European Union (Manufacture, Presentation and Sale of Tobacco and Related Products) Regulations 2016.

• Jurisdiction: Ireland
• Citation: IR SI 271/2016
• Year: 2016

ARRANGEMENT OF REGULATIONS

PART 1

PRELIMINARY AND GENERAL

1. Citation and commencement

2. Interpretation

3. Competent authority

PART 2

TOBACCO PRODUCTS — INGREDIENTS AND EMISSIONS

4. Maximum emission levels and measurement methods for tar, nicotine, carbon monoxide and other substances

5. Reporting of ingredients and emissions

6. Studies regarding market research and submitting of information

7. Comprehensive studies

8. Regulation of ingredients

9. Trade secrets

PART 3

TOBACCO PRODUCTS — LABELLING AND PACKAGING

10. General provisions

11. Images of unit packets and any outside packaging

12. General warning and information message on tobacco products for smoking

13. General warning, information message and content of a unit packet of roll-your-own tobacco

14. Combined health warnings for tobacco products for smoking

15. Layout, design and shape of the combined health warning

16. Design of the combined health warning

17. Special rules for certain unit packets of tobacco products with a flip-top lid

18. Labelling of single cigars and cigarillos

19. Labelling of smokeless tobacco products

20. Traceability

21. Security feature

PART 4

TOBACCO FOR ORAL USE, CROSS-BORDER DISTANCE SALES AND NOVEL TOBACCO PRODUCTS

22. Tobacco for oral use

23. Cross-border distance sales of tobacco products

24. Notification of novel tobacco products

PART 5

ELECTRONIC CIGARETTES AND HERBAL PRODUCTS FOR SMOKING

25. General provisions for electronic cigarettes and refill containers

26. Notification of electronic cigarettes and refill containers

27. Safety and quality requirements for electronic cigarettes and refill containers

28. Refill mechanism of electronic cigarettes

29. Information and labelling on electronic cigarettes and refill containers

30. Product presentation for electronic cigarettes

31. Commercial communications relating to electronic cigarettes and refill containers

32. Market developments concerning electronic cigarettes and refill containers

33. Public health concerns relating to electronic cigarettes and refill containers

34. Herbal products for smoking

35. Reporting of ingredients of herbal products for smoking

36. Product presentation for herbal products

PART 6

ENFORCEMENT AND SANCTIONS

37. Designated laboratories

38. Construction of references (authorised officers)

39. Indemnification of authorised officers

40. Taking of samples by authorised officers

41. Compliance notice

42. Prohibition notice

43. Offences and penalties

44. Forgery of documents

45. Evidence in proceedings for an offence

46. Service of documents

PART 7

TRANSITIONAL PROVISIONS AND REVOCATIONS

47. Transitional provisions

48. Revocations

SCHEDULE

LIST OF TEXT WARNINGS

S.I. No. 271 of 2016

EUROPEAN UNION (MANUFACTURE, PRESENTATION AND SALE OF TOBACCO AND RELATED PRODUCTS) REGULATIONS 2016

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 24th May, 2016.

I, SIMON HARRIS, Minister for Health, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972) and for the purpose of giving effect to Directive 2014/40/EU of the European Parliament and of the Council of 3 April 20141 , 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, hereby make the following regulations:

PART 1

PRELIMINARY AND GENERAL

Citation and commencement

1. (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.

Interpretation

2. (1) In these Regulations—

“combined health warning” has the meaning assigned to it by Regulation 14;

“Commission” means the European Commission;

“designated laboratory” means a laboratory designated by the Minister pursuant to Regulation 37;

“Directive” means Directive 2014/40/EU of the European Parliament and of the Council of 3 April 20141 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 as amended by Commission Delegated Directive 2014/109/EU of 10 October 20142 amending Annex II to Directive 2014/40/EU of the European Parliament and of the Council by establishing the library of picture warnings to be used on tobacco products, Commission Implementing Decision (EU) 2015/1735 of 24 September 20153 on the precise position of the general warning and the information message on roll-your-own tobacco marketed in pouches, Commission Implementing Decision (EU) 2015/1842 of 9 October 20154 on the technical specifications for the layout, design and shape of the combined health warnings for tobacco products for smoking, Commission Implementing Decision (EU) 2015/2183 of 24 November 20155 establishing a common format for the notification of electronic cigarettes and refill containers and 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 Commission Implementing Decision (EU) 2016/586 of 14 April 2016 on technical standards for the refill mechanism of electronic cigarettes7 ;

“Executive” means the Health Service Executive;

“importer” means the owner of, or a person having a right of disposal over, tobacco or related products that have been brought into the State;

“information society services” has the same meaning as it has in Article 1 of Directive 98/34/EC of the European Parliament and of the Council of 22 June 19988 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services;

“Minister” means the Minister for Health;

“relevant product” means—

(a) a tobacco product,

(b) a herbal product for smoking,

(c) an electronic cigarette, or

(d) a refill container;

“retailer” means a person who carries on, in whole or in part, the business of selling a tobacco product by retail;

“trade mark” has the same meaning as it has in the Trade Marks Act 1996 (No. 6 of 1996);

“unique identifier” has the meaning assigned to it by Regulation 20.

(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.

Competent authority

3. (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.

PART 2

TOBACCO PRODUCTS — INGREDIENTS AND EMISSIONS

Maximum emission levels and measurement methods for tar, nicotine, carbon monoxide and other substances

4. (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.

Reporting of ingredients and emissions

5. (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...