Preparing for the Technical Regulation on Cosmetic Products

Cratia participated in the XVIII Specialized Conference “Beauty Tech. Innovations in Manufacturing: Raw Materials and Technologies.” Oksana Oliynyichuk, the head of the FMCG department, spoke about a new document that establishes requirements for cosmetics and the changes it will bring, as well as the practical steps that manufacturers and importers need to take to prepare for its implementation.

The Technical Regulation on cosmetic products is a new regulatory legal act that sets requirements for cosmetic products and their circulation in the Ukrainian market. Its main purpose was not only the need to harmonize technical regulation in Ukraine with European legislation and remove barriers to trade with EU countries but also the obsolescence of existing regulatory norms in the cosmetics industry and the need to improve the quality and safety of cosmetic products.

As Oksana noted, the Technical Regulation simplifies the procedure for entering the market (replacing the issuance of permits with notification) but also establishes post-market control over the product (introducing a responsible person for each cosmetic product and appointing a market surveillance authority).

This new technical regulation makes cosmetic products as safe as possible for consumers. The products will be made from verified and approved raw materials in a safe ratio of ingredients in the formulation, manufactured under safe conditions, no longer tested on animals, and have a guarantee from a responsible person in case of problems.

The Regulation was approved by the Cabinet of Ministers of Ukraine on January 20, 2021, under Decree No. 65, and will come into effect on August 3, 2024. However, products that do not meet the Regulation’s requirements may be placed on the market until August 3, 2026.

Oksana emphasized that even though there is still some time before the Regulation comes into force, it is worth starting preparation for its implementation as early as possible. All requirements are new, numerous, and each of them requires a significant amount of time for compliance. Based on the experience of introducing Ukrainian cosmetics to the EU market, when Ukrainian manufacturers need to meet similar requirements of European regulations, practice shows that the duration of some stages can be up to six months, a year, or even longer. Therefore, manufacturers and importers need to start preparing for the Regulation now. So where should they begin?

Oksana advises that the first step is to check whether their product falls under the category of “cosmetic products” and whether it is subject to this regulation. Since the regulation introduces a new term, “cosmetic product,” and establishes a clear definition based on three criteria that must be applied simultaneously (form, application area, and function), it’s essential to determine whether the product indeed qualifies as cosmetics.

Only after establishing that the product is indeed cosmetic should they proceed with the following steps:

1. Checking the product’s composition: This is a crucial step as the regulation sets strict requirements for the composition of cosmetics, introducing lists of prohibited and restricted substances, as well as permitted colorants, preservatives, and UV filters. Therefore, be prepared to potentially adjust the product’s composition.
2. Checking and aligning product labeling: The regulation establishes requirements for both mandatory information that must be provided and claims about the product’s properties and characteristics. Marketing claims that describe the product’s features must now be substantiated by relevant studies. Additionally, it’s essential that product labeling complies not only with the regulation’s requirements but also with those of other legal acts (language requirements, metrological requirements for packaged goods, etc.).
3. Organizing and conducting all necessary product tests: Oksana noted that this stage is also quite time-consuming as a series of mandatory tests need to be conducted. In the case of claims about the product on the labeling, additional tests may be required. It’s worth mentioning that the stability test alone takes three months, which needs to be considered when planning for compliance with the regulation.
4. Collecting and preparing documents for the product information file: The most critical document in the entire information file is the Cosmetic Product Safety Report (CPSR). This document is the formalized result of the safety assessment of the product for human health. The report is the document that will be of the greatest interest to the market surveillance authority. It consists of two parts: Part A and Part B.
   Part A is prepared by the responsible person (manufacturer or with their involvement) and aims to collect data necessary for the clear identification and quantitative assessment of hazard, risk, which the cosmetic product may pose to human health. Hazards may arise from raw materials, the manufacturing process, packaging, conditions of product use, product microbiology, the amounts used, toxicological profiles of ingredients, and more.
   Oksana emphasized the importance of complying with all the requirements of the regulation. Once the regulation comes into effect, cosmetic products will be subject to market surveillance and included in the “List of types of products subject to state market surveillance” in Ukraine. Non-compliance can result in significant fines imposed on each type/batch of the product.
   Part A of the Report, along with other collected documents, will be subsequently submitted for product safety assessment, which will be conducted by a qualified expert and will complete the development of the Report by preparing Part B. If the data is insufficient for a proper assessment, the safety expert may require additional tests to be conducted.
5. Decide who will be the responsible person in Ukraine: the manufacturer/importer themselves or another company/individual appointed for this purpose.
6. Additionally, manufacturers need to develop and implement proper Good Manufacturing Practice (GMP) in production. Certification of GMP is not mandated by the regulation (though voluntary certification may be pursued), and compliance is confirmed by presumption. However, to achieve this, the manufacturer must fully comply with the requirements of the national standard DSTU EN ISO 22716 during the development of GMP. Typically, as experience shows, it takes an average of 1-1.5 years for this system to be developed, implemented, and fully operational. Only after this can the manufacturer prepare the mandatory declaration stating that their production complies with GMP.

Only after fulfilling all these requirements can the product be notified before it is introduced to the market.

Oksana emphasized the importance of complying with all the regulation’s requirements because, with the enactment of the regulation, cosmetics become subject to market surveillance and will be included in the “List of types of products for which state market surveillance authorities carry out state market surveillance.” Violations are subject to significant fines imposed on each type/batch of the product.

Cratia provides services for the certification of cosmetic products in Ukraine and the EU:

• Development and implementation of Good Manufacturing Practice (GMP) in accordance with ISO 22716.
• Development of a Product Information File (PIF).
• Preparation of a Cosmetic Product Safety Report (CPSR).
• Outsourcing the responsible person service in the EU.
• Development of labeling, instructions, and promotional materials.
• Organization of laboratory testing.
• Product notification.

We have a deep understanding of Ukrainian and EU legislation and extensive experience in conducting these tasks. We can take charge of and organize the entire process, assist in compiling the required document package, and expedite the procedures.

We offer preliminary consultations free of charge. Please feel free to contact us at +38 (044) 332-42-94, 221-71-29, or email us at info@cratia.ua, or you can visit our office for a meeting.