Terminology

Glossary of parapharmacy terms

A reference list of the technical and legal vocabulary used across this site. Terms are listed alphabetically; entries point to fuller treatments where the site has them, and to primary sources where useful.

Adverse event

An undesirable medical occurrence. The terminology differs by regulatory regime: "undesirable effect" / "serious undesirable effect" (SUE) for cosmetics under Regulation 1223/2009; "adverse reaction" / "serious adverse reaction" for medicinal products under pharmacovigilance law; "incident" for medical devices under the MDR.

AHA — alpha hydroxy acid

A family of small organic acids used in cosmetics. See alpha hydroxy acids.

Annex (Cosmetic Regulation)

The Annexes to Regulation (EC) No 1223/2009: II (prohibited substances), III (restricted substances), IV (colorants), V (preservatives), VI (UV filters). Updated by Commission regulation.

BHA — beta hydroxy acid

In cosmetic terminology, principally salicylic acid.

CAS number

Chemical Abstracts Service registry number; a unique numerical identifier assigned to chemical substances.

CE mark

The conformity mark affixed by the manufacturer to a product that falls within the scope of EU "new approach" instruments, including the Medical Device Regulation. See CE marking.

Cosmetic product

Defined in Article 2 of Regulation 1223/2009 as any substance or mixture intended to be placed in contact with the external parts of the human body, the teeth or the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning, perfuming, changing appearance, protecting, keeping in good condition, or correcting body odours.

Cosmeceutical

A marketing term suggesting a product positioned between a cosmetic and a medicine. Not a regulatory category in the EU: any product is either a cosmetic or a medicinal product (or a medical device, or another regulated class).

CosIng

The European Commission database of substances and ingredients reported for use in cosmetic products. An entry is a record of declared use, not an authorisation.

CPNP

Cosmetic Products Notification Portal. The EU portal to which responsible persons notify cosmetic products before placing them on the market, under Article 13 of Regulation 1223/2009.

Dermocosmetic

A category of cosmetic product positioned by reference to a dermatological orientation: sensitive skin, atopic-prone skin, oily skin, mature skin. Not a separate regulatory category — dermocosmetics are cosmetic products under Regulation 1223/2009.

EFP — Especialidad Farmacéutica Publicitaria

Spanish term for a non-prescription medicinal product that may be advertised to the public. In Spain, EFPs remain reserved to pharmacies.

EFSA

European Food Safety Authority. The EU agency that provides scientific opinions on food safety and on health claims.

EMA

European Medicines Agency. The EU agency that coordinates the scientific evaluation of medicinal products for human and veterinary use.

Emollient

A substance that fills inter-corneocyte spaces and improves skin surface smoothness. One of the three functional classes in moisturiser formulation. See moisturisers.

EUDAMED

European database for medical devices established under the MDR.

EUR-Lex

The official online portal of EU law: eur-lex.europa.eu. Source for consolidated texts of EU regulations and directives.

Food supplement

Defined in Article 2(a) of Directive 2002/46/EC as foodstuffs the purpose of which is to supplement the normal diet, concentrated sources of nutrients or other substances with a nutritional or physiological effect, marketed in dose form.

FSMP — food for special medical purposes

A regulated category of food under Regulation (EU) No 609/2013, intended for use under medical supervision in the dietary management of disease or specific nutritional requirements.

Humectant

A substance that attracts and binds water in the upper stratum corneum. One of the three functional classes in moisturiser formulation. Examples include glycerin and sodium hyaluronate.

INCI

International Nomenclature of Cosmetic Ingredients. The standardised naming system used on EU cosmetic product labels under Article 19 of Regulation 1223/2009. See how to read an INCI list.

IVDR

Regulation (EU) 2017/746 on in-vitro diagnostic medical devices. The companion regulation to the MDR for diagnostic devices used on samples derived from the human body.

Medical device

Defined in Article 2(1) of Regulation (EU) 2017/745. Acts principally through means that are not pharmacological, immunological or metabolic, although it may be assisted by such means.

Medicinal product

Defined in Article 1(2) of Directive 2001/83/EC. A product either presented as having properties for treating or preventing disease (by presentation), or administered with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action (by function). Either criterion is sufficient.

MDR

Medical Device Regulation — Regulation (EU) 2017/745.

MNSRM

Portuguese: medicamento não sujeito a receita médica, non-prescription medicinal product. The category that can be sold in registered locais de venda outside Portuguese pharmacies.

Notified body

A conformity-assessment body designated by a Member State to carry out conformity-assessment tasks under EU "new approach" instruments, including the MDR.

Occlusive

A substance that forms a hydrophobic film on the skin surface and reduces transepidermal water loss. The third of the three functional classes in moisturiser formulation.

OTC — over the counter

An English-language term commonly used for non-prescription medicines. National legal categorisations differ; in the EU the relevant legal distinction is "subject to medical prescription" vs. "not subject to medical prescription" under Directive 2001/83/EC.

Parafarmacia

Italian and Spanish term for parapharmacy. In Italy, a specific retail format; in Spain, an ordinary retailer of cosmetics and supplements. See Italy, Spain.

Parafarmácia

Portuguese term for parapharmacy. See Portugal.

Parapharmacie

French and Belgian term for parapharmacy. See France, Belgium.

Pharmacist's monopoly

The national legal rule reserving the supply of medicinal products to pharmacies. Scope varies by Member State.

P-medicine

A UK regulatory category: pharmacy medicines, which may be sold only by or under the supervision of a pharmacist. Not applicable in EU Member States.

PIF

Product Information File. Held by the cosmetic responsible person under Article 11 of Regulation 1223/2009. Includes the cosmetic product safety report (CPSR).

Responsible person (RP)

Defined in Article 4 of Regulation 1223/2009: the EU-established legal or natural person responsible for ensuring that a cosmetic product complies with the Regulation.

SCCS

Scientific Committee on Consumer Safety. The Commission's standing scientific committee for non-food consumer products, principally cosmetics. SCCS opinions are the scientific basis for amendments to the Annexes of Regulation 1223/2009.

SOP

Italian: medicinale senza obbligo di prescrizione, non-prescription medicinal product. May be sold in parafarmacie in Italy.

SPF

Sun Protection Factor. A measure of protection against UVB-induced erythema, determined by the method in ISO 24444. See sunscreens.

Surfactant

A surface-active molecule with both hydrophilic and hydrophobic parts. The active cleansing component of cleansers.

UDI

Unique Device Identifier. Required on medical devices under the MDR. Composed of a device identifier (UDI-DI) and a production identifier (UDI-PI).

UVA-PF

UVA Protection Factor. Measured by the in-vitro method in ISO 24443. Sunscreens carrying the EU UVA seal must have a UVA-PF of at least one-third of the labelled SPF.

Last reviewed: May 2026.