How to prepare a cosmetic product for the Ukrainian market

2. Where and how to keep the PIF

• Address. The PIF must be available at the address of the responsible person stated on the product label (para. 29 of the regulation).
• Format. Electronic or paper — what matters is that the file can be promptly provided to the market surveillance authority (State Service of Ukraine on Medicines and Drugs Control) on request.
• Language. In a language acceptable to the state market surveillance authority. The safest option is Ukrainian; manufacturer documents in English should have the key parts translated.
• Retention. At least 10 years after the last batch of the product is placed on the market (para. 27).
• Up to date. The PIF and CPSR are updated when the formula, raw materials or supplier, manufacturing process or packaging change, and to reflect new data on undesirable effects.

3. What to publish on your website for consumers

The regulation requires the responsible person to ensure public access to certain product information (para. 54) — without disclosing trade secrets. The regulation does not specify how, but the most convenient and transparent option is a separate page or section for each product on the company website. What to include:

• Qualitative composition — the full ingredient list by INCI (as on the pack).
• Quantitative composition for hazardous substances — concentrations of substances classified as hazardous.
• Perfume and aromatic compositions — name and code of the composition and the supplier's identity.
• Undesirable effects data — available information on undesirable and serious undesirable effects of the product.
• Responsible person contacts — where consumers can report an adverse reaction or ask a question.

4. Notification on the Ministry of Health portal: step by step

Before placing a product on the market, the responsible person enters information about it into the Electronic Notification System for cosmetic products. The procedure is approved by Ministry of Health Order No. 2147 of 18.12.2023; the System is owned by the Ministry of Health and administered by SE "Electronic Health" (eHealth).

1. 1
   Prepare the documentsThe Safety Report (CPSR) is signed by the assessor, the PIF is compiled and the labelling artwork is approved. Data in the System must match the PIF and labelling exactly.
2. 2
   Log in with a qualified electronic signatureOpen sen-cosmetic.moz.gov.ua and log in with the qualified electronic signature of the head or an authorised employee of the responsible person.
3. 3
   Enter the responsible person's detailsName and address (as on the label) and a contact person for the product.
4. 4
   Create the product cardCategory (third level of the classifier), name, country of origin (for imports), market status (e.g. "planned for placing"), physical form, applicator type, shades. For a kit of several components — data on the product as a whole and on each component; for hair dyes — pH.
5. 5
   Enter the formula and declarationsChoose a frame formulation or enter your own formula (INCI ingredients with concentrations). Indicate nanomaterials, confirm the absence of CMR substances and Annex 2 substances, and compliance with the restrictions of Annexes 3–6.
6. 6
   Upload the labelling filesThe labelling artwork file is mandatory for any status except "planned for placing". A photo of the packaging is optional. Leaflets with mandatory information are added too. PDF, JPG, PNG formats, up to 2 MB per file.
7. 7
   Submit the notificationThe System automatically assigns an identifier to the product (and each component). It does not change with later amendments — keep it together with the PIF.

Changes after notification

• An error in the data must be corrected within 10 working days of discovery.
• Actual changes (labelling, contact person, etc.) must be entered no later than 30 working days from the date of the change, stating the reason.
• A change of the formula, ingredients or category creates a new version of the notification; the previous one is kept in the System.
• Transfer of a product to another responsible person: the new person confirms or rejects the transfer within 5 working days and certifies it within 20 calendar days (new contact person and, if needed, a new labelling file).
• Nanomaterials: products containing them are notified 6 months before being placed on the market.
• Several importers: unless one responsible person is appointed, each importer notifies the product separately.

5. Labelling of cosmetic products

What labelling is

Labelling is all mandatory information about the product on the primary packaging (bottle, tube, jar) and secondary packaging (box), as well as on an enclosed leaflet, label, tag or sticker. Requirements are set by paragraphs 47–53 of the Technical Regulation on Cosmetic Products (CMU Resolution No. 65), and the language requirements by the Law of Ukraine "On Ensuring the Functioning of the Ukrainian Language as the State Language".

Why it matters

Seven mandatory particulars (para. 47)

Information must be visible, legible and indelible.

How to format the ingredient list

• Ingredient names follow the international nomenclature INCI (para. 52).
• Order — in descending order of weight at the time of addition; ingredients below 1% may be listed in any order after the rest.
• Perfume and aromatic compositions are labelled as «parfum» (perfume) or «aroma»; individual fragrance substances required by Annex 3 (allergens) are listed in addition.
• Nanomaterials — followed by «(nano)» after the name.
• Colorants (other than hair dyes) — in any order after the other ingredients, by Colour Index (CI) number. For decorative cosmetics in several shades, "may contain" or "+/-" is allowed.

If the information does not fit on the pack

• Precautions and ingredients may be placed on an enclosed leaflet, label, tape, tag or card; the pack then carries the symbol referring to this information — a hand with an open book (para. 48, Annex 7).
• For soap, bath balls and other small products, the ingredients may be shown on a notice in close proximity to the product at the point of sale (para. 49).

Labelling language

All mandatory labelling, directions for use and warnings must be in the state language (Ukrainian). Other languages may appear alongside the Ukrainian text. For imported products a Ukrainian sticker is allowed if it contains all mandatory information and is securely applied (para. 51).

Product claims (para. 53)

Text, product names, trademarks, pictures and other signs on the pack and in advertising must not attribute characteristics or functions the product does not have. Every claim ("moisturises for 24 hours", "hypoallergenic", "for sensitive skin") must be supported by data in the PIF.

6. Common client mistakes

• "We have a European CPSR — that's enough." An EU report is a good basis, but Ukraine requires a review, adaptation to the national regulation, Ukrainian labelling and the signature of an assessor.
• Incomplete data from the manufacturer. No ingredient concentrations, raw material SDS or fragrance allergen data — and the assessment stalls.
• No challenge test for products with a water phase — without it, microbiological safety cannot be justified.
• Unsupported advertising claims — "hypoallergenic", "natural", "clinically proven" without the relevant studies.
• Labels printed before the safety assessment — and missing mandatory warnings.
• Leaving it to the last minute. Closer to 31.07.2027, queues for assessors and portal load will grow.