Duyurular

USE OF HEALTH CLAIMS FOR FOOD AND FREQUENTLY ASKED QUESTIONS

Health Law

In the announcement of the Turkish Medicines and Medical Devices Agency (“Agency”) of the Ministry of Health (“Ministry”) dated 06/09/2024, a brief information about the use of health claims and frequently asked questions and answers about the use of health claims were published.

“Ensuring the safe and rational use of products” is an important pillar in improving the health of individuals and communities through a people-centred approach and taking necessary action on factors that threaten public health. In this context, the “health claim” is one of the first elements that comes to mind.

1.What is a health claim?

It is a statement that states, asserts or implies the relationship of any food group, food or the elements in the composition of food with human health.

2.What is the legislation on health claim?

Click here for the Law No. 1262 on Pharmaceuticals and Medicinal Preparations (Amended: 02/01/2014-6514/31-32).

Click here for the ‘Regulation on Health Claim Audit’ published in the Official Gazette dated 13/06/2023 and numbered 32220.

Click here for the ‘Regulation on the Use of Health Claim in Food and Food Supplements’ published in the Official Gazette dated 20/04/2023 and numbered 32169.

3.Which health claims are not allowed?

Statements that specifically claim to treat a disease, that health may be adversely affected if not consumed, or that refer to the amount or rate of weight loss or gain are not permitted. For example;

  • Protects against cancer
  • Solution to depression
  • End prostate
  • Slimming product, 8 to 12 kilos in 45 days
  • Removes edema
  • Cleans and regenerates the lungs

In order to create a perception of “reliability” to the public, statements stating that the product ‘can only be sold in pharmacies’ cannot be used in the sale and/or promotion of the product on the label, promotion and advertisement of the product.

4.What are the sanctions for the use of inappropriate health claims?

  • Websites and social media accounts that sell and/or promote statements contrary to the health claim legislation are submitted to the Access Providers Association with the request to block access.
  • If the advertisement is deceptive and misleading, it is reported to the Ministry of Trade. Criminal complaints are filed against those concerned and administrative fines are imposed.

5.Which product groups can use health claims?

Food and food supplements produced or imported by enterprises registered or approved by the Ministry of Agriculture and Forestry may use a health claim unless they bear the same name as human medicinal products, medical devices and food for special medical purposes.

6.Which product groups cannot use health claims?

Products other than food and food supplements and foods for special medical purposes cannot use health claims.

7.Which health claims can be used in products?

The health claims in Annex-1, Annex-2 and Annex-3 in the annexes of the Guideline are used.

8.Which health claims are not permitted in products?

Statements that suggest that health may be adversely affected if not consumed, statements referring to the amount or rate of weight loss or increase, statements that include or imply thanks, praise, advice 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 national and international institutions and organisations are strictly not permitted.

9.Is there any need to make an application for the use of health claims?

Health claims in the annexes of the Guideline may be used without an authorisation application or notification to the Agency, provided that they comply with the provisions of the Regulation and the relevant guideline.

10.Do the health claims to be used have to be the same as the statements in the annex of the Guideline?

Equivalent expressions may be used instead of the health claim expressions in the annexes of the guideline in a way that will not change and strengthen their meaning. Provided that these expressions comply with the provisions in the relevant guideline, they can be used without applying for authorisation or notification to the Agency.

11.What are the mandatory statements and warnings to be used with the health claim statement?

Health claim 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 advertisement of the product:

  • A statement indicating the importance of a healthy life with a balanced and varied diet.
  • The amount of food to be consumed and the way it should be consumed in order to achieve the declared beneficial effect.
  • Where necessary, a warning for people who should not consume the food.
  • Warning for foods that may adversely affect health if consumed in excess.

12.Can health claim statements be used in the promotion and advertisement of products covered by Provisional Article 1 of the Regulation?

No, it cannot be used. Health claim can only be included in the labelling information during the transition period.

13.What are the special conditions for foods other than food supplements to use a health claim?

At least two of the following conditions must be met in order for foods other than dietary supplements to use a health claim.

  • Sodium ratio in its composition should be maximum 100 mg/100 kcal
  • Maximum 10% of the energy it contains comes from saturated fatty acids
  • Maximum 10% of the energy it contains comes from added sugar
  • The natural calcium content should be at least 55 mg/100 kcal

14.Can images that can be interpreted as health claim be used in the labelling, promotion and advertisement of products?

In accordance with the provisions of the Regulation and the Guideline, images may be used in the labelling, promotion and advertisement of the product for which a health claim is used, provided that they are limited and related to the health claim. Such visuals should not cause concern to the consumer.

15.Can the labelling, advertising and promotion of products include a reference to the recommendation of any association, institution or doctor?

No. Statements that include or imply thanks, praise, recommendation or endorsement of national and international institutions and organisations, including the Ministry of Health, or the experience of the person whose testimony is used in relation to the products for which the health claim is used cannot be used.

16.Can a health claim be included in the product or trade mark name?

For products for which it is appropriate to use a health claim according to the provisions of the Regulation and Guidelines, the trade mark or product name may contain a health claim, provided that it is related to and limited to the health claim used. There is no need to make an application for this use, with the responsibility being with the food business operator. Expressions containing health claim cannot be used in the name or trade mark of products that do not use the health claim expressions in the annexed lists of the Guideline.

17.Can the food operator request an evaluation of a statement or image to be used in the product label, promotion, advertisement, trademark, product name, company name or logo in terms of health claim?

The food operator may request an opinion from our Agency before, during or after the approval process of the Ministry of Agriculture and Forestry.

18.Can health claim be used on company names and logos?

According to the provisions of the Regulation and Guidelines, company names and logos or label images may contain health claim on products that are suitable for the use of health claim, provided that they are related and limited to the health claim used.There is no need to apply for this use, as the responsibility lies with the food business operator. However, the names and logos of companies that do not use health claim in their products and that were established before the publication date of this Regulation may be used provided that they are approved by the Agency. The name and logo of the companies established after the publication date of the Regulation, which do not use health claims in their products, may not contain statements containing health claims.

19.Can a heart image appear on the labels of products produced for special occasions?

Only foods other than dietary supplements may have a heart image on their labels, provided that they are love-themed.

20.For dietary supplements that do not specify a serving size, how is it determined whether the product meets the health claim requirement?

Whether the claim requirement is met can be based on the daily consumption amount determined for the dietary supplement.

21.Is it possible to apply for a new health claim if a health claim statement that is not included in the annexes of the guidelines is to be used in the products?

In food and food supplements, only the health claim statements in Annex-1, Annex-2 and Annex-3 of the guideline annexes are used. The use of new health claim is not evaluated.

22.Is there a contact address for the health claim assessment unit?

For information on the use of health claim in food and food supplements, contact is provided via the e-mail address bdud.saglikbeyani@titck.gov.tr.

You can reach further information here.