1. ------IND- 2015 0706 D -- EN- ------ 20160104 --- --- PROJET  
Draft bill  
of the Federal Ministry of Food and Agriculture  
Draft Act amending the Tobacco Products Act  
A. Problem and objective  
Directive  2014/40/EU of the European Parliament and of the Counc il 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 obligates Member States , in Article  29, to adopt 
legislation by 20  May 2016 that is necessary in order to transpose Directive  2014/40/EU. 
Directive  2014/40/EU is transposed by the Tobacco Products Act of […] (Federal Law 
Gazette  I p. […]) and the Tobacco Products Ordinance enact ed on the basis of this Act.  
In addition to the stipulations under the directive, nicotine -free electronic cigarettes and 
refill containers are also to be regulated by equating them with products which contain 
nicotine if this is necessary in order to prot ect consumers from adverse health effects. 
Furthermore, provision is to be made for additional bans on advertising in relation to 
tobacco products, electronic cigarettes and refill containers.  
B. Solution  
By means of the Amending Act, nicotine -free electro nic cigarettes and refill containers are 
classed with those which do contain nicotine if this is necessary in order to protect 
consumers from adverse health effects. Additional advertising bans for tobacco products, 
electronic cigarettes and refill contain ers are incorporated. Moreover, the provision 
regarding plant protection products in or on tobacco products is revised.  
Since the regulatory content referred to represents supplementary provisions regarding 
the stipulations under Directive  2014/40/EU and g o beyond the scope of the stipulations in 
the directive, this content has to be notified in accordance with the Information 
Directive  98/34/EC. So as not to jeopardise the schedule for transposing the directive, 
these parts are carried forward as a separat e draft Act amending the Tobacco Products 
Act. 
C. Alternatives  
None.  
D. Budget expenditure without compliance costs  
None.  - 2 -  
E. Compliance costs  
E.1. Compliance costs for citizens  
No compliance costs shall be incurred by citizens.  
E.2 Compliance costs for bus inesses  
By including nicotine -free electronic cigarettes and refill containers in the regulatory 
scope, a one -off expense of just over EUR  1 million and ongoing annual compliance costs 
of EUR  300 000 shall accrue.  
Of which bureaucratic costs arising from o bligations to provide information  
By including nicotine -free electronic cigarettes and refill containers, one -off compliance 
costs in the region of approximately EUR  500 000, and ongoing annual compliance costs 
amounting to approximately EUR  8 000, both ar ising from obligations to provide 
information, shall accrue.  
Businesses cannot be compensated for the compliance costs they incur on an ongoing 
basis within this draft legislation. It shall therefore have to be examined whether an 
appropriate prospect of r elief can be demonstrated outside this draft.  
E.3 Administrative compliance costs  
No administrative compliance costs shall arise.  
F. Additional costs  
A ban on outdoor advertising is envisaged as of 1  July 2020. According to information 
from the tobacco ind ustry, published in the Federal [German] Government's 2015  report 
on drugs and addiction, in 2013, EUR  69.8 million was spent on outdoor advertising.  
Advertising in cinemas is restricted insofar as the showing of promotional films and 
programmes for tobacc o products, electronic cigarettes and refill containers is only 
allowed if a film as per the procedure defined in §  14 of the Youth Protection Act is 
characterised as "Not suitable for persons under the age of 18". According to the Federal 
[German] Governm ent's 2015  report on drugs and addiction, in 2013, EUR  7.7 million was 
spent on advertising in cinemas.  
In future, this expenditure will be curtailed and lasting reductions achieved.  
 - 3 -  
Draft bill of the Federal Ministry of Food and Agriculture  
Draft Act am ending the Tobacco Products Act1) 
dated … 
The Bundestag  has adopted the following Act with the approval of the Bundesrat : 
Article 1  
Amending the Tobacco Products Act  
The Tobacco Products Act of […] (Federal Law Gazette  I p. ) is amended as follows:  
1. In the Table of contents, the following entries are inserted after the statement relating 
to § 20: 
"§ 20a Ban on outdoor advertising  
§ 20b Ban on selling and displaying free of charge" . 
2. In § 1(1), after the statement "(OJ L 127 of 29  April 2014, p.  1).", the sent ence 
"Article  2 points  16 and 17 shall apply with the proviso that the terms indicated therein 
also include nicotine -free electronic cigarettes and refill containers."  is inserted.  
3. § 2 is amended as follows:  
a) The following new point  9 is inserted after poin t 8: 
"9. Outdoor advertising: any advertising away from business premises of specialist 
retailers involving a fixed installation which appeals to consumers directly or 
in another way, in particular by means of placards or posters, lettering, 
ornamental pai nting, sky advertising or signage,".  
b) The previous points  9 and 10 become the new points  10 and 11.  
4. § 9 is amended as follows:  
a) The wording is preceded by the following paragraph  1: 
"(1) Tobacco products which contain plant protection products within the 
meaning of Article  2(1) of Regulation  (EC) No.  1107/2009 of the European 
Parliament and of the Council of 21  October  2009 concerning the placing of plant 
protection products on the market and repealing Council Directives  79/117/EEC 
and 91/414/EEC (OJ  L 309 of  24 November  2009, p.  1) or their breakdown or 
reaction products, or to which plant protection products or their breakdown or 
reaction products adhere, may only be placed on the market if the plant 
protection products  
                                                
1) Notified in accordance with Directive  (EU) 2015/1535 of the European Parliament and of the Council 
of 9 September  2015 laying down a procedure for the provision  of information in the field of technical 
regulations and of rules on Information Society services (OJ  L 241 of 17  September  2015, p.  1). - 4 -  
1. are authorised in Germany for the r espective area of application or may 
still be utilised in accordance with §  12(5) of the Plant Protection Act, or  
2. are authorised for the respective area of application in a Member State 
of the European Union or in another Signatory State to the Agreemen t on the 
European Economic Area in accordance with the provisions of Article  4(1b) to 
(1e) of Council Directive  91/414/EEC of 15  July 1991 concerning the placing of 
plant protection products on the market (OJ  L 230 of 19  August  1991, p.  1) or in 
accordance  with the provisions of Regulation  (EC) No.  1107/2009.  
A plant protection product which is authorised for the respective area of 
application in a third country and which is used there is the equivalent of a plant 
protection product within the meaning of se ntence  1." 
b) The previous wording becomes paragraph  2. 
5. § 14 is amended as follows:  
a) In paragraph  1, after the words "Electronic cigarettes and refill containers"  the 
words "which contain nicotine,"  are inserted.  
b) In paragraph  2, after the words "Electronic cig arettes"  the words "which contain 
nicotine,"  are inserted.  
6. The wording under §  15(1) point  2a is preceded by the words "of electronic cigarettes 
and refill containers which contain nicotine," . 
7. The following §§  20a and 20b are inserted after §  20: 
"§ 20a 
Ban on outdoor advertising  
It is prohibited to engage in outdoor advertising for tobacco products, electronic 
cigarettes or refill containers. Sentence  1 shall not apply to advertising on the external 
surfaces of buildings on business premises of specialist retailers.  
§ 20b 
Ban on selling and displaying free of charge  
(1) It is prohibited to supply cigarettes, roll -your-own tobacco or water pipe 
tobacco on a commercial basis free of charge.  
(2) It is prohibited to supply smokeless tobacco products and electronic 
cigarettes or refill containers, other than those smoking tobacco products mentioned 
in paragraph  1, away from business premises of specialist retailers on a commercial 
basis, free of charge.  
(3) It is prohibited to display tobacco products, electronic cigarettes or refill 
containers on a commercial basis."  - 5 -  
8. § 21(1) is worded as follows:  
"(1) It is prohibited to use promotional information when dealing with tobacco 
products, electronic cigarettes and refill containers or in advertisements for tobacco 
products, elect ronic cigarettes and refill containers  
1. which gives the impression that enjoyment or use of the product as intended 
is harmless to health or shall have a positive effect on how the body functions, 
performance or well -being,  
2. which, according to its typ e, is especially suitable for inducing young people 
or adolescents to consume such products or for strengthening this conviction to 
consume,  
3. which presents the inhalation of tobacco smoke or vapour as 
recommendable, and  
4. which gives the impression tha t the ingredients are natural or unadulterated."  
9. § 22 is amended as follows:  
a) The following paragraph  3 is inserted after paragraph  2: 
"(3) By way of deviation from paragraph  2 points  1 and 2, any party which 
wishes to engage exclusively in cross -border dis tance selling to European Union 
consumers of nicotine -free electronic cigarettes and refill containers only has to 
be registered domestically with the competent authority."  
b) The previous paragraphs  3 to 6 become paragraphs  4 to 7.  
10. § 34(1) is amended as foll ows: 
a) Point  4c is worded as follows:  
"c) § 9(1) sentence  1 or §  11". 
b) In point  5, the statement "paragraph  2" is inserted after the statement "in 
accordance with §  9". 
11. § 35 is amended as follows:  
a) Paragraph  2 is amended as follows:  
aa) The following points  10 and  11 are inserted after point  9: 
"10. engages in outdoor advertising contrary to §  20a, 
11. supplies or displays a tobacco product, an electronic cigarette or a refill 
container on a commercial basis, contrary to §  20b."  
bb) The previous points  10 to 13 become points  12 to 15.  
b) In paragraph  3 point  2b, the statement "or 10" is replaced by the statement "or 
12". 
c) In paragraph  4, the statement "or 10" is replaced by the statement "or 12".  
12. In § 43(2), the statement "paragraph  2" is inserted after the statement "§ 9". - 6 -  
13. The following paragraphs  6 and 7 are added to §  47: 
"(6) §  20a shall apply as of 1  July 2020.  
(7) §  20b(2) shall apply as of 20  May 2020. Sentence  1 shall not apply to 
electronic cigarettes and refill containers."  
Article 2  
Amending the Youth Protection A ct 
The Youth Protection Act of 23  July 2002 (Federal Law Gazette  I p. 2730), last 
amended by Article  2(55) and Article  4(36) of the Act of 7  August  2013 (Federal Law 
Gazette  I p. 3154), is amended as follows:  
14. § 11 is amended as follows:  
a) In paragraph  5, the  words "tobacco goods or" are deleted.  
b) The following paragraph  6 is added:  
"(6) Promotional films and advertising programmes which promote tobacco 
products, electronic cigarettes or refill containers within the meaning of §  1(1) of 
the Tobacco Products Act  of […], as amended by the Act of [ …], may only be 
shown in connection with films which have been characterised as "Not suitable 
for persons under the age of 18" in the context of the procedure as per §  14(6) by 
the supreme Federal State authority or a vol untary self -regulation body."  
15. § 28(1) point  14a is worded as follows:  
"14a.  shows a promotional film or advertising programme, contrary to §  11(5) or (6)."  
Article 3  
Amending the Tobacco Duty Act  
The Tobacco Duty Act of 15  July 2009 (Federal Law Gazette  I p. 1870), last amended 
by Article  12 of the Act of 3  Dece mber  2015 (Federal Law Gazette  I p. 2178), is amended 
as follows:  
16. § 25 sentence  2 is worded as follows:  
"He may, however, open the packages in order to examine or show the contents."  
17. § 26(1) sentence  1 is worded as follows:  
"The package price indicated on the tax stamp, or the retail price following from 
this, may not be undercut by the retailer when supplying consumers with tobacco 
goods."  
18. § 29 is deleted.  - 7 -  
19. § 36(2) is amended as follows:  
a) In point  3, the word "contravenes" is replaced by the words "contravenes or".  
b) In point  4, the words "combines or" are replaced by the word "combines".  
c) Point  5 is deleted.  
Article 4  
Entry into force  
This Act shall enter into force on the day following promulgation.  
 - 8 -  
Explanatory statement  
A. General Part  
I. Objective and necessity of the provisions  
Directive  2014/40/EU is transposed by the Tobacco Products Act of [ …] (Federal Law 
Gazette  I p. […]) and the Tobacco Products Ordinance enacted on the basis of this Act.  
Over and  above the stipulations of the directive, nicotine -free electronic cigarettes and 
refill containers are also to be regulated if this is necessary in order to protect consumers 
from adverse health effects. Furthermore, provision is made for additional bans on 
advertising, and advertising restrictions, in relation to tobacco products, electronic 
cigarettes and refill containers. The provision regarding plant protection products in or on 
tobacco products is revised.  
Since the regulatory content referred to goe s beyond the scope of the stipulations in 
Directive  2014/40/EU, this content has to be notified in accordance with the Information 
Directive  98/34/EC. So as not to jeopardise the schedule for transposing the directive, 
these parts are separated and carried  forward as a separate draft Act amending the 
Tobacco Products Act.  
II. Main content of the draft  
Regulation of nicotine -free electronic cigarettes and refill containers  
In addition to tobacco products and herbal products for smoking, Directive  2014/40/EU 
also regulates nicotine -containing electronic cigarettes and refill containers.  
Over and above the stipulations of Directive  2014/40/EU, by means of this Act, nicotine -
free electronic cigarettes and refill containers are classed with those containing nicotine if 
this is necessary in order to protect consumers from adverse health effects.  
The attendant health risks posed by these products follow from inhaling an aerosol which, 
regardless of the nicotine, contains substances that are harmful to health. The Federa l 
Institute for Risk Assessment ([German designation:] BfR), in its scientific evaluation of 
25 February  2015, and the German Cancer Research Centre ([German designation:] 
dkfz), in its opinion from 2015, have arrived at these findings. Both the aforementi oned 
institute and centre state that carbonyl compounds, including formaldehyde, acrolein and 
acetaldehyde, originate when consuming both electronic cigarettes containing nicotine 
and those which are nicotine -free. Carbonyl compounds and acetaldehyde are s uspected 
of causing cancer. As of 1  April 2015, formaldehyde is classified as carcinogen 
category  1B in Annex  VI to Regulation  (EC) No.  1272/2008 of the European Parliament 
and of the Council of 16  December  2008 on classification, labelling and packaging o f 
substances and mixtures, amending and repealing Directives  67/548/EEC and 
1999/45/EC, and amending Regulation  (EC) No.  1907/2006 (OJ  L 353 of 
31 December  2008, p.  1) (Commission Regulation  (EU) No.  605/2014 of 5  June  2014 
amending, for the purposes of in troducing hazard and precautionary statements in the 
Croatian language and its adaptation to technical and scientific progress, Regulation  (EC) 
No. 1272/2008 of the European Parliament and of the Council on classification, labelling 
and packaging of substa nces and mixtures, OJ  L 167 of 6  June  2014, p.  36), which 
means that the carcinogenic effect shall be regarded as probable in the case of people. 
Acrolein can also cause irritation and inflammation of the exposed mucous membranes - 9 -  
and lead to necrosis of th e lung tissue when inhaled. Under certain conditions, exposure 
to formaldehyde and other carbonyl compounds may be similar to that experienced with 
traditional tobacco cigarettes. There is no threshold value below which a blending of these 
substances would  be quite safe.  
Advertising  
Ban on outdoor advertising, restrictions on advertising in cinemas and a ban on 
supplying tobacco products free of charge  
In addition to the existing bans on advertising on the radio, in the press and other printed 
media, in inf ormation society services and in other audiovisual commercial 
communication, including television, the draft Act makes provision for a ban on outdoor 
advertising in relation to tobacco products. This ban is to enter into force on 1  July 2020 
following the expiry of a transitional period. In addition, the existing restriction on 
advertising tobacco products in cinemas until after 18:00 in accordance with §  11(5) of the 
Youth Protection Act is replaced by a restriction on advertising tobacco products in 
cinem as which is tied in with the classification of the feature film. In future, the showing of 
promotional films and programmes for tobacco products, electronic cigarettes and refill 
containers is only permitted in connection with films which are characterised  as "Not 
suitable for persons under the age of 18" as per the procedure defined in §  14 of the 
Youth Protection Act. In addition to the ban on the free distribution of tobacco products 
which already exists in connection with the ban on the sponsorship of c ross-border 
events, provision is made for a ban on supplying cigarettes, roll -your-own tobacco and 
water pipe tobacco to consumers free of charge. Smoking tobacco products other than 
cigarettes, roll -your-own tobacco and water pipe tobacco, smokeless tobac co products 
and electronic cigarettes, as well as refill containers, may only continue to be supplied free 
of charge within the business premises of the specialist retailer. In the case of smoking 
tobacco products other than cigarettes, roll -your-own tobac co and water pipe tobacco, as 
well as in the case of smokeless tobacco products, the ban on provision free of charge 
away from business premises of the relevant specialist retailer shall only apply after the 
expiry of a four -year transitional period, i.e. from 20  May 2020.  
The Federal [German] Government estimates that bans on outdoor advertising and the 
continuing restriction on advertising in cinemas, as well as a ban on provision free of 
charge, combined with the advertising bans which are already in for ce, are an effective 
way of bringing about a further reduction in the smoking rate. Outdoor advertising for 
tobacco products is generally prevalent. Cinema advertising takes place in the positively 
perceived context of entertainment. Especially for price -conscious consumers, such as 
young adults, for example, provision free of charge may incentivise them to start or 
continue smoking.  
The Federal [German] Government regards the encroachments accompanying these 
measures on the civil rights and liberties of th e enterprises in question and the tobacco 
industry, as well as on the advertising industry, in particular on the basic rights of freedom 
of expression and the freedom to pursue a professional activity, as vindicated for reasons 
to do with the protection of  public health. In two decisions, i.e. in its decision of 
22 January  1997 – 2 BvR 1915/91 – (Federal Constitutional Court Decisions  95, 173) 
concerning warnings to be shown on unit packets of tobacco products and in its decision 
of 30  July 2008 – 1 BvR 3262/07, 1  BvR 402/08, 1  BvR 906/08 (Federal Constitutional 
Court Decisions  121, 317) concerning protection for non -smokers in restaurants and 
public houses, the Federal Constitutional Court dealt with the issue of tobacco control. 
The Court emphasises that a  high level of importance is assigned to protecting the health 
of the population in the system of values under the Basic Law. An obligation incumbent 
upon the State to protect, which involves the prevention of risk in relation to health 
hazards, could ther efore follow from Article  2(2) of the Basic Law. In view of the number of 
deaths which, on the basis of scientific findings, can be attributed to diseases caused by - 10 -  
second -hand smoke, moreover, human safety is also affected. The constitution also 
substanti ates in this respect an obligation incumbent upon the State to protect which 
dictates that it protects and promotes the life of every individual (Federal Constitutional 
Court Decisions  121, 356 with further references). Since health and, even more so, 
huma n life constitute particularly important assets, their protection may also be sought 
using means which seriously infringe the fundamental right of freedom to pursue a 
professional activity (Federal Constitutional Court Decisions  121, 357).  
With regard to t he ban on outdoor advertising, the protection of children and young 
persons shall also be cited as a further justification since young people are not able to 
evade this form of advertising which is generally prevalent. The correlation between young 
people encountering tobacco advertising and the likelihood of smoking, or starting to 
smoke, has been investigated on a statistically representative basis in several studies also 
related to Germany (e.g. Hanewinkel/Isensee/Sargen/Morgenstern, Cigarette advertisin g 
and adolescent smoking, Am  J PrevMed  2010; 28(4), pp.  359-366; 
Morgenstern/Sargent/Isensee/Hanewinkel, From never to daily smoking in 30  months: the 
predictive value of tobacco and non -tobacco advertising exposure, BMJ  Open  2013; 
3 e002907). Hence, for e xample, the data obtained from the last mentioned study 
confirms a link between the frequency of contact with cigarette advertising and the 
smoking behaviour of young people.  
Extending the bans on advertising is also compatible with the principle of propor tionality. 
Given only a slight decline in the smoking rate, warnings and other action taken previously 
in relation to tobacco control, in defiance of the highly cherished commodity which is press 
freedom, do not constitute a suitable alternative course of action in the face of the 
overriding importance of safeguarding health and young people. Advertising and 
presentation at the point of sale shall otherwise continue to be permitted. In this way, 
given the particularly important reasons of health protection and the protection of young 
people, the advertising measures shall be channelled in such a way that they primarily 
reach individuals who are already present in a relevant retail environment that includes 
presentation of merchandise and possibly promotional  sales talks.  
The Federal Republic of Germany has acceded to the WHO's Framework Convention on 
Tobacco Control of 21  May 2003 ("Tobacco Framework Convention"). This treaty entered 
into force in the Federal Republic of Germany on 16  March  2005. Article  13 o f the 
Convention provides for obligations on the part of the signatories to the convention in 
relation to tobacco advertising, among other things (ban on advertising tobacco products 
in accordance with the constitution or constitutional principles), within  a period of five 
years following its entry into force. Therefore, the bans envisaged can also draw on the 
Tobacco Framework Convention.  
Advertising bans for electronic cigarettes and refill containers  
Article  20(5) of Directive  2014/40/EU stipulates bans on advertising in relation to nicotine -
containing electronic cigarettes and refill containers which comply with the requirements of 
Directive 2003/33/EC relating to the advertising and sponsorship of tobacco products and 
Directive  2010/13/EU concerning the  provision of audiovisual media services (bans on 
advertising on the radio, in the press and other printed media, in information society 
services and in other audiovisual commercial communication).  
Over and above the stipulations of Directive  2014/40/EU  
– outdoor advertising and provision free of charge are also prohibited in relation to 
electronic cigarettes and refill containers, while advertising in cinemas continues to be 
restricted and, hence, the advertising provisions for these products are aligned wit h 
those relating to tobacco products, and  - 11 -  
– nicotine -free electronic cigarettes and refill containers are classed with those 
containing nicotine in terms of the provisions relating to advertising.  
According to Recital  55 of the directive, a Member State shou ld remain free to maintain or 
introduce national laws [applying to all products placed on its national market] for aspects 
not regulated by this directive. Recital  48 makes it especially clear that domestic 
advertising for electronic cigarettes and refill containers is not to be harmonised. Member 
States are encouraged to lay down provisions in this regard.  
The provisions are permitted under constitutional law. Encroachments on the civil rights 
and liberties of the manufacturers of electronic cigarettes and  refill containers are justified 
on the grounds of health protection and the protection of young people.  
As regards the ban on outdoor advertising, the continuing restriction on advertising in 
cinemas and the ban on provision free of charge, reference is m ade to the remarks made 
above regarding products containing nicotine. Here, already given the high level of toxicity 
exhibited by nicotine and its potential for addiction, no other assessment of the proportion 
of the fundamental rights affected can be made . 
Bans on advertising, and advertising restrictions, are also justified in relation to nicotine -
free electronic cigarettes and refill containers on the grounds of health protection and the 
protection of young people.  
Primarily for the younger generation, e lectronic cigarettes have evolved into a lifestyle 
product. Almost 10  % of all 16 -19-year-olds in Germany consumed electronic cigarettes in 
2014 (German Cancer Research Centre (publisher) (2014), E -cigarettes: Awareness and 
consumption in Germany  2012 -2014 ). As a result of the revision of the Youth Protection 
Act […], a restriction on the sale of nicotine -free electronic cigarettes and refill containers, 
and those which do contain nicotine, to young people under the age of 18 was introduced. 
In addition to this, advertising in relation to nicotine -free electronic cigarettes and refill 
containers is to be prohibited on prevention grounds.  
Regardless of the nicotine content, health risks exist in the case of electronic cigarettes as 
a result of evaporation age nts and the release of volatile substances and particles or as a 
result of the fact that many of the flavoured liquids have cytotoxic properties.  
The Federal Institute for Risk Assessment, in its scientific evaluation of 25  February  2015 
(Federal Institute  for Risk Assessment: The risk to the health of children and young people 
posed by so -called electronic shisha pens; Scientific evaluation of the Federal Institute for 
Risk Assessment of 25  February  2015) and the German Cancer Research Centre, in its 
opini on from 2015 (German Cancer Research Centre (publisher), Risk to the health of 
children and young people posed by e -cigarettes: Ban on selling to young people under 
the age of 18 required regardless of the nicotine content. Aus der Wissenschaft – für die 
Politik, Heidelberg, 2015), arrived at these findings.  
Moreover, the smoking ritual as a result of using electronic cigarettes and their "flavours", 
which are especially attractive to children and young people, can be studied through 
children and young peop le who are particularly susceptible to this end and, as a result, 
can generally be encouraged to start smoking or have corresponding behavioural patterns 
imprinted on them.  
III. Alternatives  
None.  - 12 -  
IV. Legislative powers  
The Federal Government's legislative powers f ollow from Article  74(1) point  11 of the 
Basic Law – the law relating to economic matters, and from Article  74(1) point  20 of the 
same – the law on drink and tobacco. The legislative powers relating to the sanctioning of 
individual provisions follow from A rticle  74(1) point  1 of the Basic Law.  
The Federal Government is entitled to legislate in this area of concurrent legislation if and 
insofar as the establishment of equal living conditions throughout Federal territory and the 
preservation of legal or econo mic unity in the national interest makes a Federal -wide 
uniform regulation necessary (Article  72(2) of the Basic Law). The aim of contributing to 
effective protection for the population, especially children and young people, against 
health damage which may  result from tobacco consumption can only be achieved if, 
throughout Federal territory as a whole, uniform provisions shall apply to tobacco products 
and electronic cigarettes or other related products. The provisions of this Act are designed 
to create uni form Federal law and ensure a consistent practice on the part of the 
administrative and supervisory authorities for the Federal territory as a whole so as to 
avoid unequal treatment of the economic operators in question and, hence, considerable 
disadvantag es for the economy as a whole.  
The legislative powers in terms of amending the Tobacco Duty Act follow from 
Article  105(2), in conjunction with Article  106(1), of the Basic Law.  
V. Compatibility with European Union law and international treaties  
If nicotine -free electronic cigarettes and refill containers are regulated over and above the 
stipulations of the directive, this is compatible with European Union law. According to 
Recital  55 of the directive, a Member State should remain free to maintain or introduce  
national laws [applying to all products placed on its national market] for aspects not 
regulated by this directive.  
The provisions envisaged in the area of advertising bans are compatible with European 
Union law. They supplement the bans on tobacco goods envisaged in accordance with 
Directives  2003/33/EC and 2007/65/EC, and which have been transposed into German 
law, as well as the stipulations of Article  20(5) of Directive  2014/40/EU, in areas where the 
European legislator does not have any regulatory com petence.  
VI. Legal consequences  
1. Legal and administrative simplification  
Essentially applying the same regulations to nicotine -free electronic cigarettes and refill 
containers and those which do contain nicotine represents an administrative simplification 
for the supervisory authorities in the Federal States.  
2. Sustainability aspects  
The draft Act is in keeping with the basic ideas of the Federal [German] Government 
regarding sustainable development in the context of the sustainability strategy. The Act is 
designe d to reduce avoidable risks for human health, especially in the case of children 
and young people. Consideration is thereby given to the indicator "Living Longer and in a 
healthier way". The measures laid down in this Act assist in improving the state of h ealth 
of the population.  - 13 -  
3. Budget expenditure without compliance costs  
None.  
4. Compliance costs  
Compliance costs for citizens  
No compliance costs shall be incurred by citizens.  
Compliance costs for businesses  
As regards the estimate of the number of cases, the  report from the consulting firm  PwC 
(PricewaterhouseCoopers), which compiled this report on behalf of 
Interessengemeinschaft Tabakwirtschaft e.V.  (an association concerned with 
safeguarding the specialised interests of the tobacco industry vis -à-vis polit ics, business 
and the media), was taken as a basis. This report includes data on annual rates of change 
as well as information regarding the respective total number of tobacco products.  
On the basis of the regulation of nicotine -free electronic cigarettes and refill containers 
envisaged in this Amending Act, the obligations provided for in the Tobacco Products 
Ordinance for nicotine -containing electronic cigarettes and refill containers, which shall 
result in compliance costs for businesses, shall also appl y to nicotine -free electronic 
cigarettes and refill containers.  
In the absence of reliable data, it is assumed that the compliance costs for nicotine -free 
electronic cigarettes and refill containers are of the same order of magnitude as for 
nicotine -contai ning electronic cigarettes and refill containers.  
Notification obligations are introduced in relation to electronic cigarettes by means of §  24 
of the Tobacco Products Ordinance. The expenditure associated with the first -time 
inclusion of the notification obligations for nicotine -free products is estimated at 
EUR  503 200. Assuming an annual rate of change of 8  %, resulting in new or change 
notifications, ongoing compliance costs amounting to EUR  6 254 shall ensue.  
The annual compliance costs arising from ob ligations to provide information as per §  25 of 
the Tobacco Products Ordinance are estimated at EUR  1 824 for nicotine -free products.  
One-off personnel costs associated with drawing up the instruction leaflet as per §  26 of 
the Tobacco Products Ordinance a re assessed at EUR  14 594. Instruction leaflets must 
be enclosed with all electronic cigarettes and refill containers, resulting in annual costs in 
connection with printing and materials. It is assumed that printing for 10  million units of 
nicotine -free pr oducts can be undertaken economically, resulting in assumed ongoing 
costs of EUR  300 000. 
On the basis of the obligation contained in §  27(1) of the Tobacco Products Ordinance to 
affix a list to the package and outer packaging of the electronic cigarette o r refill container, 
a one -off material cost for nicotine -free products amounting to approximately 
EUR  1 million shall accrue.  
Businesses cannot be compensated for the compliance costs they incur on an ongoing 
basis within this draft legislation. It shall t herefore have to be examined whether an 
appropriate prospect of relief can be demonstrated outside this draft.  
Compliance costs for administration  
No administrative compliance costs shall arise.  - 14 -  
5. Additional costs  
A ban on outdoor advertising is envisaged. A ccording to information from the tobacco 
industry, published in the Federal [German] Government's 2015  report on drugs and 
addiction, in 2013, EUR  69.80  million was spent on outdoor advertising.  
Advertising in cinemas is restricted insofar as the showing o f promotional films and 
programmes for tobacco products, electronic cigarettes and refill containers is only 
allowed if a film as per the procedure defined in §  14 of the Youth Protection Act is 
characterised as "Not suitable for persons under the age of 1 8". According to the Federal 
[German] Government's 2015  report on drugs and addiction, in 2013, EUR  7.7 million was 
spent on advertising in cinemas.  
In future, this expenditure will be curtailed and lasting reductions achieved.  
In the case of nicotine -free electronic cigarettes and refill containers, marginal price 
increases can be expected since these products have been included in the scope of the 
regulations under tobacco law for the first time and new provisions therefore arise for 
manufacturers and imp orters which could be apportioned among the prices as 
appropriate.  
VII. Time limitation; evaluation  
A time limitation cannot be imposed on the Act.  
B. Specific Part  
Re Article  1 (Amending the  Tobacco Products Act)  
Re Point  1 
The Table of contents is supplemented to include the newly to be inserted §§  20a and 20b 
concerning the ban on outdoor advertising and the ban on sellin g and displaying free of 
charge.  
Re Point  2 
The definitions mentioned in Article  2 of Directive  2014/40/EU under points  16 and 17 are 
expanded to include nicotine -free electronic cigaret tes and refill containers. If a situation of 
equality is not to be achieved, the individual provisions shall contain a corresponding 
clarification.  
Re Point  3 
Re Letter  a 
The definition relating to outdoor advertising is inserted. The list included is not definitive.  
Re Letter  b 
Consequential amendmen t. - 15 -  
Re Point  4 
Re Letter  a 
The newly inserted paragraph  1 stipulates that tobacco products which contain plant 
protec tion products within the meaning of Article  2(1) of Regulation  (EC) No.  1107/2009 of 
the European Parliament and of the Council of 21  October  2009 concerning the placing of 
plant protection products on the market and repealing Council Directives  79/117/EEC  and 
91/414/EEC (OJ  L 309 of 24  November  2009, p.  1) or their breakdown or reaction 
products, or to which plant protection products or their breakdown or reaction products 
adhere, may only be placed on the market if the plant protection products are author ised 
for this area of application in Germany, in another Member State, or in another Signatory 
State to the Agreement on the European Economic Area. Plant protection products which 
are authorised for this area of application in a third country, and which a re used there, 
shall be treated as equal.  
Re Letter  b 
Consequential amendment.  
Re Point  5 
Re Letter  a 
Clarification is provided of the fact that the provision under §  14(1) of the Tobacco 
Products Act shall only apply to nicotine -containing electronic cigarettes and refill 
containers. Paragraph  1 tran sposes the stipulations under Article  20(3a) and (3b) of 
Directive  2014/40/EU. According to this, liquids containing nicotine may have a maximum 
nicotine content of 20  mg/ml. Maximum volumes are also laid down in relation to refill 
containers and single -use electronic cigarettes and non -refillable cartridges. It is therefore 
not possible, or necessary, to apply this provision to nicotine -free electronic cigarettes and 
refill containers as well.  
Re Letter  b 
Clarification is provided of the fact that the provision under §  14(2) of the Tobacco 
Products Act shall only apply to nicotine -containing electronic cigarettes and refill 
containers. According to this, in order to ensure protection of h ealth and safety, e.g. to 
avoid the risk of inadvertently consuming high doses of nicotine, electronic cigarettes 
containing nicotine may only be placed on the market if the nicotine dose is provided on a 
consistent level under normal conditions of use thr oughout its operating life. It is not 
necessary to apply this provision to nicotine -free electronic cigarettes and refill containers 
as well.  
Re Point  6 
Clarification is provided of the fact that the provision under §  15(1) point  2a of the Tobacco 
Products Act shall only apply to nicotine -containing electronic cigarettes and refill 
containers. Point  2a serves to transpose Article  20(4b)(iii) of Directive  2014/40/EU and 
stipulates that pac kages and outer packaging of nicotine -containing electronic cigarettes 
and refill containers shall carry a health warning. According to Article  20(4b)(iii), this health 
warning shall relate to the nicotine content. The provision cannot apply to nicotine -free 
products.  
Re Point  7 
The newly inserted §  20a includes the ban on outdoor advertising in relation to tobacco 
products, electronic cigarettes and refill containers. Advertising on the external surfaces of - 16 -  
business premises of specialist retailers (brickwork and windows) shall continue to be 
permitted.  
In addition to the ban on the free distribution of tobacco products which already exists in 
connection with the ban on the sponsorship of  cross -border events, provision is made in 
paragraph  1 of the newly inserted §  20b for a ban on supplying cigarettes, roll -your-own 
tobacco and water pipe tobacco to consumers free of charge. According to paragraph  2, 
smoking tobacco products other than ci garettes, roll -your-own tobacco and water pipe 
tobacco, smokeless tobacco products and electronic cigarettes, as well as refill 
containers, may only continue to be supplied free of charge within the business premises 
of the specialist retailer.  
§ 20b(3) se ts out the ban hitherto contained in §  29 of the Tobacco Duty Act concerning 
the displaying of tobacco products on a commercial basis and extends this ban to include 
electronic cigarettes and refill containers.  
Re Point  8 
The area of application of §  21 of the Tobacco Products Act is expanded to include 
electronic cigarettes and refill containers. Manufacturers of electronic cigarettes and refill 
containers should also be prohibited from suggesting, either through the use of names or 
other assertions, that electronic cigarettes do not present any health risk. Promotional 
information which particularly appeals to young people or adolescents, but also, for 
instance, the pictorial representat ion of young people and adolescents, or of situations 
and environments which are typical for young people, are also prohibited. The use of 
names or assertions which point to the fact that ingredients of electronic cigarettes or refill 
containers are natura l or unadulterated is prohibited.  
Re Point  9 
Re Letter  a 
Compulsory registration, as provided for by Directive  2014/ 40/EU, with both the 
competent authority at its place of business and with the competent authorities in the 
Member State in which the distance selling takes place, or is intended to take place, 
cannot be envisaged in this way in relation to nicotine -free e lectronic cigarettes and refill 
containers. The question as to whether registration for individuals who exclusively place 
nicotine -free electronic cigarettes and refill containers on the market for the purpose of 
distance selling is possible or necessary i n other Member States is determined by national 
law in the Member State in question. In this respect, it can merely be stipulated that these 
individuals have to be registered with the competent authority at home.  
Re Letter  b 
Consequential amendment.  
Re Point  10 
Re Letter  a 
A penalty for the new §  9(1) is added.  
Re Letter  b 
The consequential amendment follows from the insertion of the new §  9(1). - 17 -  
Re Point  11 
Re Letter  a 
A reinforcement of infringements of the new §§  20a and 20b is added.  
Re Letter  b 
Consequential amendment.  
Re Letter C 
Consequential amendment.  
Re Point  12 
The consequential amendment follows from the insertion of the new §  9(1). 
Re Point  13 
In § 47 (Transitional provisions), paragraphs  6 and 7 are added.  
Paragraph  6 stipulates that the ban on outdoor advertising shall apply as of 1  July 2020.  
According to paragraph  7, the ban on provision free of charge away from business 
premis es of the relevant specialist retailer shall only apply to smoking tobacco products 
other than cigarettes, roll -your-own tobacco and water pipe tobacco, as well as to 
smokeless tobacco products, following the expiry of a four -year transitional period, i.e.  
from 20  May 2020.  
Re Article  2 (Amending the Youth Protection Act)  
Re Point  1 
Re Letter  a 
This change is made since in future, the restriction on advertising in cinemas shall no 
longer be tied to the time at which the film is shown but shall be geared to whether a film 
is characterised as "Not suitab le for persons under the age of 18" as per §  14 of the Youth 
Protection Act.  
Re Letter  b 
The showing of promotional films and programmes for tobacco products, electronic 
cigarettes and r efill containers is only permitted in connection with films which are 
characterised as "Not suitable for persons under the age of 18" as per the procedure 
defined in §  14 of the Youth Protection Act.  
Re Point  2 
A reinforcement of infringements of the new §  11(6) is added.  
Re Article  3 (Amending the Tobacco Duty Act)  
The amendment follows from the insertion of the new §  20b(2).  - 18 -  
Re Point  1 
The regulatory content regarding provision to consumers free of charge in the previous 
§ 25 sentence  2 of the Tobacco Duty Act is deleted.  
Re Point 2 
The ban on displa ying tobacco goods on a commercial basis is incorporated in §  20b(3). 
§ 29 of the Tobacco Duty Act can therefore be rescinded.  
Re Point 3 
Consequential amendments relating to point  2. 
Re Article  4 (Entry into force)  
Article  4 contains the provision relating to entry into force.