lexiara

d1e705-1-1__para__2

The concept of being ‘established’ must be interpreted as having a registered address in a Member State to ensure jurisdiction for enforcement and market surveillance, as well as a guarantee that there is a responsible party within the Union for compliance, traceability, and corrective actions.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-07 · Text as adopted (Official Journal); later amendments are not incorporated in this text.