• “CAS Registry number” means the number assigned to a substance by the Chemical Abstracts Service4;

Priority 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 and 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 European Commission or the Secretary of State 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 Secretary of State or the European Commission 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 enterprises5; and

b

the additive concerned is the subject of a report which has been submitted to the Secretary of State or the European Commission by another producer.

Research study into additives20B

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.