Tobacco Products Directive

Important notice for Retailers

All products which do not comply with the 2016 Regulations cannot be sold after 20th May 2017. Any remaining stock of products on the market must be removed from sale.

The following link to the Department of Health website will assist retailers regarding the new requirements for products

Guidance on Electronic Cigarettes and/or refill containers (Revised Aug. '17)

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).

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 regulate commercial marketing communications and investigate 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.

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. 

Cross Border Distance Sales of E-cigarettes

Cross Border Distance Sales of Tobacco Products

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 following link to the Department of Health Website;

Guidance on Cross Border Distant 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.