An EU cosmetic launch is a chain of handoffs. A responsible person has to be designated, a qualified assessor has to sign a safety report, a Product Information File (PIF) has to be kept, and the product has to be notified through the Commission’s portal. Every one of those tasks has to refer to the same formula, pack and artwork that will actually be sold. Version mismatches between these records can hold up a launch even after the portal work is done.

The checklist below follows the order in which those decisions block each other. The cosmetic product development roadmap places this market-access work alongside formulation, testing and production.

Before you begin: fix one product identity

Give every contributor the same product reference before any report is commissioned. Record:

• Formula identifier, intended use and target users.
• Container, closure, dispensing system and fill sizes.
• Product name, proposed claims and artwork version.
• Intended EU markets and every company in the supply chain.
• Existing reports, known evidence gaps and named contacts.

Keep these in a controlled register with version numbers and a named approver for changes. The law does not prescribe this format, but the safety report, PIF and notification all have to identify the product unambiguously, and a shared register is the simplest way to keep them aligned.

Step 1: Define the product and market route

“Europe” is not a launch scope. Before artwork and dates are fixed:

1. Record the Member State where the product will first be placed on the market and how it reaches the others.
2. Give the regulatory specialist the intended use, target users, formula, pack and proposed claims.
3. Ask them to identify classification questions and any additional product-specific requirements before artwork and timing become fixed.

The EU and Great Britain are separate markets. The UK government’s Great Britain cosmetics guidance covers England, Scotland and Wales, excludes Northern Ireland and points to separate Northern Ireland guidance. Plan each destination on its own terms. For the United States, use the separate MoCRA requirements for cosmetic brands; an EU work package does not cover US duties.

Step 2: Designate the responsible person and task owners

Article 4 of Regulation (EC) No 1223/2009 allows a cosmetic product to be placed on the EU market only where a legal or natural person established in the Union is designated as responsible person. That person ensures compliance with the relevant obligations of the Regulation. For a product manufactured in the EU, the EU-established manufacturer is the responsible person; for an imported product, each importer is the responsible person for the product it places on the market. In both cases the role can be transferred by written mandate to an EU-established person who accepts it in writing. A distributor becomes the responsible person when it places a product on the market under its own name or trademark, or modifies a product already on the market in a way that can affect compliance. Confirm which entity holds the role for the actual supply arrangement rather than assuming the brand or the lab holds it.

1. Confirm in writing which entity is the responsible person for this product and these markets.
2. Record its name, EU address (this address appears on the label and is where the PIF is made available) and the products the mandate covers.
3. Assign who obtains technical data, coordinates the safety assessment, maintains the PIF, reviews artwork and prepares the notification.
4. Agree how the responsible person hears about formula, pack or supplier changes and about complaints after launch.

Separate the accountable role from the person doing the paperwork. “The lab submits it” says nothing about who answers to the authority or whether they hold the evidence. The Product Information File guide covers dossier ownership and access in more detail.

Step 3: Commission the safety report and build the PIF

Article 10 requires the responsible person to ensure, before market placement, that the product has undergone a safety assessment and that a Cosmetic Product Safety Report (CPSR) is set up in accordance with Annex I. The assessment must take account of intended use and anticipated systemic exposure, use a weight-of-evidence approach and be kept up to date as new information emerges after launch. Part B of the report must be carried out by a person holding a university-level qualification in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State. A laboratory test report is an input to that assessment, not the assessment itself.

The PIF is the wider dossier that contains the CPSR. Under Article 11 it must include a product description that attributes the file to the product, the CPSR, the manufacturing method with a statement of GMP compliance, proof of claimed effects where the nature or effect of the product justifies it, and data on any animal testing. It must be readily accessible to the competent authority at the address on the label and kept for ten years after the last batch is placed on the market.

1. Ask the safety assessor for the list of data they need for this formula and pack.
2. Assign inputs to the manufacturer, testing providers and brand, each with a version reference and delivery date.
3. Log open evidence gaps and assessor questions explicitly.
4. Confirm where the signed CPSR and supporting records will live and that the responsible person can produce them on request.

Check that each report covers the product being sold. A stability or challenge test on an earlier formula or a different pack needs a documented judgement on whether it still applies. A filename or a supplier’s one-line summary is not that judgement. The PIF guide details the dossier contents.

Step 4: Reconcile claims, artwork and the technical record

Finish this step with one approved version of everything the customer sees. Article 2 of Regulation (EU) No 655/2013 requires claims to comply with the common criteria and links them to the documentation of the claimed effect in the PIF. A safety conclusion does not prove a marketing promise. Whether the product is safe for its intended use and whether an advertised benefit is substantiated are separate questions with separate evidence.

Labels also need market-specific review. Article 19(5) makes the language of specified label information subject to the law of the Member States where the product is made available. Do not assume English alone covers every destination.

1. Give the reviewer the actual pack copy, product-page text and planned advertising claims.
2. Map each performance claim to the evidence that supports it.
3. Have labeling reviewed for each target market against the final formula and pack.
4. Resolve any mismatch between artwork, product identity and records before approving print.

The cosmetic claims substantiation guide covers claim-to-evidence planning in depth.

Step 5: Notify the product through CPNP

The Cosmetic Products Notification Portal (CPNP) is the Commission’s free online notification system. Article 13 splits notification into stages:

• Before placing on the market (Art 13(1)): the product category and name, the responsible person’s name and the address where the PIF is accessible, country of origin for imports, the first Member State of placement, a contact person for emergencies, any nanomaterials with their identification and foreseeable exposure, any CMR 1A/1B substances, and the frame formulation for medical treatment.
• When placing on the market (Art 13(2)): the original labelling and, where reasonably legible, a photograph of the packaging.
• After changes (Art 13(7)): updates to the notified information without delay.

Distributors have their own duty under Article 13(3) when they translate labelling on their own initiative to make a product available in another Member State. Products containing nanomaterials may also need a separate notification under Article 16(3) six months before placing on the market. Article 16(3) states that this does not apply to cosmetic products containing nanomaterials that are in conformity with the requirements set out in Annex III. Ask the specialist whether that applies to your formula before you set the launch date.

1. Name who prepares the submission, who checks it and who keeps portal access.
2. Match the submission to the approved formula, pack and artwork versions.
3. Record completion of each stage and the procedure for later updates.

CPNP notification is not approval. The Commission describes it as notification and information-sharing. It does not assess safety, and a submission receipt does not resolve open safety, labeling or claims issues. The Commission states that a product notified through CPNP needs no further national notification within the EU, but other national and product-specific rules still apply.

Step 6: Record launch readiness and open holds

End with a decision that names which product may ship to which markets and what is still blocked. The matrix is a coordination tool. Agree the actual assignments with the parties involved.

1. Review each workstream with its owner and list open issues.
2. Name who closes each issue and what evidence will close it.
3. Record the launch decision for the identified product and markets.
4. Confirm contacts for later changes, complaints and safety issues.

Set up the complaint route before launch. Under Article 23, the responsible person and distributors must notify serious undesirable effects without delay to the competent authority of the Member State where the effect occurred, together with the product identity and any corrective measures. The Commission’s cosmetics legislation overview summarizes this reporting system.

Example hold record

This example is invented to show the level of detail that makes a hold actionable.

Product: moisturizer M01, formula F04, pack P02, artwork A06; initial EU markets recorded in brief B03.
Status: the CPSR covering F04/P02 is logged in the PIF. The draft CPNP submission refers to artwork A05.
Open issue: artwork A06 adds a performance claim with no entry in the claims review.
Decision: hold launch. Neither the safety report nor the notification resolves the new claim.
Owner: brand product lead obtains the claims review and coordinates corrected artwork and submission data with the responsible person.
Clearance condition: claims review recorded, artwork and notification reconciled to A06, other holds closed.
Record: H01, dated 23 October 2026.

A good hold record lets the next person see the issue, the owner and the evidence needed without reading the email history. Keep it with the PIF as the product changes; the PIF maintenance guide explains how.

Next step: assign the first missing handoff

Fix the product identity, confirm the responsible person, then walk through the matrix and name an owner for every missing input. Use the development roadmap to line those holds up with testing, production and commercial timing.