S.L. 315.10 Art. 5Reporting of ingredients and emissions.

(1) Manufacturers and importers are to submit to the Superintendent the following information by brand name and type:

(a) a list of all ingredients, and quantities thereof, used in the manufacture of the tobacco products, in descending order of the weight of each ingredient included in the tobacco products;

(b) the emission levels referred to in regulation 3;

(c) where available, information on other emissions and their levels.

For products already placed on the market that information shall be provided by 20 November 2016.

Manufacturers and importers shall also inform the Superintendent if the composition of a product is modified in a way that affects the information provided under these regulations. For a new or modified tobacco product, the information required under these regulations shall be submitted prior to the placing on the market of those products.

(2) The list of ingredients referred to in sub-regulation (1)(a) shall be accompanied by a statement setting out the reasons for the inclusion of such ingredients in the tobacco products concerned. That list shall also indicate the status of the ingredients, including whether they have been registered under Regulation (EC) No 1907/ 2006 of the European Parliament and of the Council as well as their classification under Regulation (EC) No 1272/2008 of the European Parliament and of the Council.

(3) The list referred to in sub-regulation (1)(a) shall also be accompanied by the relevant toxicological data regarding the ingredients in burnt or unburnt form, as appropriate, referring in particular to their effects on the health of consumers and taking into account, inter alia, any addictive effects. Furthermore, for cigarettes and roll-your-own tobacco, a technical document setting out a general description of the additives used and their properties shall be submitted by the manufacturer or importer. Other than for tar, nicotine and carbon monoxide and for emissions referred to in regulation 4(4), manufacturers and importers shall indicate the methods of measurement of emissions used. Manufacturers and importers of tobacco products into Malta may also be required to provide detailed studies assessing the effects of ingredients on health taking into account, inter alia, their addictiveness and toxicity.

(4) The Superintendent shall ensure that the information submitted in accordance with sub-regulation (1) and regulation 6 is made publicly available on a website. The Superintendent shall take the need to protect trade secrets duly into account when making that information publicly available and shall require manufacturers and importers to specify, when submitting the information pursuant to sub-regulation (1) and regulation 6, the information which they consider to constitute trade secrets.

(5) The format for the submission and the making available of information referred to in sub-regulations (1) and (6) and regulation 6 shall be in compliance with Commission Implementing Decision (EU) 2015/2186 of 25 November 2015 establishing a format for the submission and making available of information on tobacco products.

(6) Manufacturers and importers shall submit to the Superintendent internal and external studies available to them on market research and preferences of various consumer groups, including young people and current smokers, relating to ingredients and emissions, as well as executive summaries of any market surveys they carry out when launching new products. Manufacturers and importers shall also report to the Superintendent their sales volumes in Malta per brand and type, reported in sticks or kilograms, on a yearly basis starting from 1 January 2015.

(7) All data and information provided to and by the Superintendent under this regulation and under regulation 6 shall be provided in electronic form. The Superintendent shall store all the information electronically and shall ensure that the Commission and other Member States have access to that information for the purpose of applying these regulations. The Superintendent shall ensure that trade secrets and other confidential information are treated in a confidential manner.

(8) The Superintendent may charge manufacturers and importers of tobacco products proportionate fees as the Minister may by regulations prescribe, for receiving, storing, handling, analysing and publishing the information submitted to them pursuant to this regulation.