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| 1. | A third party conducting audits in accordance with Article 46 shall be considered independent from the notifier or person who arranges the shipment as well as from the audited facility if it is documented that: (a) it is not a part of or under control of these entities; (b) it has established and operates procedures guaranteeing its impartiality, including: (i) assessment of risks of its impartiality on an ongoing basis; (ii) identification, elimination and mitigation of risks to impartiality resulting from financial, commercial and other types of pressure; (iii) assessment of risk of its impartiality resulting from relationships of its personnel; (c) it is structured and managed in a way ensuring its independence and impartially, including: (i) it is clearly identifiable within the legal entity, if the legal entity conducts also activities not related to inspections; (ii) it has reporting rules on the performed audit activity; (iii) its personnel has clearly identifiable responsibilities with respect to conducting audits.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-03 · Text as adopted (Official Journal); later amendments are not incorporated in this text.