UK Cosmetics Regulation: An Introduction for New Brands

The UK cosmetics market is full of opportunity, but just like any established industry, it comes with its own set of rules. For new brands, understanding UK cosmetics regulation is a legal necessity and a smart strategic move. Getting it right from the start builds consumer trust, protects your brand, and paves the way for sustainable growth.

You might be aware that after leaving the European Union, the UK established its own independent regulatory system for cosmetics. While this system still shares many similarities with the EU’s original Cosmetics Regulation (EC) No 1223/2009, it’s crucial to understand that it has been, and continues to be, adapted specifically for the UK.

Since 2021, we’ve seen significant revisions and the introduction of unique UK-specific requirements. This means that simply complying with EU standards isn’t enough to operate legally in Great Britain. This guide offers clear, actionable steps to help your brand achieve full compliance from the moment you conceive your product to when it reaches your customers.

To successfully launch a cosmetic product in Great Britain, it’s essential to understand the legislative framework that underpins UK cosmetics regulation. The current structure has evolved significantly over time, with the most impactful amendments occurring in 2021, post-Brexit.

This regulation is fundamentally based on the European Union’s Cosmetics Regulation (EC) No 1223/2009. However, it’s vital to note that the UK has incorporated additional, specific requirements reflecting its independent regulatory demands. The UK framework is not a static copy of its EU predecessor.

This active divergence means that compliance with EU regulations doesn’t automatically guarantee compliance in the UK. That presents a dual-compliance challenge for businesses operating across both markets, requiring separate regulatory strategies and diligent monitoring of UK-specific updates. For brands focused solely on the UK market, this requires a focused approach to the unique UK requirements.

Before you consider ingredients or packaging, the first step in UK cosmetics regulation is to correctly identify whether your product is actually a cosmetic. This is the foundation upon which all other compliance efforts are built.

A product is classified as a cosmetic if it meets three specific criteria, all of which must be present:

• Its Field of Application: Cosmetic products are applied exclusively to the external parts of the human body. This includes the epidermis (your skin), hair system, nails, lips, and external genital organs. It also extends to the teeth and the mucous membranes of the oral cavity (your mouth).
• Its Function: The purpose of a cosmetic product is defined by what it does. It must be intended to:
  • Cleanse
  • Perfume
  • Change appearance
  • Protect
  • Keep in good condition
  • Correct body odours.

• Its Composition: While the exact ingredients determine safety, the type of composition must be suitable for the functions and application described above.

Crucially, certain products are explicitly excluded from the cosmetic product definition. Products that are intended to be:

• Ingested (swallowed)
• Inhaled (breathed in)
• Injected (put into the body with a needle)
• Implanted (surgically placed inside the body).

…are NOT classified as cosmetics.

For example, an aromatherapy product designed to be diffused and inhaled rather than applied to the skin would not be a cosmetic. Similarly, “beauty from within” supplements that claim to improve skin or hair by being swallowed are typically regulated as food supplements, not cosmetics.

A common challenge for new brands lies with borderline products, those that might blur the lines between a cosmetic, a medicinal product, a food supplement, or a biocidal product.

Product classification for these cases is determined on a case-by-case basis. A single product might even fall under multiple regulatory frameworks due to varied functionalities.

Why correct product classification is critical:

• Vastly Different Rules: Misclassifying a product (e.g., as a cosmetic when it’s medicinal) leads to drastically different and far more stringent compliance requirements (e.g., clinical trials for medicinal products).
• Significant Regulatory Risk: Incorrect classification can result in immediate non-compliance, costly product recalls, and severe legal repercussions.

Proactive Measures: Investing in expert regulatory advice during development is a crucial proactive step for any potentially ambiguous product. It helps avoid significant market entry risks and ensures a smooth path to market under the correct UK cosmetics regulation.

The absolute cornerstone of UK cosmetics regulation is product safety. Every cosmetic product must be safe for human health when used under normal or reasonably foreseeable conditions. This is a non-negotiable principle.

To ensure this, strict rules govern ingredient restrictions. For example, brands must adhere to “positive lists” (Annex 4, 5, or 6 of the UK Regulation) when using colourants, preservatives, or UV-filters, meaning only explicitly listed substances may be used.

Beyond safety, all claims made about a cosmetic product must be substantiated. This means you need solid, verifiable evidence to back up any benefits or effects you advertise. Brands must avoid misleading claims or those implying medicinal effects, like “cure” or “rejuvenation,” as these are unlikely to be acceptable.

There’s a critical link between your product’s formulation, its cosmetic product safety assessment, and your marketing claims. Any change in an ingredient directly impacts the safety assessment, which then dictates what claims can legally be made and how the product is labelled.

An integrated strategy is essential for new brands. Considering regulatory compliance from the earliest stages of product development and marketing will help you avoid costly rework, ensure consumer safety, and protect your brand’s integrity.

Once you understand what defines a cosmetic product in the UK, your next step is to master the essential compliance requirements. These practical steps and ongoing obligations ensure your brand operates legally and ethically in the UK market.

Before your cosmetic product can reach consumers in Great Britain, you must designate a UK Responsible Person (UK RP). This isn’t optional; it’s a mandatory legal requirement and often the first critical step for new brands, especially those without a physical presence in the UK.

The UK RP must be established in the UK and have a physical UK address (no PO boxes or mail forwarding). This individual or entity acts as your brand’s legal representative in the UK, bearing significant legal and operational responsibility.

The UK RP’s extensive duties include:

• Ensuring product safety and overall compliance with UK cosmetics regulations.
• Maintaining the Product Information File (PIF) (which we’ll discuss next).
• Submitting the Cosmetic Product Notification (SCPN) to the authorities.
• Taking necessary corrective actions, such as withdrawing or recalling products, if issues arise.
• Serving as the primary contact point for UK competent authorities (like the Office for Product Safety and Standards (OPSS)).

For new brands, particularly those based outside the UK, appointing a highly competent and reliable UK Responsible Person is vital. This decision directly impacts your ability to legally market and manage your products in the UK.

A Product Information File (PIF) is a mandatory, comprehensive document that must be compiled and maintained for every cosmetic product you place on the UK market. Think of it as your product’s complete regulatory dossier.

Key aspects of the PIF:

• Location and Availability: It must be kept in English at the UK RP’s address and readily available to market surveillance authorities upon request.
• Content: The PIF provides a detailed blueprint of your product, including:
  • A full description of the cosmetic product.
  • Its manufacturing process and proof of product efficacy.
  • Crucially, the Cosmetic Product Safety Report (CPSR), which confirms the product’s safety.
  • Information on Good Manufacturing Practice (GMP) compliance.
  • Details regarding animal testing (if applicable).
• Maintenance: The PIF is a living document. It requires regular updates to reflect any changes to the product or relevant regulatory information.
• Retention: It must be retained for at least 10 years after the last batch of the product was placed on the market.

Establishing clear internal systems for PIF creation, management, and version control is vital. A well-organised, up-to-date PIF demonstrates due diligence and ensures readiness for potential regulatory audits, minimising the risk of non-compliance penalties.

The Cosmetic Product Safety Report (CPSR) is another mandatory document that sits within your PIF and unequivocally demonstrates your product’s safety before it can be sold in Great Britain. This report is highly detailed, covering toxicological profiles, exposure assessments, and a conclusive safety assessment.

Key requirements for the CPSR:

• Qualified Assessor: The safety assessment must be conducted and signed by a suitably qualified, UK-based professional. This person typically holds a university degree in pharmacy, toxicology, medicine, or a similar scientific discipline.
• RP Responsibility: It is the explicit responsibility of the UK Responsible Person to ensure that this assessment is carried out correctly by the qualified assessor.

The CPSR process is a rigorous scientific validation, not merely an administrative step. For new brands, particularly those with novel ingredients or complex formulations, a thorough CPSR is critical. It’s a primary risk management tool, preventing unsafe products from reaching consumers and safeguarding your brand’s reputation.

All cosmetic products sold in the UK must be manufactured in accordance with Good Manufacturing Practices (GMP). This is fundamental to ensuring the consistent quality and safety of your products throughout the production process.

The international standard ISO 22716 provides the recognised guidelines for GMP, specifically within the cosmetic industry. It covers everything from raw material selection and handling to production, quality control, storage, and shipment.

Adhering to ISO 22716 offers significant benefits:

• Ensures products are safe and of high quality, boosting customer satisfaction.
• Significantly reduces the risk of costly product recalls.
• Streamlines manufacturing processes.
• Ensures compliance with broader UK cosmetics regulation requirements.

For new brands, establishing and adhering to GMP from the outset is essential. Failure to implement effective GMP can lead to inconsistencies, safety issues, and recalls.

Clear and compliant product labelling is essential under UK cosmetics regulations. Labels are not just marketing tools. They’re legal documents conveying critical safety and product information.

Mandatory information that must appear on UK cosmetic product labels includes:

• Brand name and product name.
• Nominal quantity (e.g., net weight or volume).
• A complete list of ingredients in INCI (International Nomenclature of Cosmetic Ingredients) format, ordered by weight in descending order.
• Batch number for traceability.
• A “use-by” date (if shelf life is less than 30 months) or a Period-After-Opening (PAO) symbol (an open jar with a number of months/years) for products with a longer shelf life.
• Any necessary warnings or precautions for safe use.
• The name and UK address of the Responsible Person.
• All labels must be in English.

Key differences from EU labelling requirements (critical for new brands):

• Responsible Person Address: The label must clearly display the name and UK address of your designated UK RP. If selling in both the EU and UK, both EU and UK RP addresses may be required on the label.
• Country of Origin: The specific country of origin (e.g., “Made in the UK”) must be mentioned. The general wording “Made in the EU” is not permitted for products sold in the UK.

Misleading or non-compliant labels can lead to product recalls, fines, or market bans. Investing in thorough label review and compliance checks by experts is highly advisable to avoid costly market disruptions.

Under UK cosmetics regulation, all claims made about a cosmetic product, whether explicit or implied, must be truthful, not misleading, and supported by adequate, verifiable evidence. Marketers are legally required to hold documentary evidence for their claims before publishing any marketing communication.

Key considerations for advertising and claims:

• Evidence Standard: Efficacy claims for beauty products often require support from tests conducted on people. Laboratory (in-vitro) trials are frequently insufficient on their own. For new or breakthrough claims, a strong body of data, including at least one controlled human experimental study, is typically needed.
• Avoid Misleading Practices: Do not exaggerate product effects through implied claims, “before and after” photos, or post-production retouching. Objective claims cannot be supported solely by subjective feedback.
• Medicinal Claims: Be extremely cautious. Claims suggesting a product can treat or prevent disease or modify physiological function through pharmacological means are considered medicinal. If your product is classified as medicinal by the MHRA (Medicines and Healthcare Products Regulatory Agency), it requires a Marketing Authorisation before sale in the UK, which is a vastly different regulatory pathway. Prescription-only products cannot be advertised to the public.

The Advertising Standards Authority (ASA) monitors compliance across broadcast and non-broadcast platforms. The Committee of Advertising Practice (CAP) Code specifically regulates non-broadcast advertising (including digital, print, and websites), ensuring claims are substantiated, clear, and non-misleading. New restrictions also prohibit advertising for cosmetic interventions (e.g., injectables) from being targeted at under-18s.

Over-promising or misrepresenting product effects can lead to significant regulatory action, fines, mandatory withdrawals, and severe reputational damage. It is highly advisable to seek a pre-publication review of all marketing communications by regulatory experts to ensure compliance and avoid costly challenges.

UK cosmetics regulation is undergoing significant changes, particularly concerning ingredient restrictions, coming into force in 2025. New brands must be acutely aware of these updates to ensure continuous compliance and avoid market disruptions.

Several critical changes to ingredient regulations are impacting cosmetics in 2025. These include:

• CMR Substances (Carcinogenic, Mutagenic, or Reprotoxic): The UK has introduced a phased ban on 64 CMR substances, adding them to Annex II of the UK Cosmetics Regulation, prohibiting their use. Specific deadlines apply for placing them on the market and making them available. It’s crucial to note that some chemicals banned by the EU as CMRs may still be allowed in UK cosmetics if not classified as CMR under UK law, highlighting a key divergence.
• Methyl Salicylate: New restrictions on Methyl Salicylate introduce specific concentration limits, notably for children aged 0.5 to 1 year, a provision not currently in EU regulation. The UK also sets general limits for hair products (spray/aerosol vs. non-spray) and other product types, including toothpaste and mouthwash.
• Kojic Acid: This substance is now restricted to concentrations below 1% in face and hand products, with deadlines for new and existing stock.
• BHT (Butylated Hydroxytoluene): The UK has implemented specific restrictions that extend beyond EU scope, notably banning BHT in all leave-on oral care products where the EU permits it. New limits apply to toothpaste, mouthwash, and other product types.

Before marketing any cosmetic product in Great Britain, your UK RP must legally register it on the Submit Cosmetic Product Notification (SCPN) portal. This is a cornerstone of UK cosmetics regulation, ensuring traceability and consumer safety. The Office for Product Safety and Standards (OPSS) oversees this.

Failure to notify products can lead to significant penalties, including unlimited fines in England and Wales. Successful notification provides a unique SCPN number, acting as the product’s official UK market identification. Remember, Northern Ireland continues to follow EU regulations and uses the CPNP.

Only a UK-based RP can submit products to the SCPN. The process requires accurate submission of detailed information, including:

• Product name, reference number, category, form, and packaging.
• Responsible Person’s name, address, and contact details.
• Exact location of the Product Information File (PIF).
• Country of origin and first market placement.
• The presence of nanomaterials and the identification of any CMR substances are also important.
• Full ingredient list (INCI names, concentrations).
• Confirmation of labelling compliance and a current product image.

It’s important to note that products previously registered in the EU’s CPNP need separate registration in the UK’s SCPN. The process can be complex, so new brands often benefit significantly from expert assistance.

SCPN registration isn’t a one-time event. Any changes in product formula, packaging, or labelling (if affecting mandatory information) require an update to the notification. If a brand ceases to sell a product, the RP must notify this through the SCPN. Continuous adherence is crucial. Failing to keep notifications updated can lead to severe penalties and market withdrawal.

Launching a new cosmetics brand in the UK in 2025 demands more than just a great product. It requires confident management of UK cosmetics regulation demands. Proactive compliance is paramount for sustainable success.

Managing these demands can be daunting. Russell Regulatory Consultants offers regulatory services designed to simplify this process, from safety assessments and documentation to acting as your UK Responsible Person and providing ongoing compliance monitoring. Our approach de-risks your market entry, accelerates time-to-market, and frees you to focus on innovation.

Ready to launch your brand with confidence? Don’t let regulatory complexities be a barrier. Partner with Russell Regulatory Consultants and gain the peace of mind that comes from expert guidance. We’re ready to turn your compliance challenges into clear strategies, helping you build a trusted and thriving brand.

Connect with us today, and let’s discuss your regulatory needs in the ever-changing UK market.

1. legislation.gov.uk. Regulation (EC) No 1223/2009 on cosmetic products. Accessed 10th June 2025.
2. CTPA. Definition of a Cosmetic. Accessed 10th June 2025.
3. gov.uk. Cosmetic Products Enforcement Regulations 2013 and Regulation (EC) No 1223/2009. May 2023.
4. ISO. ISO 22716:2007 Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices. Accessed 10th June 2025.
5. CIRS-REACH. International Nomenclature of Cosmetic Ingredients (INCI). Accessed 10th June 2025.
6. gov.uk. Medicines and Healthcare products Regulatory Agency. Accessed 10th June 2025.
7. ASA. Advertising Codes. Accessed 10th June 2025.
8. Coslaw.eu. UK Bans 13 Additional CMR Chemicals in Cosmetics. 7th October 2024.
9. CTPA. UK Cosmetics Regulation Amendment Published – Contains Methyl Salicylate. April 1st, 2025.
10. Vogue Business. What new rules for kojic acid mean for skincare brands. 24th June 2024.
11. The Good Face Project. New UK Cosmetic Product Regulations Mark a Significant Departure from EU Regulations. Accessed 10th June 2025.
12. gov.uk. Submit a cosmetic product notification. Accessed 10th June 2025.