Key Benefits:
Scheme of the State Secretary for Health, Welfare and Sport of 10 May 2016, characteristic 966398-150196-WJZ laying down rules on the production, presentation and sale of tobacco products and related products (Tobacco and Smoke Products Scheme)
The Secretary of State for Health, Welfare and Sport,
Having regard to 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 relating to the production, presentation and sale of tobacco products and related products, and repealing Directive 2001 /37/EC (PbEU 2014, L 127) and on the Articles 2, 4th and Fifth paragraph , 3c, third and fourth members , 13, first paragraph , and 19, 2nd paragraph, of the Tobacco and Smoke Law Act and the Article 2.1, third paragraph , 2.2, second paragraph , 2.3 , 2.4 , 3.1 , 3.2, third and fourth members , 3.3 , 4.1, second paragraph , 4.2, second paragraph , 4.3, second and third members , 4.4, first paragraph , 4.5, second paragraph , 4.6, second paragraph , 4.7, second paragraph , 4.8, second Member , 5.5, 2nd Member , 5.6, third member , and 7.1a of the Tobacco and Smoking Decree ;
Decision:
The following definitions shall apply:
Decision: Tobacco and tobacco products decision ;
common entry gate: a common European portal for the provision of information and documentation on tobacco products and related products;
Minister: Minister for Health, Welfare and Sport;
Odour or flavouring: an additive that provides smell or taste;
characteristic flavouring: a clearly discernible smell or taste than that of tobacco and which is the result of an additive or combination of additives, including but not limited to, fruit, spices, spices, alcohol, confectionery, menthol or vanilla, which may be be observed before or when consumption of the tobacco product is consumed;
Child-resistant closure: a buckle in accordance with Annex II, points 3.1.2, 3.1.3 and 3.1.4.2 of this Regulation. Regulation (EC) 1272/2008 ;
Toxicity: the extent to which a substance may have adverse effects in the human organism, including effects that occur over time, usually due to repeated or continuous consumption or exposure;
Regulation (EC) 1272/2008: Regulation (EC) No 148/EC 1272/2008 of the European Parliament and of the Council of 16 December 2008 on the classification, labelling and packaging of substances and mixtures to amend and withdraw the Directives 67 /548/EEC and 1999 /45/EC and to change of Regulation (EC) No 148/EC DEC ;
addictive effect: the pharmacological ability of a substance to cause addiction, a condition that affects a private citizen ' s ability to control his behavior, usually by giving reward or alleviating treatment. withdrawal symptoms, or both.
2 As tobacco products Directive, intended to Article 1, first paragraph, of the Tobacco and Smoke Law Act , is designated 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 relating to the production, presentation and sale of tobacco products and related products, and repealing Directive 2001 /37/EC (PbEU 2014, L 127).
1 In the case of methods of examination which, in the event of exclusion, are decisive for determining whether a cigarette satisfies the requirements of Article 2.1, first paragraph, of the Decision , shall be assigned the measurements according to the following standards:
a. NEN-ISO 4387:2000/A1:2008 Cigarettes-Determination of the total nicotine-free dry smoke condensate when using a smoking machine for routine analysis examination of cigarettes, for the emission level of tar;
b. NEN-ISO 10315:2013 Cigarettes-Determination of the nicotine content in smoke condensates-Gas chromatographic method, for the emission level of nicotine;
c. NEN-ISO 8454:2007/A1:2009 Cigarettes-Determination of carbon monoxide in the gas phase of cigarette smoke-NDIR method, for the emission level of carbon monoxide.
2 The results of the measurements shall be verified by: NEN-ISO 8243:2013 Cigarettes-Sampling .
3 The Minister shall publish the references of amendments to the standards designated in paragraph 1 in the Official Journal.
1 As a method of examination that in case of exclusion are decisive for determining whether a shekkie complies with the requirements of Article 2.1, second paragraph, of the Decision , the measurements shall be designated according to the standards:
a. NEN-ISO 15592-3:2009 'Fine-cut tobacco' and smoking articles made from shagtobacco-Sampling method, conditioning and analysis-Part 3: Determination of the total smoke condensate content when using a smoke machine for routine use analytical study, preparation for the determination of water and nicotine, and the calculation of nicotine-free smoke condensate, for the emission level of tar, measured using a shekkie with 750 mg of tobacco, where, by derogation of Annex B, table B.1, a standard type of paper used as referred to in the second paragraph;
b. NEN-ISO 10315: 2014 (Cor.2014-11) Cigarettes-Determination of the content of nicotine in smoke condensates-Gas chromatographic method, for the emission level of nicotine, measured using a shekkie with 750 mg of tobacco, using a standard type paper is used as referred to in the second paragraph;
c. NEN-ISO 8454:2007/A1:2009 Cigarettes-Determination of carbon monoxide in the gas phase of cigarette smoke-NDIR method , for the emission level of carbon monoxide, measured using a shekkie with 750 mg of tobacco, using a standard type of paper as referred to in the second paragraph.
2 The type of paper referred to in point (a), (b) and (c) of the first paragraph shall comply with the following specifications:
Unit New Paper Type| Color | White |
||
| Marking | Cylinder Marking |
||
| Paper weight | G/m 2 |
Average |
Average tolerance |
| 23.0 |
+/-1.0 |
||
| Thickness (10 times) |
Μm |
350 |
+/-20 |
| Filler CaCO3 | % |
26.8 |
+/-2.7 |
| Whiteness | % |
- |
Min 82 |
| Air permeability (at a pressure of 1 kPa) |
Cm 3 /min/cm 2 |
140 |
+/-7 |
| Relationship gradient | Linear |
||
| Sodium/potassium citrate additives | % |
1.10 |
+/-0.20 |
This is used in the EN-ISO 15592-3:2009 Fine-cut tobacco and smoking articles made from shagtobacco-Sampling method, conditioning and analysis-Part 3: Determination of the total smoke condensate content when using a smoke-machine for routine analytical purposes research, preparation for the determination of water and nicotine, and the calculation of nicotine-free smoke condensate These tests.
3 The results of the measurements shall be verified by: EN-ISO 15592-1:2001 Fine-cut tobacco and smoking articles made from shagtobacco-Methods of sampling, conditioning and analysis-Part 1: Strength .
4 The Minister shall publish the references of amendments to the standards set out in the first to third paragraph in the Official Journal.
1 For recognition in the sense of: Article 3c, second paragraph, of the Tobacco and Smoke Law Act , shall be eligible laboratories to which accreditation under NEN-EN-ISO/IEC 17025:2005/C1:2007 General requirements for the competence of test and calibration laboratories , has been granted and that are part of the Empire.
2 The Minister shall grant an application for approval. The approval may be subject to requirements aimed at ensuring the quality and independence of the verifications of measurements and investigations.
The Minister shall publish in the Official Gazette of which laboratories have been approved.
4 A recognition may be withdrawn if no longer meets the requirements of or pursuant to this Article.
1 Verification of the measurements provided in Article 2.1, second paragraph , please find by brand and type of cigarette once every three years. The costs associated with the verification shall be borne by the person for whom this work is carried out. The cost amounts to € 1,208,92 per brand and type of cigarette.
2 Verification of the measurements provided in Article 2.2, third paragraph , each brand and type of tobacco will take place once every three years. The costs associated with the verification of the measurements referred to in Article 2.2 (3) shall be borne by the person from whom the work is carried out. The costs shall be € 1,421,77 per mark and type of roll-on tobacco.
1 Cigarettes and tobacco with a characteristic flavouring shall not be placed on the market, subject to the provisions of Article 7 (2) and (5) of the Directive on tobacco products.
2 Cigarettes and shagtobacco comply with Article 7 (7) of the Tobacco Products Directive.
1 It is prohibited to place on the market tobacco products containing additives in quantities which, when consumed, contain the toxic or addictive effect or the carcinogenicity, mutagenicity or reprotoxicity of a tobacco product in significant or to be quantifiable, taking into account the provisions of Article 7, 10th and 11th paragraph of the Tobacco Products Directive.
2 Tobacco products placed on the market comply with Article 7, sixth paragraph, of the Tobacco Products Directive.
Article 3.1 shall apply mutatis mutandis to the tobacco product itself.
1 An electronic cigarette is placed on the market only if it is in the form of a disposable product, or if it is refillable by means of a refill package and a reservoir, or is rechargeable with a single-use cartridge.
2 An electronic cigarette shall, for each brand and type of use when used under normal and comparable conditions, give similar nicotine doses to it.
3 A refill tank of a refillable electronic cigarette has a volume of up to 2 ml.
1 An electronic cigarette and a refill pack are child safe and protected from tampering, breaking and leaking.
2 In addition to the provisions of Regulation (EC) 1272/2008 A refill pack shall have a child-resistant closure if it is not required for a child-resistant closure pursuant to the aforementioned Regulation.
3 An electronic cigarette and refill pack, if applicable, shall have a refill mechanism complying with the provisions of Article 20 (thirteenth) of the Tobacco Products Directive.
Nicotine-containing liquid shall be placed on the market only if it complies with Article 20 (a) (a) to (e) of the tobacco products Directive.
The labelling of a unit packet or outer packaging of a tobacco product placed on the market shall not contain any symbol, name, mark, figurative sign or other element or characteristic referred to in Article 13, first paragraph, of the tobacco products directive.
1 A health warning on a packaging unit and an outer carton of tobacco products placed on the market comply with the provisions of Article 8, first to fourth paragraph, of the Tobacco Products Directive.
2 The dimensions of a health warning as intended in the Article 3.3 , 3.4 , 3.6 and 3.8 shall be calculated in proportion to the area concerned when the unit packet or the outer packaging of a tobacco product is closed.
3 A health warning on a packaging unit or outside packaging of a tobacco product is surrounded by a 1 mm wide black border, within the area designated for this health warning. This requirement does not apply to the health warning of a unit packet or outer packaging of cigars as intended Article 3.2, second paragraph, of the Decision .
1 The general warning is: Smoking is deadly-stop now.
2 The information message is the message referred to in Article 9, second paragraph, of the Tobacco Products Directive.
3 The general warning and information message shall be sent to each packaging unit and to any outside packaging of tobacco products intended for smoking and shall comply with Article 9, third and fourth paragraph, of the Tobacco Products Directive and certain provisions of Article 9 (6) of the Directive on tobacco products.
1 A combined health warning shall contain one of the warning texts referred to in Annex I to the tobacco products Directive and an accompanying colour photograph from Annex II to the Tobacco Products Directive and information on stopping by smoking.
2 The following information concerning the cessation of smoking as referred to in paragraph 1 shall read:
Stop it now! Look at www.ikstopnu.nl
Or call the 0800-1995 stop line (free of charge).
3 A unit packet or outside pack with a combined health warning shall comply with the first sentence of Article 10 (c), (d), (e) and (g) and (g) of the tobacco products Directive.
1 From 20 May 2016 to 19 May 2017, the production is to use the first group of combined health warnings from Annex II of the Tobacco Products Directive, and this group shall be kept by a subsequent group in the following year I'm
2 The combined health warnings prescribed for the given year shall as far as possible be as much as possible on any trade mark of tobacco products intended for smoking.
1 The labelling of a unit packet and an outer carton of cigars as intended Article 3.2, second paragraph, of the Decision , meets the provisions of Article 11, first to fifth paragraph, of the Tobacco Products Directive.
2 The reference to the services which help to stop smoking, as referred to in Article 11 (1), first paragraph, of the Tobacco Products Directive, is: www.ikstopnu.nl or call 0800-1995.
1 A unit packet of cigarettes or shagtobacco shall comply with Article 14 of the tobacco products Directive.
2 A unit packet or an outer carton of cigarettes or roll-roll tobacco shall not contain ingredients containing odour or flavouring substances or containing, with technical elements, the smell, taste, or intensity of the smoke of the cigarette or the like product. For roll-over tobacco.
A unit packet and an outer packaging of a non-smokeless tobacco product shall comply with Article 12 of the Tobacco Products Directive.
A package unit of an electronic cigarette and a refill pack contains a package leaflet with:
a. Any indication of the use of the product, including in any case:
The indication that the use of the product is not recommended by young people and non-smokers;
i. where applicable, information on which other products are compatible with this product;
r. where applicable, instructions for umbilical cord, including illustrations;
b. instructions on storage of the product;
c. warnings for the following risk groups: swelling, breast-feeding women and those with illness to the lungs, cancer or heart disease;
d. information on potential adverse effects;
e. information on addictive effects and toxicity; and
f. contact details of the producer in the European Economic Area or importer in the European Economic Area.
1 On a unit packet and an outer carton of an electronic cigarette or refill pack, if applicable, a list of all the ingredients of the product shall be affixed to a descending weight, together with an indication of the packaging of the product. nicotine content of the product in mg per ml, the nicotine release per dose and the lot number.
2 To the extent that the recommendation to keep a product out of reach of children is not mandatory on the basis of Regulation (EC) 1272/2008 , a unit packet and an outer carton of an electronic cigarette or refill package in addition to this Regulation, shall contain the aforementioned recommendation.
3 A unit packet and an outer packaging of an electronic cigarette or refill pack shall comply with Article 20 (b) (ii) of the Tobacco Products Directive.
1 On a unit packet and any outer packaging of an electronic cigarette or refill container, the following warning shall be affixed, if applicable: ' This product contains the highly addictive nicotine. Their use is not recommended for non-smokers '.
The warning, referred to in paragraph 1, complies with Article 20 (4) (c) of the Tobacco Products Directive.
An outer packaging and a unit packet of herbal products for smoking shall comply with Article 21 of the Tobacco Products Directive.
1 The notification referred to in Article 4.1 of the Decision , comply with Article 5, first to third paragraphs, of the Tobacco Products Directive.
2 The costs associated with the reception, storage, processing, analysis and publication of the information and documents shall be charged to the person for whom the work is to be carried out. The cost amounts to € 44.85 per new or modified product. If a supplement of data and documents is required, another € 44,85 will be charged.
1 Producers and importers of tobacco products provide the Minister with all the internal and external studies on market research and the preferences of different groups of consumers, including young people and current smokers, on ingredients and emissions, as well as summaries of market surveys they carry out in the launch of new products. These particulars and documents shall be provided within a reasonable period of time after they have become known to the producer or importer.
2 Producers and importers of tobacco products provide an annual report on the volume of sales of tobacco products which they have placed on the market by brand and type, declared in terms of numbers or kilograms and per Member State, on an annual basis. Producers and importers shall provide the information relating to the preceding calendar year before 15 June of the calendar year following the year to which the data relate.
1 The in-depth studies referred to in Article 4.3, first paragraph, of the Decision , are carried out to determine whether the additive:
a. contributes to the toxicity or addictiveness of the products concerned, and whether it increases the toxicity or addictiveness of the products concerned in significant or measurable degree;
b. produces a characteristic flavouring;
c. Facilitates the inhalation or absorption of nicotine; and
Substances which are carcinogenic, mutagenic or reprotoxic, the quantities of those substances, and whether this has the effect of causing a significant or measurable increase in the carcinogenicity, mutagenicity or reproduction of the product concerned. will be increased.
2 In carrying out the in-depth studies, Article 6, third paragraph, of the Tobacco Products Directive shall be complied with.
3 The report of an in-depth study complies with the first paragraph of Article 6 of the Tobacco Products Directive.
4 Producers and importers provide the report of the in-depth study no later than 18 months after the additive in question is designated as intended Article 4.3, first paragraph, of the Decision .
5 The costs associated with the reception, storage, processing and publication of the detailed reports submitted for detailed studies shall be borne by the person for whom the work is carried out. The costs shall be € 322,16 per report provided. If the addition of data and documents is required, € 322,16 will be reckoned.
6 The independent assessment of the in-depth studies is carried out by the Rijksinstituut for Public Health and the Environment.
1 As a template for the submission of the data and documents, intended in the Articles 4.1 , 4.2 and 4.3 shall be designated the template established pursuant to Article 5, fifth paragraph, of the Tobacco Products Directive.
2 The particulars and documents referred to in the Articles 4.1 , 4.2 and 4.3 , shall be provided by the producers and importers electronically by means of the common entry gate. The particulars and documents referred to in Article 4.2 shall be supplied in the English language or in English.
1 The notification referred to in Article 4.5 of the Decision , according to Article 19, first paragraph, of the Tobacco Products Directive.
2 If producers or importers have new or updated information or documents as referred to in Article 19 (a), (b) or (c) of the tobacco products Directive, they shall submit them to the Minister within a reasonable period.
3 The notification shall be made electronically by means of the common entry gate in the English language or in the English language.
4 The costs associated with the reception, storage, processing and analysis of the information and documents referred to in paragraph 1 shall be borne by the person for whom the work is to be carried out. The cost amounts to € 44.85 per new tobacco product. If a supplement of data and documents is required, another € 44,85 will be charged.
1 The notification referred to in Article 4.6 of the Decision , according to Article 20, second paragraph, of the Tobacco Products Directive.
2 The notification shall be made electronically by means of the common entry gate.
3 As a template for the submission of the data and documents, the template shall be determined by virtue of Article 20, thirteenth paragraph of the Tobacco Products Directive.
4 The costs associated with the reception, storage, processing, analysis and publication of the information and documents shall be charged to the person for whom the work is to be carried out. The costs amount to € 44.85 per new or substantially modified product. In addition to data and documents, other than in particular in Article 4.5, third paragraph, of the Decision , is required, again, € 44,85 will be charged.
1 The notification referred to in Article 4.7 of the Decision , complies with the terms of Article 20, paragraph 7, introductory wording and points (i) to (iv) of the tobacco products Directive.
2 The notification shall be made electronically by means of the common entry gate in the English language or in the English language.
3 The producers and importers shall provide the data for the preceding calendar year before 15 June of the calendar year following the year to which the data relate.
1 In the case of the notification, Article 4.8 of the Decision , a list of all ingredients indicating the quantities used for the production of those products, broken down by mark and type, used for the production of the products used for smoking shall be given to the Minister.
2 The notification shall be made electronically by means of the common entry gate.
3 The costs associated with the reception, storage, processing, analysis and publication of the information and documents shall be charged to the person for whom the work has been carried out. The costs amount to 44,85 per new or modified herbal product for smoking. If a supplement of data and documents is required, another € 44,85 will be charged.
1 A retail list provided for registration on the basis of Article 5.5 of the Decision the following particulars and documents:
a. the name or trade name, the permanent address of the business premises from which tobacco products, electronic cigarettes or refill containers are delivered and the address where the responsible retail outlet is established;
b. the start date of the offering of tobacco products, electronic cigarettes or refill containers for cross-border distance selling;
c. a list of all types of products that are offered for remote cross-border sale;
d. if applicable, the addresses of the websites used and any relevant information necessary to identify the websites;
e. if subject to excise duty products, the declaration that the sale of products is carried out in accordance with the applicable legislation on excise duty; and
f. a description of the details and operation of the age verification system.
2 The registration can take place only electronically via the website of the Dutch Food and Warenauthority.
The age verification system referred to in Article 5.6, first paragraph, of the Decision , it makes it possible to confirm the age of the consumer in a reliable and unambiguous way.
1 Images of a packaging unit and an outer packaging of tobacco products aimed at consumers in the European Economic Area are displayed in such a way that the text of the largest health warning is clearly visible.
2 Images of a packaging unit and an outer carton of tobacco products intended for smoking comply with Article 3.5 , with the exception of images of a unit packet and an outer carton of cigars as intended Article 3.2, second paragraph, of the Decision . These images comply with the first sentence of the third paragraph of Article 11 of the Tobacco Products Directive.
3 The obligation in the second paragraph, first sentence, does not apply to images intended to be rendered sustainably in a tobacco or electronic cigarette case case or to a tobacco regulator, to the extent that the obligation to do so is to be used. to rotate annually with groups of combined health warnings, as provided for in the first sentence of Article 10, second paragraph, of the Tobacco Products Directive.
With the monitoring of compliance with or under the conditions of Tobacco and Smoking Law are in charge of the officials of the Netherlands Food and Warenauthority.
The following arrangements shall be repealed:
- Electronic notification and tobacco-related publications scheme 2013 ;
- Scheme of research methods of tar, nicotine and carbon monoxide levels in cigarettes and shag .
1 Laboratories designated on the basis of Article 2.3, first paragraph, of the Decision implementing the Tobacco Act , as it was worded immediately before the entry into force of the Decision of 4 May 2016, amending the Decision of Implementation of Tobacco Law and the Annex to the Tobacco and Smoke Law in relation to the implementation of the Code of Tobacco Control. Directive 2014/40 /EU, on the production, presentation and sale of tobacco and related products (Stb. 2016, 175), apply as designated on the basis of Article 2.3, second paragraph -From this arrangement.
2 On cigarettes and shagtobacco with a characteristic aroma whose sales volume represents three per cent or more of a given product category throughout the European Union, Article 2.5, first paragraph , until 20 May 2020 not applicable.
3 By way of derogation from Article 3.4, second paragraph , shall comply with Article 10 (e) (e) (e) (e) (e) (e) of the Tobacco Products Directive, instead of Article 10, first paragraph, point (e), with a single health warning until 20 May 2019. First sentence, of the Tobacco Products Directive.
4 Electronic cigarettes, refill containers, packaging units and outer packaging of electronic cigarettes and refill containers and package capers for electronic cigarettes and refill containers that comply with the requirements of the Temporary legal act of electronic cigarettes , as was immediately prior to the entry into force of this Arrangement, and which were produced or released for free circulation before 20 May 2016, may be placed on the market until 20 November 2016.
5 Producers and importers of tobacco products provide the Minister with the particulars and documents intended to Article 4.2, third paragraph , with respect to the years 2015 and 2016 in so far as they have them available. The data and documents relating to 2015 shall be provided before 1 January 2017. The data and documents relating to 2016 shall be provided before 15 June 2017.
6 Producers and importers of electronic cigarettes and refill containers shall communicate to the Minister the particulars and documents referred to in Article 4.7, first paragraph , with respect to the year 2016 to the extent that they have them available before June 15, 2017.
7 By way of derogation from the Articles 4.6, 4th paragraph , and 4.8, third member , no charges are charged related to the receipt, storage, processing, analysis and publication of the data and documents due to Article 7.1 of the Decision provided before 20 November 2016.
This scheme is quoted as: Tobacco and smoke regulations.
This arrangement enters into force at the time the Law of 26 April 2016 amending the Tobacco Act to implement the Law. Directive 2014/40 /EU, on the production, presentation and sale of tobacco and related products (Stb. 2016, 175) enters into force.
This arrangement will be set out in the Official Journal.
TheState Secretary
of Public Health, Welfare and Sport,M.J. van Rijn
