42+ defined terms covering MoCRA, EU Cosmetics Regulation, CPNP, SCCS, INCI, and more. Clear definitions with links to official sources.
The section of the US Code of Federal Regulations containing FDA regulations specific to cosmetic products, including prohibited ingredients, required warning statements, and labeling requirements. Parts 700-740 collectively govern cosmetics.
The regulatory process of reporting harmful health effects associated with cosmetic products to authorities. Under MoCRA, US responsible persons must report serious adverse events to the FDA within 15 business days; the EU requires reporting serious undesirable effects to competent authorities.
The list of over 1,600 substances prohibited from use in cosmetic products under the EU Cosmetics Regulation (EC 1223/2009). Annex II substances may not be used as cosmetic ingredients under any conditions, regardless of concentration.
The list of substances restricted to specific conditions of use in cosmetic products under EC 1223/2009. Annex III specifies maximum concentrations, product types, warnings, and other conditions under which listed substances may be used.
Brazil's health regulatory agency (Agencia Nacional de Vigilancia Sanitaria) responsible for cosmetics regulation. ANVISA classifies cosmetics into Grade 1 (low risk, notification only) and Grade 2 (higher risk, requiring registration and technical review).
Canada's Cosmetic Regulations under the Food and Drugs Act (C.R.C., c.869), administered by Health Canada, requiring cosmetic notification, ingredient disclosure using the Cosmetic Ingredient Hotlist, and bilingual labeling in English and French.
Substances classified as Carcinogenic, Mutagenic, or toxic to Reproduction under EU CLP Regulation (EC 1272/2008). CMR substances are generally prohibited in cosmetics under EC 1223/2009, with very limited exceptions requiring SCCS review and Commission authorization.
The European Commission's official database of cosmetic ingredients (Cosmetic Ingredient database). CosIng contains information on substances and ingredients used in cosmetic products, including INCI names, CAS numbers, restrictions, and references to EC 1223/2009 annexes.
Health Canada's list of substances that are prohibited or restricted in cosmetics sold in Canada. Although technically an administrative guide rather than a formal regulation, the Hotlist is enforced under the Food and Drugs Act and is regularly updated to reflect international safety assessments.
An independent, industry-funded expert panel that reviews and assesses the safety of ingredients used in cosmetics in the United States. CIR has reviewed over 2,000 cosmetic ingredients, and its findings are widely used for safety substantiation under MoCRA.
A two-part safety assessment document required within the PIF under EC 1223/2009 (Annex I). Part A compiles safety data for each ingredient; Part B is a qualified safety assessor's conclusion on whether the product is safe for human health.
The European Commission's online portal where responsible persons must notify cosmetic products before placing them on the EU market, as required by Article 13 of EC 1223/2009. Notifications include product details, ingredient composition, and labeling information.
The FDA's web-based portal for cosmetic facility registration and product listing submissions under MoCRA. It provides a user-friendly interface as an alternative to the SPL/ESG submission pathway, allowing manual entry of registration and listing data.
The FDA's electronic gateway for receiving regulatory submissions in SPL XML format, including MoCRA cosmetic facility registrations and product listings. ESG NextGen replaced the original ESG and supports automated, API-driven submissions.
The primary European Union law governing cosmetic products, establishing requirements for safety assessment, CPNP notification, responsible person designation, ingredient restrictions (Annexes II-VI), labeling, and post-market surveillance across all EU/EEA member states.
A unique numerical identifier assigned by the FDA to each establishment (facility) involved in the manufacture, processing, packing, or holding of FDA-regulated products. Under MoCRA, an FEI number is required for cosmetic facility registration.
The foundational US law (21 U.S.C. ch. 9) granting the FDA authority to oversee the safety of food, drugs, medical devices, and cosmetics. MoCRA (2022) amended the FD&C Act to significantly expand FDA's cosmetics oversight.
The US federal agency within the Department of Health and Human Services responsible for regulating cosmetics, food, drugs, medical devices, and other products. Under MoCRA, the FDA has expanded authority over cosmetics including facility registration, product listing, and mandatory recall power.
Specific fragrance substances identified as common causes of allergic contact dermatitis that must be individually declared on cosmetic product labels when present above specified concentrations. The EU currently requires declaration of 80+ fragrance allergens under updated EC 1223/2009 Annex III rules.
A system of guidelines ensuring cosmetic products are consistently produced and controlled according to quality standards. MoCRA requires FDA to establish cosmetic GMP regulations; in the EU, compliance with ISO 22716 is presumed to satisfy the GMP requirement of EC 1223/2009.
The Canadian federal department responsible for national public health, including regulation of cosmetics under the Food and Drugs Act and the Cosmetic Regulations (C.R.C., c.869). Health Canada maintains the Cosmetic Ingredient Hotlist and processes cosmetic notifications.
A standardized system of ingredient naming developed by the Personal Care Products Council (formerly CTFA), used worldwide for cosmetic ingredient labeling. INCI names are required on product labels in the EU, US, Canada, and most other regulated markets.
The international standard for cosmetics Good Manufacturing Practices (GMP), providing guidelines for the production, control, storage, and shipment of cosmetic products. Compliance with ISO 22716 creates a presumption of GMP conformity under the EU Cosmetics Regulation.
A quantitative measure used in cosmetic safety assessment, calculated as NOAEL divided by Systemic Exposure Dose (SED). A Margin of Safety of 100 or greater is generally considered acceptable by the SCCS, indicating the product is safe under normal conditions of use.
The FDA's mandatory reporting form for serious adverse events associated with cosmetics (and other FDA-regulated products). Under MoCRA, responsible persons must submit Form 3500A within 15 business days of receiving an initial serious adverse event report.
South Korea's regulatory authority for food, drugs, and cosmetics, administering the Cosmetics Act which requires product notification, GMP certification for manufacturers, and compliance with ingredient standards based on a negative-list system.
Japan's regulatory ministry overseeing cosmetics under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. Japan classifies products as 'cosmetics' or 'quasi-drugs,' each with distinct regulatory pathways.
A US federal law (Public Law 117-328, Title XXXV) signed on December 29, 2022, that gives the FDA new authority over cosmetics including mandatory facility registration, product listing, adverse event reporting, safety substantiation, and recall authority.
Materials with at least 50% of particles in the 1-100 nanometer size range used in cosmetic products. The EU Cosmetics Regulation requires specific CPNP notification of nanomaterials six months before market placement, mandatory labeling with '[nano]' in the ingredient list, and SCCS safety evaluation.
China's regulatory authority (formerly CFDA) responsible for overseeing drugs, medical devices, and cosmetics. The NMPA requires product registration or filing for all cosmetics sold in China, with distinct pathways for 'special' and 'general' cosmetics.
The highest dose or concentration of a substance at which no statistically or biologically significant adverse effects are observed in a toxicological study. The NOAEL is the numerator in the Margin of Safety (MoS) calculation used in cosmetic safety assessment.
The UK government body within the Department for Business and Trade responsible for enforcing cosmetics regulations post-Brexit, including oversight of the SCPN notification system and market surveillance of cosmetic products sold in Great Britain.
The period of time after a cosmetic product is first opened by the consumer during which the product remains safe and effective. PAO is indicated on EU/UK cosmetic labels by an open jar symbol with a number and 'M' (e.g., '12M' means 12 months after opening).
Substances added to cosmetic products to inhibit microbial growth and extend product shelf life. In the EU, only preservatives listed in the positive list (Annex V of EC 1223/2009) may be used for preservation, with specified maximum concentrations and conditions.
A mandatory dossier required under EC 1223/2009 (Article 11) that the Responsible Person must maintain for each cosmetic product on the EU market. It contains the CPSR, product description, manufacturing method, GMP evidence, and claims substantiation.
An entity established within the EU (or UK for the GB market) who is legally responsible for ensuring a cosmetic product complies with the Cosmetics Regulation. The Responsible Person maintains the PIF, submits CPNP/SCPN notifications, and reports serious undesirable effects.
The regulatory requirement that cosmetic manufacturers ensure and maintain adequate evidence demonstrating their products are safe under labeled or customary conditions of use. Under MoCRA, the FDA can request access to safety substantiation records during facility inspections.
An independent scientific committee that advises the European Commission on health and safety risks of non-food consumer products, including cosmetic ingredients. SCCS opinions form the scientific basis for EU ingredient restrictions in the Cosmetics Regulation annexes.
An XML-based document format defined by HL7 and used by the FDA for electronic submission of product information, including cosmetic facility registrations and product listings under MoCRA. SPL submissions are transmitted through the ESG NextGen gateway.
The UK government's online portal for notifying cosmetic products sold in Great Britain, managed by OPSS. It serves as the UK's post-Brexit equivalent of the EU's CPNP, requiring product and responsible person details before market placement.
The UK domestic legislation (SI 2013/1478, as amended post-Brexit) governing cosmetic product safety, requiring SCPN notification, a UK Responsible Person, and compliance with product safety standards substantially mirroring the EU Cosmetics Regulation.
Substances used in cosmetic products to absorb, reflect, or scatter ultraviolet radiation to protect the skin or hair. UV filters are regulated under positive lists: EU Annex VI permits 28 UV filters; the US classifies sunscreens as OTC drugs regulated under FDA monographs rather than as cosmetics.
Cosmetica checks your formulations against every regulation in this glossary — MoCRA, EU, UK, Canada, and 11 more markets — in seconds.
