Action on Smoking and Health

Tag Archives: Product regulation

Product regulation and labelling

Regulation Description
United Kingdom
Tobacco and Related Products Regulations 2016 UK regulations implementing the EU Tobacco Products Directive.
Standardised Packaging of Tobacco Products Regulations 2015 (PDF) These regulations introduced standardised plain packaging for cigarettes and hand-rolled tobacco, including removing visual brand elements and increasing the size of graphic health warnings.
Children and Families Act 2014
(External Web Page)
This Act, passed in March 2014, enabled the Government to bring in regulations to require standardised tobacco packaging. In addition it allowed for regulations to prohibit smoking in vehicles when children are present; to prohibit the purchasing of tobacco by adults for children (proxy purchasing); and to prohibit the sale of nicotine products (electronic cigarettes) to persons under the age of 18.
Tobacco Additives
UK Voluntary agreement on the use of new additives in tobacco products (Voluntary Agreement In Force)
(External Web Page)
Over 600 additives are allowed in the manufacture of tobacco products in the UK. Additives are controlled under a loose and decentralised regulatory framework.The scrutiny of the additives rests with the Department of Health and its Technical Advisory Group (TAG).

The agreement also includes mutual recognition arrangements that require additives approved in other EU countries to be permitted in the UK. This is a major loophole.

European Union
Product Regulation and Labelling
Article 20(5), Tobacco Products Directive: proposals for UK law Article 20(5) of the Tobacco Products Directive 2014/40/EC requires EU member states to introduce restrictions on the advertising of electronic cigarettes. In the UK, the proposed implementation will consist of changes to the Communications Act 2003, free-standing new regulations and changes by Ofcom (the communications regulator in the UK) to the BCAP Code and Broadcast Code.From 20 May 2016, across the EU, e-cigarettes and re-fill containers cannot be advertised or promoted, directly or indirectly: on TV or on-demand TV; on radio; through information society services (this includes for example internet advertising and commercial e-mail); and in certain printed publications-newspapers, magazines, periodicals and similar publications.
EU Advocate General’s Opinions on legal challenges to the Tobacco Products Directive. (Dec 2015)
ECJ press release (pdf)
Case C-547/14 – This case brought by the tobacco industry challenges the fundamental basis for the Directive, arguing that it is disproportionate and infringes the principle of subsidiarity.
Case C-477/14 – E-cigarette manufacturer Pillbox 38 (UK) Ltd, trading as Totally Wicked, argues that the Directive is in contravention of EU law and that it is in appropriate to apply rules banning advertising of tobacco products to electronic cigarettes.
Case C-358/14 – The Polish government is challenging the ban on menthol flavouring of cigarettes.
EU Advocate General Kokott dismissed 3 separate legal challenges to the Directive in Opinions released on 23 December 2015. Although not binding, AG Opinions help to inform the Court of Justice on the outcome of these challenges. The court is expected to make a ruling on each of these cases in March 2016.
EU Tobacco Products Directive 2014/40/EU
(External Web Page)
The Tobacco Products Directive, replacing Directive (2001/37/EC), lays down rules governing the manufacture, presentation and sale of tobacco and related products. As well as tobacco products, the Directive includes the regulation of electronic cigarettes and herbal products for smoking. Member States will be required to transpose the Directive into domestic law by 20 May 2016. See the European Commission website for further information.
The Directive:

  • prohibits cigarettes and roll-your-own tobacco with characterising flavours,
  • requires the tobacco industry to submit detailed reports to the Member States on the ingredients used in tobacco products, in particular cigarettes and roll-your-own tobacco,
  • requires that health warnings appear on packages of tobacco and related products. Combined (picture and text) health warnings must cover 65% of the front and back of cigarette and roll-your-own tobacco packages,
  • sets minimum dimensions for warnings and eliminates small packages for certain tobacco products,
  • bans all promotional and misleading elements on tobacco products,
  • enables Member States to introduce standardised tobacco packaging,
  • introduces EU-wide tracking and tracing to combat illicit trade of tobacco products,
  • allows Member States to prohibit internet sales of tobacco and related products,
  • sets out safety and quality requirements for consumer electronic cigarettes,
  • obliges manufacturers to notify novel tobacco products before placing them on the EU market

Technical specifications for the layout, design and shape of the combined health warnings.

Report summarising the public consultation on the revision of the Tobacco Products Directive. July 2011
(external link)

EU Tobacco Products Directive
(external link)
Council Directive 2001/37/EC incorporates measures from directive 92/41/EC, which bans the sale of oral tobacco in the EC countries with the exception of Sweden.The tobacco product directive introduced a range of measures relating to the formulation of cigarettes and their packaging. The directive required:

  • new, large, written warnings to appear on the front and back of tobacco packaging.
  • maximum yields for tar, nicotine and carbon monoxide
  • the banning of misleading descriptors such as “light” or “mild”
  • the disclosure of ingredients
  • a review of the directive
  • and enabled Member States to add picture warnings to tobacco packaging
EU Council Directive 2001/37/EC (In Force)
(External Web Page)
This directive replaces two previous directives on labelling (see 89/622/EEC, 92/41/EC) and tar levels (90/239/EEC).Directive 2001/37/EC requires a range of measures to be taken by manufacturers of tobacco products such as dedicating more surface area to health warnings on tobacco product packaging, the proscribing of misleading descriptors such as ‘mild’, ‘low-tar’, ’light’, ‘ultra-low’ and setting ceilings to the yields of tar (10mg), nicotine (1mg) and carbon monoxide (10mg) for all cigarettes manufactured within the community irrespective of whether for consumption or export.

Council Directive 2001/37/EC also incorporates measure from directive 92/41/EC, which bans the sale of oral tobacco in the EU countries with the exemption of Sweden.

The European Commission is required to carry out a review of the Directive every two years. The first review, due in December 2004 was delayed until July 2005. The second review is due in December 2007.

Time-table for implementation of Council Directive 2001/37/EC measures was as follows:

30 Sept 2002: New warnings on packs

31 Dec 2002: Picture specifications proposed by the Commission – delayed until late 2005

31 Dec 2002: Ingredients disclosure

30 Sept 2003: Branding – misleading descriptors etc banned

1 Jan 2004 : Max tar, nicotine, CO yields to apply

31 Dec 2004: First review of the directive was due. This was delayed until July 2005

31 Dec 2004: Commission proposal for common ingredients list – delayed due to lack of agreement on data collection

1 Jan 2007: Max yields applied to exports

Annex 1. Revised set of written health warnings Member States have until 28 March 2014 to implement the changes.
Statutory Instrument 2007 no. 2473 Tobacco Products (Manufacture, Presentation and Sale) (Safety) (Amendment) Regulations 2007 (Picture warnings)
Statutory Instrument 2002 N. 3041 (External Web Page) Consumer Protection. The Tobacco Products (Manufacture, Presentation and Sale) (Safety) Regulations 2002 Statutory Instrument 2002 N. 3041 implements the Directive.
Department of Health Consultation on Tobacco Regulation Directive 2001/37/EC (pdf)
Consultation on the Tobacco Products Manufacture, Presentation and Sale (Safety) Regulations 2002 implementing Directive 2001/37/EC of the European Parliament and the Council concerning the Manufacture, Presentation and Sale of Tobacco Products.
Summary of submissions to Department of Health Tobacco Regulation Directive 2001/37/EC (pdf)
Submissions received to the Department of Health Consultation on Tobacco Regulation Directive 2001/37/EC
Opinion by the Advocate General
(External Web Page)
The Directive 2001/37/EC was subject to a challenge by British American Tobacco over the proscription of descriptors such as ‘mild’ and ‘light’. However, on 10 September 2002 opinion by the Advocate General declared provisions contained in the directive 2001/37/EC as valid.
Press release by Advocate General
(External Web Page)
Press release by the Advocate General around Directive 2001/37/EC.
ECJ Ruling C-491/01
(External Web Page)
10 December 2002 a ruling by the High Court of Justice of England and Wales. This ruling deemed the banning of descriptors for tobacco product intended for the European market as valid. Tobacco products for export, however, are exempt from the restrictions on descriptors.
The provisions of the directive enter force over several years – this means that previous UK statutory instruments implementing the EC directives still stand until they are superseded. The remaining instrument still in force is Part of Council Directive 92/41/EEC (ban on oral tobacco) is implemented in England by UK Statutory Instrument 1992 No 3134 as the Tobacco for Oral Use (Safety) Regulations 1992.
UK Statutory Instrument 1992 No 3134
(External Web Page)
The Tobacco for Oral Use (Safety) Regulations 1992
European Commission first report on the application of the Tobacco Products Directive 2001/37/EC (pdf)
The report is based on the feedback from Member States. The Report demonstrates the positive effects of the regulation of tobacco products emerging at EU level.
Review of the implementation of the European Tobacco Products Directive 2001/37/EC (pdf)
The report makes the following observations:

  • Maximum tar/nicotine/CO yields: All 15 EU countries complied with the deadline. The accession countries did not request transitional periods for compliance.
  • Measurement of tar, nicotine and carbon monoxide levels: The Commission acknowledges that the use of machines to measure yields does not reflect actual smoker intake of these substances. However, the Commission is not proposing to revise the current standards until “solid evidence shows that better methods exist to replace them”.
  • Labelling: Implementation overall is satisfactory but there have been reports of industry attempts to circumvent the legislation by attempting to hide the warnings, e.g. by the placing of cardboard covers or stickers over the warnings. However such practices are now limited. Evidence suggests that the large warnings are having an impact, with smokers being more motivated to quit smoking. The warnings appear to have been particularly effective among 15-24 year olds.
  • Ingredients: There has been little progress in developing a proposal for a common list of ingredients. The Commission argues that the WHO should co-ordinate regulatory efforts through the Framework Convention on Tobacco Control.
Tobacco Additives
Consultation on tobacco additives
(External Web Page)
Results of the public consultation on the addictiveness and attractiveness of tobacco additives. 

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