Cosmetic regulatory news

A European CPSR for the Ukrainian market: why the report alone is not enough

Importers often receive a ready-made European CPSR from the manufacturer and want to use it in Ukraine. It is a good basis: the report structure is the same, since Ukraine's Technical Regulation is built on Regulation (EC) No 1223/2009. But the report is not accepted automatically — it must be checked against Ukrainian requirements and for whether it actually proves the safety of this particular product.

Three levels of review

10 common gaps found in reports

1. 1
   Not the whole formula is assessedOnly actives are considered, while preservatives and stabilisers in extracts and antioxidants are neither assessed nor reflected in the INCI list.
2. 2
   Stability without methodOnly summary charts — no test conditions (temperature, stress tests) and no justification of shelf life or PAO.
3. 3
   Generic packaging descriptionNo material composition, packaging supplier data or assessment of contact with the product.
4. 4
   Migration from packaging not assessedMissing or superficial assessment of substances migrating from the packaging into the product.
5. 5
   Microbiology "on paper" onlyPurity is supported only by the manufacturer's specification, without independent laboratory reports.
6. 6
   Flawed challenge testNo reference to ISO 11930, no criterion (A or B) stated, or no laboratory conclusion.
7. 7
   Averaged exposureScenarios do not reflect real use: application area, frequency, surface area.
8. 8
   Questionable toxicological dataInflated or irrelevant NOAELs, with no references to SCCS, ECHA or CIR.
9. 9
   No approach for "difficult" ingredientsWhere a NOAEL or MoS cannot be determined, there is no explanation of how safety is demonstrated.
10. 10
    Children's products treated as adult onesSED and MoS calculated without accounting for age, body weight and children's use patterns.

What to request from the manufacturer right away

• The full formula with concentrations of all components, including preservatives in raw materials
• Stability reports with methodology and justification of shelf life / PAO
• Packaging specification and compatibility and migration data
• Microbiology and challenge test (ISO 11930) reports from an accredited laboratory
• Raw material SDS, IFRA certificate and fragrance allergen data

Depending on the review, the existing report can be used as is, supplemented with documents from the manufacturer, refined in its calculations, or complemented by an additional assessment. CPSR quality is defined by how well the conclusion is justified, not by the number of pages — and this applies to any report, whatever country it was prepared in.

There is still time until 31.07.2027 — but less than it seems: realistic preparation timelines

Postponing the application date of the Technical Regulation does not cancel any requirement. From 31 July 2027, cosmetics placed on the market without notification on the Ministry of Health portal will be considered non-compliant. The authority may apply fines and restrictive measures, and according to lawyers, sanctions apply to each product item separately.

How long it really takes to prepare one product:

1. 1
   Document and labelling audit1–2 weeks

   I check which data the manufacturer has and what is missing: formula with concentrations, raw material SDS, IFRA, stability, microbiology. The timing depends on how quickly the manufacturer responds.
2. 2
   Laboratory testing (if not available)from 4 weeks

   The preservative efficacy challenge test alone takes at least 28 days (ISO 11930); stability studies may take months.
3. 3
   Cosmetic Product Safety Report (CPSR)7–14 working days

   After receiving the complete document package — depending on formula complexity and available laboratory data.
4. 4
   Labelling and printing1–4 weeks

   Artwork approval taking into account CPSR warnings, printing of packaging or Ukrainian stickers.
5. 5
   Notification on the Ministry of Health portala few working days

   Entering data, the formula and labelling artwork into the System for each product.

Total: from a few weeks (if all laboratory data is available) to 2–3 months or more per product if testing is needed. For a range of dozens of items — correspondingly longer.

• The PIF is not uploaded to the notification system, but without it and a signed CPSR the notification has no legal basis: the documentation must be provided to the authority on request.
• In addition to the product description, CPSR, manufacturing description with GMP confirmation and proof of claims, the PIF also includes data on undesirable effects after placing on the market — it must be collected and kept up to date.

UA CPSR vs EU CPSR: what they share and what needs extra work

Ukraine's Technical Regulation on Cosmetic Products (CMU Resolution No. 65) is based on Regulation (EC) No 1223/2009. So the structure of the safety report in Ukraine and the EU is the same — and a well-prepared Ukrainian CPSR is a solid basis for entering the EU market. But a report cannot simply be "transferred": legal requirements and how current the substance lists are differ.

Ukrainian product → EU market: what needs work

• Appoint an EU Responsible Person and notify the product in CPNP.
• Check the composition against the current EU Annexes, including Omnibus VII, Omnibus VIII and the extended allergen list (see the next article).
• Make sure exposure (SED) and margin of safety (MoS) are calculated for every ingredient according to the current SCCS Notes of Guidance — this is checked closely in the EU.
• Signature of an assessor with EU-recognised qualifications. A Ukrainian assessor signs the Ukrainian report; for the EU you usually need to work with an EU safety assessor, who can build on the existing dossier.
• Translate the PIF and labelling into the language of the country of sale.

EU product → Ukrainian market: what needs work

• Review the EU CPSR for completeness and compliance with the Ukrainian regulation.
• Issue the report signed by a Ukrainian safety assessor with appropriate qualifications.
• Appoint a responsible person in Ukraine and notify the product on the Ministry of Health portal.
• Prepare labelling in Ukrainian (e.g. a sticker) with the details of the Ukrainian responsible person.

EU changes 2025–2026: TPO ban, Omnibus VIII and 81 allergens on labels

The EU Cosmetics Regulation is updated regularly. Here are three changes that already apply or are coming into force — worth considering both for export and for the Ukrainian market.

1. Omnibus VII — TPO ban (Regulation (EU) 2025/877, from 1 September 2025)

Trimethylbenzoyl diphenylphosphine oxide (TPO) — a photoinitiator in gel and hybrid nail polishes — is classified as CMR 1B. From 1 September 2025 it is banned in all cosmetic products in the EU, with no transition period for remaining stock.

2. Omnibus VIII — new CMR restrictions (Regulation (EU) 2026/78, from 1 May 2026)

• Banned: silver (bulk and nano form); perborate derivatives are regulated as one group.
• Silver powder (micro-sized) is allowed only in toothpastes and mouthwashes — up to 0.05%.
• Hexyl salicylate is restricted by product type, with specific conditions for children under 3.
• There is no transition period for products already on the market.

3. Fragrance allergens: from 25 to 81 (Regulation (EU) 2023/1545)

• 56 new allergens have been added to the 25 that already had to be listed individually — a total of 81.
• An allergen is listed in the ingredients if its concentration exceeds 0,001 % in leave-on products and 0,01 % in rinse-off products.
• From 31 July 2026 — for products placed on the EU market for the first time; until 31 July 2028 — transition for products already on the market.

Mandatory requirements for cosmetics postponed to 31 July 2027

By CMU Resolution No. 976 of 29.07.2026, the government amended the Technical Regulation on Cosmetic Products (Resolution No. 65) and postponed the new rules by another year — from 3 August 2026 to 31 July 2027.

Cosmetics placed on the market after 31 July 2027 must meet the safety requirements of the regulation and be notified on the Ministry of Health portal. Products placed on the market before that date may be sold until the end of their shelf life.