Glossary
Cosmetics regulatory compliance, defined
Plain-language definitions for the registries, documents, and concepts that come up in multi-market cosmetic compliance — grounded in what each term actually means, not a marketing gloss on it.
Registries & regulatory bodies
EU CosIng
The European Commission's public database of cosmetic ingredients and substances, used to look up INCI names, functions, and annex (restriction) status under EU Regulation 1223/2009.
EU CosIng & INCI basicsECHA SVHC (Substances of Very High Concern)
A list maintained by the European Chemicals Agency of substances identified as carcinogenic, mutagenic, reprotoxic, or otherwise of very high concern under REACH — relevant to cosmetics where an ingredient also falls under REACH scope.
Search the ingredient databaseFDA (U.S. Food and Drug Administration)
The US federal agency responsible for cosmetics regulation, including facility registration, product listing, and enforcement under MoCRA.
FDA facility registration guideMoCRA (Modernization of Cosmetics Regulation Act)
The 2022 US federal law that introduced mandatory facility registration, product listing, and serious adverse event reporting for cosmetics — the first major update to US cosmetics law in decades.
MoCRA compliance softwareHealth Canada Cosmetic Ingredient Hotlist
Canada's list of substances prohibited or restricted for use in cosmetics, maintained by Health Canada under the Food and Drugs Act.
Search the ingredient databaseChina NMPA (National Medical Products Administration)
China's regulator for cosmetics, overseeing the Inventory of Existing Cosmetic Ingredients in China (IECIC) and product registration/notification requirements.
Search the ingredient databaseJapan MHLW (Ministry of Health, Labour and Welfare)
Japan's regulatory authority for cosmetics, setting positive and negative ingredient lists under the Pharmaceutical and Medical Device Act.
Search the ingredient databaseKorea MFDS (Ministry of Food and Drug Safety)
South Korea's cosmetics regulator, responsible for ingredient restrictions and functional cosmetic approval requirements.
Search the ingredient databaseASEAN Cosmetic Directive
A harmonized set of cosmetic ingredient rules adopted across ASEAN member states, closely modeled on the EU's annex structure.
Search the ingredient databaseUK OPSS (Office for Product Safety and Standards)
The UK body overseeing cosmetic product safety since the UK's post-Brexit divergence from the EU cosmetics framework, maintaining its own restricted-substance annexes.
Search the ingredient databaseSCCS (Scientific Committee on Consumer Safety)
The EU's independent scientific advisory body that issues safety opinions on cosmetic ingredients — its opinions frequently precede new or updated annex restrictions.
Search the ingredient databaseCore compliance concepts
INCI name
The International Nomenclature of Cosmetic Ingredients name — a standardized ingredient identifier used on product labels worldwide, distinct from an ingredient's trade name or chemical name.
EU CosIng & INCI basicsCAS number
A unique numeric identifier assigned by the Chemical Abstracts Service to a specific chemical substance — used to match an ingredient precisely, since the same substance can appear under multiple INCI names or synonyms.
Search the ingredient databasePermitted / restricted / prohibited
The three verdict states a market's regulation can apply to a cosmetic ingredient: permitted with no limit, restricted to a maximum concentration or specific conditions, or prohibited outright.
How formula compliance worksConcentration limit
The maximum percentage of a restricted ingredient allowed in a finished product under a given market's regulation — often specific to the product's application type.
How formula compliance worksApplication type (leave-on vs. rinse-off)
Whether a product stays on the skin (leave-on) or is washed off shortly after use (rinse-off) — many concentration limits differ by application type, since exposure duration changes the risk calculation.
How formula compliance worksAnnex II (EU prohibited substances)
The annex to EU Regulation 1223/2009 listing substances prohibited outright in cosmetic products.
EU CosIng & INCI basicsAnnex III (EU restricted substances)
The annex to EU Regulation 1223/2009 listing substances permitted only under specific conditions — typically a maximum concentration, application type, or required warning.
How formula compliance worksAnnex IV (EU colourants)
The annex to EU Regulation 1223/2009 listing colourants permitted in cosmetic products, identified by CI (Colour Index) number.
EU label & INCI ingredient list guideAnnex V (EU preservatives)
The annex to EU Regulation 1223/2009 listing preservatives permitted in cosmetic products, each with its own maximum concentration.
How formula compliance worksAnnex VI (EU UV filters)
The annex to EU Regulation 1223/2009 listing UV filters permitted in cosmetic products, each with its own maximum concentration.
How formula compliance worksMaster formula & regional variant
A master formula is a product's base formulation; a regional variant is a market-specific adjustment to it (e.g. swapping a restricted preservative) — linking variants to one master formula avoids re-building the same product per market from scratch.
How formula compliance worksDocuments & filings
SDS (Safety Data Sheet)
A standardized document from an ingredient or raw-material supplier listing hazard information, composition, and handling guidance — the primary source document for extracting a formula's ingredients, CAS numbers, and concentrations.
SDS parsingCPNP (Cosmetic Product Notification Portal)
The EU online portal where a Responsible Person must notify a cosmetic product before it's placed on the market, as required under Article 13 of Regulation 1223/2009.
CPNP compliance softwareCPSR (Cosmetic Product Safety Report)
The safety assessment document required for every cosmetic product placed on the EU market, prepared by a qualified safety assessor under Article 10 and Annex I of Regulation 1223/2009.
CPSR & PIF guidePIF (Product Information File)
The EU-required file containing a cosmetic product's full documentation — formula, safety report, labeling, manufacturing method — kept for 10 years and made available to authorities on request.
CPSR & PIF guideGMP & ISO 22716
Good Manufacturing Practice for cosmetics — ISO 22716 is the internationally recognized standard defining GMP requirements, referenced directly by EU Article 8; the US does not yet have a final cosmetic GMP rule under MoCRA.
Cosmetic GMP: EU vs. US statusSerious Adverse Event (SAE)
Under MoCRA, an adverse effect from a cosmetic product significant enough to require FDA notification within 15 business days — includes outcomes like hospitalization or death, not routine complaints.
MoCRA serious adverse event reportingResponsible Person (EU)
The legal entity — manufacturer, importer, or designated representative — accountable for a cosmetic product's compliance in the EU, including CPNP notification and maintaining the Product Information File.
CPNP notification guideScreening & specialty checks
IFRA 51st Amendment
The current edition of the International Fragrance Association's standard setting concentration limits for restricted fragrance materials, applied per product category (e.g. fine fragrance vs. rinse-off).
IFRA & PFAS screeningPFAS (per- and polyfluoroalkyl substances)
A class of synthetic chemicals under increasing cosmetic-specific restriction across multiple markets, screened for both structurally (known PFAS chemical patterns) and via total organic fluorine indicators.
IFRA & PFAS screeningFragrance allergen
A fragrance ingredient subject to mandatory disclosure above a concentration threshold under EU Regulation 2023/1545, due to established potential to cause allergic skin reactions.
EU fragrance allergens & labelingRetailer restricted-substance list
A retailer's own ingredient policy — separate from government regulation and often stricter — that a product must pass as a condition of being listed at that retailer.
Retailer compliance listsBlast radius (regulatory change impact)
The full set of formulas, variants, and markets affected when a regulation changes for a given ingredient — surfacing this at the time of the change, instead of only at the next manual audit, is what continuous monitoring is for.
How formula compliance works“Cosmeceutical”
A marketing term, not a legal category, in either the US or EU. A product is regulated as a cosmetic or a drug based on its claims and intended use — there is no intermediate regulatory class for products described this way.
Pharma vs. cosmetics: regulatory boundaryRecently added
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