The Regulation on the Use of Health Claims in Food and Supplements (“Regulation”) Entered Into Force After Being Published in the Official Gazette on 20.04.2023

As per the Regulation;
o Nutrient : Refers to daily reference intake values for protein, carbohydrate, fat, fiber, sodium and vitamins and minerals, and substances that belong to or are elements of one of these groups,
o Other element : Refers to elements other than nutrients that have a nutritive or physiological effect, o o o Statement on reducing the risk of disease: Refers to a health claim indicating that the consumption of a food group/food/food ingredient significantly reduces the risk factor causing human disease,
o Product : Refers to food and supplements.

As per the Regulation; health claims may be used on the label, promotion or advertisement of food
and supplements unless these (a) are vague, false or misleading, (b) raise concerns about the
adequacy or reliability of other products, (c) support or encourage excessive consumption of a
particular product (d) refer to changes in body functions through written, pictorial, graphic or
symbolic representations that may cause concern.

Beneficial effect that stated through a health claim should be easily understood by the average
consumer and a health claim should be determined on the basis of the product, prepared for
consumption according to the instructions for use.

In the health claims given according to the portion, the portion sizes and/or daily intake dose of the
foods included in Annex-12 of the Turkish Food Codex Food Labelling and Consumer Information
Regulation (“Information Regulation”) should be taken into account. In addition to this, if the
consumption unit of the product is less than the portion size, the health claim must be provided in
the consumption unit of the product.

The use of equivalent expressions replacing the health claims used, by not amending their meaning
will be determined in the relevant guideline and the health claims in the annexes of this guide may
be changed, suspended or cancelled if deemed necessary, if public health concerns require to do so.
The status of products containing health claims subject to suspension or cancellation will be
evaluated on a case-by-case basis. Against the decision, it is possible to object to the
Pharmaceuticals and Medical Devices Administration of Turkey (“the Institution”) within 30
days as of the notification date. The Institution will evaluate this objection within 30 days and
resolve a final decision.

(a) Statements emphasizing the importance of a balanced and varied diet and a healthy life; (b) the
amount and style of consumption of food to achieve the indicated beneficial effect; (c) warning for
persons that should not consume the food; and (d) warning for foods whose excessive consumption
may adversely affect health, may be used provided that these are located within the label of the food
or representation or advertisement of the food.

Statements on reducing the risk of disease, the development and health of children may be used,
provided that these comply with the provisions of the Regulation and the relevant guide. Health claims regarding reducing the risk of disease must include a statement indicating that the disease
referred to in the health claim has many risk factors and that changing one of these may or may
not have a beneficial effect.

Statements (a) alleging that health may be adversely affected if it is not consumed; (b) referring to
the amount or rate of weight loss or gain; (c) including implied expressions of thanks, praise, advice
or approval associated with the experience of a person whose testimony is taken regarding the
products or with the national/international institutions and organizations cannot be used.
Health claims cannot be used in products with the same name with medicinal products for human
use, medical devices and dietary foods for special medical purpose.

Health claims, other than statements on reducing the risk of disease, child development and
health; may be statements referring to (a) effects or role of a nutrient or other element on growth,
development and functions of the body, (b) effects on psychological and behavioural functions, or
(c) slimming, weight control, reduction of feeling of hunger, increasing feelings of satiety, or
reduction of energy provided from diet. These claims may be based on (i) generally accepted
scientific evidence (“scientific evidence”) or (ii) newly developed scientific evidence or protected
registered data.

Conditions for the use of health claims in products:

o It should be demonstrated that the presence, absence or reduction of the nutrient or other
element in a product has a nutritional or physiologically beneficial effect, as set forth through
scientific evidence.
o The nutrient or other element for which the declaration is made (a) must be present in the
product in a significant amount as defined in the Information Regulation, or in cases where
this is not determined, in an amount that will provide the nutritional or physiological effect
demonstrated by scientific evidence or (b) must not be present in the product or must be
present in such a reduced amount as to provide the nutritional or physiological effect
demonstrated by scientific evidence.
o The amount of food reasonably expected to be consumed should meet the amounts indicated
in (a) above;
o The declared nutrient or other element must be in a form that can be digested by the body;
o The requirements specified in the tenth paragraph of Article 5 must be met;
o If the health claims are used based on the daily amount of the products, these should show
the declared effect in the amounts expected to be consumed normally per day.

In addition to the above conditions, at least two of the following conditions must be met in order
to insert a health claim in foods other than supplements:,

o The sodium rate in its composition should be 100 mg/100 kcal at maximum,
o Up to 10% of the energy it contains should come from saturated fatty acids,
o Up to 10% of the energy it contains should come from additional sugar, and
o Naturally, the calcium rate in its composition should be at least 55 mg/100 kcal.

Health claims should not be used in beverages containing more than 1.2% alcohol by volume and
in dietary foods for special medical purposes.

The use of a health claim for a product in accordance with the relevant legislation will not reduce
the legal and criminal liability of the food business manager.

The food business manager is responsible for; (i) the compliance of the health claims to the
Regulation and relevant guides, (ii) manufacturing the products that health claims are used comply
with the relevant legislation of the Ministry of Agriculture and Forestry and (iii) duly replying the
requests of information and document of the Institution.

Along with the above responsibilities the food business manager, is also responsible for the duly
storage of the necessary information and documentation as per the Regulation, confirmation of the
accuracy of these and results arising out of these information and documents and when necessary,
submitting these to the Institution.

Commercial trademark, the name of the product or enterprise, logo or image of labelling may
contain a health claim, provided that these are associated and limited with the health claim. For
such use, there is no need for making any kind of application, as far as the responsibility arising
from such use belongs to the food business manager. However, the names and logos of companies
that do not use a health claim in their products which were established before the publication date
of the Regulation, may be used upon the approval of the Institution.

Sanction: In case of a non-compliance to the Regulation, the Law on Pharmaceuticals and Medical
Preparations and the Law on Veterinary Services, Plant Health, Food and Feed shall apply.
Provisional article: Within the labels of the products which are manufactured before the
publication date of the Regulation and;
(a) Supplied to the market including labels containing health claims as per the abolished Turkish
Food Codex Nutrition and Health Claims Regulation (“abolished Regulation”), but not
meeting the conditions set forth under the Regulation and relevant guides, health claims may
be used until 31.12.2024.
(b) Not supplied to the market but including health claims as per the abolished Regulation,
however, not meeting the conditions set forth under the Regulation and relevant guides, may
be used until 31.12.2024, after these products are supplied to the market within three months
as of the publication date of the Regulation.