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? Guideline for Labeling of Liquids and Predecessor Products CLP (Classification, Labeling and Packaging) REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) TabakErzG (Tobacco Product Law) TabakErzV (Tobacco Product Directive) ProdSG (Product Safety Law) May 2019
Guideline to Labeling of Liquids and Predecessor Products What is at issue? How does it work? The purpose of this guideline is to give the user an 1. The product to be labeled is assigned to a introductory guide to the labeling of liquids and corresponding product type in the assessment precursors such as flavours, bases, shots and shortfills. diagram. It represents a compact, clear and as extensive as 2. The corresponding sample label in the product possible collection of the regulations which must be category shows the required label components. adhered to when these products are placed on the market in Germany. 3. The significance of the individual components, as well as their presentation and content requirements, Who does this concern? will be described in the section Labeling Elements. The target group of this guideline is all those involved 4. The General Information contains additional in the manufacture, import, distribution or sale of the relevant regulations that needs to be complied products mentioned above. In particular, operators with. of outlets should be given an easy-to-use option to 5. If needed, the sources of the corresponding control the marketability of their goods. passages may be taken from the underlying legal texts. Why this is important? In addition to the Tobacco Products Law (TabakErzG) and the associated Tobacco Product Directive (TabakErzV), which has previously been exclusively related to liquids Further examples, additional details and current containing nicotine, the CLP-Regulation and the REACH- news concerning the topic can be found at Provision is the foundation of this guideline. www.vd-eh.de/Leitfaden 1. Assessment Diagram Yes No Liquid with nicotine Contains flavour? Shot (high) Yes (high) Nicotine Content greater than 16.6 mg/ml? (*1) Yes No No Liquid with nicotine Yes Contains flavour? Shot (low) (low) Product Contains nicotine? Yes only Shot Shot & Base No Must it yet be mixed? Shortfill Flavour Yes Contains flavour? No Liquid without Base nicotine No
Product Product Category Category Labeling Labeling Elements Elements Dieses Dieses Produkt Produkt darf nicht darf nicht in dieinHände die Hände von von 1 Signal 1 Signal WordWord [9] [9] 9 Batch-No. 9 Batch-No. [39] [39] 11 11 3 3 13 13 EC-ID: 00000-00-00000 EC-ID: 00000-00-00000 Liquid Liquid withwith nicotine nicotine Kindern Kindern und Jugendlichen und Jugendlichen gelangen. gelangen. • Determined • Determined by classifi by classifi cation, cation, hazard hazard category category andand • Notice • Notice displays displays thethe batch batch to which to which thethe refill-container refill-container (high) (high) „Produktname“ „Produktname“ 4 Nach 4 NachGebrauch Gebrauch Haut Haut gründlich gründlich waschen. waschen. hazard hazard classes. classes.[14] [14] belongs. belongs. 7 18 7 mg/ml 18 mg/ml Nikotingehalt Nikotingehalt 12 10 12 ml 10 ml InhaltInhalt Bei Gebrauch Bei Gebrauch rauchen. nichtnicht rauchen. essen, essen, trinken BEI VERSCHLUCKEN: trinken BEI VERSCHLUCKEN: oder oder SofortSofort • Must • Must be grouped be grouped withwith hazard hazard statements. statements. [23] [23] GIFTINFORMATIONSZENTRUM GIFTINFORMATIONSZENTRUM / Arzt/ anrufen. Arzt anrufen. „Danger“ „Danger“ [4] [4] „Attention“ „Attention“ depending [4] [4] depending on flonavour flavour 10 10 Tactile Tactile hazard warning hazard warning [26] [26] Shot Shot (high) (high) 1 Gefahr 1 Gefahr MundMund ausspaussp ülen.ülen. Inhalt/Behälter Inhalt/Behälter einereiner • Necessary, • Necessary, e.g.e.g. if classifi if classifi ed ased acute as acutetoxic. toxic. [6] [6] anerkannten anerkannten Abfallentsorgung Abfallentsorgung zuführen. zuführen. 11 11 GiftigGift 2 2 beiig bei 2 Hazard 2 Hazard Statements Statements [9] [9] • Regardless • Regardless of capacity. of capacity. [6] [6] Verschlucken Verschlucken 5 Enthält: 5 Enthält: KannKann „Stoff„Stoff allergische name“ allergische name“ Reaktionen Reaktionen hervorrufen hervorrufen • Determined • Determined by classifi by classifi cation, cation, hazard hazard category category andand • Must • Must comply comply withwith EN EN ISOISO11683. 11683. [6] [6] 10 10 7 Nikotinabgabe 7 Nikotinabgabe pro Dosis: 000 000 pro Dosis: Inhaltsst 14 14 Inhaltsst „Stoff offe:offe: „Stoff namename X“, „Stoff X“, „Stoff namename Y“, Y“, hazard hazard classes. classes. [15] [15] Mandatory Mandatorydepending depending on flon avour flavour 9 Ch. 9 Nr.: Ch.000-000-000 Nr.: 000-000-000 „Stoff„Stoff namename Z“, Nikotin Z“, Nikotin (ISO) (ISO) • Must • Must be grouped be grouped withwithsafety safety instructions. instructions. [23] [23] 8 Hergest 8 Hergest „PLZ„PLZ ellt von: & Ort“, & Ort“, „Name“, ellt von: „Name“, „Telefonnummer“ „Straße/Hausnr. „Straße/Hausnr. „Telefonnummer“ 6 Gefahrbest 6 Gefahrbest Nikotin Nikotin immende immende (ISO) (ISO) Komponente: Komponente: H301 H301 [4] (*1)[4] (*1) H302 H302 [4] [4] depending depending on flon avour flavour 11 Clear 11 Clear Labeling Labelingof the Product of the Product [45] [45] • Clear • Clear labeling labeling for for thethe identifi identifi cation cation of the of the consumer consumer pro-pro- Dieses Dieses Produkt Produktenthält enthält Nikotin: Nikotin:Dieses Dieses Produkt Produktenthält enthält Nikotin: Nikotin: 3 GHS 3 GHSPictogram Pictogram [9] [9] duct. duct. • Determined • Determined by classifi by classifi cation,cation, hazard hazard category category and‚and‚ • Typically • Typically product product name, name, item-no./EAN item-no./EAN Code. Code. einen einen Stoff Stoff , der , der sehr sehr stark stark 15 15 einen einen Stoff Stoff , der , der sehr sehr stark stark hazard hazardclasses. classes. [13] [13] EC-ID EC-ID is not is not mandatory mandatory yetyet recommended recommended abhängig abhängig macht. macht. abhängig abhängig macht. macht. • Black • Black symbol symbol on white on white background background withwith a reda red frame. frame. [2] [2] • Area • Area at least at least 1cm1cm . . 2 [2] 2 [2] 12 Nominal 12 Nominal volume volume [9] [9] • Must • Must be grouped be grouped withwithsafety safety instructions. instructions. [23] [23] • •A nominal A nominal quantity quantity of the of the mixture mixture in the in the package. package. GHS06 GHS06 [4] [8] [4] (*1)[8] (*1) GHS07 GHS07 [4] [8] [4] [8] depending depending on flon avour flavour Max. Max. 10ml 10ml permitted permitted 32] 32] 4 Precautionary 4 Precautionary statements statements [9] [9] 13 Youth 13 Youth Protection Protection Note Note [40] [40] Liquid Liquid withwith nicotine nicotine 11 11 • Determined • Determined by classifi by classifi cation, cation,hazardhazard category category andand • This • This product product must must be kept be keptoutout of reach of reach of children of children andand 3 3 7 67mg/ml 6 mg/ml „Produktname“ „Produktname“ 10 10 EC-ID: 00000-00-00000 EC-ID: 00000-00-00000 Nikotingehalt Nikotingehalt (low) (low) EntspEntsp richt richt hazard hazard classes. classes.[16] [16] adolescents. adolescents. [42] [42] Nikotinabgabe Nikotinabgabe pro Dosis pro Dosis • Not • Not more morethan than six six precautionary precautionary statements, statements, unlessunless Mandatory Mandatory (Dosis (Dosis = 1ml)= 1ml) neccessary neccessary to refl to refl ect ect thethe naturenature andand thethe severity severity of the of the affixing affixing recommended recommended 9 Nr.: 9 Ch. Ch.000-000-000 Nr.: 000-000-000 Shot Shot (low) (low) hazards. hazards. [18] [18] 6 6 2 2 8 Hergest 8 Hergest ellt von: ellt von: „Name“, „Name“, „Straße/Hausnr. „Straße/Hausnr. • Avoid • Avoid anyany double double andand clearly clearlyunnecessary unnecessary notices notices . [18] . [18] 14 Ingredients 14 Ingredients [37] [37] Achtung - Enthält - Enthält „PLZ„PLZ & Ort“, & Ort“, 1 1 Achtung Verschlucken. Nikotin NachNach Verschlucken. Nikotin (ISO) (ISO) Gebrauch - Gesundheitsschädlich Gebrauch - Gesundheitsschädlich Haut Haut gründlich gründlich waschen. bei bei waschen. Bei Gebrauch Bei Gebrauch „Telefonnummer“ „Telefonnummer“ 11 11 • Disposal • Disposal information information required. required. [18] [18] • In• Descending In Descending Order Order of Weight. of Weight. nichtnicht essen, essen, trinken trinken oder oder rauchen. rauchen. BEI VERSCHLUCKEN: BEI VERSCHLUCKEN: Bei Unwohlsein Bei Unwohlsein • Must • Must be grouped be grouped together. together.[23] [23] Mandatory Mandatory 10 ml 10 ml Dieses GIFTINFORMATIONSZENTRUM GIFTINFORMATIONSZENTRUM / Arzt/ anrufen. Arzt anrufen. MundMund ausspaussp ülen.ülen. Inhalt/ 4 4 13 Inhalt/ 13 Dieses Produkt Produkt darf nicht darf nicht in in Inhalt Inhalt Behälter Behälter einereiner anerkannten anerkannten Abfallentsorgung Abfallentsorgung zuführen. zuführen. die Hände die Hände von Kindern und und12 von Kindern 12 • The • The order orderis freely is freelyselectable. selectable. [23] [23] affixing affixing recommended recommended Jugendlichen Jugendlichen gelangen. gelangen. Inhaltsst P264, P264, P270,P270,P330, P330,P501,P501, P301+310( P301+310( ) /312( ) /312( ) [4] ) [4] 5 Enthält: 5 Enthält: „Stoff„Stoff name“name“ 14 14 Inhaltsst offe:offe: „Stoff„Stoff namename X“, „Stoff X“, „Stoff namename Y“, „Stoff Y“, „Stoff namename Z“, Nikotin Z“, Nikotin (ISO) (ISO) KannKann allergische allergische Reaktionen Reaktionen hervorrufen hervorrufen depending dependingon flon avour flavour 15 Health 15 Health Warning Warning [41] [41] • Wording: • Wording: “This “Thisproductproduct contains containsnicotine nicotine which which is aishighlya highly Dieses Dieses Produkt Produktenthält enthält Nikotin: Nikotin:Dieses Dieses Produkt Produktenthält enthält Nikotin: Nikotin: 5 5 Additional Additional Information Information Notices Notices[9] [9] addictive addictive substance.” substance.” [41] [41] einen einen Stoff Stoff , der , der sehr sehr stark stark 15 15 einen einen Stoff Stoff , der , der sehr sehr stark stark • Can • Can be independent be independent of hazard-determining of hazard-determining • Text: • Text: In German In German language, language, Helvetica Helvetica bold, bold, black black on white on white abhängig abhängig macht. macht. abhängig abhängig macht. macht. components. components. [17] [22] [17] [22] background, background, parallel parallel alignment alignment to the to the main main text,text, centered, centered, • E.g., • E.g., mixtures mixtures notnot classifi classifi ed ased sensitizing as sensitizing butbutcontaining containing mustmustfill outfill outat least at least 50%50% of the of the intended intended space. space.[34] [35] [34](*4) [35] (*4) at least at least oneone sensitizing sensitizing substance substance (EUH208). (EUH208). [7] [7] • On• On thethe twotwo largest largest spacesspaces of the of the packaging packaging andand outer outer depending depending on fl onavour flavour packaging, packaging, each eachof 30% of 30% of these of thesesurfaces surfaces (not(not of theof the label!) label!). [35] . [35] 6 6 Product Product Identifi Identifiers ers of Hazardous of Hazardous Substances Substances [9] [9] • Should • Should notnot containcontain comments, comments, paraphrases paraphrases or referen- or referen- 11 11 3 3 • Identities • Identities of allof substances all substances thatthat contribute contributeto the to the classifi classifi ca- ca- ces.ces. [34] (*4) [34] (*4) Liquid Liquid without without nicotine nicotine „Produktname“ „Produktname“ 1 1 tiontion of the of the mixturemixture (= hazard-determining (= hazard-determining components). components). [12] [12] • May • Maybe affi be xed affixed as long as long as itasisitneither is neither smudgeable smudgeable nornor Achtung Achtung • Necessity • Necessity is dependent is dependent uponuponthethe classifi classifi cation cation andand ha-ha- removable. removable. [34] (*4) [34] (*4) 2 Kann 2 Kann allergische allergische Hautreaktionen Hautreaktionen verursachen verursachen zardzard category category of the of the mixture mixture (i.e.,(i.e., acuteacute toxicity) toxicity) [12] [12] • Should • Should notnot be covered be covered or separated or separated whenwhenbeing being marke- marke- Shortfi Shortfi ll ll „Nicotine „Nicotine(ISO)“(ISO)“ depending depending on fl onavour flavour tedted . [34].(*4)[34] (*4) 4 Schutzhandschuhe 4 Schutzhandschuhe / Gesichtsschutz / Schutzkleidung / Gesichtsschutz tragen. / Schutzkleidung tragen. Bei Berührung / Augenschutz Bei Berührung / Augenschutz mit der mitHaut: der Haut: • Within • Within thethe space, space, shouldshouldbe bordered be bordered by aby1mm a 1mm black black Mit viel MitWasser viel Wasser und Seife und Seife waschen. waschen. Bei Hautreitzung Bei Hautreitzung 7 7 Nicotine Nicotine Content Content andand Nicotine Nicotine Level perper Level DoseDose [38] [38] border. border. [34] (*4)[34] (*4) oder oder -ausschlag: -ausschlag: Ärztlichen Ärztlichen Rat einholen Rat einholen / ärztliche / ärztliche Hilfe Hilfe hinzuziehen. hinzuziehen. Inhalt/Behälter Inhalt/Behälter einereiner anerkannten anerkannten • Nicotine • Nicotinecontent content typically typically in mg/ml. in mg/ml. Cylindrical Cylindrical Packaging: Packaging: Circumferential Circumferential affixing affixingon the on the Flavour Flavour 12 50 12 ml 50 ml Abfallentsorgung Abfallentsorgung zuführen. zuführen. • Nicotine • Nicotinelevel level perper dose dose currently currently notnot yetyetmore more closely closely lateral lateral surface, surface, double double affixing affixing of the of the safety safety notenote (*2) (*2) InhaltInhalt 6 6 defidefi ned.ned. 9 Ch. 9 Nr.: Ch.000-000-000 Nr.: 000-000-000 14 Inhaltsst 14 Inhaltsst offe:off „Stoff„Stoff namename Limett e: Limett X“, „Stoff enöl,enöl, X“, „Stoff namename Y“, „Stoff Y“, „Stoff namename Z“ Z“ e.g.e.g. DoseDose = 1 ml= 1 ml Base Base 10 10 5 Enthält: 5 Enthält: KannKann „Stoff„Stoff allergische name“name“ allergische Reaktionen Reaktionen hervorrufen hervorrufen 11 11 8 Manufacturer 8 Manufacturer Information Information [9] [9] 13 Dieses 13 Dieses Produkt Produkt darf nicht darf nicht in dieinHände die Hände von von Kindern Kindern und Jugendlichen und Jugendlichen gelangen. gelangen. • Name, • Name, address address andand phone phone number number of the of the manufacturer/ manufacturer/ 8 Hergest 8 Hergestellt von: „Name“, ellt von: „Name“, „Straße/Hausnr. „Straße/Hausnr. „PLZ„PLZ & Ort“, & Ort“, „Telefonnummer“ „Telefonnummer“ importer. importer. [44] [44]
4. General Information Safety Data Sheet (SDS) Refill Containers containing Nicotine • Structure and content are precisely regulated by the • Must be childproof, tamper-proof, shatterproof and REACH-provision . [30] [29] leakproof. [32] [25] • Must be made available by the manufacturer, importer • Childproof lids must comply with EN ISO 8317. [26] [5] and retailer (typically digital with possibility to print is • Volume may not exceed 10 ml. [32] sufficient). [28] [30] • Nicotine level may not exceed 20mg/ml. [32] • The SDS must be provided in the official language of • Must have a mechanism for leakproof refilling [32] (docking the member country of release. [30] system or at least a 9mm spout, thinner than the tank • The trade name in the SDS must be identical with the opening, securely fastened, max 20 drops per minute [43]). product’s name. [11] • Information on the packaging/labeling must comply Design of Packaging/Labeling with the information of the SDS. • Labeling in the official language of the member country • Classification and corresponding labeling elements to where the product is placed on the market. More be affixed can be found in Section 2.2 of the SDS: languages are permitted, as long as all necessary data is printed in the languages used. [10] • Labeling elements must be affixed horizontally, clearly ABSCHNITT 2: Mögliche Gefahren legible (minimum letter size 1.2 mm „x“ height [31]) and 2.1. Einstufung des Stoffes oder Gemisches indelibly marked. [20] [21] Verordnung (EG) Nr. 1272/2008 Gefahrenkategorien: • Labeling elements must be affixed directly on the refill Akute Toxizität: Akut Tox. 4 container and all other packaging unless the labeling is Gefahrenhinweise: clearly visible through container or packaging. [24] Gesundheitsschädlich bei Verschlucken. 2.2. Kennzeichnungselemente • Design should neither arouse children’s active curiosity Verordnung (EG) Nr. 1272/2008 nor appear attractive to them. [26] 6 Gefahrbestimmende Komponenten zur Etikettierung • Design should not mislead consumers by using similar Nikotin (ISO) Signalwort: Achtung packaging used for food, feed, medicines or cosmetics. 1 [26] Piktogramme: 3 Exception for Small Packaging/Labeling 2 Gefahrenhinweise: • If the packaging of a substance is either in such a H302 Gesundheitsschädlich bei Verschlucken. Sicherheitshinweise: shape or form or is so small (52x74 mm [1]), that not 4 all labeling elements can be affixed to it, these can P264 Nach gebrauch Haut gründlich waschen. P270 Bei Gebrauch nicht essen, trinken oder rauchen. also be made available on folded labels (rollup P301+P312 Ber Verschlucken: Bei Unwohlsein Giftinformationszentrum / Arzt anrufen. P330 Mund ausspühlen. labels/sandwich labels) or hangtags or on the outer P501 Inhalt / Behälter einer anerkannten Abfallentsorgungsanlage zuführen. packaging. [19] [3] • The label of the inner packaging (refill container) must Besondere Kennzeichnung bestimmter Gemische 5 EUH208 Enthält 4-Hydroxy-2,5-dimethyl-3(2H)-furanon. contain at least hazard pictograms, product identifier, Kann allergische Reaktionen hervorrufen. name and telephone number of the supplier. [3] • If multi-layer labels are used, special attention should Package Leaflet be paid to the clear marking of the peel-off point. • Mandatory for liquids and shots containing nicotine. [33] • Must display the heading “Gebrauchsinformation” Labeling Requirements in Advertising (Direction for Use). [36] • Advertising for mixtures classified hazardous must • Must be in German language, in layman‘s terms and contain hazard warnings, hazard pictograms and signal easily readable (see design). [36] words. [27] • Content Requirements: [36] • In online sales, the information should be held - Use and Storage Instructions (i.e., refill instructions, available so that the consumer must pass it before the also diagrams. [43]) goods can be placed in the shopping cart. (*3) - Contraindications • The information should be directly accessible and not - Warnings for endangered consumer groups (in via a link to other sites. (*3) particular non-smokers, the prohibition on sales to children and adolescents). - Information on possible adverse health effects. - An indication of the addictive properties. - Information concerning the toxicological data. - Name, address and electronic contact details of the manufacturer/importer.
5. List of Sources Regulation (EC) No. 1272/2008 Guideline for Labeling and Packaging under [CLP Regulation] (EC) No. 1272/2008 [1] Annex I paragraph 1.2 Tab. 1.3 July 2017 Version 3.0 [2] Annex I paragraph 1.2 [31] paragraph 5.2 [3] Annex I paragraph 1.5.1 [4] Annex I paragraph 3.1.4 3.1.3 Law for Implementing the Guideline concerning Tobacco [5] Annex II paragraph 3.1 Products and Related Products [6] Annex II paragraph 3.2 [TabakErzG] [7] Annex II paragraph 2.8 [32] §14 [8] Annex V paragraph 2 [33] §15 paragraph 1 No 1 [9] Art. 17 paragraph 1 [10] Art. 17 paragraph 2 Directive for Implementing the Guideline concerning [11] Art. 18 paragraph 1 Tobacco Products and Related Products [12] Art. 18 paragraph 3 [TabakErzV] [13] Art. 19 [34] §11 [14] Art. 20 [35] §13 paragraph 1 [15] Art. 21 [36] §26 [16] Art. 22 [37] §27 paragraph 1 No. 1 [17] Art. 25 paragraph 6 [38] §27 paragraph 1 No. 2 [18] Art. 28 [39] §27 paragraph 1 No. 3 [19] Art. 29 paragraph 1 [40] §27 paragraph 1 No. 4 [20] Art. 31 paragraph 1 [41] §27 paragraph 2-3 [21] Art. 31 paragraph 3 [22] Art. 32 paragraph 6 Second Provision for the Amendment of the Tobacco [23] Art. 32 Product Directive [24] Art. 33 paragraph 2 [42] Art. 1 No. 3 [25] Art. 35 paragraph 1 [26] Art. 35 paragraph 2 Implementing Decision (EU) 2016/586 [27] Art. 48 [43] Art. 2 [28] Art. 49 Law concerning the provision of products on the market, Regulation (EC) No. 1907/2006 ProdSG [REACH-Provision] [ProdSG / Product Safety Law] [29] Annex II [44] §6 paragraph 1 No. 2 [30] Art. 31 [45] §6 paragraph 1 No. 3 (*1) Threshold value in accordance with Regulation (EC) No 1272/2008 Annex I, Section 3.1.3.6.1 (extreme case: density ρ = 1). (*2) Letter from the Foodstuff Inspection Regulatory Agency Bochum. (*3) Letter from the District Government of Cologne. (*4) Application of §11 TabakErzV is not clearly prescribed, yet is strongly recommended. Further information at www.vd-eh.de/Leitfaden Disclaimer The information provided in this guideline only represents the current reading of relevant legal textst to facilitate both understanding and handling. Only the wording of the underlying legal texts is legally binding. The user alone is responsible for the use of this information. The Association of eCigarettes e.V. assumes no liability whatsoever for the possible use of the information in this document, and its completeness at the time of its preparation. Verband des eZigarettenhandels e.V. Tel: +49 (0)30 - 20 188 377 Vertretungsbefugnis: Vereinsregister: Franzoesische Strasse 1 Fax: +49 (0)30 - 20 188 575 Michal Dobrajc Amtsgericht Lueneburg / Hamburg VR200829 10117 Berlin · Germany ww.vd-eh.de · info@vd-eh.de Benedikt Hirtenreiter EU-Transparency Reg. 711092410756-80
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