Product Standards: Difference between revisions
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=About= | |||
The Tobacco Products Directive 2014/14/EU (TPD) introduced new rules for nicotine-containing electronic cigarettes and refill containers (Article 20) from May 2016. MHRA is the competent authority for the notification scheme for e-cigarettes and refill containers in the UK and is responsible for implementing the majority of provisions under Article 20. | The Tobacco Products Directive 2014/14/EU (TPD) introduced new rules for nicotine-containing electronic cigarettes and refill containers (Article 20) from May 2016. MHRA is the competent authority for the notification scheme for e-cigarettes and refill containers in the UK and is responsible for implementing the majority of provisions under Article 20. | ||
The TPD introduced new rules which ensure: | *The TPD introduced new rules which ensure: | ||
minimum standards for the safety and quality of all e-cigarettes and refill containers (otherwise known as e-liquids) | **minimum standards for the safety and quality of all e-cigarettes and refill containers (otherwise known as e-liquids) | ||
that information is provided to consumers so that they can make informed choices | **that information is provided to consumers so that they can make informed choices | ||
an environment that protects children from starting to use these products. | **an environment that protects children from starting to use these products. | ||
From 20 May 2017, the new requirements: | *From 20 May 2017, the new requirements: | ||
restrict e-cigarette tanks to a capacity of no more than 2ml | **restrict e-cigarette tanks to a capacity of no more than 2ml | ||
restrict the maximum volume of nicotine-containing e-liquid for sale in one refill container to 10ml | **restrict the maximum volume of nicotine-containing e-liquid for sale in one refill container to 10ml | ||
restrict e-liquids to a nicotine strength of no more than 20mg/ml | **restrict e-liquids to a nicotine strength of no more than 20mg/ml | ||
require nicotine-containing products or their packaging to be child-resistant and tamper evident | **require nicotine-containing products or their packaging to be child-resistant and tamper evident | ||
ban certain ingredients including colourings, caffeine and taurine | **ban certain ingredients including colourings, caffeine and taurine | ||
include new labelling requirements and warnings | **include new labelling requirements and warnings | ||
require all e-cigarettes and e-liquids be notified to MHRA before they can be sold | **require all e-cigarettes and e-liquids be notified to MHRA before they can be sold | ||
Consumers and healthcare professionals can report side effects and safety concerns with e-cigarettes or refill containers to MHRA through the Yellow Card reporting system. You can also report products suspected to be defective or non-compliant to your local Trading Standards or to TPDsafety@mhra.gov.uk. | Consumers and healthcare professionals can report side effects and safety concerns with e-cigarettes or refill containers to MHRA through the Yellow Card reporting system. You can also report products suspected to be defective or non-compliant to your local Trading Standards or to TPDsafety@mhra.gov.uk. | ||
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The TPD does not cover nicotine-containing products that are authorised as medicines. Further information about licensing these products as medicines can be found here | The TPD does not cover nicotine-containing products that are authorised as medicines. Further information about licensing these products as medicines can be found here | ||
Submitted products | =Submitted products= | ||
A list of products which have been notified to MHRA via the EU-CEG is available here: | A list of products which have been notified to MHRA via the EU-CEG is available here: | ||
List of submitted products, companies A to I (MS Excel Spreadsheet, 1.48MB) | *List of [https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/938406/Published_products_A-I.xlsx submitted products], companies A to I (MS Excel Spreadsheet, 1.48MB) | ||
List of submitted products, companies J to Z (MS Excel Spreadsheet, 1.76MB) | *List of [https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/938408/Published_products_J-Z.xlsx submitted products], companies J to Z (MS Excel Spreadsheet, 1.76MB) | ||
List of withdrawn UK notifications (MS Excel Spreadsheet, 199KB) | *List of [https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/938409/Withdrawn_Products.xlsx withdrawn UK notifications] (MS Excel Spreadsheet, 199KB) | ||
The Government aims to process submissions for products which have been sent to MHRA via the EU-CEG in date order and aim to publish new products within 45 to 60 days of notification. | |||
These lists may be useful for retailers, consumers and Trading Standards bodies to be able to verify the companies and brands of e-cigarettes and refill containers (e-liquids) that have been notified to MHRA or withdrawn from UK supply. Where there are more than 20 brand variants shown, click on the cell to see details of any additional brands. | These lists may be useful for retailers, consumers and Trading Standards bodies to be able to verify the companies and brands of e-cigarettes and refill containers (e-liquids) that have been notified to MHRA or withdrawn from UK supply. Where there are more than 20 brand variants shown, click on the cell to see details of any additional brands. | ||
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Under the TPD, it is the responsibility of the producer to ensure that their products comply with the TPD requirements. We check notifications submitted for completeness and verify TPD compliance with producers. Where this review has been completed, the TPD compliance status of products is recorded as ‘declared’ to indicate that the notification is complete and the product has been declared compliant by the producer. Products may be withdrawn from sale by the producer for a number of reasons including commercial changes, superseded products and compliance or safety issues. | Under the TPD, it is the responsibility of the producer to ensure that their products comply with the TPD requirements. We check notifications submitted for completeness and verify TPD compliance with producers. Where this review has been completed, the TPD compliance status of products is recorded as ‘declared’ to indicate that the notification is complete and the product has been declared compliant by the producer. Products may be withdrawn from sale by the producer for a number of reasons including commercial changes, superseded products and compliance or safety issues. | ||
Advice for producers | =Advice for producers= | ||
Putting a new product into the UK market | Putting a new product into the UK market | ||
Producers of new e-cigarette and refill container products must submit a notification to MHRA six months before they intend to put their product on the UK market. Once your notification has been published in the list on our website below, you can launch your product in the UK. If your notification has been published, you do not need to wait for the remainder of the 6 month period to elapse before you place your product on the UK market. | Producers of new e-cigarette and refill container products must submit a notification to MHRA six months before they intend to put their product on the UK market. Once your notification has been published in the list on our website below, you can launch your product in the UK. If your notification has been published, you do not need to wait for the remainder of the 6 month period to elapse before you place your product on the UK market. | ||
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If the manufacturer has submitted a UK notification for the specific product you import, then you do not need to submit a duplicate notification. Similarly, if the manufacturer has notified details of a product that you have re-branded, and your brand name is listed in the manufacturer’s notification, then you do not need to submit a duplicate notification. | If the manufacturer has submitted a UK notification for the specific product you import, then you do not need to submit a duplicate notification. Similarly, if the manufacturer has notified details of a product that you have re-branded, and your brand name is listed in the manufacturer’s notification, then you do not need to submit a duplicate notification. | ||
Manufacturers, Importers and Distributers of e-cigarettes also need to comply with the Restriction of Hazardous Substances in Electrical and Electronic Equipment Regulation 2012 (known as RoHS). These regulations limit the amount of certain hazardous substances in specific electrical equipment, of which e-cigarettes are included. They place obligations onto Manufacturers, Importers and Distributers of e-cigarette models. Details can be found here. The regulation is enforced by the Office for Product Safety and Standards, part of the Department for Business, Energy and Industrial Strategy. | Manufacturers, Importers and Distributers of e-cigarettes also need to comply with the Restriction of Hazardous Substances in Electrical and Electronic Equipment Regulation 2012 (known as RoHS). These regulations limit the amount of certain hazardous substances in specific electrical equipment, of which e-cigarettes are included. They place obligations onto Manufacturers, Importers and Distributers of e-cigarette models. Details can be found [https://www.gov.uk/guidance/rohs-compliance-and-guidance here]. The regulation is enforced by the Office for Product Safety and Standards, part of the Department for Business, Energy and Industrial Strategy. | ||
=Reporting safety concerns= | |||
E-cigarette producers must inform MHRA if they have reason to believe that a notifiable product is unsafe, not of good quality or not compliant with TPD regulations and provide details of the risk to human health and safety and any corrective action taken. E-cigarette producers should notify MHRA by email to TPDsafety@mhra.gov.uk. | E-cigarette producers must inform MHRA if they have reason to believe that a notifiable product is unsafe, not of good quality or not compliant with TPD regulations and provide details of the risk to human health and safety and any corrective action taken. E-cigarette producers should notify MHRA by email to TPDsafety@mhra.gov.uk. | ||
Trading Standards bodies have enforcement responsibilities under the legislation and MHRA works with them to ensure acceptable standards of safety. | Trading Standards bodies have enforcement responsibilities under the legislation and MHRA works with them to ensure acceptable standards of safety. | ||
Labelling and leaflets | =Labelling and leaflets= | ||
Regulation 37 of the Tobacco and Related Products Regulations 2016 sets out the requirements for labelling of e-cigarette and refill container products. For additional advice on labelling or e-liquid products read the Labelling guidance (PDF, 85.2KB, 2 pages) | [http://www.legislation.gov.uk/uksi/2016/507/regulation/37/made Regulation 37] of the Tobacco and Related Products Regulations 2016 sets out the requirements for labelling of e-cigarette and refill container products. For additional advice on labelling or e-liquid products read the [https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/520559/Labeling_Guidance.pdf Labelling guidance] (PDF, 85.2KB, 2 pages) | ||
Our interpretation of Article 20(4) of the Tobacco Products Directive (TPD) is that all ingredients in the product should be listed on the label where they are used in quantities of 0.1% or more of the final formulation of the e-liquid. Where a flavour ingredient contains several component chemicals, we consider that it is acceptable to describe the ingredient on the label by the name of the flavour, for example ‘strawberry flavour’. For confidentiality reasons companies may choose to describe individual ingredients used in quantities below 0.1% of the final formulation by category, for example ‘other flavourings’. | [http://ec.europa.eu/health/tobacco/docs/dir_201440_en.pdf Our interpretation of Article 20(4)] of the Tobacco Products Directive (TPD) is that all ingredients in the product should be listed on the label where they are used in quantities of 0.1% or more of the final formulation of the e-liquid. Where a flavour ingredient contains several component chemicals, we consider that it is acceptable to describe the ingredient on the label by the name of the flavour, for example ‘strawberry flavour’. For confidentiality reasons companies may choose to describe individual ingredients used in quantities below 0.1% of the final formulation by category, for example ‘other flavourings’. | ||
This advice only applies to product labels, and a full list of ingredients in the flavouring must be included in notifications through the EU-CEG. | This advice only applies to product labels, and a full list of ingredients in the flavouring must be included in notifications through the EU-CEG. | ||
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Where all the required leaflet information can fit on the unit pack and other labelling within the pack without loss of legibility to the consumer, our interpretation of the TPD is that the packaging can be considered to include the leaflet, and a separate leaflet insert is not required. | Where all the required leaflet information can fit on the unit pack and other labelling within the pack without loss of legibility to the consumer, our interpretation of the TPD is that the packaging can be considered to include the leaflet, and a separate leaflet insert is not required. | ||
Additional statutory labelling requirements may also apply, such as the European Regulation (EC) No 1272/2008 on classification, labelling and packaging of chemical substances (CLP). Information on CLP requirements is available from the ECHA website and the HSE website. Additional advice is available from the UK CLP Helpdesk at UKREACHCA@hse.gov.uk. | Additional statutory labelling requirements may also apply, such as the [http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32008R1272 European Regulation (EC) No 1272/2008] on classification, labelling and packaging of chemical substances (CLP). Information on CLP requirements is available from the [https://echa.europa.eu/guidance-documents/guidance-on-clp ECHA] website and the [http://www.hse.gov.uk/chemical-classification/index.htm HSE] website. Additional advice is available from the UK CLP Helpdesk at UKREACHCA@hse.gov.uk. | ||
If your e-cigarette product does not contain nicotine when sold, but can be used to contain nicotine, the warning statement ‘this product contains nicotine which is a highly addictive substance’ must still be applied. To provide clarity for consumers, we recommend adjacent wording (not part of the boxed warning) to the effect that the warning applies when the product is used as designed and charged / filled with nicotine-containing liquid. The warning statement should be included on all notified e-cigarette products. | If your e-cigarette product does not contain nicotine when sold, but can be used to contain nicotine, the warning statement ‘this product contains nicotine which is a highly addictive substance’ must still be applied. To provide clarity for consumers, we recommend adjacent wording (not part of the boxed warning) to the effect that the warning applies when the product is used as designed and charged / filled with nicotine-containing liquid. The warning statement should be included on all notified e-cigarette products. | ||
Advice for retailers | =Advice for retailers= | ||
When sourcing new supplies of any e-cigarette or e-liquid product, check that details of the notification for the product have been published in the list of Submitted Products. | |||
When sourcing new supplies of any e-cigarette or e-liquid product, check that details of the notification for the product have been published in the list of [https://www.gov.uk/guidance/e-cigarettes-regulations-for-consumer-products#submitted-products Submitted Products]. | |||
If you cannot find the product on MHRA’s website, ask your supplier to confirm that the product complies with the TPD and has been notified to MHRA. If a producer has not notified the product or it does not comply with the TPD, they may not supply it to you. | If you cannot find the product on MHRA’s website, ask your supplier to confirm that the product complies with the TPD and has been notified to MHRA. If a producer has not notified the product or it does not comply with the TPD, they may not supply it to you. | ||
See our advice for retailers setting out the key requirements (PDF, 118KB, 2 pages) | [https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/656492/Advice_for_retailers.pdf See our advice for retailers setting out the key requirements] (PDF, 118KB, 2 pages) | ||
The TPD requirements on nicotine concentration (20mg/ml maximum) and size of presentation (10ml maximum for refill container and 2ml maximum for e-cigarettes) apply to products sold to end consumers (irrespective of whether the end consumer intends to modify the product). | The TPD requirements on nicotine concentration (20mg/ml maximum) and size of presentation (10ml maximum for refill container and 2ml maximum for e-cigarettes) apply to products sold to end consumers (irrespective of whether the end consumer intends to modify the product). | ||
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Advice on the restrictions on advertising e-cigarettes and refill containers is available from the Department of Health and Social Care here and from the Advertising Standards Authority here. | Advice on the restrictions on advertising e-cigarettes and refill containers is available from the Department of Health and Social Care here and from the Advertising Standards Authority here. | ||
Are you also a producer? | =Are you also a producer?= | ||
As a retailer, you do not need to notify any products you sell unless you are also a ‘producer’ of the product. | As a retailer, you do not need to notify any products you sell unless you are also a ‘producer’ of the product. | ||