Regulatory glossary

The language of cosmetic regulation, defined plainly. The terms you will meet in a safety report, a notification or an audit.

CPSR (Cosmetic Product Safety Report): The mandatory safety assessment required before a cosmetic can be placed on the EU or UK market, set out in Annex I of Regulation (EC) No 1223/2009. It has two parts: the safety information (Part A) and the qualified assessor’s reasoned conclusion (Part B).
Responsible Person (RP): The legal entity established in the market that is accountable for a cosmetic’s compliance, under Articles 4 and 5 of Regulation (EC) No 1223/2009. The UK and EU require separate Responsible Persons.
Product Information File (PIF): The dossier a Responsible Person must hold for each product under Article 11, containing the safety report, manufacturing and GMP information, proof of claimed effects and any animal-testing data. Kept for ten years after the last batch.
CPNP (Cosmetic Products Notification Portal): The EU portal through which cosmetics are notified to the authorities before being placed on the market.
SCPN (Submit Cosmetic Product Notification): The Great Britain notification service, the post-Brexit equivalent of the CPNP, overseen by the Office for Product Safety and Standards.
MoCRA: The US Modernization of Cosmetics Regulation Act 2022, which introduced federal facility registration, product listing, safety substantiation and adverse-event reporting for cosmetics.
Toxicological Risk Assessment (TRA): The assessment of the health risk posed by a product’s ingredients at their intended exposure. It is the technical core of both the CPSR and the US MoCRA safety substantiation.
INCI (International Nomenclature of Cosmetic Ingredients): The standardised naming system used to list ingredients on a cosmetic label.
Preservative Efficacy Test (PET / Challenge Test): A microbiological test, to ISO 11930, confirming that a product’s preservative system protects it against contamination across its shelf life and period after opening.
Period After Opening (PAO): The number of months a product remains safe to use after opening, shown by the open-jar symbol on the label.
Annex I to VI: The annexes of Regulation (EC) No 1223/2009: Annex I is the safety report format; Annex II lists prohibited substances; Annex III restricted substances; Annex IV permitted colorants; Annex V permitted preservatives; Annex VI permitted UV filters.
GMP / ISO 22716: Good Manufacturing Practice for cosmetics, with ISO 22716 the recognised standard. Compliance must be stated in the Product Information File.
SCCS (Scientific Committee on Consumer Safety): The EU expert committee that assesses the safety of cosmetic ingredients and issues opinions that inform the annexes.
OPSS (Office for Product Safety and Standards): The Great Britain authority that enforces the UK Cosmetics Regulation.
Cosmetovigilance: The monitoring and reporting of undesirable effects from cosmetic products, a duty of the Responsible Person.
IFRA: The International Fragrance Association, whose Standards govern the safe use of fragrance materials.
SVHC (Substance of Very High Concern): Under REACH, a substance identified as posing serious risks to health or the environment, subject to additional obligations.
CMR: Substances classified as Carcinogenic, Mutagenic or toxic to Reproduction, which are generally prohibited in cosmetics.
REACH: Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals. Since Brexit, Great Britain runs UK REACH separately from EU REACH.
Borderline product: A product whose classification as a cosmetic, medicine or medical device is not clear-cut, decided by its presentation and function.
SPF / UVA-PF: Sun Protection Factor and UVA Protection Factor: the measured protection a sunscreen provides against UVB and UVA radiation respectively.
Critical wavelength: A measure of the breadth of a sunscreen’s UV protection, used alongside SPF and UVA-PF to substantiate broad-spectrum claims.
Nanomaterial: An insoluble material with one or more external dimensions in the 1 to 100 nanometre range, carrying a separate notification obligation under Article 16.