PART 4Reporting about tobacco products

F1Priority list of additives - enhanced reporting20A

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 F3and, 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 F4appropriate 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 F5appropriate 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 F6but, 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 F7appropriate authority by another producer.

F26

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.