S.L. 315.10 чл. 14Labelling and packaging: traceability. Cap. 586.

(1) The manufacturer and the importer shall ensure that all unit packets of tobacco products are marked with a unique identifier. In order to ensure the integrity of the unique identifier, it shall be irremovably printed or affixed, indelible and not hidden or interrupted in any form, including through tax stamps or price marks, or by the opening of the unit packet. In the case of tobacco products that are manufactured outside of the Union, the obligations laid down in these regulations apply only to those that are destined for, or placed on, the Union market.

(2) The unique identifier shall allow the following to be determined:

(a) the date and place of manufacturing;

(b) the manufacturing facility;

(c) the machine used to manufacture the tobacco products;

(d) the production shift or time of manufacture;

(e) the product description;

(f) the intended market of retail sale;

(g) the intended shipment route;

(h) where applicable, the importer into the Union;

(i) the actual shipment route from manufacturing to the first retail outlet, including all warehouses used as well as the shipment date, shipment destination, point of departure and consignee;

(j) the identity of all purchasers from manufacturing to the first retail outlet; and

(k) the invoice, order number and payment records of all purchasers from manufacturing to the first retail outlet.

(3) The information referred to in sub-regulation (2)(a), (b), (c), (d), (e), (f), (g) and, where applicable, (h) shall form part of the unique identifier.

(4) The information mentioned in sub-regulation (2)(i), (j) and

(k) shall be electronically accessible by means of a link to the unique identifier.

(5) All economic operators involved in the trade of tobacco products, from the manufacturer to the last economic operator before the first retail outlet, must record the entry of all unit packets into their possession, as well as all intermediate movements and the final exit of the unit packets from their possession. This obligation may be complied with by the marking and recording of aggregated packaging such as cartons, mastercases or pallets, provided that the tracking and tracing of all unit packets remains possible.

(6) All natural and legal persons engaged in the supply chain of tobacco products shall maintain complete and accurate records of all relevant transactions.

(7) The manufacturers of tobacco products shall provide all economic operators involved in the trade of tobacco products, from the manufacturer to the last economic operator before the first retail outlet, including importers, warehouses and transporting companies, with the equipment that is necessary for the recording of the tobacco products purchased, sold, stored, transported or otherwise handled. That equipment shall be able to read and transmit the recorded data electronically to a data storage facility pursuant to sub-regulation (8).

(8) Manufacturers and importers of tobacco products shall conclude data storage contracts with an independent third party, for the purpose of hosting the data storage facility for all relevant data. The data storage facility shall be physically located on the territory of the Union. The suitability of the third party, in particular its independence and technical capacities, as well as the data storage contract, shall be approved by the Commission.

The third party’s activities shall be monitored by an external auditor, who is proposed and paid by the tobacco manufacturer and approved by the Commission. The external auditor shall submit an annual report to the Superintendent and to the Commission, assessing in particular any irregularities in relation to access. The Commission, the competent authorities of the Member States, and the external auditor shall have full access to the data storage facilities. In duly justified cases, the Commission or the Member States may grant manufacturers or importers access to the stored data, provided that commercially sensitive information remains adequately protected in conformity with the relevant Union and national law.

(9) Recorded data shall not be modified or deleted by an economic operator involved in the trade of tobacco products.

(10) All personal data shall only be processed in accordance with the rules and safeguards of the Data Protection Act.

(11) The technical standards for the establishment and the operation of the tracking and tracing system as provided for in this regulation, including the marking with a unique identifier, the recording, transmitting, processing and storing of data and access to stored data shall be determined in accordance with a Commission Implementing Act.

(12)The technical standards for ensuring that the systems used for the unique identifier and the related functions are fully compatible with each other across the Union shall be determined in accordance with a Commission Implementing Act.

(13) The provisions of this regulation shall apply to cigarettes and roll-your-own tobacco from 20 May 2019 and to tobacco products other than cigarettes and roll-your-own tobacco from 20 May 2024.