Glossary: The terms in your product file, explained.
Cosmetics terms from EU and UK law and from the platform. For each one: what it means, which article it comes from, and where you find it in Unique Alphabet®.
A
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Active file
Platform term
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A fragrance allergen is a substance listed in Annex III that must be named in the ingredient list when it exceeds 0.001% in a leave-on or 0.01% in a rinse-off product. Regulation (EU) 2023/1545 extended the list; products placed on the market from 31 July 2026 carry the new names, and products placed earlier may be made available until 31 July 2028.
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Annexes II to VI
- DEAnhänge II bis VI
- FRannexes II à VI
- ESanexos II a VI
The annexes of the Cosmetics Regulation that govern ingredients: Annex II lists prohibited substances, Annex III restricted substances and their conditions, Annex IV permitted colourants, Annex V permitted preservatives and Annex VI permitted UV filters. Each amendment to an annex changes what a formula may contain, and by when.
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Archive
Platform term
The archive holds the products you no longer sell. Archived files stay readable while your account is active and free their active place; archiving doesn’t give a new file back.
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Assistant
Platform term
The Assistant answers questions about the products, files and findings in your account and suggests the next step; the AI model only works out the question, and the answer is built from your own records. It doesn’t decide compliance, and anything it writes needs your confirmation.
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Audit Log
Platform term
The Audit Log is Unique Alphabet®’s record of who did what, and when: sign-ins, changes to products and documents, shares, uploads and exports. Entries are chained with SHA-256, so any later change to an entry shows; each file’s log exports as CSV.
C
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CAS and EC numbers
- DECAS-Nummer, EG-Nummer
- FRnuméro CAS, numéro CE
- ESnúmero CAS, número CE
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Claims
- DEWerbeaussagen
- FRallégations
- ESreivindicaciones
A claim is any text, name, trademark, picture or sign on a cosmetic product that states or implies a characteristic or function. Claims must meet six common criteria: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making.
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CMR substance
- DECMR-Stoff
- FRsubstance CMR
- ESsustancia CMR
A CMR substance is classified as carcinogenic, mutagenic or toxic for reproduction under the CLP Regulation. CMR substances are prohibited in cosmetics, with narrow exceptions only after an SCCS opinion, and each new classification is carried into the annexes by an Omnibus regulation.
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Command Center
Platform term
The Command Center scores how ready each product is in five areas: identity, formula, label, packaging and CPSR. It lists first whatever stands in the way of a signature, and it is the first screen you see in your account.
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CosIng is the European Commission’s database of cosmetic ingredients: INCI names, CAS and EC numbers, functions, and each substance’s status under the annexes and in SCCS opinions. Unique Alphabet® uses CosIng as its ingredient reference: every formula line is matched against it.
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Cosmetic Products Regulation (Türkiye)
Kozmetik Ürünler Yönetmeliği
The Cosmetic Products Regulation is Türkiye’s cosmetics law, published in the Official Gazette on 8 May 2023 and prepared in line with Regulation (EC) No 1223/2009. It is enforced by TİTCK; its annexes follow the EU annexes with a delay; Regulatory Watch reads their amendments, and the change log lists them.
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Cosmetovigilance
- DEKosmetovigilanz
- FRcosmétovigilance
- EScosmetovigilancia
Cosmetovigilance is the collection and evaluation of undesirable effects reported for a cosmetic product on the market. The Responsible Person notifies serious undesirable effects to the competent authority without delay, and the data on undesirable effects is part of the CPSR.
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The CPNP is the European Commission’s portal through which the Responsible Person notifies a cosmetic product before placing it on the EU market. One notification covers the whole EU; the Great Britain counterpart is SCPN.
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CPSR
Cosmetic product safety report
- DESicherheitsbericht für kosmetische Mittel
- FRrapport sur la sécurité du produit cosmétique
- ESinforme sobre la seguridad del producto cosmético
The CPSR is the safety report every cosmetic product must have before it is placed on the market, in two parts: Part A gathers the safety information, Part B is the assessor’s reasoned conclusion and signature. Unique Alphabet® prepares the draft; a qualified safety assessor completes Part B and signs.
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A company profile is one legal entity inside your account: its own name, address, products and documents, kept separate from any other company on the account. An account can hold several; you switch between them from the top bar or see them all together.
G
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GMP
Good manufacturing practice
- DEgute Herstellungspraxis
- FRbonnes pratiques de fabrication (BPF)
- ESbuenas prácticas de fabricación
Good manufacturing practice is the set of production and control rules a cosmetic product must be made under; compliance is presumed when manufacture follows the harmonised standard EN ISO 22716. The PIF holds a description of the manufacturing method and a statement of GMP compliance.
I
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INCI is the naming system for cosmetic ingredients used in the ingredient list on the label and in CosIng. Ingredients are listed in descending order of weight down to 1%, then in any order; colourants may follow, and nanomaterials carry “(nano)” after the name.
M
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Making available on the market
- DEBereitstellung auf dem Markt
- FRmise à disposition sur le marché
- EScomercialización
Making available is any supply of a product for distribution, consumption or use on the market in the course of a commercial activity, with or without payment; it covers every sale down the chain, not only the first. Amendments usually set a later date for making available than for placing on the market: after it, products already on the shelf must be withdrawn.
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The margin of safety is the ratio of a substance’s NOAEL to the systemic exposure dosage calculated for its use in the product. A margin of at least 100 is the conventional threshold in the SCCS Notes of Guidance; the assessor justifies any lower value.
N
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Nanomaterial
- DENanomaterial
- FRnanomatériau
- ESnanomaterial
A nanomaterial is an insoluble or biopersistent, intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm. Nanomaterials are notified to the Commission six months before placing on the market and labelled “(nano)” after the ingredient name.
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New file
Platform term
A new file is counted each time you open a new product in Unique Alphabet®, when it is first saved, drafts included; editing, new report versions and archiving use none, and archiving doesn’t give one back. Each paid plan includes as many new files a year as its active files; Free includes one for life.
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The NOAEL is the highest dose of a substance at which no adverse effect was observed in the toxicological study it comes from, expressed in mg per kg of body weight per day. It is the numerator of the margin of safety and is always cited with its source.
O
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Omnibus regulation
- DEOmnibus-Verordnung
- FRrèglement omnibus
- ESreglamento ómnibus
An Omnibus regulation is a Commission regulation that carries substances newly classified as CMR under the CLP Regulation into Annexes II to VI of the Cosmetics Regulation, in one batch. They are numbered in sequence; Omnibus VIII, Regulation (EU) 2026/78, applies from 1 May 2026.
P
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PAO
Period after opening
- DEVerwendungsdauer nach dem Öffnen
- FRpériode après ouverture
- ESplazo después de la apertura
The period after opening is the time a product can be used after it is first opened without harm to the user, shown by the open-jar symbol and a number of months. It is required when the product’s minimum durability exceeds thirty months; otherwise the “best used before the end of” date is shown.
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Part A and Part B
- DETeil A, Teil B
- FRpartie A, partie B
- ESparte A, parte B
Part A of the CPSR collects the safety information: composition, physical and chemical characteristics, stability, microbiological quality, impurities and packaging, normal and foreseeable use, exposure, toxicological profile, undesirable effects and other data. Part B is the assessment: conclusion, label warnings, reasoning, and the assessor’s credentials and signature.
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PIF
Product information file
- DEProduktinformationsdatei
- FRdossier d’information sur le produit (DIP)
- ESexpediente de información sobre el producto
The PIF is the file the Responsible Person keeps for each cosmetic product: its description, the CPSR, the manufacturing method and GMP statement, proof of any claimed effect, and data on animal testing. It is kept for ten years after the last batch was placed on the market, at the Responsible Person’s address, and made accessible to the competent authority on request.
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Placing on the market
- DEInverkehrbringen
- FRmise sur le marché
- ESintroducción en el mercado
Placing on the market is the first making available of a product on the EU market. Amendments to the annexes usually apply first to placing on the market: after that date a product that does not meet the new rule can no longer be introduced, while stock already placed may stay until the making-available date.
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A portfolio link is a read-only, password-protected link into one company's files: product list, readiness and open Regulatory Watch findings, with no login and no download. It can be revoked at any time; every view is written to the Audit Log.
R
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Regulatory Watch
Platform term
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Responsible Person
- DEverantwortliche Person
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Responsible technical officer
- TRsorumlu teknik eleman
A Turkish requirement; the EU and UK rules have no such role.
In Türkiye, the responsible technical officer is the person the Responsible Person employs to check that a product meets the cosmetics rules and good manufacturing practice before it is placed on the market. The role is open to chemists, biochemists, chemical and biomedical engineers, biologists, microbiologists and pharmacists; a Responsible Person who qualifies may take it on personally.
- FRpersonne responsable
- ESpersona responsable
The Responsible Person is the legal or natural person established in the EU who ensures a cosmetic product complies with the Regulation: it keeps the PIF, notifies the product and answers to the authorities. The manufacturer or importer is the Responsible Person by default or appoints one in writing; Great Britain requires a Responsible Person established in the UK.
S
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Safety assessor
- DESicherheitsbewerter
- FRévaluateur de la sécurité
- ESevaluador de la seguridad
The safety assessor is the person who carries out the assessment in Part B of the CPSR and signs it; the Regulation requires a diploma or equivalent qualification in pharmacy, toxicology, medicine or a similar discipline. In Unique Alphabet® assessors are recorded once in Company Profile and their signature prints in Part B; without one, the signature is a service in Türkiye, quoted per file.
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SCCS
Scientific Committee on Consumer Safety
- DEWissenschaftlicher Ausschuss „Verbrauchersicherheit“
- FRcomité scientifique pour la sécurité des consommateurs (CSSC)
- ESComité Científico de Seguridad de los Consumidores (CCSC)
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SCPN
Submit Cosmetic Product Notifications (Great Britain)
SCPN is the Office for Product Safety and Standards’ service through which a cosmetic product is notified before it is placed on the market in Great Britain, the counterpart of the EU’s CPNP. A product sold in both markets is notified in both systems; Northern Ireland follows the EU notification.
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SED
Systemic exposure dosage
- DEsystemische Expositionsdosis
- FRdose d’exposition systémique
- ESdosis de exposición sistémica
The systemic exposure dosage is the amount of a substance expected to enter the body per kilogram of body weight per day from the product’s use, calculated from the daily amount applied, the concentration, dermal absorption and a default body weight of 60 kg. It is the denominator of the margin of safety.
T
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TİTCK is the Turkish Medicines and Medical Devices Agency, the competent authority for cosmetic products in Türkiye. The Responsible Person notifies each product to TİTCK before placing it on the market and makes the product information file available to it on request.
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A transfer moves a company profile to another account, with its products, suppliers, documents and brand. The receiving account previews what will move before accepting; files are copied, and the source rows are deleted seven days later.
U
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ÜTS is the national electronic database through which the Responsible Person notifies a cosmetic product to TİTCK before placing it on the market in Türkiye, the counterpart of the EU’s CPNP. The notification names the product, its category and the Responsible Person’s address, where the product information file is kept.
Common questions about these terms.
What is the difference between a CPSR and a PIF?
The CPSR is one document: the safety report, Parts A and B, signed by the assessor. The PIF is the whole file the Responsible Person keeps: the CPSR plus the product description, manufacturing and GMP, claim evidence and animal-testing data.
Is a safety assessment the same as a CPSR?
The assessment is the assessor’s work in Part B; the CPSR is the report that contains it together with the Part A information. In everyday use the words overlap, and some national texts call the whole report an assessment.
Do I need a separate CPSR for Great Britain?
The GB Cosmetics Regulation mirrors the EU Regulation, so one report usually serves both when the Responsible Person for each market is named and the product is notified in both CPNP and SCPN. Annex changes can diverge between the two, which is what Regulatory Watch tracks market by market.