… are uniformly defined under European law
as any substance or preparation intended to come into external contact with parts of the human body (skin, hair system, nails, lips and external intimate areas) or with the teeth and mucous membranes of the oral cavity, to the exclusive or primary purpose of cleaning, perfuming, changing their appearance, protecting them, keeping them in good condition or affecting body odor.
Special conditions regulate the import into the European Union and the placing on the market of cosmetic products.
The EU cosmetics regulations
stipulate that various requirements must be met for every cosmetic product that is marketed in the EU or is intended to be imported. During product testing, an assessment is made as to whether it is actually a cosmetic product (or whether it has to be delimitated from a biocide, for example sun-milk with antirepellents or mosquito spray as disinfectant, or a drug, for example hair remover or inhalation pens), whether the recipe (INCI declaration) consists of permissible components (thereby should be noted that many raw materials for use in cosmetics are subject to application restrictions or maximum limits or are even generally prohibited) and whether the labeling meets the legal requirements. Furthermore, in the case of cosmetic products, it must be ensured that comprehensive information on the product, its components and its compatibility is available.
Deceptive or misleading advertising (this includes, among other things, scientifically insufficiently verified information or false information on composition or effect) is prohibited in the marketing of cosmetics.
Consulting services for cosmetic products
Product checking to determine marketability in the manufacture, import and distribution of cosmetic products
In addition, we offer special consulting services for cosmetic products with regard to marketability in the German-speaking countries Germany, Austria, Switzerland, and partly Belgium, Luxembourg:
- delimitation queries: in delimitation to medicinal products – medical devices – biocides,
- checking of formulation for permissible ingredients according to type and dosage, nano, natural/organic, as well as revision of the composition if necessary,
- checking and evaluation of raw material specifications,
- selection of analysis parameters and performance of lab tests in cooperation with accredited laboratories if necessary. Subsequent evaluation and interpretation of analysis results, in particular microbiological germ load,
- requirements and framework conditions for first-time importers into the EU and Germany, as well as manufacturers and distributors within the framework of cosmetic and hygiene regulations = “compliance” for cosmetic legality, as well as information on necessary steps as a first-time importer into the EU/import into Germany and on the implementation of notification and registration requirements,
- checking, creation and revision of mandatory labeling on container and packaging (correct and complete, INCI-compliant),
- isuues of marketability of product or individual ingredients in Germany/Austria/Switzerland/Europe,
- review and revision of voluntary advertising claims,
- checking for compliance with packaging regulations,
- requirements regarding quality management according to cosmetic GMP or DIN ISO EN ISO 22716,
- safety assessment of cosmetic products,
- preparation of a safety assessment (in principle required if not yet available),
- expert opinions on special issues and objections (counter opinion),
- issuance of marketability certificates.
Manufacturers of cosmetic products or first-time importers into the EU are obliged to prepare a so-called safety assessment based on the product documentation (inventory) to be kept ready, or to be able to refer to it, before placing the product on the market for the first time.
I may prepare a safety assessment as a follow-up step after checking the formulation and creating the labeling.
See also: www.sicherheitsbewertung.com
Please note: Written checking reports and hints relating to labeling elements are given in German. We will only provide a written translation into English for an additional fee if expressly requested. We can conduct verbal advice and discussions in English.