S.L. 315.10 Art. 6Priority list of additives and enhancedreporting obligations.

(1) In addition to the reporting obligations laid down in regulation 5, enhanced reporting obligations shall apply to certain additives contained in cigarettes and roll-your-own tobacco that are included in a priority list. The priority list of additives shall be laid down and subsequently updated in accordance with Commission Implementing Acts. This list shall contain additives:

(a) for which initial indications, research, or regulation in other jurisdictions exist suggesting that they have one of the properties set out in sub-regulation (2)(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 5(1) and (3).

(2) Manufacturers and importers of cigarettes and roll-your-own-tobacco containing an additive that is included in the priority list provided for in sub-regulation (1) shall carry out comprehensive studies, which shall examine for each additive whether it:

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

(b) results in a characterising flavour;

(c) facilitates inhalation or nicotine uptake; or

(d) leads to the formation of substances that have carcinogenic, mutagenic and toxic for reproduction (hereinafter "CMR") properties, the quantities thereof, and whether this has the effect of increasing the CMR properties in any of the products concerned to a significant or measurable degree.

(3) Those studies shall take into account the intended use of the products concerned and examine in particular the emissions resulting from the combustion process involving the additive concerned. The studies shall also examine the interaction of that additive with other ingredients contained in the products concerned. Manufacturers or importers using the same additive in their tobacco products may carry out a joint study when using that additive in a comparable product composition.

(4) Manufacturers and importers shall establish a report on the results of these studies. That report shall include an executive summary, and a comprehensive overview compiling the available scientific literature on that additive and summarising internal data on the effects of the additive.

Manufacturers and importers shall submit these reports to the Commission and to the Superintendent if the tobacco product containing this additive is placed on the Maltese market at the latest eighteen (18) months after the additive concerned has been included in the priority list pursuant to sub-regulation (1). The Commission and the Superintendent may also request supplementary information from manufacturers or importers regarding the additive concerned. This supplementary information shall form part of the report. The Commission and the Superintendent may require these reports to be peer reviewed by an independent scientific body, in particular as regards their comprehensiveness, methodology and conclusions. The information received shall assist the Commission and the Superintendent in taking the decisions pursuant to regulation 7. The Superintendent may charge manufacturers and importers of tobacco products proportionate fees as the Minister may by regulations prescribe, for such peer reviews.

(5) Small and medium-sized enterprises as defined in Commission Recommendation 2003/361/EC shall be exempted from the obligations pursuant to this regulation, if a report on that additive is prepared by another manufacturer or importer.