
COMMISSION IMPLEMENTING DECISION (EU) 2018/576 of 15 December 2017 on technical standards for security features applied to tobacco products (notified under document C(2017) 8435) (Text with EEA relevance) 

THE EUROPEAN COMMISSION,
Having regard to Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC, and in particular Article 16(2) thereof,
Whereas:

(1) Directive 2014/40/EU provides that all unit packets of tobacco products placed on the market are to carry a tamper proof security feature, composed of visible and invisible elements, for the purpose of facilitating the verification of whether or not tobacco products are authentic. Technical standards for a system of security features should be laid down.

(2) The security features along with the system for ensuring the traceability of tobacco products, provided for in Article 15 of Directive 2014/40/EU and established in Commission Implementing Regulation (EU) 2018/574, should allow for monitoring and more effective enforcement of the compliance of tobacco products with Directive 2014/40/EU.

(3) Common rules on security feature standards in the Union are essential as divergent and insufficiently precise national requirements are likely to undermine efforts to improve compliance of tobacco products with Union tobacco products regulation. A more harmonised framework for security features across Member States should also facilitate the functioning of the internal market of legal tobacco products.

(4) The technical standards for security features should give due regard to the high degree of innovation that exists in this area, while enabling competent authorities of Member States to verify the authenticity of tobacco products in an effective manner. Each Member State should be able to define the combination or combinations of authentication elements that are to be used to develop security features that are applied to tobacco products manufactured on or imported into its territory. The combination or combinations used should include visible and invisible elements. According to international standards, invisible elements, which are not directly perceptible by human senses, may further be defined by reference to the sophistication of equipment necessary for the verification of their authenticity. In order to maximise the robustness of the features, it is appropriate to require the use of at least one invisible element the verification of which requires the use of purpose built tools or professional laboratory equipment. The inclusion of a variety of different types of authentication elements into a security feature should ensure the necessary balance between flexibility and a high level of security. This should also enable Member States to take into account new innovative solutions, capable of further bolstering the effectiveness of security features.

(5) The combination of different authentication elements should be required as an important step in guaranteeing that the integrity of the final security feature applied to a tobacco product is well protected.

(6) The importance of ensuring the robustness of a system for security features is recognised by internationally recognised standards. To this end, additional safeguards should be put in place, which shield security features and their different authentication elements from internal and external threats to the greatest extent possible. It should therefore be required that at least one authentication element in a security feature is provided by an independent third party solution provider, thereby reducing the potential for attacks perpetrated by persons or entities that are directly or indirectly connected with the producer or originator of authentication elements used to develop the security feature. In addition, in order to ensure the continuing respect of the requirement for independence that is critical for ensuring and maintaining the integrity of security features across the Union, the procedures for monitoring compliance with the independence criteria set out in this Decision should undergo periodic review by the Commission. Conclusions of the review should be published by the Commission and form part of the report on the application of Directive 2014/40/EU provided for under Article 28 of that Directive.

(7) Several Member States require tax stamps or national identification marks for fiscal purposes. Those Member States should be free to allow that their stamps or marks are used as the security feature subject to the requirements of Article 16 of Directive 2014/40/EU and of this Decision. In order to alleviate any unnecessary economic burden, Member States whose tax stamps or national identification marks do not comply with one or more of the requirements of Article 16 of Directive 2014/40/EU and of this Decision should be allowed to use their tax stamps or national identification marks as a part of the security feature. In such cases, Member States should ensure that manufacturers and importers of tobacco products are informed of the additional authentication elements necessary to develop a security feature that is compliant with all legislative requirements.

(8) In order to ensure the integrity of security features and to protect it from external attack, they should be applied either by affixing, printing or a combination of both, in a manner that protects them from being replaced, reused or modified in any way. In addition, security features should allow for the identification and verification of the authenticity of an individual unit packet of tobacco product for the entire time the tobacco product is placed on the market.

(9) In order to allow for the verification of the authenticity of a tobacco product and thereby stepping up the fight against illicit trade of tobacco products in the Union, Member States and the Commission should, upon request, be provided with sample products that may be used as a reference for the purposes of laboratory analysis. Additionally, in order to enable competent authorities of one Member State to verify the authenticity of a tobacco product destined for the national market of another Member State, Member States should assist each other in sharing the reference products obtained, as well as providing knowledge and expertise available insofar as this is possible.

(10) The measures provided for in this Decision are in accordance with the opinion of the Committee referred to in Article 25 of Directive 2014/40/EU,
HAS ADOPTED THIS DECISION:

Subject matter
Article 1 
This Decision lays down technical standards for security features applied to unit packets of tobacco products  supplied in Great Britain.
Definitions
Article 2 
For the purposes of this Decision, in addition to the definitions laid down in  regulation 2 of the Tobacco Products (Traceability and Security Features) Regulations 2019, the following definitions shall apply:

((a)) ‘authentication element’ means an element of a security feature;
((b)) ‘overt’ means directly perceptible by one or more of the human senses without recourse to external devices. The ‘overt’ category of authentication solutions referred to in ISO 12931:2012 shall be presumed to meet this definition;
((c)) ‘semi-covert’ means not directly perceptible by the human senses but detectable by those senses through the use of external devices, such as a UV torch or a special pen or marker, which do not require expert knowledge or specialist training. The ‘covert’ category of authentication solutions authenticated with off-the-shelf tools referred to in ISO 12931:2012 shall be presumed to meet this definition;
((d)) ‘covert’ means not directly perceptible by the human senses and detectable only through the use of purpose built tools or professional laboratory equipment. The ‘covert’ categories of authentication solutions requiring purpose built tools and forensic analysis referred to in ISO 12931:2012 shall be presumed to meet this definition.
Security feature
Article 3 
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Use of tax stamps as security feature
Article 4 
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Applying security features to unit packets
Article 5 
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Integrity of security features
Article 6 
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Verification of authenticity of tobacco products
Article 7 
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Independence of authentication element providers
Article 8 

1. For the purpose of  regulation 15(1) and (2) of the Tobacco Products (Traceability and Security Features) Regulations 2019, a provider of authentication elements, as well as, where applicable, its subcontractors, shall be considered independent, if the following criteria are met:
(a) independence from the tobacco industry in terms of legal form, organisation and decision making. In particular it shall be assessed whether the undertaking or the group of undertakings is not under the direct or indirect control of the tobacco industry, including a minority shareholding;
(b) independence from the tobacco industry in financial terms, which will be presumed if, before assuming its functions, the undertaking or the group of undertakings generates less than 10 % of its annual worldwide turnover, excluding VAT and any other indirect taxes, from goods and services supplied to the tobacco sector over the past 2 calendar years, as may be determined on the basis of the most recent approved accounts. For each subsequent calendar year, the annual worldwide turnover, excluding VAT and any other indirect taxes, from goods and services supplied to the tobacco sector shall not exceed 20 %;
(c) absence of conflicts of interests with the tobacco industry of the persons responsible for the management of the undertaking or the group of undertakings, including members of the board of directors or any other form of governing body. In particular, they:
((i)) shall not have participated in company structures of the tobacco industry for the last 5 years;
((ii)) shall act independently from any pecuniary or non-pecuniary interest linked to the tobacco industry, including possession of stocks, participation in private pension programmes or interest held by their partners, spouses or direct relatives in the ascending or descending line.
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7. For the purpose of paragraph 1, public  authorities or undertakings governed by public law along with their subcontractors shall be presumed independent from the tobacco industry.
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Transitional provision
Article 9 
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Addressees
Article 10 
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Done at Brussels, 15 December 2017.
For the Commission
Vytenis ANDRIUKAITIS
Member of the Commission
ANNEX
TYPES OF AUTHENTICATION ELEMENTS

Overt Semi-covert Covert
Guilloche 

Ornamental pattern of two or more interlaced bands that are printed in multiple non-standard colours.
 Laser images 

Image becomes visible to the human eye only when emblazed with a light of a specific wavelength, such as a laser pointer.
 DNA taggants 

Forensic marker which uses combinatorical mathematical principles to define nucleotide sequences.

Rainbow printing 

Combination of two or more colours and subtly merging of colours into each other, which leads to the formation of intervening tints (taking on rainbow colours).
 Polarised image 

Image becomes visible to the human eye only when a specific polarising filter is placed over it.
 Molecular taggants 

Chemical marker which, often formulated in the base materials of the object tagged to, allows for the detection of dilution and mix ratios in materials. Uniquely encoded and incorporated at trace levels.

Latent image 

A line pattern printed by intaglio that reveals a different image when tilting the object on which it is printed. May be combined with colour-changing ink.
 UV dull paper 

Special paper that will not reflect ultraviolet light. Suitable for printing with ultraviolet (UV) inks that will show up under special UV lamps.
 Security fibres (covert) 

Invisible fluorescent fibres that are randomly placed on suitable paper. Cannot be scanned or photocopied and will only become visible under special UV lamps.

Colour-changing ink 

Reveals changing colours when viewed under different angles.
 Security fibres (semi-covert) 

Visible fluorescent fibres fully or partially embedded in a random pattern that is non-reproducible. May come in a range of colours and shapes. Change their colour under UV light.
 Magnetic elements 

Pattern of magnetic elements that generate a signal or a series of signals, which can be detected remotely by special identification devices.

Tactile patterns 

Intaglio printing producing a raised tactile relief, which can be authenticated under oblique light. May be combined with latent image.
 Microprint 

Print using extremely small text that requires magnification to become readable with the naked eye.
 Anti-Stokes inks 

Inks with Anti-Stokes properties that can be examined using a video spectral comparator (VSC instruments).

Hologram 

Display of a fully three-dimensional photographic recording of a light field with angle of observation.
 Thermochromic ink 

Heat reactive ink that is sensitive to temperature change. Ink will change colour or disappear when exposed to temperature changes.
 Reactive inks (covert) 

Colourless or transparent inks that become visible upon reaction with a specific solvent that is applied by means of purpose built tools under laboratory conditions.

 Reactive inks (semi-covert) 

Colourless or transparent inks that become visible upon reaction with a specific solvent that is applied by means of a special pen or marker.
 