What does a cosmetics manufacturer need before selling in the EU or UK?

A named Responsible Person, a Cosmetic Product Safety Report (CPSR) as part of the Product Information File (PIF), and a process for reporting Serious Undesirable Effects (SUEs). All three need to be in place before the first product reaches the market.

What is the role of the Responsible Person for cosmetics?

The Responsible Person ensures that each product placed on the market complies with the cosmetics regulation and is the contact point for authorities. We build the governance behind the role: documented decision authority, defined escalation lines and a file that holds up to scrutiny.

What is a Serious Undesirable Effect (SUE) in cosmetics?

An undesirable effect that results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies, an immediate vital risk or death. SUEs follow their own reporting process to the competent authority, separate from general consumer complaints.

Which documents do authorities ask for first?

Market surveillance authorities typically request the Product Information File, including the CPSR. The same documents are usually the first ones requested in a liability claim, so gaps in the safety assessment should be closed before either request arrives.

Cosmetovigilance

Market entry requires a vigilance system most cosmetics manufacturers have never had to build

About

Selling cosmetics in the EU, the UK, or almost any regulated market requires a functioning vigilance system before the first unit reaches a shelf: a named Responsible Person, a Cosmetic Product Safety Report, a process for Serious Undesirable Effect reporting. For a small manufacturer or trader, none of this exists on day one, and there is rarely anyone in-house who has done it before. The gap usually stays invisible until a regulator asks a specific question, or a customer complaint turns into a legal claim, and the answer needs to already exist on paper. We build the vigilance system before that day arrives: Responsible Person governance, safety documentation, and a reporting process ready to withstand scrutiny from the start.

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From the Trenches

Common Challenges we Solve

The Challenge

Responsible Person Governance

Every cosmetic product on the EU market needs a named Responsible Person who carries personal liability for its safety. Many small manufacturers fill the role on paper, without the authority, file, or process behind it to hold up if it is ever tested.

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The Solution

A Responsible Person structure with the substance behind the title: documented decision authority, defined escalation lines, and a file built to survive scrutiny from a regulator or a claimant.

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The Challenge

CPSR & Product Information File

The Cosmetic Product Safety Report and Product Information File are the first documents a market surveillance authority asks for, and the first thing an opposing lawyer requests in a liability claim. Many manufacturers only discover gaps in the toxicological assessment once one of the two comes asking.

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The Solution

A CPSR and PIF built before either request arrives, with the safety assessment and ingredient data structured to answer the questions regulators and courts actually ask.

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The Challenge

SUE Reporting & Complaint Handling

Serious Undesirable Effect reporting runs on its own thresholds, timelines, and portals, separate from any general consumer complaint process. Without a defined process, a single bad reaction report can turn into regulatory attention with no paper trail to show it was handled correctly.

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The Solution

A complaint intake and SUE reporting process that captures every report correctly the first time, with documentation that shows a regulator or claimant it was handled the way the Regulation requires.

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The Challenge

The Solution

The Challenge

The Solution

The Challenge

The Solution