Substances classified as carcinogenic, mutagenic or toxic for reproduction pursuant to Regulation (EC) No 1272/20081.
Single component products
A 'single component product' is a product that is composed of one single element. Examples: a single jar of moisturising cream, a single bottle of shampoo, a lipstick
tube, a single bottle of aftershave, etc. Multi-component products A 'multi-component product' is a product composed of several components that are not marketed separately. Examples: hair dye sets, skin peeling kits, permanent styling products, anti-age/revitalizing kits, etc. Please not that the distinction between single and multi component products has nothing to do with the fact that the product has only one or several ingredients/substances in its composition! A notification that relates to multi-component products will be different from that of a single component product. Sets do not need to be notified as multi-component products provided that all
components that compose this set have been notified individually.
A 'multi-component product' is a product composed of several components that are not marketed separately. Examples: hair dye sets, skin peeling kits, permanent
styling products, anti-age/revitalizing kits, etc. Please not that the distinction between single and multi component products has nothing to do with the fact that the product has only one or several ingredients/substances in its composition! A notification that relates to multi-component products will be different from that of a
single component product. Sets do not need to be notified as multi-component products provided that all components that compose this set have been notified individually.
For each cosmetic product notified, the Responsible Person shall indicate the contact details of a physical person to contact in the case of necessity.
It is a European Commission database that contains information on cosmetic substances and ingredients2. click here for cosing web site
‘Cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours
Article 16 of Regulation (EC) No 1223 on cosmetic products requires that, in addition to the notification under Article 13, cosmetic products containing nanomaterials shall be notified to the Commission by the Responsible Person 6 months prior to being placed on the market. However, the provisions of Article 16 do not apply to nanomaterials used as colorants, preservatives or UV-filters regulated under Article 14, unless expressly specified. To do so the Responsible Person can mandate a Delegate for nanomaterials. Delegates for nanomaterials are restricted to Art. 16; they cannot notify products as part of Art. 13! The role of the Delegate is to enter certain data only for the nanomaterials notification.
'Distributor' means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the Community market.
EU Login (formerly known as 'ECAS') is the European Commission Authentication Service with which people can access different applications and services offered by the European Commission.
‘Frame formulation’ means a formulation which lists the category or function of ingredients and their maximum concentration in the cosmetic product or gives relevant quantitative and qualitative information whenever a cosmetic product is not covered or only partially covered by such a formulation
‘Importer’ means any natural or legal person established within the Community, who places a cosmetic product from a third country on the Community market.
A local administrator is a person who may manage the access requests to the organisation to which he/she is linked, and as well the details of the organisation. These grants are only applicable to local administrators. It is a role in SAAS. The first user creating an organisation in SAAS for requesting access to CPNP must be the local administrator of this organisation
'Making available on the market' means any supply of a cosmetic product for distribution, consumption or use on the Community market in the course of a
commercial activity, whether in return for payment or free of charge.
‘Nanomaterial’ means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.
An organisation means either a 'Responsible Person' (or its subcontractors/organisations) or a 'Distributor'. Article 19.1 of the Cosmetics Regulation states: "…cosmetic products shall be made available on the market only where the container and packaging of cosmetic products
bear the following information in indelible, easily legible and visible lettering: (a) the name or registered name and the address of the responsible person...". Please note that when you create an organisation with Responsible Person profile in SAAS, this must correspond to the Responsible Person details visible on the labelling!
'Placing on the market’ means the first making available of a cosmetic product on the
The product name must be detailed enough to enable the specific identification of the cosmetic product. It should include the trade mark/brand, the product line and the specific name of the product as they appear on the packaging. The complete name should also include the function unless it is part of the specific name of the product.
Only cosmetic products for which a legal or natural person is designated within the EU as a 'responsible person' can be placed on the EU market. The Responsible Person shall ensure compliance with the obligations set out in Regulation (EC) No 1223/2009. For a cosmetic product manufactured within the Community, and not subsequently exported and imported back into the Community, the manufacturer established within the Community shall be the responsible person. The manufacturer may designate, by written mandate, a person established within the
Community as the responsible person who shall accept in writing. Where, for a cosmetic product manufactured within the Community, and not
subsequently exported and imported back into the Community, the manufacturer is established outside the Community, he shall designate, by written mandate, a person established within the Community as the responsible person who shall accept in writing. For an imported cosmetic product, each importer shall be the responsible person for the specific cosmetic product he places on the market. The importer may, by written mandate, designate a person established within the Community as the responsible person who shall accept in writing. The distributor shall be the responsible person where he places a cosmetic product on the market under his name or trademark or modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected.The translation of information relating to a cosmetic product already placed on the market shall not be considered as a modification of that product of such a nature that compliance with the applicable requirements of this Regulation may be affected.
The SAAS (SAnte Authorisation System) provides users with a profile and access rights for a specific European Commission application. This application manages specifically the access rights. The name or registered name and the address of the Responsible Person shall be in
the cosmetic products labelling.
Individual colour, fragrance or strength variant of a cosmetic product. For example: – the different color names of the same lipstick (e.g. 'Pure rouge', 'Ruby', 'Vermeil', etc.) – the different scents of the same body lotion (e.g. 'Bali mango', 'Hawai coconut', 'Fiji passion fruit', etc.)
the different strengths of a fixing spray (e.g. 'Soft', 'Strong', 'Extra Strong', etc.)
It is the European Commission Authentication Service. It provides the user with a login and password to connect to multiple European
Commission applications. This application manages specifically logins and passwords
Any chemical substance or mixture of synthetic or natural origin, used in the formulation of cosmetic products. A cosmetic ingredient may be:
1- a chemically well-defined single substance with a molecular and structural formula, 2- a complex mixture, requiring a clear definition and
often corresponding to a mixture of substances of unknown or variable composition and biological nature, 3- a mixture of 1 and 2, used in the formulation of a finished cosmetic product. [based on Art. 5a of 93/35/EEC and SCCNFP/0321/00]
The percutaneous/dermal absorption process is a global term which describes the passage of compounds across the skin. This process can be divided into three steps:
- penetration is the entry of a substance into a particular layer or structure such as the entrance of a compound into the stratum corneum;
- permeation is the penetration through one layer into another, which is both functionally and structurally different from the first layer;
- resorption is the uptake of a substance into the vascular system (lymph and/or blood vessel), which acts as the central compartment
A general term comprising of dose, its frequency and duration [EC B.26] In the calculations of the Margin of Safety, dosage is
expressed in mg/kg body weight/day.
The amount of test substance administered. Dose is expressed as weight (grams or milligrams) or as weight of test substance per unit of weight of test animal (e.g.milligrams per kilogram body weight), or per skin surface unit (e.g. milligrams per square centimetre of skin), or as
constant dietary concentrations (parts per million or milligrams per kilogram of food) [based on EC B.26]
“Dose descriptor” is used to designate the exposure level (dose or concentration) that corresponds to a quantified level of risk of a health effect in a specific study [EChA 2008b] As used under chapter 3-7.4 Assessment of carcinogens, it is the calculated amount of a test substance
administered daily (e.g. mg/kg body weight/day) that in the case of a non-threshold carcinogen increases the net frequency of tumours at a specific site by a certain percentage (e.g. T25) [Dybing et al. 1997]
The cosmetic product in its final formulation, as placed on the market and made available to the end user, or its prototype
IFRA (International Fragrance Association) is a global self-regulatory organization for the fragrance industry. It develops and implements standards for the safe use of fragrances in products to protect consumers and the environment. IFRA also provides information, guidance, and support to its members and stakeholders.
Biological method: using organs, tissue sections and tissue cultures, isolated cells and their cultures, cell lines and
Non-biological method: such as computer modelling, chemical interaction studies, receptor binding studies etc. [based on Rogiers et al. 2000]
Test method using living (experimental) animals [Rogiers et al. 2000]
International Nomenclature of Cosmetic Ingredients
ISO (International Organization for Standardization) is an independent, non-governmental, international organization that develops and publishes standards for various industries, including cosmetics. ISO standards provide a common language, technical specifications, and guidelines that ensure quality, safety, and efficiency in the manufacture, testing, and use of cosmetics products. ISO cosmetics standards cover topics such as raw materials, product testing, labeling, and good manufacturing practices.
LD50 (Lethal Dose 50%) is a measure of the lethal toxicity of a substance. It represents the dose of a substance required to cause death in 50% of a sample population of test animals, usually rats or mice. LD50 is used to evaluate the safety of cosmetic ingredients and is calculated based on oral, dermal, or inhalation exposure to the substance. The lower the LD50 value, the greater the toxicity of the substance. However, LD50 is not a measure of all toxic effects and should be used in conjunction with other toxicity tests to assess the overall safety of a cosmetic ingredient.
The Lowest Observed (Adverse) Effect Level is the outcome of long-term toxicity studies, such as 28-day or 90-day tests with rats, mice, rabbits or dogs, chronic toxicity tests, carcinogenicity tests, teratogenicity tests, reproduction toxicity tests, etc. It is the lowest dosage
where (adverse) effects can be observed. In the calculation of the MoS, the lowest obtained LO(A)EL value is used when a NO(A)EL is not available. The LO(A)EL should be expressed as mg/kg bw/day. [ECB 2003]
MoS stands for Margin of Safety, a numerical value used to assess the safety of a chemical or product by comparing the toxic dose to the exposure level. It represents the ratio between the toxic dose and the estimated human exposure level and is used to determine the acceptable level of exposure for a given substance.
The No Observed (Adverse) Effect Level is the outcome of repeated dose toxicity studies, such as 28-day or 90-day tests with rats, mice, rabbits or dogs, chronic toxicity tests, carcinogenicity tests, teratogenicity tests,reproduction toxicity tests, etc. It is the highest dosage for which no (adverse) effects can be observed [based onEC B.26]. In the calculation of the MoS, the lowest obtained NO(A)EL value is used, in order to take into account the most sensitive species, as well as the relevant effect occurring at the lowest dosage possible. The NO(A)EL should be expressed as mg/kg body weight/day.
SCCNFP stands for the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers. It is a scientific advisory body established by the European Commission to provide scientific opinions on cosmetics and non-food consumer products in the European Union (EU). The SCCNFP assesses the safety of these products and provides recommendations to the European Commission on the measures needed to ensure their safety.
Scientific Committee on Consumer Products
The Systemic Exposure Dosage of a cosmetic substance is the amount expected to enter the blood stream (and therefore be systemically available) per kg body weight and per day. It is expressed in mg/kg body weight/day. For this definition a mean human body weight of 60 kg is commonly accepted. Since the majority of cosmetic products are applied topically, systemic availability will strongly depend on the
dermal absorption of the compound. This can be determined according to the tests described under 3-4.4. Nevertheless, the results of these tests can be interpreted in two different ways (see 3-7.2: dermal absorption issues).
An undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or deat
A chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used but excluding any solvent which may be separated without affecting the
stability of the substance or changing its composition [2009/1223/EC]
Cover the process of interaction of chemical substances with target sites and the subsequent reactions leading to adverse effects [ECB 2003]
An adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product [2009/1223/EC]
A technique that has not necessarily gone through the complete validation process, but for which sufficient scientific data exist demonstrating its relevance and reliability. [based on Rogiers 2003]
A method for which the relevance and reliability are established for a particular purpose (in most cases according to the criteria established by ECVAM, taking into account that a prediction model needs to be present from the start of the validation procedure). [based on Balls et al. 1997 and Worth et al. 2001] These methods are taken up in Regulation (EC) No 440/2008 and/or published as OECD Technical Guidelines*