New EU Tobacco Law Proposed

Health warnings and images on cigarette packs would have to take up 75% of packet space, though Member States can opt for plain unbranded packaging.

Slim cigarettes and packets of 19 cigarettes or less would be banned in the EU under radical new Commission proposals. 

Oral tobacco would remain outlawed, with the exception of Sweden, and novel tobacco products would have to follow stricter rules.

These are among the rules foreseen in the Tobacco Products Directive that the Commission proposed this week. The Commission says that these proposals are in line with scientific and international developments, and that they follow requests from both the European Parliament and Council.

Context

In the short term, the goal is to broaden the scope of the current Tobacco Products Directive (TPD) by addressing outstanding measures not already covered and prevent circumventing the TPD provisions.

In the long term, the Commission wants to tackle prevention (70% of smokers start before 18 years old and 94% before being 25) and the negative health effects associated with smoking (700 000 deaths in the EU per every year).

The proposal

This proposal builds on the current Directive 2001/37/EC on tobacco products and focuses on five areas: 
• Smokeless tobacco products and extension of the product scope (i.e. Nicotine containing products and herbal products for smoking) 
• Packaging and labelling
• Ingredients and additives
• Cross-border distance sales
• Traceability and security features
Annex I sets out a list of text warnings. The proposal is accompanied by impact assessment.

Packaging and labelling

Under the Commissions’ proposals, each unit packet of tobacco products and any outside packaging must carry health warnings in the official language of the Member State. These warnings need to take up the whole space reserved for them, and they cannot be commented on, paraphrased or referred to in any form.

The warnings need to be fully visible, but cannot hide or interrupt tax stamps, price marks, tracking and tracing marks, or security features.

The general warning text shall read “Smoking kills – quit now” and the message “Tobacco smoke contains over 70 substances known to cause cancer” on each unit package. The Commission may adopt delegated acts to adapt the wording of health warnings, and their position, format, layout and design.
Combined health warnings
Each unit packet of tobacco for smoking is to carry a combined health warnings. These warnings:
• Comprise a text from Annex I and corresponding colour photograph from the picture library
• Include support information to quit smoking (phone numbers, emails, websites etc.)
• Cover 75% of the external area of both the front and back surface
• Show the same text and photograph on both sides of the unit packet and outside packaging
• Need to be positioned on the top edge of unit packet and in the same direction as any other information on the packaging
• Follow the minimum dimensions of 64 mm in height and 55 mm in width
Labelling of tobacco for smoking other than cigarettes
These tobacco products are exempted from the obligations outlined above. This may be waived by Commission delegated acts. These products need to, however, carry the general warning “Smoking kills – quit now” and additional text warning listed in Annex I. Information on help to quit smoking needs to be included as well.

The general text must cover 30% of the external area of the corresponding surface of the unit packet and any outside packaging. This is to be 32% and 35% for Member States with two and three official languages respectively. The text warning shall cover 40% of the same area, and 45% and 50% for Member States with two and three official languages respectively.

Both warnings need to be printed in Helvetica bold type on a white background, Member States may adjust the font size; centred in the required area, parallel to the top edge; and surrounded by a black border (between 3-4 mm wide).
Labelling of smokeless tobacco products
Each unit packet and outside packaging need to carry this health warning: “This tobacco product can damage your health and is addictive”. It need to be printed in Helvetica bold type on a white background, Member States may adjust the font size; centred in the required area, parallel to the top edge; and surrounded by a black border (between 3-4 mm wide).

It also needs to be printed on the two largest surfaces and cover 30% of the external area of the corresponding surface of the unit packet and any outside packaging. This is to be 32% and 35% for Member States with two and three official languages respectively.
Product description
Unit packet can only be labelled in a way that does not promote tobacco product; diminishes the negative effects of a particular tobacco product or has vitalising, energetic and other positive effects; refers to flavour, taste, flavourings or other additives; and resembles a food product.

Cigarettes with a diameter less than 7.5 mm (slims) are considered misleading, thus prohibited.
Appearance and content of unit packets
The unit packet must be a cuboid shape, while roll your own (RYO) tobacco should be a pouch (rectangular pocket with a flap, which shall cover at least 70% of the front of the packet).

A unit packet of cigarettes shall include a minimum of 20 cigarettes. RYO packet shall weigh at least 40g. A cigarette packet will look and function in the same way as under the current Directive.

The Commission may adopt delegated acts to define these characteristics (shape, size) to ensure full visibility and integrity of the health warnings. It may also adopt delegated acts to make cuboid or cylindrical shape mandatory.
Traceability and security features
All unit packets need to be marked with a unique identifier, which are to be irremovably printed and/or affixed and provide details on manufacturing process.

All documentation throughout the manufacturing and trade chain need to be recorded to provide for tracking and tracing of unit packets. This data is to be electronically stored, and cannot by modified or deleted by economic operators, unless under exceptional circumstances and proper authorisation.

Products other than cigarettes and RYO are exempted for five years after its transposition into national legal systems.
Tobacco for oral use
Tobacco for oral use cannot be placed on the market, except in Sweden.

Ingredients and additives

Each cigarette placed on the market must not contain more than 10 mg for tar and 1 mg for nicotine, as under the current Directive. These levels may be adjusted by delegated acts adopted by the Commission based on Member State input. The Commission may also adopt delegated acts to adapt the methods of measurement based on Member States’ notification of methods.

Manufacturers and importers are obliged to provide Member States’ competent authorities with a list of ingredients and quantities used when manufacturing tobacco products by brand name and type, including emissions and yields. New products need be notified before they are placed on the market.

Tobacco products with a characterising flavour will be prohibited. Additives may be used as part of the manufacturing process. The Commission may adopt implementing acts to determine whether a product has a characterising flavour.

Vitamins (and other health-impersonating products), caffeine and taurine (and other vitality- and energy-associated compounds), and colouring additives are prohibited for use in tobacco products. Flavourings are banned also in the components of tobacco products (filters, papers, capsules, packages etc.).

Tobacco products other than cigarettes, RYO and smokeless tobacco products are exempted from these prohibitions. This exemption may be waived by Commission delegated act.

Tobacco products with toxic or addictive levels of additives are banned as well. The Commission may adopt implementing acts to determine such products. It may also adopt delegated acts to set maximum levels for those additives.
Cross-border distance sales of tobacco products
Cross-border retailers need to register with competent authorities, stating their (corporate) name, address, starting date of the activity and the website(s) used for the purpose of cross-border sale.

Complete list all retail outlets need to be published under Directive 95/46/EC, before they start business operations. Distance sales retail outlets need to put in place age verification system.

Novel tobacco products

Notification
New tobacco products need to be notified to national competent authorities electronically, six months before the intended placing on the market. Detailed description of the product; available scientific studies on toxicity, addictiveness and attractiveness; consumer studies and market research; and other available information need to be included.
Nicotine-containing products
Nicotine-containing products (NCP) can be placed on the market under Directive 2001/83/EC, and should not exceed a nicotine level of 2 mg per unit; a nicotine concentration of 4 mg per ml; or products whose intended use results in a mean maximum peak plasma concentration of more than 4 mg of nicotine per ml.

The Commission may adopt delegated acts to update these nicotine quantities.

Each unit packet and outside packaging of NCP below levels above need to carry health warning: “This product contains nicotine and can damage your health”.

The warning need to be printed in Helvetica bold type on a white background, Member States may adjust the font size; centred in the required area, parallel to the top edge; and surrounded by a black border (between 3-4 mm wide).

It also needs to be printed on the two largest surfaces and cover 30% of the external area of the corresponding surface of the unit packet and any outside packaging. This is to be 32% and 35% for Member States with two and three official languages respectively.

The Commission may adopt delegated acts to adapt these requirements.
Herbal products for smoking
Each unit packet and outside packaging of NCP below levels above need to carry health warning: “This product can damage your health”.

The warning needs to be printed on front and back external surface of the unit packet and outside packaging. It also is to be printed in Helvetica bold type on a white background, Member States may adjust the font size; centred in the required area, parallel to the top edge; and surrounded by a black border (between 3-4 mm wide).

It also needs to cover minimum 30% of the external area of the corresponding surface of the unit packet and any outside packaging. This is to be 32% and 35% for Member States with two and three official languages respectively.

They also cannot mislead consumers and state that they’re free of additives or flavourings.

Final provisions

Cooperation and enforcement
Member States need to ensure that all economic operators provide complete and correct information; all products that do not comply with this proposal are not placed on the market; and they outline penalties for infringements.
Report
The Commission will publish a report on the application of this Directive no later than five years after its transposition.

This report should contain features that need to be reviewed or developed, in particular the experience with design of package surfaces not governed by this Directive; market developments in novel tobacco products and substantial change of circumstances.

The Member States shall assist the Commission in preparation of this report. The report should also include any proposals for amendments to this Directive.

Import, sale and consumption of tobacco and related products

Member States shall not prohibit the import, sale or consumption of products that comply with this Directive. However, they may apply more stringent national provisions applicable to products under this Directive.
Transposition
This proposed Directive needs to be transposed into national legal systems in 18 months after its entry into force at the latest.
Transitional provisions
Tobacco products, NCP below the required threshold, and herbal products for smoking may be placed on the market without compliance with this Directive for 24 months after the entry into force.
Repeal
This proposal repeals current Directive 2001/37/EC. References to the current Directive shall be construed as references to this proposal according correlation table in Annex II.
Entry into force
This Directive enters into force on the 20th day following its publication in the Official Journal of the European Union. This Directive is addressed to the Member States.