In the EU, the Responsible Person is designated under Article 4 of the Cosmetics Regulation (EC) No 1223/2009 and has to be established in the EU, and the label shows the Responsible Person's name and address (Article 19). In the US, MoCRA defines the responsible person as the manufacturer, packer or distributor whose name appears on the label. Since December 29, 2024, US labels also have to carry a domestic address, domestic phone number or electronic contact through which the responsible person can receive adverse event reports. Great Britain has its own Responsible Person requirement.
Why it matters for labeling
The name and address on the label have to match who actually is the Responsible Person for that market. Importing, relabeling, changing distributors or entering a new market can all change it. The US adverse event contact is a mandatory label element, so an artwork update that drops it creates a compliance gap. See also fragrance allergens, another labeling duty that sits with the Responsible Person.
Common mistakes
- Using the same Responsible Person details for every market
- An EU address that is out of date after a change of Responsible Person
- A US label missing the adverse event contact
- Assuming the brand shown on the front is the US responsible person, when it is the manufacturer, packer or distributor named in the label statement