Electronic Cigarette Industry Trade Association

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ECITA ISE: QS Chapter 4 Classification, Labelling and Packaging Regulations

07 : QS Chapter 4 The Classification, Labelling and Packaging (CLP) Regulations (2010)

Thursday, November 6, 2014

Introduction

The CLP regulations provide a safety net for the sale of potentially hazardous consumer products. By ensuring that such products are supplied in child-resistant packaging, and bear the appropriate hazard and precautionary statements, public safety may be assured.

Classification under CLP is the responsibility of the supplier. Data for nicotine (as a pure substance) is part of the harmonised classification data contained within the CLP regulation(1), and this data formed the basis for the classification of nicotine containing mixtures(2). Since the other main constituents (propylene glycol and glycerol) are not acutely toxic, the classification of e-liquid is dependent on the level of nicotine they contain.

What the law requires

Arguably, the recommendations contained in BSI PAS 54115 and in this ISE are legal requirements under the General Products Safety Regulations (2005), which stipulate:

Part 2, Section 6:

(3) In circumstances other than those referred to in paragraphs (1) and (2), the conformity of a product to the general safety requirement shall be assessed taking into account—
    
(a) any voluntary national standard of the United Kingdom giving effect to a European standard, other than one referred to in paragraph (2),
(b) other national standards drawn up in the United Kingdom,
(c) recommendations of the European Commission setting guidelines on product safety assessment,
(d) product safety codes of good practice in the sector concerned,
(e) the state of the art and technology, and
(f) reasonable consumer expectations concerning safety.

Therefore, as in BSI PAS 54115, the labelling recommendations below should be recognised as requirements under the General Product Safety Regulations (2005).

Nicotine solutions of less than 2.5% are not classified under CLP. (Please note: This is currently  under review, and may change in the future. If such a change is introduced, this advice may no longer be applicable.) E-liquids may be sold separately from hardware, i.e. in bottles, or may be supplied prefilled into various devices. Some of the devices may be sold with the intention that they will not be refilled, while others will be intended for refilling using e-liquid in bottles. This introduces a slightly different set of labelling requirements, depending on the product in question, as set out below:

Irrespective of how the e-liquid is sold, if it has a nicotine concentration of between 0 and 2.49%, it should carry the following information:

o    the heading: “CAUTION:”
o    the text: “Keep out of the reach of children and pets”
o    the text: “Only for use in/with [delete as appropriate] electronic cigarettes*”
o    the text: “Seek medical advice if you feel unwell”
o    the text: “May contain traces of [allergen]” (see section 4 below)
o    Nicotine concentration in weight per volume (w/v) percentage and/or milligrams per millilitre (mg/ml) must be displayed on the label
o    the batch number must be displayed
o    the ‘Best Before End’ date must be displayed
o    contact details must be displayed

For e-liquids supplied in bottles for refilling various devices, the labelling should include the following additional elements:

o    the text: “* Refer to device manufacturer’s instructions for refilling”
o    the nominal quantity of the solution contained in the bottle must be displayed

For prefilled products, where the e-liquid is supplied with the hardware as a composite product (and where it is not intended for refilling), the labelling should state (in addition to the requirements above):

o    the text: “* This device is not intended for refilling”
o    the number of prefilled cartridges/cartomisers in the pack (including if there is only one) must be displayed

For prefilled products, where the e-liquid is supplied with the hardware as a composite product, but which is intended for refilling using bottled e-liquids, the labelling should state (in addition to the requirements above):

o    Either the text: “* Refer to device manufacturer’s instructions for refilling” or “*Refer to refilling instructions enclosed” (if you are providing them with your hardware). (Please note that if you are placing a product on the market which is intended for refilling, you should be providing instructions on how this is done for your specific product, to ensure that even naïve consumers can find out how to refill their device safely.)

All of these label elements must be visible, legible and indelible.

Concentrations in this range should also be supplied in child-resistant enclosures.

Please note: It is important that zero nicotine e-liquids also bear this information.

Sample labels are provided to ECITA members.

What CLP requires for e-liquids containing 2.5% and over

The nicotine component, whether prefilled cartridges or bottles of e-liquid, where it is high enough to be classified under CLP (i.e. 2.5% and over), must be supplied in child-resistant packaging, with:

a) a replaceable closure unless the packaging complies with the requirements of BS EN 28317, or ISO 8317; or
b) a non-replaceable closure unless the packaging complies with the requirements of EN 862. (Given the wide variety and quality of ‘child-resistant’ closures available, ECITA members should submit samples for assessment and expert opinion); and
c) must be appropriately labelled as follows:

The exact warnings and markings depend on the level of nicotine, as indicated below. (Please note that you are not required to provide the statement codes, e.g. ‘H300’ on your labels. These are included here to assist you with finding the appropriate translations of these statements into other Member State languages for exports across Europe. Please see the tables for all the languages for hazard statements(3), and notes on the precautionary statements(4) in English.)


The text of the hazard and precautionary statements can be found in table 1.2 of the CLP Regulation (on page 165 onwards, in the current version), which should enable appropriate terms to be used to suit the Member State where the product is to be supplied.

Please note: P361 and P363 are combined in our advice table as per the guidance given at the beginning of Annex iv of the CLP Regulation.

A tactile warning label, compliant with EN ISO 11683, should be affixed and formed as follows:

  • a tactile label must be a raised equilateral triangle which must have its corners as sharp as possible;
  • it must be in the form of a frame and have sides 16 – 20mm long, 1.5 – 1.9mm thick, raised 0.25 – 0.5mm above the surrounding surface and not more than 1mm apart at the corners;

If the tactile label is smaller, it must be:

  • a smaller triangle: as above, but the frame may be filled, and the sides must be 8 – 10mm long and if not filled 0.8 – 1.2mm thick;
  • a very small triangle: as above, but the frame must be filled and the sides must be 3 – 4mm long.

Alternatively:

  • 3 dots, each with a truncated cone shape, equally spaced on a circle with each dot having a diameter of 1.8 – 2.2mm, having a height of 0.25 – 0.5mm and being 3 – 9mm apart (centre to centre).

Tactile labels should be located so that any other embossed patterns do not cause confusion and, where the packaging has a bottom:

  • on the upright handling surface near the edge;
  • that its apex is within 50mm of the bottom of the pack (or as near as possible to the lid if there is no bottom);

Except that (unless it is technically impossible) when the warning is:

  • on a surface which is removed during normal use;
  • on plastic packaging with full opening (injection process) – it must be on the handling surface as near as possible to the opening.

Where the packaging does not have a bottom:

  • (e.g. tubes and cartridges) on the shoulder around the tube nozzle, in the form of dots and triangles evenly spaced with each triangle pointing towards the outside of the tube;
  • (other packaging) on the handling surface at the manufacturers’ discretion.

These must remain tactile throughout the product’s expected life.

•    The person who first supplies a dangerous preparation must keep a record of the details of any child-resistant fastening or tactile warning for at least 3 years after it was supplied for the last time, and must make it available on request to an enforcement officer within 14 days, along with any certificate issued by a qualified test house in relation to that fastening or tactile warning. We can offer this service for non-member companies. Please contact us for details.
•    It must clearly state on the label, and on the outer packaging if appropriate (sample labels are provided to ECITA members), that the product contains nicotine;
•    The nominal quantity of the solution contained within the bottle/package (see ANNEXES X AND XI) must be displayed;
•    The EC number for nicotine (EC 200-193-3) should be displayed on the label, and on the outer packaging if appropriate;
•    The nicotine content level, as a percentage of weight by volume must be clearly displayed, and must not exceed 7.5%. (Alternatively, it may be displayed as mg/ml, although this can be misleading, so ECITA does not recommend this practice.);
•    The batch number or code;
•    The supplier’s name, physical address (not a PO Box or simply a web address/email) and contact telephone number (landline, not just mobile);
•    Country of origin, displayed as “Made in...”; and
•    The trade name or other designation of the product.

•   The above information must be clearly and indelibly marked on the label of the receptacle containing the nicotine solution. The label must be securely attached, with its entire surface making contact with the bottle/package;
•    if the receptacle is supplied in outer packaging, such as a box, then the outermost layer must be similarly clearly and indelibly marked, unless the packaging allows the receptacle label to be clearly and legibly seen;
•    the colours of the label must be such that the hazard symbol and the risk and safety phrase wording stand out clearly from the background;
•    the wording must be of sufficient size and spacing to allow it to be easily read, and must read horizontally when the package is set down normally;
•    the hazard pictogram must be of suitable size, and must not be less than 100mm2; this is of particular relevance where bulk containers are used;

•    if the package is too small or awkward in shape for a label of the right size to be attached completely, it may be affixed in some other appropriate manner;
•    a Safety Data Sheet in addition to a label on each single product must be provided when selling in bulk or wholesale to people other than members of the public, e.g. to distributors or resellers; and
•    ECITA requires that its members also take all necessary steps to ensure that their products are not sold to minors, including displaying relevant information on the label, and outer packaging if appropriate.

The Safety Data Sheet for an e-liquid will not be the same as for nicotine, propylene glycol or glycerol on their own, since e-liquid is a mixture. Template SDS sheets are provided to ECITA members, but we can offer assistance to non-members, too, for a modest fee. Please contact us for details.

Allergens

The rules for pre-packed foods establish a list of 14 food allergens(5), which have to be indicated by reference to the source allergen whenever they, or ingredients made from them, are used at any level in pre-packed foods, including alcoholic drinks. Given the inhaled nature of e-liquid these should also logically be applied to flavourings, as there is a risk of causing an allergic reaction in vapers.

The list consists of cereals containing gluten, crustaceans, molluscs, eggs, fish, peanuts, nuts, soybeans, milk, celery, mustard, sesame, lupin, and sulphur dioxide at levels above 10mg/kg, or 10 mg/litre, expressed as SO2.

Since a majority of tobacco flavours – other than those based on tobacco extracts – contain nut extracts, it is advisable to state that the products cannot be guaranteed nut free.

 

Footnotes

1 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:353:0001... Page 707

2 http://www.scribd.com/doc/251715920/Bibra-EU-Classification-of-Nicotine-Mixtures-Acute-Oral-and-Dermal-Toxicity

3http://ec.europa.eu/enterprise/sectors/chemicals/files/ghs/w_annex_iii_e...

4http://ec.europa.eu/enterprise/sectors/chemicals/files/ghs/w_annex_iv_pa...

5http://www.food.gov.uk/safereating/allergyintol/label/