Law (2017:425) Of Electronic Cigarettes And Refills

Original Language Title: Lag (2017:425) om elektroniska cigaretter och påfyllningsbehållare

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/Entry into force: 2017-07-01/

Introductory provisions



section 1 of this Act contains provisions on notification, product requirements, sales and marketing of electronic cigarettes and refill containers.



2 for the purposes of this Act, section



1. electronic cigarette: the product can be used for the consumption of nicotine vapor through a nozzle, or component of the product, including a cartridge, a tank and the appliance without cartridge or tank, and



2. refill container: container that contains liquid containing nicotine and that can be used to fill in an electronic cigarette.



section 3 of this Act shall not apply to



1. medicinal products or medical devices covered by the medicines Act (2015:315) or Act (1993:584) on medical devices, or



2. products classified as drugs under the narkotikastrafflagen (1968:64) or as dangerous goods according to the law (1999:42) banning certain products which are hazardous to health.



For electronic cigarettes or refill container that contains tobacco, the provisions of the tobacco Act (1993:581) shall apply instead of the provisions of this law.



4 § in the case of electronic cigarettes and refill containers also applies to the product safety Act (2004:451).



Product notification



paragraph 5 of the manufacturers and importers of electronic cigarettes or refill containers going to the public health agency to notify all such products which they intend to provide consumers on the Swedish market. A new notification shall be submitted for any substantial modification of the product. The notification shall be submitted no later than six months before the product is intended to be provided to consumers in the market. The notification shall also be made when the product is withdrawn from the market.



Electronic cigarettes and refill containers must not be made available to consumers on the Swedish market if the notification referred to in the first subparagraph have not been made. The same applies if the notification does not comply with the regulations on how notification should be designed and what it should contain the given under section 48 1.



Demands for the products, supplied information and presentation



Product requirements



section 6 of the electronic cigarettes and refills shall comply with the regulations on the content and design that have been notified under section 48 2.



Manufacturers and importers of electronic cigarettes and refill container is responsible for ensuring that the products meet the requirements of the first subparagraph.



Electronic cigarettes and refill container that does not comply with the regulations on the content and design that have been notified under section 48 2 may not be provided to consumers in the market.



Information sheet



section 7 of the unit packets of electronic cigarettes and refills shall contain an information sheet.



Manufacturers and importers of electronic cigarettes and refill container is responsible for unit packaging for such products contain an information sheet.



If a unit packet to an electronic cigarette or a refill containers devoid of information sheets, the product may not be made available to consumers on the market. The same applies if the sheet does not comply with the regulations regarding its content and design that has been issued under section 48 3.



Declaration of contents



section 8 packaging for electronic cigarettes and refill containers shall be provided with a list of ingredients.

Manufacturers and importers are responsible for the packaging of electronic cigarettes and refill containers are provided with a list of ingredients.



If a package to an electronic cigarette or a refill containers have no list of ingredients, the product may not be made available to consumers on the market.

The same applies if the content declaration does not comply with the regulations on the content and design that have been handed down on the basis of § 48 4.



Product presentation



section 9 Marking on electronic cigarettes and refill containers, or on such products ' packaging, may not 1. imply that a particular electronic cigarette or refill container is less harmful than other such products,



2. include information on tar or carbon monoxide in the product,



3. similar to a food or a cosmetic product,



4. suggest that a specific product has environmental benefits, or



5. refer to the scent or additives, except as regards the condiments.



Unit packet and any outside packaging of electronic cigarettes and refill containers must not imply financial benefits by including printed coupons, discount offers, free distribution, two products for the price of one, or like deals.



Health warning



10 § packaging for electronic cigarettes and refill containers shall bear a health warning.



Manufacturers and importers of electronic cigarettes and refill container is responsible for the packaging of such products bear a health warning.



If a package to an electronic cigarette or a refill containers have no health warning, the product may not be made available to consumers on the market. The same applies if the health warning do not comply with the regulations regarding the design of the warning given by virtue of section 48 5.



Marketing and sponsorship



11 § a trader must not advertise electronic cigarettes or refill containers to consumers



1. in the field of information society services, or



2. in the audio, radio broadcasting, television broadcasting or on-demand covered by the radio and Television Act (2010:696).



The prohibition referred to in the first subparagraph shall not apply



1. marketing that only consist in providing electronic cigarettes or refill containers for sale, or



2. marketing in the transmissions or technical recordings on which freedom of expression is applicable, with the exception of marketing through commercial advertisements.



section 12 of a trader marketing electronic cigarettes or refill containers to consumers may not use commercial ads in periodicals or other comparable writings on the freedom of the Press Act is applicable.



paragraph 13 of the Manufacturers, wholesalers and importers of electronic cigarettes and refill containers may not sponsor an event or activity to which the public has access or which are likely to cause transboundary impact, if sponsorship can be assumed to mean that the marketing of the products promoted.



Provisions on the prohibition of sponsorship of programs on radio and television as well as on product placement in tv Broadcasting Act (2010:696).



Reporting of sales volumes, etc.



section 14 of the manufacturers and importers of electronic cigarettes and refill containers shall each year submit to the public health agency




1. complete information on sales volume, broken down by brand and product's residence,



2. information about the preferences of various consumer groups, including young people, non-smokers and the main types of current consumers,



3. information on the way in which the products are sold, and



4. summaries of and comments on the possible market surveys on the above, with a translation into English.



Electronic cigarettes and refill containers must not be made available to consumers on the market if the reporting obligations imposed by the first subparagraph are not complied with. The same is true of the reporting does not meet the requirements of the reporting obligation given pursuant to § 48 6.



Product control



section 15 manufacturers, importers and distributors of electronic cigarettes and refill containers shall establish and maintain a system to collect information on all suspected adverse effects that these products have on human health.



Information referred to in the first subparagraph shall, on request, be submitted to the public health agency.



section 16 if a manufacturer, importer or distributor of electronic cigarettes or refill containers considers or has reason to believe, that such a product is not safe or of high quality or that otherwise does not comply with this law, it shall immediately



1. take the corrective measures necessary to ensure that the product concerned should be compatible with that law,



2. withdraw the product, or



3. withdraw the product.



When an action under the first paragraph must be taken, the public health agency immediately notified about the deficiencies, the action taken and the results of the operation.



Commerce, etc.



Age limit



17 § electronic cigarettes and refill containers may not be sold or otherwise disclosed in commercial activities to the under the age of 18 years. Whoever leaves out such products should satisfy itself that the recipient has attained this age.



If there is particular reason to assume that an electronic cigarette or refill container is intended to be handed over to anyone under the age of 18 years, the product may not be disclosed.



At each point of sale of electronic cigarettes and refill containers, there should be a clear and clearly visible sign with information about the prohibition to sell or supply such products to anyone who has not reached 18 years of age.



18 § electronic cigarettes and refill containers sold to consumers shall be provided in such a way that it is possible to check the age of the recipient. This also applies where the sale is done by machine, via distance selling or similar.



section 19 of the electronic cigarettes and refill container can be brought into the country only by persons who have reached the age of 18.



Notice of sale



section 20 of The traders which have their registered office or their business in Sweden may not provide electronic cigarettes or refill containers for sale to consumers without first having notified the sale to the municipality in which the sale is to take place.



Cross-border distance selling



section 21 of a trader via distance selling electronic cigarettes or refill containers for sale to consumers in a country other than the country where the trader has its registered office or its commercial activities (cross-border distance selling), may not engage in such sales to or from Sweden without first having registered the sale of the public health agency and a confirmation of the registration.



The health authority shall promptly after the registration referred to in the first subparagraph shall confirm this.



section 22 of A self-employed person engaged in cross-border distance sales must not disclose personal information about the consumer to the manufacturer of such products or to companies that are part of the same group of companies or to other third parties. Personal data may not be used or transferred for purposes other than the current purchase.



The provisions of the personal data Act (1998:204) for the rectification and indemnity also applies to the processing of personal data as referred to in the first subparagraph.



Obligation to exercise self control



section 23 of the sale under section 20 or cross-border distance sales under section 21 shall exercise special control (self-check) over the sale and management of other electronic cigarettes and refill containers and ensure that an appropriate program for food safety activities.



To notification and registration under sections 20 and 21, the trader shall include the self-inspection program and the other information required for municipal and public health regulatory agency. If the information changes, it should be reported to the municipality and the public health agency without delay.



Enforcement and market surveillance



Central oversight



section 24 of the central supervision of this law and the provisions adopted pursuant to the law are respected is exercised by the public health authority as regards the immediate supervision by the municipality or municipality and the police authority is responsible for under 26 § 1 and 2.



Regional oversight



25 § länsstyrelsen exercises within the County supervision under section 26 (1) and (2). The County Board shall



1. follow local authorities ' activities and assist local governments with information and advice, and



2. promote cooperation between supervisory authorities and between supervisory authorities and others.



Immediate supervision



section 26 of the immediate enforcement of this law and the provisions adopted pursuant to the law are respected is exercised by



1. the municipality with regard to



(a)) the prohibition to provide electronic cigarettes and refill container according to 5 to 8, 10 and 14 sections at points of sale,



(b) under section 9) product presentation at points of sale,



2. the municipality and police authorities with regard to



a) age limit under §§ 17 and 18,



b) notification of sales and own control pursuant to §§ 20 and 23 in cases other than in respect of cross-border distance selling,



3. The public health authority as regards



a) provisions of 5 – 10 and 14 sections in cases other than those referred to in 1,



b) product inspection in accordance with paragraphs 15 and 16,



c) registration and inspection according to §§ 21 and 23 concerning cross-border distance selling, and



4. Consumer Agency when it comes to marketing and sponsorship according to §§ 11-13.



section 27 At the Consumer Agency Oversight applied the provisions of the marketing practices Act (2008:486).



A marketing action that contravenes any of the provisions of section 9 or 11-13 section, shall for the purposes of 5, 23 and 26 of the Marketing Act shall be deemed to be unfair towards consumers. A marketing action that is contrary to paragraph 11 (2) or section 12 can lead to market disturbance fee in accordance with the provisions of sections 29 to 36


Marketing Act.



Market control



section 28 of the public health authority in respect of product requirements of section 6 of the exercise market control of electronic cigarettes and refill containers covered by this law.



Provisions on market surveillance, see article 15(3) and 16 to 29 of the European Parliament and Council Regulation (EC) no 765/2008 of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93.



Agreement on cooperation



section 29 a municipality may conclude agreement with another municipality to supervisory tasks which the municipality has under this Act shall be made in whole or in part by the other municipality. The municipality, however, may not transfer power to decide cases in accordance with §§ 31 and 32.



Exchange of information



section 30 of the municipality and the police authorities shall inform each other about conditions that are relevant for the purposes of supervision.



A municipality which has taken the decision in a case under this Act shall send a copy of it to the public health agency, the police and the State Provincial Office concerned by the decision.



Injunctions and prohibitions



section 31 of the supervisory authority referred to in section 26 1-3, in their supervisory activities inform the injunctions or prohibitions as needed to the law or a regulation issued under the law should be followed.



section 32 in the event of serious or repeated infringements of the provisions of this law, the municipality may prohibit a trader who provides electronic cigarettes or refill containers for sale to consumers to continue the sale or, if the ban would be an overly restrictive action, notify alert.



The prohibition referred to in the first subparagraph shall be communicated for a period of up to six months.



Decision referred to in the first subparagraph shall be effective immediately, unless otherwise specified in the decision.



section 33 Of the public health agency notes or has reasonable grounds to believe that a type of or specific electronic cigarettes or refill containers may pose a serious risk to human health, despite the fact that the product meets the requirements of this Act, the authority may prohibit the products provided to consumers in the market. If such products has already been made available to consumers on the market, the public health agency, submit to the manufacturer, importer or distributor of the products, to withdraw it or to recall it.



The public health authority shall immediately inform the European Commission and the competent authorities of the other Member States of the measures taken under the first subparagraph and provide other relevant information.



When the European Commission has announced, if it considers that an action under the first paragraph is justified, the public health agency to decide on the action to be made up.



VITE



34 § decision on injunction or prohibition under 31 and 33 sections may be subject to a penalty. The penalty must not be turned into a prison.



The right to information and access



35 section a supervisory authority has the right to request the information, documents, samples and similar necessary for supervision of the authority under this Act.



36 § in order to carry out its duties under this law has a supervisory authority has the right to get access to areas, offices and other areas affected by this Act or the regulations and may make connecting where investigations and take samples.

For selected samples will not be paid compensation.



Control purchase



37 section in order to provide a basis for a dialogue between the municipality and the leaving out electronic cigarettes or refill containers on the obligation to satisfy itself that the recipient has reached the age laid down in section 17, the municipality may carry out the control purchase. When such a purchase, the municipality will only hire a person who has reached the age of 18.



A control purchases may be carried out without the trader is notified in advance of the control purchase. The municipality shall, as soon as possible after a completed control purchase, inform the trader about inspection purchase.



38 § information gained through control purchases may not form the basis for the municipality to notify injunctions or prohibitions under sections 31 and 32.



Assistance from the police authority



section 39 the police authority shall, at the request of another supervisory authority provide the assistance needed for the purposes of section 36. Such a request may be made only if the



1. the particular circumstances give reason to suspect that the operation can not be performed without a police man's special powers under section 10 of the law on police (1984:387) need to be taken, or



2. There are serious reasons.



Professional secrecy



section 40 of the one who has taken a position with any matter under this Act shall not improperly disclose or otherwise exploit what he or she thereby have gotten to know about trade secrets or business conditions.



In the public activities should apply the provisions of the public access to information and secrecy Act (2009:400).



Appeal



41 section Decision as a municipality has taken under this Act may be appealed to the administrative court.



Decisions taken by the public health agency has notified under section 31 or 33 may be appealed to the administrative court.



Leave to appeal is required for an appeal to the administrative court.

Penalties and forfeiture



42 § anyone who willfully violates section 8, third paragraph or section 10, third paragraph, or sells electronic cigarettes or refill containers in violation of the ban given under section 32 shall be liable to a fine or imprisonment of up to six months.



The same applies to those who intentionally or negligently violates section 17 of the first or second paragraph, section 20 or 21 of the first paragraph.



Is the deed to be sentenced to not call responsibility.



43 § anyone who has infringed the imposition of fines or an injunction shall not be responsible under this law for acts covered by the injunction or prohibition.



44 § electronic cigarettes or refill containers which have been the subject of an offence under this Act, or their value as well as the exchange of such breach shall be declared forfeited, unless it is manifestly unfair.



45 § Provisions on liability for the unlawful importation of electronic cigarettes and refill containers found in the Act (2000:1225) of punishment for smuggling.



Fees



§ 46 a municipality may charge a fee for their supervision by the operator of notifiable sales with electronic cigarettes or refill containers under section 20.



47 § public health authorities may by manufacturers and importers of electronic cigarettes or refill container charge fees to receive, store, manage and analyze the data according to § 5 shall be submitted to the authority.



Appropriations



48 § Government or authority that the Government may provide for



1. how a notification under section 5 shall be designed and what it should contain,




2. product contents and design of electronic cigarettes and refill container according to paragraph 6,



3. which data information sheet under section 7 shall contain and how they should be designed,



4. the content and design of the content the Declaration referred to in section 8,



5. the design of health warnings referred to in paragraph 10,



6. the fulfilment of the reporting obligation under section 14,



7. the system for the collection of information set out in section 15, first subparagraph,



8. notification obligation according to paragraph 16,



9. the design of the self-inspection programs listed in section 23,



10. the obligation to pay the costs of a supervisory authority for the sampling and examination of the sample as referred to in section 36, 11. implementation of the control purchase according to § 37, and



12. the amount of the fees referred to in section 47.



Transitional provisions



2017:425



1. this law shall enter into force on 1 July 2017.



2. Electronic cigarettes and refill containers manufactured or released for free circulation before the entry into force, and which do not meet the requirements of the law, may continue to be provided to consumers on the Swedish market following its entry into force until 1 January 2018.



3. For electronic cigarettes and refill containers provided to consumers on the market before the entry into force should a notification under section 5 shall be made by 1 January 2018.

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