EU Regulations May 2016

 

TPD Compliance

 

T.P.D. Regulations article 20 “electronic cigarettes and e-liquids”

 

Comes in to law 20th May 2016

Products which contain less than 20 mg/ml of nicotine and that have not opted Electronic cigarettes under the EU TPD  The EU TPD also includes a number of regulations regarding into medicinal regulations i.e. do not wish to make claims relating to smoking cessation, come under the TPD. These products will be regulated as consumer products. Regulatory officers will be responsible for ensuring:

1.            Products are child and tamper proof.

2.            Health warnings, instructions for use, information on addictiveness and toxicity appear on the packaging and any accompanying information leaflet.

3.            There are no promotional elements on packaging.

4.            All substances contained in the product and information on the product's nicotine content are listed.

5.            Existing rules regarding cross-border advertising and promotion of tobacco products, which will apply to electronic cigarettes, are adhered to.

6.            Manufacturers inform Member States before placing new products on the market and that they report annually to Member States.

7.            That a size limit for e-liquids of 10ml for dedicated refill containers and 2ml for electronic cigarette cartridges and tanks is adhered to. Products containing more than 20 mg/ml of nicotine or which make smoking cessation claims will be prohibited unless they are licensed as medicines.

These products will require authorisation by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK and this will be enforced by the MHRA.

EUROPEAN UNION, EU - Permitted.

Import, sale, use and advertising is permitted.

At March 2014: it appears that the new TPD (see below) will implement a range of restrictions, that, depending on how they are interpreted, could mean a ban on all current hardware, all refills over 20mg strength, all advertising, and international (but not within-country) web sales. Such restrictions will be in place by 2016 although earlier is a possibility (and a probability in some countries).

Currently, at Q1 2014, individual countries have their own regulations. One vendor tells us: "In practice only three EU countries are problem-free for import for us: UK, Germany, Italy" (note this refers to commercial imports for vendors). We think this may be a slight exaggeration as for example Holland and Czech Republic are (in theory) unrestricted. Many vendors say postal supplies to customers are hardly ever problematic.

The EU, in Q2 2013,  attempted to implement a two-tier system with additional restrictions based on a tobacco product classification (perhaps describable as a three-tier system, as they tried to impose medical licensing on some products and tobacco classification on some/all others). This failed as medicalisation was rejected by vote in the EU Parliament.

EU law is superior to national law within the 28 countries. An EU directive must be transposed into individual national law before it can be implemented in any given country. This can take two years though it may be pushed through more quickly. Below, we have left the time-related commentary at each stage, as a reference. Please scroll down to the final update, to see the current situation.

1.            nicotine-containing liquid is only placed on the market in dedicated refill containers not exceeding a volume of 10 ml,              

2.            The nicotine-containing liquid does not contain nicotine in excess of 20 mg/ml  

3.            The nicotine-containing liquid does not contain additives listed

1.            Vitamins or other additives that create the impression that a tobacco product has a health benefit or presents reduced health risks,

2.            Caffeine or taurine or other additives and stimulant compounds that are associated with energy and vitality,

3.            Additives having colouring properties for emissions,

4.            For tobacco products for smoking, additives that facilitate inhalation or nicotine uptake, and

5.            Additives that have CMR properties in unburnt form.

4.            Only ingredients of high purity are used in the manufacture of the nicotine-containing liquid. Substances other than the ingredients referred to in paragraph 2(b) of this Article are only present in the nicotine-containing liquid in trace levels, if such traces are technically unavoidable during manufacture.

5.            Except for nicotine, only ingredients are used in the nicotine-containing liquid that do not pose a risk to human health in heated or unheated form;

6.            Electronic cigarettes deliver the nicotine doses at consistent levels under normal conditions of use;

7.            Electronic cigarettes and refill containers are child- and tamper-proof, are protected against breakage and leakage and have a mechanism that ensures refilling without leakage.

8.            Carry one of the following health warnings:

“This product contains nicotine which is a highly addictive substance. It is not recommended for use by non-smokers”

Or “This product contains nicotine which is a highly addictive substance”

9.            Must carry the correct labelling - EC Label

EC 200-193-3 – This is the European Commission chemical code for nicotine.

And display the warning sign according to the E.U.regulations.

General Information

An E-Liquid is a combination (a mixture) of a number of components, all our e-liquids will contain Flavourings, Propylene Glycol, Aqueous Vegetable Glycerine, (in varying degrees depending on flavours and ratios), and a percentage of Nicotine (if selected), up to a maximum of 2.0% (20mg strength).

1.            All the Hangsen E –Liquids are made from the highest, purest components available.

2.            We do not and will not knowingly sell, or supply, e-liquid to anyone under the age of 18.

3.            Our E-liquid is only intended to be used with electronic cigarette products / vaporizers by persons over the age of 18.

Storage Advice

1.            The storage life of unopened bottles is in excess of 18 months.

2.            Store e-liquid upright, in a cool dark but well-ventilated area, in a locked cupboard or drawer, out of reach from any children or pets and away from food and drink.

3.            Keep away from naked flames or sources of heat.

4.            Store away from incompatible substances.

5.            We always supply a child resistant cap with every bottle of E-Liquid and strongly recommend that this is used when the bottle is being stored

Warnings & Safety Advice

1.            Nicotine is a Toxin.

2.            Nicotine, in its pure form and taken in high enough doses can kill.

3.            It is classed as TOXIC, hence the need for a toxic warning label.

4.            It is addictive

E-liquid will contain nicotine (if you have selected anything above 0mg).

Although it is only a small constituent part of your chosen e-liquid, we are required to give the following warnings:-

1.            May cause respiratory tract irritation.

2.            May be fatal if swallowed. Harmful if inhaled.

3.            May be fatal if absorbed through the skin.

4.            May cause central nervous system effects.

5.            May cause adverse reproductive effects based upon animal studies.

6.            May cause eye and skin irritation.

7.            Target Organs: Central nervous system, lungs, skeletal muscle.

We also offer the following advice on handling.

1.            Wash hands thoroughly after handling.

2.            Remove any contaminated clothing and wash before reuse.

3.            Use with adequate ventilation.

4.            Avoid contact with eyes, skin, and clothing.

5.            Keep container tightly closed.

6.            Avoid ingestion

7.            All our bottles of e-liquid are supplied with child resistant caps and carry CHIP compliant labelling, tactile hazard warnings, appropriate safety warnings and information on ingredients, etc.

We are constantly updating to ensure compliance.

Please read all labels and warnings on our e-liquid bottles.

Health Advice

We advise that before use, you talk to your doctor, especially if you are pregnant and/or breast feeding or if you have (or think you have) any of the following:-

1.            Any allergy to PG/VG/peg 400 or nicotine;

2.            A weak immune system;

3.            A heart disease, an irregular heartbeat, high blood pressure or chest pain;

4.            A jaw condition called TMJ (tempura mandibular joint) disease;

5.            An over-active thyroid;

6.            Diabetes;

7.            Pheochromocytoma (tumour of the adrenal gland);

8.            Liver or kidney disease;

9.            A stomach ulcer;

10.          Asthma or chronic pulmonary disease.

The above is not a full list, if you have an illness please talk to your doctor before using any e-liquid.

Also remember there are many drugs that can be affected by nicotine, including prescription and over-the-counter medications, they include vitamins, minerals, herbal products, etc. - please ask your doctor if you are unsure.

Should you require further information before purchase, please enquire through our contact form on the contact page, or via email

Disclaimers

Be advised that some flavours may not be suitable for use in polycarbonate tanks as they may cause cracks in the plastic.

We will not be held responsible for damaged equipment, you use the e-liquids in your vape equipment at your own risk

The use of E-Liquids and "Vaping" is a relatively new concept, time trials and medical studies are few and far between, quantified results and information about any potential risks therefore are hard to find.

There is much speculation about the safety concerns of using E-Liquid and the components that are used to make it.

We advise that you carry out your own research on the subject, and make up your own mind.

If you decide to use our E-Liquid, you agree that you do so at your own risk.

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