News regarding cosmetic products, disinfectants, and dietary supplements in Ukraine

We share news on the regulations concerning cosmetic products, disinfectants, and dietary supplements in Ukraine.

Cosmetic products and disinfectants (biocides):
We want to bring your attention to a situation that may occur in the regulatory field in about 3.5 months. After October 1, 2023 it might become impossible to obtain the necessary permits for introducing new cosmetic products and disinfectants (biocides) into the market.

Starting from October 1, 2023, the Law of Ukraine “On Public Health System” will come into effect, replacing the current law “On Ensuring Sanitary and Epidemiological Well-Being of the Population.” The latter law currently regulates the issuance of conclusions by the State Sanitary and Epidemiological Expertise (referred to as SSE conclusions), which are necessary for introducing cosmetic products and registering disinfectants.

Cosmetic products:
Due to the war, the implementation of the Technical Regulation on cosmetic products has been postponed until August 3, 2024. During this transitional period, which extends until August 3, 2026, it will still be possible to introduce products that do not meet the Technical Regulation requirements into the market based on the existing legislation and the SSE conclusion. However, a gap may arise where SSE conclusions will no longer be issued for cosmetic products from October 1, 2023, while conformity assessment to the Technical Regulation will not be possible until it becomes effective on August 3, 2024.

Various scenarios are being considered, including extending the implementation deadline for the new Law or its certain provisions, and the adoption of new legislative acts. If you plan to introduce new cosmetic products or if your current SSE conclusion will expire before August 3, 2024, we recommend applying for an SSE conclusion now, to receive it before October 1, 2023. To ensure a smooth process, we recommend starting the procedure as early as possible.

Disinfectants (biocides):
The current registration process for disinfectants involves two paths: one based on specific activity research, safety, quality, and practical testing, and the other based on a positive SSE conclusion.

As the research procedures have not yet been approved, registration is currently only possible based on the SSE conclusion. However, with the repeal of the Law “On Ensuring Sanitary and Epidemiological Well-Being of the Population,” obtaining SSE conclusions will no longer be possible, which will hinder the registration of new disinfectants until the legislation is updated.

If you have plans to introduce new disinfectants or re-register existing ones, we recommend initiating the procedure to obtain an SSE conclusion as soon as possible.

Dietary supplements:
Please be aware that the three-year transitional periods, which allowed the import, production, and circulation of food products that did not meet the requirements of certain regulatory acts, are about to expire:

• Order of the Ministry of Health No. 1613 dated July 16, 2020, “On Approval of the Rules for Adding Vitamins, Minerals, and Certain Other Substances to Food Products.”
  Starting from October 2, 2023, the labeling (presentation of quantities indicated in the nutritional information) and composition of such products (quantitative composition should comply with permissible deviations, absence of prohibited substances) should already comply with the requirements of this order.
• Order of the Ministry of Health No. 1145 dated May 15, 2020, “On Approval of the Requirements for Claims about the Nutritional Value of Food Products and Claims about the Health Benefits of Food Products.”
  Starting from August 21, 2023, the labeling of such products (labeling and instructions) in terms of the use of different health claims and claims about nutritional value should comply with the requirements of this order.

Therefore, we recommend that you check the labeling of your dietary supplements for compliance with the requirements of these orders and make the necessary corrections if needed.

If you need support with registration of cosmetic products, disinfection products (biocides) or with dietary supplements, please contact us by e-mail info@cratia.ua or by tel +38 044 332-42-94.