The Tobacco and Related Products Regulations 2016

[^key-887db28145c9f018204759333dc143d7]: Words in reg. 41(2) substituted (31.12.2020) by S.I. 2019/41, reg. 6(26)(b) (as substituted by The Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1316), regs. 1(3), 3(31) (with reg. 5))

[^key-c5877fd5b2abe4bac93eeb0cca40b5c4]: Words in reg. 42(3)(b) substituted (31.12.2020) by S.I. 2019/41, reg. 6(27)(a) (as substituted by The Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1316), regs. 1(3), 3(32) (with reg. 5))

[^key-ac9a987590c44e01d0a78fd92479af29]: Reg. 42(4) inserted (31.12.2020) by S.I. 2019/41, reg. 6(27)(b) (as substituted) by The Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1316), regs. 1(3), 3(32) (with reg. 5))

[^key-6e417587bb9d4f9fc168cfc8b61a355d]: Reg. 7(5) inserted (31.12.2020) by S.I. 2019/41, reg. 7(7) (as substituted by The Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1316), regs. 1(3), 3(9) (with reg. 5))

[^key-07cad7b142468014cbd899e1ecc1057b]: Reg. 13(2)-(4) substituted for reg. 13(2) (31.12.2020) by The Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1316), regs. 1(3), 3(13) (with reg. 5))

[^key-b1f5ad114a6917ef7e6cb74d411e5b26]: Reg. 26(b) substituted (31.12.2020) by S.I. 2019/41, reg. 6(18) (as substituted by The Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1316), regs. 1(3), 3(22) (with reg. 5))

[^key-b5b38fe9ce4d858de048503992a471bc]: Reg. 31(3)(a) substituted (31.12.2020) by S.I. 2019/41, reg. 6(19) (as substituted by The Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1316), regs. 1(3), 3(23) (with reg. 5))

[^key-6b980aa43bed2849c7a927ac97cae925]: Words in reg. 40(4) inserted (31.12.2020) by S.I. 2019/41, reg. 6(25) (as substituted by The Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1316), regs. 1(3), 3(30) (with reg. 5))

[^key-7d673b888c84940bd75b692a5241daec]: Reg. 15A inserted (N.I.) (23.10.2023) by The Tobacco and Related Products (Amendment) (Northern Ireland) Regulations 2023 (S.I. 2023/920), regs. 1(2), 3(3)

[^key-6b67009080cf05a103fca84e22da0d68]: Reg. 1A(3)(aa) inserted (N.I.) (23.10.2023) by The Tobacco and Related Products (Amendment) (Northern Ireland) Regulations 2023 (S.I. 2023/920), regs. 1(2), 3(2)

Priority list of additives - enhanced reporting

20A

• (1) A producer of cigarettes or hand rolling tobacco which contain an additive listed in Schedule 2 must—

• (a) carry out the study specified in regulation 20B in respect of that additive; and

• (b) on or before the relevant deadline, submit a report on the results of the study to the Secretary of State and, where the product is an NI tobacco product, to the European Commission.

• (2) The report must include—

• (a) an executive summary;

• (b) a comprehensive overview—

• (i) compiling the available scientific literature on the additive concerned; and

• (ii) summarising the data, whether published or not, which is available to the producer on the effects of that additive; and

• (c) such supplementary information regarding the additive as the appropriate authority may request.

• (3) The relevant deadline is—

• (a) 1st July 2018 where paragraph (1) applies to a producer on 1st January 2017; or

• (b) in any other case, 18 months after the day paragraph (1) first applies to a producer in respect of a particular additive.

• (4) A producer must cooperate with a requirement of the appropriate authority for the report submitted under paragraph (1)(b) to be peer reviewed by an independent scientific body.

• (5) This regulation does not apply to a person who produces cigarettes or hand rolling tobacco containing an additive listed in Schedule 2 where—

• (a) the person is a small or medium sized enterprise as defined in the Annex to Commission Recommendation 2003/361/EC concerning the definition of micro, small and medium-sized enterprises but, for the purposes of this regulation as it applies in Great Britain, with the modifications in paragraph (7); and

• (b) the additive concerned is the subject of a report which has been submitted to the appropriate authority by another producer.

• (6) Regulations may amend the list of additives in Schedule 2 as it applies in Great Britain, which list must contain additives—

• (a) for which initial indications, research, or regulation in jurisdictions outside Great Britain exist suggesting that they have one of the properties set out in regulation 20B(1)(a) to (d); and

• (b) which are amongst the most commonly used additives by weight or number according to the reporting of ingredients pursuant to regulation 18.

• (7) For the purposes of this regulation as it applies in Great Britain, the Annex to Commission Recommendation 2003/361/EC concerning the definition of micro, small and medium-sized enterprises is to be read as if—

• (a) in Article 2—

• (i) in paragraph 1, for “EUR 50 million, and/or an annual balance sheet total not exceeding EUR 43 million” there were substituted “£44,000,000, and/or an annual balance sheet not exceeding £38,000,000”;

• (ii) in paragraph 2, for “EUR 10 million” there were substituted “£8,800,000”;

• (iii) in paragraph 3, for “EUR 2 million” there were substituted “£1,750,000”;

• (b) in Article 3—

• (i) in paragraph (2)(a), for “EUR 1 250 000” there were substituted “£1,100,000”;

• (ii) in paragraph (2)(d), for “EUR 10 million” there were substituted “£8,800,000”;

• (iii) in paragraph 5, for “by national or Community rules” there were substituted “under the law of Great Britain (or any part of it)”;

• (c) in Article 5, in paragraph (b), for “national law” there were substituted “the law of Great Britain (or any part of it)”.

• (8) In this regulation “appropriate authority”—

• (a) where the product is a GB tobacco product, means the Secretary of State;

• (b) where the product is an NI tobacco product, means—

• (i) the Secretary of State, or

• (ii) the European Commission.

Research study into additives

20B

• (1) The study referred to in regulation 20A(1)(a) must be a comprehensive study which examines whether an additive—

• (a) contributes to the toxicity or addictiveness of the product concerned, and whether this has the effect of increasing the toxicity or addictiveness of the product to a significant or measurable degree;

• (b) results in a characterising flavour;

• (c) facilitates inhalation or nicotine uptake;

• (d) leads to the formation of substances that have CMR properties, and if so—

• (i) in what quantities; and

• (ii) whether this has the effect of increasing the CMR properties of the product concerned to a significant or measurable degree.

• (2) The study must also—

• (a) take into account the intended use of the product concerned;

• (b) examine in particular the emissions resulting from the combustion process involving the additive concerned; and

• (c) examine the interaction of that additive with other ingredients contained in the product concerned.

• (3) Two or more producers who use the same additive in their products, in a comparable product composition, may carry out a joint study.

Sales data and market research information

Notification of novel tobacco products

Deadline for notification of novel tobacco products

Further information about novel tobacco products

Submission of information

Use of information

No supply of tobacco product where reporting obligation not complied with

SCHEDULE 2 — Priority list of additives used in cigarettes and hand rolling tobacco subject to enhanced reporting obligations

Extent

1A

• (1) Subject to the following paragraphs, these Regulations extend to England and Wales, Scotland and Northern Ireland.

• (2) The following provisions do not extend to Northern Ireland—

• (a) regulation 5A;

• (b) regulation 7(5);

• (c) regulation 8(10);

• (d) regulation 9(12);

• (e) regulation 10(5);

• (f) regulation 13(3);

• (g) regulation 14(5) and (6);

• (h) regulation 15(3);

• (i) regulation 16(4);

• (j) regulation 16A;

• (k) regulation 20A(6) and (7);

• (l) regulation 36(11);

• (m) regulation 37(10);

• (n) Part 9A;

• (o) regulations 54ZA and 54ZB.

• (3) The following provisions extend only to Northern Ireland—

• (a) regulation 41(3) to (5);

• (aa) regulation 15A;

• (b) regulation 44;

• (d) regulation 47.

• (4) An amendment made by these Regulations has the same extent as the provision to which it relates

Interpretation

Meaning of producer and supplier etc.

Meaning of unit and container pack and the surfaces of a pack

Revision of text warnings, photographs and technical specifications : GB tobacco products

5A

Regulations may—

• (a) amend the text warnings or photographs listed in the picture library in Schedule A1, taking into account scientific and market developments;

• (b) modify for the purposes of these Regulations as they apply in relation to GB tobacco products the layout, design and proportions specified in the Combined Health Warnings Decision referred to in regulation 5, taking into account different packet shapes.

Range and rotation of combined health warnings

General warnings and information messages on tobacco products for smoking

Position of general warning and information message on cigarettes and hand rolling tobacco

Labelling of large cigars and individually wrapped cigars and cigarillos

Health warning on smokeless tobacco products

General conditions applicable to all health warnings on tobacco products

Images of tobacco products targeted at consumers

Regulations: procedures for determining characterising flavour : GB tobacco products

16A

• (1) Regulations may establish procedures for determining whether a GB tobacco product—

• (a) has a characterising flavour; or

• (b) contains additives in quantities that increase the toxic or addictive effect, or the CMR properties, of that tobacco product at the stage of consumption to a significant or measureable degree.

• (2) Regulations made under paragraph (1) may—

• (a) provide for any determination to be made by—

• (i) the Secretary of State; or

• (ii) a person authorised by the Secretary of State for that purpose;

• (b) establish, and provide for the operating procedures of, an independent advisory panel;

• (c) be varied from time to time, including to take account of scientific and market developments in relation to tobacco products;

• (d) make different provision for different cases or descriptions of case, different circumstances, different purposes or different areas;

• (e) be revoked.

• (3) Before making regulations under this regulation the Secretary of State must consult such persons (or representatives of such persons) as appear to the Secretary of State to be likely to be substantially affected by them.

Tobacco for oral use

Sponsorship of events etc. : Northern Ireland.

PART 9A — FEES: Great Britain

Fees for determining characterising flavour, toxicity, addictiveness or CMR properties: Great Britain

53A

• (1) Regulations may make provision for the charging of fees in connection with the exercise of functions relating to the determination of characterising flavour, toxicity, addictiveness or CMR properties of tobacco products for the purposes of these Regulations as they apply in Great Britain and in relation to GB tobacco products.

• (2) Regulations made under paragraph (1) may make such provision in relation to fees as may be made by the appropriate authority under paragraph 1(3)(a) or (b) of Schedule 4 to the European Union (Withdrawal) Act 2018 in relation to those functions.

Regulations: Great Britain

54ZA

• (1) Any power to make regulations under these Regulations—

• (a) is exercisable by the Secretary of State (and in the case of regulations made under regulation 53A, with the consent of the Treasury) by statutory instrument; and

• (b) includes power to make—

• (i) different provision for different cases or descriptions of case, different circumstances, different purposes or different areas;

• (ii) consequential, supplementary, incidental, transitional or transitory provision or savings.

• (2) A statutory instrument containing regulations made under—

• (a) regulation 53A may not be made unless a draft of the instrument has been laid before, and approved by a resolution of, each House of Parliament;

• (b) any other provision of these Regulations is subject to annulment in pursuance of a resolution of either House of Parliament.

Regulations: duty to consult

54ZB

Where the Secretary of State proposes to make regulations under these Regulations which will apply in Wales or Scotland, the Secretary of State must consult—

• (a) the Welsh Ministers, in respect of any proposed application in Wales; and

• (b) the Scottish Ministers, in respect of any proposed application in Scotland;

before making such regulations.

Revocation

Saving for tobacco product identification marking

Transitional provisions

Saving for product placement of electronic cigarettes in television programmes the production of which began before 20th May 2016

Review

SCHEDULE A1 — Picture Library (of combined health warnings)

No flavoured NI heated tobacco products

15A

• (1) No person may produce or supply NI heated tobacco products with a characterising flavour.

• (2) No person may produce or supply NI heated tobacco products with—

• (a) a filter, paper, package, capsule or other component containing flavourings;

• (b) a filter, paper or capsule containing tobacco or nicotine; or

• (c) a technical feature allowing the consumer to modify the smell, taste, or smoke intensity of the product.

• (3) In this regulation, “NI heated tobacco product” means a novel tobacco product which—

• (a) is heated to produce an emission containing nicotine and other chemicals, which is then inhaled by the user; and

• (b) is produced for supply, or is supplied, for consumption in Northern Ireland or through the NI travel retail sector.

No vitamins, colourings or prohibited additives in tobacco products

Regulations: procedures for determining characterising flavour : GB tobacco products

Tobacco for oral use