1. ------IND- 2016 0238 D-- EN- ------ 20160602 --- --- PROJET 
Draft bill  
of the Federal Ministry of Food and Agriculture  
Draft Second Ordinance amending the Tobacco Products Ordinance  
A. Problem and objective  
Directive  2014/40/EU of the European Parliamen t and of the Council 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 is to  be transposed by 20  May 2016. D i-
rective  2014/40/EU is transposed by the Tobacco Products Act of 4  April (Federal Law 
Gazette I p.  f569), as amended by the Act of […], and the Tobacco Products Ordinance 
enacted on the basis of this Act of 27  April 2016 (Fe deral Law Gazette I p.  980), last 
amended by […].  
In accordance with Article  7(6), in conjunction with Article  20(3c), of Directive  2014/40/EU, 
tobacco products, electronic cigarettes and refill containers containing the following add i-
tives may not be plac ed on the market:  
– vitamins or other additives that create the impression that a tobacco product, ele c-
tronic cigarette or refill container has a health benefit or presents reduced health 
risks; 
– caffeine or taurine or other additives and stimulant compounds that are associated 
with energy and vitality ; 
– additives having colouring properties for emissions ; 
– in the case of tobacco products for smoking, electronic cigarettes and refill containers: 
additives that facilitate inhalation or nicotine uptake ; 
– additives that have CMR [carcinogenic, mutagenic or reprotoxic] properties in unburnt 
form.  
The additives prohibited in particular must be substantiated by the Member States. Since 
the regulatory content referred to represents supplementary provisions regarding the stip-
ulations under Directive  2014/40/EU and takes up the stipulations in the directive, this 
content has to be notified in accordance with Directive  (EU) 2015/1535.  
B. Solution  
The stipulations under Directive  2014/40/EU relating to additives are implement ed within 
the framework of an Amending Order to the Tobacco Products Ordinance. The additives 
prohibited are listed in Appendices  1 and 2 to the Tobacco Products Ordinance.  
Furthermore, the Amending Order makes provision for supplementary regulations relat ing 
to the Tobacco Products Ordinance, necessitated as a result of the inclusion of nicotine -
free electronic cigarettes and refill containers in the regulation through the Act amending 
the Tobacco Products Act.   - 2 -   
 C. Alternatives  
None.  
D. Budget expenditure w ithout compliance costs  
None.  
E. Compliance costs  
E.1 Compliance costs for citizens  
No compliance costs shall be incurred by citizens.  
E.2 Compliance costs for businesses  
Businesses shall incur a one -off reorganisation cost amounting to EUR  13 000 as a res ult 
of this Ordinance. Ongoing compliance costs shall not arise.  
The compliance costs associated with the Tobacco Products Ordinance are illustrated 
therein in detail.  
E.3 Administrative compliance costs  
No administrative compliance costs shall arise.  
F. Additional costs  
By means of Annexes  1 and 2, provisions relating to a ban are largely newly introduced 
with regard to the ingredients of tobacco products, electronic cigarettes and refill contai n-
ers. In this way, products which do not comply with the stipu lations are to be withdrawn 
from the market.  
The result of this may be that the economy may forego profits which hitherto arose 
through the sale of these products. Lost profits for businesses cannot be estimated since 
the latter have not made any figures a vailable on demand either.   - 3 -   
 Draft bill of the Federal Ministry of Food and Agriculture  
Second Ordinance amending the Tobacco Products Ordinance1) 
dated …  
The following is decreed on the basis of  
§ 5(2) point  3, § 13(2) point  1, § 15(2) and §  23(1) point  1f(aa) of the Tobacco Pro d-
ucts Act of 4  April 2016 (Federal Law Gazette I p.  569), by the Federal Ministry of Food 
and Agriculture, in consultation with the Federal Ministry of Economic Affairs and Energy, 
and on the basis of  
§ 7(2) sentence  2 point  4 of the  Tobacco Products Act of 4  April 2016 (Fede r-
al Law Gazette I p.  569), as amended by Article  1 of the Act of […], by the Federal Mini s-
try of Food and Agriculture, in consultation with the Federal Ministry of Finance, and on 
the basis of  
§ 6(2) point  1 of th e Tobacco Products Act of 4  April 2016 (Federal  Law Gazette I 
p. 569), by the Federal Ministry of Food and Agriculture, in consultation with the Federal 
Ministry of Economic Affairs and Energy and the Federal Ministry of Health:  
Article 1  
Amending the Tobacco Produ cts Ordinance  
The Tobacco Products Ordinance of 27  April 2016 (Federal Law Gazette I p.  980), 
last amended by […], is amended as follows:  
1. In § 13(4) sentence  1, the words “ and water pipe tobacco”  are inserted after the 
words “ In the case of roll -your-own t obacco ”. 
2. § 20(4) is amended as follows:  
a) In sentence  1, the words “in writing” are deleted.  
b) The following sentence  4 is added:  
“Economic operators are obliged to keep the records for three years, starting 
from the date when the individual distinguishing fea ture of the tobacco product 
was made available to the economic operator in accordance with paragraph  1.” 
3. In § 24(1) point  3, the words “ if the electronic cigarette or the refill container contains 
nicotine, ” are added.  
4. In § 26(1) point  5, the words “ if the  electronic cigarette or the refill container contains 
nicotine, ” are added.  
5. § 27 is amended as follows:  
                                                
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 -   
 a) Paragraph  1 sentence  2 is amended as follows:  
aa) In point  2, the words “ if the electronic cigarette or the refill container contains 
nicotine,”  are added.  
bb) In point  4, the words “ and adolescents”  are inserted after the word “ children” . 
b) Paragraph  2 is worded as follows:  
“(2) If the electronic cigarette or the refill container contains nicotine, in add i-
tion to the requirements as per paragraph  1, the unit pack ets and outside packa g-
ing must carry the following health warning:  
“This product contains nicotine, a substance which is very highly addictive.”  
6. The following paragraph  3 is added to §  34: 
“(3) Appendix  1 point  4d(aa) shall apply as of 20  May 2020.”  
7. Append ix 1 is worded as follows:  
“Appendix  1 
Prohibited additives in tobacco products  
Re §  4 
1. Vitamins and the following other additives that create the impression that a t o-
bacco product would offer a health benefit or would carry lower health risks:  
a) Amino acids and modified amino acids which are approved for dietary foods 
pursuant to §  7(1) sentence  1 point  1, in conjunction with Appendix  2 categ o-
ry 3, of the Order on dietetic foodstuffs, as amended, along with S -Adenosyl 
methionine and L -5-Hydroxytryptophan  
b) Carn itine 
L-carnitine  
L-carnitine hydrochloride  
L-carnitine L -tartrate  
c) Flavonoids and phospholipids with an antioxidative effect  
d) Sodium selenite  
2. Caffeine, taurine or the following other additives and stimulant compounds that 
are associated with energy and vita lity: 
a) Maltodextrin  
b) Components, including processed components, extracts and oils, of the co f-
fee plant and coffee beans  
c) Components, including processed components, extracts and oils, of the tea 
bush Camellia sinensis  L. Kuntze   - 5 -   
 d) Components, including processe d components, extracts and oils, of the gu a-
rana plant  
e) Components, including processed components, extracts and oils, of the ye r-
ba mate  
f) Thujone  
3. Additives having colouring properties for emissions  
4. The following additives in the case of tobacco products for s moking that facilitate 
inhalation or nicotine uptake:  
a) p-menthane -3 substituted and modified compounds, including  
p-menthane -3-carboxamide, including p -menthane -3-N-[alkyl]carboxamide  
p-menthane -3-ester  
p-menthane -3-ether  
p-menthane -3-carboxylic acids and t heir esters  
Menthone 1,2 -glycerol ketal (CAS No  63187 -91-7) 
b) p-menthane alcohols and their esters  
c) The following compounds:  
3,4-dihydro -3-(2-hydroxyphenyl) -6-(3-nitrophenyl) -(1H)-pyrimidine -2-on (CAS 
No 36945 -98-9) 
2-isopropyl -N 2,3 -trimethylbutyramide (CAS No 51115 -67-4) 
Isopulegol (CAS No  7786 -67-6 or 89 -79-2) 
1-(di-sec-butyl -phoshine) -heptane  
d) The following substances:  
aa) Menthol (CAS No  1490 -04-6) 
(-)-menthol (CAS No  2216 -51-5) 
(+)-menthol (CAS No  15356 -60-2) 
bb) Menthone (CAS No  89-80-5) 
(-)-menthone (CAS No  14073-97-3) 
(+)-menthone (CAS No  3391 -87-5) 
L-carvone (CAS No  6485 -40-1) 
Geraniol (CAS No  106-24-1) 
Linalool (CAS No  78-70-6)  - 6 -   
 1,8-cineole (Eucalyptol) (CAS No  470-82-6) 
Hydroxycitronellal (CAS No  107-75-5) 
e) The following substances derived from plants:  
Oils an d components which originate from plants of the genera Mentha , Eu-
calyptos , Ocimum , Thymus  and Salvia  
5. The following additives that have CMR properties in unburnt form:  
a) Substances which are classified as category  1A, 1B or 2 CMR substances in 
accordance with  Part 3 of Annex  VI to Regulation (EC) No  1272/2008 of the 
European Parliament and of the Council [of 16  December  2008] on classif i-
cation, labelling and packaging of substances and mixtures, amending and 
repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation 
(EC) No  1907/2006 (OJ  L 351 of 31  December  2008, p.  1), last amended by 
Regulation (EU) 2015/491 (OJ  L 78 of 24  March  2015, p.  12). 
b) The following additional substances:  
Birch tar oil (CAS No  8001 -88-5 and CAS No  85940 -29-0) 
Juniper tar oil (CAS No  8013 -10-03) 
Sassafras oil  
Sassafras wood  
Sassafras leaves  
Sassafras bark  
Methyl eugenol (CAS No  93-15-2) 
Estragole (CAS No  140-67-0) 
Para -hydroxybenzoic acid propyl ester (CAS No 94 -13-3)” 
8. Appendix  2 is worded as follows:  
“Appendix  2 
Prohibited  ingredients in electronic cigarettes and refill containers  
Re §  28 
1. Vitamins and the following other additives that create the impression that the 
consumption of an electronic cigarette or a refill container would have a health 
benefit or present reduced h ealth risks:  
a) Amino acids and modified amino acids which are approved for dietary foods 
pursuant to §  7(1) sentence  1 point  1, in conjunction with Appendix  2 categ o-
ry 3, of the Order on dietetic foodstuffs, as amended, along with S -Adenosyl 
methionine and L -5-Hydroxytryptophan  
b) Carnitine   - 7 -   
 L-carnitine  
L-carnitine hydrochloride  
L-carnitine L -tartrate  
c) Flavonoids and phospholipids with an antioxidative effect  
d) Sodium selenite  
2. Caffeine, taurine or the following other additives and stimulant compounds that 
are associ ated with energy and vitality:  
a) Maltodextrin  
b) Glucose, fructose and galactose  
c) Components, including processed components, extracts and oils, of the co f-
fee plant and coffee beans  
d) Components, including processed components, extracts and oils, of the tea 
bush Camellia sinensis  L. Kuntze  
e) Components, including processed components, extracts and oils, of the gu a-
rana plant  
f) Components, including processed components, extracts and oils, of the ye r-
ba mate  
g) Thujone  
3. Additives having colouring properties for emissions  
4. The following additives that facilitate inhalation or nicotine uptake:  
Menthol (CAS No  1490 -04-6) 
(-)-menthol (CAS No  2216 -51-5) 
(+)-menthol (CAS No  15356 -60-2) 
5. The following additives that have CMR properties in unburnt form:  
a) Substances which are classified a s category  1A, 1B or 2 CMR substances in 
accordance with Part  3 of Annex  VI to Regulation (EC) No  1272/2008 of the 
European Parliament and of the Council [of 16  December  2008] on classif i-
cation, labelling and packaging of substances and mixtures, amending and 
repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation 
(EC) No  1907/2006 (OJ  L 351 of 31  December  2008, p.  1), last amended by 
Regulation (EU) 2015/491 (OJ  L 78 of 24  March  2015, p.  12). 
b) The following additional substances:  
Birch tar o il (CAS No  8001 -88-5 and CAS No  85940 -29-0) 
Juniper tar oil (CAS No  8013 -10-03) 
Sassafras oil   - 8 -   
 Sassafras wood  
Sassafras leaves  
Sassafras bark  
Methyl eugenol (CAS No  93-15-2) 
Estragole (CAS No  140-67-0) 
Para -hydroxybenzoic acid propyl ester (CAS No 94 -13-3) 
6. The following ingredients, excluding nicotine, in the liquid which, when heated or 
in its unheated form, pose a risk to human health:  
b) The following flavourings:  
Diacetyl (2,3 -butanedione) (CAS No  431-03-8) 
2,3-pentanedione (CAS No  600-14-6) 
2,3-hexanedione  (CAS No  3848 -24-6) 
2,3-heptandion (CAS No  96-04-8) 
Coumarin  
c) The following substances derived from plants:  
Bitter almond oil  
Processed components and extracts of the rootstock of the common polyp o-
dy 
Processed components, extracts and oils which originate f rom the Penn y-
royal plant  
Agaric acid”  
Article 2  
Entry into force  
Sentence  2 notwithstanding, this Ordinance shall enter into force on the day following 
promulgation. Article  1 points  7 and 8 shall enter into force as of 20  May 2016.  
Approved by the Bundesrat .  - 9 -   
 Expl anatory statement  
A. General Part  
I. Objective and necessity of the provisions  
Directive  2014/40/EU of the European Parliament and of the Council 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 is to be transposed by 20  May 2016. D i-
rective  2014/40/EU is transposed by the Tobacco Products Act of 4  April (Federal Law 
Gazette I p.  f569), as amended by the Act of […], and the Tobacco Products Ordinance 
enacted on the basis of this Act of 27  April 2016 (Federal Law Gazette I p.  980), last 
amended by […].  
Since the regulatory content referred to represents supplementary provisions regardi ng 
the stipulations under Directive  2014/40/EU and takes up the stipulations in the directive, 
this content has to be notified in accordance with Directive  (EU) 2015/1535.  
II. Main content of the draft  
In accordance with Article  7(6), in conjunction with Artic le 20(3c), of Directive  2014/40/EU, 
tobacco products, electronic cigarettes and refill containers containing the following add i-
tives may not be placed on the market:  
– vitamins or other additives that create the impression that a tobacco product, ele c-
tronic cigarette or refill container has a health benefit or presents reduced health 
risks,  
– caffeine or taurine or other additives and stimulant compounds that are associated 
with energy and vitality,  
– additives having colouring properties for emissions,  
– in the ca se of tobacco products for smoking, electronic cigarettes and refill containers: 
additives that facilitate inhalation or nicotine uptake,  
– additives that have CMR properties in unburnt form.  
The additives prohibited in particular must be substantiated by th e Member States. They 
are listed in Appendices  1 and 2 to the Ordinance.  
Furthermore, the Amending Order makes provision for supplementary regulations relating 
to the Tobacco Products Ordinance, necessitated as a result of the inclusion of nicotine -
free el ectronic cigarettes and refill containers in the regulation through the Act amending 
the Tobacco Products Act.  
The attendant health risks posed by nicotine -free electronic cigarettes and refill containers 
follow from inhaling an aerosol which, regardless o f the nicotine, contains substances that 
are harmful to health. The Federal Institute for Risk Assessment, in its scientific evaluation 
of 25  February  2015, and the German Cancer Research Centre, in its opinion from 2015, 
have arrived at these findings. Bo th the aforementioned institute and centre state that ca r-
bonyl compounds, including formaldehyde, acrolein and acetaldehyde, originate when  - 10 -   
 consuming both electronic cigarettes containing nicotine and those which are nicotine -
free. Carbonyl compounds and a cetaldehyde are suspected of causing cancer. As of 
1 April 2015, formaldehyde is classified as carcinogen category  1B in Annex  VI to Regul a-
tion (EC) No  1272/2008 of the European Parliament and of the Council of 
16 December  2008 on classification, labelling  and packaging of substances and mixtures, 
amending and repealing Directives  67/548/EEC and 1999/45/EC, and amending Regul a-
tion (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 introducing 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 packag ing of substances and mixtures, OJ  L 167 of 
6 June  2014, p.  36), which means that the carcinogenic effect shall be regarded as pro b-
able in the case of people. Acrolein can also cause irritation and inflammation of the e x-
posed mucous membranes and lead to n ecrosis of the lung tissue when inhaled. Under 
certain conditions, exposure to formaldehyde and other carbonyl compounds may be sim i-
lar to that experienced with traditional tobacco cigarettes. There is no threshold value b e-
low which a blending of these sub stances would be quite safe.  
III. Alternatives  
None.  
IV. Compatibility with European Union law and international treaties  
Application of the bans on additives arising from Appendix  2 to also include nicotine -free 
electronic cigarettes and refill containers is compa tible with the laws of the European U n-
ion. According to Recital 55 of the directive, a Member State should remain free to mai n-
tain or introduce national laws [applying to all products placed on its national market] for 
aspects not regulated by this directi ve. 
V. 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 su pervisory authorities in the Federal States.  
2. Sustainability aspects  
The Ordinance is in keeping with the basic ideas of the Federal [German] Government 
regarding sustainable development in the context of the sustainability strategy. By means 
of the Ordinan ce, avoidable risks for human health are to be reduced. Consideration is 
thereby given to the indicator “Living Longer and in a healthier way.” The measures laid 
down in this Ordinance assist in improving the state of health of the population.  
3. Budget expen diture without compliance costs  
None.   - 11 -   
 4. Compliance costs  
Compliance costs for citizens  
No compliance costs shall be incurred by citizens.  
Compliance costs for businesses  
Owing to the amendment of §  27(1) sentence  2 point  4, the notice to be affixed to the un it 
packet and outside packaging is to be supplemented by two words. In consultation with 
the Federal Statistical Office, revision of the existing text is estimated to require one hour’s 
work. The number of label designs is assumed to be 200, meaning one -off reorganisation 
costs in the region of EUR  13 000 (200 cases x EUR  65.90/hour x 1 hour). Ongoing co m-
pliance costs shall not arise.  
The compliance costs associated with the Tobacco Products Ordinance are illustrated 
therein in detail.  
Administrative compli ance costs  
No administrative compliance costs shall arise.  
5. Other legal consequences  
By means of Appendices  1 and 2, provisions relating to a ban are introduced with regard 
to the ingredients of tobacco products, electronic cigarettes and refill containers.  As a r e-
sult, products which do not comply with the stipulations are to be withdrawn from the ma r-
ket. 
The result of this may be that the economy may forego profits which hitherto arose 
through the sale of these products. Lost profits for businesses cannot be estimated since 
the latter have not made any figures available on demand either.  
VI. Time limitation; evaluation  
A time limitation cannot be imposed on the Ordinance.  
B. Specific Part  
Re Article  1 (Amending the Tobacco Products Ordinance)  
Re point  1 
§ 13 of  the Tobacco Products Act describes requirements in terms of the general warning 
and the information messages in the case of cigarettes, roll -your-own tobacco and water 
pipe tobacco. Since water pipe tobacco is sold in cuboid and cylindrical packets, as r e-
gards the cylindrical packets in §  13(4), water pipe tobacco shall be included alongside 
roll-your-own tobacco.  
This is necessary in order to ensure the capacity to act in terms of execution with regard 
to the assessment of the affixing of the warning and the information messages in the case 
of cylindrical packets of water pipe tobacco.  
The enabling act is §  6(2) point  1 of the Tobacco Products Act.   - 12 -   
 Re point  2 
Re letter  a 
Letter  a contains a clarification of the intention.  
The enabling act is §  7(2) sentenc e 2 point  4 of the Tobacco Products Act.  
Re letter  b 
As regards information to be tracked, such as invoice and order numbers as well as pa y-
ment receipts from all the purchasers in the distribution chain within the meaning of 
§ 20(1) point  2 of the Tobacco Products Ordinance, it is recommended stipulating rete n-
tion periods. Especially in the case of special tobacco products, such as water pipe toba c-
co, to some extent, a high level of market fluctuation is envisaged, involving the setting up 
and closure of bu sinesses.  
The enabling act is §  7(2) sentence  2 point  4 of the Tobacco Products Act.  
Re point  3 
Clarification is provided of the fact that the provision under §  24(1) point  3 of the Tobacco 
Products Ordinance shall only apply to nicotine -containing electro nic cigarettes and refill 
containers. §  24(1) transposes Article  20(3) of Directive  2014/40/EU and cites the info r-
mation which has to be communicated by manufacturers and importers of electronic cig a-
rettes or refill containers. Point  3 concerns information  relating to the nicotine dose and 
uptake and consequently does not apply to nicotine -free electronic cigarettes or refill co n-
tainers.  
The enabling act is §  23(1) point  1f(aa) of the Tobacco Products Act.  
Re point  4 
Clarification is provided of the fact th at the provision under §  26(1) point  5 shall only apply 
to nicotine -containing electronic cigarettes and refill containers. In transposition of Art i-
cle 20(4a) of Directive  2014/40/EU, §  26 sets out the requirements which are imposed on 
the package insert w hich has to be included in the packet as per §  15(1) point  1 of the 
Tobacco Products Act. Point  5 concerns the addictive nature and shall only apply to pro d-
ucts containing nicotine.  
The enabling act is §  15(2) point  1 of the Tobacco Products Act.  
Re point  5 
Re letter  a 
§ 27(1) transposes Article  20(4b) and (4c) of Directive  2014/40/EU and sets out the r e-
quirements pertaining to the design of unit packets and outside packaging of electronic 
cigarettes and refill containers.  
Point  2 sets out the obligation re garding the indication of nicotine content and nicotine 
output per dose and does not apply to nicotine -free products.  
The amendment of point  4 also assists in adaptation in line with the Act on the protection 
of children and adolescents against the dangers  associated with the consumption of ele c-
tronic cigarettes and electronic shisha pens of 3  March  2016 (Federal Law Gazette 
I p. 369).   - 13 -   
 The enabling act is §  15(2) points  3 and 4 of the Tobacco Products Act.  
Re letter  b 
§ 27(2) transposes Article  20(4b)(iii) of Directive  2014/40/EU and prescribes a warning for 
nicotine -containing electronic cigarettes and refill containers which relates to the nicotine 
content. The provision cannot apply to nicotine -free products.  
The enabling act is §  15(2) point  2 of the Tob acco Products Act.  
Re point  6 
Since the additives indicated in Appendix  1 point  4d(aa) are not only regarded as add i-
tives that facilitate inhalation or nicotine uptake but, at the same time, are to be classified 
as characterising flavours within the meanin g of Article  7(14) of Directive  2014/40/EU, this 
provision shall only apply in transposition of Article  7(14) referred to as of 20  May 2020.  
Re point  7 
Appendix  1 of the Tobacco Products Ordinance is reworded by means of point  7. 
Point  1: 
Appendix  1 point  1 transposes Article  7(6a) of Directive  2014/40/EU and includes the 
principle postulated therein whereby, in addition to the vitamins specifically named, add i-
tives which are designed to evoke the health -related impressions or associations cited on 
the part  of consumers, or in accordance with the suggestions of the manufacturers, are 
also prohibited. At the same time, it is irrelevant whether a health benefit or reduced 
health risk on the basis of scientific criteria is actually inherent in these additives.  
Letter  a: 
Certain amino acids and modified amino acids are approved as additives for dietary foods 
in the Order on dietetic foodstuffs as per §  7(1) point  1 in Appendix  2 category  3. The h u-
man body needs essential amino acids (in specific situations or for  certain illnesses or 
disorders, semi -essential and conditionally essential amino acids) and must absorb these 
from food. In this respect, amino acids have important physiological functions in the h u-
man body and a health benefit is associated with them.  
Letter b: 
Carnitine, including L -carnitine, L -carnitine hydrochloride and L -carnitine -L-tartrate, are 
likewise approved under the Order on dietetic foodstuffs as ingredients in foodstuffs i n-
tended for particular nutritional uses. Carnitine plays an essential  role in the energy m e-
tabolism of animal cells and is often recommended as a supplement where the intention is 
to lose weight so as to achieve improved fatty acid conversion.  
Letter  c: 
Anti-oxidant effects are especially ascribed to flavonoids and phosphol ipids with an antio x-
idative effect on account of their cell -protecting function and their properties as radical 
scavengers.   - 14 -   
 Letter  d: 
Selenium is an essential trace element and is frequently obtained through dietary suppl e-
ments. In addition to oral intake,  the inhalation of sodium selenite is also promoted by 
suppliers of inhalers with a view to improving immune function.  
Point  2: 
Appendix  1 point  2 transposes Article  7(6b) of Directive  2014/40/EU and includes the 
principle postulated therein whereby, in ad dition to caffeine and taurine, other additives 
and stimulant compounds that are associated with energy and vitality are also prohibited. 
As is the case under point  1, it is not necessary that these additives or stimulant co m-
pounds actually enhance mental alertness or physical performance.  
Maltodextrin is a readily available carbohydrate which is frequently used as an energy 
source in sports nutrition.  
Coffee, coffee beans, tea, guarana and mate tea are widely associated with stimulating 
properties on accou nt of their caffeine content.  
Thujone is especially promoted in absinthe on account of its possible euphoric and aphr o-
disiac effects.  
Point  3: 
Point  3 transposes Article  7(6c) of Directive  2014/40/EU and includes the principle wher e-
by additives having colo uring properties for emissions are prohibited.  
Point  4: 
Point  4 transposes Article  7(6d) of Directive  2014/40/EU and includes the principle wher e-
by additives that facilitate inhalation or nicotine uptake are prohibited in the case of toba c-
co products for s moking.  
According to letters  a to e, certain TRPM8 agonists are prohibited. The scientific asses s-
ment carried out by the Federal Institute for Risk Assessment has revealed that activation 
of the TRPM8 is the key physiological mechanism of action which faci litates inhalation by 
masking the components of smoke which cause respiratory tract irritation. Known TRPM8 
agonists are listed and assigned to certain groups of substances.  
Menthol, which is a monocyclic terpene and exists as a component of essential oils  in 
various species of the plant genus Mentha , must be particularly emphasised in this r e-
gard. The pharmacological effects have been investigated adequately on the basis of a 
scientific assessment carried out by the Federal Institute for Risk Assessment an d include 
an activation of heat -sensitive receptors, whereby a cooling effect arises in the area of the 
tongue and oral cavity. Added to this is a local anaesthetic effect. The effects may allev i-
ate the excitations and irritations in the oral cavity and ph arynx and, as a result, suppress 
the natural defence mechanisms associated with the inhalation of tobacco smoke.  
Point  5: 
Point  5 transposes Article  7(6d) of Directive  2014/40/EU and includes the principle wher e-
by additives that have CMR properties in unbu rnt form are prohibited.   - 15 -   
 Letter  a: 
Under letter  a, reference is made to substances which are classified as category  1A, 1B or 
2 CMR substances in accordance with Part  3 of Annex  VI to Regulation (EC) 
No 1272/2008. Category  1A CMR substances are substances where proof has been fu r-
nished of their CMR properties in people. Category  1B substances are substances where 
proof has been furnished of their CMR properties in experiments involving animals. Cat e-
gory 2 substances are substances which are suspected of hav ing CMR properties. All 
these substances are prohibited from being used as additives for reasons to do with pr e-
ventative health protection.  
Letter  b: 
Letter  b lists other substances having CMR properties.  
According to a scientific assessment carried out by  the Federal Institute for Risk Asses s-
ment, birch tar oil and juniper tar oil have relatively high levels of polycyclical aromatic 
hydrocarbons (PAH). PAH have been found to be carcinogenic. The high PAH contents 
arise as a result of the particular product ion methods of both oils, which differ from other 
oils. 
Sassafras oil, sassafras wood, sassafras leaves and sassafras bark are classified as ge n-
otoxic and carcinogenic according to the Federal Institute for Risk Assessment.  
The same applies to methyl eugen ol and estragole on account of their carcinogenic e f-
fects.  
As regards para -hydroxybenzoic acid propyl esters (E 215, E 216 and E 217), according 
to the Federal Institute for Risk Assessment, they exhibit indications of reprotoxic effects.  
The enabling act is § 5(2) point  3 of the Tobacco Products Act.  
Re point  8 
Appendix  2 of the Tobacco Products Ordinance is reworded by means of point  8. 
Points  1 to 5 transpose Article  20(3c) of Directive  2014/40/EU, according to which, add i-
tives which are prohibited for t obacco products pursuant to Article  7(6) of D i-
rective  2014/40/EU shall also be prohibited in the case of electronic cigarettes and refill 
containers. At a national level, there has been an extension of this principle inasmuch as 
the bans shall also apply t o nicotine -free electronic cigarettes and refill containers.  
Point  1: 
Reference is made to the explanation under Appendix  1 point  1. 
Point  2: 
Reference is made to the explanation under Appendix  1 point  2. 
Glucose, fructose and galactose are the most well -known simple sugars, they are rapidly 
available energy sources, and are therefore associated with energy and vitality.  
Point  3: 
Reference is made to the explanation under Appendix  1 point  3.  - 16 -   
 Point  4: 
The Federal Institute for Risk Assessment points to a cur rent study which demonstrates 
that menthol alleviates the irritating sensory effects of liquids which have high (24  mg/ml) 
nicotine contents (Rosbrook & Green, 2016). This state of affairs suggests that in the case 
of electronic cigarettes with high nicoti ne contents, menthol can make getting started with 
vaping easier. Given the inhibition of nicotine depletion by menthol which has been ver i-
fied in relation to cigarettes (Benowitz et al., 2004), the opportunity is also envisaged that 
a similar effect may a lso arise in the case of electronic cigarettes containing menthol.  
Point  5: 
Reference is made to the explanation under Appendix  1 point  5. 
Point  6: 
Point  6 transposes Article  20(3e) whereby, apart from nicotine, only ingredients which do 
not pose a risk to  human health in their heated or non -heated forms may be used.  
Letter  a: 
Different flavourings are listed under letter  a. Diacetyl is approved as a flavouring similar 
to butter for foodstuffs although, according to the Federal Institute for Risk Assessment , it 
can cause serious inflammation of the respiratory tract during inhalation. According to the 
Federal Institute for Risk Assessment, this danger likewise exists as regards several 
structurally similar diketones, in particular 2,3 -pentanedione, 2,3 -hexan edione and 2,3 -
heptandion.  
In the case of coumarin, according to the Federal Institute for Risk Assessment, the tole r-
able daily intake value (TDI value) deduced by the European Food Safety Authority 
(EFSA) of 0.1  mg/kg of body weight is already exceeded as  a result of absorption via 
nourishment or other exposure routes. As a result of the possible use in the liquid of ele c-
tronic cigarettes or refill containers, an additional exposure route would emerge which 
increases the health risk in terms of overall exp osure.  
Letter  b: 
In the case of bitter almond oil, on the basis of a scientific assessment carried out by the 
Federal Institute for Risk Assessment, considerable uncertainties exist regarding the po s-
sible hydrocyanic acid levels of the oils used. Given the  significant hazard potential of h y-
drocyanic acid, the Federal Institute for Risk Assessment therefore recommends a ban on 
bitter almond oil.  
The rootstock of the common polypody, components and extracts of which contain toxic 
saponins according to the Fed eral Institute for Risk Assessment.  
Pennyroyals, the components, extracts and oils of which contain a monoterpenoid which, 
inter alia , acts in a hepatotoxic way, as evaluated by the Federal Institute for Risk A s-
sessment.  
According to the Federal Institute for Risk Assessment, agaric acid paralyses the smooth 
muscles in the same way as a toxin.  
The enabling act is §  13(2) point  1 of the Tobacco Products Act.   - 17 -   
 Re Article  2 (Entry into force)  
Article  2 regulates the entry into force. The provisions of the Secon d Amending Order 
shall enter into force on the day following promulgation. The amendments to Appe n-
dices  1 and 2 of the Tobacco Products Ordinance shall enter into force retrospectively on 
20 May 2016.  
An assurance in need of protection to the extent that, beginning 20  May 2016, only the 
placement on the market of tobacco products, electronic cigarettes and refill containers 
which contain the additives listed in the version of the Tobacco Products Ordinance of 
4 April 2016 is prohibited, does not exist. Arti cle 2 does not therefore deploy any retroa c-
tive effect which is not permitted under constitutional law.  
On the one hand, the obligation under EU law concerning the transposition of Article  7(6) 
of the Tobacco Products Directive, also in conjunction with Ar ticle 20(3c) of the same, 
prevents the emergence of a “situation of trust”. The provisions prohibit the placement on 
the market of tobacco products, electronic cigarettes and refill containers containing the 
following additives:  
 vitamins or other additives  that create the impression that a tobacco product, ele c-
tronic cigarette or refill container has a health benefit or presents reduced health 
risks,  
 caffeine or taurine or other additives and stimulant compounds that are associated 
with energy and vitality,  
 additives having colouring properties for emissions,  
 in the case of tobacco products for smoking, electronic cigarettes and refill co n-
tainers: additives that facilitate inhalation or nicotine uptake,  
 additives that have carcinogenic, mutagenic or reprotox ic properties in unburnt 
form.  
The Tobacco Products Directive does not allow Member States any leeway in terms of 
implementing the ban on the placement on the market of tobacco products, electronic 
cigarettes and refill containers containing additives whic h come under these categories 
referred to in Article  7(6) of the aforementioned directive. The bans shall apply as of  
20 May 2016.  
The Tobacco Products Ordinance in the version of 4  April 2016 only includes the additives 
specifically named in the directive . In addition, the additives which come under the categ o-
ries in Article  7(6) of the directive have to be substantiated for legal reasons. With the 
amendments to Appendices  1 and 2 of the Tobacco Products Ordinance, this is to be e f-
fected by means of the Se cond Amending Order relating to the Tobacco Products Ord i-
nance.  
On the other hand, the Second Order amending the Tobacco Products Ordinance was 
notified on […] in accordance with the provisions of Directive (EU)  2015/1535. On 
19 May 2016, it was announced in the Federal Gazette that the Federal Ministry of Food 
and Agriculture is intending to amend Appendices  1 and 2 of the Tobacco Products Ord i-
nance. Tobacco industry organisations were made aware of this announcement in writing.