Document 76
Ref. Ares(2019)4290354 - 05/07/2019
Dear
I am writing to follow on our earlier exchange on 4 and 5 June 2019, which related to
’s
unexpected problems in validating the messages containing correct unique identifiers. I would
like to confirm that as agreed, our unit informed the Member States about the incident in the late
afternoon of 5 June 2019. According to
, the problem in question was fully resolved in the
early morning of 7 June 2019. On the same day, our unit forwarded the information concerning
the incident’s closure to the Member States. According to
that incident was of the one-
off nature and should not reproduce itself.
In general, I can assure you that we follow very closely the system’s functioning. In over a
month from the launch date, the overall operational statistics indicate that there are no major
blocking issues. All the main data flows function and where needed adequate actions are being
taken to eradicate initial bottlenecks at the level of the primary and the secondary repositories.
This brings me to the earlier correspondence received from your company during the period
before the system’s launch, in which you expressed your concerns about the timely launch of the
system (i.e. your letters of 11 and 23 April 2019). I have been asked to respond to them.
As you are surely aware, the Commission took all possible actions to allow for the timely launch
of the EU system of tobacco traceability, including the adoption of Commission Decision (EU)
2019/691, which authorises the economic operators to use the services of another appointed ID
issuer in the temporary absence of the competent entity. The modalities of this Decision were
presented during the technical briefing of 6 May 2019.
In this context, please note that it remains for each competent national authority to determine the
absence of a relevant ID issuer. For the time being, the Commission has been notified of the
absence of the ID issuer in only one Member State, i.e. Romania. At the same time, as you may
be aware, several Member States started to take actions concerning the requests for unique
identifiers that the economic operators submitted to non-competent ID issuers.
During the technical briefing of 6 May 2019, we also reminded the economic operators as to the
exhaustion of stock provision contained in Article 37(1) of Implementing Regulation 2018/574.
We underlined that the primary objective of that provision was to avoid the need for recalling
products that entered the supply chain prior to the launch date. We added that it was
understandable that some economic operators might decide to overstock certain quantities of
products to mitigate their company-level risks. However, we also insisted that that was not a call
for piling up the products for another year. We hope that our presentation clarified that the
Commission’s services took the balanced and realistic approach to this matter.
To conclude, in our overall appreciation, the EU tobacco traceability system was successfully
launched and all the necessary steps were taken to address the existing risks in the pre-launch
phase. There are no barriers to place the compliant products on the market. The further smooth
functioning of the traceability system should be in the best interest of all the involved parties,
including the authorities and the legal private operators. It is also important to recall the
particular responsibility of individual manufactures and importers who have a direct contractual
relationship with the primary repositories. High availability of the latter is one of the critical
factors for uninterrupted reporting of the trade in the products of any given manufacturer or
importer.
Kind regards,
SANTE/B2
European Commission
Directorate-General for Health and Food Safety
Unit B2 – Cross-border healthcare and tobacco control
B232
B-1049 Brussels/Belgium
SANTE/B2
European Commission
Directorate-General for Health and Food Safety
Unit B2 – Cross border healthcare and tobacco control
B232
B-1049 Brussels/Belgium
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