Navigating the UK cosmetics market: packaging, manufacturing, and regulatory compliance

The United Kingdom’s cosmetics market represents a significant and dynamic commercial landscape, offering substantial opportunities for both established brands and emerging enterprises. It is a sector characterized by high consumer engagement, continuous innovation, and robust sales. However, access to this lucrative market is not unconditional. It is predicated on strict adherence to a sophisticated and rigorous regulatory framework designed with the primary objective of ensuring a high level of protection for human health. For any business operating within this space, it is imperative to understand that packaging is far more than a mere vessel for the product. It is a critical, multi-faceted component that stands at the intersection of brand identity, consumer experience, product formulation stability, and, most crucially, legal and regulatory compliance. Every decision, from the choice of material for a bottle to the font size on a label, carries significant legal and commercial weight. Failure to comply with the stringent laws in place can lead to severe consequences, including substantial fines, product recalls, reputational damage, and even imprisonment.

The post-brexit regulatory paradigm

The departure of the United Kingdom from the European Union has fundamentally reshaped the regulatory environment for cosmetics. While the foundational principles of safety and accountability remain, the UK has established its own sovereign legal framework, which, although initially mirroring its EU predecessor, is now on a path of active and increasing divergence. This has created a new paradigm for businesses, particularly those with operations or sales channels in both Great Britain (GB)—comprising England, Scotland, and Wales—and the European Union, which for regulatory purposes includes Northern Ireland under the terms of the Windsor Framework.

This separation has given rise to a significant operational, legal, and financial challenge for the industry. Businesses aiming to serve both the GB and EU/NI markets are now confronted with the necessity of navigating two distinct, parallel regulatory systems. This is not simply a matter of duplicating paperwork; it requires maintaining separate legal representatives (known as the ‘Responsible Person’), notifying products on two different governmental portals, adhering to diverging labelling requirements, and closely monitoring the growing list of differing ingredient restrictions. This dual-track system necessitates a fundamental strategic re-evaluation for companies of all sizes. The complexities introduced by this bifurcated framework disproportionately affect small and medium-sized enterprises (SMEs) and startups, which may lack the specialized legal, financial, and personnel resources to manage two parallel compliance streams effectively. This reality can act as a significant barrier to trade and expansion, compelling businesses to make difficult strategic choices about which markets to prioritize and introducing new layers of complexity into supply chain management and the overall cost of goods.

The anatomy of cosmetic packaging

The selection of cosmetic packaging is a critical strategic decision that extends far beyond aesthetics. It is the physical manifestation of a brand’s commitment to product safety, quality, and legal compliance. The choice of materials and container design has direct and profound implications for product stability, manufacturing processes, and adherence to the stringent labelling regulations mandated in the UK. This necessitates a deeply integrated, cross-functional approach to packaging development, where marketing, research and development (R&D), operations, and legal compliance teams collaborate from the project’s inception. A decision made in isolation by one department, such as marketing selecting a uniquely shaped but small bottle for its visual appeal, can create insurmountable challenges for the compliance team tasked with fitting legally required information on the label, or for the operations team whose filling lines may not be compatible. This interconnectedness underscores that packaging is not a siloed function but a central nexus where multiple business priorities converge.

Primary and secondary packaging materials

The materials used for cosmetic packaging are chosen based on a balance of factors including product compatibility, brand positioning, cost, and increasingly, environmental impact.

Traditional materials

• Glass: Long associated with luxury and prestige, glass is highly valued for its chemical inertness, making it an ideal choice for sensitive or high-end formulations such as serums, essential oils, and perfumes. Its impermeability protects contents from atmospheric oxygen and moisture, preserving product integrity. Furthermore, glass is 100% recyclable without loss of quality or purity, a significant sustainability credential. However, its inherent weight and fragility present logistical challenges and increased shipping costs, which must be factored into the overall product budget.
• Plastics: Plastic is the most ubiquitous material in cosmetic packaging, accounting for a majority of containers due to its versatility, light weight, durability, and cost-effectiveness. Different polymers are used for specific applications. Polyethylene Terephthalate (PET) is often chosen for its clarity, resembling glass, and provides a good barrier against oils, making it suitable for lotions and cleansers. High-Density Polyethylene (HDPE) is more rigid and opaque, with excellent moisture and chemical resistance, making it a common choice for shampoo and conditioner bottles. Polypropylene (PP) is another versatile option used for jars and closures.
• Metal: Aluminum is the most common metal used in cosmetic packaging, prized for its premium, modern aesthetic and its ability to provide a robust barrier against light, moisture, and air. It is frequently used for luxury cream pots, high-end balms, and as the material for aerosol dispensers and tubes for products like hair dyes.

Sustainable & eco-conscious materials

Driven by intense consumer demand and evolving corporate responsibility standards, the industry has seen a rapid expansion in the use of sustainable packaging materials.

• Post-Consumer Recycled (PCR) Materials: This involves using plastics, glass, and aluminum recovered from consumer waste streams to create new packaging. Utilizing PCR materials reduces the demand for virgin resources, diverts waste from landfills, and lowers the carbon footprint of packaging production, supporting a circular economy.
• Bioplastics & Biodegradable Materials: Derived from renewable biological sources like corn starch, sugarcane, or cellulose, bioplastics offer an alternative to fossil-fuel-based plastics. They are particularly popular with brands marketing themselves as natural or organic. However, their adoption comes with challenges, as many bioplastics require specific industrial composting conditions to biodegrade and can contaminate conventional plastic recycling streams if not disposed of correctly.
• Bamboo & Wood: These materials are increasingly favored for their natural, tactile aesthetic and strong sustainability credentials, especially bamboo, which is a fast-growing, renewable resource. They align perfectly with the branding of organic and eco-friendly product lines, often used for caps, lids, and compacts.
• Paper & Cardboard: These materials are the standard for secondary packaging, such as the outer cartons and boxes that house the primary container. They are highly customizable, offering extensive options for printing and finishing (e.g., embossing, foiling), and are widely recyclable, making them a cost-effective and eco-friendly choice.

Container types and dispensing systems

The form of the container is intrinsically linked to the product’s formulation, its application method, and the desired user experience.

• Jars: Typically used for thicker products like creams, balms, and body butters, jars allow the user to access the entire product. Double-walled jars, often made from PP or with a glass outer and plastic inner, provide an extra layer of protection and convey a more luxurious feel.
• Bottles: The workhorse of the industry, bottles are used for a vast range of liquid and lotion-based products. Their functionality is defined by their closure or dispensing system, which can include simple screw caps, flip-top caps, lotion pumps, fine-mist sprayers, or precision droppers for serums and oils.
• Tubes: A popular choice for creams, gels, and cleansers, tubes offer hygienic, controlled, and portable dispensing. They can be made from single-layer polyethylene (PE) or more complex multi-layer or laminate structures that provide enhanced barrier protection against oxygen and light, crucial for preserving the stability of certain active ingredients.
• Airless Pump Systems: This technology is critical for advanced skincare formulations containing ingredients that are highly susceptible to degradation from air exposure, such as antioxidants like Vitamin C, retinol, and certain peptides. An airless system uses a non-pressurized vacuum mechanism, often with a piston that rises from the bottom of the container, to dispense the product without letting air in. This protects the formulation’s integrity, preserves its efficacy, and can extend its shelf life, often reducing the need for certain preservatives.
• Compacts and Sticks: These formats are designed for solid or semi-solid products. Compacts are used for pressed powders, eyeshadows, and blushes, while stick applicators are used for lip balms, deodorants, and solid perfumes.

Emerging trends in packaging design & strategy

The cosmetic packaging landscape is continuously evolving, driven by shifts in consumer behavior, technological advancements, and the pressing need for sustainability.

• Refillable & Reusable Systems: This is one of the most significant trends in sustainable packaging. The model typically involves a durable, aesthetically pleasing outer container (the “master” pack) that the consumer keeps, and a simpler, often lighter and more recyclable, inner pod, cartridge, or pouch that can be purchased separately to replenish the product. This approach drastically reduces single-use packaging waste and can foster strong brand loyalty by creating an ongoing relationship with the consumer. However, designing effective refillable systems requires careful consideration of hygiene, ease of use for the consumer, and ensuring the integrity of the product with each refill.
• Minimalist Design: This aesthetic philosophy emphasizes “less is more,” using clean lines, simple and often sans-serif typography, a restrained color palette, and an uncluttered layout. Minimalism aims to project an image of sophistication, transparency, and confidence in the product itself. It is often closely aligned with the “clean beauty” movement, where the simplicity of the packaging reflects the perceived purity of the formulation. While visually powerful, minimalist designs must still successfully incorporate all legally mandated labelling information, which can be a significant design challenge.
• Smart Packaging: This trend involves the integration of digital technologies into packaging to enhance the consumer experience. The most common application is the use of QR codes printed on the packaging. When scanned with a smartphone, these codes can link the consumer to a wealth of digital content, such as detailed ingredient information, video tutorials on how to use the product, traceability data to prove authenticity, or interactive brand experiences. This not only adds value for the consumer but can also help reduce the amount of information that needs to be printed on leaflets or inserts, thus contributing to waste reduction.

Manufacturing, bottling, and filling

The process of manufacturing and filling cosmetic products in the UK is governed by a strict legal requirement for quality and safety. This section details the mandatory framework of Good Manufacturing Practice (GMP), the technologies used in the filling process, and the critical quality control measures that ensure product integrity from production line to retail shelf.

The legal mandate: good manufacturing practice (GMP)

Adherence to Good Manufacturing Practice (GMP) is not merely a best-practice recommendation; it is a legal obligation under the UK Cosmetics Regulation. The regulation establishes that all cosmetic products placed on the UK market must be manufactured in accordance with GMP. The industry benchmark for demonstrating compliance is the internationally recognized standard ISO 22716:2007 – Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices. Adherence to this standard creates a presumption of conformity with the regulation’s GMP requirements.

ISO 22716 provides a comprehensive framework for the production, control, storage, and shipment of cosmetic products. Its core principles are designed to manage quality and safety risks effectively throughout the manufacturing process. Key tenets include:

• Personnel: All staff involved in the manufacturing process must have appropriate training, skills, and clearly defined roles and responsibilities. The standard places a strong emphasis on personal hygiene and health to prevent product contamination.
• Premises: Manufacturing facilities must be designed, constructed, and maintained to facilitate proper cleaning, prevent cross-contamination between products, and ensure a logical flow of materials and personnel. Surfaces (floors, walls, ceilings) should be smooth and easy to clean.
• Equipment: All equipment used for processing, filling, and holding cosmetic products must be of appropriate design and material to prevent corrosion or adulteration of the product with lubricants or other contaminants. Equipment must be regularly calibrated, cleaned, and sanitized according to documented procedures.
• Raw Materials and Packaging Materials: There must be strict controls over the receipt, storage, and handling of all incoming materials. Materials must be clearly labelled, stored in appropriate conditions to prevent degradation, and tested to ensure they meet defined quality criteria before use. This helps prevent mix-ups and contamination.
• Production and Documentation: Every step of the manufacturing process must be governed by clearly defined Standard Operating Procedures (SOPs). Detailed batch manufacturing records must be created and maintained for every batch produced. This documentation is critical for ensuring consistency and provides full traceability, allowing a product to be traced from its raw materials through to its final distribution.

Filling technologies and processes

The choice of filling technology is a critical operational decision, primarily dictated by the physical characteristics of the cosmetic formulation, with viscosity being the most important factor.

• For Low-Viscosity Liquids (e.g., toners, facial mists, serums): These free-flowing products are typically handled by gravity fillers, where the liquid flows from an overhead tank into the containers, or overflow fillers, which fill each container to the same level, ensuring a consistent cosmetic appearance on the shelf. These methods are generally simpler and cost-effective.
• For High-Viscosity Products (e.g., creams, lotions, gels, pastes): Thicker products require mechanical assistance to be moved accurately. Piston fillers are a common solution; they use a piston to draw a precise volume of product into a cylinder and then dispense it into the container. Pump fillers use various types of pumps (e.g., gear, lobe, or progressive cavity pumps) matched to the specific product characteristics to provide a consistent and controlled fill.
• For Powders (e.g., loose powder, blush, eyeshadow pigments): Auger fillers are the standard technology for powdered products. They utilize a rotating screw (auger) to dispense a measured and consistent amount of powder into the container.

The level of automation in a filling line can vary significantly. Manual and semi-automatic machines are suitable for small-scale production, startups, or artisanal brands, offering lower initial investment but higher labor costs. Fully automatic, integrated lines are used for mass production, incorporating bottle unscramblers, fillers, cappers, labellers, and case packers to achieve high speeds and efficiency with minimal manual intervention.

A specialized process known as Hot Filling is used for anhydrous (water-free) products like lip balms, solid deodorants, and wax-based pomades. In this method, the product is heated to a liquid state (typically between 180°F and 200°F), filled into the containers, and then allowed to cool and solidify. The high temperature of the fill helps to sterilize the product and container, which can improve microbiological stability and potentially reduce the need for chemical preservatives, aligning with the “clean beauty” trend.

Quality control and formulation challenges in production

Maintaining product quality throughout the manufacturing process involves overcoming several significant scientific and technical challenges.

• Microbiological Stability: One of the greatest risks in cosmetic production is microbial contamination, which can render a product unsafe and lead to recalls. Contamination can originate from raw materials (especially water), equipment, the manufacturing environment, or personnel. GMP protocols are designed to minimize these risks. Furthermore, during the R&D phase, formulations undergo a preservative efficacy test, commonly known as a challenge test. In this test, the product is deliberately inoculated with specific strains of bacteria, yeasts, and molds to confirm that its preservative system is robust enough to prevent microbial growth during the product’s shelf life and consumer use.
• Physical and Chemical Stability: A cosmetic product must maintain its intended physical and chemical properties throughout its shelf life. A primary challenge, particularly for emulsions like creams and lotions, is preventing phase separation (where the oil and water components split) or changes in viscosity, color, or odor. For solid products like lipsticks, instability can manifest as “sweating” (syneresis) or breakage. To predict long-term stability, formulators conduct accelerated stability testing, where product samples are stored at elevated temperatures (e.g., 45°C) and under light exposure to speed up potential degradation processes.
• Batch-to-Batch Consistency: A key goal of GMP is to ensure that every batch of a product is identical to the last in terms of its sensory profile (color, texture, fragrance) and performance. This requires strict adherence to the documented manufacturing process, precise weighing and mixing of ingredients, and rigorous in-process and final quality control checks to verify that each batch meets all specifications.

UK manufacturing and filling services landscape

For many brands, particularly new or international entrants, investing in proprietary manufacturing facilities is not feasible. The UK has a well-established ecosystem of contract manufacturing organizations (CMOs) that provide a viable path to market. Companies such as Wyepak, Jarvis Cosmetics, and Sabel Cosmetics offer comprehensive, end-to-end services. These services often span the entire product lifecycle, from initial formulation development and regulatory support to sourcing packaging, manufacturing the bulk product, filling and packing, and final logistics and delivery. They typically offer flexibility in production scale, catering to both small-batch trial runs and large-scale, continuous production, and can handle a wide variety of product viscosities and container types.

The UK regulatory framework for cosmetics

The regulatory landscape for cosmetics in the United Kingdom is a multi-layered system of legislation, government bodies, and legally mandated private actors. Understanding this framework is not optional; it is the prerequisite for legal market access. The system is designed to ensure that all cosmetic products are safe for consumers, correctly labelled, and not misleadingly marketed. For any business, compliance is a multi-front activity that involves satisfying national authorities, being prepared for local enforcement, and correctly appointing and managing legally accountable private partners. A failure in one part of this system can trigger enforcement action from another, highlighting the critical interdependence of the entire framework.

The legal foundation

The regulatory architecture for cosmetics in the UK is now split, a direct consequence of Brexit.

• Great Britain (GB): The primary piece of legislation governing the manufacture and supply of cosmetic products in England, Wales, and Scotland is the UK Cosmetics Regulation (UKCR). This is not a newly written law but is the retained version of the EU Regulation (EC) No. 1223/2009, which was integrated into UK domestic law through Schedule 34 of the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019. This regulation is frequently updated with amendments to address new scientific opinions or safety concerns.
• Enforcement: The powers for enforcement, including market surveillance activities and the specification of penalties for non-compliance, are laid out in The Cosmetic Products Enforcement Regulations 2013 (as amended). These regulations empower authorities to take action against non-compliant products and businesses.
• Northern Ireland (NI): Due to the unique trading arrangements established by the Windsor Framework (which replaced the Northern Ireland Protocol), cosmetic products placed on the market in Northern Ireland must continue to comply with the EU Cosmetic Products Regulation (EC) No. 1223/2009 (CPR). This creates the dual-compliance system that is a central challenge for businesses operating across the UK.

Key authorities and their roles

Several government bodies and agencies form the regulatory and enforcement network for cosmetics in the UK.

• Office for Product Safety and Standards (OPSS): The OPSS, part of the Department for Business and Trade, is the UK’s national competent authority for cosmetic products. Its role is to provide strategic oversight of the regulatory framework, issue guidance to businesses, and manage the UK’s mandatory product notification system.
• Department for Business and Trade (DBT): This government department holds the ultimate responsibility for the overarching policy and legislation related to cosmetic products in the UK.
• Trading Standards: These are local authority services responsible for the day-to-day enforcement of the UKCR at a local level. Trading Standards Officers (TSOs) have significant powers to conduct market surveillance, carry out inspections of premises, demand to see compliance documentation (such as the Product Information File), and initiate enforcement actions, including prosecution for offences.
• Medicines and Healthcare products Regulatory Agency (MHRA): The MHRA plays a crucial role in policing the boundary between cosmetics and medicines. It is the sole authority that decides whether a product’s intended use, function, or claims classify it as a medicinal product, which would require a medicine licence and subject it to a completely different and more stringent regulatory regime. This is particularly relevant for “borderline products,” such as creams that claim to treat skin conditions like acne or psoriasis.

The ‘responsible person’ (RP)

The concept of the ‘Responsible Person’ is a cornerstone of the UK (and EU) cosmetics regulations.

• Definition and Role: The RP is a designated legal or natural person who bears the ultimate legal responsibility for ensuring that a specific cosmetic product complies with all relevant obligations of the UKCR. This is a non-delegable duty; while the RP can subcontract tasks, the legal liability remains with them.
• The Critical Post-Brexit Requirement: For any cosmetic product to be placed on the market in Great Britain, its designated Responsible Person must be established within the United Kingdom. An RP based in the EU or elsewhere is not legally valid for the GB market. The address provided must be a physical location; a PO Box or mail forwarding service is not acceptable.
• Who can be the RP?: The RP can be the UK-based manufacturer, the importer who first brings the product into the UK, or a distributor who markets the product under their own name or brand. Alternatively, a manufacturer or importer can formally appoint a third-party, such as a professional regulatory consultancy, to act as their RP.
• Core Obligations: The responsibilities of the RP are extensive and cover the entire compliance lifecycle of the product. These include:

• Ensuring the product is safe for human health.
• Commissioning and holding the Cosmetic Product Safety Report (CPSR).
• Compiling and maintaining the Product Information File (PIF) and making it readily available for inspection by authorities.
• Verifying that manufacturing complies with Good Manufacturing Practice (GMP).
• Ensuring all labelling and claims are compliant with the regulation.
• Notifying the product to the OPSS via the SCPN portal before it is placed on the market.
• Monitoring the product post-market and taking immediate corrective measures (e.g., withdrawal or recall) if a product is found to be non-compliant or presents a safety risk.

The product information file (PIF)

The Product Information File is the master technical file for a cosmetic product. It is a mandatory, living dossier that contains all the information and data necessary to demonstrate the product’s safety and compliance with the UKCR.

• Requirement: The Responsible Person must keep a PIF for each product they are responsible for. The PIF must be kept for ten years after the last batch of the product was placed on the market and must be held at the RP’s UK address, in English, ready for inspection by enforcement authorities like Trading Standards.
• Mandatory Contents: As specified in Article 11 of the UKCR, the PIF must contain the following key elements:

1. A detailed description of the cosmetic product.
2. The Cosmetic Product Safety Report (CPSR), which is the most critical component.
3. A description of the manufacturing method and a statement confirming compliance with Good Manufacturing Practice (GMP).
4. Substantiation and proof for any effects claimed for the product.
5. Data on any animal testing performed by the manufacturer, its agents, or suppliers, relating to the development or safety assessment of the product or its ingredients (note: the UK has a ban on animal testing for cosmetics).

The cosmetic product safety report (CPSR)

The CPSR is the scientific and toxicological heart of the PIF. It is a formal safety assessment that provides the definitive evidence that a cosmetic product is safe for human health when used under normal or reasonably foreseeable conditions. It is a legal prerequisite; a product cannot be placed on the market without a completed CPSR.

• The Safety Assessor: The CPSR must be carried out by a qualified safety assessor. This individual must hold a diploma or other evidence of formal qualification awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine, or a similar discipline, or a course recognized as equivalent. Many businesses contract this work to specialist toxicologists or regulatory consultancies.
• Structure of the CPSR: In line with Annex I of the UKCR, the CPSR is divided into two distinct parts:

• Part A – Cosmetic Product Safety Information: This part is a comprehensive collection of all the data required to perform the safety assessment. It includes: the quantitative and qualitative formula of the product; its physical and chemical characteristics and stability data; its microbiological quality; details on impurities, traces, and information about the primary packaging material (and its interaction with the formula); the normal and reasonably foreseeable use of the product; exposure data for the product and its individual substances; and the toxicological profile of each ingredient.
• Part B – Cosmetic Product Safety Assessment: This is the expert conclusion drawn by the safety assessor based on the data in Part A. It must contain: the final assessment conclusion (i.e., a clear statement that the product is safe); any specific warnings or instructions for use that must be printed on the label; the scientific reasoning that justifies the conclusion; and the credentials and signature of the safety assessor.

Product notification: the submit cosmetic product notification (SCPN) service

The final regulatory step before a cosmetic product can be legally placed on the market in Great Britain is notification to the competent authority.

• The Portal: The Responsible Person must submit key information about the product to the OPSS via the UK government’s dedicated online portal: the Submit Cosmetic Product Notification (SCPN) service.
• Post-Brexit Transition: The SCPN is the UK’s independent system, replacing the EU’s Cosmetic Product Notification Portal (CPNP) for the GB market. Following the end of the Brexit transition period, there was a grace period for RPs to transfer notifications for existing products from the CPNP to the SCPN. All new products for the GB market must now be notified directly on the SCPN before launch.
• Information Required: The notification requires the submission of specific details, including the product category and name, the name and address of the RP, the country of origin, the location of the PIF, details of any nanomaterials or CMR (Carcinogenic, Mutagenic, or Reprotoxic) substances, the full formulation, and the original labelling, including a photograph of the packaging. This information allows authorities, including the National Poisons Information Service, to have immediate access to product details in case of an emergency.

Labelling, claims, and consumer information

Cosmetic labelling in the UK is not merely a marketing exercise; it is a tightly regulated aspect of product compliance designed to provide consumers with essential information for safe and effective use. The requirements are detailed and specific, and failure to comply can result in enforcement action, including fines and product recalls. All information must be presented in indelible, easily legible, and visible lettering, and must be in English. This information generally must appear on both the primary container and any outer packaging (e.g., a carton), though some exceptions exist for smaller items where information can be provided on an enclosed leaflet.

Mandatory labelling requirements (article 19, UKCR)

The UKCR specifies a comprehensive list of information that must be present on a cosmetic product’s label and/or packaging. The following table provides a detailed checklist for businesses to ensure compliance for products placed on the Great Britain market.

The international nomenclature of cosmetic ingredients (INCI)

The ingredient list is a cornerstone of consumer transparency, allowing individuals, particularly those with allergies, to make informed choices. The UKCR mandates a specific format and nomenclature for this list.

• Heading and Order: The list must be preceded by the word ‘INGREDIENTS’. Ingredients must be listed in descending order of their weight concentration at the time they are added to the formulation. Any ingredients present at a concentration of less than 1% may be listed in any order after those present at 1% or more.
• Nomenclature: Ingredient names must follow the International Nomenclature of Cosmetic Ingredients (INCI) system. This is a standardized, internationally recognized system that ensures consistency across different countries and brands. The UK continues to reference the EU’s CosIng database for the correct INCI names.
• Specific Conventions:

• Perfume and aromatic compositions are generally listed with the single term ‘PARFUM’ or ‘AROMA’, respectively. However, if the fragrance contains any of the specific fragrance allergens identified in the regulations (e.g., Linalool, Limonene, Geraniol), these must be listed individually by their INCI names if their concentration exceeds 0.001% in leave-on products or 0.01% in rinse-off products.
• Colourants are listed at the end of the ingredient list and can be denoted by their Colour Index (CI) number. For decorative cosmetics like foundations or eyeshadows that are sold in a range of shades, all colourants used across the entire range may be listed under the heading ‘[+/-]’ or ‘may contain’, simplifying labelling for the manufacturer.
• Any ingredient present in the form of a nanomaterial must be clearly indicated in the list by the word ‘(nano)’ in brackets immediately following its INCI name.

Substantiating product claims

Under the UKCR, it is a legal offence to use text, names, images, or any other signs that imply a cosmetic product has characteristics or functions which it does not possess. All claims must be compliant with the common criteria laid down in the assimilated Regulation (EU) No 655/2013, which requires them to be legal, truthful, honest, fair, and, crucially, supported by adequate and verifiable evidence.

The Responsible Person is legally required to hold this evidence within the Product Information File (PIF). For performance or efficacy claims (e.g., “reduces the appearance of wrinkles by 20%” or “provides 24-hour hydration”), the standard of evidence is high. Such claims typically require support from robust scientific testing, often involving instrumental measurements or clinical studies on human volunteers. Subjective consumer feedback alone is generally not sufficient to substantiate an objective claim.

Furthermore, brands must be extremely cautious to avoid making medicinal claims. Any claim that suggests a product can treat, prevent, or cure a disease or condition (e.g., “cures acne,” “treats psoriasis”) would automatically classify the product as a medicine, bringing it under the much stricter regulatory control of the MHRA.

Post-brexit labelling divergence: a practical guide

The creation of two separate regulatory regimes for Great Britain and the EU/NI has resulted in critical differences that businesses must manage to ensure compliance in both markets. The following table summarizes the most significant points of divergence.

Strategic recommendations and compliance checklist

Successfully launching and maintaining a cosmetic product on the UK market requires a strategic, proactive, and meticulous approach to compliance. The regulatory framework, while robust, is navigable with careful planning and an understanding of the key obligations. This final section provides a clear roadmap for new entrants, advice for managing post-Brexit complexities, and a concluding perspective on leveraging compliance as a strategic asset.

A roadmap for new market entrants

For any business, whether a startup or an established international brand, seeking to place a cosmetic product on the Great Britain market for the first time, the following step-by-step process outlines the critical compliance pathway:

1. Appoint a UK Responsible Person (RP): This is the foundational legal step. Identify and contract a legally established person or entity in the UK to assume the role of RP. This must be a physical address, not a mail forwarder.
2. Finalize the Formulation and Verify Ingredient Compliance: Ensure every ingredient in the product formulation is permitted for use under the UKCR. Check the Annexes of the regulation for any restrictions on concentration or use for substances like preservatives, UV filters, and colorants, and ensure no prohibited substances are present.
3. Commission the Cosmetic Product Safety Report (CPSR): Engage a qualified safety assessor based in the UK to conduct the safety assessment and produce the two-part CPSR. Provide the assessor with all necessary data, including the full formulation, raw material specifications, stability data, and packaging details.
4. Compile the Full Product Information File (PIF): The RP must assemble the complete PIF, including the final signed CPSR, a description of the GMP-compliant manufacturing method, and evidence to substantiate any product claims.
5. Ensure Manufacturing is GMP Compliant: Verify that the chosen manufacturing facility operates in accordance with Good Manufacturing Practice, ideally certified to the ISO 22716 standard. This is a non-negotiable legal requirement.
6. Design Compliant Packaging and Labelling: Create the product’s primary and secondary packaging artwork. Meticulously check that all mandatory labelling information as detailed in Section 5 is present, correct, in English, and clearly legible. This includes the UK RP details, country of origin, INCI list, and PAO/DMD symbols.
7. Notify the Product on the SCPN Portal: The RP must complete the final regulatory step by notifying the product to the OPSS via the online Submit Cosmetic Product Notification (SCPN) service. This must be done before the product is made available to consumers.
8. Place the Product on the Market: Once all preceding steps are complete and documented, the product can be legally supplied to the GB market. The RP must then continue to monitor the product for any adverse effects and keep the PIF updated.

Managing post-brexit regulatory risk

For businesses operating across both the UK and EU/NI markets, managing the “dual compliance burden” is a primary strategic challenge. Proactive risk management is essential to avoid costly disruptions.

• Appoint Dual Responsible Persons: The most straightforward approach is to appoint two separate RPs: one in the UK for the GB market and one in an EU member state or NI for the EU/NI market. While this incurs dual costs, it ensures clear legal accountability in each jurisdiction.
• Maintain Regulatory Intelligence: The UK and EU regulatory frameworks are actively diverging. Businesses must implement a robust process for regulatory intelligence to track changes to ingredient lists (especially Annexes II, III, and V), labelling rules, and claims criteria in both jurisdictions. Subscribing to updates from authorities like the OPSS and industry bodies like the CTPA is crucial.
• Adopt Flexible Supply Chain and Labelling Strategies: Businesses may need to manage different SKUs (Stock Keeping Units) with market-specific labels. This requires careful planning in production scheduling, inventory management, and logistics to ensure products destined for GB receive the UK-compliant label and products for the EU/NI receive the EU-compliant label.
• Engage Regulatory Expertise: Given the complexity, particularly for SMEs, engaging a specialist regulatory consultancy with expertise in both UK and EU regulations can be a highly effective strategy. These firms can act as the RP in one or both jurisdictions, manage the PIF and notification processes, and provide ongoing monitoring of regulatory changes.

Leveraging compliance for competitive advantage

While the regulatory requirements may seem like a burdensome hurdle, they can also be reframed as a strategic opportunity. In a crowded and competitive marketplace, demonstrating robust compliance and a commitment to transparency can become a powerful differentiator and a cornerstone of brand trust.

• Building Consumer Confidence: Consumers are increasingly savvy and concerned about the safety and contents of the products they use. A brand that can confidently and transparently communicate its adherence to the UK’s high safety standards can build significant trust and loyalty.
• Marketing Sustainable and Ethical Practices: Packaging trends are moving decisively towards sustainability. Brands that embrace eco-friendly materials like PCR plastics, glass, or bamboo, or innovative models like refillable systems, are not only future-proofing their operations but are also aligning with the values of a large and growing segment of consumers. These choices can be powerfully communicated through marketing to enhance brand image.
• Transparency as a Brand Pillar: Clear, honest labelling and evidence-backed claims are not just legal requirements; they are pillars of an authentic brand identity. In an era of “clean beauty” and ingredient-focused consumers, the INCI list and substantiated claims on a package are key marketing assets that demonstrate a brand’s integrity and respect for its customers.

Comprehensive compliance checklist

This checklist provides a condensed summary of the key operational and legal requirements for placing a cosmetic product on the Great Britain market.

Pre-Market Compliance:

• [ ] UK Responsible Person Appointed: A UK-based RP is legally contracted.
• [ ] Formulation Compliant: All ingredients checked against UKCR Annexes.
• [ ] CPSR Completed: A full, two-part CPSR has been signed by a qualified UK-based safety assessor.
• [ ] PIF Assembled: A complete PIF is compiled and held at the UK RP’s address.
• [ ] GMP Adherence: Manufacturing is confirmed to be compliant with ISO 22716.
• [ ] Labelling Verified: All mandatory information (UK RP, origin, quantity, INCI, etc.) is present and correct on all packaging.
• [ ] Claims Substantiated: Robust evidence for all product claims is held in the PIF.
• [ ] SCPN Notification Submitted: The product has been successfully notified to the OPSS via the SCPN portal.

Post-Market Compliance:

• [ ] PIF Maintenance: The PIF is kept up-to-date with any changes for 10 years post-market.
• [ ] Serious Undesirable Effects (SUEs) Reporting: A system is in place for the RP to report any SUEs to the OPSS.
• [ ] Market Surveillance Readiness: The RP is prepared to provide the PIF to enforcement authorities (e.g., Trading Standards) upon request.
• [ ] Corrective Action Protocol: A process is established to take immediate corrective action (withdrawal/recall) if a product is found to be non-compliant.