S.I. No. 271/2016 - European Union (Manufacture, Presentation and Sale of Tobacco and Related Products) Regulations 2016

• (d) any form of public or private contribution to any event, activity or individual person with the aim or direct or indirect effect of promoting electronic cigarettes or refill containers and involving or taking place in several Member States or otherwise having cross-border effects;

• (e) audiovisual commercial communications to which the Broadcasting Act 2009 (No. 18 of 2009) and the European Communities (Audiovisual Media Services) Regulations 2010 (S.I. 258 of 2010) applies, for electronic cigarettes or refill containers.

Market developments concerning electronic cigarettes and refill containers

Public health concerns relating to electronic cigarettes and refill containers

• (2) A manufacturer, importer or distributer of electronic cigarettes or refill containers who considers, or has reason to believe, that electronic cigarettes or refill containers, which are in his or her possession and are intended to be placed on the market or are placed on the market, are not safe or are not of good quality or are otherwise not in conformity with these Regulations, shall immediately take the corrective action necessary to bring the product concerned into conformity with these Regulations and withdraw or recall it, as appropriate.

• (3) Where a manufacturer, importer or distributer of electronic cigarettes or refill containers considers, or has reason to believe, that electronic cigarettes or refill containers are not safe or are not of good quality or in conformity with these Regulations as referred to in paragraph (2), he or she shall immediately inform the Executive in electronic form providing details, in particular, of the risk to human health and safety and of any corrective action taken, and of the results of such corrective action.

• (4) The Executive may request additional information from a manufacturer, importer or distributer of electronic cigarettes or refill containers including information on the safety and quality aspects or any adverse effects of electronic cigarettes or refill containers and the manufacturer, importer or distributor, as appropriate, shall comply with any such request.

Herbal products for smoking

“Má chaitheann tú an táirge seo, déantar dochar do do shláinte

Smoking this product damages your health.”

• (2) The health warning referred to in paragraph (1) shall—

• (a) be printed on the front and back external surface of the unit packet and on any outside packaging,

• (b) comply with the requirements set out in Regulation 12(6), and

• (c) cover 32% of the area of the corresponding surface of the unit packet and of any outside packaging.

Reporting of ingredients of herbal products for smoking

• (a) submit to the Executive a list of all ingredients, and quantities thereof that are used in the manufacture of such products by brand name and type, and

• (b) inform the Executive when the composition of a product is modified in a way that affects the information submitted pursuant to this Regulation.

• (2) The Executive shall make available on its website, the information received under paragraph (1).

• (3) The information required under this Regulation shall be submitted in electronic form to the Executive not less than 3 months prior to the placing on the market of a new or modified herbal product for smoking.

Product presentation for herbal products

• (a) promotes a herbal product or encourages its consumption by containing information or statements that create an erroneous impression in relation to the characteristics, health effects, risks or emissions of a herbal product,

• (b) suggests that a herbal product is less harmful than other herbal products or that it aims to reduce the effect of some of the harmful components of smoke,

• (c) suggests that a herbal product has vitalising, energetic, healing, rejuvenating, natural or organic properties, or that it has health or lifestyle benefits,

• (d) resembles a food or a cosmetic product, or

• (e) states that the product is free of additives or flavours.

• (2) The unit packets and any outside packaging of a herbal product shall not suggest economic advantages by including printed vouchers, offering discounts, free distribution, two-for-one or other similar offers.

• (3) The elements and features that are prohibited under paragraphs (1) and (2) shall include texts, symbols, names, trade marks, figurative or other signs.

PART 6 ENFORCEMENT AND SANCTIONS

Designated laboratories

• (a) a laboratory (in these Regulations referred to as a “designated laboratory”) as a laboratory at which—

• (i) samples taken under these Regulations may be analysed, and

• (ii) measurement methods referred to in Regulation 4 may be verified, and

• (b) a person as being a person who, or a class of persons the members of which, may, at a designated laboratory, analyse samples taken under these Regulations, and verify the measurement methods referred to in Regulation 4, and each such person or member is, in these Regulations, referred to as a “designated analyst”.

• (2) A laboratory designated under paragraph (1) shall not be owned or controlled directly or indirectly by the tobacco industry.

• (3) The Minister may revoke or amend a designation made under paragraph (1).

• (4) As soon as practicable after a sample taken by an authorised officer under these Regulations has been received at a designated laboratory it shall be analysed and the composition, the amount and concentration of its ingredients and any other properties of the sample shall be determined by a designated analyst at that laboratory.

• (5) As soon as practicable after compliance with paragraph (4), a designated analyst engaged in the analysis of samples at the designated laboratory concerned shall forward the results of the analysis carried out on the sample concerned to the Executive.

Construction of references (authorised officers)

• (a) references to “this Act” shall be construed as references to “these Regulations”;

• (b) references to “this Act and the Act of 2015” shall be construed as references to “these Regulations”;

• (c) references to “this Act or the Act of 2015” shall be construed as references “these Regulations”;

• (d) the reference to “this Act or under the Act of 2015” shall be construed as a reference “these Regulations”;

• (e) references to “tobacco products” shall be construed as references to “relevant products”;

• (f) references to “retail packaging” shall be construed as references to “packaging”;

• (g) subsection (4)(a)(i) shall be construed as including a reference to “commercial communication, promotion” after “labelling,”;

• (h) it shall include the following additional subsection:

• “(4A) An authorised officer may, for the purposes of obtaining any information which may be required in relation to a matter under investigation under these Regulations, at all reasonable times—

  • (a) pay or make tender of payment for a relevant product, or

  • (b) confirm any other information in relation to a relevant product for the purposes of the investigation.”;

• (i) any other necessary modifications.

Indemnification of authorised officers

Taking of samples by authorised officers

• (2) Where an authorised officer has complied with paragraph (1) he or she shall—

• (a) offer one of the sealed containers to the owner or person for the time being in charge or possession of the relevant product, substance or article from which the sample concerned was taken,

• (b) retain one of the sealed containers, and

• (c) forward, or cause to be forwarded, one of the sealed containers to a designated laboratory for the purposes of analysis.

• (3) Where a relevant product, or any substance or article used in the manufacturing, processing or storage of a relevant product is contained in a container and its division into parts is (for whatever reason) not practicable, an authorised officer, who wishes to take samples of such relevant product, substance or article for the purposes of analysis, shall take possession of 3 such containers belonging to the same batch, and each such container shall be deemed to be part of a sample for the purposes of paragraph (1), and the provisions of paragraphs (1) and (2) shall apply thereto accordingly.

Compliance notice

• (2) A compliance notice shall—

• (a) state the grounds for the authorised officer being satisfied that there has been a contravention referred to in paragraph (1),

• (b) for the purpose of ensuring compliance by the person concerned, require the person to do or refrain from doing such act or acts as is or are specified in the notice by such date as is so specified, and

• (c) contain information regarding the bringing of an appeal under paragraph (5) against the notice, including the manner in which an appeal shall be brought.

• (3) A compliance notice shall not specify a date in accordance with paragraph (2)(b) that falls on or before the date by which an appeal under paragraph (5) shall be brought.

• (4) An authorised officer may—

• (a) withdraw a compliance notice at any time, as he or she considers appropriate, or

• (b) where no appeal is brought under this Regulation, specify a date extending the period specified in the notice for the purposes of paragraph (2)(b), and notify the person in writing accordingly.

• (5) A person may appeal a compliance notice served on him or her to the District Court not later than 14 days after the service of the compliance notice concerned.

• (6) The authorised officer and the appellant concerned shall be entitled to be heard and to adduce evidence at the hearing of an appeal under this Regulation.

• (7) The District Court shall, upon an appeal under this Regulation, do one of the following:

• (a) affirm the compliance notice concerned;

• (b) direct the authorised officer to withdraw the compliance notice concerned.

• (8) An authorised officer shall comply with a direction under paragraph (7).

• (9) A person who fails to comply with a compliance notice by the specified date shall be guilty of an offence and shall be liable—

• (a) on summary conviction—

• (i) in the case of a first offence, to a class B fine or to imprisonment for a term not exceeding 6 months, or to both, and

• (ii) in the case of a second or subsequent offence, to a class A fine or to imprisonment for a term not exceeding 12 months, or to both, or

• (b) on conviction on indictment to a fine not exceeding €500,000 or imprisonment for a term not exceeding 3 years or both.

• (10) This Regulation shall not operate to prevent or restrict—

• (a) the entitlement of any person to bring proceedings for the purpose of securing compliance with these Regulations by a person, or

• (b) the bringing or prosecuting of any proceedings for an offence under these Regulations.

• (11) In this Regulation “specified date” means, in relation to a compliance notice—

• (a) the date specified in the notice in accordance with paragraph (2)(b), where no appeal against the notice is brought under this Regulation, or

• (b) the day falling immediately after the expiration of the period of 7 days from the date on which the District Court so affirms the notice, where an appeal against the notice is brought under paragraph (5) and the District Court affirms the notice in accordance with paragraph (7)(a).

Prohibition notice

• (2) A prohibition order shall—

• (a) be signed by the authorised officer issuing it,

• (b) state that the authorised officer is of the opinion that a particular consignment, class or batch of a relevant product does not comply with these Regulations,

• (c) specify the provision or provisions of these Regulations in relation to which the relevant product is not in compliance and the matters giving rise to the non-compliance, and

• (d) direct the person on whom the prohibition order is served to ensure that the relevant product—

• (i) is not to be placed or made available on the market until such time as all appropriate measures, including corrective measures, have been taken to bring the product into compliance with these Regulations,

• (ii) is prohibited from being placed or made available on the market,

• (iii) is to be withdrawn or recalled from the market within a specified time-limit, or

• (iv) is to be destroyed within a specified time limit and in a manner prescribed by the authorised officer or is to be detained for the purposes of destruction by an authorised officer.

• (3) The approval referred to in paragraph (1) may be given orally or in writing and if given orally, shall be recorded in writing as soon as practicable.

• (4) A prohibition order shall take effect—

• (a) where the prohibition order so declares, immediately the order is received by the person on whom it is served, or

• (b) in any other case—

• (i) where no appeal is taken against the prohibition order, on the expiration of the period during which such an appeal may be taken or the day specified in the prohibition order as the day on which it is to come into effect, whichever is the later, or

• (ii) where an appeal is taken, on the day next following the day on which the prohibition order is confirmed on appeal or the appeal is withdrawn or the day specified in the prohibition order as the day on which it is to come into effect, whichever is the later.

• (5) The bringing of an appeal against a prohibition order which is to take effect in accordance with paragraph (4)(a) shall not have the effect of suspending the operation of the prohibition order, but the appellant may apply to the District Court to have the operation of the prohibition order suspended until the appeal is disposed of and, on such application, the District Court may, if it thinks it proper to do so, direct that the operation of the prohibition order be suspended until the appeal is disposed of.

• (6) In the event of non-compliance or delay by the person on whom the prohibition order has been served, an authorised officer shall, with the approval of the Director General or other officer designated in that behalf by the Executive, take whatever steps are considered necessary to ensure compliance with the direction given under this Regulation and this may include the withdrawal, recall, seizure and destruction of the products in question or the making of any arrangements for such withdrawal, recall, seizure or destruction.

(7)(a) A person who is aggrieved by a prohibition order may, within the period of 7 days beginning on the day on which the prohibition order is served on him or her, appeal against the order to a judge of the District Court in the district court district in which the prohibition order was served in the prescribed manner and in determining the appeal the judge may—

• (i) if he or she is satisfied that in the circumstances of the case it is reasonable to do so, confirm the prohibition order, with or without modification, or

• (ii) cancel the prohibition order.

• (b) Where on the hearing of an appeal under this paragraph a prohibition order is confirmed, notwithstanding paragraph (6), the judge of the District Court by whom the appeal is heard may, on the application of the appellant, suspend the operation of the prohibition order for such period as in the circumstances of the case the judge considers appropriate.

• (8) A person who appeals against a prohibition order or who applies for a direction suspending the application of the prohibition order under paragraph (5) shall at the same time notify the Executive of the appeal or the application and the grounds for the appeal or the application and the Executive shall be entitled to appear, be heard and adduce evidence on the hearing of the appeal or the application.

• (9) The Director General of the Executive, or another officer of the Executive designated for that purpose may for stated reasons, revoke or vary a prohibition order made in accordance with this Regulation and the Executive shall be notified at the next available meeting of the Executive of any such revocation or variation and the reasons therefore.

(10)(a) Where a prohibition order has been served and activities are carried on in contravention of the prohibition order, the High Court may, on the application of the Executive, by order prohibit the continuance of the activities.

• (b) An application to the High Court for an order under this paragraph shall be by motion and the Court, when considering the matter, may make such interim or interlocutory order (if any) as it considers appropriate and the order by which an application under this paragraph is determined may contain such terms and conditions (if any) as to the payment of costs as the Court considers appropriate.

Offences and penalties

• (a) in the case of a first offence, to a class B fine or to imprisonment for a term not exceeding 6 months, or to both, and

• (b) in the case of a second or subsequent offence, to a class A fine or to imprisonment for a term not exceeding 12 months, or to both.

• (2) A person guilty of an offence under paragraph (6) of this Regulation or paragraphs (1), (2) or (3) of Regulation 44 shall be liable—

• (a) on summary conviction—

• (i) in the case of a first offence, to a class B fine or to imprisonment for a term not exceeding 6 months, or to both, and

• (ii) in the case of a second or subsequent offence, to a class A fine or to imprisonment for a term not exceeding 12 months, or to both, or

• (b) on conviction on indictment to a fine not exceeding €500,000 or imprisonment for a term not exceeding 3 years or both.

• (3) A person who contravenes Regulation 5, 8, 20, 21, 22, 25, 26, 27, 28 or 33 commits an offence and shall be liable—

• (a) on summary conviction—

• (i) in the case of a first offence, to a class B fine or to imprisonment for a term not exceeding 6 months, or to both, and

• (ii) in the case of a second or subsequent offence, to a class A fine or to imprisonment for a term not exceeding 12 months, or to both, or

• (b) on conviction on indictment to a fine not exceeding €500,000 or imprisonment for a term not exceeding 3 years or both.

• (4) Where an offence under these Regulations is committed by a body corporate and is proved to have been so committed with the consent or connivance of, or to be attributable to any wilful neglect on the part of any person, being a director, manager, secretary or other officer of the body corporate, or a person who was purporting to act in any such capacity, that person, as well as the body corporate, commits an offence and shall be liable to be proceeded against and punished as if he or she were guilty of the first-mentioned offence.

• (5) Where the affairs of a body corporate are managed by its members, paragraph (4) applies in relation to the acts and defaults of a member in connection with his or her functions of management as if he or she were a director or manager of the body corporate.

• (6) A person who provides to the Executive information which the person knows or ought reasonably to know to be false or misleading (whether on the person’s own behalf or on behalf of another person) in purported compliance with a requirement imposed by these Regulations commits an offence.

• (7) Summary proceedings for an offence under these Regulations may be brought and prosecuted by the Executive.

• (8) In proceedings for an offence under these Regulations, it shall be a defence for a person against whom such proceedings are brought to show that he or she made all reasonable efforts to ensure compliance with such provisions of these Regulations as are alleged to have been contravened.

• (9) Unless it is satisfied that there are special and substantial reasons for not so doing, the court shall, where a person is convicted of an offence under these Regulations, order the person to pay to the prosecution the costs and expenses, measured by the court, incurred by the prosecution in relation to the prosecution of the offence.

Forgery of documents

• (2) It shall be an offence for a person to alter with intent to defraud or deceive, or to utter knowing it to be so altered a notice, certificate or other document issued, granted or given under these Regulations (in this Regulation referred to as “an altered document”).

• (3) It shall be an offence for a person to have, without lawful authority, in his or her possession a forged document or an altered document.

Evidence in proceedings for an offence

• (a) that the person received a sample submitted to the designated laboratory,

• (b) that, for such period as is specified in the certificate, the person had in his or her custody a sample so submitted, or

• (c) that the person gave to such other person as is specified in the certificate a sample so submitted,

shall unless the contrary is proved be evidence of the matters stated in the certificate.

• (2) In proceedings for an offence under these Regulations, a certificate purporting to be signed by a designated analyst stating any one or more of the following, namely—

• (a) that he or she carried out any procedure for the purpose of detecting the presence of any substance in the sample so submitted, or

• (b) that the sample concerned contained such substance or such amount thereof as is specified in the certificate,

shall unless the contrary is proved be evidence of the matters stated in the certificate.

• (3) In proceedings for an offence under these Regulations the court may, if it considers that the interests of justice so require, direct that oral evidence of the matters stated in a certificate under this Regulation be given and the court may, for the purpose of receiving oral evidence, adjourn the proceedings to a later date.

• (4) A certificate under this Regulation shall be in such form as may be specified by the Minister.

• (5) In proceedings for an offence under these Regulations, a relevant product, or a package containing a relevant product, that purports to bear the name of the manufacturer or importer of that product, shall unless the contrary is proved, be evidence that the relevant product was manufactured or imported, as the case may be, by the person concerned.

• (6) In proceedings for an offence under these Regulations a relevant product, or a package containing a relevant product, that bears a trade mark shall unless the contrary is proved be evidence that the product was manufactured by the person who at the time of the alleged commission of the offence owned that trade mark.

Service of documents

• (a) by delivering it to the person,

• (b) by leaving it at the address at which the person carries on business or ordinarily resides or, in the case in which an address for service has been furnished, at that address, or

• (c) by sending it by post in a prepaid registered letter to the address at which the person carries on business or ordinarily resides or, in a case in which an address for service has been furnished, to that address.

• (2) For the purposes of this Regulation, a company within the meaning of the Companies Act 2014 shall be deemed to be ordinarily resident at its registered office, and every other body corporate and every unincorporated body shall be deemed to be ordinarily resident at its principal office or place of business.

PART 7 TRANSITIONAL PROVISIONS AND REVOCATIONS

Transitional provisions

• (a) electronic cigarettes or refill containers manufactured or released for free circulation before 20 November 2016 which are placed on the market on or before 20 May 2017, and

• (b) herbal products for smoking manufactured or released for free circulation before 20 May 2016 which are placed on the market on or before 20 May 2017.

Revocations

• (a) European Communities (Manufacture, Presentation and Sale of Tobacco Products) Regulations 2003 ( S.I. No. 425 of 2003 );

• (b) European Communities (Manufacture, Presentation and Sale of Tobacco Products) (Amendment) Regulations 2008 ( S.I. No. 255 of 2008 );

• (c) European Communities (Manufacture, Presentation and Sale of Tobacco Products) (Amendment) Regulations 2011 ( S.I. No. 655 of 2011 );

• (d) Public Health (Tobacco) (General and Combined Warnings) Regulations 2011 ( S.I. No. 656 of 2011 ).

• (2) Notwithstanding paragraph (1)—

• (a) the European Communities (Manufacture, Presentation and Sale of Tobacco Products) Regulations 2003 ( S.I. No. 425 of 2003 ), and

• (b) the Public Health (Tobacco) (General and Combined Warnings) Regulations 2011 ( S.I. No. 656 of 2011 ),

shall continue to apply in respect of tobacco products manufactured or released for free circulation and labelled before 20 May 2016 which are placed on the market before 20 May 2017.

Schedule

Regulations 14, 16 and 18

LIST OF TEXT WARNINGS

Text Warning in Irish Language	Text Warning in English Language
(1) Caitheamh tobac is cúis le naoi gcinn as gach deich n-ailse scamhóg	(1) Smoking causes 9 out of 10 lung cancers
(2) Caitheamh tobac is cúis le hailse bhéil agus scornaí	(2) Smoking causes mouth and throat cancer
(3) Déanann caitheamh tobac dochar do do scamhóga	(3) Smoking damages your lungs
(4) Caitheamh tobac is cúis le taomanna croí	(4) Smoking causes heart attacks
(5) Caitheamh tobac is cúis le strócanna agus le míchumas	(5) Smoking causes strokes and disability
(6) Nuair a chaitear tobac, tachtar na hartairí	(6) Smoking clogs your arteries
(7) Méadaíonn caitheamh tobac an riosca go dtiocfaidh daille ort	(7) Smoking increases the risk of blindness
(8) Déanann caitheamh tobac dochar do do chuid fiacla agus do do dhrandail	(8) Smoking damages your teeth and gums
(9) Féadann caitheamh tobac do leanbh sa bhroinn a mharú	(9) Smoking can kill your unborn child
(10) Déanann do dheatach tobac díobháil do do leanaí, do do theaghlach agus do do chairde	(10) Your smoke harms your children, family and friends
(11) Is é is dóichí gur caiteoirí tobac a bheidh i leanaí de chuid caiteoirí tobac ná leanaí eile	(11) Smokers’ children are more likely to start smoking
(12) Scoir de chaitheamh tobac — coinnigh beo do do mhuintir	(12) Quit smoking — stay alive for those close to you
(13) Laghdaíonn caitheamh tobac torthúlacht	(13) Smoking reduces fertility
(14) Méadaíonn caitheamh tobac an riosca go dtiocfaidh éagumas ort	(14) Smoking increases the risk of impotence

GIVEN under my Official Seal,

19 May 2016.

SIMON HARRIS,

Minister for Health.

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation.)

These Regulations give effect 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 provision of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC.

These Regulations revoke the following Regulations:

European Communities (Manufacture, Presentation and Sale of Tobacco Products) Regulations 2003 ( S.I. No. 425 of 2003 );

European Communities (Manufacture, Presentation and Sale of Tobacco Products) (Amendment) Regulations 2008 ( S.I. No. 255 of 2008 );

European Communities (Manufacture, Presentation and Sale of Tobacco Products) (Amendment) Regulations 2011 ( S.I. No. 655 of 2011 );

Public Health (Tobacco) (General and Combined Warnings) Regulations 2011 ( S.I. No. 656 of 2011 ).

The European Communities (Manufacture, Presentation and Sale of Tobacco Products) Regulations 2003 ( S.I. No. 425 of 2003 ) and the Public Health (Tobacco) (General and Combined Warnings) Regulations 2011 ( S.I. No. 656 of 2011 ) shall continue to apply in respect of tobacco products manufactured or released for free circulation and labelled before 20 May 2016 which are placed on the market before 20 May 2017.

These Regulations may be cited as the European Union (Manufacture, Presentation and Sale of Tobacco and Related Products) Regulations 2016 and come into effect on 20 May 2016.

Footnotes