Fragrance, Cosmetics & Personal Care Glossary
Le gcrs group Fragrance, Cosmetics & Personal Care Glossary explains the regulatory, scientific and technical terminology used throughout the fragrance, cosmetics and personal care industries. Whether you are developing, manufacturing, importing or marketing products in the UK, EU, USA or other international markets, this glossary provides a practical reference to help you understand the key legislation, regulatory requirements, product safety principles and industry terminology that support successful compliance and global market access.
The glossary covers cosmetic regulations, product safety assessments, Responsible Person requirements, ingredient compliance, product testing, labelling, claims substantiation, quality management, market surveillance and international regulatory authorities. It has been developed as a valuable resource for beauty brands, manufacturers, retailers, distributors and regulatory professionals navigating today's evolving global cosmetics and fragrance landscape.
A
Adverse Event Reporting is the process of documenting and reporting undesirable health effects experienced following the use of a cosmetic product. Many markets, including the USA under MoCRA, require brands to maintain records and report serious adverse events to the relevant regulatory authority.
Related terms: Serious Adverse Event (SAE), Cosmetovigilance, MoCRA
Aerosol Cosmetics are cosmetic products dispensed from pressurised containers, such as deodorants, hairsprays and body sprays. These products must comply with specific packaging, labelling and safety requirements before being placed on the market.
Related terms: Packaging Compliance, Label Compliance, Warning Statements
Allergen Declaration refers to the requirement to list specified fragrance allergens on cosmetic labels when present above regulatory thresholds. This helps consumers make informed purchasing decisions and reduces the risk of allergic reactions.
Related terms: Fragrance Allergen, Ingredient Declaration, IFRA Standards
Annex II of the EU Cosmetics Regulation lists substances that are prohibited from use in cosmetic products. Cosmetic products containing these substances cannot legally be placed on the UK or EU market where applicable.
Related terms: Annex III, Restricted Ingredients, Cosmetic Regulation
Annex III of the EU Cosmetics Regulation lists substances that may only be used under specific conditions or concentration limits. Compliance with Annex III is essential when developing products for the UK and EU markets.
Related terms: Annex II, Ingredient Review, Restricted Ingredients
The ASEAN Cosmetic Directive (ACD) provides harmonised cosmetic regulations across ASEAN member countries. It establishes common requirements for product safety, ingredient restrictions, labelling and product notification to facilitate regional trade.
Related terms: Product Registration, Cosmetic Regulation, Market Surveillance
An Audit Trail is a documented record of regulatory actions, approvals, document revisions and compliance activities throughout a product’s lifecycle. Maintaining a complete audit trail supports transparency, traceability and regulatory inspections.
Related terms: Document Control, Regulatory Audit, Traceability
Artwork Approval is the process of reviewing and approving cosmetic packaging artwork before production to ensure all mandatory regulatory information is accurate and compliant.
Related terms: Artwork Compliance, Label Compliance, Labelling Review
Artwork Compliance ensures that cosmetic packaging artwork meets applicable regulatory requirements before printing. This includes verifying ingredient lists, warning statements, claims, mandatory symbols and legal information.
Related terms: Artwork Approval, Label Compliance, Ingredient Declaration
An Authorised Representative is a legal entity appointed to act on behalf of a manufacturer in markets where local representation is required. Their responsibilities vary depending on jurisdiction and product category.
Related terms: Responsible Person (RP), Importer Responsibilities, Product Registration
B
A Batch Code is a unique identifier assigned to a production batch of cosmetic products. It enables manufacturers to trace products throughout the supply chain and supports product recalls, investigations and quality control.
Related terms: Traceability, Recall Management, Quality Control (QC)
Bioburden Testing measures the number of microorganisms present in raw materials or finished products before sterilisation or preservation. It helps demonstrate microbiological quality and product safety.
Related terms: Microbiological Testing, Preservative Efficacy Test (PET), Stability Testing
The Bureau of Indian Standards (BIS) is India’s national standards body responsible for developing product standards and certification schemes. Certain cosmetic products and manufacturing activities may be subject to applicable BIS requirements.
Related terms: CDSCO India, Product Registration, Cosmetic Regulation
A Borderline Product is a product whose classification between a cosmetic, medicinal product, medical device or another regulated category is unclear. Correct classification determines which legislation applies before market entry.
Related terms: Cosmetic Regulation, Product Claims, Regulatory Intelligence
A Bulk Manufacturing Record documents the formulation, manufacturing process, equipment, raw materials and quality checks used during cosmetic production. It provides evidence of manufacturing consistency and supports regulatory compliance.
Related terms: Good Manufacturing Practice (GMP), Document Control, Quality Assurance (QA)
C
CMR Substances are chemicals classified as Carcinogenic, Mutagenic or Toxic for Reproduction. Their use in cosmetic products is heavily restricted or prohibited under cosmetic regulations to protect consumer safety.
Related terms: Restricted Ingredients, Annex II, Annex III
A Certificate of Analysis (CoA) is a quality assurance document confirming that a raw material or finished product has been tested against defined specifications. It provides evidence that the material meets agreed quality, purity and safety requirements.
Related terms: Quality Control (QC), Raw Material Verification, Supplier Documentation
A Certificate of Free Sale (CFS) confirms that a cosmetic product is legally marketed in its country of origin. Many international regulatory authorities request this document during product registration or importation.
Related terms: Certificate of Origin (COO), Product Registration.
A Certificate of Origin verifies the country where a product was manufactured or substantially produced. It is commonly required for customs clearance and international trade.
Related terms: Certificate of Free Sale (CFS), Product Registration, Importer Responsibilities
Claims Compliance is the process of ensuring cosmetic marketing claims are truthful, supported by evidence and comply with applicable advertising and cosmetic regulations before products are placed on the market.
Related terms: Claims Substantiation, Cosmetic Claims, Green Claims Code
Claims Substantiation is the process of gathering scientific evidence, testing or supporting documentation to verify that cosmetic product claims are accurate and can be legally made.
Related terms: Cosmetic Claims, Safety Substantiation, Green Claims
The Classification, Labelling and Packaging (CLP) Regulation establishes requirements for classifying and communicating hazards associated with chemical substances and mixtures within the European Union. Although cosmetics are generally exempt, CLP may apply to certain products during transport or storage.
Related terms: Hazard Assessment, Safety Data Sheet (SDS), Label Compliance
A Clinical Safety Assessment evaluates the safety of cosmetic products through clinical testing or expert review where appropriate. The assessment helps demonstrate consumer safety before products reach the market.
Related terms: Product Safety Assessment, Safety Assessment, HRIPT
Cosmetic Claims are statements used to describe the function, performance or benefits of a cosmetic product. Claims must be truthful, supported by evidence and comply with applicable regulations.
Related terms: Claims Compliance, Claims Substantiation, Green Claims
Cosmetic Compliance is the process of ensuring cosmetic products meet all applicable regulatory, safety, labelling, testing and documentation requirements before and after being placed on the market.
Related terms: Cosmetic Regulation, Responsible Person (RP), Product Information File (PIF)
The Cosmetic Ingredient Review (CIR) is an independent scientific programme that evaluates the safety of cosmetic ingredients used in the United States. CIR assessments are widely recognised by industry and regulatory professionals.
Related terms: Ingredient Review, Safety Assessment, Toxicological Assessment
Cosmetic Product Notification is the process of submitting required product information to the relevant regulatory authority before a cosmetic product is placed on the market, where notification is legally required.
Related terms: SCPN, CPNP, Product Registration
A Cosmetic Product Safety Report (CPSR) is a mandatory safety assessment required before cosmetic products can be placed on the UK and EU markets. It is completed by a Qualified Safety Assessor and evaluates the formulation, ingredients, toxicological profile, exposure and intended use of the product to confirm it is safe for consumers. The CPSR forms part of the Product Information File (PIF).
Related terms: Product Information File (PIF), Qualified Safety Assessor, Responsible Person (RP), Safety Assessment
Cosmetic Regulation refers to the legal framework governing the manufacture, labelling, safety and marketing of cosmetic products. Requirements differ across the UK, EU, USA, GCC and other international markets.
Related terms: Product Registration, Responsible Person (RP), Regulatory Intelligence
Cosmetovigilance is the ongoing monitoring, investigation and management of adverse events associated with cosmetic products after they have been placed on the market.
Related terms: Adverse Event Reporting, Serious Adverse Event (SAE), Recall Management
A Compliance Audit is a systematic review of a company’s products, documentation, processes and quality systems to assess compliance with applicable cosmetic regulations and industry standards.
Related terms: Regulatory Audit, Gap Analysis, Good Manufacturing Practice (GMP)
D
A Declaration of Conformity (DoC) is a formal document stating that a product complies with applicable legislation, standards or regulatory requirements. While more commonly associated with other regulated product categories, a DoC may be required where cosmetic products incorporate regulated components or fall within multiple regulatory frameworks.
Related terms: Technical Documentation, Product Dossier, Regulatory Audit
A Digital Product Passport (DPP) is a digital record containing information about a product’s composition, sustainability, traceability and regulatory compliance throughout its lifecycle. It is expected to play an increasing role within future European sustainability legislation.
Related terms: Traceability, Packaging Compliance, Regulatory Intelligence
Distributor Responsibilities refer to the legal obligations placed on distributors when making cosmetic products available on the market. Distributors must verify that products meet applicable labelling, storage and compliance requirements before supplying them.
Related terms: Responsible Person (RP), Importer Responsibilities, Product Notification
Document Control is the process of managing, reviewing, approving and maintaining regulatory documentation to ensure only current and approved versions are used. Effective document control supports compliance, traceability and audit readiness.
Related terms: Audit Trail, Technical Documentation, Product Information File (PIF)
A Dossier Review is the assessment of regulatory documentation to confirm it is complete, accurate and compliant before a product is submitted for notification, registration or market launch.
Related terms: Product Dossier, Product Information File (PIF), Regulatory Audit
E
Endocrine Disruptors are substances that may interfere with the body’s hormonal system and potentially affect human health. Regulatory authorities continue to assess these substances, and restrictions may apply depending on the latest scientific evidence.
Related terms: Restricted Ingredients, Safety Assessment, Ingredient Review
Enforcement Action refers to measures taken by regulatory authorities when cosmetic products fail to comply with applicable legislation. Actions may include product recalls, withdrawal from the market, warning notices or financial penalties.
Related terms: Recall Management, Market Surveillance, Regulatory Audit
Le EU Cosmetics Regulation (EC No. 1223/2009) is the primary legislation governing cosmetic products placed on the European Union market. It establishes requirements for product safety, labelling, Responsible Persons, Product Information Files, ingredient restrictions and product notification.
Related terms: CPNP, Responsible Person (RP), Cosmetic Product Safety Report (CPSR)
Un EU Responsible Person is the legal entity responsible for ensuring cosmetic products comply with the EU Cosmetics Regulation before they are placed on the European market. The Responsible Person maintains the Product Information File (PIF), ensures product notification through the CPNP and acts as the primary contact for competent authorities.
Related terms: Responsible Person (RP), CPNP, Product Information File (PIF)
Un Exposure Assessment evaluates how consumers are expected to use a cosmetic product, including the amount applied, frequency of use and area of exposure. This information forms an important part of the Cosmetic Product Safety Report (CPSR).
Related terms: Cosmetic Product Safety Report (CPSR), Toxicological Assessment, Margin of Safety (MoS)
F
Facility Registration is a requirement introduced under MoCRA, enacted in 2022, requiring certain cosmetic manufacturing and processing facilities marketing products in the United States to register with the US Food and Drug Administration (FDA).
Related terms: MoCRA, Product Listing, FDA Cosmetics Regulation
FDA Cosmetics Regulation refers to the legal framework administered by the US Food and Drug Administration (FDA) for cosmetic products marketed in the United States. Requirements include product safety, facility registration, product listing, adverse event reporting and compliance with MoCRA.
Related terms: MoCRA, Facility Registration, Product Listing
Fine Fragrance refers to perfumes, eau de parfum, eau de toilette, colognes and other fragrance products designed primarily to provide a pleasant scent. These products must comply with applicable ingredient, allergen, labelling and safety requirements before being marketed.
Related terms: IFRA Standards, Fragrance Allergen, Cosmetic Product Safety Report (CPSR)
A Formula Review is the assessment of a cosmetic formulation to identify prohibited or restricted ingredients, regulatory risks and compliance requirements before product development or market launch.
Related terms: Ingredient Review, Formulation Assessment, Restricted Ingredients
A Formulation Assessment evaluates the ingredients used within a cosmetic product to determine whether the formulation complies with applicable cosmetic regulations, safety requirements and market-specific restrictions.
Related terms: Formula Review, Ingredient Review, Safety Assessment
A Fragrance Allergen is a fragrance ingredient known to cause allergic reactions in some individuals. Certain fragrance allergens must be declared on cosmetic labels when present above regulatory thresholds in the UK, EU and other applicable markets.
Related terms: Allergen Declaration, IFRA Standards, Ingredient Declaration
A Free Sale Certificate (FSC) is another commonly used name for a Certificate of Free Sale (CFS). It confirms that a cosmetic product is legally marketed in its country of origin and is often requested during international product registration.
Related terms: Certificate of Free Sale (CFS), Certificate of Origin (COO), Product Registration
G
A Good Manufacturing Practice (GMP) Audit assesses whether a cosmetic manufacturer complies with recognised GMP requirements, including ISO 22716. Regular GMP audits help demonstrate consistent product quality, manufacturing controls and regulatory compliance.
Related terms: Good Manufacturing Practice (GMP), ISO 22716, Compliance Audit
A Gap Analysis is a structured review used to identify differences between a cosmetic product’s current compliance status and the regulatory requirements of a target market. It helps brands address deficiencies before product launch and reduce compliance risks.
Related terms: Compliance Audit, Regulatory Audit, Product Registration
GCC Cosmetics Regulation refers to the regulatory framework governing cosmetic products marketed across the Gulf Cooperation Council (GCC) countries. Requirements vary between GCC member states but commonly include product registration, ingredient compliance, labelling and safety documentation. Brands should also consider country-specific regulatory procedures before placing products on individual GCC markets.
Related terms: SFDA, GSO, SASO, Product Registration
Good Manufacturing Practice (GMP) is a quality management system that ensures cosmetic products are consistently manufactured and controlled according to recognised quality standards. Compliance with ISO 22716 demonstrates adherence to internationally recognised cosmetic GMP principles.
Related terms: ISO 22716, GMP Audit, Quality Assurance (QA)
Green Claims are environmental or sustainability statements made about a cosmetic product, its ingredients or packaging. These claims must be truthful, evidence-based and supported by appropriate documentation to avoid misleading consumers.
Related terms: Green Claims Code, Claims Substantiation, Cosmetic Claims
Le Green Claims Code is guidance published by the Competition and Markets Authority (CMA) to help businesses make accurate, truthful and evidence-based environmental claims. It aims to prevent greenwashing by ensuring sustainability claims are clear, substantiated and not misleading.
Related terms: Green Claims, Claims Substantiation, Cosmetic Claims
Greenwashing is the practice of making misleading or exaggerated environmental or sustainability claims about a product or business. Regulators increasingly scrutinise greenwashing to ensure consumers receive accurate and substantiated information.
Related terms: Green Claims, Green Claims Code, Claims Compliance
Le GCC Standardization Organization (GSO) develops harmonised technical regulations and standards across Gulf Cooperation Council member states. These standards help support consistent regulatory requirements for cosmetic products throughout the GCC region.
Related terms: GCC Cosmetics Regulation, SFDA, SASO
H
A Hazard Assessment identifies the inherent hazardous properties of cosmetic ingredients, including toxicological concerns and potential health risks. It forms part of the scientific evaluation completed during product safety assessments.
Related terms: Toxicological Assessment, Safety Assessment, Restricted Ingredients
Health Canada is Canada’s federal regulatory authority responsible for overseeing cosmetic products. Cosmetic products marketed in Canada must be notified to Health Canada using the Cosmetic Notification Form (CNF) and must comply with applicable ingredient and labelling requirements under Canadian cosmetics legislation.
Related terms: Ingredient Declaration, Product Registration
Heavy Metal Testing analyses cosmetic products for contaminants such as lead, arsenic, cadmium and mercury to help demonstrate product safety and regulatory compliance.
Related terms: Microbiological Testing, Safety Assessment, Quality Control (QC)
Le Human Repeat Insult Patch Test (HRIPT) is a clinical study used to evaluate the skin irritation and sensitisation potential of cosmetic products under controlled conditions. It is commonly used to support product safety and marketing claims.
Related terms: Clinical Safety Assessment, Safety Assessment, Claims Substantiation
I
IFRA Standards are globally recognised safety guidelines developed by the Association Internationale de l'Industrie du Parfum (IFRA) to ensure the safe use of fragrance ingredients in cosmetic and consumer products. Based on scientific research and expert safety assessments, they help fragrance manufacturers minimise health risks while supporting regulatory compliance.
Related terms: Fragrance Allergen, Safety Assessment, Cosmetic Product Safety Report (CPSR), Allergen Declaration
Importer Responsibilities are the legal obligations placed on businesses importing cosmetic products into a market. Importers must ensure products comply with applicable regulations before making them available for sale.
Related terms: Distributor Responsibilities, Responsible Person (RP), Product Registration
Ingredient Declaration is the requirement to list cosmetic ingredients on product packaging using the International Nomenclature of Cosmetic Ingredients (INCI). Accurate ingredient declarations help consumers make informed purchasing decisions and support regulatory compliance.
Related terms: INCI, Label Compliance, Fragrance Allergen
Un Ingredient Review evaluates cosmetic ingredients against applicable legislation to identify prohibited substances, restricted ingredients or other regulatory concerns before product launch.
Related terms: Formula Review, Restricted Ingredients, Safety Assessment
INCI (International Nomenclature of Cosmetic Ingredients) is the internationally recognised naming system used to identify cosmetic ingredients on product labels. INCI names provide consistency across global markets and help consumers and regulators identify ingredients accurately.
Related terms: Ingredient Declaration, Label Compliance, Cosmetic Regulation
ISO 22716 is the internationally recognised standard for Good Manufacturing Practice (GMP) in the cosmetics industry. It provides guidance on manufacturing, production, storage and quality management to help ensure consistent product quality and regulatory compliance.
Related terms: Good Manufacturing Practice (GMP), GMP Audit, Quality Assurance (QA)
J
Le Japan PMD Act (Pharmaceuticals and Medical Devices Act) regulates cosmetics, quasi-drugs, pharmaceuticals and medical devices in Japan. Cosmetic brands entering the Japanese market must comply with ingredient restrictions, labelling requirements and importer obligations under this legislation.
Related terms: Product Registration, Importer Responsibilities, Cosmetic Regulation
K
A Key Information File (KIF) is a document used in certain regulatory frameworks to summarise essential product information, safety data and compliance documentation. While not a standard requirement under UK or EU cosmetic legislation, similar documentation may support regulatory submissions in some international markets.
Related terms: Product Information File (PIF), Technical Documentation, Product Dossier
L
Label Compliance is the process of ensuring cosmetic product labels meet all applicable legal requirements before products are placed on the market. This includes ingredient listings, warning statements, Responsible Person details, batch codes and mandatory product information.
Related terms: Labelling Review, Ingredient Declaration, Warning Statements
A Labelling Review is the regulatory assessment of cosmetic packaging to verify that all mandatory information is accurate, complete and compliant with the requirements of the intended market.
Related terms: Label Compliance, Artwork Compliance, Ingredient Declaration
Le Legal Manufacturer is the organisation legally responsible for manufacturing or placing a cosmetic product on the market. Responsibilities vary depending on the applicable regulatory framework and supply chain arrangements.
Related terms: Responsible Person (RP), Importer Responsibilities, Product Registration
M
Le Margin of Safety (MoS) is a toxicological calculation used during cosmetic safety assessments to determine whether exposure to an ingredient remains within acceptable safety limits. It is a key component of the Cosmetic Product Safety Report (CPSR).
Related terms: Cosmetic Product Safety Report (CPSR), Toxicological Assessment, Exposure Assessment
Market Surveillance is the ongoing monitoring of cosmetic products after they have been placed on the market to verify continued compliance with applicable regulations and consumer safety requirements.
Related terms: Cosmetovigilance, Enforcement Action, Recall Management
A Material Safety Data Sheet (MSDS) provides information on the safe handling, storage and transport of chemical substances. The term has largely been replaced internationally by Safety Data Sheet (SDS) under the Globally Harmonised System (GHS).
Related terms: Safety Data Sheet (SDS), Hazard Assessment, Raw Material Verification
Microbiological Testing evaluates cosmetic products for microbial contamination to help ensure they remain safe throughout their intended shelf life. Testing forms an important part of product quality and safety verification.
Related terms: Bioburden Testing, Preservative Efficacy Test (PET), Stability Testing
Le Modernization of Cosmetics Regulation Act (MoCRA) is the most significant update to US cosmetic legislation in decades, enacted in 2022. It introduced new requirements for facility registration, product listing, serious adverse event reporting, safety substantiation and FDA record access, strengthening regulatory oversight of cosmetic products marketed in the United States.
Related terms: FDA Cosmetics Regulation, Facility Registration (MoCRA), Product Listing, Serious Adverse Event (SAE)
N
Nanomaterials are intentionally manufactured materials with extremely small particle sizes that may exhibit unique physical or chemical properties. Certain markets require nanomaterials to undergo additional safety assessment and product notification.
Related terms: Safety Assessment, Ingredient Review, Cosmetic Product Notification
Natural Claims are marketing statements indicating that a cosmetic product contains naturally derived ingredients or has a natural origin. Such claims must be truthful, evidence-based and not mislead consumers.
Related terms: Green Claims, Claims Compliance, Claims Substantiation
A Notification Portal is an official online platform used by regulatory authorities to receive cosmetic product notifications before products are placed on the market. Examples include the Submit Cosmetic Product Notification (SCPN) in Great Britain and the Cosmetic Products Notification Portal (CPNP) in the European Union.
Related terms: SCPN, CPNP, Cosmetic Product Notification
Le National Medical Products Administration (NMPA) is China’s regulatory authority responsible for regulating cosmetics, pharmaceuticals and medical devices. Cosmetic products entering the Chinese market must comply with NMPA registration, notification, ingredient and safety requirements.
Related terms: Product Registration, Cosmetic Regulation.
O
Un Overseas Responsible Person is a legal representative appointed in markets where local regulatory representation is required. Their responsibilities vary by jurisdiction but generally include maintaining regulatory documentation, supporting product compliance and acting as the primary contact for regulatory authorities.
Related terms: Responsible Person (RP), EU Responsible Person, UK Responsible Person
P
Le Packaging and Packaging Waste Regulation (PPWR) is European legislation designed to reduce packaging waste and improve sustainability through requirements covering recyclability, packaging design and environmental performance.
Related terms: Digital Product Passport (DPP), Packaging Compliance, Green Claims
Period After Opening (PAO) indicates how long a cosmetic product remains safe and effective once opened by the consumer. It is displayed using the open jar symbol followed by the recommended number of months the product can be used safely.
Related terms: Shelf-Life Testing, Stability Testing, Label Compliance
Post-Market Surveillance is the ongoing monitoring of cosmetic products after they have been placed on the market to identify safety concerns, investigate complaints and ensure continued regulatory compliance.
Related terms: Cosmetovigilance, Adverse Event Reporting, Market Surveillance
A Preservative Efficacy Test (PET) evaluates whether a cosmetic product’s preservative system effectively prevents microbial growth throughout its intended shelf life. The test helps demonstrate product safety and microbiological stability.
Related terms: Microbiological Testing, Stability Testing, Bioburden Testing
Primary Packaging is the packaging that comes into direct contact with the cosmetic product, such as bottles, tubes, jars or pumps. It must be suitable for the product and comply with applicable regulatory and safety requirements.
Related terms: Secondary Packaging, Packaging Compliance, Label Compliance
Product Claims are statements describing the intended function, performance or benefits of a cosmetic product. Claims must be truthful, evidence-based and supported by appropriate scientific substantiation.
Related terms: Cosmetic Claims, Claims Compliance, Claims Substantiation
A Product Dossier is a structured collection of technical and regulatory documentation supporting a cosmetic product’s compliance. Depending on the market, it may include safety assessments, test reports, certificates and manufacturing information.
Related terms: Technical Dossier, Product Information File (PIF), Technical Documentation
Le Product Information File (PIF) is the primary regulatory file required for cosmetic products placed on the UK and EU markets. It contains the Cosmetic Product Safety Report (CPSR), product description, manufacturing information, supporting test data and evidence demonstrating regulatory compliance. The PIF must be maintained by the Personne responsable and made available to regulatory authorities upon request.
Related terms: Cosmetic Product Safety Report (CPSR), Responsible Person (RP), Technical Documentation
Product Listing is a regulatory requirement introduced under MoCRA, enacted in 2022, requiring cosmetic products marketed in the United States to be listed with the US Food and Drug Administration (FDA). Product listing improves regulatory oversight and market transparency.
Related terms: MoCRA, Facility Registration (MoCRA), FDA Cosmetics Regulation
Product Notification is the process of submitting required product information to the relevant regulatory authority before a cosmetic product is placed on the market where notification is legally required.
Related terms: SCPN, CPNP, Product Registration
Enregistrement du produit is the formal process of registering cosmetic products with regulatory authorities before they are marketed in jurisdictions where registration is required. Requirements vary across the USA, GCC, Middle East, Asia and other international markets.
Related terms: Product Notification, Responsible Person (RP)
A Product Safety Assessment is the scientific evaluation of a cosmetic product to determine whether it is safe for its intended use. It considers ingredients, toxicological data, exposure levels and product usage before market launch.
Related terms: Cosmetic Product Safety Report (CPSR), Safety Assessment, Toxicological Assessment
Q
A Qualified Safety Assessor is a suitably qualified professional responsible for preparing and signing the Cosmetic Product Safety Report (CPSR). They evaluate the formulation, ingredients, toxicological profile and intended use of a cosmetic product to confirm it is safe before being placed on the market.
Related terms: Cosmetic Product Safety Report (CPSR), Safety Assessment, Toxicological Assessment
Quality Assurance (QA) is a systematic approach to ensuring cosmetic products are consistently manufactured and controlled to meet defined quality and regulatory requirements. QA focuses on preventing issues through documented processes and continuous improvement.
Related terms: Good Manufacturing Practice (GMP), Quality Control (QC), Compliance Audit
Quality Control (QC) involves testing and inspection activities carried out during manufacturing to verify that cosmetic products meet established quality specifications before release.
Related terms: Quality Assurance (QA), Certificate of Analysis (CoA), Raw Material Verification
R
Raw Material Verification is the process of confirming that ingredients supplied for cosmetic manufacturing meet the required quality, identity and regulatory specifications. This helps ensure product consistency, traceability and compliance before production begins.
Related terms: Certificate of Analysis (CoA), Supplier Documentation, Quality Control (QC)
Recall Management is the structured process of withdrawing cosmetic products from the market when they present a safety risk or fail to comply with applicable regulations. Effective recall procedures help protect consumers and demonstrate regulatory responsibility.
Related terms: Market Surveillance, Enforcement Action, Cosmetovigilance
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is European chemicals legislation designed to protect human health and the environment by regulating chemical substances. Although cosmetics are regulated separately, certain cosmetic ingredients and raw materials may also be affected by REACH requirements.
Related terms: Restricted Ingredients, CMR Substances, Ingredient Review
A Regulatory Audit is a systematic assessment of a company’s documentation, products and processes to verify compliance with applicable cosmetic legislation and regulatory requirements. Audits help identify compliance gaps before inspections or product launches.
Related terms: Compliance Audit, Gap Analysis, Regulatory Intelligence
Regulatory Governance refers to the systems, policies and internal controls an organisation uses to ensure ongoing compliance with cosmetic regulations across all markets where it operates. Strong governance supports consistent decision-making, accountability and regulatory oversight.
Related terms: Compliance Audit, Regulatory Intelligence, Document Control
Regulatory Intelligence is the continuous monitoring and interpretation of new and evolving cosmetic legislation, regulatory guidance and industry developments. It helps businesses anticipate regulatory changes and maintain compliance across international markets.
Related terms: Regulatory Governance, Gap Analysis, Cosmetic Regulation
A Responsible Person (RP) is the legal entity responsible for ensuring a cosmetic product complies with the applicable regulations before it is placed on the market in the UK and EU. The Responsible Person is responsible for maintaining the Product Information File (PIF), ensuring product notification has been completed, verifying ongoing compliance and acting as the primary point of contact for regulatory authorities. Appointing a Responsible Person is a legal requirement before cosmetic products can be legally sold in these markets.
Related terms: UK Responsible Person, EU Responsible Person, Product Information File (PIF), Cosmetic Product Safety Report (CPSR)
Restricted Ingredients are substances that may only be used in cosmetic products under specified conditions, concentration limits or usage restrictions defined by applicable legislation. Compliance with these restrictions is essential for product safety and legal market access.
Related terms: Annex II, Annex III, Ingredient Review
A Risk Assessment is the process of identifying, evaluating and managing potential risks associated with cosmetic products, ingredients or manufacturing activities. It supports informed regulatory decisions and helps ensure consumer safety.
Related terms: Hazard Assessment, Safety Assessment, Toxicological Assessment
S
A Safety Assessment is the scientific evaluation of a cosmetic product to determine whether it is safe for its intended use. It considers ingredient safety, toxicological data, exposure levels and product formulation, and forms the basis of the Cosmetic Product Safety Report (CPSR).
Related terms: Cosmetic Product Safety Report (CPSR), Qualified Safety Assessor, Toxicological Assessment
A Safety Data Sheet (SDS) provides detailed information on the hazards, handling, storage and emergency measures relating to chemical substances and mixtures. While finished cosmetic products are generally exempt, SDSs remain important for raw materials and manufacturing operations.
Related terms: Material Safety Data Sheet (MSDS), Hazard Assessment, Raw Material Verification
Safety Substantiation is the collection and evaluation of scientific evidence demonstrating that a cosmetic product is safe for consumers when used as intended. It forms an essential part of regulatory compliance and product safety documentation.
Related terms: Safety Assessment, Cosmetic Product Safety Report (CPSR), Claims Substantiation
Le Saudi Standards, Metrology and Quality Organization (SASO) develops national standards and technical regulations that support product compliance within Saudi Arabia. Cosmetic manufacturers exporting to Saudi Arabia may need to comply with relevant SASO standards alongside SFDA requirements.
Related terms: SFDA, GSO, GCC Cosmetics Regulation
Secondary Packaging is the outer packaging that encloses the primary cosmetic container, such as cartons or boxes. It often contains mandatory regulatory information, marketing content and consumer instructions.
Related terms: Primary Packaging, Packaging Compliance, Label Compliance
A Serious Adverse Event (SAE) is an undesirable health effect associated with the use of a cosmetic product that results in significant medical consequences, such as hospitalisation, disability or other serious outcomes. Certain jurisdictions, including the United States under MoCRA, require mandatory reporting of serious adverse events.
Related terms: Adverse Event Reporting, Cosmetovigilance, MoCRA
Le Saudi Food and Drug Authority (SFDA) is the regulatory authority responsible for overseeing cosmetic products marketed in Saudi Arabia. It establishes requirements for product registration, labelling, ingredient compliance and product safety.
Related terms: GCC Cosmetics Regulation, SASO, Product Registration
Shelf-Life Testing evaluates how long a cosmetic product remains safe, stable and effective under defined storage conditions. The results help determine product expiry dates or the appropriate Period After Opening (PAO).
Related terms: Stability Testing, PAO (Period After Opening), Preservative Efficacy Test (PET)
Stability Testing assesses how cosmetic products perform over time under different environmental conditions such as temperature, humidity and light exposure. It helps verify product quality, shelf life and packaging compatibility.
Related terms: Shelf-Life Testing, Preservative Efficacy Test (PET), Product Safety Assessment
Submit Cosmetic Product Notification (SCPN) is the UK Government’s online notification portal used before cosmetic products are placed on the market in Great Britain (England, Scotland and Wales). Cosmetic products must be notified through the SCPN by the UK Responsible Person before they can legally be sold. The notification provides regulators with essential product information to support consumer safety and market surveillance.
Related terms: UK Responsible Person, CPNP, Product Notification, Product Information File (PIF)
Substantiation is the process of providing appropriate scientific evidence to support cosmetic product claims relating to safety, performance or efficacy. Claims must be supported before they are communicated to consumers.
Related terms: Claims Substantiation, Cosmetic Claims, Safety Substantiation
Supplier Documentation includes technical, quality and regulatory documents provided by ingredient or packaging suppliers, such as Certificates of Analysis (CoA), Safety Data Sheets (SDS) and technical specifications. These documents support product safety assessments and regulatory compliance.
Related terms: Certificate of Analysis (CoA), Raw Material Verification, Safety Data Sheet (SDS)
T
Technical Documentation is the collection of scientific, regulatory and quality documents that demonstrate a cosmetic product complies with applicable legislation. It may include safety assessments, test reports, manufacturing information and supporting compliance records.
Related terms: Product Information File (PIF), Technical Dossier, Document Control
A Technical Dossier is a structured file containing the technical evidence required to support cosmetic product compliance in specific markets. Depending on the jurisdiction, it may include safety assessments, certificates, formulation details and testing data.
Related terms: Product Dossier, Technical Documentation, Product Information File (PIF)
Testing Coordination is the process of planning, managing and monitoring laboratory testing required to support cosmetic product safety, quality and regulatory compliance. This may include microbiological, stability and compatibility testing.
Related terms: Stability Testing, Product Safety Assessment, Quality Assurance (QA)
The Therapeutic Goods Administration (TGA) is Australia’s regulatory authority for therapeutic goods. Most cosmetics are not regulated by the TGA and instead fall under Australia’s industrial chemicals and consumer protection framework. However, products making therapeutic claims or containing certain active ingredients may fall within the TGA’s remit.
Related terms: Cosmetic Claims, Product Registration
A Toxicological Assessment is the scientific evaluation of cosmetic ingredients to determine their safety based on toxicity data, exposure levels and intended use. It forms a key part of the Cosmetic Product Safety Report (CPSR).
Related terms: Safety Assessment, Margin of Safety (MoS), Qualified Safety Assessor
Traceability is the ability to track cosmetic products, ingredients and packaging throughout the supply chain. Effective traceability supports product recalls, regulatory inspections and ongoing compliance.
Related terms: Batch Code, Recall Management, Audit Trail
U
UAE Cosmetics Regulation refers to the regulatory framework governing cosmetic products marketed within the United Arab Emirates. Products must comply with applicable ingredient, labelling, product registration and safety requirements before they are placed on the UAE market.
Related terms: GCC Cosmetics Regulation, Product Registration, SFDA
UK Cosmetics Regulation is the legislation governing cosmetic products placed on the market in Great Britain. It establishes legal requirements relating to product safety, Responsible Persons, Product Information Files (PIF), product notification and cosmetic labelling.
Related terms: UK Responsible Person, SCPN, Cosmetic Product Safety Report (CPSR)
A UK Responsible Person is the legal entity responsible for ensuring cosmetic products comply with the UK Cosmetics Regulation before they are placed on the Great Britain market. They maintain the Product Information File (PIF), complete product notification through the SCPN and act as the primary contact for UK regulatory authorities.
Related terms: Responsible Person (RP), SCPN, Product Information File (PIF)
V
Validation Testing confirms that cosmetic products, manufacturing processes or testing methods consistently perform as intended. Validation helps demonstrate product quality, reliability and regulatory compliance.
Related terms: Stability Testing, Product Safety Assessment, Quality Assurance (QA)
Vegan Claims indicate that a cosmetic product does not contain ingredients of animal origin. These claims must be accurate, substantiated and not mislead consumers.
Related terms: Claims Compliance, Claims Substantiation, Green Claims
Verification is the process of confirming that regulatory documentation, product information or compliance activities are accurate, complete and meet applicable requirements before approval or market launch.
Related terms: Document Control, Compliance Audit, Regulatory Audit
Vigilance Reporting is the process of recording and communicating adverse events or safety concerns associated with cosmetic products after they have been placed on the market. It supports regulatory oversight and ongoing consumer protection.
Related terms: Cosmetovigilance, Adverse Event Reporting, Serious Adverse Event (SAE)
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Warning Statements are mandatory safety instructions that must appear on cosmetic labels where required by applicable legislation. They help consumers use cosmetic products safely and reduce the risk of misuse.
Related terms: Label Compliance, Ingredient Declaration, Packaging Compliance
X
Xenobiotics are chemical substances that are foreign to the human body, including certain cosmetic ingredients and environmental contaminants. Their safety is assessed during toxicological evaluations where relevant.
Related terms: Toxicological Assessment, Safety Assessment, Restricted Ingredients
Y
Yellow Card Reporting is the UK’s system for reporting suspected adverse reactions associated with medicines and certain regulated healthcare products. Although cosmetic adverse events are generally managed through cosmetic regulatory systems, the Yellow Card Scheme may be relevant where products fall into borderline or overlapping regulatory categories.
Related terms: Adverse Event Reporting, Cosmetovigilance, Borderline Product
Z
Zero-Waste Packaging refers to packaging designed to minimise waste through reuse, refill, recyclability or compostability. Brands making zero-waste claims must ensure such claims are accurate, evidence-based and compliant with applicable consumer protection legislation.
Related terms: Packaging Compliance, Green Claims, Green Claims Code