Committee on Sanitary and Phytosanitary Measures - Notification - Ukraine - Dietary supplements and food products containing added vitamins and minerals - Revision

NOTIFICATION

Revision

1.

Notifying Member: UKRAINE

If applicable, name of local government involved:

2.

Agency responsible: Ministry of Health of Ukraine

3.

Products covered (provide tariff item number(s) as specified in national schedules deposited with the WTO; ICS numbers should be provided in addition, where applicable): Food and dietary supplements

4.

Regions or countries likely to be affected, to the extent relevant or practicable:

[X]     All trading partners

[ ]      Specific regions or countries:

5.

Title of the notified document: Draft Order of the Ministry of Health of Ukraine "On Approval of Amendments to Certain Regulatory Acts of the Ministry of Health of Ukraine". Language(s): Ukrainian. Number of pages: 154

https://moz.gov.ua/uk/povidomlennya-pro-oprilyudnennya-doopracovanogo-proyektu-nakazu-ministerstva-ohoroni-zdorov-ya-ukrayini-pro-zatverdzhennya-zmin-do-deyakih-normativno-pravovih-aktiv-ministerstva-ohoroni-zdorov-ya-ukrayini

https://members.wto.org/crnattachments/2025/SPS/UKR/25_06827_00_x.pdf

https://members.wto.org/crnattachments/2025/SPS/UKR/25_06827_01_x.pdf

6.

Description of content: The draft Order has been developed to improve the regulatory framework governing the production and circulation of dietary supplements and food products containing added vitamins and minerals with a view to ensuring alignment with European Union legislation and harmonizing the terminology used therein with the legislation on food safety and certain quality indicators.

The draft Order proposes amendments to:

-_        Hygiene Requirements for dietary supplements, approved by the Order of the Ministry of Health of Ukraine No. 1114 of 19 December 2013;

-_        Requirements for nutrition and health claims made on food products, approved by the Order of the Ministry of Health of Ukraine No. 1145 of 15 May 2020;

-_        Rules on the addition of vitamins, minerals and certain other substances to foods, approved by the Order of the Ministry of Health of Ukraine No. 1613 of 16 July 2020 (notified in documents G/SPS/N/UKR/147, G/SPS/N/UKR/147/Add.1);

-_        Requirements for Food Flavours, Requirements for Food Additives and Requirements for Food Enzymes, approved by the Order of the Ministry of Health of Ukraine No. 45 of 8 January 2024 (notified in document G/SPS/N/UKR/200/Rev.1/Add.1).

The latter has been added compared to the previous version of the draft Order, notified in document G/SPS/N/UKR/246.

It is also established that dietary supplements, which complied with the requirements in force prior to the entry into effect of this Order, but do not comply with the requirements of the Law of Ukraine No. 4122-IX of 5 December 2024 "On Amendments to Certain Laws of Ukraine on Improving the Regulation of Production and Circulation of Food Supplements, and the Regulation of Other Issues in the Healthcare Sphere" (notified in documents G/SPS/N/UKR/224 and G/SPS/N/UKR/224/Add.1), may be imported into the customs territory of Ukraine, manufactured and/or placed and remain on the market for one year after the entry into force of this Law. Such dietary supplements may remain on the market until the date of minimum shelf life or use-by date, but no longer than three years from the date of entry into force of this Law.

The Law of Ukraine No. 4122-IX of 5 December 2024 came into force on 27 March 2025.

The draft Order is also notified under the TBT Agreement.

7.

Objective and rationale: [X] food safety, [ ] animal health, [ ] plant protection, [ ] protect humans from animal/plant pest or disease, [ ] protect territory from other damage from pests.

8.

Is there a relevant international standard? If so, identify the standard:

[ ]        Codex Alimentarius Commission (e.g. title or serial number of Codex standard or related text):

[ ]        World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic Animal Health Code, chapter number):

[ ]        International Plant Protection Convention (e.g. ISPM number):

[X]       None

Does this proposed regulation conform to the relevant international standard?

[ ] Yes   [ ] No

If no, describe, whenever possible, how and why it deviates from the international standard:

9.

Other relevant documents and language(s) in which these are available:

-_        Law of Ukraine "On Basic Principles and Requirements for Food Safety and Quality", available in English at https://zakon.rada.gov.ua/laws/show/en/771/97-%D0%B2%D1%80#Text;

-_        Law of Ukraine No. 4122-IX of 5 December 2024 "On Amendments to Certain Laws of Ukraine on Improving the Regulation of Production and Circulation of Food Supplements, and the Regulation of Other Issues in the Healthcare Sphere", available in Ukrainian at https://zakon.rada.gov.ua/laws/show/4122-20#Text, notified in documents G/SPS/N/UKR/224 and G/SPS/N/UKR/224/Add.1;

-_        Order of the Ministry of Health of Ukraine No. 1114 "On Approval of Hygienic Requirements for Dietary Supplements" of 19 December 2013, available in Ukrainian at https://zakon.rada.gov.ua/laws/show/z2231-13#Text;

-_        Order of the Ministry of Health of Ukraine No. 1145 "On Approval of the Requirements for nutrition and health claims made on food products" of 15 May 2020;

-_        Order of the Ministry of Health of Ukraine No. 1613 "On Approval of the Rules on the addition of vitamins, minerals and certain other substances to foods" of 16 July 2020, available in Ukrainian at https://zakon.rada.gov.ua/laws/show/z0891-20#Text, notified in documents G/SPS/N/UKR/147, G/SPS/N/UKR/147/Add.1;

-_        Order of the Ministry of Health of Ukraine No. 45 "On Approval of Requirements for Food Flavours, Requirements for Food Additives and Requirements for Food Enzymes" on 8 January 2024, available in Ukrainian at https://zakon.rada.gov.ua/laws/show/z0119-24#Text, notified in document G/SPS/N/UKR/200/Rev.1/Add.1.

10.

Proposed date of adoption (dd/mm/yy): To be determined.

Proposed date of publication (dd/mm/yy): To be determined.

11.

Proposed date of entry into force: [ ] Six months from date of publication, and/or (dd/mm/yy): This Order will enter into force on the date of its official publication.

[ ]      Trade facilitating measure

12.

Final date for comments: [X] Sixty days from the date of circulation of the notification and/or (dd/mm/yy): 8 December 2025

Agency or authority designated to handle comments: [X] National Notification Authority, [X] National Enquiry Point. Address, fax number and e-mail address (if available) of other body:

Ministry of Economу, Environment and Agriculture of Ukraine

Department for Trade Agreements

12/2 Hrushevskoho Str.

Kyiv 01008

Tel: +(38 044) 596 6839

E-mail: ep@me.gov.ua

Website: https://www.me.gov.ua

13.

Text(s) available from: [X] National Notification Authority, [X] National Enquiry Point. Address, fax number and e-mail address (if available) of other body:

Ministry of Economу, Environment and Agriculture of Ukraine

Department for Trade Agreements

12/2 Hrushevskoho Str.

Kyiv 01008

Tel: +(38 044) 596 6839

E-mail: ep@me.gov.ua

Website: https://www.me.gov.ua