Priority list of additives - enhanced reporting2
1
The principal regulations are amended as follows.
2
In regulation 2 (interpretation) at the appropriate place insert—
“CAS Registry number” means the number assigned to a substance by the Chemical Abstracts Service4;
3
After regulation 20 (sales data and market research information) insert—
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.
4
In regulation 25(4) (submission of information) after “regulation 18 (specified information)” insert “ or 20A (priority list of additives)”.
5
In regulation 26(b) (use of information)—
a
for “(specified information) and” substitute “(specified information),”;
b
after “regulations 18 (specified information)” insert “, 20A (priority list of additives)”.
6
In regulation 26(c) after “regulation 18” insert “ and 20A”.