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Marking by means of unit level UIs
1. Manufacturers and importers shall mark each unit packet manufactured or imported in the Union with a unique identifier (‘unit level UI’) compliant with Article 8. 2. In the case of tobacco products that are manufactured outside the Union, the unit level UI shall be applied on the unit packet before the tobacco product is imported in the Union.
Verification of unit level UIs
1. Manufacturers and importers shall ensure that the application of unit level UIs is directly followed by the verification of those unit level UIs in terms of correct application and readability. 2. The process referred to in paragraph 1 shall be protected with an anti-tampering device supplied and installed by an independent third party who shall provide a declaration to the relevant Member States and the Commission that the installed device meets the requirements of this Regulation. 3. Where the process referred to in paragraph 1 fails to confirm the correct application and full readability of the unit level UI, manufacturers and importers shall re-apply the unit level UI. 4. Manufacturers and importers shall ensure that the information recorded by the anti-tampering device remains available for a period of nine months from the time of recording. 5. Manufacturers and importers shall, upon request from Member States, provide full access to the record of the verification process created by the anti-tampering device. 6. By way of derogation from paragraphs 2, 4 and 5, the obligation to install an anti-tampering device shall not apply: (a) until 20 May 2020 to production processes operated by economic operators, or where applicable, the group of undertakings to which they belong, that handled less than 120 million unit level UIs at Union level during the calendar year 2019; (b) until 20 May 2021 to production processes operated by economic operators falling under the definition of small and medium enterprises set out in Commission Recommendation 2003/361/EC ( 6 ) ; (c) to fully manual production processes.
Structure of unit level UIs
1. Each unit packet of tobacco products shall be marked with a unit level UI. It shall consist of as short a sequence of alphanumeric characters as possible, not exceeding 50 characters. The sequence shall be unique to a given unit packet and shall be composed of the following data elements: (a) in the first position, the alphanumeric characters that constitute the ID issuer identification code assigned pursuant to Article 3(4); (b) an alphanumeric sequence, whose probability to be guessed shall be negligible and in any case lower than one in ten thousand (‘serial number’); (c) a code (‘product code’) allowing for the determination of the following: i. the place of manufacturing; ii. the manufacturing facility referred to in Article 16; iii. the machine used to manufacture the tobacco products referred to in Article 18; iv. the product description; v. the intended market of retail sale; vi. the intended shipment route; vii. where applicable, the importer into the Union; (d) in the last position, the time stamp in the form of a numeric sequence of eight characters, in the format YYMMDDhh, indicating the date and time of manufacture. 2. ID issuers shall be responsible for the generation of a code consisting of the elements listed in paragraph 1, points (a), (b), and (c). 3. Manufacturers or importers shall add the time stamp referred to in paragraph 1, point (d), to the code generated by the ID issuer pursuant to paragraph 2. 4. Unit level UIs shall not include any data elements other than those listed in paragraph 1. Where ID issuers use encryption or compression for the generation of unit level UIs, they shall inform the competent authorities of the Member States and the Commission of algorithms used for such encryption and compression. Unit level UIs shall not be reused.
Request and issuing of unit level UIs
1. Manufacturers and importers shall send a request to the competent ID issuer for unit level UIs referred to in Article 8. Requests shall be introduced electronically, in accordance with Article 36. 2. Manufacturers and importers introducing such a request shall supply the information listed in point 2.1. of Section 2 of Chapter II of Annex II, in the format indicated therein. 3. The ID issuer shall, within two working days from the receipt of the request and in the order indicated: (a) generate the codes referred to in Article 8(2); (b) transmit the codes along with the information referred to in paragraph 2 of this Article via the router to the primary repository of the requesting manufacturer or importer, as established under Article 26; and (c) electronically transmit the codes to the requesting manufacturer or importer. 4. However, a Member State may require ID issuers to offer physical delivery of unit level UIs as an alternative to electronic delivery. In cases where physical delivery of unit level UIs is offered, manufacturers and importers shall specify whether physical delivery is requested. In that case, the ID issuer shall within 10 working days from the receipt of the request, and in the following order: (a) generate the codes referred to in Article 8(2); (b) transmit the codes along with the information referred to in paragraph 2 via the router to the primary repository of the requesting manufacturer or importer, as established under Article 26; (c) deliver the codes to the requesting manufacturer or importer in the form of optical barcodes, compliant with Article 21, placed on physical carriers, such as adhesive labels. 5. Within one working day, manufacturers and importers may cancel a request which was sent pursuant to paragraph 1 by means of a recall message as further defined in Point 5 of Section 5 of Chapter II of Annex II.
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