We audit data repositories run by all European Commission-approved providers, including Dentsu (Aricoma), IBM, Kasi Automation, Movilizer (Brady Corporation), Zetes and Worldline (Magellan).
Article 15 of Directive 2014/40/EU establishes an EU-wide traceability system for tobacco products, designed to combat illicit trade. Under the Tobacco Products Directive (TPD), manufacturers and importers must contract independent third-party primary repository providers to securely store product data and appoint an external auditor, selected by the company but approved by the European Commission (EC), to monitor data access and safeguard the integrity of the repository.
We can coordinate this audit as your EC-approved external auditor, working directly with your repository provider and submitting a compliant annual report to the European Commission each audit cycle.
Manage your TPD primary repository audit with confidence
- Meet all applicable regulatory requirements
We conduct audits to the requirements of Directive 2014/40/EU and ISO/IEC 27001, helping you demonstrate full compliance with the EU traceability system for tobacco products.
- Appoint an EC-approved auditor with confidence
As an auditor approved by the European Commission, we give manufacturers and importers assurance that their audit meets the standards required for approval.
- Receive timely, well-structured reporting
We deliver a well-structured audit report to the European Commission by October each audit cycle, keeping your compliance timeline on track.
- Stay informed throughout the process
We provide regular progress updates and coordinate directly with your repository provider, so you always know where your audit stands.
- Access global testing, inspection and certification expertise
We bring our global experience in testing, inspection and certification to every TPD primary repository audit we conduct.
Why SGS?
We are a global testing, inspection and certification company able to audit data repositories run by all European Commission-approved providers. Our experience with the EU traceability system for tobacco products means we understand what the European Commission expects from a compliant, well-documented audit report.
Working with us gives manufacturers and importers access to auditors already recognized by the European Commission, backed by a coordinated global network that keeps your annual audit process moving smoothly from proposal through to submission.
FAQs
Send the external auditor proposal to SANTE-TT-SW@ec.europa.eu, along with three documents:
- Annex A – notification of the proposed audit firm
- Annex B – declaration of independence of the audit firm and auditors
- Annex C – declaration of professional suitability of the audit firm and auditors
The manufacturer or importer completes Annex A, while the external auditor completes Annex B and Annex C. All three annexes must be sent to the European Commission by the manufacturer or importer, together with the proposal email.
Manufacturers and importers must inform the European Commission of their intended auditor within 30 calendar days of the end of the audit year, no later than June 19.
SGS auditors contact the repository provider directly to schedule the audit dates and timeline.
No. The audit relates to the primary repository and its associated services, not to the manufacturer's facility operations.
SGS auditors follow the official guidelines on annual audit reports submitted under Article 15(8) of Directive 2014/40/EU, in the context of the EU traceability system for tobacco products: EUR-Lex – Guidelines on annual audit reports (Official Journal C 167, 2020)
An SGS auditor prepares the report following the TPD primary repository audit and submits it to the European Commission, together with a declaration of the absence of conflict of interest. The European Commission acknowledges receipt of the report to the SGS auditor, and SGS keeps manufacturers and importers informed by email at each step.
No. There is no need to renew the proposal every year, provided you remain satisfied with your external auditor's services. Previously approved auditors remain in place unless the manufacturer or importer issues a new notification.