With the Regulation on the Use of Health Claims in Foods and Food Supplements ("Health Claim Regulation"), which entered into force by being published in the Official Gazette dated 20.04.2023 and numbered 32169, the main issues regarding health claims have been re-regulated.
On the same day as this Health Claim Regulation prepared by the Turkish Medicines and Medical Devices Agency ("Agency"), the Regulation on Turkish Food Codex Nutrition Claims ("Nutrition Claim Regulation"), prepared by the Ministry of Agriculture and Forestry which sets out the rules on nutrition claims, entered into force. Accordingly, health and nutrition claims are now regulated under two different regulations. It is important for the solution of problems in practice that these claims are regulated by two different regulations prepared by two different Ministries. Hence with this new Health Claim Regulation, the Agency has been designated as the authorized institution to authorize the use of health claims, and the authorization processes will now be carried out by this Agency.
Following the Health Claim Regulation, the "Guideline on the Use of Health Claims in Foods and Food Supplements" ("Guideline") was published on the website of the Agency on 26.04.2023. This article is written to review the new regulations on health claims pursuant to the Health Claim Regulation and the Guideline.
1- General Provisions
Pursuant to the definition set out in the Health Claim Regulation, a health claim is defined as "a claim that states, asserts or implies the relationship of any food group, food or food ingredients to human health". The Health Claim Regulation determines the basic principles and general provisions regarding the use of health claims in the labeling, promotion or advertising of food and food supplements. Accordingly; the use of health claims cannot be:
(i) ambiguous, inaccurate or misleading.
(ii) likely to cause doubt as to the adequacy or safety of other products.
(iii) in a manner that promotes or encourages excessive consumption of a particular product.
(iv) in a way that may cause concern to the consumer; it may not be in a way that refers to changes in bodily functions through written, pictorial, graphic or symbolic representations.
In addition, these principles are repeated in the Guideline and it is clearly regulated in the Health Claim Regulation that the provisions of the Guideline shall be followed in order to use equivalent expressions instead of the health claims expressions used in the products so as not to change and strengthen their meaning.
The Health Claim Regulation also stipulates some specific restrictions and requirements. According to this;
(i) Health claims cannot be used for products bearing the same name as medicinal products for human use, medical devices and food for special medical purposes. Where necessary, the Agency may restrict the use of health claims on products bearing the same name as medicinal products for human use, medical devices and food for special medical purposes.
(ii) The health claim shall be such that the average consumer can easily understand the beneficial effect stated in the claim.
(iii) Health claims shall be determined on the basis of the product made ready for consumption according to the instructions for use.
(iv) Health claims may be used provided that the following information is included on the product label or, in the absence of a label, in the presentation and advertising of the product:
a) A statement of the importance of a balanced and varied diet and a healthy lifestyle.
b) The amount of food to be consumed and the mode of consumption to achieve the declared beneficial effect.
c) Where necessary, a warning for people who should not consume the food.
d) A warning for foods that may adversely affect health if consumed in excess.
(v) The use of the following health claims is strictly prohibited:
a) Statements suggesting that health may be adversely affected if not consumed.
b) Statements refer to the amount or rate of weight loss or gain.
c) Statements that include or imply expressions of thanks, praise, recommendation or endorsement, or statements of thanks, praise, recommendation or approval associated with the experience of the person whose testimony is used in relation to the products for which the health claim is used, or with national and international institutions and organizations.
(vi) Health claims shall not be used on foods for special medical purposes.
(vii) Health claims relating to disease risk reduction and to the development and health of children shall be used regardless of the third paragraph of Article 7 of the Regulation on Food Labelling and Consumer Information of the Turkish Food Codex, provided that they comply with the provisions of the Health Claim Regulation and the Guideline. In addition to the other requirements in the Health Claim Regulation and Guideline, health claims relating to disease risk reduction must include a statement that the disease referred to in the health claim used in the product has multiple risk factors and that changing one of these risk factors may or may not have a beneficial effect.
(viii) Health claims, other than those in the annexes to the Guidelines relating to disease risk reduction and to the development and health of children, are those that refer to
a) The role of a nutrient or other element in the growth, development and function of the body; or
b) Psychological and behavioral functions or
c) Slimming or weight control or reducing hunger or increasing satiety or reducing dietary energy.
These claims may be based on generally accepted scientific evidence, or they may be based on newly developed scientific evidence or protected proprietary data.
It is also important to note that, the health claims in the annexes of the Guideline for the products manufactured or imported by enterprises registered or approved by the Ministry of Agriculture and Forestry and falling within the scope of the Health Claim Regulation shall be used without an application for authorization or notification to the Agency, provided that they comply with the provisions of this Regulation and the said Guideline. However, the Agency may limit the use of health claims and request information and documents from the food operator when deemed necessary for public health.
2- Responsibilities
Without prejudice to the provisions of the legislation regarding the placing on the market of products covered by the Health Claim Regulation, the use of a health claim for a product in accordance with the provisions of this Regulation and the Guideline does not reduce the legal and criminal liability of the food operator. Thus, the food operator is responsible to the Agency for the following matters:
(i) The products for which health claims are used comply with the provisions of the Regulation and the Guideline.
(ii) The content of the products for which a health claim is used is produced in accordance with the provisions of the relevant legislation of the Ministry of Agriculture and Forestry.
(iii) Responding to the issues requested by the Agency for information or documents about the products within the specified period.
Within this scope, the food operator is obliged to record and store the information and documents in accordance with the principles specified in the Health Claim Regulation and to confirm their accuracy, accepts all kinds of responsibility arising from the results of this information and documents and is obliged to submit the relevant documents to the Agency when requested.
3- Status of Existing Products
The Health Claim Regulation, which is the subject of this article, entered into force as of 20.04.2023, the date of its publication. However, pursuant to the "Provisional Article 1" added to the Health Claim Regulation, two exceptional circumstances have been defined in terms of the transition period:
(i) Pursuant to the "Provisional Article 1" added to the Health Claim Regulation, products manufactured and placed on the market before the publication date of this Regulation and for which a health claim was used in accordance with the Repealed Regulation but which do not meet the conditions specified in the Regulation and Guideline will be able to use the relevant health claim on the label until 31.12.2024.
(ii) In addition, products manufactured before the publication date of this Health Claim Regulation but not placed on the market and for which a health claims is used in accordance with the Repealed Regulation but which do not meet the conditions specified in the provisions of the Health Claim Regulation and Guideline can be placed on the market with a health claim in accordance with the Repealed Regulation on their labels within three months from the date of publication of this Regulation and the relevant health claim can be used until 31.12.2024.
With the Guideline published following the Health Claim Regulation the use of health claims is explained in a detailed manner with various examples. It is aimed to solve the problems in practice by separating health claims from nutrition claims and making detailed regulations.
You can access the Regulation in Turkish from this link and the Guideline in Turkish from this link If you wish, you can also access our article on the Nutritional Claim Regulation from this link.