Cosmetics Regulatory Services – EU & UK Cosmetic Products Compliance

Comprehensive compliance management for cosmetic and personal care products across Europe and the United Kingdom. We handle product classification, safety assessments, mandatory documentation (Product Information Files and Cosmetic Product Safety Reports), labelling and claims review, regulatory notifications, and post-market surveillance (cosmetovigilance). Pharmafile can act as your designated Responsible Person for EU and UK markets or support your in-house team, ensuring each cosmetic product meets all regulatory requirements before it is placed on the market and throughout its lifecycle, in full alignment with EU Cosmetics Regulation 1223/2009. This Regulation reinforces the link between the product information file, the product safety report and the cosmetic safety assessment and places greater responsibilities on the Responsible Person and the safety assessor.

This service is suitable for:

• Cosmetics Brands & Manufacturers (EU/UK & Global): Small to mid-sized beauty and personal care companies including skincare, haircare, oral care, fragrance, and decorative cosmetics brands  that do not have in-house regulatory expertise. If you plan to launch products in the EU or UK, we help you navigate all compliance steps from formulation review to market notification. Non-EU manufacturers and indie brands benefit particularly, as an EU/EEA or UK-based Responsible Person (RP) is legally required for market entry. Under the UK regime, there must be a Responsible Person based in the UK.
• Importers and Distributors Becoming Responsible Persons: Since 1 January 2021, UK businesses who bring cosmetic products into Great Britain from an EU Member State are classified as ‘importers’ where they would previously have been ‘distributors’. The importer of a cosmetic product, whether from the EU or another country, becomes a Responsible Person by default, although they may appoint an agent to act as the Responsible Person for them. We assist these importers by either taking on the RP role or guiding them through their new responsibilities, such as compiling Product Information Files and adding appropriate UK RP details on labels. A seven-year transition period from 1 January 2021 applies before businesses are required to include the UK Responsible Person details on product labels, provided the EU responsible person details are included.
• Personal Care Product Start-ups & Innovators: Entrepreneurs developing novel cosmetics (e.g. products with new ingredients, nanomaterials, or atypical formulations) who need early regulatory strategy to determine the product’s classification and required safety tests. We help new entrants avoid costly delays by outlining exactly what tests and documentation are needed for compliance before launch.
• Established Companies with Compliance Bottlenecks: Larger cosmetics and FMCG companies that have internal regulatory teams but require extra capacity or specialised support  for example, handling a surge of product launches across multiple markets (needing simultaneous EU CPNP and UK SCPN notifications), executing a portfolio-wide claims audit, or preparing for an authority inspection of cosmetics manufacturing sites for ISO 22716 GMP compliance.

This service may not be the right fit if:

• You need product development or formulation services (our focus is on regulatory compliance after your formulation is decided, not R&D or laboratory testing services).
• You are looking for cosmetics marketing or branding assistance (e.g. creative copywriting, design, market positioning). Our role is to ensure regulatory compliance and safety, which sometimes means advising against certain marketing claims if they conflict with regulations.
• You require cosmetics regulatory support outside the EU or UK our expertise is centred on European and UK regulations.

Determining Product Classification & Borderlines: Is it a cosmetic, a medicine, a biocide, or something else? Many products sit on the regulatory borderline  for example, an antibacterial hand gel (cosmetic vs. biocide), an eyelash growth serum (cosmetic vs. medicine), or an aromatherapy oil (general product vs. cosmetic vs. medicinal). The classification of many products on the borderline with cosmetics can be difficult to determine; the MHRA has issued “A Guide to what is a Medicinal Product” and in case of doubt, advice may be sought from the MHRA’s Borderlines Section. Misclassification can lead to severe compliance failures: a product marketed as a cosmetic that regulators deem a medicine or biocide could be pulled from the market for not having the required authorisation.

Meeting EU & UK Responsible Person Obligations: Post-Brexit, companies face dual compliance if selling in both the EU and UK. You must have a designated Responsible Person based in the EU/EEA for the EU market, and a separate UK Responsible Person for Great Britain. Both are legally responsible for product safety and compliance in their respective jurisdictions. We address the challenge of maintaining two compliance tracks: we can serve as your RP in one or both regions or assist your chosen RPs by preparing all necessary documentation. We ensure that Product Information Files (PIFs) are maintained in the proper location in the UK, an up-to-date PIF must be maintained in English and made available to market surveillance and enforcement authorities at the UK address provided when asked to do so.

Building a Complete Product Information File (PIF): Every cosmetic product requires a comprehensive PIF containing product details, manufacturing information, safety data, test results, a Cosmetic Product Safety Report, and labelling/claims evidence. Compiling this can be daunting, especially for small companies. We help gather all necessary components and identify any gaps in required data early for instance, if a preservative efficacy test or a specific quality test is missing  so that your PIF stands up to scrutiny.

Navigating Ingredient Restrictions & Bans: The EU Cosmetics Regulation maintains extensive annexes of prohibited, restricted, and positively listed ingredients. We review your formulas against these lists to ensure no banned substances are present and that restricted ingredients are within legal concentration limits and properly labelled if required. We also monitor regulatory changes e.g. new ingredients being restricted or limits being updated  to proactively update your products and avoid non-compliance.

Claims Substantiation & Avoiding Misleading Claims: Cosmetics advertising in the EU/UK is tightly regulated. Statements like “dermatologist tested,” “hypoallergenic,” “organic,” or claims about percentage improvements must be truthful and backed by evidence. We help you navigate these requirements by reviewing your product claims, advising what is permissible, and coordinating consumer or clinical tests if needed to substantiate performance claims. This prevents a common pitfall where companies face regulatory action due to unsubstantiated or medicinal claims on a cosmetic product.

Ensuring Labelling Compliance in All Markets: We verify that your product labels include all mandatory information and conform to local language requirements. This includes the name and address of the Responsible Person, nominal content, batch code, expiry date or PAO (Period After Opening) symbol, ingredient list in correct INCI nomenclature, and any required warnings or usage instructions. For GB products, the seven-year transition period from 1 January 2021 allows EU RP addresses on labels during the phase-in period, provided the EU responsible person details are included.

Post-Market Surveillance (Cosmetovigilance): Cosmetics do not require pre-approval, but regulators expect that any undesirable effects in consumers are monitored and serious cases are reported. In the event of serious undesirable effects, the responsible person and distributors shall without delay notify the competent authority, including all serious undesirable effects which are known or which may reasonably be expected to be known, the name of the cosmetic product concerned enabling its specific identification, and the corrective measures taken.

Balancing EU and UK Regulatory Regimes: Post-2020, the EU and UK cosmetics rules are aligned in substance but are now separate in practice. Companies selling in both areas face double notifications (EU’s CPNP system and the UK’s SCPN portal) and dual record-keeping. We streamline this by preparing a single set of core documentation that can be used to satisfy both EU and UK requirements, then handling the distinct submissions.

1. Compliance with EU/UK Cosmetics Law from Day One: The primary legislation is Regulation (EC) No 1223/2009 on cosmetic products, which replaces the Cosmetics Directive 76/768/EEC as amended. In the UK, this is mirrored through Regulation 1223/2009 as amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019. The Regulation sets out requirements that must be met before cosmetics products can be placed on the GB market, with the purpose of safeguarding public health and establishing a fully competitive market. There is no pre-market product approval instead, every cosmetic product must be notified to the Cosmetic Products Notification Portal (CPNP) before being placed on the market in the EU. In the UK, the Government has established the Submit Cosmetic Product Notification (SCPN) service to replace the EU’s CPNP in Great Britain. For products not previously notified to the CPNP, UK Responsible Persons will need to provide full information to the Secretary of State via the UK SCPN service before they can be placed on the market.
2. Appointed Responsible Person & PIF Availability: Every cosmetic sold in the EU must have an appointed Responsible Person within the EU, and likewise a UK-based Responsible Person for any product on the GB market. The Responsible Person’s name and address must be on the product label. An up-to-date PIF must be maintained in English, and made available to market surveillance and enforcement authorities at the UK address provided when asked to do so. The PIF includes a detailed Cosmetic Product Safety Report (CPSR) signed by a qualified safety assessor, product formulation and test data, manufacturing information (to demonstrate GMP compliance), and evidence for claims among other elements. CPNP is a free-of-charge online notification system created for the implementation of Regulation (EC) No 1223/2009 on cosmetic products. When a product has been notified to CPNP, there is no need for any further notification at national level within the EU.
3. Safety Through Scientific Assessment (CPSR): Regulators require that each cosmetic product undergoes a safety assessment before it reaches the market. This is documented in the CPSR, which must be conducted by a suitably qualified safety assessor. The Regulation reinforces the link between the product information file, the product safety report and the cosmetic safety assessment and places greater responsibilities on the Responsible Person and the safety assessor. Our service includes writing the safety assessment of finished products based on the toxicological profile of the ingredients and preparing and auditing Product Information Files (PIF) and safety assessments and preparing Cosmetic Product Safety Reports (CPSR).
4. Adherence to Ingredient and Formula Restrictions: All ingredients in a cosmetic must comply with the rules set out in the annexes of Regulation 1223/2009. This means no prohibited substances may be present, restricted substances must be used only within prescribed limits and conditions, and only approved colorants, preservatives, and UV filters may be used. Regulators will scrutinise your product composition to ensure these rules are followed. We conduct this scrutiny proactively during the development phase to prevent non-compliant formulas. The Regulation applies to all cosmetic products made available on the GB market, and there is separate guidance for placing cosmetic products on the market in Northern Ireland.
5. Good Manufacturing Practice (GMP): Cosmetic products must be manufactured in accordance with GMP. The expectation is that manufacturers follow a standard like ISO 22716 (Cosmetics GMP). During an inspection or in case of a serious incident, authorities may review how your product is made they expect rigorous quality control and hygiene procedures, traceability of ingredients and component batches, and consistent, safe manufacturing. We help companies implement and document these practices in line with ISO 22716 to ensure this regulatory expectation is met.
6. Accurate Labelling & Claims No Misleading Information: The Regulation specifies required labelling elements. Products that are intended to be ingested, inhaled, injected or implanted are not classified as cosmetic products. Medicinal or therapeutic claims are not permitted on cosmetics making such claims can re-categorise your product as a medicine in the eyes of regulators. We review all claims to ensure they are acceptable and help gather necessary evidence to support performance claims.
7. Notification and Post-Market Obligations: Before selling a cosmetic in the EU, you must submit a notification via the CPNP. For Great Britain, a similar notification must be made through the UK SCPN. After products are on the market, regulators expect you to monitor their safety. In the event of serious undesirable effects, the responsible person and distributors shall without delay notify the competent authority. The competent authority must immediately inform all other competent authorities of any information notified.

Our approach to cosmetics compliance is structured into key stages, mirroring a product’s journey from concept to market and beyond. We ensure each stage is handled in line with regulatory best practices, making the entire process transparent and manageable.

We begin by clarifying your product’s regulatory identity and establishing a compliance roadmap:

• Product Definition & Borderline Analysis: We confirm whether your product is indeed a cosmetic under the legal definition. The EU defines a cosmetic product as any substance or preparation intended to be placed in contact with the various external parts of the human body 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 or keeping them in good condition. The Regulation specifies six functions: to clean, to perfume, to change the appearance, to protect, to keep in good condition, and to correct body odours. The field of application covers the epidermis, the hair system, the nails, the lips, the external genital organs, the teeth, and the mucous membranes of the oral cavity. If there is any ambiguity, we conduct a borderline assessment, consulting guidance like the MHRA’s “A Guide to what is a Medicinal Product”. Cosmetics are generally exempted from the biocides regulation but exceptions may arise in very rare cases.
• Regulatory Pathway & Responsible Person Setup: Based on where you want to market the product (EU, UK, or both), we devise a plan for fulfilling the Responsible Person requirement. We outline the exact documentation and steps required for each market  for example, a product intended for both EU and UK sale will need an EU notification (CPNP) and a UK SCPN notification, separate PIF access points, and potentially separate RP designations. From the outset, we create a compliance checklist tailored to the product and target markets.
• Identify Data and Testing Requirements: Early in the project, we identify what supporting data you have and what might still be needed. We map out all needed tests (and can help arrange them through partner labs) so that the safety assessor will have the evidence required for the CPSR.
• Timeline Planning: We create a timeline that accounts for each step formula finalisation, any lab testing, document drafting, internal and external reviews, and buffer for addressing unforeseen issues. Engaging us early, even during product development, can shorten the overall time to market by pre-emptively identifying information needs.