EUROPEAN UNION (MANUFACTURE, PRESENTATION AND SALE OF TOBACCO AND RELATED PRODUCTS) REGULATIONS 2016
Source: Iris Oifigiúl 2016-05-20

num: 1
paragraphs: (1) These Regulations may be cited as the European Union (Manufacture, Presentation and Sale of Tobacco and Related Products) Regulations 2016.
(2) Subject to Regulations 8(7), 13(7), 20(16), 21(2) and 27(3), these Regulations shall come into operation on 20 May 2016.
num: 2
paragraphs: (1) In these Regulations—
(a) a tobacco product,
(b) a herbal product for smoking,
(c) an electronic cigarette, or
(d) a refill container;
(2) A word or expression which is used in these Regulations and which is also used in the Directive has, unless the context otherwise requires, the same meaning in these Regulations as it has in the Directive.
num: 3
paragraphs: (1) The Executive is designated as the competent authority in the State for the purpose of Articles 5, 6, 18, 19, 20, 22(1) and 23 of the Directive.
(2) The Executive shall cooperate with competent authorities in other Member States and with the Commission to ensure the correct application and due enforcement of the Directive and shall transmit to them, all necessary information for the application of the Directive in a uniform manner.
num: 4
paragraphs: (1) A person shall not manufacture, or place on the market, cigarettes with emission levels greater than—
(a)10 milligrams of tar per cigarette,
(b)1 milligram of nicotine per cigarette, or
(c)10 milligrams of carbon monoxide per cigarette.
(2)(a) The tar, nicotine and carbon monoxide emissions from cigarettes shall be measured on the basis of—
(i) ISO standard 4387 for tar,
(ii) ISO standard 10315 for nicotine, and
(iii) ISO standard 8454 for carbon monoxide.
(b) The accuracy of the tar, nicotine and carbon monoxide measurements referred to in subparagraph (a) shall be determined in accordance with ISO standard 8243.
(3) The measurements referred to in paragraph (2) shall be verified by a designated laboratory.
(4) The Minister shall notify the Commission of—
(a) a list of designated laboratories including—
(i) the criteria used for the designation of such laboratories, and
(ii) the methods of monitoring applied to such laboratories, and
(b) any measurement methods which a designated laboratory uses for—
(i) emissions from cigarettes, other than tar, nicotine and carbon monoxide emissions, and
(ii) emissions from tobacco products other than cigarettes.
(5) The Minister shall—
(a) update the list referred to in paragraph (4)(a) whenever any change is made to the list, and
(b) notify the Commission of the updated list.
num: 5
paragraphs: (1) A manufacturer or importer of a tobacco product shall submit in electronic form to the Executive, the following information by brand name and type:
(a) a list of all ingredients, and quantities thereof, used in the manufacture of the tobacco products, in descending order of the weight of each ingredient included in the tobacco products;
(b) the emissions levels referred to in Regulation 4(1);
(c) where available, information on other emissions and their levels.
(2) The list of ingredients referred to in paragraph (1)(a) shall—
(a) be accompanied by a statement setting out the reasons for the inclusion of such tobacco ingredients in the product concerned,
(b) indicate the status of the ingredients, including—
(i) whether they have been registered under Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 20069 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency, and
(ii) the classification of the ingredients under Regulation (EC) No. 1272/2008 of the European Parliament and of the Council of 16 December 200810 on classification, labelling and packaging of substances and mixtures, and
(c) be accompanied by the relevant toxicological data regarding the ingredients in burnt or unburnt form, as appropriate, referring (in particular) to the effects on the health of consumers and taking into account any addictive effects.
(3) A manufacturer or importer of cigarettes or roll-your-own tobacco shall submit in electronic form to the Executive, a technical document setting out a general description of the additives used and their properties.
(4) Subject to paragraph (5), a manufacturer or importer of a tobacco product shall indicate in electronic form to the Executive, the methods of measurement of emissions used.
(5) Paragraph (4) shall not apply to tar, nicotine and carbon monoxide and for emissions referred to in Regulation 4.
(6) The information required under this Regulation shall be provided on or before 20 November 2016 in respect of tobacco products placed on the market before 20 May 2016.
(7) The information required under this Regulation and Regulation 6, in respect of a new or modified tobacco product, shall be provided not later than 3 months prior to placing the tobacco product on the market.
(8) Where the composition of a tobacco product is modified in any way that affects the information provided under this Regulation or Regulation 6, a manufacturer or importer shall notify in electronic form the Executive within one month of when the modified product was manufactured.
num: 6
paragraphs: (1) A manufacturer or importer of a tobacco product shall—
(a) submit in electronic form to the Executive, internal and external studies available to the manufacturer or importer on market research and preferences of various consumer groups, including young people and current smokers, relating to ingredients and emissions, as well as executive summaries of any market surveys that a manufacturer or importer carries out when launching new products, and
(b) report in electronic form to the Executive their sales volumes in the State per brand and type, reported in sticks or kilograms, on a yearly basis from 1 January 2015.
(2) The first report under paragraph (1)(b) shall be made on or before 20 November 2016 and the second and each subsequent report shall be made on or before 30 June of each subsequent calendar year.
(3) A manufacturer or importer of a tobacco product shall carry out such studies as the Executive may determine in order to assess the effects of ingredients referred to in Regulation 5(1) on health, taking into account their addictiveness and toxicity of the ingredients.
(4) A manufacturer or importer of a tobacco product shall submit in electronic form to the Executive the information referred to in this Regulation and Regulation 5, including information regarding modifications and withdrawal from the market—
(a) in accordance with the format in the Annex to Commission Implementing Decision (EU) 2015/2186 of 25 November 20156 establishing a format for the submission and making available of information on tobacco products, and
(b) by means of the common electronic entry gate for data submission.
(5) Prior to submitting information under this Regulation and Regulation 5 for the first time, a manufacturer or importer of a tobacco product shall apply to the Commission for an identification number in accordance with Article 4 of Commission Implementing Decision (EU) 2015/2186 of 25 November 20156 establishing a format for the submission and making available of information on tobacco products.
(6) A manufacturer or importer of a tobacco product shall upon request from the Commission, submit in electronic form a document providing company identification and authentication of activities in accordance with the national legislation where the company is established.
(7) A manufacturer or importer of a tobacco product shall assign a Tobacco Products ID (in this Regulation referred to as a “TP-ID”) based on the identification number referred to in paragraph (5) to each tobacco product for which information is reported.
(8) When submitting information under this Regulation and Regulation 5 on tobacco products with the same composition and design, a manufacturer or importer of a tobacco product shall use the same TP-ID to the extent possible, in particular, where data is submitted by various members of a group of companies.
(9) Paragraph (8) shall apply regardless of the brand, subtype or number of markets on which the tobacco products concerned are placed.
(10) Where a manufacturer or importer of a tobacco product is not able to ensure that the same TP-ID is used for tobacco products with the same composition and design in accordance with paragraph (8), they shall provide, in so far as possible, the different TP-ID that was assigned to each such product.
num: 7
paragraphs: (1) A manufacturer or importer of cigarettes or roll-your-own tobacco containing an additive that is included in the priority list of additives, shall carry out comprehensive studies, in addition to the reporting requirements under Regulations 5 and 6, which shall examine whether each such additive—
(a) contributes to the toxicity or addictiveness of the products concerned and whether this has the effect of increasing the toxicity or addictiveness of any of the products concerned to a significant or measurable degree,
(b) results in a characterising flavour,
(c) facilitates inhalation or nicotine uptake, or
(d) leads to the formation of substances that have CMR properties, the quantities thereof, and whether this has the effect of increasing the CMR properties in any of the products concerned to a significant or measurable degree.
(2) The studies referred to in paragraph (1) shall—
(a) take into account the intended use of the products concerned,
(b) examine, in particular, the emissions resulting from the combustion process involving the additive concerned, and
(c) examine the interaction of the additive with other ingredients contained within the products concerned.
(3) Where 2 or more manufacturers or importers use the same additive in their tobacco products, such manufacturers or importers may carry out a joint study when using that additive in a comparable product composition.
(4) Subject to paragraph (7), a manufacturer or importer shall compile a report on the results of the studies carried out under this Regulation which shall include—
(a) an executive summary, and
(b) a comprehensive overview compiling the available scientific literature on that additive and summarising internal data on the effects of the additive.
(5) A manufacturer or importer shall submit the report referred to in paragraph (4), in electronic form to the Commission and a copy shall be submitted in electronic form to the Executive where a tobacco product containing this additive is placed on the market not later than 18 months after the additive has been included in the list of priorities.
(6) The Commission or the Executive may request a manufacturer or importer to include supplementary information in the report referred to in paragraph (4) regarding the additive concerned and the manufacturer or importer, as appropriate, shall comply with any such request.
(7) Small and medium-sized enterprises as defined in Commission Recommendation 2003/361/EC of 6 May 200311 are exempt from the obligations under this Regulation, if a report on the additive concerned is prepared by another manufacturer or importer.
num: 8
paragraphs: (1) Subject to paragraph (2), a person shall not place on the market a tobacco product with a characterising flavour.
(2) Paragraph (1) does not apply to the use of additives that are essential for the manufacture of tobacco products, provided those additives do not result in a product with a characterising flavour and do not increase to a significant or measureable degree the addictiveness, toxicity or the CMR properties of the tobacco product.
(3) A person shall not place on the market a tobacco product containing any of the following additives:
(a) vitamins or other additives that create the impression that a tobacco product has a health benefit or presents reduced health risks;
(b) caffeine, taurine, other additives or stimulant compounds that are associated with energy and vitality;
(c) additives having colouring properties for emissions;
(d) for tobacco products for smoking, additives that facilitate inhalation or nicotine uptake;
(e) additives that have CMR properties in unburnt form.
(4) A person shall not place on the market—
(a) a tobacco product containing flavourings in any of their components such as filters, papers, packages or capsules,
(b) a tobacco product containing any technical features allowing modification of the smell or taste of the tobacco product concerned or its smoke intensity, or
(c) filters, papers or capsules containing tobacco or nicotine.
(5) A person shall not place on the market a tobacco product containing additives in quantities that increase the toxic or addictive effect or the CMR properties at the stage of consumption to a significant or measureable degree on the basis of scientific evidence.
(6) Paragraphs (1), (2) and (4) shall not apply to tobacco products other than cigarettes and roll-your-own tobacco.
(7) This Regulation shall apply from 20 May 2020 in the case of tobacco products with a characteristic flavour whose sales volumes in the European Union represent 3% or more in a particular product category.
num: 9
paragraphs: (1) A manufacturer or importer shall specify when submitting information under Regulations 5(1), 7, 26 or 35, the information which he or she considers a trade secret or otherwise confidential and, upon request by the Executive, duly justify their claims.
(2) When submitting the information referred to in paragraph (1), the following shall not be considered a trade secret or otherwise confidential:
(a) in the case of all tobacco products—
(i) inclusion and quantity of additives other than flavourings, and
(ii) inclusion and quantity of ingredients other than additives used in quantities above 0.5% of the total tobacco product unit weight;
(b) in the case of cigarettes and roll-your-own tobacco, inclusion and quantity of individual flavourings used in quantities above 0.1% of the total tobacco product unit weight;
(c) in the case of pipe tobacco, cigars, cigarillos, smokeless tobacco products and all other tobacco products, inclusion and quantities of individual flavourings used in quantities above 0.5% of the total tobacco unit weight;
(d) in the case of electronic cigarettes and refill containers, ingredients used in quantities above 0.1% of the final formulation of the liquid, and
(e) studies and data submitted in accordance with paragraphs (2)(c), (3) and (4) of Regulation 5, Regulation 6(3) and Regulation 26(2) in particular on toxicity and addictiveness; and where those studies are linked to specific brands, the explicit and implicit references to the brand shall be removed and the redacted version shall be accessible.
(3) The Executive shall make available on its website, information received under Regulations 5(1), 7, 26 and 35.
(4) The Executive shall take the need to protect trade secrets duly into account when making the information in paragraph (3) publicly available.
num: 10
paragraphs: (1) A person shall not—
(a) place on the market a tobacco product, or
(b) manufacture or import a tobacco product that is intended for sale by retail in the State,
(2) Each unit packet of a tobacco product and any outside packaging shall carry the health warnings provided for in this Part in the Irish language and in the English language.
(3) The health warnings shall cover the entire surface of the unit packet of a tobacco product or outside packaging that is reserved for them and they shall not be commented on, paraphrased or referred to in any form.
(4) When a tobacco product is placed on the market, the health warnings on the unit packet of a tobacco product and any outside packaging shall be irremovably printed, indelible and fully visible, including not being partially or totally hidden or interrupted by tax stamps, price marks, security features, wrappers, jackets, boxes, or other items.
(5) The health warnings on a unit packet of a tobacco product, other than cigarettes and roll-your-own tobacco in pouches, may be affixed by means of stickers, provided that such stickers are irremovable.
(6) The health warnings on a unit packet of a tobacco product shall remain intact when opening the unit packet of a tobacco product other than packets with a flip-top lid, where the health warnings may be split when opening the packet, but only in a manner that ensures the graphical integrity and visibility of the text, photographs and cessation information.
(7) The health warnings on a unit packet of a tobacco product shall not hide or interrupt the tax stamps, price marks, tracking and tracing marks, or security features on the unit packet.
(8) The dimensions of the health warnings provided for in Regulations 12 to 19 shall be calculated in relation to the surface concerned when the packet is closed.
(9) Subject to paragraph (10), the health warnings on a unit packet of a tobacco product shall be surrounded by a black border of a width of 1 mm inside the surface area that is reserved for these warnings.
(10) Paragraph (9) shall not apply to health warnings referred to in Regulation 18.
num: 11
paragraphs: A person shall ensure that images of a unit packet of tobacco product and any outside packaging targeting consumers in the European Union shall comply with the provisions of this Part.
num: 12
paragraphs: (1) Subject to paragraph (6), each unit packet and any outside packaging of tobacco products for smoking shall carry—
(a) the following general warning—
“Toradh caithimh tobac — bÃ¡s
Smoking Kills”, and
(b) the following information message—
“CuimsÃ­onn deatach tobac breis agus 70 substaint arb eol dÃºinn gur cÃºiseanna ailse iad
Tobacco smoke contains over 70 substances known to cause cancer”.
(2) The general warning referred to in paragraph (1)(a) and the information message referred to in paragraph (1)(b) shall each cover 50% of the surfaces on which they are printed.
(3) For cigarette packets and roll-your-own tobacco in cuboid packets—
(a) the general warning referred to in paragraph (1)(a) shall appear on the bottom part of one of the lateral surfaces of the unit packets, and
(b) the information message referred to in paragraph (1)(b) shall appear on the bottom part of the other lateral surface.
(4) The warnings referred to in paragraph (3) shall have a width of not less than 20 mm.
(5) For packets in the form of a shoulder box with a hinged lid that result in the lateral surfaces being split into 2 when the packet is open—
(a) the general warning referred to in paragraph (1)(a) and the information message referred to in paragraph (1)(b) shall appear in their entirety on the larger parts of those split surfaces,
(b) the general warning referred to in paragraph (1)(a) shall also appear on the inside of the top surface that is visible when the packet is open, and
(c) the lateral surfaces of the packet shall have a height of not less than 16mm.
(6) The general warning referred to in paragraph (1)(a) and the information message referred to in paragraph (1)(b) shall be—
(a) printed in black Helvetica bold type on a white background, at such a font size as to occupy the greatest possible proportion of the surface reserved for these health warnings, and
(b) at the centre of the surface reserved for such warnings, and on cuboid packets and any outside packaging parallel to the lateral edge of the unit packet or of the outside packaging.
num: 13
paragraphs: (1) A unit packet of roll-your-own tobacco shall contain tobacco weighing not less than 30g.
(2) In relation to roll-your-own tobacco—
(a) if that tobacco is marketed in pouches, the general warning referred to in Regulation 12(1)(a) and the information message referred to in Regulation 12(1)(b) shall appear on the surfaces that ensure full visibility of those health warnings, and
(b) if that tobacco is marketed in cylindrical packets, the general warning referred to in Regulation 12 (1)(a) shall appear on the outside surface of the lid and the information message referred to in Regulation 12(1)(b) shall appear on the inside surface of the lid.
(3) Subject to paragraphs (4) and (5), for roll-your-own tobacco in rectangular pockets with a flap that covers the opening (in this Regulation referred to as “rectangular pouches”), the general warning referred to in Regulation 12(1)(a) and the information message referred to in Regulation 12(1)(b) shall be—
(a) printed on the 2 surfaces which become visible when the unit packet is fully opened as illustrated in sections 1 and 2 of the Annex to Commission Implementing Decision (EU) 2015/1735 of 24 September 20154, and
(b) positioned at the top edge and shall cover 50% of the respective surfaces on which they are printed, as illustrated in sections 1 and 2 of the Annex to Commission Implementing Decision (EU) 2015/1735 of 24 September 20154.
(4) For roll-your-own tobacco in rectangular pouches, the general warning referred to in Regulation 12(1)(a) shall be printed on the top surface.
(5) Without prejudice to the generality of paragraph (3), the following shall apply to roll-your-own tobacco in rectangular wraparound pouches made of polyethylene, polypropylene or laminate material as illustrated in section 3 of the Annex to Commission Implementing Decision (EU) 2015/1735 of 24 September 20154:
(a) the information message referred to in Regulation 12(1)(b) may be positioned on the surface that becomes visible when the unit packet is partly unwrapped;
(b) the general warning referred to in Regulation 12(1)(a) may be positioned on the bottom surface, which becomes visible when the unit packet is fully opened;
(c) the inside of the flap, which becomes visible when the unit packet is fully opened, shall not be printed upon or used in any other way;
(d) the general warning referred to in Regulation 12(1)(a) and information message referred to in Regulation 12(1)(b) shall be positioned at the top edge of the respective surfaces on which they are printed.
(6) Paragraph (5) shall have effect until 20 May 2018.
(7) Roll-your-own tobacco in pouches manufactured or released for free circulation on or before 20 May 2018 and labelled in accordance with paragraph (5) may be placed on the market on or before 20 May 2019.
(8) For roll-your-own tobacco in standing pouches, the general warning referred to in Regulation 12(1)(a) and information message referred to in Regulation 12(1)(b) shall—
(a) be positioned on the surfaces on the bottom of the standing pouch that become visible when the pouch is laid on its back, as illustrated in section 4 of the Annex to Commission Implementing Decision (EU) 2015/1735 of 24 September 20154, and
(b) cover 50% of the respective surfaces on which they are printed, which surfaces shall be calculated using their dimensions after the edges are sealed.
(9) For roll-your-own tobacco in standing pouches—
(a) the general warning referred to in Regulation 12(1)(a) shall be printed on the surface above the crease on the base of the unit packet, and
(b) the information message referred to in Regulation 12(1)(b) shall be printed on the surface below the crease.
num: 14
paragraphs: (1) Each unit packet and any outside packaging of tobacco products for smoking shall carry one of the combined health warnings (in these Regulations referred to as a “combined health warning”) which shall—