Public Consultation on Transposition of the Revised European Tobacco Products Directive (2014/40/EU) October 2015 Page 1 of 15 1. Purpose of this consultation 1.1 The purpose of the consultation is to obtain views on discretionary elements within certain Articles of the revised European Tobacco Products Directive (2014/40/EU).1 1.2 The mandatory requirements of the Directive must be transposed by Member States into their national legislation. Within a number of those mandatory requirements Member States may determine certain discretionary elements. This consultation focuses on those discretionary elements. 1.3 In April 2014, the European Parliament adopted a revised Tobacco Products Directive (2014/40/EU). The Directive, which is 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, replaces Directive 2001/37/EC.2 1.4 Directive 2001/37/EC set out rules at EU level on the regulation of tobacco products concerning their composition and labelling. The main provisions established reporting requirements for ingredients and emissions of cigarettes and set labelling requirements, including text warnings and optional picture warnings. Directive 2001/37/EC is implemented in Ireland by the European Communities (Manufacture, Presentation and Sale of Tobacco Products) Regulations 2003 (S.I. No. 524/2003).3 1.5 Directive 2014/40/EU revises many of the provisions of the previous Directive to take account of the significant international market and scientific changes and developments since its implementation in 2001. It also sets out rules for areas not previously covered, for example electronic cigarettes (e-cigarettes) and refill containers. 1.6 Summary of the Articles in the Directive: Articles 1 and 2 set out the subject matter and the definitions within the Directive. Articles 3 to 7 outline the regulations for ingredients and emissions for tobacco products. Articles 8 to 14 provide for labelling, packaging, presentation and appearance of tobacco products. Articles 15 and 16 deal with the tracking and tracing of tobacco products. Articles 17 to 19 set out the rules for tobacco for oral use, cross-border sales and novel tobacco products. Article 20 relates to electronic cigarettes and refill containers. 1 Directive 2014/40/EU 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. OJ.L 127, 29.4.2014, p.1. 2 Directive 2001/37/EC on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products. OJ. L194, 18.7.2001 p.26 3European Communities (Manufacture, Presentation and Sale of Tobacco Products) Regulations 2003 (S.I. No. 524/2003) is available at www.irishstatutebook.ie Page 2 of 15 Articles 21 and 22 outline the regulations for herbal products for smoking. Articles 23 and 24 relate to cooperation, enforcement and free movement. Articles 25 and 26 provide for committee procedures and the designation of competent authorities. Article 27 lays down the conditions for the adoption of delegated acts by the EU Commission. Article 28 provides that the EU Commission must submit a report on the application of the Directive to the European Parliament, the Council and the European Economic and Social Committee and the Committee of the Regions by May 2021. Articles 29 and 30 cover the transposition of and transitional provisions for the Directive. Article 31 repeals Directive 2001/37/EC with effect from 20 May 2016. Articles 32 and 33 are standard provisions relating to the entry into force and the addressees to the Directive. 1.7 Member States must transpose this Directive into national legislation by 20 May 2016. The transposition will be done by way of secondary legislation, i.e. Regulations. 1.8 The main provisions of the Directive 2014/40/EU are as follows: a) continue, and enhance in some areas, the reporting of ingredients and emissions of tobacco products and introduce a standardised reporting format; b) increase the size of combined health warnings consisting of a text and photograph warning and cessation information, increased in size to cover 65% of front and back of pack (previously 30% on front and 40% on back of pack for unilingual countries); c) introduce a minimum pack size of 20 cigarettes and minimum weight of 30g for roll-your-own tobacco; d) ban certain descriptions on packaging, such as ‘natural’, ‘healing’ or ‘rejuvenating’; e) ban cigarettes and roll-your-own tobacco containing characterising flavours; f) introduce a traceability system and security features to track and trace tobacco products; g) provide Member States with the option of prohibiting cross-border distance sales of tobacco products and electronic cigarettes; h) regulate electronic cigarettes and refill containers; i) regulate herbal cigarettes; and j) introduce, at a minimum, a notification system for novel tobacco products Member States may opt to introduce an authorisation system. Page 3 of 15 How to get involved in the consultation 1.9 Details of discretionary elements within the provisions of the Directive and a preview of the questions are set out in this paper. Please use the online questionnaire, available at http://health.gov.ie/news-centre/ to submit your views. Only views submitted using the online questionnaire will be included in the consultation process. 1.10 Please note that the questionnaire must be completed in one session. If you would prefer to prepare your response in advance of making the online submission, it is possible to copy and paste material from a Word document. 1.11 There are a number of questions at the beginning of the online questionnaire relating to you or the party you represent which must be answered in order to progress to the questions on the Directive. 1.12 As a Party of the World Health Organisation’s Framework Convention on Tobacco Control (FCTC), Ireland has an obligation to protect the development of public health policy from the vested interests of the tobacco industry. To meet this obligation, the Department asks all respondents to disclose whether they have any direct or indirect links to, or receive funding from, the tobacco industry. We will still carefully consider all consultation responses from the tobacco industry and from those with links to the tobacco industry. 1.13 All submissions received by the Department are subject to the Freedom of Information (FOI) Act, 2014 and may be released in response to an FOI request. The Department publishes responses to FOI requests online. 1.14 The consultation will remain open until 5pm on Wednesday, 18th November 2015. Any queries should be submitted by email to tpdconsultation@health.gov.ie Page 4 of 15 2. Ingredients and Emissions (Articles 3 to 8) Overview of Articles 3 to 7: Ingredients and emissions 2.1 Articles 3 to 7 outline the regulations for ingredients and emissions for tobacco products. Some provisions update or amend regulations established in Directive 2001/37/EC, while others set out new regulations for ingredients and emissions. 2.2 The testing of emission levels of tar, nicotine, carbon monoxide and other substances (TNCO) in cigarettes against the maximum limits (10mg for tar, 1 mg of nicotine and 10 mg of carbon monoxide) was first laid down in the Directive 2001/37/EC. This requirement continues in the new Directive. 2.3 Under the new Directive manufacturers are no longer allowed to display TNCO levels on packs. However this data must be published and made available to the public, subject to the protection of trade secrets. 2.4 Manufacturers and importers of tobacco products must submit information on ingredients and emissions, as well as available market research studies and data on sales volumes. The Directive provides that this information must be published. 2.5 Enhanced reporting obligations will apply to certain additives contained in cigarettes and roll-your-own tobacco that are included in a priority list (to be established by the EU Commission by way of an implementing act). Manufacturers of products containing priority additives will also be obliged to carry out studies examining issues including toxicity and addictiveness. 2.6 The Directive prohibits the placing on the market of cigarettes and roll-your-own tobacco with characterising flavours and tobacco products with certain additives, including vitamins and caffeine. 2.7 Discretionary elements relating to Articles 3 to 7 are set out in the following sections. Discretionary elements relating to Articles 3 and 4: Measurement of tar, nicotine, carbon monoxide and other substances in cigarettes 2.8 Under Article 4, manufacturers of tobacco products must measure emission levels of tar, nicotine, carbon monoxide and other substances in cigarettes against the maximum limits set out in Article 3. These measurements must be verified by laboratories which are approved and monitored by the competent authority of the Member State. Members States may charge manufacturers and importers proportionate fees for the verification of the measurements required under this Article. Page 5 of 15 Question Q) Should manufacturers and importers of tobacco products be charged proportionate fees for the verification of measurements of tar, nicotine, carbon monoxide and other substances in cigarettes? Please provide an explanation for your answer (maximum 600 characters (approx. 100 words)). Discretionary elements relating to Article 5: Reporting of ingredients and emissions 2.9 The Directive requires Member States to require manufacturers and importers of tobacco products to report information on ingredients and emissions for each product using a standardised electronic format. The EU Commission must adopt a standardised reporting format for tobacco products by way of an implementing act. 2.10 Member States may also request manufacturers or importers to carry out studies as may be prescribed by the competent authority in order to assess the effects of ingredients on health, taking into account, inter alia, their addictiveness and toxicity. 2.11 Member States may charge manufacturers and importers proportionate fees for receiving, storing, handling, analysing and publishing the information on ingredients and emissions of tobacco products under Article 5. Questions Q) Should manufacturers and importers be requested to carry out studies to assess the effects of ingredients on health as and when required? Please provide an explanation for your answer (maximum 600 characters (approx. 100 words)). Q) Should manufacturers and importers of tobacco products be charged proportionate fees for receiving, storing, handling, analysing and publishing the information on ingredients and emissions of tobacco products? Please provide an explanation for your answer (maximum 600 characters (approx. 100 words)). Discretionary elements relating to Article 6: Priority list of additives and enhanced reporting obligations 2.12 Under Article 6, the EU Commission must adopt implementing acts laying down a priority list of additives to which enhanced reporting obligations shall apply. Manufacturers and importers of cigarettes and roll-your-own tobacco containing an additive included on the priority list will be subject to additional obligations for such products, including the requirement to carry out comprehensive scientific studies on these priority additives and to submit reports to the EU Commission. Small and medium enterprises are exempt from the obligations of this Article if a report on an additive is prepared by another manufacturer. Page 6 of 15 2.13 The Directive allows that Member States and the EU Commission may require the reports to be peer reviewed by an independent scientific body, in particular as regards their comprehensiveness, methodology and conclusions. Furthermore, the Directive provides that Members States may charge manufacturers and importers proportionate fees for those peer reviews. Questions Q) Should scientific reports received from manufacturers and importers of cigarettes and roll-your-own tobacco be peer reviewed by an independent scientific body? Please provide an explanation for your answer (maximum 600 characters (approx. 100 words)). Q) Should manufacturers and importers of cigarettes and roll-your-own tobacco be charged proportionate fees for having the scientific reports peer reviewed? Please provide an explanation for your answer (maximum 600 characters (approx. 100 words)). Discretionary elements relating to Article 7: Regulation of ingredients 2.14 Under Article 7, Member States must prohibit the placing on the market of tobacco products with a characterising flavour. A ‘characterising flavour’ is defined as ‘a clearly noticeable smell or taste other than one of tobacco, resulting from an additive or a combination of additives’. Products with more than a 3% share of the EU market are provided with a transitional period of four years. 2.15 Other tobacco products, such as cigars, cigarillos, pipe tobacco, water pipe tobacco and smokeless tobacco products, are exempted from the ban on characterising flavours. However the EU Commission is empowered to remove this exemption if there is a substantial change of circumstances for any of those products. 2.16 The EU Commission will establish an independent advisory panel to assist Member States and the EU Commission to determine whether a product has a characterising flavour. 2.17 Member States must also prohibit tobacco products containing certain additives, including vitamins and caffeine, and additives in quantities that increase the toxic or addictive effect, or the carcinogenic, mutagenic or reprotoxic (CMR) properties of a tobacco product to a significant or measureable degree. 2.18 Article 7 allows Member States to charge manufacturers and importers proportionate fees for assessing whether a tobacco product has a characterising flavour, whether prohibited additives are used and whether a tobacco product contains additives in quantities that increase to a significant and measurable degree the toxic or addictive effect or the CMR properties of the tobacco product concerned. Page 7 of 15 Question Q) 3. Should manufacturers and importers be charged proportionate fees for assessing whether a tobacco product has a characterising flavour, whether prohibited additives are used and whether a tobacco product contains additives in quantities that increase to a significant and measurable degree the toxic or addictive effect or the CMR properties of the tobacco product concerned? Please provide an explanation for your answer (maximum 600 characters (approx. 100 words)). Labelling and Health Warnings (Articles 8 to 12) Overview of Articles relating to labelling and health warnings (Articles 8 to 12) 3.1 The Directive strengthens existing labelling requirements for tobacco products. This includes increasing the size and prominence of health warnings and mandating combined text and picture health warnings for tobacco products. It sets out the technical specification on the size, shape and appearance of the general warning and information message on packets of tobacco products. The general warning and information message must cover 50% of the surface on which they are printed. 3.2 Discretionary elements relating to Articles 8 to 12 are set out in the following sections. Discretionary elements relating to Articles 8 and 9: General warnings on tobacco products for smoking 3.3 The Directive requires that every unit packet and any outside packaging of tobacco products for smoking carries a general warning. It also requires that the warning be in the official languages of the Member State where the product is placed on the market. Member States can decide which of the general warnings below is to be used. The Irish translation, which must be included is set out beside each English version. (a) ‘Smoking kills – quit now’ ‘Toradh caithimh tobac — bás. Scoir de anois.’ or (b) ‘Smoking kills’ ‘Toradh caithimh tobac — bás’ Question Q) Which general warning as set out above should be used on unit packets and outside packaging of tobacco products? Page 8 of 15 Discretionary elements relating to Article 11: Labelling of tobacco products for smoking other than cigarettes, roll-your-own tobacco and water pipe tobacco 3.4 The Directive provides that Member States may exempt tobacco products for smoking other than cigarettes, roll-your-own tobacco and water pipe tobacco from the obligations to carry the information message laid down in Article 9(2) and the combined warnings laid down in Article 10. 3.5 This means that tobacco products other than cigarettes, roll-your-own and water pipe tobacco, for example individually wrapped cigars or cigarillos, would be subject to less stringent rules in relation to labelling. An exemption would provide that those products would not carry the ‘Tobacco smoke contains over 70 substances known to cause cancer’ ‘Cuimsíonn deatach tobac breis agus 70 substaint arb eol dúinn gur cúiseanna ailse iad.’ message. Nor would they have a combined health warning (picture and text). 3.6 They would, however, carry a general warning ‘Smoking Kills’ ‘Toradh caithimh tobac — bás’ or ‘Smoking Kills – Quit Now’‘Toradh caithimh tobac — bás. Scoir de anois.’; one of the text warnings from the combined warning list but no picture; and smoking cessation information, on the two most visible surfaces of the unit packaging. Question Q) Should tobacco products other than cigarettes, roll-your-own tobacco and water pipe tobacco be exempt from carrying the information message and the combined health warnings as set out above? If yes, to what products should an exemption apply and why? If no, please provide an explanation for your answer (maximum 1500 characters (approx. 250 words)). 4. Cross-border Distance Sales of Tobacco Products (Article 18) Discretionary elements relating to Article 18: Cross-border distance sales of tobacco products 4.1 The Directive provides Member States with the option to prohibit the cross-border distance sales of tobacco products i.e. prohibit businesses in Ireland from selling tobacco products to consumers in other Member States, for example, via the internet, telephone or mail order and prohibit businesses in other Member States from selling to consumers in Ireland. 4.2 Should the Department choose not to exercise this option, it is obliged to introduce a registration system for all retailers intending to engage in cross-border distance sales both into and out of Ireland. Page 9 of 15 4.3 If a registration system is introduced, Irish retailers selling tobacco products to consumers in other Member States (provided that Member State has not imposed a ban) through distance selling arrangements will be required to register with the Irish competent authority and the competent authority in the Member State(s) where the consumers are based. All non-Irish business intending to sell in Ireland through distance selling arrangements must similarly register with the Irish competent authority. The Directive also provides the option of requiring retailers to nominate a person to be responsible for verifying that products comply with Irish legislation. 4.4 To register, retailers would be required to provide contact details of their business, the starting date of activities, and details of the website(s) to be used for selling their products. Furthermore, they would be obliged to operate and provide details on an age verification system, ‘which verifies at the time of sale, that the purchasing consumer complies with the minimum age requirements provided for under the national law of the Member State of destination.’ 4.5 The placing of products on the market via cross-border distance sales arrangements would only be allowed following receipt of confirmation of registration with the relevant competent authorities. A list of all retailers registered with the Irish competent authority would be made publicly available. Questions Q) Should cross-border distance sales of tobacco products be prohibited? Please provide an explanation for your answer (maximum 1500 characters (approx. 250 words)). Q) If cross-border distance sales of tobacco products are not prohibited, thereby requiring the introduction of a registration system, should retailers be required to nominate a person to be responsible for verifying that products comply with Irish legislation? Please provide an explanation for your answer (maximum 600 characters (approx. 100 words)). 5. Novel Tobacco Products (Article 19) Discretionary elements relating to Article 19: Novel tobacco products 5.1 Article 19 requires Member States to introduce at a minimum, a notification system whereby manufacturers and importers of novel tobacco products must submit an electronic notification to the competent authority six months before placing any new product on the market. 5.2 Under a notification system, manufacturers and importers would be required to provide the following: (a) a detailed description of the product and instructions for its use; (b) information on all ingredients, reasons for their inclusion and emissions levels; Page 10 of 15 (c) relevant toxicological data; (d) available scientific studies on toxicity, addictiveness and attractiveness of the novel tobacco product, in particular on its ingredients and emissions; (e) available studies, executive summaries thereof and market research on the preferences of various consumer groups, including young people and current smokers; and (f) other available and relevant information, including a risk/benefit analysis of the product, its expected effects on cessation of tobacco consumption, its expected effects on initiation of tobacco consumption and predicted consumer perceptions. 5.3 Member States may charge manufacturers and importers proportionate fees for receiving, storing, handling, analysing and publishing the information provided under a notification system. 5.4 The Directive also allows Member States to require manufacturers and importers to carry out additional tests or submit additional information if needed. 5.5 Furthermore, the Directive provides that novel tobacco products placed on the market shall respect the requirements of this Directive. Therefore, if on receipt of notification the competent authority deems that the product does not comply with the requirements under the Directive, the competent authority can prohibit the product from being placed on the market. 5.6 Notwithstanding the obligation to introduce a notification system, Member States have the option of going further by introducing an authorisation system whereby prior authorisation must be obtained by manufacturers and importers before placing novel tobacco products on the market. Under an authorisation system, the same information set out in 5.2(a) to (f) above would be required, however unlike a notification system, official sanction would be required from the competent authority to permit the manufacturer or importer place a product on the market. Questions Q) Under a notification system should manufacturers and importers of novel tobacco products be charged proportionate fees for receiving, storing, handling, analysing and publishing the information provided? Please provide an explanation for your answer (maximum 600 characters (approx. 100 words)). Q) Should an authorisation system be introduced for the sale of novel tobacco products? Please provide an explanation for your answer (maximum 1500 characters (approx. 250 words)). Q) If the Department chooses to implement an authorisation system, should manufacturers and importers be charged proportionate fees for that authorisation? Please provide an explanation for your answer (maximum 600 characters (approx. 100 words)). Page 11 of 15 6. Electronic Cigarettes and Refill Containers (Article 20) Overview of Article relating to Electronic cigarettes and refill containers (Article 20) 6.1 The Directive sets new rules across Member States for nicotine containing electronic cigarettes (e-cigarettes) and refill containers. The new rules are designed to ensure the safety and quality of these products and to ensure equal treatment across the EU for nicotine containing e-cigarettes. 6.2 It provides that Member States must ensure that e-cigarettes and refill containers are only placed on the market if they comply with the Directive and all other relevant Union legislation. 6.3 The Directive introduces notification/reporting obligations for manufacturers and importers of e-cigarettes which will allow authorities to monitor and learn more about these products. 6.4 It sets mandatory safety and quality requirements for nicotine content, ingredients and devices. There will be maximum nicotine concentration levels for e-cigarettes and maximum volumes for cartridges, tanks and containers of nicotine liquids. Only ingredients of high purity may be used in the nicotine-containing liquid. Products must be child and tamper-proof and protected against leakage to limit the risk of exposure to possible adverse effects. 6.5 E-cigarettes will be required to deliver nicotine doses at consistent levels under normal conditions of use. This means that a similar level of nicotine should be delivered each time an e-cigarette is puffed for the same amount of time and with the same strength. 6.6 The Directive introduces packaging and labelling requirements of e-cigarettes and refill containers. Health warnings on e-cigarettes will be mandatory, as will instructions for their use, information on addictiveness and toxicity, a list of all substances contained in the product and information on the product’s nicotine content. No promotional elements will be allowed on packs. 6.7 E-cigarette manufacturers and importers will be required to notify the designated competent authority before placing new products on the market. They will also be required to report annually to the competent authority on sales volumes of their products, types of users and users’ preferences and trends. 6.8 The Directive extends existing rules for cross-border advertising and promotion of tobacco products to e-cigarettes. Commercial communications ‘with the aim of direct or indirect effect of promoting electronic cigarettes’ in the press, on television, on radio and the internet will be prohibited. So too will sponsorship of events and activities taking place in more than one Member State or those which have crossborder effects for example, where they are broadcast on television or radio. It also imposes stricter rules on monitoring of market developments. Page 12 of 15 6.9 Member States have the option to prohibit cross-border distance sales of e-cigarettes and refill containers. 6.10 Under the Directive, the EU Commission has the power to prohibit any e-cigarette or refill container if concern is raised regarding an unforeseen risk to public health. 6.11 Questions relating to the options with this Article are set out in the following sections. Notification requirements for e-cigarettes and refill containers (Article 20(2)) 6.12 Manufacturers and importers of e-cigarettes and refill containers must submit an electronic notification to the competent authority of the Member State six months in advance of placing any product on the market. For products on the market prior to 20 May 2016, notifications must be submitted within six months of that date. Furthermore a new notification must be submitted for each substantial modification to any product. 6.13 The notification must contain a range of information, including information on the manufacturer and importer, the ingredients used, emission levels, toxicological data, nicotine doses and uptake when consumed, product and production process and a declaration that the manufacturer and importer bear full responsibility for the quality and safety of the product under normal use. 6.14 Member States may charge manufacturers and importers proportionate fees for receiving, storing, handling, analysing and publishing the information on ingredients for e-cigarettes and refill containers submitted under Article 20. Question Q) Should manufacturers and importers of e-cigarettes be charged proportionate fees for receiving, storing, handling, analysing and publishing the information on ingredients for e-cigarettes and refill containers? Please provide an explanation for your answer (maximum 600 characters (approx. 100 words)). Health warnings and information requirements for e-cigarettes and refill containers (Article 20(4)) 6.15 Under the Directive, e-cigarette and refill container packs must include a leaflet with information on instructions for use and storage of the product, contra-indications; warnings for specific risk groups; possible adverse effects; addictiveness and toxicity; and contact details of the manufacturer or importer. 6.16 Unit packets and any outside packaging of e-cigarettes and refill containers must include a list of all ingredients, nicotine content, batch number and a recommendation to keep the product out of reach of children. Page 13 of 15 6.17 Each unit packets and any outside packaging must also carry health warnings. The Directive provides two options on the wording to be used for e-cigarettes. The Irish translation, which must be included is set out beside each English version. (a) ‘This product contains nicotine which is a highly addictive substance. It is not recommended for use by non-smokers.’ ‘Cuimsíonn an táirge seo nicitín, ar substaint an-andúile é. Ní mholtar do dhaoine nach gcaitheann tobac é a úsáid.’ or (b) ‘This product contains nicotine which is a highly addictive substance.’ ‘Cuimsíonn an táirge seo nicitín, ar substaint an-andúile é.’ Question Q) Which general warning as set out above should be used on unit packets and outside packaging of e-cigarettes and refill containers? Cross-border distance sales of e-cigarettes and refill containers (Article 20(6)) 6.18 The Directive provides Member States with the option to prohibit the cross-border distance sales of e-cigarettes and refill containers to consumers, i.e. to ban businesses in Ireland from selling these products to consumers in other Member States, for example, via the internet, telephone or mail order and to ban businesses in other Member States from selling to consumers in Ireland. 6.19 Should the Department choose not to exercise this option, it is obliged to introduce a registration system for all retailers intending to engage in cross-border distance sales both into and out of Ireland. 6.20 If a registration system is introduced, Irish retailers selling e-cigarettes and refill containers to consumers in other Member States (provided that Member State has not imposed a ban) through distance selling arrangements will be required to register with the Irish competent authority and the competent authority in the Member State(s) where the consumers are based. All non-Irish businesses intending to sell in Ireland through distance selling arrangements must register with the Irish competent authority. Retailers would be required to provide contact details of their business, the starting date of activities, and details in relation to the website(s) used for selling such products. 6.21 Furthermore, retailers would be obliged to operate and provide details on an age verification system, ‘which verifies at the time of sale, that the purchasing consumer complies with the minimum age requirements provided for under the national law of the Member State of destination.’ It is worth noting that whilst there is currently no legislation governing the age at which e-cigarettes and refill can be purchased, the Government intends introducing legislation prohibiting the sale of these products and Page 14 of 15 other non-medicinal nicotine delivery systems to, and by, persons under 18 years of age. 6.22 The placing of products on the market via cross-border distance sales arrangements would only be allowed following receipt of confirmation of registration with the relevant competent authorities. A list of all retailers registered with the Irish competent authority would be publicly available. 6.23 Member States also have the option of requiring retailers to nominate a person to be responsible for verifying that products comply with Irish legislation. Questions Q) Should cross-border distance sales of e-cigarettes and refill containers be prohibited? Please provide an explanation for your answer (maximum 1500 characters (approx. 250 words)). Q) If cross-border distance sales of e-cigarettes and refill containers are not prohibited thereby requiring the introduction of a registration system, should retailers be required to nominate a person to be responsible for verifying that products comply with Irish legislation? Please provide an explanation for your answer (maximum 600 characters (approx. 100 words)). 7. 7.1 Queries If you have any queries relating to this consultation please email tpdconsultation@health.gov.ie with your query. Please do not send your consultation submission to this email address as it will not be processed. Page 15 of 15