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.
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.
This page explains Patient Guard’s Cosmetic Product Safety Report (CPSR) services, helping manufacturers demonstrate the safety of cosmetic products before they are placed on the market. If you're looking for a broader introduction to cosmetic compliance, including Regulation (EC) No. 1223/2009, Cosmetic Product Safety Reports (CPSRs), Product Information Files (PIFs), Responsible Person requirements, CPNP notification and labelling obligations, read our Cosmetics Regulation for Beginners Guide.
We have supported cosmetic manufacturers with UK regulatory compliance for over 9 years.
We support start-ups, SMEs and global brands with cosmetic compliance and UK market access.
We deliver CPSRs quickly while ensuring full compliance with EU and UK cosmetic regulations.
We provide clear annual or project pricing with no hidden fees, helping you budget with confidence.
We compile and assess all relevant data, including formulation details, toxicological profiles, exposure assessment, and stability data.
We prepare the formal safety assessment, including conclusions on product safety, labelling requirements, and conditions of use.
We assess all ingredients against regulatory restrictions and toxicological data to ensure compliance.
We verify that your cosmetic product complies with EU and UK cosmetic regulations.
We ensure your CPSR aligns with requirements for product notification in both the EU and UK.
Under EU and UK cosmetic regulations:
We assess your formulation, ingredients, and product details
We gather toxicological, stability, and safety data
We perform a full CPSR safety assessment
We prepare your CPSR (Part A and Part B)
We ensure your CPSR is compliant and ready for regulatory submission
We support a wide range of cosmetic products, including:
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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.
Provide full ingredient composition, specifications, and supporting documentation
Our qualified safety assessors perform a full toxicological review and compile the CPSR
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.
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.
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:
Transition Timelines: When exactly you must stop placing non-compliant products on the market in each region.
Sell-Through Periods: How long existing stock can remain on shelves in the UK vs. the EU.
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.
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
Click on the links below to discover more:
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Preparing to sell digital health technology to the NHS requires more than completing DTAC. This guide explains how manufacturers can build a procurement-ready position by aligning regulatory compliance, clinical safety, data protection, cybersecurity, interoperability, accessibility and commercial evidence for NHS market access.
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.
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.
A complete guide to NHS DTAC compliance for digital health manufacturers, covering the five DTAC assessment areas, required evidence, clinical safety, data protection, technical security, interoperability and usability, and how to prepare your digital health technology for NHS procurement.
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.
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