T.C.
TARIM ve KÖYİŞLERİ BAKANLIĞI
Koruma ve Kontrol Genel Müdürlüğü
The Communiqué for Follow-on Infant Foods - Follow-on Formula
Authorization Law: Turkish Food Codex
The Official Gazette: 16.08.2000-24142
Communication No : 2000/30
Objective
Article 1. The objective of this Communiqué is to determine the characteristics of sustain infant foods - sustain formula in order to fulfil the production, preparation, processing, preservation, storage, transportation and marketing of these products conforming to technical and hygienic conditions.
Scope
Article 2. This Communiqué covers the follow-on infant foods used for the nourishment of healthy infants 4 months after their birth and infants. This Communiqué does not cover infant formula, supplementary child nourishment and special child nourishment.
Legal basis
Article 3. This Communiqué has been prepared in accordance with the Regulation of Turkish Food Codex published in Official Gazette, dated 16.11.1997 and reiterated number 23172.
Definitions
Article 4. The definitions stated in this Communiqué are as follows:
a) Infant: 0 - 12 month age group.
b) Young Children: 12 - 38 month age group.
c) Follow-on formula: According to preperation and instructions for use; the products containing nourishment elements proper for the normal growth and development of healthy infants 4 months after their birth and young children such as protein, fat, carbohydrate, vitamins and mineral substances; which are prepared technically with permitted additives and being resistant to heat treatment; which are the major liquid part for the nourishment of this age group; which are consumed directly or ready to consume and do not need any other processes except addition of water.
d) Follow-on milk: Follow-on formula produced completely from cow milk.
e) Water capacity of the Container: the water volume of the container when it is completely filled with distilled water at 20 C.
Characteristics of the product
Article 5. The characteristics of the products covered in this Communiqué are given below.
a) Follow-on formulae contains milk and/or animal and/or vegetable originated components of cows or other animals which are approved as proper for infants and young children. The basic composition of the product shall be in accordance with Annex-1.
b) Energy values stated in Annex-1 are beneficial calorie.
c) The contents of proteins stated in Annex-1 are for the proteins which have the nourishment value equal to casein. In case the nourishment value is more than casein, the content of protein is decreased proportionally. The protein quality can not be less than 85% of casein.
d) Essential amino acids can only be added to follow-on formula in order to increase the nutrition value of the formula or to improve the protein quality. With this aim only the L forms of the aminoacids can be used.
e) Minerals, vitamins, aminoacids and nitrogen compounds and other compounds to be used with this aim which can be added to follow-on formula are stated in Annex-1.
f) The use of sesame oil and cotton oil is forbidden in follow-on formula.
g) The use of components including gluten as a source of carbohydrate is forbidden.
h) Follow-on formula should include Minimum 15 mg vitamin B per each 1gram protein.
ı) The colour, odour and flavour of follow-on formula in liquid or powder should have characteristics peculiar to themselves and should be in consistency and homogenous that infants and young children can consume easily.
i) The follow-on formula should not be reacted with radiation.
j) The head space of container follow-on formula not requiring any other process and ready to be consumed after the original package is opened:
For the products which have water capacity of the container less than 150 ml, the head space should be maximum 20% of total volume.
For the products which have water capacity of the container between 150-250 ml, the head space should be maximum 15% of total volume.
For the products which have water capacity of the container more than 250 ml, the head space should be maximum 10% of total volume.
Additives
Article 6. The additives used in follow-on formula should be in accordance with the second section of Regulation of Turkish Food Codex and the Annex 11 of the same Regulation and the Annex 7 of this Communiqué. Additives taken from the raw material or the other components and the additives not stated in this section should not be used in the Follow-on formula.
Flavourings
Article 7. Flavourings used in follow-on formula should be in accordance with Annex 3
Contaminants
Article 8. Follow-on formula should be purified from residues of hormone and antibiotic and all active substances particularly the pharmacologic ones which can be determined with standard analysis methods and should be in accordance with " Contaminant" section of the Regulation of Turkish Food Codex.
Hygiene
Article 9. Follow-on formula should be in accordance with microbiologic characteristics stated in Annex- 4.
Packing And Labelling-Marking
Article 10. The principles concerning the packing and marking of Follow-on formula are as follows:
a) The containers of the follow-on formula should be hygienic in a quality which do not give harm to the characteristics of the product; if the follow-on formula submitted to consumption in the liquid form, it should be hermetically sealed. Nitrogen and carbondioxide gases can be used in the packing process. The all packing materials to be used for the formula should be in accordance with the "Packing" section of the Regulation of Turkish Food Codex published at Official Gazette, dated 16.11.1997 and reiterated no 23172.
b) In addition to the 9th section of the Regulation of Turkish Food Codex, the followings should be stated on the label:
- The recommended shelf-life date after the container is opened.
- That the product should be used for the nourishment of the infants older then 4 months and should not be used as a substitution for breast milk.
- The names of all the protein sources in squence of degreasing weight just adjacent to the product name.
- The statement " milk or milk component not included" for the products that do not include milk or milk component.
- The necessity of giving other foods to the infant besides the follow-on formula.
- The suitability of formulae for which condition and age group of infants
- That the mispreperation of the follow-on formula to be ready to consume and the reuse of the prepared follow-on formula can be harmful.
- Together with the information guidance of infant formulae, the information including, storage conditions, the instructions for use and preparation, the preservation in home conditions and the protection after opening, the proper use of infant food for not giving up breast milk and if necessary warnings.
- The available energy value, expressed in kcal and kJ, protein content, fat and carbohydrates, the average content of each mineral and vitamin and the contents of colin, inositol, carnitin and taurine when necessary that the formula of 100 ml ready to be consumed include.
c) If the 100 ml infant food ready to be consumed provides 15 % of the nourishment reference values stated in Annex-5, the % of the reference values of the vitamin and minerals in addition to quantitive contents should be written on the label.
Transportation and Storage
Article 11. During transporting and storing the follow-on formula, the principles stated in the " Transportation and Storage" section of the Regulation of Turkish Food Codex should be carried out.
Sampling and Methods of Analysis
Article 12. During taking sample from follow-on formula in the production line and the preservation depots, the principles stated in the 11th section of the Regulation of the Turkish Food Codex should be carried out. The sample should be analyzed in accordance with internationally adopted methods.
Special Provisions
Article 13. The special provisions that should be complied with this Communiqué are as follows :
a. The foods not conforming with the provisions of this Communiqué should not be sold or introduced as follow-on formula.
b. Follow-on formula should not be sold as a substitute for breast milk.
c. It is compulsory to place measuring spoon in the package of follow-on formula for powder and the content of infant food that this spoon contains should be stated in grams.
Registration and Inspection
Article 14. The establishments producing and selling follow-on formula should comply with the provisions of this Communiqué while registering and taking permission, during importation procedures, controlling and inspection. The establishments not conforming with these provisions shall be subject to legal procedures in accordance with the Decree in the power of Law on the Production, Consumption and Inspection of the Foods of 24.6.1995 and no 560.
Inspection
Article 15. The provisions of this Communiqué are controlled by the Ministry of Agriculture and Rural Affairs and the Ministry of Health in accordance with the Decree Law on the Production, Consumption and Control of the Foods of 24.6.1995 and no 560.
Provisional Article 1. The establishments still operating and producing and selling the products stated in this Communiqué should comply with the provisions of this Communiqué within one year. The establishments and outlets not making the necessary arrangements within this term shall not be allowed to operate. These establishments shall be subject to legal procedures in accordance with the provisions of Decree in the power of Law no 560.
Enforcement
Article 16. This Communiqué shall go into force on the date of publication.
Execution
Article 17. The provisions of this Communiqué are executed by the Minister of Agriculture and Rural Affairs and Minister of Health.
ANNEX 1
THE COMPOSITION OF THE FOLLOW-ON FORMULA MADE READY FOR CONSUMPTION IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE
1. Energy
| Minimum | Maximum |
| 250 kj/100ml | 355 kj/100ml |
| 60 kcal/100ml | 85 kcal/100ml |
2.Proteins
The protein content for the cow milk proteins = The nitrogene content X 6.38
The protein content for the soybean protein izolates = The nitrogene content X 6.25
| Minimum | Maximum |
| 0.5 g/100kj | 1.3 g/ 100kj |
| 2.25 g/100kcal | 5.5 g/100kcal |
The ratio of each content of aminoacid in these formula to the ratio of the content of amino acid in casein and breast milk stated in Annex-6 should be Minimum 80%.
The protein isolates produced by only soybean can be used in formula produced by only soybean protein or the mixture of soybean and cow milk protein.
These formula should include methionine which is equal to methionine in breast milk stated in Annex-6 for the equal energy values of the breast milk and Follow-on formula.
3. Fats
| Minimum | Maximum |
| 0.7 g/100kj | 1.5 g/100kj |
| 3.0 g/100kcal | 6.5 g/100kcal |
3.1. Lauric Acid
| Minimum | Maximum |
| ----- | 15 % of total fat content |
3.2. Miristic Acid
| Minimum | Maximum |
| --- | 15 % of total fat content |
3.3. Linoleic Acid (In glycerid forms=Linoleats)
| Minimum | Maximum |
| 70 mg/100kj | --- |
| 300 mg/100kcal | --- |
Applied in follow-on formula including only vegetable fat.
3.4. The content of trans fat acid should not exceed 4% of the content of total fat
3.5. The content of erusic acid should not exceed 1% content of total fat.
4. Carbonhydrates
| Minimum | Maximum |
| 1.7 g/100kj | 3.4 g/100kj |
| 7 g/100kca | 14 g/100kcal |
4.1. Lactose
| Minimum | Maximum |
| 0.45 g/100kj | --- |
| 1.8 g/100kcal | --- |
The limitations concerning lactose can not be applied in case soybean is more than 50% in total protein.
4.2. Sucrose, fructose, honey
| Minimum | Maximum |
| 20% of the total carbohydrate content (seperately or totaly) | |
5. Minerals
5.1. Zinc
5.1.1. In follow-on formula produced by only cow milk
| Minimum | Maximum |
| 0.12 mg/100kj | --- |
| (0.5 mg/100kcal) | --- |
5.1.2. In follow-on formula produced by only soybean isolates or by the mixture of soybean protein isolates and cow milk proteins.
| Minimum | Maximum |
| 0.18 mg/100kj | --- |
| (0.75 mg/100kcal) | --- |
5.2. Other Minerals
| Expressed as 100kj | Expressed as 100kcal | |||
| Minimum | Maximum | Minimum | Maximum | |
| Sodium (mg) | 5 | 21 | 20 | 85 |
| Potassium(mg) | 20 | - | 80 | - |
| Chlorine (mg) | 14 | - | 55 | - |
| Calcium(mg) | 14 | - | 55 | - |
| Phosphorus(mg) | 14 | - | 60 | - |
| Magnesium(mg) | 1,4 | - | 6 | - |
| Iron(mg) | 0,25 | 0,5- | 1 | 2 |
| Iodine(mg) | 1,2 | - | 5 | - |
5.3. The Ratio of Calcium/Phosphorus shall be between the values of 1.2-2.0
6. Vitamins
| Expressed as 100kJ | Expressed as 100kcal | |||
| Minimum | Maximum | Minimum | Maximum | |
| Vitamin A (mg-RE)* | 14 | 54 | 62 | 225 |
| Vitamin D(mg)# | 0,25 | 0,75 | 1 | 3,0 |
| Vitamin C(mg) | 1,9 | - | 8 | - |
| Titamin(mg) | 10 | - | 40 | - |
| Riboflavin(mg) | 14 | - | 60 | - |
| Nicotinamid (mg) | 60 | - | 250 | - |
| Pantonetic acid(mg) | 70 | - | 300 | - |
| Vitamin B6(mg) | 11 | - | 45 | - |
| Biotin(mg) | 0,4 | - | 1,5 | - |
| Folic acid(mg) | 1 | - | 4 | |
| Vitamin B12(mg) | 0,04 | - | 0,15 | - |
| Vitamin K1 | 1 | - | 4 | - |
| Vitamin E (mg a -TE)(3) | 0.1mg/100kj and multi non-saturated fatty acids for 0.5mg/g linoleic acid | - | 0.5mg/100kcal and multi non-saturated fatty acids for 0.5 mg/g linoleic acid | - |
* RE = Transretinol equivalent
1 mg Re= 3.33I.U.Vitamin A
# In Colecalciferol form 1mg = 40 I.U. Vitamin D
" a-TE = d -a-tokoferol equivalent
7. Nucleotides to be Added
| Minimum mg/100kj | Maximum mg/100kcal | |
| crystidine 5-monophosphate | 0.60 | 2.50 |
| uridine 5- monophosphate | 0.42 | 1.75 |
| adenosine 5-monophosphate | 0.36 | 1.50 |
| guanosine 5-monophosphate | 0.12 | 0.50 |
| monophosphate | 0.24 | 1.00 |
Total content of nucleotids shall be maximum 1.2 mg/100kj (5mg/100kcal)
ANNEX 2
NUTRITIOUS ELEMENTS
1.Vitamins
| Vitamin | Formulation of Vitamin |
| Vitamin A | Retinyl Acetate Retinyl palmitate Beta-carotene Retinol |
| Vitamin D | Vitamin D2 ( ergocalciferol) Vitamin D3 ( cholecalciferol) |
| Vitamin B1 | Thalmin hydrochloride Thalmin mononitrate |
| Vitamin B2 | Riboflavin Riboflavin –5’-Phosphate,Sodium |
| Niacin | Nictotinamide Nicotinic acid |
| Vitamin B6 | Pyridoxine hydrochloride Pyridoxine-5’-phosphate |
| Folat | Folic acid |
| Pantotenic acid | D-Pantothenate, calcium D-Pantothenate, sodium |
| 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) |
| Vitamin E | D-alpha tocopherol DL-alpha tocopherol D-alpha tokoferol acetade |
| Vitamin K | Phylloquinone ( Phytomenadione) |
2. Mineral Substances
| Mineral substances | Permitted salts |
| Calcium(Ca) | calcium carbonate calcium chloride calcium salts of citric acid calcium gluconate calcium glycerophosphate calcium lactate calcium salts of orthophosphoric acid calcium hydroxide |
| magnesium (Mg) | magnesium carbonate magnesium chrolide magnesium oxide magnesium salts of orthophosphoric acid magnesium sulphate magnesium gluconate magnesium hydroxide magnesium salts of citric acid |
| iron (Fe) | ferrous citrate ferrous gluconate ferrous lactat ferrous sulphate ferric ammonium citrate ferrous fumarate ferric diphosphate ( ferric pyrophosphate) |
| copper (Cu) | cupric citrate cupric gluconate cupric sulphate copper- lysine complex cupric carbonate |
| iodine (I) | potassium iodide sodium iodide potassium iodate |
| zinc (Zn) | zinc acetate zinc chloride zinc lactate zinc sulphate zinc citratee zinc gluconate zinc oxide |
| manganese ( Mn) | magnesium carbonate magnesium chloride magnesium citrate magnesium sulphate magnesium gluconate |
| sodium (Na) | sodium bicarbonate sodium chlorine sodium citrate sodium gluconate sodium carbonate sodium lactate sodium salts of ortophosphoric acid sodium hydroxide |
| potassium (K) | potassium bicarbonate potassium carbonate potassium chloridepotassium salts of citrate acid potassium gluconate potassium lactate potassium salts of ortophoshoric acid potasium hydroxide |
| selenium (Se) | sodium selenate sodium selenite |
3. Amino acids and other nitrogeneous compenents
L-arginine and its hydrochlorides
L-cystineand its hydrochlorides
L-histidine and its hydrochlorides
L-isoleucine and its hydrochlorides
L-leucine and its hydrochlorides
L-cystein and its hydrochlorides
L-methionine
L-pheynlalanine
L-threonine
L-trptophan
L-tyrosine
L-valine
L-carnitine and its hydrochlorides
Taurine
Cystidine5’-monophosphate and its sodium salt
Uridine 5-monophosphate and its sodium salt
Adenosine 5-monophosphate and its sodium salt
Guanosine 5-monophosphate and its sodium salt
Inosine 5-monophosphate and its sodium salt
4. Others
Choline
Choline chloride
Choline citrate
Cholinebitartarat
Inosinol
ANNEX 3
AROMATIC SUBSTANCES TO BE USED IN FOLLOW-ON FORMULA
| The Name of the Substance | Maximum |
| vanilla extract | GMP |
| natural fruit extracts and flavourings | GMP |
| ethyl vanillin | 5 mg/100ml |
| vanillin | 5mg/100ml |
ANNEX 4
MICROBIOLOGICAL CHARACTERISTICS OF FOLLOW-ON FORMULA
| Characteristics | Powder type Follow-on formula |
| Total mesophyllic aerobic bacteria (cfu*/g) | 10 |
| Coliform (cfu /g) | 20 |
| E. coli (cfu/g) | should not be exist |
| Salmonella (cfu /25 g) | should not be exist |
| Bacillus cereus (cfu /g) | 102 |
| Staphylococcus aureous | should not be exist |
| Mold,yeast (cfu /g) | 102 |
| Clostridium perfringens | should not be exist |
* cfu = it is the unit that constitutes microorganism colony
Alive microorganism should not be exist in follow-on formula which is ready for consumption and made stable by sterilisation.
ANNEX 5
NOURISHMENT REFERENCE VALUES FOR INFANTS
| Vitamin A(mg) | 400 |
| Vitamin D(mg) | 10 |
| Vitamin C (mg) | 25 |
| Thiamine(mg) | 0.5 |
| Riboflavin(mg) | 0.8 |
| Niacin equivalents | 9 |
| Vitamin B6 (mg) | 0.7 |
| Pholate (mg) | 100 |
| Vitamin B12 (mg) | 0.7 |
| Calcium (mg) | 400 |
| Iron (mg) | 6 |
| Zinc (mg) | 4 |
| Iodine (mg) | 70 |
| Selenium | 10 |
| Copper (mg) | 0.4 |
ANNEX 6
AMINO ACID CONTENT OF CASEIN AND BREAST MILK PROTEIN
(g/100 g protein) |
||
| casein | 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
FOLLOW-ON İNFANT FOOD-ADDITIVES USED IN FOLLOW-ON FORMULA
| EC CODE AND THE NAME OF THE SUBSTANCE | TYPE OF FOLLOW-ON FORMULA | MAX. DOSE |
| E 304 L-Ascorbil palmitate | in all follow-on formula | 5 mg/100 ml (in ascorbic acid) |
| E 300 L-Ascorbic acid E 301 Sodium ascorbate E 302 Calcium ascorbate |
single or together |
|
| E 331 Sodium citrate E 332 Potassium citrate E 500 Sodium hydrogene carbonate E 500 Sodium carbonate E 501 Potassium hydrogene carbonate E 501 Potassium carbonate E 524 Sodium hydroxide E 525 Potassium hydroxide E 526 Calcium hydroxide |
in all follow-on formula | GMP in accordance with the limit in Article 5.2 of Annex 1 |
| E 338 Phosphoric acid | in all Follow-on formula | GMP |
| E 1412 Distarch phosphate | in soybean based sustaianble formula | 0.5 g/100 ml |
| E 1413 Phosphated distarch phosphate | in hydrolized protein and/or aminoacid based Follow-on formula |
2.5 g/100 ml |
| E 1414 Asetylled distarch phosphate E 1422 Asetylled distarch adipaet |
single or together |
The maximum doses stated are for the infant foods which are ready for consumption.