazard to health)

No specific regulations stipulate that follow up formula shall contain Choline in the product.

No specific health claim of choline is allowed.

Reference

Ministry of Health Malaysia. (2017). Food Regulation 1985. Regulation 389.

 

Sri Lanka

According to Infant formula (SLS 651), Choline must be added into infant formula at minimum of 7mg/100 kcal and the GUL (Guidance Upper Levels) is 50mg/100kcal. However, the maximum level is not specified.

According to Follow up formula (SLS 1381), Choline may be added at a minimum of 7mg/100 kcal and the GUL (Guidance Upper Levels) is 50mg/100kcal in follow up formula. However, the maximum level is not specified.

There is no health claim permitted for Choline.

References

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

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

 

China

According to National Food Safety Standard – Infant formula (GB 10765-2010) and National Food Safety Standard – Older infants and young children formula (GB 10767-2010), Choline is one of the optional components that may be added at a minimum of 7.1mg/ 100kcal and maximum of 50.2mg/kcal.

According to National Food Safety Standard – Food Labeling of Prepackaged Foods for Special Dietary Supplies (GB/T 13432-2013), content claim may be conducted when the content of energy or nutritional ingredients in the product reaches the minimum value of corresponding product standard or the permissible intensified minimum value. The content claim wording includes “contain”, “provide”, “source”, “including” and “have”, etc.

References

Ministry of Health of the People’s Republic of China. (2011). National Food Safety Standard – Infant formula (GB 10765-2010).

Ministry of Health of the People’s Republic of China. (2011). National Food Safety Standard – Older infants and young children formula (GB 10767-2010).

Ministry of Health of the People’s Republic of China. (2011). National Food Safety Standard – Food Labeling of Prepackaged Foods for Special Dietary Supplies (GB/T 13432-2013).

 

Indonesia

According to Perubahan Kedua Atas Peraturan Kepala Badan Pengawas Obat Dan Makanan Nomor HK.03.1.23.08.11.07517 Tahun 2011 Tentang Persyaratan Teknis Bahan Kosmetika (Nomor 2 Tahun 2014), Choline only permitted to use in cosmetic products.

Reference

Badan Pengawas Obat Dan Makanan Republik Indonesia. (2014). Perubahan Kedua Atas Peraturan Kepala Badan Pengawas Obat Dan Makanan Nomor HK.03.1.23.08.11.07517 Tahun 2011 Tentang Persyaratan Teknis Bahan Kosmetika (Nomor 2 Tahun 2014).

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