What are CLP Regulations of E-cigarette and Tactile Warning Labels?

E-cigarettes and CLP Labelling:

E-cigarettes and e-liquids are regulated by several different pieces of legislation that cover their packaging, use and disposal but their classification is dependent upon the level of nicotine that they contain. Under the CLP regulations E-liquid mixtures containing over 1.67% nicotine are classified as ‘Toxic’; between 0.25% and 1.66% they are Harmful; and under 0.25% they are not classified at all.

The European Union (EU) set up a regulatory framework for e-cigarettes as part of its broader revision of the Tobacco Products Directive (TPD), which regulates tobacco products within the EU.  This came into force May 2016.  Under the TPD, E-Cigarettes are allowed to be placed on the market providing the nocotine dose is less than 20mg/ml. If the dose exceeds this then they must be sold under medical licence and must be sold as an over the counter medecine such as nicotie gums and patches.

· Compulsory consumer information on use/storage; addictiveness/toxicity; ingredients; nicotine content and delivery per dose; and health warnings, including warnings on nicotine content, covering 30% of the front andback of packs

· Rules requiring e-cigarettes to deliver nicotine doses at consistent levels

· Safety measures such as child-proof fastenings and an obligation that ingredients, other than nicotine, do not pose a risk to human health

Under the TPD, e-cigarette/liquids also ·have a 10ml size limit for e-cigarette refill containers and 2ml for cartridges and tanks.

CLP labels for nicotine preparations must include:

· The product identifiers – this can include trade names or other designations of the product as well as the EC number for nicotine (EC 200-193-3)

· The correct hazard and precautionary statements

· A ‘toxic’ hazard pictogram

· A signal word (either ‘warning’ or ‘danger’)

· The name, full address and telephone number (landline, not mobile) of the supplier

· The nominal quantity of the substance or mixture in the package made available to the general public (unless this is specified elsewhere on the package)

· Identification of the hazardous constituents of the preparation. The nicotine content level, as a percentage of weight by volume must be clearly displayed

· Batch numbers, expiry dates and the nominal volume of the contents must also be also be shown on the label (5ml/10ml etc)

The design of the label must ensure that the hazard pictogram and hazard and precautionary statements stand out clearly and are easy to read. Warnings must read horizontally when the package is set down normally.

E-cigarettes and Tactile Warning Labels:

As nicotine is classified as a toxic substance, E-cigarette products must have child resistant packaging and they must bear the tactile warning labels to alert the blind and partially sighted that they are handling a hazardous product.

Tactile warning labels must be applied to all products which are classified as toxic, very toxic, corrosive, harmful, extremely flammable and highly flammable, as well as to some aerosols classified as harmful, toxic or corrosive.

The tactile warning labels must be produced in accordance with EN ISO 11683 which sets out detailed specifications of the label, which may appear as either:

· A raised equilateral triangle in a frame 16 – 20mm long and 1.5 – 1.9mm thick. (the corners of the triangle must be as sharp as possible and the triangle must be raised 0.25 – 0.5mm above the surface of the label)

· A smaller raised equilateral triangle in a frame 8 -10mm long and 0.8 – 1.2mm thick

· A very small solid triangle with sides 3 – 4mm long

· 3 dots each of truncated cone shape, equally spaced. The diameter of the dot must be between 1.8 – 2.2mm and have a height of between 0.25 – 0.5mm. The dots must be between 3 – 9mm apart (centre to centre)

The tactile warning must not be placed on surfaces which are removed during normal use, they are not required on outer packaging such as cardboard boxes protecting glass bottles.

They must not be placed near any other embossed or raised patterns that could cause confusion.

Where the packaging has a base, the tactile warning must be located on an upright handling surface near the edge and the apex of the triangle must be positioned within 50mm of the bottom of the pack (or as near as possible to the lid if there is no bottom).

If the packaging has no base (such as tubes or cartridges) then the tactile warning must be placed on the shoulder around the tube nozzle. On aerosols, the tactile warning must be positioned where the finger is placed to operate the spray.

If the warning is placed on plastic packaging with a full opening, it must be on the handling surface as near as possible to the opening.

The tactile warning must remain tactile throughout the product’s expected life.

Any E-cigarette products that are not labelled correctly, or don’t include the tactile warning label, are liable to be seized for non compliance with CLP Regulations.