Regulation on tobacco products and related products (Tobacco Products Regulation-Tobacco Products Act)

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Tobacco

Date of completion: 27.04.2016

Full quote:

" Tobacco Products Ordinance of 27 April 2016 (BGBl. 980), as defined by Article 1 V. of 21 June 2016 (BGBl. I p. 1468).

Note:

Amendment by Art. 1 V. v. 21.6.2016 I 1468 (No 29) in a textual, documentary form not yet concludedly edited

For more details, please refer to the menu under Notes

Footnote

(+ + + Text proof: 20.5.2016 + + +) 
(+ + + For application cf.  § 34 + + +) 

  

The V was referred to as Article 1 of the V v. 27.4.2016 I 980 by the Federal Ministry of Food and Agriculture in agreement with the Federal Ministry for Economic Affairs and Energy, in agreement with the Federal Ministry of Finance and the Federal Ministry of Finance and the Federal Ministry of Food and Agriculture. Federal Ministry of Health, with the approval of the Federal Council. The V is gem. Art. 7 sentence 1 of this V entered into force on 20.5.2016. Unofficial table of contents

Content Summary

Section 1Tobacco products subsection 1Measurement procedures, testing laboratories

§ 1	Measurement Procedures
§ 2	Testing laboratories
§ 3	Authorisation procedure

Subsection 2Additives, notification requirements,
Authorisation of novel tobacco products

§ 4	Additives
§ 5	Plant protection products
Section 5a	Determination of tobacco products with a characteristic flavouring
§ 6	Participation obligations
§ 7	Studies and information requirements
§ 8	Special notification requirements for certain additives
§ 9	Authorisation of novel tobacco products

Subsection 3Packaging and warnings

§ 10	Presentation of packs of cigarettes and tobacco for self-rotation
§ 11	General rules on the labelling of tobacco products
§ 12	Labelling of cigarettes, tobacco for self-turning and water-pipe tobacco
§ 13	General warning and information message for cigarettes, tobacco for self-turning and water-pipe tobacco
§ 14	Combined text-picture-warning labels for cigarettes, tobacco for self-turning and water-pipe tobacco
§ 15	Labelling of smoke tobacco products other than cigarettes, tobacco for self-turning and water-pipe tobacco
§ 16	General warning and text warning for other smoking tobacco products than cigarettes, tobacco for self-turning and water-pipe tobacco
§ 17	Labelling of smokeless tobacco products
§ 18	Prohibitions to protect against deception

Subsection 4Traceability and security feature

§ 19	Individual Recognition Property
§ 20	Traceability
Section 21	Data storage by third parties
Section 22	External Reviewer
Section 23	Security Property

Section 2Electronic
Cigarettes and refill containers

§ 24	Participation obligations
Section 25	Information requirements
Section 26	Package Sheet
§ 27	Warning and packaging
§ 28	Ingredients
Section 28a	Refill mechanism

Section 3Plant smoking products

§ 29	Participation obligations
§ 30	Warning

Section 4General provisions

Section 31	Cross-border distance sales to consumers
Section 32	Publication of information

Section 5Administrative Offences,
Final provisions

§ 33	Irregularities
Section 34	Transitional arrangements
Appendix 1		Prohibited additives in tobacco products
Appendix 2		Prohibited ingredients in electronic cigarettes and refill containers
Appendix 3		Maximum residue levels for plant protection products

Section 1
Tobacco products

Subsection 1
Measurement procedures, testing laboratories

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§ 1 Measurement procedure

The following requirements shall apply to the determination of the emission values referred to in § 4 (1) of the Tobacco Products Act:

1.

The analytical methods used in the Official Collection of Investigation Procedures in accordance with Section 38 of the Tobacco Products Act (Official Collection) ^* under the outline numbers

T 60.05-3 (DIN ISO 4387)

June 2012

T 60.05-4 (DIN ISO 10315)

April 2011

T 60.05-7 (DIN ISO 8454)

January 2013

shall be published, and

2.

the accuracy of the measurements shall be determined in accordance with the procedure laid down in the Official Collection under the outline number

T 60.05-1 (DIN ISO 8243)

October 2009

is published.

*

To be received by Beuth-Verlag GmbH, Berlin and Cologne.

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§ 2 Test laboratories

(1) Test laboratories which carry out provisions in accordance with § 1 in the framework of the second sentence of § 29 (1) or 2 (2), second sentence, point 2 or 3 of the Tobacco Products Act must be approved by the competent authorities. As far as testing laboratories are part of the direct or indirect federal or state administration, they shall be deemed to be approved. (2) The approval shall be granted if the test laboratory meets the following requirements:

1.

valid accreditation in accordance with the Accreditation Body Act; the accreditation of a testing laboratory by the national accreditation body of another Member State must be recognised;

1a.

successful participation in laboratory comparison tests, which must take place at least once a year, and

2.

reliability and independence; a test laboratory shall not be independent in particular if:

a)

the test laboratory is under the direct or indirect control of the tobacco industry, or

b)

the person in charge of the test laboratory or staff who is involved in the provisions of § 1, in an employment relationship or in economic dependence on the tobacco industry, or in paid or unpaid consultative bodies Activities for the tobacco industry.

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§ 3 Authorisation procedure

(1) The application for admission is to be submitted in writing to the competent authority. (2) The application shall be accompanied by:

1.

the certificate of accreditation in the original or in a certified copy; and

2.

a declaration by the applicant testing laboratory that there is no grounds for exclusion in accordance with Section 2 (2) (2) (a) or (b).

3. The competent authority shall verify at least once a year whether the requirements referred to in paragraph 2 (2) are met. In the event of non-compliance with the requirements, the authorisation shall be revoked; the provisions of the administrative procedural laws of the Länder concerning the revocation of administrative acts shall remain unaffected. (4) The admission in accordance with § 2 (1) shall be the responsibility of the competent authorities. Authority of another Member State of the European Union or of any other Contracting State of the Agreement on the European Economic Area. Their presence shall be established by the competent authority.

Subsection 2
Additives, notification requirements, authorisation of new tobacco products

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§ 4 Additives

Tobacco products may not be placed on the market if they contain one of the additives listed in Appendix 1. Unofficial table of contents

§ 5 Plant protection products

(1) For the plant protection products listed in Appendix 3, the maximum quantities referred to in Annex 3 shall be fixed in or on tobacco products when they are placed on the market. (2) Official control of residues of plant protection products shall be subject to analysis methods listed in the Official Collection. Other analytical methods not listed in the Official Collection may also be used if they are equivalent to the analytical methods listed in the Official Collection. The equivalence of the methods of analysis shall be based on the Annex to Council Directive 85 /591/EEC of 20 December 1985 on the introduction of Community methods of sampling and analysis for the control of foodstuffs (OJ L 327, 30.12.1985, p. EC No OJ No L 372, 31.12.1985, p. 50). Unless analysis methods are listed in the Official Collection for certain substances, other methods of analysis may also be used. In the case of the fourth sentence, the methods of analysis shall, as far as possible, comply with the requirements of the Annex to Directive 85 /591/EEC. Unofficial table of contents

Section 5a Determination of tobacco products with a characteristic flavouring

To be applied in the determination of cigarettes and tobacco for self-rotation with a characteristic aroma according to Article 5 (1) (1) (a) of the Tobacco Products Act by the Federal Office of Consumer Protection and Food Safety Procedures shall be laid down in accordance with Articles 2 and 4, Article 5 (1) and (4), Articles 6 and 7 (1), Articles 8 and 9 (1) and (4) and Article 12 of Commission Implementing Regulation (EU) 2016/779 of 18 May 2016. uniform rules for the procedures to determine whether a tobacco product is a characteristic Flavouring (OJ L 327, OJ L 131, 20.5.2016, p. Unofficial table of contents

§ 6 Duty of notification

(1) Manufacturers and importers of tobacco products shall be obliged to inform the competent authority of the following in a list broken down by brand name and type of tobacco products:

1.

the name, address and electronic contact details of the manufacturer or importer;

2.

all ingredients used in the manufacture, including their quantities, in descending order of weight,

3.

the emission values referred to in Article 4 (1) of the Tobacco Products Act;

4.

where available, information on further emissions and their values, and

5.

further, in Article 2 (1), in conjunction with the Annex to the Commission Implementing Decision (EU) 2015/2186 of 25 November 2015 establishing a format for the provision and making available of information on Tobacco products (OJ L 327, 5) provides information on product characteristics, product description, packaging, the specification of tobacco products and the place and time of market introduction and withdrawal.

(2) The list referred to in paragraph 1 shall be accompanied by a statement containing the following:

1.

the reasons for the use of the ingredients referred to in paragraph 1 (2),

2.

the status of the ingredients, in particular whether they are in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), on the creation of of a European Chemicals Agency, amending Directive 1999 /45/EC and repealing Council Regulation (EEC) No 793/93, Commission Regulation (EC) No 1488/94, Council Directive 76 /769/EEC and Directives 91 /155/EEC, 93 /67/EEC, 93 /105/EC and 2000 /21/EC (OJ No L 73, 27.3.1991, p. OJ L 136, 29.5.2007, p.

3.

the classification of ingredients in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on the classification, labelling and packaging of substances and mixtures, amending and repealing the Directives 67 /548/EEC and 1999 /45/EC and amending Regulation (EC) No 1907/2006 (OJ L 210, 31.7.2006, p. OJ L 353, 31.12.2008, p. 1) and,

4.

where available, the toxicological data of the ingredients in burnt form or, in the case of smokeless tobacco products, in unburned form, in particular with regard to their impact on the health of consumers and their search-producing products; Effect.

(3) In addition, manufacturers and importers of cigarettes and tobacco for self-rotation shall submit a technical document containing a general description of the additives used and their properties. (4) The notification shall be in electronic form before placing on the market. Articles 2, 4, 5 and 6 (1) in conjunction with the Annex to the Implementing Decision (EU) 2015/2186 shall apply to the communication and to the procedures to be followed in this respect. At the request of the body referred to in the first sentence of Article 4 of the Implementing Decision (EU) 2015/2186, a current excerpt shall be submitted

1.

from an official company register established on a legal basis, or

2.

from another official register established on a statutory basis, if the official register contains an indication for the purpose or subject of the business operation of the manufacturer or importer.

The Federal Office for Consumer Protection and Food Safety ensures that the information referred to in paragraphs 1 to 3 is centrally stored and that the Commission and the Member States have access to the purposes of the Tobacco Products Act and to the Member States. of this Regulation. (5) In the event of changes in the composition of a tobacco product from which the information referred to in paragraphs 1 to 3 is affected, a new communication shall be made before placing the product on the market. In the case of tobacco products which have already been placed on the market on 20 May 2016, the notification must be made within six months from that date. (6) Manufacturers and importers shall be obliged to submit, at the request of the competent authority, the to carry out the scientific studies to be determined in order to assess the impact of the ingredients on consumer health, taking into account in particular their addictive effect and toxicological data. The results of these studies shall be submitted to the competent authority upon request. Unofficial table of contents

§ 7 Studies and information requirements

(1) Manufacturers and importers of tobacco products shall be obliged to submit annually, by 30 June of each calendar year, the competent authority in electronic form:

1.

available studies on market research, in particular on the preferences of the consumer groups concerned with regard to ingredients and emissions, and summaries of the market studies they have carried out on the occasion of the market launch of new tobacco products , and

2.

Communications on the sales volumes of the previous calendar year, in units or kilograms, beginning on 1 January 2015 and broken down by brand name and type of tobacco products.

(2) In the case of communications referred to in paragraph 1 (2), Section 6 (4) shall apply. Unofficial table of contents

§ 8 Special notification requirements for certain additives

(1) Manufacturers and importers of cigarettes and tobacco for self-rotation, containing an additive contained in a list of priorities published by the institutions of the European Union in accordance with the first sentence of Article 6 (1) of Directive 2014 /40/EU of 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 products and related products and repealing Directive 2001 /37/EC (OJ L 327, 22. 1), it is obliged to carry out studies on this additive. The list of priorities set out in the first sentence of the first sentence is published by the Federal Ministry of Food and Agriculture in the Federal Gazette (Bundesanzeiger), which lists only the content-like implementation of binding, binding to the Member States. Implementing acts referred to in the second sentence of Article 6 (1) of Directive 2014 /40/EU. (2) In the studies it is necessary to examine, in particular, whether the additive is used in the

1.

contributing to the toxicity or the addictive effects of the cigarette or tobacco for self-rotation, and whether the additive is measurably increasing the toxicity or the addictive effect,

2.

a characteristic aroma,

3.

the inhalation or the nicotine uptake is facilitated or

4.

for the formation of substances which have carcinogenic, mutagenic or reproductive properties (CMR properties), in which quantities these substances are formed and whether this causes the CMR properties to be found in the cigarette or the tobacco for self-rotation can be measurably increased.

(3) The studies must, in the course of the investigation, be based on the use of the cigarette or tobacco intended for self-rotation purposes and explain the following:

1.

emissions caused by the incineration process, including the additive, and

2.

the interaction of the additive with other ingredients contained in the cigarette or tobacco for self-rotation.

(4) Manufacturers and importers who use the same additive in a comparable product composition may have this additive examined in a joint study. (5) Manufacturers and importers are obliged to summarya summary of the Report on the results of the studies on the additive. The report shall contain an overview of the available scientific literature on the additive and a summary of the internal data on its effects. The report is

1.

within 18 months of the inclusion of the additive in the list of priorities, in accordance with the first sentence of Article 6 (1) of Directive 2014 /40/EU, in electronic form, and

2.

in copy to the competent authorities of those Member States where cigarettes or tobacco for self-rotation containing the additive have been placed on the market.

Manufacturers and importers shall be required to submit additional information on the additive to the Commission or to the competent authority on request. This additional information is part of the report. (6) Manufacturers and importers are obliged to have the report examined by an independent scientific body, at the request of the Commission or the competent authority, in particular with regard to completeness, methodology and conclusions. (7) Small and medium-sized enterprises as defined in the Commission Recommendation of 6 May 2003 on the definition of micro-enterprises and small and medium-sized enterprises Company (OJ C 327 36) shall be exempted from the obligations laid down in paragraphs 1 to 6 if they provide evidence to the competent authority that a report on the additive is already available or that a report on the additive is available from another manufacturer, or Importer is created. Unofficial table of contents

Section 9 Approval of new tobacco products

(1) The authorisation in accordance with § 12 (1) of the Tobacco Products Act shall be made on the electronic request of the manufacturer or importer. (2) The following shall be attached in electronic form to the application:

1.

the name, address and electronic contact details of the manufacturer or importer,

2.

a description of the novel tobacco product and a statement of use and information on ingredients and emissions, as well as the methods of analysis and measurement used in accordance with Article 6 (1) (2) to (4),

3.

available scientific studies on toxicity, addictive effects and attractiveness of the novel tobacco product, in particular in relation to its ingredients and emissions,

4.

available studies on market research and on the preferences of the consumer groups concerned with regard to ingredients and emissions, and summaries of the market studies they have carried out on the occasion of the market launch of new tobacco products , and

5.

Other available information, including a risk-benefit analysis of the novel tobacco product, its expected impact on tobacco consumption and the entry into tobacco consumption, as well as the expected impact on tobacco consumption and the expected impact on tobacco consumption and on the expected impact of tobacco consumption. Consumer perceptions.

In the case of changes to the composition from which the information referred to in paragraph 2 (2) is affected, or where new studies or information within the meaning of paragraph 2 (3) to (5) are available, appropriate documents shall be submitted to the competent authority (4) Manufacturers and importers of novel tobacco products are required to carry out additional studies, at the request of the competent authority, and to provide additional information to the competent authority on request. (5) The authorisation shall also include a determination as to whether the novel Tobacco product is a smoking tobacco product or a smokeless tobacco product.

Subsection 3
Packaging and warnings

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§ 10 Presentation of the packs of cigarettes and tobacco for self-rotation

(1) cigarettes may be placed on the market only in cuboid packs containing at least 20 cigarettes. (2) The packs may consist only of cardboard or of a soft material. They must not be closed or sealed again after the first opening, with the exception of packs with flap covers and cap boxes. In the case of packs with a hinged lid, the hinge must be located on the back of the packs. The side surfaces of cap boxes with hinged lid must be at least 16 millimetres high. (3) Self-rotation tobacco may only be placed on the market in quase-shaped or cylindrical packages or in bags, which shall be at least 30 millimetres. Grams of tobacco. Unofficial table of contents

Section 11 General provisions on the labelling of tobacco products

(1) The following general requirements apply to the design and affixing of health warnings in accordance with § § 12 to 17 on packs and outer packaging of tobacco products:

1.

are to be written in German,

2.

may not be accompanied by comments, rewrites or references,

3.

may not be indelible or detachable; in the case of tobacco products other than cigarettes and tobacco for self-rotation in bags, the health warnings may be applied by means of stickers, provided that they cannot be removed,

4.

shall not be partially or completely concealed or separated at the time of placing on the market; in the case of packs with a lid which separates the warnings when the package is opened, this may be done only in a manner which is ensuring graphical integrity and readability,

5.

do not cover or separate tax marks, price tags, individual recognition features and security features; and

6.

are to be surrounded by a black, 1 mm wide frame within the area provided for them.

The dimensions of the health warnings shall be calculated in relation to the area in question when the package is closed. (2) Images of packings and outer packaging intended for advertising to consumers in the European Union. Union shall meet the requirements of this sub-section. Unofficial table of contents

§ 12 Labelling of cigarettes, tobacco for self-turning and water-pipe tobacco

Cigarettes, self-turning tobacco and water-pipe tobacco may only be placed on the market if packages and outer packaging bear the following health warnings:

1.

the general warning "Smoking is deadly",

2.

the information message "tobacco smoke contains more than 70 substances which have been proven to be carcinogenic." and

3.

combined text-picture warnings.

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§ 13 General warning and information message for cigarettes, tobacco for self-turning and water-pipe tobacco

(1) The following requirements shall apply to the design and installation of the general warning in accordance with Section 12 (1) and the information message in accordance with Section 12 (2):

1.

they must each take 50 per cent of the areas they have designated for them; and

2.

they shall be printed as follows:

a)

in Helvetika fat, black on a white background,

b)

centered and

c)

In the case of cuboid packs and outer packaging, parallel to the side edge.

(2) In the case of cuboid packs, the general warning on the lower part of one of the lateral surfaces and the information message shall be placed on the lower part of the other side surface; the general warning and the general warning Information message must be at least 20 millimetres wide. (3) In the case of cap boxes with hinged lid, in which the lateral surfaces are divided into two parts when the package is open, the general warning and the information message are fully attached to the larger of the two faces; the general Warning message must also be placed on the inside of the hinged lid. (4) In the case of tobacco for self-rotation in cylindrical packings with lid, the general warning on the outer and information messages on the inner surface of the lid is . In the case of tobacco for self-rotation in rectangular bags and in a stand-up bag, the requirements laid down in Article 2 (1) and Article 3 in conjunction with points 1, 2 and 4 shall apply to the affixing of the general warning and the information message. Annex to the Commission Implementing Decision (EU) 2015/1735 of 24 September 2015 on the precise arrangement of the general warning and the information message on tobacco sold in bags (OJ L 327, 30.12.2015, p. OJ L 252 of 29.9.2015, p. 49). By way of derogation from the first sentence, the affixing in the case of tobacco for self-rotation in rectangular winding bags made of polyethylene, polypropylene or laminate material may, until 20 May 2018, in accordance with Article 2 (2), read in conjunction with point 3 of the Annex to the Implementing Decision (EU) 2015/1735. Unofficial table of contents

§ 14 Combined text-picture-warning labels for cigarettes, tobacco for self-turning and water-pipe tobacco

(1) The combined text-picture warnings according to Section 12 (3) are to be found in Annex II of Directive 2014 /40/EU in the respective version in force. For their format, layout, design and proportions, the requirements set out in Articles 2 to 4 shall apply in conjunction with points 1 to 4 of the Annex to Commission Implementing Decision (EU) 2015/1842 of 9 December 2002. 3 October 2015 on the technical specifications for the layout, design and form of combined health warnings for smoking tobacco products (OJ C 327, 28.11.2015, p. OJ L 267, 14.10.2015, p.5). They must be changed every year in such a way that they appear in the same number on the packs, and supplemented by the following information on smoking cessation: ' Do you want to stop? The BZgA helps: Tel.: 0800 8 313131 (cost free) ,www.rauchfrei-info.de ". (2) The following requirements apply for the installation of the combined text-image warnings:

1.

they must each occupy 65 percent of the areas they have designated for them,

2.

if they are applied to cigarette packs, they must be at least 44 millimetres high and at least 52 millimetres wide,

3.

they must be attached to the upper edge and aligned parallel to the rest of the information on the packaging surface,

4.

they are to be used twice on each package,

5.

in the case of cuboid packs, they shall be placed on the outer front and rear sides, and

6.

they must be placed at the same distance from each other in the case of cylindrical packages.

(3) By 20 May 2019, the combined text-to-picture warnings may be applied as follows:

1.

Box packs: on the back, directly below the control plate attached to the top edge,

2.

Packs of soft material: directly below a rectangular area beginning at the upper edge and provided for the control character, with a height of not more than 13 millimetres.

Brand names or logos must not be placed above the combined text-image warning. Unofficial table of contents

Section 15 Labelling of smoking tobacco products other than cigarettes, tobacco for self-turning and water-pipe tobacco

(1) Other smoking tobacco products other than cigarettes, self-turning tobacco and water-pipe tobacco may only be placed on the market if packages and outer packaging bear the following health warnings:

1.

the general warning "Smoking is deadly",

2.

one of the text warnings contained in Annex I to Directive 2014 /40/EU in the current version.

(2) The general warning is to be supplemented by the following information on smoking cessation: " Do you want to stop? The BZgA helps: Tel.: 0800 8 313131 (free of charge), www.rauchfrei-info.de ". Unofficial table of contents

§ 16 General warning and text warning for other smoking tobacco products as cigarettes, tobacco for self-turning and water-pipe tobacco

(1) The following general requirements shall apply to the design and installation of the health-related warnings in accordance with § 15:

1.

they must comply with the requirements of section 13 (1) (2);

2.

they must be aligned parallel to the main text on the respective package area,

3.

by way of derogation from Article 11 (1) (6), they shall be surrounded by a black, at least 3 millimetre and a maximum of 4 millimetres wide frame outside the area intended for them; and

4.

they must occupy an area of 45 square centimetres if they are mounted on an area of more than 150 square centimetres.

(2) The following requirements shall apply to the general warning in accordance with Article 15 (1) (1):

1.

it shall be affixed to the most visible surface, and

2.

it has to take 30 percent of that area.

(3) The following requirements shall apply to the text warning in accordance with Article 15 (1) (2):

1.

it shall be affixed to the area at the top of the eye; in the case of packs with a hinged lid, the area visible when the pack is open shall be the same;

2.

it has to take 40 percent of that area, and

3.

Each mark must appear in the same number as the text warning in Annex I to Directive 2014 /40/EU in the relevant version.

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Section 17 Labelling of smokeless tobacco products

(1) Smoke-free tobacco products may only be placed on the market if the packs and outer packaging bear the following health warning: " This tobacco product is harmful to your health and makes it addictive. " (2) The warning must be placed on the two largest areas of the package and the outer packaging and must each occupy 30 per cent of these areas. The warning must comply with the requirements of Section 13 (1) (2) and must be aligned parallel to the main text. Unofficial table of contents

§ 18 prohibitions on protection against deception

It must not be placed on the market:

1.

Cigars containing tobacco foils with a tobacco content of less than 75 per cent in dry matter, as an insert,

2.

Cigars in which the proportion of tobacco film exceeds 25% of the weight of the product, less the weight of a mouthpiece; in the case of cigars with an artificial reed, this maximum quantity shall be reduced by the weight of the reed of art,

3.

Smoking tobacco products containing less than 75% tobacco in the dry matter,

4.

Smoking tobacco products in which the proportion of tobacco film exceeds 25% of the weight of the tobacco mixture,

5.

tobacco products which are chemically bleached,

6.

-coloured tobacco for smoking tobacco products, other than black roll tobacco, or

7.

Cigars, which have an artificial reed or reed of tobacco foil, provided that this is not indicated on the packs by the clearly visible and easily legible indication "with the art reed"; if the proportion by weight of the tobacco in the reed is more than 50%, it can be used instead "with tobacco-containing artificial reed"; in the case of cigars, which have a reed made of tobacco foil, it is not possible to make the information available if the proportion by weight of tobacco in the tobacco film is not is at least 75 per cent of the dry matter.

Subsection 4
Traceability and safety feature

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§ 19 Individual recognition characteristic

(1) Manufacturers and importers of tobacco products shall, in accordance with paragraph 2, be obliged to affix the individual recognition characteristic in accordance with Article 7 (1) (1) of the Tobacco Products Act. (2) The individual recognition property shall be subject to the conditions laid down in paragraph 2. The recognition feature may neither be obscured nor be dissolvable and must not be concealed or separated. It contains the following information:

1.

the day and place of manufacture,

2.

the manufacturing site;

3.

details of the identification of the machinery used for the manufacture,

4.

the working shift or the date of manufacture,

5.

a product description,

6.

the intended sales market,

7.

the intended route and

8.

the name, address and electronic contact details of the importer.

Footnote

(+ + + § 19: For application see Section 34 (1) + + +) Unofficial table of contents

§ 20 Traceability

(1) Economic operators, with the exception of dealers who make tobacco products directly to the consumer, shall ensure that the following information is provided and with the individual identification characteristic referred to in Article 7 (1) (1) (1) (1) 1 of the Tobacco Products Act shall be electronically linked:

1.

the actual transit route, including all the warehouses used and the place and date of dispatch, and the names and addresses of all customers in the distribution chain; and

2.

the invoice and order number as well as the payment receipts of all purchasers in the distribution chain.

(2) In order to obtain the information referred to in paragraph 1, the economic operators referred to in that paragraph shall record the receipt and exit of all packages, including all interim shipments. The goods inlet and outlet may also be recorded by marking aggregated packaging provided that all packages are traced. (3) Manufacturers of tobacco products are obliged to meet the requirements referred to in paragraph 1, which are to provide the equipment necessary to collect the information referred to in paragraph 1. The equipment must be able to read the information collected electronically and to transmit it to a data store in accordance with § 21. (4) All economic operators shall record in writing the information referred to in paragraph 1 and the information shall be provided to the data storage in accordance with the provisions of paragraph 1. competent authority and the customs authorities, upon request. For traders who hand tobacco products directly to the consumer, this does not apply directly to the consumer for the goods exit. The records may not be modified or deleted.

Footnote

(+ + + § 20: For application, see Section 34 (1) + + +) Unofficial table of contents

§ 21 Data storage by third parties

(1) Manufacturers and importers of tobacco products shall be obliged to provide an independent third party authorised by the Commission with the electronic processing of all information collected through the individual recognition feature (data); by a written contract approved by the Commission. (2) The location of the data store must be located in the territory of the European Union. (3) The storage, modification, transfer, locking or erasure of the data may only be be made by the independent third party. In the processing of the data, corresponding measures are to be taken in accordance with the respective state of the art in order to ensure data security. The rules on the protection of personal data and the protection of business and business secrets remain unaffected. (4) The independent third party shall be obliged to provide the data of the Commission, the competent authorities of the Member States, the The customs authorities, the competent German authority and an external auditor, in accordance with § 22, on request and, where necessary for the performance of their duties, to be provided at the location of the data store. (5) In justified cases, the Commission or the competent authority shall also access manufacturers or importers to the stored data. The data may not be changed or deleted by any economic operator.

Footnote

(+ + + § 21: For application, see Section 34 (1) + + +) Unofficial table of contents

Section 22 External Auditor

(1) Manufacturers of tobacco products shall be obliged to appoint an external auditor at their expense. The external auditor must be authorised by the Commission. (2) The external auditor supervises the management of the data storage by the independent third party commissioned in accordance with § 21. It is obliged to submit a report to the Commission and to the competent authority each year. In particular, the report shall include an assessment of irregularities in the access to the data.

Footnote

(+ + + § 22: For application, see Section 34 (1) + + +) Unofficial table of contents

§ 23 Security feature

(1) The security feature referred to in Section 7 (1) (2) of the Tobacco Products Act shall not be able to be wiped out or be dissolvable and shall not be concealed or separated. (2) The security feature shall be the tax sign in accordance with § 4, point 12 of the Tobacco Control Act of 15 July 2009 (BGBl. I p. 1870), most recently by Article 6 of the Law of 4 April 2016 (BGBl. I p. 569).

Footnote

(+ + + § 23: For application, see Section 34 (1) + + +)

Section 2
Electronic cigarettes and refill containers

Unofficial table of contents

Section 24 Duty of notification

(1) Manufacturers and importers of electronic cigarettes and refill containers shall be obliged to inform the competent authority of the following in a list broken down by brand name and type of product:

1.

the name, address and electronic contact details of the manufacturer, importer or a competent legal or natural person to be determined by the manufacturer or importer and established in the European Union;

2.

all ingredients and emissions included in the electronic cigarette or in the refill container, including

a)

their quantities in descending order of their weight,

b)

its toxicological data in heated and non-heated form, and

c)

its impact on consumer health and its addictive impact,

3.

information on nicotine dose and intake in the case of consumption under normal or reasonably foreseeable conditions,

4.

a description of the components of the electronic cigarette or the refill container, including existing opening and refilling mechanisms;

5.

a description of the manufacturing process, including whether it is a series production,

6.

further, in Article 2 (1), in conjunction with the Annex to the Commission Implementing Decision (EU) 2015/2183 of 24 November 2015 establishing a format for the reporting of electronic cigarettes and refill containers (OJ L 327, 22.12.2015, p. 15) on product characteristics, product description, packaging, specification and location and time of market introduction and withdrawal.

(2) The notification shall be accompanied by a declaration that the manufacturer or the importer

1.

the manufacturing process shall guarantee compliance with the requirements of this Section; and

2.

the full responsibility for quality and safety, if the electronic cigarette or the refill container is placed on the market and is used under normal or reasonably foreseeable conditions.

(3) The notification referred to in paragraphs 1 and 2 shall take place in electronic form six months prior to placing on the market. Articles 2, 4, 5 and 6 (1) in conjunction with the Annex to the Implementing Decision (EU) 2015/2183 shall apply to the notification and the procedure to be followed in this respect. At the request of the body referred to in the first sentence of Article 4 of the Implementing Decision (EU) 2015/2183, a current excerpt shall be submitted

1.

from an official company register established on a legal basis, or

2.

from another official register established on a legal basis, to the extent that it contains an indication for the purpose or subject of the business operation of the manufacturer or importer.

The fourth sentence of Paragraph 6 (4) shall apply. (4) In the event of changes to the composition or components of an electronic cigarette or a refill container from which the particulars referred to in paragraph 1 are affected, up to the provisions of the first sentence of paragraph 3 To make a new communication. In the case of electronic cigarettes and refill containers which have already been placed on the market on 20 May 2016, the notification shall take place within six months from that date. Unofficial table of contents

Section 25 Information requirements

Manufacturers and importers of electronic cigarettes and refill containers shall be required to submit annually, by 30 June of each calendar year, in electronic form to the competent authority, the following:

1.

the sales volume data of the previous calendar year, starting from 1 January 2015, broken down by brand name and type;

2.

information on the preferences of the consumer groups concerned, including young people, non-smokers and the main categories of current users,

3.

information on the nature of the sale and

4.

Summaries of all market research studies carried out in this respect, including an English version of these summaries.

Unofficial table of contents

Section 26 leaflet

(1) Manufacturers and importers of electronic cigarettes and refill containers shall be obliged to draw up the package leaflet in accordance with Section 15 (1) (1) of the Tobacco Products Act. The package leaflet shall bear the heading "Package Leaflet" and shall contain:

1.

Use and storage instructions,

2.

contra-indications,

3.

Warnings for those consumer groups which are more vulnerable to use of the electronic cigarette or the refill container than others, including an indication that the product is not recommended for non-smokers; and that the levy, as well as the use by children and young people, are prohibited,

4.

Information on possible adverse health effects,

5.

Information on the addictive effect,

6.

Information on toxicological data,

7.

the name, address and electronic contact details of the manufacturer, importer or a competent legal or natural person to be determined by the manufacturer or importer and established in the European Union; and

8.

Article 2 (2) of the Commission Implementing Decision (EU) 2016/586 of 14 April 2016 on the technical standards for the refilling mechanism of electronic cigarettes (OJ L 327, 30.4.2016, p. OJ L 101, 16.4.2016, p. 15).

(2) The package leaflet must be written in German, in general understandable and legible. Unofficial table of contents

Section 27 Warning and packaging

(1) Manufacturers and importers of electronic cigarettes and refill containers shall be obliged to apply a list of electronic cigarettes and refill containers prior to placing them on the market. The list shall contain the following information:

1.

all ingredients in descending order of weight,

2.

the nicotine content and the amount of nicotine per dose,

3.

a notice indicating the lot to which the electronic cigarette or the refill container belongs, and

4.

the indication that the product must not be placed in the hands of children.

(2) In addition to the requirements referred to in paragraph 1, the packs and outer packaging shall bear the following health warning: " This product contains nicotine: a substance that makes a very strong dependence. " (3) The warning must be placed on the two largest areas of the package and the outer packaging and must each occupy 30 per cent of these areas. It must comply with the requirements of Section 13 (1) (2) and be aligned in parallel with the main text. Unofficial table of contents

§ 28 Ingredients

Electronic cigarettes and refill containers may not be placed on the market if they contain one of the ingredients listed in Appendix 2. Unofficial table of contents

Section 28a Refill mechanism

The mechanism for repleniation in accordance with Article 14 (3), first sentence, of the Tobacco Products Act has to comply with the requirements of Article 2 (1) of the Implementing Decision (EU) 2016/586.

Section 3
Herbal smoke products

Unofficial table of contents

Section 29 Duty of notification

In the case of vegetable smoking products, Article 6 (1) (1) and (2), (4), first sentence, and (5), first sentence, shall apply. The notification may be made in accordance with the procedure laid down in the second sentence of Article 6 (4). Unofficial table of contents

§ 30 Warning

(1) Plant smoking products may only be placed on the market if the packs and outer packaging bear the following health warning: " Smoking of this product is harmful to your health. " (2) The following requirements shall apply to the design and affixing of the warning on packs and outer packaging:

1.

on the outer front and the outer rear side,

2.

each 30 per cent of these areas, and

3.

comply with the requirements of Section 13 (1) (2).

Section 4
General provisions

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Section 31 Cross-border distance sales to consumers

The registration in accordance with Section 22 (1) (2) of the Tobacco Products Act shall be made on request. The application must contain the following information:

1.

the name, address and electronic contact details of the person who wishes to operate cross-border distance selling of tobacco products, electronic cigarettes or refill containers to consumers in the European Union;

2.

the date on which the person for the first time provides tobacco products, electronic cigarettes or refill containers in the cross-border distance selling to consumers,

3.

the clear order of order, the domain information and the land allocation via which the tobacco products, electronic cigarettes or refill containers are offered on the Internet, and

4.

a description of the details and the functioning of the age review system in accordance with Section 22 (1) (1) of the Tobacco Products Act.

Unofficial table of contents

Section 32 Publication of information

(1) The Federal Ministry of Food and Agriculture or the Federal Office for Consumer Protection and Food Safety shall disclose the information it receives on the Internet pursuant to § 6 (1) number 2 to 4, § 8, § 24 (1) and § 29. (2) It may not be published legally as business secrets or other information that is classified as confidential. The provisions on the protection of personal data shall remain unaffected.

Section 5
Procedural offences, final provisions

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§ 33 Administrative Offences

(1) Administrative offences within the meaning of Section 35 (2) (1) (a) of the Tobacco Products Act are those who intentionally or negligently

1.

, contrary to Article 10 (1) or (3), a cigarette or tobacco shall be placed on the market for self-rotation, or

2.

Contrary to § 27 (1) sentence 1, a list of the information provided for in the second sentence of § 27 (1) (1) or (2) does not apply, not correct, not complete or not in good time.

(2) In the sense of Section 35 (2) (1) (b) of the Tobacco Products Act, who intentionally or negligently contrasts

1.

§ 19 (1) does not apply an individual identification mark or does not apply in good time, or

2.

Article 20 (1) does not ensure that any information referred to therein is provided.

(3) In the sense of Section 35 (2) (1) (c) of the Tobacco Products Act, who intentionally or negligently does not submit an item of information, or does not submit it in due time, in accordance with § 20 (4) sentence 1. Unofficial table of contents

Section 34 Transitional arrangements

(1) Articles 19 to 23 shall apply to cigarettes and tobacco for self-rotation as from 20 May 2019 and for the rest of tobacco products from 20 May 2024. (2) Tobacco for self-rotation in sachets, which shall:

1.

before 20 May 2018

a)

produced or

b)

put into free circulation and

2.

in accordance with Article 13 (4), third sentence,

may still be placed on the market or remain on the market until 20 May 2019. Unofficial table of contents

Appendix 1 (to § 4)
Prohibited additives in tobacco products

(Fundstelle: BGBl. I 2016, 990)

1.

vitamins,

2.

Caffeine, Taurine

Unofficial table of contents

Appendix 2 (to § 28)
Prohibited ingredients in electronic cigarettes and refill containers

(Fundstelle: BGBl. I 2016, 990)

1.

vitamins,

2.

Caffeine, Taurine

Unofficial table of contents

Appendix 3 (to § 5 (1))
Maximum residue levels for plant protection products

(Fundstelle: BGBl. I 2016, 991-992)



StoffCAS- Number of active substances, maximum quantity mg/kg, in relation to the Tobacco share

Aldicarb	116-06-3	2-methyl-2-(methylthio)- propionaldehyde-O- (methylcarbamoyl) oxim		Total calculated as aldicarb	10
Aldicarbsulfoxide	1646-87-3	2-methyl-2-(methylsulfinyl)- propionaldehyde-O- (methylcarbamoyl) oxim
Aldoxycarb	1646-88-4	2-methyl-2-(methylsulfonyl)- propionaldehyde-O- (methylcarbamoyl) oxim
Aldrin	309-00-2	1,2,3,4,10 ,10 -Hexachlor- 1,4,4a, 5,8, 8a-hexa-hydro-1,4- endo-5,8-exo-dimethanonaphthalene		Total calculated as Dieldrin	0.3
Dieldrin	60-57-1	1,2,3,4,10 ,10-Hexachlor-6,7-epoxy-1,4, 4a, 5,8, 8a-octaphydro-1,4- endo-5,8-exo-dimethanonaphthalene
Camphechlor (Toxaphene) (see in the case of Polychloro- terpene)	8001-35-2
Chlordan	57-47-9	1,2,4,5,6,7,8,8-octachlor-3a, 4,7,7a- tetrahydro-4,7-endomethanoindan			0.2
DDT	50-29-3	1,1,1-trichloro-2,2-bis- (4-chlorophenyl)-ethane		Total calculated as DDT	10
DDD	72-54-8	1,1-dichloro-2,2-bis- (4-chlorophenyl)-ethane
DDE and isomers	72-55-9	1,1-dichloro-2,2-bis- (4-chlorophenyl)-ethylene
Diflubenzuron	35367-38-5	1-(4-chlorophenyl) -3-(2,6- difluorobenzoyl)-urea			100
Dimefox	115-26-4	N, N, N ', N'-tetramethyl-diamino- phosphoric acid fluoride			0.01
Endrin	72-20-8	1,2,3,4,10 ,10-hexachloro-6,7-epoxy-1,4, 4a, 5,6,7,8, 8a-octahydro-1,4- endo-5,8-endodimethanonaphthalene			0.3
Flumetralin	62924-70-3	N-(2-chloro-6-fluorobenzyl) -N-ethyl- 4-trifluoromethyl-2,6-dinitroaniline			20
HCH-isomers except Lindan	608-73-1	1,2,3,4,5,6-hexachlorocyclohexane- Isomers except gamma-1,2,3,4,5,6- hexachlorocyclohexane			1
Heptachlor (alpha and beta-isomer)	76-44-8	1,4,5,6,7,8,8-heptachlore-3a, 4,7,7a- tetrahydro-4,7-endomethanoindene		Total calculated as Heptachlor	0.2
alpha-isomer	28044-83-9
beta-Isomer	1024-57-3
Heptachlor- epoxide	1024-57-3	1,4,5,6,7,8,8-heptachlor-2,3- epoxy-3a, 4,7, 7a-tetrahydro-4,7- endomethanoindan
Hexachlorobenzene	118-74-1				0.3
Hydrogen phosphorous Phosphide	7803-51-2			Total calculated as Phosphorus Hydrogen	0.01
Polychlorterpenes (Camphechlor, Stroban and other poly- chlorinated terpenes)		Chlorinated Camphene (67 to 69% chlorine)		Total	5
Terbufos	13071-79-9	O, O-Diethyl-S-tertbutyl- thiomethyl-dithiophosphate		Total calculated as Terbufos	0.05
Terbufossulphoxide	10548-10-4	O, O-Diethyl-S-tertbutyl- sulfinylmethyl-dithiophosphate
Terbufossulfone	56070-16-7	O, O-Diethyl-S-tertbutyl- sulfonylmethyl-dithiophosphate