Due to martial law, the Ukrainian government has postponed the Technical Regulations on Cosmetic Products (the UA Cosmetics Regulation) entering into force from the originally scheduled 3 August 2022 to 3 August 2024. In addition, the amendment will permit the commercialisation of cosmetics non-compliant with the UA Cosmetics Regulation before the latter date for two more years, until 3 August 2026.
Therefore, the cosmetics market remains regulated by the largely outdated State Sanitary Regulations and Product Safety Standards for the Perfumery and Cosmetic Industry as of 1999. To illustrate the difference, the old regulation lists only 412 substances prohibited for use in cosmetics, while the new UA Cosmetics Regulation lists 1,641.
Overall, the purpose of UA Cosmetics Regulation is to align Ukrainian legislation with EU Regulation No. 1223/2009 of the European Parliament and the Council on cosmetic products. It provides for a new cosmetics regulatory framework, and its implementation requires preparation both by industry and the government. Since the government failed to make several the required preparatory steps, the decision to postpone the UA Cosmetics Regulation seems to be reasonable. Additionally, the industry generally supports this decision[1].
Below we discuss the key novelties of UA Cosmetics Regulation:
- Alternative testing methods
The UA Cosmetics Regulation prohibits the circulation of products whose final composition, ingredient or combinations of ingredients underwent animal testing.
The following exceptions remain acceptable:
- if an ingredient or combination is widely used and cannot be practically replaced;
- animal testing provides for a substantiated conclusion on the lack of adverse effects on human health, where without testing reasonable doubt remains.
- Responsible person
The UA Cosmetics Regulation provides for the “responsible person” concept. Only Ukrainian individuals or Ukrainian registered legal entities can be appointed as a responsible person. Non-resident manufacturers of cosmetics produced in Ukraine not for export and re-import, can appoint a responsible person in Ukraine. For imported cosmetic products, each importer is a responsible person. Importers may also delegate the responsible person’s role to another entity or individual, as long as they are a resident of Ukraine.
Meanwhile, Ukrainian manufacturers can either carry out this role themselves or assign it with local individuals or legal entities. A distributor will be considered the responsible person if it puts a cosmetic product into circulation under its own trademark or modifies products already in circulation.
- Changes to market surveillance
Currently the Law of Ukraine on market surveillance and control over non-food products, dated 2 December 2010, defines the legal framework for the surveillance of the cosmetics market along with other non-food products. However, the UA Cosmetics Regulation includes detailed and cosmetic-specific rules, in particular related to notifications, compulsory requests from market surveillance authority, etc.
The role of the market surveillance agency will move from the State Service of Ukraine for Food Safety and Consumer Protection to the State Service of Ukraine for Medicinal Products and Drug Control.
- Distinction between a cosmetic and other products
The current definition of “cosmetic product” is quite broad and therefore covers almost any product, including cosmetics with therapeutic effects. Instead, European legislation requires a clearer distinction between cosmetics and other products. The UA Cosmetics Regulation gives a clear and comprehensive definition of cosmetic products, excluding products intended for ingestion, inhalation, injection or implantation in the human body.
- Notification procedure
The UA Cosmetics Regulation requires that before putting cosmetics into circulation, the responsible person (and in some cases also the distributor) must provide certain information clearly defined in the UA Cosmetics Regulation. The Ministry of Health must approve an appropriate procedure to clarify certain details, e.g. which authorities exactly should receive it.
The notification procedure will most likely resemble the European notification procedure through a special portal. For this purpose, a special portal must be developed and launched.
As for cosmetics containing nanomaterials, in addition to the general requirement, the responsible person must notify the appropriate authority six months before placing a product on the market. For cosmetics containing nanomaterials and placed on the market before the UA Cosmetics Regulation enters into force, the responsible person must notify the appropriate authority within six months from the date of such entry into force.
- Notification of serious undesirable effects (SUE)
If serious undesirable effects of cosmetic products are detected in Ukraine, the responsible person, distributor, end user or healthcare professional should immediately notify the market surveillance authority.
- Compliance with GMP requirements
Cosmetics must be manufactured in accordance with the Good Manufacturing Practice (GMP).
The state standard DSTU EN ISO 22716:2015 adopted in 2015 is the Ukrainian equivalent of the European GMP.
- Documentation for cosmetic products
The responsible person must ensure the availability and updating of the documentation for each cosmetic product, including:
- a description of the cosmetic product;
- a product safety report;
- a description of the method of manufacturing and declaration of compliance with GMP;
- where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product;
- data on any animal testing performed by the manufacturer.
The responsible person must keep this documentation for at least ten years from putting the cosmetic product into circulation, and make it available to the market surveillance authority.
The UA Cosmetics Regulation gives hope for a much higher quality cosmetics market after 2024. It does however require the development of additional acts, e.g. the procedure for notifying information about cosmetics and the launch of a special portal to register cosmetics. Thus, close collaboration between the Ministry of Health and the industry is essential.
[1] For example, the European Business Association made a public statement supporting the move to postpone the implementation of the UA Cosmetics Regulation (https://eba.com.ua/en/advocacy-diary/success/423579-2022-07-27-20-14/).
