Cosmetics

In Germany the commerce of cosmetic products is regulated by the Foods and Other Commodities Act (Lebensmittel-, Bedarfsgegenstände- und Futtermittelgesetzbuch, LFGB) from June 3rd, 2013.

Cosmetic products are "substances or mixtures of substances intended to be placed in contact with the various external parts of the human body or in the oral cavity with a view to cleaning them, keeping them in good condition, changing their appearance or perfuming them" (§ 4 of the LFGB).

The cosmetics themselves do not require marketing authorisation, however specific ingredients and additives of cosmetics like preservatives, colouring agents and UV filters do so. The assessment of the ingredients on a national level is performed by the Federal Institute for Risk Assessment (Advisory Committee on Cosmetic Products of the BfR, Öffnet externen Link in neuem Fensterwww.bfr.bund.de), and on a European level by the Öffnet externen Link in neuem Fenster „Scientific Committee on Consumer Safety (SCCS)".

Regulation (EC) N° 1223/2009 on cosmetic products is regularly adopted and has been implemented into national law by the “Kosmetik-Verordnung”. The German “Kosmetik-Verordnung” also regulates all obligations for the producers to supply certain information to the inspecting authorities, like a general toxicological profile of the ingredients used, the chemical nature and the level of exposure occurring during application.

The Scientific Committee on Consumer Safety SCCS publishes so called "Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation" Leitet Herunterladen der Datei ein (download pdf) (9th revision from April 2016).

Beside chemical-physical data, also several toxicological studies and mutagenicity tests are required. The toxicity tests have to be performed following the principles of good laboratory practice (GLP). Notably animal tests have to be avoided as far as possible, if accepted alternative methods are available. Now these alternative methods are successively developed and improved, with the "European Union Reference Laboratory for Alternatives to Animal Testing" (Öffnet externen Link in neuem FensterEURL ECVAM) as the practical and co-ordinating partner.

The SCCS publishes a so called "Memorandum on Alternative Methods"Leitet Herunterladen der Datei ein (download pdf) on the Use of Experimental Animals in the Safety Assessment of Cosmetic Ingredients in the European Union (2009).

Hydrotox GmbH offers several in-vitro test methods for the toxicological assessment of cosmetic ingredients. Among others several in-vitro mutagenicity tests, such as the bacterial reverse mutation test with Salmonella typhimurium (Ames test) or the mammalian cell gene mutation test (Mouse-Lymphoma test), are carried out.