This Regulation relates only to cosmetic products and not to medicinal products, medical devices or biocidal products. The delimitation follows in particular from the detailed definition of cosmetic products, which refers both to their areas of application and to the purposes of their use.
Cosmetic products (KosmetikVO)
The assessment of whether a product is a cosmetic product, has to be made on the basis of a case-by-case examination, taking into account all characteristics of the product. Cosmetic products may include creams, emulsions, lotions, gels and oils for the skin, face masks, tinted bases (liquids, pastes, powders), make-up powders, after-bath powders, hygienic powders, toilet soaps, deodorant soaps, perfumes, toilet waters and eau de Cologne, bath and shower preparations (salts, foams, oils, gels), depilatories, deodorants and anti-perspirants, hair colorants, products for waving, straightening and fixing hair, hair-setting products, hair-cleansing products (lotions, powders, shampoos), hair-conditioning products (lotions, creams, oils), hairdressing products (lotions, lacquers, brilliantine), shaving products (creams, foams, lotions), make-up and products removing make-up, products intended for application to the lips, products for care of the teeth and the mouth, products for nail care and make-up, products for external intimate hygiene, sunbathing products, products for tanning without sun, skin-whitening products and anti-wrinkle products.
Safety of cosmetics according to Cosmetics Law
Cosmetic products should be safe under normal or reasonably foreseeable conditions of use.
The presentation of a cosmetic product and in particular its form, odour, colour, appearance, packaging, labelling, volume or size should not endanger health and safety of consumers due to confusion with foodstuffs.
In order to establish clear responsibilities, each cosmetic product should be linked to a responsible person allocated within the Community.
Ensuring traceability of a cosmetic product throughout the whole supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates market surveillance authorities’ task of tracing economic operators.
In order to ensure the safety of the cosmetic products placed on the market, they must be manufactured in accordance with a good production practices.
In order to be comparable and of high quality, the results of the non-clinical safety studies carried out for the purposes of assessing the safety of a cosmetic product should comply with the relevant Community legislation.
The use of nanomaterials in cosmetic products may increase with the further development of technology. In order to ensure a high level of consumer protection, free movement of goods and legal certainty for manufacturers, it is necessary to develop a uniform definition for nanomaterials at international level. Currently, there is inadequate information on the risks associated with nanomaterials. Substances classified as carcinogenic, mutagenic or toxic to reproduction (“CMR”) of categories 1A, 1B and 2 are due to their hazardous properties in cosmetic products are forbidden.
In order to ensure product safety, prohibited substances should only be allowed in traces if this is technically unavoidable under good manufacturing practices and only if the cosmetic product is considered safe.
Cosmetic products counterfeiting
The European cosmetic sector is affected by product counterfeiting, and this can lead to increased health-risks.
Animal Protection and Cosmetics Law
The protection and welfare of animals must be fully taken into account. In this regards, EU regulations do not allow the use of animals for experimental purposes if scientifically satisfactory alternatives are available.
Expiration date of cosmetic products
In order to inform consumers, cosmetic products should have precise and easily understandable indications concerning their durability for use.
Given that consumers should be informed of the date until which the cosmetic product will continue to fulfil its initial function and remain safe, it is important to know the date of minimum durability i.e. the date by which it is best to use the product.
Where the minimum durability is more than 30 months, the consumer should be informed of the period of time after opening, so that the cosmetic product may be used without any harm to the consumer. However, this requirement should not apply where the concept of the durability after opening is not relevant: it is the case of single-use products, products not at risk of deterioration or products that can not be open.
Misleading advertising statements of cosmetics products
The consumer should be protected from misleading claims concerning efficacy and other characteristics of cosmetic products. It should be possible to claim on a cosmetic product that no animal testing was carried out in relation to its development. In addition to the labelled information, consumers should be given the possibility to request certain product-related information from the responsible person in order to make aware product choices.
Terms of the Cosmetics Law
“cosmetic product” means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair , nails, lips and external genital organs) or with teeth or mucous membranes of the oral cavity in order to clean them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;
“Substance” means 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 effecting the stability of the substance of changing its composition;
“Mixture” means a mixture or solution composed of two or more substances;
“Manufacturer” means any natural or legal person who manufactures a cosmetic product or has such a product designed or manufactured, and markets that cosmetic product under his name or trademark;
“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;
“End user“ is either a consumer or a professional using the cosmetic product;
Making available on the market
“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;
Placing on the market
“Placing on the market” means the first-time provision of a cosmetic product on the Community Market;
“Importer” means any natural or legal person established within the Community, who places a cosmetic product from a third country on the Community market;
“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;
“Preservatives” means substances which are exclusively or mainly intended to inhibit the development of micro-organisms in the cosmetic product;
“Colorants” means substances which are exclusively or mainly intended to colour the cosmetic product, the body as a whole or certain parts thereof, by absorption or reflection of visible light; in addition, precursors of oxidative hair colorants shall be deemed colorants.
“UV-Filters” means substances which are exclusively or mainly intended to protect the skin against certain UV radiation by absorbing, reflecting or scattering UV radiation.
“Undesirable effect” means an adverse reaction for human health attributable to the normal or reasonable foreseeable use of a cosmetic product;
Serious undesirable effect
“Serious undesirable effect” means an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalization, congenital anomalies or an immediate vital risk or death;
Withdrawal of the cosmetic products
“Withdrawal” means any measure aimed at preventing the introduction of a cosmetic product on the market in the supply chain;
Recall of the cosmetic products
“Recall” means any measure aimed at achieving the return of a cosmetic product that has already been made available to the end user;
“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 by such a formulation. The Commission shall provide indications for the establishment of the frame formulation and adapt them regularly to technical and scientific progress.
Security of cosmetics products in Cosmetics Law
A cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use, taking account, in particular, of the following aspects:
- Presentation, including conformity with the directive 87/357/ EWG;
- Instructions for use and disposal;
- Any other indication or information.
The provision of warning shall not exempt from the obligation, to observe the other requirements.
Persons in charge in Cosmetics Law
Only cosmetics products, for which a legal or natural person within the Community has been designed as “responsible person”, may be placed on the market.
For any cosmetic product placed on the market, the person responsible shall ensure the observance of the relevant obligations explained in this regulation.
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.
For an imported cosmetic product, each importer shall be the responsible person for the specific cosmetic product he places on the market.
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.
What can we do for you?
- General legal cosmetics law consultation and representation
- Consultation and representation for the development of a cosmetic product
- Examination of the marketability of the physical composition of the cosmetic means and definition of particular legal classifications (such as medical products, foodstuffs and biomedicine)
- Preparation, examination and optimization of contracts and agreements in regard to cosmetic products (manufacturing agreements, import agreements, liability agreements etc.)
- Protection of the product designation
- Examination and consultation regarding the advertisement and marking of a cosmetic product
- Support, examination and preparation of safety assessment, product documentation and product dossier
- Warning letters on competition and preliminary injunctions in the cosmetic industry.