Product regulation and labelling
United Kingdom
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.
A report - Tobacco Additives: cigarette engineering and nicotine addiction - provides a comprehensive overview of the various voluntary agreements, regulations and agencies involved in the control of additives in tobacco.
European Union
Product Regulation and Labelling
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
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 is 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
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 this.
Department of Health Consultation on Tobacco Regulation Directive 2001/37/EC
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
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.
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
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.
Latest Archived Items
Review of the implementation of the European Tobacco Products Directive 2001/37/EC
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.
