EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2017) XXX  draft  
ANNEX 1  
  
ANNEX  
to the  
Commission Implementing Regulation (EU) .../...  
on technical standards for the establishment and operation of a traceability system for 
tobacco products    
EN 2   EN ANNEX  
to the  
Commission Implementing Regulation (EU) .../...  
on technical standards for the establishment and operation of a traceability system for tobacco 
products  
This draft annex has not been adopted or endorsed by the European Commission. Any views expressed are 
the preliminary views of the Commission services and may not in any circumstance s be regarded as stating 
an official position of the Commission. The information transmitted is intended only for the Member State or 
entity to which it is addressed for discussions and may contain confidential and/or privileged material.  
 
SELECTION PROCEDURE FOR INDEPE NDENT THIRD PARTY PR OVIDERS OF 
REPOSITORY SYSTEMS  
 
PART A  
The following  procedure s shall apply to the selection of an independent third party provider operating a 
primary repository:  
1. Each manufacturer and importer of cigarettes and roll -your-own tobacco shall notify to the 
Commission, no later than two months following the entry into force of Delegated Regulation  
XXX:  
(a) the name of the third party that it proposes to appoint to operate a primary repository  
(the " propose d provider "), and  
(b) a draft data storage contract containing the key elements laid down in the Delegated 
Regulation for approval by the Commission.  
2. The notification shall be accompanied by:  
(a) the written declaration of technical and operational expertise, ref erred to in Article 4 of 
Delegated Regulation  XXX,  
(b) the written declaration of the l egal and financial independence , referred to in Article 8 
of Delegated Regulation  XXX, and  
(c) a table setting out the correspondence between the contractual clauses and the 
requirements laid down in Delegated Regulation  XXX.  
3. The Commission shall, within three months of the date of receiving the notification, approve or 
reject the proposed provider and the draft contract. In the absence of a reply by the Commission 
within the period of three months, the provider and the draft contract shall be deemed to be 
approved.  
4. Where the Commission does not approve the proposed provider or the draft contract, or where it 
considers that the contract does not incorporate the key elements la id down in Delegated Regulation 
XXX, the manufacturer or importer concerned shall, within one month  of being informed by the  
EN 3   EN Commission,  propose an alternative provider and/or make necessary amendments to the draft 
contract.  
5. Once the proposed provider and  the draft contract has been approved, the manufacturers and 
importers shall, within two weeks of such approval, provide in electronic format : 
(a) a copy of the contract signed by both parties, and  
(b) the declarations required to be pr ovided as part of the contra ct under Articles 4 and 8 of 
Delegated Regulation  XXX.  
6. Manufacturers and importers of tobacco products other than cigarettes and roll -your-own tobacco 
shall notify to the Commission, by 31 December 2022, the name of the proposed provider and a 
draft data s torage contract containing the key elements laid down in the Delegated Regulation  for 
approval by the Commission .  
7. The provider appointed to operate the primary repository shall only integrate its repository into the 
traceability system following the concl usion of the contract.  
8. A list of notified and approved third parties shall be made publicly available by the Commission on 
a website.  
9. Any amendment to the key elements of the contract, as defined in Delegated Regulation XXX, shall 
be subject to approval b y the Commission. Any other amendment to the contract shall require prior 
communication to the Commission.  
 
PART B  
The following procedures shall apply to the selection of an independent third party operating the secondary 
repository system:  
1. The providers  of the primary repositories who have been approved in accordance with point 4 of 
Part A within six months following the entry into force of the Delegated Regulation XXX shall 
appoint, from amongst themselves, a provider tasked with operating the secondary  repository (" the 
operator of the secondary repository ") for the purpose of carrying out the services specified in 
Chapter V of this Regulation.  
2. The appointed operator of the secondary repository shall be notified to the Commission, no later 
than eight months following the entry into force of Delegated Regulation XXX. In the absence of 
agreement, the secondary operator is to be appointed by simple majority vote of the providers 
referred to in paragraph 1.  
3. In the event that the providers have failed to appoint and notify the appointment of the operator of 
the secondary repository system to the Commission, within the eight month period referred to in  
paragraph 2, the Commission shall appoint the provider of the secondary repository based on an 
assessment of objective criteria.  
4. Each primary  repository provider appointed in accordance with Part A shall enter into an individual 
contract with the provider  appointed to operate the secondary repository for the purpose of carrying 
out the services specified in Chapter V of Implementing Regulation XXX.  
5. Where the provider of the secondary repository is appointed in accordance with paragraph 2, the 
contracts sh all be signed and submitted to the Commission within one month from the date of the 
appointment.  
  
EN 4   EN PART C  
The following requirements shall apply in addition to the selection procedures outlined in Parts A and B:  
1. Where, at any time after the appointment of a  provider of a primary repository, the Commission 
determines that such a provider no longer possesses the independence or capacity requirements as 
provided for in Article 15(8) of Directive 2014/40/EU, it shall inform the parties to the data storage 
contra ct who shall initiate the termination of that contract.  
2. Where the contractual relationship between a manufacturer and importer and the provider of a 
primary repository is terminated , or expected to be terminated,  by any of the parties to the contract,  
for any reason, including for the reasons referred to in paragraph 1, t he manufacturer or importer 
shall  immediately inform the Commission of such termination, or expected termination, and as 
soon as it is known, the date of the notification of termination an d the date at which the termination 
is to take effect. The manufacturer or importer shall propose  and notify to the Commission a 
replacement provider as soon as pra cticable, and at the latest, three  months prior to the termination 
date of the existing cont ract. 
3. The appointment of the replacement provider shall take place in accordance with paragraphs 3 to 7 
of Part A.   
4. In the event that the operator of the secondary repository gives notice of its intention to cease 
operating that repository in accordance wi th the contract entered into pursuant to Part B, it shall 
immediately inform the Commission thereof and of the date at which the termination is to take 
effect. The providers of the primary repository system shall nominate and notify to the Commission 
a rep lacement operator as soon as practicable, and at the latest,  three months prior to the 
termination date of the existing contract.  
5. Where the finding referred to in paragraph 1 applies to the provider who has been appointed to 
operate the secondary repositor y, the parties to the contract for the operation of that secondary 
repository shall, in turn, be terminated.  
6. The termination of the contract for the operation of the secondary repository system and the 
appointment of the replacement operator of the seconda ry repository shall take place in accordance 
with termination and appointment provisions set out in Part B.