On Thursday November 17, Belgium discovers this publication of the new Royal Decree on the manufacture and marketing of electronic cigarettes
THE DEFINITIONS OF THE STOP
For the purposes of this decree, the term :
1 ° electronic cigarette : a product, or any component thereof, including a cartridge, a reservoir and the device without the cartridge or reservoir, which can be used, by means of a mouthpiece, for the consumption of vapor containing nicotine . Electronic cigarettes can be disposable or refillable by means of a refill bottle and a reservoir or by means of single-use cartridges;
2 ° refill bottle : a container containing a liquid containing nicotine, which can be used to refill an electronic cigarette;
3 ° nicotine : nicotinic alkaloids;
4 ° emissions : substances released when an electronic cigarette or refill bottle is used for its intended purpose, such as substances contained in smoke;
5 ° additive : a substance that is added to an electronic cigarette or refill bottle, its unit packaging or any outside packaging;
6 ° ingredient an additive and any other substance or element present in an electronic cigarette or in related products;
7 ° toxicity : the extent to which a substance can produce harmful effects on the human organism, including effects appearing over time, generally as a result of repeated or continuous consumption or exposure;
8 ° outside package : any packaging in which electronic cigarettes or refill bottles are placed on the market, comprising a packaging unit or a set of packaging units; transparent overpacks are not considered as outer packaging;
9 ° conditioning unit : the smallest individual packaging of an electronic cigarette or a refill bottle placed on the market;
10 ° distance selling : any sale concluded within the framework of an organized distance selling system, without the simultaneous physical presence of the seller and the buyer, by the exclusive use of one or more remote communication techniques, until the moment, and including when the sale is concluded;
11 ° consumer : a natural person acting for purposes which do not fall within the scope of his commercial or professional activities;
12 ° manufacturer : any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his own name or trademark;
13 ° importer of electronic cigarettes and refill bottles : the owner or the person having the right of disposal of electronic cigarettes and refill bottles introduced into the territory of Belgium;
14 ° placing on the market : the fact of making products, whatever their place of manufacture, available to consumers in Belgium, whether in return for payment or not, including by distance selling;
15 ° Service : the General Directorate for Animals, Plants and Food of the Federal Public Service Public Health, Food Chain Safety and Environment;
16 ° CMR : carcinogenic, mutagenic and reprotoxic;
17 ° Minister : the Minister of Public Health.
REGULATION OF THE ELECTRONIC CIGARETTE
Art. 3. Notification
§ 1. The manufacturer of electronic cigarettes and refill bottles or the importer, if the former does not have a registered office in Belgium and has not notified the product, submits a notification to the Service concerning any product of this type that he intends to put on the market.
§ 2. This notification is submitted in electronic form six months before the planned date of placing on the market. As regards electronic cigarettes and refill bottles already placed on the market before the date of entry into force of this decree, the notification is submitted within six months from this date.
A new notification shall be submitted for each substantial change in the product, in particular in the event of a change in the qualitative or quantitative composition, change in the name of the product brand, the volume of the refill bottle, the reservoir or the cartridge and the composition of the electrical or electronic system that would affect emissions.
§ 3. The notification contains, depending on whether it concerns an electronic cigarette or a refill bottle, the following information :
1 ° the name and contact details of the manufacturer and the importer;
2 ° a list of all the ingredients contained in the product and the emissions resulting from the use of this product, by brand and by type, with their quantities;
3 ° toxicological data relating to the ingredients and emissions of the product, including when they are heated, with particular regard to their effects on the health of consumers when they are inhaled and taking into account, among other things, any effect dependency engendered;
4 ° information on the dosage and inhalation of nicotine under normal or reasonably foreseeable conditions of consumption;
5 ° a description of the components of the product, including, where applicable, the mechanism for opening and recharging the electronic cigarette or the refill bottle;
6 ° a description of the production process, indicating in particular whether it involves mass production, and a declaration that the production process guarantees compliance with the requirements of this article;
7 ° a declaration that the manufacturer and the importer assume full responsibility for the quality and safety of the product when it is placed on the market and under normal or reasonably foreseeable conditions of use.
§ 4. When the Service considers that the information presented is incomplete, it is entitled to request that they be completed.
§ 5. The Service disseminates the information provided in accordance with paragraph 3 on a website with a view to informing consumers. The Service takes due account of the need to protect trade secrets when making them public. The Service requires manufacturers and importers to identify information that they believe constitutes trade secrets when disclosing information.
§ 6. Anyone who submits a notification to the Service pursuant to paragraphs 1 to 4, is obliged to pay a fee of 165 euros to the Commodities and Commodities Budget Fund. Proof of payment of this fee must be sent to the Service. This fee is uncollectible.
§ 7. The manufacturer of electronic cigarettes and refill bottles or the importer, if the former does not have a registered office in Belgium and has not notified the product submits each year to the Service :
1 ° comprehensive data on sales volumes, by brand and by product type;
2 ° information on the preferences of different groups of consumers, including young people, non-smokers and the main types of current users;
3 ° the mode of sale of products;
4 ° summaries of any market research carried out with regard to the foregoing, including their translation into English.
§ 8. The manufacturer or the importer, if the former does not have a registered office in Belgium, of electronic cigarettes and refill bottles sets up and keeps up to date a system for collecting information on all effects. suspected adverse effects of these products on human health.
If any of these economic operators considers or has reason to believe that the electronic cigarettes or refill bottles which are in their possession and are intended to be placed on the market or are being placed on the market are not safe, do not are not of good quality or do not comply with this order, he immediately takes the necessary corrective measures to bring the product concerned into compliance with this order, withdraw it or recall it, if necessary. In these cases, the economic operator is also required to immediately inform the Service specifying, in particular, the risks to human health and safety and any corrective measures taken, as well as the results of these corrective measures.
The Service may also request additional information from economic operators, for example on aspects of safety and quality or any potential adverse effects of electronic cigarettes or refill containers.
§ 9. The model applicable to the transmission and provision of the information referred to and the method of transmission of the information required in this article may be specified by the Minister.
COMPOSITION OF E-LIQUIDS
§ 1st. Liquid containing nicotine is only marketed :
(1) in specific refill bottles with a maximum volume of 10 milliliters;
2 ° in disposable electronic cigarettes;
3 ° in disposable cartridges.
Cartridges or reservoirs do not exceed 2 milliliters.
§ 2. The liquid containing nicotine does not contain nicotine beyond 20 milligrams per milliliter.
§ 3. The liquid containing nicotine does not contain the following additives :
(1) vitamins or other additives creating the impression that the electronic cigarette has beneficial effects on health or that the risks it presents to health have been reduced;
2 ° caffeine or taurine or other additives and stimulants associated with energy and vitality;
3 ° additives which confer coloring properties on emissions;
4 ° additives which, without combustion, have CMR properties.
§ 4. Only high purity ingredients are used for the manufacture of the liquid containing nicotine. Substances other than the ingredients referred to in article 3, § 3, 2 °, are only present in the liquid containing nicotine in the form of traces, if these traces are technically unavoidable during manufacture.
§ 5. Only ingredients that, whether heated or not, present a risk to human health, are used in the liquid containing nicotine, with the exception of nicotine.
§ 6. Electronic cigarettes distribute doses of nicotine constantly under normal conditions of use.
§ 7. Electronic cigarettes and refill bottles are fitted with a child safety device and are tamper-proof; they are protected against breakage and leaks and are fitted with a device ensuring that there are no leaks when filling.
The Minister sets the technical standards for the filling mechanism.
§ 1. Each packaging unit of an electronic cigarette or a refill bottle as well as any outer packaging bears the health warnings provided for in this chapter in Dutch, French and German. Each language is printed on a new line.
§ 2. Health warnings occupy the entire surface of the packaging unit or the outer packaging reserved for them. They are not commented on, paraphrased and cannot be referenced in any way.
§ 3. Health warnings on a packaging unit or any outside packaging are printed immovably, indelibly and fully visible. They are not concealed or interrupted, in whole or in part, by tax stamps, price tags, security features, overpacks, envelopes, boxes or anything else.
§ 4. The health warnings remain intact when the packaging unit is opened.
§ 5. The health warnings are framed by a black border with a width of 1 mm inside the area reserved for these warnings.
§ 6. The packaging units for electronic cigarettes and refill bottles include a leaflet presenting :
1 ° the instructions for use and storage of the product, and in particular a note indicating that the use of the product is not recommended for young people and non-smokers;
2 ° contraindications;
3 ° warnings for specific risk groups;
4 ° possible side effects;
5 ° the effect of dependence and toxicity;
6 ° the contact details of the manufacturer or importer and of a natural or legal person within the European Union.
§ 7. Packing units and any outer packaging of electronic cigarettes and refill containers include a list with :
1 ° all ingredients contained in the product in descending order of their weight;
2 ° an indication of the nicotine content of the product and the quantity released per dose;
3 ° the lot number;
4 ° a recommendation that the product be kept out of the reach of children.
§ 8. Without prejudice to paragraph 7, packaging units and any outer packaging of electronic cigarettes and refill containers do not contain the following :
1 ° the suggestion that an electronic cigarette or a given refill bottle is less harmful than others or aims to reduce the effect of certain harmful components of smoke or has vitalizing, energizing, curative, rejuvenating, natural properties, biological or has beneficial effects on health or lifestyle;
2 ° the resemblance with a food or cosmetic product;
3 ° the suggestion that a given electronic cigarette or refill bottle is more easily biodegradable or has other advantages for the environment.
§ 9. Packaging units and any outer packaging do not suggest economic benefits through printed coupons, discount offers, free distribution, “two for the price of one” promotion or other similar offers.
§ 10. Items and devices that are prohibited under 8 and 9 may include, but are not limited to, messages, symbols, names, trademarks, figurative signs, or others.
§ 11. The packaging units as well as any outer packaging of electronic cigarettes and refill bottles carry the following health warning: :
“The nicotine in this product is very addictive. Its use by non-smokers is not recommended. "
§ 12. The text of the health warning is parallel to the main text on the area reserved for these warnings. In addition the health warning :
1 ° appears on the two largest surfaces of the packaging unit and of any outer packaging;
2 ° covers 35% of the corresponding surface of the packaging unit and of any outer packaging;
3 ° is printed in black Helvetica bold type on a white background with a character size such that the text occupies the largest possible portion of the area intended for it without affecting its readability; and
4 ° is in the center of the area reserved for them, and, on parallelepipedal packages and any outer packaging, parallel to the side edge of the packaging unit or outer packaging.
§ 13. The Minister may set additional conditions as to the content and presentation of the information referred to in paragraph 6.
REMOTE SALE OF ELECTRONIC CIGARETTES
The remote sale of electronic cigarettes and refill bottles to consumers is prohibited.
Art. 7. sanctions
§ 1. Electronic cigarettes and refill bottles which do not comply with the provisions of this decree are to be considered as harmful within the meaning of article 18 of the law of 24 January 1977 relating to the protection of the health of consumers with regard to food and other products.
§ 2. Infringements of the provisions of this order are sought, recorded, prosecuted and punished in accordance with the provisions of the aforementioned law of 24 January 1977.
Art. 8. Repeal
The Royal Decree of February 15, 2016 relating to the manufacture and marketing of electronic cigarettes is repealed.
Art. 9. Coming into force
This decree comes into force two months after its publication in the Moniteur belge.
Art. 10. Execution
The Minister who has Public Health in his attributions is responsible for the execution of this decree.
Source : ejustice.just.fgov.be