T.C.
TARIM ve KÖYÝÞLERÝ BAKANLIÐI
Koruma ve Kontrol Genel Müdürlüğü
Communiqué on Dietary Foods for Special Medical Purpose 
Authorization Law: Turkish Food Codex
The Official Gazette: 24.12.2001-24620
Communication No : 2001/42
The Official Gazette:31.08.2003-25215
Objective
Article 1- The objective of this Communiqué is to determine the composition and labelling conditions of dietary foods for special medical purpose to ensure production, preparation, preservation, storage, transportation and marketing of these products in proper techniques and under hygienic conditions
Scope
Article 2- The provisions of this Communiqué cover the foods that are prepared to meet the nutritional requirements of the persons who are affected by disease, disorder or medical condition or who have nutritional disorders for above reasons, and that require to be used under medical supervision.
Legal basis
Article 3- This Communiqué has been prepared in accordance with the “Turkish Food Codex Regulation” published in Official Gazette, dated 16/11/1997, reiterated No. 23172.
Definitions
Article 4- For the purpose of this Communiqué;
a) Infants; means group of age between 0-12 months,
b) Dietary foods for special medical purpose; means the foods that are specially processed or formulated and intended for the dietary management of patients and that require to be used under medical supervision. These foods have been prepared for the patients who have limited, impaired or disturbed capacity to take in, digest, absorb, metabolise or to excrete ordinary foodstuffs or certain nutrients or metabolites which exist in these foodstuffs, or for the persons whose dietary management can not be achieved only by modification of normal diet or by other foods or a combination of the two.
Product specifications
Article 5- The specifications of dietary foods for special medical purposes that are included in the scope of this Communiqué are given here below:
a) The formulation of dietary foods for special medical purposes should based on internationally valid medical and nutrition principles, when used in accordance with the manufacturer’s instructions, shall be safe, benefical and effective in meeting the particular nutritional requirements of the people whom they are intended, as demonstrated by generally accepted scientific data.
b) Dietary foods for special medical purpose should comply with the compositional criteria given in Annex-1.
c) Dietary foods for special medical purpose are classified under 3 groups:
i) Nutritionally complete foods with a standard nutrient formulation that can solely constitute a source of nutrition, when used in accordance with the manufacturer’s instructions,
ii) Nutritionally complete foods with a nutrient-adopted formulation spesific for disease, disorder or medical conditions that can solely constitute a source of nutrition, when used in accordance with the manufacturer’s instructions,
iii) Nutritionally incomplete foods that are not suitable to be used as sole source of nutrition, that have standard formula or nutrient-adopted formulation specific for a disease, disorder or medical condition,
The foods indicated in (i) and (ii) can be used as a supplement to the patients diet or as partial replacement foods.
Additives
Article 6- Additives used in the products that are included in the scope of this Communiqué must comply with the chapter “Additives” of Turkish Food Codex Regulation.
Flavourings
Article 7- The flavourings used in the products that are included in the scope of this Communiqué must comply with the chapter “ Flavourings” of Turkish Food Codex Regulation.
Contaminants
Article 8- The products that are included in the scope of this Communiqué must comply with the chapter “Contaminants” of Turkish Food Codex Regulation.
Hygiene
Article 9- The products that are included in the scope of this Communiqué must comply with the chapter “Food Hygiene” of Turkish Food Codex Regulation.
Packing and labeling-marking
Article 10- In addition to the requirements specified in chapter “Packing and labeling-marking” of Turkish Food Codex Regulation, the following expressions should also be included on the label:
a) In each 100 g or 100 ml of the product sold as ready to consume, or in each 100 g or 100 ml of the product ready for use in accordance with manufacturer’s instructions, energy value is given as kJ or kcal and protein, carbohydrate and fat content given numerically. This information can also be provided from the amount of portion given with the label or total number of portion of the product in the package.
b) As indicated in Annex-1, average amount of each mineral and vitamin in the product are given numerically for each 100 g or 100 ml of the product ready to consume or for each 100 g or 100 mL of the product ready to use in accordance with the manufacturer’s instructions. This information can also be provided from the amount of portion given with the label or total number of portion of the product in the package.
c) In order to be able to use the product according to the requirements, especially protein, carbohydrate and fatty contents and/or other nutrients as well as their components should be declared numerically for each 100 g or 100 ml of the product ready to consume, or for each 100 g or 100 ml of the product ready to use in accordance with the manufacturer’s instructions. This information can also be provided at the same time from the amount of portion given with the label or total number of portion of the product in the package.
d) information on the osmolality or the osmolarity of the product should be given when required
e) Information on the origin and nature of protein and/or protein hydrolysates contained in the product should be given.
f) The product is presented to the market under the name “Dietary Foods for Special Medical Purpose”.
g) the following additional statements starting with “important notice” or an equivalent notice should also be placed on the labels:
- product must be used under medical supervision,
- product is suitable or not to use as a sole source of nourishment,
- product is intended for a specific group of age, when required,
- product poses health hazard when consumed by the persons who do not have the diseases, disorders or medical conditions
h) Labeling should also include the following statements:
- Diseases, disorders or medical condition for the intended product should be written in the blank space of: “This is for dietary management of ..............” statement
- Where appropriate; a warning involving the adequate precautions and contra-indications of the product,
- The definition of specifications that make the product special in use such as increase, decrease, elimination or modification of nutrients and/or distinctive properties and prescription thereof,
- A warning, as required, indicating if the product is not proper for parenteral use,
- Labeling should involve the instructions related with the appropriate preparation, use and correct storage of the product after opening the package.
Transportation and storage
Article 11- Transportation and storage of dietary foods for special medical purpose should comply with the chapter “Transportation and Storage of Foods” of Turkish Food Codex Regulation.
Sampling and Methods of Analysis
Article 12- The rules in the chapter “Sampling and Analysis Methods” of Turkish Food Codex Regulation should be obeyed during sampling from the production line and storage of dietary foods for special medical purpose. The sample taken should be analyzed according to internationally recognized methods.
Registration and Inspection
Article 13- The establishments producing and selling dietary foods for special medical purpose should comply with the provisions of this Communiqué during registration, permission, importation, control and inspection. The enterprises that do not comply with these provisions are subject to legal procedure according to the provisions of the Decree Law No: 560, dated 24/06/1995, on Production, Consumption and Inspection of Foodstuffs.
Inspection
Article 14- The provisions of this Communiqué are inspected by the Ministry of Health, and Ministries of Agriculture and Rural Affairs according to the provisions of the Decree Law No: 560, dated 24/06/1995, on Production, Consumption and Inspection of Foodstuffs.
Compliance with European Union
Article 15- This Communiqué has been prepared within the framework in compliance with European Union considering the Commission Directive 1999/21/EC for “Dietary Foods for Special Medical Purpose”.
Provisional Article-1 Presently active establishments producing and selling the products in the scope of this Communiqué are obliged to obey the provisions of this Communiqué within 1 year.
Enforcement
Article 16- This Communiqué enters into force on the date of publication.
Execution
Article 17- The provisions of this Communiqué are executed by the Minister of Health and the Minister of Agriculture and Rural Affairs.
ANNEX-1
Basic Composition of Dietary Foods for Special Medical Purpose
The following properties are intended for the products either ready to consume or made ready to reuse in accordance with manufacturer’s instructions.
1. The products specified in the paragraph c(i) of Article 5 of this Communiqué and intended to be used specifically for infants, should contain the vitamins and minerals listed in Table 1.
2. he products specified the paragraph c(ii) of Article 5 of this Communiqué and intended to be used specifically for infants, should contain the vitamins and minerals listed in Table 1 in accordance with the modifications to be made on one or more of these nutrients in as much as required for the use of product.
3. Maximum levels of vitamin and mineral substance presented in products specified at paragraph c(iii) of Article 5 of this Communiqué and intended to be used specifically for infants, should not exceed the values given in Table 1 in accordance with the modifications to be made on one or more of these nutrients in as much as required for the use of product.
4. If it is not on the contrary to the requirements dictated by the intended use, foods for special medical purpose that are intended to be consumed specifically by infants, depending on the situation, should comply with the provisions of “Communiqué of Infant Foods-Infant Formulaetions” published in the Official Gazette dated 28/08/1998 and numbered 23447, and of the “Communiqué of Follow-on Foods-Follow-on Formulaetions” published in Official Gazette dated 16/08/2000 and numbered 24142.
5. The products other than those specified in the pragraph c(i) of Article 5 of this Communiqué and intended to be used specifically for infants, should contain the vitamins and minerals listed in Table 2.
6. The products other than those specified in the paragraph c(ii) of Article 5 of this Communiqué and intended to be used specifically for infants, should contain the vitamins and minerals listed in Table 2 in accordance with the modifications to be made on one or more of these nutrients according to the designed use of the product.
7. Maximum levels of vitamin and mineral substance presented in products other than those specified at paragraph c(iii) of Article 5 of this Communiqué and intended to be used specifically for infants, should not exceed the values given in Table 2 in accordance with the modifications required on one or more of these nutrients according to the designed use of the product.
Table 1: Values for vitamin, mineral and trace element in nutritionally complete foods intended for use by infants
Vitamins
| Per 100 kJ | Per 100kcal | |||
| Minimum | Maximum | Minimum | Maximum | |
| Vitamin A (µg, RE) | 14 | 43 | 60 | 180 |
| Vitamin D (µg) | 0.25 | 0.75 | 1 | 3 |
| Vitamin K (µg) | 1 | 5 | 4 | 20 |
| Vitamin C (mg) | 1.9 | 6 | 8 | 25 |
| Thiamin (mg) | 0.01 | 0.075 | 0.04 | 0.3 |
| Riboflavin (mg) | 0.014 | 0.1 | 0.06 | 0.45 |
| Vitamin B6 (mg) | 0.009 | 0.075 | 0.035 | 0.3 |
| Niacin (mg NE) | 0.2 | 0.75 | 0.8 | 3 |
| Folic acid (µg) | 1 | 6 | 4 | 25 |
| Vitamin B12 (µg) | 0.025 | 0.12 | 0.1 | 0.5 |
| Pantolenic acid (mg) | 0.07 | 0.5 | 0.3 | 2 |
| Biotin (µg) | 0.4 | 5 | 1.5 | 20 |
| Vitamin E (mg a-TE) | 0.5/g poly unsaturated fatty acids. Expressed as linoleik acid but in no case less than 0.1 mg per 100 kJ available | 0.75 | 0.5/g poly unsaturated fatty acids. Expressed as linoleic acid but in no case less than 0.5 mg per 100 kcal available | 3 |
Minerals
| Per 100 kJ | Per 100kcal | |||
| Minimum | Maximum | Minimum | Maximum | |
| Sodium (mg) | 5 | 14 | 20 | 60 |
| Chlorine (mg) | 12 | 29 | 50 | 125 |
| Potassium (mg) | 15 | 35 | 60 | 145 |
| Calcium (mg) | 12 | 60 | 50 | 250 |
| Phosphor (mg)1 | 6 | 22 | 25 | 90 |
| Magnesium (mg) | 1.2 | 3.6 | 5 | 15 |
| Iron (mg) | 0.12 | 0.5 | 0.5 | 2 |
| Zinc (mg) | 0.12 | 0.6 | 0.5 | 2.4 |
| Copper (µg) | 4.8 | 29 | 20 | 120 |
| Iodine (µg) | 1.2 | 8.4 | 5 | 35 |
| Selenium (µg) | 0.25 | 0.7 | 1 | 3 |
| Manganese (mg) | 0.012 | 0.05 | 0.05 | 0.2 |
| Chrome (µg) | - | 2.5 | - | 10 |
| Molybdenum (µg) | - | 2.5 | - | 10 |
| Fluor (mg) | - | 0.05 | - | 0.2 |
1 Calcium/Phosphor ratio should not be less than 1.2 and more than 2.0
Table 2: Values for vitamin, mineral and trace element in nutritionally complete other than those that are intended for use by infants
Vitamins
| Per 100 kJ | Per 100kcal | |||
| Minimum | Maximum | Minimum | Maximum | |
| Vitamin A (µg, RE) | 8.4 | 43 | 35 | 180 |
| Vitamin D (µg) | 0.12 | 0.65/0.751 | 0.5 | 2.5/31 |
| Vitamin K (µg) | 0.85 | 5 | 3.5 | 20 |
| Vitamin C (mg) | 0.54 | 5.25 | 2.25 | 22 |
| Thiamin (mg) | 0.015 | 0.12 | 0.06 | 0.5 |
| Riboflavin (mg) | 0.02 | 0.12 | 0.08 | 0.5 |
| Vitamin B6 (mg) | 0.02 | 0.12 | 0.08 | 0.5 |
| Niacin (mg NE) | 0.22 | 0.75 | 0.9 | 3 |
| Folic acid (µg) | 2.5 | 12.5 | 10 | 50 |
| Vitamin B12 (µg) | 0.017 | 0.17 | 0.07 | 0.7 |
| Pantolenic acid (mg) | 0.035 | 0.35 | 0.15 | 1.5 |
| Biotin (µg) | 0.18 | 1.8 | 0.75 | 7.5 |
| Vitamin E (mg a-TE) | 0.5/g poly unsaturated fatty acids. Expressed as linoleic acid but in no case less than 0.1 mg per 100 kJ available | 0.75 | 0.5/g poly unsaturated fatty acids. Expressed as linoleic acid but in no case less than 0.1 mg per 100 kJ available | 3 |
1In the products intended for children of 1-10 ages
Minerals
| Per 100 kJ | Per 100kcal | |||
| Minimum | Maximum | Minimum | Maximum | |
| Sodium (mg) | 7.2 | 42 | 30 | 175 |
| Chlorine (mg) | 7.2 | 42 | 30 | 175 |
| Potassium (mg) | 19 | 70 | 80 | 295 |
| Calcium (mg) | 8.4/121 | 42/601 | 35/501 | 175/2501 |
| Phosphor (mg)1 | 7.2 | 19 | 30 | 80 |
| Magnesium (mg) | 1.8 | 6 | 7.5 | 25 |
| Iron (mg) | 0.12 | 0.3 | 0.5 | 2 |
| Zinc (mg) | 0.12 | 0.36 | 0.5 | 1.5 |
| Copper (µg) | 15 | 125 | 60 | 500 |
| Iodine (µg) | 1.55 | 8.4 | 6.5 | 35 |
| Selenium (µg) | 0.6 | 2.5 | 2.5 | 10 |
| Manganese (mg) | 0.012 | 0.12 | 0.05 | 0.5 |
| Chrome (µg) | 0.3 | 3.6 | 1.25 | 15 |
| Molybdenum (µg) | 0.72 | 4.3 | 3.5 | 18 |
| Fluor (mg) | - | 0.05 | - | 0.2 |
1In the products intended for children of 1-10 ages
RE: Transretinol equivalent
NE: Niacin equivalent = mg nicotinic acid + mg tripiofase/60
a-TE: a-locopferol equivalent
Official Gazette: 31.08.2003 – No. 25215
Communiqué on the Amendment of Turkish Food Codex Communiqué on Dietary Foods for Special Medical Purpose
(Communiqué No: 2003/30)
Article 1 – Article 7 of Annex 1 under the title “The Basic Composition of the Dietary Foods for Special Medical Purpose” in the Turkish Food Codex Communiqué on Dietary Foods for Special Medical Purpose published in the Official Gazette dated 24.12.2001 and no. 24620 has been amended in the following way.
“7 - The maximum levels of vitamins and minerals which are present in the products described in paragraph c (iii) of Article 5 of this Communiqué except those intended for use exclusively on the babies, must not be over the values determined in Table 2. Depending on the purpose of the product use, necessary changes on any one or several of these foodstuff may be permitted by the approval of the related commission.”
Article 2 – Article 6 with title “ Special Provisions” has been added to the same Communiqué and the other articles are put in succession accordingly.
“Special Provisions”
Article 6 – If the maximum levels of vitamins and minerals which are present in the products described in paragraph c (iii) of Article 5 of this Communiqué except those intended for use exclusively on the infants, exceed the values determined in Table 2, these products shall be assessed by the “Enteral Food Products Assessment Commission” to be formed by the Ministry of Health.”
Enforcement
Article 3 – This Communiqué enters into force on the date of publication.
Execution
Article 4- The provisions of this Communiqué are executed by the Minister of Health and the Minister of Agriculture and Rural Affairs.