The Tobacco and Related Products Regulations 2016

[F1 Priority list of additives - enhanced reporting U.K.

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 [F2 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 [F3 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 [F4 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 [F5 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 [F6 appropriate authority] by another producer.

[F7 (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.]]

Textual Amendments

F1 Regs. 20A, 20B inserted (1.1.2017) by The Tobacco and Related Products (Amendment) Regulations 2016 (S.I. 2016/1127), reg. 2(2)(3)

F2 Words in reg. 20A(1)(b) substituted (31.12.2020) by S.I. 2019/41, reg. 6(16)(a) (as substituted by The Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1316), regs. 1(3), 3(19) (with reg. 5))

F3 Words in reg. 20A(2)(c) substituted (31.12.2020) by S.I. 2019/41, reg. 6(16)(b) (as substituted by The Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1316), regs. 1(3), 3(19) (with reg. 5))

F4 Words in reg. 20A(4) substituted (31.12.2020) by S.I. 2019/41, reg. 6(16)(c) (as substituted by The Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1316), regs. 1(3), 3(19) (with reg. 5))

F5 Words in reg. 20A(5)(a) inserted (31.12.2020) by S.I. 2019/41, reg. 6(16)(d)(i) (as substituted by The Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1316), regs. 1(3), 3(19) (with reg. 5))

F6 Words in reg. 20A(5)(b) substituted (31.12.2020) by S.I. 2019/41, reg. 6(16)(d)(ii) (as substituted by The Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1316), regs. 1(3), 3(19) (with reg. 5))

F7 Reg. 20A(6)-(8) inserted (31.12.2020) by S.I. 2019/41, reg. 6(16)(e) (as substituted by The Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1316), regs. 1(3), 3(19) (with reg. 5))