Updated: 2nd July 2026
Reviewed by: David Small BSc (Hons), MSc, MTOPRA (Founder and CEO)
Cosmetics Regulation
If you’re a brand owner, manufacturer, distributor, or importer, understanding how cosmetics are regulated in the EU is essential. Whether you’re launching a new skincare line or importing makeup from outside Europe, you must comply with strict legal requirements before your product can be sold.
This beginner-friendly guide explains the basics of EU cosmetics regulation, including key responsibilities, product safety requirements, labelling, and registration. If you’re new to the process, this article will help you navigate compliance step by step.
What Is a Cosmetic Product?
Under EU law, a cosmetic product is defined as:
“Any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips, and external genital organs), or with the teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.”
This includes:
Skincare creams and lotions
Makeup (lipstick, foundation, mascara)
Hair care (shampoo, conditioner, dye)
Perfumes and deodorants
Oral care products like toothpaste
The Main Law: Regulation (EC) No 1223/2009
The primary law for cosmetics in the EU is Regulation (EC) No 1223/2009 on cosmetic products. It has been in force since July 2013 and applies across all EU Member States.
This regulation sets high standards to ensure that only safe and properly labelled cosmetics are placed on the EU market. It covers:
Product safety and ingredients
Good manufacturing practices (GMP)
Labelling and claims
Responsible person designation
Cosmetic Product Notification Portal (CPNP) registration
Post-market surveillance
The Cosmetic Product Compliance Lifecycle
Bringing a cosmetic product to market involves far more than developing an attractive formulation or eye-catching packaging. Before a product can legally be sold in the European Union, manufacturers, importers and brand owners must complete a series of regulatory steps designed to ensure consumer safety and legal compliance.
Understanding this compliance lifecycle helps businesses avoid costly delays, enforcement action and product withdrawals.
Although the exact process varies depending on the product and where it is manufactured, most cosmetic products follow the same regulatory journey.
1. Product Development
The process begins with product formulation and ingredient selection. Every ingredient used within a cosmetic product must comply with Regulation (EC) No 1223/2009.
Manufacturers should confirm that ingredients are permitted for cosmetic use and that any preservatives, colourants or UV filters comply with the relevant Annexes of the Regulation.
At this stage it is also important to consider intended product claims, packaging, target consumers and the countries where the product will be marketed.
2. Safety Assessment
Before the product can be placed on the market, a qualified cosmetic safety assessor must complete a Cosmetic Product Safety Report (CPSR).
The safety assessment evaluates:
• Ingredient toxicology
• Exposure levels
• Microbiological quality
• Product stability
• Packaging compatibility
• Intended method of use
• Potential risks to consumers
The completed CPSR demonstrates that the cosmetic product is safe when used under normal or reasonably foreseeable conditions.
3. Product Information File (PIF)
Every cosmetic product must have a Product Information File (PIF).
The PIF contains the technical evidence supporting compliance and must be kept available for inspection by Competent Authorities for ten years after the final batch has been placed on the market.
The Product Information File typically includes:
• Cosmetic Product Safety Report (CPSR)
• Product description
• Manufacturing information
• Evidence supporting product claims
• Good Manufacturing Practice documentation
• Animal testing declarations
• Labelling artwork
If you’d like to learn more about preparing this documentation, read our Complete Guide to the Cosmetic Product Information File.
4. Responsible Person Appointment
Every cosmetic product placed on the EU market must have a designated Responsible Person established within the European Union.
The Responsible Person is legally responsible for ensuring that all regulatory requirements have been met before the product is made available to consumers.
For manufacturers located outside the EU, appointing an EU Responsible Person is a legal requirement before products can be imported or sold.
5. Product Notification
Before the cosmetic product can be sold, it must be notified through the Cosmetic Product Notification Portal (CPNP).
The notification includes information such as:
• Product details
• Ingredient information
• Responsible Person details
• Packaging images
• Country of manufacture
This information allows Competent Authorities and poison centres to rapidly identify products if safety concerns arise.
6. Labelling Compliance
The product label must contain all mandatory information required under Article 19 of the Cosmetic Products Regulation.
This includes:
• Responsible Person details
• Ingredients using INCI names
• Batch number
• Product function
• Warnings
• Nominal contents
• Shelf life or Period After Opening
Products marketed across multiple EU Member States must also ensure labelling is translated into the appropriate national languages.
7. Post-Market Monitoring
Regulatory compliance does not end once the product reaches the market.
Manufacturers and Responsible Persons should continue to monitor:
• Consumer complaints
• Serious undesirable effects
• Product quality issues
• Regulatory updates
• Ingredient restrictions
Where necessary, corrective actions, product recalls or updated safety assessments may be required to maintain compliance throughout the product’s lifecycle.
By understanding the complete cosmetic compliance lifecycle, businesses can plan regulatory activities more effectively, reduce delays and ensure products remain compliant long after they have entered the European market.
Who Is Responsible for Compliance?
One of the fundamental principles of the EU Cosmetics Regulation is that every cosmetic product placed on the European market must have a designated Responsible Person (RP).
The Responsible Person is the legal entity responsible for ensuring that a cosmetic product complies with Regulation (EC) No 1223/2009 before it is made available to consumers. This requirement applies regardless of whether the product is manufactured inside or outside the European Union.
The Responsible Person acts as the primary regulatory contact for Competent Authorities and is responsible for ensuring that the product remains compliant throughout its lifecycle.
Without a valid Responsible Person established within the European Union, a cosmetic product cannot legally be placed on the EU market.
Who Is Responsible for Compliance?
One of the fundamental principles of the EU Cosmetics Regulation is that every cosmetic product placed on the European market must have a designated Responsible Person (RP).
The Responsible Person is the legal entity responsible for ensuring that a cosmetic product complies with Regulation (EC) No 1223/2009 before it is made available to consumers. This requirement applies regardless of whether the product is manufactured inside or outside the European Union.
The Responsible Person acts as the primary regulatory contact for Competent Authorities and is responsible for ensuring that the product remains compliant throughout its lifecycle.
Without a valid Responsible Person established within the European Union, a cosmetic product cannot legally be placed on the EU market.
Who Can Be the Responsible Person?
Depending on the supply chain, the Responsible Person may be:
• The manufacturer, if they are established within the European Union.
• The importer bringing cosmetic products into the EU from a non-EU country.
• A distributor, where they place a product on the market under their own name or modify an existing cosmetic product in a way that may affect compliance.
• An independent third-party regulatory consultancy, appointed under a written mandate, such as Patient Guard.
For manufacturers located outside the European Union, appointing an EU-based Responsible Person is mandatory before products can be sold within the EU.
Responsibilities of the Responsible Person
The Responsible Person has a wide range of regulatory responsibilities designed to ensure consumer safety and ongoing compliance.
These include:
• Verifying that the cosmetic product complies with Regulation (EC) No 1223/2009.
• Ensuring that a Cosmetic Product Safety Report (CPSR) has been completed by a suitably qualified safety assessor.
• Maintaining the Product Information File (PIF) and making it available to Competent Authorities upon request.
• Submitting product notifications through the Cosmetic Product Notification Portal (CPNP) before products are placed on the market.
• Ensuring that product labelling complies with Article 19 of the Cosmetics Regulation.
• Monitoring product safety once the product is on the market.
• Reporting Serious Undesirable Effects (SUEs) to the relevant Competent Authorities where required.
• Cooperating with market surveillance authorities during inspections or investigations.
These responsibilities continue for as long as the cosmetic product remains available on the European market.
Responsibilities of Manufacturers
Although the Responsible Person has legal obligations under the Cosmetics Regulation, manufacturers also play a vital role in maintaining compliance.
Manufacturers should ensure that:
• Products are manufactured in accordance with Good Manufacturing Practice (ISO 22716).
• Raw materials and ingredients comply with the Cosmetics Regulation.
• Product claims are supported by appropriate evidence.
• Manufacturing records and batch documentation are maintained.
• Changes to formulations, packaging or manufacturing processes are communicated to the Responsible Person before implementation.
Close collaboration between the manufacturer and Responsible Person is essential to ensure that regulatory documentation remains accurate and up to date.
Importers and Distributors
Importers and distributors also have responsibilities under the Cosmetics Regulation.
Importers must ensure that products entering the European market comply with all applicable requirements before they are supplied.
Distributors should verify that cosmetic products bear the required labelling, that storage and transport conditions do not compromise product safety, and that products remain traceable throughout the supply chain.
If an importer or distributor believes that a cosmetic product does not comply with the Regulation, they must not place it on the market until corrective actions have been taken.
Working with Patient Guard as Your Responsible Person
Patient Guard provides independent EU Responsible Person services for cosmetic manufacturers worldwide.
Our experienced regulatory team works closely with manufacturers to ensure products meet all applicable requirements before entering the European market.
Our services include:
• EU Responsible Person appointment.
• Regulatory compliance reviews.
• Product Information File (PIF) support.
• Cosmetic Product Safety Report (CPSR) coordination.
• CPNP notification.
• Label and artwork reviews.
• Ongoing regulatory advice.
• Market surveillance support.
By appointing an experienced Responsible Person, cosmetic manufacturers can reduce regulatory risk, simplify market access and demonstrate ongoing compliance with the EU Cosmetics Regulation.
Key Compliance Requirements for EU Cosmetics
Let’s look at the main compliance steps every cosmetic brand or importer must follow.
1. Product Safety Report (CPSR)
Before a cosmetic product can be sold in the EU, a Cosmetic Product Safety Report (CPSR) must be completed. This report assesses the safety of the product and its ingredients.
The CPSR is divided into two parts:
Part A – Safety Information (includes composition, toxicological profile, microbiology, exposure levels)
Part B – Safety Assessment (performed by a qualified safety assessor)
The safety assessment must be conducted by someone with a degree in pharmacy, toxicology, or a related field.
2. Product Information File (PIF)
Each cosmetic product must have a Product Information File (PIF). This is a detailed document containing all the information about the product and must be available to EU authorities upon request.
The PIF must include:
Cosmetic Product Safety Report (CPSR)
Description of the product
Manufacturing method (to show GMP compliance)
Proof of effect (if claims are made)
Animal testing statements
Label artwork and packaging
Certificate of analysis (if applicable)
The PIF must be stored for 10 years after the last batch is placed on the market.
3. Notification via the CPNP
Before placing the product on the EU market, the Responsible Person must notify it through the Cosmetic Product Notification Portal (CPNP).
The CPNP is a central EU database used by authorities and poison centres. It contains key product information, such as:
Product name and category
Responsible Person’s details
Country of manufacture
Ingredients (with CAS and INCI names)
Product packaging images and labels
This step must be completed before the product becomes available for sale.
4. Label Requirements
Labels must comply with Article 19 of the Cosmetic Regulation. Labels must be clear, permanent, and easy to read, and must include:
Product function (if not obvious)
Nominal content (e.g., 50 ml)
Date of minimum durability or PAO (Period After Opening) symbol
Batch number
Precautions or warnings
Name and address of the Responsible Person
Country of origin (if manufactured outside the EU)
Ingredient list in INCI format (descending order of weight)
All information must be provided in the official language of the country where the product is sold.
5. Claims and Advertising
All product claims (e.g., “anti-ageing”, “moisturising”, “natural”) must be:
Truthful and supported by evidence
Not misleading to consumers
In line with EU guidelines on cosmetic claims
Misleading advertising can lead to enforcement action or product withdrawal.
Good Manufacturing Practice (GMP) and ISO 22716
Producing a safe cosmetic product does not depend solely on its ingredients or formulation. It also relies on consistent manufacturing processes that ensure every batch is produced to the same quality standards.
For this reason, Regulation (EC) No 1223/2009 requires cosmetic products to be manufactured in accordance with Good Manufacturing Practice (GMP). Compliance with GMP helps minimise the risk of contamination, manufacturing errors, product mix-ups and quality defects that could compromise consumer safety.
The internationally recognised standard for cosmetic Good Manufacturing Practice is ISO 22716, which provides practical guidance for manufacturers on implementing robust quality management and manufacturing controls.
What is ISO 22716?
ISO 22716 is the international standard that provides guidance on Good Manufacturing Practice for cosmetic products.
Rather than focusing solely on the finished product, ISO 22716 covers the entire manufacturing process, including:
• Personnel
• Premises
• Equipment
• Raw materials
• Production
• Packaging
• Storage
• Quality control
• Documentation
• Complaint handling
• Product recalls
The aim is to ensure cosmetic products are consistently manufactured under controlled conditions that protect product quality and consumer safety.
Why is GMP Important?
Even a well-formulated cosmetic product can become unsafe if it is manufactured incorrectly.
Poor manufacturing controls may lead to:
• Microbiological contamination
• Cross-contamination between products
• Incorrect ingredient concentrations
• Packaging errors
• Labelling mistakes
• Reduced product stability
• Batch inconsistencies
Implementing Good Manufacturing Practice helps reduce these risks while providing confidence that products consistently meet the required quality standards.
Documentation and Traceability
One of the key principles of ISO 22716 is maintaining accurate documentation throughout the manufacturing process.
Manufacturers should retain records covering:
• Raw material suppliers
• Incoming material inspections
• Manufacturing instructions
• Batch production records
• Equipment maintenance
• Cleaning procedures
• Calibration records
• Quality control testing
• Product release
• Distribution records
Maintaining complete documentation allows manufacturers to demonstrate compliance during inspections and enables products to be traced quickly if quality issues arise.
Personnel and Training
Employees play a critical role in maintaining product quality.
Staff should receive appropriate training covering:
• Hygiene requirements
• Manufacturing procedures
• Cleaning practices
• Equipment operation
• Documentation requirements
• Health and safety procedures
Training should be documented and reviewed regularly to ensure personnel remain competent for their assigned responsibilities.
Quality Control
Quality control activities should be performed throughout the manufacturing process rather than only at the final inspection stage.
Typical quality control activities include:
• Raw material verification
• In-process inspections
• Finished product testing
• Packaging verification
• Label approval
• Batch release
Where non-conformities are identified, appropriate corrective actions should be implemented before products are released to the market.
Storage and Distribution
Maintaining product quality continues after manufacturing has been completed.
Manufacturers should ensure cosmetic products are stored and transported under conditions that prevent deterioration or contamination.
Storage areas should be clean, organised and capable of protecting products from excessive heat, moisture, sunlight or other environmental conditions that may affect product quality.
Complaints and Product Recalls
ISO 22716 also requires manufacturers to establish procedures for handling customer complaints and investigating product quality issues.
Where necessary, manufacturers should be able to identify affected batches quickly and implement corrective actions, including product recalls if consumer safety could be affected.
Effective traceability systems significantly reduce the time required to investigate complaints and remove affected products from the market where necessary.
How Patient Guard Can Help
Patient Guard supports cosmetic manufacturers with GMP compliance by providing regulatory advice, quality management guidance and documentation reviews aligned with ISO 22716.
Whether you are establishing manufacturing processes for a new cosmetic product or reviewing an existing quality system, our consultants can help ensure your manufacturing activities support compliance with Regulation (EC) No 1223/2009 and recognised Good Manufacturing Practice principles.
Brexit and Cosmetic Compliance
Since the United Kingdom left the European Union, cosmetic products sold in the UK and the EU are now subject to separate regulatory systems. Although the legislation remains very similar, manufacturers wishing to market products in both regions must understand the additional compliance requirements.
Businesses that previously relied on a single regulatory process may now need separate Responsible Persons, separate product notifications and, in some cases, different product labelling.
Understanding these requirements early can help avoid delays, product withdrawals and unnecessary regulatory costs.
Selling Cosmetics in the European Union
Cosmetic products placed on the EU market must comply with Regulation (EC) No 1223/2009.
Manufacturers must ensure that:
• An EU Responsible Person has been appointed.
• A Cosmetic Product Safety Report (CPSR) has been completed.
• A Product Information File (PIF) is maintained.
• The product has been notified through the Cosmetic Product Notification Portal (CPNP).
• Product labelling complies with Article 19 of the Cosmetics Regulation.
These requirements apply to both EU manufacturers and companies exporting products into the European Union.
Selling Cosmetics in Great Britain
Cosmetic products sold in England, Scotland and Wales must comply with the UK Cosmetics Regulation.
Although much of the legislation mirrors the EU framework, products must comply with UK-specific requirements.
Manufacturers must ensure that:
• A UK Responsible Person has been appointed.
• Product notifications are submitted through the Submit Cosmetic Product Notifications (SCPN) portal.
• Product labels display the name and address of the UK Responsible Person where required.
• Product Information Files are available for inspection by UK authorities.
Northern Ireland continues to operate under separate arrangements due to the Windsor Framework, and manufacturers should consider these requirements where applicable.
EU Responsible Person vs UK Responsible Person
One of the most significant changes following Brexit is the requirement for separate Responsible Persons.
If a cosmetic product is marketed in both the European Union and Great Britain, manufacturers will generally require:
• An EU Responsible Person for products sold within the European Union.
• A UK Responsible Person for products sold within Great Britain.
Although these roles perform similar regulatory functions, they are appointed under different legal frameworks and interact with different Competent Authorities.
CPNP and SCPN Notifications
Manufacturers selling products in both markets should also understand the difference between the two notification systems.
The Cosmetic Product Notification Portal (CPNP) is used for products placed on the EU market.
The Submit Cosmetic Product Notifications (SCPN) service is used for products marketed in Great Britain.
Products marketed in both regions will normally require separate notifications through each system.
Product Labelling After Brexit
Labelling is another area that may require attention.
Depending on where products are marketed, manufacturers may need to update:
• Responsible Person details.
• Country of origin statements.
• Contact information.
• Product packaging.
Where cosmetic products are sold in multiple markets, careful planning can often minimise the number of packaging variations required while maintaining compliance.
Planning for Both Markets
Many cosmetic manufacturers choose to develop products for both the UK and EU simultaneously.
Preparing regulatory documentation for both jurisdictions at the same time can simplify product launches, reduce administrative effort and avoid duplicate work later in the product lifecycle.
Early planning is particularly beneficial where manufacturers intend to expand into additional international markets.
How Patient Guard Can Help
Patient Guard supports cosmetic manufacturers with both UK and EU regulatory compliance.
Our services include:
• EU Responsible Person services.
• UK Responsible Person services.
• Product Information File (PIF) preparation and review.
• Cosmetic Product Safety Report (CPSR) coordination.
• CPNP notifications.
• SCPN notifications.
• Cosmetic label reviews.
• Regulatory consultancy for UK and EU market access.
Whether you are launching a new cosmetic product or expanding into additional markets, our regulatory specialists can help you develop a compliance strategy that supports successful product launches in both the UK and European Union.
Importing Cosmetics into the EU
If you’re importing cosmetics from outside the EU (e.g. the USA, China, or the UK), you must:
Appoint an EU-based Responsible Person
Ensure the product meets all safety, labeling, and PIF requirements
Notify the product via CPNP
Make sure animal testing bans are respected
Non-EU companies cannot act as their own Responsible Person. They must work with a third-party regulatory expert based in the EU.
Cosmetic Ingredients and Restricted Substances
One of the primary objectives of the EU Cosmetics Regulation is to ensure that cosmetic products are safe for consumers. Achieving this starts with the careful selection of ingredients and compliance with the restrictions set out in Regulation (EC) No 1223/2009.
Not every ingredient can be used in cosmetic products, and many substances are either prohibited entirely or subject to strict concentration limits, purity requirements or conditions of use.
Manufacturers are responsible for ensuring that every ingredient used within a cosmetic formulation complies with the applicable regulatory requirements before the product is placed on the market.
Prohibited Ingredients
Annex II of the Cosmetics Regulation contains a list of substances that are prohibited in cosmetic products.
These ingredients must not be present in cosmetic formulations because they have been identified as posing unacceptable risks to human health.
The list is regularly updated to reflect new scientific evidence, meaning manufacturers should continually monitor regulatory developments to ensure ongoing compliance.
Restricted Ingredients
Some ingredients may be used safely, but only under specific conditions.
Annex III contains substances that are restricted according to factors such as:
• Maximum concentration.
• Product type.
• Intended user.
• Area of application.
• Warning statements.
• Method of use.
Manufacturers must ensure that these conditions are fully respected when developing cosmetic formulations.
Colourants
Many cosmetic products contain colouring agents to enhance appearance or provide decorative effects.
Only approved colourants listed in Annex IV may be used unless another legal exemption applies.
Each authorised colourant includes specific conditions governing its use, including permitted product categories and concentration limits.
Preservatives
Preservatives help protect cosmetic products from microbial contamination throughout their shelf life.
Only preservatives listed within Annex V may be used, and each preservative has defined concentration limits and conditions of use.
Using preservatives outside these permitted conditions may render the cosmetic product non-compliant.
UV Filters
Products such as sunscreens and moisturisers containing sun protection rely on ultraviolet filters.
Only UV filters authorised within Annex VI may be used for this purpose.
Manufacturers must ensure that UV filters are used within the permitted concentrations and only for their authorised functions.
Ingredient Safety Assessments
Ingredient compliance alone does not demonstrate that a cosmetic product is safe.
Every ingredient must also be considered within the Cosmetic Product Safety Report (CPSR), where the safety assessor evaluates factors including:
• Toxicological profile.
• Exposure level.
• Route of exposure.
• Frequency of use.
• Vulnerable user groups.
• Potential interactions between ingredients.
This ensures that the finished cosmetic product remains safe under normal and reasonably foreseeable conditions of use.
Keeping Up with Regulatory Changes
The European Commission regularly updates the Cosmetics Regulation to reflect advances in toxicology, scientific understanding and consumer safety.
New ingredients may become restricted, concentration limits may change and additional warning statements may be introduced.
Manufacturers should therefore maintain an ongoing process for monitoring regulatory updates and reviewing product formulations whenever changes occur.
Regular compliance reviews can help prevent products becoming non-compliant after they have already entered the market.
How Patient Guard Can Help
Understanding ingredient restrictions can be challenging, particularly for manufacturers marketing products across multiple countries.
Patient Guard supports cosmetic manufacturers by reviewing ingredient compliance, coordinating Cosmetic Product Safety Reports (CPSRs), preparing Product Information Files (PIFs) and advising on formulation changes to help ensure products continue to meet the requirements of Regulation (EC) No 1223/2009.
Cosmetic Claims and Supporting Evidence
A cosmetic product’s claims are often one of its strongest marketing tools. Statements such as “anti-ageing”, “clinically proven”, “natural”, “organic” or “dermatologically tested” can influence purchasing decisions, but under the EU Cosmetics Regulation these claims must be truthful, supported by evidence and must not mislead consumers.
The European Commission has established common criteria for cosmetic claims to ensure consumers receive accurate and reliable information. Manufacturers are responsible for ensuring that every claim made on product labels, packaging, websites, advertisements and social media can be substantiated.
The Six Common Criteria
Under Commission Regulation (EU) No 655/2013, cosmetic claims should comply with six common criteria:
• Legal compliance.
• Truthfulness.
• Evidential support.
• Honesty.
• Fairness.
• Informed decision-making.
Together, these principles help ensure that consumers are not misled about a cosmetic product’s characteristics, performance or benefits.
Supporting Product Claims
Every claim should be supported by appropriate evidence before the product is placed on the market.
Depending on the nature of the claim, supporting evidence may include:
• Laboratory testing.
• Stability studies.
• Clinical or consumer studies.
• Instrumental measurements.
• Published scientific literature.
• Ingredient supplier data.
The level of evidence should always be proportionate to the strength of the claim being made.
For example, a claim that a moisturiser “helps improve skin hydration” may require different evidence than a claim stating it “reduces wrinkles by 50%.”
Common Cosmetic Claims
Some of the most frequently used cosmetic claims include:
• Moisturising.
• Hydrating.
• Nourishing.
• Anti-ageing.
• Anti-wrinkle.
• Soothing.
• Sensitive skin.
• Dermatologically tested.
• Clinically tested.
• Natural.
• Organic.
• Vegan.
• Cruelty-free.
Each of these claims carries different regulatory considerations, and manufacturers should ensure they understand the evidence required before using them.
Natural and Organic Claims
Consumers increasingly look for cosmetic products described as “natural” or “organic.”
Although these terms are widely used within the cosmetics industry, manufacturers should ensure that such claims accurately reflect the composition of the product and are supported by appropriate evidence.
Using these descriptions in a misleading way may attract scrutiny from Competent Authorities or consumer protection organisations.
Before and After Images
Before and after photographs can be effective marketing tools but should accurately represent typical product performance.
Images should not exaggerate results through editing, lighting or other techniques that could mislead consumers regarding the effectiveness of the cosmetic product.
Social Media and Influencer Marketing
The same regulatory principles apply regardless of where a cosmetic claim is made.
Claims used on websites, online marketplaces, social media platforms or by influencers should all be consistent with the approved product claims and supported by appropriate evidence.
Manufacturers remain responsible for ensuring that promotional material complies with the Cosmetics Regulation.
Reviewing Claims Before Launch
Before launching a cosmetic product, manufacturers should review all marketing materials alongside the Product Information File (PIF) and Cosmetic Product Safety Report (CPSR).
This helps ensure that product claims remain consistent with the available evidence and reduces the risk of enforcement action, consumer complaints or product withdrawals.
How Patient Guard Can Help
Patient Guard supports cosmetic manufacturers by reviewing product claims alongside regulatory documentation to help ensure that marketing materials remain compliant with Regulation (EC) No 1223/2009. Our consultants can assess product claims, review supporting evidence and provide practical guidance before products are launched onto the European market.
Enforcement and Market Surveillance
Each EU country has its own competent authority (e.g., health or consumer safety agency) that enforces cosmetics regulation.
Authorities can:
Request access to the PIF
Test products for banned ingredients
Check label accuracy and claims
Investigate complaints or adverse events
Failure to comply can lead to:
Product recalls
Market bans
Fines or legal penalties
How Patient Guard Can Help
Navigating cosmetic regulations can be challenging, particularly for manufacturers launching products for the first time or expanding into new international markets. From product formulation and safety assessments through to Responsible Person services and ongoing regulatory compliance, every stage of the product lifecycle requires careful planning and documentation.
At Patient Guard, we provide practical regulatory support to cosmetic manufacturers, importers, distributors and brand owners, helping businesses confidently place compliant cosmetic products on both the European Union and UK markets.
Our experienced regulatory consultants work with organisations of all sizes, from start-ups launching their first skincare range to established international manufacturers managing extensive product portfolios.
Our Cosmetic Regulatory Services
Our cosmetic compliance services include:
• EU Responsible Person services.
• UK Responsible Person services.
• Cosmetic Product Safety Report (CPSR) coordination.
• Product Information File (PIF) preparation and review.
• Cosmetic Product Notification Portal (CPNP) submissions.
• Submit Cosmetic Product Notifications (SCPN) submissions for the UK market.
• Cosmetic label and artwork reviews.
• Cosmetic claims reviews and regulatory compliance assessments.
• Ingredient compliance reviews.
• ISO 22716 Good Manufacturing Practice guidance.
• Regulatory gap analysis.
• Ongoing regulatory support following product launch.
Whether you are developing a single cosmetic product or managing hundreds of formulations across multiple international markets, our team can provide scalable regulatory support tailored to your business.
Why Choose Patient Guard?
Patient Guard combines regulatory expertise with practical commercial experience.
Rather than simply identifying compliance issues, we work alongside manufacturers to develop realistic, proportionate solutions that support successful market access while maintaining consumer safety and regulatory compliance.
Our consultants understand both the technical and commercial challenges faced by cosmetic manufacturers, allowing us to provide advice that is both practical and aligned with current regulatory expectations.
By working with Patient Guard, you gain access to experienced regulatory professionals who can help simplify complex compliance requirements, reduce regulatory risk and support the successful launch of your cosmetic products.
Ready to Launch Your Cosmetic Products?
Whether you need an EU or UK Responsible Person, support preparing a Product Information File, assistance coordinating Cosmetic Product Safety Reports or advice on cosmetic regulations, Patient Guard can help.
Contact our regulatory specialists today to discuss your cosmetic compliance requirements and discover how we can support your journey from product development through to successful market launch.
Frequently Asked Questions About Cosmetic Regulations
Under Regulation (EC) No 1223/2009, a cosmetic product is any substance or mixture intended to come into contact with the external parts of the human body, such as the skin, hair, nails, lips or teeth, for the primary purpose of cleaning, perfuming, changing appearance, protecting, keeping in good condition or correcting body odours. Products intended to treat or prevent disease may instead be regulated as medicines or medical devices.
The EU Cosmetics Regulation (Regulation (EC) No 1223/2009) is the primary legislation governing cosmetic products placed on the European market. It establishes requirements covering product safety, ingredients, Good Manufacturing Practice (GMP), labelling, Product Information Files (PIFs), Responsible Persons and post-market surveillance.
Yes. Every cosmetic product placed on the EU market must have a designated Responsible Person established within the European Union. The Responsible Person is legally responsible for ensuring that the product complies with the Cosmetics Regulation before it is made available to consumers.
A Cosmetic Product Safety Report (CPSR) is a mandatory safety assessment completed before a cosmetic product is placed on the EU market. It evaluates the formulation, ingredients, toxicological profile, microbiological quality and intended use of the product to demonstrate that it is safe under normal or reasonably foreseeable conditions of use.
The Product Information File (PIF) is the technical documentation supporting the compliance of a cosmetic product. It typically includes the Cosmetic Product Safety Report (CPSR), manufacturing information, product description, evidence supporting product claims, labelling, and other regulatory documentation. The PIF must be retained for at least ten years after the final batch has been placed on the market.
The Cosmetic Product Notification Portal (CPNP) is the European Commission’s online notification system for cosmetic products. Before a cosmetic product is placed on the EU market, the Responsible Person must submit key information about the product through the CPNP to support market surveillance and poison centre activities.
ISO 22716 is the internationally recognised standard providing guidance on Good Manufacturing Practice (GMP) for cosmetic products. It covers manufacturing processes, quality management, documentation, personnel, equipment, storage and traceability to help ensure cosmetic products are consistently produced to appropriate quality standards.
Yes, but imported cosmetic products must fully comply with the EU Cosmetics Regulation before they are placed on the market. This includes appointing an EU Responsible Person, preparing a Product Information File (PIF), completing a Cosmetic Product Safety Report (CPSR), notifying the product through the CPNP and ensuring the product is correctly labelled.
Non-compliant cosmetic products may be subject to enforcement action by Competent Authorities. This can include requests for corrective actions, product withdrawals, recalls, financial penalties or restrictions on placing the product on the market. Maintaining complete regulatory documentation and monitoring products after launch helps reduce these risks.
Yes. Patient Guard provides comprehensive cosmetic regulatory support, including EU and UK Responsible Person services, Product Information File (PIF) preparation, Cosmetic Product Safety Report (CPSR) coordination, CPNP and SCPN notifications, cosmetic label reviews, claims assessments and ongoing regulatory consultancy to help manufacturers achieve and maintain compliance with both EU and UK cosmetic regulations.
Summary
Navigating the world of the EU cosmetics regulations may seem overwhelming at first. But once you understand the basics—product safety, documentation, labeling, and Responsible Person requirements—compliance becomes manageable.
Taking the right steps early on will protect your business, your customers, and your brand reputation.
If you need expert help with your cosmetic product compliance, Patient Guard is here to support you every step of the way.
Patient Guards Recent Posts
Why Notified Bodies Reject IVDR Performance Evaluation Reports: The Top 3 Mistakes Manufacturers Make
More than half of IVDR submissions face deficiencies during Notified Body review, with Performance Evaluation Reports (PERs) among the most common areas of concern. Learn the three critical mistakes that lead to PER rejections—including weak State of the Art justification, non-systematic literature reviews, and poor traceability between Scientific Validity, Analytical Performance, and Clinical Performance data—and discover how to build a compliant, audit-ready IVDR technical file.
10 Common Technical Documentation Deficiencies Found During EU MDR and IVDR Notified Body Reviews
Preparing technical documentation for EU MDR or IVDR certification is only half the challenge. Successfully passing a Notified Body review depends on demonstrating consistency across your Quality Management System, Clinical Evaluation, Risk Management, Biological Evaluation, Performance Evaluation and Post-Market Surveillance activities. Discover ten of the most common technical documentation deficiencies identified during MDR and IVDR conformity assessments—and learn how to reduce the likelihood of costly review cycles and certification delays.
EU Authorised Representative Services for Medical Device & IVD Manufacturers
Selling medical devices or IVDs in Europe? If your company is based outside the EU, appointing an EU Authorised Representative (EC Rep) is a legal requirement under EU MDR 2017/745 and IVDR 2017/746. Patient Guard provides expert EU Authorised Representative services, EUDAMED support, regulatory guidance, and ongoing compliance management to help manufacturers access and maintain the European market with confidence.
