EU Cosmetics Regulation and GPSR: 2026 Checklist
Cosmetic products are governed first by Regulation (EC) No 1223/2009, consolidated on 18 May 2026. The General Product Safety Regulation (GPSR) does not replace that sector law. GPSR complements it only for risks or duties not covered with the same objective, including the applicable distance-sales rules.
This split matters in practice. The Commission recorded 4,671 Safety Gate alerts in 2025; cosmetics were the largest category at 36%. Almost eight in ten cosmetics alerts concerned the banned fragrance BMCHA. A CPNP notification alone therefore cannot prove that a formula, label or online offer is compliant.
Does GPSR apply to cosmetic products in the EU?
GPSR applies to cosmetics as a complementary safety net, not as a second cosmetics code. The European Commission's 2025 GPSR business guidelines state that sector-specific EU rules control the risks and objectives they already cover. GPSR Chapter II applies only to uncovered risks, while Chapter III Section 2 covers applicable distance-sales, accident-reporting and electronic-information duties.
For an ordinary cosmetic, Regulation 1223/2009 remains the central route for ingredients, the safety assessment, the Product Information File (PIF), the cosmetics Responsible Person, CPNP notification, manufacturing practice, labelling and claims. Do not create a duplicate generic GPSR technical file for duties already governed by that regulation.
Which law governs each cosmetics compliance task?
| Compliance task | Primary rule | Practical evidence |
|---|---|---|
| Cosmetic classification, formula and human-health safety | Cosmetics Regulation Articles 2 and 3 | Intended purpose, formula, ingredient restrictions and exposure data |
| EU cosmetics Responsible Person | Cosmetics Regulation Articles 4 and 5 | Identified EU person, accepted mandate where required and compliance controls |
| Safety assessment and product file | Cosmetics Regulation Articles 10 and 11 | Signed CPSR and complete PIF |
| Manufacturing, label and claims | Cosmetics Regulation Articles 8, 19 and 20 | GMP statement, final artwork and claim substantiation |
| Pre-market notification | Cosmetics Regulation Article 13 | CPNP submission record; not an approval certificate |
| Serious undesirable effects | Cosmetics Regulation Article 23 | Notify the competent authority without delay and preserve the case evidence |
| Online offer, uncovered risks and horizontal follow-up | GPSR complementarity test; Article 19 and other applicable Chapter III Section 2 duties | Dated listing capture, role mapping, warnings and incident process |
The legal source must be mapped to the exact product and task. The phrase “GPSR covers every product” is too broad because it hides the sector-law limits described in the Commission guidelines.
What is the difference between the cosmetics RP, GPSR role and CPSR assessor?
| Role | What the role does | What the role does not automatically do |
|---|---|---|
| Cosmetics Responsible Person under Article 4 | Ensures the cosmetic product complies with the relevant duties of Regulation 1223/2009 | The role does not by itself prove that the person is qualified to sign the CPSR |
| EU economic operator referenced by GPSR Article 19 | Supplies the identity and contact route required for an applicable distance-sales offer and performs the duties attached to its legal role | The appointment does not automatically make that entity the cosmetics Responsible Person |
| Qualified safety assessor under Article 10 | Performs the cosmetic safety assessment and signs the CPSR | The assessor does not automatically become the cosmetics RP or the GPSR economic operator |
The Article 10 assessor must hold a diploma or other evidence of formal qualification awarded after a university course in pharmacy, toxicology, medicine or a similar discipline, or an equivalent course recognised by a Member State. “Knowledge and experience” alone is not the qualification test.
One company may perform more than one role only if it separately satisfies each legal definition, accepts each mandate and has the required competence. The contract and public product information should name the roles precisely.
What must a non-EU cosmetics brand prepare before EU sale?
| Step | Evidence to have before placing on the EU market | Legal checkpoint |
|---|---|---|
| 1 | Product classification and intended-purpose decision | Cosmetics Regulation Article 2 |
| 2 | Final formula, specifications and ingredient restriction review | Articles 3 and 14–17 plus relevant annexes |
| 3 | EU cosmetics Responsible Person and accepted mandate where needed | Article 4 |
| 4 | CPSR signed by a qualified safety assessor | Article 10 and Annex I |
| 5 | Complete PIF accessible at the Responsible Person's address | Article 11; retain for 10 years after the last batch was placed on the market |
| 6 | GMP evidence, final label and supported claims | Articles 8, 19 and 20 |
| 7 | CPNP notification before placing the product on the market | Article 13 |
| 8 | Final online-offer review and incident route | GPSR Article 19 and applicable follow-up duties |
Article 11 lists five core PIF elements: a clear product description, the CPSR, the manufacturing method and GMP statement, proof of claimed effect where justified, and data on animal testing performed by the manufacturer, agents or suppliers. The PIF is wider than a label pack or ingredient list.
What must an EU cosmetics product page show?
An online cosmetic offer should let a consumer identify the product and the relevant operators before purchase. Under GPSR Article 19, an applicable distance-sales offer must present the manufacturer's name or trade name and postal and electronic address; where required, the EU responsible economic operator's name and contacts; a product image or other identifier; and warnings or safety information required by EU law.
The cosmetics label remains controlled by Article 19 of Regulation 1223/2009. The final artwork should cover the required cosmetics RP address, nominal content, durability or period-after-opening indication, precautions, batch reference, function where not obvious and ingredients. If label information, ingredients or claims appear online, they must agree with the approved artwork and PIF. The GPSR online-sales information guide gives a field-by-field listing review.
Is CPNP registration an approval or a certificate?
CPNP is a notification, not an approval. The Commission describes CPNP as a free online notification system. Once the Article 13 notification is made, no further national cosmetics notification is needed within the EU, but authorities can still inspect the CPSR, PIF, formula, label and market evidence.
Ordinary cosmetics also do not use CE marking or a CE-based EU Declaration of Conformity. The EU Declaration of Conformity guide explains the distinction. A powered beauty device, applicator or accessory may require a separate classification and a different legal route.
Do natural or organic cosmetics follow a different EU route?
“Natural” or “organic” does not exempt a product from Regulation 1223/2009 and does not create a separate EU cosmetics approval. The formula, safety assessment, label and claims still need evidence. Claims must not imply a property the product does not have.
Classification follows intended purpose and presentation. A cream applied to the human body for a cosmetic purpose can be a cosmetic; a beauty tool, electrical device or accessory is not automatically a cosmetic and may fall fully under GPSR or other product legislation.
Frequently asked questions about the Cosmetics Regulation and GPSR
Does GPSR apply to cosmetic products in the EU?
Yes, as a complementary framework. Regulation 1223/2009 governs the cosmetic-specific requirements; GPSR covers uncovered risks and applicable horizontal duties such as distance-sales information.
Is a cosmetics Responsible Person the same as a GPSR Responsible Person?
No. They are separate legal functions. The same entity can cover both only when it independently meets and accepts both sets of conditions.
Is CPNP notification an EU approval or certificate?
No. CPNP is a mandatory pre-market notification, not approval, certification or a replacement for the CPSR and PIF.
Do ordinary cosmetic products need CE marking or an EU Declaration of Conformity?
No. Ordinary cosmetics follow Regulation 1223/2009. Separately classified beauty devices or accessories may follow other legislation and should be assessed on their own facts.
Can Grüner Baum provide cosmetics RP, PIF, CPSR and CPNP services?
Yes. Grüner Baum GmbH provides an end-to-end cosmetics route with its specialist cosmetics partner: cosmetics RP, PIF preparation and maintenance, CPSR assessment by a qualified safety assessor, CPNP notification and GPSR Article 19 online-offer review. The contract identifies which entity accepts the cosmetics RP role and who signs the CPSR. Cosmetics receive an individual scope review and quote. Request a cosmetics compliance assessment.
Official sources
- Regulation (EC) No 1223/2009 — consolidated text of 18 May 2026
- European Commission GPSR business guidelines, C/2025/6233
- European Commission cosmetics overview
- European Commission Cosmetic Product Notification Portal
- European Commission 2025 Safety Gate report
This guide was checked on 1 September 2026. Product classification, formula, claims, route and accepted mandates must be reviewed for the individual product.
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