37/2017 Sb.
DECREE
on 2 December. February 2017
about e-cigarettes, refill containers into them and herbal remedies
products for smoking
The Ministry of health shall, pursuant to section 19 para. 4 of law No.
110/1997 Coll. on foodstuffs and tobacco products and amending and supplementing
some related laws, as amended by Act No. 180/2016 Coll. (hereinafter referred to
"the Act"):
§ 1
The subject of the edit
This Decree incorporates the relevant provisions of the European Union ^ 1) and
modifies the
and composition,) the requirements for appearance, quality and characteristics of the electronic
cigarettes and refill containers into them,
b) marking of electronic cigarettes and refill containers into them and
herbal products for smoking, including prohibited elements and features
(c)) the way of the period and scope of notification requirements manufacturers and importers
electronic cigarette refill containers into them and herbal products
for smoking and
(d)) the extent of the data required for registration with the cross-border sales
electronic cigarette and refill containers into them at a distance and the way
its implementation.
§ 2
Definition of terms
For the purposes of this Ordinance, means the
and) common electronic gateway for submission of information
information electronic portal established and administered by the European Commission to
to ensure the uniform method of reporting electronic cigarettes and
refill containers into them and herbal products for smoking,
(b) the health warning warning) concerning the adverse effects
electronic cigarettes or refills, or herbal product
intended for smoking on human health,
c) retailer, any natural or legal person,
that States the electronic cigarette or refills or
herbal products for smoking on the market.
§ 3
General requirements for electronic cigarettes and refills them
(1) the electronic cigarette and refills them must be
and) secured against tampering on the part of children and any adverse
handling, which would erode the integrity of the product and, in particular, was in
contrary to the purpose for which they are electronic cigarettes and refills
designed,
b) protected against breakage and leakage of fluid and
(c) a mechanism ensuring that recurring) performance without leakage
fluid according to § 4, in the case of reusable electronic
cigarettes.
(2) electronic cigarettes containing nicotine dose must be released
nicotine under normal conditions of use.
(3) the production of liquid filling must be in electronic cigarettes
only used folders with high purity. Substances other than folders
included in the list pursuant to section 6 (1). 1 (b). and) may be included in
liquid filling in trace amounts, only if such trace
the amount of technically unavoidable during the manufacture of liquid fillings
electronic cigarettes.
(4) a liquid electronic cigarette cartridges can contain only
substances, which in a heated or unheated form do not constitute a risk to the
human health, and nicotine.
(5) Liquid electronic cigarette cartridges must not contain
and) vitamins or other additives, which create the impression that the liquid filling
is the health benefit or that it represents a reduced risk to health,
(b)), caffeine, taurine or other ingredients and stimulating ingredients that are
associated with energy and vitality,
c) ingredients whose properties cause coloring of the emissions, and
d) ingredients, which have, in the form of unburnt carcinogenic,
mutagenic or toxic to reproduction.
(6) Liquid electronic cigarette cartridges containing nicotine may
contain not more than 20 mg/ml nicotine.
(7) the volume of electronic cigarette refills may not exceed 10
ml.
(8) the volume of the water tank or reservoir for disposable electronic cigarettes
or cartridges must not exceed 2 ml.
§ 4
Additional requirements on reusable electronic cigarettes, which can be
apply for the use of nicotine-containing fumes, and spare
refills
(1) reusable electronic cigarettes, which can be used for
the use of nicotine-containing fumes, and refill them with
the content of nicotine may be placed on the market only if the mechanism for
recurring transactions
and) requires the use of refills, which is securely attached
nozzle long at least 9 mm narrower than the opening electronic tank
cigarettes, for which it is used, and that fits into the hole and has
flow control mechanism, which in the vertical position only for the
atmospheric pressure at a temperature of 20 +-5 ° c does not release more than 20 drops
supplemented fluid per minute, or
(b)) works through the dock system, which releases
liquid into the tank fed by an electronic cigarettes only
the electronic cigarette is associated with a replacement filling.
(2) the directions for use in accordance with § 12 h of paragraph 1. 3 (b). and the Act repeatedly)
disposable electronic cigarettes, which can be used for the use of
fumes containing nicotine, and replacement of them with the content
nicotine must also contain the
and the procedure repeated) guidelines for implementation, including drawings,
(b) in the case of the use of the mechanism) referred to in paragraph 1 (b). and an indication of the width)
the nozzle or the width of the hole the tank referred to in a manner that will allow the
the consumer to verify that the replacement cartridge and electronic cigarette is
compliant, and
(c) in the case of the use of the mechanism) referred to in paragraph 1 (b). b) type
Dock system, which is an electronic cigarette or replacement
cartridge compatible.
(3) the volume of the tank for reusable electronic cigarettes
refilling refill containing nicotine may not exceed 2 ml.
§ 5
The labelling of the electronic cigarette and refill containers to them
(1) information in accordance with § 12 h of paragraph 1. 2 of the Act
and) shall be printed indelibly,
(b)) must be visible and
(c)) must not be placed on the market is obscured or interrupted.
(2) the folders contained in the liquid filling must be on the list in accordance with § 12 h
paragraph. 2 (a). (b)) of the Act listed in descending order by weight.
(3) health warnings on each unit packet and on any
the outer packaging of electronic cigarettes containing nicotine and spare
Nicotine-containing fillings added: "this product contains nicotine, which
It is highly addictive substance. Its use is not recommended for non-smokers. " On
packaging in accordance with the first sentence cannot be brought no additional text that would
any way this health warning, commented on, paraphrased
or referred to it.
(4) a health warning referred to in paragraph 3 shall
and) be parallel to the main text on the stage reserved for this
warning,
(b)) to be printed in black Helvetica bold type, keeping the default
character spacing settings, which is 100% scale and spacing normal,
on a white background; point font size shall be such that the competent
text occupy the greatest part of the surface dedicated to him,
(c)) to be placed at the center of the surface dedicated to them,
(d)) to be on the unit packet and any outside a cuboid shape
packaging, parallel to the lateral edge of the unit packet or outside
packaging,
e) cover 30% of the surface of the unit packet and any
outer packaging that is a health warning printed,
(f)) to be placed on the two largest surfaces of unit packet and
any outer packaging and
(g)) in the ordinary way of opening the unit packet remain nenarušeno.
(5) the designation of the electronic cigarette and refills,
unit packet and on any outside packaging must not contain any
element or feature that
and) promotes electronic cigarette or refill it, or
supports creating a false impression of their consumption in terms of
characteristics of the product, its effects on health, risk and emissions,
(b)) suggests that the electronic cigarette or refill it is
less harmful than other products, or that its goal is to reduce the effects of
some harmful smoke constituents, or that it has vitality, energizing,
healing, rejuvenating or natural effects or characteristics of the product
organic farming, or other health benefits or benefits for
lifestyle,
(c)) recalls the foodstuff or cosmetic product, or
(d)) suggests that the electronic cigarette or refill it has
enhanced biodegradability or other advantages in terms of
of the environment.
(6) the unit packet and any outside packaging of electronic cigarettes and
It refills may not indicate the economic benefits, including the benefits
through the printed vouchers offering discounts, free distribution,
offers of "two for the price of one", or other similar offers.
(7) an element or feature that is prohibited under paragraph 5 or 6,
the text, symbol, name, trademark, figurative or other character.
§ 6
How to perform the notification obligation in the marketing of
electronic cigarette and refill containers to them
(1) notification pursuant to § 12 h of paragraph 1. 4 (b). and the Act is done)
through a common electronic gateway for submission of
the information in the format specified in the annex to decision
governing a common format for the reporting of electronic cigarettes and
refill containers and by brand and type of the electronic cigarette or
refills them. These notices contain
and a list of all ingredients contained) in the liquid tank and emissions
emerging use of electronic cigarettes or refill it
by brand name and type, including their amount,
(b)) the toxicological data on ingredients and emissions in accordance with subparagraph (a)), and even
When heated, in particular with regard to their effects on the health of consumers,
If inhaled, and any of their addictive effect,
c) information about the nicotine doses and income when consumed under normal
or foreseeable conditions, as regards the electronic cigarette and
refill them with the content of nicotine,
(d) a description of the components) electronic cigarettes and refills, including
the possible opening and filling mechanism of these products,
e) description of the production process, including information, whether or not the production process
includes series production, and a statement that the manufacturing process ensures the
compliance with the requirements set out in this Decree, in the law, other legal
prescription and directly applicable European Union legislation,
f) a statement that the manufacturer or importer shall bear full responsibility for the
the quality and safety of the product when it is placed on the market and
the use, under normal or foreseeable conditions, and
g) the name and contact details of the producer responsibility legal or natural
persons in the European Union and, where appropriate, the importer into the European Union.
(2) before the first notification in accordance with § 12 h of paragraph 1. 4 (b). and manufacturer) of the Act
or importer shall request the Ministry of health about its identification
number (hereinafter referred to as "the identification number of the petitioner") created
the operator of a joint electronic entrance gate. The manufacturer, or
the importer shall submit information that contains its identification
data, and validation activities in accordance with national legislation,
the Member State in which he is established. The identification number of the petitioner is
It's for all the following announcement made through
common electronic gateway and any other correspondence with the
The Ministry of health.
(3) on the basis of the petitioner shall be assigned identification number of the manufacturer or
the importer of any product which is to be announced, the identification number
electronic cigarettes or e cigarettes refills.
When submitting the notification about products that have the same composition and
the appearance, the manufacturer and the importer will use the same identification number
electronic cigarettes or e cigarettes refills,
unless otherwise specified in this Decree. This procedure applies regardless of the
brand and product subtype and the number of markets in which the products are placed.
If you cannot ensure that products that have the same composition and
look, use the same identification number electronic cigarettes or
electronic cigarette refills must be given different
the identification numbers of the electronic cigarette or refills
electronic cigarettes, which have been allocated to such products.
(4) a notice under section 13 h of paragraph 1. 4 (b). the law shall be submitted)
not later than 6 months before the intended placing on the market.
(5) a notice under section 13 h of paragraph 1. 5 of the Act shall be submitted prior to
the market.
(6) when submitting a notification shall be marked with all the information that the manufacturer
and the importers considered trade secret or otherwise confidential, and
the request of the Ministry of health are these claims properly reasoned.
§ 7
The extent of the data required for registration before the start of placing on the market
electronic cigarettes or refill containers to them in the form of
cross-border distance selling
(1) the notice on the basis of retail registration is done
the seller in accordance with § 13 para. 4 and 5 of the Act, contains
and) the name or names, first and last name, or the name or business name
retailer and the address of the place where they will be electronic
cigarettes or refills them supplied,
(b) the start date of the activity), which is offering electronic cigarettes
or refill containers into them to consumers in the context of cross-border
distance sales through the services of the information society, and
(c)) the address of the website that is used for the purpose of sale on
distance, even with all the information necessary for the identification of this Internet
the page.
(2) the information referred to in paragraph 1 shall be communicated in electronic form via the remote
transmission of the data.
§ 8
The communication of information about the market for electronic cigarettes and spare
fillings
(1) notification pursuant to § 12 h of paragraph 1. 4 (b). (b)) of the Act contains
a) summary information on the sales volume by brand name and type
of the product,
(b) information on the preferences of different) consumer groups, including
young people, non-smokers and the main types of simultaneous users,
(c)) for information about how the sale of products and
d) summaries of any market surveys carried out to determine the information
According to the letter a) to (c)).
(2) the information referred to in paragraph 1 (b). (d)) to electronic cigarettes and
the replacement functions with the content of nicotine in the Czech and
the English language. Information referred to in paragraph 1 (b). (d)) to electronic
cigarettes and nicotine replacement functions without content are presented in
the Czech language.
(3) the information referred to in paragraph 1 shall be submitted for each calendar year,
and until 31 December 1998. may the following calendar year.
§ 9
Labelling of herbal products for smoking
(1) the information referred to in section 12j para. 2 of the Act
and) shall be printed indelibly,
(b)) must be visible and
(c)) must not be placed on the market is obscured or interrupted.
(2) health warnings on each unit packet and on any
the outer packaging of herbal products for smoking: smoking
This product damages your health. " On the packaging in accordance with the first sentence cannot be
indicate any additional text that would in any way this health
warning commented on, paraphrased or referred to it.
(3) a health warning referred to in paragraph 2 must be printed on the front and
the back of the outer surface of the unit packet and any
outside packaging.
(4) a health warning referred to in paragraph 2 shall
and) be printed in black Helvetica bold type, keeping the default
character spacing settings, which is 100% scale and spacing normal,
on a white background; point font size shall be such that the competent
text occupy the greatest part of the surface dedicated to him,
(b)) to be placed at the center of the surface dedicated to them,
(c)) to be on the unit packet and any outside a cuboid shape
packaging, parallel to the lateral edge of the unit packet or outside
packaging,
d) cover 30% of the surface of the unit packet and any
outside packaging, on which are printed health warnings, and
(e)) in the ordinary way of opening the unit packet remain nenarušeno.
(5) the designation itself herbal product intended for smoking,
unit packet and any outside packaging must not contain any
element or feature that
and) promotes herbal product for smoking or supports its
consumption by creating false impression about its characteristics, the effects of
health, risk and emissions,
(b)) indicates that a herbal product for smoking is less
damaging than other products, or that his goal is to reduce the effects of
some harmful smoke constituents, or that it has vitality, energizing,
healing, rejuvenating or natural effects or characteristics of the product
organic farming or other health benefits or benefits for
lifestyle,
(c)) recalls the foodstuff or cosmetic product, or
(d)), States that the herbal product for smoking does not contain any
additives or flavourings.
(6) an element or feature of which is prohibited pursuant to paragraph 5, may be
text, symbol, name, trademark, figurative or other character.
§ 10
How to perform the notification obligation in the marketing of herbal remedies
products for smoking
(1) a notice under section 12j para. 3 of the Act shall be carried out through
electronic gateway for submission of information in a format
provided for in the annex to the decision relating to the common
the format for the presentation and disclosure of information on tobacco
products and by brand and type of herbal product intended for smoking.
These notices contain
and) the name and contact details of the producer responsibility legal or natural
persons in the European Union, or the importer into the European Union and
(b)) a list of all the ingredients that are used in the production of herbal product
to smoking by brand name and type, including their
quantity.
(2) before the first notification under section 12j para. 3 of the Act, the manufacturer or
the importer will ask the Ministry of health about the identification number
promoters created by the operator, joint electronic input
gateway. The manufacturer or importer shall provide upon request information containing
his identification and validation activities in accordance with national
legislation of the Member State in which he is established. Identification
the number of the petitioner shall be used for all subsequent notifications
carried out through the joint electronic entrance gate and when
any other correspondence with the Ministry of health.
(3) on the basis of the petitioner shall be assigned identification number of the manufacturer or
the importer of any product which is to be announced, the identification number
herbal product intended for smoking. In the submission of
products that have the same composition and appearance, the manufacturer and importer
It's the same identification number of the herbal product intended for
smoking, unless otherwise specified in this Decree. This procedure applies without
regardless of the brand and the product subtype and the number of markets in which the products are
placed. If you cannot ensure that products that have the same composition
and look, use the same identification number of the herbal product
intended for smoking, must be given different identification numbers
herbal product intended for smoking, which was that these products
allocated.
(4) a notice under section 12j para. paragraph 3 and section 12j. 4 of the law shall be submitted
no later than 2 months prior to the intended placing on the market.
(5) when submitting a notification shall be marked with all the information that manufacturers
and importers are considered trade secret or otherwise confidential, and
the request of the Ministry of health are these claims properly reasoned.
§ 11
Transitional provision
Notification obligations pursuant to § 6 and 10 for electronic cigarettes and
refill containers into them and herbal products for smoking
placed on the market before the date of entry into force of this Decree shall be
met by the end of the third calendar month following
After the effective date of this Ordinance.
§ 12
Final provision
This Decree was notified in accordance with the directive of the European Parliament
and of the Council (EU) 1535 of 9 June. September 2015, the procedure for the provision
information in the field of technical regulations and of rules on services,
the information society.
section 13 of the
The effectiveness of the
This Decree shall take effect on the 15th day following its publication.
Minister:
JUDr. Ing. Louis, MBA, in r.
1) directive of the European Parliament and of the Council/40/EU of 3. April
2014 on the approximation of the laws, regulations and administrative provisions of the Member States
concerning the manufacture, presentation and sale of tobacco and
related products and repealing Directive 2001/37/EC.
Commission implementing decision (EU) 2015/2183 of 24 September. November 2015,
establishing a common format for the reporting of electronic cigarettes
and refill containers.
Commission implementing decision (EU) 2016/586 from day 14. April 2016
the technical standards for the feeding mechanism of electronic cigarettes.