\n
Evolution of UK Cosmetics Legislation<\/span><\/h2>\nThe development of UK cosmetics regulations has gone through the following stages:<\/p>\n
\n- November 30, 2009<\/strong>
\nThe EU issued the EU Cosmetics Regulation (EC) No 1223\/2009.<\/li>\n- June 2013<\/strong>
\nThe UK issued the Cosmetics Enforcement Regulations 2013, establishing the enforcement authority of the EU Cosmetics Regulation in the UK.<\/li>\n- July 11, 2013<\/strong>
\nAs an EU member state, the EU Cosmetics Regulation (EC) No 1223\/2009 came into effect in the UK.<\/li>\n- March 27, 2019<\/strong>
\nThe UK amended retained EU regulations and issued the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, with Schedule 34 specifically addressing cosmetics regulations.<\/li>\n- January 1, 2021<\/strong>
\nThe amended UK Cosmetics Regulations came into effect.<\/li>\n<\/ul>\n
\nUK Cosmetics Regulatory Documents<\/h2>\n\n\n\n\nRegulatory Document<\/strong><\/th>\nApplicable Regions<\/strong><\/th>\n<\/tr>\n<\/thead>\n\n\nThe Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 – Schedule 34<\/td>\n Great Britain (England, Scotland, Wales)<\/td>\n<\/tr>\n \nEU Cosmetics Regulation (EC) No 1223\/2009<\/td>\n Northern Ireland*<\/td>\n<\/tr>\n \nUK Cosmetics Regulations and EU Cosmetics Regulations<\/td>\n Great Britain and Northern Ireland<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n*Note: Under the Windsor Framework Agreement, Northern Ireland’s cosmetics regulations remain aligned with the EU.<\/p>\n
\nGovernment Bodies Responsible for Legislation and Implementation<\/h2>\n
The following three government bodies are primarily responsible for the legislation and implementation of UK cosmetics regulations:<\/p>\n
\n- Secretary of State<\/strong>\n
\n- Responsibilities: Formulating and implementing cosmetics safety policies, regularly reviewing the implementation of regulations, and assessing and making necessary changes.<\/li>\n<\/ul>\n<\/li>\n
- Office for Product Safety and Standards (OPSS)<\/strong>\n
\n- Responsibilities: Acting as the national regulatory authority, providing guidance and support to the industry, and exercising the Secretary of State’s powers during enforcement.<\/li>\n<\/ul>\n<\/li>\n
- Scientific Advisory Group on Chemical Safety in Consumer Products (SAG-CS)<\/strong>\n
\n- Responsibilities: Commissioned by OPSS to assess the chemical\/biological risks of consumer products (excluding food and medicine) and provide scientific opinions on cosmetic ingredients.<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n
\nSteps for Submitting Cosmetics to the UK Market<\/h3>\n
Follow these steps to ensure your product enters the UK market smoothly:<\/p>\n
\n\n\n\nStep<\/strong><\/th>\nDescription<\/strong><\/th>\n<\/tr>\n<\/thead>\n\n\n1<\/td>\n Product Classification: Classify the product as a cosmetic.<\/td>\n<\/tr>\n \n2<\/td>\n Identify the Responsible Person (RP): Appoint a UK-based RP.<\/td>\n<\/tr>\n \n3<\/td>\n Prepare the Product Information File (PIF): Compile all required documentation.<\/td>\n<\/tr>\n \n4<\/td>\n Notify via SCPN\/CPNP: Submit the required notifications.<\/td>\n<\/tr>\n \n5<\/td>\n Enter the UK Market: Launch the product in compliance with regulations.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\nStep 1: Product Classification<\/h4>\n
Refer to the definition of cosmetics in the amended UK Cosmetics Regulation based on (EC) No 1223\/2009:<\/p>\n
A “cosmetic product” means 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 odors.<\/p><\/blockquote>\n
Step 2: Responsible Person (RP) Requirements<\/h4>\n\n- Every product entering the UK must have a designated RP.<\/li>\n
- The RP must be a natural or legal person based in the UK.<\/li>\n
- The RP can be the manufacturer, importer, distributor, or a third party authorized in writing.<\/li>\n
- The RP is responsible for ensuring product safety, compliance with standards, submitting notifications, and maintaining the PIF.<\/li>\n<\/ul>\n
Step 3: Preparing the Product Information File (PIF)<\/h4>\n
The PIF must include the following seven sections:<\/p>\n
\n- Good Manufacturing Practices (GMP):<\/strong>
\nCompliance with ISO 22716:2007 or equivalent standards.<\/li>\n- Manufacturing Process Description<\/strong><\/li>\n
- Product Label<\/strong><\/li>\n
- Product Images<\/strong><\/li>\n
- Evidence of Claims<\/strong><\/li>\n
- Cosmetic Product Safety Report (CPSR):<\/strong>\n
\n- Part A: Safety Information<\/strong>\n
\n- Qualitative and quantitative composition of the product.<\/li>\n
- Physicochemical properties of raw materials and finished products.<\/li>\n
- Stability (compatibility) of the product.<\/li>\n
- Microbiological specifications of raw materials and finished products.<\/li>\n
- Preservative challenge tests.<\/li>\n
- Information on impurities, traces, and packaging materials (including stability).<\/li>\n
- General or foreseeable use of the product.<\/li>\n
- Exposure scenarios for the product and its substances.<\/li>\n
- Toxicological profile of substances (raw materials).<\/li>\n
- Adverse or serious adverse reactions.<\/li>\n
- Other relevant information (e.g., clinical tests).<\/li>\n<\/ul>\n<\/li>\n
- Part B: Safety Assessment<\/strong>\n
\n- Assessment conclusions.<\/li>\n
- Warning labels and instructions for use.<\/li>\n
- Justification for the conclusions.<\/li>\n
- Qualifications and approval of the safety assessor (e.g., a degree in pharmacy, toxicology, medicine, or equivalent recognized by authorities).<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n
Step 4: Product Labeling<\/h4>\n
The product label must include:<\/p>\n
\n- Product function.<\/li>\n
- Ingredient list.<\/li>\n
- Special precautions for use.<\/li>\n
- Name and address of the RP.<\/li>\n
- Country of origin.<\/li>\n
- Nominal content (quantity).<\/li>\n
- Expiry date.<\/li>\n
- Batch number.<\/li>\n
- Product claims.<\/li>\n<\/ul>\n
All required information must be displayed on both the outer packaging and the product itself. Exceptions include:<\/p>\n
\n- Outer Packaging:<\/strong>\u00a0Special precautions and ingredient lists can be indicated with easily recognizable symbols.<\/li>\n
- Product Content:<\/strong>\u00a0Special precautions can also be indicated with symbols. Batch numbers may be omitted.<\/li>\n<\/ul>\n
Step 5: SCPN\/CPNP Notification<\/h4>\n
Before entering the market, the RP must submit product notifications. Failure to do so may result in fines (unlimited in England and Wales, up to \u00a35,000 in Scotland and Northern Ireland) or imprisonment (up to 3 months).<\/p>\n
Mandatory notification details include:<\/p>\n
\n- Product category and name.<\/li>\n
- RP’s name.<\/li>\n
- Address where the PIF is stored.<\/li>\n
- Contact details of a natural person for emergencies.<\/li>\n
- Identification of nanomaterials (if applicable) and foreseeable exposure conditions.<\/li>\n
- Identification of CMR substances (if applicable).<\/li>\n
- Product formula.<\/li>\n
- Original labels and packaging (post-market).<\/li>\n<\/ul>\n
Notification Portals:<\/strong><\/p>\n\n\n<\/div>\n<\/div>\n\n
\nThe EU issued the EU Cosmetics Regulation (EC) No 1223\/2009.<\/li>\n
\nThe UK issued the Cosmetics Enforcement Regulations 2013, establishing the enforcement authority of the EU Cosmetics Regulation in the UK.<\/li>\n
\nAs an EU member state, the EU Cosmetics Regulation (EC) No 1223\/2009 came into effect in the UK.<\/li>\n
\nThe UK amended retained EU regulations and issued the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, with Schedule 34 specifically addressing cosmetics regulations.<\/li>\n
\nThe amended UK Cosmetics Regulations came into effect.<\/li>\n<\/ul>\n
\n
UK Cosmetics Regulatory Documents<\/h2>\n\n\n\n\nRegulatory Document<\/strong><\/th>\nApplicable Regions<\/strong><\/th>\n<\/tr>\n<\/thead>\n\n\nThe Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 – Schedule 34<\/td>\n Great Britain (England, Scotland, Wales)<\/td>\n<\/tr>\n \nEU Cosmetics Regulation (EC) No 1223\/2009<\/td>\n Northern Ireland*<\/td>\n<\/tr>\n \nUK Cosmetics Regulations and EU Cosmetics Regulations<\/td>\n Great Britain and Northern Ireland<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n*Note: Under the Windsor Framework Agreement, Northern Ireland’s cosmetics regulations remain aligned with the EU.<\/p>\n
\nGovernment Bodies Responsible for Legislation and Implementation<\/h2>\n
The following three government bodies are primarily responsible for the legislation and implementation of UK cosmetics regulations:<\/p>\n
\n- Secretary of State<\/strong>\n
\n- Responsibilities: Formulating and implementing cosmetics safety policies, regularly reviewing the implementation of regulations, and assessing and making necessary changes.<\/li>\n<\/ul>\n<\/li>\n
- Office for Product Safety and Standards (OPSS)<\/strong>\n
\n- Responsibilities: Acting as the national regulatory authority, providing guidance and support to the industry, and exercising the Secretary of State’s powers during enforcement.<\/li>\n<\/ul>\n<\/li>\n
- Scientific Advisory Group on Chemical Safety in Consumer Products (SAG-CS)<\/strong>\n
\n- Responsibilities: Commissioned by OPSS to assess the chemical\/biological risks of consumer products (excluding food and medicine) and provide scientific opinions on cosmetic ingredients.<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n
\nSteps for Submitting Cosmetics to the UK Market<\/h3>\n
Follow these steps to ensure your product enters the UK market smoothly:<\/p>\n
\n\n\n\nStep<\/strong><\/th>\nDescription<\/strong><\/th>\n<\/tr>\n<\/thead>\n\n\n1<\/td>\n Product Classification: Classify the product as a cosmetic.<\/td>\n<\/tr>\n \n2<\/td>\n Identify the Responsible Person (RP): Appoint a UK-based RP.<\/td>\n<\/tr>\n \n3<\/td>\n Prepare the Product Information File (PIF): Compile all required documentation.<\/td>\n<\/tr>\n \n4<\/td>\n Notify via SCPN\/CPNP: Submit the required notifications.<\/td>\n<\/tr>\n \n5<\/td>\n Enter the UK Market: Launch the product in compliance with regulations.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\nStep 1: Product Classification<\/h4>\n
Refer to the definition of cosmetics in the amended UK Cosmetics Regulation based on (EC) No 1223\/2009:<\/p>\n
A “cosmetic product” means 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 odors.<\/p><\/blockquote>\n
Step 2: Responsible Person (RP) Requirements<\/h4>\n\n- Every product entering the UK must have a designated RP.<\/li>\n
- The RP must be a natural or legal person based in the UK.<\/li>\n
- The RP can be the manufacturer, importer, distributor, or a third party authorized in writing.<\/li>\n
- The RP is responsible for ensuring product safety, compliance with standards, submitting notifications, and maintaining the PIF.<\/li>\n<\/ul>\n
Step 3: Preparing the Product Information File (PIF)<\/h4>\n
The PIF must include the following seven sections:<\/p>\n
\n- Good Manufacturing Practices (GMP):<\/strong>
\nCompliance with ISO 22716:2007 or equivalent standards.<\/li>\n- Manufacturing Process Description<\/strong><\/li>\n
- Product Label<\/strong><\/li>\n
- Product Images<\/strong><\/li>\n
- Evidence of Claims<\/strong><\/li>\n
- Cosmetic Product Safety Report (CPSR):<\/strong>\n
\n- Part A: Safety Information<\/strong>\n
\n- Qualitative and quantitative composition of the product.<\/li>\n
- Physicochemical properties of raw materials and finished products.<\/li>\n
- Stability (compatibility) of the product.<\/li>\n
- Microbiological specifications of raw materials and finished products.<\/li>\n
- Preservative challenge tests.<\/li>\n
- Information on impurities, traces, and packaging materials (including stability).<\/li>\n
- General or foreseeable use of the product.<\/li>\n
- Exposure scenarios for the product and its substances.<\/li>\n
- Toxicological profile of substances (raw materials).<\/li>\n
- Adverse or serious adverse reactions.<\/li>\n
- Other relevant information (e.g., clinical tests).<\/li>\n<\/ul>\n<\/li>\n
- Part B: Safety Assessment<\/strong>\n
\n- Assessment conclusions.<\/li>\n
- Warning labels and instructions for use.<\/li>\n
- Justification for the conclusions.<\/li>\n
- Qualifications and approval of the safety assessor (e.g., a degree in pharmacy, toxicology, medicine, or equivalent recognized by authorities).<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n
Step 4: Product Labeling<\/h4>\n
The product label must include:<\/p>\n
\n- Product function.<\/li>\n
- Ingredient list.<\/li>\n
- Special precautions for use.<\/li>\n
- Name and address of the RP.<\/li>\n
- Country of origin.<\/li>\n
- Nominal content (quantity).<\/li>\n
- Expiry date.<\/li>\n
- Batch number.<\/li>\n
- Product claims.<\/li>\n<\/ul>\n
All required information must be displayed on both the outer packaging and the product itself. Exceptions include:<\/p>\n
\n- Outer Packaging:<\/strong>\u00a0Special precautions and ingredient lists can be indicated with easily recognizable symbols.<\/li>\n
- Product Content:<\/strong>\u00a0Special precautions can also be indicated with symbols. Batch numbers may be omitted.<\/li>\n<\/ul>\n
Step 5: SCPN\/CPNP Notification<\/h4>\n
Before entering the market, the RP must submit product notifications. Failure to do so may result in fines (unlimited in England and Wales, up to \u00a35,000 in Scotland and Northern Ireland) or imprisonment (up to 3 months).<\/p>\n
Mandatory notification details include:<\/p>\n
\n- Product category and name.<\/li>\n
- RP’s name.<\/li>\n
- Address where the PIF is stored.<\/li>\n
- Contact details of a natural person for emergencies.<\/li>\n
- Identification of nanomaterials (if applicable) and foreseeable exposure conditions.<\/li>\n
- Identification of CMR substances (if applicable).<\/li>\n
- Product formula.<\/li>\n
- Original labels and packaging (post-market).<\/li>\n<\/ul>\n
Notification Portals:<\/strong><\/p>\n\n\n<\/div>\n<\/div>\n\n
Regulatory Document<\/strong><\/th>\n| Applicable Regions<\/strong><\/th>\n<\/tr>\n<\/thead>\n\n | The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 – Schedule 34<\/td>\n | Great Britain (England, Scotland, Wales)<\/td>\n<\/tr>\n | EU Cosmetics Regulation (EC) No 1223\/2009<\/td>\n | Northern Ireland*<\/td>\n<\/tr>\n | UK Cosmetics Regulations and EU Cosmetics Regulations<\/td>\n | Great Britain and Northern Ireland<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n | *Note: Under the Windsor Framework Agreement, Northern Ireland’s cosmetics regulations remain aligned with the EU.<\/p>\n \n Government Bodies Responsible for Legislation and Implementation<\/h2>\nThe following three government bodies are primarily responsible for the legislation and implementation of UK cosmetics regulations:<\/p>\n
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