According to the Cabinet of Ministers Resolution No. 833 dated July 26, 2022, the Technical Regulation on Cosmetic Products (TRCP) will come into force on August 3, 2024. Simultaneously, as of October 1, 2023, sanitary and epidemiological conclusions / SES conclusions are canceled and not issued, as the Law of Ukraine "On the Public Health System" has entered into force, revoking the Law of Ukraine "On Ensuring Sanitary and Epidemiological Well-being of the Population," which provided for state sanitary and epidemiological expertise of products.
Given that the principles of introducing non-food products into circulation in Ukraine and ensuring their safety are defined by the laws of Ukraine "On the Public Health System," "On the General Safety of Non-Food Products," and "On State Market Surveillance and Control of Non-Food Products," manufacturers and importers of cosmetics need to prove safety based on these laws until the TRCP comes into effect.
What do manufacturers and importers need to do today to stay in the cosmetics market or avoid entering the gray zone when the technical regulation on cosmetic products comes into force?
Let's highlight 3 crucial steps to ensure compliance with the technical regulations:
Develop and implement a management system for the production of cosmetic products that complies with the requirements of the standard DSTU EN ISO 22716:2015 Cosmetics. Good Manufacturing Practice (GMP).
Ensure the cosmetic product undergoes safety assessment tests and compile a safety report for the cosmetic product.
Complete notification (submission) of information about cosmetic products on the relevant electronic portal of the Ministry of Health, providing data on cosmetic products.
Now, what awaits manufacturers and importers at each step?
Development and Implementation of the Management System for Manufacturers: The development and implementation of a system for manufacturers may take no less than 6-12 months. If it was previously said that implementing and maintaining GMP is quite an expensive endeavor, one should not relax because much new and costly work lies ahead.
Safety Assessment and Compilation of Safety Report: Safety assessment and compiling a safety report are new for domestic manufacturers. The safety assessment should include data on the physicochemical characteristics and stability of the cosmetic product, microbiological quality and preservation testing, control of impurities, information on the cleanliness and stability of packaging materials, determination of the purity of substances and mixtures, possible impact of ingredients contained in the cosmetic product on important toxicological indicators, and a toxicological profile of substances. The manufacturer needs to ensure not only the availability of all documentation for ingredients and components but also conduct additional tests that prove the safety of the product.
Unfortunately, there is a lack of the necessary number of laboratories in Ukraine that can provide the required tests for all manufacturers. Information about laboratories in Ukraine may change over time, and we recommend checking the current possibilities in each region. We utilize the capabilities of both EU and domestic laboratories. When conducting tests in the EU, you provide an opportunity to prepare your products for registration in the European Union and subsequently export if necessary.
However, it should be noted that the safety assessment of cosmetic products and the preparation of a safety report are carried out by an expert - a person who has obtained higher education in the specialty "222 Medicine" or "226 Pharmacy, Industrial Pharmacy" at the second (master's) level of higher education or other higher education recognized as equivalent by the Ministry of Education and Science. That is, if a technologist with an education in chemistry or another different from the ones mentioned above is working in production, the manufacturer must ensure the presence of personnel with the necessary qualifications.
It is important to pay attention to the prohibition on the use of cosmetic products containing substances classified as CMR substances category 2, as well as the features of cosmetic products containing nanomaterials, and restrictions on testing products on animals. Notification of products containing CMR substances will be prohibited.
It is also necessary to pay attention to the appendices to the Technical Regulation on cosmetic products to check the products for:
The presence of substances prohibited for use in cosmetic products according to the list (1641 substances) in Appendix 2;
Permitted substances for use in cosmetic products taking into account the established restrictions according to the list in Appendix 3 (312 substances);
The allowed list of dyes that can be used in cosmetic products according to Appendix 4 (153 names);
The list of preservatives allowed for use in cosmetic products according to Appendix 5 (60 names);
The list of UV filters allowed for use in cosmetic products in Appendix 6 (31 names);
Symbols used on packaging according to Appendix 7.
Thus, by checking for substances, manufacturers should make the necessary changes to the formulations if needed.
Documentation for cosmetic products should, if necessary, be updated and include the following information:
Description of the cosmetic product, allowing unambiguously establishing that the documentation relates to the considered cosmetic product;
Safety report for the cosmetic product;
Description of production methods and a statement of compliance of the production of cosmetic products with good manufacturing practices;
Confirmation of the declared effectiveness of the cosmetic product, where justified by the nature of the impact of the cosmetic product;
Information on any animal testing conducted by the manufacturer or authorized persons of the manufacturer, or suppliers related to the development or safety assessment of cosmetic products or their ingredients, including any animal testing conducted to comply with legislative or regulatory requirements of other countries.
In case of introducing cosmetic products to the market, the responsible person must keep the documentation for this product for the next ten years from the date of introduction into circulation of the last batch of this product.
When all the necessary documents are available, the authorized person has the right to start the notification of the product on the electronic portal, which is under development. Currently, the testing of the electronic notification system is underway.
For the introduction of cosmetic products to the market, a "responsible person" must be determined. For cosmetic products produced on the customs territory of Ukraine and not subsequently exported or re-imported into Ukraine, the responsible person is the manufacturer - a resident of Ukraine. For imported cosmetic products, each importer is the responsible person for the cosmetic products it introduces into circulation. In this case, the importer may designate, based on written authorization, a physical or legal person - a resident of Ukraine, provided that the latter gives their written consent to this.
That is, in the case when several different importers import the same product into Ukraine, each importer must notify the product. In the case when a foreign company has several importers in Ukraine and there is a likelihood of their change in the process, one option may be to issue a power of attorney to the responsible person for the cosmetic product. Find out about other options for optimizing costs for registration and conformity assessment when working with several importers.
Notification requires detailed information about the product, namely:
Determination of the type of product - single or multi-component;
Trade name/brand and product name;
Possibility of use for children under 3 years old;
Country of origin;
Graphic file of labeling (prepare a file up to 2 Mb, File format (pdf, jpg, png, jpeg);
Photo of the packaging sample (prepare a file up to 2 Mb, File format (pdf, jpg, png, jpeg);
Information about the presence of CMR substances and nanomaterials;
Names of shades and the need to wash off the cosmetic product;
Determination of methods of application (epidermal, oral, inhalation);
Data on the category of products by purpose and composition (names of ingredients, CAS/EC number of ingredients, concentration in %);
Category of products by purpose.
A mandatory requirement is the registration of the user with an EDS (qualified electronic signature) by the head of the enterprise, the responsible person, who can provide certain authorizations for the performance of certain roles in the system to his employees or other persons who must also have an EDS for further product registration in the system.
Understanding the basic steps to meet the requirements of the technical regulation on cosmetic products, you can already assess the time and costs that will need to be invested in the respective processes.
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Now it becomes clear what will be happening and what to prepare for, but the question remains: "How to confirm the conformity of the products until the technical regulation comes into effect?"
Let's delve into the three primary scenarios for cosmetic production and importation:
Domestic Manufacturer in Ukraine: Adherence to state sanitary rules and safety norms (SanPiN) is crucial.
With the nullification of SES conclusions, the focus shifts to the hope of bridging any gaps.
Future notification plans demand preparation for TRCP compliance, including the implementation of GMP, updated product testing, safety reports, and eventual notification.
Foreign Manufacturer with EU Facilities and EU Notification:
Compliance with the Law on General Safety of Non-Food Products aligns with EU standards.
Gathering safety reports, test results, and GMP standard implementation is key.
Collaboration with a local specialist ensures document verification and paves the way for notification.
Foreign Manufacturer with Non-EU Facilities:
A parallel process to domestic manufacturers, necessitating safety tests, reports, and alignment with future TRCP requirements.
Present challenges stem from the limited availability of testing laboratories in Ukraine.
In the interim period before TRCP enforcement, securing a voluntary conformity certificate is recommended. While issuance involves safety confirmation through sample testing, it serves as a testament to product safety and compliance with regulatory standards.
The certificate becomes a valuable asset for market presence, retail network distribution, and participation in tenders where such documentation is mandated. Share your challenges in ensuring safety in production or during imports.
Addressing Common Concerns:
Compliance Confirmation Until TRCP Enactment:
For domestic and foreign entities, a proactive approach involves system development compliant with DSTU EN ISO 22716:2015 (GMP).
Rigorous safety assessments, report compilation, and product notification ensure a seamless transition.
Document Expertise and Preparation:
ETS Certification offers document expertise and assists in the preparation of necessary documents for cosmetic product notification, including extract acquisition.
Ensuring Market Access:
Early engagement with regulatory changes positions manufacturers and importers for a smooth transition.
Transparent collaboration with regulatory bodies facilitates compliance.
Conclusion: The evolving landscape requires a nuanced approach to regulatory compliance.
ETS Certification drawing from experience in product registration under EU regulations, stands ready to provide consultations and support in preparing for TRCP compliance and subsequent notification.
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