Advisory Council on Food and Environmental Hygiene

For Discussion ACFEH Paper 2/2012 on 14 September 2012 Advisory Council on Food and Environmental Hygiene Japanese Infant Formula Purpose This paper briefs Members on the recent incident of iodine deficiency in certain Japanese infant formulae. Background 2. At present, there are about 40 brands from different countries encompassing about 60 infant formula 1 products in the retail market in Hong Kong. In its regular Food Surveillance Programme, the Centre for Food Safety (CFS) takes milk powder samples (including infant formulae) at import, wholesale and retail levels for chemical and microbiological testing each year. Chemical testing covers testing for food additives, contaminants, toxins and other harmful residues whereas microbiological testing covers testing for pathogens. Since the Fukushima nuclear incident in March 2011, imports of formula products from five prefectures in Japan, i.e. Fukushima, Ibaraki, Tochigi, Gunma and Chiba, have been prohibited, and all consignments of formula products from other parts of Japan are sample-tested on the radiation level. 3. In addition to the above-mentioned regular surveillance, CFS has since May 2012 embarked on a two-year survey on the nutritional composition of infant formulae available in the local market. The Codex Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants (Codex Stan 72-1981), which prescribes the energy content and levels of 33 essential nutrients in infant formula intended for infants during the first months of life up to the introduction of complementary feeding (see Annex 1), is used as the testing benchmark. 1 Codex defines infant formula as a breast-milk substitute specially manufactured to satisfy, by itself, the nutritional requirements of infants during the first months of life up to the introduction of appropriate complementary feeding. In Hong Kong, it usually refers to formula products for infants between 0 to 6 months of age.

4. At present, there is no specific legislation governing the nutritional composition, including the level of iodine, of infant formulae. However, section 54 of the Public Health and Municipal Services Ordinance (Cap. 132) stipulates that all food for sale must be fit for human consumption. This covers all food including infant formula. Findings 5. The first round of testing was conducted in May to July 2012, covering a total of 14 popular brands of infant formula. The initial testing results were available in end July 2012. The iodine levels of six products were found to be lower than the level prescribed by Codex 2. Risk assessment revealed that two of the six products, both from Japan, had low iodine content to an extent that could pose health risks for infants 3. When infants are fed solely on the two formulae concerned according to the instructions provided by the manufacturers as printed on the label, their iodine intake would be less than one-third of the World Health Organization s (WHO) recommended daily iodine intake of 15 micrograms per kilogram of body weight per day 4, even after taking into account the iodine content in tap water. This may affect the functioning of the thyroid 2 3 Codex requires the iodine content in infant formula to be within 10 to 60mcg per 100kcal provided by the product. However, iodine content requirement of infant formula varies in different jurisdictions. For example, US and Canada required infant formula to contain at least 5mcg per 100kcal. Japan has not established specific legal requirement for iodine content in infant formula. Iodine is an essential nutrient used for the synthesis of thyroid hormones by the thyroid gland. Diet is the major source of iodine intake for humans. Certain foods such as marine fish and marine algae are naturally relatively rich in iodine. Iodine is also present in milk. For formula-fed infants, before the introduction of complementary food (normally at around 6 months), infant formula is their only food source of dietary iodine. Besides, small amount of iodine is also present in local tap water (about 10mcg/liter) whereas iodine is not detected in bottled distilled water. For the four infant formula products which did not meet the Codex requirement for iodine content in preliminary testing but did not pose health risks for infants, CFS subsequently conducted testing on further samples of those products. All of them were found meeting the Codex requirement. The results of subsequent testing were announced to the public. 4 The World Health Organization (WHO) recommended a daily intake of 90mcg for infants from 0 to 59 months of age (corresponding to 15 mcg/kg/day for a child of 6 months with an average body weight of 6 kg). Mild hypothyroidism with the risk of brain damage might occur when the iodine intake is about one third of this value (i.e. 5 mcg/kg/day). When the intake is less than one tenth of this value (i.e. 1.5 mcg/kg/day), endemic cretinism might result. - 2 -

gland. If thyroid function is significantly affected, there may be potential impact on the brain development of infants. 6. After further testing, more comprehensive risk assessment, and consultation with medical professionals specialized in pathology, endocrinology and paediatrics, the Government decided to adopt a prudent course of action outlined in paragraphs 7 to 9 below and announced the test results on 8 August. Follow-up Measures 7. The trade was informed of the results and the relevant importers were asked to stop sale of the two products concerned and initiate recall. Parents were advised to stop feeding their infants with these products and switch to other infant formulae with adequate iodine content if breastfeeding is not feasible. 8. CFS has set up hotlines to provide information to concerned parents and handle any related enquiries from the public. In addition, CFS has set up a dedicated website with frequently asked questions regarding iodine in infant formula, iodine levels in selected infant formulae available in Hong Kong, and the test results announced. 9. The Department of Health (DH) has also set up a hotline to provide health advice and provided thyroid function test for infants of one to eight months old who had been taking the infant formulae with low iodine content. As at 27 August 2012, 112 infants had their blood samples taken for a thyroid function test at DH s designated clinics. The test results revealed that the thyroid-stimulating hormone level of only 2 blood samples were outside the reference range, with one being slightly below and the other slightly above. According to the specialists of the Hospital Authority (HA), the abnormal result in these two cases was not due to iodine deficiency. Nonetheless, both cases were referred to HA paediatric specialist clinic for follow-up. Further Testing and Summary of Test Results 10. As a result of the above findings, CFS has speeded up the testing of iodine content in infant formula products available in the local market. - 3 -

As at 4 September 2012, 60 products were tested. Amongst them, 49 products were found to have iodine level meeting the Codex requirement. Seven products, including six from Japan (three by Morinaga ( 森永 ), two by Wakodo ( 和光堂 ) and one by Meiji ( 明治 )) and one from New Zealand (by WIOM), were found to have a low iodine level such that when infants are fed on milk reconstituted by these formulae as the sole source of nutrition, the iodine intake would be less than one-third of the daily intake recommended by WHO. Parents who had bought the affected products were advised to switch products and the trade was asked to stop selling the products concerned immediately. For the remaining four infant formula products, though their iodine levels do not meet the Codex requirement, risk assessment did not reveal any health concern. A summary of the test results is in Annex 2. Way Forward 11. As at 4 September 2012, tests on iodine content for all but two infant formula products known to be available for sale locally were completed. While testing on one of them is expected to be completed by mid-september, adequate samples of the other formula cannot be collected from the market for conducting tests. Results will be announced as soon as possible when tests are completed. 12. CFS will continue testing the nutritional composition with respect to the Codex standard in infant and follow-up formulae available in the local market. Tests on the remaining 32 nutrients plus energy content in all formulae catering for infants below six months old are expected to be completed by the end of this year and tests on those catering for young children between six and 36 months old within the first half of next year. CFS will release the test results in phases. Appropriate follow-up actions will be taken promptly if the findings indicate potential health concern for infants. 13. In view of the findings on iodine level in infant formulae, the Government will expedite its work to formulate regulatory proposals regarding powdered formulae and food for infants and young children. Food and Health Bureau Food and Environmental Hygiene Department Centre for Food Safety September 2012-4 -

Annex 1 Codex Requirement of Nutritional Composition in Infant Formula specified in CODEX STAN 72 1981 (NS = not specified) Composition/Nutrient Unit Infant Formula Remarks Energy kcal/100ml 60.0-70.0 Protein g/100kcal 1.8-3.0 Total fat g/100kcal 4.4-6.0 Linoleic acid mg/100kcal -Linolenic acid mg/100kcal 300.0 - NS 50.0 - NS Ratio of linoleic acid to -linolenic acid between 5:1 to 15:1 GUL: 1400 Total carbohydrates g/100kcal 9.0-14.0 Vitamins Vitamin A iu/100kcal 200.0-600.0 (or 60.0-180.0) ugre/100kcal Vitamin D ug/100kcal (Vit D3: 1.0-2.5 ) Vitamin E mg alpha-te/100kcal 0.5 - NS GUL: 5 Vitamin K ug/100kcal 4.0 - NS GUL: 27 Thiamin ug/100kcal 60.0 - NS GUL: 300 Riboflavin ug/100kcal 80.0 - NS GUL: 500 Niacin ug/100kcal 300.0 - NS GUL: 1500 Vitamin B6 ug/100kcal 35.0 - NS GUL: 175 Vitamin B12 ug/100kcal 0.1 - NS GUL: 1.5 Pantothenic acid ug/100kcal 400.0 - NS GUL: 2000 Folic acid ug/100kcal 10.0 - NS GUL: 50 - Annex 1-1 -

Composition/Nutrient Unit Infant Formula Remarks Vitamin C mg/100kcal 10.0 - NS GUL: 70 Biotin ug/100kcal 1.5 - NS GUL: 10 Minerals Iron mg/100kcal Calcium mg/100kcal 0.45 - NS 50 - NS Calcium to phosphorus ratio between 1:1 to 2:1 GUL: 140 Phosphorus mg/100kcal 25 - NS GUL: 100 Magnesium mg/100kcal 5 - NS GUL: 15 Sodium mg/100kcal 20-60 Chloride mg/100kcal 50-160 Potassium mg/100kcal 60-180 Manganese ug/100kcal 1 - NS GUL: 100 Iodine ug/100kcal 10 - NS GUL: 60 Selenium ug/100kcal 1 NS GUL: 9 Copper ug/100kcal 35 NS GUL: 120 Zinc mg/100kcal 0.5 - NS GUL: 1.5 Other micronutrients Choline mg/100kcal 7 - NS GUL: 50 Myo-Inositol mg/100kcal 4 - NS GUL: 40 L-Carnitine mg/100kcal 1.2 - NS GUL: Guidance upper levels are for nutrients without sufficient information for a scientific-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. They may be adjusted based on relevant scientific or technological progress. The purpose of the GUL is to provide guidance to manufacturers and they should not be interpreted as goal values. Nutrient contents in infant formula should usually not exceed the GUL unless higher nutrient levels cannot be avoided due to high or variable contents in constituents of infant formula or due to technological reasons. - Annex 1-2 -

Annex 2 香港部分品牌的嬰兒配方奶粉中的碘含量 Iodine Level in Selected Infant Formulae available in Hong Kong 1) 碘含量符合食品法典委員會標準 ( 每 100 千卡 10 至 60 微克或每 100 千焦 2.5-14 微克 ) 的嬰兒配方奶粉註 : 碘含量是以嬰兒配方奶粉中驗出的碘值 ( 微克 / 每公斤 ) 及驗出或奶粉標籤上的能量值計算所得 ; * 初步檢測中驗出的碘含量 1) Infant formulae meeting the Codex requirement on iodine content (10-60 mcg/100kcal or 2.5-14 mcg/100kj) Iodine content (mcg/100kcal) is calculated using the tested iodine level of the infant formula by weight (mcg per kg) and the energy value tested or declared on the label. * Tested iodine content (mcg/100kcal) from preliminary testing Note: 產品名稱 ( 英文 )Product Name (English) 產品名稱 ( 中文 )Product Name (Chinese) 重量 Weight ( 克 g) 來源地 Country of Origin 註碘含量 Iodine Content Note (mcg/100kcal) 產品標示的碘值 ( 標示值 / 計算值 ) Iodine Value on Label (Declared/Calculated) mcg/100kcal ( 微克 /100 千焦 ) mcg/100kj 1 Abbott Similac Infant Formula 1 雅培皇牌心美力初生嬰兒奶粉 1 900 愛爾蘭 Ireland 27 * 19.49 2 Abbott Similac Isomil Soy Infant Formula 1 雅培皇牌愛心美 ( 豆奶配方 ) 1 900 荷蘭 The Netherlands 14.9 14.87 3 Abbott Similac NeoSure 雅培加營心美力 370 西班牙 Spain 17.2 15.01 4 Ausnutria Allnutria Infant Formula Milk Powder (2) 澳優能力多嬰兒配方奶粉 2 800 澳洲 Australia 15.3 2.8-9.34 5 Ausnutria Allnutria New Birth Formula Milk Powder 1 澳優能力多初生嬰兒配方奶粉 1 800 澳洲 Australia 17.7 2.75-9.16 6 Babynat Organic Infant Milk - 900 法國 France 10.3 16.13 7 Beingmate Newborn Formula 1 貝因美愛 + 新生兒配方奶粉 1 900 中國 China 13.3 3.3 8 Bellamy's Organic Infant Formula - 900 澳洲 Australia 17.0 2.75-9.17 9 Bimbosan Bisoja Soy Infant Milk Powder 恩寶心嬰兒純豆奶粉 [ 罐裝 ] 450 瑞士 Switzerland 10.6 15.37 10 Bimbosan Organic Baby Milk Powder 恩寶心百分百純有機奶粉 400 瑞士 Switzerland 13.3 14.42 11 Cow & Gate Infant Formula 1 牛欄牌初生嬰兒奶粉 1 900 新西蘭 New Zealand 15 * 4.7 12 Cow & Gate Pepti-Junior 牛欄牌百佳力 400 荷蘭 The Netherlands 17.7 18.06 13 Earth's Best Organic Infant Formula with Iron - 658 美國 USA 11 * 9 14 Friso Frisolac Gold Infant Formula 1 美素佳兒美素力金裝嬰兒配方奶粉 1 900 荷蘭 The Netherlands 12.4 15.10 15 Friso Gold Infant Formula 1 美素佳兒金裝嬰兒配方奶粉 1 900 荷蘭 The Netherlands 12.4 15.10 16 Gilbert Laboratoires Physiolac - Hypo-Allergenic Formula Physiolac 低敏嬰兒配方奶粉 400 法國 France 11.4 11.81 17 Gilbert Laboratoires Physiolac Infant Milk 1 菲思力嬰兒配方奶粉 1 900 法國 France 10.5 15.87 18 Gilco Icreo Balance Milk Powder 固力果愛力奧均衡奶粉 [ 罐裝 ] 1000 日本 Japan 12 * 19 Glico (No English product name) 固力果 ICREO 細仔奶粉 [ 盒裝 ] 12.7g x 10 日本 Japan 19.1 20 Growell EX1 高樂兒 EX1 初生嬰兒配方奶粉 750 韓國 Korea 25.1 2.78 21 HiPP Organic First Infant Milk 1-800 德國 Germany 16.1 15.67 22 HiPP Organic Hungry Infant Milk 2-800 德國 Germany 13.8 15.22 23 Holle Organic Infant Formula 1-400 德國 Germany 19.3 21.66 24 Karihome Goat Infant Formula with Iron 1 (400g) 卡洛塔妮添加鐵質嬰兒羊奶粉 1 (400g) 400 新西蘭 New Zealand 11.4 12.16 25 Les Viva Organic Infant Formula Les Viva 有機初生牛奶粉 800 新西蘭 New Zealand 11.7 37.61 26 Maeil Absolute Stage 1 萬朝 Absolute 宮 stage 1 有機嬰兒初乳奶粉 800 韓國 Korea 13 * 12 27 Mead Johnson Enfamil A+ Infant Formula with Iron 1 美贊臣安嬰兒 A+ 初生嬰兒配方奶粉 1 900 荷蘭 The Netherlands 14 * 13 28 Mead Johnson Enfamil A+ LactoFree Infant Formula 美贊臣安嬰兒 A+ 無乳糖配方 400 荷蘭 The Netherlands 21.2 25 29 Meiji (No English product name) 明治初生嬰兒奶粉 850 日本 Japan 11.1 30 Meiji (No English product name) 明治旅行粒裝奶粉 (5 袋裝 ) 21.6g x 5 日本 Japan 10.3 31 Milupa Aptamil First Milk 1-900 歐盟 EU 16.8 18.18 32 Nature's Baby Formula (Stage 1) 利全嬰兒奶粉 1 399 美國 USA 20.0 15 33 Nature's Baby Formula (Stage N) 利全嬰兒奶粉 ( 階段 N) 399 美國 USA 19.1 15.03 34 Neoangelac Plus Infant Formula 1 (Acidified) 安琪兒皇牌嬰兒奶粉 1( 酸化配方 ) 900 法國 France 35.4 34.45 35 Neocate LCP Neocate LCP 無敏配方奶粉 400 英國 United Kingdom 16.6 9.89 36 Nestle AL110 Lactose-free Infant Formula 雀巢 AL110 無乳糖配方嬰兒奶粉 400 荷蘭 The Netherlands 15.1 13.52 37 Nestle NAN HA 1 雀巢金裝能恩 NAN HA 1 900 德國 Germany 19 * 24.07 38 Nestle NAN PRO Advanced Formula 1 雀巢金裝能恩 NAN PRO 升級配方 1 800 德國 Germany 15.2 10.92 39 PBM Nutritionals Infant Formula for Newborns 美國皇牌智多健 AAA 900 美國 USA 17.8 4.41 40 S-8 Komplex Infant Formula 1 智靈寶初生嬰兒奶粉 1 900 瑞士 Switzerland 10.5 13.83 41 Snow Brand Smart Baby 1 Infant Formula with Iron 雪印思敏兒 1 初生嬰兒奶粉 900 澳洲 Australia 10.0 9.63 42 Symbiotics ImmunoMilk Infant Formula Milk Powder 善兒寶嬰兒初乳奶粉 900 新西蘭 New Zealand 12.9 11.99 1

43 Topfer Lactana Organic Infant Milk 1-600 德國 Germany 21.6 2.5-14 44 Ustrong Infant Formula 1 優萌新西蘭奶粉 1 900 新西蘭 New Zealand 29.4 13.33 45 Wyeth Illuma Infant Formula Milk Powder (Stage 1) - 900 愛爾蘭 Ireland 14.0 14.95 46 Wyeth Nursoy GOLD Soy Protein Infant Formula Powder 惠氏金裝愛兒素大豆蛋白嬰兒配方粉 900 愛爾蘭 Ireland 18.8 17.79 47 Wyeth Nursoy Soy Protein Infant Formula Powder 惠氏愛兒素豆類蛋白嬰兒配方奶粉 400 愛爾蘭 Ireland 18.1 17.69 48 Wyeth S-26 Gold Infant Formula Milk Powder (1) 惠氏金裝愛兒樂初生嬰兒配方奶粉 (1) 900 愛爾蘭 Ireland 14* 15.09 49 Wyeth S-26 HA Gold Hypoantigenic Infant Formula Powder 惠氏金裝愛兒樂 HA 低敏嬰兒配方奶粉 900 愛爾蘭 Ireland 15.1 14.89 2) 碘含量不符合食品法典委員會標準 ( 每 100 千卡 10 至 60 微克或每 100 千焦 2.5-14 微克 ) 的嬰兒配方奶粉 ; 但根據風險評估結果, 未有構成健康風險註 : 碘含量是以嬰兒配方奶粉中驗出的碘值 ( 微克 / 每公斤 ) 及奶粉標籤上的能量值計算所得 ; # 碘含量符合出產國的標準 2) Infant formulae not meeting the Codex requirement on iodine content (10-60 mcg/100kcal or 2.5-14 mcg/100kj), but risk assessment did not show health concern Note: Iodine content (mcg/100kcal) is calculated using the tested iodine level of the infant formula by weight (mcg per kg) and the energy value declared on the label. # Comply with the standard of the country of origin 產品名稱 ( 英文 )Product Name (English) 產品名稱 ( 中文 )Product Name (Chinese) 重量 Weight ( 克 g) 來源地 Country of Origin 註碘含量 Iodine Content Note (mcg/100kcal) 產品標示的碘值 ( 標示值 / 計算值 ) Iodine Level on Label (Declared/Calculated) mcg/100kcal 1 Gilbert Laboratoires Osmolac-Diarrheic episode Osmolac 適合肚瀉情况用嬰兒配方奶粉 400 法國 France 6.2 # 6.16 2 Namyang XO Five Secret 1 南陽 - 5S 林貝兒 XO - 1 階段初生嬰兒配方奶粉 800 韓國 Korea 6.0 # 11.67 3 Namyang XO Five Secret 2 南陽 - 5S 林貝兒 XO - 2 階段嬰兒配方奶粉 800 韓國 Korea 5.9 # 11.83 4 Smileygrowth Infant Formula Whey Dominant 1 詩妙健全方位嬰兒配方 1 900 新西蘭 New Zealand 5.3 # 3.5 ( 微克 /100 千焦 ) mcg/100kj 3) 碘含量不符合食品法典委員會標準 ( 每 100 千卡 10 至 60 微克或每 100 千焦 2.5-14 微克 ) 的嬰兒配方奶粉 ; 風險評估結果顯示會構成健康風險註 : 碘含量是以嬰兒配方奶粉中驗出的碘值 ( 微克 / 每公斤 ) 及奶粉標籤上的能量值計算所得 3) Infant formulae not meeting the Codex requirement on iodine content (10-60 mcg/100kcal or 2.5-14 mcg/100kj) and risk assessment showed health concern Note: Iodine content (mcg/100kcal) is calculated using the tested iodine level of the infant formula by weight (mcg per kg) and the energy value declared on the label. 產品名稱 ( 英文 )Product Name (English) 產品名稱 ( 中文 )Product Name (Chinese) 重量 Weight ( 克 g) 來源地 Country of Origin 註碘含量 Iodine Content Note (mcg/100kcal) 產品標示的碘值 ( 標示值 / 計算值 ) Iodine Level on Label (Declared/Calculated) mcg/100kcal ( 微克 /100 千焦 ) mcg/100kj 1 Meiji (No English product name) 明治 HP 無乳糖配方奶粉 850 日本 Japan 1.8 2 Morinaga (No English product name) 森永縮氨酸低敏奶粉 [ 罐裝 ] 820 日本 Japan 2.7 3 Morinaga (No English product name) 森永細仔奶粉 [ 罐裝 ] 850 日本 Japan 3.9 4 Morinaga (No English product name) 森永細仔奶粉 [ 盒裝 ] 13g x 10 日本 Japan 3.7 5 Wakodo (No English product name) 和光堂初生嬰兒奶粉 [ 罐裝 ] 850 日本 Japan 2.1 6 Wakodo (No English product name) 和光堂細仔奶粉 [ 盒裝 ] 13g x 10 日本 Japan 1.8 7 WIOM Infant Formula Stage 1-900 新西蘭 New Zealand 3.8 2