Main Regulatory Requirements for Cosmetic Products in the EU and the Notification Procedure. Practical Guide for Non-EU Manufacturers

Why the EU is a Complex but Highly Attractive Market

The EU cosmetics market is one of the most:

• solvent and profitable,

• strictly regulated,

• legally protected.

Any cosmetic product placed on the EU market must comply with:

• Regulation (EC) No 1223/2009 on cosmetic products

• Good Manufacturing Practice (ISO 22716)

• EU labelling requirements

• notification via the Cosmetic Products Notification Portal (CPNP)

Without these, the product is considered illegal — even if sold through online marketplaces.

Who is the Responsible Person (RP)

For a non-EU manufacturer, the key concept is the Responsible Person in the EU.

The Responsible Person is a legal or natural person established within the EU who:

• bears full legal responsibility for product compliance

• keeps the Product Information File (PIF)

• submits the CPNP notification

• communicates with competent authorities and market surveillance bodies

Without an RP, legal notification is impossible.

This is where the real value of KRP CG services begins.

Safety Assessment

Each cosmetic product must have a Cosmetic Product Safety Report (CPSR):

• Part A — technical data (composition, toxicology, exposure)

• Part B — safety conclusion issued by a qualified safety assessor

Without a CPSR, CPNP notification is not permitted.Most importantly, absence of a proper safety assessment creates a high risk of harm to consumer health, leading to reputational damage and regulatory penalties.

Product Information File (PIF)

The PIF is the product dossier stored within the EU and includes:

• product description

• CPSR

• manufacturing method description

• GMP compliance declaration

• labelling

• evidence supporting claims

The PIF must be available to market surveillance authorities for 10 years after the last batch is placed on the market.

Manufacturing and GMP

The manufacturer must operate in accordance with ISO 22716 or demonstrate implementation of GMP principles if certification is not available.

Labelling — Typical Mistakes of Foreign Brands

Most common non-compliances:

❌ missing EU RP address

❌ product name inconsistent with CPNP notification

❌ claims such as “dermatologically tested” without evidence

❌ incorrect INCI ingredient order

❌ missing fragrance allergens at required thresholds

Labelling violations are one of the leading causes of fines.

CPNP Notification

CPNP is not a registration — it is an official notification to EU Member States that the product is being placed on the market.

The notification is submitted before market placement, by the Responsible Person, and includes:

• composition data

• label artwork

• product photos

• contact details

Consequences of Missing CPNP Notification

• customs import refusal

• withdrawal from sale by market surveillance authorities

• significant financial penalties

Nanomaterials — a Separate Risk

If the product contains nanomaterials, Article 16 applies:

• separate notification

• possible SCCS scientific evaluation

• market entry delay of 6–12 months

Real Risks for Non-EU Brands

Situation	Consequence
No Responsible Person	Sales ban
No CPSR	Market withdrawal
Incorrect claims	Fines
No PIF	Legal liability
Fake GMP	Criminal liability of RP

How KRP CG Solves These Issues

KRP CG (Poland) provides:

• Responsible Person services in the EU

• cosmetic safety assessment and CPSR preparation

• PIF dossier preparation

• CPNP notification submission

• label compliance verification

• ongoing regulatory support

For you this means: one point of entry + full legal coverage in the EU.

Entering the EU cosmetics market is not about “product registration”.It is about building a legally compliant system around your brand.

Responsible Person, CPSR, CPNP and PIF are not optional services — they are a mandatory compliance package that we implement together with manufacturers.