Manufacturers within the EU/EEA or the party responsible for the first import of a product into the EU/EEA must keep detailed information of the product available for the relevant authorities to inspect.
This information must include the qualitative and the quantitative composition, specifications of raw materials and finished product, details of the manufacturing method, safety evaluation, information on possible adverse reactions, and in certain cases proof of the effect claimed.
Furthermore, the manufacturer/importer must keep the qualitative composition of the product accessible to the public on questioning. Information on the quantitative composition of some dangerous substances must also be accessible, as well as information on possible adverse reactions.
Further details on the Product Information requirements are available in Sections 22-24 of LVFS 2004:12 (English translation). Guidelines on safety evaluation may be accessed on the European Commission’s website on Cosmetics.
The manufacturing must be carried out in accordance with good manufacturing practice (GMP). Guidelines on GMP are available in the European Standard EN ISO 22716:2007 Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices.