The UK cosmetic industry is a dynamic and highly competitive market, known for its innovation, diversity, and robust regulatory standards. Valued at approximately £10 billion annually, it includes a wide range of products such as skincare, haircare, makeup, fragrances, and personal hygiene items. With strong domestic brands, international players, and a thriving export market, the industry is a significant contributor to the UK economy.
Authority Overseeing United Kingdom (UK) Cosmetic Regulations
The regulatory authority for cosmetics in the United Kingdom is the Office for Product Safety and Standards (OPSS), which is part of the Department for Business, Energy & Industrial Strategy (BEIS). OPSS oversees the compliance, safety, and enforcement of cosmetics regulations, including monitoring products on the market and ensuring they adhere to safety standards. The OPSS also coordinates with other regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA) if a product falls into the borderline category between a cosmetic and a medicinal product.
OPSS Regulatory Framework for Cosmetics in UK
The primary regulation is the UK Cosmetics Regulation (UKCR), which mirrors the EU’s Cosmetic Products Regulation (EC) No. 1223/2009 but was amended to reflect the UK's regulatory autonomy post-Brexit. It applies to England, Wales, and Scotland, with Northern Ireland following EU regulations under the Northern Ireland Protocol.
Definition of Cosmetics
According to the UK Cosmetics Regulation, cosmetics are 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."
Borderline Products under UK Cosmetic Regulations
Borderline products are products that may have characteristics or claims that overlap with more than one regulatory category, such as cosmetics, medicines, medical devices, or biocides. Determining the regulatory classification of a borderline product is crucial, as each category has distinct safety, efficacy, and labeling requirements.
Products that claim to treat or prevent disease, or have a therapeutic effect, are not considered cosmetics and are regulated separately as medicinal products under the UK's Medicines and Healthcare products Regulatory Agency (MHRA).
Key Regulatory Requirements for Cosmetics in UK
Here are the key regulatory requirements under UK Cosmetics Regulations -
Product Safety and Responsible Person (RP): Every cosmetic product must be safe for human health when used under normal or reasonably foreseeable conditions. A "Responsible Person" (RP) must be based in the UK and is accountable for product safety, compliance, and ensuring proper labeling.
Product Information File (PIF): Every cosmetic product sold in the UK must have a Product Information File (PIF), which contains detailed information such as the product’s composition, safety assessment, manufacturing method, and proof of its effects. The PIF should be accessible to the authorities at all times.
Notification Requirements: The RP must notify the product on the UK’s Submit Cosmetic Product Notification (SCPN) portal before placing it on the market. This is a separate system from the EU’s Cosmetic Products Notification Portal (CPNP).
Good Manufacturing Practices (GMP): Manufacturers are required to adhere to Good Manufacturing Practices (GMP), as outlined in ISO 22716. This ensures consistent product quality and safety across batches.
Labelling Requirements for Cosmetics in UK: The cosmetics must comply with the labeling requirements under the UK Cosmetics Regulation and ensure that the consumers are informed about the product’s contents, safe usage, and origins. Here are the key elements required on cosmetic product labels:
Product Name and Function: The label must clearly state the product’s name and intended purpose (e.g., "moisturizer," "shampoo").
Country of Origin: For products manufactured outside the UK, the country of origin.
Batch Number or Lot Code: A batch or lot number is required for traceability, ensuring that defective or unsafe batches can be identified and recalled if necessary.
List of Ingredients: Ingredients must be listed in descending order of weight at the time of formulation, using the International Nomenclature of Cosmetic Ingredients (INCI) names. Ingredients present at less than 1% can be listed in any order after the main ingredients.
Nominal Content (Weight/Volume): The packaging should indicate the net quantity of the product by weight (e.g., grams) or volume (e.g., milliliters) at the time of packaging, excluding any outer packaging.
Usage Instructions and Warnings: Instructions for safe usage, including any necessary warnings, must be clearly provided. Examples include “Avoid contact with eyes” or “Do not use on broken skin.” These instructions are critical for products that might pose risks if misused, such as hair dyes or peels.
Expiry Date or Period After Opening (PAO): If the product has a minimum shelf life of less than 30 months, an expiry date (e.g., "Best before end of") must be indicated. For products with a shelf life exceeding 30 months, a Period After Opening (PAO) symbol (open jar symbol with a number and 'M' for months, e.g., “12M”) indicates how long the product can be used safely after opening.
Precautionary Symbols:
"e" Mark: Indicates compliance with EU weight and volume requirements, showing the product is measured accurately.
Refer to Insert Symbol (hand and book icon): This symbol directs consumers to additional information on an insert when required (such as for smaller packaging where full instructions cannot fit).
Safety Assessments for Cosmetics in UK
In the UK, all cosmetic products must undergo a Cosmetic Product Safety Report (CPSR) before being placed on the market. This safety assessment, required by the UK Cosmetics Regulation, ensures that cosmetics are safe for human health. Here’s a breakdown of the key components and requirements:
Cosmetic Product Safety Report (CPSR): The CPSR is a document that evaluates the safety of a cosmetic product, containing two main parts:
Part A: Cosmetic Product Safety Information
Part B: Cosmetic Product Safety Assessment
Part A: Cosmetic Product Safety Information
Quantitative and Qualitative Formula: Lists all ingredients with their concentrations.
Physico-Chemical Characteristics and Stability: Details the product’s physical and chemical properties, along with stability data to confirm that the product remains safe and effective throughout its shelf life.
Microbiological Quality: Ensures the product is free from harmful microorganisms, especially for products used around sensitive areas (e.g., eyes) or on damaged skin. Preservatives are tested to confirm their effectiveness.
Impurities, Traces, and Packaging: Assesses potential contaminants and interactions between the product and its packaging materials.
Normal and Foreseeable Use: Describes the intended use, application area, and foreseeable misuse, crucial for assessing exposure risks.
Exposure Assessment: Calculates potential exposure by considering factors like frequency of use, application area, and user demographics.
Toxicological Profile of Ingredients: Evaluates each ingredient’s safety, including potential irritancy, sensitization, or toxicity risks. Special attention is given to allergens and restricted substances.
Part B: Cosmetic Product Safety Assessment
Assessment Conclusion: States whether the product is safe for intended use and provides justifications for the safety conclusion.
Warnings and Instructions for Use: Includes any necessary warnings (e.g., “Avoid contact with eyes”) based on the assessment, which must appear on the product label.
Reasoning: Details the scientific rationale behind the safety conclusion, addressing any potential risks.
Assessor’s Credentials and Approval: Includes the name, qualifications, and signature of the safety assessor responsible for the CPSR.
Qualifications of the Safety Assessor: The CPSR must be completed by a qualified safety assessor with expertise in toxicology, dermatology, or a related field. This expert should have a strong understanding of cosmetic regulations and toxicological evaluation.
Continuous Monitoring and Adverse Effects Reporting: The Responsible Person (RP) must monitor consumer complaints and serious undesirable effects (SUEs). Any adverse reactions should be reported to the UK’s Office for Product Safety and Standards (OPSS) and, if necessary, corrective actions taken.
Access and Availability: The CPSR is part of the Product Information File (PIF) and must be readily available for review by regulatory authorities, such as the OPSS, upon request.
By aligning with international standards, the UK cosmetic regulations maintain market accessibility for both domestic and international brands while ensuring that consumers are protected from unsafe or misrepresented products. As the industry continues to evolve, with increasing demands for sustainable, natural, and personalized beauty products, the UK’s regulatory framework provides a solid foundation to support innovation while prioritizing consumer safety and market integrity.
Ensure your products meet regulatory standards with confidence. Reach out to Artixio at info@artixio.com for comprehensive consultation services today!
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