Recommendation French DGCCRF Electronic cigarettes: regulation and advice
The electronic cigarette has been imposed for several years. You have to know that there are disposable and rechargeable models. But how to be sure to buy a product that complies with the regulations?
ABOUT THE BATTERIES
The batteries As regards safety, in the absence of specific regulations, the general safety requirement applies to batteries (Article L. 421-1 et seq. Of the French Consumer Code). Good to know In 2016 and 2017, the DGCCRF was the recipient of several reports of the explosion of batteries of electronic cigarettes. According to the information provided by the consumers at the origin of these reports, the batteries exploded while they were in the pocket of the clothing they were wearing, causing burns. Although battery explosions are rare in relation to the number of products in circulation, they can have serious consequences. It is therefore important to follow the usage and safety recommendations commonly communicated by electronic cigarette retailers and their customers. As a general rule, it is thus recommended:
• do not carry these batteries without a protective case, especially when in a bag or pocket of clothing;
• store them in a case or an insulating case and not loose in a box or drawer;
• to prevent any contact with metal parts (keys, coins, etc.) or with liquids;
• avoid shocks or exposure to heat sources;
• keep the batteries clean and dry, and do not use them if they appear damaged (deformation, torn sheath, leaking liquid, etc.);
• to use a suitable charger and to respect the instructions supplied with the charger, in particular to respect the polarity and the precautions of use;
• do not attempt to disassemble or open the battery envelope;
• Do not leave batteries charged too long or unattended.
The batteries must, moreover, comply with the environmental regulations applicable to them (Directive No. 2006/66 / EU of the European Parliament and of the Council of 6 September 2006, as amended, relating to batteries and accumulators as well as waste batteries and batteries. accumulators and repealing Directive 91/157 / EEC, Articles R. 543-124 to R. 543-134 and Article L. 541-44 of the Environmental Code). The above items are for information only. They are not necessarily exhaustive and can not replace official texts.
The electronic cigarette is the generic name for aerosol generators whose shape is reminiscent of the cigarette and used to deliver flavored artificial smoke containing or not nicotine. The filter location contains a wick or reservoir for the tobacco substitute aromatic liquid. The main ingredients found in the majority of products are nicotine (optional), propylene glycol, glycerine and aroma. The products marketed are either single-use cigarettes, or cigarettes using pre-filled cartridges or refillable cartridges with refill liquid. Refill liquids are subject to the regulations applicable to chemicals. The electronic cigarette is usually equipped with batteries that are powered by a USB type charger with a transformer (voltage adapter) to connect to the mains. The charger (transformer) is subject to regulations on electrical safety and electromagnetic compatibility. The electronic cigarette as a medicine According to a press release dated 30 May 2011 from the National Agency for Drug Safety (ANSM), the electronic cigarette falls under the provisions of the Public Health Code relating to the drug if:
• she claims help with smoking cessation (article L.5121-2 of the Public Health Code);
• the quantity of nicotine contained in the cartridge (disposable cigarette or pre-filled cartridge) is greater than or equal to 10 mg;
• the refill liquid has a nicotine concentration greater than or equal to 20 mg / ml.
In all three cases, the product must have a Marketing Authorization (MA). Currently, no product placed on the market has been the subject of a marketing authorization of this type. Electronic cigarettes that are not drugs: refill liquids are subject to the CLP Regulation When the product is not considered a medicine, the provisions of the Consumer Code apply regarding the general safety requirement. Refill liquids, when they are not considered as medicinal products, are also subject to the provisions of Regulation (EC) No 1272/2008 on the classification, labeling and packaging of dangerous mixtures known as “CLP”. .
The toxicity of nicotine has recently been re-evaluated at the European level (Commission Regulation (EC) No 2017/776 of 05 May 2017, known as the 10th ATP). This ranking came into effect on December 1, 2018, liquid refills of electronic cigarettes containing only nicotine as a dangerous substance must be labeled using the harmonized classification of the 10th ATP:
Between 0.25% and 1.66% m / m of nicotine
Warning Harmful if swallowed Recommended precautionary statements:
• when consulting a doctor, keep the container or label at disposal;
• keep out of reach of children;
• wash hands thoroughly after handling;
• do not eat, drink or smoke while handling the product;
• IF SWALLOWED: Call a POISON CENTER or doctor; • Rinse mouth.
Above 1.67% m / m of nicotine
Danger Toxic if swallowed Recommended precautionary statements:
• when consulting a doctor, keep the container or label at disposal;
• keep out of reach of children;
• wash hands thoroughly after handling;
• do not eat, drink or smoke while handling the product;
• IF SWALLOWED: Call a POISON CENTER or doctor;
• rinse the mouth;
• keep locked up.
Any additional classifications provided, particularly by flavorings, must also be taken into account for each reference by professionals. Good to know Liquid refills must not include a graphic representation of the fruit or the edible plant symbolizing the product’s fragrance. Products should not be likely to attract or encourage children’s active curiosity or mislead consumers about the nature of the product. In addition, web pages presenting liquid refills of electronic cigarettes containing nicotine marketed on the internet, must contain information on the classification of the product as “Harmful in contact with skin”, “Harmful if swallowed” “,” Toxic if ingested “or” Toxic by skin contact “depending on the nicotine concentration of the product or allow the consumer to have a clear view of the label.
Applicable provisions of the Public Health Code to electronic cigarettes that are not drugs In the context of toxicovigilance, the Public Health Code contains several provisions concerning dangerous substances and mixtures:
• Toxically classified refill liquids must be declared toxicovigilantly to the poison control and toxicovigilance centers;
• all advertising for liquid refills containing nicotine must be marked “Dangerous. Observe the precautions for use “. Other obligations arising from the transposition of Directive No 2014/40 / EU on tobacco products concerning, in particular, the limitation of container volumes, the mandatory presence of a safety device, additional labeling, rules governing advertising of these products, prohibition of sale to minors and prior declaration to ANSES, are provided for in Chapter III of Title I of Book V of Part III of the Public Health Code (Articles L.3513 -1 and following and R.3513-1 and following of the Code of Public Health).
Electric chargers Chargers are subject to the provisions of Decree No. 2015-1084 of 27 August 2015 on the electromagnetic compatibility of electrical and electronic equipment (“CEM” decree). In addition, shippers who connect to the sector are subject, in terms of safety, to decree n ° 2015-1083 of 27 August 2015 relating to the making available on the market of electrical equipment intended to be used within certain voltage limits. (“low voltage” decree). To assess the safety of the chargers they place on the market, professionals can rely on safety standards applicable to transformers, power supplies, inductors and similar products. Under the two regulations referred to above, electrical chargers must in particular bear the CE marking and the details of the manufacturer and / or the importer. At the stage of placing on the market (manufacture or import), the products must be accompanied by a declaration of conformity and the professionals must have a technical documentation. As chargers, electric chargers must also comply with the environmental regulations applicable to them (Directive No. 2011/65 / EU of the European Parliament and of the Council of 8 June 2011 as amended on the limitation of the use of certain hazardous substances in electrical and electronic equipment, Articles R.543-171-1 et seq. of the Environment Code and Directive No. 2012/19 / EU of the European Parliament and of the Council of 4 July 2012 on equipment waste electrical and electronic, Article L. 541-10-2 and Articles R. 543-172 to R. 543-206-4 of the Environmental Code).
The body of the cigarette (vaporizer) As regards safety, in the absence of specific regulations, the general safety requirement applies to vaporizers (Article L. 421-1 and following of the Consumer Code). Some vaporizers are likely to disturb or be disturbed by their electromagnetic environment, which explains that the rules on electromagnetic compatibility are also applicable to them (decree “CEM” above). The body of the electronic cigarette must also, where appropriate, comply with the environmental regulations applicable to it (Directive No 2011/65 / EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of of certain hazardous substances in electrical and electronic equipment, Articles R.543-171-1 and following of the Environmental Code and Directive No. 2012/19 / EU of the European Parliament and of the Council of 4 July 2012 on electrical and electronic equipment, article L. 541-10-2 and articles R. 543-172 to R. 543-206-4 of the Environmental Code).
