Regulation

EU and national frameworks

Products sold in parapharmacies fall under several EU regimes — cosmetics, medical devices, food supplements, biocides. These pages summarize the principal regulations, what they require, and which authorities enforce them.

• EU Cosmetic Regulation (1223/2009)Scope, the responsible person, CPNP notification, safety assessment, prohibited and restricted substances, and claims.
• Medical Device Regulation (2017/745)The MDR: scope, the definition of a medical device, classification rules, CE marking, notified bodies, EUDAMED and UDI.
• Food Supplements Directive (2002/46/EC)Definition, permitted vitamins and minerals, labelling, national implementation, and the relationship with the EU health-claims regime.
• Nutrition & health claims regulationRegulation (EC) No 1924/2006: the EU Register, the role of EFSA, the article 13 list, and claims under articles 13(5) and 14.
• CE marking for medical devicesWhat the CE mark signifies, classes I to III, self-certification versus notified-body certification, UDI, and what CE does not mean.
• National authoritiesThe national medicines, medical-device and food authorities: ANSM, AIFA, AEMPS, INFARMED, FAMHP, BfArM, BVL — names, scope, and links.
• Cosmetovigilance & adverse-event reportingHow undesirable effects of cosmetic products are reported in the EU, the obligations of the responsible person, and consumer reporting channels.