Introducing a cosmetic product to the EU market is more than just an efficient supply chain and competitive pricing. For Ukrainian cosmetic manufacturers and distributors, it means facing a range of legal and documentation requirements which – although they may seem complex at first glance – serve one purpose: ensuring the safety of the end user.
The new cosmetics law in force in Ukraine since August 2024 significantly brings national standards closer to EU regulations. However, from our experience, exporting to the EU still poses many challenges – particularly in the areas of documentation, labeling, and safety assessment.
When the MSDS is not enough
We often see clients who believe that possessing a Material Safety Data Sheet (MSDS) is sufficient for introducing a cosmetic product to the EU market. This belief is especially common among first-time exporters.
The situation usually changes when an inspection occurs, followed by a list of requirements that had not been mentioned before: a complete Product Information File (PIF), safety assessment report, properly labeled product, CPNP notification, and production in compliance with GMP.
Documentation that protects the manufacturer
The foundation for introducing a cosmetic product to the EU market is the Product Information File (PIF) – technical documentation containing, among others:
- description of the product’s composition and properties,
- full documentation of raw materials used in the cosmetic product,
- test results of the product, including microbiological tests and preservation efficacy,
- details of the manufacturing process and its compliance with GMP principles,
- CPSR safety assessment report (prepared by a Safety Assessor),
- information about the responsible person within the European Union.
This is not just “paperwork.” It’s a set of information that has real importance – both for consumers and regulatory authorities.
Most common difficulties in preparing the PIF
In working with Ukrainian manufacturers, we see that the biggest challenges arise already at the data collection stage:
- ingredient identification – not everyone knows that full documentation from raw material suppliers is necessary to correctly identify ingredients and prepare the INCI list on the label,
- missing raw material documentation – especially for fragrance compositions or ingredients regulated under Regulation 1223/2009,
- insufficient quality of test results – e.g. microbiological test reports stating “microbial purity: 0”, which indicates a lack of awareness of standards,
- labeling problems – such as incorrect order of ingredients, missing responsible person information, or marketing claims that exceed the definition of a cosmetic product.
Labeling – the detail that makes the difference
Correct labeling of a cosmetic product is not just a matter of aesthetics or marketing – it is a legal obligation and a factor directly impacting consumer safety.
Packaging is the first point of contact with the consumer, but also the first element reviewed during compliance inspections.
From our experience, many companies are unaware of key rules, such as:
- the obligation to declare allergens depending on product category and formulation,
- differences in the order of ingredients above and below 1%,
- correct labeling of shelf life or PAO (open jar symbol),
- the need to indicate the responsible person in the EU (and in Ukraine – under the new law),
- the requirement to include precautions and usage conditions for certain ingredients,
- we also often see claims that should not appear on cosmetics – such as those suggesting medicinal effects, which may lead to product misclassification.
Notification in the CPNP, safety assessment report, and the role of the responsible person
Before introducing a product to the EU market, it must be notified in the Cosmetic Product Notification Portal (CPNP) and have a positive safety assessment report. This is the responsibility of the responsible person – who must be established in the EU and fulfill a formal role throughout the process.
Without this step, the product cannot be legally sold, and failure to comply may result in serious consequences – from market withdrawal to significant financial liability.
GMP standard – quality demanded by the market
Ukrainian cosmetic manufacturers increasingly declare compliance with GMP (Good Manufacturing Practice), but in practice, this is often not supported by documentation.
Meanwhile, GMP, according to ISO 22716, is a foundation of European requirements: production procedure descriptions, batch documentation, hygiene condition monitoring, and regular quality control.
Professional support – when is it worth seeking help?
Exporting to the EU is not about ticking boxes on a checklist, but about partnering with an experienced professional in the process.
At CosmetoSAFE, we support companies at various stages:
- we audit ready product documentation,
- help fill in missing elements of the PIF,
- develop safety assessment reports,
- provide advice on labeling and marketing communication,
- prepare CPNP notifications and help define the responsibilities of the responsible person.
Exporting cosmetics to the EU is not just an obligation – it’s an opportunity
The new regulations in Ukraine are the first step towards harmonizing laws with EU standards. For Ukrainian companies, this is a moment to seize – not only to meet requirements but to truly improve product quality and gain credibility with European partners.
Professional documentation and familiarity with EU rules not only protect against financial penalties – they also open doors to new markets.
If you are a cosmetics manufacturer or distributor in Ukraine and want to enter the EU markets safely – let’s talk.
We don’t work with templates. We adapt to your realities and help you build a foundation for export that really works.
