T.C.
TARIM ve KÖYİŞLERİ BAKANLIĞI
Koruma ve Kontrol Genel Müdürlüğü
Communiqué On Infant Foods - Infant Formulae 
Authorization Law :Turkısh Food Kodeks
National Press : 28.08.1998-23447/17.12.1998-23556
Communication No.: 98/20
Objective
Article 1- The objective of this Communiqué is to determine the characteristics of the infant foods-infant formulae in order to provide the infant foods- infant formulae with hygienic production, preparation, preservation, storage, transportation and marketing.
Scope
Article 2 – This Communiqué contain infant foods-infant formulae that are used in nutrition of infants between 4 and 6 months age. It does not include follow-on formulae, child supplementary foods and child special nutriment.
Legal basis
Article 3- This Communiqué has been prepared in accordance with Regulation of Turkish Food Codex published in Official Gazette, dated 16/11/1997 with reiterated number 23172.
Definitions
Article 4- Definitions mentioned in this Communiqué are;
a) Infant: Between 0-12 month group,
b) Infant formula means; in accordance with preparation and instructions for use; that can provide nutritional needs of infants between 4 and 6 month ages having normal weight and health; that are produced for normal growing and fostering; that has composition close to breast-milk; that are prepared in accordance with protein, fat, carbohydrate, vitamins, minerals, additives prepared suitable for their technologies and being resistant to heat treatment; consumed directly or does not need any other operation apart from addition of water and ready for consumption of dairy based products,
c) Infant milk means; infant formulae produced completely from cow milk’s protein,
d) Water capacity of the container means; the water volume when it is completely filled with distilled water at 20ºC,
Characteristics of the product
Article 5- The characteristics of these products covered in this Communiqué are mentioned below:
a- Infant formulae basically includes cow and other animal’s milks and edible components of animals including fish and plants. The basic component of the product will be suitable to (Annex-1).
b- The energy value given in Annex-1 is calorie that can be benefited from it.
c- The protein value given in Annex-1 is protein that can be benefited from it. In case of energy values are equal to the content of each essential benefited and semi-essential benefited amino acid have to be equal or more than breast milk given in Annex-2.
d- Addition of amino acid mentioned in Annex-3 to infant formulae can be solely with the purpose of to increase nutritive value of it.
e- It is forbidden to use of sesame and cotton oil in the infant formulae.
f- As a carbohydrate source only lactose, maltose, sucrose, malto-deckstrine glucose syrup or glucose syrup powder and starch having no gluten and gelatinized starch can be used.
g- In the infant formulae, 15 mg B6 vitamin should be included per 1 gram.
h- The colour, odour and taste of liquid and powder infant formulae should have specific characteristics and can be easily used up by infants. When infant formulae is prepared in accordance with infant formulae regulation, it should be viscous to be passed over feeding bottle and homogeneous.
i- Infant formulae shall not be exposed to radiation.
j- When its original package is opened, head space of infant formulae container that has no need any other operation for consumption should be as it mentioned below:
The head space of container that has water capacity lower than 150 ml, should not be more than 20 % of the container volume.
The head space of container that has water capacity between 150-250 ml should not be more than 15% of the container volume.
The head space of container that has water capacity more than 250 ml should not be more than 10 % of the container volume.
Additives
Article 6 - The additives used in infant formulae must be appropriate to the second section of Regulation of Turkish Food Codex and must be in compliance with 8th and 9th Annexes of the same regulation. Another ingredients and raw materials that are not mentioned in this section can not be used in infant formulae.
Contaminants
Article 7 – Infant formulae can not be contaminated by residues of hormone and antibiotic that can be determined by any standard analysis methods and formulae also should not be contaminated by active materials, particularly Pharmaceutics and it should be obeyed by “Contaminants” section of the Regulation of Turkish Food Codex.
Hygiene
Article 8- Infant formulae should be appropriate to micro biologic characteristics given Annex 4.
Packaging and labelling-marking
Article 9- The rules for packaging and marking of infant formulae are mentioned below:
a) The containers of infant formulae should be hygienic and should not be changed the characteristics of the product and if infant formulae is produced aqueous form it should be opened hermetically. Nitrogen and carbon dioxide gasses can be used for packaging. All materials that are used for packaging of formulae must comply with the “packaging” section of Regulation of Turkish Food Codex published in Official Gazette, dated 16/11/1997 with the number of 23172.
b) All infant pictures, photographs, cartoons and writings that idealize infant formulae should not be put on package or label. Any faith arousing that nutrition with infant formulae is equal to sucking, can not be created even it can not be implied. These restrictions are valid for product’s shape and appearances. However, graphics provided to be understood of products as a infant formulae and to show methods of preparation of the products can be put on the package.
c) Statements belongs to the special composition can be put on the label if it is appropriate to the conditions mentioned in the Annex 5.
d) In addition to 9th section of Regulation of Turkish Food Codex:
- The expiration date after the container opened,
- With an important note or an equal expression; “the most appropriate nutrition for child is breast-milk and infant formulae”, and “infant formulae can be used only in case of lack of breast-milk and should be used upon of the advise of competents” writings,
- In which month and situation of the formulae are suitable for babies,
- Mispreperation of infant formulae for consumption and re-usage of infant formulae can be harmful for babies,
- Together with the information guidance of infant formulae, storage conditions, preparations and instructions for use, storage at home conditions and protection after opening and relevant information should also given at labelling,
- In the case of infant formulae that do not contain added iron, if it is used for infants over the age of 4 months, infants’ total iron requirements must meet from other additional sources,
The available energy value, expressed in kJ and kcal, the contents of protein, lipids and carbohydrates per 100ml of ready for use product; the average quantity of each mineral substance and vitamins and where applicable choline, inositol, carnitine and taurine,
should be on the label.
Transportation and storage
Article 10- The rules for “Transportation and Storage” section of the Regulation of Turkish Food Codex, must be obeyed during the transportation and storage of infant formulae.
Sampling and Methods of Analysis
Article 11- Regulation of Turkish Food Codex’ 11th chapter’s rules should be obeyed during the sampling from product line and storage rooms. The sample should be analysed in accordance with internationally accepted methods.
Specific Provisions
Article 12- Specific provisions that should be obeyed in this communiqué are mentioned below:
The foods that are not appropriate to the Turkish Food Codex- Infant Food-Infant Formulae should not be sold and promoted as infant formulae.
a) There shall be no point-of-scale advertising, promotion and distribution of the infant formulae to the public through press, radio, television, on other media and special sales, special displays, discount coupons and tickets shall not be given. The promotion of the product and the distribution of sample can only be done due to the demand of doctors or relevant health institute demand.
b) The advertisement and distribution of the infant formulae can not be done at maternity hospitals and clinics.
c) A dose spoon should be included in the powder infant formulae package and the food content of the dose spoon should be mentioned as a gram.
Registration and inspection
Article 13- The registration and import permission licence of establishments selling or producing infant formulae obliged to obey with the provisions of this Communiqué during control and inspection. Legal procedure will be applied to those establishments which do not obey these provisions in accordance with the law that amended on 24/6/1995 and number 560 the decree in the power of law over production, consumption, and control of the foods.
Inspection
Article 14- The provisions of this Communiqué are controlled by the Minister of Agriculture and Rural Affairs in accordance with and with The Decree Law number 560 and of 24/6/1995 on production, consumption, and control of the foods.
Provisional Article- The establishments producing and selling the products involving in this Communiqué obliged to obey the provisions of this Communiqué within a year. If the establishments do not make necessary arrangement within this period of the time, they are not allowed to work. And legal procedure against these establishments shall be executed in accordance with Decree Law number 560, dated 24/6/1995.
Enforcement
Article 15- This Communiqué shall go into force on its date of publication.
Execution
Article 16 – The provisions of this Communiqué are executed by Minister of Agriculture and Rural Affairs together with the Minister of Health.
ANNEX -1
THE COMPOSITION OF INFANT FORMULAE READY FOR CONSUMPTION
Energy
| Minimum | Maximum | |
| 250 kJ/100 ml | 315 kJ/100 ml | |
| 60 kcal/100 ml | 75 kcal/100 ml |
Proteins
The protein content for cow milk proteins = Nitrogen content X 6,38
The protein content of the Soybean protein’s isolates and partly hydrolized proteins = Nitrogen content X 6.25
2.1- The formulae produced from cow milk proteins ;
| Minimum | Maximum | |
| 0.45 g/ 100 kJ | 0.7 g/100 kJ | |
| 1.8 g/ 100 kcal | 3 g/100 kcal |
2.2 - The formulae produced from partly hydrolized proteins;
| Minimum | Maximum | |
| 0.56 g/ 100 kJ | 0.7 g/100 kJ | |
| 2.25 g/ 100 kcal | 3 g/100 kcal |
The productivity and utility of proteins should be equal to casein.
The content of tourine should be Minimum 10 m mol/100 kJ or 42 m mol/100 kcal and
the content of L-carnitine should be Minimum 1.8 m mol/100 kJ or 7.5 m mol/100 kcal .
2.3 – Formula produced from only soybean protein isolates or complication of Soybean protein isolate with cow milk proteins;
| Minimum | Maximum | |
| 0.56 g/ 100 kJ | 0.7 g/100 kJ | |
| 2.56 g/ 100 kcal | 3 g/100 kcal |
In these formulates only isolates of soybean proteins can be used. The content of L-carnitine should be Minimum 1.8 m mol / 100 kJ or 7.5 m mol / 100 kcal. The proportion of amino acid of all formulae should be Minimum 80 % when they compared to breast-milk mentioned in the Annex 6.
Fats
| Minimum | Maximum | |
| 1.05 g/ 100 kJ | 1.5 g/100 kJ | |
| 4.4 g/ 100 kcal | 6.5 g/100 kcal |
3.1 – Lauric acid
| Minimum | Maximum | |
| -- | 15 % of total fat content | |
3.2 – Miristic acid
| Minimum | Maximum | |
| -- | 15 % of total content of fat | |
3.3 - Linoleic acid ( In the forms of glycerids = linoleates )
| Minimum | Maximum | |
| 70 mg/ 100 kJ | 285 mg/100 kJ | |
| 300 mg/ 100 kcal | 1200 mg/100 kcal |
3.4 – Alfa – linoleic acid content should be Minimum 12 mg/100 kJ or 50 mg/100 kcal.
The proportion of linoleic acid/alfa- linoleic acid should be between 5 and 15.
3.5 – Trans fat acid content should not exceed 4 % of total fat content.
3.6 – Erucic acid content should not exceed 1 % of total fat content.
3.7 – Having 20-22 carbon atoms with long chain polyunsaturated fatty acids can be added to the formulae if it is obeyed restrictions mentioned below:
The content of n-3 long chain polyunsaturated fatty acids should not exceed 1 % of total fat content.
The content of n-6 long chain polyunsaturated fat acids should not exceed 2 % of total fat content. (This limit should be 2 % for arachidonic acid)
The content of Eikosapentaenoic acid ( 20:5 n-3), should not exceed the Content of dokhosaheksaonic acid (22: 6 n-3)
4 – Carbohydrates
| Minimum | Maximum | |
| 1,7 g/100 kJ | 3.4 g/100 kJ | |
| 7 g/100 kcal | 14 g/100 kcal |
4.1- Lactose
| Minimum | Maximum | |
| 0,85 g/100 kJ | - | |
| 3,5 g/100 kcal | - |
Restrictions over lactose usage can not be applied if soybean protein become more than 50 % in the total protein.
4.2 – Sucrose
| Minimummum | Maximum | |
| -- | 20 % of total carbohydrate content | |
4.3 – Pre-cooked starch and/or gelatinized starch
| Minimummum | Maximum | |
| -- | 2 g/100 ml and 30 % of total carbohydrate | |
5 – Minerals
5.1 – The formulae produced from cow milk proteins
| 100kJ üzerinden | 100 kcal üzerinden | ||||
| En Az | En Çok | En Az | En Çok | ||
| Sodium (mg) | 5 | 15 | 20 | 60 | |
| Potassium (mg) | 15 | 35 | 60 | 145 | |
| Chloride (mg) | 12 | 29 | 50 | 125 | |
| Calcium (mg) | 12 | - | 50 | - | |
| Phosphorus (mg) | 6 | 22 | 25 | 90 | |
| Magnesium (mg) | 1,2 | 3,6 | 5 | 15 | |
| Ferric (mg)(1) | 0,12 | 0,36 | 0,5 | 1,5 | |
| Zinc (mg) | 0,12 | 0,36 | 0,5 | 1,5 | |
| Copper (µg) | 4,8 | 19 | 20 | 80 | |
| İodine (µ g) | 1,2 | - | 5 | - | |
| Selenium (µ g)(2) | - | 0,7 | - | 3 | |
| (1) Demir ilaveli formüllere uygulanır. | |||||
| (2) Selenyum ilaveli formüllere uygulanır. | |||||
The proportion of calcium/ phosphorus ratio values shall be between 1.2-2.0 values.
5.2 - The formula produced only from soybean protein or complication of cow milk protein and soybean protein
| Over 100kJ | Over 100 kcal | |||||
| Minimum | Maximum | Minimum | Maximum | |||
| Ferric(mg) | 0,25 | 0,5 | 1 | 2 | ||
| Zinc (mg) | 0,18 | 0,6 | 0,75 | 2,4 | ||
6-Vitamins
| over 100kJ | over 100 kcal | ||||
| Minimum | Maximum | Minimum | Maximum | ||
| Vitamin A(µg-RE) (1) | 14 | 43 | 60 | 180 | |
| Vitamin D(µ g)(2) | 0,25 | 0,65 | 12 | 5 | |
| Thiamine (µ g) | 10 | - | 40 | - | |
| Riboflavin(µ g) | 14 | - | 60 | - | |
| Niacin (mg-NE)(3) | 0,2 | - | 0,8 | - | |
| Pantothenic acid (µ g) | 70 | - | 300 | - | |
| Vitamin B6 (µ g) | 9 | - | 35 | - | |
| Biotin (µ g) | 0,4 | - | 1,5 | - | |
| Floic Acit (µ g) | 1 | - | 4 | - | |
| Vitamin B12 (µ g) | 0,025 | - | 0,1 | - | |
| Vitamin C (mg) | 1,9 | - | 8 | - | |
| Vitamin K (µ g) | 1 | - | 4 | - | |
| Vitamin E(mg-TE) | 0,1mg/100 kj or 0,5 mg/g linoleic acid | - | 0,5mg/100 kj or 0,5 mg/g linoleic acid | - | |
| (1) RE= Transretinol equivalence (2) In Cholecalciferol form, 1 m g = 40 I.U.D Vitamin (3) NE= Niacin equivalence = mg nicotinic acid + mg triptophan (4) Alpha-TE= d-Alpha-tocopherol equivalence |
|||||
7- Nucleotides that can be added
| Maximum(1) | |||
| (mg)/100 kJ) | (mg/100 kcal) | ||
| cystidine 5' monophosphate | 0,60 | 2,50 | |
| Üridin 5'- monophosphate | 0,42 | 1,75 | |
| Adenozin 5'- monophosphate | 0,36 | 1,50 | |
| Guanozin 5'- monophosphate | 0,12 | 0,50 | |
| İnosin 5'- monophosphate | 0,24 | 1,00 | |
| (1) Total content of nucleotides should not be more than 1,2 mg/100kJ (5 mg/100kcal) | |||
ANNEX 2
ESSENTIAL AND SEMI-ESSENTIAL AMINO ACIDS IN BREAST MILK
| for 100 kj | for 100 kcal | ||
| Arjinin | 16 mg | 69 mg | |
| Cystine | 6 mg | 24 mg | |
| Histidine | 11 mg | 45 mg | |
| Isoleucine | 17 mg | 72 mg | |
| Leucine | 37 mg | 156 mg | |
| Lysine | 29 mg | 122 mg | |
| Methionine | 7 mg | 29 mg | |
| Phenylalanine | 15 mg | 62 mg | |
| Threonine | 19 mg | 80 mg | |
| Tyrosine | 7 mg | 30 mg | |
| Valine | 14 mg | 59 mg | |
| 19 mg | 80 mg |
ANNEX 3
NUTRITIVE ELEMENTS
1-Vitamins
| Vitamin | Vitamin Formulation | |
| Vitamin A | Retinyl acetate
Retinil palmitat Beta-karoten Retinol |
|
| Vitamin D | D2 Vitamin(ergocalciferol) D3 Vitamin(cholecalciferol) |
|
| Vitamin B1 | Talmin hydrochloric Talmin mononitrate |
|
| Vitamin B2 | Riboflavin Riboflavin –5’-phosphate,sodium |
|
| Niacin | Nicotinamide Nicotinic acid |
|
| Vitamin B6 | Pyridoxine hydrochloric Pyridoxine -5’-phosphate |
|
| Folate | Folic acid | |
| Pantothenic acid | D-pantothenate, calcium D-pantothenate, sodium Dexpanthenol |
|
| Vitamin B12 | Cyanocobalamin Hydroxocobalamin |
|
| Biotin | D- Biotin | |
| Vitamin C | L-ascorbic acid Sodium L- ascorbate Calcium L- ascorbate 6-palmityl- L- ascorbic acid (ascorbyl palmitate) Potassium ascorbate |
|
| Vitamin E | D-alpha tocopherol DL-alpha tocopherol D-alpha tocopherolacetate DL-alpha tocopherol acetate |
|
| K Vitamin | Phylloquinone (Phytomeradione) |
2- Minerals
| Minerals | Permitted salts | |
| Calcium (Ca) | Calcium carbonate Calcium chloride Calcium salts of citric acid Calcium gluconate Calcium glycerophosphate Calcium lactate Calcium salts of orthophosphoric acid Calciumhydroxide |
|
| Magnesium(Mg) | Magnesium carbonate Magnesium chloride Magnesium oxide Magnesium salts of orthophosphoric acid Magnesium sulphate Magnesium gluconate Magnesium hydroxide Magnesium salts of citric acid |
|
| Ferric (Fe) | Ferrous citrate Ferrous gluconate Ferrous lactate Ferrous sulphate Ferrous ammonium citrate Ferrous fumarate Ferric diphosphate (Ferric pyrophosphate) |
|
| Copper(Cu) | Cupric citrate Cupric gluconate Cupric sulphate Copper-lysin complex Cupric carbonate |
|
| Iodine (I) | Potassium iodide Sodium iodide Potassium iodide |
|
| Zinc(Zn) | Zinc acetate Zinc chloride Zinc lactate Zinc sulphate Zinc citrate Zinc gluconate Zinc oxide |
|
| Manganese (Mn) | Manganese carbonate Manganese chloride Manganese citrate Manganese sulphate Manganese gluconate |
|
| Sodium (Na) | Sodium bicarbonate Sodium chloride Sodium citrate Sodium gluconate Sodium carbonate Sodium lactate Sodium salts of orthophosphoric acid Sodium hydroxide |
|
| Potassium(K) | Potassium bicarbonate Potassium carbonate Potassium chloride Potassium salts of citric acid Potassium gluconate Potassium lactate Potassium salts of orthophosphoric acid Potassium hydroxide |
|
| Selenium (Se) | Sodium selenate Sodium selenide |
3- Amino Acids And Other Nitrogen Components
L-cystine and its hydrochloride L-histidine and its hydrochloride L-isoleucine and its hydrochloride L-leucine and its hydrochloride L-cysteine and its hydrochloride L-methionine L-phenylalanine L-threonine L-tryptophan L-tyrosine L-valine L- carnitine and its hydrochloride Taurine Cystidine 5’-monophosphate and sodium salt Uridine 5’-monophosphate and sodium salt Adenosine 5’-monophosphate and sodium salt Guanosine 5’-monophosphate and sodium salt Inosine 5’-monophosphate and sodium salt |
|
| 4- Others | |
Choline Choline chloride Choline citrate Choline bitartrate inositol |
|
ANNEX 4
MICROBIOLOGIC CHARACTERISTICS OF INFANT FORMULAE
| Characteristics | Powder infant formulae | |
| Total mesophyllic Aerobic bacteria (colony unit/g) | 10 | |
| Coliform ( colony unit) | 20 | |
| E.coli ( colony unit) | should not be exist | |
| Salmonella ( colony unit/25 g ) | should not be exist | |
| Bacillus cereus ( colony unit/g) | 102 | |
| Staphylococcus aureus | should not be exist | |
| Ferment, mould ( colony unit/g) | 102 | |
| Clostridium perfringens | should not be exist |
Living microorganism should not be existed in the infant formulae ready for consumption which are sterilized and made resistant.
ANNEX 5
DECLARATIONS FOR INFANT FORMULA COMPONENTS
| Declaration | Conditions for declaration | |
| Adopted protein | Protein content should be less than 0.6g/100 kJ (2.5g/100 kcal) Whey protein /casein be Minimum 1.0 |
|
| Low sodium | Sodium content should be 9 mg/100 kJ (39 mg/100 kcal) | |
| Sucrose free | No sucrose should be present | |
| Lactose only | Lactose should be only carbohydrate being present | |
| No lactose | Lactose should not be exist | |
| Iron enriched | Iron should be added | |
| The risk of allergy Against milk proteins Should be lowered | The formula should provide conditions involving in Annex-1,2.2 and the content of immunoreactive Protein should be less than 1 % of nitrogen content taking part in the formula. The formula should be proved by clinic tests that at least 90 % of infants who have sensitivity against proteins can tolerate it When the formulae are given to animals by oral ways, It should not cause sensitivity. Scientific and objective data that prove this Declaration should be exists. |
ANNEX 6
AMINO ACID COMPOSITIONS OF CASEIN AND BREAST MILK
| Casein | (g/100 g protein) Breast milk |
||
| Arginine | 3,7 | 3,8 | |
| Cystine | 0,3 | 1,3 | |
| Histidine | 2,9 | 2,5 | |
| Isoleucine | 5,4 | 4,0 | |
| Leucine | 9,5 | 8,5 | |
| Lysine | 8,1 | 6,7 | |
| Methionine | 2,8 | 1,6 | |
| Phenylalanine | 5,2 | 3,4 | |
| Threonine | 4,7 | 4,4 | |
| Tryptophan | 1,6 | 1,7 | |
| Tyrosine | 5,8 | 3,2 | |
| Valine | 6,7 | 4,5 |
ANNEX 7
REFERENCE VALUES FOR INFANT NUTRITION
| Vitamin A (µ g) | 400 | |
| Vitamin D (µ g) | 10 | |
| Vitamin C (mg) | 25 | |
| Thiamine(µ g) | 0,5 | |
| Riboflavin(µ g) | 0,8 | |
| Niacin equivalence (mg) | 9 | |
| Vitamin B6 (µ g) | 0,7 | |
| Pholate (µ g) | 100 | |
| Vitamin B12 (µ g) | 0,7 | |
| Calcium (mg) | 400 | |
| Ferric(mg) | 6 | |
| Zinc(mg) | 4 | |
| Iodine (µ g) | 70 | |
| Selenium (µ g) | 10 | |
| Copper (µ g) | 0,4 |
ANNEX 8
AS AN ADDITION TO REGULATION OF TURKISH FOOD CODEX ANNEX-9, ADDITIVES USED IN İNFANT FORMULAE-İNFANT FOODS
| EC Code And The Name of Material | Type Of Infant Formulae | Maximum Dose | Explanation |
| E 304L-Ascorbile palmitate | in the all infant formula | 1 mg/ 100 ml | |
E 331 sodium citrate E 332 Potassium citrate E 500 Sodium hydrogen carbonate E 500 Sodium carbonate E 501 potassium hydrogen carbonate E 501 potassium carbonate E 524 sodium hydroxide E 525 potassium hydroxide E 526 calcium hydroxide |
in the all infant formula | GMP | harmonious with Na and K limits given Annex-1 |
E 407 Carrageenan
|
only for milk and soybean based liquid infant formulae only for hydrolysed protein and/or amino acid based liquid infant formulae |
0,03 g/100 ml 0,1 g/100 ml |
|
E 412 Guar gum E 410 Lokust bean gum |
in the all infant formulae | 0,1 g/100 ml | |
E 1412 Distarch phosphate E 1413 Distarch phosphate with phosphated E 1414 Distarch phosphate with aciof E 1440 hydroxyl propel starch |
in the soybean formulae for only hydrolysed protein and/or amino acid based formulae |
0,5 g/100 ml 2,5 g/100 ml |
single or together single or together |
The given maximum dosages are for the infant food that have been rendered ready for consumption.