Cosmetic products

"The new regulation in the field of cosmetic products sets clear requirements for labeling, documentation and notification of information about such products. Our practice has the relevant experience and is ready to accompany the entry of cosmetic products into the Ukrainian market in accordance with the requirements of the Technical Regulations on cosmetic products," Associate Partner Lidiia Sanzharovska said.

On August 3, 2024, the Technical Regulations on cosmetic products (hereinafter referred to as the Technical Regulations) entered into force. Their purpose is to align national requirements for the placement and availability of cosmetic products on the market with the relevant European legislation. In contrast to the previous regulatory framework in this industry, the Technical Regulations establish more detailed and clear requirements for all processes related to cosmetic products, from updating the definition of such products to a list of prohibited substances.

Given the significant changes in the regulation of the cosmetics industry and the transitional period until August 3, 2026, manufacturers and distributors of cosmetic products are actively implementing measures to comply with new regulatory requirements. Our practice brings together a team of highly skilled lawyers providing a comprehensive range of services to ensure product compliance with the requirements of the Technical Regulations.

SERVICES

The main areas of our work include:

• Checking the composition of cosmetic products (we will check the composition of your cosmetic product for compliance with the requirements of clauses 37-39 of the Technical Regulations).
• Consultations on the implementation of good manufacturing practice (GMP) (we will analyze the situation, upon your request, we will accompany the certification process for compliance with the DSTU EN ISO 22716:2015 national standard).
• Preparation of a package of documents (we will review or prepare draft documents required by the Technical Regulations; we will form a single file with documentation for cosmetic products).
• Support for the assessment of cosmetic product safety (we will form Part A of the cosmetic product safety report based on the information provided by the manufacturer; we will organize the assessment of cosmetic product safety by experts who meet the requirements of the Technical Regulations (filling out Part B of the cosmetic product safety report)).
• Checking the labeling (we will verify the compliance of the cosmetic product labeling with the requirements of the Technical Regulations, legislation in the field of consumer protection and protection against unfair competition; we will provide the necessary recommendations).
• Support for notification (we will support the notification of information on cosmetic products using the Electronic Notification (Submission) Systems for Information on Cosmetic Products (Cosmetic Product Notification Portal).

EXPERT ACTIVITIES

• Full support for the introduction of over 50 cosmetic products from a European manufacturer into the Ukrainian market in compliance with the Technical Regulations.
• Participation of Lidiia Sanzharovska as an expert at the 2nd and 3rd Ukrainian Forum of Cosmetic and Disinfection Products Market Operators.
• Participation of Lidiia Sanzharovska as a speaker in meetings of the European Business Association (EBA) Regulatory Committee regarding Technical Regulations on Cosmetic Products.
• Publication of multiple articles on problematic issues of cosmetic product regulation:
  • Notification of information on cosmetic products;
  • Requirements of the Technical Regulations on cosmetic products: on compliance with GMP;
  • Draft procedure for notification (submission) of information on cosmetic products: attempt No. 2.

Disinfection products

"The introduction of new approaches to the marketing authorisation (re-authorisation) of disinfectants creates new challenges for disinfectant market operators. We have the necessary experience and knowledge for legal support of the relevant processes," Associate Partner Lidiia Sanzharovska said.

Article 48 of the Law of Ukraine On the Public Health System, which entered into force on October 1, 2022, introduced new requirements for marketing authorisation (re-authorisation) of disinfectants.

The Regulation on marketing authorization of disinfectants, approved by CMU Resolution No. 863 of August 15, 2023, outlines the procedure for marketing authorization (re-authorization) of disinfectants; defines the requirements for an application for their marketing authorization and other necessary documents, research (testing) and establishes the procedure for maintaining the State Register of Disinfectants.

Given the aforementioned regulatory changes, the demand for legal services in this area is expected to increase substantially.

SERVICES

The core areas of our work include:

• Consulting businesses on the marketing authorisation (re-authorisation) of disinfectants.
• Preparation of an application and a regulatory package of documents for the marketing authorisation (re-authorisation) of disinfectants.
• Support in applying to enterprises authorized by the Ministry of Health of Ukraine to perform activities necessary for the marketing authorisation (re-authorisation) of disinfectants.
• Support in submitting an application and a specific package of documents to SOE "Committee on Hygienic Regulation under the Ministry of Health of Ukraine" as an expert institution.
• Communication with the expert institution when reviewing the package of documents (if necessary).