Cosmetic Product Safety Report (CPSR) Services for Cosmetic Products

Patient Guard provides Cosmetic Product Safety Report (CPSR) services for cosmetic products, supporting compliance with UK cosmetic regulations. We ensure your CPSR is scientifically robust, compliant, and ready for market access.

500+ Manufacturers Supported
BSI ISO 13485 Certified
UK & EU Offices
Former MHRA Expertise
Established 2017
Patient Guard medical device regulatory consultancy illustration showing UKCA, CE MDR, FDA, ISO 13485, IVDR and technical documentation.

Cosmetic Product Safety Report (CPSR) Services for Cosmetic Products

Cosmetic manufacturers must prepare a Cosmetic Product Safety Report (CPSR) to demonstrate that their products are safe for human use in accordance with EU Cosmetic Regulation (EC) No 1223/2009 and UK cosmetic regulations.

A CPSR is a mandatory requirement for placing cosmetic products on the market in both the European Union and the United Kingdom. It forms a key part of the Product Information File (PIF) and must be completed by a qualified safety assessor.

Patient Guard acts as your cosmetic regulatory consultancy, supporting manufacturers with CPSR preparation, safety assessments, and regulatory compliance.

Without a compliant CPSR, cosmetic products cannot be legally registered on the Cosmetic Product Notification Portal (CPNP) or the Submit Cosmetic Product Notifications (SCPN) system in the UK.

We provide expert CPSR services for cosmetic manufacturers worldwide, ensuring your products meet safety requirements and are ready for market access.

Speak to our regulatory experts today to ensure your cosmetic products are fully compliant and safe for consumers.

David Small - Patient Guard - CEO and Founder
“A Cosmetic Product Safety Report is far more than a regulatory requirement—it provides the scientific evidence that a cosmetic product is safe for consumers when used as intended. A well-prepared CPSR not only supports compliance but also helps manufacturers protect their brand and bring products to market with confidence.”
cosmetic product safety report CPSR services

Why Choose Patient Guard for CPSR Services?

Established regulatory consultancy since 2017

We have supported cosmetic manufacturers with UK regulatory compliance for over 9 years.

Trusted by 500+ companies

We support start-ups, SMEs and global brands with cosmetic compliance and UK market access.

Efficient and compliant approach

We deliver CPSRs quickly while ensuring full compliance with EU and UK cosmetic regulations.

Transparent and clear pricing

We provide clear annual or project pricing with no hidden fees, helping you budget with confidence.

What Our CPSR Service Includes

Part A – Cosmetic product safety information

We compile and assess all relevant data, including formulation details, toxicological profiles, exposure assessment, and stability data.

Part B – Cosmetic product safety assessment

We prepare the formal safety assessment, including conclusions on product safety, labelling requirements, and conditions of use.

Ingredient and toxicological review

We assess all ingredients against regulatory restrictions and toxicological data to ensure compliance.

Regulatory compliance verification

We verify that your cosmetic product complies with EU and UK cosmetic regulations.

Support for CPNP and SCPN registration

We ensure your CPSR aligns with requirements for product notification in both the EU and UK.

Who Requires a CPSR?

CPSR Regulatory Requirements

Under EU and UK cosmetic regulations:

Our Process

01

Product information review

We assess your formulation, ingredients, and product details

02

Scientific Data collection

We gather toxicological, stability, and safety data

03

Product Safety assessment

We perform a full CPSR safety assessment

04

Product Documentation preparation

We prepare your CPSR (Part A and Part B)

05

Final review and support

We ensure your CPSR is compliant and ready for regulatory submission

CPSR cosmetic safety assessment

Cosmetic types we support

We support a wide range of cosmetic products, including:

Cost of Service

Premium

Cosmetic Product Safety Report (CPSR)

£ 1000

From

Ensure regulatory compliance and market readiness with expertly prepared Cosmetic Product Safety Reports (CPSRs). Pricing starts from £1,000, with preferential rates for multiple products.

Features

  • Prepared by qualified safety assessors
  • Full toxicological and ingredient assessment
  • Compliance with EU and UK regulations
  • Supports product notification and market access

Time Lines

01

Submit product formulation and data

Provide full ingredient composition, specifications, and supporting documentation

02

Safety assessment and CPSR preparation

Our qualified safety assessors perform a full toxicological review and compile the CPSR

03

Final report delivery and support

Receive your completed CPSR, ready for notification, with ongoing regulatory support if needed

Fast turnaround: most CPSRs are delivered within 7–15 working days, subject to completeness of product information.

Managing UK and EU Regulatory Divergence in 2026

As we move further into 2026, the regulatory requirements for the UK and EU markets are no longer identical. For brands selling in both regions, understanding the differing enforcement timelines is critical to avoiding wasted stock or legal non-compliance.

Key Divergence Alerts:

  • EU Market (Omnibus VIII): Under Regulation (EU) 2026/78, bans on specific CMR substances (including various nano-materials and Silver Powder) come into full force on May 1, 2026.

  • UK Market (Great Britain): The UK follows its own timeline via the UK Amending Instrument (SI 2026/109). While many restrictions align, certain ingredients—most notably Hexyl Salicylate—have a later enforcement date in the UK, applying from August 2026.

What this means for your CPSR:

A “one-size-fits-all” safety assessment may no longer be sufficient. Our assessors ensure that your CPSR Part B explicitly addresses these diverging grace periods. We provide clear guidance on:

  1. Transition Timelines: When exactly you must stop placing non-compliant products on the market in each region.

  2. Sell-Through Periods: How long existing stock can remain on shelves in the UK vs. the EU.

  3. Reformulation Strategy: Prioritizing ingredient changes to meet the earliest deadline (May 1st) to maintain uninterrupted access to the European Single Market.

Expert Tip: Don’t get caught out by “shadow bans.” Even if a substance is legal in the UK until August, your EU Responsible Person cannot represent that product after May 1st. We help you synchronize your compliance strategy to save costs.

Frequently Asked Questions (FAQs)

A CPSR is a safety assessment document that demonstrates a cosmetic product is safe for human use in accordance with EU and UK cosmetic regulations.

Yes, a CPSR is a legal requirement before placing a cosmetic product on the market in the EU or UK.

A CPSR must be prepared by a qualified safety assessor with appropriate expertise in toxicology and cosmetic safety.

The timeline depends on product complexity and availability of data, but typically ranges from a few days to a few weeks.

Starting May 1, 2026, several CMR substances (including nano and non-micronised silver) are prohibited, and new restrictions apply to Hexyl Salicylate. We are currently performing emergency formula reviews to ensure your safety assessments remain valid

Generally, products placed on the market before May 1st can be sold until stock is exhausted, but no new batches can be released

Related Services

Click on the links below to discover more:

Recent Blog Posts

DCB0129 and Clinical Safety: What Digital Health Manufacturers Need for NHS DTAC

For digital health manufacturers preparing to enter the NHS, clinical safety can be one of the most important—and sometimes misunderstood—parts of DTAC.
It is not enough to demonstrate that your software works.
Manufacturers need to consider what could happen if the technology fails, produces incorrect information, presents information incorrectly, contributes to a workflow error or is used in circumstances that could expose patients to harm.
This is where clinical risk management and DCB0129 become particularly important.
NHS England identifies DCB0129 as the clinical risk management standard for manufacturers of health IT systems. Its counterpart, DCB0160, applies to health organisations deploying and using health IT systems. NHS England states that compliance with these standards is required under the Health and Social Care Act 2012.
For manufacturers working towards NHS DTAC readiness, understanding the distinction—and having the right clinical safety evidence—is essential.

Read More »

DTAC Requirements Explained: The 5 Areas Digital Health Manufacturers Need to Get Right

If your digital health technology is heading towards the NHS, understanding the Digital Technology Assessment Criteria (DTAC) should be part of your market-access planning.
But one of the biggest mistakes manufacturers can make is treating DTAC as simply another questionnaire to complete.
The questions are only part of the process.
Behind your answers needs to be evidence showing that your technology and organisation have appropriate arrangements for clinical safety, data protection, technical security, interoperability, and usability and accessibility.
These five areas form the core of NHS DTAC. NHS England describes DTAC as national baseline criteria for digital health technologies entering NHS and social care.
For digital health manufacturers, the practical question is therefore not simply:
“Can we complete the DTAC assessment?”
It is:
“Can we demonstrate that our product meets the requirements?”
This guide looks at each of the five DTAC areas, the types of evidence manufacturers should consider and some of the common gaps that can delay NHS readiness.

Read More »

Cosmetic Product Safety Report (CPSR): A Complete Guide to UK Cosmetic Compliance

Before a cosmetic product can legally be placed on the UK market, manufacturers and Responsible Persons must demonstrate that it is safe for human use under normal or reasonably foreseeable conditions. The Cosmetic Product Safety Report (CPSR) is one of the most important regulatory documents required under the UK Cosmetics Regulation. This guide explains what a CPSR is, who can prepare one, what information it must contain, how it relates to the Product Information File (PIF) and how it supports legal cosmetic compliance.

Read More »

IVDR PMPF Explained: A Complete Guide to Post-Market Performance Follow-up

Post-Market Performance Follow-up (PMPF) is a fundamental requirement under the EU In Vitro Diagnostic Regulation (IVDR), ensuring that manufacturers continually monitor the scientific validity, analytical performance and clinical performance of their in vitro diagnostic medical devices after CE marking. This guide explains IVDR PMPF requirements, PMPF Plans, PMPF Reports, Annex XIII expectations and how ongoing performance monitoring supports continued regulatory compliance throughout the device lifecycle.

Read More »

IVDR Scientific Validity Explained: A Complete Guide for Manufacturers

Scientific Validity is the first pillar of IVDR Performance Evaluation and provides the scientific foundation demonstrating that an analyte or biomarker is associated with a specific clinical condition or physiological state. This guide explains Scientific Validity under Regulation (EU) 2017/746, including literature reviews, Scientific Validity Reports, Annex XIII requirements, evidence appraisal and how Scientific Validity supports successful CE marking.

Read More »
Posted on Google Google
Jay Verma profile picture
Jay Verma
15 days ago
Google star 1Google star 2Google star 3Google star 4Google star 5Trustindex verifies that the original source of the review is Google.
I found Patient Guard Ltd to be an exceptional partner. Their assessment was thorough, their guidance clear, and their support instrumental in helping us achieve our objectives. Steve and Ellie, in particular, were outstanding in steering us through the MHRA Class I medical device registration process.
Posted on Google Google
Munna P profile picture
Munna P
68 days ago
Google star 1Google star 2Google star 3Google star 4Google star 5Trustindex verifies that the original source of the review is Google.
Working with the Patient Guard team has been a great experience throughout our MHRA and ISO 13485 documentation journey. Their expertise, structured approach, and practical guidance helped our team build a robust quality management system while keeping us aligned with regulatory expectations. The collaboration was professional, responsive, and focused on finding solutions rather than simply identifying issues. A special thank you to Alex and Steve for their outstanding coordination, responsiveness, and continuous support throughout the project. They were always approachable, provided valuable feedback, and worked closely with our team to resolve challenges efficiently. Their commitment made a significant difference in keeping our documentation effort on track. I highly recommend Patient Guard to any healthcare or MedTech organization looking for experienced regulatory and quality system partners for MHRA, ISO 13485, and broader medical device compliance initiatives. Thank you again to the entire Patient Guard team for being such reliable partners.
Posted on Google Google
Peter Reeve profile picture
Peter Reeve
94 days ago
Google star 1Google star 2Google star 3Google star 4Google star 5Trustindex verifies that the original source of the review is Google.
STEPPER design, manufacture & distribute eyewear across the globe. With the increasingly complex landscape concerning the placing of Mecial Devices onto the market, we realised we needed professional guidance. We found Patient Guard via a simple internet search and are delighted we did! They provide a pragmatic solution to our needs, are totally reliable & always available to answer our (often simplistic) questions. They are highly efficient & responsive to what is a changing picture in our world and nothing is too much trouble. We have a much better understanding of regulatory affairs and our responsibilities as manufacturers & distributors and they support us in navigating the requirements in different territories. Updating our Declaration of Conformity, ensuring our labelling is compliant and acting as our PRRC are the key areas of their service for us.
Posted on Google Google
Derek Timm profile picture
Derek Timm
95 days ago
Google star 1Google star 2Google star 3Google star 4Google star 5Trustindex verifies that the original source of the review is Google.
For those companıes lookıng to comply to ISO standards and ın partıcular ISO13485 whıch to be honest ıs a nıghtmare I would strongly suggest goıng to the professıonals as ındeed we dıd by joınıng forces wıth Patıent Guard Ltd The staff are fantastıc nothıng ıs too much trouble and as a medıcal supply company we sımply cannot lıve wıthout them Thanks ın partıcular to Alex and Steve for all the hard work and our best regards from Dan Medıca South Lımıted
Posted on Google Google
BMSCriticalCare profile picture
BMSCriticalCare
132 days ago
Google star 1Google star 2Google star 3Google star 4Google star 5Trustindex verifies that the original source of the review is Google.
Great service, very helpful and always willing to answer any questions we have,
Posted on Google Google
Thomson Software profile picture
Thomson Software
803 days ago
Google star 1Google star 2Google star 3Google star 4Google star 5Trustindex verifies that the original source of the review is Google.
Alex Lewis of PatientGuard guided us through the ISO13485 process in a thorough, systematic and efficient manner. He was friendly, patient and willing to go the extra mile. Excellent service.
Posted on Google Google
Hannah Maddison profile picture
Hannah Maddison
906 days ago
Google star 1Google star 2Google star 3Google star 4Google star 5Trustindex verifies that the original source of the review is Google.
Fantastic, knowledgeable team that are always there to help. My appointments have always been booked in very promptly and have always ended with all my queries resolved. I have found the team very flexible and their breadth of knowledge is second to none. Patient Guard are without doubt my go-to for all the regulatory aspects of my medical device role.
Posted on Google Google
Richard Crow profile picture
Richard Crow
941 days ago
Google star 1Google star 2Google star 3Google star 4Google star 5Trustindex verifies that the original source of the review is Google.
Patientguard are an excellent source of Medical regulatory compliance advice, we have taken advantage of their various services from their EU Rep service, to helping with Technical Files all the way through to using their ISO Templates to implement our ISO 13485 system.
Posted on Google Google
George Kitching profile picture
George Kitching
944 days ago
Google star 1Google star 2Google star 3Google star 4Google star 5Trustindex verifies that the original source of the review is Google.
David Small and PatientGuard have been extremely helpful and supportive in assisting us with producing and updating our Technical File and Appendices for MDR certification.
Posted on Google Google
Tracey Slater profile picture
Tracey Slater
944 days ago
Google star 1Google star 2Google star 3Google star 4Google star 5Trustindex verifies that the original source of the review is Google.
Patient Guard have been a great support service to Cormed, providing help and advice promptly when ever requested. They have become a virtual department within Cormed enabling us to keep up to date and comply with the regulatory requirements whilst ensuring our QMS works for us at the same time.
Verified by Trustindex
Trustindex verified badge is the Universal Symbol of Trust. Only the greatest companies can get the verified badge who has a review score above 4.5, based on customer reviews over the past 12 months. Read more

Get in touch

Our Friendly Team are here to help.

Book a Free Consultation

Speak to one of our regulatory and compliance experts to arrange an obligation-free call. Our experienced team is ready to help you get your medical device to market.

UK Office

Get the Medical Device Technical Checklist

Thank you! The checklist is now ready to download.