Reporting Suspected Adverse Effects with Electronic Cigarette* and E-liquid** Usage
- Please attend your GP or A&E in the event of any serious undesirable side effects you associate with the use of e-cigarettes. You can ring the Poisons Information Centre of Ireland at 01 8092166 in cases of accidental poisoning.
- Email info.tpd@hse.ie to report any issues including suspected undesirable side effects that occurred after the use of e-cigarettes and e-liquids. This includes any cases of accidental poisoning, which may involve children and non-users.
- You may also report any safety issues or defects relating to e-cigarettes to info.tpd@hse.ie
- You should also contact the manufacturer or importer - their contact details are on the information leaflet supplied with the product- and inform them of your concerns. They are obliged by law to collect information on suspected adverse effects on human health.
This information will assist us in identifying any previously unrecognised side effects associated with e-cigarette use.
* An electronic cigarette (E-cigarette) is a product that can be used for consumption of nicotine-containing vapour via a mouthpiece or any component of that product.
** An e-liquid is a nicotine-containing liquid which is used in an electronic cigarette.
Important Notice on the Collecting of Information on the Suspected Adverse Effects to Human Health of Electronic Cigarettes and Refill Containers by Manufacturers, Importers and Distributors
Manufacturers, importers and distributors of electronic cigarettes and refill containers shall establish and maintain a system for collecting information about all of the suspected adverse effects on human health of electronic cigarettes and refill containers. This adverse effects form will assist you in collecting information reported to you by consumers.
Reporting safety concerns by Manufacturers, Importers and Distributors
Electronic cigarette and refill container (e-liquid) manufacturers, importers and distributors are legally obliged to inform the Health Service Executive (HSE) if they have reason to believe that an electronic cigarette or refill container is unsafe, not of good quality or non-compliant with the Tobacco Products Directive 2014/40/EU and Irish Regulations. Details of the risk to human health and safety and any corrective action taken must also be provided. Manufacturers, importers and distributors must notify the HSE by email at info.tpd@hse.ie
Information for Manufacturers, Importers, Distributors & Retailers of Electronic Cigarettes & Refill Containers
See link to a product checklist to support you in the assessment of electronic cigarettes and refill containers you wish to place on the market.
All products which do not comply with the 2016 Regulations must be removed from sale.
The following link to the Department of Health website will also further assist retailers regarding the new requirements for products
Guidance on Electronic Cigarettes and/or refill containers; (Revised Nov. '17)
See updated notice by the EU Commission May 2020 on the "Withdrawal of the United Kingdom and EU Rules on Tobacco and Related Products"
Websites
Commercial Communications in Information Society Services
Regulation 31 requires that the content of websites must not have the aim or the direct or indirect effect of promoting e-cigarettes or refill containers (e-liquids containing nicotine).
The following are examples of practices that are considered to breach Regulation 31:
- Offering discounts or offers on products.
- Free delivery.
- Offers for bulk buying.
- Non-factual information e.g. expansive descriptions of the taste or smell of the product.
- Pictures surrounding the image of the product, e.g. of food products etc.
- Health warnings not as prescribed i.e. products offered for sale in the Republic of Ireland must carry the health warning as prescribed in the Irish and English language on the unit packet (refill container/bottle) and on the outside packaging.
- Star ratings, reviews.
- Reward points etc.
- The use of other social media sites to promote e-cigarettes and refill containers (e-liquids containing nicotine) is also prohibited.
The Department of Health has issued a guidance document available here: Department of Health Guidance on Commercial Communication Restrictions
Please review your website to ensure compliance with Regulation 31.
Tobacco Products Directive
The Minister for Health Simon Harris T.D. has signed Regulations transposing the Tobacco Products Directive into Irish law. The European Union (Manufacture, Presentation and Sale of Tobacco and Related Products) Regulations 2016 (S.I. No. 271 of 2016) came into force on 20 May 2016 and were amended in June 2017 (S.I. 252 of 2017), in April 2018 (S.I. No. 132 of 2018) and in September 2018 (S.I. No. 365 of 2018).
Certain sections of the Public Health (Standardised Packaging of Tobacco) Act 2015 transpose in part Articles 13 and 14 of the Tobacco Products Directive. Those sections were also commenced on the 20th May 2016 by means of The Public Health (Standardised Packaging of Tobacco Act 2015) Commencement Order 2016 (S.I. No. 270 of 2016).
The Environmental Health Service of the HSE is responsible for the enforcement of many provisions of the legislation. Should you wish to contact us or make a complaint regarding e-cigarettes, refill containers (e-liquids), tobacco products, or novel or herbal products for smoking, please email us at info.tpd@hse.ie.
The Advertising Standards Authority of Ireland (ASAI) is an independent self-regulatory body which regulates commercial marketing communications and investigates complaints.
They implement the Code of Standards for Advertising and Marketing Standards for Communication in Ireland. This Code includes a section on e-cigarettes. A complaint may be made here. Make a complaint
The Regulations include a number of measures as such: –
- A ban on cigarettes and roll-your-own tobacco with characterising flavours such as fruit flavours, menthol or vanilla;
- Minimum unit pack size of 30g for Roll-Your-Own tobacco;
- A ban on tobacco products containing certain additives;
- A ban on any misleading labelling (such as “natural” or “organic”);
- Increased size for combined health warnings and a requirement to place them on the front and back of the product;
- Additional reporting requirements for tobacco products;
- Notification requirements for electronic cigarettes, refill containers, herbal and novel tobacco products;
- Registration requirement for cross-border distance sales of tobacco products, electronic cigarettes or refill containers;
- Introduction of a tracking and tracing system;
- Regulation of electronic cigarettes and refill containers;
- Stricter rules on advertising/sponsorship for electronic cigarettes and refill containers;
- Mandatory safety and quality requirements for electronic cigarettes and refill containers;
- Certain provisions of the Public Health (Standardised Packaging of Tobacco) Act 2015 have been commenced in order to the transpose the measures relating to Articles 13 and 14 of the Directive.
For up-to-date information on reporting/notification process, Manufacturers and Importers should refer to http://ec.europa.eu/health/euceg/
Guidance on notification of e-cigarettes and refill containers
Under Regulation 26 of the 2016 Regulations, a manufacturer or importer of an e-cigarette or refill container must submit a notification to the Health Service Executive of any such products he or she intends to place on the Irish market.
The notification must be submitted through a European Union Common Entry Gate (EU-CEG) made available by the European Commission. Guidance on the EU-CEG and how to apply for a submitter ID and a European Commission Authentication Account (ECAS) account is available from the European Commission’s website here http://ec.europa.eu/health/euceg/
Notification of a product on the Irish market before 20 May 2016 must be submitted by 20 November 2016. Notification of a new or a substantially modified product must be submitted not less than 6 months before placing it on the Irish market.
The obligation to notify a product does not apply to retailers unless he or she also falls within the definition of a manufacturer or importer.
A manufacturer is defined as any natural or legal person who manufactures a product or has a product designed or manufactured and markets that product under their name or trademark.
If a retailer also qualifies as a manufacturer, he or she must submit a notification for each relevant product.
An importer is defined as the owner of, or a person having the right of disposal over, tobacco or related products that have been brought into the territory of the European Union.
If a retailer also qualifies as an importer, he or she should check with his or her manufacturer if they have already submitted a notification for each relevant product.
If the manufacturer has already done so, the importer does not need to submit a duplication notification.
Guidance on the content and format of notifications
The content and format of a notification are set out in Regulation 26 of the 2016 Regulations and Commission Implementing Decision (EU) 2015/2183 of 24 November 2015
Discussion papers developed by Member States are set out below (see links). The aim of the papers is to provide guidance to manufacturers and importers submitting notifications for their products
E-cigarette Working Group Discussion Papers on Submission of Notifications under Article 20 of Directive 2014/40/EU:
For further information see:
Guidance on the notification of e-cigarettes and refill containers under the European Union (Manufacture, Presentation and Sale of Tobacco and Related Products) Regulations 2016
Fees
Under the 2016 Regulations, there is no fee for notifying e-cigarettes or refill containers. This reflects the current legislative position and is subject to any future legislative amendment.
Contacts
Should you experience technical difficulties with the EU-CEG, please contact: SANTE-EUCEG-ITSUPPORT@ec.europa.eu
(include in your message a ‘print screen’ of the window where the problem appears)
For general matters related to the functioning of the EU-CEG, please contact SANTE-EU-CEG@ec.europa.eu
To contact the National Tobacco Control Operational Unit of the Health Service Executive, please email info.tpd@hse.ie
To contact the Tobacco and Alcohol Control Unit of the Department of Health, please email tobacco@health.gov.ie
Cross-Border Distance Sales
Retailers established in the Republic of Ireland who intend to engage in cross-border distance sales of tobacco products or electronic cigarettes to consumers located in the European Union must register with the HSE and with the competent authority in the member state where the actual or potential consumers are located.
Retailers established outside the Republic of Ireland but in another Member State who engage or intend to engage in cross-border distance sales of tobacco products or electronic cigarettes to actual or potential consumers located in the Republic of Ireland must register with the HSE.
Retailers established outside the European Union who engage or intend to engage in cross-border distance sales of tobacco products or electronic cigarettes to actual or potential consumers located in the Republic of Ireland must register with the HSE.
In the case of tobacco products sold in the Republic of Ireland, the retailer must appoint a tax representative, established in Ireland, who is liable for the payment of Excise Duty and Value Added Tax. Further information is available at https://www.revenue.ie/en/companies-and-charities/excise-and-licences/tobacco-products-tax/information-for-traders.aspx
List of Registered Retailers
This list of registered retailers who engage in cross border distance sales is published in accordance with Regulation 23(5)(c) of the EU (Manufacture, Presentation and Sale of Tobacco and Related Products) Regulations 2016.
See below links to the Application forms for Registration as a Cross-Border Distance Sales (CBDS) retailer and a Change of Details form. The change of details form must be used if any of the details relating to your application change including your business ceasing to trade. These forms may be printed for completion and return to National Tobacco Control Office, Health Service Executive, 2nd Floor, Oak House, Limetree Ave, Millennium Park, Naas, Co Kildare W91 KDC2.
Application form for CBDS retailer based in ROI
Application form for CBDS retailer based outside ROI
Change of details form
For further information on the registration process please email: info.tpd@hse.ie
For further information on Cross Border Distance Sales see the following link to the Department of Health Website;
Guidance on Cross Border Distance Sales
Data Protection
The HSE fully respects your right to privacy. Any personal information relating to a notification of e-cigarettes or refill containers will be treated in accordance with the Data Protection Acts, 1988 and 2003 (and any amending or substituting legislation). Your personal information will be used only for the purposes for which it is provided, for example, for conducting regulatory checks or requirements or to comply with a legal process. You are entitled to access information that the HSE holds relating to you and can do so by applying to the HSE in writing and on payment of the prescribed statutory fee. The HSE reserve the right to charge a reasonable administration fee for each access request. The HSE are entitled to take reasonable steps to establish your identity in relation to any query, amendment, access or deletion request in respect of the information notified.
Freedom of Information
The Department of Health and the HSE are both prescribed as a ‘Public Body’ within the meaning of the Freedom of Information Act 2014. Pursuant to the provisions of the Freedom of Information Act 2014, certain information provided to either the Department of Health or the HSE may form the subject of a Freedom of Information request. Personal information concerning identifiable individuals is not disclosable under the Freedom of Information Act other than to the individual concerned except under limited circumstances provided for in the legislation.
