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EU & UK Cosmetic Regulations – Compliance Guide
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Regulation EU & UK Cosmetic Regulations – Compliance Guide
Ensuring compliance with EU & UK cosmetic regulations is essential for launching and maintaining cosmetic products on the market. Since the regulatory landscape differs between the EU and UK, it is important for brands to follow distinct processes. Therefore, this guide explains the fundamental legal requirements, notification processes, and essential documentation for achieving full compliance in both regions.
Key Differences Between EU & UK Cosmetic Regulations
European Union (EU)
United Kingdom (UK)
Governed by Regulation (EC) No. 1223/2009, which mandates strict compliance with safety assessments, Responsible Person designation, and centralized product notification through the Cosmetic Product Notification Portal (CPNP). As a result, companies must ensure that they meet these requirements before placing products on the EU market.
Following Brexit, the UK implemented The UK Cosmetics Regulation (Schedule 34 of the Product Safety and Metrology Statutory Instrument 2019), which introduced the requirement for a UK-based Responsible Person (RP) and product registration via the Submit Cosmetic Product Notification (SCPN) system. This means that brands now need to comply with slightly different regulatory requirements depending on the market in which they are operating.
Key Compliance Differences
Regulatory Body: EU (European Commission) vs. UK (OPSS – Office for Product Safety & Standards)
Notification Portal: CPNP (EU) vs. SCPN (UK)
Responsible Person Location: RP must be in the respective market
With time there are more and more differences in the Safety assessment requirements and undividual ingredients regulation
EU Cosmetic Compliance Process
Cosmetic Product Safety Report (CPSR): Every cosmetic product must undergo a comprehensive safety assessment, ensuring compliance with Regulation (EC) No. 1223/2009. Moreover, this step is essential for demonstrating product safety.
Responsible Person (RP): The designated RP ensures legal compliance, maintains the Product Information File (PIF), and is responsible for post-market surveillance. In addition, the RP acts as the primary contact for regulatory authorities.
CPNP Notification: Before launching a product, it must be registered on the CPNP. Consequently, this step ensures that regulatory bodies have access to product data in case of safety concerns.
UK Cosmetic Compliance Process
CPSR for UK: Safety assessments remain a requirement, similar to EU legislation but must comply with UK-specific regulations. Similarly, this ensures that products meet all necessary safety criteria.
UK Responsible Person (UK RP): A company or individual based in the UK must take legal responsibility for compliance. In other words, brands outside the UK must appoint a local representative to oversee regulatory obligations.
SCPN Notification: All cosmetic products must be registered through the Submit Cosmetic Product Notification (SCPN). Thus, compliance with this requirement is mandatory for selling products in the UK market
Key Documents Required for EU & UK Compliance
Product Information File (PIF): Contains full details of the product, formulation, manufacturing process, and safety assessment.
Safety Data Sheets (MSDS): Provides chemical and hazard details to ensure safe handling.
Challenge Testing & Stability Testing: Essential for ensuring long-term product safety and efficacy.
Common Compliance Challenges & How We Help
Navigating Brexit Changes: Understanding the divergence between EU & UK regulations is often complex. However, our expert team simplifies the process and ensures compliance.
Product Classification Issues: Ensuring your product is correctly classified under cosmetic law is crucial. Otherwise, misclassification may result in regulatory issues and delays.
Labeling & Claims Compliance: Meeting legal requirements for ingredient listings and product claims is necessary. Therefore, we provide thorough label reviews to ensure compliance with EU and UK standards.
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PIF
Every cosmetic product sold in the European Union have to have a Product Information File (PIF), containing all information about the product, such as product description, Cosmetic Product Safety Report, details of methods of manufacture (GMP), proof of the effect claimed,…
PIF is a legal requirement and the files must be open to the competent authorities. The PIF has to be kept by the Responsible Person for ten years from the date when the last batch of the product was placed on the market.
CLAIM SUPPORT
In Europe Cosmetic claims, which are usually used to market purposes, are highly regulated as to avoid any misleading advertising and are mentioned in article 20 of Regulation 1223/2009: “In the labeling, making available on the market and advertising of cosmetic products, text, names, trademarks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have.”
FORMULA REVIEW
Before entering European market you should make sure that products that you want to place on the market are fully compliant with the Annexes of the Regulation. As these annexes are updated several times a year, it is important to note that this work must be done on a regular basis.
SA
Safety assessment/ Cosmetic product safety report (CPSR) is a paper that ensures the safety of a product and includes all the necessary testing. Safety assessor which is required to have an official qualification recognized by a Member State. checks whether the product is compliant with the EU cosmetics regulation and whether it is safe for use or not. Its aim is to prove that the cosmetic product does not pose a threat to human health. Based on the information and tests compiled in part A of the CPSR, safety assessment contains the safety assessor’s conclusion on the safety of the cosmetic product.
CPNP
Cosmetic Products Notification Portal (CPNP) is an EU online notification system, where responsible persons and, under certain circumstances, the distributors of cosmetic products, submit certain information about the cosmetic products that they place or make available on the EU market. This information is then made available to the EU member states’ competent authorities and poison centres. Cosmetic Regulation no. 1223/2009 demands to that any organization wishing to place a cosmetic product on the European market must notify it online via CPNP portal before doing so. The CPNP is making this information available electronically to the Competent Authorities.
LABEL REVIEW
Dr. Burstein & Waymore can also provide labelling guidance for products which includes advice on ingredient labelling and regulatory labelling requirements.
DR. Burstein & Waymore will review your cosmetic label and packaging, and introduce you with mandatory information that must be printed on every product label and identify and correct any mistakes or enforcement risks before you place your products on EU market.
Ensuring cosmetic product safety is not just an industry best practice—it is a legal requirement in both the EU and UK. According to EU Regulation (EC) No. 1223/2009, all cosmetics sold in the European market must undergo strict safety assessments before they can be made available to consumers. This includes toxicological risk evaluations, stability testing, microbiological testing, and compliance with Good Manufacturing Practices (GMP).
Similarly, in the UK, cosmetic products must comply with the UK Cosmetic Products Regulation 2019. Companies that intend to sell their products in the UK must register them via the Submit Cosmetic Product Notification (SCPN) portal, ensuring full transparency with local regulatory authorities.
What Are the Key Requirements for Cosmetic Certification?
Compliance with EU & UK Safety Regulations
To sell cosmetics legally in the EU and UK, brands must ensure compliance with strict regulatory frameworks. This includes:
- Product Safety Assessments (CPSR)
- Product Information Files (PIF)
- Responsible Person (RP) Appointment
- Proper Labeling and Claim Substantiation
For detailed guidance on international safety standards, companies can refer to the ISO 22716 standard for GMP in cosmetics, which outlines best practices for manufacturing, storage, and distribution of cosmetic products.
Product Testing & Certification
Cosmetic products must undergo rigorous testing to ensure consumer safety and product efficacy. Standard tests include:
- Microbiological Testing – Ensuring the product is free from harmful bacteria.
- Challenge Testing (Preservative Efficacy Test) – Verifying the effectiveness of preservatives in preventing contamination.
- Stability & Compatibility Testing – Checking how the product performs under different environmental conditions.
Manufacturers looking to meet international certification standards should adhere to ISO 22716, ensuring quality control and regulatory compliance in production.
Notification in EU & UK Regulatory Portals
Before a cosmetic product can enter the market, it must be notified to the relevant regulatory body:
- For the EU, brands must submit product details via the Cosmetic Product Notification Portal (CPNP).
- For the UK, companies must register products via the Submit Cosmetic Product Notification (SCPN) system.
By ensuring regulatory compliance, robust testing, and proper documentation, brands can confidently bring their products to market while maintaining consumer trust and avoiding legal risks.
Need Help with Cosmetic Certification?
Navigating cosmetic regulations and certification can be complex, but our team of regulatory experts can help. Whether you need assistance with safety assessments, product testing, or Responsible Person services, we provide tailored compliance solutions to help your business grow.
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CONSULTANCY SERVICES for EU regulation in cosmetics
We provide consultancy services in the cosmetics industry on regulatory affairs and the EU legislations compliance. Dr. Burstein and Waymore team can advise and support you in ensuring the compliance of your cosmetic products, as per Regulation (EC) No.1223/2009 and in your development activities.
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